Foa_Content_of_RFA-PS-24-039 final.pdf

Centers for Disease Control and Prevention

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

Improving the Quality of Life of People with HIV Aged 50 Years and Older in the United States

RFA-PS-24-039

02/26/2024

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 Improving the Quality of Life of People with HIV Aged 50 Years and Older in the United States Activity Code U01 – Research Project - Cooperative Agreements

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

RFA-PS-24-039

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 investigator-driven research to explore and identify factors related to quality of life (QOL) for persons with HIV aged 50 years and older (PWH50+). QOL has been recognized as an important aspect of health for people with HIV. Applicants are expected to conceive, design, develop, direct, and conduct formative qualitative and mixed method research to explore factors that impact QOL for PWH50+, translate findings into strategies to improve QOL for PWH50+, assess strategies for acceptability with PWH50+ and/or their HIV service providers, and disseminate findings to organizations and partners serving PWH50+. Findings from this NOFO are expected to contribute towards improving QOL for people with HIV and are aligned with the National HIV/AIDS Strategy 2022-2025 (NHAS) and the goals of the national Ending the HIV Epidemic in the U.S. (EHE) initiative, Treat Pillar.

Key Dates Publication Date:

To receive notification of any changes to RFA-PS-24-039, 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:

01/25/2024 1/25/2024

Application Due Date:

02/26/2024 02/26/2024

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 application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review:

05/01/2024 Secondary Review:

06/06/2024 Estimated Start Date:

09/01/2024 Expiration Date:

https://www.grants.gov/ http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov

02/27/2024 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: This Notice of Funding Opportunity (NOFO) is to support investigator-driven research to explore and identify factors related to quality of life (QOL) for persons with HIV aged 50 years and older (PWH50+). QOL has been recognized as an important aspect of health for people with HIV. Applicants are expected to conceive, design, develop, direct, and conduct formative qualitative and mixed method research to explore factors that impact QOL for PWH50+, translate findings into strategies to improve QOL for PWH50+, assess strategies for acceptability with PWH50+ and/or their HIV service providers, and disseminate findings to organizations and partners serving PWH50+.

Findings from this NOFO are expected to contribute towards improving QOL for people with HIV and are aligned with the HIV National Strategic Plan (2022-2025) and the goals of the national Ending the HIV Epidemic in the U.S. (EHE) initiative, “Treat” Pillar.

• Mechanism of Support: U01-Research Project - 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 project period is $1,050,000. The number of awards will be one (1). The award issued under this NOFO is 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 Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) will be $350,000. The estimated total funding (direct and indirect) for the entire project period will be $1,050,000. The project period is anticipated to run from 09/01/2024 to 08/31/2027.

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

https://grants.nih.gov/grants/how-to-apply-application-guide.html

• 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. NOTE:

CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic 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. Applicant organizations may submit more than one application, provided that each application is scientifically distinct, with different titles and projects.

• Application Type. New

• Application Materials. See Section IV.1 for application materials. Please note that

SF424 (R&R) Form H is to be used when completing the application package. Please see https://grants.nih.gov/grants/how-to-apply-application-guide.html

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 Owing to improvements in earlier HIV diagnosis and use of increasingly potent HIV treatments, the cohorts of persons with HIV (PWH) in the United States are aging, with approximately 567,000 persons aged 50 years and older living with diagnosed HIV in 2020. In 2020, the prevalence of people living with diagnosed HIV infection was the highest among people aged 55–59 years, followed by those aged 50–54 years, and those aged 60–64 years. In addition, there was a higher proportion of new HIV diagnoses among women (17%) compared with men (9%) aged 55 and older. PWH now have a life expectancy approaching that of persons without HIV in the United States. Beyond achieving HIV viral suppression and maintaining healthy immune and clinical HIV status, maximizing quality of life (QOL) with HIV is a priority for patients, communities, healthcare providers, and the Office of National AIDS Policy at the White House.

