RFA-PS-25-113_20241216.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR HIV, VIRAL HEPATITIS, STD AND TB PREVENTION

Develop and Test HIV Prevention Interventions for Black and Hispanic Gay, Bisexual, and Other Men Who Have Sex with Men Who Use Substances

RFA-PS-25-113

02/20/2025

Table of Contents Section I. Funding Opportunity Description

Section II. Award Information

Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contacts

Section VIII. Other Information

Overview

Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Components of Participating Organizations:

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Notice of Funding Opportunity (NOFO) Title Develop and Test HIV Prevention Interventions for Black and Hispanic Gay, Bisexual, and Other Men Who Have Sex with Men Who Use Substances Activity Code U01 – Research Project - Cooperative Agreements

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-PS-25-113

Assistance Listings Number(s) 93.084 Category of Funding Activity HL - Health NOFO Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to support pilot research to develop and test behavioral implementation strategies for biomedical interventions (e.g., oral PrEP, condoms) to improve HIV and STI prevention implementation among disproportionately affected populations, especially Black/African American (Black) and Hispanic/Latino (Hispanic) gay, bisexual, and other men who have sex with men (MSM) without HIV who report substance use (drug or alcohol). The study design and sample size should meet minimum requirements for consideration of the CDC Compendium of Best Evidence (https://www.cdc.gov/hivpartners/php/compendium/), and thus may have the potential for future CDC HIV prevention implementation in jurisdictions around the United States. Applicants should have access to research participants in priority jurisdictions outlined in Ending the HIV Epidemic in the United States (EHE), in support of the goals of EHE (Ending the HIV Epidemic in the US (EHE) | EHE Initiative | CDC), the HIV National Strategic Plan for the United States:

A Roadmap to End the HIV Epidemic (2021-2025) (https://www.cdc.gov/nchhstp/media/pdfs/2024/08/hiv-national-strategic-plan-2021-2025.pdf), and other federal prevention planning efforts.

This NOFO, including funding and eligibility, is not limited based on, and does not discriminate on the basis of race, color, national origin, disability, age, sex (including gender identity, sexual orientation, and pregnancy) or other constitutionally protected statuses.

Key Dates Publication Date:

To receive notification of any changes to RFA-PS-25-113, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link.

An email address is needed for this service.

Letter of Intent Due Date:

01/20/2025

Application Due Date:

02/20/2025

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 11:59 PM U.S. Eastern Time.

Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission and prevents errors.

For more information on accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via http://grants.nih.gov/support/index.html.

• E-mail: commons@od.nih.gov

• Phone: 301-402-7469 or (toll-free) 1-866-504-9552

• Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time to correct any error or warning notices of noncompliance with https://www.cdc.gov/hivpartners/php/compendium/ https://www.cdc.gov/ehe/index.html https://www.cdc.gov/ehe/index.html https://www.cdc.gov/nchhstp/media/pdfs/2024/08/hiv-national-strategic-plan-2021-2025.pdf https://www.grants.gov/ http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review:

04/22/2025 Secondary Review:

05/22/2025 Estimated Start Date:

09/01/2025 Expiration Date:

03/21/2025 Required Application Instructions It is critical that applicants follow the instructions in the How to Apply - Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note:The Research Strategy component of the Research Plan is limited to 12 pages.

Page Limitations: Pages that exceed the page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

Applications that do not comply with these instructions may be delayed or may not be accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary

• Purpose: The purpose of this Notice of Funding Opportunity (NOFO) is to support pilot research to develop and test behavioral implementation strategies for biomedical interventions (e.g., oral PrEP, condoms) to improve HIV and STI prevention implementation among disproportionately affected populations, especially Black/African American (Black) and Hispanic/Latino (Hispanic) gay, bisexual, and other men who have sex with men (MSM) without HIV who report substance use (drug or alcohol). The study design and sample size should meet minimum requirements for consideration of the CDC Compendium of Best Evidence (https://www.cdc.gov/hivpartners/php/compendium/) and thus may have the potential for future CDC HIV prevention funding implementation in jurisdictions around the United States. The applicants should have access to research participants in priority jurisdictions outlined in Ending the HIV Epidemic in the United States (EHE), in support of the goals of EHE (Ending the HIV Epidemic in the US (EHE) | EHE Initiative | CDC), the HIV National Strategic Plan for the United States: A Roadmap to End the HIV Epidemic (2021-2025) (https://www.cdc.gov/nchhstp/media/pdfs/2024/08/hiv-national-strategic-plan-2021- 2025.pdf), and other federal prevention planning efforts. This NOFO, including funding and eligibility, is not limited based on, and does not discriminate on the basis of race, https://grants.nih.gov/grants/how-to-apply-application-guide.html https://www.cdc.gov/hivpartners/php/compendium/ https://www.cdc.gov/ehe/index.html https://www.cdc.gov/ehe/index.html https://www.cdc.gov/nchhstp/media/pdfs/2024/08/hiv-national-strategic-plan-2021-2025.pdf https://www.cdc.gov/nchhstp/media/pdfs/2024/08/hiv-national-strategic-plan-2021-2025.pdf color, national origin, disability, age, sex (including gender identity, sexual orientation, and pregnancy) or other constitutionally protected statuses.

• Mechanism of Support: U01 - Research - Cooperative Agreement

• Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire three (3)-year period of performance is $2,850,000. The number of awards will be two (2). Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded, and the number of awards will depend upon the number, quality, duration and cost of the applications received.

• Budget and Period of Performance: The estimated total funding (direct and indirect) for the first year (12-month budget period) will be $950,000 for the NOFO, with individual awards of $475,000 for the first year. The estimated total funding (direct and indirect) for the entire period of performance will be $2,850,000. The period of performance is anticipated to run from 9/01/2025 to 08/31/2028.

• Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. “Application and Submission Information” of this announcement.

• Eligible Institutions/Organizations. Institutions/organizations listed in Section III of this announcement are eligible to apply.

• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. CDC does not make awards to individuals directly. Individuals from organizations that are uniquely prepared to examine research relevant to undeserved groups as well as individuals with disabilities are always encouraged to apply.

• Number of PDs/PIs. There will only be one PD/PI for each application.

• Number of Applications. Each institution, identified by a unique entity identifier (UEI) number, may submit up to two (2) applications, with each application focusing on one population as either Black MSM or Hispanic MSM. Each application must clearly specify its focused population.

• Application Type. New

• Application Materials. See Section IV.1 for application materials.

Section I. Funding Opportunity Description Statutory Authority Sections 301(a) and 317(k)(2) of the Public Health Service Act, 42 U.S.C. Sections 241(a) and 247b(k)(2)

1. Background and Purpose Gay, bisexual, and other MSM continue to be disproportionately affected by HIV in the United States, accounting for an estimated 67% of annual incident infections when MSM are estimated to be approximately 4% of the general population (HIV Diagnoses, Deaths, and Prevalence | HIV Data | CDC; JMIR Public Health and Surveillance - Estimating the Population Sizes of Men https://www.cdc.gov/hiv-data/nhss/hiv-diagnoses-deaths-prevalence.html https://www.cdc.gov/hiv-data/nhss/hiv-diagnoses-deaths-prevalence.html https://publichealth.jmir.org/2016/1/e14/

Who Have Sex With Men in US States and Counties Using Data From the American Community Survey). Further, minority individuals are also disproportionately affected by HIV, with Black persons accounting for 43% of HIV diagnoses (13% of the general population) and Hispanic/Latino persons accounting for 26% of HIV diagnoses (18% of the general population) (Epidemiology of HIV in the USA: epidemic burden, inequities, contexts, and responses - ScienceDirect).

The CDC Compendium of Evidence-Based Interventions (EBIs) and Best Practices for HIV Interventions is a comprehensive resource that identifies and summarizes effective interventions and strategies for preventing and treating HIV. By compiling research findings and best practices that meet rigorous evidence-based criteria, it aids health departments, community-based organizations, and other collaborators in implementing impactful interventions. The Compendium serves as a guide for entities including CDC-funded programs that seek to adopt proven strategies, ensuring that resources are used effectively to address the epidemic.

