Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

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.

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

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of 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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

This Notice of Funding Opportunity (NOFO) issued by the Fogarty International Center (FIC) seeks to support research to develop and pilot test interventions to reduce the impact of HIV-associated stigma on the prevention and treatment of HIV and/or AIDS, and on the quality of life of People Living with HIV and/or AIDS (PLWH). The NOFO will also support interventions to address the multiple intersecting stigmas due to co-occurring diseases and/or conditions faced by PLWH. Specifically, this initiative will support work to be done in Low and Middle-Income Countries (LMICs) to stimulate new and impactful research on a) novel stigma-reduction and/or resilience building interventional strategies that link to increase in care-seeking behavior and/or promote decrease in transmission, b) reducing the impact of stigma on adolescent and/or youth health, c) strategies to address the syndemics of intersecting stigmas due to one or more co-morbidities/co-infections/socio-structural environment affecting PLWH, d) reducing the effects of stigma on, and/or by, family members or caregivers of PLWH and e) development of innovative and improved stigma measurement in the context of intervention development or implementation of the proposed intervention. The small R01 grant mechanism is intended to provide more money and time than a traditional R21 mechanism but with similar goal to encourage exploratory/developmental research by providing support for the early and conceptual stages of project development. While preliminary data are not expected, a strong premise from published literature must provide the rationale for the study. Additionally, prior research collaborations between investigators is not required, but evidence of complementary expertise of the co-investigators should be provided.

Background/Rationale:

Despite significant advances in biomedical approaches to prevent HIV transmission, acquisition of new infections has not abated, suggesting the need for further research into the possible causes of and new ways to mitigate the spread of the disease (1). While introduction of Pre-exposure Prophylaxis (PrEP) and anti-retroviral therapy (ART) use for PLWH had significant effects on preventing HIV transmission to seronegative partners, along with other known prevention approaches such as condom use and medical male circumcision, several pockets of new infection have emerged globally (2). Similarly, protocols for the prevention of mother-to-child transmission (PMTCT) have been very effective; however, women still bear the burden of increased infection globally, especially adolescent girls, who can potentially continue to transmit HIV to their newborns. These women may not be accessing health care services to obtain information about PMTCT due to stigma associated with their HIV status and/or pregnancy (3, 4). Professional health communities acknowledge that stigma is one of the many reasons for continued transmission of HIV (3, 4), and that stigma creates a barrier to getting tested, treated, and retained in care, especially in LMICs (4).

Stigma is a behavioral manifestation of self or societal disapproval of a condition affecting those who are stigmatized. Stigma affects all PLWH, including key populations such as sex workers, people who inject drugs, transgender people, prisoners, and men who have sex with men. Adolescents and youth are vulnerable and suffer from public- and/or self-stigma. Early awareness of stigma and its consequences, and exposure to resources that can prevent infection and transmission, may have a large impact during this crucial period, suggesting the importance of further work with this group. Because of their unique psychological and physiological makeup, the ability of adolescents to respond to stigma-related stress have not been well studied. Interventions that increase resiliency and/or provide coping mechanisms may be effective for better health outcomes in all of these groups.

People living with HIV (PLWH) often also suffer from other infections such as tuberculosis; and other non-communicable diseases such as mental health, metabolic and other neurological disorders, which are themselves subject to stigma. They also suffer stigma due to perceived lifestyle choices. The compounded effect of stigma associated with multiple conditions (layered or intersecting stigma) imposes an extra burden on these people. To develop effective interventions to improve the health outcomes in these groups, it will be important to understand and dissect out the major contributors to stigma and design appropriate interventions.

Another understudied population are exposed but uninfected people, especially children of parents living with HIV, and caregivers tending to the sick, who can themselves be targets of stigma that can affect their health in different ways. It is not clear how much of HIV/AIDS stigma-related stress in this group of people is the cause of prevention failures and breakdown in care, and what type of interventions may be optimal for providing resilience and motivation to this group of caregivers and family members.

There is a need for better stigma measures to assess the efficacy of stigma-reduction interventions at different stages of implementation, in different contexts and populations, and at different steps of the HIV/AIDS disease care continuum. This may be particularly necessary to dissecting out the relative contribution of layered or intersecting stigma either due to HIV/AIDS comorbities and coinfections, or HIV compounded by other factors such as racism, sexism, religious intolerance, and sexual orientation among others.

