RFA-PS-25-112_20241213.pdf

Centers for Disease Control and Prevention

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

PEP Packs: Postexposure Prophylaxis Packs for Immediate Access to HIV and Sexually Transmitted Infection Prevention

RFA-PS-25-112

02/19/2025

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 PEP Packs: Postexposure Prophylaxis Packs for Immediate Access to HIV and Sexually Transmitted Infection Prevention Activity Code U01 – Research Project - Cooperative Agreements

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

RFA-PS-25-112

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 the implementation and evaluation of effective strategies for incorporating a postexposure prophylaxis-in-pocket (PiP) approach into existing preexposure prophylaxis (PrEP) services. This effort aims to prevent HIV and sexually transmitted infections (STIs) among disproportionately affected populations, for example, men who have sex with men (MSM) and transgender women (TGW).

The PiP approach is designed to enhance access to nonoccupational postexposure prophylaxis (nPEP) for HIV prevention. nPEP is a critical intervention for use after a potential HIV exposure but is often underused due to challenges in accessing timely healthcare. PiP addresses this issue by providing individuals with a supply of nPEP medication and related resources, enabling immediate prevention following a potential HIV exposure.

This research study will focus on implementing and evaluating the integration of PiP "PEP packs" into existing PrEP and STI clinical services. These PEP packs will contain antiretroviral medications for HIV nPEP, doxycycline for STI postexposure prophylaxis (DoxyPEP), HIV and STI self-test kits, and instructional materials. The study aims to increase access to nPEP by providing medication starter packs for immediate use after known or potential HIV or STI exposure and ensuring access to clinical follow-up after nPEP initiation.

The intervention should be conducted in clinical settings that serve communities with high rates of HIV diagnoses among disproportionately affected populations, e.g., Black/African American (Black) and Hispanic/Latino (Hispanic) MSM and TGW. If successful, this approach would enhance HIV and STI prevention among populations, including disproportionately affected populations, leading to more equitable health outcome. 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-25-112, 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:

01/19/2025

Application Due Date:

02/19/2025

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.

https://www.grants.gov/

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 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:

03/20/2025 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 the implementation and evaluation of effective strategies for incorporating a postexposure prophylaxis-in-pocket (PiP) approach into existing preexposure prophylaxis (PrEP) services. This effort aims to prevent HIV and sexually transmitted infections (STIs) among disproportionately affected populations, for example, men who have sex with men (MSM) and transgender women (TGW). The PiP approach is designed to enhance access to nonoccupational postexposure prophylaxis (nPEP) for HIV prevention. nPEP is a critical intervention for use after a potential HIV exposure but is often underused due to http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov https://grants.nih.gov/grants/how-to-apply-application-guide.html challenges in accessing timely healthcare. PiP addresses this issue by providing individuals with a supply of nPEP medication and related resources, enabling immediate prevention following a potential HIV exposure. This research study will focus on implementing and evaluating the integration of PiP "PEP packs" into existing PrEP and STI clinical services. These PEP packs will contain antiretroviral medications for HIV nPEP, doxycycline for STI postexposure prophylaxis (DoxyPEP), HIV and STI self-test kits, and instructional materials. The study aims to increase access to nPEP by providing medication starter packs for immediate use after known or potential HIV or STI exposure and ensuring access to clinical follow-up after nPEP initiation. The intervention should be conducted in clinical settings that serve communities with high rates of HIV diagnoses among disproportionately affected populations, for example, Black/African American (Black) and Hispanic/Latino (Hispanic) MSM and TGW. If successful, this approach would enhance HIV and STI prevention among populations, including disproportionately affected populations, leading to more equitable health outcome.

• 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 4-year period of performance is $4,800,000. The number of awards will be up to one (1). 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 $1,200,000. The estimated total funding (direct and indirect) for the entire period of performance will be $4,800,000. The period of performance is anticipated to run from 09/01/2025 to 08/31/2029.

• 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. Only one application per institution (normally identified by having a unique entity identification or UEI number) is allowed.

