Updates to the Uniform Standard for Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure, 67448-67452 [2024-18649]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES 67448 Federal Register / Vol. 89, No. 161 / Tuesday, August 20, 2024 / Notices effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. PENNSAID (diclofenac sodium) Topical Solution 2%, is the subject of NDA 204623, held by Horizon Therapeutics Ireland DAC, and initially approved on January 16, 2014. PENNSAID is a nonsteroidal antiinflammatory drug indicated for the treatment of the pain of osteoarthritis of the knees. PENNSAID (diclofenac sodium) Topical Solution 2%, is currently listed in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Encube Ethicals Private Limited submitted a citizen petition dated May 6, 2024 (Docket No. FDA–2024–P– 2220), under 21 CFR 10.30, requesting that the Agency determine whether PENNSAID (diclofenac sodium) Topical Solution 2%, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that PENNSAID (diclofenac sodium) Topical Solution 2%, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that PENNSAID (diclofenac sodium) Topical Solution 2%, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of PENNSAID (diclofenac sodium) Topical Solution 2%, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list PENNSAID (diclofenac sodium) Topical Solution 2%, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued VerDate Sep<11>2014 17:24 Aug 19, 2024 Jkt 262001 from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: August 15, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–18615 Filed 8–19–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Updates to the Uniform Standard for Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Request for public comment on updates to uniform standard for waiver of the Ryan White HIV/AIDS Program core medical services expenditure requirement. AGENCY: The Ryan White HIV/AIDS Program (RWHAP) statute of the Public Health Service Act requires that RWHAP Parts A, B, and C recipients expend 75 percent of Parts A, B, and C grant funds on core medical services for individuals who are identified with HIV/AIDS and eligible for RWHAP services under the statute, after reserving statutorily permissible amounts for administrative and clinical quality management costs. The statute also grants the Secretary authority to waive this requirement if certain factors are met. HRSA is proposing to update Policy Notice 21–01, ‘‘Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure Requirement,’’ pertaining to the associated data collection form to clarify applicants’ proposed allocation of resources between core medical and support services. DATES: Submit comments no later than September 19, 2024. ADDRESSES: Written/and or electronic comments should be submitted to Division of Policy and Data, HRSA, SUMMARY: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 HIV/AIDS Bureau, 5600 Fishers Lane, Rockville, MD 20857, or RyanWhiteComments@hrsa.gov. FOR FURTHER INFORMATION CONTACT: Kristina Barney, Senior Public Health Policy Analyst, Division of Policy and Data, HRSA, HIV/AIDS Bureau, 5600 Fishers Lane, Rockville, MD 20857, email RyanWhiteComments@hrsa.gov. SUPPLEMENTARY INFORMATION: The RWHAP statute grants the Secretary authority to waive this requirement for RWHAP Parts A, B, or C recipients if certain factors are met and a waiver request is submitted to HRSA for approval. RWHAP Parts A, B, and C core medical services waiver requests, if approved, are effective for a 1-year budget period and apply to funds awarded under the Minority AIDS Initiative. For a core medical services waiver request to be approved, core medical services must be available and accessible, regardless of the payment source, within 30 days to all RWHAPeligible individuals identified in the recipient’s service area. The recipient may use existing, non-RWHAP resources in the service area to ensure availability and access to core medical services. Additionally, there must be no AIDS Drug Assistance Program waiting lists in the recipient’s service area. Finally, a public process must be used to obtain input from impacted communities on the availability of core medical services and the decision to request the waiver. Impacted communities include clients and RWHAP-funded core medical services providers. The same method used to seek input on community needs as part of the annual priority setting and resource allocation, comprehensive planning, statewide coordinated statement of need, public planning, and/ or needs assessment processes may be used to meet this requirement. Policy Notice 21–01, ‘‘Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure Requirement,’’ outlines the requirements and includes the one-page ‘‘HRSA RWHAP Core Medical Services Waiver Request Attestation Form’’ that must be submitted to request a waiver. HRSA proposes to modify Policy Notice 21–01 to reflect a new policy requiring that the proposed percentages of HIV service dollars allocated to core