PKG00264373-instructions.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Bureau of Primary Health Care Health Center Program

Fiscal Year 2021 Ending the HIV Epidemic – Primary Care HIV Prevention

Funding Opportunity Number: HRSA-21-092 Funding Opportunity Types: New

Assistance Listings (CFDA) Number: 93.527

NOTICE OF FUNDING OPPORTUNITY

Fiscal Year 2021

Application Due Date in Grants.gov: February 2, 2021 Supplemental Information Due Date in EHBs:

March 1, 2021

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: December 4, 2020

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-21-092 i

EXECUTIVE SUMMARY

The Health Resources and Services Administration (HRSA) is accepting applications for the fiscal year (FY) 2021 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 geographic locations identified by Ending the HIV Epidemic: A Plan for America. This FY 2021 funding will make available HIV prevention investments to Health Center Program operational (H80) grant award recipients located in Ending the HIV Epidemic:

A Plan for America geographic locations that did not receive FY 2020 PCHP funding.

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) 2021 Ending the HIV Epidemic - Primary Care HIV Prevention

(PCHP)

Funding Opportunity Number: HRSA-21-092 Due Date for Applications – Grants.gov: February 2, 2021 (11:59 p.m. ET) Due Date for Supplemental Information – HRSA Electronic Handbooks (EHBs):

March 1, 2021 (5 p.m. ET)

Anticipated Total Annual Available Funding: Approximately $83 million Estimated Number and Type of Awards: Up to 300 awards Estimated Award Amount: $275,000, subject to availability of funds Cost Sharing/Match Required: No Period of Performance: 2 years, beginning August 1, 2021 Eligible Applicants: Organizations that:

• Are receiving Health Center Program operational (H80) grant funding,

• Are located in the 57 geographic locations identified by Ending the HIV Epidemic: A Plan for America, and

• Did not receive an FY 2020 PCHP award.

See Section III.1 of this notice of funding opportunity (NOFO) for details.

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

HRSA-21-092 ii

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.

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 People and Health Information Technology 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 to advance 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 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://bphc.hrsa.gov/programopportunities/fundingopportunities/sac/supportnetworks/index.html https://bphc.hrsa.gov/programopportunities/fundingopportunities/sac/supportnetworks/index.html

HRSA-21-092 iii

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) ... 18

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

HRSA-21-092 1

I. Program Funding Opportunity Description

1. Purpose

This notice announces the opportunity to apply for FY 2021 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 geographic locations identified by Ending the HIV Epidemic: A Plan for America. This FY 2021 funding opportunity will make available HIV prevention investments to Health Center Program operational (H80) award recipients located in Ending the HIV Epidemic: A Plan for America geographic locations that did not receive FY 2020 PCHP funding.

Announced in 2019, Ending the HIV Epidemic: A Plan for America is a Department of Health and Human Services (HHS) initiative to reduce the number of new HIV infections by 75 percent within 5 years, and by at least 90 percent within 10 years. Initiative activities currently focus on identified HIV hot spots (targeted geographic locations2), which are: 48 counties; Washington, D.C.; San Juan, Puerto Rico; and seven states that have a substantial rural HIV burden.3

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).4

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

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

3 Centers for Disease Control and Prevention. HIV Surveillance Report, 2017; vol. 29. Published November 2018. Accessed February 11, 2020. Available at https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2017-vol-29.pdf.

4 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 February 12, 2020. 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/overview https://www.hiv.gov/ending-hiv-epidemic https://files.hiv.gov/s3fs-public/Ending-the-HIV-Epidemic-Counties-and-Territories.pdf http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section254b&num=0&edition=prelim 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

HRSA-21-092 2

and/or (i)), as appropriate. For the purpose of this NOFO, existing health centers are defined as those receive 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.5 Annual HIV infections in the United States have decreased by more than two-thirds since the mid- 1980s. However, the number of new infections has remained relatively stable in recent years (36,400 estimated in 2018), indicating that effective HIV prevention and treatment strategies are not adequately reaching individuals in need. New HIV infections are preventable through testing, treatment, and PrEP when clinically indicated.6

Health centers are a key point of entry to HIV prevention and treatment services. In 2019, 2.2 million (2,233,156) 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).7

