[Federal Register Volume 85, Number 67 (Tuesday, April 7, 2020)]
[Notices]
[Pages 19494-19495]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07247]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission to OMB for 
Review and Approval; Public Comment Request; AIDS Drug Assistance 
Program Data Report ADR, OMB No. 0915-0345--Revision

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

ACTION: Notice.

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SUMMARY: In compliance with of the Paperwork Reduction Act of 1995, 
HRSA has 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.

DATES: Comments on this ICR should be received no later than May 7, 
2020.

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 30-day 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 Lisa Wright-Solomon, the 
HRSA Information Collection Clearance Officer at [email protected] or 
call (301) 443-1984.

SUPPLEMENTARY INFORMATION:
    Information Collection Request Title: AIDS Drug Assistance Program 
Data Report (ADAP) OMB No. 0915-0345--Revisions.
    Abstract: HRSA's Ryan White HIV/AIDS Program AIDS Drug Assistance 
Program (RWHAP ADAP) is authorized under Part B of the RWHAP 
legislation, codified in sections 2611 et seq. of the Public Health 
Service Act, which provides grants to U.S. states and territories. 
HRSA's 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. HRSA's RWHAP ADAP funds may 
also be used to purchase health insurance 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 several changes to the ADR Recipient and Client 
Reports to improve question clarity, delete obsolete data elements, 
combine related data elements, add new data elements, and improve 
response options to reflect program practices and support HRSA's 
analysis and understanding of program impact. In addition, a new 
initiative,

[[Page 19495]]

Ending the HIV Epidemic: A Plan for America (EHE), began in Fiscal Year 
2020 and some of its data collection requirements will be incorporated 
in existing annual data collections, including the ADR, in order to 
limit recipient burden. Specifically, the Recipient Report includes the 
following proposed changes:
     Addition of two new ``Yes/No'' questions
     addition of one new follow-up question that requests the 
number of new clients enrolled
     addition of one question on funding to monitor the use of 
funds provided to ADAPs for the EHE initiative
     clarification on two existing questions
     revision to one existing question that requests program 
income and manufacturer rebates reinvested in ADAP, and
     deletion of six obsolete data elements.
    The Client Report includes the following proposed changes:
     Revision to reporting of RWHAP ADAP-funded medications to 
include all medications rather than a subset of medications;
     revision to one existing question that requests reporting 
of all RWHAP ADAP-funded medications using the National Drug Code from 
the Drug Identification Code (d-codes);
     revision to reporting of clinical data for clients to 
include all clients rather than a subset of clients; and
     deletion of three data elements that were combined with 
other existing data elements.
    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 December 
3, 2019, vol. 84, No. 232; pp. 66202-03. There were two public 
comments. Both comments were requests to clarify the data reporting 
changes, which included requests for a copy of the ADR instrument.
    Need and Proposed Use of the Information: HRSA's RWHAP requires the 
submission of annual reports by the Secretary of Department of Health 
and Human Services to the appropriate committees of Congress. HRSA uses 
the ADR to evaluate the national impact of the HRSA RWHAP ADAP by 
providing 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 HRSA RWHAP ADAP, to monitor the use of 
HRSA RWHAP ADAP funds in addressing the HIV epidemic and its impact on 
vulnerable 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.

                                    Total Estimated Annualized Burden--Hours
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                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
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Recipient Report................              54               1              54               6             324
Client-Level Report.............              54               1              54              81           4,374
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    Total.......................            * 54  ..............              54  ..............           4,698
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Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-07247 Filed 4-6-20; 8:45 am]
BILLING CODE 4165-15-P