medical and support services be included on the waiver request form. This information will inform HRSA as to whether recipients are able to meet the statutory requirements found in sections 2604(c), 2612(b), and 2651(c) of the Public Health Service Act and will E:\FR\FM\20AUN1.SGM 20AUN1 Federal Register / Vol. 89, No. 161 / Tuesday, August 20, 2024 / Notices VerDate Sep<11>2014 17:24 Aug 19, 2024 Jkt 262001 state AIDS Drug Assistance Program has no waiting lists, all core medical services are available and accessible within 30 days in the jurisdiction or service area, and that the recipient has used a public process to determine the need for a waiver. HRSA will consider public comment on these changes and intends for the policy to become effective on October 1, 2024. Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure Requirement Policy Notice 21–01(Revised 10/01/24) Replaces Policy Notice 13–07 Scope of Coverage Health Resources and Services Administration (HRSA) HIV/AIDS Bureau Ryan White HIV/AIDS Program (RWHAP) Parts A, B, and C. Purpose of Policy Notice This Policy Notice provides the processes and requirements for RWHAP Parts A, B, and C recipients to request waivers of the statutory requirement regarding expenditure amounts for core medical services. The revised policy notice describes a new requirement included on the RWHAP Core Medical Services Waiver Attestation Form. It also includes various editorial changes to respond to stakeholder feedback to make the form clearer. The revised policy is effective beginning on October 1, 2024. Background Recipients must spend at least 75 percent of grant funds on core medical services. See Title XXVI of the Public Health Service Act (the RWHAP legislation, Part A section 2604(c), Part B section 2612(b), and Part C section 2651(c)). Grant funds include Minority AIDS Initiative funding but exclude the amounts allowable by statute for PO 00000 Frm 00043 Fmt 4703 Sfmt 4725 administrative and clinical quality management costs. The Secretary can waive this requirement for a recipient if: (1) there are no waiting lists for the AIDS Drug Assistance Program (ADAP), (2) core medical services are available and accessible to all HRSA RWHAP eligible individuals in the recipient’s service area, and (3) a public process must be used to obtain input on the waiver request. Approved RWHAP Part A, Part B, and Part C core medical services waivers are effective for one budget period of a grant award, which is 1 year. Requirements A HRSA RWHAP Parts A, B, or C recipient must meet the following requirements: (1) Core medical services must be available and accessible, regardless of the payment source, within 30 days to all HRSA RWHAP eligible individuals identified in the recipient’s service area. The recipient may use existing nonRWHAP resources in the service area to ensure availability and access to core medical services. (2) There must be no ADAP waiting lists in the recipient’s service area. (3) There must be a public process to obtain input on the waiver request. This public process must seek input from impacted communities on the availability of core medical services and the decision to request the waiver. Impacted communities include clients and RWHAP-funded core medical services providers. The same method to seek input on community needs as part of the annual priority setting and resource allocation, comprehensive planning, statewide coordinated statement of need, public planning, and/ or needs assessment processes may be used. E:\FR\FM\20AUN1.SGM 20AUN1 EN20AU24.001</GPH> khammond on DSKJM1Z7X2PROD with NOTICES clarify what proposed portion of funds will be allocated to core medical and support services. In response to stakeholder feedback, minor changes will also be made to the policy notice. The current policy notice is accessible at the following link: https://ryanwhite. hrsa.gov/sites/default/files/ryanwhite/ grants/pn-21-01-core-medical-serviceswaivers.pdf and the proposed revised policy notice is included in this announcement. This notice provides the opportunity for public comment before implementation. In a separate notice entitled, Ryan White HIV/AIDS Program Core Medical Services Waiver Form, OMB No. 0906–0065–Revision, 89 FR 122, 53110–12 (June 25, 2024), HRSA seeks comment on the changes to the data collection form associated with this proposed policy notice change. Summary of Proposed Changes: Sections 2604(c), 2612(b), and 2651(c) of the Public Health Service Act require recipients to spend not less than 75 percent of funds on core medical services after reserving statutorily permissible amounts for administrative and clinical quality management costs. HRSA intends to add a requirement to include the proposed percentages of HIV service dollars allocated to core medical and support services. This proposed change will be included as a requirement on the Ryan White HIV/ AIDS Program Core Medical Services Waiver Form and will be used to clarify what portion of HIV service dollars will be allocated to