Updates to Uniform Standard for Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure, 20500-20505 [2021-08016]

Download as PDF 20500 Federal Register / Vol. 86, No. 74 / Tuesday, April 20, 2021 / Notices services for individuals with HIV identified and eligible under the statute, after reserving statutory permissible amounts for administrative and clinical quality management costs. The RWHAP statute also grants the Secretary authority to waive this requirement for RWHAP Parts A, B, or C recipients if a number of requirements are met and a waiver request is submitted to HRSA for approval. RWHAP Part 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. Currently, for a core medical services waiver request to be approved, (1) core medical services must be available and accessible to all individuals identified and eligible for the RWHAP in the recipient’s service area within 30 days, without regard to payer source; (2) there cannot be any AIDS Drug Assistance Program waiting lists in the recipient’s service area; and (3) a public process to obtain input on the waiver request from impacted communities, including clients and RWHAP-funded core medical services providers, on the availability of core medical services and the decision to request the waiver must have occurred. The public process may be a part of the same one used to seek input on community needs as part of the annual priority setting and resource allocation, comprehensive planning, statewide coordinated statement of need (SCSN), public planning, and/or needs assessment processes. HRSA is proposing to simplify the waiver request process for RWHAP Parts A, B, and C recipients by revising Policy Number 13–07: Uniform Standard for Waiver of Core Medical Services Requirement for Grantees Under Part, A, B, and C. The proposed changes would reduce the administrative burden for recipients by lessening the documentation they must submit to HRSA when requesting a waiver. Under the proposed policy, recipients would be required to submit a one-page ‘‘HRSA RWHAP Core Medical Services Waiver Request Attestation Form’’ to HRSA in lieu of the multiple documents currently required to submit a waiver request. Waiver request submission deadlines would also be revised. When finalized, the policy would replace HAB Policy Number 13–07 effective October 1, 2021, and would be named ‘‘Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure Requirement.’’ HRSA is inviting comments on the proposed policy change under a separate policy notice titled, Updates to Uniform Standard for Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure Requirement. Need and Proposed Use of the Information: HRSA uses the documentation submitted in core medical services waiver requests to determine if the grant applicant or recipient meets the statutory requirements for waiver eligibility outlined in Sections 2604(c), 2612(b), and 2651(c) of the Public Health Service Act. Likely Respondents: HRSA expects responses from RWHAP Parts A, B, and C grant applicants and recipients. The number of grant recipients requesting waivers has fluctuated annually and has ranged from 15 to up to 22 per year since the Program’s implementation in FY 2007. Given the changes in the health care environment, HRSA anticipates receiving possibly up to 22 applications in a given year. 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. Public reporting burden for this collection of information is estimated to average four hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. The total annual burden hours estimated for this ICR are summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Form name Number of responses per respondent Total responses Average burden per response (in hours) Total burden hours Waiver Request ................................................................... 22 1 22 4 88 Total .............................................................................. 22 ........................ 22 ........................ 88 HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information VerDate Sep<11>2014 17:10 Apr 19, 2021 Jkt 253001 technology to minimize the information collection burden. DEPARTMENT OF HEALTH AND HUMAN SERVICES Maria G. Button, Director, Executive Secretariat. Health Resources and Services Administration [FR Doc. 2021–08017 Filed 4–19–21; 8:45 am] BILLING CODE 4165–15–P PO 00000 Updates to 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 (HHS). ACTION: Request for public comment on updates to uniform standard for waiver of the Ryan White HIV/AIDS Program AGENCY: Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\20APN1.SGM 20APN1 Federal Register / Vol. 86, No. 74 / Tuesday, April 20, 2021 / Notices core medical services expenditure requirement. The Ryan White HIV/AIDS Program (RWHAP) statute of the Public Health Services Act requires that RWHAP Part A, B, and C recipients expend 75 percent of Parts A, B, and C grant funds on core medical services for individuals with HIV/AIDS identified and eligible under the statute, after reserving statutory permissible amounts for administrative and clinical quality management costs. The statute also grants the Secretary authority to waive this requirement if certain requirements are met. HRSA is proposing to simplify the process for RWHAP Part A, B, and C recipients to request a waiver of the core medical services expenditure amount requirement by replacing HRSA Policy Number 13–07, ‘‘Uniform Standard for Waiver of Core Medical Services Requirement for Grantees Under Parts, A, B, and C’’ (accessible at the following link) https://hab.hrsa.gov/ sites/default/files/hab/Global/1307waiver.pdf. This notice seeks to make public the proposed policy and provide an opportunity for public comment before its implementation. In a separate notice entitled, Updates to Uniform Standard for Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure Requirement, OMB No. 0906–XXXX–NEW, HRSA is inviting comments on the data collection changes associated with this proposed policy change. DATES: Submit comments no later than June 21, 2021. The policy will become effective on October 1, 2021. ADDRESSES: Electronic comments on this policy should be sent to RyanWhiteComments@hrsa.gov by June 21, 2021. FOR FURTHER INFORMATION CONTACT: Lieutenant Commander Emeka Egwim, U.S. Public Health Service, Senior Policy Analyst, Division of Policy & Data, HRSA, HIV/AIDS Bureau, 5600 Fishers Lane, Rockville, MD 20857, Phone: (301) 945–9637 or by emailing 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 a number of requirements are met and a waiver request is submitted to HRSA for approval. RWHAP Part 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. Currently, for a core medical services waiver request to be approved, (1) core SUMMARY: VerDate Sep<11>2014 17:10 Apr 19, 2021 Jkt 253001 medical services must be available and accessible to all individuals identified and eligible for the RWHAP in the recipient’s service area within 30 days, without regard to payer source; (2) there cannot be any AIDS Drug Assistance Program (ADAP) waiting lists in the recipient’s service area; and (3) a public process to obtain input on the waiver request from impacted communities, including clients and RWHAP-funded core medical services providers, on the availability of core medical services and the decision to request the waiver must have occurred. The public process may be a part of the same one 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. The proposed changes would reduce the administrative burden for recipients by lessening the documentation they must submit to HRSA when requesting a waiver. Under the proposed policy, recipients would be required to submit a one-page ‘‘HRSA RWHAP Core Medical Services Waiver Request Attestation Form’’ to HRSA in lieu of the multiple documents currently required to submit a waiver request. Waiver request submission deadlines would also be revised. When finalized, the policy would replace HIV/AIDS Bureau (HAB) Policy Number 13–07 effective October 1, 2021, and would be named ‘‘Waiver of the Ryan White HIV/ AIDS Program Core Medical Services Expenditure Requirement.’’ Summary of Proposed Changes: Currently, all waiver requests must be signed by the Chief Elected Official or the project director, and include several documents, regardless of when they are submitted relative to the grant application. The documents required under the current waiver request process outlined in HAB Policy Number 13–07 are: (1) A letter signed by the Director of the RWHAP Part B state/ territory recipient indicating that there is no current or anticipated ADAP services waiting list in the state/ territory; (2) evidence that all core medical services listed in the statute are available and accessible within 30 days for all identified and eligible individuals with HIV in the service area; (3) evidence of a public process; and (4) a narrative of up to 10 pages. HRSA has determined that some of this required information is duplicative of information recipients already submit as part of recipients’ grant applications or other reporting requirements. The current documentation for preparing and submitting waiver requests requires PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 20501 a substantial amount of time for recipients. Likewise, HRSA requires a substantial amount of time to review and process them. Therefore, HRSA is proposing that recipients submit the proposed ‘‘HRSA RWHAP Core Medical Services Waiver Request Attestation Form’’ in lieu of the supporting documentation required per HAB Policy Number 13–07. HRSA may request additional information or supporting documentation upon request. Availability of Core Medical Services Currently, consistent with HAB Policy Number 13–07, recipients requesting core medical services waivers must provide evidence that all core medical services listed in the RWHAP statute are available for all identified and eligible individuals with HIV/AIDS in the service area without regard to the source of funding. However, as part of their grant application, RWHAP Part A, B, and C recipients provide sufficient information to satisfy this requirement. RWHAP Part A recipients describe the comprehensive system of care in the entire eligible metropolitan area or transitional grant area. This description includes the available core medical and support services funded by RWHAP Part A and other funding sources (including Minority AIDS Initiative funds), where those services are located, and how clients may access those services. Similarly, RWHAP Part B recipients provide a general description of the HIV service delivery system in the state/ territory, including what services are available, where those services are located, and how clients may access those services. RWHAP Part C recipients also provide a description of services available to people with HIV in the entire designated service area; a map showing locations of all current and proposed local providers of HIV outpatient primary health care services, including the recipient’s organization; and a list of all public and private organizations that provide HIV outpatient primary health care services to people with HIV in the entire designated service area. Therefore, it is duplicative to require additional documentation of this information separately as part of the core medical services waiver application. ADAP Waiting Lists Consistent with the current requirements outlined in HAB Policy Number 13–07, recipients requesting core medical services waivers are required to submit a letter from the director of the RWHAP Part B state/ territory recipient indicating there are no current or anticipated ADAP services E:\FR\FM\20APN1.SGM 20APN1 20502 Federal Register / Vol. 86, No. 74 / Tuesday, April 20, 2021 / Notices waiting lists in the service area. All RWHAP Part B recipients already indicate in their grant applications whether there are ADAP waiting lists in their state or territory, and whether the recipient anticipates implementing one. Under the proposed changes, RWHAP Part A, B, and C recipients must still attest that there are no ADAP waiting lists in the RWHAP Part B program on the RWHAP Core Medical Services Waiver Request Attestation Form to HRSA. Evidence of a Public Process Currently, recipients submitting waiver requests also submit letters from the Planning Council Chair(s) and the state HIV/AIDS director describing the public process that occurred in the jurisdiction related to the availability of core medical services and the decision to request a waiver. RWHAP program recipients describe how they engaged affected communities regarding the availability of core medical services as part of their grant applications, and include evidence describing the community input process and how it informs the priority setting and resource allocation process for the jurisdiction. Specifically, the community input process described in RWHAP Part A grant applications addresses how data were used in the priority setting and allocation processes to increase access to core medical services. RWHAP Part B recipients’ grant applications include needs assessments that in part, describes the Public Advisory Planning Process models to ensure inclusion of people with HIV, other RWHAP recipients, other HIV related programs, other general and local stakeholders, and community leaders. Similarly, RWHAP Part C recipients’ grant applications include documentation on the process used to obtain community VerDate Sep<11>2014 17:10 Apr 19, 2021 Jkt 253001 input on the design and implementation of activities related to the grant. HRSA notes that these public processes are not done in the context of RWHAP Part A, B, or C recipients requesting waivers of the RWHAP core medical services expenditure requirements. Therefore, consistent with the requirements outlined in the statute, RWHAP Parts A, B, and C recipients should ensure the completion of a public process to obtain input on their desire to request a core medical services waiver prior to submitting the HRSA RWHAP Core Medical Services Waiver Request Attestation Form. In addition to the three requirements outlined above and in HAB Policy Number 13–07, HRSA currently requires recipients to submit a narrative of up to 10 pages describing how their proposed percentage allocation will allow for services to be provided if the waiver is granted. These narratives also include any underlying local or state issues that influenced the decision to request a waiver, a proposed resource allocation table, as well as a description of the general healthcare landscape in the service area and how it may have changed over time. Given that recipients provide this information as part of the narrative in their grant applications or other submitted documentation, when a recipient submits a core medical services waiver application under the proposed policy, HRSA would be able to refer to that information or could request additional information from the recipient if needed. For the reasons outlined above, HRSA has determined that these duplicative requirements outlined in HAB Policy Number 13–07 are administratively burdensome and can be reduced with a more streamlined process. The proposed policy would replace waiver requests with a one-page ‘‘HRSA RWHAP Core Medical Services Waiver Request PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 Attestation Form (see below).’’ The Chief Elected Official, Chief Executive Officer, or a designee of either, would complete and submit the HRSA RWHAP Core Medical Services Waiver Request Attestation Form to HRSA certifying that the recipient has met the requirements outlined in the RWHAP statute and the new policy notice. This attestation form would be included as the last page of HAB Policy Notice 21– 01, and would consist of the following: 1. Instructions stating the form is to be completed by the Chief Elected Official, Chief Executive Officer, or a designee of either, and the person completing it should initial the included checkboxes to attest to meeting each requirement after reading and understanding its explanation. 2. A field in which the recipient can fill in its name. 3. Checkboxes with which the recipient can indicate the following: a. If they are a RWHAP Part A, B, or C recipient b. Whether the request is an initial request or renewal request c. The year the waiver is being requested 4. Checkboxes with which the recipient attests to meeting the following requirements: a. Not having an ADAP waiting list b. Availability of and accessibility to core medical services to all eligible individuals within the service area within 30 days c. Evidence of having conducted a public process 5. Fields for the following details of the official completing the form: a. Signature b. Printed name c. Title 6. The date the form was signed E:\FR\FM\20APN1.SGM 20APN1 Federal Register / Vol. 86, No. 74 / Tuesday, April 20, 2021 / Notices 20503 HRSA Ryan White HIV/AIDS Program {RWHAP) core Medical servlces waivet Request Attestation Form Tft~ rorm ~to fje:ccJmpfer;edt,y /:he CNef~fjjct:edQff,c1al,.Ch~f#eMite o.m~; pr e./:ksignee of'.e~her. Pleasl!! iriltla(t'Q attest tt, meeting each rl!!qu/rement after.reeding and undetst:endJng 'the explimatkm. Name:of ~c;ipient~.____________________________ D llV(HAP Part A. r:iecls-ient D RWttAP PartB recipient D Xnitiatrequest· D Renewal.request Av11ilabdity of, and accessibility to·core .medical servicesto .all eligibi. individuafs: D RWHAP Part.c recipient. By fnitialing here and signiJ"Jg this document; you attest; to the avail:abtlity ofand access.to core:medrcal services:for all HRS.A RWHAP .eligible individuals in the service.·areawithin 30 days .. Such access is. WithQut regard to fuhding .source, anc:1 Without the treed to spenct OH these services, at least 7~ pe~el'lt offunds:remailiing from your RWHAP awlilrd after reserving statutory perm:rssit>te•ampunts for administrative aridclinlcai quality management, You also . ·•□ 21gree to proVide-HRSA HAB' SL!PPort:ive evidence of m~ting thl!=i tl?C)Oirement upon request; SIGN"TUREOFCt:11.Ef ELECTEl>,OffICIALOR Ct:IIEF EXEClJTIVE·OffICER ('OR ~ESIGNEE} l>RINTNAME TITlE Although the proposed policy’s purpose is to reduce administrative burden for recipients, if finalized, it would not change the underlying requirements necessary to obtain a waiver, i.e., ensuring that: (1) All core medical services are available and accessible within 30 days in the jurisdiction or service area, (2) the state ADAP has no waiting lists, and (3) the recipient has used a public process to determine the need for a waiver. The HRSA RWHAP Core Medical Services Waiver Request Attestation Form provides recipients applying for waivers the ability to attest to having satisfied these requirements. Notwithstanding, recipients may still be required to VerDate Sep<11>2014 17:10 Apr 19, 2021 Jkt 253001 provide further information to HRSA upon request. Submission Deadlines In addition to reducing the volume of documentation, HRSA is proposing to change the deadlines for submitting waiver requests. Currently, consistent with the process outlined in HAB Policy Number 13–07, RWHAP Parts A, B, and C recipients may choose to submit a waiver request at any time prior to submission of the annual grant application, with the annual grant application, or up to 4 months after the start of the grant year for which the waiver is being requested. PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 To facilitate a more efficient review of waiver requests, the proposed changes would require waiver requests to be submitted by specific programmatic deadlines. A RWHAP Part A recipient would submit their waiver request as an attachment with the annual grant application or non-competing continuation (NCC) progress report. Because RWHAP Part B recipients submit their final budget 90 days after receiving their Notice of Award, the need for a waiver may not be identified until the final budget is approved. Therefore, a RWHAP Part B recipient would submit their waiver request either in advance of the grant application, with the grant application, E:\FR\FM\20APN1.SGM 20APN1 EN20AP21.000</GPH> DATE 20504 Federal Register / Vol. 86, No. 74 / Tuesday, April 20, 2021 / Notices with the mandatory NCC progress report, or up to 4 months into the grant award budget period for which the waiver is being requested. A RWHAP Part C recipient would submit their request for a waiver as an attachment with the grant application or the mandatory NCC progress report. These proposed changes are intended to better align waiver requests with programmatic processes, thereby allowing HRSA to better manage the review and processing of waiver requests. The proposed policy maintains that applicants submit their waiver requests with their grant applications through www.grants.gov. Recipients submit their waiver requests with the mandatory NCC progress report through the Electronic Handbooks (EHB). For waiver requests that are not submitted with grant applications or the mandatory NCC progress report, the proposed policy would require a recipient to notify its HRSA project officer (PO) of its intention to request a waiver in order to initiate a request for information in the EHB. In the current process, HRSA reviews requests and notifies recipients of waiver approval or denial no later than the date of issuance of the Notices of Award. In the proposed process, HRSA would notify recipients of waiver approval or denial within 4 weeks of receipt of the request, thereby saving weeks when compared to the current process. As with the current process, approved core medical services waivers will be effective for the 1-year budget period for which they are approved; recipients must submit a new request for each budget period. Also as with the current process, a recipient would not be required to implement an approved waiver should it no longer be needed. Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure Requirement HAB Policy Notice 21–01 Replaces HAB Policy Number 13–07 Scope of Coverage HRSA HIV/AIDS Bureau RWHAP Parts A, B, and C. Purpose of Policy Notice This HRSA policy notice replaces HAB Policy Number 13–07 Uniform Standard for Waiver of Core Medical Services Requirement for Grantees Under Parts, A, B, and C. It provides modified processes and requirements for HRSA RWHAP Parts A, B, and C recipients to request waivers of the statutory requirement regarding VerDate Sep<11>2014 17:10 Apr 19, 2021 Jkt 253001 expenditure amounts for core medical services. Deadlines for Submitting Waiver Requests Requirements RWHAP Part A Waiver Requests A HRSA RWHAP Part A recipient should submit their request for a waiver as an attachment with the grant application or the mandatory NCC progress report, if applicable. In each case, waiver requests do not count towards the submission page limit. Do not submit requests for waivers prior to the grant application or mandatory NCC progress report, nor after the start of the grant award budget period for which the waiver is being requested. A RWHAP Part A, B, or C recipient must meet a number of requirements, and submit a waiver request to HRSA to receive a waiver of the core medical services expenditure requirement. 