Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Fogarty International Center (FIC)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute on Drug Abuse (NIDA)

Funding Opportunity Title
Infrastructure Development Training Programs for Critical HIV Research at Low-and Middle-Income Country Institutions (G11 Clinical Trials Not Allowed)
Activity Code

G11 Extramural Associate Research Development Award (EARDA)

Announcement Type
Reissue of PAR-19-285
Related Notices

NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022

Funding Opportunity Announcement (FOA) Number
PAR-22-153
Companion Funding Opportunity
PAR-22-151 , D43 International Training Grants in Epidemiology (FIC)
PAR-22-152 , D71 International Training Program Planning Grant
Assistance Listing Number(s)
93.989, 93.279, 93.121
Funding Opportunity Purpose

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) by enhancing the functional resources required to conduct HIV research on the evolving HIV epidemic in their countries.

This Funding Opportunity Announcement (FOA) encourages collaborative applications from U.S. and LMIC institutions to develop training programs to achieve technical, administrative, and financial management expertise required for one of several research infrastructure support functions considered critical to a successful high-quality research environment. These are: a) research administration and management, b) research integrity oversight, c) ethical review of research for the protection of human subjects, d) laboratory animal welfare oversight, e) advanced laboratory instrument services, f) health sciences library and information services, g) information and communications technology systems (ICT) for research, h) biostatistics and data analysis, i) technology transfer and intellectual property protection, j) harassment and discrimination policy and prevention and k) any area not mentioned above that justifiably will contribute to enhancing Institutional services that can support research activities.

Training programs to support research infrastructure will maximize previous investments, further strengthen the LMIC institution's research capabilities, and potentially provide more accessible research infrastructure training opportunities to others at Institutions in their own country and in other LMICs.

Key Dates

Posted Date
April 21, 2022
Open Date (Earliest Submission Date)
July 22, 2022
Letter of Intent Due Date(s)

30 days before application due date.

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
Not Applicable Not Applicable August 22, 2022 November 2022 January 2023 April 2023
Not Applicable Not Applicable August 22, 2023 November 2023 January 2024 April 2024
Not Applicable Not Applicable August 22, 2024 November 2024 January 2025 April 2025

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.

Expiration Date
August 23, 2024
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Program Objectives

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 related to the evolving HIV epidemic in their country.

The HIVRT Program currently invites applications under three different Funding Opportunity Announcements (FOAs). This FOA (G11) encourages applications for infrastructure development training programs to strengthen one of several infrastructure functions critical to support HIV research at LMIC institutions. Applicants interested in scientific research training should consult the D43 FOA (PAR-22-151). A third FOA (D71), (PAR-22-152), provides the option for a planning grant to LMIC institutions prior to an application for the D43 research training grant.

This FOA complements the other two FOAs in the HIVRT Program, which are focused on scientific research training, by supporting training that addresses several infrastructure functions considered critical to successful high-quality research. Research infrastructure training programs will maximize previous investments and further strengthen the LMIC institution's research capabilities, as well as potentially provide more accessible research infrastructure training opportunities to other Institutionsin their own country and in other LMICs.

This FOA will support training related to acquiring and/or enhancing technical expertise, administration, and management skills, including the following functions:

  1. Research administration and management - The general business management practices common to the administration of all grants, such as financial accountability, reporting, equipment management, and retention of records. These include the development and implementation of standard operating procedures for tracking grant expenditures and compliance with NIH and other donor funding policies during pre – and post-award periods.
  2. Research integrity and compliance oversight - Administrative processes in place at an institution to promote research ethics, and to handle allegations of research misconduct among its leadership, faculty, investigators, trainees, and administrative staff.
  3. Ethical review of research for the protection of human subjects - An institutional system that reviews proposed research, using a framework based on established, internationally recognized ethical principles, to safeguard the rights and welfare of individuals who participate as subjects in research activities.
  4. Advanced laboratory instrument services – A core Institutional resource center available for investigators such as biomedical and molecular imaging, flow cytometry, genomics, proteomics, and structural analysis services.
  5. Biostatistics and data analysis – An institutional center that is staffed with experts able to provide researchers with statistical and data analysis help to meet rigor and reproducibility standards in biological studies.
  6. Laboratory animal welfare oversight- An institutional system that addresses the humane use of animals in research, using a framework based on established internationally recognized guiding principles for biomedical research involving animals.
  7. Health sciences library and information services - Print collection and electronic information resources on a wide range of health science topics that are organized by an institution as a service to its researchers, faculty, staff, and students.
  8. Information and communications technology systems (ICT) for research- Computer systems that provide, coordinate, and manage information technology, and advance computational science.
  9. Technology transfer and Intellectual Property protection – An institutional body that can educate researchers on intellectual property and patentable inventions as well as information on commercializing their discoveries.
  10. Harassment and Discrimination Policy and Prevention - An institutional office to develop policy, procedure, awareness, and training for preventing and responding to allegations of harassment including sexual harassment.
  11. Any area not mentioned above that justifiably will contribute to enhancing Institutional services that can support research activities.