QOL is a multi-dimensional concept that includes physical, mental/emotional, social, and related (i.e., structural/subsistence) domains of health and functioning. PWH may age differently than persons without HIV, and studies suggest long-term HIV infection could have an impact on the acquisition of age-related chronic diseases (e.g., diabetes, hypertension, osteoporosis, Alzheimer's) and onset of aging-related syndromes, such as frailty and cognitive dysfunction.

Furthermore, some increases in age-related onset of chronic diseases are disproportionately experienced by women and non-Hispanic Black people, groups that also tend to be underrepresented in HIV and aging-related research.

Ending the HIV Epidemic in the United States entails not only reducing new HIV infections by 90% by 2030, but also improving care and treatment of people living with HIV. However, barriers to wellbeing and healthy lifespan with HIV remain. PWH, including those aged 50 and http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf above, commonly report social isolation, depression, trauma, polymorbidity, challenges in activities of daily living, as well as food insecurity, homelessness or housing instability, financial insecurity, and unemployment. Objective 2.5 of the National HIV/AIDS Strategy 2022-2025 (NHAS) is to expand capacity to provide whole-person care to older adults with HIV and long-term survivors, with strategies calling for identifying holistic models of care that meet the needs of older PWH, identifying best practices for addressing psychosocial and health needs, and increasing capacity of service providers to support older PWH. Developing evidence-informed and evidence-based interventions to address QOL in support of the Treat Pillar of EHE and NHAS is urgently needed and bolstering existing programming by state and local agencies, federal agencies and community partners is imperative.

Quantitative QOL-related variables (including measures of self-rated health, and HIV stigma, homelessness, food insecurity, unemployment, and unmet need for mental health services) are collected by the national HIV surveillance Medical Monitoring Project (MMP); patient reported outcomes related to QOL and social determinants of health are also collected through HIV cohort studies. Poor self-rated health is significantly associated with worse clinical outcomes for PWH 45+ years of age, women, heterosexual men, and race/ethnic minority persons. Reasons for poor self-rated health include mental health (symptoms of depression, anxiety) and social determinants of health (experiences of poverty, food insecurity, homelessness). However, there is limited data on perspectives of patient-centered and healthcare teams on how to prioritize issues in, and address QOL for, PWH50+ of diverse social backgrounds. Strategies that intervene on QOL likely require multidisciplinary approaches with multidisciplinary care teams (e.g., HIV clinicians, primary care providers, geriatricians, social workers, mental health providers, pharmacists, case managers, community health workers, etc.). There is a need to develop and optimize models of care and prevention for people aging with HIV, to improve whole-person-health, through syndemics and equity lenses that are informed by the perspectives of people with lived experience in the affected communities.

Healthy People 2030 and other National Strategic Priorities Healthy People 2030 Goals

• HIV-1: Reduce the number of new HIV infections

• HIV-2: Increase knowledge of HIV status

• HIV-3: Reduce the number of new HIV diagnoses

• HIV-5: Increase viral suppression

National Goals

HIV National Strategic Plan (2022-2025) https://files.hiv.gov/s3fs-public/HIV-National- Strategic-Plan-2021-2025.pdf

Goal 2: Improve HIV-related health outcomes of people with HIV.

• 2.3: Increase retention in care and adherence to HIV treatment to achieve and maintain long-term viral suppression and provide integrative HIV services for HIV-associated comorbidities, coinfections, and complications, including STIs.

• 2.4: Increase the capacity of the public health, health care delivery systems, and health care workforce to effectively identify, diagnose, and provide holistic care and treatment for people with HIV.

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

Goal 3: Reduce HIV-Related Disparities and Health Inequities.

• 3.4 Address social and structural determinants of health and co-occurring conditions that impede access to HIV services and exacerbate HIV-related disparities.

Goal 4: Achieve integrated, coordinated efforts that address the HIV epidemic among all partners and interested parties.

• 4.2: Increase coordination among and sharing of best practices from HIV programs across all levels of government (federal, state, tribal, local, and territorial) and with public and private health care payers, faith-based and community-based organizations, the private sector, academic partners, and the community.