1. Core medical services must be available and accessible to all individuals identified and eligible for the RWHAP in the recipient’s service area within 30 days. This access must be: a. Without regard to payer source, and b. without the need to spend at least 75 percent of funds remaining from the recipient’s RWHAP award after statutory permissible amounts for administrative and clinical quality management costs are reserved. 2. The recipient must ensure there are no ADAP waiting lists in its service area. 3. A public process to obtain input on the waiver request must have occurred. a. This process must seek input from impacted communities including clients and RWHAP-funded core medical services providers on the availability of core medical services, and the decision to request the waiver. b. The public process may be a part of the same one 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. 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 (appended below) to HRSA. The form should be submitted according to the applicable deadlines and methods for submission outlined below. By completing and submitting this form, the Chief Elected Official, Chief Executive Officer, or a designee of either attests to meeting the requirements outlined above and agrees to provide supportive evidence to HRSA upon request. No other documentation is required to be submitted with the HRSA RWHAP Core Medical Services Waiver Request Attestation Form, although recipients may be required to submit additional documentation to HRSA upon request. PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 RWHAP Part B Waiver Requests A HRSA RWHAP Part B recipient may submit their request for a waiver either in advance of the grant application, as an attachment to the grant application, with the mandatory NCC progress report, or up to 4 months into the grant award budget period for which the waiver is being requested. RWHAP Part C Waiver Requests A HRSA RWHAP Part C recipient should submit their request for a waiver as an attachment to the grant application or the mandatory NCC progress report. Do not submit requests for waivers prior to the grant application or mandatory NCC progress report, nor after the start of the grant award budget period for which the waiver is being requested. Methods for Submitting Waiver Requests Applicants must submit their waiver requests with their grant applications through www.grants.gov. Recipients must submit their waiver requests with the mandatory NCC progress report through the Electronic Handbooks (EHB). Recipients who do not submit their waiver requests with their grant applications, or with their mandatory NCC progress reports must notify its HRSA PO of its intention to request a waiver. The PO will initiate a Request for Information in the EHB. The recipient must respond to the EHB task consistent with the deadlines for submitting waiver requests outlined above. Waiver Review and Notification Process HRSA will review requests and notify recipients of waiver approval or denial within 4 weeks of receipt of the request. Approved core medical services waivers will be effective for the 1-year budget period for which it is approved; recipients must submit a new request for each budget period. A recipient E:\FR\FM\20APN1.SGM 20APN1 Federal Register / Vol. 86, No. 74 / Tuesday, April 20, 2021 / Notices approved for a core medical services waiver is not required to implement the waiver if it is no longer needed. Diana Espinosa, Acting Administrator. [FR Doc. 2021–08016 Filed 4–19–21; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Special Topics: Vision Imaging, Bioengineering and Low Vision Technology Development. Date: May 20–21, 2021. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Susan Gillmor, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, Bethesda, MD 20892, 240– 762–3076, susan.gillmor@nih.gov. Name of Committee: Healthcare Delivery and Methodologies Integrated Review Group; Community Influences on Health Behavior Study Section. Date: June 2–3, 2021. Time: 10:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Tasmeen Weik, DRPH, MPH, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3141, Bethesda, MD 20892, 301–827–6480, weikts@ mail.nih.gov. Name of Committee: Infectious Diseases and Immunology A Integrated Review Group; Virology—B Study Section. Date: June 9–10, 2021. Time: 9:30 a.m. to 7:00 p.m. VerDate Sep<11>2014 17:10 Apr 19, 2021 Jkt 253001 Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Neerja Kaushik-Basu, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3198, MSC 7808, Bethesda, MD 20892, (301) 435– 1742, kaushikbasun@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Bioengineering Science and Technology. Date: June 21, 2021. Time: 8:30 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Nitsa Rosenzweig, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4152, MSC 7760, Bethesda, MD 20892, (301) 404– 7419, rosenzweign@csr.nih.gov. Name of Committee: Digestive, Kidney and Urological Systems Integrated Review Group; Digestive System Host Defense, Microbial Interactions and Immune and Inflammatory Disease Study Section. Date: June 24–25, 2021. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Aiping Zhao, MD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2188, Bethesda, MD 20892–7818, (301) 435–0682, zhaoa2@csr.nih.gov. Name of Committee: Infectious Diseases and Immunology A Integrated Review Group; Cellular and Molecular Immunology—B Study Section. Date: June 24–25, 2021. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Liying Guo, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4198, MSC 7812, Bethesda, MD 20892, (301) 827– 7728, lguo@mail.nih.gov. Name of Committee: Infectious Diseases and Immunology A Integrated Review Group; Virology—A Study Section. Date: June 24–25, 2021. Time: 9:30 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Kenneth M. Izumi, Ph.D., Scientific Review Officer, Center for PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 20505 Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3204, MSC 7808, Bethesda, MD 20892, 301–496– 6980, izumikm@csr.nih.gov. Name of Committee: Infectious Diseases and Immunology B Integrated Review Group; Host Interactions with Bacterial Pathogens Study Section. Date: June 24–25, 2021. Time: 9:45 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Fouad A. El-Zaatari, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3186, MSC 7808, Bethesda, MD 20892, (301) 435– 1149, elzaataf@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Biomedical Data Repositories and Knowledgebases. Date: June 24, 2021. Time: 10:00 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Joseph Thomas Peterson, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4118, MSC 7814, Bethesda, MD 20892, 301–408– 9694, petersonjt@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: April 15, 2021. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–08083 Filed 4–19–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant E:\FR\FM\20APN1.SGM 20APN1

