HRSA 22-034 (X08) PartB Supp.final.pdf

U.S. Department of Health and Human Services

HIV/AIDS Bureau (HAB)

Division of State HIV/AIDS Programs (DSHAP)

Ryan White HIV/AIDS Program Part B States/Territories Supplemental Grant Program

Funding Opportunity Number: HRSA-22-034 Funding Opportunity Type(s): New, Limited Competition

Assistance Listings (AL/CFDA) Number: 93.917

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2022

Application Due Date: May 9, 2022 Ensure your SAM.gov and Grants.gov registrations and passwords are current immediately!

HRSA will not approve deadline extensions for lack of registration.

Registration in all systems may take up to 1 month to complete.

Issuance Date: February 28, 2022

Susan Robilotto, D.O.

Director, Division of State HIV/AIDS Programs Telephone: (301) 443-6554 Fax (301) 594-5524 Email: SRobilotto@hrsa.gov

See Section VII for a complete list of agency contacts.

Authority: 42 U.S.C. § 300ff-29a (§ 2620 of the Public Health Service Act) 508 Compliance Disclaimer Note: Persons using assistive technology may not be able to fully access information in this file. For assistance, please email or call one of the HRSA staff above in Section VII.

Agency Contacts.

mailto:SRobilotto@hrsa.gov

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EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA) is accepting applications for the fiscal year (FY) 2022 Ryan White HIV/AIDS Program (RWHAP) Part B States/Territories Supplemental Grant Program. The purpose of this program is to supplement the HIV care and treatment services provided by the states/territories through the HIV Care Grant Program – RWHAP Part B States/Territories Formula and AIDS Drug Assistance Program (ADAP) Formula and ADAP Supplemental Awards Notice of Funding Opportunity (HRSA-22-033). The amount of funding awarded will be determined by the amount of funding available and the applicant’s ability to demonstrate the need for supplemental funding to provide comprehensive HIV care and treatment services for people with HIV in the state/territory.

Funding Opportunity Title: Ryan White HIV/AIDS Program Part B States/Territories Supplemental Grant Program

Funding Opportunity Number: HRSA-22-034

Due Date for Applications: May 9, 2022

Anticipated Total Annual Available FY 2022 Funding:

$52,000,000. Approximately $6,000,000 will be used for priority funding.*

Estimated Number and Type of Award(s): Up to 30 grants

Estimated Award Amount: Up to $9,000,000

Cost Sharing/Match Required: No

Period of Performance: September 30, 2022 through September 29, 2023

(1 year)

Eligible Applicants: All 50 States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, the Republic of Palau, the Federated States of Micronesia, and the Republic of the Marshall Islands.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=333257

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See Section III.1 of this notice of funding opportunity (NOFO) for complete eligibility information.

* Estimated annual available funding level based on current projections.

Application Guide

You (the applicant organization/agency) are responsible for reading and complying with the instructions included in HRSA’s SF-424 Application Guide, available online, except where instructed in this NOFO to do otherwise.

HRSA has scheduled the following technical assistance:

Topic: FY 2022 RWHAP Part B Supplemental NOFO (HRSA-22-034) TA Webinar Date: Wednesday, March 16, 2022 Time: 3:00 PM Eastern Time (US and Canada)

Join ZoomGov Meeting https://hrsa-gov.zoomgov.com/j/1615415970?pwd=OUlPczBHeVl2eStwZzQ2Tm1JZVVjUT09

Meeting ID: 161 541 5970 Passcode: k37zh2cg One tap mobile +16692545252,,1615415970#,,,,*68873437# US (San Jose) +16468287666,,1615415970#,,,,*68873437# US (New York)

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Table of Contents

I. PROGRAM FUNDING OPPORTUNITY DESCRIPTION

1. PURPOSE

2. BACKGROUND

http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf https://hrsa-gov.zoomgov.com/j/1615415970?pwd=OUlPczBHeVl2eStwZzQ2Tm1JZVVjUT09 https://hrsa-gov.zoomgov.com/j/1615415970?pwd=OUlPczBHeVl2eStwZzQ2Tm1JZVVjUT09 https://hrsa-gov.zoomgov.com/u/abD5bKqBLH

