Non-Substantive Change Memo 0915-0345 12232025

5600 Fishers Lane

Rockville, MD 20857

DATE: December 30, 2025

TO: Dan Cline, Desk Officer, Office of Management and Budget

FROM: Samantha Miller, Information Collection Clearance Officer, Office of Planning, Analysis and Evaluation, Health Resources and Services Administration

______________________________________________________________________________

Request: The Health Resources and Services Administration (HRSA) HIV/AIDS Bureau (HAB) requests approval for changes to the HRSA AIDS Drug Assistance Program (ADAP) Data Report, OMB No. 0915-0345 Revision.

Purpose: HRSA’s Ryan White HIV/AIDS Program (RWHAP) 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 and certification information, details on medication and/or health care coverage assistance received (including associated costs), and HIV clinical information. 

HRSA is proposing three revisions to the ADR Recipient and Client Reports. These revisions are necessary to comply with Executive Order 14168, Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government (January 2025), and/or to streamline data collection for RWHAP recipients.

This memo explains the changes and supporting rationale.

Changes: 1. No longer collecting GenderID in client-level file

2. Adding a response option to sex at birth to allow for “unknown” values

3. Combining two distinct response options (“Full Premium Payment” and “Partial Premium Payment”) for  InsuranceAssistanceTypeId  into one new category “Full or Partial Premium Payment”

Time Sensitivity: The changes to data collection must be completed promptly to ensure their inclusion in the Fiscal Year 2026 ADAP ADR collection form. Approval of these changes is needed as soon as possible, to allow for updates to the form and modifications to the data collection application system used by RWHAP recipients and providers for their annual data submissions.

Burden: The changes outlined here do not alter the estimated reporting burden for RWHAP providers. This burden is expected to remain consistent with the approved Notice of Office of Management and Budget Action (NOA) dated February 01, 2023.

PROPOSED CLARIFICATIONS AND NON-SUBSTANTIVE CHANGES:

Table A

Instrument	Variable	Change implemented	Rationale
HRSA HAB’s AIDS Drug Assistance Program (ADAP) Data Report (ADR) Changes – 2025	Gender	Remove variable	Alignment with EO 14168 (January 2025).
HRSA HAB’s AIDS Drug Assistance Program (ADAP) Data Report (ADR) Changes – 2025	Sex-at-birth	Add “Unknown” to the response option	Provide reporters with an option to respond when information is missing or unknown.
HRSA HAB’s AIDS Drug Assistance Program (ADAP) Data Report (ADR) Changes – 2025	Insurance Assistance Type	Combining two distinct response options	Clarify and simplify the response option.

Attachments:

1. HRSA HAB’s AIDS Drug Assistance Program (ADAP) Data Report (ADR) Changes – 2025