BPHC HRSA-22-104 (H8H) FY 2022 PCHP Ending the HIV Epidemic_Final.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Bureau of Primary Health Care Health Center Program

Fiscal Year 2022 Ending the HIV Epidemic – Primary Care HIV Prevention

Funding Opportunity Number: HRSA-22-104 Funding Opportunity Type: New

Assistance Listings (AL/CFDA) Number: 93.527

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2022

Application Due Date in Grants.gov: December 14, 2021 Supplemental Information Due Date in EHBs:

January 18, 2022

Ensure your SAM and Grants.gov registrations and passwords are current immediately!

HRSA will not approve deadline extensions for lack of registration.

Registration in all systems, including SAM.gov, Grants.gov, and EHBs may take up to one month to complete.

Issuance Date: October 7, 2021

Rebecca Levine Public Health Analyst, Bureau of Primary Health Care Office of Policy and Program Development Contact: https://bphccommunications.secure.force.com/ContactBPHC/BPHC_Contact_Form Telephone: (301) 594-4300 PCHP Technical Assistance webpage: https://bphc.hrsa.gov/program-opportunities/primary-care-hiv-prevention

Authority: Section 330(e), (g), (h), and/or (i) of the Public Health Service Act (42 U.S.C. § 254b(e), (g), (h), and/or (i)), as appropriate.

https://bphccommunications.secure.force.com/ContactBPHC/BPHC_Contact_Form https://bphccommunications.secure.force.com/ContactBPHC/BPHC_Contact_Form https://bphc.hrsa.gov/program-opportunities/primary-care-hiv-prevention

HRSA-22-104 i

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.

EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA) is accepting applications for the fiscal year (FY) 2022 Ending the HIV Epidemic – Primary Care HIV Prevention (PCHP) funding opportunity under the Health Center Program. The purpose of PCHP is to expand HIV prevention services that decrease the risk of HIV transmission in underserved communities in support of Ending the HIV Epidemic in the U.S. This FY 2022 funding will make available HIV prevention investments to Health Center Program operational (H80) grant award recipients located in the Ending the HIV Epidemic in the U.S. geographic locations that did not receive an FY 2020 or FY 2021 PCHP award.

This notice is a contingency action taken to ensure that, should funds become available for this purpose, HRSA can process applications and award funds efficiently.

Funding Opportunity Title:

Fiscal Year (FY) 2022 Ending the HIV Epidemic - Primary Care HIV Prevention

(PCHP)

Funding Opportunity Number: HRSA-22-104 Due Date for Applications – Grants.gov: December 14, 2021 (11:59 p.m. ET) Due Date for Supplemental Information – HRSA Electronic Handbooks (EHBs):

January 18, 2022 (5 p.m. ET)

Anticipated Total Annual Available Funding: Approximately $50 million Estimated Number and Type of Awards: Up to 150 awards

Estimated Award Amount: $325,000 per year, subject to availability of funds

Cost Sharing/Match Required: No Period of Performance: 2 years, beginning August 1, 2022 https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/jurisdictions/phase-one

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Eligible Applicants: Organizations that:

• Are Health Center Program operational (H80) grant award recipients,

• Are located in the 57 geographic locations identified by Ending the HIV Epidemic in the U.S., and

• Did not receive an FY 2020 or FY 2021 PCHP award.

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

Application Guide

You (the applicant organization/agency) are responsible for reading and complying with the instructions included in HRSA’s SF-424 Two-Tier Application Guide, available online at https://www.hrsa.gov/sites/default/files/hrsa/grants/apply/applicationguide/sf-424-program-specific-app-guide.pdf, except where instructed in this NOFO to do otherwise.

Technical Assistance

Application resources, including example forms and documents, as well as a frequently asked questions document, are available at the PCHP technical assistance webpage (https://bphc.hrsa.gov/program-opportunities/primary-care-hiv-prevention). HRSA will hold a pre-application technical assistance (TA) webinar that will include an overview of these instructions and address questions on the application process and PCHP objectives. Refer to “Apply for a Grant”, available at http://www.hrsa.gov/grants/apply, for general (i.e., not PCHP specific) information on a variety of application and submission components.

The HRSA Primary Health Care Digest is a weekly email newsletter containing information and updates pertaining to the Health Center Program, including competitive funding opportunities. Organizations interested in seeking funding under the Health Center Program are encouraged to have several staff subscribe.

Health center strategic partners are available to assist you in preparing a competitive application, including National Training and Technical Assistance Partners (NTTAPs), Primary Care Associations (PCAs), and Health Center Controlled Networks (HCCNs).