Definitions:

For the purposes of this NOFO:

• HIV-related health outcomes include any measurable or identifiable positive change in the health status of the affected person, group or community that result from an intervention, including but not limited to: employing preventative methods for protection from infection, undergoing HIV testing, adhering to medications, and retention in and maintaining linkage to HIV care. Care-seeking behaviors can also be assessed by biological outcomes such as decrease in viral load, improved mental health, among others.
• Interventions may employ biomedical, behavioral or structural approaches that are designed to produce a decrease in stigma. Processes that address individual (for example self-stigma), interpersonal, intersectional, or structural (for example cultural norms, institutional practices, and other) stigma for which an intervention can be developed would be considered an appropriate focus for the proposed research

Objectives:

The objective of this NOFO is to lay the groundwork for, or pilot, stigma-reduction interventions to improve HIV health seeking behavior across the HIV prevention and care continuum and improve biological and mental health outcomes for PLWH or their caregivers. In the context of an intervention, the areas of focus may include but are not limited to:

• Adapting, developing, validating or implementing stigma-reduction interventions in PLWH. Target populations may include adolescents and/or youth, caregivers, and other key populations such as sex workers, people who inject drugs, transgender people, prisoners, and men who have sex with men, among others.
• Adapting, developing, or validating measurement instruments to assess the success of the intervention in reducing stigma and in improving health outcomes.
• Formative research on novel stigma-reduction interventions to understand the obstacles to seeking care.
• Formative research to assess the complexities in layered or intersecting stigma that might lead to strategies to address the synergistic burden.
• Studies to assess stigma-reduction interventions in specific social groups (for example, unmarried pregnant women); or across multiple groups (for example PLWH and their health care workers) linking to a health outcome such as decrease in transmission.
• Studies to assess the association of structural level stigma-reduction interventions with better health outcomes; for example, modifiable structural factors such as health policy and its impact on health outcomes.
• Tools for addressing stigma awareness in HIV+ adolescents, youth, young children and orphans and increase their participation in care-seeking and prevention services.

In keeping with the suggested research topics above of interest to FIC, the following lists some specific focus areas of interest to the partner ICs that is within the scope of this NOFO as described above.

• The National Cancer Institute (NCI) encourages research on cancer-associated stigma in PLWH that contributes to existing barriers to get cancer diagnosis, prevention, treatment, and palliative care. Applicants interested on cancer related stigma in PLWH should propose research projects that expand the current understanding of the intersectionality between HIV- and cancer- associated stigma, its impact on cancer control and prevention that impact health outcomes for PLWH. The proposed studies must lead to the development of stigma-reduction interventions.
• The NICHD mission is to lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. The NICHD's broad and diverse research portfolio includes research related to conception and pregnancy; typical and atypical development in childhood; childhood trauma and critical illness; the transition from adolescence to adulthood; reproductive health; rehabilitation; intellectual, developmental, and physical disabilities; and population dynamics across the lifespan. The NICHD Strategic Plan includes Health Disparities, Infectious Diseases, Global Health and Disease Prevention as cross-cutting topics. For this PAR, NICHD is particularly interested in research that addresses HIV/AIDS stigma reduction in maternal and pediatric populations.
• The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) encourages projects on stigmas associated with comorbidities within its mission, such as obesity, nutritional deficiencies, diabetes, kidney diseases, and liver diseases. Projects should address the intersectionality between HIV- and comorbidity-associated stigma and how this impacts the management of the comorbidities and health outcomes for PLWH. The proposed studies must lead to the development of stigma-reduction interventions
• The National Institute of Dental and Craniofacial Research (NIDCR) is interested in clinical and social-behavioral interventional research addressing the HIV related stigma that impact oral transmission, comorbidities, co-infections, and complications (CCCs) in People with HIV (PWH). These include but are not limited to studies elucidating the barriers and facilitators of reducing stigma that impact the oral health outcomes, and testing/developing potential stigma-reduction interventions and strategies to improve oral health in PWH.
• The National Institute on Drug Abuse (NIDA) is interested in supporting pilot clinical trials of stigma-reduction interventions and formative work to support development of future interventions. Trials should address drug use-related stigmas, including self-stigma among people who use drugs (PWUD) and perceived, anticipated or enacted stigma experienced by PWUD, as well as stigma experienced by providers working with PWUD. The full range of drug use will be considered as long as it has demonstrated associations with HIV acquisition and/or issues related to viremia or ART adherence. NIDA recognizes that intersectional stigmas (e.g., gender, sexual minority, religion, ethnic/racial minority) including HIV-related stigmas also may need to be addressed in these projects. Outcomes should focus on the HIV prevention and care continuum. Interventions and related formative work at the individual, patient-provider, family, community, and system level are welcome (including multi-level intervention approaches), as are efforts to adapt evidence-based interventions that have demonstrated effectiveness among other populations or settings.
• The National institute of Mental Health (NIMH) is interested in theoretically driven research grant applications that will: 1) advance measurements of HIV-related intersectional stigma (or intersectional discrimination) to examine the mechanisms and pathways by which they are a barrier to HIV prevention and HIV treatment; or 2) develop and test interventions to address their impact to improve HIV prevention and HIV treatment outcomes. Multilevel interventions targeting individuals, families, peers, providers, and structural or organizational factors are encouraged, as well as are studies that include mental illness stigma as a component of intersectional stigma. Applicants are strongly encouraged to utilize community-based participatory research approaches to meaningfully engage and collaborate with communities most impacted by HIV-related intersectional stigma or intersectional discrimination. Non-intervention research applications should clearly indicate how this is the first step in a planned program of research that would inform future interventions to reduce the impact of HIV-related intersectional stigma (or intersectional discrimination) on HIV prevention and treatment outcomes.

Additional Considerations:

• Through this NOFO, FIC seeks to support pilot studies to determine the feasibility of implementable and ultimately scalable approaches to understand and reduce stigma as a factor in HIV transmission. Applicants should assemble teams with the appropriate range of expertise required to accomplish the aims of the study, which may include a collaborative team with multi-disciplinary expertise. The proposed collaborative feasibility research is expected to help build the capacity for full research programs by improving the research environment and strengthening LMIC individual and institutional research capabilities in the proposed research areas. The proposed work and follow up research are expected to contribute to the long-term goals of building sustainable capacity for stigma research in LMICs.
• One or more investigators from an academic or research institution in the U.S. and one or more investigators from an academic or research institution in an LMIC are strongly encouraged to collaborate as key personnel on the application. US investigators must have LMIC collaborators. Applicants should explicitly address the needs of collaborating LMIC institutions to develop capacity for carrying out research in this field, and plans for sustaining the research activity.

Proposed studies must be consistent with the NIH HIV/AIDS Research Priorities (https://www.oar.nih.gov/hiv-policy-and-research/research-priorities; https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-018.html ).

Applications Not Responsive to this NOFO:

The following types of studies are not responsive to this NOFO. Applications proposing such studies will be considered non-responsive and will not be reviewed or considered for funding.

• Applications proposing studies that do not address, or are not relevant to the development of a stigma-reduction intervention strategy linked to measurement of a beneficial health outcome in PLWH.

References:

1. 2021 News Releases | Newsroom | NCHHSTP | CDC

2. UNAIDS Global AIDS Update 2022 reveals millions of lives are "In Danger" - U.S. Embassy in Mozambique (usembassy.gov)

3. Women and HIV A spotlight on adolescent girls and young women (abu.edu.ng)

4. https://www.unaids.org/sites/default/files/media_asset/global-partnership-hiv-stigma-discrimination_en.pdf

See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH 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
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Other

• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic entities are restricted to higher education and/or research institutions and other non-profit organizations in LMICs, which are defined by The World Bank as low-, lower-middle-, or upper-middle-income economies - http://data.worldbank.org/about/country-classifications/country-and-lending-groups . Hong Kong-based institutions are not eligible as applicant or primary LMIC -partner institutions. If Hong Kong is included, a second institution in mainland China must be involved as the primary collaborating LMIC institution.

