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 Training (T) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) 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.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Note: This Funding Opportunity Announcement (FOA) allows appointment of Trainees (D43) proposing to serve as the lead investigator of an independent clinical trial; or proposing a separate ancillary clinical trial; or proposing to gain research experience in a clinical trial led by another investigator, as part of their research and career development.

Program Objective

The overall goal of the Fogarty HIV Research Training (HIVRT) Program is to strengthen the scientific capacity of institutions in low- and middle-income countries (LMICs) to conduct HIV research on the evolving HIV epidemic in their country.

The HIVRT Program encourages applications for three different Funding Opportunity Announcements (FOAs). This FOA (D43) encourages applications to support research training to strengthen scientific expertise needed for HIV research at LMIC institutions. The second FOA (D71) PAR-19-284 encourages planning grant applications from LMIC institutions to develop a training program and application to submit under this FOA at a later date. The third FOA (G11) encourages applications for infrastructure development training in several research infrastructure functions described in PAR-19-285. This FOA can support biomedical research training in a broad range of HIV research areas including but not limited to:

• basic, epidemiologic, clinical, behavioral, and social science research across HIV prevention, care and treatment;
• pathophysiology and therapeutics research to address HIV infection, the effects of HIV on body systems, and HIV’s interaction with other co-morbidities and co-infections;
• implementation, operations, health services, and health systems research to improve the HIV prevention, care and treatment care continuum;
• research on integrated bio-behavioral HIV prevention, care and treatment among high risk populations, including polysubstance drug (injection and non-injection) and alcohol use;
• research on HIV co-infections, AIDs-defining and HIV-related cancers, neurological and neuro-psychiatric morbidities, and other co-morbidities and health conditions, both infectious and non-infectious, that contribute to HIV transmission or poor health in HIV-infected individuals, including HIV infected substance (drug and alcohol) users;
• community-based HIV research, HIV research on complex/multi-component interventions, structural interventions, and comparative effectiveness, and HIV research on impact evaluation or health economics;
• cross-disciplinary HIV research among vulnerable or under-researched LMIC populations, including women, substance (drug and alcohol) users, men who have sex with men, transgendered populations, aging populations, orphans, and children;
• clinical research for team members to support HIV clinical research and HIV clinical trials;
• bio-statistics and bioinformatics research methodologies for enhanced HIV research design, data analysis, data management, and data quality assurance and control to support HIV research;
• basic laboratory-based HIV research that will incorporate acquiring laboratory skills, bio-safety practices, and maintenance of laboratory quality assurance as components of research methodologies for conducting HIV clinical research.

The beneficiary of the training supported through this FOA are LMIC institutions. When available and relevant to their objectives, HIVRT program should optimally leverage in-country institutional research training capacity and leadership.

Within the context of the broad range of training areas mentioned above, NIDCR will support HIV research training programs directly related to dental, oral and craniofacial health. Participation of schools of dentistry is encouraged. For more information on NIDCR HIV/AIDS research priorities, see: https://www.nidcr.nih.gov/grants-funding/grant-programs/hiv-aids-oral-health-research-program/more..

The NIH Office of Research on Women's Health (ORWH) is interested in supporting mentored research trainees who will be engaged in interdisciplinary research relevant to the health of women and, where appropriate, the use of both sexes to better understand the influence of sex as a biological variable on health and disease. For the purpose of this D43 International Research Training Grants program, some of the ORWH’s HIV research topics of interest can include but are not limited to : 1- HIV and HPV co-infections in women and specifically the prevention of HPV and HIV. 2- HIV and Reproductive Health issues in women.

Background

The Fogarty International Center (FIC), with co-funding from other NIH Institutes, Centers and Offices (ICOs), provided over 30 years of support to enhance HIV research through HIV research training programs. Awards supported research training of LMIC scientists who participated in important HIV research conducted at LMIC institutions in partnership with U.S. and other international scientists and scientific institutions. Over the years, some of the most important recent scientific advances in HIV/AIDS, including interventions to reduce mother-to-child HIV transmission, address HIV/TB co-infection, and prevent HIV infection through behavior change, microbicides, and antiretroviral drugs, have been facilitated through partnerships with LMIC scientists and supported by the FIC research training programs. Continued investment in training to strengthen research at LMIC institutions is needed to address the on-going HIV epidemic and to achieve the goals of a "Cure" and an "AIDS-Free Generation."