Additionally, the Compendium informs program development, funding priorities, and public health policies, while serving as a training resource for providers. By assisting organizations in evaluating and improving their programs through evidence-based approaches, it maximizes the impact of efforts to reduce HIV transmission and enhance health outcomes. Given that Black and Hispanic MSM are especially disproportionately affected by HIV, the goal of this study is to support evaluation research that identifies effective HIV prevention interventions for Black and Hispanic MSM who use substances, with the aim of including these interventions in the Compendium.

CDC has an established history of HIV prevention research on reducing risk for HIV infection among MSM who use substances in the time when condoms were the only available prevention product. Project MIX (CDC IRB Protocol #3985) was a large, randomized control trial of a small-group based intervention focusing on the link between substance use and sexual risk behavior (sometimes in the context of “party-n-play” or “chemsex”) for MSM in Chicago, New York, and San Francisco. This study focused on all substance-using MSM, and not by race/ethnicity.

Although significant intervention effects were not found in this rigorous 3-arm study, several important implications were noted for future research – including methodological considerations for more manageable steps of smaller trials, focused populations, and approaches that can be relatively easy to implement in communities. Others have found it challenging to determine efficacy of behavioral interventions for reducing sexual risk of MSM who use substances, however some also found differential effects of such interventions by race/ethnicity of MSM that suggest a need for tailored approaches for Black and Hispanic men.

A next generation research on this topic was a pilot initiative for testing innovative approaches to increasing sexual protective behavior of methamphetamine-using MSM (RFA-PS-06-007), which included four independent projects. The project found efficacy and promising evidence for the approaches studied, including a text messaging intervention, a couples-based intervention for Black MSM, a single-session motivational interview session, and a modular approach to prevention for out-of-treatment methamphetamine users. The 3-year pilot study model was a successful, relatively “quick win” for determining interventions for further assessment or community implementation.

https://publichealth.jmir.org/2016/1/e14/ https://publichealth.jmir.org/2016/1/e14/ https://www.sciencedirect.com/science/article/pii/S0140673621003950?via%3Dihub https://www.sciencedirect.com/science/article/pii/S0140673621003950?via%3Dihub

These interventions were in the time when condoms were the only biomedical device available for HIV prevention, and even then, there was a lack of effective HIV prevention interventions for MSM who use substances. The field is now in need of behavioral interventions for MSM who use substances in the time of PrEP use and adherence, as well as use of doxycycline postexposure prophylaxis for bacterial STI prevention (i.e., Doxy-PEP).

MSM continue to be the most disproportionally affected group among incident and prevalent HIV infections in the United States (U.S.), particularly Black and Hispanic MSM, who are disproportionately affected by HIV as noted above. Substance (drug or alcohol) use has a well-documented association with sexual risk behavior and, more recently, potentially adherence to oral PrEP use. National epidemiologic data lacks representative community estimates for substance use during sexual risk behavior, particularly in an intentional, sexualized substance use context like “party-n-play” or “chemsex”; however, substance use during sex has been a well-established community behavior for decades for many MSM in the U.S. and abroad. This NOFO addresses the lack of effective HIV prevention programs designed for Black or Hispanic MSM who use substances, especially in the time of oral PrEP. At the same time, HIV prevention intervention research often is a long road from concept to implementation.

This NOFO aims to prioritize pilot intervention research that meets the minimum CDC evidence-based criteria for "best evidence." This research will support recommendations for the CDC Compendium and potential future funding for health departments and community-based organizations in their HIV programs.