The Lesbian, Gay, Bisexual, and Transgender Populations and Health Information Technology and Data NTTAPs have materials that may advance your work plan and support its successful implementation. The HRSA-supported Telehealth Resource Centers offer technical assistance and coaching specific to advancing the use of telehealth. For a list of HRSA-supported PCAs, NTTAPs, and HCCNs, refer to HRSA’s Strategic Partnerships webpage.

https://www.hrsa.gov/sites/default/files/hrsa/grants/apply/applicationguide/sf-424-program-specific-app-guide.pdf https://www.hrsa.gov/sites/default/files/hrsa/grants/apply/applicationguide/sf-424-program-specific-app-guide.pdf https://bphc.hrsa.gov/program-opportunities/primary-care-hiv-prevention http://www.hrsa.gov/grants/apply https://public.govdelivery.com/accounts/USHHSHRSA/subscriber/new?topic_id=USHHSHRSA_118 https://bphc.hrsa.gov/qualityimprovement/strategicpartnerships/ncapca/natlagreement.html https://bphc.hrsa.gov/qualityimprovement/strategicpartnerships/ncapca/associations.html https://bphc.hrsa.gov/qualityimprovement/strategicpartnerships/hccn.html https://www.lgbthealtheducation.org/ https://hiteqcenter.org/ https://hiteqcenter.org/ https://www.telehealthresourcecenter.org/ https://www.telehealthresourcecenter.org/ https://bphc.hrsa.gov/programopportunities/fundingopportunities/sac/supportnetworks/index.html

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Table of Contents

I. PROGRAM FUNDING OPPORTUNITY DESCRIPTION

1. Purpose

2. Background

II. AWARD INFORMATION

1. Type of Application and Award

2. Summary of Funding

III. ELIGIBILITY INFORMATION

1. Eligible Applicants

2. Cost Sharing/Matching

IV. APPLICATION AND SUBMISSION INFORMATION

1. Address to Request Application Package

2. Content and Form of Application Submission

i. Project Abstract (Submit in Grants.gov)

ii. Project Narrative (Submit in EHBs – required for completeness)

iii. Budget (Submit in EHBs)

iv. Budget Narrative (Submit in EHBs)

v. Program-Specific Forms (Submit in EHBs)

vi. Attachments (Submit in EHBs)

3. Dun and Bradstreet Data Universal Numbering System (DUNS) Number Transition to the Unique Entity Identifier (UEI) and System for Award Management (SAM) ... 19

4. Submission Dates and Times

5. Intergovernmental Review

6. Funding Restrictions

V. APPLICATION REVIEW INFORMATION

1. Review Criteria

2. Review and Selection Process

3. Assessment of Risk

VI. AWARD ADMINISTRATION INFORMATION

1. Award Notices

2. Administrative and National Policy Requirements

3. Reporting

VII. AGENCY CONTACTS

VIII. OTHER INFORMATION

APPENDIX A: EXAMPLE USES OF PCHP FUNDING

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I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for FY 2022 Ending the HIV Epidemic – Primary Care HIV Prevention (PCHP) funding. PCHP funding will expand HIV prevention services1 that decrease the risk of HIV transmission in underserved communities2 in support of Ending the HIV Epidemic in the U.S. This FY 2022 funding opportunity will make available HIV prevention investments to Health Center Program operational (H80) award recipients located in Ending the HIV Epidemic in the U.S.

geographic locations that did not receive FY 2020 or FY 2021 PCHP funding.

Announced in 2019, Ending the HIV Epidemic in the U.S. (EHE) is a Department of Health and Human Services (HHS) initiative to reduce the number of new HIV infections by 75 percent by 2025, and by at least 90 percent by 2030. Activities in the first 5 years of the initiative focus on identified HIV hot spots (targeted geographic locations3): 48 counties; Washington, D.C.; San Juan, Puerto Rico; and seven states that have a substantial rural HIV burden.4 The initiative includes four strategies:

• Diagnose all people with HIV as early as possible after transmission.

• Treat people with HIV rapidly and effectively to reach sustained viral suppression.

• Prevent new HIV transmission by using proven interventions, including pre-exposure prophylaxis (PrEP) and syringe services programs (SSPs).5

• Respond quickly to potential HIV outbreaks to get needed prevention and treatment services to people who need them.

1 The Centers for Disease Control and Prevention (CDC) describes HIV prevention to include multiple strategies, such as pre- and post-exposure prophylaxis, and taking antiretroviral therapy as prescribed.

See Appendix A for example activities that support HIV prevention, and CDC HIV prevention resources available at https://www.cdc.gov/hiv/basics/prevention.html.

2 Underserved communities are “[the] populations sharing a particular characteristic, as well as geographic communities, that have been systematically denied a full opportunity to participate in aspects of economic, social, and civic life, as exemplified by the list in the . . . definition of ‘equity.’” See Executive Order 13985, at § 2(b).

3 Targeted geographic locations may be referred to in other resources as “geographic areas,” “Phase I jurisdictions,” or “Priority Jurisdictions.”

4 Centers for Disease Control and Prevention. HIV Surveillance Report, 2017; vol. 29. Published November 2018. Accessed May 11, 2021. Available at https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2017-vol-29.pdf.

5 Under federal law and policy, Federal funds may not be used to purchase sterile needles or syringes for the hypodermic injection of any illegal drug. For SSP information see, U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Summary of Information on The Safety and Effectiveness of Syringe Services Programs (SSPs). Published May 2019. Accessed May 12, 2021.

Available at https://www.cdc.gov/ssp/syringe-services-programs-summary.html.

https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/jurisdictions/phase-one https://www.hiv.gov/ending-hiv-epidemic https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/jurisdictions https://www.cdc.gov/hiv/basics/prevention.html https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2017-vol-29.pdf https://www.cdc.gov/ssp/syringe-services-programs-summary.html

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2. Background

The Health Center Program is authorized by section 330 of the Public Health Service Act (PHSA) (42 U.S.C. § 254b). Awards under this NOFO are authorized under section 330(e), (g), (h), and/or (i) of the Public Health Service Act (42 U.S.C. § 254b(e), (g), (h), and/or (i)), as appropriate. For the purpose of this NOFO, existing health centers are defined as those receiving funding, as appropriate, under sections 330(e), (g), (h) and/or (i) of the PHSA (42 U.S.C. § 254b(e), (g), (h), and/or (i)). PCHP funding will be awarded to existing health centers under the same subsection(s) of section 330 as their Health Center Program operational grant, or H80, award.

An estimated 1.2 million people in the United States currently live with HIV.6 Following a period of general stability in new HIV infections in the United States, new HIV infections decreased by 8 percent from 2015 to 2019 (34,800 estimated in 2019). This progress is likely due to increased testing, treatment, and PrEP when clinically indicated.7

Health centers are a key point of entry to HIV prevention and treatment services. In 2019, over 2.2 million health center patients received an HIV test. Of those who tested positive for HIV for the first time (7,164), over 87 percent were successfully linked to treatment within 90 days. More than 196,000 patients living with HIV receive medical care services at health centers, and many sites are co-funded by the Ryan White HIV/AIDS Program (RWHAP).8

FY 2022 PCHP awards will build upon FY 20209 and FY 202110 PCHP awards by funding additional health centers with service delivery sites in the targeted geographic locations at the time of the NOFO release.

For information on HRSA-supported HIV and primary care resources, technical assistance, and training, visit the HRSA webpages on EHE and HIV and Health Centers.

6 Centers for Disease Control and Prevention. Estimated HIV incidence and prevalence in the United States, 2015–2019. HIV Surveillance Supplemental Report 2021;26(No. 1). Published May 2021.

Accessed May 27, 2021. Available at http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html.

7 Clinical indication for PrEP is described by the U.S. Preventive Services Task Force Prevention of Human Immunodeficiency Virus (HIV) Infection: Preexposure Prophylaxis recommendations released June 2019 and the Centers for Disease Control and Prevention U.S. Public Health Service “Preexposure Prophylaxis for the Prevention of HIV Infection in the United States- 2017 Update.”

8 U.S. Department of Health and Human Services, Health Resources and Services Administration, Health Center Data and Reporting, available at https://data.hrsa.gov/tools/data-reporting.

9 HRSA-20-091, awarded February 26, 2020.

10 HSRA-21-092, awarded September 16, 2021.

http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section254b&num=0&edition=prelim https://www.hrsa.gov/about/organization/bureaus/hab/index.html https://www.hrsa.gov/about/organization/bureaus/hab/index.html https://bphc.hrsa.gov/program-opportunities/primary-care-hiv-prevention/fy2020-awards https://bphc.hrsa.gov/program-opportunities/primary-care-hiv-prevention/fy21-awards https://www.hrsa.gov/ending-hiv-epidemic https://bphc.hrsa.gov/qualityimprovement/clinicalquality/hivprimarycare.html https://bphc.hrsa.gov/qualityimprovement/clinicalquality/hivprimarycare.html http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/prevention-of-human-immunodeficiency-virus-hiv-infection-pre-exposure-prophylaxis?ds=1&s=prep https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/prevention-of-human-immunodeficiency-virus-hiv-infection-pre-exposure-prophylaxis?ds=1&s=prep https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf https://data.hrsa.gov/tools/data-reporting

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Funding Requirements

You must propose to use PCHP funds to achieve three objectives:

1. Increase the number of patients counseled and tested for HIV.11

2. Increase the number of patients prescribed PrEP.12

3. Increase the number of patients linked to HIV care and treatment within 30 days of diagnosis.13

You will advance progress on the PCHP objectives by implementing activities within four focus areas:

• PrEP prescribing;

• Outreach;

• Testing; and

• Workforce development.

PCHP funds may support HIV prevention activities throughout your service area with a focus on the EHE targeted geographic location. To maximize PrEP access, your proposed project must make reasonable efforts to incorporate the use of available medication assistance and donation programs, including Ready, Set, PrEP,14 before using PCHP funds to support access to PrEP for health center patients.15

HRSA encourages you to consider your team’s cultural and clinical competence, and patients’ barriers to seeking HIV prevention care, such as trauma, stigma, and social determinants of health (SDOH), as you develop your project. HHS defines SDOH as the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks. SDOH can be grouped into five domains: economic stability; education access and quality; health care access and quality; neighborhood and built environment; and social and community context. SDOH affect a wide range of health, functioning, and quality-of-life outcomes and risks.16

11 Branson BM et al. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep 2006 Sep 22; 55:1-17.

12 Centers for Disease Control and Prevention: US Public Health Service: Preexposure prophylaxis for the prevention of HIV infection in the United States—2017 Update: a clinical practice guideline. Published March 2018. Accessed May 11, 2021 at https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines- 2017.pdf.

13 For more information, see Understanding the HIV Care Continuum available at https://www.cdc.gov/hiv/pdf/library/factsheets/cdc-hiv-care-continuum.pdf.