core medical and support services. The section of this notice entitled ‘‘Requesting a Waiver’’ contains a description of the new information that must be included on the waiver request form. Language and editorial changes have been made throughout. The proposed change is in addition to the underlying requirements necessary to obtain a waiver: ensuring that the 67449 67450 Federal Register / Vol. 89, No. 161 / Tuesday, August 20, 2024 / Notices Requesting a Waiver To request a waiver, the Chief Elected Official, Chief Executive Officer, or a designee of either must complete and submit the HRSA RWHAP Core Medical Services Waiver Request Attestation Form (attached below) to HRSA as specified by the deadlines and methods described below. Update to the Waiver Request Form The form must specify the percentages of HIV service dollars, including Minority AIDS Initiative funds, the recipient proposes to allocate to core medical and support services, if the waiver is approved. Signature indicates attestations for eligibility and the requirement of documentation upon request. No other documentation is required to be submitted with the HRSA RWHAP Core Medical Services Waiver Request Attestation Form. Submitting Waiver Requests khammond on DSKJM1Z7X2PROD with NOTICES RWHAP Part A and RWHAP Part C waiver requests must be submitted as an VerDate Sep<11>2014 17:24 Aug 19, 2024 Jkt 262001 attachment with the grant application or the mandatory non-competing continuation (NCC) progress report. Waiver requests do not count towards grant application or NCC progress report page limits. RWHAP Part B recipients may submit a waiver request prior to the submission of a grant application, with the grant application or NCC progress report as an attachment or up to 4 months after the start of the budget period for which the waiver is requested. RWHAP Part B recipients may request a waiver for the RWHAP Part B States/ Territories Formula and ADAP Formula and ADAP Supplemental Awards (X07) and/or the RWHAP Part B States/ Territories Supplemental Grant Program (X08). Recipients must request each waiver separately. Methods for Submitting Waiver Requests progress report must be submitted through the Electronic Handbooks. Part B recipients planning to request a waiver before or after the submission of a grant application or NCC progress report must notify their project officer who will send a Request for Information through the Electronic Handbooks. Waiver Review and Notification Process HRSA will review waiver requests and notify recipients of its approval or denial within 4 weeks of receipt of the request. Approved core medical services waivers are only effective for one budget period. Approved waivers are not required to be implemented, should circumstances change. Recipients must submit a new request(s) each budget period. BILLING CODE 4165–15–P Waiver requests submitted with grant applications must be submitted through www.grants.gov. Waiver requests submitted with the mandatory NCC PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\20AUN1.SGM 20AUN1 Federal Register / Vol. 89, No. 161 / Tuesday, August 20, 2024 / Notices 67451 0MB Number: 0906-0065 HRSA Ryan White HIV/ AIDS Program (RWHAP) Core Medical Services Waiver Request Attestation Form This form is to be completed by the Chief Elected Official, Chief Executive Officer, or a designee of either. Please initial to attest to meeting each requirement after reading and understanding the corresponding explanation. Include the proposed percentages of HIV service dollars allocated to core medical and support services in the Proposed Ratio for RWHAP Core Medical and Support Services section. Name of r e c i p i e n t - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - □ D □ RWHAP Part B recipient RWHAP Part A recipient D Initial request Availability of, and accessibility to core medical services to all eligible individuals □ RWHAP Part C recipient Renewal request By initialing here and signing this document, you attest to the availability of and access within 30 days to core medical services for all HRSA RWHAP eligible individuals in the service area. Such access is without regard to funding source, and without the need to spend at least 75 percent of funds remaining from your RWHAP award (after reserving statutory permissible amounts for administrative and clinical quality management costs). You also agree to provide HRSA HABD supportive evidence of meeting this requirement upon request. 0/o SIGNATURE OF CHIEF ELECTED OFFICIAL OR CHIEF EXECUTIVE OFFICER (OR DESIGN EE) PRINT NAME VerDate Sep<11>2014 17:24 Aug 19, 2024 Jkt 262001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4725 E:\FR\FM\20AUN1.SGM 20AUN1 EN20AU24.002</GPH> khammond on DSKJM1Z7X2PROD with NOTICES TITLE 67452 Federal Register / Vol. 89, No. 161 / Tuesday, August 20, 2024 / Notices Public Burden Statement: 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 with HIV identified and eligible under Title XXVI of the Public Health Services Act. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid 0MB control number. The 0MB control number for this information collection is 0906-0065 and it is valid until 08/31/2027. This information collection is required to obtain or retain a benefit (Ryan White HIV/AIDS Treatment Extension Act of 2009, Part A section 2604CC>, Part B section 2612(b), and Part C section 2651(c)). Data will be kept private to the extent required by law. Public reporting burden for this collection of information is estimated to average 0.49 hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Information Collection Clearance Officer, 5600 Fishers Lane, Room 14N39, Rockville, Maryland, 20857 or paperwork@hrsa.gov. Please see https://www.hrsa.gov/about/508-resources for the HRSA digital accessibility statement. Expiration Date 08/31/2027 the ACTPCMD website meeting page at https://www.hrsa.gov/advisorycommittees/primarycare-dentist/ meetings. [FR Doc. 2024–18649 Filed 8–19–24; 8:45 am] BILLING CODE 4165–15–C FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD or Committee) will hold one additional public meeting in the 2024 calendar year. Information about ACTPCMD, agendas, and materials for these meetings can be found on the ACTPCMD website at https:// www.hrsa.gov/advisory-committees/ primarycare-dentist/meetings. This notice is consistent with information about ACTPCMD’s 2024 meetings published in the Federal Register on May 15, 2024, titled ‘‘Meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry.’’ DATES: The ACTPCMD meeting will be held on: • November 15, 2024, 10:00 a.m. to 5:00 p.m. Eastern Time. ADDRESSES: This meeting will be held by teleconference and/or a video conference platform. For updates on how the meeting will be held, visit the ACTPCMD website 20 days before the date of the meeting, where instructions for joining the meeting will be posted. For meeting information updates, go to khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:24 Aug 19, 2024 Jkt 262001 Shane Rogers, Designated Federal Officer, Division of Medicine and Dentistry, Bureau of Health Workforce, HRSA, 5600 Fishers Lane, Rockville, Maryland 20857; 301–443–5260; or SRogers@hrsa.gov. SUPPLEMENTARY INFORMATION: ACTPCMD provides advice and recommendations to the Secretary of Health and Human Services on policy, program development, and other matters of significance concerning the activities under section 747 of title VII of the Public Health Service (PHS) Act, as it existed upon the enactment of section 749 of the PHS Act in 1998. ACTPCMD prepares an annual report describing the activities of the Committee, including findings and recommendations made by the Committee concerning the activities under section 747, as well as training programs in oral health and dentistry. The annual report is submitted to the Secretary of Health and Human Services as well as the Chair and ranking members of the Senate Committee on Health, Education, Labor and Pensions and the House of Representatives Committee on Energy and Commerce. ACTPCMD also develops, publishes, and implements performance measures and guidelines for longitudinal evaluations of programs authorized under title VII, part C of the PHS Act, and recommends appropriation levels for programs under this Part. Since priorities dictate meeting times, be advised that start times, end times, and agenda items are subject to change. For the November 15, 2024, meeting, agenda items may include, but are not limited to, discussion of recommendations for the Committee’s 23rd report, as well as exploratory topic discussions for the Committee’s 24th PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 report. Refer to the ACTPCMD website listed above for all current and updated information concerning the November ACTPCMD meeting, including the agenda and meeting materials that will be posted 20 calendar days before the meeting. Members of the public will have the opportunity to provide comments. Public participants may submit written statements in advance of the scheduled meeting. Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to submit a written statement or make oral comments to the ACTPCMD should be sent to Shane Rogers using the contact information above at least 5 business days before the meeting date. Individuals who need special assistance or another reasonable accommodation should notify Shane Rogers using the contact information listed above at least 10 business days before the November 15, 2024, meeting. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2024–18553 Filed 8–19–24; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Advancing Translational Sciences; Notice of Meeting Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Center for Advancing Translational Sciences Advisory Council. This will be a hybrid meeting held inperson and virtually and will be open to the public as indicated below. Individuals who plan to attend inperson or view the virtual meeting and E:\FR\FM\20AUN1.SGM 20AUN1 EN20AU24.003</GPH> Carole Johnson, Administrator.

Agencies

[Federal Register Volume 89, Number 161 (Tuesday, August 20, 2024)]
[Notices]
[Pages 67448-67452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-18649]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Updates to the Uniform Standard for Waiver of the Ryan White HIV/
AIDS Program Core Medical Services Expenditure

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

ACTION: Request for public comment on updates to uniform standard for 
waiver of the Ryan White HIV/AIDS Program core medical services 
expenditure requirement.

-----------------------------------------------------------------------

SUMMARY: The Ryan White HIV/AIDS Program (RWHAP) statute of the Public 
Health Service Act requires that RWHAP Parts A, B, and C recipients 
expend 75 percent of Parts A, B, and C grant funds on core medical 
services for individuals who are identified with HIV/AIDS and eligible 
for RWHAP services under the statute, after reserving statutorily 
permissible amounts for administrative and clinical quality management 
costs. The statute also grants the Secretary authority to waive this 
requirement if certain factors are met. HRSA is proposing to update 
Policy Notice 21-01, ``Waiver of the Ryan White HIV/AIDS Program Core 
Medical Services Expenditure Requirement,'' pertaining to the 
associated data collection form to clarify applicants' proposed 
allocation of resources between core medical and support services.

DATES: Submit comments no later than September 19, 2024.

ADDRESSES: Written/and or electronic comments should be submitted to 
Division of Policy and Data, HRSA, HIV/AIDS Bureau, 5600 Fishers Lane, 
Rockville, MD 20857, or [email protected].

FOR FURTHER INFORMATION CONTACT: Kristina Barney, Senior Public Health 
Policy Analyst, Division of Policy and Data, HRSA, HIV/AIDS Bureau, 
5600 Fishers Lane, Rockville, MD 20857, email 
[email protected].

SUPPLEMENTARY INFORMATION: The RWHAP statute grants the Secretary 
authority to waive this requirement for RWHAP Parts A, B, or C 
recipients if certain factors are met and a waiver request is submitted 
to HRSA for approval. RWHAP Parts A, B, and C core medical services 
waiver requests, if approved, are effective for a 1-year budget period 
and apply to funds awarded under the Minority AIDS Initiative.
    For a core medical services waiver request to be approved, core 
medical services must be available and accessible, regardless of the 
payment source, within 30 days to all RWHAP-eligible individuals 
identified in the recipient's service area. The recipient may use 
existing, non-RWHAP resources in the service area to ensure 
availability and access to core medical services. Additionally, there 
must be no AIDS Drug Assistance Program waiting lists in the 
recipient's service area. Finally, a public process must be used to 
obtain input from impacted communities on the availability of core 
medical services and the decision to request the waiver. Impacted 
communities include clients and RWHAP-funded core medical services 
providers. The same method used to seek input on community needs as 
part of the annual priority setting and resource allocation, 
comprehensive planning, statewide coordinated statement of need, public 
planning, and/or needs assessment processes may be used to meet this 
requirement.
    Policy Notice 21-01, ``Waiver of the Ryan White HIV/AIDS Program 
Core Medical Services Expenditure Requirement,'' outlines the 
requirements and includes the one-page ``HRSA RWHAP Core Medical 
Services Waiver Request Attestation Form'' that must be submitted to 
request a waiver.
    HRSA proposes to modify Policy Notice 21-01 to reflect a new policy 
requiring that the proposed percentages of HIV service dollars 
allocated to core medical and support services be included on the 
waiver request form. This information will inform HRSA as to whether 
recipients are able to meet the statutory requirements found in 
sections 2604(c), 2612(b), and 2651(c) of the Public Health Service Act 
and will

