Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Integrated Viral Hepatitis Surveillance and Prevention Funding for Health Departments (CDC-RFA-PS21-2103)” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on July 14, 2023, to obtain comments from the public and affected agencies. CDC received one non-substantive comment related to the 60-day Federal Register notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.

Proposed Project

Integrated Viral Hepatitis Surveillance and Prevention Funding for Health Departments (CDC-RFA-PS21-2103) (OMB Control No. 0920-1353, Exp. 11/30/2024)—Revision—National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Centers for Disease Control and Prevention (CDC) requests 3-year OMB approval for the Extension of an information collection request (ICR) package (OMB #0920-1353 Exp. Date 11/30/2024). CDC is authorized under section 318 of the Public Health Service Act (42 U.S.C. 247c) to collect information on viral hepatitis (VH) prevention and control projects.

In 2021, CDC implemented activities under a new cooperative agreement Integrated Viral Hepatitis Surveillance and Prevention Funding for Health Departments (CDC-RFA-PS21-2103). Tools exist to prevent new cases of hepatitis A, hepatitis B, and hepatitis C, to treat people living with hepatitis B, and to cure people living with hepatitis C. Yet, new cases of VH continue to rise, many people infected with VH remain undiagnosed, and far too many VH-related deaths occur in the U.S. each year. The purpose of these activities is to enable state and local health departments to collect data to evaluate disease burden and trends and to analyze and disseminate that data to develop or refine recommendations, policies, and practices that will ultimately reduce the burden of VH in their jurisdictions. The goals of the activities are to reduce new VH infections, VH-related morbidity and mortality, and VH-related disparities and to establish comprehensive national VH surveillance, which are in accordance with the Division of Viral Hepatitis 2025 Strategic Plan. In addition, the cooperative agreement supports VH elimination planning in these jurisdictions and maximize access to testing, treatment, and prevention services for populations at high risk for VH (including service provision in in high-impact settings).

The activities of this cooperative agreement include three components. Component 1: Surveillance and Component 2: Prevention contain six strategies: 1.1, develop, implement, and maintain a plan to rapidly detect and respond to outbreaks for hepatitis A, B, and C; 1.2, collect, analyze, interpret, and disseminate data to characterize trends, and implement public health interventions for hepatitis A, acute hepatitis B and acute and chronic hepatitis C; 1.3 (contingent on available funding), collect, analyze, interpret, and disseminate data to characterize trends and implement public health interventions for chronic hepatitis B and perinatal hepatitis C; 2.1, support VH elimination planning and surveillance, and maximize access to testing, treatment, and prevention; 2.2 (contingent on available funding), increase access to HCV and HBV testing and referral to care in high-impact settings; and 2.3 (contingent on available funding), improve access to services preventing VH among persons who inject drugs. Contingent on funding, a third, optional component (Component 3: Special Projects) will support improved access to prevention, diagnosis, and treatment of viral, bacterial, and fungal infections related to drug use in settings disproportionately affected by drug use.

In 2023, CDC will also fund health department recipients to implement additional activities through supplemental funding. These activities relate to increasing access to VH testing and linkage to care in high-impact settings. Specific activities include increasing routine VH testing in high-impact settings; providing counseling, linkage to treatment, and referral to prevention services in high-impact settings; and building public health laboratory capacity. These activities are similar to activities described in the cooperative agreement for Component 3 but provide additional funding to health department recipients to expand/increase these services in their jurisdictions.

Performance measures are monitored to assess recipient performance, including quality of data, effective program implementation, and accountability of funds. Data collection via the Annual Performance Report is used for program accountability and to inform performance improvement.

Outbreak reporting is submitted throughout the year. These data are a key component of national VH surveillance and are critical to determining both the level of VH activity within a jurisdiction as well as the effectiveness of each jurisdiction's approach to cluster and outbreak response. Required activities of this project include developing, implementing, and maintaining a plan to rapidly detect and respond to outbreaks for hepatitis A, hepatitis B, and hepatitis C and to report and notify CDC of outbreaks within 5 business days of identifying the outbreak. Timely reporting of clusters and outbreaks is essential to ensuring that recipients have the assistance they need to implement a prompt and effective response.

In the first three years of this cooperative agreement, health department recipients worked toward establishing a jurisdictional framework to respond to VH-related outbreaks; assessed public health reporting of chronic and perinatal hepatitis C and chronic hepatitis B infection, and undetectable hepatitis C RNA and hepatitis B DNA laboratory results; increased engagement with community partners in elimination planning across their jurisdiction; and increased the level of hepatitis testing services in a variety of setting types (including linkage to care and treatment for individuals diagnosed with VH).

With the data submitted through the Annual Performance Report data collection forms in Years 1-3, CDC assessed the progress of jurisdictions in meeting the deliverables of CDC-RFA-PS21-2103. Additionally, CDC developed and provided annual feedback reports to recipients to summarize progress made toward meeting the overarching objectives of the funding award which include: establishment of comprehensive national VH surveillance, reduced new VH infections, increased access to care for persons with VH, improved health outcomes for people with VH, reduced deaths among people with VH, reduced VH-related health disparities and decreased overdose deaths. Specifically, jurisdictions reported developing VH outbreak response plans and elimination plans and serving persons who inject drugs, including number of clients tested for hepatitis B and hepatitis C and number of clients vaccinated against hepatitis A and hepatitis B.

CDC requests OMB approval for an estimated 245 annual burden hours. There is no cost to respondents other than their time.