Healthy People 2030 and other National Strategic Priorities This NOFO aims to accelerate evidence-informed decision-making and performance improvements to HIV prevention strategies. Several Healthy People 2030 (HP 2030) https://odphp.health.gov/healthypeople objectives are supported through this NOFO:

Reduce new HIV infections

• HIV-1 Reduce the number of new HIV diagnoses

• HIV-2 Reduce the number of new HIV infections among adolescents and adults Increase HIV testing and prevent HIV risk

• HIV-13 Increase the proportion of persons living with HIV who know their serostatus

• HIV-17 Increase the proportion of sexually active persons who use condoms Increase access to care and improve health outcomes for people living with HIV

• HIV-19 Increase the percentage of persons with newly diagnosed HIV infection linked to HIV medical care (had a routine HIV medical visit) within one month of their HIV diagnosis

Public Health Impact This NOFO aligns with the Ending the HIV Epidemic (EHE) Initiative and CDC Strategic Plan to (1) reduce the number of new HIV infections; (2) increase access to care and optimize health outcomes for people with HIV; and (3) reduce HIV-related disparities.

• Ending the HIV Epidemic: A Plan for America - https://www.hiv.gov/ending-hiv-epidemic

• Secretary’s Minority HIV/AIDS Fund (MAI) - https://www.hiv.gov/federal-response/smaif/overview https://odphp.health.gov/healthypeople https://www.hiv.gov/ending-hiv-epidemic https://www.hiv.gov/ending-hiv-epidemic https://www.hiv.gov/federal-response/smaif/overview https://www.hiv.gov/federal-response/smaif/overview

• The United States National HIV/AIDS Strategy and National Strategic Plan (2021-2015) HIV National Strategic Plan for the United States: A Roadmap to End the HIV Epidemic (2021-2025)

• HIV/AIDS Care Continuum: https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum

Relevant Work This NOFO builds upon previous and current HIV prevention research programs, including:

• RFA-PA-02-136: Reducing sexual risk for HIV transmission in substance-using MSM

• RFA-PS-06-007: Reducing sexual risk behavior of methamphetamine-using MSM

2. Approach This NOFO supports investigator-driven research and invites applicants to design, develop, direct, and conduct data collection to achieve the project outcomes outlined in the NOFO, with the understanding that the CDC will provide technical assistance and consultation as needed. The research proposed in the application should aim to meet the minimum criteria for CDC’s best evidence-based study standards, with the goal of recommendation and community implementation (see CDC HIV Compendium of Best Practices :

https://www.cdc.gov/hivpartners/php/compendium/).

NOTE: As noted above (see Background section), Black and Hispanic MSM are disproportionately affected by HIV. Each application must clearly specify in the Specific Aim section of the application the focused population as either:

• Black MSM, or

• Hispanic MSM.

Given that Black and Hispanic MSM are especially disproportionately affected by HIV, applications should focus on either Black or Hispanic MSM who reported recent substance use (drug or alcohol) during condomless and PrEPless anal sex with a non-primary male partner.

Applications will need to demonstrate cultural competence through community engagement and access to and experience with enrolling and retaining Black or Hispanic MSM who use substances in research.

Research should be conducted in, and participants should be recruited from one or more of the EHE jurisdictions: https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/jurisdictions/phase-one. In support to the Ending the HIV Epidemic (EHE) strategy, the CDC Compendium highlights published interventions that have undergone rigorous evaluation and are recognized as effective in the field. The research proposed in this application should aim to meet the minimum criteria for CDC's best evidence-based study standards, with the ultimate goal of recommendation and community implementation. The minimum criteria for best evidence include:

• A prospective study with random allocation of participants to a minimum of two comparison arms (e.g., intervention arm and control arm).

• Common and concurrent assessment of study arms with a minimum of baseline, immediate intervention post-test, and 3-month follow-up measurement points.

https://files.hiv.gov/s3fs-public/HIV-National-Strategic-Plan-2021-2025.pdf https://files.hiv.gov/s3fs-public/HIV-National-Strategic-Plan-2021-2025.pdf https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum https://www.cdc.gov/hivpartners/php/compendium/ https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/jurisdictions/phase-one

• Minimum 60% retention at follow-up assessment for each study arm, with a resultant sample size of at least n=40 per study arm for outcome analysis.

Applications should describe the design and development of research strategies to conduct an independent pilot intervention for HIV prevention focusing on either Black or Hispanic MSM who use substances. Results from the pilot study will be used to develop and test the efficacy of enhancements to oral PrEP use/adherence and condom use interventions to increase sexual protective behavior. Formative (e.g., qualitative) research will be implemented by each recipient to further develop the intervention’s approach and materials needed to successfully implement the quantitative study trial, including evidence of understanding psychosocial and behavioral complexities in HIV prevention. The research design will need to meet or exceed minimum required criteria for determination of CDC best-evidence interventions, known as evidence-based interventions or EBIs, for post-study evaluation. The proposal should include data collection and analysis methods that are appropriate and rigorous to qualitative and quantitative research approaches. In addition to the best-evidence criteria applications should also propose a minimum enrollment of n=75 per arm at enrollment (n=150 for a 2-arm design). The intervention should consider and address potential scalability among the key population if it is found to be efficacious.

CDC best evidence criteria is essential for study design and implementation. Efficacious pilot projects will be well situated for evaluation review by CDC EBI staff for official recognition and inclusion in the CDC Compendium of best evidence interventions. This will allow for CDC funded agencies and community-based organizations (CBOs) to implement the program throughout the United States in the future by using CDC HIV prevention funding. This is a unique aspect of the project, balancing between broader scientific requirements of randomized control trials (RCTs) and more practical criteria for Compendium evidence-based interventions (EBIs) and CDC programs (see CDC HIV Compendium of Best Practices :

https://www.cdc.gov/hivpartners/php/compendium/).

Objectives/Outcomes The primary study objective is to develop and pilot test HIV prevention interventions for Black and Hispanic MSM, with one recipient focusing on Black and one focusing on Hispanic MSM populations who use substances. Each recipient will conduct formative (e.g., qualitative) research and quantitative outcome research for their intervention. The study design and outcomes are intended to meet minimum criteria for CDC Best Practices Compendium “best evidence” inclusion if found to be efficacious.

Outcomes of interest are recent use of oral PrEP and condoms, and PrEP and condom awareness, knowledge, motivations, and acceptance, including condomless/PrEPless anal sex overall and substance use during condomless/PrEPless anal sex.

Population of Focus Research participants should be recruited in one or more of the EHE jurisdictions https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/jurisdictions/phase-one. The sample size is based on what is required for CDC best-evidence criteria (EBIs listed online in the CDC Compendium), for efficiency in potential implementation of programs following outcome analyses and CDC best-evidence intervention determination.

https://www.cdc.gov/hivpartners/php/compendium/

The intent of this NOFO is to address drug use and alcohol use as it relates to HIV and STI prevention among Black and Hispanic gay, bisexual, and other MSM. This could include alcohol abuse (e.g., binge-drinking) as well as drug use.

Collaboration/Partnerships Applicants are encouraged to partner with HIV prevention community organizations and/or health departments in intervention development, testing, and overall study implementation, and to link study participants to HIV prevention and medical care services as needed. Collaborators should demonstrate cultural competence for the intended key population of the study.

Evaluation/Performance Measurement The application should include measurable goals and aims based on a 3-year research period of performance. The application should describe specific, measurable, achievable, realistic and time-phased (SMART) project objectives for each activity described in the application’s project plan and describe the development and implementation of project performance measures based on specific programmatic objectives.

The NOFO supports research and invites recipients to design, develop, and conduct data collection to meet the project goals outlined in the Purpose section. Outcomes of interest are recent use of oral PrEP and condoms, and PrEP and condom awareness, knowledge, motivations, and acceptance, including condomless/PrEPless anal sex overall and substance use during condomless/PrEPless anal sex.

Translation Plan Key findings will be shared locally through community and health department partners in the designated geographical area of the study. Outcome analyses will be written up for conference abstracts and peer-reviewed journal articles and presented widely for the scientific and programmatic communities.

Final outcome analysis will determine the efficacy of each pilot behavioral intervention and whether they meet the CDC Compendium criteria for best evidence. If found efficacious while meeting those criteria, a successful intervention will be officially listed in the CDC Compendium as an evidence-based intervention endorsed for community implementation through health departments and CBOs. To apply study findings, it is critical to disseminate these findings to communities through written and oral presentations. The implementation of these prevention findings by community prevention programs would result in improved HIV prevention for communities of MSM.

3. Funding Strategy N/A

Section II. Award Information Funding Instrument Type:

CA (Cooperative Agreement) A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding:

$2,850,000 Estimated Total Annual Budget Period Funding for the NOFO is:

Year 1: $950,000 ($475,000 per award)

Year 2: $950,000 ($475,000 per award)

Year 3: $950,000 ($475,000 per award)

Anticipated Number of Awards:

Estimated total funding available for the first year (first 12 months), including direct and indirect costs: $950,000 ($475,000 per award)

Estimated total funding available for the entire period of performance, including direct and indirect costs: $2,850,000 ($1,425,000 per award)

Awards issued under this NOFO are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award Ceiling:

$475,000 Per Budget Period

Award Floor:

$350,000 Per Budget Period

Total Period of Performance Length:

3 year(s)

Throughout the Period of Performance, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this NOFO.

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR Part 75, currently in https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category:

00 (State governments)

01 (County governments)

02 (City or township governments)

04 (Special district governments)

05 (Independent school districts)

06 (Public and State controlled institutions of higher education)

07 (Native American tribal governments (Federally recognized))

08 (Public housing authorities/Indian housing authorities)

11 (Native American tribal organizations (other than Federally recognized tribal governments))

12 (Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education)

13 (Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education)

20 (Private institutions of higher education)

22 (For profit organizations other than small businesses)

Additional Eligibility Category:

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions

Historically Black Colleges and Universities (HBCUs)

Tribally Controlled Colleges and Universities (TCCUs)

Alaska Native and Native Hawaiian Serving Institutions

Nonprofits (Other than Institutions of Higher Education):

Nonprofits (Other than Institutions of Higher Education)

Governments:

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other:

Faith-based or Community-based Organizations

Regional Organizations

Bona Fide Agents: A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms."

Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency's existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to https://gov.ecfr.io/cgi-bin/searchECFR.

2. Foreign Organizations Foreign Organizations are not eligible to apply.

Foreign components of U.S. Organizations are not eligible to apply.

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Additional Information on Eligibility N/A

4. Justification for Less than Maximum Competition N/A

5. Responsiveness If an application requests a funding amount greater than the ceiling of $475,000 for the first budget period and the total of $1,425,000 for the entire period of performance as indicated in Section II. of this NOFO, CDC may consider the application non-responsive.

An application that does not specify the focused population in the Specific Aim section is deemed to be non-responsive.

Non-responsive applications will not enter into the review process. CDC will notify the applicants that their applications did not meet the submission requirements.

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Unique Entity Identifier (UEI) number in order to begin each of the following registrations.

https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true

PLEASE NOTE: Effective April 4, 2022, applicants must have a Unique Entity Identifier (UEI) at the time of application submission. The UEI replaced the Data Universal Numbering System (DUNS) and is generated as part of SAM.gov registration. Current SAM.gov registrants have already been assigned their UEI and can view it in SAM.gov and Grants.gov. Additional information is available on the GSA website, SAM.gov, and Grants.gov-Finding the UEI.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: NCAGE Tool / Products / NCS Help Center (nato.int).

System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, SAM.gov.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The one-time registration process will take three to five days to complete.

However, it is best to start the registration process at least two weeks prior to application submission.

All Senior/Key Personnel (including Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principal Investigator (PD/PI) eRA Commons account is affiliated with the eRA commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the eRA Commons registration process at least four (4) weeks prior to the application due date. ASSIST requires that applicant users have an active eRA Commons account in order to prepare an application. It also requires that the applicant organization's Signing Official have an active eRA Commons Signing Official account in order to initiate the submission process.

During the submission process, ASSIST will prompt the Signing Official to enter their Grants.gov Authorized Organizational Representative (AOR) credentials in order to complete the submission, therefore the applicant organization must ensure that their Grants.gov AOR credentials are active.

7. Universal Identifier Requirements and System for Award Management

(SAM)

All applicant organizations must obtain a Unique Entity Identifier (UEI) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The UEI number is a twelve-digit number assigned by SAM.gov. An AOR should be consulted to determine the appropriate number. If the organization does not have a UEI number, an AOR should register through SAM.gov. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a UEI number.

Additionally, organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is https://www.gsa.gov/about-us/organization/federal-acquisition-service/technology-transformation-services/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-id-is-here https://sam.gov/content/home https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ https://sam.gov/content.gov https://grants.gov https://public.era.nih.gov/commons https://www.Grants.gov made, until a final financial report is submitted or the final payment is received, whichever is later.

SAM.gov is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient.

Additional information about registration procedures may be found at SAM.gov and the SAM.gov Knowledge Base.

If an award is granted, the recipient organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its UEI number to the recipient organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. CDC does not make awards to individuals directly. Individuals from organizations that are uniquely prepared to examine research relevant to undeserved groups as well as individuals with disabilities are always encouraged to apply.

9. Cost Sharing This NOFO does not require cost sharing as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same Notice of Funding Opportunity generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this NOFO that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Each institution, identified by a unique entity identifier (UEI) number, may submit up to two (2) applications, with each application focusing on one population as either Black MSM or Hispanic MSM. Each application must clearly specify its focused population.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because, unlike other platforms, it provides a validation of all requirements prior to submission and prevents errors.

https://sam.gov/content/home https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fsd.gov%2Fgsafsd_sp%3Fid%3Dgsa_kb_view2%26kb_id%3Df66d8e6cdb76d4100d73f81d0f9619c6&data=04%7C01%7Ccshifflett%40dminc.com%7C8eee7a2adab549a3b3c008d925e9a364%7Cdb7ac9ef779d46e59bca00509580ad6b%7C0%7C0%7C637582507851821018%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=UrR%2B%2FM2wWF2fZG05Z8O6JS2C3FXXSl%2F7B3%2FB45XHRrg%3D&reserved=0

To use ASSIST, applicants must visit https://public.era.nih.gov where you can login using your eRA Commons credentials, and enter the Notice of Funding Opportunity Number to initiate the application, and begin the application preparation process.

If you experience problems accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via: http://grants.nih.gov/support/index.html

• Email: commons@od.nih.gov

• Phone: 301-402-7469 or (toll-free) 1-866-504-9552.

Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays.

2. Content and Form of Application Submission Application guides for FORMS-H application packages are posted to the How to Apply - Application Guide page.

It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide How to Apply - Application Guide except where instructed in this Notice of Funding Opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. The package associated with this NOFO includes all applicable mandatory and optional forms. Please note that some forms marked optional in the application package are required for submission of applications for this NOFO. Follow the instructions in the SF-424 Application Guide to ensure you complete all appropriate “optional” components.

When using ASSIST, all mandatory forms will appear as separate tabs at the top of the Application Information screen; applicants may add optional forms available for the NOFO by selecting the Add Optional Form button in the left navigation panel.

Please note: If requesting indirect costs in the budget based on a federally negotiated rate, a copy of the indirect cost rate agreement is required. Include a copy of the current negotiated federal indirect cost rate agreement or cost allocation plan approval letter.

Letters of Support from partners or other organizations should be placed in the PHS 398 Research Plan "Other Research Plan Section" of the application under "9. Letters of Support".

Please note: Follow the instructions in this NOFO for including a Data Management Plan in the Resource Sharing Plan section of the PHS 398 Research Plan Component of your application.

Please include all the eight (8) mandatory forms listed below in the application package:

Mandatory

1. SF424 (R&R)

2. PHS 398 Cover Page Supplement

3. Research and Related Other Project Information

4. Project/Performance Site Location(s)

5. Research and Related Senior/Key Person Profile (Expanded)

6. Research and Related Budget https://public.era.nih.gov http://grants.nih.gov/support/index.html https://grants.nih.gov/grants/how-to-apply-application-guide.html https://grants.nih.gov/grants/how-to-apply-application-guide.html https://grants.nih.gov/grants/how-to-apply-application-guide.html https://grants.nih.gov/grants/how-to-apply-application-guide.html

7. PHS 398 Research Plan

8. PHS Human Subjects and Clinical Trials Information

If multiple collaborating institutions will be involved, please include in this section of the application your single IRB (sIRB) Plan:

• Describe how you will comply with the single IRB review requirement under the Revised Common Rule at 45 CFR 46.114 (b) (cooperative research). If available, provide the name of the IRB that you anticipate will serve as the sIRB of record.

• Indicate that all identified engaged institutions or participating sites will agree to rely on the proposed sIRB and that any institutions or sites added after award will rely on the sIRB.

• Briefly describe how communication between institutions and the sIRB will be handled.

• Indicate that all engaged institutions or participating sites will, prior to initiating the study, sign an authorization/reliance agreement that will clarify the roles and responsibilities of the sIRB and participating sites.

• Indicate which institution or entity will maintain records of the authorization/reliance agreements and of the communication plan.

• Note: Do not include the authorization/reliance agreement(s) or the communication plan(s) documents in your application.

• Note: If you anticipate research involving human subjects but cannot describe the study at the time of application, include information regarding how the study will comply with the single Institutional Review Board (sIRB) requirement prior to initiating any multi-site study in the delayed onset study justification.

3. Letter of Intent Due Date for Letter Of Intent 01/20/2025

A Letter of Intent is requested as the information that it contains allows CDC staff to better plan and line up proper review panels for applications.

By the date listed in Part 1. “Overview Information”, prospective applicants are asked to submit a letter of intent that includes the following information:

Name of the applicant organization Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this notice of funding opportunity Focused population (Black MSM or Hispanic MSM)

The letter of intent should be emailed to:

Seraphine Pitt Barnes, PhD, MPH, CHES Extramural Research Program Office Office of the Associate Director of Science

National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention Centers for Disease Control and Prevention U.S. Department of Health and Human Services Telephone: 770-488-6115 Email: SPittBarnes@cdc.gov

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this NOFO in Grants.gov includes all applicable components for this NOFO, required and optional. In ASSIST, all required and optional forms will appear as separate tabs at the top of the Application Information screen.

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of components. Not all components of the Research Plan apply to all Notices of Funding Opportunities (NOFOs). Specifically, some of the following components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guide at How to Apply

- Application Guide for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Notice of Funding Opportunity Description).

Follow the page limits stated in the SF 424 unless otherwise specified in the NOFO. As applicable to and specified in the NOFO, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the NOFO.

2. Specific Aims – state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.

3. Research Strategy – the research strategy should be organized under 3 headings:

Significance, Innovation, and Approach. Describe the proposed research plan, including staffing and timeline.

4. Progress Report Publication List (for Continuation ONLY)

Other Research Plan Sections

5. Vertebrate Animals

6. Select Agent Research

7. Multiple PD/PI Leadership Plan

8. Consortium/Contractual Arrangements

9. Letters of Support

10. Resource Sharing Plan(s)

11. Other Plan(s) mailto:SPittBarnes@cdc.gov

12. Authentication of Key Biological and/or Chemical Resources

13. Appendix

All instructions in the SF424 (R&R) Application Guide at How to Apply - Application Guide must be followed along with any additional instructions provided in the NOFO.

Applicants that plan to collect public health data must submit a Data Management Plan (DMP) in the Other Plan(s) section of the PHS 398 Research Plan Component of the application. A DMP is required for each collection of public health data proposed. Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds.

The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include:

• A description of the data to be collected or generated in the proposed project;

• Standards to be used for the collected or generated data;

• Mechanisms for providing access to and sharing of the data (include a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights - this section should address access to identifiable and de-identified data);

• A statement (required) of any limitations you may encounter with sharing data collected or generated under this award with CDC (such as legal, regulatory, policy, or technical concerns);

• Statement of the use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use; and

• Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified (this section should address archiving and preservation of identifiable and deidentified data).

The AR-25 outlines the components of a DMP and provides additional information for investigators regarding the requirements for data accessibility, storage, and preservation.

https://www.cdc.gov/grants/additional-requirements/ar-25.html

CDC OMB approved…