Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; HRSA AIDS Drug Assistance Program Data Report

AGENCY:

Health Resources and Services Administration (HRSA), Department of Health and Human Services.

ACTION:

Notice.

SUMMARY:

In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

DATES:

Comments on this ICR must be received no later than March 2, 2023.

ADDRESSES:

Written 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 Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:

To request a copy of the clearance requests submitted to OMB for review, email Samantha Miller, the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call 301-594-4394.

SUPPLEMENTARY INFORMATION:

Information Collection Request Title: HRSA AIDS Drug Assistance Program Data Report, OMB No. 0915-0345 Revision.

Abstract: HRSA's Ryan White HIV/AIDS Program (RWHAP) AIDS Drug Assistance Program (ADAP) is authorized under Part B of the RWHAP legislation, codified in sections 2611 to 2631 of the Public Health Service Act, which provides grants to U.S. states and territories. RWHAP ADAP is a state and territory-administered program that provides Food and Drug Administration-approved medications to low-income people with HIV who have limited or no health coverage from private insurance, Medicaid, or Medicare. RWHAP ADAP funds may also be used to purchase health care coverage for eligible clients and for services that enhance access, adherence, and monitoring of drug treatments.

All 50 states, the District of Columbia, Puerto Rico, Guam, the U.S. Virgin Islands, and the five U.S. Pacific Territories or Associated Jurisdictions receive RWHAP Part B grant awards, including funds for RWHAP ADAP. RWHAP Part B reporting requirements include the annual submission of an ADAP Data Report (ADR), including a Recipient Report and a Client Report. The Recipient Report is a collection of basic information about grant recipient characteristics and policies including program administration, purchasing mechanisms, funding, and expenditures. The Client Report is a collection of client-level records (one record for each client enrolled in the RWHAP ADAP), which includes the client's encrypted unique identifier, basic demographic data, enrollment information, services received, and clinical data.

HRSA is proposing two revisions and one re-installment of questions to the ADR Recipient and Client Reports to reflect program practices and support HRSA's analysis and understanding of program impact. Specifically, the Recipient Report includes the following proposed changes:

• Replacement of the Recertification Date variable with the Last Date of Eligibility Confirmation will remove the previous 6 month recertification requirement, which is no longer required by policy, see Policy Clarification Notice 21-02, and allow Recipients to report the latest eligibility confirmation date for existing clients;
• Reinstate a question that was inadvertently removed from the 2021 ADR that is needed to assess the quality of medication data; and
• Change the Data Universal Numbering System (DUNS) number variable to Unique Entity Identifier. On April 4, 2022, the federal government stopped using DUNs numbers, making it less burdensome for entities to do business with the federal government. As a result, Recipients no longer have to report the DUNs number in the ADR.

HRSA does not anticipate these proposed revisions resulting in a change in the reporting burden. New and revised data elements require reporting of information that should already be collected by recipients to meet legislative or programmatic requirements for the proper oversight and administration of the program.

A 60-day notice was published in the Federal Register on November 9, 2022 (Vol. 87, No. 216, pp. 67702-03). No comments were received.

Need and Proposed Use of the Information: RWHAP requires the submission of annual reports by the Secretary of Health and Human Services to the appropriate committees of Congress. HRSA uses the ADR to evaluate the national impact of the RWHAP ADAP by providing deidentified client-level data on individuals being served, services being delivered, and costs associated with these services. The client-level data is used to monitor health outcomes of people with HIV receiving care and treatment through the RWHAP ADAP, to monitor the use of RWHAP ADAP funds in addressing the HIV epidemic and its impact on communities, and to track progress toward achieving the goals identified in the National HIV/AIDS Strategy.

Likely Respondents: State ADAPs of RWHAP Part B recipients.

Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.

HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.