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II. AWARD INFORMATION

1. TYPE OF APPLICA TION A ND AWARD

2. SUMMA RY OF FUNDING

III. ELIGIBILITY INFORMATION

1. ELIGIBLE APPLICA NTS

2. COST SHA RING/MA TCHING

3. OTHER

IV. APPLICATION AND SUBMISSION INFORMATION

1. ADDRESS TO REQUEST APPLICA TION PACKAGE

2. CONTENT A ND FORM OF APPLICA TION SUBMISSION

i. Project Abstract

ii. Project Narrative

iii. Budget

iv. Budget Narrative

v. Attachments

3. UNIQUE ENTITY IDENTIFIER (UEI) A ND SYSTEM FOR AWARD MA NAGEMENT (SAM)

4. SUBMISSION DA TES AND TIMES

5. INTERGOV ERNMENTAL REV IEW

6. FUNDING RESTRICTIONS

V. APPLICATION REVIEW INFORMATION

1. REV IEW CRITERIA

2. REV IEW A ND SELECTION PROCESS

3. ASSESSMENT OF RISK

VI. AWARD ADMINISTRATION INFORMATION

1. AWARD NOTICES

2. ADMINISTRA TIV E A ND NATIONAL POLICY REQUIREMENTS

3. REPORTING

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

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I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for funding under the Ryan White HIV/AIDS Program (RWHAP) States/Territories Part B Supplemental Grant Program, which includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, the Republic of Palau, the Federated States of Micronesia, and the Republic of the Marshall Islands. The purpose of this program is to supplement formula-based funding provided through the HIV Care Grant Program – RWHAP Part B States/Territories Formula and AIDS Drug Assistance Program (ADAP) Formula and ADAP Supplemental Awards Notice of Funding Opportunity (HRSA-22-033).

States/territories use RWHAP Part B Supplemental Grant Program funding in conjunction with RWHAP Part B HIV Care Grant Program funding to develop and/or enhance access to a comprehensive continuum of high-quality care and treatment services for low-income people with HIV. To obtain funding, states/territories must demonstrate that RWHAP Part B supplemental funding is necessary to provide comprehensive HIV care and treatment services for people with HIV in the state/territory. Proposed activities should include the provision of core medical and/or support services, as defined in HRSA HAB Policy Clarification Notice (PCN) 16-02:

RWHAP Services: Eligible Individuals and Allowable Uses of Funds, and other activities to ensure responsiveness to unmet needs. States/territories must describe how proposed activities will address unmet needs and improve client-level health outcomes across the HIV care continuum, including viral suppression.

Eligible RWHAP Part B states/territories that are focus areas, or have counties that are focus areas, for the Ending the HIV Epidemic (EHE) initiative should consider if there is an increased need for RWHAP Part B supplemental funding due to the EHE initiative efforts using criteria below.

As required in section 2620(b) of the Public Health Service (PHS) Act, states/territories must demonstrate the severity of the need for RWHAP Part B supplemental funding using quantifiable data in one or more of the following areas:

1. The unmet need for such services, as determined under section 2617(b) of the PHS Act.

2. An increasing need for HIV/AIDS-related services, including relative rates of increase in the number of cases of HIV/AIDS.

3. The relative rates of increase in the number of cases of HIV/AIDS within new or emerging subpopulations.

4. The current prevalence of HIV/AIDS.

5. Relevant factors related to the cost and complexity of delivering health care to individuals with HIV/AIDS in the eligible area.

6. The impact of co-morbid factors, including co-occurring conditions, determined relevant by the Secretary.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=333257 https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf

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7. The prevalence of homelessness.

8. The prevalence of individuals who were released from federal, state, or local prisons during the preceding three (3) years, and had HIV/AIDS on the date of their release.

9. The relevant factors that limit access to health care, including geographic variation, adequacy of health insurance coverage, and language barriers.

10. The impact of a decline in the amount of RWHAP Part B funding received on services available to all individuals with HIV/AIDS identified and eligible under this title.

Pursuant to section 2620(c) of the PHS Act, the Secretary prioritizes funds to states/territories to address the reduction or disruption of services related to a decline in the amount of formula funding. Such a decline in funding is determined by comparing the amount of formula funding received in the current fiscal year (FY) to the amount received in FY 2006.

If you are a state/territory with current or potential shortfalls in ADAP resources, HRSA strongly encourages you to prioritize use of RWHAP Part B supplemental funds to augment ADAP resources when the following conditions exist:

1. Existing or anticipated ADAP waiting list,

2. Capped enrollment,

3. Reductions in ADAP formulary,

4. Reduction in the percentage of federal poverty level (FPL) eligibility requirement, and/or

5. Other ADAP restrictions within the state/territory.

2. Background

This program is authorized by 42 U.S.C. § 300ff-29a (§ 2620 of the Public Health Service Act).

The Ryan White HIV/AIDS Program (RWHAP) provides a comprehensive system of HIV primary medical care, essential support services, and medications for low-income people with HIV. The program funds grants to states, cities, counties, and local community-based organizations to provide care and treatment services to people with HIV to improve health outcomes and reduce HIV transmission among people we have not yet successfully maintained in care.

The RWHAP has five statutorily defined Parts (Parts A, B, C, D, and F) that provide funding for core medical, support services, and medications; technical assistance;

clinical training; and the development of innovative models of care to meet the needs of different communities and populations affected by HIV.

An important framework in the RWHAP is the HIV care continuum, which depicts the series of stages a person with HIV engages in from initial diagnosis through their

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successful treatment with HIV medication to achieve viral suppression. Supporting people with HIV to reach viral suppression not only increases their own quality of life and lifespan, it also prevents sexual transmission to an HIV-negative partner.

The HIV care continuum framework allows recipients and planning groups to measure progress and to direct HIV resources most effectively. RWHAP recipients are encouraged to assess the outcomes of their programs and should work with their community and public health partners to improve outcomes across the HIV care continuum. HRSA encourages recipients to use the performance measures developed for the RWHAP at their local level to assess the efficacy of their programs and to analyze and improve the gaps along the HIV care continuum.