Agencies

[Federal Register Volume 86, Number 74 (Tuesday, April 20, 2021)]
[Notices]
[Pages 20500-20505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08016]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Updates to 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 (HHS).

ACTION: Request for public comment on updates to uniform standard for 
waiver of the Ryan White HIV/AIDS Program

[[Page 20501]]

core medical services expenditure requirement.

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SUMMARY: The Ryan White HIV/AIDS Program (RWHAP) statute of the Public 
Health Services Act requires that RWHAP Part A, B, and C recipients 
expend 75 percent of Parts A, B, and C grant funds on core medical 
services for individuals with HIV/AIDS identified and eligible under 
the statute, after reserving statutory permissible amounts for 
administrative and clinical quality management costs. The statute also 
grants the Secretary authority to waive this requirement if certain 
requirements are met. HRSA is proposing to simplify the process for 
RWHAP Part A, B, and C recipients to request a waiver of the core 
medical services expenditure amount requirement by replacing HRSA 
Policy Number 13-07, ``Uniform Standard for Waiver of Core Medical 
Services Requirement for Grantees Under Parts, A, B, and C'' 
(accessible at the following link) https://hab.hrsa.gov/sites/default/files/hab/Global/13-07waiver.pdf. This notice seeks to make public the 
proposed policy and provide an opportunity for public comment before 
its implementation. In a separate notice entitled, Updates to Uniform 
Standard for Waiver of the Ryan White HIV/AIDS Program Core Medical 
Services Expenditure Requirement, OMB No. 0906-XXXX-NEW, HRSA is 
inviting comments on the data collection changes associated with this 
proposed policy change.

DATES: Submit comments no later than June 21, 2021. The policy will 
become effective on October 1, 2021.

ADDRESSES: Electronic comments on this policy should be sent to 
[email protected] by June 21, 2021.