Non-U.S. High Income Country Institutions are not eligible as the primary partner for a LMIC Institution, but may be included as consultants, especially if they present special opportunities for the proposed research. LMIC-U.S. or LMIC-LMIC partnerships between institutions are eligible.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA strongly encourages inclusion of women and individuals from groups underrepresented in clinical, biomedical, and socio-behavioral research (including individuals from racial, ethnic, and socially disadvantaged backgrounds and those living with disabilities) as principal investigators/program directors, faculty and scientific collaborators.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) 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.

Letter of Intent

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 IC 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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Geetha P. Bansal, Ph.D.
Fogarty International Center
Telephone: 301-496-1492
Email: [email protected]

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

Applicant should budget funds for at least one PD/PI to attend the annual program network meeting in Bethesda, MD.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy: All applicants should incorporate the following elements while preparing the application:

• Succinctly define the stigma-associated problem and describe the magnitude of, and factors involved in, the problem to be addressed in the LMIC population
• Identify the needs of the affected group targeted for the appropriate stigma-reduction intervention
• Clearly articulate research questions to be addressed and the methodological approach that will be used to answer the questions
• Justify the relevance of the proposed research to the HIV-related health outcomes of people in the LMIC setting
• Discuss briefly how the proposed research will prepare for or test an intervention to reduce stigma and increase the health of stigmatized individuals or populations
• Describe the resources and research capabilities that will be needed to develop the intervention and how they will be acquired and used
• Discuss the outcome measures that will be utilized to determine whether the intervention is successful in increasing the health of the target population, including biological and psychological endpoints in addition to potential behavioral changes; and any formative research required to develop these instruments, measures, and interventions
• Integrate strategies for research capacity strengthening at the LMIC institution into the proposed research program
• The small R01 mechanism is intended to support feasibility studies to test stigma reduction interventions by providing more time and funds than would have been possible with an R21 mechanism. Therefore preliminary data are not required. However, a strong premise and rationale for the proposed studies must be clearly stated.

Collaboration:

The purpose of this NOFO is to foster the development of collaborative work focused on HIV-associated stigma relevant to LMICs; accordingly, investigators are not required to demonstrate in the application any history of prior collaboration. However, those factors in the investigators' background and/or institutional circumstances that will facilitate success in such collaboration, beyond the information stated on individual biosketches, should be clearly delineated. The role of each key personnel and institution and the plans for the coordination of the research activities should be described.

One or more investigators from an academic or research institution in the U.S. and one or more investigators from an academic or research institution in an LMIC are strongly encouraged to collaborate as key personnel on the application. Applicants should explicitly address the needs of collaborating LMIC institutions to develop capacity for carrying out research in this field, and the plans for sustaining the research activity.

Letters of Support: Letters of support should be provided by each collaborator and collaborating institution.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the Fogarty International Center (FIC)/NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The small R01 grant mechanism will support investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. The applications are not required to have extensive background material or preliminary information. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding of the identified scientific issues in the LMIC context for appropriate intervention development. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned to the Fogarty International Center (FIC). Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the FIC Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Geographic balance of projects.
• Scientific topics for programmatic balance.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Sonia Lee, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-594-4783
Email: [email protected]

Geetha P. Bansal, Ph.D.
Fogarty International Center
Telephone: 301-496-1492
Email:[email protected]

Vasundhara Varthakavi
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 240-669-5020
E-mail: [email protected]

Geraldina Dominguez, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-781-3420
Email: [email protected]

Peter J Perrin, Ph.D.
NIDDK - NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
Phone: 301 451-3759
E-mail: [email protected]

Gregory Greenwood, PhD, MPH
National Institute of Mental Health (NIMH)
Telephone: 240-669-5532
Email: [email protected]

Hiroko Iida, DDS, MPH
National Institute of Dental and Craniofacial Research (NIDCR)
Phone: 301-594-7404
Email: [email protected]

Center for Scientific Review (CSR)

Email: FOA[email protected]

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

Mollie Shea
Fogarty International Center
Telephone: 301-451-6830
Email: [email protected]

Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: [email protected]

Dawn Mitchum
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email: [email protected]

Sunshine Wilson
NIDDK - NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
Phone: (301) 827-4670
E-mail: [email protected]

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: [email protected]

Gabriel Hidalgo, MBA
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-827-4630
E-mail: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.