14 HHS launched Ready, Set, PrEP as part of EHE. This national program makes PrEP medications available at no cost to people without prescription drug insurance coverage.

15 Medication assistance and donation programs have their own application and/or data tracking requirements. PCHP funding can be used to support staffing and/or systems to satisfy those requirements.

16 Addressing SDOH, such as intimate partner violence, is a HRSA objective to improve the health and well-being of individuals and the communities in which they reside.

https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-PayingforPrEP-flyer.pdf https://www.hhs.gov/about/news/2019/05/09/trump-administration-secures-historic-donation-of-billions-of-dollars-in-hiv-prevention-drugs.html https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/prep-program https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2017.pdf https://www.cdc.gov/hiv/pdf/library/factsheets/cdc-hiv-care-continuum.pdf https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/prep-program

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HRSA encourages you to leverage PCHP funding to address:

• Equitable access to HIV prevention services;

• Other current and anticipated HIV prevention needs in the service area; and

• Population and SDOH that may affect access to care, contribute to poor health outcomes, and exacerbate health disparities.

Equity is “the consistent and systematic fair, just, and impartial treatment of all individuals, including individuals who belong to underserved communities that have been denied such treatment, such as Black, Latino, Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons;

persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality.”17

Addressing issues of equity should include an understanding of intersectionality and how multiple forms of discrimination impact individuals’ lived experiences. Individuals and communities often belong to more than one group that has been historically underserved, marginalized, or adversely affected by persistent poverty and inequality.

Individuals at the nexus of multiple identities often experience unique forms of discrimination or systemic disadvantages, including in their access to needed services.18

HRSA strongly encourages you to consider how telehealth19 and mobile units can support your proposed service delivery plan. Specifically, tele-PrEP (i.e., PrEP-related clinical services delivered virtually in alignment with your scope of project) can increase medication access and adherence for patients at risk for HIV who face barriers to accessing care.20

HRSA also encourages you to establish or enhance partnerships with RWHAP-funded organizations, health departments, and other community and faith-based organizations.

These partnerships may facilitate referrals of individuals in need of HIV prevention services to health centers for testing and PrEP and, as appropriate, to link individuals testing positive for HIV to these organizations for care and treatment within 30 days of diagnosis. Additionally, partnerships with health departments and other agencies may support comprehensive responses to identified HIV clusters and outbreaks.

17 Executive Order 13985 on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government, 86 FR 7009, at § 2(a) (Jan. 20, 2021), https://www.govinfo.gov/content/pkg/FR-2021-01-25/pdf/2021-01753.pdf.

18 Executive Order 13988 on Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation, 86 FR 2023, at § 1 (Jan. 20, 2021), https://www.govinfo.gov/content/pkg/FR-2021-01- 25/pdf/2021-01761.pdf.

19 Telehealth is the use of electronic information and telecommunications technologies to support and promote, at a distance, health care, patient and professional health-related education, health administration, and public health. Technologies include video conferencing, the internet, store-and-forward imaging, streaming media, and terrestrial and wireless communications.

20 For information about tele-PrEP delivery, see PrEP Telehealth, available at https://www.ncsddc.org/wp-content/uploads/2018/04/PrEP-Telehealth-IB.pdf.

https://www.govinfo.gov/content/pkg/FR-2021-01-25/pdf/2021-01753.pdf https://www.govinfo.gov/content/pkg/FR-2021-01-25/pdf/2021-01761.pdf https://www.govinfo.gov/content/pkg/FR-2021-01-25/pdf/2021-01761.pdf https://www.ncsddc.org/wp-content/uploads/2018/04/PrEP-Telehealth-IB.pdf https://www.ncsddc.org/wp-content/uploads/2018/04/PrEP-Telehealth-IB.pdf

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II. Award Information

1. Type of Application and Award

Type of applications sought: New.

HRSA will provide funding in the form of a grant.

2. Summary of Funding

HRSA expects approximately $50,000,000 to be available annually to fund 150 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 $325,000 (includes both direct and indirect costs) per year. This program notice is subject to the appropriation of funds and is a contingency action taken to ensure that, should funds become available for this purpose, HRSA can process applications and award funds appropriately. The period of performance is August 1, 2022 through July 31, 2024 (2 years). You will apply for 2 years of funding. Funding beyond the first year is subject to the availability of appropriated funds for the Health Center Program in subsequent fiscal years, satisfactory recipient performance, and a decision that continued funding is in the best interest of the Federal Government.

HRSA may adjust the final award amounts based on the number of fundable applications and final FY 2022 appropriations.

If funded, HRSA will award PCHP funding as new grant awards, separate from your H80 award. Under 45 C.F.R. § 75.302, you must document use of PCHP funds separately and distinctly from other Health Center Program funds and other federal award funds.

While PCHP funding will be issued as a new award, all uses of PCHP funds must align with your current Health Center Program scope of project. Your scope of project includes the approved service sites, services, providers, service area, and target population, which are supported (wholly or in part) under your total approved health center budget. You must comply with all Health Center Program requirements as described in the Health Center Program Compliance Manual, and applicable law.21

Funding to support EHE may be made available beyond the 2 years of initial funding under this NOFO. If further funding is made available, HRSA will assess your performance on the PCHP objectives and activities through various means, including triannual reports and the calendar year 2023 Uniform Data System (UDS) data.

Performance assessments may result in increased, level, reduced, or no funding

21 Requirements are stated in 42 U.S.C. § 254b (section 330 of the PHSA), and in applicable program regulations (42 C.F.R. parts 51c and 56, as appropriate) and grants regulations (HHS Grants Policy Statement and 45 C.F.R. part 75).

https://bphc.hrsa.gov/programrequirements/compliancemanual/introduction.html

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beyond the initial 2-year funding period. If funding is continued, this initial award may be supplemented and/or additional funding may be made available under your H80 award.

All HRSA awards are subject to the Uniform Administrative Requirements, Cost Principles, and Audit Requirements at 45 C.F.R. part 75. See Section IV.2.iii for instructions on the development of the application budget.

III. Eligibility Information

1. Eligible Applicants

Organizations eligible for PCHP funding:

• Are Health Center Program operational (H80) grant award recipients under sections 330(e), (g), (h), and/or (i),

• Have at least one operational service delivery site at a fixed address22 in one of the targeted geographic locations, and

• Did not receive an FY 2020 or FY 2021 PCHP award.

See the PCHP technical assistance webpage for a list of eligible health centers.

2. Cost Sharing/Matching

Cost sharing/matching is not required for this program.

3. Other

HRSA will consider any application that exceeds the ceiling amount of $325,000 for Year 1 on the SF-424A and Budget Narrative non-responsive and will not consider it for funding under this notice.

HRSA will consider any application that does not include the Project Narrative described in Section IV.2.ii non-responsive and will not consider it for funding under this notice.

HRSA will consider any application that fails to satisfy the deadline requirements referenced in Section IV.4 non-responsive and will not consider it for funding under this notice.

HRSA will only accept one validated electronic submission under HRSA-22-104 in Grants.gov.23 Applications submitted after the first submission will be marked as duplicates and considered ineligible for review. If you wish to change information submitted in a Grants.gov application, you may do so in the HRSA Electronic Handbooks (EHBs) application phase.

22 Intermittent and temporary sites do not qualify.

23 Grants.gov has compatibility issues with Adobe Reader DC. Direct questions pertaining to software compatibility to Grants.gov. See Section VII for contact information.

http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=4d52364ec83fab994c665943dadf9cf7&ty=HTML&h=L&r=PART&n=pt45.1.75 https://files.hiv.gov/s3fs-public/Ending-the-HIV-Epidemic-Counties-and-Territories.pdf https://bphc.hrsa.gov/program-opportunities/primary-care-hiv-prevention/fy2020-awards https://bphc.hrsa.gov/program-opportunities/primary-care-hiv-prevention/fy21-awards https://bphc.hrsa.gov/program-opportunities/funding-opportunities/pchp

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If you wish to change information submitted in EHBs, you may reopen and revise your application. You must ensure that the application is resubmitted to HRSA before the EHBs deadline or HRSA will not consider it for funding under this notice.

IV. Application and Submission Information

1. Address to Request Application Package

HRSA requires you to apply electronically through Grants.gov and EHBs. You must use a two-phase submission process associated with this NOFO and follow the directions provided at http://www.grants.gov/applicants/apply-for-grants.html and in EHBs.

• Phase 1 – Grants.gov – Required information must be submitted and validated via Grants.gov with a due date of December 14, 2021 at 11:59 p.m. ET; and

• Phase 2 – EHBs – Supplemental information must be submitted via EHBs with a due date of January 18, 2022 at 5 p.m. ET.

Only applicants who successfully submit the workspace application package associated with this NOFO in Grants.gov (Phase 1) by the due date may submit the additional required information in EHBs (Phase 2).

The NOFO is also known as “Instructions” on Grants.gov. You must select “Subscribe” and provide your email address for HRSA-22-104 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 5 of HRSA’s SF-424 Two-Tier Application Guide provides instructions for the budget, budget narrative, certifications, etc. You must submit the information outlined in the 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 Two-Tier Application Guide except where instructed in the NOFO to do otherwise. You must submit the application in English and U.S. dollars (45 C.F.R. § 75.111(a)).

The following application components must be submitted in Grants.gov:

• Application for Federal Assistance (SF-424)

• Project Abstract

• Project/Performance Site Locations http://www.grants.gov/applicants/apply-for-grants.html https://www.grants.gov/web/grants/applicants.html https://www.hrsa.gov/sites/default/files/hrsa/grants/apply/applicationguide/sf-424-program-specific-app-guide.pdf https://www.hrsa.gov/sites/default/files/hrsa/grants/apply/applicationguide/sf-424-program-specific-app-guide.pdf https://www.hrsa.gov/sites/default/files/hrsa/grants/apply/applicationguide/sf-424-program-specific-app-guide.pdf https://ecfr.io/Title-45/Section-75.111

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• Grants.gov Lobbying Form

• Key Contacts

The following application components must be submitted in EHBs:

• Project Narrative

• Budget Information – Non-Construction Programs (SF-424A)

• Budget Narrative and Table of Personnel Paid with Federal Funds

• Program-Specific Forms

• Attachments

See Section 9.5 of the SF-424 Two-Tier Application Guide for the Application Completeness Checklist.

Application Page Limit The total size of all uploaded files may not exceed the equivalent of 60 pages when printed by HRSA. The page limit includes the project and budget narratives, attachments, and letters of support. Note that effective April 22, 2021, the abstract is no longer an attachment that counts in the page limit. The abstract is the standard form "Project Abstract Summary.” Standard OMB-approved forms do not count in the page limit. However, if you use an OMB-approved form that is not included in the application package for HRSA-22-104, it may count against the page limit. Therefore, HRSA strongly recommends that you only use the Grants.gov workspace and EHBs forms associated with this NOFO to avoid exceeding the page limit. The indirect cost rate agreement does not count in the page limit. It is therefore important to take appropriate measures to ensure that your application does not exceed the specified page limit.

Applications must be complete, within the specified page limit, validated by Grants.gov, and submitted under HRSA-22-104 before the Grants.gov and EHBs deadlines.

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 C.F.R. § 75.371, including suspension or debarment. (See also 2 C.F.R.

parts 180 and 376, and 31 U.S.C. § 3321.)

3) If you are unable to attest to the statements in this certification, you must include an explanation in ATTACHMENT 2: Other Relevant Documents.

See Section 5.1.viii of HRSA’s SF-424 Two-Tier Application Guide for additional information on all certifications.

http://www.hrsa.gov/grants/apply/applicationguide/sf424programspecificappguide.pdf https://www.hrsa.gov/sites/default/files/hrsa/grants/apply/applicationguide/sf-424-program-specific-app-guide.pdf

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Program-Specific Instructions In addition to application requirements and instructions in Sections 4 and 5 of HRSA’s SF-424 Two-Tier Application Guide (including the budget, budget narrative, certifications, and abstract), include the following:

i. Project Abstract (Submit in Grants.gov) See Section 5.1.ix of HRSA’s SF-424 Two-Tier Application Guide. In addition, provide your Health Center Program grant number (H80CSXXXXX – reminder: this is an eligibility factor) and a brief summary of how your proposed project will increase the number of patients counseled and tested for HIV, the number of patients prescribed PrEP, and the number of patients linked to HIV care and treatment within 30 days of diagnosis, and a brief description of how the proposed project will focus on the targeted geographic locations.

NARRATIVE GUIDANCE

To ensure that you fully address the review criteria, this table 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, Forms, and Attachments Review Criteria Need section of the Project Narrative (1) Need Response section of the Project Narrative Project Overview Form: Work Plan (2) Response

Collaboration section of the Project Narrative Attachment 1: Letters of Support

(3) Collaboration

Resources/Capabilities section of the Project Narrative (4) Resources/Capabilities

Evaluative Measures section of the Project Narrative (5) Evaluative Measures

Support Requested section of the Project Narrative Forms: SF-424A Budget Information Form, Federal Object Class Categories Form, Equipment List Forms (if applicable) Budget Narrative

(6) Support Requested

ii. Project Narrative (Submit in EHBs – required for completeness) 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 numbering format below so that reviewers can understand the proposed project.

https://www.hrsa.gov/sites/default/files/hrsa/grants/apply/applicationguide/sf-424-program-specific-app-guide.pdf http://www.hrsa.gov/grants/apply/applicationguide/sf424programspecificappguide.pdf

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Use the following section headers for the narrative: Need, Response, Collaboration, Resources/Capabilities, Evaluative Measures, and Support Requested.

NEED – Corresponds to Section V.1 Review Criterion 1: NEED

Information provided in the NEED section must:

• Serve as the basis for, and align with, the activities, focus areas, and objectives described throughout the application.

• Be used to inform and improve the delivery of the proposed PCHP services.

1) Describe the HIV testing and treatment needs of your service area. Specifically:

a) Provide the estimated number of people, including current health center patients, in need of HIV testing in your service area and how you determined that number.

Sources of needs information may include, but are not limited to, your current needs assessment,24 as well as community health needs assessments (such as those conducted by a hospital, health department, or other organization that serves the service area).

b) Describe factors in your service area that affect access to or use of HIV testing (e.g., transportation, income level, employment, insurance, education, stigma/bias, perceived HIV risk). Include any unique population-specific health care needs or characteristics that affect health status (e.g., food or housing insecurity, financial strain, physical environment, intimate partner violence (including human trafficking), language or cultural barriers).

c) Describe the effect of COVID-19 on access to or use of HIV testing in your service area.

2) Describe the PrEP needs of the service area. Specifically:

a) Provide the estimated number of people, including current health center patients, in need of PrEP in your service area and how you determined that number.

Sources of needs information may include, but are not limited to, your current needs assessment,24 persons with PrEP indications estimation tool (https://prepind.shinyapps.io/prepind2/), and community health needs assessments.

b) Describe factors in your service area that affect access to or use of PrEP (e.g., transportation, income level, employment, insurance, education, stigma/bias, perceived HIV risk). Include any unique population-specific health care needs or characteristics that affect health status (e.g., food or housing insecurity, financial strain, physical environment, intimate partner violence (including human trafficking), language or cultural barriers).

c) Describe the effect of COVID-19 on access to or use of PrEP in your service area.

3) Describe the linkage to HIV care and treatment needs of the service area.

Specifically:

24 See Chapter 3: Needs Assessment of the Compliance Manual.

https://prepind.shinyapps.io/prepind2/ https://bphc.hrsa.gov/programrequirements/compliancemanual/chapter-3.html

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a) Provide the estimated number of people, including current health center patients, in need of HIV care and treatment in your service area and how you determined that number. Sources of information may include, but are not limited to, your current needs assessment,24 as well as community health needs assessments (such as those conducted by a hospital, health department, or other organization that serves the service area).

b) Describe factors in your service area that affect linkage to HIV care and treatment (e.g., transportation, income level, employment, insurance, education, stigma/bias, perceived HIV risk). Include any unique population-specific health care needs or characteristics that affect health status (e.g., food or housing insecurity, financial strain, physical environment, intimate partner violence (including human trafficking), language or cultural barriers).

c) Describe the effect of COVID-19 on linkage to HIV care and treatment needs in your service area.

RESPONSE – Corresponds to Section V.1 Review Criterion 2: RESPONSE

1) Complete the structured work plan on the Project Overview Form in EHBs by selecting or describing activities that you will conduct to achieve the PCHP objectives:

1. Increase the number of patients counseled and tested for HIV.

2. Increase the number of patients prescribed PrEP.

3. Increase the number of patients linked to HIV care and treatment within 30 days of diagnosis.

Describe in EHBs how each specific activity proposed addresses an unmet need or barrier to achieving increases in HIV testing, PrEP prescribing, and/or linkage to HIV care and treatment within 30 days of diagnosis. Refer to Section IV.2.v. Program- Specific Forms for detailed guidance.

Appendix A: Example Uses of Funding lists example activities that may help your health center to expand HIV prevention services.

2) Describe how you will avoid or lessen the effect of COVID-19 on your planned activities.

3) Describe how the proposed personnel (direct hire and contracted) listed in the Budget Narrative are essential and sufficient to successfully implement the proposed project, including clearly describing each individuals’ role in the proposed project.

4) Describe how the HIV prevention services supported with PCHP funding will be delivered in an integrated manner with other comprehensive primary care services to ensure optimal health results and advance health equity within your service area (e.g., patient navigation, team-based care, testing for and treating co-occurring health conditions).

5) Describe how you will incorporate medication assistance/donation programs, including Ready, Set, PrEP, to help patients afford PrEP.

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6) Describe how you will use heath IT, including electronic health record (EHR) systems and telehealth, to improve the quality of HIV prevention services.

Specifically address plans for use of mobile technologies (e.g., text reminders) and tele-PrEP, including integration with home testing (see the BPHC Bulletin on HIV self-testing, for more information:

https://content.govdelivery.com/accounts/USHHSHRSA/bulletins/28da1bc).

COLLABORATION – Corresponds to Section V.1 Review Criterion 3:

COLLABORATION

1) Describe partnerships with other providers/organizations in your service area, including health departments, RWHAP-funded organizations, other health centers, and other community-based organizations providing services to the target population, to ensure that HIV testing, PrEP prescribing, and HIV care and treatment are available to all individuals in need in your service area, including how you will:

a) Establish or enhance partnerships.

b) Work together to build upon existing and forthcoming EHE activities.

c) Leverage these relationships to facilitate referrals of patients to your health center for PrEP.

d) Leverage these relationships to prepare for or respond to identified clusters and outbreaks of HIV.

2) Provide letters of support from partnering providers/organizations that will play a significant role in the implementation of your project, if any (e.g., will provide HIV care and treatment for your referred patients). Letters of support must be current and must include a signature. Additional letters of support may also be provided, as desired.

RESOURCES/CAPABILITIES – Corresponds to Section V.1 Review Criterion 4:

RESOURCES/CAPABILITIES

1) Describe the capabilities and expertise that qualify your health center to carry out the proposed project, including the skills and experience of proposed project personnel, including specific operational and/or clinical experience related to HIV prevention or associated services.

2) Describe efforts that you will make to enhance cultural competence in the area of HIV prevention or associated services (i.e., HIV testing, treatment, and linkage to care and treatment) in your health center.

3) Describe resources that you will leverage to support project implementation, such as technical assistance providers and peer support programs (e.g., hotlines, peer virtual groups, PrEP SMS support).

https://content.govdelivery.com/accounts/USHHSHRSA/bulletins/28da1bc https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/funding

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EVALUATIVE MEASURES – Corresponds to Section V.1 Review Criterion 5:

EVALUATIVE MEASURES

1) Provide baseline and estimated data showing estimated patient increases for the following metrics by your 2023 UDS25 report:

a) Patients tested for HIV.

b) Patients prescribed PrEP.

c) Percentage of patients newly diagnosed with HIV who were seen for follow-up treatment within 30 days of diagnosis.

Describe how you determined your estimations and why you consider them achievable by December 31, 2023.