Strategic Frameworks and National Objectives

National objectives and strategic frameworks like the Healthy People 2030, the National HIV AIDS Strategy (NHAS) (2022-2025); the Sexually Transmitted Infections National Strategic Plan for the United States (2021–2025); and the Viral Hepatitis National Strategic Plan for the United States: A Roadmap to Elimination (2021–2025) are crucial to addressing key public health challenges facing low-income people with HIV. These strategies detail the principles, priorities, and actions to guide the national public health response and provides a blueprint for collective action across the Federal Government and other sectors. The RWHAP supports the implementation of these strategies and recipients should align their organization’s efforts, within the parameters of the RWHAP statute and program guidance, with these strategies to the extent possible.

Expanding the Effort: Ending the HIV Epidemic in the United States

According to recent data from the 2020 Ryan White Services Report (RSR), the RWHAP has made tremendous progress toward ending the HIV epidemic in the United States. From 2016 to 2020, HIV viral suppression among RWHAP patients who have had one or more medical visits during the calendar year and at least one viral load with a result of <200 copies/mL reported, has increased from 84.9 percent to 89.4 percent.

Additionally, racial/ethnic, age-based, and regional disparities reflected in viral suppression rates have significantly decreased.[1] For example, the disparity in viral suppression rates between Black/African American and White clients has decreased since 2010.[2] These improved outcomes mean more people with HIV in the United States will live near-normal lifespans and have a reduced risk of transmitting HIV to others.[3]

[1] Health Resources and Services Administration. Ryan White HIV/AIDS Program Annual Client-Level Data Report 2020. http://hab.hrsa.gov/data/data-reports. Published December 2021. Accessed December 2, 2021.

[2] Viral suppression among Black/African American clients increased from 81.3 percent in 2016 to 86.7 percent in 2020, while viral suppression for White clients increased from 89.4 percent in 2016 to 92.5 percent in 2020; therefore the gap in viral suppression between these two groups decrease from 8.1 percentage points different to 5.8 percentage points different.

[3] National Institute of Allergy and Infectious Diseases (NIAID). Preventing Sexual Transmission of HIV with Anti-HIV Drugs. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US).

2000- [cited 2016 Mar 29]. Available from: https://clinicaltrials.gov/ NCT00074581 NLM Identifier:

NCT00074581.

http://hab.hrsa.gov/deliverhivaidscare/habperformmeasures.html https://health.gov/healthypeople https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2021-2025 https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2021-2025 https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html https://www.hhs.gov/programs/topic-sites/sexually-transmitted-infections/plan-overview/index.html https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/national-viral-hepatitis-action-plan-overview/index.html https://www.hhs.gov/hepatitis/viral-hepatitis-national-strategic-plan/national-viral-hepatitis-action-plan-overview/index.html https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/data/rwhap-annual-client-level-data-report-2020.pdf http://hab.hrsa.gov/data/data-reports https://clinicaltrials.gov/

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In February 2019, the Ending the HIV Epidemic in the United States (EHE) initiative was launched to further expand federal efforts to reduce HIV infections. This 10-year initiative seeks to achieve the important goal of reducing new HIV infections in the United States to fewer than 3,000 per year by 2030. The initiative promotes and implements four strategies to substantially reduce HIV transmissions – Diagnose, Treat, Prevent, and Respond. The initiative is a collaborative effort among key HHS agencies, primarily HRSA, the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Indian Health Service (IHS), and the Substance Abuse and Mental Health Services Administration (SAMHSA).

For the RWHAP, the EHE initiative expands the program’s ability to meet the needs of clients, specifically focusing on linking people with HIV who are either newly diagnosed, diagnosed but currently not in care, or are diagnosed and in care but not yet virally suppressed, to the essential HIV care, treatment, and support services needed to help them achieve viral suppression.

Using Data Effectively: Integrated Data Sharing and Use

HRSA and CDC’s Division of HIV/AIDS Prevention support integrated data sharing, analysis, and utilization for the purposes of program planning, conducting needs assessments, determining unmet need estimates, reporting, quality improvement, enhancing the HIV care continuum, and public health action. HRSA strongly encourages RWHAP recipients to:

• Follow the principles and standards in the Data Security and Confidentiality Guidelines for HIV, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Programs: Standards to Facilitate Sharing and Use of Surveillance Data for Public Health Action.

• Establish data sharing agreements between surveillance and HIV programs to ensure clarity about the process and purpose of the data sharing and utilization.

Integrated data sharing, analysis, and utilization of HIV data by state and territorial health departments can help further progress toward reaching the HIV National Strategic Plan goals and improve outcomes on the HIV care continuum.

