0906-0022 - HAB - HIVQM - Supporting Statement A - 09232025

Health Resources and Services Administration

Supporting Statement A

HRSA Ryan White HIV/AIDS Program HIV Quality Measures Module, OMB No. 0906-0022 - Revision

A. Justification

1. Circumstances Making the Collection of Information Necessary

The Health Resources and Services Administration (HRSA) is requesting continued OMB approval to collect information for the Ryan White HIV/AIDS Program’s (RWHAP) HIV Quality Measures (HIVQM) Module. The RWHAP HIVQM Module, which expires on October 31, 2025, is a voluntary data system that allows grant recipients funded under RWHAP Parts A, B, C, and D to monitor their performance in providing quality HIV services. The RWHAP legislation, title XXVI of the Public Health Service Act, 42 U.S.C. 300ff-11, et seq., is administered by HRSA’s HIV/ AIDS Bureau (HAB). The RWHAP provides a comprehensive system of HIV primary medical care, medications, and essential support service for over half a million low-income people with HIV.¹

Title XXVI of the PHS Act RWHAP Parts A – D establishes requirements for clinical quality management (CQM). RWHAP recipients must follow statutory CQM requirements to assess the extent to which HIV health services provided to patients under the grant are consistent with the most recent Federally Approved Clinical Practice Guidelines for HIV/AIDS; and develop strategies for ensuring that such services are consistent with the guidelines for improvement in the access to and quality of HIV services.² The performance measure portfolio focuses on:

1. Identifying core performance measures that are most critical to the care and treatment of people with HIV.

2. Combining performance measures to address people of all ages with HIV.

3. Identifying relevant performance measures used in other federal programs.

4. Archiving performance measures that are no longer consistent with Department of Health and Human Services Clinical Treatment guidelines or applicable to the general population.³

HRSA performance measures include several priority performance measures categories: 1) core, 2) all ages, 3) adolescent/adult, 4) pediatric HIV, 5) HIV-exposed children, 6) medical case management, 7) oral health, 8) AIDS Drug Assistance Program, and 9) systems-level.⁴ Recipients can enter their performance measures data into the RWHAP HIVQM Module and generate reports to assess their efforts and trend performance measure data over time and analyze them for disparities in care. Recipients can also compare performance measures to other recipients who also entered data into the RWHAP HIVQM Module.

HRSA HAB proposes the following modifications to bring the ICR into alignment with Administration priorities: 

• "Gender" will be removed and replaced with "Sex at Birth." 

• The available response options are: “Male”, “Female”, “Unknown” 

  • Unknown is a response option used when sex information is not provided by the provider or is unavailable in the provider's data submission. This category distinguishes missing or undisclosed data from reported sex data, preserving data integrity and transparency.

2. Purpose and Use of Information Collection

HAB created the RWHAP HIVQM Module as an online tool to support recipients in meeting the clinical quality management program requirement. The use of the module is voluntary for RWHAP recipients and subrecipients but strongly encouraged.

The RWHAP HIVQM Module provides recipients an easy-to-use and structured platform to regularly monitor their performance serving their clients served through the RWHAP. The main purpose of the module is to help recipients set goals and monitor performance measures and their quality improvement projects. HRSA acknowledges that the RWHAP HIVQM Module will better support clinical quality management, performance measurement, service delivery, and client monitoring at both the recipient and client levels. The module also provides HRSA with a better assessment of the quality of the services provided by RWHAP and monitors improvements in the HAB performance measures over time.

3. Use of Improved Information Technology and Burden Reduction

The RWHAP HIVQM Module is available in an online environment where recipients can enter various data required for agencies funded by the Ryan White HIV/AIDS Program, including the Ryan White HIV/AIDS Program Services Report (RSR). Users must obtain access to this system for purposes beyond the use of the RWHAP HIVQM Module. In addition, some information, particularly the provider information, is pre-populated using data from the organization’s RSR. Data entered is saved for the next data collection so that users can easily update or change their data. See Attachment A for the RWHAP HIVQM Module Manual.

4. Efforts to Identify Duplication and Use of Similar Information

The RWHAP HIVQM Module is an optional tool that recipients may choose to enter their performance measures data into and generate reports to assess their performance. Per the RWHAP statutory requirement to establish clinical quality management programs, recipients may also be already collecting this data for this purpose.

Recipients report on some clinical data elements electronically through the required RSR, OMB control #0906-0039, and the AIDS Drug Assistance Program Data Report (ADR), OMB control #0915-0345, annually; however, this information provides recipients and HAB only a snapshot of the quality of HIV services provided.

5. Impact on Small Businesses or Other Small Entities

This information collection includes small entities; however, this activity does not impose a significant impact on such entities. To minimize the burden of small entities, entering performance measure data and using the RWHAP HIVQM Module is entirely voluntary, and the information being requested has been held to the absolute minimum required for the intended use of the data.

6. Consequences of Collecting the Information Less Frequently

The RWHAP HIVQM Module is a voluntary data collection. However, for organizations to appropriately assess their performance measures, HAB recommends that they collect their data quarterly, at a minimum.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

The data will be collected in a manner fully consistent with the guidelines in 5 CFR 1320.5.