Efforts to implement research findings in the context of increased HIV prevention, care and treatment services in LMICs over the years led to the emergence of new issues, such as how to best combine HIV prevention interventions, link newly diagnosed individuals into care programs, and integrate HIV programs with other health services. As LMICs implement HIV prevention, care and treatment programs, these and other, yet undefined, issues will need evidence-based solutions.

The social context of an LMIC influences the design of research to answer many of these evolving HIV research questions. Therefore, LMIC institutions and researchers are best positioned to conduct the most relevant HIV research, disseminate the results in-country, and influence policymakers, program managers and medical/public health practice. In the HIVRT Program, each research training award is expected to focus on strengthening specific high priority HIV research capacity at an identified LMIC institution and collaborating LMIC partner institutions.

The HIVRT Program is designed to move beyond simple output indicators (number and type of people trained, research products) to outcome indicators such as increased research capacity at an LMIC institution. Applicants are expected to design a monitoring and evaluation plan to address these goals. Applicants should design a training plan for individuals that will also demonstrate in an explicit and defined way how the training will contribute to a higher level of research capacity at the LMIC institution.

Program Considerations

This program provides opportunities for U.S. and LMIC institutions to collaborate with their partners, to fill gaps in research areas to strengthen the HIV research capacity at the proposed LMIC institutions. Applicants should design HIV research training programs such that trainees can address both long-standing and emerging HIV research questions, responsive to the needs of their institutions and countries. The program is also expected to enhance the capacity for LMIC institutions to collaborate with NIH, U.S. Government, other donors and LMICs in their HIV/AIDS efforts.

The selected scientific area of the proposed research training may need expertise that crosses research disciplines, especially to reach underserved and vulnerable populations. Applicants are encouraged to develop research training programs that include all the disciplines needed to address the selected scientific area and the populations of interest. The proposed training is expected to raise the LMIC institution to the next level of research capacity in the selected scientific area. The research training should include training that incorporates research methods and processes that enhance research rigor and reproducibility, as recently highlighted by NIH (https://grants.nih.gov/reproducibility/faqs.htm).

In many cases, it is anticipated that the proposed program will complement other ongoing research training programs relevant to the selected scientific area at the LMIC institution(s). Proposed research training should be designed to be synergistic and not duplicative of these other programs, which can be evidenced by including a description of the current programs available at the LMICs regardless of funding sources.

It is anticipated that some LMIC institutions could serve as training sites in the proposed HIV scientific area for other LMIC institutions. Faculty and scientific staff from these more advanced LMIC institutions may serve as training faculty. As a result, the following different scenarios for applications may be proposed:

• a U.S. institution as the applicant with an LMIC institution as collaborator and beneficiary of the research training;

• a LMIC institution as applicant with their own institution as the beneficiary of the research training to further strengthen its own capacity;
• a LMIC institution as applicant with another one or more LMIC institution(s) as the collaborator and beneficiary of the research training. For example, a LMIC institution with more advanced expertise in the chosen HIV area can serve as a training hub and help establish research training programs in less experienced LMIC institutions by training students and fellows from those institutions. It is expected that these trainees will establish a collaborative research environment at their own institutions..

Proposed programs can support a combination of short- (three months or less), medium- (over three months and up to six months) and long- (six months and longer, including degree) term training to support increased research capacity in the selected scientific area at the identified LMIC institution. Part-time long-term training is permitted but should be well described and justified in the application. Emphasis should be given to training that provides the theoretical and applied depth needed by an individual or by a group of individuals in the LMIC institution to maintain the research capacity in the selected HIV scientific area at the higher level after the five-year training period.

Short-term training should provide selected trainees with a thorough exposure to the principles and skills of specific research methods or research-related competencies that are needed to support their current research or career development activities. Mentorship should be provided to ensure short-term training achieves this expectation. Short-term training support is limited to:

• Training in specific research skills or methods directly applicable to trainee research projects.
• Research leadership, management or career development skills, such as expertise in research ethics and compliance issues, grant management and administration, grant and scientific manuscript writing, information technology and data management, technology transfer and intellectual property.