Health centers are well-positioned to advance the Ending the HIV Epidemic initiative by leveraging their integrated service delivery model. The model integrates comprehensive primary care services, which includes HIV prevention, with behavioral health and enabling services. Integrated care can reduce transmission of HIV infection; improve health outcomes for people with HIV infection; and prevent, identify, and treat co-infections and co-morbidities, such as sexually transmitted infections and substance use disorders.8 Furthermore, the health centers’ use of inter-professional teams, patient-centric approaches, care management, and coordinated care have demonstrated success in overcoming common barriers to patients initiating and continuing services for HIV prevention and treatment.9

5 Centers for Disease Control and Prevention. Estimated HIV incidence and prevalence in the United States, 2014–2018. HIV Surveillance Supplemental Report 2020;25(No. 1). Published May 2020.

Accessed May 19, 2020. Available at http://www.cdc.gov/hiv/library/reports/hiv-surveillance.html.

6 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.”

7 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.

8 Remien RH, Berkman A, Myer L, Bastos FI, Kagee A, El-Sadr WM. Integrating HIV care and HIV prevention: legal, policy and programmatic recommendations. AIDS. 2008;22 Suppl 2(Suppl 2):S57–S65.

9 U.S. Department of Health and Human Services, Health Resources and Services Administration, Bureau of Primary Health Care. Integrating HIV Care, Treatment & Prevention Services into Primary Care

– A Toolkit for Health Centers. Rockville, Maryland: U.S. Department of Health and Human Services, 2017.

https://www.hrsa.gov/about/organization/bureaus/hab/index.html https://www.hrsa.gov/about/organization/bureaus/hab/index.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

HRSA-21-092 3

FY 2021 PCHP awards will build upon FY 2020 PCHP awards10 to 195 health centers by funding additional health centers with permanent service delivery sites (i.e., sites that operate at a fixed address and are open year round) 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 Ending the HIV Epidemic: A Plan for America and HIV and Health Centers.

http://bphc.hrsa.gov/programopportunities/fundingopportunities/SAC/index.html Funding Requirements

Your application must demonstrate how you will 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.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 Ending the HIV Epidemic targeted geographic location. To maximize PrEP access, your proposed project should 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

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

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 on March 25, 2020 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 the Ending the HIV Epidemic initiative. 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.

https://bphc.hrsa.gov/program-opportunities/primary-care-hiv-prevention/fy2020-awards https://www.hrsa.gov/ending-hiv-epidemic https://www.hrsa.gov/ending-hiv-epidemic https://bphc.hrsa.gov/qualityimprovement/clinicalquality/hivprimarycare.html http://bphc.hrsa.gov/programopportunities/fundingopportunities/SAC/index.html https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-PayingforPrEP-flyer.pdf 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

HRSA-21-092 4

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. SDOH include factors like socioeconomic status, neighborhood and physical environment, social support networks, community violence, and intimate partner violence. SDOH affect a wide range of health, functioning, and quality-of-life outcomes and risks. 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.

HRSA strongly encourages you to consider how telehealth16 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.17

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.

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 estimates approximately $83 million to be available annually to fund 300 recipients. You may apply for a ceiling amount of $275,000 total cost (includes both direct and indirect costs) per year. The actual amount available will not be determined until enactment of the final FY 2021 federal appropriation. 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 in a timely manner.

16 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.

17 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.ncsddc.org/wp-content/uploads/2018/04/PrEP-Telehealth-IB.pdf https://www.ncsddc.org/wp-content/uploads/2018/04/PrEP-Telehealth-IB.pdf

HRSA-21-092 5

The funding start date is August 1, 2021. 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 2021 appropriations.

PCHP funding will have a separate grant number than your H80 award. You must document use of PCHP funds separately and distinctly from other Health Center Program 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. As a condition of this grant, you must comply with all Health Center Program requirements as described in the Health Center Program Compliance Manual, and applicable law.18

Funding to support the Ending the HIV Epidemic initiative 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 through various means, including triannual reports and annual Uniform Data System (UDS) data.