HRSA strongly encourages complete CD4, viral load (VL), and HIV nucleotide sequence reporting to the state and territorial health departments’ HIV surveillance systems to benefit fully from integrated data sharing, analysis, and utilization. State health departments may use CD4, VL, and HIV nucleotide sequence data to identify cases, stage of HIV disease at diagnosis, and monitor disease progression. These data can also be used to evaluate HIV testing and prevention efforts, determine entry into and retention in HIV care, measure viral suppression, monitor prevalence of antiretroviral drug resistance, detect transmission clusters and understand transmission patterns, and assess unmet health care needs. Analyses at the national level to monitor progress toward ending the HIV epidemic in the United States can only occur if all HIV-related CD4, VL, and HIV nucleotide sequence test results are reported by all jurisdictions. CDC requires the reporting to the National HIV Surveillance System https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview/ending-epidemic-timeline http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf http://www.cdc.gov/nchhstp/programintegration/docs/pcsidatasecurityguidelines.pdf

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(NHSS) all HIV-related CD4 results (counts and percentages), all VL results (undetectable and specific values), and HIV nucleotide sequences.

Program Resources and Innovative Models

HRSA has a number of projects and resources that may assist RWHAP recipients with program implementation. These include a variety of HRSA HAB cooperative agreements, contracts, and grants focused on specific technical assistance (TA), evaluation, and intervention activities. A list of these resources is available on TargetHIV. Recipients should be familiar with these resources and are encouraged to use them as needed to support their program implementation.

In addition, many RWHAP Special Projects of National Significance (SPNS) projects have demonstrated promising new approaches for linking and retaining priority populations into care. As resources permit, RWHAP recipients are encouraged to review and integrate these tools within their HIV system of care in accordance with the allowable service categories defined in Policy Clarification Notice (PCN) 16-02 Ryan White HIV/AIDS Program Services: Eligible Individuals & Allowable Uses of Funds.

Examples of these resources include:

• E2i: Using Evidence-Informed Interventions to Improve Health Outcomes among People Living with HIV E2i uses an implementation science approach to evaluate and understand existing and new intervention strategies that can be used in RWHAP provider settings. Once interventions or strategies are demonstrated and evaluated using implementation science, manuals, guides, interactive online tools, publications, and instructional materials are developed and disseminated for replication and integration into RWHAP provider settings.

• Integrating HIV Innovative Practices (IHIP) Resources on the IHIP website include easy-to-use training manuals, curricula, case studies, pocket guides, monographs, and handbooks, as well as informational handouts and infographics about SPNS generally. IHIP also hosts TA training webinars designed to provide a more interactive experience with experts, and a TA help desk exists for you to submit additional questions and share your own lessons learned.

• Replication Resources from the SPNS Systems Linkages and Access to Care There are intervention manuals for patient navigation, care coordination, state bridge counselors, data to care, and other interventions developed for use at the state and regional levels to address specific HIV care continuum outcomes among people we have not yet successfully maintained in care.

• Dissemination of Evidence Informed Interventions The Dissemination of Evidence-Informed Interventions initiative ran from 2015-2020 and disseminated four adapted linkage and retention interventions from prior SPNS and the Minority HIV/AIDS Funds (MHAF) from the HHS Secretary’s Office initiatives to improve health outcomes along the HIV care continuum. The initiative produced four evidence-informed care and treatment interventions (CATIs) that are replicable, cost-effective, capable of producing optimal HIV care continuum outcomes, and https://targethiv.org/help/ta-directory https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf https://targethiv.org/e2i https://targethiv.org/e2i https://targethiv.org/ihip https://targethiv.org/library/replication-resources-spns-systems-linkages-and-access-care https://targethiv.org/deii

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easily adaptable to the changing health care environment. Manuals are currently available at the link provided and will be updated on an ongoing basis.

HRSA HAB also recognizes the importance of addressing emerging issues, as well as supporting the needs of special populations. To help recipients in responding to these critical issues, HRSA HAB funds projects to provide technical assistance and resources for recipients. Examples of projects include:

• Building Futures: Supporting Youth Living with HIV

• The Center for Engaging Black MSM Across the Care Continuum (CEBACC)

• Using Community Health Workers to Improve Linkage and Retention in Care

II. Award Information

1. Type of Application and Award

Type(s) of applications sought: New, Limited Competition

HRSA will provide funding in the form of a grant.

2. Summary of Funding

HRSA estimates approximately $52,000,000 to be available to fund up to 30 recipients.

The actual amount available will not be determined until enactment of the final FY 2022 federal appropriation. You may apply for a ceiling amount of up to $9,000,000 total cost (includes both direct and indirect, facilities and administrative costs).

The period of performance is September 30, 2022 through September 29, 2023 (1 year).