Within the context of the topic areas mentioned above it is expected that applicant Institutions have sufficient level of HIV/AIDS research ongoing at their Institutions. NIDCR will support Infrastructure Development Training Programs for institutions conducting HIV research and 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. .

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 have participated in important HIV research conducted at LMIC institutions, often 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, 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 ten 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 partner institutions.

The HIVRT Program is designed to move beyond simple output indicators such as number and type of people trained, or research products/grants, to outcome indicators such as increased institutional research support capacity available to all research faculty, staff, and students at the LMIC institution. Applicants are expected to design a monitoring and evaluation plan to address those goals.

Program Considerations

This FOA provides opportunities for a U.S. or LMIC institution to collaborate with their partners to fill gaps in a particular research infrastructure function that will strengthen the HIV research capacity at the proposed LMIC institution by training LMIC scientists and staff at the LMIC institution(s) to support those functions. The resulting strengthened infrastructure should allow these institutions to be more responsive to research needs at the institution(s) and enhance their capacity to obtain funds from and collaborate with the NIH, U.S. Government, other donors, and LMICs in their HIV/AIDS efforts.

The selected infrastructure function may need expertise that crosses disciplines. Applicants are encouraged to develop programs that include training in all disciplines needed to address the selected infrastructure function. The training proposed is expected to raise the LMIC institution to the next level of capacity in the selected infrastructure function.

In some cases, it is anticipated that the proposed program will complement ongoing efforts to strengthen the research support function at the LMIC institution(s). Proposed training should be designed to be synergistic and not duplicative of these programs and a clear justification provided for why additional training is required. The justification should include the level of HIV research ongoing at the applicant Institution and collaborating LMIC partners.

It is anticipated that some LMIC institutions could serve as training sites in the selected research support function for other LMIC institutions. Faculty and staff from LMIC institutions with a more developed capability may serve as training faculty. As a result, three different scenarios for applications may be proposed: a) a U.S. institution as the applicant with an LMIC institution as beneficiary of the training; b) a LMIC institution as applicant in collaboration with U.S. and other appropriate partners, with their own institution as the beneficiary of the training to further strengthen its own capacity; and c) an eligible LMIC institution with a developed capability for the research support function as applicant with one or more additional LMIC institutions as the beneficiary of the training. The beneficiary as noted above is the Institution and not an individual training or research program.

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) term training to support increased capacity in the specified infrastructure function at the LMIC institution. 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 sustain the higher level of capacity in the selected infrastructure function after the three-year training period.

Innovative training models such as practicum experiences to gain technical expertise, collaborative exchanges, organizational planning, and mediation/negotiation training may be proposed. Distance learning with sufficient mentoring and support at the LMIC institution are encouraged. Training-related projects must be conducted at or involve data from the LMIC institution or, if relevant, from other participating LMIC sites, identified in the application.

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 (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

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are limited to $94,000 direct costs per year exclusive of consortium indirect costs.

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, consortium costs in excess of $25,000, and expenditures for equipment), rather than on the basis of a negotiated rate agreement. The Indirect Cost limitation applies to direct awards and to subcontracts.

Awards may support travel for trainees to participate in appropriate training experiences at other institutions or to attend scientific meetings and workshops that the training program determines to be necessary f

Awards may support travel for trainees to present training-related research results at conferences and meetings.

Funds may be requested for lodging and per diem at other institutions for short-term trainees.

Award Project Period
The maximum project period is 3 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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)

An application may be submitted by a foreign institution in a LMIC or by a domestic (U.S.) institution that demonstrates active HIV research collaborations with the LMIC institution named in the application. Collaboration should be documented by strong prior scientific/professional interactions, such as, conference organization, joint publications, grants or previous research training activities. The applicant institution must have a strong and high-quality program in the research infrastructure function proposed under this FOA and must have the requisite training staff and facilities to conduct the proposed training program.

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). Additional restrictions outlined in Country Eligibility for Fogarty International Training Grants (http://www.fic.nih.gov/Grants/Pages/country-eligibility.aspxhttps://www.fic.nih.gov/Grants/Pages/country-eligibility.aspx) now apply to this G11 FOA. If there are any questions about eligibility, please contact the Scientific Officer named below. Other High-Income Country (HIC) Faculty and institutions, and institutions that fall under restricted eligibility for training in the linked Notice, may be named as partners and serve as training sites.