The applicant may propose advanced training to support the career development of former trainees from this or other FIC training programs, as long as the training contributes to increased and sustainable research and research training capacity in the selected scientific area at the LMIC institution.

Innovative training models appropriate for the context of the LMIC institution are highly encouraged Training should take place at the most appropriate site. The training site may include institutions other than the applicant or LMIC institution(s) named in the application, including other high-income or "ineligible" middle-income countries (see http://www.fic.nih.gov/Grants/Pages/country-eligibility.aspx). Distance learning with sufficient mentoring and support at the LMIC institution may be proposed.

Training-related research must be conducted in or use data from the country of the LMIC institution. The training-related research must be designed to incorporate research methods and processes that consider rigor and reproducibility and take into account potential sex and gender differences that may affect the questions asked and the analyses performed. These might include different responses to and impacts of health interventions, differences in physiology, and different behavioral bases for disease prevention strategies.

All mentored research projects under this award must receive independent scientific review through procedures established by the applicant and must comply with the federal requirements for the protection of human subjects and animals in medical research. If human subjects are involved, the trainee must receive education in the protection of human subjects, and the research must receive annual approval from an institutional (or ethical) review board or committee at the applicant institution and, if different, at the institution in which the research is conducted. If animals are involved, institutions where research is conducted need to have an Animal Welfare Assurance in place.

Specific Interests of the National Heart, Lung, and Blood Institute (NHLBI)

The National Heart, Lung, and Blood Institute (NHLBI) is interested in training programs that sustainably strengthen the HIV-associated heart, lung, blood, and sleep (HLBS) research capacity of low- and middle-income country (LMIC) institutions; train in-country experts to develop and conduct research to strengthen the HIV research capacity at the proposed LMIC institutions related to HIV-associated HLBS diseases and disorders; and maximize NHLBI’s current global health investments, with the long-range goal of developing and implementing evidence-based, contextualized HIV-associated HLBS interventions to reduce the burden of chronic diseases. Multidisciplinary Training programs across the spectrum of research disciplines is encouraged, from basic biomedical, behavioral, and social science to clinical and applied sciences, including translational and implementation science that support evidence integration and emphasize the resources, context, and needs of multiple stakeholders in local settings. Training programs should include basic research skills, research design and methodology, ethics, data management and analysis, grant writing, manuscript writing, scientific presentations, as well as research administration and execution.

Examples of Research training programs include those that advance clinical translational research in understudied conditions, or those that grow capacity in new approaches to research. These include but are not limited to:

• Research training programs to improve HIV-related cardiovascular, pulmonary, hematologic sciences and transfusion medicine or sleep health
• Research training programs identifying prevention, screening, and/or treatment approaches to reduce HLBS disease burden in HIV-infected individuals across the lifespan
• Research training programs examining basic, epidemiologic, clinical, behavioral, and/or social science questions, related to HIV- and ART-associated HLBS risk factors in adults and aging population to curtail disease progression
• Research training programs deciphering the pathophysiology and mechanisms of disease progression related to HIV-associated HLBS disorders
• Research training programs focused on community-based research related to HIV-associated HLBS risk factors in vulnerable communities using complex/multi-component interventions, structural interventions, comparative effectiveness, impact evaluation or health economics models
• Research training programs focused on dissemination and implementation science, to improve the prevention, care and treatment for HIV-associated HLBS complications
• Research training programs developing cross-disciplinary HIV-associated HLBS studies among vulnerable or under-researched LMIC populations, including women, substance (drug and alcohol) users, men who have sex with men, transgendered populations, aging populations, orphans, and children
• Research training programs focused on data science, biostatistics and bioinformatics capacity to drive clinical translational research in HIV associated HLBS conditions (e.g., data analysis, data management, and data quality assurance and control)

Applicants are encouraged to review the NIH HIV/AIDS Research Priorities (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-018.html), the NIH Plan for HIV-Related Research for the year they are applying (https://www.oar.nih.gov/sites/default/files/NIH_StrategicPlan_FY2021-2025.pdf), and the FIC Strategic Plan (https://www.fic.nih.gov/about/pages/strategic-plan.aspx) to inform the planning process proposed.