• 4.4: Foster private-public-community partnerships to identify and scale up best practices and accelerate HIV advances.

Ending the HIV Epidemic in the U.S. https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview

Goal: Reducing new HIV infections by 75% by 2025 and 90% by 2030.

Public Health Impact This NOFO is aligned with the priorities in the National HIV/AIDS Strategy 2022-2025 (NHAS), specifically to address QOL among persons living with HIV. Goal 2.5 of NHAS is to expand capacity to provide whole-person care to older adults with HIV and long-term survivors.

It calls for identifying models of care that meet the needs of older PWH, identifying best practices for addressing psychosocial and health needs, and increasing capacity of service providers to support PWH aged 50 and over. There is a demonstrated need to develop and optimize models of care and prevention for people aging with HIV, and to improve whole-person-health through syndemic and equity lenses that are informed by the perspectives of people with lived experience in the affected community.

Relevant Work Funding Opportunity PS21-2102: Comprehensive High-Impact HIV Prevention Programs for Community Based Organizations. https://www.cdc.gov/hiv/funding/announcements/PS21- 2102/index.html

Funding Opportunity PS20-2010: Integrated HIV Programs for Health Departments to Support Ending the HIV Epidemic in the United States.

https://www.cdc.gov/hiv/funding/announcements/ps20-2010/index.html

Funding Opportunity PS23-003: Exploring Preferences for Long-Acting Antiretroviral Therapies (LA-ART) in a Community-Based Sample of Priority Populations Living with HIV Who are Disproportionately Affected. https://www.cdc.gov/hiv/funding/announcements/ps23- 003/index.html

2. Approach Applicants are expected to, design, develop, and conduct formative research on QOL for PWH50+, translate findings into strategies to improve QOL, assess strategies for acceptability https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.cdc.gov/hiv/funding/announcements/PS21-2102/index.html https://www.cdc.gov/hiv/funding/announcements/PS21-2102/index.html https://www.cdc.gov/hiv/funding/announcements/ps20-2010/index.html https://www.cdc.gov/hiv/funding/announcements/ps23-003/index.html https://www.cdc.gov/hiv/funding/announcements/ps23-003/index.html with PWH50+ and/or their HIV service providers, and disseminate findings to organizations and partners serving PWH50+.

Proposed formative research activities may include sampling diverse participants recruited via collaborations with local partners (e.g., publicly funded health facilities, private healthcare systems, community-based organizations, long-term care facilities, local health departments). An example of a diverse sample includes persons with different race/ethnicity, sexual orientation, gender, age (50+, 60+, 70+), age at HIV diagnosis (to capture longevity of living with HIV and geriatric status), geography (rural, urban, suburban, exurban), and degree of engagement with HIV treatment services. In addition to PWH50+, applicants may choose to conduct research with medical providers (such as physicians, case managers, social workers, mental health professionals). Formative research can include qualitative and mixed methods, such as in-depth interviews, semi-structured interviews, focus groups, and surveys using quantitative QOL measures. Data can be collected in person or virtually. Applicants may propose rapid qualitative data collection approaches to facilitate translation of findings. Formative research should answer the following question: what factors impact QOL for PWH50+?

Using findings from the formative research, applicants should identify potential strategies to improve QOL for PWH50+. A strategy can be any practice, program, policy, or product intended to change behavioral, social, environment, structural, and/or social determinants of health and that improves QOL for PWH50+. For example, identified strategies might address one or more factors found to impact QOL for PWH50+, such as a group physical education strategy to address social isolation, mental health, and physical health, or a strategy to include mental health providers in existing patient-centered care or trauma-informed care approaches used by clinics.

Acceptability of strategies should be assessed with individuals from priority population(s).

Applicants should explore the acceptability of strategies by conducting focus groups with PWH50+ and/or service providers to assess what about the proposed strategy is acceptable and/or or not acceptable to PWH50+. Applications should propose activities to answer the following research question: is the proposed strategy acceptable to PWH50+?

