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 stimulate innovative ideas and impactful research to better understand the complexities around developing, testing and implementing appropriate approaches for effective diagnosis, prevention, therapeutic interventions and integrated clinical care for HIV-associated non-communicable diseases (NCDs) in Low and Middle-Income Countries (LMICs). Specifically, this initiative will support research in the following areas: a) Basic sciences to address etiopathogenesis of NCDs in People Living with HIV (PLWH), and the exposed and uninfected population, across the lifespan; b) Aging process in PLWH to understand the early onset of geriatric diseases; c) Diagnostics tools for early detection of NCDs in PLWH; d) Therapeutic interventions to explore optimal drug regimens for PLWH with NCDs; e) Behavioral studies for better quality of life of PLWH with NCDs; and f) Clinical studies for better patient centered care for PLWH with NCDs. The R21 grant mechanism is intended to encourage exploratory/developmental research by providing support for the early and conceptual stages of project development and assessing feasibility of the proposed studies (https://grants.nih.gov/grants/funding/r21.htm). It is hoped that this preliminary research will lay the foundation for larger studies that can lead to applications to other organizations or NIH institutes that support HIV-associated NCD research.

Through this initiative FIC seeks to support exploratory research on the interplay between HIV and development of NCDs in PLWH and uncovering to what extent HIV infection influences the pathogenic effects of comorbid conditions. Applicants will also be expected to address the needs of collaborating LMIC institutions to develop capacity for carrying out research in this field. The FOA is intended to foster partnerships between HIV and NCD researchers to develop interdisciplinary collaborations that may also include basic and clinical researchers, policy makers, health economists, and health systems experts. Research teams should contain an appropriate mix of the relevant disciplines to accomplish the proposed studies. It is expected that this small research grant mechanism will initiate new ideas and determine feasibility of studies of novel approaches to understand and reduce the long-term suffering from the comorbid disorders.

Background/Rationale:

NCDs are responsible for over 70% of deaths globally representing 41 million lives, of which 15 million people die prematurely between the ages of 30 and 69. Eighty-five percent of such premature deaths occur in LMICs and exert a substantial toll on the socio-economic structure of these resource-challenged communities, impeding any progress towards targeted prevention strategies (https://www.who.int/news-room/fact-sheets/detail/noncommunicable-diseases). NCDs include, among many others, cardiovascular diseases, diabetes, obesity, chronic kidney, liver and respiratory diseases, cancer, alcohol and substance abuse and mental disorders. NCDs share the common feature that they are not transmissible and are often chronic in nature. While NCDs might have been triggered by an infectious agent, the chronic disease is often not dependent on the presence of the infectious agent and rather is the result of a combination of genetic, physiological, environmental and behavioral factors. Tobacco and alcohol use dependency, physical inactivity and unhealthy diets all increase the risk of dying from an NCD. WHO also recognizes that air pollution is a critical risk factor for NCDs (http://www.euro.who.int/en/media-centre/events/events/2019/04/WHO-conference-NCDs-Ashgabat-2019/key-questions-on-the-agenda). Detection, screening and treatment of NCDs, as well as palliative care, are key components of the response to NCDs. In 1981 when AIDS cases were first reported, there was the general assumption that people diagnosed with HIV would live 1-2 years. With the prescribed use of highly effective antiretroviral drugs and potent combination drugs, the life expectancy of PLWH has dramatically increased, and this population is living longer and relatively healthier lives. However, routine clinical care of these patients has shown increased risk of NCDs and life-style disorders and a new spectrum of comorbidities that raise new questions (https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5710a2.htm?; https://www.amfar.org/Non-AIDS-Defining-Illnesses-Impact-Health/).

The chronic nature of most NCDs has adverse health and economic consequences for the individual and the household, ultimately affecting the communities and nation as a whole, and that impact is more pronounced in resource limited settings such as LMICs. This concomitant presence of NCDs is more serious in PLWH where scientific evidence points to increased severity and compounded debilitating consequences of multimorbid conditions.

HIV infection results in a chronically inflamed physiological state and it is believed that monocyte activation likely is responsible for initiating the development of NCDs by promoting metabolic and cellular changes leading to early immune aging. The aging process itself is a risk factor for a number of NCDs and whether the presence of HIV infection compounds the risk factors is not well understood. In addition, HIV infection and the normal aging process share immune changes that result in the premature aging of HIV-positive subjects, which in turn increases their susceptibility to diseases associated with normal aging. Understanding these processes may help in the design of therapeutic interventions to stem the premature development of NCDs in HIV-infected subjects, especially in children, adolescents and young people. In addition, specific diagnostic markers to identify immune aging will be extremely useful in predicting the risk for developing a specific NCD.

There is a need for strong epidemiological, clinical and management related evidence that takes into consideration the differences in the disease epidemiology among different countries, the specific HIV-associated NCD and/or combinations of such diseases, and health system environment and types of services available towards developing a context specific integrated care model that is feasible, affordable, and effective in the specific LMIC.

The research priorities need to be adapted to comprehensively understand the role of HIV in causing or exacerbating a wide range of diseases and the clinical manifestations of these diseases. Clinicians caring for patients with HIV will likely require new tools for optimal detection to prevent and to monitor for early signs of developing NCDs. The long-term goals for the FOA are to support locally relevant and catalytic research at LMIC Institutions in critical areas of HIV-associated NCDs to enhance research capacity building efforts at the LMIC institutions, and to build a network of researchers both within and across LMICs to collaborate and complement unique resources and strengths to build the scientific workforce locally.

Definitions:

For the purposes of this NOFO

• NCD is defined as a chronic condition that may or may not have emerged from an infectious pathogen, but the chronic condition is not dependent on the presence of an active infection and hence is not communicable .
• HIV-associated NCD refers to an NCD whose emergence, severity and/or pathogenic course is influenced by HIV infection and/or anti-HIV drugs.
• HIV-associated NCD can also include a disease, disorder or condition affecting a person exposed to high risk environments who remains uninfected by HIV. An example of such a situation is the effects of stigma and associated mental health and depression suffered by Exposed/Uninfected individuals.
• Where needed, it may be required to disentangle the effects of HIV infection on NCD incidence from the confounding disease. Therefore, comparison studies with demographically and behaviorally similar uninfected individuals will be needed.

Objectives:

The objective of this NOFO is to enhance understanding of the complex mechanisms leading to an increased susceptibility to NCDs, drug-induced metabolic disorders leading to a higher risk for developing NCDs, and an accelerated aging process in PLWH that may lead to better design of future interventions aimed at decreasing the effects of such co-morbidities. In vitro studies and use of applicable animal models are allowed; however, the relevance of these studies to human disease should be clear. The areas of focus under each topic area may include but are not limited to:

• Basic sciences:
  • Address etiopathogenesis of NCDs in PLWH
  • Conduct mechanistic studies to understand the cause for the accelerated disease in PLWH
  • Investigate the biological, physiological, biochemical and metabolic processes that are affected by HIV infection resulting in the exaggerated pathology
• Aging process in PLWH:
  • Investigate causes for early onset of NCDs in the stable PLWH population on antiretroviral therapy (ART) in relation to the time of HIV diagnosis and starting on ART
  • Understand the mechanisms of immune aging that may be helpful in designing appropriate interventions to stem the aging process initiated by HIV
• Diagnostics:
  • Develop better tools for early diagnosis of NCDs in PLWH
  • Identify early markers of NCDs in PLWH who start on ART post diagnosis
• Therapeutic interventions:
  • Explore optimal drug regimens and drug-drug interactions (DDI), including drug interactions with traditional medicines, which complicate therapy decisions in PLWH with NCDs
  • Explore the role of drug-drug interactions resulting in ineffective treatment outcomes and developing alternate drug regimens,
  • Explore the role of nutritional imbalance and nutritional supplementation in therapeutic uptake and health outcomes of PLWH with NCDs
• Behavioral studies:
  • Examine long-term options for better quality of life in PLWH with NCDs, including decreasing the effects of stigma, mental health and neurocognitive disorders
• Clinical studies:
  • Develop approaches for better patient centered care and care outcomes
  • Conduct implementation research for more integrated care management of HIV and HIV-associated NCDs
  • Develop research-based evidence needed for integrating HIV and HIV-associated NCD care for future decisions on health care delivery and policy

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 in HIV-associated NCDs.

• NCI is interested in research projects aimed at identifying specific contributions of HIV infection and its potential interaction with other pathogens towards the development and pathogenesis of cancer, or provide information on the clinical outcomes in PLWH and cancer.
• NIDDK is interested in basic, translational, clinical, and epidemiologic research on AIDS-related noncommunicable comorbidities within its mission. These include loss of gastrointestinal immune and microbial homeostasis, enteropathy and gastrointestinal diseases; liver diseases; kidney, urologic, and hematologic diseases; and metabolic perturbations, obesity, diabetes and associated complications.
• NIDCR is interested in basic, translational, epidemiologic, clinical, and social-behavioral research on noncommunicable comorbidities and complications relevant to dental, oral, and craniofacial (DOC) health in the context of HIV/AIDS. These include but are not limited to chronic oral diseases such as dental caries, periodontal diseases, HIV-associated salivary gland disease (HIV-SGD), oropharyngeal and/or head and neck cancers and orofacial pain. Proposed studies must be consistent with the FY22-25 NIH Strategic Plan for HIV and HIV-Related Research and NIDCR Strategic Plan 2021-2026. NIDCR will not accept clinical trials under this NOFO.

Proposed studies must be consistent with the NIH Office of AIDS Research priorities for HIV research ( https://www.oar.nih.gov/hiv-policy-and-research/research-priorities;

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-018.html).

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.

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.

This NOFO provides an avenue for investigators in the LMICs and in the U.S. with interests in studying the intersection of HIV and/or AIDS with chronic NCDs to establish research collaborations and research capacity strengthening activities at the LMIC institution. It is expected that collaborating investigators will provide complementary expertise in proposing studies to investigate HIV-associated NCDs.

R&R or Modular Budget

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

R&R Subaward Budget

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

Applicants should budget funds for at least one PD/PI or designated co-Investigator to attend the annual program network meeting each year in Bethesda, MD.

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:

?T?he R21 grant will provide support to assess needs, to initiate preliminary studies and strengthen research capabilities at the LMIC institution, and to organize, plan, prepare, and assemble or solidify partnerships, additional expertise, information and data as needed for an application for a more comprehensive research grant (e.g. a R01). The application should define an exploratory research project and associated plan for assessing, developing, and strengthening research capabilities.

Research Strategy:

Justify the relevance of the proposed research to the HIV-related health outcomes of people in the LMIC setting.

Establish Research Collaboration

1. The purpose of this grant is to foster initial development of collaborative work focused on HIV-associated N?C?D?s 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 a collaboration, beyond the information stated on individual biosketches, should be clearly delineated;

2. The role of each key personnel and institution and the plans for the coordination of the research activities should be noted.

3. In the case of a collaboration between researchers in an LMIC and a U.S.-based institution, the application should include plans for coordination of research (and activities to strengthen LMIC research capabilities) between the partner institutions, which should be described and should include regular meetings (virtual and/or physical).

4. Collaborations between two or more LMIC investigators can be at the same or different LMIC Institutions, and the application must describe plans to build research capacity in their proposed research area.

Develop Research Networks

1. Applicants are encouraged to identify and interact with other relevant research and research training being conducted at the LMIC institution, and more widely within the country and region as feasible.