Performance assessments may result in increased, level, reduced, or no additional funding. If further funding is awarded, this award may be supplemented and/or further 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

PCHP funding is available to organizations that:

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

• Have at least one permanent operational service delivery site (i.e., sites that operate at a fixed address and are open year round) in one of the targeted geographic locations, and

18 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 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

HRSA-21-092 6

• Did not receive an FY 2020 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 non-responsive any application that exceeds the ceiling amount on the SF-424A and Budget Narrative 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 this funding opportunity number in Grants.gov.19 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.

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 February 2, 2021 at 11:59 p.m. ET; and

• Phase 2 – EHBs – Supplemental information must be submitted via EHBs with a due date of March 1, 2021 at 5 p.m. ET.

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

https://bphc.hrsa.gov/program-opportunities/primary-care-hiv-prevention/fy2020-awards https://bphc.hrsa.gov/program-opportunities/funding-opportunities/pchp http://www.grants.gov/applicants/apply-for-grants.html

HRSA-21-092 7

Note: The EHBs application module will be available December 18, 2020.

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-21-092 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, and abstract. 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 (attached under box 15 of the SF-424)

• Project/Performance Site Locations

• 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 abstract, project and budget narratives, attachments, and letters of support. Standard OMB-approved forms do not count in the page limit. The indirect cost rate agreement does not count in the page limit. We 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 http://www.hrsa.gov/grants/apply/applicationguide/sf424programspecificappguide.pdf

HRSA-21-092 8

strongly urge you 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-21-092 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.

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), 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; and a brief description of how the proposed project will focus on the targeted geographic locations.

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.

Successful applications will contain the information below. 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

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

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

HRSA-21-092 9

a) Provide the estimated number of people in need of HIV testing in your service area and how you determined that number. Sources of information may include, but are not limited to, your current needs assessment,20 Centers for Disease Control and Prevention’s HIV surveillance reports (https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html), CDC National HIV Behavioral Surveillance (NHBS) reports (https://www.cdc.gov/hiv/statistics/systems/nhbs/index.html), and 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, intimate partner violence (including human trafficking), language or cultural barriers).

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

a) Provide the estimated number of people in need of PrEP in your service area and how you determined that number. Sources of information may include, but are not limited to, your current needs assessment, persons with PrEP indications estimation tool (https://prepind.shinyapps.io/prepind2/),CDC HIV surveillance reports (https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html), CDC NHBS reports (https://www.cdc.gov/hiv/statistics/systems/nhbs/index.html), 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, intimate partner violence (including human trafficking), language or cultural barriers).

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

Specifically:

a) Provide the estimated number of people 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,21 Centers for Disease Control and Prevention’s HIV surveillance reports (https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html), CDC National HIV Behavioral Surveillance (NHBS) reports (https://www.cdc.gov/hiv/statistics/systems/nhbs/index.html), and community

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

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

https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html https://www.cdc.gov/hiv/statistics/systems/nhbs/index.html https://prepind.shinyapps.io/prepind2/ https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html https://www.cdc.gov/hiv/statistics/systems/nhbs/index.html https://www.cdc.gov/hiv/library/reports/hiv-surveillance.html https://www.cdc.gov/hiv/statistics/systems/nhbs/index.html https://bphc.hrsa.gov/programrequirements/compliancemanual/chapter-3.html https://bphc.hrsa.gov/programrequirements/compliancemanual/chapter-3.html

HRSA-21-092 10

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, intimate partner violence (including human trafficking), language or cultural barriers).

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.

In the structured work plan, describe how each activity proposed addresses an unmet need or barrier to achieving increases in HIV testing, PrEP prescribing, and/or linkage to HIV care and treatment. Refer to Section IV.2.v. Program-Specific Forms for detailed guidance. In your narrative response, describe mitigation strategies that will be utilized to avoid or lessen the impact of COVID-19 or other public health emergency disruptions on your planned activities.

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

2) 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 individual’s role in the PCHP project.

3) 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).

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

5) 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

HRSA-21-092 11

self-testing, for more information:

https://content.govdelivery.com/accounts/USHHSHRSA/bulletins/28da1bchttps://ww w.cdc.gov/hiv/testing/self-testing.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fhiv%2Ftesting%2Fhome-specimen-collection.html).