[[Page 67449]]

clarify what proposed portion of funds will be allocated to core 
medical and support services. In response to stakeholder feedback, 
minor changes will also be made to the policy notice. The current 
policy notice is accessible at the following link: https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pn-21-01-core-medical-services-waivers.pdf and the proposed revised policy notice is 
included in this announcement. This notice provides the opportunity for 
public comment before implementation. In a separate notice entitled, 
Ryan White HIV/AIDS Program Core Medical Services Waiver Form, OMB No. 
0906-0065-Revision, 89 FR 122, 53110-12 (June 25, 2024), HRSA seeks 
comment on the changes to the data collection form associated with this 
proposed policy notice change.
    Summary of Proposed Changes: Sections 2604(c), 2612(b), and 2651(c) 
of the Public Health Service Act require recipients to spend not less 
than 75 percent of funds on core medical services after reserving 
statutorily permissible amounts for administrative and clinical quality 
management costs. HRSA intends to add a requirement to include the 
proposed percentages of HIV service dollars allocated to core medical 
and support services. This proposed change will be included as a 
requirement on the Ryan White HIV/AIDS Program Core Medical Services 
Waiver Form and will be used to clarify what portion of HIV service 
dollars will be allocated to core medical and support services. The 
section of this notice entitled ``Requesting a Waiver'' contains a 
description of the new information that must be included on the waiver 
request form. Language and editorial changes have been made throughout.
    The proposed change is in addition to the underlying requirements 
necessary to obtain a waiver: ensuring that the state AIDS Drug 
Assistance Program has no waiting lists, all core medical services are 
available and accessible within 30 days in the jurisdiction or service 
area, and that the recipient has used a public process to determine the 
need for a waiver. HRSA will consider public comment on these changes 
and intends for the policy to become effective on October 1, 2024.

Waiver of the Ryan White HIV/AIDS Program Core Medical Services 
Expenditure Requirement