The final end-product of this research study is to provide recommendations to the field on how to approach QOL issues for PWH50+, a group whose needs are complex and often unmet.

Applications should propose a final product for disseminating findings, for example, via one or more avenues such as learning collaboratives, written reports, infographics, webinars, and websites. The end-product should describe the research process used to identify the strategies highlighted and the final dissemination product(s). The application should propose the format and design of the end-product for the most effective translation of key insights for external audiences.

The application should include a research plan that addresses all activities described in this NOFO that is ethical, uses appropriate and rigorous methods, and addresses concept validity, verification, and reliability.

Objectives/Outcomes The objectives for this research are:

• Engage PWH50+ and their providers to explore key concerns related to quality of life for persons with HIV, including factors related to physical and mental health and social determinants of health.

• Identify acceptable strategies to improve QOL for PWH50+.

The expected outcomes for this research will contribute to our understanding of the issues impacting PWH50+ by:

• Increasing knowledge of the factors that impact QOL among PWH50+.

• Dissemination of acceptable strategies to intervene on QOL for PWH50+.

Target Population The target population for this research is persons with HIV who are 50 years of age and older (PWH50+). The sample of participants can be recruited from the community and represent those engaged in defined groups and settings, such as residents of long-term care facilities, patients and staff in HIV clinics or healthcare systems, or persons in a specific geographic area. PWH50+ commonly report social isolation, depression, trauma, polymorbidity, challenges in activities of daily living, and adverse experiences associated with social determinants of health including food insecurity, housing instability, financial insecurity, and unemployment. Applications should use local area data to identify communities of PWH50+ that may be disproportionately affected by factors associated with poor QOL, and to identify strategies for these communities that have the potential to reduce this disproportionate impact.

Goal 2.5 of NHAS 2022-2025 is to expand capacity to provide whole-person care to older adults with HIV and long-term survivors. It calls for identifying models of care that meet the needs of older PWH, identifying best practices for addressing psychosocial and health needs, and increasing capacity of service providers to support older PWH. Participants should not be excluded from the study based on disability, sexual orientation, limited health literacy, or other social or economic vulnerabilities.

Collaboration/Partnerships Applications that include partnering with other agencies or organizations should propose formal partnerships that meet the following criteria:

• Provide HIV treatment and essential support services or is partnered with agencies providing treatment or essential support services to PWH50+.

• Demonstrate the ability to recruit an adequate sample of PWH50+ and/or medical providers to achieve the research objectives.

• Agree to: (a) engage in the primary recruitment, (b) allow the applicant access to patients, providers and agency staff, (c) allow distribution of promotional materials; and if necessary, (d) provide space for data collection and other related activities.

Memorandums of Agreement or Understanding (MOA/MOU), letters of commitment or service agreements should be included to document proposed and current partnerships with participating agencies/organizations. The purpose of the MOU/MOA is to set forth the responsibilities of the applicant and the participating agency relative to the proposed goals of the project. An MOU/MOA should indicate a commitment by partnering agencies to participate for the entire three (3)-year project period.

The following are elements that are recommended for inclusion in each MOU/MOA:

• An effective date range that aligns with all three (3) years of the NOFO.

• Overview of the participating agency’s plan and the estimated budget for implementing required study activities.

• Agreement that the applicant will engage agency representatives in relevant study-related meetings and processes, where appropriate, and that the agency will participate accordingly.

• Commitment of the applicant to work with the agency and other collaborative partners to address study requirements, including the designation of a point of contact among the study team dedicated to the implementation of study activities.

• Commitment of the agency to either participate in or assist applicant with required data reporting and evaluation activities.

• Signatures for both parties by authorized representatives.

Evaluation/Performance Measurement The application should include measurable goals and aims based on a three (3)-year research project period. The application should describe specific, measurable, achievable, realistic and time-phased (SMART) project objectives for each activity described in the application’s project research 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 objectives/outcomes described in the NOFO. The proposal should include a timeline to achieve project milestones, staffing, recruitment and enrollment.