2) Describe how your quality improvement/quality assurance (QI/QA) program will support the proposed project, including:

a) How you include or will incorporate HIV prevention activities and patient data into your QI/QA program.

b) How your QI/QA program will support evolution of your HIV prevention activities commensurate with the evolving needs of your patient population and service area.

c) How you will use QI/QA reports for PCHP project improvement.

d) How you include or will incorporate into your QI/QA procedures and processes current clinical guidelines, standards of care, and standards of practice in the provision of HIV-prevention services.

SUPPORT REQUESTED – Corresponds to Section V.1 Review Criterion 6: SUPPORT

REQUESTED

1) Provide a consistent budget presentation (i.e. SF-424A, Federal Object Class Category (FOCC), Budget Narrative) that aligns with the proposed plan to expand HIV prevention services (as outlined in the RESPONSE section and the work plan) and estimated measures improvement (as outlined in the Evaluative Measures section).

iii. Budget (Submit in EHBs) Follow the instructions included in Section 5.1.iv of HRSA’s SF-424 Two-Tier Application Guide and the additional budget instructions provided below. A budget that follows the Application Guide will ensure that, if HRSA selects your application for funding, you will have a well-organized financial plan and, by carefully following the approved plan, may be able to avoid audit issues during the implementation phase.

Reminder: The Total Project or Program Costs are the total allowable costs26 (inclusive

25 For more information about these measures, see the 2021 UDS Manual, available at https://bphc.hrsa.gov/sites/default/files/bphc/datareporting/pdf/2021-uds-manual.pdf.

26 For details on allowable costs, see 45 C.F.R. part 75, available at http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75.

https://www.hrsa.gov/sites/default/files/hrsa/grants/apply/applicationguide/sf-424-program-specific-app-guide.pdf https://www.hrsa.gov/sites/default/files/hrsa/grants/apply/applicationguide/sf-424-program-specific-app-guide.pdf https://bphc.hrsa.gov/sites/default/files/bphc/datareporting/pdf/2021-uds-manual.pdf http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75 http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75

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of direct and indirect costs) you incur to carry out a HRSA-supported project or activity.

Total project or program costs include costs charged to the award and costs borne by you.

In addition, PCHP requires the following.

You must present the total budget for the project, which includes PCHP funds (up to $325,000 annually) and all non-federal funds that will support the proposed project. You have discretion about how you propose to allocate the total budget between PCHP federal funds and other funding that supports the project, provided that the projected budget complies with all applicable HHS policies and other federal requirements.27

PCHP funding may support eligible costs associated with SSPs, which are an effective public health approach to reduce the spread of infectious diseases such as HIV.28 All activities must be carried out consistent with Health Center Program requirements as described in the Health Center Program Compliance Manual, including those associated with Chapter 9: Sliding Fee Discount Program.

Budget Information Form (SF-424A):

• In Section A, enter the PCHP funding requested in the Federal column for year 1

(12 months) of funding. The maximum amount you may request cannot exceed $325,000.

• In Section A – Budget Summary, under New or Revised Budget, in the Federal column, enter the federal funding requested for year 1 for each type of section 330 funding under subsections (e), (g), (h) and/or (i) of the PHSA (Community Health Center, Migrant Health Center, Health Care for the Homeless, and/or Public Housing Primary Care, collectively “population types”) that you currently receive. Funding must be requested and will be awarded proportionately for all population types for which you currently receive Health Center Program funding.

No new population types may be added for this purpose. Enter all other project costs in the Non-Federal column. Estimated Unobligated Funds are not applicable for this funding opportunity.

• In Section B – Budget Categories, enter an object class category (line item) budget for year 1, broken out by federal and nonfederal funding. The amounts for each category in the Federal and Non-Federal columns, as well as the totals, should align with the Budget Narrative.

• In Section C – Non-Federal Resources, enter the amount of all other sources of funding for the proposal for year 1, not including the federal funding request. The total in Section C must be consistent with the Non-Federal Total in Section A.

When providing Non-Federal Resources by funding source, include other federal funds supporting the proposed project in the “other” category.

27 See Chapter 17: Budget of the Compliance Manual.

28 For guidance on using federal funding to support SSPs, see Department of Health and Human Services Implementation Guidance to Support Certain Components of Syringe Services Programs, 2016 and the HRSA-Specific Implementation Guidance to Support Certain Components of Syringe Services Programs, 2016.

https://www.hiv.gov/federal-response/policies-issues/syringe-services-programs https://bphc.hrsa.gov/programrequirements/compliancemanual/introduction.html https://bphc.hrsa.gov/programrequirements/compliancemanual/chapter-9.html#titletop https://bphc.hrsa.gov/programrequirements/compliancemanual/chapter-17.html https://www.cdc.gov/hiv/pdf/risk/hhs-ssp-guidance.pdf https://www.cdc.gov/hiv/pdf/risk/hhs-ssp-guidance.pdf https://www.hiv.gov/sites/default/files/hhs-ssp-hrsa-guidance.pdf https://www.hiv.gov/sites/default/files/hhs-ssp-hrsa-guidance.pdf

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• In Section E – Federal Funds Needed for Balance of the Project, enter your federal PCHP funding request for year 2 in the first column for each type of section 330 funding that you currently receive (similar to Section A). The maximum amount you may request cannot exceed $325,000.

The Further Consolidated Appropriations Act, 2021 (P.L. 116-260), Division H, § 202 states, “None of the funds…