Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions-Fall 2022

AGENCY:

Regulatory Information Service Center.

ACTION:

Introduction to the Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions.

SUMMARY:

Publication of the Fall 2022 Unified Agenda of Federal Regulatory and Deregulatory Actions represents a key component of the regulatory planning mechanism prescribed in Executive Order (“E.O.”) 12866, “Regulatory Planning and Review,” (58 FR 51735) and reaffirmed in E.O. 13563, “Improving Regulation and Regulatory Review,” (76 FR 3821). The Regulatory Flexibility Act requires that agencies publish semiannual regulatory agendas in the Federal Register describing regulatory actions they are developing that may have a significant economic impact on a substantial number of small entities (5 U.S.C. 602).

The Unified Agenda of Regulatory and Deregulatory Actions (Unified Agenda), published in the fall and spring, helps agencies fulfill all of these requirements. All federal regulatory agencies have chosen to publish their regulatory agendas as part of this publication. The complete Unified Agenda and Regulatory Plan can be found online at www.reginfo.gov and a reduced print version can be found in the Federal Register . Information regarding obtaining printed copies can also be found on the Reginfo.gov website (or below, VI. How Can Users Get Copies of the Plan and the Agenda?).

The Fall 2022 Unified Agenda publication appearing in the Federal Register includes the Regulatory Plan and agency regulatory flexibility agendas, in accordance with the publication requirements of the Regulatory Flexibility Act. Agency regulatory flexibility agendas contain only those Agenda entries for rules that are likely to have a significant economic impact on a substantial number of small entities and entries that have been selected for periodic review under section 610 of the Regulatory Flexibility Act.

The complete Fall 2022 Unified Agenda contains the Regulatory Plans of 29 Federal agencies and 67 Federal agency regulatory agendas.

ADDRESSES:

Regulatory Information Service Center (MV), General Services Administration, 1800 F Street NW, Washington, DC 20405.

FOR FURTHER INFORMATION CONTACT:

For further information about specific regulatory actions, please refer to the agency contact listed for each entry. To provide comment on or to obtain further information about this publication, contact: Boris Arratia, Director, Regulatory Information Service Center (MV), General Services Administration, 1800 F Street NW, Washington, DC 20405, 703-795-0816. You may also send comments to us by email at: RISC@gsa.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

Introduction to the Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions

I. What are the Regulatory Plan and the Unified Agenda?

II. Why are the Regulatory Plan and the Unified Agenda published?

III. How are the Regulatory Plan and the Unified Agenda organized?

IV. What information appears for each entry?

V. Abbreviations

VI. How can users get copies of the Plan and the Agenda?

Introduction to the Fall 2022 Regulatory Plan

Agency Regulatory Plans

Cabinet Departments

Department of Agriculture

Department of Commerce

Department of Defense

Department of Education

Department of Energy

Department of Health and Human Services

Department of Homeland Security

Department of Housing and Urban Development

Department of the Interior

Department of Justice

Department of Labor

Department of Transportation

Department of the Treasury

Department of Veterans Affairs

Other Executive Agencies

Corporation for National and Community Service

Environmental Protection Agency

General Services Administration

National Aeronautics and Space Administration

National Archives and Records Administration

National Science Foundation

Office of Personnel Management

Pension Benefit Guaranty Corporation

Small Business Administration

Social Security Administration

Department of Defense/General Services Administration/National Aeronautics and Space Administration (Federal Acquisition Regulation)

Independent Regulatory Agencies

Consumer Product Safety Commission

Federal Trade Commission

National Indian Gaming Commission

Nuclear Regulatory Commission

Regulatory Flexibility Agendas

Cabinet Departments

Department of Agriculture

Department of Commerce

Department of Defense

Department of Education

Department of Energy

Department of Health and Human Services

Department of Homeland Security

Department of the Interior

Department of Justice

Department of Labor

Department of Transportation

Department of the Treasury

Other Executive Agencies

Environmental Protection Agency

General Services Administration

Office of Personnel Management

Small Business Administration

Joint Authority

Department of Defense/General Services Administration/National Aeronautics and Space Administration (Federal Acquisition Regulation)

Independent Regulatory Agencies

Consumer Financial Protection Bureau

Consumer Product Safety Commission

Federal Communications Commission

Federal Reserve System

National Labor Relations Board

Nuclear Regulatory Commission

Securities and Exchange Commission

Surface Transportation Board

Introduction to the Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions

I. What are the Regulatory Plan and the Unified Agenda?

The Regulatory Plan serves as a defining statement of the Administration's regulatory and deregulatory policies and priorities. The Plan is part of the fall edition of the Unified Agenda. Each participating agency's regulatory plan contains: (1) A narrative statement of the agency's regulatory and deregulatory priorities, and, for the most part; and (2) a description of the most important significant regulatory and deregulatory actions that the agency reasonably expects to issue in proposed or final form during the upcoming fiscal year. This edition includes the regulatory plans of 29 agencies.

The Unified Agenda provides information about regulations that the Government is considering or reviewing. The Unified Agenda has appeared in the Federal Register twice each year since 1983 and has been available online since 1995. The complete Unified Agenda is available to the public at www.reginfo.gov. The online Unified Agenda offers flexible search tools and access to the historic Unified Agenda database to1995. The complete online edition of the Unified Agenda includes regulatory agendas from 65 Federal agencies. Agencies of the United States Congress are not included.

The Fall 2022 Unified Agenda publication appearing in the Federal Register consists of the Regulatory Plan and agency regulatory flexibility agendas, in accordance with the publication requirements of the Regulatory Flexibility Act. Agency regulatory flexibility agendas contain only those Agenda entries for rules that are likely to have a significant economic impact on a substantial number of small entities and entries that have been selected for periodic review under section 610 of the Regulatory Flexibility Act. Printed entries display only the fields required by the Regulatory Flexibility Act. Complete agenda information for those entries appears, in a uniform format, in the online Unified Agenda at http://reginfo.gov.

The regulatory agendas for agencies not publishing Regulatory flexibility agendas are available to the public at http://reginfo.gov.

Cabinet Departments

Department of Housing and Urban Development*

Department of State

Department of Veterans Affairs*

Other Executive Agencies

Agency for International Development

Architectural and Transportation Barriers Compliance Board

Committee for Purchase From People Who Are Blind or Severely Disabled

Commission on Civil Rights

Corporation for National and Community Service*

Council on Environmental Quality

Court Services and Offender Supervision Agency for the District of Columbia

Federal Mediation Conciliation Service

Institute of Museum and Library Services

Inter-American Foundation

National Aeronautics and Space Administration*

National Archives and Records Administration*

National Endowment for the Arts

National Endowment for the Humanities

National Mediation Board

National Science Foundation*

Office of Government Ethics

Office of the Intellectual Property Enforcement Coordinator

Office of Management and Budget

Office of National Drug Control Policy

Peace Corps

Pension Benefit Guaranty Corporation*

Railroad Retirement Board*

Social Security Administration*

U.S. Agency for Global Media

U.S. Commission on Civil Rights

Independent Agencies

Commodity Futures Trading Commission

Farm Credit Administration

Federal Deposit Insurance Corporation

Federal Energy Regulatory Commission

Federal Housing Finance Agency

Federal Maritime Commission

Federal Mine Safety and Health Review Commission

Federal Permitting Improvement Steering Council

Federal Trade Commission*

National Credit Union Administration

National Indian Gaming Commission*

National Transportation Safety Board

Postal Regulatory Commission

The Regulatory Information Service Center compiles the Unified Agenda for the Office of Information and Regulatory Affairs (OIRA), part of the Office of Management and Budget. OIRA is responsible for overseeing the Federal Government's regulatory, paperwork, and information resource management activities, including implementation of Executive Order 12866 (incorporated in Executive Order 13563). The Center also provides information about Federal regulatory activity to the President and his Executive Office, the Congress, agency officials, and the public.

The activities included in the Agenda are, in general, those that will have a regulatory action within the next 12 months. Agencies may choose to include activities that will have a longer timeframe than 12 months. Agency agendas also show actions or reviews completed or withdrawn since the last Unified Agenda. Executive Order 12866 does not require agencies to include regulations concerning military or foreign affairs functions or regulations related to agency organization, management, or personnel matters.

Agencies prepared entries for this publication to give the public notice of their plans to review, propose, and issue regulations. They have tried to predict their activities over the next 12 months as accurately as possible, but dates and schedules are subject to change. Agencies may withdraw some of the regulations now under development, and they may issue or propose other regulations not included in their agendas. Agency actions in the rulemaking process may occur before or after the dates they have listed. The Regulatory Plan and Unified Agenda do not create a legal obligation on agencies to adhere to schedules in this publication or to confine their regulatory activities to those regulations that appear within it.

II. Why are the Regulatory Plan and the Unified Agenda published?

The Regulatory Plan and the Unified Agenda helps agencies comply with their obligations under the Regulatory Flexibility Act and various Executive orders and other statutes.

Regulatory Flexibility Act

The Regulatory Flexibility Act requires agencies to identify those rules that may have a significant economic impact on a substantial number of small entities (5 U.S.C. 602). Agencies meet that requirement by including the information in their submissions for the Unified Agenda. Agencies may also indicate those regulations that they are reviewing as part of their periodic review of existing rules under the Regulatory Flexibility Act (5 U.S.C. 610). Executive Order 13272, “Proper Consideration of Small Entities in Agency Rulemaking,” signed August 13, 2002 (67 FR 53461), provides additional guidance on compliance with the Act.

Executive Order 12866

Executive Order 12866, “Regulatory Planning and Review,” September 30, 1993 (58 FR 51735), requires covered agencies to prepare an agenda of all regulations under development or review. The Order also requires that certain agencies prepare annually a regulatory plan of their “most important significant regulatory actions,” which appears as part of the fall Unified Agenda. Executive Order 13497, signed January 30, 2009 (74 FR 6113), revoked the amendments to Executive Order 12866 that were contained in Executive Order 13258 and Executive Order 13422.

Executive Order 13563

Executive Order 13563, “Improving Regulation and Regulatory Review,” January 18, 2011 (76 FR 3821) supplements and reaffirms the principles, structures, and definitions governing contemporary regulatory review that were established in Executive Order 12866, which includes the general principles of regulation and public participation, and orders integration and innovation in coordination across agencies; flexible approaches where relevant, feasible, and consistent with regulatory approaches; scientific integrity in any scientific or technological information and processes used to support the agencies' regulatory actions; and retrospective analysis of existing regulations.

Executive Order 13132

Executive Order 13132, “Federalism,” August 4, 1999 (64 FR 43255), directs agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have “federalism implications” as defined in the Order. Under the Order, an agency that is proposing a regulation with federalism implications, which either preempt State law or impose non-statutory unfunded substantial direct compliance costs on State and local governments, must consult with State and local officials early in the process of developing the regulation. In addition, the agency must provide to the Director of the Office of Management and Budget a federalism summary impact statement for such a regulation, which consists of a description of the extent of the agency's prior consultation with State and local officials, a summary of their concerns and the agency's position supporting the need to issue the regulation, and a statement of the extent to which those concerns have been met. As part of this effort, agencies include in their submissions for the Unified Agenda information on whether their regulatory actions may have an effect on the various levels of government and whether those actions have federalism implications.

Unfunded Mandates Reform Act of 1995

The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, title II) requires agencies to prepare written assessments of the costs and benefits of significant regulatory actions “that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any 1 year.” The requirement does not apply to independent regulatory agencies, nor does it apply to certain subject areas excluded by section 4 of the Act. Affected agencies identify in the Unified Agenda those regulatory actions they believe are subject to title II of the Act.

Executive Order 13211

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” May 18, 2001 (66 FR 28355), directs agencies to provide, to the extent possible, information regarding the adverse effects that agency actions may have on the supply, distribution, and use of energy. Under the Order, the agency must prepare and submit a Statement of Energy Effects to the Administrator of the Office of Information and Regulatory Affairs, Office of Management and Budget, for “those matters identified as significant energy actions.” As part of this effort, agencies may optionally include in their submissions for the Unified Agenda information on whether they have prepared or plan to prepare a Statement of Energy Effects for their regulatory actions.

Small Business Regulatory Enforcement Fairness Act

The Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121, title II) established a procedure for congressional review of rules (5 U.S.C. 801 et seq.), which defers, unless exempted, the effective date of a “major” rule for at least 60 days from the publication of the final rule in the Federal Register . The Act specifies that a rule is “major” if it has resulted, or is likely to result, in an annual effect on the economy of $100 million or more or meets other criteria specified in that Act. The Act provides that the Administrator of OIRA will make the final determination as to whether a rule is major.

III. How are the Regulatory Plan and the Unified Agenda organized?

The Regulatory Plan appears in part II in a daily edition of the Federal Register . The Plan is a single document beginning with an introduction, followed by a table of contents, followed by each agency's section of the Plan. Following the Plan in the Federal Register , as separate parts, are the regulatory flexibility agendas for each agency whose agenda includes entries for rules which are likely to have a significant economic impact on a substantial number of small entities or rules that have been selected for periodic review under section 610 of the Regulatory Flexibility Act. Each printed agenda appears as a separate part. The sections of the Plan and the parts of the Unified Agenda are organized alphabetically in four groups: Cabinet departments; other executive agencies; the Federal Acquisition Regulation, a joint authority (Agenda only); and independent regulatory agencies. Agencies may in turn be divided into subagencies. Each printed agency agenda has a table of contents listing the agency's printed entries that follow. Each agency's part of the Agenda contains a preamble providing information specific to that agency. Each printed agency agenda has a table of contents listing the agency's printed entries that follow.

Each agency's section of the Plan contains a narrative statement of regulatory priorities and, for most agencies, a description of the agency's most important significant regulatory and deregulatory actions. Each agency's part of the Agenda contains a preamble providing information specific to that agency plus descriptions of the agency's regulatory and deregulatory actions.

The online, complete Unified Agenda contains the preambles of all participating agencies. Unlike the printed edition, the online Agenda has no fixed ordering. In the online Agenda, users can select the particular agencies' agendas they want to see. Users have broad flexibility to specify the characteristics of the entries of interest to them by choosing the desired responses to individual data fields. To see a listing of all of an agency's entries, a user can select the agency without specifying any particular characteristics of entries.

Each entry in the Agenda is associated with one of five rulemaking stages. The rulemaking stages are:

1. Prerule Stage —actions agencies will undertake to determine whether or how to initiate rulemaking. Such actions occur prior to a Notice of Proposed Rulemaking (NPRM) and may include Advance Notices of Proposed Rulemaking (ANPRMs) and reviews of existing regulations.

2. Proposed Rule Stage —actions for which agencies plan to publish a Notice of Proposed Rulemaking as the next step in their rulemaking process or for which the closing date of the NPRM Comment Period is the next step.

3. Final Rule Stage —actions for which agencies plan to publish a final rule or an interim final rule or to take other final action as the next step.

4. Long-Term Actions —items under development but for which the agency does not expect to have a regulatory action within the 12 months after publication of this edition of the Unified Agenda. Some of the entries in this section may contain abbreviated information.

5. Completed Actions —actions or reviews the agency has completed or withdrawn since publishing its last agenda. This section also includes items the agency began and completed between issues of the Agenda.

6. Long-Term Actions —are rulemakings reported during the publication cycle that are outside of the required 12-month reporting period for which the Agenda was intended. Completed Actions in the publication cycle are rulemakings that are ending their lifecycle either by Withdrawal or completion of the rulemaking process. Therefore, the Long-Term and Completed RINs do not represent the ongoing, forward-looking nature intended for reporting developing rulemakings in the Agenda pursuant to Executive Order 12866, section 4(b) and 4(c). To further differentiate these two stages of rulemaking in the Unified Agenda from active rulemakings, Long-Term and Completed Actions are reported separately from active rulemakings, which can be any of the first three stages of rulemaking listed above. A separate search function is provided on www.reginfo.gov to search for Completed and Long-Term Actions apart from each other and active RINs.

A bullet (•) preceding the title of an entry indicates that the entry is appearing in the Unified Agenda for the first time.

In the printed edition, all entries are numbered sequentially from the beginning to the end of the publication. The sequence number preceding the title of each entry identifies the location of the entry in this edition. The sequence number is used as the reference in the printed table of contents. Sequence numbers are not used in the online Unified Agenda because the unique Regulation Identifier Number (RIN) is able to provide this cross-reference capability.

Editions of the Unified Agenda prior to fall 2007 contained several indexes, which identified entries with various characteristics. These included regulatory actions for which agencies believe that the Regulatory Flexibility Act may require a Regulatory Flexibility Analysis, actions selected for periodic review under section 610(c) of the Regulatory Flexibility Act, and actions that may have federalism implications as defined in Executive Order 13132 or other effects on levels of government. These indexes are no longer compiled, because users of the online Unified Agenda have the flexibility to search for entries with any combination of desired characteristics. The online edition retains the Unified Agenda's subject index based on the Federal Register Thesaurus of Indexing Terms. In addition, online users have the option of searching Agenda text fields for words or phrases.

IV. What information appears for each entry?

All entries in the online Unified Agenda contain uniform data elements including, at a minimum, the following information:

Title of the Regulation —a brief description of the subject of the regulation. In the printed edition, the notation “Section 610 Review” following the title indicates that the agency has selected the rule for its periodic review of existing rules under the Regulatory Flexibility Act (5 U.S.C. 610(c)). Some agencies have indicated completions of section 610 reviews or rulemaking actions resulting from completed section 610 reviews. In the online edition, these notations appear in a separate field.

Priority —an indication of the significance of the regulation. Agencies assign each entry to one of the following five categories of significance.

(1) Economically Significant

As defined in Executive Order 12866, a rulemaking action that will have an annual effect on the economy of $100 million or more or will adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. The definition of an “economically significant” rule is similar but not identical to the definition of a “major” rule under 5 U.S.C. 801 (Pub. L. 104-121). (See below.)

(2) Other Significant

A rulemaking that is not Economically Significant but is considered Significant by the agency. This category includes rules that the agency anticipates will be reviewed under Executive Order 12866 or rules that are a priority of the agency head. These rules may or may not be included in the agency's regulatory plan.

(3) Substantive, Nonsignificant

A rulemaking that has substantive impacts, but is neither Significant, nor Routine and Frequent, nor Informational/Administrative/Other.

(4) Routine and Frequent

A rulemaking that is a specific case of a multiple recurring application of a regulatory program in the Code of Federal Regulations and that does not alter the body of the regulation.

(5) Informational/Administrative/Other

A rulemaking that is primarily informational or pertains to agency matters not central to accomplishing the agency's regulatory mandate but that the agency places in the Unified Agenda to inform the public of the activity.

Major —whether the rule is “major” under 5 U.S.C. 801 (Pub. L. 104-121) because it has resulted or is likely to result in an annual effect on the economy of $100 million or more or meets other criteria specified in that Act. The Act provides that the Administrator of the Office of Information and Regulatory Affairs will make the final determination as to whether a rule is major.

Unfunded Mandates —whether the rule is covered by section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). The Act requires that, before issuing an NPRM likely to result in a mandate that may result in expenditures by State, local, and tribal governments, in the aggregate, or by the private sector of more than $100 million in 1 year, agencies, other than independent regulatory agencies, shall prepare a written statement containing an assessment of the anticipated costs and benefits of the Federal mandate.

Legal Authority —the section(s) of the United States Code (U.S.C.) or Public Law (Pub. L.) or the Executive order (E.O.) that authorize(s) the regulatory action. Agencies may provide popular name references to laws in addition to these citations.

CFR Citation —the section(s) of the Code of Federal Regulations that will be affected by the action.

Legal Deadline —whether the action is subject to a statutory or judicial deadline, the date of that deadline, and whether the deadline pertains to an NPRM, a Final Action, or some other action.

Abstract —a brief description of the problem the regulation will address; the need for a Federal solution; to the extent available, alternatives that the agency is considering to address the problem; and potential costs and benefits of the action.

Timetable —the dates and citations (if available) for all past steps and a projected date for at least the next step for the regulatory action. A date displayed in the form 12/00/19 means the agency is predicting the month and year the action will take place but not the day it will occur. In some instances, agencies may indicate what the next action will be, but the date of that action is “To Be Determined.” “Next Action Undetermined” indicates the agency does not know what action it will take next.

Regulatory Flexibility Analysis Required —whether an analysis is required by the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) because the rulemaking action is likely to have a significant economic impact on a substantial number of small entities as defined by the Act.

Small Entities Affected —the types of small entities (businesses, governmental jurisdictions, or organizations) on which the rulemaking action is likely to have an impact as defined by the Regulatory Flexibility Act. Some agencies have chosen to indicate likely effects on small entities even though they believe that a Regulatory Flexibility Analysis will not be required.

Government Levels Affected —whether the action is expected to affect levels of government and, if so, whether the governments are State, local, tribal, or Federal.

International Impacts —whether the regulation is expected to have international trade and investment effects, or otherwise may be of interest to the Nation's international trading partners.

Federalism —whether the action has “federalism implications” as defined in Executive Order 13132. This term refers to actions “that have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Independent regulatory agencies are not required to supply this information.

Included in the Regulatory Plan —whether the rulemaking was included in the agency's current regulatory plan.

Agency Contact —the name and phone number of at least one person in the agency who is knowledgeable about the rulemaking action. The agency may also provide the title, address, fax number, email address, and TDD for each agency contact.

Some agencies have provided the following optional information:

RIN Information URL —the internet address of a site that provides more information about the entry.

Public Comment URL —the internet address of a site that will accept public comments on the entry.

Alternatively, timely public comments may be submitted at the Governmentwide e-rulemaking site, www.regulations.gov.

Additional Information —any information an agency wishes to include that does not have a specific corresponding data element.

Compliance Cost to the Public —the estimated gross compliance cost of the action.

Affected Sectors —the industrial sectors that the action may most affect, either directly or indirectly. Affected sectors are identified by North American Industry Classification System (NAICS) codes.

Energy Effects —an indication of whether the agency has prepared or plans to prepare a Statement of Energy Effects for the action, as required by Executive Order 13211 “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” signed May 18, 2001 (66 FR 28355).

Related RINs —one or more past or current RIN(s) associated with activity related to this action, such as merged RINs, split RINs, new activity for previously completed RINs, or duplicate RINs.

Statement of Need —a description of the need for the regulatory action.

Summary of the Legal Basis —a description of the legal basis for the action, including whether any aspect of the action is required by statute or court order.

Alternatives —a description of the alternatives the agency has considered or will consider as required by section 4(c)(1)(B) of Executive Order 12866.

Anticipated Costs and Benefits —a description of preliminary estimates of the anticipated costs and benefits of the action.

Risks —a description of the magnitude of the risk the action addresses, the amount by which the agency expects the action to reduce this risk, and the relation of the risk and this risk reduction effort to other risks and risk reduction efforts within the agency's jurisdiction.

V. Abbreviations

The following abbreviations appear throughout this publication:

ANPRM —An Advance Notice of Proposed Rulemaking is a preliminary notice, published in the Federal Register , announcing that an agency is considering a regulatory action. An agency may issue an ANPRM before it develops a detailed proposed rule. An ANPRM describes the general area that may be subject to regulation and usually asks for public comment on the issues and options being discussed. An ANPRM is issued only when an agency believes it needs to gather more information before proceeding to a notice of proposed rulemaking.

CFR —The Code of Federal Regulations is an annual codification of the general and permanent regulations published in the Federal Register by the agencies of the Federal Government. The Code is divided into 50 titles, each title covering a broad area subject to Federal regulation. The CFR is keyed to and kept up to date by the daily issues of the Federal Register .

E.O. —An Executive order is a directive from the President to Executive agencies, issued under constitutional or statutory authority. Executive orders are published in the Federal Register and in title 3 of the Code of Federal Regulations.

FR —The Federal Register is a daily Federal Government publication that provides a uniform system for publishing Presidential documents, all proposed and final regulations, notices of meetings, and other official documents issued by Federal agencies.

FY —The Federal fiscal year runs from October 1 to September 30.

NPRM —A Notice of Proposed Rulemaking is the document an agency issues and publishes in the Federal Register that describes and solicits public comments on a proposed regulatory action. Under the Administrative Procedure Act (5 U.S.C. 553), an NPRM must include, at a minimum: A statement of the time, place, and nature of the public rulemaking proceeding.

Legal Authority —A reference to the legal authority under which the rule is proposed; and either the terms or substance of the proposed rule or a description of the subjects and issues involved.

Pub. L. —A public law is a law passed by Congress and signed by the President or enacted over his veto. It has general applicability, unlike a private law that applies only to those persons or entities specifically designated. Public laws are numbered in sequence throughout the 2-year life of each Congress; for example, Public Law 112-4 is the fourth public law of the 112th Congress.

RFA —A Regulatory Flexibility Analysis is a description and analysis of the impact of a rule on small entities, including small businesses, small governmental jurisdictions, and certain small not-for-profit organizations. The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires each agency to prepare an initial RFA for public comment when it is required to publish an NPRM and to make available a final RFA when the final rule is published, unless the agency head certifies that the rule would not have a significant economic impact on a substantial number of small entities.

RIN —The Regulation Identifier Number is assigned by the Regulatory Information Service Center to identify each regulatory action listed in the Regulatory Plan and the Unified Agenda, as directed by Executive Order 12866 (section 4(b)). Additionally, OMB has asked agencies to include RINs in the headings of their Rule and Proposed Rule documents when publishing them in the Federal Register , to make it easier for the public and agency officials to track the publication history of regulatory actions throughout their development.

Seq. No. —The sequence number identifies the location of an entry in the printed edition of the Regulatory Plan and the Unified Agenda. Note that a specific regulatory action will have the same RIN throughout its development but will generally have different sequence numbers if it appears in different printed editions of the Unified Agenda. Sequence numbers are not used in the online Unified Agenda.

U.S.C. —The United States Code is a consolidation and codification of all general and permanent laws of the United States. The U.S.C. is divided into 50 titles, each title covering a broad area of Federal law.

VI. How can users get copies of the Plan and the Agenda?

Copies of the Federal Register issue containing the printed edition of The Regulatory Plan and the Unified Agenda (agency regulatory flexibility agendas) are available from the Superintendent of Documents, U.S. Government Publishing Office, P.O. Box 371954, Pittsburgh, PA 15250-7954. Telephone: (202) 512-1800 or 1-866-512-1800 (toll-free).

Copies of individual agency materials may be available directly from the agency or may be found on the agency's website. Please contact the particular agency for further information.

All editions of The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions since fall 1995 are available in electronic form at www.reginfo.gov, along with flexible search tools.

The Government Publishing Office's GPO GovInfo website contains copies of the Agendas and Regulatory Plans that have been printed in the Federal Register . These documents are available at www.govinfo.gov.

Introduction to the Fall 2022 Regulatory Plan

Executive Order 12866, issued in 1993, requires the annual production of a Unified Regulatory Agenda and Regulatory Plan. It does so in order to promote transparency—or in the words of the Executive Order itself, “to have an effective regulatory program, to provide for coordination of regulations, to maximize consultation and the resolution of potential conflicts at an early stage, to involve the public and its State, local, and tribal officials in regulatory planning, and to ensure that new or revised regulations promote the President's priorities and the principles set forth in this Executive order.” The requirements of Executive Order 12866 were reaffirmed in Executive Order 13563, issued in 2011.

We are now providing the Fall 2022 Regulatory Plan. The regulatory plans and agendas submitted by agencies and included here offer a window into how the Administration plans to continue delivering on the President's agenda to advance economic prosperity and equity, tackle the climate crisis, advance public health, and much more to improve the lives of the American people. Agencies will also be continuing their work to implement landmark new legislation passed in 2022, including the implementation of the PACT Act, (Pub. L. 117-168); the Inflation Reduction Act, (Pub. L. 117-169); and the CHIPS and Science Act, (Pub. L. 117-167); as well as ongoing efforts to implement the Infrastructure Investment and Jobs Act (Bipartisan Infrastructure Law), Pub. L. 117-58.

DEPARTMENT OF AGRICULTURE

Statement of Regulatory Priorities

The U.S. Department of Agriculture's (USDA) fall 2022 Regulatory Agenda and Plan prioritizes initiatives fostering 21st century innovation like delivering broadband to farmers, ranchers, small businesses, and rural communities, addressing the effects of climate change such as drought and wildfire risks via climate-smart agriculture, expanding economic and market opportunity at home and abroad, job creation, improving access and delivery of our programs, particularly among historically underserved people and communities, and tackling food and nutrition insecurity while maintaining a safe food supply. Meanwhile, as we've responded to immediate needs during the past two years, USDA will continue to leverage our existing programs in response to those unforeseen domestic and international events and national emergencies that impact the American farm economy, schools, individual households, and our National Forests. Finally, we note that all USDA programs, including the priorities contained in this Regulatory Plan, will be structured to advance the cause of equity by removing barriers and opening new opportunities.

In 2022, the USDA:

Risk Management Agency implemented the Pandemic Cover Crop Program that reduced crop insurance premiums for agricultural producers to help them maintain cover crop systems, an important conservation practice, while keeping producers eligible for a premium benefit under the program.

Food and Nutrition Service (FNS) implemented a final rule that establishes Standards for Milk, Whole Grains, and Sodium in its Child Nutrition Programs for school years 2022-2023 and 2023-2024 to give schools time to transition in the short term as FNS works to develop long-term nutrition standards—based on the newest Dietary Guidelines for America and extensive input from a wide range of partners—that will work for schools, families, and industry alike. In 2022, FNS also implemented streamlining requirements in its Child Nutrition Programs to simplify the application process, enhance monitoring requirements, offer more clarity on existing requirements, and provide more discretion at the State agency level to manage program operations.

In late 2022, USDA plans to announce Phase 2 of the Emergency Relief Program that provides assistance to producers who suffered crop losses due to qualifying disaster events, and the Pandemic Assistance Revenue Program, a new program that provides support for agricultural producers impacted by the COVID-19 pandemic. In addition, this action makes changes to the Coronavirus Food Assistance Program; the Emergency Conservation Program; the Emergency Assistance for Livestock, Honeybees, and Farm-Raised Fish Program; the Livestock Forage Disaster Program; the Livestock Indemnity Program; the Noninsured Crop Disaster Assistance Program; and general payment eligibility provisions. For more information about this rule, see RIN 0503-AA75.

Outlined below are some of USDA's most important upcoming regulatory actions for 2023. These include efforts to restore and expand economic opportunity; address the climate crisis; and support agricultural markets that are free, open and promote competition. This Regulatory Plan also reflects USDA's continued commitments to ensuring a safe and nutritious food supply and animal welfare protections. As always, our Semiannual Regulatory Agenda contains information on a broad-spectrum of USDA's initiatives and upcoming regulatory actions.

Combat Climate Change To Support America's Working Lands, Natural Resources and Communities

Special Areas; Roadless Area Conservation; National Forest System Lands in Alaska: In November 2021, USDA proposed to repeal a final rule promulgated in 2020 that exempted the Tongass National Forest from the 2001 Roadless Area Conservation Rule (2001 Roadless Rule). The 2001 Roadless Rule prohibited timber harvest and road construction or reconstruction within designated Inventoried Roadless Areas, with limited exceptions. USDA is planning to finalize this proposed rule in a manner consistent with President Biden's Executive Order 13990, Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis, directing review of Federal regulations issued during the previous four years that may conflict with protecting the environment, and in support of efforts to confront the climate crisis. For more information about this rule, see RIN 0596-AD51.

Foster an Equitable and Competitive Marketplace for All Agricultural Producers

Inclusive Competition and Market Integrity Rules Under the Packers and Stockyards Act: In October 2022, USDA proposed to revise regulations under the Packers and Stockyards (P&S) Act, prohibiting certain prejudices and disadvantages and unjustly discriminatory conduct against covered producers in the livestock, meat, and poultry markets. The proposal identified retaliatory practices that interfere with lawful communications, assertion of rights, and participation in associations, among other protected activities. The proposal also identified unlawfully deceptive practices that violate the P&S Act with respect to contract formation, contract performance, contract termination and contract refusal. The purpose of the final rule is to promote inclusive competition and market integrity in the livestock, meats, and poultry markets. For more information about this rule, see RIN 0581-AE05.

Transparency in Poultry Grower Contracting and Tournaments Systems: The final rule would address the use of poultry grower ranking systems as a method of payment and settlement grouping for poultry growers under contract in poultry growing arrangements with live poultry dealers. The final rule would establish certain requirements with which a live poultry dealer must comply if a poultry grower ranking system is utilized to determine grower payment. A live poultry dealer's failure to comply would be deemed an unfair, unjustly discriminatory, and deceptive practice according to factors outlined in the final rule. A proposed rule was published in the Federal Register on June 8, 2022, 87 FR 48091. For more information about this rule, see RIN 0581-AE03.

Unfair Practices, Undue Preferences, and Harm to Competition under the Packers and Stockyards Act: The proposal would revise regulations under the Packers and Stockyards Act (Act), providing clarity regarding conduct that may violate the Act, including addressing harm to competition. For more information about this rule, see RIN 0581-AE04.

Poultry Growing Tournament Systems: Fairness and Related Concerns—Harm to Competition: The proposal seeks to address the use of poultry grower ranking systems, commonly known as “tournaments” in contract poultry production. Based on inputs from poultry growers, the proposal will seek to improve the market for poultry grower services. An advance notice of proposed rulemaking was published in the Federal Register on June 8, 2022, 87 FR 34814. For more information about this rule, see RIN 0581-AE18.

Provide All Americans Safe, Nutritious Food

USDA's Food Safety and Inspection Service (FSIS) continues to ensure that meat, poultry, and egg products are safe, wholesome, and properly marked, labeled, and packaged, and prohibits the distribution in-commerce of meat, poultry, and egg products that are adulterated or misbranded. One of FSIS' top priorities is to develop a more comprehensive and effective strategy to reduce Salmonella illnesses associated with poultry products. The agency is gathering the data and information necessary to support future action and move closer to the national target of a 25 percent reduction in Salmonella illnesses.

In addition, to enhance the safety of raw beef products, FSIS is strengthening its sampling and testing programs for shiga-toxin producing Escherichia coli in these products.

Moreover, consistent with the President's priorities of advancing the country's economic recovery and promoting economic resilience, FSIS is proposing several rules to improve regulatory certainty, which assure consumers that meat, poultry, and egg products are safe and truthfully labeled and fosters fair competition among the regulated industry. In a similar vein, AMS has prepared proposed standards for organic livestock and poultry production.

Voluntary Labeling of Meat Products With “Product of USA” and Similar Statements: In accordance with Executive Order 14036, Promoting Competition in the American Economy, FSIS will propose to address concerns that the voluntary “Product of USA” label claim may confuse consumers about the origin of FSIS regulated products and undermine fair competition. FSIS intends to define the voluntary claim so that it is more meaningful to consumers and ensures a fair and competitive marketplace for American farmers and ranchers. For more information about this rule, see RIN 0583-AD87.

Labeling of Meat or Poultry Products Comprised of or Containing Cultured Animal Cells; Revision of the Nutrition Facts Panels for Meat and Poultry Products and Updating Certain Reference Amounts Customarily Consumed; and Prior Label Approval System: Expansion of Generic Label Approval: FSIS will propose to establish new requirements for the labeling of meat or poultry products made using animal cell culture technology. FSIS also plans to finalize two other labeling rules, one to update nutrition labeling for meat and poultry products and another to expand the categories of meat and poultry product labels deemed generically approved that may be used in commerce without prior FSIS review and approval. The rule expanding the categories of generically approved labels will reduce labeling costs for meat and poultry establishments, including small and very small establishments. The three rules will provide additional certainty about what is required for meat and poultry labeling while ensuring that consumers have accurate information about the food they buy. For more information about these rules, see RINs 0583-AD56, 0583-AD78, and 0583-AD89.

National Organic Program; Organic Livestock and Poultry Standards: The final rule would establish standards that support additional practice standards for organic livestock and poultry production. This final action would add provisions to the USDA organic regulations to address and clarify livestock and poultry living conditions (for example, outdoor access, housing environment and stocking densities), health care practices (for example physical alterations, administering medical treatment, euthanasia), and animal handling and transport to and during slaughter. For more information about this rule, see RIN 0581-AE06.

FNS' Child Nutrition Programs: Revisions to Meal Patterns Consistent with the 2020 Guidelines for Americans: The proposed revisions would revise meal patterns in the National School Lunch Program and School Breakfast Program to make school meals healthier and more consistent with the most recent Dietary Guidelines for Americans while reflecting the nutrient needs of children at risk for food insecurity. For more information about this rule, see RIN 0584-AE88.

FNS' Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Revisions in the WIC Food Packages: Consistent with recommendations from the National Academies of Sciences, Engineering, and Medicine and the latest Dietary Guidelines for Americans, the proposal seeks to provide participants with greater choices in variety and food package sizes. For more information about this rule, see RIN 0584-AE82.

FNS' Community Eligibility Provision: Increasing Options for Schools: The Community Eligibility Provision (CEP) is an option for schools to offer no-cost meals to all students without the burden of collecting household applications. This provision saves local educational agencies time and money by streamlining paperwork and administrative requirements and facilitates low-income children's access to nutritious school meals. This rule would lower the minimum participation threshold, which would expand access to CEP and provide greater flexibility to States and schools that want to use additional State and local funds to provide no-cost meals to students. For more information about this rule, see RIN 0584-AE93.

USDA—AGRICULTURAL MARKETING SERVICE (AMS)

Proposed Rule Stage

1. Unfair Practices, Undue Preferences, and Harm to Competition Under the Packers and Stockyards Act (AMS-FTPP-21-0046) [0581-AE04]

Priority: Other Significant.

Legal Authority:7 U.S.C. 181 to 229c

CFR Citation:9 CFR 201.

Legal Deadline: None.

Abstract: This action proposes to revise regulations issued under the Packers and Stockyards Act (Act) (7 U.S.C.181 229c), providing clarity regarding conduct that may violate the Act. Revisions are intended to support market growth, assure fair trade practices and competition, and protect livestock and poultry growers and producers. The action addresses long-standing issues related to competitiveness and showings of harm or likely harm to competition.

Statement of Need: Revisions to regulations pertaining to the Packers and Stockyards Act (Act) clarify the types of conduct by packers, swine contractors, or live poultry dealers that the Agricultural Marketing Service (AMS) considers unfair practices or undue preferences and a violation of sections 202(a) or 202(b) of the Act.

Sections 202(a) and 202(b) of the P&S Act are broadly written to prohibit unjustly practices and undue preferences. Industry members have complained that the regulations effectuating the Act are too vague and do not provide adequate clarity about the types of conduct or action that are likely to violate the Act. This rule is needed to provide essential clarity about what would be considered violations of the Act.

Revisions to regulations pertaining to the Packers and Stockyards Act (Act) that would also clarify the scope of the Act are needed to establish what conduct or action, depending on their nature and the circumstances, violate the Act without a finding of harm or likely harm to competition or as they may relate to harm or likely harm to competition as such terms were contemplated under the Act. Such revisions reflect the Department of Agriculture's (USDA) longstanding position in this regard.

Summary of Legal Basis: The Packers and Stockyards Act (Act) authorizes AMS to determine if conduct within the poultry and livestock industries are unfair practices or undue preferences and, therefore a violation of the Act.

The Act provides USDA with the authority to assure fair competition and trade practices and to safeguard farmers against receiving less than the true market value of their livestock. Sections 202(c), (d), and (e) of the Act limit the application of those sections to acts or practices that have an adverse effect on competition, such as acts restraining commerce, creating a monopoly, or producing another type of antitrust injury. However, provisions in sections 202(a) and (b) restrict practices that are deceptive, unfair, unjust, undue, and unreasonable; terms that are understood to encompass more than anticompetitive conduct. USDA's position is that Congress did not intend application of sections 202(a) and (b) to be limited to instances in which there is harm to competition.

Alternatives: USDA considered doing nothing. However, courts are not unanimous in their findings. Further, several courts disagree with USDA's position. Lack of clarity hinders the agency's ability to consistently administer and enforce the Act.

Anticipated Cost and Benefits: USDA estimate annual costs related to this rule of $9 million for the first five years, decreasing in subsequent years, for total ten-year costs of $66 million. We believe the primary benefit of the proposed regulation is the increased ability to protect producers and growers through enforcement of the Act for violations of section 202(a) and/or (b) that do not result in harm, or a likelihood of harm, to competition.

Risks: Courts have recognized that the proper analysis of alleged violations of these two sections depends on the facts of each case. However, four courts of appeals have disagreed with USDA's interpretation of the Act and have concluded that plaintiffs could not prove their claims under those sections without proving harm to competition or likely harm to competition. There is a risk if future legal challenge of USDA interpretation of sections 202(c), (d), and (e) of the Act.

Timetable:

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Michael V. Durando, Deputy Administrator, Fair Trade Practices Program, Department of Agriculture, Agricultural Marketing Service, 1400 Independence Avenue SW, Washington, DC 20250-0237, Phone: 202 720-219.

RIN: 0581-AE04

USDA—AMS

2. Inclusive Competition and Market Integrity Under the Packers and Stockyards Act (AMS-FTPP-21-0045) [0581-AE05]

Priority: Other Significant.

Legal Authority:7 U.S.C. 181 to 229c

CFR Citation:9 CFR 201.

Legal Deadline: None.

Abstract: This final rule would supplement a recent revision to regulations issued under the Packers and Stockyards Act (Act) (7 U.S.C.181 229c) that provided criteria for the Secretary to consider when determining whether certain conduct or action by packers, swine contractors, or live poultry dealers is unduly or unreasonably or advantageous. Supplemental amendments clarify the conduct the Department considers unfair, preferential unjustly discriminatory, or deceptive and a violation of sections 202(a) and (b) of the Act. The rule also clarifies the criteria and types of conduct that would be considered unduly or unreasonably preferential, advantageous, prejudicial, or disadvantageous and violations of the Act.

Statement of Need: Revisions to regulations pertaining to the Packers and Stockyards Act (Act) clarify the types of conduct by packers, swine contractors, or live poultry dealers that the Agricultural Marketing Service (AMS) considers unfair, unjustly discriminatory, or deceptive and a violation of section 202(a) of the Act, regardless of whether such action harms or is likely to harm competition. The rule also clarifies the criteria and/or types of conduct that would be considered unduly or unreasonably preferential, advantageous, prejudicial, or disadvantageous and a violation of section 202(b) of the Act.

Sections 202(a) and 202(b) of the P&S Act are broadly written to prohibit unjustly practices and undue preferences and prejudices. Industry members have complained that the regulations effectuating the Act are too vague and do not provide adequate clarity about the types of conduct or action that are likely to violate the Act. This rule is needed to provide essential clarity about what would be considered violations of the Act, regardless of whether such violations harm or are likely to harm competition.

Summary of Legal Basis: The Packers and Stockyards Act (Act) authorizes AMS to determine if conduct within the poultry and livestock industries are unfair, unjustly discriminatory, or deceptive and, therefore a violation of the Act.

Alternatives: AMS considered taking no further action, allowing 100 years of case law to determine precedent in making determinations about whether certain behaviors violate the Act. AMS also considered revisiting the withdrawn 2016 rulemaking approach that would have identified criteria with which to determine whether certain behaviors violate the Act.

Anticipated Cost and Benefits: USDA estimates first-year costs associated with this rule to be $517 thousand, with decreased costs each year thereafter, resulting in a ten-year total cost of $2.88 million. AMS expects this rule to benefit all segments of the industry, providing greater clarity about what would be considered violations of the Act. AMS expects this rule, coupled with a concurrent rule on the scope of the Act, to strengthen enforcement of the Act, resulting in fairer and more competitive markets for producers and poultry growers.

Risks: Industry is divided about adding lists or examples of specific prohibited conduct to the regulations. Some argue such lists would inhibit freedom to forge contracts that fit individual situations, while others contend greater specificity is required so that affected parties can more readily identify violative behavior. Industry is also split on the question of whether identified prohibited behaviors must be found to harm or likely harm competition to be considered violations of the Act. AMS expects to resolve some of the controversy by being proactive and transparent with the industry to allow for critical discussions and decisions on the rule.

Timetable:

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Michael V. Durando, Deputy Administrator, Fair Trade Practices Program, Department of Agriculture, Agricultural Marketing Service, 1400 Independence Avenue SW, Washington, DC 20250-0237, Phone: 202 720-0219.

RIN: 0581-AE05

USDA—AMS

3. Poultry Growing Tournament Systems: Fairness and Related Concerns—Harm to Competition (AMS-FTPP-22-0046) [0581-AE18]

Priority: Other Significant.

Legal Authority:7 U.S.C. 181 et seq., 192

CFR Citation:9 CFR 201.

Legal Deadline: None.

Abstract: This action seeks comments on proposed amendments to regulations that promote transparency in the poultry grower ranking systems, more commonly known as tournaments, in contract poultry production. Proposed amendments serve to remove obstacles to fair contracting.

Statement of Need:Executive Order 14036 Promoting Competition in the American Economy, directs the Secretary of Agriculture to address unfair treatment of farmers and improve conditions of competition in their markets by considering rulemaking to address, among other things, certain practices related to poultry grower ranking systems. AMS is responding to numerous complaints from poultry growers about the use of tournament systems and recognizes that measures beyond disclosure and transparency may be necessary to address those practices, given the economic power imbalances and competition concerns that exist in today's markets. Responses to requests for comment have helped AMS tailor further policy development and rulemaking under the Packers and Stockyards Act, as amended, to address, through specific prohibitions, limits, and/or conventionalities, potential unfairness that may arise from the use of the tournament contracts in the poultry sector.

Summary of Legal Basis: Sections 202(a) and 202(b) of the Packers and Stockyards Act prohibits unfair practices and undue preferences.

Alternatives: The alternative considered is to continue with other efforts already underway to enhance fair and competitive markets in poultry. These include: (1) a separate rulemaking, under RIN 0581-AE03, in which USDA proposed a series of new transparency measures designed to address many grower concerns relating to deception and lack of access to critical information in connection with poultry contracting and tournament systems; (2) under the American Rescue Plan Act's provision to enhance supply chain resiliency, investing directly into the creation of new, and expansion of existing, local and regional meat and poultry processing enterprises; and (3) in partnership with DOJ, through such means as a newly established joint complaints and tips portal, www.farmerfairness.gov, enhancing enforcement activities including responding in a more coordinated manner to a range of competition and fair markets concerns.

Anticipated Cost and Benefits: AMS is at an early stage of evaluating the costs and benefits of the contemplated regulatory interventions. However, expected benefits include greater certainty, investment, and supply of poultry products, greater returns to poultry growers and enhanced rural economic welfare, and expanded competitive choices in the poultry sector. Expected costs may include compliance costs, such as certain contract change costs.

Risks: Agricultural production is an inherently risky endeavor, and returns have some level of risk no matter the marketing channel or structural arrangement. Tournament systems do not insulate growers from the financial risk, liquidity risk, the risk from incomplete contracts, and the lack of control over inputs and production variables. Tournaments also introduce new categories of risks to growers: Group composition risk and added risks of settlement-related deception or fraud. The risks of deception or fraud as discussed above include the inability of growers to verify the accuracy of payments, and to detect discrimination or retaliation.

Timetable:

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Stephen Slinsky, Department of Agriculture, Agricultural Marketing Service, 1400 Independence Avenue SW, Washington, DC 20250, Phone: 901 287-9719, Email: stephen.slinsky@usda.gov.

RIN: 0581-AE18

USDA—AMS

Final Rule Stage

4. Transparency in Poultry Grower Contracting and Tournaments (AMS-FTPP-21-0044) [0581-AE03]

Priority: Other Significant.

Legal Authority:7 U.S.C. 181 to 229c

CFR Citation:9 CFR 201.

Legal Deadline: None.

Abstract: This action amends regulations issued under the Packers and Stockyards Act (P&S Act), revising the list of disclosures and information live poultry dealers must furnish to poultry growers and sellers with whom dealers make poultry growing arrangements. The rule establishes parameters for the use of poultry grower ranking systems by dealers to determine settlement payments for poultry growers. Amendments are intended to promote transparency in poultry production contracting and to give poultry growers relevant information with which to make business decisions.

Statement of Need: Differences in size and imbalances of power between parties in contractual poultry growing arrangements can have detrimental effects on one of the contracting parties and may result in marketplace inefficiencies. An often-cited concern is the live poultry dealer's full control over inputs, e.g., chick, feed, medication, etc., to the poultry growing process. Industry members have asked the Agricultural Marketing Service (AMS) to address such imbalances by specifying the conduct that would be considered violative of the Packers and Stockyards Act (Act).

Summary of Legal Basis: The Agricultural Marketing Service (AMS) is delegated authority by the Secretary of Agriculture to enforce the P&S Act. AMS has received numerous complaints regarding the imbalance of power in poultry growing agreements, wherein one side controls all of the inputs, then arbitrarily ranks grower performance against other growers to determine pay.

Alternatives: AMS considered finalizing a 2016 proposed rule that would have identified criteria for determining whether a live poultry dealer's use of a grower ranking system for payment purposes might be unlawful under the Packers and Stockyards Act.

Anticipated Cost and Benefits: USDA estimates the first-year costs associated with this proposed rule to be $17.37 million. Subsequent year costs are expected to be significantly less than first-year costs, resulting in a ten-year total cost of $34.64 million. USDA expects the primary benefit of the regulation will be the increased ability to protect poultry growers from unfair practices associated with the use of poultry grower ranking systems. At the same time, the rule is expected to improve efficiencies through the use of new technologies and to reduce market failures among poultry growers.

Risks: Extended litigation over legal challenges from the industry could result in the rule being struck down by the courts, hindering the agency's ability to enforce the Act for years.

Timetable:

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Michael V. Durando, Deputy Administrator, Fair Trade Practices Program, Department of Agriculture, Agricultural Marketing Service, 1400 Independence Avenue SW, Washington, DC 20250-0237, Phone: 202 720-0219.

RIN: 0581-AE03

USDA—AMS

5. Organic Livestock and Poultry Standards (AMS-NOP-21-0073) [0581-AE06]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority:7 U.S.C. 6501 to 7 U.S.C. 6524

CFR Citation:7 CFR 205.

Legal Deadline: None.

Abstract: This action establishes additional practice standards for organic livestock and poultry production. The rule amends the USDA organic regulations related to: livestock and poultry living conditions (for example, outdoor access, housing environment, and stocking densities); animal health care (for example, physical alterations, administering medical treatment, and euthanasia); animal transport; and slaughter.

Statement of Need: The Organic Livestock and Poultry Standards (OLPS) rule is needed to clarify the USDA organic standards for livestock and poultry living conditions and health practices. The current regulations for livestock production provide general requirements but some of these provisions are ambiguous and have led to inconsistent divergent practices, particularly in the organic poultry sector. This rule responds to nine recommendations from the National Organic Standards Board and findings from a USDA Office of Inspector General (OIG) report. (See USDA, Office of the Inspector General. March 2010. Audit Report 01601-03-Hy, Oversight of the National Organic Program. Available at: http://www.usda.gov/oig/rptsauditsams.htm.) This rule includes provisions to support the expression of natural behaviors and the welfare of organic livestock and poultry.

Summary of Legal Basis: OLPS is authorized by the Organic Foods Production Act of 1990 (OFPA), 7 U.S.C. 65016524. OFPA authorizes the USDA to establish national standards governing the marketing of certain agricultural products as organically produced products to assure consumers that organically produced products meet a consistent standard and to facilitate interstate commerce in fresh and processed food that is organically produced.

Alternatives: AMS considered several alternatives and presents these in the rule. AMS presents two compliance date alternatives in the rule that would affect the costs and benefits of the rule. Additionally, AMS discusses alternatives to specific policies included in the rule, including alternative indoor and outdoor space requirements, and non-regulatory alternatives, including consumer education or no rule.

Anticipated Cost and Benefits: AMS assumes no costs or benefits are accumulated for clarifying and codifying existing practices. However, AMS does expect costs and benefits to occur for organic broiler production through increased indoor space and for organic broilers and in egg production through increased outdoor access for layers.

AMS estimates that the discounted costs for layer operations would range between $3.6 million and $8.4 million annually. To monetize the benefits of this rule, AMS used research that measured consumers' willingness-to-pay for outdoor access at a premium of between $0.16 and $0.25 per dozen eggs, controlling for other factors, including the organic label. Based on this, AMS estimates the annually discounted benefits falling between $11.6 million to $27.1 million.

AMS estimates that the total annual discounted costs for broiler compliance would be between $5.7 million and $6.3 million. The benefits for broilers are calculated using a willingness-to-pay at a premium of $0.34/lb. With this willingness-to-pay, the annual discounted benefits range between $97 million and $107 million.

Qualitatively, AMS also anticipates the rule will establish a clear standard protecting the value of the USDA organic seal to consumers, provide a consistent, level playing field for organic livestock producers, and facilitate enforcement of organic livestock and poultry standards.

Risks: This rule is similar to the rule published on January 19, 2017 (82 FR 7042). That rule was subsequently withdrawn and never became effective. The USDA continues to face two legal challenges related to the withdrawal of that rule. USDA argued in its withdrawal of the rule that USDA had no authority under the Organic Foods Production Act to promulgate the rule, so there is legal risk in reversing direction and publishing a similar rule.

Publishing a new proposed rule indicated that the USDA is taking new steps to advance the regulations. This has been viewed favorably by some, although others would prefer reinstating the January 2017 rule without the associated steps required to finalize a new rule.

Timetable:

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Erin Healy, Director, Standards Division, National Organic Program, Department of Agriculture, Agricultural Marketing Service, Washington, DC 20024, Phone: 202 617-4942, Email: erin.healy@usda.gov.

Related RIN: Related to 0581-AD44, Related to 0581-AD74, Related to 0581-AD75

RIN: 0581-AE06

USDA—FOOD AND NUTRITION SERVICE (FNS)

Proposed Rule Stage

6. Special Supplemental Nutrition Program for Women, Infants and Children (WIC): Revisions in the WIC Food Packages [0584-AE82]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority:42 U.S.C. 1786, sec. 17(f)(11)(C)

CFR Citation:7 CFR 246.10.

Legal Deadline: None.

Abstract: This proposed rulemaking would amend regulations governing the WIC food packages to: (1) incorporate recommendations of the National Academies of Science, Engineering, and Medicine 2017 scientific report, Review of WIC Food Packages: Improving Balance and Choice; (2) align with 2020 Dietary Guidelines for Americans; and (3) make other administrative revisions or clarifications to food package requirements.

Statement of Need: The National Academies of Sciences, Engineering, and Medicine (NASEM) issued a 2017 report with recommendations to align the WIC food packages with the available nutrition science and to reflect the supplemental nature of the Program. In December 2020, the USDA and the Department of Health and Human Services released the 2020-2025 Dietary Guidelines for Americans (DGAs). USDA FNS will propose rulemaking to incorporate NASEM recommendations and align the food package with the latest DGAs.

Summary of Legal Basis:42 U.S.C. 1786, sec. 17(f)(11)(C).

Alternatives: N/A.

Anticipated Cost and Benefits: This is discussed in the Regulatory Impact Analysis which was published on November 21, 2022 as an appendix to the rule, available at 87 FR 71090.

Risks: N/A.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Federal, Local, State.

Federalism: This action may have federalism implications as defined in E.O. 13132.

Agency Contact: Michael DePiro, Department of Agriculture, Food and Nutrition Service, 1320 Braddock Place, Alexandria, VA 22314, Phone: 703 305-2876, Email: michael.depiro@usda.gov.

Maureen Lydon, Department of Agriculture, Food and Nutrition Service, 1320 Braddock Place, Alexandria, VA 22314, Phone: 703 457-7713, Email: maureen.lydon@usda.gov.