• Application Type. New

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

Section I. Funding Opportunity Description Statutory Authority Public Health Service Act, 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 HIV disparities persist in the United States among Black and Hispanic men who have sex with men (MSM) and transgender women (TGW), who experience the highest rates of new HIV diagnoses. HIV infection can be effectively prevented through pre- and post-exposure medication regimens. The CDC recommends that pre-exposure prophylaxis (PrEP) services integrate comprehensive HIV prevention strategies, including non-occupational post-exposure prophylaxis (nPEP) and appropriate STI prevention measures to maximize prevention.

nPEP is an effective intervention that can prevent HIV acquisition following potential exposure.

Individuals seeking to initiate PrEP may have experienced a recent HIV exposure—whether through sexual contact or injection drug use—within the past 72 hours, which indicates a potential need for nPEP. Additionally, those using on-demand PrEP (such as the 2-1-1 regimen) may not have taken the pre-sex dose that significantly enhances the regimen's efficacy.

Doxycycline post-exposure prophylaxis (DoxyPEP) has been found to decrease bacterial STI incidence in MSM and TGW. DoxyPEP, when taken within 72 hours of exposure, has proven effective in preventing the acquisition of syphilis, chlamydia, and gonorrhea. Including DoxyPEP along with nPEP as part of a PiP strategy could provide access to a more comprehensive sexual health approach to decrease the syndemics of HIV and STIs.

nPEP has been underutilized, largely due to structural barriers that limit access during the critical 72-hour initiation window. Barriers such as lack of healthcare insurance or a primary care provider, limited transportation options, lack of awareness of PEP, and low health literacy can make it difficult to access timely nPEP services. These barriers disproportionally impact population of focus of Black and Hispanic MSM and TGW persons. The CDC's nPEP guidelines, issued in 2016, recommend initiating treatment as soon as possible and no later than 72 hours after a known or potential HIV exposure. This recommendation is based on evidence indicating that nPEP is more effective the sooner it is started after exposure. An analysis of a cohort prescribed nPEP at a large community-based clinic found that the odds of HIV seroconversion were three times higher if nPEP was initiated more than 48 hours after exposure, compared to those who started treatment earlier.

The PiP approach is an effective intervention to decrease the time to nPEP initiation and to overcome barriers to nPEP use. It has been implemented in Canada using a strategy that provides HIV prevention education and a supply of nPEP medication to persons with infrequent but high-risk HIV exposures. Persons are instructed to initiate nPEP using their PiP supply immediately after a possible HIV exposure, and to follow-up in a clinic for further evaluation with HIV and STI testing. They are also assessed for the need to continue nPEP based on guidelines. Some clinics that have implemented this strategy reported high proportions of persons used PiP correctly and had a clinical follow-up visit. None were diagnosed with an HIV infection. Although the PiP strategy was found to be effective in some settings in Canada, it should be assessed in diverse U.S. populations to inform CDC guideline recommendations.

Under this NOFO’s implementation and evaluation of the PiP approach, the Post Exposure Prophylaxis (PEP) in Pocket kits will be referred to as “PEP packs”. These PEP packs should include a sample or prescription of antiretroviral medication for nPEP, doxycycline for DoxyPEP, HIV and STI self-test kits, and instruction materials. The materials should provide information to schedule an expedited follow-up clinical visit. HIV and STI prevention outcomes of interest include: 1) time to PEP initiation after a known or potential HIV exposure, 2) proportion of persons initiating PEP within 72 hours of exposure, 3) proportion of persons completing a full course of nPEP, 4) HIV and STI acquisition, 5) PEP pack acceptability and feasibility, 6) patterns of nPEP, DoxyPEP, and PrEP use over time, and 7) clinician adherence to PrEP, PEP, and DoxyPEP guidelines. This intervention should be conducted in clinical settings that serve communities with high rates of HIV diagnoses among disproportionately affected populations, including Black and Hispanic MSM and TGW. Results of this study will provide critical information about the impact of this strategy among U.S. populations.

If Successful, the outcome of this NOFO would enhance HIV and STI prevention among populations, including disproportionately affected populations leading to more equitable health outcomes.

Healthy People 2030 and other National Strategic Priorities By facilitating access to HIV nPEP among MSM and TGW in the United States, as well as facilitating access to HIV self-testing strategies, this NOFO supports the following Healthy People 2030 goals https://odphp.health.gov/healthypeople:

• HIV-01: Reduce the number of new HIV infections.

• HIV-02: Increase knowledge of HIV status.

• HIV-03: Reduce the number of new HIV diagnoses.