A thorough evaluation plan should include:

• An acceptable formative research design that includes a sampling plan that satisfies the NOFO’s outcome criteria and addresses the following: proposed activities are ethical, use appropriate and rigorous methods, and address concept validity, verification, and reliability.

o A sufficient sample size of PWH50+ to achieve saturation of themes in qualitative analyses.

o A sufficiently diverse sample of PWH50+ and/or providers to assess identified strategies for acceptability.

• MOU/MOAs with collaborating or partnering agencies, including summaries of:

o HIV prevalence and estimated number of PWH50+ served.

o Description of services provided to PWH50+.

o Demographics of PWH50+ served.

• A sampling plan for recruiting the target population, prioritizing diversity of respondents.

• If appropriate, a plan to recruit HIV service provider staff (including medical providers, case managers, nurses, mental health professionals, and others).

• Procedures for collection and analysis of qualitative or mixed methods data as described in this NOFO.

• Procedures for collection and analysis of data on strategy acceptability as described in this NOFO.

• A plan for training data collection staff.

Translation Plan A goal of this research project is to demonstrate how the findings may be used to promote, enhance, or advance QOL of PWH50+ in practice. Considerations for translation of findings for dissemination include, but are not limited to:

• Recommendations addressing barriers and facilitators to improving QOL for PWH50+ and/or that assist service providers in addressing QOL for PWH50+.

• Recommendations acceptable to PWH50+ and that can be used by service providers and community partners to adapt and tailor QOL programs/materials for PWH50+.

• Recommendations for promoting uptake of the QOL strategies for PWH50+.

• Recommendations for HIV service providers offering QOL programming to PWH50+.

Applicants are expected to develop products to disseminate the findings of this project to relevant partners and public health audiences. Other dissemination products may include the development of conference presentations and peer-reviewed publications, which may be subject to CDC clearance.

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:

$1,050,000 The estimated total funding (direct and indirect) for the first year (12-month budget period) will be $350,000.

The estimated total funding (direct and indirect) for the entire project period will be $1,050,000.

Year 1: $350,000

Year 2: $350,000

Year 3: $350,000

Anticipated Number of Awards:

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

Award Ceiling:

$350,000 Per Budget Period

Award Floor:

$265,000 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 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)) https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

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.

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

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 N/A

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.

• (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 https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-identifier-update 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://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 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.

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 Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

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), 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 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.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct, with different titles and projects.

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

• 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 Applicants must use FORMS-G application packages for due dates on or before January 24, 2023 and must use FORMS-H application packages for due dates on or after January 25, 2023.

Application guides for FORMS-G and 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 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

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 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

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: 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.

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.

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.

Please include the one (1) optional form listed below, if applicable, in the application package:

Optional

1. R&R Subaward Budget Attachment(s) Form 5 YR 30 ATT.

Applicants must use FORMS-H application packages for due dates on or after January 25, 2023.

3. Letter of Intent Due Date for Letter Of Intent 01/25/2024

01/25/2024 Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC staff to estimate the potential review workload and plan the review.

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 sent 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).

mailto:SPittBarnes@cdc.gov

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 time line.

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. Authentication of Key Biological and/or Chemical Resources

12. 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 Resource Sharing Plan 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, or limitations to, 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);

• 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).

CDC OMB approved templates may be used (e.g. NCCDPHP template https://www.cdc.gov/chronicdisease/pdf/nofo/DMP-Template-508.docx)

Other examples of DMPs may be found here: USGS, http://www.usgs.gov//products/data-and-tools/data-management/data-management-plans

Applicants must use FORMS-G application packages for due dates on or before January 24, 2023 and must use FORMS-H application packages for due dates on or after January 25, 2023.

Application guides for FORMS-G and FORMS-H application packages are posted to the How to Apply - Application Guide page.

Please use the form and instructions for SF424 (R&R) FORMS-H for applications due on or after January 25, 2023.

6. Appendix Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix.