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 inSection 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

Clinical trials are not allowed.

Purpose and Background Information

The Fogarty HIV Research Training (HIVRT) Program supports research training that strengthens HIV research capacity of institutions in low-and middle-income countries (LMICs). This FOA offers an opportunity for LMIC institutions to submit a planning grant application to participate in the Fogarty HIV Research Training Program.

These planning grant applications must propose a plan to develop a research training program and the subsequent application that will be submitted in response to the companion D43 FOA (PAR-22-151). The planned research training program should strengthen research capacity in a defined high priority HIV scientific area aligned with NIH research priorities (NOT-OD-20-018) at a specific LMIC institution.

Program Objective

The overall goal of the Fogarty HIV Research Training (HIVRT) Program is to strengthen the scientific capacity of institutions in LMICs to conduct HIV research related to the evolving HIV epidemic in their country.

The HIVRT Program currently invites applications for three different Funding Opportunity Announcements (FOAs). This D71 FOA for a planning grant to develop a subsequent training grant application to the companion D43 FOA (PAR-22-151). The third FOA (G11) encourages applications for infrastructure development training in several research support functions described in PAR-22-153. Through these FOAs the HIVRT Program is expected to strengthen scientific research environment needed for HIV research at LMIC institutions.

This FOA provides support for LMIC institutions with strong HIV research experience, expertise and resources to plan a research training program that will maximize prior investments in research and research training, further strengthen the LMIC institution's research and research training capabilities and provide more accessible research training opportunities to others in their own country and in other LMICs. A planning grant provides support for LMIC institutions to consult their partners, assess strengths and gaps in research and research training capacity with the goal to submit a competitive application for funding in response to the D43 FOA.

LMIC institutions have the option to apply for a planning grant (in response to this FOA) or may apply for a research training award (in response to the D43 FOA). This FOA for a D71 application is not a pre-requisite for a submitting a D43 application, but is designed to allow the PDs/PIs to conduct a needs assessment at their institutions for research training in a defined scientific area and assemble the core team for the development of the D43 training program. The core team is expected to demonstrate evidence of collaboration during the D71 period, at the time of D43 submission.

Background

The FIC, with co-funding from other NIH Institutes, Centers and Offices (ICOs), has provided over 30 years of support to enhance HIV research through HIV research training programs. Scientists supported through these awards have 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 scientific advances in HIV/AIDS, including interventions to reduce mother-to-child HIV transmission, address HIV/TB co-infection, prevent HIV infection through behavior change, and develop microbicides and antiretroviral drugs, were 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 past 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 D43 program, each research training award is expected to focus on strengthening specific high priority HIV research capacity at an identified LMIC institution(s).

The HIVRT Program is designed to move beyond simple output indicators (number and type of people trained, research products) to outcome indicators (including increased research capacity at an LMIC institution). During the planning phase, applicants should design a monitoring and evaluation plan to meet those goals.

Program Considerations

The program provides opportunities for U.S and LMIC institutions to collaborate with each other and their partners to fill gaps in training in a particular area that will strengthen 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 objectives of the planning grant are to:

• Engage new or solidify existing relationships with individual and institutional partners who will be involved in the envisioned research training program.
• Define an organizational structure to support the future research training program.
• Define the pool of potential trainees to be recruited for a future research training program. Individual trainees should not be named in this application
• Design research training approaches that address the selected HIV scientific focus.
• Ensuring infrastructural needs will be met, such as platforms and connectivity needed for any envisioned eLearning components.
• Organize and develop a training grant (D43) application in response to the D43 FOA.

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.

Within the context of the requirements for the planning grant as described above, NIDCR will support Planning Grants for institutions proposing HIV research training as it relates 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.

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

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)

Non-domestic (non-U.S.) Entities (Foreign Institutions) in LMICs eligible for support under FIC International Training grants. (See below for more information on country eligibility).

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.

Non-domestic (non-U.S.) Entities (Foreign Institutions) in LMICs eligible for support under FIC International Training grants. (See below for more information on country eligibility).

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 for additional restrictions. U.S., other High-Income Country (HIC), or ineligible LMIC Faculty and institutions may be named as partners and serve as future 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 planned program must provide a letter of support from all participating institutions.

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

Non-domestic (non-U.S.) components of U.S. Organizations are not 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(s)/PI(s) should be an established HIV investigator at the applicant institution and capable of providing both administrative and scientific leadership to the proposed planning process. 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.

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

2. Cost Sharing

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.

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 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.

Project Summary/Abstract.Provide an abstract of the entire application, including identification of the selected scientific area for which future research training is being proposed, and how this addresses the HIV research priorities identified by NIH as "aligned". Include the name of any partnering institutions and their countries.

Project Narrative:Include the selected scientific area for which HIV research training is being planned and how this addresses the HIV research priorities identified by NIH as "aligned . Include the name of any partnering institutions and their countries.

Describe the public health relevance of the future increased HIV research capacity to the LMIC institution.

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.

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.

• The PHS 398 Research Training Program Plan Form should be used for this planning grant application, and is comprised of the following sections:
  • Planning for a Training Program
  • Faculty, Trainees, and Training Record
  • Other Training Program Sections
  • Appendix- Note that the Appendix should only be used in circumstances covered in the NIH policy on appendix materials or if the FOA specifically instructs applicants to do so.

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

Background - Substitute the following for instructions for the Program Plan in the SF424 (R&R) Application Guide:

• Define the potential scientific focus for the future HIV research training to be planned and describe how it addresses HIV research that is considered "high priority" by the LMIC and the NIH.
• Describe how the leadership and relevant participating collaborators were involved in the development of the planning grant application.
• Describe the existing scientific and administrative resources at the applicant and participating institutions that will contribute to the success of the HIV research training program to be planned.
• Describe gaps in existing scientific and administrative resources, and how the proposed program will fill or address them.

Program Faculty - Substitute the following for instructions in the SF424 (R&R) Application Guide:

• Provide a short description of the relevant research training expertise for faculty/mentors expected to participate in the planning process and future research training program. The PD(s)/PI(s) will be responsible for the overall direction, management, day-to day administration, and monitoring/evaluation of the planning process. The PD(s)/PI(s) will be expected to submit all documents and reports as required.
• Include relevant information on the past training record of the participating faculty/mentors and the subsequent career success of former LMIC trainees regardless of funding source.

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

• Describe a stepwise detailed plan of activities to meet the objectives of the planning grant that will lead to the submission of an application to the D43 FOA. (see Section I)
• Identify any existing research training programs at the LMIC institution and describe strategies that will be considered to integrate future research training into existing research capacity building activities.
• Describe strategies to avoid duplication of the research training to be planned with other research training activities in which the applicant institution is involved, if applicable.
• A planning grant applicant should identify the specific HIV scientific area that will be the potential focus of the future research training program. Applicants should provide a rationale for why this area was selected, describe how it addresses the high priorities defined by NIH (NOT-OD-20-018) and meets the needs of the LMIC(s) involved, and propose detailed plans for developing the D43 FOA application. Applicants are encouraged to refer to the D43 FOA (PAR-22-151) as they prepare their planning grant application to this FOA.
• If distance learning activities will be proposed for the Research Training program, describe how the planning grant period will be used to assess readiness and effectiveness of this approach, and pilot methods to be used.

Training Program Evaluation - Substitute the following for instructions in the SF424 (R&R) Application Guide:

• Describe an evaluation plan for the two-year planning process culminating in the development of the D43 training program application.

Trainee Candidates - Substitute the following for instructions in the SF424 (R&R) Application Guide:

• Describe how the potential pool of candidates for the future research training will be assessed and possible strategies and criteria that will be considered to select and recruit trainees.
• In the event that a clinical trial may be proposed in a subsequent D43 application, 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) (D43).

Institutional Environment and Commitment to the Program.Substitute the following for instructions in the SF424 (R&R) Application Guide:

• Describe the institutional support and commitment to the goals of the planning process by the applicant institution and other partner institutions.
• The application should include a description of support (financial and otherwise) to be provided to the proposed planning grant.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 improve the planning process environment for the envisioned research 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.

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.

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 the SF424 (R&R) Application Guide instructions. Failure to follow Appendix Guidelines will result in rejection of the application.

PHS Assignment Request Form

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

All applications will be assigned to the Fogarty International Center,

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.

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.

Planning for Training Program and Environment

• Do the applicants propose an HIV area for planning future research training that is of high priority to the LMICs involved?
• Do the applicants demonstrate the need for planning research training in the selected scientific topic? Do they propose a needs assessment or gap analysis to identify the specifics for the training area in the D43 phase in terms of the science as well as the courses?
• Do applicants lay out clearly the constitution of the training faculty and mentors, the type of training (for e.g., degree vs non-degree or post-doctoral or specialized training)?
• Does the applicant propose a realistic time frame for developing an application to the D43 FOA in the HIVRT Program? Is it likely that a training program will be developed at the end of this planning grant period?
• Does the applicant propose creative approaches to develop a HIV research training program?
• Do they address any duplication of programs at the applicant and/or collaborating Institutions?
• Is there adequate potential for a supportive HIV research training environment at the applicant and proposed partner institutions?
• Is there evidence of a significant institutional commitment from all the participating institutions to collaboratively plan a research training program?

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

Mentors

• Do applicant(s) present a plan to identify a pool of mentors who will constitute the training faculty in the subsequent D43 training program?

Trainees

• Does there seem to be an adequate plan to identify a suitable pool of candidates for the future training program?
• Is there a plan to develop the proposed recruitment and selection strategies likely to attract good candidates?

Training Record

• How successful has the applicant institution been in previous research training efforts?
• Do the LMIC faculty and their partners have histories of training successful LMIC researchers?

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

Not Applicable

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 the Center for Scientific Review in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

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

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

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

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.

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

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.

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.html and https://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.

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]

Denise A. Russo, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6871
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: drusso1@mail.nih.gov

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]

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]

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

Vicky Tran
Fogarty International Center
Phone: 240-726-0654
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]

Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
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.