• STI-02: Reduce gonorrhea rates in male adolescents and young men

• STI-05: Reduce the syphilis rate in men who have sex with men

This NOFO also supports the following national goals:

• Ending the HIV Epidemic in the U.S. (https://www.cdc.gov/ehe/index.html)

• Reducing the number of new HIV infections 75% by 2025 and 90% by 2030 National

HIV/AIDS Strategy 2022-2025 (https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025)

Public Health Impact nPEP is the only effective intervention to prevent acquisition of HIV after an exposure has occurred. nPEP has been underutilized and significant structural barriers limit access during the critical 72-hour initiation window. This study aims to increase nPEP access by providing medication starter packs with sample medication or prescription for immediate initiation of nPEP and DoxyPEP after a known or potential HIV or STI exposure, and access to clinical follow-up after nPEP initiation. If this strategy is effective, it can prevent HIV and STIs in persons in key populations leading to more equitable HIV and STI prevention. Increasing nPEP and DoxyPEP access and use supports national goals of reducing HIV incidence and STIs. Also, findings of this study may inform nPEP, PrEP, and STI clinical guidelines and programmatic activities.

Relevant Work https://odphp.health.gov/healthypeople https://www.cdc.gov/ehe/index.html https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025 https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025

• RFA-PS-23-001: HerPrEP: Increasing PrEP Use Among Black Cisgender Women in the United States (https://www.cdc.gov/hiv/funding/announcements/ps23-001/index.html)

• CDC-RFA-PS22-2209: TRANSCEND: Transgender Status-Neutral Community-to- Clinic Models to End the HIV Epidemic (https://www.cdc.gov/hiv/research/demonstration/transcend/index.html)

• RFA-PS-21-003: PrEP Choice: Increasing the Use of HIV PrEP in an Era of Choices (https://www.grants.gov/search-results-detail/328319)

2. Approach This NOFO supports the implementation and evaluation of strategies for a PiP approach for prevention of HIV and STIs among MSM and TGW. This implementation research study aims to understand real-world use of PiP services. Clinics should use existing payment methods such as health insurance and clinic sliding scales to cover the cost of PrEP care including PrEP medications. CDC research awards are intended for research-related activities; therefore, funds under this award cannot be used to pay for direct medical care expenses. The application should describe the implementation and evaluation of a comprehensive strategy to integrate medication starter kits, “PEP packs”, as a component of existing PrEP and STI clinical services. PEP packs should include a sample or prescription for a 5–7-day nPEP supply, a doxycycline prescription for use of a single dose, HIV and STI self-test kits, and instruction materials. The instruction materials should provide medication information, a guide for test use and contact information to schedule an expedited clinical follow-up prior to the end of the PEP pack supply. Currently, an oral swab HIV self-test is available, and additional HIV and STI self-tests might become available over the next few years. CDC will provide technical assistance for selection of HIV and STI self-tests to include in the PEP pack among those available at the time of study initiation. In addition, the strategy should include technology for participant logging of PEP doses taken and other study-relevant information using a modern data collection approach (e.g., a smartphone application).

The application should describe development of a study protocol to assess implementation and effectiveness outcomes of the PiP strategy and PEP packs. Outcomes can include time to PEP initiation after a known or potential HIV exposure, proportion of persons initiating PEP within 72 hours after an exposure, proportion of persons completing a full course of nPEP, HIV and STI acquisition, PEP pack acceptability and feasibility, patterns of nPEP, DoxyPEP, and PrEP use over time, and clinician adherence to PrEP, PEP, and DoxyPEP guidelines. The application should describe plans for data collection (e.g., conducting surveys, focus groups, interviews, or other assessments of clinical providers, clinic staff, and PEP users) to understand acceptability and feasibility of the PiP strategy.

The application should focus the PiP strategy on MSM and TGW who could benefit from PiP, particularly those initiating on-demand PrEP who might miss the preexposure PrEP dose, those who have recently completed an nPEP course of medication, and individuals who self-report at least one known or potential HIV exposure per year but are hesitant to use PrEP. Study participants should be provided with HIV and STI education, PEP packs, and HIV and STI self-test kits. Standard clinical care should be provided consistent with CDC guidelines, including recommendations for PrEP and ancillary PrEP services such as lab testing.

An objective of the study is to understand patterns of PiP use over time. Consideration should be given to monitoring participants for at least 2 months with longitudinal person-level data https://www.cdc.gov/hiv/funding/announcements/ps23-001/index.html https://www.cdc.gov/hiv/research/demonstration/transcend/index.html https://www.grants.gov/search-results-detail/328319 collection from their electronic health records (EHRs). The application should also develop a plan to evaluate study implementation strategies using a defined framework such as Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM). The application should describe an analytic strategy to evaluate study outcomes. This strategy may include comparisons to historical or contemporaneous cohorts to assess differences in the proportion of MSM and TGW initiating nPEP and DoxyPEP within 72 hours of a possible HIV or STI exposure, completing a full course of nPEP, and HIV and STI diagnoses after known or potential exposure.

In 2023, MSM accounted for 67% (21,400) of the 31,800 estimated new HIV infections in 2022. Among all MSM, 34% of new HIV infections were among Black persons and 38% were among Hispanic persons. In 20202, in a CDC survey 62% of Black transgender women and 35% of Hispanic transgender women had HIV. The application should describe plans to partner with clinical sites that serve Black and Hispanic MSM and TGW (patient population that is at least 50% Black and/or Hispanic and at least 25% MSM and TGW) to enroll a sufficient number of participants to assess study outcomes. The collaborating clinic site should provide PrEP and/or STI services to at least 3000 or more patients annually in order to provide geographic diversity and a large number of participants for sufficient statistical power to compare outcomes. Study clinics should be in communities with high rates of HIV diagnoses among these populations. Study clinics that have well-established EHRs for patient care for at least five years in order to provide historical data that can serve as a control for the study cohort.

Objectives/Outcomes The primary goal of this implementation research study is a decreased time to nPEP initiation for participants with a possible HIV exposure. An additional goal of this study is a decreased time to DoxyPEP initiation for participants with a possible STI exposure. The secondary goal is the clinical impact of the study including fewer HIV and STI diagnoses among participants. The implementation strategy should be assessed using a framework such as the RE-AIM. Whenever possible, applications should be written with SMART objectives (i.e., Specific, Measurable, Achievable, Realistic, and Time-bound).

This NOFO supports investigator-driven research and invites recipients 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 applicants should address the following objectives:

• Objective 1. Reduce the proportion of persons with an HIV or STI diagnosis after a known or potential sexual exposure.

• Objective 2: Understand the use of HIV and STI clinical services provided to persons.

• Objective 3: Measure HIV and STI positivity among persons.

• Objective 4: Compare patterns of PEP, PrEP, and DoxyPEP use over the study period among a cohort of persons.

• Objective 5: Assess the implementation strategy for PEP packs, including acceptability and feasibility, among PEP users and providers.

• Objective 6. Assess the acceptability and feasibility of HIV and STI self-testing among providers and PEP users.

• Objective 7: Assess the performance of HIV and STI self-tests.

The research outcomes are as follows:

• Outcome 1. Increased number of PrEP users provided PiP medications.

• Outcome 2. Increased proportion of persons who initiate nPEP within 72 hours after a known or potential exposure to HIV.

• Outcome 3. Decreased time to nPEP initiation as measured by hours after a known or

HIV exposure.

• Outcome 4. Increased proportion of persons who complete a full course of nPEP.

• Outcome 5. Increased proportion of persons who initiate DoxyPEP within 24 hours of a known or potential exposure to an STI.

• Outcome 6. Decreased time to DoxyPEP initiation as measured by hours from a known or potential STI exposure.

• Outcome 7: Decreased number of persons diagnosed with HIV.

• Outcome 8: Decreased number of persons diagnosed with a syphilis, chlamydia, or gonococcal infection.

Population of Focus The population of focus for this study are Black and Hispanic MSM and TGW in communities with high rates of HIV diagnoses. For this study, TGW are persons who were assigned male sex at birth but whose current gender is female. Barriers to timely healthcare access disproportionally affect populations of Black and Hispanic MSM and TGW persons. PEP pack implementation strategies will be tailored to the needs of disproportionately affected populations and the efficacy of these strategies for the population of focus will be evaluated.

Collaboration/Partnerships Collaborating with partners who reflect the target population enhances cultural competence, trust, and program relevance, resulting in more effective and tailored interventions. These partners also facilitate outreach, provide valuable feedback, and foster greater community ownership, increasing the likelihood of long-term sustainability.

Applications should outline plans to work with collaborative partners that have a proven track record in delivering PrEP and STI services to disproportionately affected populations, including Black and Hispanic MSM and TGW. Community-based organizations (CBOs) that serve these groups should be considered as potential collaborators, particularly if their involvement aligns with project goals. CBOs can help educate clients about nPEP and DoxyPEP and refer them to study sites for HIV prevention services, including PrEP.

Additionally, applications should include detailed plans to collaborate with local health departments if this would support project objectives. Health departments may provide educational materials for clinicians and PEP users, navigation services for obtaining health insurance or scheduling clinic visits, and STI testing services. Finally, applications should include plans for reporting diagnosed HIV and STIs to local health authorities.

Evaluation/Performance Measurement The application should include measurable goals and aims based on 4-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 evaluation plan should align with the stated purpose and outcomes described in the NOFO.

The application should describe an implementation plan that includes a timeline for achieving study milestones such as the development of relevant protocols and data collection instruments, including human subjects research (IRB) protocol development and a staffing, recruitment, and enrollment.

Study Evaluation

The application should describe an evaluation plan that encompasses the following components:

• The collection of pre-implementation data on outcomes.

• Longitudinal, cumulative quantitative assessment of clinical HIV prevention services provided for PEP users and their outcomes.

• Comparison of service use and outcomes in clinics that implemented the PiP strategy with PEP packs with those that did not, either contemporaneously or using a pre- and post-implementation design.

• Surveys, focus groups, interviews, or other assessments of clinical providers, other staff, and PEP users to understand acceptability and feasibility of the PiP strategy.

• Quantitative assessment of the number of providers who provided nPEP and DoxyPEP ancillary services, such as lab testing, in accordance with CDC clinical practice guidelines.

• PEP user-level HIV and STI prevention evaluation.

• Time to nPEP initiation after a known or potential HIV exposure.

• Time to DoxyPEP initiation after a known or potential STI exposure.

• Proportion of persons completing a full course of nPEP.

• Number of persons diagnosed with HIV.

• Number of persons diagnosed with an STI.

o Number of persons diagnosed with syphilis.

o Number of persons diagnosed with chlamydia.

o Number of persons diagnosed with gonorrhea.

• Number of persons who used PEP more than once during the study period.

• Number of persons who initiated PrEP after using PEP.

Quality Assurance

A quality assurance plan to ensure educational materials provided to PEP users and providers are accurate and up-to-date and that survey, focus group, and interview protocols are culturally appropriate and tailored for the focus populations of Black and Hispanic MSM and TGW persons.

Translation Plan Applicants should plan to disseminate study findings as presentations at national and international conferences and research articles in peer-reviewed journals. The findings will also inform future updates of CDC nPEP, PrEP, and other clinical practice guidelines. If the PEP pack implementation strategy is found to be effective, materials for healthcare provider training, PEP user education, and guidance for PEP pack content selection will be made available to facilitate scale-up of the intervention. CDC will support the communication of findings to healthcare organizations and clinical professional societies.

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:

$4,800,000

Estimated Total Annual Budget Period Funding:

Year 1: $1,200,000

Year 2: $1,200,000

Year 3: $1,200,000

Year 4: $1,200,000

Anticipated Number of Awards:

Estimated the total funding available for the first year (first 12 months), including direct and indirect costs: $1,200,000

Estimated the total funding available for the entire period of performance, including direct and indirect costs: $4,800,000

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

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

Award Ceiling:

$1,200,000 Per Budget Period

Award Floor:

$900,000 Per Budget Period

Total Period of Performance Length:

4 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 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) https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

20 (Private institutions of higher education)

22 (For profit organizations other than small businesses)

25 (Others (see text field entitled "Additional Information on Eligibility" for clarification))

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

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 $1,200,000 for the first budget period and $4,800,000 for the whole period of performance as indicated in Section II. of this NOFO, HHS/CDC may consider the application non-responsive. Non-responsive applications will not enter into the review process. HHS/CDC will notify the applicants that the application 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.

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.

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/

(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 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.

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 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

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.

Only one application per institution (normally identified by having a unique UEI number) is allowed.

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.

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 https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://public.era.nih.gov http://grants.nih.gov/support/index.html

• 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".

• 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 of 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

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 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

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 01/19/2025

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

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 mailto: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)

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…