2. Applicants can discuss the potential to take advantage of synergies for networking and collaboration for research and for activities to strengthen research capabilities. Such activities may include but are not limited to:

• leveraging NIH or other funder investments already in place in specific foreign countries,
• using common measures/data elements across research studies in a country/region,
• sharing or pooling data or creating data repositories,
• making efficient use of local/regional oversight bodies such as IRBs, DSMBs
• sharing education platforms to develop expertise across programs

Promote Research Capacity Building

1. Applicants should show evidence of institutional support for capacity building in the specific research area by providing letters of support from Institutional leadership.

2. Such support may take many forms, such as by encouraging networking seminars and symposia, by facilitating communications and partnership with other Institutional leaders to consider joint funding opportunities, and other similar avenues.

Letters of Support: Letters of support should be provided by each consultant, collaborator and collaborating institution. Letters of support are not required from those identified as key personnel or co-Investigator.

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.

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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

.

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 R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not 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. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

In addition, specific for this NOFO, note the following:

The R21 exploratory/developmental grant mechanism will support established partnerships as well as new partnerships between HIV researchers and NCD researchers that have not previously collaborated on joint projects. Thus, investigators are not required to demonstrate in the application any history of prior collaboration. However, factors in the investigators' background and/or institutional circumstances that will facilitate success in such collaboration should be assessed. The role of each key personnel and institution and the plans for the coordination of the research activities should be evaluated. It is expected that the new partnership will foster interdisciplinary collaboration to answer unaddressed questions in HIV-associated NCDs and develop appropriate integrated strategies for prevention, treatment and care for PLWH.

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.

Significance: In addition, specific for this NOFO: Does the application clearly identify the nature of the HIV-associated NCD affecting the specific LMIC population, and justify the need for the proposed work?

Investigator(s): In addition, specific for this NOFO: Do the PD(s)/PI(s) with HIV and NCD research expertise have experience working in the LMIC to provide strong leadership, direction, management, and administration of the proposed research? Are appropriate LMIC investigators included in key roles on the project with clearly defined roles on the project to plan coordination of the research activities? While prior history of collaboration is not required, will investigators' background and/or institutional circumstances facilitate success of interdisciplinary new collaboration to answer unaddressed questions in HIV-associated NCDs, and to develop appropriate integrated strategies for prevention, treatment, and care for PLWH? Is there an appropriate mix of HIV and NCD researchers from the LMIC whose combined expertise will provide an integrated approach to working on the proposed project?

Innovation: In addition, specific for this NOFO: Will the proposed study be able to strengthen and sustain HIV-associated NCD research capabilities at the LMIC institution by engaging new partnerships? Is the study proposing to test the feasibility of a new or previously tested intervention in a new cohort?

Approach: In addition, specific for this NOFO: Does the proposed approach integrate the role of HIV in the investigation of the NCD related research in the study?

Environment: In addition, specific for this NOFO: Is there evidence of Institutional support to PD/PI(s) to build research capacity in HIV-associated NCDs at the LMIC Institution(s)? Is there evidence of support for interdisciplinary activities related to HIV-associated NCD research?

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 will be assigned to the Fogarty International Center. 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 Fogarty International Center's 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 of FIC and the partnering ICs.
• Geographical balance of projects.
• ?Programmatic balance i?n scientific topics.

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]

Kendall J. Bryant, Ph.D.
National Institute on Alcoholism and Alcohol Abuse (NIAAA)
Telephone: 301-402-0332
Email: [email protected]

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

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

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

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

Peter Perrin, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-3759
Email: [email protected]

Anais Stenson, Ph.D.
National Institute of Mental Health (NIMH)
Email: [email protected]

Center for Scientific Review (CSR)
Email: [email protected]

Judy Fox
National Institute on Alcoholism and Alcohol Abuse (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

Victoria Tran
Fogarty International Center (FIC)
Telephone: 301-594-1650
Email: [email protected]

Erik Edgerton
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-7760
Email: [email protected]

Alania Foster
National Cancer Institute (NCI)
Phone: 240-276-5375
E-mail: alania.foster@nih

Maurice Koo
National Institute on Aging (NIA)
Phone: 301-827-6372
Email: [email protected]

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

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

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