Supporting Statement A_06172024

Supporting Statement A

HRSA Ryan White HIV/AIDS (RWHAP) Core Medical Services Waiver Request Attestation Form

OMB Control No. 0906-0065

Terms of Clearance: For revisions, extensions, or reinstatements list terms of clearance here. Explain how the terms of clearance are addressed in the submission. If there were no terms of clearance, please state “None”.

None.

A. Justification

1. Circumstances Making the Collection of Information Necessary

The Ryan White HIV/AIDS Treatment Extension Act of 2009, Part A section 2604(c), Part B section 2612(b), and Part C section 2651(c) requires recipients to expend not less than 75 percent of grant funds on core medical services after reserving statutorily permissible amounts for administrative and clinical quality management (CQM) costs. The Secretary has the authority to waive this requirement for a recipient if 1) there are no waiting lists for the AIDS Drug Assistance Program (ADAP), and 2) core medical services are available to all individuals identified and eligible for the RWHAP in the recipient’s service area. Approved RWHAP Part A, Part B, and Part C core medical services waivers are effective for one grant year.

In September 2021, a package was approved under OMB Control No. 0906-0065 that simplified the process for requesting a waiver of the core medical services expenditure amount requirement. Instead of sending multiple documents to make a waiver request, recipients now submit a one-page “HRSA RWHAP Core Medical Services Waiver Request Attestation Form” to HRSA. This is a revision package for this collection.

However, on the current version of the form, the portion of HIV service dollars to be allocated to core medical and support services was sometimes unclear. Therefore, this revision package proposes modifying the current one-page form to include the proposed percentages of HIV service dollars allocated to core medical and support services. Under the proposed changes, a field will be added to the form to capture the proposed percentages. This information will inform HRSA whether recipients are able to meet the statutory requirements in sections 2604(c), 2612(b), and 2651(c) of the Public Health Service Act and will clarify what proposed portion of funds will be allocated to core medical and support services. Minor changes will also be made to the form to increase readability.

The process for RWHAP Parts A, B, and C grant recipients to request a waiver of the minimum expenditure amount requirements for core medical services is outlined in Policy Notice 21-01, Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure Requirement. Policy Notice 21-01 is currently being revised and will be effective October 1, 2024. Please note that clearance for Policy Notices is handled through a separate process. However, a copy of the current version of the Policy Notice is included as Attachment 1 under Supporting Documentation.

2. Purpose and Use of Information Collection

HRSA uses the documentation submitted in core medical services waiver requests to determine if the applicant/grant recipient meets the statutory requirements for waiver eligibility including: (1) No waiting lists for AIDS Drug Assistance Program (ADAP) services; and (2) evidence of core medical services availability within the grant recipient’s jurisdiction, state, or service area to all people identified with HIV and eligible under Title XXVI of the PHS Act. See sections 2604(c)(2), 2612(b)(2), and 2651(c)(2) of the PHS Act.

HRSA anticipates receiving approximately 23 applications a year from recipients, including state, local, or tribal governments, as well as for-profit businesses, and not-for-profit institutions.

Without the collected information, HRSA cannot determine if the applicant/grant recipient meets the statutory requirements set forth above, and thus cannot grant any such waiver in accordance with the PHS Act.

3. Use of Improved Information Technology and Burden Reduction

All respondents submit electronically. The data collection request is one-page in length and requires a signature to attest to the statutory requirements being met. Burden for recipients is minimal and has decreased from an estimated average of four burden hours per response to 0.49. The decrease is likely due to familiarity and ease of use with the data collection instrument. Forms will be made 508-complaint after OMB approves the updated form.

4. Efforts to Identify Duplication and Use of Similar Information

HRSA uses the documentation submitted in core medical services waiver requests to determine if the applicant/grant recipient meets the statutory requirements. There are no similar collections for this information.

5. Impact on Small Businesses or Other Small Entities

All respondents submit electronically. The data collection request is one-page in length and requires respondents to attest to meeting the statutory requirements.

No small businesses are involved in this data collection.

6. Consequences of Collecting the Information Less Frequently

Without the collected information, HRSA will not be able to determine if the applicant/grant recipient meets the statutory requirements for waiver eligibility including: (1) no waiting lists for AIDS Drug Assistance Program (ADAP) services; and (2) evidence of core medical services availability within the relevant service area to all people with identified HIV and eligible under Title XXVI of the PHS Act. See sections 2604(c)(2), 2612(b)(2), and 2651(c)(2) of the PHS Act. HRSA needs the collected information to grant any such waiver in accordance with the statutory requirements.