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

COLLABORATION

1) Describe how you will establish or enhance partnerships with other providers/organizations delivering HIV testing, PrEP prescribing, and HIV care and treatment, including health departments, RWHAP-funded organizations, and other health centers.

a. Describe how you will work together to build upon existing and forthcoming Ending the HIV Epidemic activities.

b. Describe how you will leverage these relationships to facilitate referrals of patients to your health center for PrEP.

2) In ATTACHMENT 1, include letters of support.

a) Required: Providers/organizations that will provide HIV testing, PrEP prescribing, HIV care and treatment, and/or other related services on behalf of your health center (through an agreement/arrangement) in support of your PCHP project.

b) Optional: Other health centers (Health Center Program award recipients and look-alikes) and/or other HIV prevention service providers/organizations in the service area (health department, community-based organization) to demonstrate support for the proposed project.

Letters of support must be current and must include a signature. If you are not able to obtain a required support letter, include documentation of efforts made to obtain the letter.

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, and also cultural competence in the area of HIV prevention or associated services (i.e., HIV testing, treatment, and linkage to care and treatment).

2) 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://content.govdelivery.com/accounts/USHHSHRSA/bulletins/28da1bc https://www.cdc.gov/hiv/testing/self-testing.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fhiv%2Ftesting%2Fhome-specimen-collection.html https://www.cdc.gov/hiv/testing/self-testing.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fhiv%2Ftesting%2Fhome-specimen-collection.html https://www.cdc.gov/hiv/testing/self-testing.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fhiv%2Ftesting%2Fhome-specimen-collection.html https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/funding

HRSA-21-092 12

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

EVALUATIVE MEASURES

1) Describe how you will measure progress on the following metrics for reporting annually in the UDS as well as in triannual reports:22

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.

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

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 Categories (FOCC) Form, Budget Narrative) that aligns with the proposed plan to expand HIV prevention services (as outlined in the RESPONSE section and the work plan) and projected measures improvement (as outlined in the Evaluative Measures section).

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

22 For more information about these measures, see the 2020 UDS Manual, available at https://bphc.hrsa.gov/sites/default/files/bphc/datareporting/pdf/2020-uds-manual.pdf.

https://bphc.hrsa.gov/sites/default/files/bphc/datareporting/pdf/2020-uds-manual.pdf

HRSA-21-092 13

Narrative Section, Forms, and Attachments Review Criteria

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

(3) Collaboration

Evaluative Measures section of the Project Narrative (4) Evaluative Measures

Resources/Capabilities section of the Project Narrative (5) Resources/Capabilities

Support Requested section of the Project Narrative

SF-424A

Budget Narrative

FOCC

(7) Support Requested

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 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 costs23 (inclusive 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 $275,000 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.24

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.25 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.

23 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.

24 See Chapter 17: Budget of the Compliance Manual.

25 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.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.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 http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75 http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75 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

HRSA-21-092 14

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 $275,000.

• 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.

• 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 $275,000.

The Further Consolidated Appropriations Act, 2020 (P.L. 116-94), Division A, § 202 states, “None of the funds appropriated in this title shall be used to pay the salary of an individual, through a grant or other extramural mechanism, at a rate in excess of Executive Level II.” See Section 5.1.iv Budget – Salary Limitation of HRSA’s SF-424 Two-Tier Application Guide for additional information. Note that these or other salary limitations will apply in the following fiscal years, as required by law.

iv. Budget Narrative (Submit in EHBs) PCHP requires a detailed budget narrative that outlines federal and non-federal costs for year 1 and year 2 by object class category. The sum of line item costs for each category must align with those presented on the SF-424A Budget Information Form.

See Section 5.1.v of HRSA’s SF-424 Two-Tier Application Guide. In addition, provide a table of personnel to be paid with federal funds, as shown in the example provided in HRSA’s SF-424 Two-Tier Application Guide. For year 2, the narrative should highlight the changes from year 1 or clearly indicate that there are no substantive changes. See the PCHP Technical Assistance webpage for an example Budget Narrative.

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://www.hrsa.gov/sites/default/files/hrsa/grants/apply/applicationguide/sf-424-app-guide-2-tier.pdf

HRSA-21-092 15

Your budget narrative must:

• Demonstrate that you will use PCHP funds for costs that will advance progress on the PCHP objectives.

• Clearly detail proposed costs for each line item on the SF-424A Budget

Information…