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.

Foreign Institutions

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

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

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

Required Registrations

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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for 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 SF424 (R&R) Application Guide.

The PD(s)/PI(s) should be an established expert in the research infrastructure function to which the application is targeted and capable of providing both administrative and professional leadership to the development and implementation of the proposed training. The PD(s)/PI(s) should have experience in supporting high priority HIV research and be knowledgeable about the infrastructure needs of the LMIC institution. The PD(s)/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required. The PD(s)/PI(s) is responsible for appointing members of the Training Advisory Committee (TAC) and for establishing a structure to obtain regular feedback from the TAC.

Applicants are encouraged to include LMIC individuals who meet the eligibility requirement as a Multiple PD/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 clinical, biomedical, and socio-behavioral research (including individuals from racial, ethnic, and socially disadvantaged backgrounds and those living with disabilities) as principal investigators/program directors, faculty, and scientific collaborators.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Faculty/Mentors

Proposed training staff and mentors should have expertise and experience relevant to the proposed training program to build or enhance the specific research infrastructure function. Mentors must be committed to continue their involvement throughout the total period of the trainee’s participation in this award.

Trainees

Only LMIC individuals who are or are expected to be associated with that LMIC institution are eligible for training under this FOA. Individuals who also have citizenship or permanent residency in the U.S. or other high-income countries 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 instructions in the Research (R) 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.
Telephone: 301-496-1492
Email: geetha.bansal@nih.gov

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, with the following additional instructions:

Include the applicant institution, the LMIC institution and any other participating institutions, both U.S. and foreign, as performance sites.

SF424(R&R) Other Project Information

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

Project Summary/Abstract: Provide an abstract of the entire application, including the long-term goals and objectives of the program, key elements of the training plan, and a brief description of the planned training program. Include the name(s) of the LMIC(s), and the name of the in-country institution. Identify the research infrastructure function for which training is proposed, and how the increased capacity will strengthen the HIV research capacity at the LMIC institution. Include the rationale and design of the program, the expected increased capacity in the infrastructure function and the measures the applicant will use to demonstrate the impact of the increased infrastructure capacity.

Project Narrative: Include the selected research infrastructure function for which training is proposed, and how this addresses the HIV research priorities identified by NIH as "aligned". Include the LMIC and name of the in-country institution. Describe the public health relevance of the strengthened infrastructure support to the HIV research enterprise that will be supported at the LMIC institution.

Other Attachments:

Advisory Committee: A Training Advisory Committee (TAC) is required for this grant. A description of the responsibilities, frequency of meetings, and other relevant information should be included. Describe the composition of the TAC, identifying the role and the desired expertise of members. The TAC should include expert faculty and staff in the research infrastructure function proposed and persons with experience in training and mentoring LMIC staff or supporting HIV research at the LMIC institution. TAC members can be from the LMICs, U.S., or other countries. Describe how the TAC will provide feedback and advice to the PD(s)/PI(s) in the implementation of the training program. They should be included as key personnel as described in SF 424(R&R) Senior/Key Person Profile Expanded Component. Please name your 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.

SF424(R&R) Senior/Key Person Profile

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

  • Describe the qualifications and experience, including relevant scientific or professional background and relevant training experience in LMICs, of the proposed PI(s)/PD(s) to lead the proposed training program should be described in the bio-sketch.
  • For applications from U.S. institutions, include the name of one person at the LMIC institution who will serve as the main collaborator(s), select “Other,” and list their role as “Key Collaborator.”
  • Include at least ONE person at all of the other U.S. and foreign participating institutions as senior/Key Personnel and identify their role. 
  • Describe the roles of the investigators and their qualifications to provide and sustain the required training.
  • List all members of the Training Advisory Committee (TAC) as Senior/Key Personnel, select “Other” and list their role as “TAC member”.