8. Comments in Response to the Federal Register Notice/Outside Consultation

Section 8A

A 60-day notice was published in the Federal Register on June 3, 2025, Volume 90, No. 105, pages 23532-33. There were no comments on the collection. There was one request for clarification about the nature of the revisions in the collection. Therefore, the 30-day FRN has language explaining the changes to the collection.

A 30-day notice was published in the Federal Register on November 19, 2025, Volume 90, No. 221, pages 52078-79.

Section 8B:

A pilot with fewer than 10 respondents that tested submitting performance measure data into the RWHAP HIVQM Module was conducted in January 2025. All respondents reported no issues with the process, and one noted that their workflow had improved due to the ability to import data instead of relying on manual entry. Despite no reported issues, the overall burden slightly increased from the previously submitted package in 2022, mostly due to the increase in the estimated number of respondents.

9. Explanation of any Payment/Gift to Respondents

Respondents will not receive any payments or gifts.

10. Assurance of Confidentiality Provided to Respondents

The HIVQM Module does not require any information that could identify individual clients. Aggregate data on the number of clients who received services is collected, but client names or other personally identifiable information is not collected

11. Justification for Sensitive Questions

No questions of a sensitive nature are asked in the RWHAP HIVQM Module.

12. Estimates of Annualized Hour and Cost Burden

The Module is a voluntary data collection and is open for 2,063 recipients and subrecipients four times a year: March, June, September, and December. During the pilot of the RWHAP HIVQM Module, respondents’ estimated burden averaged 14 minutes to submit their data. The total burden is 1,925 hours.

12A. Estimated Annualized Burden Hours

Type of Respondent	Form Name	No. of Respondents	No. Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours
HIVQM Report	2,063	4	8,252	14/60	1,925

12B. Estimated Annualized Burden Costs

Type of Respondent	Total Burden Hours	Hourly Wage Rate (x2)	Total Respondent Costs
Data Administrators	1,925	$100.60	$193,655
Total			$193,655

Hourly Wage Rate for Database Administrators, based on the United States Department of Labor, Bureau of Labor Statistics (https://data.bls.gov/oes/#/industry/000000). Hourly wage doubled to account for benefits.

13. Estimates of other Total Annual Cost Burden to Respondents or Recordkeepers/Capital Costs

Other than their time, there is no other annual cost burden to respondents.

14. Annualized Cost to Federal Government

HRSA has maintained a contract to provide technical assistance, distribute the OMB-approved HRSA Ryan White HIV/AIDS Program HIV Quality Measures forms, and perform data entry and analysis. For 2025, this contract value was $1,816,103.00. In addition, government personnel require 10% time of one (1) FTE at a GS-14 level 6 at $24,935 to review and prepare award notices. Wage has been multiplied by 1.5 to account for overhead costs. The total annual cost is $1,841,038.

15. Explanation for Program Changes or Adjustments

The current estimated time for submitting inventory is 13 minutes. This includes data collection, data cleaning, and entering data into the RWHAP HIVQM Module. This request proposes an increase in average burden per response to 14 minutes, adding one minute to the reported burden from 2022. The reason for the slight difference in average burden per response is that different pilot groups are used each time a pilot is conducted, except for AETCs (which are consistently the same). Pilot respondents did not report any issues or concerns regarding the process of entering data into the RWHAP HIVQM Module. Additionally, the time spent on data collection and cleaning is not included in the current burden estimation, as this data already exists for other purposes.

16. Plans for Tabulation, Publication, and Project Time Schedule

The information collected will not be published, tabulated, or manipulated by HRSA or any other entity. The purpose of this data collection is to give RWHAP recipients and subrecipients the ability to calculate their performance measures by entering a denominator that represents the number of clients/patients who should receive specific care or service and a numerator that represents the number of clients/patients who received the care or service during a 12-month period. Recipients and subrecipients can then create their own reports for the purposes of evaluating their program and/or comparing their data with other organizations regionally and nationally.

The RWHAP HIVQM Module will be available to RWHAP recipients and subrecipients to enter annual data four times a year. Below is the schedule specifying the annual period.

HIVQM Module Opens	HIVQM Module Closes	Measurement Year/ Period
March 1st	March 31st	January 1st – December 31st
June 1st	June 30th	April 1st – Mar 31st
September 1st	September 30th	July 1st – June 30th
December 1st	December 31st	Oct 1st – Sept 30th

17. Reason(s) Display of OMB Expiration Date is Inappropriate

The OMB number and expiration date will be displayed on every page of every form/instrument.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

This information collection fully complies with the guidelines in 5 CFR 1320.9. The necessary certifications are included in the package.

1 HRSA. Ryan White HIV/AIDS Program Report 2023. https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/2023-ryan-white-annual-data-report.pdf. Published December 2024. Accessed March 25, 2022.

2 See Sections 2604(h)(5), 2618(b)(3)(E), 2664(g)(5), and 2671(f)(2) of the PHS Act.

3 Performance Measure Portfolio | HIV/AIDS Bureau (hrsa.gov). Accessed July 27, 2022.

4 Ibid.