The amount of each award will be based on the total amount of funding available and your ability to demonstrate the need for additional funding due to the severity of the HIV epidemic in the state/territory, unmet need for core medical services, and/or unique service delivery challenges. Funding will be based on the external Objective Review Committee (ORC) review and scoring of the criteria published in Section V.1 of this announcement. The applications will be evaluated as follows:

a. The ORC will score applications and establish the rank order for awarding funds.

b. All applicants that request RWHAP Part B supplemental funding to develop and/or enhance access to a comprehensive continuum of high-quality care and treatment services for people with HIV and are recommended for an award by the ORC, will be considered for awards at amounts based on their ORC scores.

c. HRSA will fund applicants based upon funding availability up to the requested amount for allowable services under this NOFO (see Section VIII. Other Information for further details), as long as the amount requested falls under the amount allowable detailed previously in this NOFO.

https://targethiv.org/library/hrsa-hab-building-futures-supporting-youth-living-hiv https://targethiv.org/cebacc https://targethiv.org/chw

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d. If determined eligible for priority funding, HRSA will calculate the amount to be included in the final award. (See Section V.2 Review and Selection Process, Priority Funding for further details.)

All HRSA awards are subject to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements at 45 CFR part 75.

Please see HRSA HAB PCN 15-01: Treatment of Costs under the 10% Administrative Cap for Ryan White HIV/AIDS Program Parts A, B, C, and D for information regarding the statutory 10 percent limitation on administrative costs.

III. Eligibility Information

1. Eligible Applicants

Under Sections 2620 and 2689(11) of the PHS Act, all “States” – defined as all 50 States, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, the Republic of Palau, the Federated States of Micronesia, and the Republic of the Marshall Islands – are eligible for RWHAP Part B supplemental funding, unless any such state/territory had an unobligated balance of more than five percent of a prior year’s formula funds.

However, the Coronavirus Disease 2019 (COVID-19) public health emergency has posed significant challenges for RWHAP recipients, providers, and clients to provide and access care. On February 23, 2021, HRSA HAB released a letter that waived certain statutory penalties and administrative requirements for funds awarded in FY 2020 and 2021 in accordance with the Consolidated Appropriations Act, 2021, Pub. L.

116- 260, Division M, § 307. Requirements regarding the timeframe for obligation and expenditure of formula and supplemental RWHAP funds within the designated timeframe, including the requirement to submit an estimated unobligated balance and carryover request prior to the end of the grant year, and associated penalties were waived. Therefore, no states/territories will be deemed ineligible for the FY 2022 RWHAP States/Territories Part B Supplemental Grant Program.

Failure to expend at least 95 percent of RWHAP Part B/ADAP formula funds in FY 2022 or future years will result in penalties.

2. Cost Sharing/Matching

Cost sharing/matching is not required for this program.

3. Other

HRSA will not consider an application for funding if it contains any of the non-responsive criteria below:

• Exceeds the ceiling amount

• Fails to satisfy the deadline requirements referenced in Section IV.4 http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75 https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pcn-15-01.pdf https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/pcn-15-01.pdf https://ryanwhite.hrsa.gov/sites/default/files/ryanwhite/grants/penalties-waivers-program-letter.pdf

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HRSA will only accept your last validated electronic submission, under the correct funding opportunity number, before the Grants.gov application due date as the final and only acceptable application.

IV. Application and Submission Information

1. Address to Request Application Package

HRSA requires you to apply electronically. HRSA encourages you to apply through Grants.gov using the SF-424 workspace application package associated with this NOFO following the directions provided at Grants.gov: HOW TO APPLY FOR GRANTS.

The NOFO is also known as “Instructions” on Grants.gov. You must select “Subscribe” and provide your email address for HRSA 22-034 in order to receive notifications including modifications, clarifications, and/or republications of the NOFO on Grants.gov.

You will also receive notifications of documents placed in the RELATED DOCUMENTS tab on Grants.gov that may affect the NOFO and your application. You are ultimately responsible for reviewing the For Applicants page for all information relevant to this

NOFO.

2. Content and Form of Application Submission

Application Format Requirements Section 4 of HRSA’s SF-424 Application Guide provides general instructions for the budget, budget narrative, staffing plan and personnel requirements, assurances, certifications, etc. You must submit the information outlined in the HRSA SF-424 Application Guide in addition to the program-specific information below. You are responsible for reading and complying with the instructions included in HRSA’s SF-424 Application Guide except where instructed in the NOFO to do otherwise. You must submit the application in the English language and in the terms of U.S. dollars (45 CFR § 75.111(a)).

See Section 8.5 of the HRSA SF-424 Application Guide for the Application Completeness Checklist.

Application Page Limitation The total size of all uploaded files included in the page limit may not exceed the equivalent of 50 pages when printed by HRSA. The page limit includes the project and budget narratives, attachments, and letters of commitment and support required in the Application Guide and this NOFO. Hyperlinks are not allowed and will not be accessed or reviewed by the ORC reviewers. Standard OMB-approved forms that are included in the workspace application package do not count in the page limit. Please note: If you use an OMB-approved form that is not included in the workspace application package for HRSA-22-034, it may count against the page limit. Therefore, we strongly recommend you only use Grants.gov workspace forms associated with this NOFO to avoid exceeding the page limit. Indirect Cost Rate Agreement and proof of https://www.grants.gov/ http://www.grants.gov/applicants/apply-for-grants.html https://www.grants.gov/web/grants/applicants.html http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf

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non-profit status (if applicable) do not count in the page limit. It is therefore important to take appropriate measures to ensure your application does not exceed the specified page limit.

Applications must be completed, within the specified page limit, and validated by Grants.gov under the correct funding opportunity number prior to the deadline.

Debarment, Suspension, Ineligibility, and Voluntary Exclusion Certification

1) You certify on behalf of the applicant organization, by submission of your proposal, that neither you nor your principals are presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participation in this transaction by any federal department or agency.

2) Failure to make required disclosures can result in any of the remedies described in 45 CFR § 75.371, including suspension or debarment. (See also 2 CFR parts 180 and 376, and 31 U.S.C. § 3354).

3) If you are unable to attest to the statements in this certification, you must include an explanation in Attachments 8-15: Other Relevant Documents.

See Section 4.1 viii of HRSA’s SF-424 Application Guide for additional information on all certifications.

Temporary Reassignment of State and Local Personnel during a Public Health Emergency Section 319(e) of the PHS Act provides the Secretary of HHS with discretion upon request by a state or tribal organization to authorize the temporary reassignment of state, tribal, and local personnel during a declared federal public health emergency. The temporary reassignment provision is applicable to state, tribal, and local public health department or agency personnel whose positions are funded, in full or part, under PHS programs and allows such personnel to immediately respond to the public health emergency in the affected jurisdiction. Funds provided under the award may be used to support personnel who are temporarily reassigned in accordance with Section 319(e).

Please reference detailed information available on the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) website.

Program-Specific Instructions In addition to application requirements and instructions in Section 4 of HRSA’s SF-424 Application Guide (including the budget, budget narrative, staffing plan and personnel requirements, assurances, certifications, and abstract), include the following:

i. Project Abstract Use the Standard OMB-approved Project Abstract Summary Form 2.0 that is included in the workspace application package. Do not upload the abstract as an attachment or it will count toward the page limitation. Please use the guidance below. It is most current and differs slightly from that in Section 4.1.ix of HRSA’s SF-424 Application Guide.

Provide a summary of the application in the Project Abstract box of the Project Abstract Summary Form using 4,000 characters or less.

https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75#se45.1.75_1371 http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf http://www.phe.gov/Preparedness/legal/pahpa/section201/Pages/default.aspx http://www.phe.gov/Preparedness/legal/pahpa/section201/Pages/default.aspx http://www.hrsa.gov/grants/apply/applicationguide/sf424guide.pdf

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Address Project Director Name Contact Phone Numbers (Voice, Fax) Email Address Website Address, if applicable List all grant program funds requested in the application, if applicable If requesting a funding preference, priority, or special consideration as outlined in Section V. 2. indicate here.

Because the abstract is often distributed to provide information to the public and Congress, prepare this so that it is clear, accurate, concise, and without reference to other parts of the application. It must include a brief description of the proposed project including the needs to be addressed, the proposed services, and the population group(s) to be served. If the application is funded, your project abstract information (as submitted) will be made available to public websites and/or databases including USAspending.gov.

In addition to the information addressing the elements for the project abstract described above, provide a brief paragraph addressing the information below, not to exceed one page:

a. Why RWHAP Part B supplemental funding is necessary to ensure a comprehensive system of HIV care and treatment for people with HIV in your state/territory;

b. How this supplemental funding will improve viral suppression and achieve positive client-level health outcomes across the HIV care continuum; and

c. Describe the severity of the HIV epidemic in the state/territory, using quantifiable data on epidemiology, co-morbidities, cost of care, the service needs of emerging populations, unmet need for core medical services (as defined by HRSA HAB PCN 16-02), and unique service delivery challenges.

NARRATIVE GUIDANCE

To ensure that you fully address the review criteria, the table below provides a crosswalk between the narrative language and where each section falls within the review criteria. Any forms or attachments referenced in a narrative section may be considered during the objective review.

Narrative Section Review Criteria

Introduction (1) Need

Needs Assessment (1) Need and (6) Support Requested

Methodology (2) Response http://www.usaspending.gov/ https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf

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Narrative Section Review Criteria

Work Plan (2) Response, (4) Impact, (5) Resources/Capabilities, and (6) Support Requested

Resolution of Challenges (2) Response

Evaluation and Technical Support Capacity

(3) Evaluative Measures and

(5) Resources/Capabilities

Organizational Information (5) Resources/Capabilities

Budget Narrative (6) Support Requested

ii. Project Narrative This section provides a comprehensive description of all aspects of the proposed project. It should be succinct, self-explanatory, consistent with forms and attachments, and organized in alignment with the sections and format below so that reviewers can understand the proposed project.

Use the following section headers for the narrative:

INTRODUCTION -- Corresponds to Section V’s Review Criterion 1 Briefly describe how the state/territory will utilize RWHAP Part B supplemental funding in support of a comprehensive system of high-quality care and treatment for people with HIV. Describe the current prevalence of HIV/AIDS in the state/territory and provide corresponding data tables or figures as in Attachment

6. You may provide your HIV/AIDS epidemiological profile that was submitted with your NOFO # HRSA-22-033 application. Describe how the comprehensive system of care and treatment will improve outcomes across the HIV care continuum.