R&R Budget

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

  • Use "Senior/Key Person"section for Senior/Key personnel. The salary requested must be commensurate with the salary structure and benefits at the institution where they are employed and within the limits described at https://grants.nih.gov/grants/policy/salcap_summary.htm. Collaborators may receive appropriate compensation for significant activities on the program.
  • Use" Other Personnel” section to submit costs for salary support for administrative staff. The salary requested must be commensurate with the salary structure and benefits at the institution where they are employed and within the limits described at https://grants.nih.gov/grants/policy/salcap_summary.htm. Use Section E for trainee expenses.
  • Use the" Travel” section to submit costs for key personnel and staff travel that is directly related to the training program and to attend necessary meetings and HIV Research Training Program network meetings, usually held in the U.S. Support for senior/key personnel, faculty and collaborators to attend scientific meetings and conferences is not allowed.
  • Use the “Participant/Trainee Support Costs” section to submit costs for:
  • Trainees Tuition and Fees for tuition and academic fees at the U.S. or foreign institutions. Include health insurance under Training Related Expenses category rather than in the Tuition/Fees/health insurance category
  • Stipend as a subsistence allowance for trainees to help defray living expenses during the training experience in accordance with their institutional policy. Partial stipends for part time trainees should reflect the amount of time they need to be supported for training in the budget and be described in the budget justification. Living expense for trainees should be covered by per diem and included under Trainee Travelexpenses
  • Trainee Travel to allow trainees to participate in training experiences in other institutions or to attend scientific meetings and workshops related to their area of training that the training program determines to be necessary for the individual’s training. Awards may support travel for current trainees to present training-related results at conferences and meetings.
  • Funds may be requested for lodging and per diem at other institutions for short-term trainees.
  • Do not use the Subsistence category.
  • Use Other to submit costs for Training Related Expenses to help defray other training expenses, such as:
    • health insurance (self-only or family, as applicable)
    • trainee project costs
    • laptop computers
    • internet connectivity
    • relevant journal subscriptions and publication costs.
  • Use "Other Direct Costs" to request costs for short- term courses. Equipment, software and other non-training expenses are not allowed.
  • Provide details in the budget justification for expenses requested in each section.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims:

The specific aims page should:

  • List succinctly the specific objectives of the proposed training.
  • Identify the research infrastructure support function and the LMIC institution that will benefit from the proposed training.
  • State concisely the goals of the proposed training and summarize the expected outcome(s), including the impact that the results of the proposed training will exert on the high priority HIV research capacity of the LMIC institution.

Research Strategy: Include the following information:

  • Significance:
    • Provide the rationale for the selection of the specific research infrastructure support function.
    • Describe the current level of capacity in the selected research support function at the LMIC institution and describe how training will further strengthen that infrastructure to support “high priority” HIV research at the proposed training sites.
    • Describe the current funded HIV research at the participating institutions.
    • Identify the research support gaps that will be addressed by this training program.
    • Indicate how the proposed program relates to prior and current training activities at the proposed training sites, regardless of funding source, that are relevant to the selected infrastructure function. Provide justification for more training at the LMIC institution and describe how the proposed training will leverage and support, but not duplicate, other training activities.

  • Innovation:
    • Describe strategies that will be used to engage trainees in training-related research infrastructure activities that will directly benefit the on-going priority HIV research at the LMIC institution(s). Highlight the innovative aspects of the training models and/or strategies for these activities that are likely to prepare them to support HIV research at the LMIC institution(s).
    • If relevant, describe how the training program will be designed to enable the proposed training sites to become future training sites in the infrastructure function for other LMIC institutions, and, if relevant, other partnering LMIC institutions.

  • Approach:
    • Describe the administrative structure of the training program and the distribution of responsibilities, including a description of how the PD(s)/PI(s) will obtain continuing advice with respect to the operation of the program from collaborators, professional staff at the LMIC institution, other participating institutions, and the TAC.
    • Provide a three-year training implementation plan that describes and provides the rationale for the type of training, topics of the training and the expected candidates for each type of training included.
    • Describe courses and research support infrastructure project opportunities that will be available to trainees.
    • Describe a plan for providing mentoring that will support trainees while in courses and conducting training-related projects.
    • Describe the criteria, recruitment and selection procedures for trainees to ensure that trainees have appropriate prior training or experience and are likely to complete the training and contribute to the increased capacity of the LMIC institution in the selected infrastructure function.
    • Describe the role of the LMIC institution and their professional staff in the recruitment and selection of trainees. Describe recruitment efforts to attract women and other populations who are under-represented in the proposed infrastructure function in that LMIC to apply for training opportunities.
    • If multiple PD(s)/PI(s) are involved in the training program, describe how they will coordinate their efforts, resolve disputes, and provide additional value to the training program.
    • Describe the pool of potential trainees. Identify any potential trainees from existing LMIC institution staff and why they would be recruited.
    • Describe a plan for retaining trainees after completion of training.
    • Describe the increased capacity in the function expected at the end of the three-year funding period and how it will strengthen high priority HIV research capacity at the LMIC institution
    • Describe an evaluation plan that will assess the quality and effectiveness of the training over the three-year period. Include a process to obtain feedback from current and former trainees
    • Include measures in the evaluation plan that can be used to demonstrate increased capacity in the infrastructure function at the end of and beyond the three-year funding period. Describe how the data will be collected and monitored over time.
        • Describe the extent of HIV and HIV-related scientific research environment being conducted at the LMIC Institution and partnering LMIC institutions.
        • Describe the institutional support, equipment and other physical resources available to the investigators from each of the participating institutions to carry out the training program.
        • Describe the administrative and training support provided for the program from each of the participating institutions.