RIN: 0584-AE82

USDA—FNS

7. Child Nutrition Programs: Revisions to Meal Patterns Consistent With the 2020 Dietary Guidelines for Americans [0584-AE88]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority:42 U.S.C. 1758, sec. 9(f)(1)

CFR Citation:7 CFR 210.10; 7 CFR 210.11; 7 CFR 215.7a; 7 CFR 220.8; 7 CFR 226.20; . . .

Legal Deadline: None.

Abstract: This rule will propose long-term school nutrition standards based on the Dietary Guidelines for Americans, 2020-2025, and feedback from child nutrition program stakeholders. The proposed revisions are expected to make school meals more nutritious and more consistent with the goals of the most recent Dietary Guidelines, as required by statute. In addition, FNS is merging “Buy American Provision in the National School Lunch and School Breakfast Programs” (0584-AE91),which was listed as a long-term rule on the Fall 2021 Regulatory Agenda, with this rule (0584-AE88). When developing this proposed rule, FNS will consider comments submitted in response to the February 2022 final rule, “Child Nutrition Programs: Transitional Standards for Milk, Whole Grains, and Sodium” (0584-AE81). FNS will also consider comments submitted in response to the August 2021 “Request for Information: Buy American in the National School Lunch Program and School Breakfast Program,” including feedback on how FNS can better support local schools as they strive to purchase domestic foods and food products.

Statement of Need: The proposed revisions are needed to make school meals more nutritious and more consistent with the goals of the most recent Dietary Guidelines, as required by statute.

Summary of Legal Basis:42 U.S.C. 1758, sec. 9(f)(1).

Alternatives: Alternatives not identified to date.

Anticipated Cost and Benefits: These would be addressed in the Regulatory Impact Analysis for the rule.

Risks: None known at this time.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Local, State.

Federalism: Undetermined.

Agency Contact: Michael DePiro, Department of Agriculture, Food and Nutrition Service, 1320 Braddock Place, Alexandria, VA 22314, Phone: 703 305-2876, Email: michael.depiro@usda.gov.

Maureen Lydon, Department of Agriculture, Food and Nutrition Service, 1320 Braddock Place, Alexandria, VA 22314, Phone: 703 457-7713, Email: maureen.lydon@usda.gov.

Related RIN: Merged with 0584-AE913

RIN: 0584-AE88

USDA—FNS

8. • Community Eligibility Provision: Increasing Options for Schools [0584-AE93]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Legal Authority:42 U.S.C. 1759a(a)(1)(F)

CFR Citation:7 CFR 245.9.

Legal Deadline: None.

Abstract: This proposed rule would lower the minimum participation threshold for Community Eligibility Provision (CEP) elections. Currently, to elect CEP, a local educational agency (LEA), group of schools, or individual school must meet a minimum identified student percentage threshold of 40 percent. This rule would lower the minimum participation threshold, which would provide an additional option for LEAs and schools to receive special assistance payments as Federal reimbursement for meals served to students, in lieu of taking applications.

Statement of Need: The Community Eligibility Provision (CEP) is an option for schools to offer no-cost meals to all students without the burden of collecting household applications. This provision saves local educational agencies time and money by streamlining paperwork and administrative requirements and facilitates low-income children's access to nutritious school meals. Lowering the participation threshold expands access to CEP and provides greater flexibility to States and schools that want to use additional State and local funds to provide no-cost meals to students.

Summary of Legal Basis: Per the Richard B. Russell National School Lunch Act (42 U.S.C. 1759a(a)(1)(F)(viii)(II)): “For each school year beginning on or after July 1, 2014, the Secretary may use a threshold that is less than 40 percent.”

Alternatives: None.

Anticipated Cost and Benefits: Expanding access to CEP to additional schools is not expected to measurably increase costs to the Federal government due to the cost sharing aspect. FNS anticipates that this provision could impact State and/or local costs. FNS expects that local educational agencies that choose to elect CEP at lower eligibility levels will have increased State and/or local obligations. A cost/benefit analysis will be addressed in the economic analysis section to be included within the rule.

Risks: No risks have been identified at this time.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Governmental Jurisdictions.

Government Levels Affected: Federal, Local, State, Tribal.

Agency Contact: Michael DePiro, Department of Agriculture, Food and Nutrition Service, 1320 Braddock Place, Alexandria, VA 22314, Phone: 703 305-2876, Email: michael.depiro@usda.gov.

Maureen Lydon, Department of Agriculture, Food and Nutrition Service, 1320 Braddock Place, Alexandria, VA 22314, Phone: 703 457-7713, Email: maureen.lydon@usda.gov.

RIN: 0584-AE93

USDA—FNS

Final Rule Stage

9. • Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Implementation of the Access to Baby Formula Act of 2022 and Related Provisions [0584-AE94]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Legal Authority:Pub. L. 117-129

CFR Citation:7 CFR 246.

Legal Deadline: None.

Abstract: This rule would amend 7 CFR 246 to codify the provisions of the Access to Baby Formula Act of 2022 (ABFA). ABFA amends Section 17 of the Child Nutrition Act of 1966 to (1) add requirements to State agency infant formula cost containment contracts; and (2) establish waiver authority to the Secretary of Agriculture to address certain emergencies, disasters, and supply chain disruptions impacting WIC. FNS would make other related technical corrections and updates as necessary to modernize applicable WIC Program regulations.

Statement of Need: This rule would codify requirements for State agencies to include language in their WIC infant formula rebate contracts that describes remedies in the event of an infant formula recall, including how an infant formula manufacturer would protect against disruption to program participants in the State ( i.e., ensure that WIC participants can purchase formula using WIC benefits). The rule would also codify permanent expanded waiver authority to aid participants in obtaining and redeeming WIC benefits during certain emergencies, disasters, and supply chain disruptions impacting WIC. Finally, the rule would make other miscellaneous technical corrections and updates as necessary to update WIC regulations.

Summary of Legal Basis: The Access to Baby Formula Act of 2022 (ABFA, Pub. L. 117-129) amends section 17 of the Child Nutrition Act of 1966 (Pub. L. 89-642).

Alternatives: No alternatives have been identified at this time.

Anticipated Cost and Benefits: The costs associated with implementing the rule's regulatory requirements are not expected to significantly add to current program costs at the State and local levels.

Risks: No risks have been identified at this time.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Local, State.

Agency Contact: Michael DePiro, Department of Agriculture, Food and Nutrition Service, 1320 Braddock Place, Alexandria, VA 22314, Phone: 703 305-2876, Email: michael.depiro@usda.gov.

Maureen Lydon, Department of Agriculture, Food and Nutrition Service, 1320 Braddock Place, Alexandria, VA 22314, Phone: 703 457-7713, Email: maureen.lydon@usda.gov.

RIN: 0584-AE94

USDA—FOOD SAFETY AND INSPECTION SERVICE (FSIS)

Proposed Rule Stage

10. Voluntary Labeling of Products With “Product of USA” and Similar Statements [0583-AD87]

Priority: Other Significant.

Legal Authority:21 U.S.C. 601 et seq.;21 U.S.C. 451 et seq.;21 U.S.C. 1031 et seq.

CFR Citation:9 CFR 317.8.

Legal Deadline: None.

Abstract: The Food Safety and Inspection Service (FSIS) is proposing to amend its regulations to define the conditions under which the labeling of products can bear voluntary statements indicating that the product is of United States (U.S.) origin, such as Product of USA or Made in the USA.

Statement of Need: In 2018 and 2019, FSIS received two petitions requesting that it change its policy regarding the labeling of meat products to indicate U.S. origin. After considering the petitions and the public comments submitted in response to them, FSIS concluded that adherence to the current labeling policy guidance may be causing confusion in the marketplace with respect to certain imported products and that the current labeling policy may no longer meet consumer expectations of what the Product of USA claim signifies. In 2021, FSIS received another petition related to its Product of USA policy. The Agency wants to ensure that any changes to its current policy are accomplished by an open and transparent process. Therefore, FSIS commissioned a consumer survey and decided that, instead of changing the Policy Book entry, it would initiate rulemaking to define the conditions under which the labeling of FSIS-regulated products would be permitted to bear voluntary statements indicating that the product is of U.S. origin.

Summary of Legal Basis: Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601-695, at 607), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451-470, at 457), and the Egg Products Inspection Act (21 U.S.C. 1031-1056, at 1036) (the Acts), the labels of meat, poultry, and egg products must be approved by the Secretary of Agriculture, who has delegated this authority to FSIS, before these products can enter commerce. The Acts prohibit the sale or offer for sale by any person, firm, or corporation of any article in commerce under any name or other marking or labeling that is false or misleading or in any container of a misleading form or size (21 U.S.C. 607(d); 21 U.S.C. 457(c)). The Acts also prohibit the distribution in commerce of meat or poultry products that are adulterated or misbranded. The FMIA and PPIA give FSIS broad authority to promulgate such rules and regulations as are necessary to carry out the provisions of the Acts (21 U.S.C. 621 and 463(b)).

Alternatives: FSIS has considered the current labeling guidance and the alternatives proposed in the two petitions: (1) to amend the FSIS Policy Book to state that FSIS-regulated products may be labeled as Product of USA only if significant ingredients are of domestic origin and; (2) to amend the FSIS Policy Book to provide that any FSIS regulated product labeled as Made in the USA, Product of the USA, USA Beef or in any other manner that suggests that the origin is the United States, be derived from animals that have been born, raised, and slaughtered in the United States. FSIS is conducting a comprehensive review of origin labeling claims and conducting a consumer perception survey pursuant to developing the proposed regulations.

Anticipated Cost and Benefits: Establishments may incur costs associated with voluntarily changing their labels as a result of any revised Product of USA labeling claim definition. This proposed rule is expected to benefit consumers as well as producers by providing them more specific information on what Product of USA means for FSIS-regulated products.

Risks: N/A.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Melissa Hammar, Acting Director, Regulations Development Staff, Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Washington, DC 20250-3700, Phone: 202 720-2096, Email: melissa.hammar@usda.gov.

RIN: 0583-AD87

USDA—FSIS

11. Labeling of Meat and Poultry Products Made Using Animal Cell Culture Technology [0583-AD89]

Priority: Other Significant.

Legal Authority:21 U.S.C. 451 et seq.

CFR Citation:9 CFR ch. III.

Legal Deadline: None.

Abstract: This notice of proposed rulemaking seeks public comments to inform future Food Safety and Inspection Service (FSIS) regulations for the labeling of meat and poultry products made using animal cell culture technology.

Statement of Need: Many companies, both domestic and foreign, are currently developing cultured products derived from the cells of food animals amenable to the Federal Meat Inspection Act (FMIA; 21 U.S.C. 601 et seq.) (cattle, sheep, swine, goats, and fish of the order Siluriformes, e.g., catfish) or the Poultry Products Inspection Act (PPIA; 21 U.S.C. 451 et seq.) (chickens, turkeys, ducks, geese, guineas, ratites, and squabs). Human food products derived from these species fall under FSIS jurisdiction.

Summary of Legal Basis: The Federal Meat Inspection Act (FMIA; 21 U.S.C. 601 et seq.) and the Poultry Products Inspection Act (PPIA; 21 U.S.C. 451 et seq.) require that meat and poultry products be truthfully and accurately labeled and that their labels be pre-approved by FSIS (21 U.S.C. 607(d) and 457(c), respectively), prior to movement in commerce. FSIS issues labeling regulations and reviews and approves meat and poultry product labels pursuant to these statutory labeling requirements. Food products made using animal cell culture technology and derived from the cells of livestock subject to the FMIA or the PPIA are subject to the labeling (and other applicable) requirements of these Acts and the regulations issued thereunder.

Alternatives: FSIS will consider at least three alternatives for the rule: (1) Adopting a naming convention that is preferred by cellular agriculture industry; (2) Adopting a naming convention that is preferred by traditional agriculture industry; (3) Adopting a naming convention that is preferred by consumers groups.

Anticipated Cost and Benefits: This proposed rule would benefit the public by providing truthful and accurate labeling of meat and poultry products produced using animal cell culture technology.

FSIS expects its costs to be minimal and that current FSIS staffing would meet sketch approval needs.

Risks: None.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Melissa Hammar, Acting Director, Regulations Development Staff, Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Washington, DC 20250-3700, Phone: 202 720-2096, Email: melissa.hammar@usda.gov.

RIN: 0583-AD89

USDA—FSIS

Final Rule Stage

12. Revision of the Nutrition Facts Panels for Meat and Poultry Products and Updating Certain Reference Amounts Customarily Consumed [0583-AD56]

Priority: Other Significant.

Legal Authority:21 U.S.C. 601 et seq.;21 U.S.C. 451 et seq.

CFR Citation:9 CFR 317; 9 CFR 381; 9 CFR 413.

Legal Deadline: None.

Abstract: Consistent with the changes that the Food and Drug Administration (FDA) finalized, the Food Safety and Inspection Service (FSIS) is amending the Federal meat and poultry products inspection regulations to update and revise the nutrition labeling requirements for meat and poultry products to reflect recent scientific research and dietary recommendations and to improve the presentation of nutrition information to assist consumers in maintaining healthy dietary practices.

Statement of Need: On May 27, 2016, the Food and Drug Administration (FDA) published two final rules: (1) “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” (81 FR 33742); and (2) “Food Labeling: Serving Sizes of Foods that Can Reasonably be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments” (81 FR 34000). FDA finalized these rules to update the Nutrition Facts label to reflect new nutrition and public health research, to reflect recent dietary recommendations from expert groups, and to improve the presentation of nutrition information to help consumers make more informed choices and maintain healthy dietary practices. FSIS has reviewed FDA's analysis and, to ensure that nutrition information is presented consistently across the food supply, FSIS is amending the nutrition labeling regulations for meat and poultry products to parallel, to the extent possible, FDA's regulations. This approach will help increase clarity of information for consumers and will improve efficiency in the marketplace.

Summary of Legal Basis: Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601-695, at 607), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451-470, at 457), and the Egg Products Inspection Act (21 U.S.C. 1031-1056, at 1036) (the Acts), the labels of meat, poultry, and egg products must be approved by the Secretary of Agriculture, who has delegated this authority to FSIS, before these products can enter commerce. The Acts prohibit the sale or offer for sale by any person, firm, or corporation of any article in commerce under any name or other marking or labeling that is false or misleading or in any container of a misleading form or size (21 U.S.C. 607(d); 21 U.S.C. 457(c)). The Acts also prohibit the distribution in commerce of meat or poultry products that are adulterated or misbranded. The FMIA and PPIA give FSIS broad authority to promulgate such rules and regulations as are necessary to carry out the provisions of the Acts (21 U.S.C. 621 and 463(b)).

To prevent meat and poultry products from being misbranded, the meat and poultry product inspection regulations require that the labels of meat and poultry products include specific information, such as nutrition labels, and that such information be displayed as prescribed in the regulations (9 CFR part 317 and part 381). The nutrition labeling requirements for meat and meat food products are in 9 CFR 317.300-317.400, and the nutrition labeling requirements for poultry products are in 9 CFR 381.400-381.500.

Alternatives: FSIS considered three alternatives for the final rule: (1.) No action; (2.) A 24-month compliance period for large businesses and a 36-month compliance period for small businesses (as proposed); or (3.) A 12-month compliance period for large businesses and a 24-month compliance period for small businesses for faster label harmonization.

Anticipated Cost and Benefits: These regulations are expected to benefit consumers by increasing and improving dietary information available in the market. Firms will incur a one-time cost for relabeling, recordkeeping costs, and costs associated with voluntary reformulation. Many firms have voluntarily begun using the FDA format, which will reduce costs.

Risks: None.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Melissa Hammar, Acting Director, Regulations Development Staff, Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Washington, DC 20250-3700, Phone: 202 720-2096, Email: melissa.hammar@usda.gov.

RIN: 0583-AD56

USDA—FSIS

13. Prior Label Approval System: Expansion of Generic Label Approval [0583-AD78]

Priority: Other Significant.

Legal Authority:21 U.S.C. 601 et seq.;21 U.S.C. 451 et seq.;21 U.S.C. 1031 et seq.

CFR Citation:9 CFR 412.2(a)(1); 9 CFR 317.7; 9 CFR 381.128; 9 CFR 412.2(b).

Legal Deadline: None.

Abstract: The Food Safety and Inspection Service (FSIS) is amending its labeling regulations to expand the categories of meat, poultry, and egg product labels that it will deem generically approved and thus not required to be submitted to FSIS. These reforms will reduce the regulatory burden on producers seeking to bring products to market, as well as the Agency costs expended to evaluate the labels.

Statement of Need: This action is needed to reduce the regulatory burden on producers seeking to bring products to market, as well as the Agency costs expended to evaluate the labels. Based on FSIS experience evaluating the labels in question and the ability of inspection personnel to verify labeling in the field, FSIS anticipates this action will have no impact on food safety or the accuracy of meat, poultry, and egg product labeling.

Summary of Legal Basis: The Acts direct the Secretary of Agriculture to maintain meat, poultry, and egg inspection programs designed to assure consumers that these products are safe, wholesome, not adulterated, and properly marked, labeled, and packaged. Section 7(d) of the Federal Meat Inspection Act (21 U.S.C. 607(d)) states: No article subject to this title shall be sold or offered for sale by any person, firm, or corporation, in commerce, under any name or other marking or labeling which is false or misleading, or in any container of a misleading form or size, but established trade names and other marking and labeling and containers which are not false or misleading and which are approved by the Secretary are permitted. The Poultry Products Inspection Act and the Egg Products Inspection Act contain similar language in section 21 U.S.C. 457(c) and 1036(b), respectively.

Alternatives: FSIS considered three alternatives for the rule: taking no action, adopting the current proposal except with continued evaluation of labels that would otherwise be generically approved, and allowing all labels to be generically approved.

Anticipated Cost and Benefits: There are no additional costs to industry, or the Agency associated with this rule. FSIS will continue to verify that product labels, including those that are generically approved, are truthful and not misleading and otherwise comply with FSIS' requirements.

This rule is expected to reduce the number of labels industry is required to submit to FSIS for evaluation by approximately 35 percent. Establishments will realize a cost savings because they will no longer need to incur costs for submitting certain types of labels to FSIS for evaluation ( e.g., preparing a printer's proof). In addition, streamlining the evaluation process for specific types of labels will allow a faster introduction of products into the marketplace by reducing wait times for label approvals.

FSIS will also benefit from a reduction in the number of labels submitted to it for review. FSIS will be able to reallocate staff hours from evaluating labels towards the development of labeling policy.

Risks: None.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Melissa Hammar, Acting Director, Regulations Development Staff, Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW, Washington, DC 20250-3700, Phone: 202 720-2096, Email: melissa.hammar@usda.gov.

RIN: 0583-AD78

DEPARTMENT OF COMMERCE

Statement of Regulatory and Deregulatory Priorities

Established in 1903, the Department of Commerce (Commerce or Department) is one of the oldest Cabinet-level agencies in the Federal Government. Commerce's mission is to create the conditions for economic growth and opportunity across all American communities by promoting innovation, entrepreneurship, competitiveness, and environmental stewardship. Commerce has 12 operating units, which manage a diverse portfolio of programs and services ranging from trade promotion and economic development assistance to improved broadband access and the National Weather Service, and from standards development and statistical data production, including the decennial census, to patents and fisheries management. Across these varied activities, the Department seeks to provide a foundation for a more equitable, resilient, and globally competitive economy.

To fulfill its mission, Commerce works in partnership with businesses, educational institutions, community organizations, government agencies, and individuals to:

• Innovate by creating new ideas through cutting-edge science and technology, from advances in nanotechnology to ocean exploration to broadband deployment, and by protecting American innovations through the patent and trademark system;
• Support entrepreneurship and commercialization by enabling community development and strengthening minority businesses and small manufacturers;
• Maintain U.S. economic competitiveness in the global marketplace by promoting exports and foreign direct investment, ensuring a level playing field for U.S. businesses, and ensuring that technology transfer is consistent with our nation's economic and security interests;
• Provide effective management and stewardship of our nation's resources and assets to ensure sustainable economic opportunities; and
• Make informed policy decisions and enable better understanding of the economy and our communities by providing timely, accessible, and accurate economic and demographic data.

Responding to the Administration's Regulatory Philosophy and Principles

Commerce's Regulatory Plan tracks the most important regulations that the Department anticipates issuing to implement these policy and program priorities and foster sustainable and equitable growth. Of Commerce's 12 primary operating units, three bureaus—the National Oceanic and Atmospheric Administration (NOAA), the United States Patent and Trademark Office (USPTO), and the Bureau of Industry and Security (BIS)—issue the vast majority of the Department's regulations, and these three bureaus account for all the planned actions that are considered the Department's most important significant pre-regulatory or regulatory actions for FY 2022.

National Oceanic and Atmospheric Administration

NOAA's mission is built on three pillars: science, service, and stewardship—to understand and predict changes in climate, weather, oceans, and coasts; to share that knowledge and information with others; and to conserve and manage coastal and marine ecosystems and resources.

At its core, NOAA is a scientific agency. It observes, measures, monitors, and collects data from the depths of the ocean to the surface of the sun, and it does so following principles of scientific integrity. These data are turned into weather and climate models and forecasts that are then used for everything from local weather forecasts to predicting the movement of wildfire smoke to identifying the impacts of climate change on fisheries and living marine resources.

With respect to service, NOAA not only collects data but is mandated to make it operational, and NOAA seeks to be the authoritative provider of climate products and services. By providing Federal, State, and local government partners, the private sector, and the public with actionable environmental information, NOAA can facilitate decisions in the face of climate change. Such decisions can range from businesses planning the location of offices; insurance companies trying to incorporate climate risk into their insurance policies; and municipalities looking to ensure that plans for construction of new housing developments will be resilient to increasing sea level risk, flooding, and heavy precipitation.

The final pillar of NOAA's mission is stewardship. NOAA seeks to conserve our lands, waters, and natural resources, protecting people and the environment now and for future generations. As part of Commerce, moreover, NOAA recognizes that economic growth must go hand-in-hand with environmental stewardship. For example, with respect to the nation's fisheries, NOAA looks simultaneously to optimize productivity and ensure sustainability in order to boost long-term economic growth and competitiveness in this vital sector of the U.S. economy. Similarly, national marine sanctuaries both protect important natural resources and also are significant drivers of eco-tourism and local recreation.

Within NOAA, the National Marine Fisheries Services (NMFS) and the National Ocean Service (NOS) are the components that most often exercise regulatory authority to implement NOAA's mission. NMFS oversees the management and conservation of the nation's marine fisheries; protects marine mammals and Endangered Species Act (ESA)-listed marine and anadromous species; and promotes economic development of the U.S. fishing industry. NOS assists the coastal states in their management of land and ocean resources in their coastal zones, including estuarine research reserves; manages national marine sanctuaries; monitors marine pollution; and directs the national program for deep-seabed minerals and ocean thermal energy.

Much of NOAA's rulemaking is conducted pursuant to the following key statutes:

Magnuson-Stevens Fishery Conservation and Management Act

Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) rulemakings concern the conservation and management of fishery resources in the U.S. Exclusive Economic Zone (generally 3-200 nautical miles from shore). As itemized in the Unified Agenda, NOAA plans to take several hundred actions in FY 2022 under Magnuson-Stevens Act authority, of which roughly 20 are expected to be significant rulemakings, as defined in Executive Order 12866. With certain exceptions, rulemakings under Magnuson-Stevens are usually initiated by the actions of eight regional Fishery Management Councils (FMCs or Councils). These Councils are comprised of representatives from the commercial and recreational fishing sectors, environmental groups, academia, and Federal and State government, and they are responsible for preparing fishery management plans (FMPs) and FMP amendments, and for recommending implementing regulations for each managed fishery. FMPs address a variety of issues, including maximizing fishing opportunities on healthy stocks, rebuilding overfished stocks, and addressing gear conflicts. After considering the FMCs' recommendations in light of the standards and requirements set forth in the Magnuson-Stevens Act and in other applicable laws, NOAA may issue regulations to implement the proposed FMPs and FMP amendments.

Marine Mammal Protection Act

The Marine Mammal Protection Act of 1972 (MMPA) provides the authority for the conservation and management of marine mammals under U.S. jurisdiction. It expressly prohibits, with certain exceptions, the intentional take of marine mammals. The MMPA allows, upon request and subsequent authorization, the incidental take of marine mammals by U.S. citizens who engage in a specified activity ( e.g., oil and gas development, pile driving) within a specified geographic region. NMFS authorizes incidental take under the MMPA if it finds that the taking would be of small numbers, have no more than a “negligible impact” on those marine mammal species or stock, and would not have an “unmitigable adverse impact” on the availability of the species or stock for “subsistence” uses. NMFS also initiates rulemakings under the MMPA to establish a management regime to reduce marine mammal mortalities and injuries as a result of interactions with fisheries. In addition, the MMPA allows NMFS to permit the take or import of wild animals for scientific research or public display or to enhance the survival of a species or stock.

Endangered Species Act

The Endangered Species Act of 1973 (ESA) provides for the conservation of species that are determined to be “endangered” or “threatened,” and the conservation of the ecosystems on which these species depend. NMFS and the Department of Interior's Fish and Wildlife Service (FWS) jointly administer the provisions of the ESA: NMFS manages marine and several anadromous species, and FWS manages land and freshwater species. Together, NMFS and FWS work to protect critically imperiled species from extinction. NMFS rulemaking actions under the ESA are focused on determining whether any species under its responsibility is an endangered or threatened species and whether those species must be added to the list of protected species. NMFS is also responsible for designating, reviewing and revising critical habitat for any listed species. In addition, as indicated in the list of highlighted actions below, NMFS and FWS may also issue rules clarifying how particular provisions of the ESA will be implemented.

The National Marine Sanctuaries Act

The National Marine Sanctuaries Act (NMSA) authorizes the Secretary of Commerce to designate and protect as national marine sanctuaries areas of the marine environment with special national significance due to their conservation, recreational, ecological, historical, scientific, cultural, archeological, educational, or aesthetic qualities. The primary objective of the NMSA is to protect marine resources, such as coral reefs, sunken historical vessels, or unique habitats.

NOAA's Office of National Marine Sanctuaries (ONMS), within NOS, has the responsibility for management of national marine sanctuaries. ONMS regulations, issued pursuant to NMSA, prohibit specific kinds of activities, describe and define the boundaries of the designated national marine sanctuaries, and set up a system of permits to allow the conduct of certain types of activities that would otherwise not be allowed.

These regulations can, among other things, regulate and restrict activities that may injure natural resources, including all extractive and destructive activities, consistent with community-specific needs and NMSA's purpose to “facilitate to the extent compatible with the primary objective of resource protection, all public and private uses of the resources of these marine areas.” In FY 2022, NOAA is expected to have at least three regulatory actions under NMSA.

Coastal Zone Management Act

The Coastal Zone Management Act (CZMA) was passed in 1972 to preserve, protect, and develop and, where possible, to restore and enhance the resources of the nation's coastal zone. The CZMA creates a voluntary state-federal partnership, where coastal states (States in, or bordering on, the Atlantic, Pacific or Arctic Ocean, the Gulf of Mexico, Long Island Sound, or one or more of the Great Lakes), may elect to develop comprehensive programs that meet federal approval standards. Currently, 34 of the 35 eligible entities are implementing a federally approved coastal management plan approved by the Secretary of Commerce.

NOAA's Regulatory Plan Actions

Of the numerous regulatory actions that NOAA is planning for this year and that are included in the Unified Agenda, there are five, described below, that the Department considers to be of particular importance.

1. Illegal, Unreported, and Unregulated Fishing; Fisheries Enforcement; High Seas Driftnet Fishing Moratorium Protection Act (0648-BG11): The United States is a signatory to the Port State Measures Agreement (PSMA). The agreement is aimed at combating illegal, unreported, and unregulated (IUU) fishing activities through increased port inspection of foreign fishing vessels and by preventing the products of illegal fishing from landing and entering into commerce. The High Seas Driftnet Fishing Moratorium Act (Fishing Moratorium Act) implemented provisions of the PSMA, and NOAA issued regulations under the Fishing Moratorium Act in 2011 and 2013. Since then, the provisions of the Fishing Moratorium Act have been amended by the Illegal, Unreported and Unregulated Fishing Enforcement Act of 2015 (Pub. L. 114-81) and the Ensuring Access to Pacific Fisheries Act (Pub. L. 114-327). This proposed rule would implement amendments made by these later two laws. NMFS will also propose changes to the definition of IUU fishing for the purposes of identifying and certifying nations.

2. Amendments to the North Atlantic Right Whale Vessel Strike Reduction Rule (0648-BI88): Regulatory modifications are needed to further reduce the likelihood of mortalities and serious injuries to endangered North Atlantic right whales from vessel collisions, which are a primary cause of the species' decline and greatly contributing to the ongoing Unusual Mortality Event (2017-present). Following two decades of growth, the species has been in decline over the past decade with a population estimate of only 368 individuals as of 2019. Vessel strikes are one of the two primary causes of North Atlantic right whale mortality and serious injury across their range, and human-caused mortality to adult females in particular is limiting recovery of the species. Entanglement in fishing gear is the other primary cause of mortality and serious injury, which is being addressed by separate regulatory actions.

3. Endangered and Threatened Wildlife and Plants; Revision of the Regulations for Listing Endangered and Threatened Species and Designation of Critical Habitat (0648-BJ44): This action responds to section 2 of the Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis (E.O. 13990) and the associated Fact Sheet (List of Agency Actions for Review). This is a joint rulemaking by NMFS and the FWS (the Services) to rescind the regulatory definition of the term “habitat.” This previously undefined term was defined by regulation for the first time in 2020 for the purpose of designating critical habitat under the ESA. Pursuant to Executive Order 13990, the Services also considered the alternatives of retaining the existing habitat definition or revising the habitat definition and will be considering any alternatives provided during the public comment period on the proposed rule.

4. Endangered and Threatened Wildlife and Plants; Regulations for Listing Species and Designating Critical Habitat (0648-BK47): This action responds to section 2 of the Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis (E.O. 13990) and the associated Fact Sheet (List of Agency Actions for Review). This is a joint rulemaking by the Services to revise joint regulations issued in 2019 implementing section 4 of the ESA. Specifically addressed in this action are joint regulations that address the classification of species as threatened or endangered and the criteria and process for designating critical habitat for listed species. Pursuant to Executive Order 13990, the Services reviewed the specific regulatory provisions that had been revised in the 2019 final rule. Following a review of the 2019 rule, the Services are proposing to revise a portion of these regulations but are also soliciting public comments on all aspects of the 2019 rule before issuing a final rule.

5. Endangered and Threatened Wildlife and Plants; Revision of Regulations for Interagency Cooperation (0648-BK48): This action responds to section 2 of the Executive Order on Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis (E.O. 13990) and the associated Fact Sheet (List of Agency Actions for Review). This is a joint rulemaking by the Services to revise joint regulations implementing section 7 of the ESA, which requires Federal agencies to consult with the Services whenever any action the agency undertakes, funds, or authorizes may affect endangered or threatened species or their critical habitat, to ensure that the action does not jeopardize listed species or adversely modify critical habitat. In 2019, the Services revised various aspects of the regulations governing the consultation process under ESA Section 7 including, significantly, how the Services define the “effects of the action,” which has importance for determining the scope of consultation. Pursuant to Executive Order 13990, the Services reviewed the specific regulatory provisions that had been revised in the 2019 final rule. Following this review of the 2019 rule, the Services are proposing to revise a portion of these regulations, including “effects of the action,” but are also soliciting public comments on all aspects of the 2019 rule before issuing a final rule. In addition to revising provisions from the 2019 rule, the Services are proposing to clarify the responsibilities of a Federal agency and the Services regarding the requirement to reinitiate consultation.

The United States Patent and Trademark Office

The USPTO's mission is to foster innovation, competitiveness, and economic growth, domestically and abroad, by delivering high quality and timely examination of patent and trademark applications, guiding domestic and international intellectual property policy, and delivering intellectual property information and education worldwide.

Major Programs and Activities

The USPTO is responsible for granting U.S. patents and registering trademarks. This system of secured property rights, which has its foundation in Article I, Section 8, Clause 8, of the Constitution (providing that Congress shall have the power to “promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries”) has enabled American industry to flourish. New products have been invented, new uses for old ones discovered, and employment opportunities created for millions of Americans. The continued demand for patents and trademarks underscores the importance to the U.S. economy of effective mechanisms to protect new ideas and investments in innovation, as well as the ingenuity of American inventors and entrepreneurs.

In addition to granting patents and trademarks, the USPTO advises the President of the United States, the Secretary of Commerce, and U.S. government agencies on intellectual property (IP) policy, protection, and enforcement; and promotes strong and effective IP protection around the world. The USPTO furthers effective IP protection for U.S. innovators and entrepreneurs worldwide by working with ther agencies to secure strong IP provisions in free trade and other international agreements. It also provides training, education, and capacity building programs designed to foster respect for IP and encourage the development of strong IP enforcement regimes by U.S. trading partners. As part of its work, the USPTO administers regulations located at title 37 of the Code of Federal Regulations concerning its patent and trademark services and the other functions it performs.

The USPTO's Regulatory Plan Actions

1. Final Rule: Changes to Implement Provisions of the Trademark Modernization Act of 2020 (0651-AD55): The USPTO amends the rules of practice in trademark cases to implement provisions of the Trademark Modernization Act of 2020. This rule establishes ex parte expungement and reexamination proceedings for cancellation of a registration when the required use in commerce of the registered mark has not been made; provides for a new nonuse ground for cancellation before the Trademark Trial and Appeal Board; establishes flexible USPTO action response periods; and amends the existing letter-of-protest rule to indicate that letter-of-protest determinations are final and non-reviewable. The rule also sets fees for petitions requesting institution of ex parte expungement and reexamination proceedings, and for requests to extend USPTO action response deadlines.

The two new ex parte proceedings created by this rulemaking—one for expungement and one for reexamination—are intended to help ensure the accuracy of the trademark register by providing a new mechanism for removing a registered mark from the trademark register or cancelling the registration as to certain goods and/or services, when the registrant has not used the mark in commerce. The proposed changes will give U.S. businesses new tools to clear away unused registered trademarks from the federal trademark register and will give the USPTO the ability to move applications through the system more efficiently.

Bureau of Industry and Security

BIS advances U.S. national security, foreign policy, and economic objectives by maintaining and strengthening adaptable, efficient, and effective export control and treaty compliance systems as well as by administering programs to prioritize certain contracts to promote the national defense and to protect and enhance the defense industrial base.

Major Programs and Activities

BIS administers four sets of regulations. The Export Administration Regulations (EAR) regulate exports and reexports to protect national security, foreign policy, and short supply interests. The EAR includes the Commerce Control List (CCL), which describes commodities, software, and technology that are subject to licensing requirements for specific reasons for control. The EAR also regulates U.S. persons' participation in certain boycotts administered by foreign governments. The National Security Industrial Base Regulations provide for prioritization of certain contracts and allocations of resources to promote the national defense, require reporting of foreign government-imposed offsets in defense sales, provide for surveys to assess the capabilities of the industrial base to support the national defense, and address the effect of imports on the defense industrial base. The Chemical Weapons Convention Regulations implement declaration, reporting, and on-site inspection requirements in the private sector necessary to meet United States treaty obligations under the Chemical Weapons Convention treaty. The Additional Protocol Regulations implement similar requirements for certain civil nuclear and nuclear-related items with respect to an agreement between the United States and the International Atomic Energy Agency.

BIS also has an enforcement component with nine offices covering the United States, as well as BIS export control officers stationed at several U.S. embassies and consulates abroad. BIS works with other U.S. Government agencies to promote coordinated U.S. Government efforts in export controls and other programs. BIS participates in U.S. Government efforts to strengthen multilateral export control regimes and promote effective export controls through cooperation with other governments.

In FY 2022, BIS plans to publish a number of proposed and final rules amending the EAR. These rules will cover a range of issues, including emerging and foundational technology, country specific policies, CCL revisions based on decisions by the four multilateral export control regimes (Australia Group, Missile Technology Control Regime, Nuclear Suppliers Group, and Wassenaar Arrangement), and implementation of any interagency agreed transfers from the United States Munitions List to the CCL.

BIS's Regulatory Plan Actions

1. Authorization of Certain “Items” to Entities on the Entity List in the Context of Specific Standards Activities (0694-AI06): BIS is amending the EAR to clarify its applicability to releases of technology for standards setting or development to support U.S. participation in standards efforts.

2. Commerce Control List: Implementation of Controls on “Software” Designed for Certain Automated Nucleic Acid Assemblers and Synthesizers (0694-AI08): BIS is publishing this final rule to amend the CCL by adding a new Export Control Classification Number (ECCN) 2D352 to control software that is designed for automated nucleic acid assemblers and synthesizers controlled under ECCN 2B352.j and capable of designing and building functional genetic elements from digital sequence data. These amendments to the CCL are based upon a finding, consistent with the emerging and foundational technologies interagency process set forth in section 1758 of the Export Control Reform Act of 2018 (ECRA) (50 U.S.C. 4817), that such software is capable of being utilized in the production of pathogens and toxins and, consequently, the absence of export controls on such software could be exploited for biological weapons purposes.

3. Information Security Controls: Cybersecurity Items (0694-AH56): In 2013, the Wassenaar Arrangement (WA), a multilateral export control regime in which the United States participates, added cybersecurity items to the WA List, including a definition for “intrusion software.” In 2015, public comments on a BIS proposed implementation rule revealed serious issues concerning scope and implementation regarding these controls. Based on these comments, as well as substantial commentary from Congress, the private sector, academia, civil society, and others on the potential unintended consequences of the 2013 controls, the U.S. government returned to the WA to renegotiate the controls. This interim final rule outlines the progress the United States has made in this area, revises implementation, and requests from the public information about the impact of these revised controls on U.S. industry and the cybersecurity community. These items warrant controls because these tools could be used for surveillance, espionage, or other actions that disrupt, deny or degrade the network or devices on it.

4. Imposition of Export Controls on Certain Brain-Computer Interface (BCI) Emerging Technology (0694-AI41): Section 1758 of ECRA, as codified under 50 U.S.C. 4817, authorizes BIS to establish appropriate controls on the export, reexport or transfer (in-country) of emerging and foundational technologies. Pursuant to ECRA, BIS has identified Brain Computer Interface technology as part of a representative list of technology categories for which BIS will seek public comment to determine whether this is an emerging technology that is important to U.S. national security and for which effective controls can be implemented. In this Advance Notice of Proposed Rulemaking, BIS is seeking comments specifically concerning whether this technology could provide the United States, or any of its adversaries, with a qualitative military or intelligence advantage. In addition, BIS is seeking public comments on how to ensure that the scope of any controls that may be imposed on this technology in the future would be effective and appropriate with respect to their potential impact on legitimate commercial or scientific applications.

5. Foundational Technologies: Proposed Controls (0694-AH80): BIS is considering expanding controls on certain foundational technologies. Foundational technologies may be items that are currently subject to control for military end use or military end user reasons. Additionally, foundational technologies may be additional items, for which an export license is generally not required (except for certain countries), that also warrant review to determine if they are foundational technologies essential to the national security. For example, such controls may be reviewed if the items are being utilized or are required for innovation in developing conventional weapons or enabling foreign intelligence collection activities or weapons of mass destruction applications. In an effort to address this concern, this proposed rule would amend the CCL by adding controls on certain aircraft reciprocating or rotary engines and powdered metals and alloys. This rule requests public comments to ensure that the scope of these proposed controls will be effective and appropriate, including with respect to their potential impact on legitimate commercial or scientific applications.

6. Removal of Certain General Approved Exclusions (GAEs) Under the Section 232 Steel and Aluminum Tariff Exclusions Process (0694-AH55): On December 14, 2020, BIS published an interim final rule (the December 14 rule) that revised aspects of the process for requesting exclusions from the duties and quantitative limitations on imports of aluminum and steel discussed in three previous Commerce interim final rules implementing the exclusion process authorized by the President under section 232 of the Trade Expansion Act of 1962, as amended (232), as well as a May 26, 2020, notice of inquiry. The December 14 rule added 123 General Approved Exclusions (GAEs) to the regulations. The addition of GAEs was an important step in improving the efficiency and effectiveness of the 232 exclusions process for certain Harmonized Tariff Schedule of the United States (HTSUS) codes for steel and aluminum that had not received objections. Commerce determined it could authorize imports under GAEs for these specified HTSUS codes for all importers instead of requiring each importer to submit an exclusion request. Subsequently, based on Commerce's review of the public comments received in response to the December 14 rule and additional analysis conducted by Commerce of 232 exclusion request submissions, Commerce determined that a subset of the GAEs added in the December 14 rule did not meet the criteria for inclusion as a GAE and should therefore be removed. Commerce is removing these GAEs in this interim final rule to ensure that only those GAEs that meet the stated criteria from the December 14 rule will continue to be included as eligible GAEs. Lastly, this interim final rule makes two conforming changes to the GAE list for a recent change to one HTSUS classification and adds a footnote to both GAE supplements to address future changes to the HTSUS.

DOC—BUREAU OF INDUSTRY AND SECURITY (BIS)

Proposed Rule Stage

14. Section 1758 Technologies: Proposed Controls; Request for Comments [0694-AH80]

Priority: Other Significant.

Legal Authority:50 U.S.C. 4801 to 4852

CFR Citation:15 CFR 742; 15 CFR 774.

Legal Deadline: None.

Abstract: The Bureau of Industry and Security (BIS), Department of Commerce, which maintains controls on the export, reexport, and transfer (in-country) of dual-use and less sensitive military items through the Export Administration Regulations (EAR), including the Commerce Control List (CCL), is considering imposing controls pursuant to Section 1758. This rule requests public comments to ensure that the scope of these proposed controls will be effective and appropriate, including with respect to their potential impact on legitimate commercial or scientific applications.

Statement of Need: As part of the National Defense Authorization Act (NDAA) for Fiscal Year 2019 (Public Law 115-232), Congress enacted the Export Control Reform Act of 2018 (ECRA) (50 U.S.C. 4817). Section 1758 of ECRA authorizes the Bureau of Industry and Security (BIS) to establish appropriate controls on the export, reexport, or transfer (in-country) of emerging and foundational technologies. With this proposed rule, BIS continues to identify technologies that may warrant more restrictive controls than they have at present and establishes a control framework applicable to certain unilaterally-controlled emerging and foundational technologies.

Summary of Legal Basis: There are a variety of legal authorities under which BIS operates. However, ECRA (50 U.S.C. 4817) provides the most substantive legal basis for BIS's actions under this proposed rule.

Alternatives: There are not alternatives to this rule. This rule serves as the first tranche of controls specifically outlining foundational technologies.

Anticipated Cost and Benefits: The anticipated costs and benefits of this proposed rule are not applicable.

Risks: There are no applicable risks to this proposed rule.

Timetable:

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Logan D. Norton, Department of Commerce, Bureau of Industry and Security, 1401 Constitution Avenue, Washington, DC 20230, Phone: 202 812-1762, Email: logan.norton@bis.doc.gov.

RIN: 0694-AH80

DOC—BIS

15. The Imposition of Emerging Technology Export Controls on Instruments for the Automated Chemical Synthesis of Peptides [0694-AI84]

Priority: Other Significant.

Legal Authority:50 U.S.C. 4817(a)(2)(C)

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: The Bureau of Industry and Security (BIS) has identified instruments for the automated synthesis of peptides (automated peptide synthesizers) for evaluation according to the criteria in section 1758 of the Export Control Reform Act of 2018 (ECRA) pertaining to emerging and foundational technologies. On September 13, 2022, BIS published an advance notice of proposed rulemaking (87 FR 55930) that requested public comments on the potential uses of this technology, particularly with respect to its impact on U.S. national security ( e.g., whether such technology could provide the United States, or any of its adversaries, with a qualitative military or intelligence advantage). Taking into consideration the public comments on BIS's September 2022 ANPRM, this rule proposes to implement export controls on certain automated peptide synthesizers, consistent with the criteria in section 1758 of ECRA.

Statement of Need: Recent advances in peptide synthesis technology and instrumentation have increased both the speed of peptide synthesis and the length of peptide products, including peptides and proteins greater than 100 amino acids in length. Most protein toxins that are controlled under Export Control Classification Number (ECCN) 1C351 on the Commerce Control List (CCL) (see Supplement No. 1 to part 774 of the EAR) are over 100 amino acids in length and have an average length of 300 amino acids (with the notable exception of conotoxins, which range between 10-100 amino acids in length). Consequently, absent the imposition of additional controls on the export, reexport or transfer (in-country) of certain peptide synthesis technology and instrumentation ( e.g., automated peptide synthesizers), there would be an increased risk that such technology and instrumentation could be used to produce controlled toxins for biological weapons purposes.

Summary of Legal Basis: Certain instruments for the automated synthesis of peptides (automated peptide synthesizers) have been identified by BIS for evaluation according to the criteria in Section 1758 of the Export Control Reform Act of 2018 (ECRA) (50 U.S.C. 4801-4852) pertaining to emerging and foundational technologies.

Alternatives: Consistent with 5 U.S.C. 603(c), BIS is considering significant alternatives to the imposition of controls on automated peptide synthesizers and will assess whether the alternatives would: (1) accomplish the stated objectives of this rule (consistent with the Section 1758 requirements in ECRA); and (2) minimize any significant economic impact of this rule on U.S. industry and academia. BIS could impose broad controls on automated peptide synthesizers that would capture most of these instruments. However, that option would have a greater impact not only on small businesses, but also on research and development laboratories (both academic and corporate), which are involved in advancing biological technology. BIS is considering focused controls on automated peptide synthesizers that are determined to be capable of posing a greater risk of diversion to biological weapons activities. BIS considers that this approach would be the least disruptive alternative for implementing export controls in a manner consistent with controlling technology that has been determined, through the Section 1758 technology interagency process authorized under ECRA, to be essential to U.S. national security.

Anticipated Cost and Benefits: BIS estimates that it will receive roughly 15 license applications per year if Section 1758 export controls are imposed on automated peptide synthesizers. To the extent that compliance with these controls would impose a burden on U.S. industry and academia, BIS believes the burden would be minimal. In addition, the reclassification process would need to be done only once per license applicant for exports, reexports or transfers (in-country) of these items and, consequently, would constitute a one-time burden for each applicant. Similarly, assessing the availability of license exceptions and/or applying for and using BIS licenses would impose some minimal burden on affected persons. The benefit, from a national security perspective, would be the imposition of export controls on those automated peptide synthesizers that are determined to be capable of posing a greater risk of diversion to biological weapons activities.

Risks: The imposition of overly broad (or otherwise improperly targeted) Section 1758 export controls on peptides or peptide synthesizers could impair the ability of companies in the United States to compete effectively with potential competitors in other countries, which could adversely affect the leadership of U.S. companies in the field of peptide manufacturing. On the other hand, failure to impose controls that effectively target those automated peptide synthesizers that could be of concern for biological weapons purposes, could increase the potential threat of terrorist attacks involving toxins produced by such synthesizers.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Willard Fisher, Export Administration Specialist, Department of Commerce, Bureau of Industry and Security, 14th Street and Pennsylvania Avenue NW, Washington, DC 20230, Phone: 202 482-2440, Fax: 202 482-3355, Email: willard.fisher@bis.doc.gov.

RIN: 0694-AI84

DOC—NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY (NIST)

Final Rule Stage

16. Updates to Bayh-Dole Implementing Regulations [0693-AB66]

Priority: Other Significant.

Legal Authority:37 U.S.C. 206 et seq.

CFR Citation:37 CFR 401; 37 CFR 404; 37 CFR 501.

Legal Deadline: None.

Abstract: The revisions will add language to provide additional clarity in subject invention and utilization reporting requirements, U.S. industry preference, and other regulations that impact the transfer of technology from federally funded research and development. The final rule aims to improve the transition of federally funded innovations from the laboratory to the marketplace by reducing the regulatory burdens for technology transfer.

Statement of Need: This rule would revise the Bayh Dole Act implementing regulations in order to make technical corrections; reorganize certain subsections; remove outdated and/or unnecessary sections; improve reporting by federal agencies; and provide clarifications.

Summary of Legal Basis: The rule revisions would be promulgated under the University and Small Business Patent Procedures Act of 1980, Public Law 96-517 (as amended), codified at 35 U.S.C. 200 et seq., commonly known as the Bayh-Dole Act or Bayh-Dole.

Alternatives: There are not alternatives to this rule.

Anticipated Cost and Benefits: The action would remove duplicative text, streamline the implementing regulations, and reduce regulatory burdens, all at no additional cost.

Risks: There are no applicable risks to this rule.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Agency Contact: Henry N. Wixon, Chief Counsel for NIST, Department of Commerce, National Institute of Standards and Technology, 100 Bureau Drive, Stop 1052, Gaithersburg, MD 20899-1052, Phone: 301 975-2803, Fax: 301 926-6241, Email: henry.wixon@nist.gov.

RIN: 0693-AB66

DOC—NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION (NOAA)

Final Rule Stage

17. Illegal, Unreported, and Unregulated Fishing; Fisheries Enforcement; High Seas Driftnet Fishing Moratorium Protection Act [0648-BG11]

Priority: Other Significant.

Legal Authority:Pub. L. 114-81

CFR Citation:50 CFR 300.

Legal Deadline: None.

Abstract: This proposed rule would make conforming amendments to regulations implementing the various statutes amended by the Illegal, Unreported and Unregulated Fishing Enforcement Act of 2015 (Pub. L. 114-81). The Act amends several regional fishery management organization implementing statutes as well as the High Seas Driftnet Fishing Moratorium Protection Act. It also provides authority to implement two new international agreements under the Antigua Convention, which amends the Convention for the establishment of an Inter-American Tropical Tuna Commission, and the United Nations Food and Agriculture Organization Agreement on Port State Measures to Prevent, Deter, and Eliminate Illegal, Unreported and Unregulated Fishing (Port State Measures Agreement), which restricts the entry into U.S. ports by foreign fishing vessels that are known to be or are suspected of engaging in illegal, unreported, and unregulated fishing. This proposed rule would also implement the Port State Measures Agreement. To that end, this proposed rule would require the collection of certain information from foreign fishing vessels requesting permission to use U.S. ports. It also includes procedures to designate and publicize the ports to which foreign fishing vessels may seek entry and procedures for conducting inspections of these foreign vessels accessing U.S. ports. Further, the rule would establish procedures for notification of: the denial of port entry or port services for a foreign vessel, the withdrawal of the denial of port services if applicable, the taking of enforcement action with respect to a foreign vessel, or the results of any inspection of a foreign vessel to the flag nation of the vessel and other competent authorities as appropriate.

Statement of Need: The United States is a signatory to the Port State Measures Agreement (PSMA). The agreement is aimed at combating illegal, unreported and unregulated (IUU) fishing activities through increased port inspection of foreign fishing vessels and thereby closing seafood markets to the products of illegal fishing. In addition, regulations to identify and certify nations for IUU fishing and other adverse fishing activities under the authority of the High Seas Driftnet Fishing Moratorium Protection Act must be updated to conform to statutory changes. NMFS will also propose changes to the definition of IUU fishing for the purposes of identifying and certifying nations under that Act.

Summary of Legal Basis: This action is required under several statutes: Magnuson-Stevens Fishery Conservation and Management Act (P.L. 94-265 as amended by P.L. 109-479); Illegal, Unreported, and Unregulated Fishing Enforcement Act of 2015 (P.L. 114-81); Ensuring Access to Pacific Fisheries Act (P.L. 114-327); High Seas Driftnet Fishing Moratorium Protection Act (P.L. 104-43). The Secretary of Commerce is authorized to issue regulations to implement the statutory obligations to counter IUU fishing by foreign fishing vessels and to prevent the importation of illegally harvested seafood.

Alternatives: Alternatives to taking action at the port would include taking action at sea against IUU fishing vessels and in the supply chain against detected IUU fishing products. At-sea monitoring and inspection is part of an overall strategy to combat IUU fishing, but it is extremely expensive, resources are limited, and the U.S. has limited jurisdiction to board foreign-flag vessels at sea. Likewise, tracing and removing illegal products already released into the U.S. seafood market would be difficult and resource intensive.

Preventing entry of IUU fishing vessels into ports or investigating fishing vessels at the port is an efficient and effective approach to combat illegal activity and to prevent illegal products from entering the supply chain. There are no alternatives to the conforming amendments to the High Seas Driftnet Fishing Moratorium Protection Act. Without these changes, the implementing regulations would not be consistent with the revised statute. However, the statute authorizes the Secretary of Commerce to amend the regulatory definition of IUU fishing for the purposes of identifying and certifying nations. NMFS has considered several activities that constitute illegal fishing and proposes amendments to the definition to counter these forms of IUU fishing. Alternatives to amending the IUU fishing definition would include the adoption of binding measures at regional fishery organizations to counter the activities of concern. While NMFS is pursuing this approach, amending the definition provides a more direct means of addressing the problem through the identification of nations and potential trade restrictions.

Anticipated Cost and Benefits: The anticipated costs will be minimal in that foreign vessels requesting permission to visit U.S. ports are already required to report. Under this rule, fishing vessel masters will have to include more information about the vessel and its cargo when they submit an electronic notice of arrival to the U.S. Coast Guard. Based on the information submitted, NMFS may deny port privileges for vessels known to have engaged in illegal fishing or may meet the vessel in port to conduct an inspection. The minimal additional data elements required of foreign fishing vessels will be submitted through the existing U.S. Coast Guard system for electronic Notices of Arrival and Departure, thus reporting costs are not anticipated to affect shipping patterns, port usage, or international commerce. In addition, vessel inspections will be coordinated and planned based on the notice of arrival submitted prior to entry into port, thus delays for inspection will be minimal and not result in significant costs to legitimate vessels. Benefits of the rule will accrue when IUU vessels are denied entry, and illegal seafood products are precluded from the U.S. supply chain, thereby maintaining higher prices and market share for legitimate producers of fishery products. In addition, benefits will accrue from reduced costs of inspection and monitoring at ports of entry due to the advance notice provided and the ability of NMFS and Coast Guard to take a risk management approach to vessel inspection. Should the United States impose trade restrictions on foreign nations due to the expanded definition of IUU fishing, some costs would be borne by U.S. importers who would have to adjust their supply chains. However, many U.S. importers and seafood dealers are already adjusting supply chains to respond to consumer demand for lawfully-acquired, sustainable and environmentally responsible seafood. The benefits of additional steps to counter IUU fishing will accrue to law-abiding harvesters, processors and traders as fish stocks are recovered and they no longer must compete with illegitimate products in the supply chain.

Risks: If the port entry reporting and inspection provisions of this rule were not implemented, there is an increased risk of IUU fishing vessels entering U.S. ports and/or the products of IUU fishing infiltrating the U.S. supply chain. In addition, the U.S. would be out of compliance with its international obligations under the PSMA. If the revisions to the High Seas Driftnet Fishing Moratorium Protection Act are not implemented through conforming amendments to the regulations and through additions to the definition of IUU fishing, nations might not be identified under the statute, therefore diminishing the likelihood of corrective actions to counter IUU fishing.

Timetable:

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Alexa Cole, Director, Office of International Affairs and Seafood Inspection, Department of Commerce, National Oceanic and Atmospheric Administration, 1315 East-West Highway, Silver Spring, MD 20910, Phone: 301 427-8286, Email: alexa.cole@noaa.gov.

RIN: 0648-BG11

DOC—NOAA

18. Amendments to the North Atlantic Right Whale Vessel Strike Reduction Rule [0648-BI88]

Priority: Other Significant.

Legal Authority:16 U.S.C. 1361 et seq.;16 U.S.C. 1531 et seq.

CFR Citation:50 CFR 224.

Legal Deadline: None.

Abstract: NMFS has completed a review of the North Atlantic right whale vessel speed rule (per 50 CFR 224.105; 78 FR 73726, December 9, 2013). Through this action, NMFS invites comment on the report as well as information that may inform potential revisions to existing management strategies and regulations to further reduce the risk of vessel strikes of North Atlantic right whales.

Statement of Need: This action is needed to further reduce the likelihood of mortalities and serious injuries to endangered North Atlantic right whales from vessel collisions, which are a leading cause of the species' decline and contributing to the ongoing Unusual Mortality Event (2017-present). Following two decades of growth, the species has been in decline over the past decade with a best population estimate of fewer than 350 individuals. Entanglement in fishing gear and vessel strikes are the two primary causes of North Atlantic right whale mortality and serious injury across their range, and human-caused mortality to adult females, in particular, is limiting recovery of the species.

Summary of Legal Basis: NMFS is implementing this rule pursuant to its rulemaking authority under MMPA section 112(a) (16 U.S.C. 1382(a)), and ESA section 11(f) (16 U.S.C. 1540(f)).

Alternatives: In January 2021, NMFS released, and solicited public comment on, an assessment of the current right whale vessel speed rule (50 CFR 224.105). The assessment highlighted the need to address collision risk from vessels less than 65 ft in length and modify the boundaries and timing of Seasonal Management Areas (SMAs) to better reflect current whale and vessel traffic distribution, along with other recommendations to improve vessel strike mitigation efforts. In 2022, NMFS completed a coastwide right whale vessel strike risk model (Garrison et al. 2022), which informed development of the proposed modifications to the existing speed rule. At the proposed rule stage, there are a number of alternatives considered in the draft Regulatory Impact Review and draft Environmental Assessment. The Preferred Alternative would modify the spatial and temporal boundaries of the existing SMAs to create newly proposed Seasonal Speed Zones (SSZs), add smaller vessels down to 35 ft in length, and establish a mandatory Dynamic Speed Zone program.

Anticipated Cost and Benefits: Under the Preferred Alternative, NMFS estimated modifications to the speed rule would cost just over $46 million per year. Estimated costs would be borne primarily by the owners and operators of vessels currently transiting within newly expanded portions of SSZs along the U.S. East Coast. Owners and operators of vessels of applicable size classes that regularly transit within active SSZs at speeds in excess of 10 knots would be most affected. Vessels operating in the Northeast and Mid-Atlantic regions are expected to bear the majority of costs (89%). Potential benefits stemming from this action include a reduction in North Atlantic right whale mortalities and serious injuries resulting from collisions with vessels, with potential reduction in vessel strike risk for other large whale species.

Risks: This will be a high-profile action and is essential to ensure long-term recovery of North Atlantic right whales. Given the endangered status of the North Atlantic right whale, the large geographic area, and number of stakeholders subject to the updated regulations, modification to the current speed rule will be both controversial and of high interest. Changes to the current speed rule are necessary to: (1) address a misalignment between existing Seasonal Management Areas and places/times with elevated strike risk, and (2) mitigate currently unregulated lethal strike risk from vessels 35-65 ft in length.

Timetable:

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Kim Damon-Randall, Director, Office of Protected Resources, Department of Commerce, National Oceanic and Atmospheric Administration, 1315 East-West Highway, Silver Spring, MD 20910, Phone: 301 427-8400, Email: kimberly.damon-randall@noaa.gov.

Related RIN: Related to 0648-AS36

RIN: 0648-BI88

DOC—PATENT AND TRADEMARK OFFICE (PTO)

Proposed Rule Stage

19. • Setting and Adjusting Trademark Fees [0651-AD65]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Legal Authority:Pub. L. 112-29

CFR Citation:37 CFR 2.

Legal Deadline: None.

Abstract: The United States Patent and Trademark Office (USPTO or Office) takes this action to set and adjust Trademark fee amounts to provide the Office with a sufficient amount of aggregate revenue to recover its aggregate cost of operations while helping the Office maintain a sustainable funding model, ensure the integrity of the Trademark register, and promote efficiency of processes.

Statement of Need: The purpose of this rule is to set and adjust trademark fee amounts to provide sufficient aggregate revenue to cover the agency's aggregate cost of operations. To this end, this rule creates new or changes existing fees for trademark services.

Summary of Legal Basis: The Leahy-Smith America Invents Act (AIA), enacted in 2011, provided USPTO with the authority to set and adjust its fees for patent and trademark services. This authority was extended by the Study of Underrepresented Classes Chasing Engineering and Science Success (SUCCESS) Act of 2018. Since then, USPTO has conducted an internal biennial fee review, in which it undertook internal consideration of the current fee structure, and considered ways that the structure might be improved, including rulemaking pursuant to the USPTO's fee-setting authority. This fee review process involves public outreach, including, as required by the Act, a public hearing held by the USPTO's Trademark Public Advisory Committee, as well as public comment and other outreach to the user community and public in general.

Alternatives: This rulemaking action is currently in development and alternatives have not yet been determined.

Anticipated Cost and Benefits: This rulemaking action is currently in development and aggregate annual economic impacts have not yet been determined. The user fees charged by the USPTO for its services are considered transfer payments that do not affect the total resources available to society, and therefore the changes to trademark fees proposed by this rulemaking are transfers, and are not costs of this rulemaking.

Risks: The USPTO will set and adjust trademark fee amounts to provide the Office with a sufficient amount of aggregate revenue to recover its aggregate cost of operations while helping the Office maintain a sustainable funding model, ensure the integrity of the Trademark register, and promote efficiency of processes. Therefore, one risk of taking no action could be that USPTO might not be able to recover its aggregate costs of operations in the long run.

Timetable:

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Organizations.

Government Levels Affected: None.

Agency Contact: Brendan Hourigan, Director, Office of Planning and Budget, Department of Commerce, Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450, Phone: 571 272-8966, Fax: 571 273-8966, Email: brendan.hourigan@uspto.gov.

RIN: 0651-AD65

DEPARTMENT OF DEFENSE

Statement Of Regulatory Priorities

Background

The Department of Defense (DoD) is the largest Federal department, employing over 1.6 million military personnel and 750,000 civilians with operations all over the world. DoD's enduring mission is to provide combat-credible military forces needed to deter war and protect the security of our nation. To guide this mission, the Secretary of Defense has outlined three top priorities, which are to defend the nation, take care of our people, and succeed through teamwork. In addition, the National Defense Strategy sets out how DoD will contribute to advancing and safeguarding vital U.S. national interests—protecting the American people, expanding America's prosperity, promoting global security, seizing new strategic opportunities, and realizing and defending our democratic values. Because of this expansive and diversified mission and reach, DoD regulations can address a broad range of matters and have an impact on varied members of the public, as well as other federal agencies.

Pursuant to Executive Order 12866, “Regulatory Planning and Review” (September 30, 1993) and Executive Order 13563, “Improving Regulation and Regulatory Review” (January 18, 2011), the DoD issues this Regulatory Plan and Agenda to provide notice about the DoD's regulatory and deregulatory actions.

Retrospective Review of Existing Regulations

Pursuant to section 6 of Executive Order 13563 “Improving Regulation and Regulatory Review” (January 18, 2011), the Department continues to review existing regulations with a goal to eliminate outdated, unnecessary, or ineffective regulations; account for the currency and legitimacy of each of the Department's regulations; and ultimately reduce regulatory burden and costs.

DOD Priority Regulatory Actions

The regulatory and deregulatory actions identified in this Regulatory Plan embody the core of DoD's regulatory priorities for Fiscal Year (FY) 2023 and help support President Biden's regulatory priorities, the Secretary of Defense's top priorities, and those priorities set out in the National Defense Strategy. The DoD regulatory prioritization is focused on initiatives that:

• Promote the country's economic resilience, including addressing COVID-related and other healthcare issues.
• Support underserved communities and improve small business opportunities.
• Promote competition in the American economy.
• Promote diversity, equity, inclusion, and accessibility in the Federal workforce.
• Support national security efforts, especially safeguarding Federal Government information and information technology systems.
• Tackle the climate crisis and protect the environment; and
• Address military family matters.

Rules That Promote the Country's Economic Resilience

Pandemic COVID-19 Rules

Pursuant to Executive Order 13987, “Organizing and Mobilizing the United States Government to Provide a Unified and Effective Response to Combat COVID-19 and to Provide United States Leadership on Global Health and Security,” January 20, 2021; Executive Order 13995, “Ensuring an Equitable Pandemic Response and Recovery,” January 21, 2021; Executive Order 13997, “Improving and Expanding Access to Care and Treatments for COVID-19,” January 21, 2021; and Executive Order 13999, “Protecting Worker Health and Safety,” January 21, 2021, the Department temporarily modified its TRICARE regulation so TRICARE beneficiaries have access to the most up-to-date care required for the diagnosis and treatment of COVID-19. TRICARE continues to reimburse like Medicare, to the extent practicable, as required by statute. The Department is researching the impacts of making some of those modifications permanent and may pursue such future action.

These modifications include:

TRICARE Coverage of National Institute of Allergy and Infectious Disease—Coronavirus Disease 2019 Clinical Trials. RIN 0720-AB83

This final rule is required to finalize certain temporary flexibilities enacted in interim final rules published in 2020 in response to the COVID-19 pandemic. This rule finalizes provisions published in two interim final rules (IFRs) with request for comment, which temporarily added coverage for the treatment use of investigation drugs under U.S. Food and Drug Administration (FDA) approved expanded access programs when for the treatment of coronavirus disease 2019 (COVID-19) and permitted coverage of National Institute of Allergy and Infectious Disease (NIAID)-sponsored clinical trials for the treatment or prevention of COVID-19.

Expanding TRICARE Access to Care in Response to the COVID-19 Pandemic. RIN 0720-AB85

This interim final rule with comment will temporarily amend the TRICARE regulation at 32 CFR part 199 by: (1) adding freestanding End Stage Renal Disease facilities as a category of TRICARE-authorized institutional provider and modifying the reimbursement for such facilities; and (2) adopting Medicare New COVID-19 Treatments Add-on Payments (NTCAPs). The TRICARE regulation is temporarily being modified (except for the modifications to paragraphs 199.6(b)(4)(xxi) and 199.14(a)(1)(iii)(E)(7), which will not expire), but, in each case, only to the extent necessary to ensure that TRICARE beneficiaries have access to the most up-to-date care required for the prevention, diagnosis, and treatment of COVID-19, and that TRICARE continues to reimburse like Medicare, to the extent practicable, as required by statute. The modifications to paragraphs 199.6(b)(4)(xxi) and 199.14(a)(1)(iii)(E)(7) establish freestanding End Stage Renal Disease (ESRD) facilities as a category of TRICARE-authorized institutional provider and modify TRICARE reimbursement of freestanding ESRD facilities. These provisions will improve TRICARE beneficiary access to medically necessary dialysis and other ESRD services and supplies. These provisions also support the requirement that TRICARE reimburse like Medicare, and will help to alleviate regional health care shortages due to the COVID-19 pandemic by ensuring access to dialysis care in freestanding ESRD facilities rather than hospital outpatient departments. The modification to paragraph 199.14(a)(iii)(E) adopts Medicare's New COVID-19 Treatments Add-on Payment (NCTAP) for COVID-19 cases that meet Medicare's criteria. This provision increases access to emerging COVID-19 treatments and supports the requirement that TRICARE reimburse like Medicare.

Restriction on Acquisition of Personal Protective Equipment and Certain Items From Non-Allied Foreign Nations (DFARS Case 2022-D009). RIN 0750-AL60

This rule implements section 802 of the National Defense Authorization Act for Fiscal Year 2022, which prohibits acquisition of personal protective equipment related to healthcare and certain other healthcare-related items from non-allied foreign nations. Decreasing dependence on personal protective equipment and certain other items originating in non-allied foreign nations is a matter of public health and national security, especially during a declared public health emergency. The domestic supply chain for personal protective equipment and certain other items is critical. An adequate continued supply is vital to ensure domestic control with minimal disruption in production and to reduce U.S. dependence on non-allied foreign nations. Potential benefits of this rule will be the elimination of counterfeit covered items within the domestic supply chain and reduced dependence on foreign sources that are not allies of the United States. In addition, this restriction will further promote growth in domestic capabilities and may provide additional opportunities to domestic small businesses for future procurement and manufacturing efforts, increasing domestic sourcing of personal protective equipment and other covered items.

Medical Debt Relief

Collection From Third Party Payers of Reasonable Charges for Healthcare Services. RIN 0720-AB87

This rule discusses new debt waiver process for medical debt owed for services rendered at Military Treatment Facilities to civilians who are not covered beneficiaries and implements section 702 of the FY 2021 NDAA. Under section 702, the Secretary of Defense may waive a fee charged to a civilian who is not a covered beneficiary if after any insurance payments the civilian is not able to pay for the trauma or other medical care provided to the civilian; and the provision of such care enhanced the medical readiness of the health care provider or health care providers furnishing such care.

Executive Order 13985, “Advancing Racial Equity and Support for Underserved Communities Through the Federal Government” January 20, 2021

Rules That Promote Diversity, Equity, Inclusion, and Accessibility in the Federal Workforce

Nondiscrimination on the Basis of Disability in Program or Activities Assisted or Conducted by the DoD and in Equal Access to Information and Communication Technology Used by DoD, and Procedures for Resolving Complaints. RIN: 0790-AJ04

Revisions to this regulation: (1) update and clarify the obligations that Section 504 of the Rehabilitation Act of 1973 (section 504) imposes on recipients of Federal financial assistance and the Military Departments and Components (DoD Components); (2) reflect the most current Federal statutes and regulations, as well as developments in Supreme Court jurisprudence, regarding unlawful discrimination on the basis of disability and promotes consistency with comparable provisions implementing title II of the Americans with Disabilities Act (ADA); (3) implement section 508 of the Rehabilitation Act of 1973 (section 508), requiring DoD make its electronic and information technology accessible to individuals with disabilities; (4) establish and clarify obligations under the Architectural Barriers Act of 1968 (ABA), which requires that DoD make facilities accessible to individuals with disabilities; and (5) Provide complaint resolution and enforcement procedures pursuant to section 504 and the complaint resolution and enforcement procedures pursuant to section 508. These revisions incorporate the directive of Executive Order 14035, “Diversity, Equity, Inclusion, and Accessibility in the Federal Workforce” by defining, clarifying, advancing accessibility throughout DoD programs and activities.

USACE Implementing Procedures for Principles, Requirements, and Guidelines Applicable to Actions Involving Investment in Water Resources. RIN 0710-AB41

Section 2031 of the Water Resources Development Act of 2007 (Pub. L. 110-114) called for revisions to the 1983 Principles and Guidelines for Water and Land Related Resources Implementation Studies, resulting in the issuance of the Principles and Requirements (P&R) guidance document in March 2013 and the Interagency Guidelines in December 2014, which together comprise the Principles, Requirements, and Guidelines (PR&G). The PR&G are intended to provide a common framework and comprehensive policy and guidance for analyzing a diverse range of water resources projects, programs, activities, and related actions involving Federal investment in water resources. The U.S. Army Corps of Engineers (Corps) proposes a regulation to show how it would apply the PR&G to the Corps' mission and authorities. In this proposed regulation, the Corps intends to increase consistency and compatibility in Federal water resources investment decision making to include considerations such as analyzing a broader range of long-term costs and benefits, enhancing collaboration, including a more thorough and transparent risk and uncertainty analyses, and improving resilience for dealing with emerging challenges, including climate change.

Flood Control Cost-Sharing Requirements Under the Ability To Pay Provision. RIN: 0710-AB34

Section 103(m) of the Water Resources Development Act (WRDA) of 1986, as amended (33 U.S.C. 2213(m)), authorizes the USACE to reduce the non-Federal share of the cost of a study or project for certain communities that are not able financially to afford the standard cost-share. Part 241 of title 33 in the Code of Federal Regulations provides the criteria that the USACE uses in making these determinations where the primary purpose of the study or project is flood damage reduction. The proposed rule would update this regulation, by broadening its applicability to include projects with other purposes (instead of just flood damage reduction) and the feasibility study of a project (instead of just design and construction). The WRDA 2000 modified section 103(m) to also include the following mission areas: environmental protection and restoration, flood control, navigation, storm damage protection, shoreline erosion, hurricane protection, and recreation or an agricultural water supply project which have not yet been added to the regulation. It also included the opportunity to cost share all phases of a USACE project to also include feasibility in addition to the already covered design and construction. This rule would provide a framework for deciding which projects are eligible for consideration for a reduction in the non-Federal cost share based on ability to pay.

Rules That Support Underserved Communities and Improve Small Business Opportunities

Rules of Particular Interest to Small Business

Small Business Innovation Research Program Data Rights (DFARS Case 2019-D043). RIN 0750-AK84

This rule implements changes made by the Small Business Administration (SBA) related to data rights in the Small Business Innovation Research (SBIR) Program and Small Business Technology Transfer (STTR) Program Policy Directive, published in the Federal Register on April 2, 2019 (84 FR 12794). The SBIR and STTR programs fund a diverse portfolio of startups and small businesses across technology areas and markets to stimulate technological innovation, meet Federal research and development (R&D) needs, and increase commercialization to transition R&D into impact. The final SBA Policy Directive includes several revisions to clarify data rights, which require corresponding revisions to the Defense Federal Acquisition Regulation Supplement (DFARS). These changes include harmonizing definitions, lengthening the SBIR/STTR protection period from 5 years to 20 years, and providing for the granting of Government-purpose rights license in place of an unlimited rights license upon expiration of the SBIR/STTR protection period.

Executive Order 14036, “Promoting Competition in the American Economy” July 9, 2021

Rule That Promotes Competition in the American Economy

Past Performance of Subcontractors and Joint Venture Partners (DFARS Case 2018-D055). RIN 0750-AK16

This rule implements section 823 of the National Defense Authorization Act for Fiscal Year 2019, which establishes a requirement for use of the best available information regarding past performance of subcontractors and joint venture partners when awarding DoD construction and architect-engineer contracts. Section 823 requires annual performance evaluations for first-tier subcontractors and individual parties to joint ventures performing construction and architect-engineer contracts valued at either $750,000 or more, or 20 percent of the value of the prime contract (whichever is higher), in accordance with specified conditions. In addition, processes for exceptions from the annual evaluation requirement will be established for construction and architect-engineer contracts where submission of annual evaluations would not provide the best representation of the performance of a contractor, including subcontractors and joint venture partners under specified conditions. This rule will make it easier for subcontractors and individual parties to joint ventures to establish a record of their past performance. These entities will be able to take credit for the work they performed on contracts and subcontracts, which will help them be more competitive when bidding on future DoD contracts. This will help increase competition for DoD contracts.

Defense Commercial Solutions Opening (DFARS Case 2022-D006). RIN 0750-AL57

This rule implements section 803 of the National Defense Authorization Act for Fiscal Year 2022 (Pub. L. 117-81), which establishes a permanent authority for the Secretary of Defense and those of the military departments to acquire innovative commercial products and commercial services through a competitive selection of proposals resulting from a general solicitation and the peer review of such proposals. Products and services purchased under this authority are treated as commercial. This rule will enable DoD to access innovative products and services of entities that may not have done business with DoD in the past. Such entities may compete for additional DoD contracts, thereby increasing competition for DoD contracts.

Modification of Prize Authority for Advanced Technology Achievements (DFARS Case 2022-D014). RIN 0750-AL65

This rule implements section 822 of the National Defense Authorization Act for Fiscal Year 2022 (Pub. L. 117-81). Section 822 revises 10 U.S.C. 2374a regarding the award of prizes for advanced technology achievement to: (1) authorize the award of procurement contracts and other agreements “as another type of prize” (as in other than cash prizes); (2) permit the award of prizes, including procurement contracts and other agreements, in excess of $10,000,000 with the approval of the Under Secretary of Defense for Research and Engineering; and (3) require DoD provide Congress with notice of an award of a procurement contract or other agreement under this program that exceeds $10 million. This rule will help to expand the Defense Industrial Base, thereby increasing competition for future DoD contracts.

DFARS Buy American Act Requirements (DFARS Case 2022-D019). RIN 0750-AL74

This rule implements the requirements of Executive Order 14005, Ensuring the Future Is Made in All of America by All of America's Workers. Changes to the Federal Acquisition Regulation (FAR) are being made via RIN 9000-AO22 (FAR Case 2021-008, Amendments to the FAR Buy American Act Requirements). This rule proposes conforming changes to the DFARS.

Rules That Support National Security Efforts

Assessing Contractor Implementation of Cybersecurity Requirements (DFARS Case 2019-D041). RIN 0750-AK81

The purpose of this rule is to ensure that Defense Industrial Base (DIB) contractors will adequately protect sensitive unclassified information at a level commensurate with the risk, accounting for information flow down to its subcontractors in a multi-tier supply chain.

Cybersecurity Maturity Model Certification (CMMC) Program. RIN 0790-AL49

This rule establishes a requirement for Defense Industrial Base (DIB) contractors to be assessed against the Cybersecurity Maturity Model Certification (CMMC) 2.0 in order to qualify for award of designated future DoD contracts. This model is designed to provide increased assurance to the Department that contractors are compliant with existing information security standards for Federal Contract Information (FCI) and Controlled Unclassified Information (CUI) and are fully capable of protecting such information at a level commensurate with risk from cybersecurity threats.

Department of Defense (DoD)-Defense Industrial Base (DIB) Cybersecurity (CS) Activities. RIN: 0790-AK86

This rule will allow a broader community of defense contractors to access to relevant cyber threat information the Department believes is critical in defending unclassified networks and information systems and protecting DoD warfighting capabilities. These revisions seek to address the increasing cyber threat targeting all defense contractors by expanding eligibility to defense contractors that process, store, develop, or transmit DoD Controlled Unclassified Information (CUI). This rule is part of DoD's approach to collaborate with industry to counter cyber threats through information sharing.

Rules That Tackle the Climate Crisis and Protect the Environment

Policy and Procedures for Processing Requests To Alter U.S. Army Corps of Engineers Civil Works Projects Pursuant to 33 U.S.C. 408. RIN: 0710-AB22

Where a party other than the USACE seeks to use or alter a Civil Works project that USACE constructed, the proposed use or alteration is subject to the prior approval of the USACE. Some examples of such alterations include an improvement to the project; relocation of part of the project; or installing utilities or other non-project features. These alterations may be proposed by local or state governments, other federal agencies, private corporations, or private citizens, for example. This requirement was established in section 14 of the Rivers and Harbors Act of 1899 and is codified at 33 U.S.C. 408 (section 408). Section 408 provides that the USACE may grant permission for another party to alter a Civil Works project, upon a determination that the alteration proposed will not be injurious to the public interest and will not impair the usefulness of the Civil Works project. The USACE is proposing to convert its policy that governs the section 408 program to a binding regulation. This policy, Engineer Circular 1165-2-220, Policy, and Procedural Guidance for Processing Requests to Alter U.S. Army Corps of Engineers Civil Works Projects Pursuant to 33 U.S.C. 408, was issued in September 2018.

Natural Disaster Procedures: Preparedness, Response, and Recovery Activities of the Corps of Engineers. RIN 0710-AA78

The U.S. Army Corps of Engineers (Corps) is proposing to update the Federal regulation that covers the procedures that the Corps uses under section 5 of the Flood Control Act of 1941, as amended (33 U.S.C. 701n), commonly referred to as Public Law 84-99. The Corps relies on this program to prepare for, respond to, and help communities recover from a flood, hurricane, or other natural disaster, including the repair of damage to eligible flood risk reduction infrastructure. The Corps initiated this rulemaking process through an advanced notice of proposed rulemaking (ANPRM) on February 13, 2015. As a next step, the Corps is planning to propose revisions to the program to address statutory changes under various Water Resources Development Act provisions and to formalize certain agency guidance relating to natural disaster procedures. Hurricane Katrina (2005), Hurricane Sandy (2012), flooding on the Mississippi and Missouri Rivers (2008, 2011, and 2013), and Hurricanes Harvey, Irma, and Maria (2017) have provided a more detailed understanding of the nature and severity of risk associated with flood control projects. In addition, the maturation of risk-informed decision-making approaches and technological advancements influenced the outlook on the implementation of Public Law 84-99 activities, with a shift toward better alignment with Corps Levee Safety and National Flood Risk Management Programs, as well as the National Preparedness and Response Frameworks. Through these programs, the Corps works with non-Federal sponsors and stakeholders to assess, communicate, and manage the risks to people, property, and the environment associated with levee systems and flood risks.

Credit Assistance for Water Resources Infrastructure Projects. RIN: 0710-AB31

The USACE proposes to implement a new credit program for dam safety work at non-Federal dams. The program is authorized under the Water Infrastructure Finance and Innovation Act of 2014 (WIFIA) and Division D, Title 1 of the Consolidated Appropriations Act of 2021. WIFIA authorizes the USACE to provide secured (direct) loans and loan guarantees (Federal Credit instruments) to eligible water resources infrastructure projects and to charge fees to recover all or a portion of the USACE' cost of providing credit assistance and the costs of conducting engineering reviews and retaining expert firms, including financial and legal services, to assist in the underwriting and servicing of Federal credit instruments. Projects would be evaluated and selected by the Secretary of the Army (the Secretary), based on the requirements and the criteria described in this rule.

Appendix C Procedures for the Protection of Historic Properties. RIN 0710-AB46

The U.S. Army Corps of Engineers (Corps) considers the effects of its actions on historic properties pursuant to section 106 of the National Historic Preservation Act (NHPA). The Corps' Regulatory Program's regulations for complying with the NHPA are outlined at 33 CFR 325 Appendix C. Since these regulations were promulgated in 1990, there have been amendments to the NHPA and revisions to the Advisory Council on Historic Preservation's (ACHP) regulations at 36 CFR part 800. In response, the Corps issued interim guidance until rulemaking could be completed in order to ensure full compliance with the NHPA and ACHP's regulations. Appendix C is intended to provide the implementing procedures for the Regulatory Program's compliance with Section 106 of the National Historic Preservation Act.

Rulemaking is required to ensure the Regulatory Program is compliant with the NHPA and ACHP's implementing regulations at 36 CFR 800 for federal agency compliance with Section 106.

Revised Definition of “Waters of the United States”—Rule 1 RIN: 0710—AB40. Related RIN: 2040-AG19

In April 2020, the EPA, and the Department of the Army (“the agencies”) published the Navigable Waters Protection Rule (NWPR) that revised the previously codified definition of “waters of the United States” (85 FR 22250, April 21, 2020). The agencies are now initiating this new rulemaking process that restores the regulations (51 FR 41206) in place prior to the 2015 “Clean Water Rule: Definition of `Waters of the United States” (80 FR 37054, June 29, 2015), updated to be consistent with relevant Supreme Court decisions. The agencies conducted a substantive re-evaluation of the definition of “waters of the United States” in accordance with the Executive Order 13990 and determined that they need to revise the definition to ensure the definition is consistent with the best available science, protects the environment, ensures access to clean water, considers how climate change resiliency may be affected by the definition of waters of the United States, and ensures environmental justice is prioritized in the rulemaking process. The agencies intend to consider further revisions in a second rule in light of additional stakeholder engagement and implementation considerations, scientific developments, and environmental justice values. This effort will also be informed by the experience of implementing the pre-2015 rule, the 2015 Clean Water Rule, and the 2020 Navigable Waters Protection Rule.

Revised Definition of “Waters of the United States”—Rule 2 RIN: 0710-AB47

The Department of the Army and the Environmental Protection Agency intend to pursue a second rule defining “Waters of the United States” to consider further revisions to the agencies' first rule (RIN 0710-AB40) which proposes to restore the regulations in place prior to the 2015 “Clean Water Rule: Definition of 'Waters of the United States” (80 FR 37054, June 29, 2015), updated to be consistent with relevant Supreme Court Decisions, and reflect a reasonable interpretation based on the record before the agencies, including the best available science. This second rule proposes to include revisions reflecting on additional stakeholder engagement and implementation considerations, scientific developments, and environmental justice values. This effort will also be informed by the experience of implementing the pre-2015 rule, the 2015 Clean Water Rule, and the 2020 Navigable Waters Protection Rule.

Rules That Address Military Family Matters

Definitions of Gold Star Family and Gold Star Survivor. RIN 0790-AL56

This rule implements section 626 of the FY 2022 NDAA to define the terms “gold star family” and “gold star survivor” for consistent use across all military departments. The Defense Department treats all surviving family members equally and survivor benefits are the same across the board unless their Service member is killed or dies from causes under dishonorable conditions.

TRICARE; Reimbursement of Ambulatory Surgery Centers and Outpatient Services Provided in Cancer and Children's Hospitals. RIN 0720-AB73

This final rule will revise: (1) 32 CFR 199.2 by adding, in alphabetical order, the definitions of “Ambulatory Surgery Center”, “Cancer hospital”, and “Children's hospital”; (2) 32 CFR 199.6 to include news requirements that Ambulatory Surgery Centers (ASC) participating in Medicare must meet all program requirements; and (3) 32 CFR 199.14 to implement Medicare's payment methodologies for reimbursing ambulatory surgery centers and Cancer and Children's Hospitals. The combined impact of is rule is a cost-saving of approximately $45 million, which would be offset by $1.5 million in administrative costs to implement the changes. This estimated reduction in costs of $45 million is a transfer from providers to DoD.

DOD—OFFICE OF THE SECRETARY (OS)

Proposed Rule Stage

20. Department of Defense (DOD)-Defense Industrial Base (DIB) Cybersecurity (CS) Activities [0790-AK86]

Priority: Other Significant.

Legal Authority:10 U.S.C. 391; 10 U.S.C. 2224; 44 U.S.C. 3541; 10 U.S.C. 393

CFR Citation:32 CFR 236.

Legal Deadline: None.

Abstract: The DIB CS Program currently provides cyber threat information to cleared defense contractors. Proposed revisions would allow all defense contractors who process, store, develop, or transit DoD controlled unclassified information to be eligible for the program and to receive cyber threat information. Expanding participation will allow a broader community of defense contractors to participate in the DIB CS Program and is in alignment with the National Defense Strategy.

Statement of Need: The unauthorized access and compromise of DoD unclassified information and operations poses an imminent threat to U.S. national security and economic security interests and contractors are being targeted on a daily basis. Many of these contractors are small and medium size contractors that can benefit from partnering with DoD to enhance and supplement their cybersecurity capabilities.

Summary of Legal Basis: This revised regulation supports the Administration's effort to promote public-private cyber collaboration by expanding eligibility for the DIB CS voluntary cyber threat information sharing program to all defense contractors. This regulation aligns with DoD's statutory responsibilities for cybersecurity engagement with those contractors supporting the Department.

Alternatives: (1) No action alternative: Maintain status quo with the ongoing voluntary cybersecurity program for cleared contractors. (2) Next best alternative: DoD posts generic cyber threat information and cybersecurity best practices on a public accessible website without directly engaging participating companies.

Anticipated Cost and Benefits: Participation in the voluntary DIB CS Program enables DoD contractors to access Government Furnished Information and collaborate with the DoD Cyber Crime Center (DC3) to better respond to and mitigate cyber threats. In order to join the DIB CS Program, there is an initial labor burden to apply to the program and provide point of contact information which is estimated to take 20 minutes per company. In addition, there is a cost for defense contractors to voluntarily share cyber indicator information. DoD estimates that each response will take a respondent two hours to complete. The costs are under review as part of 0704-0489 and 0704-0490. For DIB participants, this program provides cyber threat information and technical assistance through analyst-to-analyst exchanges, mitigation and remediation strategies, and cybersecurity best practices in a collaborative environment for participating companies.

Risks: Threats to unclassified information systems represent a risk of compromise of DoD information and mission. This threat is particularly acute for small and medium size companies with less mature cybersecurity capabilities. Through collaboration with DoD and the sharing with other contractors in the DIB CS Program, defense contractors will be better prepared to mitigate the cyber risk they face today and in the future.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Federal.

Agency Contact: McKay Tolboe, Director, Cybersecurity Policy and Partnerships CIO, Department of Defense, Office of the Secretary, 4800 Mark Center, Alexandria, VA 22311, Phone: 571 372-4640, Email: mckay.r.tolboe.civ@mail.mil.

RIN: 0790-AK86

DOD—OS

21. Cybersecurity Maturity Model Certification (CMMC) Program [0790-AL49]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: This action may affect the private sector under PL 104-4.

Legal Authority:5 U.S.C. 301; Pub. L. 116-92, sec. 1648

CFR Citation:32 CFR 170.

Legal Deadline: None.

Abstract: DOD is proposing to implement the Cybersecurity Maturity Model Certification (CMMC) Framework, to help assess a Defense Industrial Base (DIB) contractor's compliance with and implementation of cybersecurity requirements to safeguard Federal Contract Information (FCI) and Controlled Unclassified Information (CUI) transiting non-federal systems and mitigate the threats posed by Advanced Persistent Threats—adversaries with sophisticated levels of expertise and significant resources.

Statement of Need: CMMC is designed to provide increased assurance to the DoD that a DIB contractor can adequately protect sensitive unclassified information ( i.e., FCI and CUI) at a level commensurate with the risk, and accounting for information flow down to its subcontractors in a multi-tier supply chain.

Summary of Legal Basis:5 U.S.C. 301 authorizes the head of an Executive department or military department to prescribe regulations for the government of his or her department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property.

41 U.S.C 1303; Pub. L. 116-92, sec. 1648 directs the Secretary of Defense to develop a consistent, comprehensive framework to enhance cybersecurity for the U.S. defense industrial base. Developing the CMMC Program was as an important first step toward meeting these requirements.*

Alternatives: DoD considered and adopted several alternatives during the development of this rule that reduce the burden on the DIB community and still meet the objectives of the rule. These alternatives include: (1) maintaining status quo, leveraging only the current requirements implemented in DFARS provision 252.204-7019 and DFARS clause 252.204-7020 requiring DIB contractors and offerors to self-assess utilizing the DoD Assessment Methodology and entering a Basic Summary Score; (2) revising CMMC 1.0 to CMMC 2.0 in response to public comments, to reduce the burden for small businesses and contractors who do not process, store or transmit critical CUI by eliminating the requirement to hire a C3PAO and instead allow self-assessment with annual affirmations to maintain compliance at CMMC Level 1, and llowing triennial self-certification with an annual affirmation to maintain compliance for some CMMC Level 2 programs; (3) exempting contracts and orders exclusively for the acquisition of commercially available off-the-shelf items; and (4) implementing a phased implementation for CMMC.

In addition, the Department took into consideration the timing of the requirement to achieve a specified CMMC level: (1) at time of proposal or offer submission, (2) post contract award, or (3) at the time of contract award.

Anticipated Cost and Benefits: The theft of intellectual property and sensitive information, including FCI and CUI, from all U.S. industrial sectors due to malicious cyber activity threatens U.S. economic and national security. The Council of Economic Advisors estimates that malicious cyber activity cost the U.S. economy between $57 billion and $109 billion in 2016. Over a ten-year period, that burden would equate to an estimated $570 billion to $1.09 trillion dollars in costs.

Risks: The aggregate loss of intellectual property and certain unclassified information from the DoD supply chain can undercut U.S. technical advantages and innovation, as well as significantly increase risk to national security.

Timetable:

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Diane L. Knight, Senior Management and Program Analyst, Department of Defense, Office of the Secretary, 4800 Mark Center Drive, Suite 12E08, Alexandria, VA 22350, Phone: 202 770-9100, Email: diane.l.knight10.civ@mail.mil.

RIN: 0790-AL49

DOD—OS

Final Rule Stage

22. Nondiscrimination on the Basis of Disability in Programs or Activities Assisted or Conducted by the DOD and in Equal Access to Information and Communication Technology Used by DOD [0790-AJ04]

Priority: Other Significant.

Legal Authority: Pub. L. 100-259; Pub. L. 102-569; 29 U.S.C. 791 to 794d; 42 U.S.C. ch. 51 and 126; E.O. 12250

CFR Citation:32 CFR 56.

Legal Deadline: None.

Abstract: The Department is finalizing revisions to implement Section 504 of the Rehabilitation Act of 1973, which prohibits discrimination on the basis of disability in programs or activities receiving Federal financial assistance from DoD and those programs or activities conducted by DoD. The regulation also implements section 508 of the Rehabilitation Act, which requires DoD make its electronic and information technology accessible to individuals with disabilities. Additionally, the regulation implements the Architectural Barriers Act of 1968, which requires that DoD make facilities accessible to individuals with disabilities. Finally, the regulation updates the complaint resolution and enforcement procedures pursuant to section 504 and the complaint resolution and enforcement procedures pursuant to section 508.

Statement of Need: Finalization of this Department-wide rule will clarify the longstanding policy of the Department. It will modernize the Department's practices in addressing issues of discrimination. This rule amends the Department's prior regulation to include updated accessibility standards for recipients of Federal financial assistance to be more user-friendly and to support individuals with disabilities. This update incorporates the directive of Executive Order 14035, Diversity, Equity, Inclusion, and Accessibility in the Federal Workforce by defining, clarifying, advancing accessibility throughout DoD programs and activities.

Summary of Legal Basis:Title 28, Code of Federal Regulations, part 41, implementing Executive Order 12250, assigns the DOJ responsibility to coordinate implementation of section 504 of the Rehabilitation Act.

This rule is being finalized under the authorities of title 29, U.S.C., chapter 16, subchapter V, sections 794 through 794d, codifying legislation prohibiting discrimination on the basis of disability under any program or activity receiving Federal financial assistance or under any program or activity conducted by any Federal agency, including provisions establishing the United States Access Board and requiring Federal agencies to ensure that information and communication technology is accessible to and usable by individuals with disabilities

Alternatives: The Department considered taking no new action and continuing to rely on the existing regulation. The Department considered issuing sub-regulatory guidance to clarify existing regulation. Both options were rejected because of the need to update and clarify the Department's obligations pursuant to section 504 and section 508 of the Rehabilitation Act of 1973, as amended.

Anticipated Cost and Benefits: TBD.

Risks: Without this final rule, the Department's current regulation is inconsistent with current Federal statutes and regulations, as well as developments in Supreme Court jurisprudence, regarding unlawful discrimination on the basis of disability. Consistent with congressional intent, the provisions in the final rule are consistent with the nondiscrimination provisions in DOJ regulations implementing title II of the ADA Amendments Act (applicable to state and local government entities).

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Additional Information: DoD internal guidance will be located in DoD Instruction 1020.dd (“Unlawful Discrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance from, or Conducted by, the DoD”). This Instruction will publish after the finalization of this rule.

Agency Contact: Randy Cooper, Director, Department of Defense Disability EEO Policy and Compliance Department of Defense, Office of the Secretary 4000 Defense Pentagon Room 5D64, Washington, DC 20301-4000, Phone: 703 571-9327, Email: randy.d.cooper3.civ@mail.mil.

RIN: 0790-AJ04

DOD—OS

23. Definitions of Gold Star Family and Gold Star Survivor [0790-AL56]

Priority: Other Significant.

Legal Authority:Pub. L. 117-81

CFR Citation:32 CFR 46.

Legal Deadline: Final, Statutory, December 27, 2022, Sec 626 of the NDAA 2022 (Pub. L. 117-81).

Section 626 of the NDAA 2022 (Pub. L. 117-81) requires publication of an interim final rule no later than one year after the date of the enactment of this Act.

Abstract: This rule implements section 626 of the National Defense Authorization Act for Fiscal Year 2022 (Pub. L. 117-81) to establish standard definitions, for use across the military departments, of the terms “gold star family” and “gold star survivor.”

Statement of Need: The objective of the rule is to establish standard definitions, for use across the military departments, of the terms gold star family and gold star survivor.

Summary of Legal Basis: This rule is proposed under the authorities of section 626(c) of Public Law 117-81, FY 2022 NDAA.

Alternatives: The alternative is to take no action.

Anticipated Cost and Benefits: The cost to publish this new rule and update the Defense Department's policies is estimated at $900,000. This includes the public's time to review the proposed rule and resources needed to respond to any public comments, publish the interim rule, revise policies, and possibly revamp the Navy and Coast Guard's long-term case management programs.

Risks: This action does not reduce risks to public health, safety, or the environment, or effect other risks within the jurisdiction of the Defense Department.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Deborah S. Skillman, Director, Department of Defense, Office of the Secretary, 1500 Defense Pentagon, Washington, DC 20301-1500, Phone: 571 372-5333, Email: deborah.s.skillman.civ@mail.mil.

RIN: 0790-AL56

DOD—DEFENSE ACQUISITION REGULATIONS COUNCIL (DARC)

Proposed Rule Stage

24. Assessing Contractor Implementation of Cybersecurity Requirements (DFARS Case 2019-D041) [0750-AK81]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority:41 U.S.C. 1303; Pub. L. 116-92, sec. 1648

CFR Citation:48 CFR 204; 48 CFR 212; 48 CFR 217; 48 CFR 252.

Legal Deadline: None.

Abstract: DoD is amending an interim rule to implement the CMMC framework 2.0 in order to protect against the theft of intellectual property and sensitive information from the Defense Industrial Base (DIB) sector. The CMMC framework is a DoD certification process that measures a company's institutionalization of processes and implementation of cybersecurity practices. This rule provides the Department with assurances that a DIB contractor can adequately protect sensitive unclassified information at a level commensurate with the risk, accounting for information flow down to its subcontractors in a multi-tier supply chain.

Statement of Need: The purpose of this DFARS rule is to ensure that Defense Industrial Base (DIB) contractors will adequately protect sensitive unclassified information at a level commensurate with the risk, accounting for information flow down to its subcontractors in a multi-tier supply chain.

Summary of Legal Basis: This rule is being implemented under the authority of 41 U.S.C. 1303 and section 1648 of the National Defense Authorization Act for Fiscal Year (FY) 2020 (Pub. L. 116-92). The USD (A&S) has the authority and responsibility for promulgating DoD procurement rules under the OFPP statute, codified at title 41 of the U.S. Code. Section 1648 of the National Defense Authorization Act for Fiscal Year 2020 (Pub. L. 116-92) directs the Secretary of Defense to develop a risk-based cybersecurity framework for the DIB sector, such as CMMC, as the basis for a mandatory DoD standard.

Alternatives: DoD considered and adopted several alternatives during the development of the interim rule that reduced the burden on small entities and still meet the objectives of the rule. DoD will consider similar alternatives for the amendment rule. These alternatives include: (1) exempting contracts and orders exclusively for the acquisition of commercially available off-the-shelf items; and (2) implementing a phased rollout and stipulating that the inclusion a CMMC requirement in new contracts until that time be approved by the Office of the Under Secretary of Defense for Acquisition and Sustainment.

Anticipated Cost and Benefits: The annualized value of costs beginning in fiscal year 2021 (calculated in perpetuity in 2016 dollars at a 7 percent discount rate) associated with implementing the CMMC Framework in the interim is $4 billion. The primary benefit of this rule is improving the protection of the Department's sensitive information and reducing the threat to DIB sector intellectual property by:

• Enabling assessments at the entity-level of contractor implementation of cyber security processes and practices that should already be in place;
• Requiring comprehensive implementation of cybersecurity requirements rather than plans of action to accomplish implementation;
• Verifying DIB sector contractor and subcontractor cybersecurity postures; and
• Reducing duplicative or repetitive assessments of our industry partners through standardization.

Risks: The theft of intellectual property and sensitive information from all U.S. industrial sectors due to malicious cyber activity threatens economic security and national security. Malicious cyber actors have and continue to target the DIB sector and the supply chain of the Department of Defense. These attacks not only focus on the large prime contractors, but also target subcontractors that make up the lower tiers of the DoD supply chain. Many of these subcontractors are small entities that provide critical support and innovation. The aggregate loss of intellectual property and certain unclassified information from the DoD supply chain can undercut U.S. technical advantages and innovation, as well as significantly increase risk to national security.

Timetable:

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

Public Compliance Cost: Base Year for Dollar Estimates: 2021.

Agency Contact: Jennifer D. Johnson, Office of the Under Secretary of Defense for Acquisition and Sustainment, Department of Defense, Defense Acquisition Regulations Council, Defense Pricing and Contracting, Defense Acquisition Regulations System, Room 3B938, 3060 Pentagon, Washington, DC 20301-3060, Phone: 703 717-8226, Email: jennifer.d.johnson1.civ@mail.mil.

Related RIN: Split from 0750-AL68, Related to 0790-AL49

RIN: 0750-AK81

DOD—DARC

25. Small Business Innovation Research Program Data Rights (DFARS Case 2019-D043) [0750-AK84]

Priority: Other Significant.

Legal Authority:41 U.S.C. 1303

CFR Citation:48 CFR 227; 48 CFR 252.

Legal Deadline: None.

Abstract: DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement changes related to data rights in the Small Business Administration's Policy Directive for the Small Business Innovation Research (SBIR) Program, published in the Federal Register on April 2, 2019 (84 FR 12794). The final SBA Policy Directive includes several revisions to clarify data rights, which require corresponding revisions to the DFARS.

Statement of Need: This rule is necessary to implement the Small Business Administration (SBA) policies related to data rights in the Small Business Innovation Research (SBIR) Program and Small Business Technology Transfer (STTR) Program Policy Directive, published in the Federal Register on April 2, 2019 (84 FR 12794). The final SBA Policy Directive includes several revisions to clarify data rights, which require corresponding revisions to the DFARS.

Summary of Legal Basis: The legal basis for this rule is 15 U.S.C. 638, which provides the authorization, policy, and framework for SBIR/STTR programs.

Alternatives: There are no alternatives that would meet the stated objective of this rule.

Anticipated Cost and Benefits: While specific costs and savings have not been quantified, this rule is expected to have significant benefit for small businesses participating in the DoD SBIR and STTR programs. SBIR and STTR enable small businesses to explore their technological potential and provide the incentive to profit from its commercialization. By including qualified small businesses in the nation's research and development arena, high-tech innovation is stimulated, and the United States gains entrepreneurial spirit as it meets its specific research and development needs.

Risks: The continuous protection of a contractor's SBIR/STTR data while actively pursuing or commercializing its technology with the Federal Government, provides a significant incentive for innovative small businesses to participate in these programs.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Federal.

Agency Contact: Jennifer D. Johnson, Office of the Under Secretary of Defense for Acquisition and Sustainment, Department of Defense, Defense Acquisition Regulations Council, Defense Pricing and Contracting, Defense Acquisition Regulations System, Room 3B938, 3060 Pentagon, Washington, DC 20301-3060, Phone: 703 717-8226, Email: jennifer.d.johnson1.civ@mail.mil.

RIN: 0750-AK84

DOD—DARC

26. Defense Commercial Solutions Opening (DFARS Case 2022-D006) [0750-AL57]

Priority: Other Significant.

Legal Authority:41 U.S.C. 1303; Pub. L. 117-81, sec. 803; 10 U.S.C. 2380(c)

CFR Citation:48 CFR 212.

Legal Deadline: None.

Abstract: DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement to implement section 803 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2022 (Pub. L. 117-81) that amends 10. U.S.C. 2380 to establish a permanent authority for the Secretary of Defense and those of the military departments to acquire innovative commercial products and commercial services through a competitive selection of proposals resulting from a general solicitation and the peer review of such proposals. Products and services purchased under this authority are treated as commercial.

Statement of Need: This rule is necessary to implement section 803 of the National Defense Authorization Act for Fiscal Year 2022 (Pub. L. 117-81), which establishes a permanent authority for the Secretary of Defense and those of the military departments to acquire innovative commercial products and commercial services through a competitive selection of proposals resulting from a general solicitation and the peer review of such proposals. Products and services purchased under this authority are treated as commercial.

Summary of Legal Basis: The legal basis for this rule is 41 U.S.C. 1303 and section 803 of Public Law 117-81.

Alternatives: There are no alternatives that would meet the requirements of section 803 of Public Law 117-81.

Anticipated Cost and Benefits: This rule will enable DoD to access innovative products and services of entities that may not have not done business with DoD in the past. Such entities may compete for additional DoD contracts, thereby increasing competition for DoD contracts.

Risks: The difficulty of accessing innovative products and services of these entities creates a risk for DoD with regard to finding solutions and obtaining products and services that meet the Department's needs.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Federal.

Agency Contact: Jennifer D. Johnson, Office of the Under Secretary of Defense for Acquisition and Sustainment, Department of Defense, Defense Acquisition Regulations Council, Defense Pricing and Contracting, Defense Acquisition Regulations System, Room 3B938, 3060 Pentagon, Washington, DC 20301-3060, Phone: 703 717-8226, Email: jennifer.d.johnson1.civ@mail.mil.

RIN: 0750-AL57

DOD—DARC

27. Modification of Prize Authority for Advanced Technology Achievements (DFARS Case 2022-D014) [0750-AL65]

Priority: Other Significant.

Legal Authority:41 U.S.C. 1303; 10 U.S.C. 2374a; Pub. L. 117-81, sec. 822

CFR Citation:48 CFR 235.

Legal Deadline: None.

Abstract: DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement to implement section 822 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2022 (Pub. L. 117-81), which revises 10 U.S.C. 2374a regarding the award of prizes for advanced technology achievement to: (1) authorize the award of procurement contracts and other agreements “as an other type of prize” (as in other than cash prizes); (2) permit the award of prizes, including procurement contracts and other agreements, in excess of $10,000,000 with the approval of the Under Secretary of Defense for Research and Engineering; and (3) require DoD provide Congress with notice of an award of a procurement contract or other agreement under this program that exceeds $10 million.

Statement of Need: This rule is necessary to implement section 822 of the National Defense Authorization Act for Fiscal Year 2022 (Pub. L. 117-81). Section 822 revises 10 U.S.C. 2374a regarding the award of prizes for advanced technology achievement to: (1) authorize the award of procurement contracts and other agreements as an other type of prize (as in other than cash prizes); (2) permit the award of prizes, including procurement contracts and other agreements, in excess of $10,000,000 with the approval of the Under Secretary of Defense for Research and Engineering; and (3) require DoD provide Congress with notice of an award of a procurement contract or other agreement under this program that exceeds $10 million.

Summary of Legal Basis: The legal basis for this rule is 41 U.S.C. 1303 and section 822 of Public Law 117-81.

Alternatives: There are no alternatives that would meet the requirements of section 822 of Public Law 117-81.

Anticipated Cost and Benefits: This rule will help to expand the Defense Industrial Base, thereby increasing competition for future DoD contracts.

Risks: The difficulty of accessing advanced technologies creates a risk for DoD with regard to finding solutions and obtaining products and services that meet the Department's needs.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Federal.

Agency Contact: Jennifer Johnson, Defense Acquisition Regulations System, Department of Defense, Defense Acquisition Regulations Council, 3060 Defense Pentagon, Room 3B941, Washington, DC 20301-3060, Phone: 571 372-6100, Email: jennifer.d.johnson1.civ@mail.mil.

RIN: 0750-AL65

DOD—DARC

28. • DFARS Buy American Act Requirements (DFARS Case 2022-D019) [0750-AL74]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Legal Authority:41 U.S.C. 1303

CFR Citation:48 CFR 225; 48 CFR 252.

Legal Deadline: None.

Abstract: DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement the requirements of Executive Order 14005, Ensuring the Future Is Made in All of America by All of America's Workers. Changes to the Federal Acquisition Regulation (FAR) are being made via RIN 9000-AO22 (FAR Case 2021-008, Amendments to the FAR Buy American Act Requirements). This rule proposes conforming changes to the DFARS.

Statement of Need: This rule is necessary to implement Executive Order 14005, Ensuring the Future Is Made in All of America by All of America's Workers, which increases the required percentage of domestic content for end products and construction material. Changes to the Federal Acquisition Regulation (FAR) are being made via RIN 9000-AO22 (FAR Case 2021-008, Amendments to the FAR Buy American Act Requirements). This rule proposes conforming changes to the DFARS.

Summary of Legal Basis: The legal basis for this rule is 41 U.S.C. 1303 and Executive Order 14005, Ensuring the Future Is Made in All of America by All of America's Workers.

Alternatives: There are no alternatives that would meet the requirements of Executive Order 14005.

Anticipated Cost and Benefits: This rule increases the percentage for use in the domestic content text applied to offers of end products and construction materials to determine domestic or foreign origin. The rule will strengthen domestic preferences under the Buy American statute. It is expected that this rule will benefit large and small U.S. manufacturers supplying domestic end products and materials.

Risks: There is a risk that U.S. manufacturers would experience a competitive disadvantage without the increase in the required domestic content.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Federal.

Agency Contact: Jennifer D. Johnson, Office of the Under Secretary of Defense for Acquisition and Sustainment, Department of Defense, Defense Acquisition Regulations Council, Defense Pricing and Contracting, Defense Acquisition Regulations System, Room 3B938, 3060 Pentagon, Washington, DC 20301-3060, Phone: 703 717-8226, Email: jennifer.d.johnson1.civ@mail.mil.

RIN: 0750-AL74

DOD—DARC

Final Rule Stage

29. Past Performance of Subcontractors and Joint Venture Partners (DFARS Case 2018-D055) [0750-AK16]

Priority: Other Significant.

Legal Authority:41 U.S.C. 1303; Pub. L. 115-232, sec. 823

CFR Citation:48 CFR 215; 48 CFR 236; 48 CFR 242; 48 CFR 252.

Legal Deadline: Final, Statutory, February 9, 2019, 180 days after enactment.

Abstract: DoD is issuing a final rule to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement section 823 of the National Defense Authorization Act for Fiscal Year 2019, which establishes a requirement for use of the best available information regarding past performance of subcontractors and joint venture partners when awarding DoD construction and architect-engineer (A&E) contracts. Section 823 requires annual performance evaluations for first-tier subcontractors and individual partners of joint venture construction and A&E contracts valued at either $750,000 or more, or 20 percent of the value of the prime contract (whichever is higher), in accordance with specified conditions. In addition, processes for exceptions from the annual evaluation requirement will be established for construction and A&E contracts where submission of annual evaluations would not provide the best representation of the performance of a contractor, including subcontractors and joint venture partners under specified conditions. This rule will amend DFARS part 242 to incorporate these new requirements and processes.

Statement of Need: This rule is necessary to implement section 823 of the National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232), which establishes a requirement for use of the best available information regarding past performance of subcontractors and joint venture partners when awarding DoD construction and architect-engineer contracts. Section 823 requires annual performance evaluations for first-tier subcontractors and individual parties to joint ventures performing construction and architect-engineer contracts valued at either $750,000 or more, or 20 percent of the value of the prime contract (whichever is higher), in accordance with specified conditions. In addition, processes for exceptions from the annual evaluation requirement will be established for construction and architect-engineer contracts where submission of annual evaluations would not provide the best representation of the performance of a contractor, including subcontractors and joint venture partners under specified conditions.

Summary of Legal Basis: The legal basis for this rule is 41 U.S.C. 1303 and section 823 of Public Law 115-232.

Alternatives: There are no alternatives that would meet the requirements of section 823 of Public Law 115-232.

Anticipated Cost and Benefits: This rule will make it easier for subcontractors and individual parties to joint ventures to establish a record of their past performance. These entities will be able to take credit for the work they performed on contracts and subcontracts, which will help them be more competitive when bidding on future DoD contracts. This will help increase competition for DoD contracts.

Risks: Due to the difficulty of establishing a record of past performance on DoD contracts, there is a risk of reduced competitiveness for subcontractors and individual parties to joint ventures.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

Agency Contact: Jennifer D. Johnson, Office of the Under Secretary of Defense for Acquisition and Sustainment, Department of Defense, Defense Acquisition Regulations Council, Defense Pricing and Contracting, Defense Acquisition Regulations System, Room 3B938, 3060 Pentagon, Washington, DC 20301-3060, Phone: 703 717-8226, Email: jennifer.d.johnson1.civ@mail.mil.

RIN: 0750-AK16

DOD—DARC

30. Restriction on Acquisition of Personal Protective Equipment and Certain Items From Non-Allied Foreign Nations (DFARS Case 2022-D009) [0750-AL60]

Priority: Other Significant.

Legal Authority:41 U.S.C. 1303; Pub. L. 117-81 sec. 802; 10 U.S.C. 2533e

CFR Citation:48 CFR 225; 48 CFR 252.

Legal Deadline: None.

Abstract: DoD is issuing an interim rule to amend the Defense Federal Acquisition Regulation Supplement to implement section 802 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2022 NDAA (Pub. L. 117-81). Section 802 adds 10 U.S.C. 2533e which prohibits the acquisition of personal protective equipment and certain other items from non-allied foreign nations. An exception applies if: (1) the Secretary of Defense determines that a covered item of satisfactory quality and quantity, in the required form, cannot be procured as and when needed from nations other than a covered country to meet requirements at a reasonable price; (2) a covered item is for use outside of the United States; or (3) if the procurement for a covered material is at or below $150,000. A limitation provides that a proposed procurement in an amount greater than $150,000 may not be divided into several purchases or contracts for lesser amounts in order to qualify for an exception.

Statement of Need: This rule is needed to implement section 802 of the National Defense Authorization Act for Fiscal Year 2022 (Pub. L. 117-81), which prohibits the acquisition of personal protective equipment related to healthcare and certain other healthcare-related items from non-allied foreign nations. The prohibition does not apply to items for use outside of the United States or if the procurement is valued at or below $150,000. In addition, the prohibition does not apply if the Secretary of Defense determines that a covered item of satisfactory quality and quantity, in the required form, cannot be procured as and when needed from nations other than non-allied nations to meet requirements at a reasonable price.

Summary of Legal Basis: The legal basis for this rule is 41 U.S.C. 1303 and section 802 of Public Law 117-81.

Alternatives: There are no alternatives that would meet the requirements of section 802 of Public Law 117-81.

Anticipated Cost and Benefits: Decreasing dependence on personal protective equipment and certain other items, as identified in section 802, originating in non-allied foreign countries is a matter of public health and national security especially during a declared public health emergency. The domestic supply chain for personal protective equipment and certain other items is critical. An adequate continued supply is vital to ensure domestic control with minimal disruption in production and to reduce U.S. dependence on non-allied foreign countries. This restriction is similar to other domestic sourcing restrictions required by 10 U.S.C. 2533 in effect to reduce dependence on non-allied foreign sources and to continue to promote growth in domestic capability.

This rule restricts the acquisition of covered items (personal protective equipment for use in preventing the spread of disease and certain other items) from non-allied foreign nations. The restriction will not apply—

• To acquisitions of the covered items for use outside of the United States;
• For acquisitions at or below $150,000; or
• If it is determined that covered items of satisfactory quality and quantity, in the required form, cannot be procured as and when needed from nations other than the covered countries to meet the requirements at a reasonable price.

Estimated impacts to industry may include minor compliance costs to validate with suppliers the origin of covered items to comply with the prohibition. Based on data from the Federal Procurement Data System for fiscal years 2019, 2020, and 2021 for contracts awarded in Product Service Code 65 (Medical, Dental, and Veterinary Equipment and Supplies) in the United States valued at or above $150,000, DoD awarded an average of 1,677 such contracts to 192 unique entities, of which 105 were small businesses. It is not known what percentage of these awards might involve personal protective equipment and other covered items from the covered countries.

Potential benefits of this rule will be the elimination of counterfeit covered items within the domestic supply chain and reduced dependence on foreign sources that are not allies of the United States. In addition, this restriction will further promote growth in domestic capabilities and may provide additional opportunities to domestic small businesses for future procurement and manufacturing efforts, increasing domestic sourcing of personal protective equipment and other covered items.

Risks: A shortage of supply of personal protective equipment and certain other items would put at risk public health and the safety and well-being of the general public. A shortage of these items also would hinder DoD's mission readiness.

Timetable:

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Federal.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Jennifer Johnson, Defense Acquisition Regulations System, Department of Defense, Defense Acquisition Regulations Council, 3060 Defense Pentagon, Room 3B941, Washington, DC 20301-3060, Phone: 571 372-6100, Email: jennifer.d.johnson1.civ@mail.mil.

RIN: 0750-AL60

DOD—U.S. ARMY CORPS OF ENGINEERS (COE)

Proposed Rule Stage

31. Natural Disaster Procedures: Preparedness, Response, and Recovery Activities of the Corps of Engineers [0710-AA78]

Priority: Other Significant.

Legal Authority:33 U.S.C. 701n

CFR Citation:33 CFR 203.

Legal Deadline: None.

Abstract: The U.S. Army Corps of Engineers (Corps) is proposing to update the Federal regulation that covers the procedures that the Corps uses under section 5 of the Flood Control Act of 1941, as amended (33 U.S.C. 701n), commonly referred to as Public Law 84-99. The Corps relies on this program to prepare for, respond to, and help communities recover from a flood, hurricane, or other natural disaster, including the repair of damage to eligible flood risk reduction infrastructure. The Corps initiated this rulemaking process through an advanced notice of proposed rulemaking (ANPRM) on February 13, 2015. As a next step, the Corps is planning to propose revisions to the program to address statutory changes under various Water Resources Development Act provisions and to formalize certain agency guidance relating to natural disaster procedures. The notice of proposed rulemaking (NPRM) would also include a summary of the comments to the ANPRM.

Statement of Need: Since the last revision in 2003, significant disasters, including Hurricane Katrina (2005), Hurricane Sandy (2012), flooding on the Mississippi and Missouri Rivers (2008, 2011, and 2013), and Hurricanes Harvey, Irma, and Maria (2017) have provided a more detailed understanding of the nature and severity of risk associated with flood control projects. In addition, the maturation of risk-informed decision making approaches and technological advancements influenced the outlook on the implementation of Public Law 84-99 activities, with a shift toward better alignment with Corps Levee Safety and National Flood Risk Management Programs, as well as the National Preparedness and Response Frameworks. Through these programs, the Corps works with non-Federal sponsors and stakeholders to assess, communicate, and manage the risks to people, property, and the environment associated with levee systems and flood risks. Revisions to part 203 are necessary to implement statutes that amended or otherwise affected Public Law 84-99, as explained in the next section.

Summary of Legal Basis: Public Law 84-99 authorizes an emergency fund to be expended at the discretion of the Chief of Engineers for preparation for natural disasters, flood fighting, rescue operations, repairing or restoring flood control works, emergency protection of federally authorized hurricane or shore protection projects, and the repair and restoration of federally authorized hurricane and shore protection projects damaged or destroyed by wind, wave, or water of other than ordinary nature.

1. Subsection 3029(a) of the Water Resources Reform and Development Act of 2014 (WRRDA 2014) (Pub. L. 113-121) authorized the Chief of Engineers, under certain circumstances, to make modifications to flood control and hurricane or shore protections works damaged during flood or coastal storms events, as well as the authority to implement nonstructural alternatives in the repair and restoration of hurricane or shore protection works.

2. Subsection 3029(b) of WRRDA 2014 authorized the Secretary of the Army to undertake a review of implementation of Public Law 84-99 to ensure the safety of affected communities to future flooding and storm events; the resiliency of water resources development projects to future flooding and storm events; the long-term cost-effectiveness of water resources development projects that provide flood control and hurricane and storm damage reduction benefits; and the policy goals and objectives that were the President outlined as a response to recent extreme weather events at that time are met.

3. Section 3011 of WRRDA 2014 states that a levee system shall remain eligible for rehabilitation assistance under Public Law 84-99, as long as the system sponsor continues to make satisfactory progress, as determined by the Secretary of the Army, on an approved system wide improvement framework or letter of intent.

4. Section 1176 of the Water Resources Development Act of 2016 (WRDA 2016) (Pub. L. 114-322, title I) provided an express definition of nonstructural alternatives, as that term is used in Public Law 84-99, and authorized the Chief of Engineers, under certain circumstances, to increase the level of protection of flood control or hurricane or shore protection works or increase the capacity of a pumping station when conducting repair or restoration activities to such works under Public Law 84-99.

Alternatives:

1. No rule update: Implement all changes through agency discretion. Alternative not selected because the Public Law 84-99 amendments are very prescriptive, and it is inappropriate for those conflicts to exist.

2. Modify: Evaluate required changes and determine which require implementation via agency discretion and those requiring an update to the rule. Alternative not selected because of inconsistent implementation that would result and the repeal and replace alternative is the most straightforward, given the number of update changes throughout this CFR section.

3. Repeal and replace (Selected Alternative): Incorporate and integrate the current state of practice for flood risk management principles and concepts through the provision of agency policy codified in a federal rule. The intended benefit is to encourage broader community flood risk management activities, as undertaken by non-Federal project sponsors. The rule alternative also consolidates recent Public Law 84-99 amendments into one comprehensive rule, ensuring the public understands how the Corps would implement them.

Anticipated Cost and Benefits: Overall, the purpose of the proposed changes to this regulation are expected to improve the effectiveness of federal and local investments to reduce flood risks in both riverine and coastal settings. These proposed changes take advantage of our increased understanding of project risks, moving from an assessment of how the project is expected to perform to a focus on a broader set of actions to reduce risk to life, including operations, maintenance, planning, and execution actions to improve emergency warning and evacuation and other activities to improve the ability of communities and individuals to understand and manage project-related risks. Informed by more detailed understanding of risk for levee systems, the Federal Government and non-Federal sponsors should be able to apply the available resources to the risk management activities that most effectively reduce riverine flood risk and avoid expenditures that have little risk reduction benefit.

Risks: The rule is not expected to have a significant effect on risks to public health and safety. It would revise and update 33 CFR 203 and reflect the current state of practice for flood risk management principles and concepts. It would also amend and clarify the current role of the Corps in preparing for, and responding a natural disaster, and in helping in the recovery effort. The rule may also encourage broader community flood risk management activities, as undertaken by non-Federal project sponsors.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Willem Helms, Department of Defense, U.S. Army Corps of Engineers, CECW-HS, 441 G Street NW, Washington, DC 20314, Phone: 202 761-5909, Email: willem.h.helms@usace.army.mil.

RIN: 0710-AA78

DOD—COE

32. Policy and Procedures for Processing Requests To Alter U.S. Army Corps of Engineers Civil Works Projects Pursuant to 33 U.S.C. 408 [0710-AB22]

Priority: Other Significant.

Legal Authority:33 U.S.C. 408

CFR Citation:33 CFR 350.

Legal Deadline: None.

Abstract: Where a party other than the U.S. Army Corps of Engineers (Corps) seeks to use or alter a Civil Works project that the Corps constructed, the proposed use or alteration is subject to the prior approval of the Corps. Some examples of such alterations include an improvement to the project; relocation of part of the project; or installing utilities or other non-project features. This requirement was established in section 14 of the Rivers and Harbors Act of 1899 and is codified at 33 U.S.C. 408 (section 408). Section 408 provides that the Corps may grant permission for another party to alter a Civil Works project upon a determination that the alteration proposed will not be injurious to the public interest and will not impair the usefulness of the Civil Works project. The Corps is proposing to convert its policy that governs the section 408 program to a binding regulation. This policy, Engineer Circular 1165-2-220, Policy and Procedural Guidance for Processing Requests to Alter U.S. Army Corps of Engineers Civil Works Projects Pursuant to 33 U.S.C. 408, was issued in September 2018.

Statement of Need: Through the Civil Works program, the U.S. Army Corps of Engineers (Corps), in partnership with stakeholders, has constructed many Civil Works projects across the Nation's landscape. Given the widespread locations of these projects, there may be a need for others outside of the Corps to alter or occupy these projects and their associated lands. Reasons for alterations could include activities such as improvements to the project; relocation of part of the project; or installing utilities or other non-project features. In order to ensure that these projects continue to provide their intended benefits to the public, Congress provided that any use or alteration of a Civil Works project by another party is subject to the prior approval of the Corps. This requirement was established in section 14 of the Rivers and Harbors Act of 1899 and is codified at 33 U.S.C. 408 (section 408). Specifically, section 408 provides that the Corps may grant permission for another party to alter a Civil Works project upon a determination that the alteration proposed will not be injurious to the public interest and will not impair the usefulness of the Civil Works project. The Corps is proposing to convert its policy that governs the section 408 program to a binding regulation. Engineer Circular 1165-2-220, Policy and Procedural Guidance for Processing Requests to Alter U.S. Army Corps of Engineers Civil Works Projects Pursuant to 33 U.S.C. 408 was issued in September 2018.

Summary of Legal Basis: The Corps has legal authority over the section 408 program under 33 U.S.C. 408.

Alternatives: The preferred alternative would be to conduct rulemaking to issue the requirements governing the section 408 review process in the form of a binding regulation. The current Corps policy appears in an Engineer Circular that has expired. The next best alternative would involve issuing these requirements in the form of an Engineer Regulation. That alternative would not fulfill the intent of the law because it would not be binding on the regulated public.

Anticipated Cost and Benefits: The proposed rule would reduce costs to the regulated public by clarifying the applicable requirements and providing consistent implementation of these requirements across the Corps program. It is anticipated that a form would be developed for submission of requests which would trigger the Paperwork Reduction Act compliance process and any associated costs will be evaluated at that time.

Risks: The proposed action is not anticipated to increase risk to public health, safety, or the environment because it outlines the procedures the Corps will follow when evaluating requests for section 408 permissions. The Corps will comply with all statutory requirements when reviewing requests.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Virginia Rynk, Department of Defense, U.S. Army Corps of Engineers, Attn: CECW-EC, 441 G Street NW, Washington, DC 20314, Phone: 202 761-4741.

RIN: 0710-AB22

DOD—COE

33. Flood Control Cost-Sharing Requirements Under the Ability To Pay Provision [0710-AB34]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Unfunded Mandates: Undetermined.

Legal Authority:33 U.S.C. 2213(m)

CFR Citation:33 CFR 241.

Legal Deadline: None.

Abstract: Section 103(m) of the Water Resources Development Act (WRDA) of 1986, as amended (33 U.S.C. 2213(m)), authorizes the U.S. Army Corps of Engineers (Corps) to reduce the non-Federal share of the cost of a study or project for certain communities that are not able financially to afford the standard non-Federal cost-share. Part 241 of Title 33 in the Code of Federal Regulations provides the criteria that the Corps uses in making these determinations where the primary purpose of the study or project is flood damage reduction. The proposed rule would update this regulation, by broadening its applicability to include projects with other purposes (instead of just flood damage reduction) and the feasibility study of a project (instead of just design and construction).

Statement of Need: The Corps may conduct a rulemaking to propose amendments to the Corps' regulations at 33 CFR part 241 for Corps projects. The WRDA 2000 modified section 103(m) to also include the following mission areas: environmental protection and restoration, flood control, navigation, storm damage protection, shoreline erosion, hurricane protection, and recreation or an agricultural water supply project which have not yet been added to the regulation. It also included the opportunity to cost share all phases of a USACE project to also include feasibility in addition to the already covered design and construction. This rule would provide a framework for deciding which projects are eligible for consideration for a reduction in the non-Federal cost share based on ability to pay.

Summary of Legal Basis:33 U.S.C. 2213(m).

Alternatives: The preferred alternative is to conduct rulemaking to amend 33 CFR 241 by broadening the project purposes for which the Corps could reduce the non-Federal cost-share based on ability to pay and by allowing such a reduction for feasibility studies. The next best alternative would be to provide additional guidance instead of amending the existing regulation. This alternative could lead to confusion for the regulated public.

Anticipated Cost and Benefits: The proposed rule would add Corps procedures on the ability to pay provision allowing for consistent implementation across the Corps and clear understanding of the program and its requirements by the regulated public.

Risks: The proposed action is not anticipated to increase risk to public health, safety, or the environment because it outlines the procedures the Corps will follow when evaluating the ability to pay provision for cost-sharing with the non-Federal sponsor.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

Agency Contact: Amy Frantz, Program Manager, Department of Defense, U.S. Army Corps of Engineers, CECW-P, 441 G Street NW, Washington, DC 20314, Phone: 202 761-0106, Email: amy.k.frantz@usace.army.mil.

Related RIN: Previously reported as 0710-AA91

RIN: 0710-AB34

DOD—COE

34. USACE Implementing Procedures for Principles, Requirements, and Guidelines Applicable to Actions Involving Investment in Water Resources [0710-AB41]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Unfunded Mandates: Undetermined.

Legal Authority: Sec. 2031 of Pub. L. 110-114

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: Section 2031 of the Water Resources Development Act of 2007 (Pub. L. 110-114) called for revisions to the 1983 Principles and Guidelines for Water and Land Related Resources Implementation Studies, resulting in the issuance of the Principles and Requirements (P&R) guidance document in March 2013 and the Interagency Guidelines in December 2014, which together comprise the Principles, Requirements, and Guidelines (PR&G). The PR&G are intended to provide a common framework and comprehensive policy and guidance for analyzing a diverse range of water resources projects, programs, activities, and related actions involving Federal investment in water resources. The U.S. Army Corps of Engineers (Corps) proposes a regulation to show how it would apply the PR&G to the Corps' mission and authorities. In this proposed regulation, the Corps intends to increase consistency and compatibility in Federal water resources investment decision making to include considerations such as analyzing a broader range of long-term costs and benefits, enhancing collaboration, including a more thorough and transparent risk and uncertainty analyses, and improving resilience for dealing with emerging challenges, including climate change.

Statement of Need: The Corps needs to develop implementing procedures for the Principles, Requirements, and Guidelines (PR&G) per a requirement under section 110 of the Water Resources Development Act of 2020.

Summary of Legal Basis: Section 110 of the Water Resources Development Act of 2020 directed the Corps to implement the PR&G. Also see section 2031 of Public Law 110-114.

Alternatives: The Corps could implement PR&G with guidance rather than through rulemaking; however, such procedures would not be binding on the Corps or the public as any procedures would not have undergone APA rulemaking. The Corps would not develop procedures to implement PR&G and instead rely solely on the PR&G documents to implement. This could result in confusion and a lack of consistency for the Corps and the public as to how and when to apply PR&G to Civil Works authorities. The Corps proposes to conduct rulemaking to ensure the PR&G implementing procedures are clear for the Corps and the public as well as binding.

Anticipated Cost and Benefits: As this rulemaking action is implementing procedures for the Corps to ensure compliance with the PR&G, there may be some administrative costs incurred to the Corps for implementation and training. There would be benefits accrued to the public in the form of reduced confusion and assurance of consideration of comprehensive benefits for water resource development projects. The rulemaking action would also result in more net beneficial project outcomes from improved decision making.

Risks: The proposed action is not anticipated to increase risk to public health, safety, or the environment because it outlines the procedures the Corps will follow for implementing a federal statutory requirement in WRDA as well as Administration policy. The Corps will comply with all statutory requirements when implementing PR&G.

Timetable:

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Stacey M. Jensen, Office of the Assistant Secretary of the Army, Department of Defense, U.S. Army Corps of Engineers, 108 Army Pentagon, Washington, DC 22202, Phone: 703 695-6791, Email: stacey.m.jensen.civ@army.mil.

RIN: 0710-AB41

DOD—COE

35. Appendix C Procedures for the Protection of Historic Properties [0710-AB46]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Unfunded Mandates: Undetermined.

Legal Authority:33 U.S.C. 401; 33 U.S.C. 1344; 33 U.S.C. 1413

CFR Citation:33 CFR 325.

Legal Deadline: None.

Abstract: The U.S. Army Corps of Engineers (Corps) considers the effects of its actions on historic properties pursuant to section 106 of the National Historic Preservation Act (NHPA). The Corps' Regulatory Program's regulations for complying with the NHPA are outlined at 33 CFR 325 appendix C. Since these regulations were promulgated in 1990, there have been amendments to the NHPA and revisions to the Advisory Council on Historic Preservation's (ACHP) regulations at 36 CFR part 800. In response, the Corps issued interim guidance until rulemaking could be completed in order to ensure full compliance with the NHPA and ACHP's regulations. The Corps proposes to revise its regulations to conform to the ACHP regulations.

Statement of Need: Appendix C intends to provide the implementing procedures for the Regulatory Program's compliance with section 106 of the National Historic Preservation Act. Rulemaking is required to ensure the Regulatory Program is compliant with the NHPA and ACHP's implementing regulations at 36 CFR 800 for federal agency compliance with Section 106. The NHPA and the ACHP regulations have been updated since Appendix C was promulgated.

Summary of Legal Basis: Appendix C was promulgated through an APA rulemaking process intended to provide compliance with section 106 of the NHPA specific to the Regulatory Program.

Alternatives: Alternatives considered include retaining appendix C, which in its current state is not compliant with the updates to NHPA or the ACHP implementing regulations for federal agencies. The current appendix C is also not compliant with the NHPA and Administration policies regarding Tribal Nations. Another alternative is to rescind Appendix C and have the Regulatory Program rely on the ACHP implementing regulations. This would ensure consistency with the Civil Works program of the Corps and ensure compliance with the statutory and regulation language. Another alternative is to modify appendix C to update the regulation incorporating changes made since promulgation to the NHPA and ACHP implementing regulations. The goal would be to ensure compliance with NHPA and the ACHP implementing regulations but the end result would be comparable to the rescission alternative with more resource and workload effort. It would also result in continued confusion for the public with the differing name from ACHP's regulations and Civil Works implementation.

Anticipated Cost and Benefits: As this rulemaking action is implementing procedures for the Corps to ensure compliance with the NHPA, there may be some administrative costs incurred to the Corps for training. There would be benefits accrued to the public in the form of reduced confusion and assurance of consideration of potential adverse effects to historic properties and items and areas of cultural/religious significance.

Risks: The proposed action is not anticipated to increase risk to public health, safety, or the environment because it outlines the procedures the Corps will follow for implementing a federal statutory requirement. The Corps will comply with all statutory requirements when reviewing permit applications.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

Federalism: Undetermined.

Agency Contact: Margaret Gaffney-Smith, Regulatory Program Manager, Department of Defense, U.S. Army Corps of Engineers, Attn: CECW-CO, 441 G Street NW, Washington, DC 20314, Phone: 202 761-4229.

RIN: 0710-AB46

DOD—COE

36. Revised Definition of “Waters of the United States”—Rule 2 [0710-AB47]

Priority: Economically Significant. Major status under 5 U.S.C. 801 is undetermined.

Unfunded Mandates: Undetermined.

Legal Authority:33 U.S.C. 1344

CFR Citation:33 CFR 328.

Legal Deadline: None.

Abstract: The EPA and the Department of the Army (the agencies”) intend to pursue a second rule defining ”Waters of the United States” to consider further revisions to the agencies' first rule (RIN 2040-AG13), which proposes to develop regulations that are founded on the familiar framework of the pre-2015 regulations, are consistent with the statute and informed by relevant Supreme Court decisions, and that reflect a reasonable interpretation based on the record before the agencies, including the best available science. This second rule proposes to include revisions reflecting on additional stakeholder engagement and implementation considerations, scientific developments, and environmental justice values. This effort would also be informed by the experience of implementing the pre-2015 rule, the 2015 Clean Water Rule, and the 2020 Navigable Waters Protection Rule.

Statement of Need: In 2015, the Environmental Protection Agency and the Department of the Army (“the agencies”) published the “Clean Water Rule: Definition of `Waters of the United States' (80 FR 37054, June 29, 2015).” In April 2020, the agencies published the Navigable Waters Protection Rule (85 FR 22250, April 21, 2020). The agencies conducted a substantive re-evaluation of the definition of “waters of the United States” in accordance with the Executive Order 13990 and determined that they need to revise the definition to ensure the agencies listen to the science, protect the environment, ensure access to clean water, consider how climate change resiliency may be affected by the definition of waters of the United States, and to ensure environmental justice is prioritized in the rulemaking process.

Summary of Legal Basis: The Clean Water Act (33 U.S.C. 1251 et seq.).

Alternatives: Please see EPA's alternatives. EPA is the lead for this rulemaking action.

Anticipated Cost and Benefits: Please see EPA's statement of anticipated costs and benefits. EPA is the lead for this rulemaking action.

Risks: Please see EPA's risks. EPA is the lead for this rulemaking action.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

Agency Contact: Stacey M. Jensen, Office of the Assistant Secretary of the Army, Department of Defense, U.S. Army Corps of Engineers, 108 Army Pentagon, Washington, DC 22202, Phone: 703 695-6791, Email: stacey.m.jensen.civ@army.mil.

RIN: 0710-AB47

DOD—COE

Final Rule Stage

37. Credit Assistance for Water Resources Infrastructure Projects [0710-AB31]

Priority: Other Significant.

Legal Authority:Pub. L. 114-94; Pub. L. 114-322; Pub. L. 115-270; 33 U.S.C. 3901

CFR Citation:33 CFR 386.

Legal Deadline: None.

Abstract: The U.S. Army Corps of Engineers (Corps) is implementing a new credit program for dam safety work at non-Federal dams. The program is authorized under the Water Infrastructure Finance and Innovation Act of 2014 (WIFIA) and Division D, title 1 of the Consolidated Appropriations Act of 2020. WIFIA authorizes the Corps to provide secured (direct) loans and loan guarantees (Federal Credit instruments) to eligible water resources infrastructure projects and to charge fees to recover all or a portion of the Corps' cost of providing credit assistance and the costs of conducting engineering reviews and retaining expert firms, including financial and legal services, to assist in the underwriting and servicing of Federal credit instruments. Projects will be evaluated and selected by the Secretary of the Army (the Secretary) based on the requirements and the criteria described in this rule.

Statement of Need: The USACE WIFIA program is focused on providing Federal loans, and potentially to also include loan guarantees, to projects for maintaining, upgrading, and repairing dams identified in the National Inventory of Dams owned by non-federal entities. These loans will be repaid with non-Federal funding.

Summary of Legal Basis: The USACE WIFIA program was authorized under subtitle C of title V of the Water Resources Reform and Development Act of 2014 (WRRDA 2014), which authorizes USACE to provide secured (direct) loans, and potentially to also include loan guarantees, to eligible water resources infrastructure projects (needed further authorization was provided by Division D, title 1 of the Consolidated Appropriations Act of 2020). The statute also authorizes USACE to charge fees to recover all or a portion of USACE's cost of providing credit assistance and the costs of conducting engineering reviews and retaining expert firms, including financial and legal services, to assist in the underwriting and servicing of Federal credit instruments.

The Fiscal 2021 Consolidated Appropriations Act, provided USACE WIFIA appropriations of $2.2M admin, and $12M credit subsidy and a loan volume limit of $950M. These appropriated funds are limited to fund projects focused on maintaining, upgrading, and repairing dams identified in the National Inventory of Dams owned by non-federal entities, essentially dams where the primary owner is a state, local government, public utility, or private owner.

Alternatives: The preferred alternative would be to conduct proposed rulemaking to implement a new credit program for dam safety work at non-Federal dams in the form of a binding regulation in compliance with the Water Infrastructure Finance and Innovation Act of 2014 (WIFIA) and Division D, title 1 of the Consolidated Appropriations Act of 2020. The next best alternative would involve issuing these implementing procedures in the form of an Engineer Regulation. That alternative would not fulfill the intent of the law because it would not be binding on the regulated public. The no action alternative would be to not conduct rulemaking which would not fulfill the authorization provided by Congress.

Anticipated Cost and Benefits: The proposed rule would add Corps procedures to the CFR on the implementation of a new credit program for dam safety work at non-Federal dams to allow for consistent implementation across the Corps and clear understanding of the program and its requirements by the regulated public. The USACE would incur costs to administer the loan program while benefits are expected for the public in the form of benefits from projects enabled by WIFIA loans. WIFIA compliance costs likely include costs associated with application and transaction processing fees, which are waived or reduced for small and disadvantaged communities, obtaining a credit rating letter, any consultant fees (not required), completing applications, reporting requirements, and record keeping. These costs are not anticipated to represent a significant economic impact, especially given that participation in the program is voluntary.

Risks: The proposed action is not anticipated to increase risk to public health, safety, or the environment because it outlines the procedures the Corps will follow for implementing a federal loan program. The Corps will comply with all statutory requirements when reviewing requests.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Aaron Snyder, Department of Defense, U.S. Army Corps of Engineers, 441 G Street NW, Washington, DC 20314, Phone: 651 290-5489, Email: aaron.m.snyder@usace.army.mil.

Related RIN: Merged with 0710-AB32

RIN: 0710-AB31

DOD—COE

38. Revised Definition of “Waters of the United States”—Rule 1 [0710-AB40]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: Undetermined.

Legal Authority:33 U.S.C. 1344

CFR Citation:33 CFR 328.

Legal Deadline: None.

Abstract: In April 2020, the EPA, and the Department of the Army (the “agencies”) published the Navigable Waters Protection Rule (NWPR) that revised the previously-codified definition of “waters of the United States” (85 FR 22250, April 21, 2020). The agencies initiated the development of regulations that are founded on the familiar framework of the pre-2015 regulations, are consistent with the statute and informed by relevant Supreme Court decisions, and that reflect a reasonable interpretation based on the record before the agencies, including the best available science. The proposal was open for public comment between Dec 2021 and Feb 2022. It is planned that this rule will be finalized by the end of the calendar year (2022).

Statement of Need: In 2015, the Environmental Protection Agency and the Department of the Army (“the agencies”) published the “Clean Water Rule: Definition of `Waters of the United States (80 FR 37054, June 29, 2015).” In April 2020, the agencies published the Navigable Waters Protection Rule (85 FR 22250, April 21, 2020). The agencies conducted a substantive re-evaluation of the definition of “waters of the United States” in accordance with the Executive Order 13990 and determined that they need to revise the definition to ensure the agencies listen to the science, protect the environment, ensure access to clean water, consider how climate change resiliency may be affected by the definition of waters of the United States, and to ensure environmental justice is prioritized in the rulemaking process.

Summary of Legal Basis: The Clean Water Act (33 U.S.C. 1251 et seq.).

Alternatives: Please see EPA's alternatives. EPA is the lead for this rulemaking action.

Anticipated Cost and Benefits: Please see EPA's statement of anticipated costs and benefits. EPA is the lead for this rulemaking action.

Risks: Please see EPA's risks. EPA is the lead for this rulemaking action.

Timetable:

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Federalism: Undetermined.

Agency Contact: Stacey M. Jensen, Office of the Assistant Secretary of the Army, Department of Defense, U.S. Army Corps of Engineers, 108 Army Pentagon, Washington, DC 22202, Phone: 703 695-6791 Email: stacey.m.jensen.civ@army.mil.

RIN: 0710-AB40

DOD—OFFICE OF ASSISTANT SECRETARY FOR HEALTH AFFAIRS (DODOASHA)

Final Rule Stage

39. TRICARE Reimbursement of Ambulatory Surgery Centers and Outpatient Services Provided in Cancer and Children's Hospitals [0720-AB73]

Priority: Other Significant.

Legal Authority:5 U.S.C. 301; 10 U.S.C. ch. 55

CFR Citation:32 CFR 199.

Legal Deadline: None.

Abstract: The Department of Defense, Defense Health Agency, is revising its regulation on the reimbursement of ambulatory surgery centers (ASC) and outpatient services provided in Cancer and Children's Hospitals (CCHs). Revisions are in accordance with the statutory provision at title 10 of the U.S.C., section 1079(i)(2) that requires TRICARE's payment methods for institutional care be determined, to the extent practicable, in accordance with the same reimbursement rules as apply to payments to providers of services of the same type under Medicare. In accordance with this requirement, TRICARE will: (1) adopt Medicare's payment methodology for Ambulatory Surgery Centers (ASC) and (2) adopt Medicare's payment methodology for outpatient services provided in Cancer and Children's Hospitals (CCHs). Although Medicare's reimbursement methods for ASC and CCHs are different, it is prudent to adopt both the Medicare ASC system and to adopt the Outpatient Prospective Payment System (OPPS) with hold-harmless adjustments (meaning the provider is not reimbursed less than their costs) for CCHs simultaneously to align with our statutory requirement to reimburse like Medicare at the same time. This rule makes the modifications necessary to implement TRICARE reimbursement methodologies similar to those applicable to Medicare beneficiaries for outpatient services rendered in ASCs and CCHs.

Statement of Need: The rule finalizes modifications to TRICARE regulation necessary to implement Medicare-similar reimbursement methods for Ambulatory Surgery Centers (ASCs) and Cancer and Children's Hospitals (CCHs). This is outlined in 10 U.S.C. 1079(i)(2) which requires TRICARE's payment methods for institutional care be determined, to the extent practicable, in accordance with the same reimbursement rules as apply to payments to providers of services of the same type under Medicare.

Summary of Legal Basis: This rule is issued under 10 U.S.C. 1073 (a)(2) giving authority and responsibility to the Secretary of Defense to administer the TRICARE program.

Alternatives:

(1) No action.

(2) Permitting a transition period for Ambulatory Surgery Centers (ASCs). DHA explored the use of a transition period that blended the current reimbursement method with the proposed method. This would slowly shift the rates to be fully aligned with Medicare at the end of the transition and would protect providers from lower payments. After comparing the differences in rates, DHA found that many providers are likely to see an increase in reimbursement, which would not be effective until the end of the transition period. Some providers may see a decrease in payments, but on the whole, Medicare's payments have been found to be adequate based upon a Medicare Payment Advisory Committee (MedPAC) review. As a result, DHA will not adopt a transition period.

(3) Permitting a transition period for Cancer and Children's Hospitals (CCHs). DHA explored the use of a transition period that blended the current reimbursement method with the proposed, and slowly shifted the rates to be fully aligned with Medicare at the end of the transition. This would be done to protect providers from payments below their cost, in the event that the rates are significantly affected. To protect CCHs, DHA will ensure that CCHs are reimbursed the greater of 100% of their costs or the OPPS payment. Because many CCH providers will receive payment increases, a transition period would not be beneficial for them. Historically, transitions are done to protect providers from payments below their costs. However, in this case, providers will be held-harmless, so no transition is necessary.

Anticipated Cost and Benefits: Economic impact of this rule is based on analysis of expected outcomes had the rule been implemented in 2021. The overall impact to the DoD, for ASC reimbursement, would be $10 million in reduced payments for ASCs. The overall impact to the DoD, for adopting OPPS for CCHs, would be $35 million in reduced payments to these providers. The combined impact is a cost-saving of approximately $45 million, which would be offset by $1.5 million in administrative costs to implement the changes. This estimated reduction in costs of $45 million is a transfer from providers to DoD.

Risks: None. DHA is adopting the new Ambulatory Surgery Center (ASC) and Cancer and Children's Hospital (CCH) reimbursement systems to be consistent with Medicare's, as required by statute. Although DHA expects a decrease in total TRICARE payments for ASCs; however, rates for almost half the high-volume ASC surgeries will increase under the new ASC payment system. DHA also notes that even if some ASCs deny access to some surgeries, TRICARE beneficiaries would be largely protected from access problems as these patients could have their surgeries performed in hospital outpatient departments (HOPDs). Additionally, CCHs will be held harmless, as they will receive, at a minimum, one-hundred percent of its costs, or the higher payment under Outpatient Prospective Payment System (OPPS). Under the new method, CCHs may be eligible for the General Temporary Military Contingency Payment Adjustments (GTMCPA) that will ensure network adequacy during military contingency operations. These GTMCPAs will be issued in the same manner as those made currently under TRICARE's OPPS.

Timetable:

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Jahanbakhsh Badshan, Department of Defense, Office of Assistant Secretary for Health Affairs, 16401 East Centretech Parkway, Aurora, CO 80011, Phone: 303 676-3881, Email: jahanbakhsh.badshah.civ@health.mil.

RIN: 0720-AB73

DOD—DODOASHA

40. TRICARE Coverage of National Institute of Allergy and Infectious Disease Coronavirus Disease 2019 Clinical Trials [0720-AB83]

Priority: Other Significant.

Legal Authority:5 U.S.C. 301; 10 U.S.C. ch. 55

CFR Citation:32 CFR 199.

Legal Deadline: None.

Abstract: This rule finalizes provisions published in two interim final rules with request for comment, which temporarily added coverage for the treatment use of investigation drugs under U.S. Food and Drug Administration (FDA) approved expanded access programs when for the treatment of coronavirus disease 2019 (COVID-19) and permitted coverage of National Institute of Allergy and Infectious Disease (NIAID)-sponsored clinical trials for the treatment or prevention of COVID-19.

Statement of Need: This final rule is required to finalize certain temporary flexibilities enacted in interim final rules published in 2020 in response to the COVID-19 pandemic.

Pursuant to the President's national emergency declaration and as a result of the worldwide COVID-19 pandemic, the Assistant Secretary of Defense for Health Affairs hereby temporarily modified the regulation at 32 CFR 199.4(e)(26) to permit TRICARE coverage for National Institute of Allergy and Infectious Disease (NIAID)-sponsored COVID-19 phase I, II, III, and IV clinical trials for the treatment or prevention of coronavirus disease 2019 (COVID-19). This provision supports increased access to emerging therapies for TRICARE beneficiaries.

Summary of Legal Basis: This rule is issued under 10 U.S.C. 1073(a)(2) giving authority and responsibility to the Secretary of Defense to administer the TRICARE program.

Alternatives:

(1) No action.

(2) The second alternative the DoD considered was implementing a more limited benefit change for COVID-19 patients by not covering phase I clinical trials. Although this would have the benefit of reimbursing only care that has more established evidence in its favor, this alternative is not preferred because early access to treatments is critical for TRICARE beneficiaries given the rapid progression of the disease and the lack of available approved treatments.

Anticipated Cost and Benefits: Any cost to beneficiaries would be consistent with existing costs under the TRICARE Program (such as cost-shares and copayments). Finalizing TRICARE coverage of clinical trials will benefit TRICARE beneficiaries by ensuring they continue to have access to emerging therapies in the safest setting possible.

In the interim final rule, DoD estimated the total cost for TRICARE participation in NIAID-sponsored COVID-19 clinical trials would be $3.2M for the duration of the national emergency, with an additional $4.0M for continued care for beneficiaries enrolled in clinical trials prior to termination of the national emergency. There were several assumptions we made in developing this estimate. The duration of the COVID-19 national emergency is uncertain; however, for the purposes of this estimate, we assumed the national emergency would expire on September 30, 2021. As of the drafting of the IFR, there were 27 NIAID-sponsored COVID-19 clinical trials begun since the start of the national emergency. We assumed 6.2 new trials every 30 days, for a total of 126 trials by September 2021. We assumed, based on average trial enrollment and that TRICARE beneficiaries would participate in trials at the same rate as the general population, that 4,549 TRICARE beneficiaries would participate through September 2021. Each of the assumptions in this estimate is highly uncertain, and our estimate could be higher or lower depending on real world events (more or fewer trials, a longer or shorter national emergency, and/or higher or lower participation in clinical trials by TRICARE beneficiaries).

Benefits: These changes expand the therapies available to TRICARE beneficiaries in settings that ensure informed consent of the beneficiary, and where the benefits of treatment outweigh the potential risks. Participation in clinical trials may provide beneficiaries with benefits such as reduced hospitalizations and/or use of a mechanical ventilator. Although we cannot estimate the value of avoiding these outcomes quantitatively, the potential long-term consequences of serious COVID-19 illness, including permanent cardiac or lung damage, are not insignificant. Beneficiary access to emerging therapies that reduce these long-term consequences or even death can be considered to be high-value for those able to participate.

TRICARE providers will be positively affected by being able to provide their patients with a broader range of treatment options. The general public will benefit from an increased pool of available participants for the development of treatments and vaccines for COVID-19, as well as the evidence (favorable or otherwise) that results from this participation.

Risks: None. This rule will not directly affect the efficient functioning of the economy or private markets. However, increasing the pool of available participants for clinical trials may help speed the development of treatments or vaccines for COVID-19. Once effective treatments or vaccines for COVID-19 exist, individuals are likely to be more confident interacting in the public sphere, resulting in a positive impact on the economy and private markets.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Agency Contact: Jennifer Stankovic, Department of Defense, Office of Assistant Secretary for Health Affairs, 16401 E Centretech Parkway, Aurora, CO 80011-9066, Phone: 303 676-3742, Email: jennifer.l.stankovic.civ@health.mil.

Related RIN: Related to 0720-AB81, Related to 0720-AB82

RIN: 0720-AB83

DOD—DODOASHA

41. Expanding TRICARE Access to Care in Response to the COVID-19 Pandemic [0720-AB85]

Priority: Other Significant.

Legal Authority:5 U.S.C. 301; 10 U.S.C. ch. 55

CFR Citation:32 CFR 199.

Legal Deadline: None.

Abstract: This interim final rule with comment will temporarily amend the TRICARE regulation at 32 CFR part 199 by: (1) adding freestanding End Stage Renal Disease facilities as a category of TRICARE-authorized institutional provider and modifying the reimbursement for such facilities; and (2) adopting Medicare New COVID-19 Treatments Add-on Payments (NTCAPs).

Statement of Need: Pursuant to the President's emergency declaration and as a result of the COVID-19 pandemic, the Assistant Secretary of Defense for Health Affairs is temporarily modifying the following regulations (except for the modifications to paragraphs 199.6(b)(4)(xxi) and 199.14(a)(1)(iii)(E)( 7), which will not expire), but, in each case, only to the extent necessary to ensure that TRICARE beneficiaries have access to the most up-to-date care required for the prevention, diagnosis, and treatment of COVID-19, and that TRICARE continues to reimburse like Medicare, to the extent practicable, as required by statute.

The modifications to paragraphs 199.6(b)(4)(xxi) and 199.14(a)(1)(iii)(E)( 7) establish freestanding End Stage Renal Disease (ESRD) facilities as a category of TRICARE-authorized institutional provider and modify TRICARE reimbursement of freestanding ESRD facilities. These provisions will improve TRICARE beneficiary access to medically necessary dialysis and other ESRD services and supplies. These provisions also support the requirement that TRICARE reimburse like Medicare, and will help to alleviate regional health care shortages due to the COVID-19 pandemic by ensuring access to dialysis care in freestanding ESRD facilities rather than hospital outpatient departments.

The modification to paragraph 199.14(a)(iii)(E) adopts Medicare's New COVID-19 Treatments Add-on Payment (NCTAP) for COVID-19 cases that meet Medicare's criteria. This provision increases access to emerging COVID-19 treatments and supports the requirement that TRICARE reimburse like Medicare.

Summary of Legal Basis: This rule is issued under 10 U.S.C. 1073 (a)(2) giving authority and responsibility to the Secretary of Defense to administer the TRICARE program.

Alternatives:

(1) No action.

(2) The second alternative the Department of Defense considered was to adopt Medicare's ESRD reimbursement methodology, the ESRD Prospective Payment System (PPS), in total. While this would have been completely consistent with the statutory provision to pay institutional providers using the same reimbursement methodology as Medicare, this alternative is not preferred because there is still a relatively low volume of TRICARE beneficiaries who receive dialysis services from freestanding ESRDs and who are not enrolled to Medicare. The cost of implementing the full ESRD PPS system is estimated to be at least $600,000.00 in start-up costs, plus ongoing administrative costs, to ensure all adjustments were made for each claim, plus additional special pricing software or algorithms. In contrast, we estimate that the option provided in this IFR can be implemented relatively quickly (within six months of publication), and for approximately $300,000.00 in start-up costs with lower ongoing administrative costs. Further, the flat rate will provide the ESRD facilities with predictability with regard to TRICARE payments and will reduce uncertainty and specialized coding or case-mix documentation requirements that may be required by the ESRD PPS, reducing the administrative burden on the provider.

To summarize, adopting the ESRD PPS was considered, but was deemed impracticable and overly burdensome to both the Government and providers due to the relative low volume of claims that will be priced and paid by TRICARE as primary under this system.

Anticipated Cost and Benefits: $8.08 million. Only the ESRD provisions are expected to result in recurring incremental health care costs; the remaining two provisions are expected to result in one-time cost increases.

This estimate includes approximately $0.9M in administrative costs and $5.9M in direct health care costs.

$1.8M of the total cost impact is expected to be a one-time start-up cost for both the temporary and permanent provisions, while the permanent ESRD provisions are expected to result in $5M in incremental annual costs.

Risks: None. This rule will promote the efficient functioning of the economy and markets by modifying the regulations to better reimburse health care providers for care provided during the COVID-19 pandemic, particularly as strain on the health care economy is being felt due to reductions in higher cost elective procedures. Additionally, this rule will increase the access of TRICARE beneficiaries to more providers administering COVID-19 vaccinations, which promotes the efficient functioning of the U.S. economy by quickening the pace at which the public receives COVID-19 vaccinations.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Jahanbakhsh Badshah, Healthcare Program Specialist—Reimbursement, Department of Defense, Office of Assistant Secretary for Health Affairs, 16401 E Centretech Parkway, Aurora, CO 80011, Phone: 303 676-3881, Email: jahanbakhsh.badshah.civ@health.mil.

RIN: 0720-AB85

DOD—DODOASHA

42. Collection From Third Party Payers of Reasonable Charges for Healthcare Services; Amendment [0720-AB87]

Priority: Other Significant.

Legal Authority: NDAA 2021, sec. 702

CFR Citation:32 CFR 220.

Legal Deadline: None.

Abstract: The National Defense Authorization Act (NDAA) section 702 for Fiscal Year (FY) 2021 provides authority to waive fees charged for certain civilian non-beneficiary patients: (1) after the patient's insurance pays, if any, the civilian is not able to pay for the trauma or other medical care provided to the civilian; and (2) the provision of such care enhances the knowledge, skills, and abilities of health care providers, as determined by the Secretary. The amendment of 32 CFR 220.7 would delegate authority to the Secretary of Defense or a Secretary of Defense established representative to waive medical debt owed for services rendered at Military Treatment Facilities (MTF) if the patient requests a medical debt waiver and meets the two specified criteria.

This amendment should be made as current legislation and policies can lead to an undue financial burden on non-beneficiary patients who have incurred medical debt from treatment at MTFs. The Debt Collection Improvement Act of 1996 and the Digital Accountability and Transparency act of 2014 drive federal collection activities and can place individuals indebted to the government at risk of financial hardship. By making these changes, the Secretary of Defense would have the ability to waive non-beneficiary civilian debt in cases where the patient is unable to pay as determined using U.S. Treasury guidelines and when the care provided enhances the knowledge, skills, and abilities of health care providers.

Statement of Need: Section 702 of the FY 2021 NDAA amends 10 U.S.C. 1079b by inserting a new subsection regarding the waiver of fees. Under section 702, the Secretary of Defense may waive a fee charged to a civilian who is not a covered beneficiary if after insurance payments, if any, the civilian is not able to pay for the trauma or other medical care provided to the civilian; and the provision of such care enhanced the medical readiness of the health care provider or health care providers furnishing such care. This rule prescribes a new debt waiver process for medical debt owned for services rendered at Military Treatment Facilities to civilians who are not covered beneficiaries.

Summary of Legal Basis: Section 702 of the FY 2021 NDAA amends 10 U.S.C. 1079b by inserting a new subsection regarding the waiver of fees. Under section 702, the Secretary of Defense may waive a fee charged to a civilian who is not a covered beneficiary if after insurance payments, if any, the civilian is not able to pay for the trauma or other medical care provided to the civilian; and the provision of such care enhanced the medical readiness of the health care provider or health care providers furnishing such care.

Alternatives:

Alternative #1: The first alternative will use an outside agency, the Centralized Receivable Service (CRS) to complete the patient ability-to-pay assessment and make a recommendation to the DHA Cost Accounting Division (CAD) Financial Operations (FO). CAD FO will then make the final determination based on that recommendation. This alternative will utilize DHA's existing relationship with CRS, a program under the U.S. Department of Treasury focused on managing pre-delinquent debt and debt in the early stages of delinquency before it is referred to the U.S. Treasury.

Alternative #2: The DoD considered a second alternative in which the DHA UBO will stand up a cell to complete the ability-to-pay assessments and make a recommendation. The recommendations will be directed to either the DHA CAD FO for accounts under $100,000 or to the Deputy Assistant Director (DAD) FO for accounts over $100,000.

Alternative #3: Option 3, which is DoD's preferred approach due to operational efficiency gains, would leverage existing partnerships with CRS and U.S. Treasury. For active or non-delinquent debt, the MTF UBO will direct all uninsured non-beneficiary accounts to CRS for billing. The patient can request a waiver by contacting CRS as directed on their invoice, the MTF will direct the account information to CRS to complete the financial analysis. If a patient is deemed financially culpable, collections will be pursued by CRS. If not, CRS will calculate an amount the debtor can pay within 3-5 years and waive the remaining debt. CRS would report decisions to DHA following established business rules and guidelines including monthly accounting of all waiver and compromise agreements to DHA, and immediately report waived amounts over $100,000. Any additional business rules will be decided by DHA FO and DHA General Counsel.

Anticipated Cost and Benefits: This cost will be the fee paid to CRS for their services, totaling an estimated $145,711. Time required for this alternative is an estimated 17 days based on CRS reported process completion estimates from the DAMP program. This would include time for the civilian to compile required documents, for CRS to draft the package and assess ability to pay, as well as CRS response time for a decision and any other follow-up activities for each request for waiver.

Risks: None.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: DeLisa Prater, DHA Uniform Business Office Program Manager, Department of Defense, Office of Assistant Secretary for Health Affairs, 8111 Gatehouse Road, Suite #221, Falls Church, VA 22042-5101, Phone: 703 275-6380, Email: delisa.e.prater.civ@mail.mil.

RIN: 0720-AB87

DEPARTMENT OF EDUCATION

Statement of Regulatory Priorities

I. Introduction

The U.S. Department of Education (Department) supports States, local communities, institutions of higher education, and families in improving education and other services nationwide to ensure that all Americans, including those with disabilities and who have been underserved, receive a high-quality and safe education and are prepared for employment that provides a livable wage. We provide leadership and financial assistance pertaining to education and related services at all levels to a wide range of stakeholders and individuals, including State educational and other agencies, local school districts, providers of early learning programs, elementary and secondary schools, institutions of higher education, career and technical schools, nonprofit organizations, students, members of the public, families, and many others. These efforts are helping to advance equity, recover from the COVID-19 pandemic, and ensure that all children and students from pre-kindergarten through grade 12 will be ready for, and succeed in, postsecondary education and employment, and that students attending postsecondary institutions, or participating in other postsecondary education options, are prepared for a profession or career.

We also vigorously monitor and enforce the implementation of Federal civil rights laws in educational programs and activities that receive Federal financial assistance from the Department, and support innovative and promising programs, research and evaluation activities, technical assistance, and the dissemination of data, research, and evaluation findings to improve the quality of education.

Overall, the laws, regulations, and programs that the Department administers will affect nearly every American during his or her life. Indeed, in the 2021-22 school year, about 56 million students attended an estimated 129,000 elementary and secondary schools in approximately 13,600 districts, and about 20 million students enrolled in postsecondary institutions of higher education. Many of these students benefit from some degree of financial assistance or support from the Department.

In developing and implementing regulations, guidance, technical assistance, evaluations, data gathering and reporting, and monitoring related to our programs, we are committed to working closely with affected persons and groups. Our core mission includes serving the most vulnerable, and facilitating equal access for all, to ensure all students receive a high-quality and safe education and complete it with a well-considered and attainable path to a sustainable career. Toward these ends, we work with a broad range of interested parties and the general public, including families, students, and educators; State, local, and Tribal governments; other Federal agencies; and neighborhood groups, community-based early learning programs, elementary and secondary schools, postsecondary institutions, rehabilitation service providers, adult education providers, professional associations, civil rights organizations, nonprofits, advocacy organizations, businesses, and labor organizations.

If we determine that it is necessary to develop regulations, we seek public participation at the key stages in the rulemaking process. We invite the public to submit comments on all proposed regulations through the internet or by regular mail. We also continue to seek greater public participation in our rulemaking activities through the use of transparent and interactive rulemaking procedures and new technologies.

To facilitate the public's involvement, we participate in the Federal Docket Management System (FDMS), an electronic single Government-wide access point ( www.regulations.gov) that enables the public to submit comments on different types of Federal regulatory documents and read and respond to comments submitted by other members of the public during the public comment period. This system provides the public with the opportunity to submit comments electronically on any notice of proposed rulemaking or interim final regulations open for comment as well as read and print any supporting regulatory documents.

II. Regulatory Priorities

The following are the key rulemaking actions the Department is planning for the coming year. These rulemaking actions advance the Department's mission of “promot[ing] student achievement and preparation for global competitiveness by fostering educational excellence and ensuring equal access.” These rulemaking actions also advance the President's priorities of ensuring that every American has access to a high-quality education, regardless of background, and that government should affirmatively work to expand educational opportunities for underserved communities. During his time in office, the President has repeatedly made clear the importance of advancing equity and opportunity for those who have historically been underserved, both as a general matter and with regard to the education system in particular.

See Executive Order 13985 (On Advancing Racial Equity and Support for Underserved Communities Through the Federal Government); Executive Order 14021 (Guaranteeing an Educational Environment Free From Discrimination on the Basis of Sex, Including Sexual Orientation or Gender Identity); Executive Order 14041 (White House Initiative on Advancing Educational Equity, Excellence, and Economic Opportunity Through Historically Black Colleges and Universities); Executive Order 14045 (White House Initiative on Advancing Educational Equity, Excellence, and Economic Opportunity for Hispanics); Executive Order 14049 (White House Initiative on Advancing Educational Equity, Excellence, and Economic Opportunity for Native Americans and Strengthening Tribal Colleges and Universities); and Executive Order 14050 (White House Initiative on Advancing Educational Equity, Excellence, and Economic Opportunity for Black Americans). The rulemaking actions on the Department's agenda seek to advance the President's priorities, as set out in these executive orders and more broadly. Our regulatory agenda covers a wide range of topics, and a wide range of educational institutions— from those serving our youngest children to colleges, universities, and adult education programs. In each of these contexts, promoting equity and opportunity for students who have been historically underserved is central to the Department's regulatory plan.

Postsecondary Education/Federal Student Aid

The Department's upcoming higher education regulatory efforts include the following areas:

• Improving Income Driven Repayment
• Gainful Employment

These rulemakings are focused on improving the rules governing student loan repayment and protecting students and taxpayers from career-training programs that fail to provide sufficient value, among other topics. These rulemakings reflect the Department's commitment to helping borrowers successfully manage their student loans and protecting students from harmful programs and practices that may derail their postsecondary and career goals. Through these regulatory efforts, the Department plans to address gaps in postsecondary outcomes, particularly those related to student loan repayment delinquency, and default, as well as the returns students receive for their investments. For its higher education rulemakings, generally the Department uses a negotiated rulemaking process. We selected participants for the negotiated rulemaking committees from nominees of the organizations and groups that represent the interests significantly affected by the proposed regulations. To the extent possible, we selected nominees who reflect the diversity among program participants.

The Department used this negotiated rulemaking process for its rulemakings on Improving Income Driven Repayment and Gainful Employment. On Improving Income Driven Repayment, the Department plans to create or adjust an income driven repayment plan that would allow borrowers to more easily afford their student loan payments. For Gainful Employment, the Department plans to propose regulations on program eligibility under the HEA, including regulations that determine whether postsecondary educational programs prepare students for gainful employment in recognized occupations, and the conditions under which programs remain eligible for student financial assistance programs under Title IV of the HEA.

Civil Rights/Title IX

The Secretary proposed to amend its regulations implementing Title IX of the Education Amendments of 1972, as amended, consistent with the priorities of the Biden-Harris Administration. These priorities include those set forth in Executive Order 13988 on Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation and Executive Order 14021 on Guaranteeing an Educational Environment Free from Discrimination on the Basis of Sex, Including Sexual Orientation and Gender Identity.

Student Privacy

The Department is considering policy options to amend the Family Educational Rights and Privacy Act (FERPA) regulations, to update, clarify, and improve the current regulations. The proposed regulations are also needed to implement statutory amendments to FERPA contained in the Uninterrupted Scholars Act of 2013 and the Healthy, Hunger-Free Kids Act of 2010, to reflect a change in the name of the office designated to administer FERPA, and to make changes related to the enforcement responsibilities of the office concerning FERPA.

Recently Completed Rulemakings

Additionally, the Department has recently concluded a number of critical rulemakings, including Public Service Loan Forgiveness; Borrower Defense to Repayment; Improving Discharges for Total and Permanent Disabilities, Closed Schools, and False Certification; Determining the Amount of Federal Education Assistance Funds Received by Institutions of Higher Education (90/10); and Pell Grants for Prison Education Programs. For Public Service Loan Forgiveness, the Department streamlined the process for receiving loan forgiveness after 10 years of qualifying payments on qualifying loans while engaging in public service. For Borrower Defense, the Secretary amended the regulations that specify the acts or omissions of an institution of higher education that a borrower may assert as a defense to repayment of a loan made under the Federal Direct Loan Program. In Improving Discharges for Total and Permanent Disabilities, Closed Schools, and False Certification, the Department improved areas where Congress has provided borrowers with relief or benefits related to Federal student loans. This includes authorities granted under the Higher Education Act (HEA) that allow the Department to cancel loans for borrowers who meet certain criteria, such as having a total and permanent disability, attending a school that closed, or having been falsely certified for a student loan. For these borrowers, the Secretary amended the regulations relating to borrower eligibility and streamlined application requirements and the application and certification processes. On the 90/10 rule, in response to changes to the HEA made by the American Rescue Plan Act of 2021, the Department amended provisions governing whether proprietary institutions meet requirements that institutions receive at least 10 percent of their revenue from sources other than Federal education assistance funds. To increase access to educational opportunities, the Department also issued regulations that would guide correctional facilities and eligible institutions of higher education that seek to establish eligibility for the Pell Grant program for individuals who are incarcerated.

III. Principles for Regulating

Over the next year, we may need to issue other regulations because of new legislation or programmatic changes. In doing so, we will follow the Principles for Regulating, which determine when and how we will regulate. Through consistent application of those principles, we have eliminated unnecessary regulations and identified situations in which major programs could be implemented without regulations or with limited regulatory action.

In deciding when to regulate, we consider the following:

• Whether regulations are essential to promote quality and equality of opportunity in education.
• Whether a demonstrated problem cannot be resolved without regulation.
• Whether regulations are necessary to provide a legally binding interpretation to resolve ambiguity.
• Whether entities or situations subject to regulation are similar enough that a uniform approach through regulation would be meaningful and do more good than harm.
• Whether regulations are needed to protect the Federal interest, that is, to ensure that Federal funds are used for their intended purpose and to eliminate fraud, waste, and abuse.

In deciding how to regulate, we are mindful of the following principles:

• Regulate no more than necessary.
• Minimize burden to the extent possible and promote multiple approaches to meeting statutory requirements if possible.
• Encourage coordination of federally funded activities with State and local reform activities.
• Ensure that the benefits justify the costs of regulating.
• To the extent possible, establish performance objectives rather than specify the behavior or manner of compliance a regulated entity must adopt.
• Encourage flexibility, to the extent possible and as needed to enable institutional forces to achieve desired results.

ED—OFFICE FOR CIVIL RIGHTS (OCR)

Proposed Rule Stage

43. • Nondiscrimination on the Basis of Sex in Athletics Education Programs or Activities Receiving Federal Financial Assistance [1870-AA19]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Unfunded Mandates: Undetermined.

Legal Authority:20 U.S.C. 1681 et seq.

CFR Citation:34 CFR 106.

Legal Deadline: None.

Abstract: The Department plans to issue a final rule amending its regulations implementing Title IX of the Education Amendments of 1972, 20 U.S.C. 1681 et seq., consistent with the priorities of the Biden-Harris Administration. These priorities include those set forth in Executive Order 13988 on Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation and Executive Order 14021 on Guaranteeing an Educational Environment Free from Discrimination on the Basis of Sex, Including Sexual Orientation and Gender Identity.

Statement of Need: This rulemaking is necessary to align the Title IX regulations to fully implement the statute.

Summary of Legal Basis: We are conducting this rulemaking under 20 U.S.C. 1681 et seq.

Alternatives: We have limited information about the alternatives at this time.

Anticipated Cost and Benefits: We have limited information about the costs and benefits at this time.

Risks: We have limited information about the risks at this time.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

Agency Contact: Alejandro Reyes, Department of Education, Office for Civil Rights, 400 Maryland Avenue SW, Room PCP-6125, Washington, DC 20202, Phone: 202 245-7272, Email: alejandro.reyes@ed.gov.

RIN: 1870-AA19

ED—OCR

Final Rule Stage

44. Nondiscrimination on the Basis of Sex in Education Programs or Activities Receiving Federal Financial Assistance [1870-AA16]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Unfunded Mandates: Undetermined.

Legal Authority:20 U.S.C. 1681 et seq.

CFR Citation:34 CFR 106.

Legal Deadline: None.

Abstract: The Department plans to issue a final rule amending its regulations implementing Title IX of the Education Amendments of 1972, 20 U.S.C. 1681 et seq., consistent with the priorities of the Biden-Harris Administration. These priorities include those set forth in Executive Order 13988 on Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation and Executive Order 14021 on Guaranteeing an Educational Environment Free from Discrimination on the Basis of Sex, Including Sexual Orientation and Gender Identity. The proposed amendments include, among others, revisions to 34 CFR 106.2 (Definitions), 106.6 (Effect of other requirements and preservation of rights), 106.8 (Designation of coordinator, dissemination of policy, and adoption of grievance procedures), 106.10 (Scope), 106.11 (Application), 106.30 (Definitions), 106.31 (Education programs or activities), 106.40 (Parental, family, or marital status; pregnancy or related conditions), 106.44 (Action by a recipient to operate its education program or activity free from sex discrimination), 106.45 (Grievance procedures for the prompt and equitable resolution of complaints of sex discrimination), 106.46 (Grievance procedures for the prompt and equitable resolution of complaints of sex-based harassment involving student complainants or student respondents at postsecondary institutions); 106.51 (Employment), 106.57 (Parental, family, or marital status; pregnancy or related conditions), 106.60 (Pre-employment inquiries), and 106.71 (Retaliation).

Statement of Need: This rulemaking is necessary to align the Title IX regulations with the priorities of the Biden-Harris Administration, including those set forth in the Executive Order on Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation (E.O. 13988) and the Executive Order on Guaranteeing an Educational Environment Free from Discrimination on the Basis of Sex, Including Sexual Orientation and Gender Identity (E.O. 14021).

Summary of Legal Basis: We are conducting this rulemaking under 20 U.S.C. 1681 et seq.

Alternatives: This was discussed in the notice of proposed rulemaking (NPRM) and will be discussed in the final regulations.

Anticipated Cost and Benefits: This was discussed in the notice of proposed rulemaking (NPRM) and will be discussed in the final regulations.

Risks: This was discussed in the notice of proposed rulemaking (NPRM) and will be discussed in the final regulations.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: State.

Federalism: This action may have federalism implications as defined in E.O. 13132.

Agency Contact: Alejandro Reyes, Department of Education, Office for Civil Rights, 400 Maryland Avenue SW, PCP-6125, Washington, DC 20202, Phone: 202 245-7705, Email: t9nprm@ed.gov.

RIN: 1870-AA16

ED—OFFICE OF POSTSECONDARY EDUCATION (OPE)

Proposed Rule Stage

45. Gainful Employment [1840-AD57]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: Undetermined.

Legal Authority:20 U.S.C. 1001; 20 U.S.C. 1002; 20 U.S.C. 1003; 20 U.S.C. 1088; 20 U.S.C. 1091; 20 U.S.C. 1094; 20 U.S.C. 1099(b); 20 U.S.C. 1099(c); 20 U.S.C. 1082; . . .

CFR Citation:34 CFR 668; 34 CFR 600.

Legal Deadline: None.

Abstract: The Secretary plans to propose to amend 34 CFR parts 668 and 600 on institution and program eligibility under the HEA, including regulations that determine whether postsecondary educational programs prepare students for gainful employment in recognized occupations, and the conditions under which institutions and programs remain eligible for student financial assistance programs under Title IV of the HEA.

Statement of Need: This rulemaking is necessary to determine whether postsecondary educational programs prepare students for gainful employment and the conditions under which institutions and programs remain eligible for student financial assistance programs under Title IV of the HEA.

Summary of Legal Basis: We are conducting this rulemaking under the following authorities: 20 U.S.C. 1001; 20 U.S.C. 1002; 20 U.S.C. 1003; 20 U.S.C. 1088; 20 U.S.C. 1091; 20 U.S.C. 1094; 20 U.S.C. 1099(b); 20 U.S.C. 1099(c); and 20 U.S.C. 1082.

Alternatives: We have limited information about the alternatives at this time.

Anticipated Cost and Benefits: We have limited information about the anticipated costs and benefits at this time.

Risks: We have limited information about the risks at this time.

Timetable:

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

Agency Contact: Gregory Martin, Department of Education, Office of Postsecondary Education, 400 Maryland Avenue SW, Room 2C136, Washington, DC 20202, Phone: 202 453-7535, Email: gregory.martin@ed.gov.

RIN: 1840-AD57

ED—OPE

46. • Improving Income Driven Repayment [1840-AD81]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority:20 U.S.C. 1070g; 20 U.S.C. 1087a, et seq.

CFR Citation:34 CFR 685.

Legal Deadline: None.

Abstract: The Secretary plans to propose amendments to the regulations governing income-contingent repayment plans by amending the Revised Pay as You Earn (REPAYE) repayment plan, and to restructure and rename the repayment plan regulations under the William D. Ford Federal Direct Loan (Direct Loan) Program, including combining the Income Contingent Repayment (ICR) and the Income-Based Repayment (IBR) plans under the umbrella term of Income-Driven Repayment (IDR) plans.

Statement of Need: This rulemaking is necessary to make improvements to the income-driven repayment plans created under the ICR authority in Higher Education Act of 1965 that allows the Secretary to cap payments at a set share of a borrower's income.

Summary of Legal Basis:20 U.S.C. 1070g, 1087a, et seq., unless otherwise noted.

Alternatives: We have limited information about the alternatives at this time.

Anticipated Cost and Benefits: We have limited information about the anticipated costs and benefits at this time.

Risks: We have limited information about the risks at this time.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Tamy Abernathy, Department of Education, Office of Postsecondary Education, 400 Maryland Avenue SW, 2C-232, Washington, DC 20202, Phone: 202 453-5970, Email: tamy.abernathy@ed.gov.

RIN: 1840-AD81

DEPARTMENT OF ENERGY

Statement of Regulatory and Deregulatory Priorities

The Department of Energy (Department or DOE) makes vital contributions to the Nation's welfare through its activities focused on improving national security, energy supply, energy efficiency, environmental remediation, and energy research. The Department's mission is to:

• Promote dependable, affordable and environmentally sound production and distribution of energy;
• Advance energy efficiency and conservation;
• Provide responsible stewardship of the Nation's nuclear weapons;
• Provide a responsible resolution to the environmental legacy of nuclear weapons production; and
• Strengthen U.S. scientific discovery, economic competitiveness, and improve quality of life through innovations in science and technology.

The Department's regulatory activities are essential to achieving its critical mission and to implementing the President's clean energy and climate initiatives. Among other things, the Regulatory Plan and the Unified Agenda contain the rulemakings the Department will be engaged in during the coming year to fulfill the Department's commitment to meeting deadlines for issuance of energy conservation standards and related test procedures. The Regulatory Plan and Unified Agenda also reflect the Department's continuing commitment to cut costs, reduce regulatory burden, and increase responsiveness to the public.

Energy Efficiency Program for Consumer Products and Commercial Equipment

The Energy Policy and Conservation Act (EPCA) requires DOE to set appliance efficiency standards at levels that achieve the maximum improvement in energy efficiency that is technologically feasible and economically justified. The Department continues to follow its schedule for setting new appliance efficiency standards by both tackling its backlog of rulemakings with missed statutory deadlines and advancing rulemakings with upcoming statutory deadlines. In 2022, DOE has published 55 actions relating to energy conservation standards, including nine final actions; 45 actions relating to test procedures, including 18 final rules; and four actions related to coverage determinations, including three final rules. DOE tentatively plans to publish three additional actions relating to energy conservation standards and seven actions relating to test procedures by the end of the year. These rulemakings are expected to save American consumers billions of dollars in energy costs over a 30-year timeframe.

The Department is highlighting one important energy conservation standard rule entitled “Energy Conservation Standards for Residential Non-Weatherized Gas Furnaces and Mobile Home Gas Furnaces.” For non-weatherized gas furnaces and mobile home gas furnaces, DOE estimates that energy savings for active mode operation (in terms of annual fuel utilization efficiency (AFUE)) will be 5.48 quads over 30 years and that the net benefit to the Nation will be between $6.2 billion and $21.6 billion. DOE estimates that energy savings for standby mode and off mode operation will be 0.28 quads over 30 years and that the net benefit to the Nation will be between $1.1 billion and $3.4 billion.

Federal Agency Leadership in Climate Change

Beyond the appliance program, DOE is supporting Federal agency leadership in climate change in various ways, including in its “Clean Energy Rule for New Federal Buildings and Major Renovations” (Clean Energy Rule), which implements a provision of the Energy Independence and Security Act of 2007 (EISA) that requires the Department to establish revised-performance standards for the construction of all new Federal buildings, including commercial buildings, multi-family high-rise residential buildings, and low-rise residential buildings. Consistent with the requirements in EISA, this rule presents revised Federal building energy performance standards that would require reductions in Federal agencies' on-site use of fossil fuels (which include coal, petroleum, natural gas, oil shales, bitumens, tar sands, and heavy oils) consistent with the targets of EPCA and EISA, and provides processes by which agencies can petition DOE for the downward adjustment of these targets for buildings. For covered buildings for which design for construction or whole building renovation begins in fiscal year 2030 or beyond, the fossil fuel-generated energy consumption of the building must be zero for all building types and climate zones, based on the calculation established in the regulations.

Investing in Clean Energy Projects

The “Loan Guarantees for Clean Energy Projects” interim final rule would amend DOE's regulations implementing the Title XVII loan guarantee program to incorporate new categories of eligible projects and other provisions of the Energy Act of 2020, the Infrastructure Investment Act of 2021, and the Inflation Reduction Act of 2022. The rule would also include other changes to the existing regulations based on experiences gained implementing the Title XVII program and on comments recently received from stakeholders in response to DOE's Request for Information. The rule would enable DOE's use of nearly $300 billion of additional loan authority for a broad range of energy projects.

DOE—ENERGY EFFICIENCY AND RENEWABLE ENERGY (EE)

Proposed Rule Stage

47. Clean Energy Rule for New Federal Buildings and Major Renovations [1904-AB96]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority:42 U.S.C. 6834(a)(3)(D)

CFR Citation:10 CFR 433; 10 CFR 435.

Legal Deadline: Other, Statutory, Subject to the requirements in 42 U.S.C. 6834(a)(3)(D).

Abstract: This rulemaking implements provisions of the Energy Independence and Security Act of 2007 that require the U.S. Department of Energy (DOE) to establish revised-performance standards for the construction of all new Federal buildings, including commercial, multi-family high-rise residential and low-rise residential buildings. This rulemaking will specifically address the reduction of fossil fuel-generated energy consumption in new buildings and buildings undergoing major renovations, as well as how agencies may petition DOE for a downward adjustment of the requirements if they believe meeting required energy reduction levels would be technically impracticable. This effort was previously reported as the Fossil Fuel-Generated Energy Consumption Reduction for New Federal Buildings and Major Renovations of Federal Buildings rulemaking.

Statement of Need: The Energy Independence and Security Act of 2007 (EISA 2007) requires certain new Federal buildings and Federal buildings undergoing major renovations to meet fossil fuel-generated consumption reduction targets based on fiscal year.

Summary of Legal Basis: Section 433(a) of EISA 2007 2007 (Pub. L. 110-140) amended section 305 of the Energy Conservation and Production Act (ECPA) and directed the DOE to establish regulations that require fossil fuel-generated energy consumption reductions for certain new Federal buildings and Federal buildings undergoing major renovations. (42 U.S.C. 6834(a)(3)(D)(i)) For these buildings, section 305 of ECPA, as amended by EISA 2007, mandates that the buildings be designed so that a building's fossil fuel-generated energy consumption is reduced as compared with such energy consumption by a similar building in fiscal year (FY) 2003 (as measured by Commercial Buildings Energy Consumption Survey (CBECS) or Residential Energy Consumption Survey (RECS) data from the DOE's Energy Information Administration (EIA)) by 55 percent beginning in FY2010, 65 percent beginning in FY2015, 80 percent beginning in FY2020, 90 percent beginning in FY2025, and 100 percent beginning in FY2030. (42 U.S.C. 6834(a)(3)(D)(i)(I)).

Alternatives: The statute requires DOE to establish regulations implementing the specific fossil fuel-generated energy consumption targets for certain new Federal buildings and Federal buildings undergoing major renovations. The targets may be adjusted with respect to a specific building upon petition from an agency, with agreement from the DOE Secretary. In implementing these regulations, DOE considers the technologies available to achieve the statutory targets and those relevant for petitions submitted by agencies.

Anticipated Cost and Benefits: The cumulative net present value (NPV) of the proposed Clean Energy Rule compliant buildings ranges from −$16.0 Million (at a 7-percent discount rate) to −$85.3 Million (at a 3-percent discount rate).DOE also analyzed an additional case where the future grid emission factors were assumed to follow a 95% reduction by 2035 (95 by 2035) profile as defined in the National Renewable Energy Laboratory's (NREL) 2021 Standard Scenarios Report: A U.S. Electricity Sector Outlook. This case represents a change in national electricity generation which assumes national power sector CO² emissions reach 95% below 2005 levels by 2035 and are eliminated on a net basis by 2050. The cumulative NPV of the proposed Clean Energy Rule compliant buildings in the 95 by 2035 case ranges from $104.6 Million (at a 7-percent discount rate) to $83.4 Million (at a 3-percent discount rate).

Risks: Optional field—no response.

Timetable:

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Federal.

URL For More Information: www.energy.gov/eere/femp/notices-and-rules.

URL For Public Comments: www.regulations.gov.

Agency Contact: Ashley Armstrong, Director Regulatory Buildings, EE-5B, Department of Energy, Energy Efficiency and Renewable Energy, Building Technologies Office, 1000 Independence Avenue SW, Washington, DC 20585, Phone: 202 586-6590, Email: ashley.armstrong@ee.doe.gov.

RIN: 1904-AB96

DOE—EE

Final Rule Stage

48. Energy Conservation Standards for Residential Non-Weatherized Gas Furnaces and Mobile Home Gas Furnaces [1904-AD20]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority:42 U.S.C. 6295(f)(4)(C); 42 U.S.C. 6295(m)(1); 42 U.S.C. 6295(gg)(3)

CFR Citation:10 CFR 429; 10 CFR 430.

Legal Deadline: NPRM, Judicial, April 24, 2015, Final Rule, Judicial, the later date of April 24, 2016, or one year after the issuance of the proposed rule.

Abstract: The Energy Policy and Conservation Act, as amended, (EPCA) prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including residential furnaces. EPCA also requires the U.S. Department of Energy (DOE) to determine whether more-stringent amended standards would be technologically feasible and economically justified and would save a significant amount of energy. DOE proposes amended and new energy conservation standards for non-weatherized gas furnaces and mobile home gas furnaces pursuant to a court-ordered remand of DOE's 2011 rulemaking for these products and other statutory requirements.

Statement of Need: EPCA requires minimum energy efficiency standards for certain appliances and commercial equipment, including residential furnaces.

Summary of Legal Basis: Title III of the Energy Policy and Conservation Act of 1975 (EPCA), Public Law 94-163 (42 U.S.C. 6291-6309, as codified), established the Energy Conservation Program for Consumer Products Other Than Automobiles. Pursuant to EPCA, any new or amended energy conservation standard that the U.S. Department of Energy (DOE) prescribes for certain products, such as residential furnaces, shall be designed to achieve the maximum improvement in energy efficiency that is technologically feasible and economically justified (42 U.S.C. 6295(o)(2)(A)) and result in a significant conservation of energy (42 U.S.C. 6295(o)(3)(B)).

Alternatives: The statute requires DOE to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified in the statute.

Anticipated Cost and Benefits: DOE finds that the benefits to the Nation of the proposed energy standards for Residential Non-Weatherized Gas Furnaces and Mobile Home Gas Furnaces (such as energy savings, consumer average lifecycle cost savings, an increase in national net present value, and emission reductions) outweigh the burdens (such as loss of industry net present value). For non-weatherized gas furnaces and mobile home gas furnaces, DOE estimates that energy savings for active mode operation (in terms of annual fuel utilization efficiency (AFUE)) will be 5.48 quads over 30 years and that the net benefit to the Nation will be between $6.2 billion and $21.6 billion. DOE estimates that energy savings for standby mode and off mode operation will be 0.28 quads over 30 years and that the net benefit to the Nation will be between $1.1 billion and $3.4 billion.

Risks: Optional field—no response.

Timetable:

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

URL For More Information: www1.eere.energy.gov/buildings/appliance_standards/product.aspx/productid/72.

URL For Public Comments: www.regulations.gov/#!docketDetail;D=EERE-2014-BT-STD-0031.

Agency Contact: Julia Hegarty, Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585, Phone: 240 597-6737, Email: julia.hegarty@ee.doe.gov.

RIN: 1904-AD20

DOE—DEPARTMENTAL AND OTHERS (ENDEP)

Final Rule Stage

49. • Loan Guarantees for Clean Energy Projects [1901-AB59]

Priority: Economically Significant. Major status under 5 U.S.C. 801 is undetermined.

Unfunded Mandates: Undetermined.

Legal Authority:42 U.S.C. 16511 et seq.

CFR Citation:10 CFR 609.

Legal Deadline: None.

Abstract: The Inflation Reduction Act (IRA) has added new categories of eligible projects to the U.S. Department of Energy (DOE) Loan Programs Office's program authorized by Title XVII of the Energy Policy Act of 2005, as amended (42 U.S.C. 16511 et seq.). This requires immediate and material changes to DOE's existing regulations (10 CFR part 609) implementing the Title XVII program for DOE to be able to accept applications and issue loan guarantees for those categories of projects. The loan authority and appropriations authorized under the IRA are available through September 30, 2026, making the implementation of the authority time-sensitive. The rule would also include changes to the existing regulations based on experience gained implementing the Title XVII loan guarantee program and to reflect amendments to Title XVII enacted by the Energy Policy Act of 2020 and the Infrastructure Investment and Jobs Act of 2021.

Statement of Need: The existing regulations governing Title XVII do not contemplate certain categories of projects and terms applicable to Title XVII, as amended by recent legislation. As such, DOE must revise its regulations in order to effectuate the new categories of eligible projects and terms.

Summary of Legal Basis: Title XVII of the Energy Policy Act of 2005, Public Law 109-58 (42 U.S.C. 16511 et seq.) established a program for the Department of Energy to guarantee loans for innovative projects that avoid, reduce, or sequester air pollutants or anthropogenic emissions of greenhouse gases. Title XVII has since been amended, including most recently under the Consolidated Appropriations Act of 2021 (Energy Act of 2020), Public Law 116-260, the Infrastructure Investment and Jobs Act of 2021, Public Law 117-158 (IIJA), and the Inflation Reduction Act of 2022, Public Law 117-169 (IRA).

Alternatives: This rulemaking seeks to codify recent legislative changes to the Title XVII program and make changes to DOE's regulations to improve implementation of the program. DOE recently solicited input from stakeholders to understand how it could improve the Title XVII program.

Anticipated Cost and Benefits: The Title XVII rule sets forth the policies and procedures DOE uses for the application process, which includes receiving, evaluating, and approving loan guarantees to support eligible projects under Title XVII. While the rule itself will not have a direct economic impact, it will enable DOE's use of nearly $300 billion of additional loan authority provided under the IIJA and IRA.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Agency Contact: Rebecca Limmer, Chief Counsel, Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585, Phone: 202 586-1174, Email: rebecca.limmer@hq.doe.gov.

RIN: 1901-AB59

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Statement of Regulatory Priorities for Fiscal Year 2023

As the federal agency with principal responsibility for protecting the health of all Americans and for providing essential human services, the Department of Health and Human Services (HHS or the Department) implements programs that strengthen the health care system; advance scientific knowledge and innovation; and improve the health, safety, and wellbeing of the American people.

The Department's Regulatory Plan for fiscal year (FY) 2023 is focused on expanding access to health care, tackling disparities and advancing equity, increasing the nation's public health preparedness, and supporting the wellbeing of families and communities. To highlight a few of these regulatory priorities:

• This Plan expands access to health care and strengthens behavioral health, with rules that expand evidence-based behavioral health treatment via telehealth and streamline enrollment and improve access to care for children and families through the Medicaid program and the Children's Health Insurance Program (CHIP), among others.

• The Department is also taking action to advance equity in health and social outcomes, including through rules designed to prevent discrimination and protect every person's ability to equitably obtain health care and human services, regardless of where they live, who they are, or their background.
• Forthcoming rules would also increase the nation's public health preparedness, such as measures aimed at ensuring Americans are able to access safe produce and imported foods, and rules that would bolster the Department's ability to respond to the spread of COVID-19 and prevent future public health threats.
• This Plan supports the wellbeing of families and communities by including rules that would strengthen services for older Americans to allow them to live in their communities, as well as ensure that children and youth receive the care and support they need to thrive.

In short, the Department's Regulatory Plan reflects the Biden-Harris Administration's commitment to continue building a better, healthier America, through rules designed to help protect the public health and to improve the health and wellbeing of every person touched by HHS programs.

I. Building and Expanding Access to Affordable Health Care

The Biden-Harris Administration is committed to ensuring that high-quality health care is accessible and affordable for every American. The Inflation Reduction Act of 2022 (IRA), signed by President Biden in August, lowers costs for American families by continuing increased premium tax credits for plans under the Affordable Care Act (ACA), allowing the federal government to negotiate prices for certain drugs under Medicare, and more. The Bipartisan Safer Communities Act of 2022, signed by President Biden in June, expands capacity and advances access to behavioral health treatment, particularly for children and youth. Additionally, President Biden's Executive Order on Continuing to Strengthen Americans' Access to Affordable, Quality Health Coverage (E.O. 14070) calls on federal agencies—including the Department— to continue to expand the availability of health care coverage, improve its quality, strengthen benefits, and help more Americans enroll.

Charged with overseeing federal health programs such as Medicare, Medicaid, CHIP, and the ACA Marketplace, the Department plays a central role in the Administration's agenda to protect and strengthen access to health care. From day one of this Administration, the Department has worked closely with states to expand Medicaid to hundreds of thousands of newly eligible people and to allow Medicaid enrollees who are pregnant to keep their coverage for up to one year after pregnancy. The Department has also maximized opportunities to enroll a record number of people in ACA coverage and strengthened policies related to coverage and benefits in the ACA Marketplace. These actions, alongside others, have contributed to an all-time low uninsured rate among Americans.

Over the next year, the Department will build upon its previous efforts by pursuing rules aimed at enhancing coverage and access to benefits in the ACA Marketplaces and the Medicaid, CHIP, and Medicare programs; expanding the accessibility and affordability of drugs and medical products; addressing behavioral health needs; and streamlining the secure exchange of health information.

a. Enhancing Coverage and Access in the ACA Marketplaces, Medicaid, CHIP, and Medicare

The Department will take several regulatory actions in the next year to improve access to care for Americans in the ACA Marketplace, Medicaid, CHIP, and Medicare. For example, the Department expects to finalize a rule on eligibility and enrollment processes in Medicaid and CHIP that will streamline the application, eligibility determination, enrollment, and renewal processes for these programs and create new pathways to maximize enrollment and retention of eligible individuals.

Additional rules would promote access to care in Medicaid and CHIP and raise standards for hospitals, providers, and other entities participating in Medicare and Medicaid. For example, the Department plans to issue a proposed rule that would establish cultural competency and person-centered care requirements for all provider and supplier types that participate in the Medicare and Medicaid programs.

The HHS Regulatory Plan also includes regulations aimed at improving access to care for consumers in the ACA Marketplaces. For instance, the Department plans to propose a rule on provider nondiscrimination requirements for certain health plans and issuers. This rule would protect patients' access to care and promote competition by ensuring that plans do not engage in unlawful discrimination against health care providers. The Department will also work to ensure access to benefits and services afforded under the law. A critical part of this work will include amending regulations on contraceptive coverage which guarantee cost-free coverage to the consumer under the ACA. Finally, the Department will propose to amend regulations on short-term limited duration plans to better ensure access to comprehensive coverage for Americans, especially those with pre-existing conditions.

In addition to the above, the Centers for Medicare & Medicaid Services (CMS) will issue several annual payment rules and notices over the next year that affect federal health programs, including Medicare and the ACA Marketplace. These rules, though they are not included in the HHS Regulatory Plan, will include policies that further the Secretary's priority of expanding access to affordable, high-quality health care.

b. Expanding the Accessibility and Affordability of Drugs and Medical Products

Over the next year, the Department will continue expanding the accessibility and affordability of drugs and other medical products for Americans. For example, the Department expects to issue a final rule to set requirements for nonprescription drug products with an additional condition to ensure appropriate self-selection or appropriate actual use (or both) for consumers. This rule is expected to increase consumer access to nonprescription drugs, which could mean a reduction in under-treatment of certain diseases and conditions. The Department also plans to propose updates to the Food and Drug Administration (FDA) biologics regulations to support competition and enhance consumer choice through changes that would prevent efforts to delay or block competition from biosimilars and interchangeable products.

The Department is also working to implement the IRA through policies aimed at reducing the high cost of prescription drugs for people with Medicare. Furthermore, the Department is committed to making sure Medicare beneficiaries are able to access emerging technologies and will initiate notice and comment rulemaking in the coming months to explore policy options that would create an accelerated approval pathway. This pathway would build on prior initiatives, including coverage with evidence development.

In addition, in November 2022, the Department issued a proposed rule on the Administrative Dispute Resolution (ADR) process used to settle certain disputes among covered entities and manufacturers arising under the 340B Drug Pricing Program. This rule would establish new requirements and procedures for the Program's ADR process, making the process more equitable and accessible for participation by program participants, and supporting the Program's mission to expand access to health care for underserved communities.

c. Addressing Behavioral Health Needs

The Secretary remains committed to expanding access to integrated and equitable behavioral health services, including by addressing the impacts of the COVID-19 pandemic on mental health and substance use, which have disproportionately affected young people and underserved communities. This commitment will guide the Department's planned regulatory activity for FY 2023, which includes several rules aimed at tackling mental health challenges and substance use disorders.

For example, the HHS Regulatory Plan includes a proposed rule that is intended to make permanent certain telehealth flexibilities for substance use disorder treatments that were granted during the COVID-19 public health emergency. This rule would allow certain providers to provide buprenorphine via telehealth, as well as provide extended take-home doses of methadone to patients, when it is safe and appropriate to do so. Both changes are intended to increase access to comprehensive opioid use disorder treatment and may address barriers to treatment such as transportation, geographic proximity, employment, or other required activities of daily living.

Working closely with the Departments of Labor and the Treasury, the Department will also issue a proposed rule to implement portions of the Mental Health Parity and Addiction Equity Act (MHPAEA) and the Consolidated Appropriations Act, 2021. The MHPAEA is a federal law that prevents group health plans and health insurance issuers that provide mental health or substance use disorder benefits from imposing less favorable benefit limitations on those benefits than on medical and surgical benefits. This rule would clarify group health plans and health insurance issuers' obligations under the MHPAEA and promote compliance with MHPAEA, among other improvements.

In November 2022, the Department also announced a proposed rule on the confidentiality of substance use disorder patient records. Consistent with the CARES Act, this rule would align HHS regulations governing the disclosure and use of substance use disorder patient records (42 CFR part 2) with aspects of the HIPAA Privacy, Breach Notification, and Enforcement Rules; strengthen protections against uses and disclosures of patients' substance use disorder records for civil, criminal, administrative, and legislative proceedings; and require that a HIPAA Notice of Privacy Practices address privacy practices with respect to Part 2 records.

d. Streamlining the Secure Exchange of Health Information

The secure exchange of health information and interoperability among health care providers and other entities improves patient care, promotes competition, reduces costs, and provides more accurate public health data.

To help ensure greater interoperability and transparency, the HHS Regulatory Plan includes rules focused on addressing and preventing information blocking, consistent with the 21st Century Cures Act (Cures Act). For instance, the Department plans to finalize a rule that would, among other things, empower the HHS Office of the Inspector General (OIG) to investigate claims of information blocking and impose civil monetary penalties on health IT developers and health information networks where appropriate. Another complementary proposed rule would implement the Secretary's authority under the Cures Act to establish appropriate disincentives for health care providers found to have committed information blocking. The Department is also proposing a rule on the Electronic Health Record (EHR) Reporting Program condition and maintenance of certification requirements under the Office of the National Coordinator for Health Information Technology (ONC) Health IT Certification Program, which would include enhancements to support information sharing under the information blocking regulations.

The Department is also advancing interoperability policies in the context of the federal health programs it administers and oversees. For example, the Department will propose rules to improve the electronic exchange of health care data and streamline processes related to prior authorization for Medicare Advantage (MA) organizations, Medicaid managed care plans, CHIP managed care entities, state Medicaid and CHIP fee-for-service (FFS) programs, and Qualified Health Plan (QHP) issuers on the Federally Facilitated Exchange (FFE). Similarly, the Department's upcoming proposed rule on strengthening and improving the Medicare Advantage and prescription drug programs will include provisions proposing to enhance interoperability within Medicare.

II. Tackling Disparities and Advancing Equity

Equity is the focus of over a dozen Executive Orders issued by President Biden, and it remains a cornerstone of the Biden-Harris Administration's agenda. The Department recognizes that people of color, people with disabilities, lesbian, gay, bisexual, transgender, queer, and intersex (LGBTQI+) people, and other underserved groups in the U.S. have been systematically denied a full and fair opportunity to participate in economic, social, and civic life. Among its other manifestations, this history of inequality shows up as persistent disparities in health and social outcomes and in access to care.

As the federal agency responsible for ensuring the health and wellbeing of Americans, the Department, under Secretary Becerra's leadership, is committed to tackling these entrenched inequities and their root causes throughout its programs and policies. The Department's regulatory priority of tackling disparities and advancing equity includes rules aimed at preventing and remedying discrimination; strengthening health and safety standards for consumer products that impact underserved communities; and promoting equity in federally supported health care services.

In addition to the specific rulemakings identified in this section, HHS is committed to advancing equity in all aspects of the Department's work. Consistent with President Biden's Executive Order on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (E.O. 13985), the Department's efforts in this area include an ongoing assessment of whether underserved communities face barriers in accessing benefits and opportunities in HHS programs and whether policy changes are necessary to advance equity. This process continues to inform the Department's broader regulatory agenda.

a. Preventing and Remedying Discrimination

The HHS Regulatory Plan includes actions to eliminate discrimination as a barrier for historically marginalized communities seeking access to HHS programs and activities. For instance, the Department plans to finalize its rule on nondiscrimination in health programs and activities, which would amend the existing regulations implementing section 1557 of the ACA, ensuring that the regulations reflect the proper scope of the statute's protections. Because discrimination in the U.S. health care system is a driver of health disparities, the Section 1557 regulations present a key opportunity for the Department to promote equity and ensure protection of health care as a right.

Additionally, the Department will issue a proposed rule addressing discrimination on the basis of disability in health and human services programs or activities. This rule would revise regulations under section 504 of the Rehabilitation Act of 1973 to address unlawful discrimination on the basis of disability in HHS-funded health and human services programs. Topics that HHS may cover include nondiscrimination in medical treatment, child welfare programs and services, value assessment methodologies, accessible medical equipment, information and communication technology, and other relevant health and human services activities.

b. Strengthening Health and Safety Standards for Consumer Products That Impact Underserved Communities

To protect the public health and advance equity, the Department continues to pursue regulatory action with respect to consumer products that harm the health of underserved groups.

Over the next year, the Department plans to finalize two rules that prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors (other than tobacco) in cigars. These and other potential future regulatory actions have the potential to significantly reduce disease and death from combusted tobacco product use, the leading cause of preventable death in the United States.

The regulations are also expected to promote better health outcomes across population groups. Evidence shows that tobacco is disproportionately marketed to underserved communities and vulnerable populations—such as disproportionate storefront and outdoor marketing, as well as point-of-sale marketing, in Black, Hispanic, and low-income communities. The disparities in tobacco marketing and use shape disparities in tobacco-related disease and death. These planned regulatory actions by the Department on tobacco are expected not only to benefit the population as a whole, but, in doing so, also substantially decrease tobacco-related health disparities.

c. Promoting Equity in Federally Supported Health Care Services

The Department continues to seek out opportunities to embed equity throughout HHS programs and policies, including in federally supported health care services. The World Trade Center (WTC) Health Program is a limited federal health program that provides no-cost medical monitoring and treatment for certified WTC-related health conditions to those directly affected by the 9/11 attacks. The Department plans to issue a proposed rule to add uterine cancer to the List of WTC-Related Health Conditions.Permitting the Program to pay for medically necessary treatment, this rule would advance health equity for those WTC Health Program members who are found to have WTC-related uterine cancer.

III. Increasing Public Health Preparedness

Protecting the nation's public health is a primary responsibility of the Department. This responsibility includes ensuring that the right protections and infrastructure are in place to help the nation to respond to public health threats and outbreaks quickly and effectively, including COVID-19. It also includes ensuring healthy and safe food for every American through protections against foodborne illness in the food supply chain.

In service of this regulatory priority, over the next year, the Department is pursuing rules that would bolster the nation's resilience to handle COVID-19 and future public health threats and improve Americans' access to safe and nutritious food.

a. Bolstering the Nation's Resilience To Handle COVID-19 and Future Public Health Threats

The Department continues to play a central role in the Biden-Harris Administration's whole-of-government response to the COVID-19 pandemic. From ensuring access to COVID-19 testing, treatment, and vaccines, to bolstering the capacity of the health care system in a public health emergency, Secretary Becerra has leveraged the Department's full resources to pursue a comprehensive strategy to combat COVID-19.

In the context of COVID-19 and other disease outbreaks, it is crucial for public health authorities to be able to identify and evaluate persons who may have been exposed to a communicable disease. Currently, on an interim basis, the Centers for Disease Control and Prevention (CDC) is authorized to require airlines to collect certain data regarding passengers and crew arriving from foreign countries for the purposes of health education, treatment, prophylaxis, or other appropriate public health interventions, including contact tracing and travel restrictions. The Department intends to finalize this regulation in FY 2023. This would allow the Department to continue to receive data in a timely manner and more effectively provide critical public health services in response to COVID-19 and other communicable diseases that may put Americans' health at risk.

In addition to strengthening the public health system, the Department is continuing to address the need for flexibility in HHS programs to minimize disruptions and alleviate burdens that may be caused by COVID-19 or future emergencies. To that end, the Department also plans to finalize its rule allowing current grantees under the Administration for Native Americans (ANA) to request an emergency waiver for the non-federal share match. This update to ANA's regulation would provide a new provision for recipients to request an emergency waiver in the event of a natural or man-made emergency such as a public health pandemic.

b. Improving Access to Safe and Nutritious Food

To help ensure healthy and safe food for every American, the HHS Regulatory Plan includes rules that improve the Department's ability to identify foodborne illnesses, prevent them from reoccurring, and remove unsafe products from the market. It also supports the goals of the White House Conference on Hunger, Nutrition, and Health, by advancing work to improve consumers' ability to access nutritious food to prevent disease and protect public health.

For example, the Department will finalize a rule intended to improve the safety of produce by requiring farms to conduct comprehensive assessments of pre-harvest agricultural water that would help farms identify and mitigate hazards in water used to grow produce. Moreover, the Department is proposing a rule that would require importers of certain foods to certify, or otherwise provide appropriate assurances, that these imported foods comply with U.S. safety requirements. This rule would help prevent potentially harmful imported foods from reaching consumers and thereby improve the safety of the U.S. food supply. In November 2022, the Department finalized its rule establishing additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods identified on the Food Traceability List (FTL). This rule is intended to make it easier to rapidly and effectively track the movement of a food to prevent or mitigate a foodborne illness outbreak.

In addition, the Department seeks to improve dietary patterns in the United States to help reduce the burden of diet-related chronic diseases. One way HHS is working towards creating a healthier food supply is by proposing a rule that would permit use of salt substitutes, rather than salt, to help reduce the amount of sodium in standardized foods.

IV. Supporting the Wellbeing of Families and Communities

The Department strives to support the wellbeing of Americans by funding and providing access to a range of critical social services. Millions of people benefit from HHS programs that help older adults and people with disabilities participate fully in their communities, promote opportunity and economic security for families, help refugees and other eligible newcomers integrate and thrive, and provide care for unaccompanied children. The Secretary recognizes that these programs and forms of assistance are more important than ever due to the COVID-19 pandemic and its economic consequences, which have had an outsized impact on people of color and other underserved communities.

To sustain and strengthen these essential benefits and services, the Department is prioritizing regulations that would improve their quality and accessibility while reducing burdens and increasing the efficiency of service delivery. The Secretary's regulatory priority in this area includes rules aimed at strengthening high-quality services for older adults, expanding opportunities for children and youth to thrive, and providing pathways to economic success.

a. Strengthening High-Quality Services for Older Adults

The HHS Regulatory Plan includes rules aimed at enhancing the ability of Administration for Community Living (ACL) programs to protect the rights and wellbeing of older adults. For instance, the Department plans to propose regulations for Adult Protective Services (APS) programs that will strengthen services for older adults and adults with disabilities that experience adult maltreatment. Additionally, the Department will propose changes to its Older Americans Act (OAA) regulations to support long-term care services, nutrition, caregiver supports, and more, for older adults. In both rulemakings, the Department plans to incorporate applicable elements E.O. 13985 and ensure access to services for individuals with the greatest social and economic need.

Furthermore, consistent with the Biden-Harris Administration's Nursing Home Reform Action Plan, the Department's Regulatory Plan includes efforts to improve the safety and quality of care in the nation's nursing homes. For example, in the next year, the Department plans to issue proposed rules that are intended to institute minimum staffing standards in nursing homes, protect residents, and prevent fraud, waste, and abuse.

b. Expanding Opportunities for Children and Youth To Thrive

The Department's mission to provide effective human services includes a focus on protecting the wellbeing of children and youth. This focus has special significance given the COVID-19 pandemic and its economic consequences, which have deeply affected the lives of children and youth—particularly Black, Latino, Indigenous, Native American, and other underserved youth with disproportionate involvement in the child welfare system. Several rules planned for FY 2023 are aimed at enhancing programs and protections for youth and families experiencing foster care, unaccompanied children in the Department's care, and individuals entitled to child support.

As part of its focus on the foster care and the child welfare system, the Department will propose changes to the Adoption and Foster Care Analysis and Reporting System (AFCARS) regulations that would help the Department to administer foster care and adoption assistance programs more effectively and better serve children and families. This rule would require title IV-E agencies to collect and report for AFCARS additional information related to the Indian Child Welfare Act of 1978 and the sexual orientation of youth in the reporting population and their foster parents, adoptive parents, and legal guardians. The Department will also propose a rule allowing licensing standards for relative or kinship foster family homes that are different from non-relative or non-kinship homes. The proposed change would address barriers to licensing relatives and kin who can provide continuity and a safe and loving home for children when they cannot be with their parents. Additionally, the Department will issue a proposed rule to facilitate the provision of independent legal representation to a child who is a candidate for foster care, or in foster care, and to a parent preparing for participation in foster care legal proceedings. Improving access to independent legal representation may help prevent the removal of a child from the home or, for a child in foster care, achieve permanence faster.

Moreover, the Department's commitment to children and youth includes rules intended to ensure the highest level of services and care for unaccompanied children in the Department's custody. For instance, the Department will propose a new rule to strengthen and codify protections and service provisions for children cared for by the Office of Refugee Resettlement's (ORR's) Unaccompanied Children Program. Furthermore, the Department will issue a proposed rule that would provide new regulations governing the federal licensing of ORR facilities, which may be used in certain situations when state governments do not provide state licensing for such facilities.

Finally, the Department is taking action to protect the sustainability of tribal child support programs. The Department's forthcoming proposed rule on tribal child support programs would modify the non-federal share of the program expenditures requirement, including 90/10 and 80/20 cost sharing rates.

c. Providing Pathways to Economic Success

In administering the Temporary Assistance for Needy Families (TANF) program, the Department works with states, territories, and tribes to help children and families achieve economic success. The COVID-19 pandemic highlighted the importance of using federal investments and existing program flexibilities strategically to reduce family poverty and alleviate economic crises, especially for families of color and underserved communities. In the next year, the Department plans to issue a proposed rule to reform the TANF program to strengthen the safety net and work preparation program for families and individuals with the lowest income, change allowable uses of TANF funds to refocus on the intended purposes of TANF, improve work program effectiveness, and reduce administration burden. These changes are intended to improve the overall wellbeing of families while addressing inequities in program services and policies.

HHS—OFFICE OF THE INSPECTOR GENERAL (OIG)

Final Rule Stage

50. Amendments to Civil Monetary Penalty Law Regarding Grants, Contracts, and Information Blocking [0936-AA09]

Priority: Other Significant.

Legal Authority: 21st Century Cures Act; Pub. L. 114-255; secs. 4004 and 5003; Bipartisan Budget Act of 2018 (BBA 2018), Pub. L. 115-123. sec. 50412

CFR Citation:42 CFR 1003; 42 CFR 1005.

Legal Deadline: None.

Abstract: The final regulation modifies 42 CFR 1003 and 1005 by addressing three issues. First, the 21st Century Cures Act (Cures Act) provision that authorizes the Department of Health and Human Services (HHS) to impose civil monetary penalties, assessments, and exclusions upon individuals and entities that engage in fraud and other misconduct related to HHS grants, contracts, and other agreements. Second, the Cures Act information blocking provisions that authorize the Office of Inspector General to investigate claims of information blocking and provide HHS the authority to impose CMPs for information blocking. Third, the Bipartisan Budget Act of 2018 increases in penalty amounts in the Civil Monetary Penalties Law.

Statement of Need: The 21st Century Cures Act (Cures Act) set forth new authorities which need to be added to HHS's existing civil monetary penalty authorities. This final rule seeks to add the new authorities to the existing civil monetary penalty regulations and to set forth the procedural and appeal rights for individuals and entities. The Bipartisan Budget Act of 2018 (BBA) amended the Civil Monetary Penalties Law (CMPL) to increase the amounts of certain civil monetary penalties which requires amending the existing regulations for conformity. The final rule seeks to ensure alignment between the increased civil monetary penalties in the statute and the civil monetary penalties set forth in the OIG's rules.

Summary of Legal Basis:

The legal authority for this regulatory action is found in: (1) section 1128A(a)-(b) of the Social Security Act, the Civil Monetary Penalties Law (42 U.S.C. 1320a-7a), which provides for civil monetary penalty amounts; (2) section 1128A(o)-(s) of the Social Security Act, which provides for civil monetary penalties for fraud and other misconduct related to grants, contracts, and other agreements; and (3) section 3022(b) of the Public Health Service Act (42 U.S.C. 300jj-52), which provides for investigation and enforcement of information blocking.

Alternatives: The regulations incorporate the statutory changes to HHS's authority found in the Cures Act and the BBA. The alternative would be to rely solely on the statutory authority and not align the regulations accordingly. However, we concluded that the public benefit of providing clarity by placing the new civil monetary penalties and updated civil monetary penalty amounts within the existing regulatory framework outweighed any burdens of additional regulations promulgated.

Anticipated Cost and Benefits: We believe that there are no significant costs associated with these proposed revisions that would impose any mandates on State, local, or Tribal governments or the private sector. The regulation will provide a disincentive for bottlenecks to the flow of health data that exist, in part, because parties are reticent to share data across the healthcare system or prefer not to do so. The final rule will help foster interoperability, thus improving care coordination, access to quality healthcare, and patients' access to their healthcare data.

Risks: To be determined.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Chris Hinkle, Senior Advisor, Department of Health and Human Services, Office of the Inspector General, 330 Independence Avenue SW, Washington, DC 20201, Phone: 202 891-6062, Email: christina.hinkle@oig.hhs.gov.

RIN: 0936-AA09

HHS—OFFICE FOR CIVIL RIGHTS (OCR)

Proposed Rule Stage

51. Rulemaking on Discrimination on the Basis of Disability in Health and Human Services Programs or Activities [0945-AA15]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: sec. 504 of the Rehabilitation Act of 1973; 29 U.S.C. 794

CFR Citation:45 CFR 84.

Legal Deadline: None.

Abstract: This proposed rule would revise regulations under section 504 of the Rehabilitation Act of 1973 to address unlawful discrimination on the basis of disability in vital HHS-funded health and human services programs. Covered topics may include nondiscrimination in medical treatment, child welfare programs and activities, value assessment methods, accessible medical equipment, information and communication technology, and other relevant health and human services activities.

Statement of Need: To robustly enforce the prohibition of discrimination on the basis of disability, OCR will update the section 504 of the Rehabilitation Act regulations to clarify obligations and address issues that have emerged in our enforcement experience (including complaints OCR has received), case law, and statutory changes under the Americans with Disabilities Act and other relevant laws, in the forty-plus years since the regulation was promulgated. OCR has heard from complainants and many other stakeholders, as well as Federal partners, including the National Council on Disability, on the need for updated regulations in a number of important areas.

Summary of Legal Basis: The current regulations have not been updated to be consistent with the Americans with Disabilities Act, the Americans with Disabilities Amendments Act, or the 1992 Amendments to the Rehabilitation Act, all of which made changes that should be reflected in the HHS section 504 regulations. Under Executive Order 12250, the Department of Justice has provided a template for HHS to update this regulation.

Alternatives: OCR considered issuing guidance, and/or investigating individual complaints and compliance reviews. However, we concluded that not taking regulatory action could result in continued discrimination, inequitable treatment and even untimely deaths of people with disabilities. OCR continues to receive complaints alleging serious acts of disability discrimination each year. While we continue to engage in enforcement, we believe that our enforcement and recipients' overall compliance with the law will be better supported by the presence of a clearly articulated regulatory framework than continuing the status quo. Continuing to conduct case-by-case investigations without a broader framework risks lack of clarity on the part of providers and violations of section 504 that could have been avoided and may go unaddressed. By issuing a proposed rule, we are undertaking the most efficient and effective means of promoting compliance with section 504.

Anticipated Cost and Benefits: The Department anticipates that this rulemaking will result in significant benefits, namely by providing clear guidance to the covered entity community regarding requirements to administer their health programs and activities in a non-discriminatory manner. In turn, the Department anticipates cost savings as individuals with disabilities can access a range of health care services. The Department expects that the rule, when finalized, will generate some changes in action and behavior that may generate some costs. The rule will address a wide range of issues, with varying impacts and a comprehensive analysis is underway.

Risks: To be determined.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Agency Contact: Molly Burgdorf, Section Chief, Civil Rights Division, Department of Health and Human Services, Office for Civil Rights, 200 Independence Avenue SW, Washington, DC 20201, Phone: 800 368-1019, TDD Phone: 800 537-7697, Email: ocrmail@hhs.gov.

RIN: 0945-AA15

HHS—OCR

Final Rule Stage

52. Nondiscrimination in Health Programs And Activities [0945-AA17]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: sec. 1557 of the Patient Protection and Affordable Care Act (42 U.S.C. 18116); 42 U.S.C. 1302; 42 U.S.C. 1395; 42 U.S.C. 1395eee(f); 42 U.S.C. 1396u-4(f); 42 U.S.C. 2000d-1; 20 U.S.C. 1405; 29 U.S.C. 794; 42 U.S.C. 290dd-2; 21 U.S.C. 1174; 42 U.S.C. 300gg to 300gg-63; 42 U.S.C. 300gg-91; 42 U.S.C. 300gg-92; 42 U.S.C. 300gg-111 to 300gg-139 as amended, sec. 3203; Pub. L. 116-136, 134 Stat. 281; 42 U.S.C. 18021 to 18024; 42 U.S.C. 18031 to 18033; 42 U.S.C. 18041 to 18042; 42 U.S.C. 18044; 42 U.S.C. 18051; 42 U.S.C. 18054; 42 U.S.C. 18061; 42 U.S.C. 18063; 42 U.S.C. 18071; 42 U.S.C. 18081 to 18083; 26 U.S.C. 36B

CFR Citation:42 CFR 438; 42 CFR 440; 42 CFR 457; 42 CFR 460; 45 CFR 80; 45 CFR 84; 45 CFR 86; 45 CFR 91; 45 CFR 92; 45 CFR 147; 45 CFR 155; 45 CFR 156; . . .

Legal Deadline: None.

Abstract: This rule will address changes to the 2020 Final Rule implementing section 1557 of the Patient Protection and Affordable Care Act (PPACA). Section 1557 of PPACA prohibits discrimination on the basis of race, color, national origin, sex, age, or disability under any health program or activity, any part of which is receiving Federal financial assistance, including credits, subsidies, or contracts of insurance, or under any program or activity that is administered by an Executive Agency, or any entity established under title l of the PPACA.

Statement of Need: The Biden-Harris Administration has made advancing health equity and nondiscrimination in health care a cornerstone of its policy agenda. The current section 1557 implementing regulation significantly curtails the scope of application of section 1557 protections and creates uncertainty and ambiguity as to what constitutes prohibited discrimination in covered health programs and activities. Issuance of a revised section 1557 implementing regulation is important because it would provide clear and concise regulations that are consistent with the statutory text and protect historically marginalized communities as they seek access to health programs and activities.

Summary of Legal Basis: The Secretary of the Department is statutorily authorized to promulgate regulations to implement section 1557. 42 U.S.C. 18116(c). The current section 1557 Final Rule is pending litigation.

Alternatives: The Department has considered the alternative of maintaining the section 1557 implementing regulation in its current form; however, the Department believes it is appropriate to undertake rulemaking given the Administration's commitment to advancing equity and access to health care and in light of the issues raised in litigation challenges to the current rule.

Anticipated Cost and Benefits: In enacting section 1557 of the ACA, Congress recognized the benefits of equal access to health services and health insurance that all individuals should have, regardless of their race, color, national origin, sex, age, or disability. The Department anticipates that this rulemaking will result in significant benefits that are difficult to quantify, namely by providing clear guidance to the covered entity community regarding requirements to administer their health programs and activities in a non-discriminatory manner. In turn, the Department anticipates cost savings as individuals are able to access a range of health care services that will result in decreased health disparities among historically marginalized groups and increased health benefits. The Department estimates annualized costs over a 5-year time horizon of about $551 million or $560 million; however, it is important to recognize that this rule applies pre-existing nondiscrimination requirements in Federal civil rights laws to various entities, the great majority of which have been covered by these requirements for years.

Risks: To be determined.

Timetable:

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Federal, Local, State.

URL For More Information: https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html.

URL For Public Comments: https://www.regulations.gov/document/HHS-OS-2022-0012-0001.

Agency Contact: Dylan Nicole De Kervor, Senior Advisor to the Director, Department of Health and Human Services, Office for Civil Rights, 200 Independence Avenue SW, Washington, DC 20201, Phone: 202 240-3110, Email: 1557ocrmail@hhs.gov.

Related RIN: Related to 0945-AA02, Related to 0945-AA11

RIN: 0945-AA17

HHS—OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH INFORMATION TECHNOLOGY (ONC)

Proposed Rule Stage

53. ONC Health IT Certification Program Updates, Health Information Network Attestation Process for the Trusted Exchange Framework and Common Agreement, and Enhancements To Support Information Sharing [0955-AA03]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Legal Authority:42 U.S.C. 300jj-11; 42 U.S.C. 300jj-14; 42 U.S.C. 300jj-19a; 42 U.S.C. 300jj-52; 5 U.S.C. 552; Pub. L.114-255; Pub. L. 116-260

CFR Citation:45 CFR 170; 45 CFR 171; 45 CFR 172.

Legal Deadline: Final, Statutory, December 13, 2017, Conditions of certification and maintenance of certification. Final, Statutory, July 24, 2019, Publish a list of the health information networks that have adopted the common agreement and are capable of trusted exchange pursuant to the common agreement.

Abstract: The rulemaking implements certain provisions of the 21st Century Cures Act, including: the Electronic Health Record Reporting Program condition and maintenance of certification requirements under the ONC Health IT Certification Program; a process for health information networks that voluntarily adopt the Trusted Exchange Framework and Common Agreement to attest to such adoption of the framework and agreement; and enhancements to support information sharing under the information blocking regulations. The rulemaking would also include proposals for new standards and certification criteria under the Certification Program related to the United States Core Data for Interoperability, real-time benefit tools, electronic prior authorization, and potentially other revisions to the Certification Program.

Statement of Need: The rulemaking would implement certain provisions of the 21st Century Cures Act, including: the Electronic Health Record (EHR) Reporting Program condition and maintenance of certification requirements under the (Certification Program); a process for health information networks that voluntarily adopt the Trusted Exchange Framework and Common Agreement to attest to such adoption of the framework and agreement; and enhancements to support information sharing under the information blocking regulations. The rulemaking would also include proposals for new standards and certification criteria under the Certification Program related to the United States Core Data for Interoperability, real-time benefit tools, and electronic prior authorization. These proposals would fulfill statutory requirements, provide transparency, advance interoperability, and support the access, exchange, and use of electronic health information. Transparency regarding health care information and activities as well as the interoperability and electronic exchange of health information are central to the efforts of the Department of Health and Human Services to enhance and protect the health and well-being of all Americans.

Summary of Legal Basis: The provisions would be implemented under the authority of the Public Health Service Act, as amended by the HITECH Act and the 21st Century Cures Act.

Alternatives: ONC will consider different options and measures to improve transparency, and the interoperability and access to electronic health information so that the benefits to providers, patients, and payers are maximized and the economic burden to health IT developers, providers, and other stakeholders is minimized.

Anticipated Cost and Benefits: The majority of costs for this proposed rule would be incurred by health IT developers in terms of meeting new requirements and continual compliance with the EHR Reporting Program condition and maintenance of certification requirements. We also expect that implementation of new standards and information sharing requirements may also account for some costs. We expect that through implementation and compliance with the regulations, the market (particularly patients, payers, and providers) will benefit greatly from increased transparency, interoperability, and streamlined, lower cost access to electronic heath information.

Risks: At this time, ONC has not been able to identify any substantial risks that would undermine likely proposals in the proposed rule. ONC will continue to consider and deliberate regarding any identified potential risks and will be sure to identify them for stakeholders and seek comment from stakeholders during the comment period for the proposed rule.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: Undetermined.

Agency Contact: Michael Lipinski, Director, Regulatory & Policy Affairs Division, Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, Mary E. Switzer Building, 330 C Street SW, Washington, DC 20201, Phone: 202 690-7151, Email: michael.lipinski@hhs.gov.

RIN: 0955-AA03

HHS—ONC

54. • Establishment of Disincentives for Health Care Providers Who Have Committed Information Blocking [0955-AA05]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Legal Authority:42 U.S.C. 300jj-52; 42 U.S.C. 1315a; 42 U.S.C. 1395jjj; 42 U.S.C. 1395ww; 42 U.S.C. 1395f; 42 U.S.C. 1395w-4; 42 U.S.C. 1395yy; 42 U.S.C. 1395rr; 42 U.S.C. 1395f; 42 U.S.C. 1395l; 42 U.S.C. 195fff

CFR Citation:45 CFR 171; 42 CFR 495; 42 CFR 413; 42 CFR 41.

Legal Deadline: None.

Abstract: The rulemaking implements certain provisions of the 21st Century Cures Act to establish appropriate disincentives for health care providers determined by the Inspector General to have committed information blocking. Consistent with the 21st Century Cures Act, the rulemaking establishes a first set of disincentives using HHS authorities under applicable Federal law, including authorities delegated to the Centers for Medicare & Medicaid Services, and includes related policies necessary to implement these provisions.

Statement of Need: The rulemaking would implement a provision of the 21st Century Cures Act which requires OIG to refer health care providers that OIG determines to have committed information blocking to the appropriate agency to be subject to appropriate disincentives using authorities under applicable Federal law, as the Secretary sets forth through notice and comment rulemaking. Release of the proposed rule is needed to implement this critical component of the Cures Act and ensure effective enforcement of information blocking rules.

Summary of Legal Basis: The provisions would be implemented under the authority of the Public Health Service Act, as amended by the 21st Century Cures Act.

Alternatives: ONC will consider different available authorities under which appropriate disincentives could be established to minimize regulatory burden for health care providers.

Anticipated Cost and Benefits: The costs of this proposed rule would be minimal. Investigated parties may incur some costs in response to an OIG investigation or enforcement action by an HHS agency, however this would depend on the frequency of prohibited conduct. The expected benefits of the regulation are deterring information blocking conduct that interferes with effective health information exchange and negatively impacts many important aspects of health care, including patient access, duplicative testing and costs, and the availability and quality of care.

Risks: We anticipate that health care providers will express concern with the potential complexity of the approach ( i.e., the application of a range of disincentives based on available authorities) as compared to a range of civil monetary penalties or fines. ONC will continue to consider additional potential risks, identify them for stakeholders, and seek comment from stakeholders during the comment period for the proposed rule.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Alex Baker, Federal Policy Branch Chief, Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, 330 C Street SW, 7th Fl., Washington, DC 20201, Phone: 202 260-2048, Email: alexander.baker@hhs.gov.

RIN: 0955-AA05

HHS—ONC

55. • Patient Engagement, Information Sharing, and Public Health Interoperability [0955-AA06]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Legal Authority:42 U.S.C. 300jj-11; 42 U.S.C. 300jj-14; 42 U.S.C. 300jj-19a; 42 U.S.C. 300jj-52; 5 U.S.C. 552; Pub. L., 114-255

CFR Citation:45 CFR 170; 45 CFR 171.

Legal Deadline: None.

Abstract: The rulemaking builds on policies adopted in the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification final rule (85 FR 25642) and included in the Health Information Technology: ONC Health IT Certification Program Updates, Health Information Network Attestation Process for the Trusted Exchange Framework and Common Agreement, and Enhancements to Support Information Sharing proposed rule (0955-AA03). The rulemaking advances electronic health information sharing through proposals for: standards adoption; the certification of health IT to support expanded uses of application programming interfaces (APIs), such as electronic prior authorization, patient engagement, and interoperable public health exchange; and supporting patient engagement and other information sharing principles under the information blocking regulations.

Statement of Need: The rulemaking builds on policies adopted in the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification final rule (85 FR 25642) and included in the Health Information Technology: ONC Health IT Certification Program Updates, Health Information Network Attestation Process for the Trusted Exchange Framework and Common Agreement, and Enhancements to Support Information Sharing proposed rule (0955-AA03). The rulemaking is needed to advance electronic health information sharing through proposals for: standards adoption; the certification of health IT to support expanded uses of application programming interfaces (APIs), such as electronic prior authorization, patient engagement, and interoperable public health exchange; and supporting patient engagement and other information sharing principles under the information blocking regulations.

Summary of Legal Basis: The regulatory proposals would be implemented under the authority of the Public Health Service Act, as amended by the HITECH Act and the 21st Century Cures Act.

Alternatives: ONC will consider different options to improve electronic health information interoperability and sharing so that the benefits to providers, patients, and payers are maximized and the economic burden to health IT developers, providers, and other stakeholders is minimized.

Anticipated Cost and Benefits: The majority of costs for this proposed rule would be incurred by health IT developers in terms of meeting new requirements. We also expect that implementation of new standards for interoperability and information sharing requirements may account for some costs. We expect that through implementation and compliance with the regulations, the market (particularly patients, payers, and providers) will benefit greatly from improved interoperability and the access, exchange, and use of electronic heath information.

Risks: At this time, ONC has not been able to identify any substantial risks that would undermine likely proposals in the proposed rule. ONC will continue to consider and deliberate regarding any potential risks and will be sure to identify them for stakeholders and seek comment from stakeholders during the comment period for the proposed rule.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses.

Government Levels Affected: Undetermined.

Agency Contact: Michael Lipinski, Director, Regulatory & Policy Affairs Division, Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, Mary E. Switzer Building, 330 C Street SW, Washington, DC 20201, Phone: 202 690-7151, Email: michael.lipinski@hhs.gov.

RIN: 0955-AA06

HHS—SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION (SAMHSA)

Proposed Rule Stage

56. Medications for the Treatment of Opioid Use Disorder [0930-AA39]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority:21 U.S.C. 823(g)(1)

CFR Citation:42 CFR 8.

Legal Deadline: None.

Abstract: The Substance Abuse and Mental Health Services Administration (SAMHSA) will revise 42 CFR part 8 to make permanent some regulatory flexibilities for Opioid Treatment Programs (OTPs) granted under the COVID-19 Public Health Emergency (PHE), and to expand access to care for people with Opioid Use Disorder (OUD). Specifically, SAMHSA will propose making permanent those flexibilities pertaining to unsupervised doses of methadone and also initiation of buprenorphine via telemedicine. To expand access to care, SAMHSA will also review admission criteria, particularly rules that may limit timely access to treatment in an OTP. To achieve this, sections of 42 CFR part 8 will require updating. SAMHSA's changes will impact roughly 1900 opioid treatment programs and state opioid treatment authorities.

Statement of Need: These proposed changes will help facilitate access to Medications for Opioid Use Disorder (MOUD) in SAMHSA-regulated opioid treatment programs ( https://www.samhsa.gov/medication-assisted-treatment/become-accredited-opioid-treatment-program). Research and stakeholder feedback indicate that flexibilities granted under the COVID-19 PHE have been well received by treatment programs and patients. There are very few reports of diversion or overdose, and the flexibilities have been shown to facilitate patient engagement in activities, such as employment, that support recovery. Moreover, those with limited access to transportation benefit from these flexibilities since they are not required to attend the OTP as frequently. In this way, making permanent the methadone extended take home flexibility and buprenorphine initiation via telehealth flexibility will facilitate treatment engagement. To further support this and to help surmount increasing mortality and morbidity due to the growing fentanyl-driven overdose crisis, it is necessary to review OTP admission criteria. This will further expand access to care.

Summary of Legal Basis: The current OTP flexibilities allow OTPs to operate in a manner that is otherwise inconsistent with existing OTP regulations, and therefore, a permanent extension of such exemptions would effectively revise the OTP regulations. If such action is pursued without rulemaking, it could be interpreted as inconsistent with SAMHSA's exemption authority under 42 CFR 8.11(h) and the Administrative Procedures Act, which requires agencies to go through notice and comment rulemaking before establishing legally binding rules. Therefore, incorporating the OTP flexibilities at issue into 42 CFR part 8 through rulemaking is the optimal approach for making the OTP flexibilities permanent.

Alternatives: Congressional action; allowing the flexibilities to lapse.

Anticipated Cost and Benefits: This change will help facilitate access to opioid use disorder treatment in SAMHSA-regulated OTPs. Programs have already incorporated COVID-19 flexibilities into practice and have systems in place that support their delivery in a cost effective, safe, and patient centered manner. This proposed rule is not expected to impart a cost to patients. In fact, the proposed rule allows patients to more readily engage in employment and necessary daily activities. This supports patient workforce participation, income generation, and also recovery. Further to this, expanded access will potentially limit the long-term effects of opioid misuse among those seeking rapid access to treatment.

Risks: Patients seeking extended take-home doses of methadone or who have been reviewed via telehealth for initiation of buprenorphine should still be required to have an in-person visit at the OTP at intermittent intervals. Without this provision, there is risk of patients receiving a lower standard of care and increased risk of diversion of medications.

Timetable:

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: State.

Agency Contact: Dr. Neeraj Gandotra, Chief Medical Officer, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane, 18E67, Rockville, MD 20857, Phone: 202 823-1816, Email: neeraj.gandotra@samhsa.hhs.gov.

RIN: 0930-AA39

HHS—CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

Final Rule Stage

57. Control of Communicable Diseases; Foreign Quarantine [0920-AA75]

Priority: Other Significant.

Legal Authority:42 U.S.C. 264; 42 U.S.C. 265

CFR Citation:42 CFR 71.

Legal Deadline: None.

Abstract: This rulemaking amends current regulation to enable CDC to require airlines to collect and provide to CDC certain data elements regarding passengers and crew arriving from foreign countries under certain circumstances.

Statement of Need: In order to control the introduction, transmission, and spread of communicable diseases such as COVID-19 into the United States, the collection of traveler contact information helps ensure that CDC and state and local health authorities are able to identify and locate persons arriving in, or transiting through, the United States from a foreign country who may have been exposed to a communicable disease abroad.

Summary of Legal Basis: The Public Health Service Act (42 U.S.C. 264 and 268) authorizes the Secretary of the Department of Health and Human Services to make and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the United States, or from one State or possession into any other State or possession. Regulations that implement federal quarantine authority are currently promulgated in 42 CFR parts 70 and 71. CDC's authority for collecting these data fields is contained in 42 CFR 71.4.

Alternatives: The transmission of disease, as seen during the COVID-19 pandemic, has the potential to lead to thousands or millions of deaths in addition to the significant healthcare and economic costs. Follow-up with passengers arriving from foreign countries who may be infectious or exposed to a communicable disease is critical. The alternative to collecting traveler contact information before their flight is to collect the information from airlines following the passenger's flight. When this was done in the past, some airlines took several days to respond to a single request if the information was available. In addition, there is significant time and labor required for CDC to obtain additional information from federal databases and process the received information into a format suitable for distribution to state and local health authorities in the United States. As a result, obtaining contact information after a flight, assuming that information is available, can lead to a delay of several days before health authorities can start contacting potentially exposed travelers. This time delay allows for travelers to be lost to follow-up or become symptomatic or infectious. The time required and costs incurred under this alternative increase exponentially with multiple post-flight manifest requests to airlines.

Anticipated Cost and Benefits: The annual, ongoing costs to collect traveler contact information, in the form of airline and travel agency staff time and passenger time, are estimated to be approximately $285 million. This does not include the initial costs for updating IT systems and employee training, which have already been incurred. The costs to the government are minimal, as the vast majority of passenger information that is being collected is transmitted to the government via established data systems that are already in use for other purposes.

The benefits to this rulemaking include rapid follow-up by public health authorities with passengers who may be infectious or exposed to a communicable disease, resulting in less spread and transmission of disease into and throughout the United States, helping to prevent public health and economic costs. The availability of passenger contact data may be used by public health authorities to slow the introduction and transmission of novel infectious diseases, including new variants of the SARS-CoV-2 virus, which causes COVID-19 disease.

Risks: The risk to not collecting this information is that CDC would have to revert back to previous ways of obtaining this information for public health follow up. Some of those methods were time intensive and resulted in delays in follow up.

The risk, although minimal, in collecting this information is that airlines and international passengers often do not want to comply (or may not want to comply) with the requirement. To date, however, CDC has found instances of noncompliance have been very limited.

Timetable:

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Ashley C. Altenburger JD, Public Health Analyst, Department of Health and Human Services, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS: H 16-4, Atlanta, GA 30307, Phone: 800 232-4636, Email: dgmqpolicyoffice@cdc.gov.

RIN: 0920-AA75

HHS—CDC

58. World Trade Center Health Program; Addition of Uterine Cancer to the List of WTC-Related Health Conditions [0920-AA81]

Priority: Other Significant.

Legal Authority:Pub. L. 111-347; Pub. L. 114-113

CFR Citation:42 CFR 88.15.

Legal Deadline: NPRM, Statutory, February 28, 2022.

Authorizing statute requires publication of a rulemaking in the Federal Register not later than 90 days after receipt of advisory committee recommendation.

Abstract: With this rulemaking, HHS/CDC proposes to add uterine cancer to the List of WTC-Related Health Conditions.

Statement of Need: Uterine cancer is the only type of cancer not included on the List of WTC-Related Health Conditions (List) eligible for coverage by the WTC Health Program. Following requests from WTC responders and survivors, as well as a letter from five WTC Health Program Clinical Centers of Excellence requesting the addition of uterine cancer to the List, the Program reviewed the available scientific evidence of an association between uterine cancer and 9/11 exposures in accordance with the WTC Health Program's Policy and Procedures for Adding Cancers to the List of WTC-Related Health Conditions. The disproportionately low representation of women in the most studied cohorts of exposed responders makes it unlikely that a definitive association between toxic exposure arising from the September 11, 2001, terrorist attacks and the occurrence of uterine cancer will be identified during the lifetimes of most WTC Health Program members.

The Administrator of the WTC Health Program exercised discretion to seek a recommendation from the Program's Scientific/Technical Advisory Committee (STAC) and asked the STAC to review the available scientific evidence concerning potential associations between 9/11 exposures and uterine cancer. During public meetings, the STAC considered public comments and deliberated on whether there is a reasonable basis to recommend the addition of uterine cancer to the List, ultimately providing the Administrator with its recommendation and rationale for the addition. Based on the STAC's recommendation and the Program's evaluation of the available scientific literature, the Administrator determined that there is a sufficient evidentiary basis to propose the addition of uterine cancer to the List. This action will promote equity for Program members who are found to have WTC-related uterine cancer.

Summary of Legal Basis: Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 amended the Public Health Service (PHS) Act to establish the WTC Health Program within HHS. See42 U.S.C. 300mm to 300mm61. The WTC Health Program provides medical monitoring and treatment benefits to eligible responders to the September 11, 2001, terrorist attacks in New York City, at the Pentagon, and in Shanksville, Pennsylvania (responders), and eligible survivors in the New York City disaster area (survivors). Treatment is available under the Program for specified health conditions included on the List. Section 3312(a)(6) of the PHS Act requires the Administrator of the WTC Health Program to conduct rulemaking to propose the addition of a health condition to the List codified in 42 CFR 88.15.

Alternatives: If the WTC Health Program did not add uterine cancer to the List of WTC-Related Health Conditions, current and future WTC Health Program members who have or develop uterine cancer likely related to 9/11 exposures will not be eligible to receive treatment services from the Program.

Anticipated Cost and Benefits: This final rulemaking is estimated to cost the WTC Health Program between $1,718,691 and $3,617,447 per annum for 2022-2025. Due to the implementation of provisions of the Patient Protection and Affordable Care Act and as required under the authorizing statute for the WTC Health Program, all of the members and future members are assumed to have or have access to medical insurance coverage other than through the WTC Health Program. Therefore, all treatment costs to be paid by the WTC Health Program are considered transfer payments. This final rulemaking will not impose costs on Program members or any other interested party.

WTC Health Program members with certified WTC-related uterine cancer are expected to experience better treatment outcomes with Program physicians as compared to receiving care outside of the Program. Members may experience higher survival rates compared with those not enrolled and have improved access to timely care, which is associated with improved treatment outcomes.

Risks: The WTC Health Program may be perceived as a policy decision as a result of this rulemaking because the science informing proposed additions to the List is limited by incomplete information on 9/11 exposures, health outcomes, and the relationships they share. For example, the exposures experienced by the responders and survivors on and after September 11, 2001 were not measured and can only be estimated. Also, there are relatively few women in the 9/11-exposed populations; therefore, studies lack the statistical power needed to observe a causal association among women with a high degree of certainty. Given incomplete information, some may argue against the sufficiency of the science supporting the addition of uterine cancer to the List.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Federal.

Agency Contact: Rachel Weiss, Public Health Analyst, Department of Health and Human Services, Centers for Disease Control and Prevention, 1090 Tusculum Avenue, MS C-46, Cincinnati, OH 45226, Phone: 404 498-2500, Email: nioshregs@cdc.gov.

RIN: 0920-AA81

HHS—FOOD AND DRUG ADMINISTRATION (FDA)

Proposed Rule Stage

59. Biologics Regulation Modernization [0910-AI14]

Priority: Other Significant.

Legal Authority:42 U.S.C. 262; 21 U.S.C. 301, et seq.

CFR Citation:21 CFR 601.

Legal Deadline: None.

Abstract: FDA's biologics regulations will be updated to clarify existing requirements and procedures related to Biologic License Applications and to promote the goals associated with FDA's implementation of the abbreviated licensure pathway created by the Biologics Price Competition and Innovation Act of 2009.

Statement of Need: As biologics regulations were primarily drafted in the 1970s, before passage of the BPCI Act, the regulations need to be updated and modernized to account for the existence of biosimilar and interchangeable biological products. The intent of this rulemaking is to make high priority updates to FDA's biologics regulations with the goals of (1) providing enhanced clarity and regulatory certainty for manufacturers of both originator and biosimilar/interchangeable products and (2) helping prevent the gaming of FDA regulatory requirements to prevent or delay competition from biosimilars and interchangeable products.

Summary of Legal Basis: FDA's authority for this rule derives from the biological product provisions in section 351 of the PHS Act (42 U.S.C. 262), and the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301, et seq.) applicable to biological products.

Alternatives: FDA would continue to rely on guidance and one-on-one communications with sponsors through formal meetings and correspondence to provide clarity on existing requirements and procedures related to Biologic License Applications, increasing the risk of potential confusion and burden.

Anticipated Cost and Benefits: This proposed rule would impose compliance costs on affected entities to read and understand the rule and to provide certain information relevant to the regulation. The provisions in this proposed rule would reduce regulatory uncertainty for manufacturers of originator and biosimilar and interchangeable products. This reduction of uncertainty may lead to time-savings to industry and cost-savings to government due to better organized and more complete BLAs and increased procedural clarity and predictability.

Risks: None.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

Federalism: Undetermined.

Agency Contact: Sandra Benton, Senior Policy Coordinator, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 22, Room 1132, Silver Spring, MD 20993, Phone: 301 796-1042, Email: sandra.benton@fda.hhs.gov.

RIN: 0910-AI14

HHS—FDA

60. Certifications Concerning Imported Foods [0910-AI66]

Priority: Other Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: Undetermined.

Legal Authority:21 U.S.C. 381; 21 U.S.C. 371(b); 42 U.S.C. 243; 42 U.S.C. 264; 42 U.S.C. 271; . . .

CFR Citation:21 CFR 1, Subpart F.

Legal Deadline: None.

Abstract: This regulation, if finalized, will help prevent potentially harmful imported foods from reaching consumers and thereby improve the safety of the U.S. food supply by allowing the agency to require, as a condition of importation of food with known safety risk, a certification or such other assurances as the Agency determines appropriate, that imported food complies with U.S food safety requirements.

Statement of Need: Imported food is increasingly implicated in U.S. foodborne illness outbreaks. These illnesses emphasize the importance of ensuring imported food meets applicable requirements of the Act. Historically, FDA has relied on its staff to detect safety problems with imported food by intercepting and examining food products when they are offered for import into the United States or by performing inspections of foreign facilities that produce food for export to the United States. This rule, if finalized, would establish requirements for implementing import certification as a condition of granting admission to an article of food imported into the United States, pursuant to section 801(q) of the FD&C Act. We anticipate that this regulation, if finalized, will help prevent potentially harmful imported foods from reaching consumers and thereby improve the safety of the U.S. food supply.

Summary of Legal Basis: Section 303 of FSMA, Authority to Require Import Certifications for Food, amended section 801 of the FD&C Act (21 U.S.C. 381) to create a new subsection (q) entitled, Certifications Concerning Imported Foods. Section 801(q) gives FDA authority to require import certification based on the risk of the food. FDA also derives authority for these proposed requirements from section 701(b) of the FD&C Act (21 U.S.C. 371(b)), which authorizes the Secretaries of Treasury and Health and Human Services to jointly prescribe regulations for the efficient enforcement of section 801 of the FD&C Act. Additionally, sections 311, 361, and 368 of the Public Health Service Act (PHS Act) (42 U.S.C. 243, 264, and 271, respectively), which relate to communicable disease, provide FDA with authority to make and enforce such regulations as in FDA's judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession (see section 361(a) of the PHS Act) (42 U.S.C. 264(a)).

Alternatives: None.

Anticipated Cost and Benefits: The primary estimate for annualized costs is $74.3 million, including costs from third-party audits, foreign government inspections, and foreign government certification associated with complying with an import certification requirement.

The primary estimate for annualized benefits is $109.7 million, including food safety benefits to consumers, cost savings from reduced transit and storage time, and cost savings from reduced food testing.

Risks: During 1996-2014, 195 outbreaks with 10,685 associated illnesses were reported where the implicated food was imported into the U.S., representing an increasing percentage of reported outbreaks during that timeframe. These illnesses underscore the importance of ensuring imported food meets applicable requirements of the FD&C Act. This rule, if finalized, would implement a risk-based approach to requiring import certification for food as a condition of admissibility. FDA would obtain assurances that imported food meets applicable requirements of the FD&C Act and implementing regulations before the food is offered for import into the U.S. This rule is intended to protect public health by strengthening FDA's import oversight activities for foods and preventing unsafe foods from reaching domestic markets.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: Undetermined.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Peter Fox, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 12420 Parklawn Drive, ELEM, RM 41416, Rockville, MD 20857, Phone: 240 402-1857, Email: peter.fox@fda.hhs.gov.

RIN: 0910-AI66

HHS—FDA

61. Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods [0910-AI72]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Legal Authority:21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 336; 21 U.S.C. 346; 21 U.S.C. 343; 21 U.S.C. 348; 21 U.S.C. 371; 21 U.S.C. 379e

CFR Citation:21 CFR 130; 21 CFR 131; 21 CFR 133; 21 CFR 136; 21 CFR 155; . . .

Legal Deadline: None.

Abstract: The Food and Drug Administration (FDA) is proposing to amend its regulations to permit the use of salt substitutes in standardized foods in which salt (sodium chloride) is a required or optional ingredient. The proposed rule, if finalized, would support industry efforts to reduce sodium content in standardized foods and improve dietary patterns by helping to reduce consumer sodium consumption.

Statement of Need: FDA seeks to improve dietary patterns in the United States to help reduce the burden of diet-related chronic diseases and advance health equity. We are committed to accomplishing this by, in part, creating a healthier food supply for all. One way FDA is working towards this goal is by helping to reduce sodium across the food supply.

FDA is proposing to amend 80 standards of identity (SOI) that include salt as a required or optional ingredient to allow the use of salt substitutes. Salt substitutes are ingredients that can help to reduce sodium in the food supply. FDA is proposing to permit the use of salt substitutes to reduce the sodium content in standardized foods. Most SOI regulations that include salt as a required or optional ingredient do not allow the use of salt substitutes. Therefore, food manufacturers are currently precluded from using salt substitutes in the production of these standardized foods. The proposed rule does not identify specific salt substitutes, but rather, proposes a broad definition to provide flexibility and facilitate industry innovation.

The proposed rule would permit the use of salt substitutes across 80 SOI that require salt as an ingredient or provide for salt as an optional ingredient. In addition, the proposed rule would update the incorporation by reference (IBR) information of several SOI to refer to the most recent versions of the IBR materials and to provide up-to-date contact information for obtaining the IBR materials. The proposed rule would also make technical amendments to correct typographical errors in some SOI regulations.

Summary of Legal Basis: FDA is issuing this proposed rule under sections 201, 401, 402, 409, and 701 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321, 341, 342, 348, 371). These sections authorize FDA to issue regulations establishing a reasonable definition and standard of identity to promote honesty and fair dealing in the interest of consumers; define food additives, provide authorizations and exemptions from regulation as a food additive, and allow the agency to issue regulations for the efficient enforcement of the FD&C Act.

Alternatives: The rule is a voluntary or permitting rule with no regulatory costs. Therefore, we did not consider alternatives designed to reduce the regulatory impact.

Anticipated Cost and Benefits: Voluntary or permitting rules generate potential for social benefits that depend on voluntary behavior for their realization. Being voluntary, they do not generate regulatory costs. Net social costs are possible if the newly allowed voluntary behavior generates net social costs, in which case we should not have permitted that behavior. In this case, we can identify only a potential social benefit. However, the size of any actually occurring benefit is unknown. Because we cannot rule out economic significance, we set the primary estimated annualized benefits at the minimum that would make the rule economically significant, which is $165 M. That social benefit is calculated net of the cost of the voluntary activity that generates those benefits. We set the uncertainty range to give that figure as the mean, so it runs from $0 to $330 M.

Risks: There are no known risks.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

Agency Contact: Jeanmaire Hryshko, Lead Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, HFS-265, College Park, MD 20740, Phone: 240 402-2371, Email: jeanmaire.hryshko@fda.hhs.gov.

RIN: 0910-AI72

HHS—FDA

62. Tobacco Product Standard for Nicotine Level of Certain Tobacco Products [0910-AI76]

Priority: Economically Significant. Major status under 5 U.S.C. 801 is undetermined.

Unfunded Mandates: Undetermined.

Legal Authority:21 U.S.C. 387g

CFR Citation:21 CFR 1160.

Legal Deadline: None.

Abstract: The proposed rule is a tobacco product standard that would establish a maximum nicotine level in cigarettes and certain other finished tobacco products.

Statement of Need: Each year, 480,000 people die prematurely from a smoking-attributed disease, making tobacco use the leading cause of preventable disease and death in the United States. Nearly all these adverse health effects are ultimately the result of addiction to the nicotine in combusted tobacco products, leading to repeated exposure to toxicants from those products. Nicotine is powerfully addictive. The U.S. Surgeon General has reported that 87 percent of adult smokers start smoking before age 18, and half of adult smokers become addicted before age 18. This proposed rule is a tobacco product standard that would establish a maximum nicotine level in cigarettes and certain other finished tobacco products. Because tobacco-related harms primarily result from addiction to products that repeatedly expose users to toxins, FDA would take this action to reduce addictiveness of certain tobacco products, thus giving addicted users a greater ability to quit. This product standard would also help to prevent experimenters (mainly youth) from initiating regular use, and, therefore, from becoming regular smokers. The proposed product standard is anticipated to benefit the population as a whole, while also advancing health equity by addressing disparities associated with cigarette smoking, dependence, and cessation.

Summary of Legal Basis: Section 907 of the FD&C Act authorizes the adoption of tobacco product standards if the Secretary finds that a tobacco product standard is appropriate for the protection of public health, and includes authority related to provisions for nicotine yields in tobacco product standards.

Alternatives: In addition to the costs and benefits of the product standard as proposed, FDA plans to assess the costs and benefits of a different effective date for the rule and the impact of including additional tobacco products in the product standard.

Anticipated Cost and Benefits: The anticipated benefits of the product standard include benefits from reduced death and disease resulting from decreased tobacco use among adult consumers, reduced death and disease from secondhand smoke, and reduced death and disease among youth who are deterred from initiating under the product standard. The qualitative benefits of the proposed rule include impacts such as reduced illness and increased productivity for smokers and nonsmokers, as well as reduced smoking-related fires, cigarette litter, and other environmental impacts.

The proposed rule is expected to generate compliance costs on affected entities, such as one-time costs to read and understand the rule and alter manufacturing and importing practices; and costs to some consumers, such as search and temporary withdrawal costs.

Risks: None.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Federal, Local, State, Tribal.

Federalism: This action may have federalism implications as defined in E.O. 13132.

Agency Contact: Courtney Smith, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, Document Control Center Building 71, Room G335, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 877 287-1373, Fax: 877 287-1426, Email: ctpregulations@fda.hhs.gov.

RIN: 0910-AI76

HHS—FDA

Final Rule Stage

63. Mammography Quality Standards Act [0910-AH04]

Priority: Other Significant. Major under 5 U.S.C. 801.

Legal Authority:21 U.S.C. 360i; 21 U.S.C. 360nn; 21 U.S.C. 374(e); 42 U.S.C. 263b

CFR Citation:21 CFR 900.

Legal Deadline: None.

Abstract: FDA is amending its regulations governing mammography. The amendments will update the regulations issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is taking this action to address changes in mammography technology and mammography processes that have occurred since the regulations were published in 1997 and to address breast density reporting to patient and healthcare providers.

Statement of Need: FDA is updating the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the FD&C Act. FDA is taking this action to address changes in mammography technology and mammography processes.

FDA is also updating to modernize the regulations by incorporating current science and mammography best practices, including addressing breast density reporting to patients and healthcare providers. These updates are intended to improve the delivery of mammography services.

Summary of Legal Basis: The MQSA (Pub. L. 102-539) is codified under the Public Health Service (PHS) Act (42 U.S.C. 263b; section 354 of the PHS Act). Under the MQSA, all mammography facilities, except facilities of the Department of Veterans Affairs, must be accredited by an approved accreditation body and certified by FDA (or an approved State certification agency) to provide mammography services (42 U.S.C. 263b(b)(1), (d)(1)(iv)). FDA is amending the mammography regulations (set forth in part 900 (21 CFR part 900)) under section 354 of the PHS Act (42 U.S.C. 263b), and sections of the FD&C Act (sections 519, 537, and 704(e); 21 U.S.C. 360i, 360nn, and 374(e)).

Alternatives: The Agency will consider different options so that the health benefits to patients are maximized and the economic burdens to mammography facilities are minimized.

Anticipated Cost and Benefits: The benefits and costs associated with this final rule include qualitative benefits related to reduced mortality, morbidity and breast cancer treatment costs resulting from the breast density reporting requirements. Additional benefits that we are not able to quantify include improvements in the accuracy of mammography by improving quality control and strengthening the medical audit, and effects on morbidity.

Risks: None.

Timetable:

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Laurie Sternberg, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Room 5517, Silver Spring, MD 20993, Phone: 240 402-0425, Email: laurie.sternberg@fda.hhs.gov.

RIN: 0910-AH04

HHS—FDA

64. Nonprescription Drug Product With an Additional Condition for Nonprescription Use [0910-AH62]

Priority: Other Significant.

Legal Authority:21 U.S.C. 321; 21 U.S.C. 352; 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262; 42 U.S.C. 264; . . .

CFR Citation:21 CFR 201.67; 21 CFR 314.56; 21 CFR 314.81; 21 CFR 314.125; 21 CFR 314.127.

Legal Deadline: None.

Abstract: The final rule is intended to increase access to nonprescription drug products. The final rule would establish requirements for a drug product that could be marketed as a nonprescription drug product with an additional condition that an applicant must implement to ensure appropriate self-selection, appropriate actual use, or both by consumers.

Statement of Need: Currently, nonprescription drug products are limited to drugs that can be labeled with sufficient information for consumers to appropriately self-select and use the drug product. For certain drug products, limitations of labeling present challenges for adequate communication of information needed for consumers to appropriately self-select or use the drug product without the supervision of a healthcare practitioner. FDA is finalizing regulations that would establish the requirements for a drug product that could be marketed as a nonprescription drug product with an additional condition that an applicant must implement to ensure appropriate self-selection, appropriate actual use or both by consumers.

Summary of Legal Basis: FDA's revisions to the regulations regarding labeling and applications for nonprescription drug products labeling are authorized by the FD&C Act (21 U.S.C. 321 et seq.) and by the Public Health Service Act (42 U.S.C. 262 and 264).

Alternatives: FDA evaluated various requirements for new drug applications to assess flexibility of nonprescription drug product design through drug labeling for appropriate self-selection and appropriate use.

Anticipated Cost and Benefits: The benefits of the final rule would include increased consumer access to drug products and reduced access costs to these products as compared to their prescription alternatives. Benefits to industry would arise from the flexibility in drug product approval and the potential expansion of market revenue. Other benefits would include a reduction in repetitive meetings with industry and the Agency regarding this approval pathway. In addition, private and government-sponsored drug coverage plans may experience cost savings. Although applicants would incur the costs to develop and submit an application for a nonprescription drug with an ACNU, they would likely submit applications only when they expect that the profits from the approval would exceed the costs of the application. Lastly, we anticipate one-time costs of reading and understanding the rule that potential applicants would incur.

Risks: None.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Chris Wheeler, Supervisory Project Manager, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Room 3330, Silver Spring, MD 20993, Phone: 301 796-0151, Email: chris.wheeler@fda.hhs.gov.

RIN: 0910-AH62

HHS—FDA

65. Tobacco Product Standard for Characterizing Flavors in Cigars [0910-AI28]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: This action may affect State, local or tribal governments and the private sector.

Legal Authority:21 U.S.C. 331; 21 U.S.C. 333; 21 U.S.C. 371(a); 21 U.S.C. 387b and 387c; 21 U.S.C. 387f(d) and 387g; . . .

CFR Citation:21 CFR 1166.

Legal Deadline: None.

Abstract: This rule is a tobacco product standard that would prohibit characterizing flavors (other than tobacco) in all cigars. We are taking this action with the intention of reducing the tobacco-related death and disease associated with cigar use. Evidence shows that flavored tobacco products appeal to youth and also shows that youth may be more likely to initiate tobacco use with such products. Characterizing flavors in cigars, such as strawberry, grape, orange, and cocoa, enhance taste and make these products easier to use. Over a half million youth in the United States use flavored cigars, placing these youth at risk for cigar-related death and disease.

Statement of Need: The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), authorizes FDA to adopt tobacco product standards under section 907 if the Secretary finds that a tobacco product standard is appropriate for the protection of the public health. This product standard will prohibit characterizing flavors (other than tobacco) in all cigars. Characterizing flavors in cigars, such as strawberry, grape, cocoa, and fruit punch, increase appeal and make the cigars easier to use, particularly among youth and young adults. This product standard will reduce the appeal of cigars, particularly to youth and young adults, and thereby decrease the likelihood of experimentation, development of nicotine dependence, and progression to regular use. This product standard will improve public health by increasing the likelihood of cessation among existing cigar smokers; this product standard will also improve health outcomes within groups that experience disproportionate levels of tobacco use, including certain vulnerable populations.

Summary of Legal Basis: Section 907 of the FD&C Act authorizes the adoption of tobacco product standards if the Secretary finds that a tobacco product standard is appropriate for the protection of public health. Section 907 also authorizes FDA to include in a product standard a provision that restricts the sale and distribution of a tobacco product to the extent that it may be restricted by a regulation under section 906(d) of the FD&C Act. Section 906(d) of the FD&C Act authorizes the Secretary to issue regulations requiring restrictions on the sale and distribution of a tobacco product, including restrictions on the access to, and the advertising and promotion of, the tobacco product, if the Secretary determines that such regulation would be appropriate for the protection of the public health. Section 701(a) of the FD&C Act authorizes the promulgation of regulations for the efficient enforcement of the FD&C Act.

Alternatives: In addition to the costs and benefits of the product standard, FDA will assess the costs and benefits of, among other things, a different effective date for the rule, and including pipe tobacco in the product standard.

Anticipated Cost and Benefits: The anticipated benefits of the product standard include those coming from reduced death and disease that are the result of cigar use among adult cigar smokers, reduced death and disease from secondhand smoke, and reduced death and disease among youth who are deterred from initiating under the product standard.

Risks: None.

Timetable:

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal, Local, State, Tribal.

Federalism: This action may have federalism implications as defined in E.O. 13132.

Agency Contact: Nathan Mease, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Center for Tobacco Products, Document Control Center, Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373, Email: ctpregulations@fda.hhs.gov.

RIN: 0910-AI28

HHS—FDA

66. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water [0910-AI49]

Priority: Other Significant.

Legal Authority:21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 350h; 21 U.S.C. 371; 42 U.S.C. 243; 42 U.S.C. 264; 42 U.S.C. 271; . . .

CFR Citation:21 CFR 112.

Legal Deadline: None.

Abstract: This rulemaking would revise certain requirements for agricultural water in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (produce safety) regulation for covered produce other than sprouts.

Statement of Need: Agricultural water can be a major conduit of pathogens that can contaminate produce. Recent produce outbreaks potentially linked to agricultural water have emphasized the importance of ensuring that FDA's agricultural water standards are workable across the diversity of domestic and foreign farms and account for the variety of factors that impact water sources and uses. FDA plans to amend its produce safety regulation to address concerns about the practical challenges of implementing certain agricultural water requirements, while protecting the public health.

Summary of Legal Basis: FDA's authority for issuing this rule is provided by sections 402, 419, and 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342, 350h, and 371(a)) and sections 311, 361, and 368 of the Public Health Service Act (PHS Act) (42 U.S.C. 243, 264, and 271).

Specifically, this rulemaking would amend certain agricultural water requirements in the produce safety regulation, codified at 21 CFR part 112, and issued under the following authorities: Section 419(c)(1)(A) of the FD&C Act (21 U.S.C. 350h(c)(1)(A)) authorizes FDA to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which such standards minimize the risk of serious adverse health consequences or death. Section 419(c)(1)(B) of the FD&C Act (21 U.S.C. 350h(c)(1)(B)) further requires that these minimum standards provide sufficient flexibility to be practicable for all sizes and types of businesses. Section 402(a)(3) of the FD&C Act (21 U.S.C. 342(a)(3)) provides that a food is adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food. Section 402(a)(4) of the FD&C Act (21 U.S.C. 342(a)(4)) provides that a food is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Additionally, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) grants the authority to promulgate regulations for the efficient enforcement of the FD&C Act. Sections 311, 361, and 368 of the PHS Act (21 U.S.C. 243, 264, and 271), provide authority for FDA to issue regulations to prevent the spread of communicable diseases from one State to another.

Alternatives: None.

Anticipated Cost and Benefits: FDA anticipates costs associated with complying with the proposed water risk assessment provisions for non-sprout covered produce.

This final rule would generate unquantified benefits stemming from increasing flexibility and addressing practical implementation challenges associated with certain agricultural water provisions in the produce safety regulation and quantified benefits resulting from fewer illnesses caused by pre-harvest agricultural water.

Risks: In a 2019 Report, the Interagency Food Safety Analytics Collaboration (IFSAC) estimated that produce commodities cause 65 percent of foodborne E. coli O157 illnesses and over 40 percent of foodborne Salmonella illnesses. Agricultural water can be a major conduit for produce contamination. This rule is intended to address the practical implementation challenges of certain agricultural water requirements, while protecting public health by setting forth standards to minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce, and provide reasonable assurances that the produce is not adulterated on account of those hazards.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Agency Contact: Samir Assar, Supervisory Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Safety, 5001 Campus Drive, College Park, MD 20740, Phone: 240 402-1636, Email: samir.assar@fda.hhs.gov.

RIN: 0910-AI49

HHS—FDA

67. Tobacco Product Standard for Menthol in Cigarettes [0910-AI60]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: This action may affect State, local or tribal governments and the private sector.

Legal Authority:21 U.S.C. 387g; 21 U.S.C 371; 21 U.S.C 387f

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: This final rule is a tobacco product standard to prohibit the use of menthol as a characterizing flavor in cigarettes.

Statement of Need: The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), authorizes FDA to adopt tobacco product standards under section 907 if the Secretary finds that a tobacco product standard is appropriate for the protection of the public health. This product standard would prohibit menthol as a characterizing flavor in cigarettes. The standard would reduce the appeal of cigarettes, particularly to youth and young adults, and thereby decrease the likelihood that nonusers who would otherwise experiment with menthol cigarettes would progress to regular cigarette smoking. In addition, the tobacco product standard would improve the health and reduce the mortality risk of current menthol cigarette smokers by decreasing cigarette consumption and increasing the likelihood among current menthol cigarette smokers, the tobacco product standard is likely to improve the health of current menthol cigarette smokers by decreasing consumption and increasing the likelihood of cessation.

Summary of Legal Basis: Section 907 of the FD&C Act authorizes the adoption of tobacco product standards if the Secretary finds that a tobacco product standard is appropriate for the protection of public health.

Alternatives: In addition to the costs and benefits of the rule, FDA will assess the costs and benefits of extending the effective date of the rule, creating a process by which some products may apply for an exemption or variance from the product standard, and prohibiting menthol as an intentional additive in cigarette products rather than prohibiting menthol as a characterizing flavor.

Anticipated Cost and Benefits: The rule is expected to generate compliance costs on affected entities, such as one-time costs to read and understand the rule and alter manufacturing/importing practices. The quantified benefits of the rule stem from improved health and diminished exposure to tobacco smoke for users of cigarettes from decreased experimentation, progression to regular use, and consumption of menthol cigarettes. The qualitative benefits of the rule include impacts such as reduced illness for smokers and non-smokers.

Risks: None.

Timetable:

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal, Local, State, Tribal.

Federalism: This action may have federalism implications as defined in E.O. 13132.

Agency Contact: Beth Buckler, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335, Silver Spring, MD 20993, Phone: 877 287-1373, Email: ctpregulations@fda.hhs.gov.

RIN: 0910-AI60

HHS—CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS)

Proposed Rule Stage

68. Provider Nondiscrimination Requirements for Group Health Plans and Health Insurance Issuers in the Group and Individual Markets (CMS-9910) [0938-AU64]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Legal Authority:Pub. L. 116-260, Division BB, title I; 42 U.S.C. 300gg-5(a)

CFR Citation: Not Yet Determined.

Legal Deadline: NPRM, Statutory, January 1, 2022, Statutory Deadline for Issuing a Proposed Rule.

Abstract: This proposed rule would implement section 108 of the No Surprises Act.

Statement of Need: Not yet determined.

Summary of Legal Basis: The Department of Health and Human Services regulations are adopted pursuant to the authority contained in sections 2701 through 2763, 2791, 2792, 2794, 2799A-1 through 2799B-9 of the PHS Act (42 U.S.C. 300gg-63, 300gg-91, 300gg-92, 300gg-94, 300gg-139), as amended.

Alternatives: Not yet determined.

Anticipated Cost and Benefits: Not yet determined.

Risks: Not yet determined.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Federal, State.

Federalism: Undetermined.

Agency Contact: Lindsey Murtagh, Director, Market-Wide Regulation Division, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Consumer Information and Insurance Oversight, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 492-4106, Email: lindsey.murtagh@cms.hhs.gov.

RIN: 0938-AU64

HHS—CMS

69. Short-Term Limited Duration Insurance; Update (CMS-9904) [0938-AU67]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority:Pub. L. 111-148, title I

CFR Citation:45 CFR 144; 45 CFR 146; 45 CFR 148.

Legal Deadline: None.

Abstract: This rule would propose amendments to the definition of `short-term, limited-duration insurance' under section 2791(b)(5) of the Public Health Service Act. The rule's proposals would be designed to ensure this type of coverage does not undermine the Affordable Care Act, including its protections for people with pre-existing conditions, the Health Insurance Exchanges, or the individual, small group, or large group markets for health insurance in the United States.

Statement of Need: Not yet determined.

Summary of Legal Basis: The Department of Health and Human Services regulations are adopted pursuant to the authority contained in sections 2701 through 2763, 2791, 2792, 2794, 2799A-1 through 2799B-9 of the PHS Act (42 U.S.C. 300gg-300gg-63, 300gg-91, 300gg-92, 300gg-94, 300gg-300gg-139), as amended.

Alternatives: Not yet determined.

Anticipated Cost and Benefits: Not yet determined.

Risks: Not yet determined.

Timetable:

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Federal.

Agency Contact: Lindsey Murtagh, Director, Market-Wide Regulation Division, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Consumer Information and Insurance Oversight, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 492-4106, Email: lindsey.murtagh@cms.hhs.gov.

RIN: 0938-AU67

HHS—CMS

70. Assuring Access to Medicaid Services (CMS-2442) [0938-AU68]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Unfunded Mandates: Undetermined.

Legal Authority:42 U.S.C. 1302

CFR Citation:42 CFR 438; 42 CFR 447.

Legal Deadline: None.

Abstract: This rule proposes to address elements related to assuring access in Medicaid and/or the Children's Health Insurance Program (CHIP). These elements could include processes that support the implementation of a comprehensive access strategy as well as payment processes, such as those related to specific payment systems.

Statement of Need: In order to assure equitable access to health care for all Medicaid and CHIP beneficiaries across all delivery systems, access regulations need to be multi-factorial and focus beyond payment rates. Barriers to accessing health care services can be as heterogeneous as Medicaid and CHIP populations which can be measured through provider availability and provider accessibility to realized or perceived access barriers which can be measured through utilization and satisfaction with services. CMS is developing a comprehensive access strategy that will address not only Fee-For-Service (FFS) payment, but also access in managed care and Home and Community-Based Services (HCBS).

Summary of Legal Basis: There are no broad access requirements specified in the statute beyond payment: section 1902(a)(30)(A) of the Act requires states to “assure that payments are consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area.”

Alternatives: In developing the policies contained in this rule, we will consider numerous alternatives to the presented proposals, including maintaining existing requirements. These alternatives will be described in the rule.

Anticipated Cost and Benefits: This proposed rule would be expected to result in potential costs for states to come into and remain in compliance. Estimates for associated costs are unknown at this time and may vary by state. Information about anticipated costs will be included in the proposed rule.

Risks: Risks of the proposals in this rule are still under development and will be included in the published rule for comment.

Timetable:

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: State.

Federalism: Undetermined.

Agency Contact: Karen Llanos, Director, Medicaid Innovation Accelerator Program and Strategy Support, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and CHIP Services, MS: S2-04-28, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-9071, Email: karen.llanos@cms.hhs.gov.

RIN: 0938-AU68

HHS—CMS

71. Transitional Coverage for Emerging Technologies (CMS-3421) [0938-AU86]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: Undetermined.

Legal Authority:42 U.S.C. 263a; 42 U.S.C. 405(a); 42 U.S.C. 1302; 42 U.S.C. 1320b-12; . . .

CFR Citation:42 CFR 405.

Legal Deadline: None.

Abstract: This proposed rule would establish the criteria for an expedited coverage pathway to provide Medicare beneficiaries with faster access to innovative and beneficial technologies. This pathway would build off of prior initiatives, including coverage with evidence development. The proposed rule will meet the following principles previously published by CMS:

(1) Manufacturers may enter the process on a voluntary basis. This process will be limited to medical devices that fall within the Medicare statute and that are relevant to the Medicare population.

(2) CMS may conduct early evidence review (before the device secures FDA marking authorization) and discuss with the manufacturer the best Medicare coverage pathway, depending upon the strength of the evidence collected.

(3) At the manufacturer's request, CMS may initiate the coverage process before FDA market authorization, which could require developing an additional evidence development plan and confirming that there are appropriate safeguards and protections for Medicare beneficiaries.

(4) If CMS determines that further evidence development is the best coverage pathway, the agency would explore how to reduce the burden on manufactures, clinicians and patients while maintaining rigorous evidence requirements.

Statement of Need: This rule is necessary to codify the Coverage with Evidence Development (CED) coverage pathway in regulation and aims to incresase predictability, transparency, and timeliness of Transitional Coverage for Emerging Technologies (TCET).

Summary of Legal Basis: This rule would be proposed under the authority of sections 1862(a)(1)(A) and 1862(a)(1)(E) of the Social Security Act.

Alternatives: Not yet determined.

Anticipated Cost and Benefits: Not yet determined.

Risks: Not yet determined.

Timetable:

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Governmental Jurisdictions.

Government Levels Affected: Federal, State.

Federalism: Undetermined.

Agency Contact: Lori Ashby, Senior Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, MS: S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6322, Email: lori.ashby@cms.hhs.gov.

RIN: 0938-AU86

HHS—CMS

72. Interoperability and Prior Authorization for MA Organizations, Medicaid and CHIP Managed Care and State Agencies, FFE QHP Issuers, MIPS Eligible Clinicians, Eligible Hospitals and CAHs (CMS-0057) [0938-AU87]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority:42 U.S.C. 1395hh

CFR Citation:42 CFR 422; 42 CFR 431; 42 CFR 435; 42 CFR 438; . . .

Legal Deadline: None.

Abstract: This proposed rule would place new requirements on Medicare Advantage (MA) organizations, Medicaid managed care plans, Children's Health Insurance Program (CHIP) managed care entities, state Medicaid and CHIP fee-for-service (FFS) programs, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs) to improve the electronic exchange of health care data and streamline processes related to prior authorization, while continuing CMS' drive toward interoperability, and reducing burden in the health care market. This proposed rule would also add a new measure for eligible hospitals and critical access hospitals under the Medicare Promoting Interoperability Program and for Merit-based Incentive Payment System (MIPS) eligible clinicians under the Promoting Interoperability performance category of MIPS. These policies taken together would play a key role in reducing overall payer and provider burden and improving patient access to health information.

Statement of Need: The proposed changes further support CMS' efforts to improve the electronic exchange of healthcare data and streamline processes related to prior authorization, while continuing CMS' drive toward interoperability in the healthcare market. The proposals in this rule build on the foundation we laid out in the CMS Interoperability and Patient Access final rule to move the healthcare system toward increased interoperability and reduced burden by proposing to enhance the data sharing capabilities of impacted payers and providers through the use of innovative technologies. The proposals also empower patients by making health-related data more easily available through standards-based technology.

Summary of Legal Basis: This rule addresses multiple sections of the Social Security Act, as well as Executive Order 13985, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government.

Alternatives: We carefully considered alternatives to the policies we are proposing in this rule and concluded that none of the alternatives would adequately or immediately begin to address the critical issues related to patient access to health information and interoperability or help to address the processes that contribute to payer, provider, and patient burden. Alternatives considered will be included in the proposed rule.

Anticipated Cost and Benefits: We believe that the proposed policies, if finalized, would result in some financial burdens for impacted payers and providers. We have weighed these potential burdens against the potential benefits, and believe the potential benefits outweigh any potential costs. We anticipate the long-term savings to be significant. As we move toward publication, estimates of costs and benefits will be included in the proposed rule.

Risks: Risks of the proposals in this rule are still under development and will be included in the published rule for comment.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Federal, State.

Agency Contact: Alexandra Mugge, Director & Deputy Chief Health Informatics Officer, Health Informatics and Interoperability Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Burden Reduction and Health Informatics, MS: C5-02-00, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4457, Email: alexandra.mugge@cms.hhs.gov.

RIN: 0938-AU87

HHS—CMS

73. Medicare and Medicaid Program Integrity (CMS-6084) [0938-AU90]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: Undetermined.

Legal Authority:42 U.S.C. 1302; 42 U.S.C. 1395hh

CFR Citation:42 CFR 400; 42 CFR 402; 42 CFR 405; 42 CFR 406; . . .

Legal Deadline: None.

Abstract: This proposed rule includes provisions that would promote payment accuracy and efficiency and help CMS identify and deter fraud, waste, and abuse in a timely, effective manner, enabling the Agency to protect the Medicare and Medicaid programs and the Children's Health Insurance Program (CHIP). This rule would implement portions of section 6101(a) of the Patient Protection and Affordable Care Act (Affordable Care Act), which require the disclosure of certain ownership, managerial, and other information regarding Medicare skilled nursing facilities (SNFs) and Medicaid nursing facilities.

Statement of Need: This rule is necessary to strengthen CMS's program integrity efforts across Medicare, Medicaid, and the CHIP and increase transparency and accountability.

Summary of Legal Basis: The proposals included in this rule will address several sections of title XVIII of the Social Security Act.

Alternatives: Alternatives considered will be described in the rule.

Anticipated Cost and Benefits: As many of the provisions to be included in this rule are still under development, it is not possible at this time to provide cost and benefit estimates. As it is developed further, such estimates will be included in the proposed rule.

Risks: The proposed provisions included in this rule would address a number of program integrity vulnerabilities. Risks of the proposals are still under development and will be included in the rule.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Federal, State.

Federalism: Undetermined.

Agency Contact: John Spiegel, Senior Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Program Integrity, MS: AR-19-15, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-1909, Email: john.spiegel@cms.hhs.gov.

RIN: 0938-AU90

HHS—CMS

74. Culturally Competent and Person-Centered Requirements To Increase Access to Care and Improve Quality for All (CMS-3418) [0938-AU91]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: Undetermined.

Legal Authority:42 U.S.C. 1821; 42 U.S.C 1832(a)(2)(F)(I); 42 U.S.C. 1861(dd)(1); 42 U.S.C. 1905(a)

CFR Citation:42 CFR 403; 42 CFR 416; 42 CFR 418; 42 CFR 441; . . .

Legal Deadline: None.

Abstract: The proposed rule would establish culturally competent and person-centered requirements for all provider and supplier types that participate in Medicare and Medicaid programs. These requirements revise the Conditions of Participations/Conditions for Coverage (CoPss/CfCs) pertaining to governance, patient/resident/client rights (such as nondiscrimination and accessibility), clinical quality standards, quality assessment and performance improvement, staff training, discharge planning, and care planning in an effort to increase quality and improve access to health care. These proposals also include additional requirements for transplant programs, organ procurement organizations, and end-stage renal disease facilities that would advance equity and reduce disparities in organ transplantation and organ donation.

Statement of Need: This rule would advance health equity, increase access to care, improve quality of care, and reduce health disparities for all individuals. The proposals are in accordance with Executive Orders 13985, 13988, 13995, and 14301 on Advancing Racial Equity and Support for Underserved Communities through the Federal Government, Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation, Ensuring an Equitable Pandemic Response and Recovery, and on Advancing Equity, Justice, and Opportunity for Asian Americans, Native Hawaiians, and Pacific Islanders, respectively. Despite the existence of Federal civil rights laws, disparities in care still persist. Revising the CoPs/CfCs by adding culturally competent and person-centered requirements will incentivize providers to address disparities that exist within their facilities by requiring specific actions or face a noncompliance determination that may affect their participation status in the Medicare and Medicaid programs. Discrimination, or even the fear of discriminatory behavior by healthcare providers, negatively impacts a patient's health and safety and health outcomes, and presents barriers to accessing quality health care. The establishment of culturally competent and person-centered requirements are a necessary step to protect an individual's health and safety. The provisions of this rule would help ensure that everyone has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography, preferred language, or other factors that affect access to care and health outcomes. Further, culturally competent and person-centered focused health and safety requirements could lead to improved access to care, improved quality of care, and better health outcomes for all.

Summary of Legal Basis: The statutory authority to revise the health and safety standards for Medicare and Medicaid participating providers and suppliers is contained within Section 1102 (42 U.S.C. 1302) of the Social Security Act. In addition, this rule revises the health and safety regulations to advance health equity and reduce disparities for all individuals in accordance with Executive Orders 13985, 13988, 13995, and 14301 on Advancing Racial Equity and Support for Underserved Communities through the Federal Government, Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation, Ensuring an Equitable Pandemic Response and Recovery, and on Advancing Equity, Justice, and Opportunity for Asian Americans, Native Hawaiians, and Pacific Islanders, respectively.

Alternatives: In developing the policies contained in this rule, we considered numerous alternatives to the presented proposal. These alternatives will be included in the proposed rule.

Anticipated Cost and Benefits: The provisions in this rule aim to advance health equity, increase access to care, improve quality of care, and reduce health disparities for all individuals. This regulation will ultimately remove barriers to access health care, ensure that all individuals have equitable care, and improve quality of care for all. As we move toward publication, estimates of the cost and benefits of these provisions will be included in the rule.

Risks: This action furthers the goals of the Executive Orders on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (E.O. 13985), Executive Order on Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation (E.O. 13988), Executive Order on Ensuring an Equitable Pandemic Response and Recovery (E.O. 13995), and Executive Order on Advancing Equity, Justice, and Opportunity for Asian Americans, Native Hawaiians, and Pacific Islanders (E.O. 14301). While there may be some risks associated with an increased burden on providers as a result of these regulations, we believe benefits related to addressing the challenges that historically underserved populations (those that have been subject to racism, discrimination, or systemic disadvantage) face when accessing and receiving care from a health care organization, would far outweigh any risks.

Timetable:

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Federal, State.

Agency Contact: Alpha-Banu Wilson, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, MS: S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-8687, Email: alphabanu.wilson@cms.hhs.gov.

RIN: 0938-AU91

HHS—CMS

75. Mental Health Parity and Addiction Equity Act and the Consolidated Appropriations Act, 2021 (CMS-9902) [0938-AU93]

Priority: Other Significant.

Legal Authority:Pub. L. 116-260, Division BB, title II; Pub. L. 110-343, secs. 511 to 512

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: This rule would propose amendments to the final rules implementing the Mental Health Parity and Addiction Equity Act. The amendments would clarify plans' and issuers' obligations under the law, promote compliance with MHPAEA, and update requirements taking into account experience with MHPAEA in the years since the rules were finalized as well as amendments to the law recently enacted as part of the Consolidated Appropriations Act, 2021.

Statement of Need: There have been a number of legislative enactments related to MHPAEA since issuance of the 2014 final rules, including the 21st Century Cures Act, the Support Act, and the Consolidated Appropriations Act, 2021. This rule would propose amendments to the final rules and incorporate examples and modifications to account for this legislation and previously issued guidance.

Summary of Legal Basis: The Department of Health and Human Services regulations are adopted pursuant to the authority contained in sections 2701 through 2763, 2791, 2792, 2794, 2799A-1 through 2799B-9 of the PHS Act (42 U.S.C. 300gg-63, 300gg-91, 300gg-92, 300gg-94, 300gg-139), as amended.

Alternatives: Not yet determined.

Anticipated Cost and Benefits: Not yet determined.

Risks: Not yet determined.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Federal, State.

Federalism: This action may have federalism implications as defined in E.O. 13132.

Agency Contact: Lindsey Murtagh, Director, Market-Wide Regulation Division, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Consumer Information and Insurance Oversight, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 492-4106, Email: lindsey.murtagh@cms.hhs.gov.

RIN: 0938-AU93

HHS—CMS

76. Coverage of Certain Preventive Services Under the Affordable Care Act (CMS-9903) [0938-AU94]

Priority: Other Significant.

Legal Authority:Pub. L. 111-148, sec. 1001

CFR Citation:45 CFR 147; 45 CFR 156.

Legal Deadline: None.

Abstract: This rule would propose amendments to the final rules regarding religious and moral exemptions and accommodations regarding coverage of certain preventive services under title I of the Patient Protection and Affordable Care Act.

Statement of Need: Not yet determined.

Summary of Legal Basis: The Department of Health and Human Services regulations are adopted pursuant to the authority contained in sections 2701 through 2763, 2791, 2792, 2794, 2799A-1 through 2799B-9 of the PHS Act (42 U.S.C. 300gg-63, 300gg-91, 300gg-92, 300gg-94, 300gg-139), as amended.

Alternatives: Not yet determined.

Anticipated Cost and Benefits: Not yet determined.

Risks: Not yet determined.

Timetable:

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Federal, Local, State.

Agency Contact: Lindsey Murtagh, Director, Market-Wide Regulation Division, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Consumer Information and Insurance Oversight, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 492-4106, Email: lindsey.murtagh@cms.hhs.gov.

RIN: 0938-AU94

HHS—CMS

77. Contract Year 2024 Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Medicare Cost Plan Programs, Medicare Overpayment Provisions of the Affordable Care Act, and PACE (CMS-4201) [0938-AU96]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority:Pub. L. 115-271

CFR Citation:42 CFR 422; 42 CFR 423.

Legal Deadline: None.

Abstract: This proposed rule would implement changes to strengthen and improve the Medicare Advantage (Part C) and prescription drug (Part D) programs. It also proposes changes to the Medicare Cost Plan Program, Medicare Parts A, B, C, and D Overpayment Provisions of the Affordable Care Act, and Programs of All-Inclusive Care (PACE).

Statement of Need: This rule is necessary to make revisions to the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), and PACE regulations to implement changes related to Star Ratings, medication therapy management, marketing and communications, health equity, provider directories, prior authorization, passive enrollment, network adequacy, identification of overpayments, formulary changes, and other programmatic areas. This proposed rule would also codify regulations implementing Section 118 of the Consolidated Appropriations Act of 2021 and includes a large number of provisions that would codify existing sub-regulatory guidance in the Part C, Part D, and PACE programs. This proposed rule would also amend the existing regulations for Medicare Parts A, B, C, and D regarding the standard for an identified overpayment.

Summary of Legal Basis: This rule addresses multiple sections of the Social Security Act, the Bipartisan Budget Act of 2018, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, and the Consolidated Appropriations Act of 2021.

Alternatives: This rule implements provisions that require public notice and comment and are necessary for the upcoming contract year. We continue to explore alternatives as we develop the rule.

Anticipated Cost and Benefits: As we move toward publication, estimates of costs and benefits will be included in the proposed rule.

Risks: Risks of the proposals in this rule are still under development and will be included in the published rule for comment.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

Agency Contact: Christian Bauer, Director, Division of Part D Policy, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C1-26-16, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6043, Email: christian.bauer@cms.hhs.gov.

Related RIN: Related to 0938-AV01

RIN: 0938-AU96

HHS—CMS

78. • FY 2024 Skilled Nursing Facility (SNFs) Prospective Payment System and Consolidated Billing and Updates to the Value-Based Purchasing and Quality Reporting Programs (CMS-1779) [0938-AV02]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: Undetermined.

Legal Authority:42 U.S.C 1395hh; 42 U.S.C. 1302

CFR Citation:42 CFR 413.

Legal Deadline: Final, Statutory, October 1, 2023, By statute, rule must be effective by October 1 annually.

Abstract: This annual proposed rule would update the payment rates used under the prospective payment system for SNFs for fiscal year 2024. The rule also includes proposals for the SNF Quality Reporting Program (QRP) and for the Skilled Nursing Facility Value-Based Purchasing (VBP) Program that will affect Medicare payment to SNFs. In addition, this rule also proposes to establish new minimum staffing requirements that facilities must meet to ensure safe and quality care.

Statement of Need: This proposed rule would update the SNF prospective payment rates as required under the Social Security Act (the Act). The Act requires the Secretary to provide, before the August 1 that precedes the start of each FY, the unadjusted Federal per diem rates, the case-mix classification system, and the factors to be applied in making the area wage adjustment.

Summary of Legal Basis: In accordance with sections 1888(e)(4)(E)(ii)(IV) and 1888(e)(5) of the Act, the Federal rates in this proposed rule would reflect an update to the rates that we published in the SNF PPS final rule for FY 2023. These changes would be applicable to services furnished on or after October 1, 2023.

Alternatives: None. This is a statutory requirement.

Anticipated Cost and Benefits: Total expenditures will be adjusted for FY 2024.

Risks: None. The rule is necessary for SNF services to be paid appropriately.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

Agency Contact: Tammy Luo, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C5-06-17, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4325, Email: tammy.luo@cms.hhs.gov.

RIN: 0938-AV02

HHS—CMS

Final Rule Stage

79. Streamlining the Medicaid and CHIP Application, Eligibility Determination, Enrollment, and Renewal Processes (CMS-2421) [0938-AU00]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority:42 U.S.C. 1302

CFR Citation:42 CFR 431; 42 CFR 435; 42 CFR 457.

Legal Deadline: None.

Abstract: This final rule streamlines eligibility and enrollment processes for all Medicaid and Children's Health Insurance Program (CHIP) populations and creates new enrollment pathways to maximize enrollment and retention of eligible individuals.

Statement of Need: Since the implementation of the Affordable Care Act (ACA), CMS has made improvements in streamlining the Medicaid and CHIP application, eligibility determination, enrollment, and renewal processes. Simplifying enrollment in Medicaid and CHIP coverage is a foundational step in efforts to address health disparities for low-income individuals. However, gaps remain in States' ability to seamlessly process beneficiaries' eligibility and enrollment in order to maximize coverage. This rule will provide States with the tools they need to reduce unnecessary barriers to enrollment in Medicaid and CHIP and to keep eligible beneficiaries covered.

Summary of Legal Basis: This rule responds to the January 28, 2021, Executive Order on Strengthening Medicaid and the Affordable Care Act. It addresses components of title XIX and title XXI of the Social Security Act and several sections of the Patient Protection and Affordable Care Act (Pub. L. 111-148) and the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), which amended and revised several provisions of the Patient Protection and Affordable Care Act.

Alternatives: In developing the policies contained in this rule, we considered numerous alternatives to the presented proposals, including maintaining existing requirements. These alternatives will be described in the rule.

Anticipated Cost and Benefits: The provisions in this rule will streamline Medicaid and CHIP enrollment processes and ensure that eligible beneficiaries can maintain coverage. While states and the Federal Government may incur some initial costs to implement these changes, this rule aims to reduce administrative barriers to enrollment, which is expected to reduce administrative costs over time. The provisions in this rule are designed to increase access to affordable health coverage, and we believe that the benefits will justify any costs. Additionally, through clear and consistent requirements for the timely renewal of eligibility for all beneficiaries, this rule promotes program integrity, thereby protecting taxpayer funds at both the state and federal levels. As we move toward publication, estimates of the cost and benefits of these provisions will be included in the rule.

Risks: We anticipate that the provisions of this rule will further the administration's goal of strengthening Medicaid and making high-quality health care accessible and affordable for every American. At the same time, through clear and consistent requirements for conducting regular renewals of eligibility, acting on changes reported by beneficiaries and maintaining thorough recordkeeping on these activities, this rule will reduce the risk of improper payments.

Timetable:

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Local, State.

Agency Contact: Sarah Delone, Deputy Director, Children and Adults Health Programs Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and CHIP Services, MS: S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-5647, Email: sarah.delone2@cms.hhs.gov.

RIN: 0938-AU00

HHS—ADMINISTRATION FOR CHILDREN AND FAMILIES (ACF)

Proposed Rule Stage

80. Foster Care Legal Representation [0970-AC89]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: sec. 474(a)(3) of the Social Security Act; sec. 1102 of the Social Security Act

CFR Citation:45 CFR 1356.60(c).

Legal Deadline: None.

Abstract: This regulation proposes to allow a title IV-E agency to claim Federal financial participation for the administrative cost of providing independent legal representation to a child who is either a candidate for foster care or in foster care, and his/her parent to prepare for and participate in judicial determinations in foster care and other related civil legal proceedings.

Statement of Need: Allowing title IV-E agencies to claim Federal reimbursement for independent legal representation in legal proceedings that are necessary to carry out the requirements in the agency's title IV-E plan, including civil proceedings, may help prevent the need to remove a child from the home or, for a child in foster care, achieve permanency faster. Research demonstrates that some of the circumstances bringing families into contact with the child welfare system (poverty, educational neglect, inadequate housing, failure to provide adequate nutrition, and failure to safeguard mental health due to domestic violence) can be addressed before a child enters foster care by providing legal representation early in foster care legal proceedings and in civil legal matters. When children are removed from the home, studies show having access to legal representation for civil legal issues earlier in a case can improve the rate of reunification, nearly double the speed to legal guardianship or adoption, and result in more permanent outcomes for children and families.

Summary of Legal Basis: Section 474(a)(3) of the Act authorizes Federal reimbursement for title IV-E administrative costs, which are defined as costs found necessary by the Secretary for the provision of child placement services and for the proper and efficient administration of the State [title IV-E] plan. Section 1102 of the Act authorizes the Secretary to publish regulations, not inconsistent with the Act, as may be necessary for the efficient administration of the functions with which the Secretary is responsible under the Act.

Alternatives: If this NPRM is not published, agencies may only continue to claim FFP for administrative costs of independent legal representation provided by attorneys representing children in title IV-E foster care, children who are candidates for title IV-E foster care, and the child's parents in all stages of foster care legal proceedings, but not in other civil proceedings (See Child Welfare Policy Manual (CWPM) 8.1B #30, 31 and 32).

Anticipated Cost and Benefits: This final rule impacts state and tribal title IV-E (child welfare) agencies. ACF estimates that the proposed regulatory change would cost the federal government $2,731 billion in FFP over 10 years. This proposal does not impose a burden or cost on the title IV-E agency. The title IV-E agency has discretion to provide allowable independent legal representation to families.

Risks: None.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Kathleen McHugh, Director, Division of Policy, Children's Bureau, ACYF/ACF/HHS, Department of Health and Human Services, Administration for Children and Families, 330 C Street SW, Room 3411, Washington, DC 20201, Phone: 202 401-5789, Fax: 202 205-8221, Email: kmchugh@acf.hhs.gov.

RIN: 0970-AC89

HHS—ACF

81. Separate Licensing Standards for Relative or Kinship Foster Family Homes [0970-AC91]

Priority: Other Significant.

Legal Authority:42 U.S.C. 620 et seq.;42 U.S.C. 670 et seq.;42 U.S.C. 1302

CFR Citation:45 CFR 1355.20.

Legal Deadline: None.

Abstract: This regulation proposes to allow title IV-E agencies to adopt separate licensing standards for relative or kinship foster family homes.

Statement of Need: Currently, the regulation provides that in order to claim title IV-E, all foster family homes must meet the same licensing standards, regardless of whether the foster family home is a relative or non-relative placement. This Notice of Proposed Rulemaking (NPRM) allows a title IV-E agency to adopt licensing or approval standards for all relative foster family homes that are different from the licensing standards used for non-related foster family homes.

Summary of Legal Basis: This NPRM is published under the authority granted to the Secretary of Health and Human Services by section 1102 of the Social Security Act (Act), 42 U.S.C. 1302. Section 1102 of the Act authorizes the Secretary to publish regulations, not inconsistent with the Act, as may be necessary for the efficient administration of the functions for which the Secretary is responsible pursuant to the Act. Section 472 of the Act authorizes federal reimbursement for a FCMP for an otherwise eligible child when the child is placed in a fully licensed or approved foster family home.

Alternatives: There are no satisfactory alternatives to publishing this NPRM. This change cannot be made in sub-regulatory guidance.

Anticipated Cost and Benefits: This NPRM impacts state and tribal title IV-E agencies and does not impose a burden. The title IV-E agency has discretion to develop separate licensing standards for relatives and non-relatives and if they do so, they may claim title IV-E funding. ACF estimates that the proposed regulatory change would cost the Federal Government $3.085 billion in title IV-E foster care federal financial participation over 10 years.

Risks: None.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Kathleen McHugh, Director, Division of Policy, Children's Bureau, ACYF/ACF/HHS, Department of Health and Human Services, Administration for Children and Families, 330 C Street SW, Room 3411, Washington, DC 20201, Phone: 202 401-5789, Fax: 202 205-8221, Email: kmchugh@acf.hhs.gov.

RIN: 0970-AC91

HHS—ACF

82. Unaccompanied Children Program Foundational Rule [0970-AC93]

Priority: Other Significant.

Legal Authority: sec. 462 of the Homeland Security Act (6 U.S.C. 279)

CFR Citation:45 CFR 410.

Legal Deadline: None.

Abstract: This rule would establish the regulatory framework for a variety of activities currently conducted by the Office of Refugee Resettlement's Unaccompanied Children (UC) Program. The rule would target activities currently mandated under the Flores Settlement Agreement (FSA), and it would further strengthen and codify additional protections and service provisions for unaccompanied children.

Statement of Need: Historically, the UC Program has operated largely without authorizing regulations enacted under the Administrative Procedures Act or subject to notice-and-comment rulemaking. Instead, virtually all ORR policies and procedures are contained in an ORR Policy Guide, and more recently, official ORR Field Guidance.

The UC Program is currently subject to the FSA, a consent decree which was first agreed to on January 28, 1997, in the United States District Court for the Central District of California. The court continues to supervise the agreement, which, based on a subsequent amendment, cannot terminate until 45 days after the agency publishes rules implementing the agreement.

At this time, ORR seeks to promulgate a new UC Program Foundational Rule, which will govern ORR activities that are currently governed by the FSA along with the federal statutes concerning the UC program, and address additional areas not contemplated in 1997 when the FSA was instituted.

It is important to note that this rule will codify new and vital protections for all children in ORR care, most of which currently are only provided in ORR policies and procedures. Upon promulgation of the final UC Program Foundational Rule, ORR will seek to terminate the FSA. The long-term goal is for ORR to codify FSA requirements and provide programmatic enhancements that will result in better and more durable protections for all children in ORR care, including greater transparency of ORR policies.

Summary of Legal Basis: ORR has broad statutory authority concerning the care and custody of UC through the Homeland Security Act of 2002 (HSA), 6 U.S.C. 279, and the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 (TVPRA), 8 U.S.C. 1232.

Alternatives: The agency could choose to not issue regulations and continue to be governed by the FSA. However, as noted above, although the FSA provides important protections, it was never intended to permanently govern the program, and regulations are needed to codify enhancements that will result in better and more durable protections for all children in ORR care.

Anticipated Cost and Benefits: ORR anticipates new costs associated with this rule particularly those associated with staffing increases ( e.g., related to administrative hearings as part of due process protections) and will work to estimate the costs based on updated staffing requirements, costs associated with promulgation of the federal rule, and any other associated costs.

Risks: No programmatic risks are anticipated.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses, Organizations.

Government Levels Affected: None.

Agency Contact: Toby Biswas, Senior Supervisory Policy Counsel, Department of Health and Human Services, Administration for Children and Families, 330 C Street SW, Washington, DC 20201, Phone: 202 555-4440, Email: ucpolicy@acf.hhs.gov.

RIN: 0970-AC93

HHS—ACF

83. Federal Licensing of Office of Refugee Resettlement Facilities [0970-AC94]

Priority: Other Significant.

Legal Authority: sec. 462 of the Homeland Security Act (6 U.S.C. 279)

CFR Citation:45 CFR 412.

Legal Deadline: None.

Abstract: This rule would provide the regulatory framework for new Federal licensing of shelter care providers for unaccompanied children. This framework would be used when State governments do not provide State licensing for such providers under certain circumstances. The new office created to manage the Federal licensing will be proposed to be located within the Administration for Children and Families, but not within the Office of Refugee Resettlement.

Statement of Need: ORR's Unaccompanied Children (UC) Program is responsible for the administration of childcare shelters that provide care to UC arriving in the United States, prior to being placed with vetted sponsors. As of December 2021, ORR supports over 250 licensed care provider shelters in 25 states under approximately 150 separate grants between ORR and its network of care providers.

In addition, the Flores Settlement Agreement (FSA) generally requires that UC be placed in a state-licensed shelters subject to certain exceptions and expresses a specific preference for placements in geographic locations in which a majority of children are apprehended. Critically, none of ORR's authorizing statutes mandate placement in state-licensed shelters.

ORR has cultivated a large network of state-licensed shelters and developed close, cooperative relationships with many of the partner states that oversee and enforce their own licensing processes for ORR care providers. Accordingly, ORR has not attempted to fulfill all of the functions of, nor provide the services typically performed by, state agencies involved in the licensure and oversight of child care facilities with respect to compliance with state licensing requirements, such as conducting facility inspections, facilitating and processing background checks, and investigating child abuse/neglect allegations.

Recent actions by Texas and Florida to restrict or exempt from state licensure of ORR UC care provider facilities have required ORR to re-evaluate how to continue providing care for UC consistent with the FSA's expectation that children be placed in state-licensed shelters in those states, which represent a significant proportion of ORR's overall UC bed space. ACF has determined that the HSA's and TVPRA's broad grant of authority to ORR to manage the care and custody of UC authorizes the Department of Health and Human Services (HHS) to federally license shelters that house UC where states abdicate their traditional licensing responsibilities. This authority has been further delegated to ACF. ACF believes this change is necessary because additional states have recently taken steps to sever ORR grantees' access to state licensure through executive action. ACF has determined that implementing federal licensure in these states can substantively address concerns underlying the FSA's requirement that UC shelters be state licensed ( e.g. establishment and monitoring of facility standards not addressed by ORR policies, by authorities that are independent of ORR).

To continue serving UC and maintain quality of care in states that have restricted the availability of licensure to UC care providers, ORR has determined that the most effective response is for HHS, through ACF, to develop federal licensing standards for its care provider facilities under certain circumstances.

ORR will propose that this function be carried out by the proposed Office of Residential Licensure for Unaccompanied Children (ORLUC), to sit within ACF but independent of ORR. That office would oversee the issuance of licensing standards, implement monitoring, and oversee associated processes including federal license revocations.

Summary of Legal Basis: ORR has broad statutory authority concerning the care and custody of UC through the Homeland Security Act of 2002 (HSA), 6 U.S.C. 279, and the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 (TVPRA), 8 U.S.C. 1232.

Alternatives: If this rule is not issued, ACF will lack the legal authority to issue licenses and enforce licensing requirements in states that have acted to restrict the availability of licensure to organizations funded by ORR to carry out the UC program. This would limit ACF's ability to ensure the safety and well-being of children in its care, and to comply with the intent of the FSA.

Anticipated Cost and Benefits: The proposed regulations would result in costs to federal licensees, prospective federal licensees, ORR, and to ACF in implementing the proposed federal licensure program. Based on ACF's analysis, costs associated with the proposed regulations range from approximately $153 to $220 per licensee for submitting licensure applications and corrective action plans, as necessary. In addition, ACF conducted a regulatory impact analysis to assess costs associated with other requirements in the proposed rule such as updating policy and/or training staff, hiring additional staff, and implementing facility changes. At this time, ACF lacks the ability to estimate the potential costs specific to potentially affected care providers, especially with regard to changes to facilities. Therefore, ACF is required to make assumptions general to all prospective federal licensees in implementing any necessary changes. On average, ACF estimates that updates to affected facility policies or staff training will cost licensees between $17.32 and $34.68 per childcare worker. Should a federal licensee need to hire additional staff in order to come into compliance with federal licensure standards, ACF estimates the average cost to be $36,361 per year per worker.

The proposed rule would also result in associated federal costs of the establishment and operation of ORLUC. Based on ACF's analysis, the federal costs associated with the proposed regulations would be approximately $6.4 million in the first fiscal year once they are finalized. ACF also notes that many potential federal licensees discussed in this proposed rule are ACF grantees and the costs of maintaining compliance with licensing requirements are allowable costs to grant awards under the Basic Considerations for cost provisions at 45 CFR part 75, sections 403 through 405, if that the costs are reasonable, necessary, ordinary, treated consistently, and are allocable to the award. Additional costs associated with the policies discussed in this proposed rule that were not budgeted, and cannot be absorbed within existing budgets, would be allowable for the grant recipient to submit a request for supplemental funds to cover the costs, and may therefore result in additional federal costs.

Risks: No programmatic risks are anticipated.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses, Organizations.

Government Levels Affected: None.

Agency Contact: Toby Biswas, Senior Supervisory Policy Counsel, Department of Health and Human Services, Administration for Children and Families, 330 C Street SW, Washington, DC 20201, Phone: 202 555-4440, Email: ucpolicy@acf.hhs.gov.

RIN: 0970-AC94

HHS—ACF

84. • Strengthening TANF as a Safety Net and Work Program [0970-AC97]

Priority: Other Significant.

Legal Authority:42 U.S.C. 609

CFR Citation:45 CFR 260.

Legal Deadline: None.

Abstract: This rule would strengthen the Temporary Assistance for Needy Families (TANF) program as a safety net and a work preparation program, make changes to allowable uses of TANF funds, improve work program effectiveness, and reduce administrative burden. The rule responds to the President's Executive Order on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, as well as the Biden-Harris Administration's priority to build a bridge towards economic recovery. The rule aims to increase support for families with the greatest needs and the services most integral to the safety net, including cash assistance, and help to reduce racial inequities across states. Additionally, the rule aims to help states to tailor effective workforce services to the needs of each family and reduce administrative burden.

Statement of Need: In fiscal year (FY) 2020, combined federal TANF and state maintenance-of-effort (MOE) expenditures and transfers totaled $31.6 billion. Of that amount only 22 percent was spent on basic assistance, compared to 71 percent in FY 1997. As a result, TANF currently serves less than 25 percent of eligible families across the country, as compared to 1997 when TANF served almost 70 percent of eligible families. States in which the lowest proportion of families in poverty receive cash benefits also have proportionally larger shares of Black and Latinx children. The rule aims to address these shortcomings and would align with the Administration's efforts to address equity, focus on upstream preventions, and increase opportunities for economic mobility for low-income families. The NPRM may consider changes around use of funds, eligible families, state MOE spending, and work flexibilities.

Summary of Legal Basis: The proposed regulations will relate to allowable spending, eligible work activities and penalties, and administrative simplification. The NPRM would be issued under the Secretary's authority to issue regulations where Congress has charged the Department with enforcing penalties, 42 U.S.C. 609.

Alternatives: Without these regulatory changes around allowable uses of funds, states will continue to underinvest in services most integral to the safety net, including cash assistance, and supports for families with the greatest needs. Without regulatory changes to improve work program effectiveness, states will have less flexibility to tailor employment and training services to the needs of each family. Lastly, in the absence of these regulatory changes, states will not experience any relief in their administrative burden to operate the TANF program.

Anticipated Cost and Benefits: This NPRM imposes no costs on the federal government nor does it change overall funding amounts or spending requirements for states, territories, and tribes, as TANF is a fixed block grant. We anticipate a benefit in the transfer of funding toward critical supports to families experiencing economic hardships.

Risks: While we expect more low-income families to receive TANF benefits and receive more effective work-related services, this action may result in states having to increase their own spending to fund activities previously funded by federal TANF dollars or previously counted as state MOE spending.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Deborah List, Associate Deputy Director, Office of Family Assistance, Department of Health and Human Services, Administration for Children and Families, 330 C Street SW, Washington, DC 20201, Phone: 202 401-5488, Email: deborah.list@acf.hhs.gov.

RIN: 0970-AC97

HHS—ACF

85. • Adoption and Foster Care Analysis and Reporting System (AFCARS) [0970-AC98]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Legal Authority:42 U.S.C. 679

CFR Citation:45 CFR 1355.41 et seq.

Legal Deadline: None.

Abstract: To ensure equitable treatment of all children and youth in child welfare, including Native American and LGBTQ+ children and youth, this rule will propose to require title IV-E agencies to collect and report for AFCARS additional information related to youth, foster parents, adoptive parents, and legal guardians. AFCARS data is used for planning, technical assistance, discretionary service grants, and research and evaluation, all with the goal of reducing entry into and improving outcomes of children in foster care.

Statement of Need: This NPRM is consistent with the Administration's priority of advancing equity for those historically underserved and adversely affected by persistent poverty and inequality. Native and LGBTQI+ children are over-represented populations in the child welfare system; however, the experiences of LGBTQI+ children in foster care and Native children are not fully captured in current child welfare data systems. As such, adding sexual orientation and ICWA data elements removed from the 2020 rule would make the experiences of these children more visible and may provide better insight into the trajectory of LGBTQI+ and Native children in foster care. It will also provide avenues for collaboration between states and tribes, in areas such as technical assistance, training and resource allocation that would be informed by the additional ICWA data elements. We anticipate that this is a critical step in addressing the needs of this population, and also will assist title IV-E agencies in recruiting and training foster care providers in meeting the needs of these youth. We will also consider potentially adding other elements that were removed by a May 2020 AFCARS Final Rule, such as health and education data.

Summary of Legal Basis: AFCARS is authorized by section 479 of the Social Security Act (the Act), which mandates that the Department of Health and Human Services (HHS) regulate a data collection system for national adoption and foster care data. Section 474(f) of the Act requires HHS to impose penalties for non-compliant AFCARS data. Section 1102 of the Act authorizes the Secretary to publish regulations, not inconsistent with the Act, as may be necessary for the efficient administration of the functions with which the Secretary is responsible under the Act.

Alternatives: If this NPRM is not published, title IV-E agencies are required to report to AFCARS (beginning 10/1/22 under the 2020 final rule) related to ICWA: the child's tribal membership and name of Tribe; tribal membership for the child's the parents, foster parents, adoptive parents, and legal guardians; whether the state made inquiries if the child is an Indian child as defined in ICWA; whether ICWA applies for the child and if yes, the date that the state was notified by the Indian tribe or state or tribal court that ICWA applies; and whether the child's tribe(s) was sent legal notice. Title IV-E agencies are not required to report on sexual orientation in AFCARS currently.

Anticipated Cost and Benefits: There will be new state/tribe and federal costs associated with requiring title IV-E agencies to report additional AFCARS data elements, and the cost is contingent on the scope of the NPRM.

Risks: None.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Local, State.

Agency Contact: Kathleen McHugh, Director, Division of Policy, Children's Bureau, ACYF/ACF/HHS, Department of Health and Human Services, Administration for Children and Families, 330 C Street SW, Room 3411, Washington, DC 20201, Phone: 202 401-5789, Fax: 202 205-8221, Email: kmchugh@acf.hhs.gov.

RIN: 0970-AC98

HHS—ACF

86. • Modification of the Tribal Non-Federal Share Requirement [0970-AC99]

Priority: Other Significant.

Legal Authority:42 U.S.C. 1302; 42 U.S.C. 655(f)

CFR Citation:45 CFR 309; 45 CFR 310.

Legal Deadline: None.

Abstract: This rule would modify the non-Federal share of program expenditures requirement, including the 90/10 and 80/20 cost sharing rates, for Tribal child support enforcement programs.

Statement of Need: The requirement to provide the non-Federal share of program expenditures has been a longstanding issue for Tribal child support enforcement programs. It limits growth, causes disruptions, and creates instability. Modifying the non-Federal share requirement prevents existing Tribal child support enforcement programs from closing. It implements guidance provided by the Secretary that the match rate would be revised if it were disruptive and imposed hardship (see 65 Fed Reg. at 50823). It also removes a major barrier that hinders prospective Tribes and Tribal organizations from administering a Tribal child support enforcement program. Most importantly, it ensures the opportunity for Tribal families to receive child support services that reflect and affirm their Tribal cultures and traditions, promote parental responsibility, create financial stability, and lift Tribal families out of poverty. In FY 2020, Tribal child support enforcement programs collected $58 million in child support payments and 96 percent went to families.

Summary of Legal Basis: Section 455(f) of the Social Security Act (the Act) requires the Secretary to issue regulations governing the grants to Tribes and Tribal organizations operating child support enforcement programs. Additionally, section 1102 of the Act authorizes the Secretary to publish regulations, not inconsistent with the Act, as may be necessary for the efficient administration of the functions with which the Secretary is responsible under the Act.

Alternatives: If the NPRM is not published, many Tribal child support enforcement programs will continue to reduce services, delay filling vacancies, forgo system upgrades, and operate at a limited capacity so that they can meet the non-Federal share of program expenditures. Some Tribal child support enforcement programs will continue to face the danger of closing and may eventually be forced to close. Additionally, many prospective Tribes and Tribal organizations will be unable to apply for funding to operate a Tribal child support enforcement program due to the non-Federal share requirement.

Anticipated Cost and Benefits: ACF estimates that a modification to the regulation will result in increased costs to the Federal government but will also result in additional tribal child support programs added to serve children and families.

Risks: None.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Chad Sawyer, Senior Policy Specialist, Department of Health and Human Services, Administration for Children and Families, 330 C Street SW, Washington, DC 20201, Phone: 202 774-2323, Email: chad.sawyer@acf.hhs.gov.

RIN: 0970-AC99

HHS—ACF

Final Rule Stage

87. ANA Non-Federal Share Emergency Waivers [0970-AC88]

Priority: Other Significant.

Unfunded Mandates: Undetermined.

Legal Authority:42 U.S.C. 2991b

CFR Citation:45 CFR 1336.

Legal Deadline: None.

Abstract: This regulation proposes to streamline the process for Administration for Native Americans (ANA) grant program applicants to request a waiver for non-federal share for the 20 percent match required by statute for ANA grants. The regulation will also propose the ability for current grantees to request an emergency waiver for the non-federal share match.

Statement of Need: The Native American Programs Act of 1974 (NAPA), as amended, requires projects awarded funding through sections 803, 804, and 805 provide a 20 percent match of the total cost of the project, unless a waiver is obtained through objective criteria as outlined in ANA's regulations. The current regulations outline the requirements and criteria for applicants to request a waiver for non-federal share (NFS) at 45 CFR part 1336.50 at the time of application for a new or continuation award. The COVID-19 pandemic had a detrimental impact on the economies and financial resources of ANA's Native American recipients, most of whom had to close their borders to protect their citizens. Many tribal enterprises were forced to close, and tourism revenues became non-existent. Partnerships and vendors were no longer able to contribute previously committed resources for NFS. During this time, many recipients grew concerned that they would be unable to fully meet their NFS of their grant award. ANA explored the possibility of providing emergency NFS waivers to ANA grantees. Unfortunately, ANA learned that it does not currently have the authority to issue emergency NFS waivers, as neither emergency waiver authority nor a process to approve such requests exists in ANA's regulations. Current regulations require waiver requests to be submitted at the time of application or during the non-competitive continuation process. This request to update ANA's regulation would provide a new provision for recipients to request an emergency NFS waiver in the event of a natural or man-made emergency such as a public health pandemic.

Summary of Legal Basis: The Native American Programs Act of 1974 (NAPA), as amended, requires projects awarded funding through sections 803, 804, and 805 provide a 20 percent match of the cost of the project, unless a waiver is obtained through objective criteria as outlined in ANA's regulations. Current regulations outline the requirements and criteria to request a waiver at 45 CFR part 1336.50 at the time of application for a new or continuation award. However, there is no existing regulations or criteria to provide an emergency waiver for NFS to recipients experience a natural or man-made disaster or public health emergency such as COVID-19.

Alternatives: The alternative would be to not offer the emergency waiver.

Anticipated Cost and Benefits: There are no known costs to the program by issuing this rule. This final rule is responsive to the President's Executive Order 13995 (Ensuring an Equitable Pandemic Response and Recovery) and Executive Order 14002 (Economic Relief Related to the COVID-19 Pandemic), as well as responsive to the needs of Native American communities. Existing regulations state that ANA must determine that approval of an NFS waiver will not prevent the award of other grants at levels it believes are desirable for the purposes of the program. Approval of this emergency waiver regulation will also decrease the potential audit findings of entities not meeting the required NFS. In addition, it reduces further harm to recipients that are impacted by an emergency situation, which caused unforeseen and additional financial hardships.

Risks: There are no known risks to the program by issuing this rule.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Mirtha Beadle, Senior Policy Advisor, Department of Health and Human Services, Administration for Children and Families, 330 C Street SW, Washington, DC 20201, Phone: 202 401-6506, Email: mirtha.beadle@acf.hhs.gov.

RIN: 0970-AC88

HHS—ADMINISTRATION FOR COMMUNITY LIVING (ACL)

Proposed Rule Stage

88. Older Americans Act, Titles III, VI, and VII [0985-AA17]

Priority: Other Significant.

Legal Authority:42 U.S.C. 3001 et seq.

CFR Citation:45 CFR 1321 to 1324.

Legal Deadline: None.

Abstract: The proposed rule would amend the regulations implementing programs under the Older Americans Act (OAA) (42 U.S.C. 3001 et seq.): 45 CFR part 1321 (Grants to State and Community Programs on Aging); 45 CFR part 1322 (Grants to Indian Tribes for Support and Nutrition Services); 45 CFR part 1323 (Grants for Supportive and Nutritional Services to Older Hawaiian Natives); and 45 CFR part 1324 (Allotments for Vulnerable Elder Rights Protection Activities, including Subpart A State Long-Term Care Ombudsman Program). The proposed rule would make revisions to these regulations to align with the OAA as reauthorized in 2020. Current OAA regulations are more than 30 years old (issued in 1988), other than portions of 45 CFR part 1321 and 1324 regarding the State Long-Term Care Ombudsman Program, which were issued in 2015.

Statement of Need: The proposed rule would make important revisions to these regulations following the reauthorization of the Act in 2020. The majority of the current regulations associated with this Act are more than 30 years old, so updates to these regulations will allow for an overall alignment of regulations with current statutory language, related regulatory language and circumstances in the field. These regulations also provide an important opportunity to advance equity in the OAA programs as envisioned by the statute and consistent with current executive orders.

Summary of Legal Basis: Development, promulgation and implementation of regulations for OAA programs have been and will be carried out consistently with the statute. This particular regulatory action is not required by the reauthorization of the statute or court order.

Alternatives: ACL considers sub-regulatory guidance, information and education outreach, and voluntary approaches as alternatives to regulatory action. None of these alternatives are the appropriate option for promulgating and administering the provisions that will be included in the regulations consistent with statute. Economic incentives and instruments are not an option.

Anticipated Cost and Benefits: To be determined. A regulatory impact analysis is concurrently underway.

Risks: These regulations would update past and establish new regulatory provisions consistent with the reauthorization of the OAA in 2020. Promulgating this NPRM and obtaining public feedback in order to issue a new final rule will result in decreased risk for administering agencies at the federal, state and local level in ensuring the administration of the OAA programs consistent with the statute, and in also supporting the statute's purpose of reducing the risk of injury, disease, disability and institutional placement of older adults.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Local, State, Tribal.

Agency Contact: Richard Nicholls, Chief of Staff and Executive Secretary, Department of Health and Human Services, Administration for Community Living, 330 C Street SW, Room 1004B, Washington, DC 20201, Phone: 202 795-7415, Fax: 202 205-0399, Email: rick.nicholls@acl.hhs.gov.

RIN: 0985-AA17

HHS—ACL

89. • Adult Protective Services Functions and Grant Programs [0985-AA18]

Priority: Other Significant.

Legal Authority: Elder Justice Act (SSA sec. 2042. [42 U.S.C. 1397m-1] (a) Secretarial Responsibilities)

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: The proposed rule would create federal regulations for Adult Protective Services (APS) programs as authorized by the Elder Justice Act. APS programs were originally recognized by federal law in 1975 under title XX of the Social Security Act via the Social Services Block Grant (SSBG). States have wide discretion whether to allocate any funding to APS via the SSBG program, and there are no regulations pertaining to APS under SSBG. Since 1975, all 50 states, the District of Columbia, and four territories have developed APS programs in accordance with local needs, structures, and laws. Historic investments through the Coronavirus Relief and Response Supplemental Appropriations Act (CRRSA) and the American Rescue Plan Act (ARPA) provided the very first funding for APS program formula funding to states as authorized by the Elder Justice Act (EJA). These regulations would promote an effective APS response across the country so that all older adults and adults with disabilities, regardless of the state or jurisdiction in which they live, have similar protections and service delivery from APS systems.

Statement of Need: The proposed rule would create federal regulations for Adult Protective Services (APS) programs as authorized by the Elder Justice Act (EJA). These regulations are critical in establish consistent national requirements and standards for EJA APS program formula funding to states.

Summary of Legal Basis: Development, promulgation and implementation of this regulation will be carried out consistently with the statute; however, this regulatory action is not required by the statute or a court order.

Alternatives: ACL considers sub-regulatory guidance, information and education outreach, and voluntary approaches as alternatives to regulatory action. Prior to the availability of appropriations for formula funding for this program ACL utilized guidance and voluntary approach for the establishment of a national data system and in supporting the establishment and dissemination of program best practices. However, now that federal funding is available to all states and territories, none of these alternatives are the appropriate option for promulgating and administering the provisions that will be included in the regulations consistent with statute. Economic incentives and instruments are not an option.

Anticipated Cost and Benefits: To be determined. A regulatory impact analysis is concurrently underway.

Risks: These regulations would establish first ever regulations for APS programs consistent with the Elder Justice Act passed in 2010. Promulgating this NPRM and obtaining public feedback in order to issue a new final rule will result in decreased risk for administering agencies at the federal, state and local level in ensuring the administration of appropriations for APS programs consistent with the statute, and in also supporting the statute's programmatic purpose of detecting, preventing and reducing the abuse, neglect and exploitation of adults, including older adults.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: State.

Agency Contact: Richard Nicholls, Chief of Staff and Executive Secretary, Department of Health and Human Services, Administration for Community Living, 330 C Street SW, Room 1004B, Washington, DC 20201, Phone: 202 795-7415, Fax: 202 205-0399, Email: rick.nicholls@acl.hhs.gov.

RIN: 0985-AA18

DEPARTMENT OF HOMELAND SECURITY (DHS)

Fall 2022 Statement of Regulatory Priorities

The Department of Homeland Security (DHS or Department) was established in 2003 pursuant to the Homeland Security Act of 2002, Public Law 107-296. The DHS mission statement provides the following: “With honor and integrity, we will safeguard the American people, our homeland, and our values.”

DHS was created in the aftermath of the horrific attacks of 9/11, and its distinctive mission is defined by those words. The phrase “homeland security” refers to the security of the American people, the homeland (understood in the broadest sense), and the nation's defining values. A central part of the mission of protecting “our values” includes fidelity to law and the rule of law, reflected above all in the Constitution of the United States, and also in statutes enacted by Congress, including the Administrative Procedure Act. That commitment is also associated with a commitment to individual dignity. Among other things, the attacks of 9/11 were attacks on that value as well.

The regulatory priorities of DHS are founded an insistence on the rule of law—and also on a belief that individual dignity, symbolized and made real by the opening words of the Constitution (“We the People”), the separation of powers, and the Bill of Rights (including the Due Process Clause), helps to define our mission.

Fulfilling that mission requires the dedication of more than 240,000 employees in jobs that range from aviation and border security to emergency response, from cybersecurity analyst to chemical facility inspector, from the economist seeking to identify the consequences of our actions to the scientist and policy analyst seeking to make the nation more resilient against flooding, drought, extreme heat, and wildfires. Our duties are wide-ranging, but our goal is clear: keep America safe.

There are six overarching homeland security missions that make up DHS's strategic plan: (1) Counter terrorism and homeland security threats; (2) secure U.S. borders and approaches; (3) secure cyberspace and critical infrastructure; (4) preserve and uphold the Nation's prosperity and economic security; (5) strengthen preparedness and resilience (including resilience from risks actually or potentially aggravated by climate change); and (6) champion the DHS workforce and strengthen the Department. See also 6 U.S.C. 111(b)(1) (identifying the primary mission of the Department).

In promoting these goals, we attempt to evaluate our practices by reference to evidence and data, and to improve them in real time. We also attempt to deliver our multiple services in a way that, at once, protects the American people and does not impose excessive or unjustified barriers and burdens on those who use them.

In achieving those goals, we are committed to public participation and to listening carefully to the American people (and to noncitizens as well). We are continually strengthening our partnerships with communities, first responders, law enforcement, and Government agencies—at the Federal, State, local, tribal, and international levels. We are accelerating the deployment of science, technology, and innovation in order to make America more secure against risks old and new—and to perform our services better. We are becoming leaner, smarter, and more efficient, ensuring that every security resource is used as effectively as possible. We are reducing administrative burdens and simplifying our processes. For a further discussion of our mission, see the DHS website at https://www.dhs.gov/mission.

The regulations we have summarized below in the Department's Fall 2022 regulatory plan and agenda support the Department's mission. We are committed to continuing evaluation of our regulations, consistent with Executive Order 13563, and Executive Order 13707, and in a way that improves them over time. These regulations will improve the Department's ability to accomplish its mission. Also, these regulations address legislative initiatives such as the ones found in the Implementing Recommendations of the 9/11 Commission Act of 2007 (9/11 Act) and the FAA Extension, Safety, and Security Act of 2016.

We emphasize here our commitments (1) To fidelity to law; (2) to treating people with dignity and respect; (3) to increasing national resilience against multiple risks and hazards, including those actually or potentially associated with climate change; (4) to modernization of existing requirements; and (5) to reducing unjustified barriers and burdens, including administrative burdens.

DHS strives for organizational excellence and uses a centralized and unified approach to managing its regulatory resources. The Office of the General Counsel manages the Department's regulatory program, including the agenda and regulatory plan. In addition, DHS senior leadership reviews each significant regulatory project in order to ensure that the project fosters and supports the Department's mission.

The Department is committed to ensuring that all of its regulatory initiatives are aligned with its guiding principles to remain faithful to law, protect civil rights and civil liberties, integrate our actions, listen to those affected by our actions, build coalitions and partnerships, develop human resources, innovate, and be accountable to the American public.

DHS is strongly committed to the principles described in Executive Orders 13563 and 12866 (as amended). Both Executive Orders direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Executive Order 13563 explicitly draws attention to human dignity and to equity.

Finally, the Department values public involvement in the development of its regulatory plan, agenda, and regulations. It is particularly concerned with the impact its regulations have on small businesses and startups, consistent with its commitment to promoting economic growth. DHS is also concerned to ensure that its regulations are equitable, and that they do not have unintended or adverse effects on (for example) women, disabled people, people of color, or the elderly. Its general effort to modernize regulations, and to remove unjustified barriers and burdens, is meant in part to avoid harmful effects on small businesses, startups, and disadvantaged groups of multiple sorts. DHS and its components continue to emphasize the use of plain language in our regulatory documents to promote a better understanding of regulations and to promote increased public participation in the Department's regulations. We want our regulations to be transparent and “navigable,” so that people are aware of how to comply with them (and in a position to suggest improvements).

The Fall 2022 regulatory plan for DHS includes regulations from multiple DHS components, including the Federal Emergency Management Agency (FEMA), U.S. Citizenship and Immigration Services (USCIS), the U.S. Coast Guard (the Coast Guard), U.S. Customs and Border Protection (CBP), Transportation Security Administration (TSA), U.S. Immigration and Customs Enforcement (ICE), and the Cybersecurity and Infrastructure Security Agency (CISA). We next describe the regulations that comprise the DHS fall 2022 regulatory plan.

Federal Emergency Management Agency

The Federal Emergency Management Agency (FEMA) is the government agency responsible for helping people before, during, and after disasters. FEMA supports the people and communities of our Nation by providing experience, perspective, and resources in emergency management. FEMA is particularly focused on national resilience in the face of the risks of flooding, drought, extreme heat, and wildfire; it is acutely aware that these risks, and others, are actually or potentially aggravated by climate change. FEMA seeks to ensure, to the extent possible, that changing weather conditions do not mean a more vulnerable nation. FEMA is also focused on individual equity, and it is aware that administrative burdens and undue complexity might produce inequitable results in practice.

Consistent with President Biden's Executive Order on Climate Related Financial Risk (Executive Order 14030), FEMA will propose a regulation titled National Flood Insurance Program: Standard Flood Insurance Policy, Homeowner Flood Form. The National Flood Insurance Program (NFIP), established pursuant to the National Flood Insurance Act of 1968, is a voluntary program in which participating communities adopt and enforce a set of minimum floodplain management requirements to reduce future flood damages. Property owners in participating communities are eligible to purchase NFIP flood insurance. This proposed rule would revise the Standard Flood Insurance Policy by adding a new Homeowner Flood Form and five accompanying endorsements. The new Homeowner Flood Form would replace the Dwelling Form as a source of coverage for homeowners of one-to-four family residences. Together, the new Form and endorsements would more closely align with property and casualty homeowners' insurance and provide increased options and coverage in a more user-friendly and comprehensible format.

FEMA will also propose a regulation titled Individual Assistance Program Equity to further align with Executive Order 13985, Advancing Racial Equity and Support for Underserved Communities Through the Federal Government. FEMA will propose to amend its Individual Assistance (IA) regulations to increase equity and ease of entry to the IA Program. To provide a full opportunity for underserved communities to participate in the program, FEMA will propose to amend application of “safe, sanitary, and functional” for the Individuals and Households Program Home Repair assistance; re-evaluate the requirement to apply for a Small Business Administration loan prior to receipt of certain types of Other Needs Assistance; add eligibility criteria for its Serious Needs and Displacement Assistance; amend its requirements for Continued Temporary Housing Assistance; re-evaluate its approach to insurance proceeds; and amend its appeals process. FEMA will also propose revisions to reflect changes to statutory authority that have not yet been implemented in regulation, to include provisions for utility and security deposit payments, lease and repair of multi-family rental housing, child care assistance, maximum assistance limits, and waiver authority. Finally, FEMA will propose allowing self-employed individuals to receive assistance for essential tools under Other Needs Assistance, allowing certain home repair accessibility-related items, and allowing the reopening of the registration period when the President adds new counties to the major disaster declaration.

In addition, FEMA will propose a regulation titled Update of FEMA's Public Assistance Regulations. FEMA proposes to revise its Public Assistance program regulations to reflect current statutory authorities and implement program improvements. The proposed rule would incorporate changes brought about by amendments to the Robert T. Stafford Disaster Relief and Emergency Assistance Act. FEMA is also proposing clarifications and corrections to improve the efficiency and consistency of the Public Assistance program.

Additionally, FEMA will propose a regulation titled Updates to Floodplain Management and Protection of Wetlands Regulations consistent with President Biden's Executive Order on Climate Related Financial Risk (Executive Order 14030). FEMA proposes to amend its existing regulations to incorporate amendments that have been made to Executive Order 11988 and the Federal Flood Risk Management Standard (FFRMS). The FFRMS is a flexible framework allowing agencies to choose among three approaches to define the floodplain and corresponding flood elevation requirements for federally funded projects. Existing regulations describe FEMA's process for determining whether the proposed location for an action falls within a floodplain and how to complete the action in the floodplain, in light of the risk of flooding. The proposed rule would change how FEMA defines a floodplain with respect to certain actions. Additionally, under the proposed rule, FEMA would use natural systems, ecosystem process, and nature-based approaches, where practicable, when developing alternatives to locating the proposed action in the floodplain.

Finally, FEMA continues to engage with the public related to its floodplain management standards. On October 12, 2021, FEMA issued a Request for Information to receive the public's input on revising the NFIP's floodplain management standards for land management and use regulations to better align with the current understanding of flood risk and flood risk reduction approaches. FEMA's authority under the National Flood Insurance Act requires the agency to, from time to time, develop comprehensive criteria designed to encourage the adoption of adequate State and local measures. The agency is reviewing potential actions to better align the NFIP minimum floodplain management standards with FEMA's current understanding of flood risk, flood insurance premium rates, and risk reduction approaches to make communities safer, stronger, and more resilient to increased flooding. FEMA is considering revisions to the minimum standards to better protect people and property in a nuanced manner that balances community needs with the national scope of the NFIP while also incorporating opportunities for improving resilience in communities that have been historically underserved. FEMA is also considering revisions to the minimum standards that would advance the conservation of threatened and endangered species and their habitat. In response to a separate Request for Information, FEMA is also reviewing ways to further promote enhanced resilience efforts through the Community Rating System.

United States Citizenship and Immigration Services

U.S. Citizenship and Immigration Services (USCIS) is the government agency that administers the nation's lawful immigration system, safeguarding its integrity and promise by efficiently and fairly adjudicating requests for immigration benefits with integrity and respect for all we serve. To the extent permitted by law, USCIS is committed to meeting the economic needs of U.S. employers, reducing unnecessary barriers to legal immigration, increasing access to legally authorized immigration benefits, and reinvigorating the size and scope of humanitarian relief. In the coming year, USCIS intends to pursue several regulatory actions that support these goals while balancing this work with our fiscal stability goals.