Policy Notice 21-01(Revised 10/01/24) Replaces Policy Notice 13-07

Scope of Coverage
    Health Resources and Services Administration (HRSA) HIV/AIDS Bureau 
Ryan White HIV/AIDS Program (RWHAP) Parts A, B, and C.
Purpose of Policy Notice
    This Policy Notice provides the processes and requirements for 
RWHAP Parts A, B, and C recipients to request waivers of the statutory 
requirement regarding expenditure amounts for core medical services.
    The revised policy notice describes a new requirement included on 
the RWHAP Core Medical Services Waiver Attestation Form. It also 
includes various editorial changes to respond to stakeholder feedback 
to make the form clearer. The revised policy is effective beginning on 
October 1, 2024.
Background
    Recipients must spend at least 75 percent of grant funds on core 
medical services. See Title XXVI of the Public Health Service Act (the 
RWHAP legislation, Part A section 2604(c), Part B section 2612(b), and 
Part C section 2651(c)). Grant funds include Minority AIDS Initiative 
funding but exclude the amounts allowable by statute for administrative 
and clinical quality management costs. The Secretary can waive this 
requirement for a recipient if: (1) there are no waiting lists for the 
AIDS Drug Assistance Program (ADAP), (2) core medical services are 
available and accessible to all HRSA RWHAP eligible individuals in the 
recipient's service area, and (3) a public process must be used to 
obtain input on the waiver request. Approved RWHAP Part A, Part B, and 
Part C core medical services waivers are effective for one budget 
period of a grant award, which is 1 year.
Requirements
    A HRSA RWHAP Parts A, B, or C recipient must meet the following 
requirements:
    (1) Core medical services must be available and accessible, 
regardless of the payment source, within 30 days to all HRSA RWHAP 
eligible individuals identified in the recipient's service area. The 
recipient may use existing non-RWHAP resources in the service area to 
ensure availability and access to core medical services.
    (2) There must be no ADAP waiting lists in the recipient's service 
area.
    (3) There must be a public process to obtain input on the waiver 
request. This public process must seek input from impacted communities 
on the availability of core medical services and the decision to 
request the waiver. Impacted communities include clients and RWHAP-
funded core medical services providers. The same method to seek input 
on community needs as part of the annual priority setting and resource 
allocation, comprehensive planning, statewide coordinated statement of 
need, public planning, and/or needs assessment processes may be used.
[GRAPHIC] [TIFF OMITTED] TN20AU24.001


[[Page 67450]]


Requesting a Waiver
    To request a waiver, the Chief Elected Official, Chief Executive 
Officer, or a designee of either must complete and submit the HRSA 
RWHAP Core Medical Services Waiver Request Attestation Form (attached 
below) to HRSA as specified by the deadlines and methods described 
below.
Update to the Waiver Request Form
    The form must specify the percentages of HIV service dollars, 
including Minority AIDS Initiative funds, the recipient proposes to 
allocate to core medical and support services, if the waiver is 
approved. Signature indicates attestations for eligibility and the 
requirement of documentation upon request.
    No other documentation is required to be submitted with the HRSA 
RWHAP Core Medical Services Waiver Request Attestation Form.
Submitting Waiver Requests
    RWHAP Part A and RWHAP Part C waiver requests must be submitted as 
an attachment with the grant application or the mandatory non-competing 
continuation (NCC) progress report. Waiver requests do not count 
towards grant application or NCC progress report page limits.
    RWHAP Part B recipients may submit a waiver request prior to the 
submission of a grant application, with the grant application or NCC 
progress report as an attachment or up to 4 months after the start of 
the budget period for which the waiver is requested.
    RWHAP Part B recipients may request a waiver for the RWHAP Part B 
States/Territories Formula and ADAP Formula and ADAP Supplemental 
Awards (X07) and/or the RWHAP Part B States/Territories Supplemental 
Grant Program (X08). Recipients must request each waiver separately.
Methods for Submitting Waiver Requests
    Waiver requests submitted with grant applications must be submitted 
through www.grants.gov. Waiver requests submitted with the mandatory 
NCC progress report must be submitted through the Electronic Handbooks.
    Part B recipients planning to request a waiver before or after the 
submission of a grant application or NCC progress report must notify 
their project officer who will send a Request for Information through 
the Electronic Handbooks.
Waiver Review and Notification Process
    HRSA will review waiver requests and notify recipients of its 
approval or denial within 4 weeks of receipt of the request.
    Approved core medical services waivers are only effective for one 
budget period. Approved waivers are not required to be implemented, 
should circumstances change. Recipients must submit a new request(s) 
each budget period.
BILLING CODE 4165-15-P

[[Page 67451]]

[GRAPHIC] [TIFF OMITTED] TN20AU24.002


[[Page 67452]]


[GRAPHIC] [TIFF OMITTED] TN20AU24.003


Carole Johnson,
Administrator.
[FR Doc. 2024-18649 Filed 8-19-24; 8:45 am]
BILLING CODE 4165-15-C

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