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

The request fully complies with the regulation.

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

Section 8A:

HRSA published a 60-day Federal Register Notice in the Federal Register on February 27,2024, vol. 89 No. 39; pp. 14507-08. There were no public comments. HRSA published a 30-day Federal Register Notice in the Federal Register on June 25, 2024, vol. 89, No. 122, pp. 53110-11.

Section 8B:

HRSA utilized a contractor in 2024 to complete the Burden Statement Pilot. Entities contacted were Ryan White HIV/AIDS Program (RWHAP) Part A, Part B and Part C recipients. The consultant reached out to nine recipients by email and/or telephone to inquire about potential challenges submitting the information requested in the data collection instrument (the form), the estimated time to complete the form, the estimated burden in hours as well as additional information related to their experience populating the form.

Responses from the estimated burden indicated there are no issues with the changes made to the form, the form is easy to complete compared to the prior requirement that was lengthy, and the information is easy to retrieve.

No problems were noted to the data collection instrument during the collection of estimated burden.

9. Explanation of any Payment/Gift to Respondents

Respondents will not receive any payments or gifts.

10. Assurance of Confidentiality Provided to Respondents

Data will be kept private to the extent required by law.

11. Justification for Sensitive Questions

There is no sensitive data included in the information request.

12. Estimates of Annualized Hour and Cost Burden

12A. Estimated Annualized Burden Hours

HRSA anticipates that the number of grant recipients requesting waivers (utilizing the OMB approved form) to fluctuate annually. Requests have been as high as 23 per year since its implementation in FY 2007. For the purposes of the burden estimates, we will use the maximum number of annual responses as the estimated number of responses in case we get the same number of requests in the future.

The form requires less than 1 hour to complete per respondent; therefore, the burden is displayed as a decimal (0.49). The burden estimates include the time for reviewing instructions, searching existing data sources to gather two estimated percentages, and signing the form. The individual or entity completing the form must submit the form electronically in the HRSA supported Electronic Handbook (EHB). All grant reporting requirements for HRSA are submitted through the EHB.

The estimated annualized burden hours for respondents varies by the type of grant recipient. The burden response indicated some states and municipalities experience more burden when providing the information. This could be due to staff vacancies and new staff who are less familiar with the statute and the data collection instrument. Burden responses varied from an estimated five minutes to three and a half burden hours. The average burden per respondent was calculated by dividing the total estimated burden reported by all respondents in the pilot study described in 8B by the number of total respondents.

Type of Respondent	Form Name	No. of Respondents	No. Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours
Program Directors	RWHAP Core Medical Services Waiver Request Attestation Form	23	1	0.49	11.27
Total		23	1	0.49	11.27

12B.

Chief Executives, occupational code 11-1011, are required to sign and submit the waivers (the form). The median hourly wage is $93.20 for Chief Executives and the total cost per respondent including overhead cost is $2,100.73.

Estimated Annualized Burden Costs

Type of Respondent	Total Burden Hours	Hourly Wage Rate (x2)	Total Respondent Costs
Chief Executives	11.27	$186.40	$2,100.73
Total	11.27	$186.40	$2,100.73

Hourly Wage Rate based on the United States Department of Labor, Bureau of Labor Statistics https://www.bls.gov/oes/2019/may/oes111011.htm. 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 cost to respondents.

14. Annualized Cost to Federal Government

The contract task that supports this collection is for approximately $ 3,708.20 per year.

Government personnel require 10% time of 23 full-time employees at a GS-14, step 1 level (Washington-Baltimore-Arlington, DC-MD-VA-WV-PA General Schedule locality region) to perform data entry, review, processing of the waiver requests and notifying the Ryan White HIV/AIDS Program Grant Recipient. The wage multiplied by 1.5 to account for overhead costs is $480,912.75. The waiver reviews occur once per year.

The total cost to the federal government is $484,620.95, rounded up to $484,621.

15. Explanation for Program Changes or Adjustments

Burden for respondents is minimal and decreased from an estimated average of four burden hours per response to 0.49 hours per response. This is likely due to familiarity and ease of use with the data collection instrument. The new programmatic requirement added to the form did not increase burden levels for respondents because this information is gathered through an existing planning process. This information is necessary for the creation of a budget that is submitted with the grant application. It is also needed to determine whether a waiver is necessary.

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

The data collection instrument is an attestation form. The information collected will not be published, tabulated, or manipulated. The data can be published as appropriate in compliance with the OPEN Government Data Act. HHS and HRSA are working on mechanisms that would facilitate increased data sharing.

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

Not applicable.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.