See Frequently Asked Questions for the Fogarty HIV Research Training for more information.

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

Section II. Award Information

Other Award Budget Information

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)

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

An application may be submitted by a foreign institution in an eligible LMIC or by a domestic (U.S.) institution that demonstrates collaboration with an LMIC institution in an eligible LMIC(s). Collaboration should be documented by joint publications, grants (including a HIVRT D71), or previous research training activities.

LMICs are defined by the World Bank classification system according to Gross National Income (GNI) per capita as low-income, lower-middle-income, and upper-middle-income (http://data.worldbank.org/about/country-classifications/country-and-lending-groups). See Country Eligibility for Fogarty International Training Grants (https://www.fic.nih.gov/Grants/Pages/country-eligibility.aspx) for additional restrictions. Other High-Income Country (HIC) or ineligible LMIC Faculty and institutions may be named as partners and serve as training sites.

The applicant institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

The applicant institution must have a strong and high-quality research program in the area(s) proposed under this FOA and must have the requisite faculty, staff, potential trainees, and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing research training programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating trainees may gain relevant experiences consistent with their research interests and goals.

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.

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. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
• Dun and Bradstreet Universal Numbering System (DUNS) Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and 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.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities in the US (see, e.g., Notice of NIH’s Interest in Diversity, NOT-OD-20-031) and in the eligible LMIC are always encouraged to apply for NIH support.

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 SF 424 (R&R) Application Guide.

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program.

Applicants may demonstrate a history of relevant collaboration with researchers or faculty at the partnering U.S. and LMIC institution(s) involved, or they may establish new collaborations needed for the training program that will be developed during the planning grant phase.

The PD/PI will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program.

The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

The PD/PI is responsible for appointing members of the Training Advisory Committee (TAC) and for establishing a structure to obtain regular feedback from the TAC.

U.S. and LMIC applicants who meet the eligibility requirement are encouraged to apply as a Multiple PD/PI with either serving as the contact PI (see https://grants.nih.gov/grants/multi_pi/ for more information).

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

2. Cost Sharing

3. Additional Information on Eligibility

Applicant organizations may submit more than one application, provided that each application is programmatically 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).

Program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program. Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NIH mission. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

Trainees

Only individuals from LMICs that meet the Country Eligibility requirement are eligible for training under this FOA. Individuals who also have citizenship or permanent residency in the U.S., other high-income countries, or countries not eligible under the Country Eligibility are not eligible for support under this FOA.

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 FOA. 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 Training (T) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement 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 (FIC)
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.

Instructions for Application Submission

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

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 with the following modifications.

Project Title:

The title should reflect the goals of the proposed training program and scientific area.

Project Summary/Abstract:

Provide an abstract of the entire application, including the long-term goals and objectives of the program, key elements, and a brief description of the planned HIV research training program. Include the selected scientific area for which research training is proposed and describe how this addresses the HIV research priorities identified by NIH as aligned. Include the LMIC name(s) and the name of the in-country institution. Include the rationale and design of the program, and the expected increased research capacity in the selected HIV scientific area at the end of the five-year grant period. Describe the key activities in the training plan. Indicate the planned duration of training, the projected number of trainees including their levels, and intended trainee outcomes.

Project Narrative:

Include the selected scientific area for which HIV research training is proposed, and describe how this addresses the HIV research priorities identified by NIH as aligned . Describe the public health relevance of the expected increased HIV research capacity to the LMIC institution.

Other Attachments:

Training Advisory Committee (TAC):

A plan must be provided for the appointment of a Training Advisory Committee (TAC) to monitor progress. The TAC should include research faculty and relevant professionals with expertise in the selected HIV scientific area or in research training and mentoring for LMIC scientists. TAC members must not be directly involved in the training program or in mentoring trainees. TAC members should be included as key personnel as described in SF 424 (R&R) Senior/Key Person Profile Expanded Component.

Describe the composition of the TAC, identifying the role and the desired expertise of TAC members. Describe how the TAC will provide feedback and advice to the PD(s)/PI(s) on trainee recruitment strategies, trainee selection and retention, monitoring of the progress of the training program, training-related research projects, and the overall effectiveness of the program. Responsibilities, frequency of meetings, and other relevant information should be included. Please name the file Advisory_Committee.pdf

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Commons.

SF424(R&R) Senior/Key Person Profile Expanded

Follow all instructions provided in the SF424 (R&R) Application.

• For applications from U.S. institutions, include the name of at least one person at the LMIC institution who will serve as the main collaborator(s), select Other, and list their role as Key Collaborator.
• For applications from LMIC or U.S. Institutions, include at least one person at each of the other U.S. and foreign participating institutions as senior/Key Personnel and identify their role.
• List all members of the Training Advisory Committee (TAC) as Senior/Key Personnel, select Other and list their role as TAC member .

PHS 398 Cover Page Supplement

Follow all instructions provided in the SF424 (R&R) Application.

PHS 398 Training Subaward Budget Attachment(s)

Follow all instructions provided in the SF424 (R&R) Application Guide.

Research & Related (R&R) Budget

Follow all instructions provided in the SF424 (R&R) Application Guide with the following additional modifications:

• Use the Other Personnel section to submit costs for salary support for administrative staff.
• Use the Travel section to submit costs for key personnel and faculty travel including the annual network meeting.
• Use the Participant/Trainee Support Costs section to submit costs for Trainees and training-related expenses. Include health insurance under Training Related Expenses (not in Tuition/Fees/Health Insurance). Do not use the Subsistence category. Provide details of trainees and training related expenses in the budget justification and identify by name any continuing trainees.
• Use the Other Direct Costs section to submit costs for other direct costs related to training activities. Describe fully in the budget justification.

PHS 398 Research Training Program Plan

The PHS 398 Research Training Program Plan Form is comprised of the following sections:

• Training Program
• Faculty, Trainees, and Training Record
• Other Training Program Sections

Follow all instructions provided in the SF424 (R&R) Application Guide.

The following modifications apply:

International Training Data tables are required.
Applicants should summarize, in the body of the application, key data from the tables.

Particular attention must be given to the required Training Data Tables. Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of participants, and other factors that contribute to the overall environment of the program.

Training Program Plan

Background/Rationale: In addition to the instructions in the SF424 (R&R) Application Guide, briefly discuss the following points:

Describe prior and current HIV research collaborations among the applicant institution, LMIC institution and other proposed participating institution(s), and how they serve as a research foundation to support the proposed training.

• Define the scientific area for which HIV research training is proposed. Describe how it addresses HIV research that is considered high priority in the LMIC.
• Identify the LMIC institution(s) that will be the beneficiary(ies) of the proposed training.
• Describe the current level of research capacity in the selected scientific area at the proposed LMIC institution. Provide a list of other all relevant training programs involving the scientific and/or methodological areas proposed for this training program, regardless of funding source, at the institution, and justify the need for more research training in the selected area at the LMIC institution, if appropriate.
• Indicate how the proposed program relates to prior and/or current HIV research training activities relevant to the selected scientific area, regardless of funding source, and describe the synergy with the proposed program.
• Describe how the leadership and relevant participating collaborators were involved in the development of the planning grant application

Program Administration: In addition to the instructions in the SF424 (R&R) Application Guide:

• Include the relevant scientific or professional background and research training experience of the Key Collaborator(s) at the partner institutions and the LMIC institution.
• Describe the role of the Key Collaborator(s) at the partner institutions and LMIC institution in the on-going administration of the proposed research training program.
• Describe the decision-making process, including how the PD(s)/PI(s) will incorporate feedback from the TAC.
• Describe the processes that will be used to provide independent scientific review for trainee research projects, and document education in the protection of human subjects, compliance with federal requirements for the protection of human subjects and animals in medical research, and annual approval from relevant institutional (or ethical) review board(s) or committee(s).
• If clinical trials are proposed, provide documentation of the PD/PI(s) expertise, experience, and ability to oversee the organization, management and implementation of the clinical trial, including any feasibility or ancillary study, proposed by Trainee(s).

Proposed Training: Substitute the following for instructions in the SF424 (R&R) Application Guide:

• Describe the immediate and long-term objectives of the training program. Include information about planned courses, curricula, seminars, and/or workshops and appropriate interdisciplinary or multidisciplinary mentored research training opportunities. Describe courses and research opportunities that will be available to trainees at each of the participating institutions or other identified training sites.
• Describe a training plan designed to incorporate research methods and processes that consider rigor and reproducibility and take into account potential sex and gender differences that may affect the questions asked and the analyses performed.
• Provide a five-year training implementation plan that elucidates the rationale for the proposed balance of training options (degree-related and non-degree, long-, medium and short-term training), the areas/disciplines selected for training, and the training sites selected.
• Describe how the proposed short-term training will contribute to long term objectives of the program.
• Describe a plan for trainee mentorship throughout the training period. Describe how training plans will be tailored to the needs of the selected trainees, accounting for their past experiences and competences.
• Describe the professional research career development skills and career guidance that will be provided, including the use of Individual Development Plans.
• Include a plan for retaining students in the program until completion and describe strategies to encourage and prepare trainees to pursue further research opportunities in their LMIC.
• Describe the plans for the integration of the proposed training with other relevant capacity building activities at the LMIC institution. The applicant should describe these other researchtraining programs, regardless of the source of funding, and explain what distinguishes the proposed training from these other research training programs, how their program will synergize with these other training programs, and demonstrate that the pool of training staff, potential trainees, and resources are robust enough to support an additional research training program.
• If relevant, describe strategies that will be used to support the LMIC institution to achieve a level of research capacity to become a future research training site for the selected scientific area.
• Applicants should describe program activities intended to develop the working knowledge needed for trainees to prepare for the next step in varied research career options available in the biomedical workforce. For example, programs should provide all trainees with instruction and training in oral and written presentation and in skills needed to apply for individual fellowship or grant support. All postdoctoral trainees should also be provided with instruction in laboratory and project management.
• If clinical trials are proposed, provide documentation of the administrative, data coordinating, enrollment, and laboratory/testing capability, appropriate for the clinical trial, including any feasibility or ancillary study, proposed by Trainee(s).

For renewal applications:

• Highlight how the training program evolved in response to changes in relevant scientific and technical knowledge, educational practices, and evaluation of the training program.
• If there has been a training program in HIV/AIDS with these partners for more than two cycles (including historical AITRP and HIVRT programs), then there is an expectation that along with building capacity in research, capacity will have been developed in research leadership and that a training program in HIV will transition to the leadership of the LMIC institution. If the U.S. institution is the lead on this renewal, explain why that transition has not occurred and describe plans to effect that transition during the current cycle.
• Provide evidence of Institutional Capacity Building. This can be demonstrated by

a) Transitioning of U.S. PI to an LMIC PI and having the LMIC institution be the direct recipient of the award.

b) Documenting that former trainees have obtained their own grants or have progressed in their careers, including assuming research leadership positions.

Program Faculty: In addition to the instructions in the SF424 (R&R) Application Guide:

• Provide a short description of the training role for each faculty in the proposed training. Describe how the proposed faculty will contribute to the strengthening of the LMIC institution to the next level of capacity in the selected scientific area.
• For each faculty, include relevant scientific and research training experiences and information on the subsequent success of former LMIC trainees, to pursue further career development and productive research careers. This may be documented in the training tables and summarized in the Biosketch.
• If a mentor will supervise a Trainee proposing to either lead a clinical trial, or gain research experience in a clinical trial, provide documentation of his/her expertise, experience, and ability to provide guidance in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help him/her to meet the study timelines.

Trainee Candidates: In addition to the instructions in the SF424 (R&R) Application Guide:

• Describe the recruitment plan with strategies likely to attract well-qualified trainees for the training program?
• Describe the role of the LMIC institution faculty in the trainee recruitment process. What steps will be taken to ensure that an pool of eligible trainees will be available?
• Describe the criteria that will be used to select trainees to ensure that trainees have appropriate prior training and experience, are likely to complete the training, and likely to contribute to the increased capacity of the LMIC institution in the selected scientific area, as scientists and staff.
• Describe recruitment efforts to attract women and other populations who are under-represented in sciences in the LMIC to apply for training opportunities.
• Describe how the TAC will provide feedback and advice to these processes.
• If clinical trial is proposed, discuss the potential of prospective Trainees to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study.

Training Program Evaluation: In addition to the instructions in the SF424 (R&R) Application Guide:

• Describe the roles in the evaluation process of faculty and professional staff at the applicant, LMIC and other participating institutions, and of current and former trainees.
• Describe how the PD(s)/PI(s) will incorporate feedback from the TAC into the evaluation process.
• Describe the increased research capacity expected at the end of the five-year funding period.
• Define measures that will be used to assess increased research capacity in the selected scientific area at the end of and beyond the five-year funding period. Describe how the data will be collected and monitored over time.
• If short term training is proposed, include specific assessments of the effectiveness of the short-term training activities in the evaluation plan.

Institutional Environment and Commitment to the Program:

Letters of support from all participating institutions and should:

• Describe the institutional support and commitment to the goals of the planning process by the applicant institution and other partner institutions.
• Include a description of support (financial or otherwise) to be provided to the proposed training program. This could include, for example, space, funds for curriculum development, release time for the PD(s)/PI(s) and/or participating faculty, or other innovative approaches to provide an academic and research environment for the success of the training program

Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in the SF424 (R&R) Application Guide.

?????Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in the SF424 (R&R) Application Guide.

Program Faculty.

If any mentors will supervise a Trainee proposing to either lead a clinical trial, or gain research experience in a clinical trial, provide documentation of his/her expertise, experience, and ability to provide guidance in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help him/her to meet the study timelines.

Trainee Candidates.

If the event that a clinical trial may be proposed, discuss the potential of prospective Trainees to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study.

Appendix:

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to theSF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

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

Study Record: PHS Human Subjects and Clinical Trials Information

DO NOT USE. Attempts to submit a full, detailed study record will result in a validation error.

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).

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must complete a Delayed Onset Study.

PHS Assignment Request Form

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

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. Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on an institutional training grant.

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 fieldof 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.

The applicant organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number 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 . Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

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.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained 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 the merit of the training program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Training Program and Environment

• Does the proposed training address an HIV area that is of high priority to the LMICs involved?

Training Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

• Does the PD/PI have the scientific background, expertise, and administrative and training experience to provide strong leadership, direction, management, and administration of the proposed research training program? Is sufficient effort committed to ensure the program’s success?
• Are sufficient administrative and research training support provided for the program?
• If clinical trial and/or clinical trial training is proposed, do the PD/PI(s) have the expertise, experience, and ability to oversee the organization, management and implementation of the proposed clinical trials in the LMIC?

For applications designating multiple PDs/PIs:

• Is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the trainees?
• Is a strong and compelling leadership approach evident, including the designated roles and responsibilities, governance, conflict resolution and organizational structure consistent with and justified by the aims of the training program and the complementary expertise of the PDs/PIs?

• If the program will support clinical trial research experience for the Trainees, do the mentor(s) who will supervise the Trainee(s) have the expertise, experience, resources, and ability to provide appropriate guidance and help the Trainee(s) to meet the timelines?

For applications proposing clinical trials and/or clinical trials training:

Do the mentors who will supervise the Trainee(s) have the expertise, experience, and ability to provide guidance in the organization, management and implementation of a clinical trial, ancillary, or feasibility study and help him/her to meet timelines?

Trainees

• Is a recruitment plan proposed with strategies likely to attract well-qualified trainees for the training program?
• Is there a competitive applicant pool of sufficient size and quality, at each of the proposed levels (predoctoral, postdoctoral and/or short-term), to ensure a successful training program?
• Are there well-defined and justified selection and retention strategies?

For applications proposing clinical trials and/or clinical trials training:

• Do prospective Trainees have the potential to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study?
• Are there plans to provide instruction in data management and statistics including those relevant to clinical trials to the prospective Trainees?

Training Record

• Is there evidence that LMIC trainees (or, for new applications, other past students/post-doctorates in similar training environments) were able to complete their program?
• Has the training program ensured that LMIC trainees were productive (or, for new applications, other past students/post-doctorates in similar training environments) in terms of research accomplishments, publication of research conducted during the training period, and subsequent training appointments and fellowship or career development awards?
• Is there evidence that LMIC trainees (or, for new applications, other past students/post-doctorates in similar training environments) were able to achieve productive scientific careers as evidenced by successful competition for research positions in industry, academia, government, or other research venues; grants; receipt of honors, awards, or patents; high-impact publications; promotion to scientific leadership positions; and/or other such metrics?
• How successful was the training program in retaining trainees in positions conducting HIV research at the LMIC institution?
• How well did the applicant define measures to demonstrate increased capacity in the selected scientific area at the end of and beyond the five-year funding period?
• How adequate is the proposed method to monitor the long-term impact of the training experience on the subsequent research capacity at the LMIC institution?
• If short term training is proposed, does the evaluation plan include specific assessments of the effectiveness of the short-term training activities to increased capacity in the selected scientific area?
• Does the program propose a rigorous evaluation plan to assess the quality and effectiveness of the training?
• Are effective mechanisms in place for obtaining feedback from current and former trainees?