NEEDS ASSESSMENT -- Corresponds to Section V’s Review Criteria 1 and 6 The RWHAP legislation, Section 2620(b) of the PHS Act, requires RWHAP Part B supplemental funding applicants to demonstrate need in one or more of the categories listed. You only need to respond to the needs assessment sections below that are relevant to your request for RWHAP Part B supplemental funding. The needs assessment narrative and data must support the service category(ies) (as described in HRSA HAB PCN 16-02) chosen to respond to the demonstrated need and the request for funds.

1) Need for HIV-Related Services

If you are applying for RWHAP Part B supplemental funding due to a need for HIV-related services in the state/territory which may include addressing unmet need, an increased need due to an increase in relative rates or prevalence in HIV cases, or the decline in the amount of funding received for HIV services, please https://hab.hrsa.gov/sites/default/files/hab/program-grants-management/ServiceCategoryPCN_16-02Final.pdf

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provide a narrative describing all relevant factors that will be addressed, and how requested funds will be used to address each factor.

If you are applying for RWHAP Part B supplemental funding to augment ADAP services in the state/territory, please provide a narrative identifying which of the following conditions exist, its impact on developing and/or enhancing access to a comprehensive continuum of high-quality care and treatment services for people with HIV, and how requested funds will be used to address this condition/s:

a. Existing or anticipated ADAP waiting list,

b. Capped enrollment,

c. Reductions in ADAP formulary

d. Reduction in the percentage of FPL eligibility requirement, and/or

e. Other ADAP restrictions within the state/jurisdiction.

If you are applying for RWHAP Part B supplemental funding due to unmet need in the state/territory, then please indicate that in this section and provide the Unmet Need Framework and corresponding narrative from your application in response to NOFO # HRSA-22-033 as Attachment 7.

If you are NOT applying for RWHAP Part B supplemental funding due to unmet need in the state/territory, then please indicate that requested funds are to address a different demonstrated need as listed in Section 2620(b) of the RWHAP legislation (see Section I.1. of this NOFO) and do not provide a narrative addressing unmet need.

2) Assessment of New or Emerging Populations with Special Needs

The RWHAP legislation requires the state/territory to determine the needs of emerging populations who may have limited access to existing HIV care and services. These needs and service gaps should be addressed in the FY 2022 implementation plan narrative of this application. You can use RWHAP Part B supplemental funding to address identified needs.

If you are applying for RWHAP Part B supplemental funding due to new or emerging populations in the state/territory, identify no more than six (6) new or emerging populations to be served. Provide a narrative that addresses each of the following elements:

• Unique challenges that each population presents to the service delivery system and how funds will be used to overcome those challenges;

• Service gaps for each population and how funds will be used to address service gaps;

• Estimated cost of care associated with delivering services to each of these populations and how funds will be used to cover those costs; and

• Viral suppression rates for each population and how funds will be used to increase viral suppression rates.

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If you are NOT applying for RWHAP Part B supplemental funding due to new or emerging populations in the state/territory, then please indicate that requested funds are to address a different demonstrated need as listed in Section 2620(b) of the RWHAP legislation (see Section I.1. of this NOFO) and do not provide a narrative addressing new or emerging populations.

3) Impact of Co-Morbidities and Other Factors on the Cost and Complexity of

Providing Care

If you are applying for RWHAP Part B supplemental funding due to the impact of co-morbidities in the state/territory, please provide quantitative evidence in a table format on the impact of co-morbidities on the cost and complexity of providing HIV care and treatment, including the data sources. You only have to include information in the table for co-morbidities you plan to use RWHAP Part B supplemental funding to address. You must submit the table as Attachment 4. Please provide the following information in the table:

• Rates of sexually transmitted infections (STIs), hepatitis, tuberculosis, substance use, and mental health disorders.

• Estimated number of people who are homeless.

• Estimated number of people with HIV who were released from federal, state, or local prisons during the preceding three (3) years.

• The number and percent of people without insurance coverage (including those without Medicaid).

• The number and percent of people with HIV living at or below 138 percent and

400 percent of the 2022 FPL (see https://aspe.hhs.gov/poverty-guidelines).

Also, include the percentage of FPL used to determine RWHAP eligibility in the state/territory.

Include a narrative explanation of the data provided in the table using the available program and surveillance data sources.

If you are NOT applying for RWHAP Part B supplemental funding due to the impact of co-morbidities in the state/territory, then please indicate that requested funds are to address a different demonstrated need as listed in Section 2620(b) of the RWHAP legislation (see Section I.1. of this NOFO) and do not provide a narrative addressing impact of co-morbidities..

4) Access to Health Care

If you are applying for RWHAP Part B supplemental funding due to factors that limit access to health care in the state/territory, including, but not limited to, geographic variation, deficiencies of health insurance coverage, or language barriers, please provide a narrative describing each factor that will be addressed, how each factor impacts access to care, and how requested funds will be used to address each factor.

https://aspe.hhs.gov/poverty-guidelines

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If you are NOT applying for RWHAP Part B supplemental funding due to factors that limit access to health care in the state/territory, then please indicate that requested funds are to address a different demonstrated need as listed in Section 2620(b) of the RWHAP legislation (see Section I. 1. of this NOFO) and do not provide a narrative addressing factors that limit access to health care.