Letters of Support: The application should include letters of support from institutional leaders from all the collaborating institutions, and from the leaders of the research infrastructure function at the LMIC institution proposed for training. The letters of support should describe how the proposed training program will collaborate/synergize with other research and training programs and how the institution will provide future career development opportunities for trainees.

Training faculty and mentors who do not have bio-sketches included in the application should submit a letter of support to indicate their contribution and role in the proposed training, and their willingness to participate.

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

The following modifications also apply:

  • Applicants are expected to describe how the outcomes of this grant will help in the long-term sustained enhancement of the research infrastructure. Applicants are expected to describe a plan for sharing the outcomes with other LMIC institutions and how these resources will enhance collaborative capacity building for the LMIC.

Appendix:

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

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

Foreign Institutions

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential 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. See Section III of this FOA for information on registration requirements.

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.

In order to expedite review, applicants are requested to notify Dr. Geetha Bansal by email at {geetha.bansal@nih.gov} when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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

1. Criteria

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

Overall Impact

Overall Impact

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

Scored Review Criteria

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

 

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA:

Does the project address an important problem in research support at the LMIC institution or a critical barrier to research at the institution? If the aims of the project are achieved, will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the institutional environment to enhance the ability to carry out high priority HIV research?

 

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA:

Are sufficient numbers of experienced professional staff and mentors with appropriate expertise available to support the proposed training program? Do the professional staff/mentors have strong records supporting priority HIV research? Do the training staff and mentors have strong records of training individuals from LMICs?

 

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this FOA:

Has the applicant described innovative training models and/or innovative strategies for trainees to engage in the research support infrastructure function proposed that are likely to prepare them to support HIV research at the LMIC institution(s)?

 

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? 

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to

Will the design of the proposed training (learning objectives and mix of short-, medium- and long- term training) provide an effective training program in the proposed research infrastructure function? Does the proposed training program build on the LMIC institution’s research infrastructure and investments from FIC, NIH, and other organizations?

Will the proposed recruitment, selection criteria and retention strategies engage and sustain the highest quality trainees?

Does the applicant describe a rigorous evaluation plan to assess the quality and effectiveness of the training over the three-year period? Are effective mechanisms in place for obtaining feedback from current and former trainees? Does the applicant define measures to demonstrate increased capacity in the selected infrastructure function at the end of the three-year funding period? Is the proposed method to monitor the long-term impact of training in the proposed function on the HIV research capacity at the LMIC institution adequate?

If relevant, will the training approach result in expected increased capacity in the infrastructure function at the LMIC institution, and other participating LMIC institutions?

 

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific to this FOA:

Will the proposed training benefit from unique features of the scientific environment, subject populations, or collaborative arrangements at the applicant, LMIC institution or other partners?

Is sufficient administrative and training support provided for the program? Do/does the application and training program design ensure equitable partnerships among all collaborating institutions?

Additional Review Criteria

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

   

For research that involves human subjects but does not involve one of the  categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the  categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

 

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

 

For Resubmissions, 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.

 

Not applicable

 

Not applicable

Additional Review Considerations

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.

 

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

 

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).

 

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

 

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

 

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Reviewin 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 submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the FIC Advisory Board. The following will be considered in making funding decisions:

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities of FIC and partnering ICs.
    • Consideration of geographic balance of projects..
    • Consideration of programmatic balance of topics.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this 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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that 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.

2. Administrative and National Policy Requirements

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

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.

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

Finding Help Online: 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 instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Geetha P. Bansal, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-496-1492 
Email: geetha.bansal@nih.gov

Vasundhara Varthakavi
National Institute on Drug Abuse (NIDA)
Phone: 240-669-5020
E-mail: varthakaviv@mail.nih.gov

Hongen Yin, MD, PhD, MHSc
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-496-0525
Email: hongen.yin@nih.gov

Leslie Frieden, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-496-4263
Email: leslie.frieden@nih.gov

Peer Review Contact(s)

Center for Scientific Review (CSR)
Email: FOAReviewContact@csr.nih.gov

Financial/Grants Management Contact(s)

Vicky Tran
Fogarty International Center (FIC)
Phone: 240-726-0654
Email:Vicky.Tran@nih.gov

Pamela G Fleming
National Institute on Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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

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