FOR FURTHER INFORMATION CONTACT: Lieutenant Commander Emeka Egwim, U.S. 
Public Health Service, Senior Policy Analyst, Division of Policy & 
Data, HRSA, HIV/AIDS Bureau, 5600 Fishers Lane, Rockville, MD 20857, 
Phone: (301) 945-9637 or by emailing [email protected].

SUPPLEMENTARY INFORMATION: The RWHAP statute grants the Secretary 
authority to waive this requirement for RWHAP Parts A, B, or C 
recipients if a number of requirements are met and a waiver request is 
submitted to HRSA for approval. RWHAP Part 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.
    Currently, for a core medical services waiver request to be 
approved, (1) core medical services must be available and accessible to 
all individuals identified and eligible for the RWHAP in the 
recipient's service area within 30 days, without regard to payer 
source; (2) there cannot be any AIDS Drug Assistance Program (ADAP) 
waiting lists in the recipient's service area; and (3) a public process 
to obtain input on the waiver request from impacted communities, 
including clients and RWHAP-funded core medical services providers, on 
the availability of core medical services and the decision to request 
the waiver must have occurred. The public process may be a part of the 
same one 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.
    The proposed changes would reduce the administrative burden for 
recipients by lessening the documentation they must submit to HRSA when 
requesting a waiver. Under the proposed policy, recipients would be 
required to submit a one-page ``HRSA RWHAP Core Medical Services Waiver 
Request Attestation Form'' to HRSA in lieu of the multiple documents 
currently required to submit a waiver request. Waiver request 
submission deadlines would also be revised. When finalized, the policy 
would replace HIV/AIDS Bureau (HAB) Policy Number 13-07 effective 
October 1, 2021, and would be named ``Waiver of the Ryan White HIV/AIDS 
Program Core Medical Services Expenditure Requirement.''
    Summary of Proposed Changes: Currently, all waiver requests must be 
signed by the Chief Elected Official or the project director, and 
include several documents, regardless of when they are submitted 
relative to the grant application. The documents required under the 
current waiver request process outlined in HAB Policy Number 13-07 are: 
(1) A letter signed by the Director of the RWHAP Part B state/territory 
recipient indicating that there is no current or anticipated ADAP 
services waiting list in the state/territory; (2) evidence that all 
core medical services listed in the statute are available and 
accessible within 30 days for all identified and eligible individuals 
with HIV in the service area; (3) evidence of a public process; and (4) 
a narrative of up to 10 pages.
    HRSA has determined that some of this required information is 
duplicative of information recipients already submit as part of 
recipients' grant applications or other reporting requirements. The 
current documentation for preparing and submitting waiver requests 
requires a substantial amount of time for recipients. Likewise, HRSA 
requires a substantial amount of time to review and process them. 
Therefore, HRSA is proposing that recipients submit the proposed ``HRSA 
RWHAP Core Medical Services Waiver Request Attestation Form'' in lieu 
of the supporting documentation required per HAB Policy Number 13-07. 
HRSA may request additional information or supporting documentation 
upon request.

Availability of Core Medical Services

    Currently, consistent with HAB Policy Number 13-07, recipients 
requesting core medical services waivers must provide evidence that all 
core medical services listed in the RWHAP statute are available for all 
identified and eligible individuals with HIV/AIDS in the service area 
without regard to the source of funding. However, as part of their 
grant application, RWHAP Part A, B, and C recipients provide sufficient 
information to satisfy this requirement. RWHAP Part A recipients 
describe the comprehensive system of care in the entire eligible 
metropolitan area or transitional grant area. This description includes 
the available core medical and support services funded by RWHAP Part A 
and other funding sources (including Minority AIDS Initiative funds), 
where those services are located, and how clients may access those 
services. Similarly, RWHAP Part B recipients provide a general 
description of the HIV service delivery system in the state/territory, 
including what services are available, where those services are 
located, and how clients may access those services. RWHAP Part C 
recipients also provide a description of services available to people 
with HIV in the entire designated service area; a map showing locations 
of all current and proposed local providers of HIV outpatient primary 
health care services, including the recipient's organization; and a 
list of all public and private organizations that provide HIV 
outpatient primary health care services to people with HIV in the 
entire designated service area. Therefore, it is duplicative to require 
additional documentation of this information separately as part of the 
core medical services waiver application.

ADAP Waiting Lists

    Consistent with the current requirements outlined in HAB Policy 
Number 13-07, recipients requesting core medical services waivers are 
required to submit a letter from the director of the RWHAP Part B 
state/territory recipient indicating there are no current or 
anticipated ADAP services

[[Page 20502]]

waiting lists in the service area. All RWHAP Part B recipients already 
indicate in their grant applications whether there are ADAP waiting 
lists in their state or territory, and whether the recipient 
anticipates implementing one. Under the proposed changes, RWHAP Part A, 
B, and C recipients must still attest that there are no ADAP waiting 
lists in the RWHAP Part B program on the RWHAP Core Medical Services 
Waiver Request Attestation Form to HRSA.

Evidence of a Public Process

    Currently, recipients submitting waiver requests also submit 
letters from the Planning Council Chair(s) and the state HIV/AIDS 
director describing the public process that occurred in the 
jurisdiction related to the availability of core medical services and 
the decision to request a waiver. RWHAP program recipients describe how 
they engaged affected communities regarding the availability of core 
medical services as part of their grant applications, and include 
evidence describing the community input process and how it informs the 
priority setting and resource allocation process for the jurisdiction. 
Specifically, the community input process described in RWHAP Part A 
grant applications addresses how data were used in the priority setting 
and allocation processes to increase access to core medical services. 
RWHAP Part B recipients' grant applications include needs assessments 
that in part, describes the Public Advisory Planning Process models to 
ensure inclusion of people with HIV, other RWHAP recipients, other HIV 
related programs, other general and local stakeholders, and community 
leaders. Similarly, RWHAP Part C recipients' grant applications include 
documentation on the process used to obtain community input on the 
design and implementation of activities related to the grant.
    HRSA notes that these public processes are not done in the context 
of RWHAP Part A, B, or C recipients requesting waivers of the RWHAP 
core medical services expenditure requirements. Therefore, consistent 
with the requirements outlined in the statute, RWHAP Parts A, B, and C 
recipients should ensure the completion of a public process to obtain 
input on their desire to request a core medical services waiver prior 
to submitting the HRSA RWHAP Core Medical Services Waiver Request 
Attestation Form.
    In addition to the three requirements outlined above and in HAB 
Policy Number 13-07, HRSA currently requires recipients to submit a 
narrative of up to 10 pages describing how their proposed percentage 
allocation will allow for services to be provided if the waiver is 
granted. These narratives also include any underlying local or state 
issues that influenced the decision to request a waiver, a proposed 
resource allocation table, as well as a description of the general 
healthcare landscape in the service area and how it may have changed 
over time. Given that recipients provide this information as part of 
the narrative in their grant applications or other submitted 
documentation, when a recipient submits a core medical services waiver 
application under the proposed policy, HRSA would be able to refer to 
that information or could request additional information from the 
recipient if needed.
    For the reasons outlined above, HRSA has determined that these 
duplicative requirements outlined in HAB Policy Number 13-07 are 
administratively burdensome and can be reduced with a more streamlined 
process. The proposed policy would replace waiver requests with a one-
page ``HRSA RWHAP Core Medical Services Waiver Request Attestation Form 
(see below).'' The Chief Elected Official, Chief Executive Officer, or 
a designee of either, would complete and submit the HRSA RWHAP Core 
Medical Services Waiver Request Attestation Form to HRSA certifying 
that the recipient has met the requirements outlined in the RWHAP 
statute and the new policy notice. This attestation form would be 
included as the last page of HAB Policy Notice 21-01, and would consist 
of the following:
    1. Instructions stating the form is to be completed by the Chief 
Elected Official, Chief Executive Officer, or a designee of either, and 
the person completing it should initial the included checkboxes to 
attest to meeting each requirement after reading and understanding its 
explanation.
    2. A field in which the recipient can fill in its name.
    3. Checkboxes with which the recipient can indicate the following:

a. If they are a RWHAP Part A, B, or C recipient
b. Whether the request is an initial request or renewal request
c. The year the waiver is being requested

    4. Checkboxes with which the recipient attests to meeting the 
following requirements:

a. Not having an ADAP waiting list
b. Availability of and accessibility to core medical services to all 
eligible individuals within the service area within 30 days
c. Evidence of having conducted a public process

    5. Fields for the following details of the official completing the 
form:

a. Signature
b. Printed name
c. Title

    6. The date the form was signed

[[Page 20503]]

[GRAPHIC] [TIFF OMITTED] TN20AP21.000

    Although the proposed policy's purpose is to reduce administrative 
burden for recipients, if finalized, it would not change the underlying 
requirements necessary to obtain a waiver, i.e., ensuring that: (1) All 
core medical services are available and accessible within 30 days in 
the jurisdiction or service area, (2) the state ADAP has no waiting 
lists, and (3) the recipient has used a public process to determine the 
need for a waiver. The HRSA RWHAP Core Medical Services Waiver Request 
Attestation Form provides recipients applying for waivers the ability 
to attest to having satisfied these requirements. Notwithstanding, 
recipients may still be required to provide further information to HRSA 
upon request.

Submission Deadlines

    In addition to reducing the volume of documentation, HRSA is 
proposing to change the deadlines for submitting waiver requests.
    Currently, consistent with the process outlined in HAB Policy 
Number 13-07, RWHAP Parts A, B, and C recipients may choose to submit a 
waiver request at any time prior to submission of the annual grant 
application, with the annual grant application, or up to 4 months after 
the start of the grant year for which the waiver is being requested.
    To facilitate a more efficient review of waiver requests, the 
proposed changes would require waiver requests to be submitted by 
specific programmatic deadlines. A RWHAP Part A recipient would submit 
their waiver request as an attachment with the annual grant application 
or non-competing continuation (NCC) progress report. Because RWHAP Part 
B recipients submit their final budget 90 days after receiving their 
Notice of Award, the need for a waiver may not be identified until the 
final budget is approved. Therefore, a RWHAP Part B recipient would 
submit their waiver request either in advance of the grant application, 
with the grant application,