METHODOLOGY -- Corresponds to Section V’s Review Criterion 2

Describe how your state/territory will implement the following actions to address demonstrated needs indicated above:

• Use programmatic and fiscal forecasting tools to increase your ability to meet projected program service needs for the period of performance;

• Develop new, maintain existing, streamline, and/or diversify service delivery models, service contracts, strategic partnerships, and/or collaborations;

• Ensure timely and ongoing training of program staff, contractors, and/or service providers;

• Sustain activities beyond the federal funding period. Recipients are expected to sustain key elements of proposed projects. These may include but not be limited to strategies or services and interventions which have been effective in improving program operations and improving health outcomes for the target population;

• Provide opportunities for involvement of clients, families, and communities with and affected by HIV, as appropriate.

WORK PLAN -- Corresponds to Section V’s Review Criteria 2, 4, 5, and 6

FY 2022 Implementation Plan Narrative

The Implementation Plan Narrative should be commensurate with your request for RWHAP Part B supplemental funding, address demonstrated needs identified in the Needs Assessment section, and correspond with the approach proposed in the Methodology and Evaluation sections.

Describe how funded services 1) will be implemented to promote access to high-quality HIV care, 2) will address any significant health disparities in your state/territory, and 3) will maximize positive health outcomes along the HIV care continuum.

Describe the core medical and support services that will be provided to address the demonstrated needs described in the Needs Assessment section. Funded services should show impact along the HIV care continuum. A core medical or support service category may be related to more than one stage on the HIV care continuum. (For example, proposed activities falling under the Outpatient/Ambulatory Health Service category may have a positive impact on

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diagnosis, linkage to care, retention in care, antiretroviral therapy (ART) prescription, and viral suppression.) Please see the HIV Care Continuum Crosswalk developed by HRSA to assist with identifying funded services that impact each stage of the HIV care continuum.

Describe implementation of each of the following through current or planned activities:

• Addressing gaps, barriers, and significant health disparities across the HIV care continuum that may exist among people with HIV;

• Addressing unmet need and reducing the number of persons out of care;

• Addressing the needs of emerging populations who may have limited access to existing HIV care and services;

• Improving engagement of people with HIV and health outcomes at each stage of the HIV care continuum;

• Engaging people with HIV and other internal and external stakeholders in planning programmatic activities;

• Utilizing the HIV care continuum in planning, prioritizing, targeting, and monitoring available resources in response to needs of people with HIV; and

• Ensuring geographic parity for all activities supported by RWHAP Part B supplemental funding.

Include goals and objectives that are tied to stages of the HIV care continuum and the core medical and support services to be provided. Objectives should be specific, measurable, achievable, realistic, and time-framed (SMART). Activities proposed in the implementation plan should align with their corresponding objectives, and identify the specific outcomes to be achieved during the period of performance. Please present these goals and objectives in table or outline format for clarity.

RESOLUTION OF CHALLENGES -- Corresponds to Section V’s Review Criterion

Discuss any challenges you anticipate encountering in planning and implementing the proposed project. Be sure to discuss anticipated challenges regarding each demonstrated need for which you are requesting funding, as described in the Needs Assessment section. Describe the specific activities or strategies you will use to identify risks and mitigate or resolve anticipated challenges for each demonstrated need. The methodology and implementation plan narrative sections should reflect the proposed activities or strategies, as appropriate.

EVALUATION AND TECHNICAL SUPPORT CAPACITY -- Corresponds to Section V’s Review Criteria 3 and 5

Describe how you will evaluate your proposed program, assess whether proposed SMART objectives have been achieved, and ensure continuous quality https://hab.hrsa.gov/sites/default/files/hab/Global/hivcarecontinuumcrosswalk.pdf https://hab.hrsa.gov/sites/default/files/hab/Global/hivcarecontinuumcrosswalk.pdf

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improvement. The evaluation plan should align with the methodology and implementation plan narrative proposed in this application.

Describe the specific goals, objectives, benchmarks, and/or outcomes you will use for program evaluation and continuous quality improvement. Describe the staff (e.g., position, knowledge, skills, experience), systems (e.g., software, tools), procedures (e.g., actions, responsible parties, timelines), and other resources that will support your evaluation. Identify what data you will collect and how you will analyze and use the collected data for continuous quality improvement. Describe what control mechanisms you will use to ensure accurate and timely data collection, analysis, reporting, and use. Describe how you will share evaluation results internally with program staff and externally with key stakeholders to improve program implementation and outcomes.

ORANIZATIONAL INFORMATION—Corresponds to Section V’s Review Criterion

Briefly describe, regardless if using RWHAP Part B supplemental funding for staffing, how the state/territory will ensure proper oversight, management, and administration of FY2022 RWHAP Part B supplemental funding; including a brief overview of the capabilities of your organization, and the quality and availability of facilities and personnel.

If you propose…