Specific to applications involving clinical trials:

• Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
• Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Training in Methods for Enhancing Reproducibility

Does the plan for Instruction in Methods for Enhancing Reproducibility describe how the program will provide training in scientific reasoning, rigorous research design, relevant experimental methods, consideration of relevant biological variables such as sex, authentication of key biological and/or chemical resources, quantitative approaches, and data analysis and interpretation, appropriate to field of study and the level and prior preparation of the trainees?

Renewals

For Renewals, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project, the progress made in the last funding period on accomplishing the training goals.

Revisions

Not Applicable.

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.

Recruitment Plan to Enhance Diversity

Peer reviewers will separately evaluate the recruitment plan to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used in the recruitment of prospective individuals from underrepresented groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and the consensus of the review committee will be included in an administrative note in the summary statement.

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? For renewal applications, are all training faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period named in the application? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

For renewal applications, does the progress report document acceptable RCR instruction in the five components described above? Does the plan describe how participation in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction proposed in response to feedback and in response to evolving issues related to responsible conduct of research?

Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by 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:

• 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.
• 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 submitted in response to this FOA. 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. as articulated in the NIH HIV/AIDS Research Priorities, the NIH Plan for HIV-Related Research for the year they are applying, and the FIC Strategic Plan.
• Consideration of programmatic and geographic distribution.
• Interests of participating organizations and components.

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 on the basis of established PHS referral guidelines to the appropriate NIH Institute or 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 appropriate national Advisory Council or Board.

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

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.5. 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 FOA 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).

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:

• Federalwide 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 must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 FOA.

• 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 reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/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 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

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.

Failure by the recipient institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees 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 $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In addition to the instructions in the SF424 (R&R) Application Guide,

• Grantees will be asked to enter data on each trainee in CareerTrac, a database maintained by the Fogarty International Center.

A final RPPR, the expenditure data portion of the Federal Financial Report, are required for closeout of an award as described in the NIH Grants Policy Statement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, 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 Award Term and Conditions for Recipient Integrity and Performance Matters.

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

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 on-time submission, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding 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]

Mary Masterson, PhD, MS
National Heart, Lung, and Blood Institute (NHLBI)
Center for Translation Research and Implementation Science (CTRIS)
Telephone: 301-827-6113
Email: [email protected]

Makeda Williams, PhD, MPH
National Heart, Lung, and Blood Institute (NHLBI)
Center for Translation Research and Implementation Science (CTRIS)
Telephone: 301-451-7594
Email: [email protected]

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

Denise A. Russo, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6871
Email: [email protected]

Elizabeth Begg
Office of Research on Women's Health (ORWH)
Phone: 301-496-3975
E-mail: [email protected]

Hongen Yin, MD, PhD, MHSc
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301- 496-0525
Email: [email protected]

Anissa J. Brown, PhD
Research Training and Career Development Branch
National Institute of Dental and Craniofacial Research
Telephone: (301) 594-4805
Email: [email protected]

Susannah Allison, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 240-627-3861
Email: [email protected]

Vasundhara Varthakavi
National Institute on Drug Abuse (NIDA)
Phone: 240-669-5020
E-mail: [email protected]

Geraldina Dominguez, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-781-3291
Email: [email protected]

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

Fatima Kamara
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-7196
Email: [email protected]

Vicky Tran
Fogarty International Center (FIC)
Telephone: 240-726-0654
Email: [email protected]

Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: [email protected]

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

Pamela G Fleming
National Institute on Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: [email protected]

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

Section VIII. Other Information

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 287b) and under Federal Regulations 42 CFR Part 63a.