Employment Issues, Economic Needs, and Lawful Pathways. USCIS is focused on promulgating policies that are responsive to the needs of the U.S. economy and U.S. employers, while providing lawful pathways to work in the United States and also protecting the rights of both U.S. and noncitizen workers. USCIS will propose a rule to modernize and reform the H-2A and H-2B programs. The proposed rule will incorporate necessary program efficiencies and meet the legitimate needs of U.S. employers; it will include provisions designed to protect against the exploitation or other abuse of H-2A and H-2B workers. ( Modernization and Reform of the H-2 Programs.)

Improvements to the Overall Immigration System. USCIS will propose adjustments to certain immigration and naturalization benefit request fees (after performing the required biennial fee review) to ensure that fees recover full costs borne by USCIS. In doing so, USCIS will adhere to the ideals of removing unjustified barriers and promoting access to the immigration system (to promote, among other things, economic needs and economic growth); improving and expanding naturalization processing; and implementing the administration's humanitarian priorities. ( USCIS Fee Schedule and Changes to Certain Other Immigration Benefit Request Requirements.) In addition, USCIS plans to take steps to reform the regulations governing the adjustment of status to lawful permanent residence to improve the efficiency and administration of that program. USCIS will propose a rule that updates outdated regulations, reduces the potential for visa retrogression, and promotes the efficient use of immediately available immigrant visas. ( Improving the Regulations Governing the Adjustment of Status to Lawful Permanent Residence and Related Immigration Benefits.) Lastly, USCIS will propose a rule to clarify and update eligibility requirements governing citizenship and naturalization. ( Citizenship and Naturalization and Other Related Flexibilities.)

Humanitarian Relief. USCIS will propose reforms to the U nonimmigrant visa classification. The U nonimmigrant status is for noncitizen victims of certain qualifying criminal activities, and their eligible family members, who have been, are, or are likely to be helpful in the investigation or prosecution of those crimes. To streamline the procedures and enhance operational efficiency, USCIS will propose a rule to update eligibility, procedural and filing requirements governing U nonimmigrant status, and adjustment of status for those nonimmigrants. ( Victims of Qualifying Criminal Activities; Eligibility Requirements for U Nonimmigrant Status and Adjustment of Status). In addition, USCIS will propose a rule to update the regulations governing self-petitions in cases where the noncitizen has been subjected to battery or extreme cruelty by their U.S. citizen spouse, parent, son, or daughter, or lawful permanent resident spouse or parent. USCIS will also propose to update the regulations to align with statutory updates made as a result of subsequent reauthorizations of the Violence Against Women Act. ( Relief Under the Violence Against Women Act of 1994 and Subsequent Legislation.)

Asylum Reforms. USCIS is focused on pursuing regulations to strengthen, rebuild, and (where appropriate) streamline the asylum system, consistent with law and mission imperatives. For example, USCIS and DOJ will take steps to remove regulatory provisions that are currently enjoined (Bars to Asylum Eligibility and Related Procedures), propose updates to clarify eligibility for asylum and withholding of removal ( Particular Social Group and Related Definitions and Interpretations for Asylum and Withholding of Removal), and propose modifications or withdrawal of other asylum-related regulatory provisions ( Security Bars and Processing).

United States Coast Guard

The Coast Guard is a military, multi-mission, maritime service of the United States and the only military organization within DHS. It is the principal Federal agency responsible for maritime safety, security, and stewardship in U.S. ports and waterways.

Effective governance in the maritime domain hinges upon an integrated approach to safety, security, and stewardship. The Coast Guard's policies and capabilities are integrated and interdependent, delivering results through a network of enduring partnerships with maritime stakeholders. Consistent standards of universal application and enforcement, which encourage safe, efficient, and responsible maritime commerce, are vital to the success of the maritime industry. The Coast Guard's ability to field versatile capabilities and highly trained personnel is one of the U.S. Government's most significant and important strengths in the maritime environment.

America is a maritime nation, and our security, resilience, and economic prosperity are intrinsically linked to the oceans. Safety, efficient waterways, and freedom of transit on the high seas are essential to our well-being. The Coast Guard is leaning forward, poised to meet the demands of the modern maritime environment. The Coast Guard creates value for the public through solid prevention and response efforts. Activities involving oversight and regulation, enforcement, maritime presence, and public and private partnership foster increased maritime safety, security, and stewardship.

The statutory responsibilities of the Coast Guard include ensuring marine safety and security, preserving maritime mobility, protecting the marine environment, enforcing U.S. laws and international treaties, and performing search and rescue. The Coast Guard supports the Department's overarching goals of mobilizing and organizing our Nation to secure the homeland from terrorist attacks, natural disasters, and other emergencies. These goals include protection against the risks associated with climate change, and the Coast Guard seeks to obtain scientific information to assist in that task, while also acting to promote resilience and adaptation.

The Coast Guard highlights the following regulatory actions:

Cybersecurity in the Marine Transportation System. The Coast Guard is proposing to update its maritime security regulations by adding cybersecurity requirements to existing regulations. This proposed rulemaking is part of an ongoing effort to address emerging cybersecurity risks and threats to maritime security by including additional security requirements to safeguard the marine transportation system.

Shipping Safety Fairways Along the Atlantic Coast. The Coast Guard published an ANPRM on June 19, 2020. The Coast Guard is reviewing comments to help develop a proposed rule that would establish shipping safety fairways along the Atlantic Coast of the United States. Fairways are marked routes for vessel traffic. They facilitate the direct and unobstructed transit of ships. The proposed fairways will be based on studies about vessel traffic along the Atlantic Coast. The Coast Guard is taking this action to ensure that obstruction-free routes are preserved to and from U.S. ports and along the Atlantic coast and to reduce the risk of collisions, allisions and grounding, as well as alleviate the chance of increased time and expenses in transit.

MARPOL Annex VI; Prevention of Air Pollution From Ships. The Coast Guard is proposing regulations to carry out the provisions of Annex VI of the MARPOL Protocol, which is focused on the prevention of air pollution from ships. The Act to Prevent Pollution from Ships has already given direct effect to most provisions of Annex VI, and the Coast Guard and the Environmental Protection Agency have carried out some Annex VI provisions through previous rulemakings. This proposed rulemaking would fill gaps in the existing framework for carrying out the provisions of Annex VI. Chapter 4 of Annex VI contains shipboard energy efficiency measures that include short-term measures reducing carbon emissions linked to climate change. This proposed rulemaking would apply to U.S.-flagged ships. It would also apply to foreign-flagged ships operating either in U.S. navigable waters or in the U.S. Exclusive Economic Zone.

United States Customs and Border Protection

Customs and Border Protection (CBP) is the Federal agency principally responsible for the security of our nation's borders, both at and between the ports of entry into the United States. CBP must accomplish its border security and enforcement mission without stifling the flow of legitimate trade and travel. The primary mission of CBP is its homeland security mission, that is, to prevent terrorists and terrorist weapons from entering the United States. An important aspect of this mission involves improving security at our borders and ports of entry, but it also means extending our zone of security beyond our physical borders.

CBP is also responsible for administering laws concerning the importation of goods into the United States and enforcing the laws concerning the entry of persons into the United States. This includes regulating and facilitating international trade; collecting import duties; enforcing U.S. trade, immigration and other laws of the United States at our borders; inspecting imports; overseeing the activities of persons and businesses engaged in importing; enforcing the laws concerning smuggling and trafficking in contraband; apprehending individuals attempting to enter the United States illegally; protecting our agriculture and economic interests from harmful pests and diseases; servicing all people, vehicles, and cargo entering the United States; maintaining export controls; and protecting U.S. businesses from theft of their intellectual property.

In carrying out its mission, CBP's goal is to facilitate the processing of legitimate trade and travel efficiently without compromising security. Consistent with its primary mission of homeland security, CBP intends to issue several regulations that are intended to improve security at our borders and ports of entry. During the upcoming year, CBP will also work on various projects to streamline CBP processing, reduce duplicative processes, reduce various burdens on the public, and automate various paper forms. CBP highlights one those projects below.

Advance Passenger Information System: Electronic Validation of Travel Documents. CBP intends to amend current Advance Passenger Information System (APIS) regulations to incorporate additional carrier requirements that would further enable CBP to determine whether each passenger is traveling with valid, authentic travel documents prior to the passenger boarding the aircraft. The proposed regulation would require commercial air carriers to receive a second message from CBP that would state whether CBP matched the travel documents of each passenger to a valid, authentic travel document recorded in CBP's databases. The proposed regulation would also require air carriers to transmit additional data elements regarding contact information through APIS for all commercial aircraft passengers arriving in the United States to support border operations and national security. CBP expects that the collection of these elements would enable CBP to further support the Center for Disease Control and Prevention's mission in monitoring and tracing the contacts for persons involved in health incidents. This action will result in time savings to passengers and cost savings to CBP, carriers, and the public.

In addition to the regulations that CBP issues to promote DHS's mission, CBP issues regulations related to the mission of the Department of the Treasury. Under section 403(1) of the Homeland Security Act of 2002, the former-U.S. Customs Service, including functions of the Secretary of the Treasury relating thereto, transferred to the Secretary of Homeland Security. As part of the initial organization of DHS, the Customs Service inspection and trade functions were combined with the immigration and agricultural inspection functions and the Border Patrol and transferred into CBP. The Department of the Treasury retained certain regulatory authority of the U.S. Customs Service relating to customs revenue function. In the coming year, CBP expects to continue to issue regulatory documents that will facilitate legitimate trade and implement trade benefit programs. For a discussion of CBP regulations regarding the customs revenue function, see the regulatory plan of the Department of the Treasury.

Transportation Security Administration

The Transportation Security Administration (TSA) protects the Nation's transportation systems to ensure freedom of movement for people and commerce. TSA applies an intelligence-driven, risk-based approach to all aspects of its mission. This approach results in layers of security to mitigate risks effectively and efficiently. In the coming fiscal year, TSA is prioritizing the following actions that are required to meet statutory mandates or that are necessary for national security.

Enhancing Surface Cyber Risk Management. TSA intends to issue a rulemaking that will permanently codify critical cybersecurity requirements for pipeline and rail modes of transportation. On January 28, 2021, the President issued the National Security Memorandum on Improving Cybersecurity for Critical Infrastructure Controls Systems. Consistent with this priority of the Administration and in response to the ongoing cybersecurity threat to surface transportation systems, TSA issued security directives to owners and operators of TSA-designated critical pipeline systems and facilities, and higher-risk rail operations (freight, passenger, and mass transit) to implement several urgently needed protections against cyber intrusions. Through these directives, TSA has imposed measures to report cybersecurity incidents; designate a cybersecurity coordinator; review current cybersecurity measures; identify and report any gaps and related remediation measures to address cyber-related risks; implement specific mitigation measures to protect against cyber-attacks; develop and implement a cybersecurity incident response plan; and develop an assessment program to proactively address and audit cybersecurity measures. TSA is committed to enhancing and sustaining cybersecurity for all modes of transportation and intends to issue a rulemaking that may codify these and other requirements.

Vetting of Certain Surface Transportation Employees. Consistent with the Implementing Recommendations of the 9/11 Commission Act of 2007, TSA will propose a rule requiring security threat assessments for security coordinators and other frontline employees of certain public transportation agencies (including rail mass transit and bus systems), railroads (freight and passenger), and over-the-road bus owner/operators. The NPRM will also propose provisions to implement TSA's statutory requirement to recover its cost of vetting through user fees. While many stakeholders conduct background checks on their employees, their actions are limited based upon the data they can access. Through this rule, TSA will be able to conduct a more thorough check against terrorist watch-lists of individuals in security-sensitive positions.

Flight Training Security Program. TSA published an interim final rule in 2004 related to flight schools. The IFR requires flight schools to notify TSA when noncitizens, and other individuals designated by TSA, apply for flight training or recurrent training. TSA subsequently issued exemptions and interpretations in response to comments on the IFR and questions raised during operation of the program since 2004. TSA published a notice reopening the comment period on May 18, 2018. Based on the comments and questions received, TSA is finalizing the rule with modifications that may include changing the frequency of security threat assessments from a high-frequency event-based interval to a time-based interval, clarify the definitions and other provisions of the rule, and enable industry to use TSA-provided electronic recordkeeping systems for all documents required to demonstrate compliance with the rule. These and other changes would provide significant cost-savings to the industry and individuals seeking flight training while also enhancing security.

Amending Vetting Requirements for Employees With Access to a Security Identification Display Area. The FAA Extension, Safety, and Security Act of 2016 mandates that TSA consider modifications to the list of disqualifying criminal offenses and criteria, develop a waiver process for approving the issuance of credentials for unescorted access, and propose an extension of the look back period for disqualifying crimes. Based on these requirements, and current intelligence pertaining to the “insider threat,” TSA will propose a rule to revise current vetting requirements to enhance eligibility requirements and disqualifying criminal offenses for individuals seeking or having unescorted access to any Security Identification Display Area of an airport.

United States Immigration and Customs Enforcement

U.S. Immigration and Customs Enforcement (ICE) is the principal criminal investigative arm of DHS and one of the three Department components charged with the criminal and civil enforcement of the Nation's immigration laws. Its primary mission is to protect national security, public safety, and the integrity of our borders through the criminal and civil enforcement of Federal law governing border control, customs, trade, and immigration. During the coming fiscal year, ICE will focus rulemaking efforts on regulations pertaining to processing improvements, including the rules mentioned below.

Immigration Bond Notifications and Electronic Service. ICE is revising regulations that authorize the means to serve decisions and other notices in-person or by mail, to include electronic and other means of service. This rule is consistent with Executive Order 14058, which directs agencies to take actions that improve service delivery and customer experience by decreasing administrative burdens, enhancing transparency, and improving the efficiency and effectiveness of government. Current regulations limit ICE to serve documents in-person, or by certified, registered, or ordinary mail, which is time consuming, inefficient, and unreliable. This interim final rule would enable ICE to issue and serve certain notices, decisions, and other documents electronically to noncitizens, parties, attorneys, or other persons of interest who voluntarily opt-in to be served electronically. The intent is to improve convenience, transparency, and provide quicker information and communication to both the public and the government.

Optional Alternative to the Physical Examination Associated With Employment Eligibility Verification (Form I-9). In August of 2022, ICE published a proposed rule that would revise employment eligibility verification regulations to allow the Secretary to authorize alternative document examination procedures in certain circumstances or with respect to certain employer. As explained in the rule, future exercises of such authority may reduce burdens on employers and employees while maintaining the integrity of the employment verification process. DHS will complete this rulemaking following review of public comments received. This rulemaking is consistent with Executive Order 14058, which directs agencies to take actions that improve service delivery and customer experience by decreasing administrative burdens, enhancing transparency, and improving the efficiency and effectiveness of government.

Cybersecurity and Infrastructure Security Agency

The Cybersecurity and Infrastructure Security Agency (CISA) is responsible for leading the national effort to develop cybersecurity and critical infrastructure security programs, operations, and associated policy to enhance the security and resilience of physical and cyber infrastructure.

Ammonium Nitrate Security Program. This rule implements a 2007 amendment to the Homeland Security Act. The amendment requires DHS to “regulate the sale and transfer of ammonium nitrate facility . . . to prevent the misappropriation or use of ammonium nitrate in an act of terrorism.” CISA published an Notice of Proposed Rulemaking in 2011. CISA is planning to issue a Supplemental Notice of Proposed Rulemaking.

Chemical Facility Anti-Terrorism Standards (CFATS). This rule would update CFATS' Risk Based Performance Standards to enhance cybersecurity requirements, modify the counting rules associated with release-flammable chemicals, remove release-explosive chemicals, and adjust the Screening Threshold Quantities of Appendix A to account for the updated risk analysis methodology. CISA previously invited public comment on an Advance Notice of Proposed Rulemaking (ANPRM) during August 2014 for potential revisions to the CFATS regulations. The ANPRM provided an opportunity for the public to provide recommendations for possible program changes. In June 2020, CISA published for public comment a retrospective analysis of the CFATS program. And in January 2021, CISA invited additional public comment through an ANPRM concerning the removal of certain explosive chemicals from CFATS. CISA intends to address many of the subjects raised in both ANPRMs and the retrospective analysis in this regulatory action, including potential updates to CFATS cybersecurity requirements and Appendix A to the CFATS regulations. CISA is planning to issue a notice of proposed rulemaking.

A more detailed description of the priority regulations that comprise the DHS regulatory plan follows

DHS—U.S. CITIZENSHIP AND IMMIGRATION SERVICES (USCIS)

Proposed Rule Stage

90. Victims of Qualifying Criminal Activities; Eligibility Requirements for U Nonimmigrant Status and Adjustment of Status [1615-AA67]

Priority: Other Significant.

Legal Authority:5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C. 1101; 8 U.S.C. 1101 (note); 8 U.S.C. 1102; Pub. L. 113-4

CFR Citation:8 CFR 214; 8 CFR 274a; 8 CFR 103; 8 CFR 299.

Legal Deadline: None.

Abstract: This proposed rule would clarify and update eligibility, procedural, and filing requirements for U nonimmigrant status (commonly known as the “U” visa) and adjustment of status for U nonimmigrants. U nonimmigrant status is for noncitizen victims of certain qualifying criminal activities who have been, are being, or are likely to be helpful in the investigation or prosecution of those crimes and eligible family members. There is a statutory limit of 10,000 U visas per year for principal petitioners. DHS published an interim final rule in 2007 (72 FR 53013) to establish the procedures to be followed in order to petition the U nonimmigrant status and published an interim final rule in 2008 (73 FR 75540) to establish the procedures for applying for adjustment of status as a U nonimmigrant, and this rule would address relevant comments and stakeholder feedback received since publication of those interim final rules, as well as update the regulations for changes in legislation.

Statement of Need: This regulation is necessary to allow noncitizen victims of certain crimes to petition for U nonimmigrant status and to adjust status to that of a lawful permanent resident. The U classification is for noncitizen victims of certain qualifying criminal activities who have been, are being, or are likely to be helpful in the investigation or prosecution of those crimes. This rule would address the eligibility requirements that must be met for classification as a U nonimmigrant and implements statutory amendments to these requirements, streamlines the procedures to petition for U nonimmigrant status, provides evidentiary guidance to assist in the petition process, and clarifies adjustment of status requirements.

Summary of Legal Basis: This regulation is necessary to allow noncitizen victims of certain crimes to petition for U nonimmigrant status and to adjust status to that of a lawful permanent resident. The U classification is for noncitizen victims of certain qualifying criminal activities who have been, are, or are likely to be helpful in the investigation or prosecution of those crimes. This rule would address the eligibility requirements that must be met for classification as a U nonimmigrant and implements statutory amendments to these requirements, streamlines the procedures to petition for U nonimmigrant status, provides evidentiary guidance to assist in the petition process, and clarifies adjustment of status requirements.

Anticipated Cost and Benefits: DHS is currently considering the specific cost and benefit impacts of the proposed provisions.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Federal, Local, State.

Additional Information: Transferred from RIN 1115-AG39.

URL For More Information: www.regulations.gov.

URL For Public Comments: www.regulations.gov.

Agency Contact: Rena Cutlip-Mason, Chief, Division of Humanitarian Affairs, OP&S, Department of Homeland Security, U.S. Citizenship and Immigration Services, 5900 Capital Gateway Drive, Camp Springs, MD 20746, Phone: 240 721-3000.

RIN: 1615-AA67

DHS—USCIS

91. Improving the Regulations Governing the Adjustment of Status to Lawful Permanent Residence and Related Immigration Benefits [1615-AC22]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Unfunded Mandates: Undetermined.

Legal Authority:8 U.S.C. 1101; 8 U.S.C. 1103(a); 8 U.S.C. 1153 to 1155; 8 U.S.C 1160; 8 U.S.C 1254a; 8 U.S.C. 1255 and 1324a; . . .

CFR Citation:8 CFR 204.5; 8 CFR 204.12; 8 CFR 205.1; 8 CFR 209.1; 8 CFR 209.2; 8 CFR 244.15; 8 CFR 245.1; 8 CFR 245.2; 8 CFR 245.5; 8 CFR 245.11; 8 CFR 245.15; 8 CFR 245.18; 8 CFR 249.2; 8 CFR 264.2; 8 CFR 274a.12; . . .

Legal Deadline: None.

Abstract: The Department of Homeland Security (DHS) proposes to amend its regulations governing adjustment of status to lawful permanent residence in the United States. The proposed changes include permitting concurrent filing of a visa petition and the application for adjustment of status for the employment-based 4th preference (certain special immigrants) category, including religious workers; permitting the transfer of underlying basis of a pending adjustment of status application; amending the definition relating to ineligibilities under section 245(c) of the INA; changing the age calculation under the Child Status Protection Act; and authorizing employment authorization for certain derivative beneficiaries waiting for immigrant visa availability when they present compelling circumstances. DHS also proposes to amend the regulations relating to temporary protected status and travel authorization and the impact on the adjustment of status eligibility. The intent of these proposed changes is to reduce processing times, improve the quality of inventory data provided to partner agencies, reduce the potential for visa retrogression, and promote the efficient use of immediately available immigrant visas.

Statement of Need: This rulemaking is necessary to address outdated regulations and to improve the efficiency and the administration of the adjustment of status of immigrants to lawful permanent residence in the United States, improve the quality of inventory data that DHS provides to agencies, reduce the potential for visa retrogression, and promote the efficient use of immediately available immigrant visas. This proposed rule would revise travel authorization regulations for temporary protected status beneficiaries and clarify the impact on adjustment of status eligibility. This rule also changes eligibility requirements for certain classifications for what constitutes compelling circumstances for employment authorization.

Anticipated Cost and Benefits: DHS is currently considering the specific cost and benefit impacts of the proposed provisions.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

Agency Contact: Mark Phillips, Residence and Naturalization Division Chief, Department of Homeland Security, U.S. Citizenship and Immigration Services, Office of Policy and Strategy, 5900 Capital Gateway Drive, Suite 4S190, Camp Springs, MD 20588-0009, Phone: 240 721-3000.

RIN: 1615-AC22

DHS—USCIS

92. Particular Social Group and Related Definitions and Interpretations for Asylum and Withholding of Removal [1615-AC65]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Unfunded Mandates: Undetermined.

Legal Authority:8 U.S.C. 1101(a)(42); 8 U.S.C. 1158; 8 U.S.C. 1225; 8 U.S.C. 1231 and 1231 (note); E.O. 14010; 86 FR 8267 (Feb. 2, 2021)

CFR Citation:8 CFR 2; 8 CFR 208; 8 CFR 1208.

Legal Deadline: None.

Abstract: This rule proposes to amend Department of Homeland Security (DHS) and Department of Justice (DOJ) (collectively, “the Departments”) regulations that govern eligibility for asylum and withholding of removal. The amendments focus on portions of the regulations that deal with the definitions of membership in a particular social group and the interpretation of various other elements of eligibility for asylum, including some that are often determinative in particular social group claims, such as the requirements for failure of State protection, and determinations about whether persecution is on account of a protected ground. The rule will also propose to modify or rescind portions of the Procedures for Asylum and Withholding of Removal; Credible Fear and Reasonable Fear Review final rule (RINs 1125-AA94 and 1615-AC42). This rule is consistent with Executive Order 14010 of February 2, 2021, which directs the Departments to promulgate joint regulations, consistent with applicable law, addressing the circumstances in which a person should be considered a member of a particular social group.

Statement of Need: The Departments propose this rule to clarify standards governing numerous elements of eligibility for asylum, withholding of removal under section 241(b)(3) of the Immigration and Nationality Act, and protection from removal under the regulations that implement U.S. obligations in immigration cases under Article 3 of the Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment. The rule proposes to rescind certain provisions of the Procedures for Asylum and Withholding of Removal; Credible Fear and Reasonable Fear Review final rule, which had addressed many of the same issues. See 85 FR 80274. The previous rule was the subject of multiple suits challenging the rule on numerous procedural and substantive grounds, and was preliminarily enjoined before it became effective. Pangea Legal Servs. v. U.S. Dep't of Homeland Sec., 512 F. Supp. 3d 966, 977 (N.D. Cal. 2021). In some circumstances the Departments have decided to republish changes made in the Global Asylum Rule without amendment. The purpose of doing so is to remedy any alleged procedural deficiencies with the enactment of those provisions. In other instances, the Departments now propose different provisions with the goal of adopting clearer and simpler analyses that would reduce burdens on adjudicators and applicants, and result in more consistent and accurate adjudications. The Departments believe that the existing standards governing these issues have become confusing, overly complex, and subject to inconsistent interpretations among adjudicators and across federal circuit courts on numerous issues. The Departments propose this rule to rectify these problems.

Anticipated Cost and Benefits: DHS is currently considering the specific cost and benefit impacts of the proposed provisions.

Timetable:

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Rena Cutlip-Mason, Chief, Division of Humanitarian Affairs, OP&S, Department of Homeland Security, U.S. Citizenship and Immigration Services, 5900 Capital Gateway Drive, Camp Springs, MD 20746, Phone: 240 721-3000.

Related RIN: Related to 1615-AC42, Related to 1125-AB13, Related to 1125-AA94

RIN: 1615-AC65

DHS—USCIS

93. U.S. Citizenship and Immigration Services Fee Schedule and Changes to Certain Other Immigration Benefit Request Requirements [1615-AC68]

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority:8 U.S.C. 1356(m), (n)

CFR Citation:8 CFR 103; 8 CFR 106.

Legal Deadline: None.

Abstract: DHS will propose to adjust the fees charged by U.S. Citizenship and Immigration Services (USCIS) for immigration and naturalization benefit requests. On August 3, 2020, DHS adjusted the fees USCIS charges for immigration and naturalization benefit requests, imposed new fees, revised certain fee waiver and exemption policies, and changed certain application requirements via the rule “USCIS Fee Schedule & Changes to Certain Other Immigration Benefit Request Requirements.” DHS has been preliminarily enjoined from implementing that rule by court order. This rule would rescind and replace the changes made by the August 3, 2020, rule and establish new USCIS fees to recover USCIS operating costs.

Statement of Need: USCIS projects that its costs of providing immigration adjudication and naturalization services will exceed the financial resources available to it under its existing fee structure. DHS proposes to adjust the USCIS fee structure to ensure that USCIS recovers the costs of meeting its operational requirements.

The CFO Act requires each agency's chief financial officer to “review, on a biennial basis, the fees, royalties, rents, and other charges imposed by the agency for services and things of value it provides, and make recommendations on revising those charges to reflect costs incurred by it in providing those services and things of value.”

Summary of Legal Basis: INA 286(m) and (n), 8 U.S.C. 1356(m) and (n), authorize the Attorney General and Secretary of Homeland Security to recover the full cost of providing immigration adjudication and naturalization services by establishing and collecting fees deposited into the Immigration Examinations Fee Account.

Anticipated Cost and Benefits: DHS is currently considering the specific cost and benefit impacts of the proposed provisions.

Timetable:

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations.

Government Levels Affected: None.

Agency Contact: Kika Scott, Chief Financial Officer, Department of Homeland Security, U.S. Citizenship and Immigration Services, 5900 Capital Gateway Drive, Suite 4S190, Camp Springs, MD 20588-0009, Phone: 240 721-3000.

RIN: 1615-AC68

DHS—USCIS

94. Bars to Asylum Eligibility and Related Procedures [1615-AC69]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Legal Authority: Homeland Security Act of 2002, Pub. L. 107-296, 116 Stat. 2135, sec. 1102, as amended; 8 U.S.C. 1103(a)(1); 8 U.S.C. 1103(a)(3); 8 U.S.C. 1103(g); 8 U.S.C. 1225(b); 8 U.S.C. 1231(b)(3) and 1231 (note); 8 U.S.C. 1158

CFR Citation:8 CFR 208; 8 CFR 235; 8 CFR 1003; 8 CFR 1208; 8 CFR 1235.

Legal Deadline: None.

Abstract: In 2020, the Department of Homeland Security and Department of Justice (collectively, the Departments) published final rules amending their respective regulations governing bars to asylum eligibility and procedures, including the Procedures for Asylum and Bars to Asylum Eligibility (RINs 1125-AA87 and 1615-AC41), 85 FR 67202 (Oct. 21, 2020), and Asylum Eligibility and Procedural Modifications (RINs 1125-AA91 and 1615-AC44), 85 FR 82260 (Dec. 17, 2020), final rules. The Departments will propose to modify or rescind the regulatory changes promulgated in these two final rules consistent with Executive Order 14010 (Feb. 2, 2021).

Statement of Need: The Departments are reviewing these regulations in light of the issuance of Executive Order 14010 and Executive Order 14012. This rule is needed to restore and strengthen the asylum system and to address inconsistencies with the goals and principles outlined in Executive Order 14010 and Executive Order 14012.

Anticipated Cost and Benefits: The Departments are currently considering the specific cost and benefit impacts of the proposed provisions.

Timetable:

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Rena Cutlip-Mason, Chief, Division of Humanitarian Affairs, OP&S, Department of Homeland Security, U.S. Citizenship and Immigration Services, 5900 Capital Gateway Drive, Camp Springs, MD 20746, Phone: 240 721-3000.

Related RIN: Related to 1125-AA87, Split from 1615-AC41, Related to 1125-AA91, Related to 1615-AC44, Related to 1125-AB12

RIN: 1615-AC69

DHS—USCIS

95. Modernization and Reform of the H-2 Programs [1615-AC76]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Unfunded Mandates: Undetermined.

Legal Authority:8 U.S.C. 1103(a)(3); 8 U.S.C. 1001(a)(15)(H)(ii)(a) and (b); 8 U.S.C. 1184(a), (c) and (g)

CFR Citation:8 CFR 214; 8 CFR 274a.

Legal Deadline: None.

Abstract: DHS plans to issue a notice of proposed rulemaking that will modernize and reform the H-2A and H-2B nonimmigrant worker programs. DHS will propose to incorporate policies that produce program efficiencies, address current aspects of the program that may unintentionally result in exploitation or other abuse of persons seeking to come to this country as H-2A and H-2B workers, build upon existing protections against prohibited payments or other assessment of fees and/or salary deductions by H-2A and H-2B workers in connection with recruitment and/or employment, and otherwise add protections for workers. This rule would not revise the temporary labor certification process or the regulations contained in 20 CFR part 655 or 29 CFR part 501 and 503.

Statement of Need: This rulemaking is needed to enhance protections for workers and better ensure the integrity of the H-2A and H-2B programs. In addition, this proposed rule is necessary to improve H-2 program efficiencies and remove certain barriers to program access.

Summary of Legal Basis: The Immigration and Nationality Act (INA) charges the Secretary of Homeland Security with the administration and enforcement of the immigration laws and provides that the Secretary shall establish such regulations and perform such other acts as he deems necessary for carrying out his authority under the INA. See INA section 103(a)(1),(3), 8 U.S.C. 1103(a)(1), (3). In addition, the Homeland Security Act of 2002, also charges the Secretary with establishing and administering rules governing the granting of visas or other forms of permission to enter the United States to individuals who are not a citizen, or an alien lawfully admitted for permanent residence in the United States. SeePublic Law 107-296, 116 Stat. 2135, 6 U.S.C. 202(4). With respect to nonimmigrants in particular, the INA provides that the admission to the United States of any alien as a nonimmigrant shall be for such time and under such conditions as the Secretary may by regulations prescribe. See INA section 214(a)(1), 8 U.S.C. 1184(a)(1). The INA also tasks DHS with approving petitions filed by the importing employers of nonimmigrants, including those in the H nonimmigrant visa classification, before a nonimmigrant visa may be granted. See INA section 214(c)(1), 8 U.S.C. 1184(c)(1).

Anticipated Cost and Benefits: DHS is currently considering the specific cost and benefit impacts of the proposed provisions.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

Agency Contact: Charles Nimick, Chief, Business and Foreign Workers Division, Office of Policy and Strategy, Department of Homeland Security, U.S. Citizenship and Immigration Services, 5900 Capital Gateway Drive, Suite 4S190, Camp Springs, MD 20588-0009, Phone: 240 721-3000.

RIN: 1615-AC76

DHS—USCIS

96. • Citizenship and Naturalization and Other Related Flexibilities [1615-AC80]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Unfunded Mandates: Undetermined.

Legal Authority: sec. 102 of the Homeland Security Act of 2002; 6 U.S.C. 112(a)(3); 8 U.S.C. 1101; 8 U.S.C. 1103; 8 U.S.C. 1151; 8 U.S.C. 1153; 8 U.S.C. 1154; 8 U.S.C. 1159; 8 U.S.C. 1182; 8 U.S.C. 1255; 8 U.S.C. 1401; 8 U.S.C. 1409; 8 U.S.C. 1421; 8 U.S.C. 1423; 8 U.S.C. 1427; 8 U.S.C. 1429 to 1431; 8 U.S.C. 1433; 8 U.S.C. 1435; 8 U.S.C. 1438 to 1440; 8 U.S.C. 1443; 8 U.S.C. 1445 to 1449; 8 U.S.C. 1452; 8 U.S.C. 1454; 8 U.S.C. 1481

CFR Citation:8 CFR 1.2; 8 CFR 103; 8 CFR 106; 8 CFR 204; 8 CFR 209; 8 CFR 245; 8 CFR 300; 8 CFR 306; 8 CFR 312; 8 CFR 316; 8 CFR 318; 8 CFR 319; 8 CFR 320; 8 CFR 322; 8 CFR 324; 8 CFR 329; 8 CFR 333; 8 CFR 334; 8 CFR 335; 8 CFR 336; 8 CFR 337; 8 CFR 338; 8 CFR 339; 8 CFR 341; 8 CFR 343a; 8 CFR 349; . . .

Legal Deadline: None.

Abstract: The Department of Homeland Security (DHS) will propose to amend its regulations governing citizenship and naturalization. This includes clarifying the testing requirements, updating eligibility requirements, and proposing amendments to clarify definitions. DHS will also propose removing certain outdated provisions and amending other provisions to align with current statutory framework, such as updating the adoption-related regulatory provisions consistent with the Intercountry Adoption Universal Accreditation Act of 2012.

Statement of Need: These proposed changes, some of which were requested by the public, are needed to improve the efficiency, effectiveness, accessibility, uniformity, and consistency of adjudications.

Anticipated Cost and Benefits: DHS is currently considering the specific cost and benefit impacts of the proposed provisions.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

Agency Contact: Mark Phillips, Residence and Naturalization Division Chief, Department of Homeland Security, U.S. Citizenship and Immigration Services, Office of Policy and Strategy, 5900 Capital Gateway Drive, Suite 4S190, Camp Springs, MD 20588-0009, Phone: 240 721-3000.

RIN: 1615-AC80

DHS—USCIS

97. • Relief Under the Violence Against Women Act of 1994 and Subsequent Legislation [1615-AC81]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Unfunded Mandates: Undetermined.

Legal Authority: 8.U.S.C. 1103; 8 U.S.C. 1154; 8 U.S.C. 1155; 8 U.S.C. 1182; 8 U.S.C. 1183a; 8 U.S.C. 1186; 8 U.S.C. 1324a; 8 U.S.C. 1225; 8 U.S.C. 1255; . . .

CFR Citation:8 CFR 103; 8 CFR 204; 8 CFR 205; 8 CFR 213a; 8 CFR 216; 8 CFR 245; 8 CFR 274a; . . .

Legal Deadline: None.

Abstract: This proposed rule would amend regulations governing self-petitions for immigrant classification and related relief available to certain spouses, children, and parents who have been subjected to battery or extreme cruelty by their U.S. citizen spouses, parents, sons, or daughters, or lawful permanent resident spouses or parents. DHS also proposes to amend regulations governing petitions to remove conditions on permanent residence in which conditional permanent residents (CPR) request a waiver of the joint filing requirement due to battery or extreme cruelty by their U.S. citizen or lawful permanent resident (LPR) spouses or parents.

Statement of Need: The Violence Against Women Act of 1994 (VAWA) provides noncitizens who have been abused by their U.S. citizen or lawful permanent resident relative the ability to independently petition for themselves for immigrant classification without the abuser's knowledge, consent, or participation in the immigration process. Current VAWA regulations, which were codified to implement the Immigration Act of 1990 and the Violence Against Women Act of 1994, were published in the Federal Register on May 16, 1991, and March 26, 1996. Subsequently, Congress has reauthorized VAWA through the Victims of Trafficking and Violence Protection Act of 2000, the Violence Against Women and Department of Justice Reauthorization Act of 2005 and the Violence Against Women and Department of Justice Reauthorization Act of 2005 Technical Amendments, and the Violence Against Women Reauthorization Act of 2013. This rule is necessary to update USCIS regulations to comport with these subsequent reauthorizations of VAWA. The amendments contained in this proposed rule would reflect the subsequent legislative enactments and incorporate current USCIS policy.

Anticipated Cost and Benefits: DHS is currently considering the specific cost and benefit impacts of the proposed provisions.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

Agency Contact: Rena Cutlip-Mason, Chief, Division of Humanitarian Affairs, OP&S, Department of Homeland Security, U.S. Citizenship and Immigration Services, 5900 Capital Gateway Drive, Camp Springs, MD 20746, Phone: 240 721-3000.

RIN: 1615-AC81

DHS—USCIS

Final Rule Stage

98. Security Bars and Processing [1615-AC57]

Priority: Other Significant.

Legal Authority: Illegal Immigration Reform and Immigrant Responsibility Act of 1996 (“IIRIRA”), Pub. L. 104-208, 110 Stat. 3009, sec. 604(a) (codified at INA 208(b)(2)(C), 8 U.S.C. 1158(b)(2)(C)); INA 241(b)(3)(B), 8 U.S.C. 1231(b)(3)(B); Foreign Affairs Reform and Restructuring Act (“FARRA”), Pub. L. 105-277, 112 Stat. 2681-822, sec. 2242 (1998); INA 235(b), 8 U.S.C. 1225(b)

CFR Citation:8 CFR 208; 8 CFR 1208.

Legal Deadline: None.

Abstract: On December 23, 2020, DHS and the DOJ (collectively, the Departments) published a final rule to clarify that the danger to the security of the United States statutory bar to eligibility for asylum and withholding of removal encompasses certain emergency public health concerns and make certain other changes. As of December 28, 2021, the rule's effective date was delayed to December 31, 2022. The Departments plan to further delay the effective date and to propose modification or withdrawal of the December 23, 2020, rule.

Statement of Need: The Departments are reviewing and reconsidering whether the Security Bars and Processing final rule is consistent with the goals of ensuring the safe and orderly reception and processing of asylum seekers consistent with public health and safety, with the additional context of the complex relationship between the Procedures for Asylum and Withholding of Removal; Credible Fear and Reasonable Fear Review final rule (RINs 1125-AA94 and 1615-AC42) and the Security Bars rule. The Departments are reevaluating whether the Security Bars rule provides the most appropriate and effective framework for achieving its goals of mitigating the spread of communicable diseases, including COVID-19, among certain noncitizens in the credible fear screening process, as well as DHS personnel and the public. Based on such reconsideration, the Departments will publish rules to delay the effective date of the Security Bars rule and propose to modify or withdraw the Security Bars rule.

Anticipated Cost and Benefits: DHS is currently considering the specific cost and benefit impacts of the proposed provisions.

Timetable:

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

URL For More Information: www.regulations.gov.

URL For Public Comments: www.regulations.gov.

Agency Contact: Ashley Caudill-Mirillo, Acting Asylum Division, Office of Refugee, Asylum, and International Operations, Department of Homeland Security, U.S. Citizenship and Immigration Services, 5900 Capital Gateway Drive, Camp Springs, MD 20746, Phone: 240 721-3000.

Related RIN: Related to 1125-AB08, Related to 1615-AC69

RIN: 1615-AC57

DHS—U.S. COAST GUARD (USCG)

Proposed Rule Stage

99. Cybersecurity in the Marine Transportation System [1625-AC77]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Legal Authority:46 U.S.C. 70101; 46 U.S.C. 70102; 46 U.S.C. 70104; 46 U.S.C. 70124; . . .

CFR Citation:33 CFR 101; . . .

Legal Deadline: None.

Abstract: The Coast Guard proposes to update its maritime security regulations by adding cybersecurity requirements to existing Maritime Security regulations in 33 CFR part 101 et seq. This proposed rulemaking is part of an ongoing effort to address emerging cybersecurity risks and threats to maritime security by including additional security requirements to safeguard the marine transportation system.

Statement of Need: The purpose of this rulemaking is to set minimum cybersecurity requirements for vessels and facilities to safeguard the Marine Transportation System (MTS) from cybersecurity vulnerabilities.

Summary of Legal Basis: The Coast Guard exercises the Maritime Transportation Security Act of 2002 (MTSA) authorities of Chapter 701 of Title 46 of the U.S. Code. This includes the authority to promulgate Chapter 701 regulations under 46 U.S.C. 70124. This statute provides that the DHS Secretary may issue regulations necessary to implement Chapter 701 of Title 46.

Anticipated Cost and Benefits: The regulatory analysis for the proposed rule is still being developed.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Agency Contact: Frank Strom, Chief, Systems Engineering Division (CG-ENG-3), Department of Homeland Security, U.S. Coast Guard, Office of Design and Engineering Standards, 2703 Martin Luther King Jr. Avenue SE, STOP 7509, Washington, DC 20593-7509, Phone: 202 372-1375, Email: frank.a.strom@uscg.mil.

RIN: 1625-AC77

DHS—USCG

100. MARPOL Annex VI; Prevention of Air Pollution From Ships [1625-AC78]

Priority: Other Significant.

Legal Authority:33 U.S.C. 1903

CFR Citation:33 CFR 151.

Legal Deadline: None.

Abstract: The Coast Guard is proposing regulations to carry out the provisions of Annex VI of the MARPOL Protocol, which is focused on the prevention of air pollution from ships. The Act to Prevent Pollution from Ships has already given direct effect to most provisions of Annex VI, and the Coast Guard and the Environmental Protection Agency have carried out some Annex VI provisions through previous rulemakings. This proposed rule would fill gaps in the existing framework for carrying out the provisions of Annex VI. Chapter 4 of Annex VI contains shipboard energy efficiency measures that include short-term measures reducing carbon emissions linked to climate change and supports Administration goals outlined in Executive Order 14008 titled Tackling the Climate Crisis at Home and Abroad. This proposed rule would apply to U.S.-flagged ships. It would also apply to foreign-flagged ships operating either in U.S. navigable waters or in the U.S. Exclusive Economic Zone.

Statement of Need: The Coast Guard is proposing regulations to carry out the provisions of Annex VI of the MARPOL Protocol, which is focused on the prevention of air pollution from ships. The Act to Prevent Pollution from Ships has already given direct effect to most provisions of Annex VI, and the Coast Guard and the Environmental Protection Agency have carried out some Annex VI provisions through previous rulemakings. This proposed rule would fill gaps in the existing framework for carrying out the provisions of Annex VI and explain how the United States has chosen to carry out certain discretionary aspects of Annex VI. This proposed rule would apply to U.S.-flagged ships. And it would also apply to foreign-flagged ships operating in U.S. navigable waters or in the U.S. Exclusive Economic Zone.

Summary of Legal Basis: Section 4 of the Act to Prevent Pollution from Ships (Pub. L. 96-478, Oct. 21, 1980, 94 Stat 2297), as reflected in 33 U.S.C. 1903, directs the Secretary of Homeland Security to prescribe any necessary or desired regulations to carry out the provisions of the MARPOL Protocol. The “MARPOL Protocol” is defined in 33 U.S.C. 1901 and includes Annex VI of the International Convention for the Prevention of Pollution from Ships, 1973.

Anticipated Cost and Benefits: USCG anticipates the costs for the proposed rule to come primarily from additional labor for 5 requirements including overseeing surveys; developing and maintaining a fuel-switching procedure; recording various data during each fuel switching; developing and managing a Volatile organic compounds (VOC) management plan; crew member to calculate and report the attained Energy Efficient Design Index (EEDI) of the vessel, and crew member to develop and maintain the Ship Energy Efficiency Management Plan (SEEMP). USCG expects the proposed rule to have unquantified benefits from reduction in fatalities and injuries due to pollutant in engine emissions, and also reduced risk of retaliation due to breaching international agreement.

Timetable:

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Federalism: Undetermined.

Agency Contact: Frank Strom, Chief, Systems Engineering Division (CG-ENG-3), Department of Homeland Security, U.S. Coast Guard, Office of Design and Engineering Standards, 2703 Martin Luther King Jr. Avenue SE, STOP 7509, Washington, DC 20593-7509, Phone: 202 372-1375, Email: frank.a.strom@uscg.mil.

RIN: 1625-AC78

DHS—U.S. CUSTOMS AND BORDER PROTECTION (USCBP)

Proposed Rule Stage

101. Advance Passenger Information System: Electronic Validation of Travel Documents [1651-AB43]

Priority: Other Significant.

Legal Authority:49 U.S.C. 44909; 8 U.S.C. 1221

CFR Citation:19 CFR 122.

Legal Deadline: None.

Abstract: U.S. Customs and Border Protection (CBP) regulations require commercial air carriers to electronically transmit passenger information to CBP's Advance Passenger Information System (APIS) prior to an aircraft's arrival in or departure from the United States. CBP proposes to amend these regulations to incorporate additional carrier requirements that will enable CBP to validate each passenger's travel documents prior to the passenger boarding the aircraft. This proposed rule would also require air carriers to transmit additional data elements through APIS for all commercial aircraft passengers arriving in the United States in order to support border operations and national security. The collection of additional data elements will support the efforts of the Centers for Disease Control, within the Department of Health and Human Services, to monitor and contact-trace health incidents. This rule is consistent with Executive Order 14058, which directs agencies to take actions that improve service delivery and customer experience by decreasing administrative burdens, enhancing transparency, and improving the efficiency and effectiveness of government.

Statement of Need: Current regulations require U.S. citizens and foreign travelers entering and leaving the United States via air travel to submit travel documents containing biographical information, such as a passenger's name and date of birth. For security purposes, CBP compares the information on passengers' documents to various databases and the terrorist watch list through APIS. While in the case of security threats CBP may require an air carrier to deny boarding to the passenger. CBP recommends that air carriers deny boarding to those likely to be deemed inadmissible upon arrival in the United States. To further improve CBP's vetting processes with respect to identifying and preventing passengers with fraudulent or improper documents from traveling to or leaving the United States, CBP proposes to require carriers to receive from CBP a message that would state whether CBP matched the travel documents of each passenger to a valid, authentic travel document prior to departure to the United States from a foreign port or place or departure from the United States. The proposed rule also would require carriers to submit passenger contact information while in the United States to CBP through APIS. Submission of such information would enable CBP to identify and interdict individuals posing a risk to border, national, and aviation safety and security more quickly. Collecting these additional data elements would also enable CBP to further assist CDC to monitor and trace the contacts of those involved in serious public health incidents upon CDC request. Additionally, the proposed rule would allow carriers to include the aircraft tail number in their electronic messages to CBP and make technical changes to conform with current practice.

Anticipated Cost and Benefits: The proposed rule would result in costs to CBP, air carriers, and passengers for additional time spent coordinating to resolve a passenger's status should there be a security issue upon checking in for a flight. In addition, CBP will incur costs for technological improvements to its systems. CBP, air carriers, and passengers would benefit from reduced passenger processing times during customs screening. Unquantified benefits would result from greater efficiency in passenger processing pre-flight, improved national security, and fewer penalties for air carriers following entry denial of a passenger.

Timetable:

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Robert Neumann, Program Manager, Office of Field Operations, Department of Homeland Security, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW, Washington, DC 20229, Phone: 202 412-2788, Email: robert.m.neumann@cbp.dhs.gov.

RIN: 1651-AB43

DHS—TRANSPORTATION SECURITY ADMINISTRATION (TSA)

Prerule Stage

102. Enhancing Surface Cyber Risk Management [1652-AA74]

Priority: Other Significant.

Legal Authority:49 U.S.C. 114

CFR Citation:49 CFR 1570.

Legal Deadline: None.

Abstract: On July 28, 2021, the President issued the National Security Memorandum on Improving Cybersecurity for Critical Infrastructure Control Systems. In response to the ongoing threat to pipeline systems, TSA used its authority under 49 U.S.C. 114 to issue emergency security directives to owners and operators of TSA-designated critical pipelines that transport hazardous liquids and natural gas to implement a number of urgently needed protections against cyber intrusions. TSA also issued security directives in the freight, passenger, and transit-rail sectors under the same statutory authority. TSA is committed to enhancing and sustaining industry's resilience to cybersecurity attacks. TSA intends to issue a rulemaking that will permanently codify critical cybersecurity requirements for pipeline and rail modes.

Statement of Need: This rulemaking is necessary to address the ongoing cybersecurity threat to U.S. transportation modes.

Anticipated Cost and Benefits: TSA is in the process of determining the costs and benefits of this rulemaking.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Agency Contact: Victor Parker, Chief, Policy Development Section, Surface Division, Department of Homeland Security, Transportation Security Administration, Policy, Plans and Engagement, 6595 Springfield Center Drive, Springfield, VA 20598-6028, Phone: 571 227-3664, Email: victor.parker@tsa.dhs.gov.

James Ruger, Chief Economist, Economic Analysis Branch-Coordination & Analysis Division, Department of Homeland Security, Transportation Security Administration, Policy, Plans, and Engagement, 6595 Springfield Center Drive, Springfield, VA 20598-6028, Phone: 571 227-5519, Email: james.ruger@tsa.dhs.gov.

David Kasminoff, Senior Counsel, Regulations and Security Standards, Department of Homeland Security, Transportation Security Administration, Chief Counsel's Office, 6595 Springfield Center Drive, Springfield, VA 20598-6002, Phone: 571 227-3583, Email: david.kasminoff@tsa.dhs.gov.

RIN: 1652-AA74

DHS—TSA

Proposed Rule Stage

103. Vetting of Certain Surface Transportation Employees [1652-AA69]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Unfunded Mandates: Undetermined.

Legal Authority:49 U.S.C. 114; Public Law 108-90, sec. 520; Pub. L. 110-53, secs. 1411, 1414, 1512, 1520, 1522, and 1531

CFR Citation: Not Yet Determined.

Legal Deadline: Other, Statutory, August 3, 2008, Background and immigration status check for all public transportation frontline employees is due no later than 12 months after date of enactment. Sections 1411 and 1520 of Public Law 110-53, Implementing Recommendations of the 9/11 Commission Act of 2007 (9/11 Act), (121 Stat. 266, Aug. 3, 2007), require background checks of frontline public transportation and railroad employees not later than one year from the date of enactment. Requirement will be met through regulatory action.

Abstract: The 9/11 Act requires vetting of certain railroad, public transportation, and over-the-road bus employees. Also, 6 U.S.C. 469 requires TSA to collect fees to recover the costs of the vetting services. Through this rulemaking, the Transportation Security Administration (TSA) intends to propose the standards and procedures to conduct the required vetting and recover costs. This regulation is related to 1652-AA55, Security Training for Surface Transportation Employees.

Statement of Need: Employee vetting is an important and effective tool for averting or mitigating potential attacks by those with malicious intent who may target surface transportation and plan or perpetrate actions that may cause significant injuries, loss of life, or economic disruption.

Anticipated Cost and Benefits: The vetting of freight rail, public transportation, and over-the-road bus employees covered under the rule will result in costs to TSA and to industry. TSA is proposing to establish fees to recover vetting costs. TSA also anticipates ancillary costs ( e.g., updating contact information, compliance inspections) associated with compliance with the rule. Anticipated benefits include reducing security risks by identifying and/or mitigating potential insider threats through vetting.

Timetable:

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses.

Government Levels Affected: Local.

URL For More Information: www.regulations.gov.

URL For Public Comments: www.regulations.gov.

Agency Contact: Victor Parker, Chief, Policy Development Section, Surface Division, Department of Homeland Security, Transportation Security Administration, Policy, Plans and Engagement, 6595 Springfield Center Drive, Springfield, VA 20398-6028, Phone: 571 227-3664, Email: victor.parker@tsa.dhs.gov.

James Ruger, Chief Economist, Economic Analysis Branch-Coordination & Analysis Division, Department of Homeland Security, Transportation Security Administration, Policy, Plans, and Engagement, 6595 Springfield Center Drive, Springfield, VA 20598-6028, Phone: 571 227-5519, Email: james.ruger@tsa.dhs.gov.

Christine Beyer, Senior Counsel, Regulations and Security Standards, Department of Homeland Security, Transportation Security Administration, Chief Counsel's Office, 6595 Springfield Center Drive, Springfield, VA 20598-6002, Phone: 571 227-3653, Email: christine.beyer@tsa.dhs.gov.

Related RIN: Related to 1652-AA55, Related to 1652-AA56

RIN: 1652-AA69

DHS—TSA

104. Amending Vetting Requirements for Employees With Access to a Security Identification Display Area (SIDA) [1652-AA70]

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Unfunded Mandates: Undetermined.

Legal Authority:Pub. L. 114-190, sec. 3405

CFR Citation:49 CFR 1542.209; 49 CFR 1544.229.

Legal Deadline: Final, Statutory, January 11, 2017, Rule for individuals with unescorted access to any Security Identification Display Area (SIDA) due 180 days after date of enactment. Section 3405 of title III of the FAA Extension, Safety, and Security Act of 2016 (FESSA) Extension, Public Law 114-190 (130 Stat. 615, July 15, 2016), requires the Transportation Security Administration (TSA) to revise the regulations issued under 49 U.S.C. 44936 within 180 days after the date of enactment.

Abstract: As required by the FESSA, TSA will propose a rule to revise its regulations, reflecting current knowledge of insider threat and intelligence, to enhance the eligibility requirements and disqualifying criminal offenses for individuals seeking or having unescorted access to any SIDA of an airport. Consistent with the statutory mandate, TSA will consider adding to the list of disqualifying criminal offenses and criteria, develop an appeal and waiver process for the issuance of credentials for unescorted access, and propose an extension of the lookback period for disqualifying crimes. As part of TSA's reevaluation of the eligibility and redress standards for aviation workers required by the Act, TSA is also reevaluating the current vetting process to minimize any security risks that may exist.

Statement of Need: Employee vetting is an important and effective tool for averting or mitigating potential attacks by those with malicious intent who wish to target aviation and plan or perpetrate actions that may cause significant injuries, loss of life, or economic disruption. Enhancing eligibility standards for airport workers will improve transportation and national security.

Anticipated Cost and Benefits: TSA anticipates costs associated with implementing and administering revised aspects of aviation vetting including potential changes to the list of disqualifying criminal offenses, the lookback period for convictions, and new waiver eligibility. Anticipated benefits include reducing security risks through enhanced vetting of aviation workers while also providing greater flexibility and access through waivers as well as increased efficiencies of the vetting process.

Timetable:

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

Agency Contact: Kevin Knott, Branch Manager, Airports Policy Branch-Aviation Division, Department of Homeland Security, Transportation Security Administration, Policy, Plans, and Engagement, 6595 Springfield Center Drive, Springfield, VA 20598-6028, Phone: 571 227-4370, Email: kevin.knott@tsa.dhs.gov.

James Ruger, Chief Economist, Economic Analysis Branch-Coordination & Analysis Division, Department of Homeland Security, Transportation Security Administration, Policy, Plans, and Engagement, 6595 Springfield Center Drive, Springfield, VA 20598-6028, Phone: 571 227-5519, Email: james.ruger@tsa.dhs.gov.

Christine Beyer, Senior Counsel, Regulations and Security Standards, Department of Homeland Security, Transportation Security Administration, Chief Counsel's Office, 6595 Springfield Center Drive, Springfield, VA 20598-6002, Phone: 571 227-3653, Email: christine.beyer@tsa.dhs.gov.