[[Page 20504]]

with the mandatory NCC progress report, or up to 4 months into the 
grant award budget period for which the waiver is being requested. A 
RWHAP Part C recipient would submit their request for a waiver as an 
attachment with the grant application or the mandatory NCC progress 
report. These proposed changes are intended to better align waiver 
requests with programmatic processes, thereby allowing HRSA to better 
manage the review and processing of waiver requests.
    The proposed policy maintains that applicants submit their waiver 
requests with their grant applications through www.grants.gov. 
Recipients submit their waiver requests with the mandatory NCC progress 
report through the Electronic Handbooks (EHB). For waiver requests that 
are not submitted with grant applications or the mandatory NCC progress 
report, the proposed policy would require a recipient to notify its 
HRSA project officer (PO) of its intention to request a waiver in order 
to initiate a request for information in the EHB.
    In the current process, HRSA reviews requests and notifies 
recipients of waiver approval or denial no later than the date of 
issuance of the Notices of Award. In the proposed process, HRSA would 
notify recipients of waiver approval or denial within 4 weeks of 
receipt of the request, thereby saving weeks when compared to the 
current process. As with the current process, approved core medical 
services waivers will be effective for the 1-year budget period for 
which they are approved; recipients must submit a new request for each 
budget period. Also as with the current process, a recipient would not 
be required to implement an approved waiver should it no longer be 
needed.

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

HAB Policy Notice 21-01
Replaces HAB Policy Number 13-07

Scope of Coverage

    HRSA HIV/AIDS Bureau RWHAP Parts A, B, and C.

Purpose of Policy Notice

    This HRSA policy notice replaces HAB Policy Number 13-07 Uniform 
Standard for Waiver of Core Medical Services Requirement for Grantees 
Under Parts, A, B, and C. It provides modified processes and 
requirements for HRSA RWHAP Parts A, B, and C recipients to request 
waivers of the statutory requirement regarding expenditure amounts for 
core medical services.

Requirements

    A RWHAP Part A, B, or C recipient must meet a number of 
requirements, and submit a waiver request to HRSA to receive a waiver 
of the core medical services expenditure requirement.
    1. Core medical services must be available and accessible to all 
individuals identified and eligible for the RWHAP in the recipient's 
service area within 30 days. This access must be:
    a. Without regard to payer source, and
    b. without the need to spend at least 75 percent of funds remaining 
from the recipient's RWHAP award after statutory permissible amounts 
for administrative and clinical quality management costs are reserved.
    2. The recipient must ensure there are no ADAP waiting lists in its 
service area.
    3. A public process to obtain input on the waiver request must have 
occurred.
    a. This process must seek input from impacted communities including 
clients and RWHAP-funded core medical services providers on the 
availability of core medical services, and the decision to request the 
waiver.
    b. The public process may be a part of the same one 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.

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 (appended 
below) to HRSA. The form should be submitted according to the 
applicable deadlines and methods for submission outlined below. By 
completing and submitting this form, the Chief Elected Official, Chief 
Executive Officer, or a designee of either attests to meeting the 
requirements outlined above and agrees to provide supportive evidence 
to HRSA upon request. No other documentation is required to be 
submitted with the HRSA RWHAP Core Medical Services Waiver Request 
Attestation Form, although recipients may be required to submit 
additional documentation to HRSA upon request.

Deadlines for Submitting Waiver Requests

RWHAP Part A Waiver Requests

    A HRSA RWHAP Part A recipient should submit their request for a 
waiver as an attachment with the grant application or the mandatory NCC 
progress report, if applicable. In each case, waiver requests do not 
count towards the submission page limit. Do not submit requests for 
waivers prior to the grant application or mandatory NCC progress 
report, nor after the start of the grant award budget period for which 
the waiver is being requested.

RWHAP Part B Waiver Requests

    A HRSA RWHAP Part B recipient may submit their request for a waiver 
either in advance of the grant application, as an attachment to the 
grant application, with the mandatory NCC progress report, or up to 4 
months into the grant award budget period for which the waiver is being 
requested.

RWHAP Part C Waiver Requests

    A HRSA RWHAP Part C recipient should submit their request for a 
waiver as an attachment to the grant application or the mandatory NCC 
progress report. Do not submit requests for waivers prior to the grant 
application or mandatory NCC progress report, nor after the start of 
the grant award budget period for which the waiver is being requested.

Methods for Submitting Waiver Requests

    Applicants must submit their waiver requests with their grant 
applications through www.grants.gov. Recipients must submit their 
waiver requests with the mandatory NCC progress report through the 
Electronic Handbooks (EHB). Recipients who do not submit their waiver 
requests with their grant applications, or with their mandatory NCC 
progress reports must notify its HRSA PO of its intention to request a 
waiver. The PO will initiate a Request for Information in the EHB. The 
recipient must respond to the EHB task consistent with the deadlines 
for submitting waiver requests outlined above.

Waiver Review and Notification Process

    HRSA will review requests and notify recipients of waiver approval 
or denial within 4 weeks of receipt of the request.
    Approved core medical services waivers will be effective for the 1-
year budget period for which it is approved; recipients must submit a 
new request for each budget period. A recipient

[[Page 20505]]

approved for a core medical services waiver is not required to 
implement the waiver if it is no longer needed.

Diana Espinosa,
Acting Administrator.
[FR Doc. 2021-08016 Filed 4-19-21; 8:45 am]
BILLING CODE 4165-15-P