It is critical that applicants follow the Training (T) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Purpose and Background Information

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

These 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-19-283). The planned research training program should strengthen research capacity in a defined high priority HIV scientific area (NOT-OD-15-137) at a specific LMIC institution

The overall goal of the Fogarty International Center (FIC) HIV Research Training 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 Fogarty HIV Research Training Program currently invites applications for three different Funding Opportunity Announcements (FOAs). This FOA (D71) requests planning grant applications from LMIC institutions to develop a research training program and the subsequent application that will be submitted in response to the companion D43 FOA (PAR-19-283). The future research training is expected to strengthen scientific expertise needed for HIV research at LMIC institutions. The third FOA (G11) encourages applications for infrastructure development training several functions described in PAR-19-285.

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, and plan an HIV research training program that can be submitted 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), either directly or in collaboration with their LMIC or U.S. partners. This FOA is designed to allow the PDs/PIs to do 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 team is expected to demonstrate evidence of prior collaboration and commitment by the time of D43 submission.

Background

The FIC, with co-funding from other NIH Institutes, Centers and Offices (ICOs), has provided almost 30 years of support to enhance HIV research through HIV research training programs. Awards supported research training of LMIC scientists who participated in important HIV research conducted at LMIC institutions in partnership with U.S. and other international scientists and scientific institutions. Over the years, some of the most important 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 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 Fogarty HIV Research Training Program, each research training award is expected to focus on strengthening specific high priority HIV research capacity at an identified LMIC institution and/or at the partner LMIC institutions.

The Fogarty HIV Research Training 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 to meet those goals.

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.
• Organize and develop a training grant (D43) application in response to D43 FOA.

Applicants are encouraged to review the NIH HIV/AIDS Research Priorities (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-137.html), the NIH Plan for HIV-Related Research for the year they are applying (https://www.oar.nih.gov/sites/default/files/NIH-OAR_FY2019-2020_NIH_Plan_FINAL_508.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.

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

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.

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

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. 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.
• 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.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program as the Training Program Director/Principal Investigator (Training PD/PI) 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 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. The PD(s)/PI(s) is expected to demonstrate a history of relevant collaboration with researchers or faculty at the LMIC institution(s) involved. 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.

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

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. 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 NOT-OD-11-101).

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.

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]

All page limitations described in the SF424 (R&R) 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.

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

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

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

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 "high." 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 "high. 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.

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

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

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

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, optionally, the annual HIV Research Training network meeting.
• 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 with the following additional modifications:

Training Program

Planning for a Training Program

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

• Define the 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 professional staff of the LMIC institution 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.

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.
• Include relevant information on past training record and the subsequent career success of former trainees regardless of funding source, especially those from LMICs.

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

• Describe a step-wise 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 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-15-137) 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-19-NNN) 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.

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. Failure to follow Appendix Guidelines will result in rejection of the application.

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

If you check the Anticipated Clinical Trial box within your Delayed Onset Study, then the Justification attachment must acknowledge that additional clinical trial information will be provided to the awarding component before any appointee begins independent clinical trial research.

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

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

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.

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.

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. 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 DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). 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.

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.

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.

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 D71 program 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.

Planning for the Training Program and Environment

• Does the applicant propose an HIV area for planning future research training that is of high priority to the LMICs involved?
• Does the applicant demonstrate the need for planning research training in the selected scientific topic? Do they propose a needs assessment or gap analysis to identify 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 Fogarty HIV Training 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))

• Does the Training PD(s)/PI(s) have the necessary HIV scientific background, expertise, and administrative and training experience to provide strong leadership, direction, management, and administration for the proposed planning process?
• Is there a history of HIV research or training collaborations among the PD(s)/PI(s), the proposed faculty and staff at the applicant and participating institutions? Or, is there a strong rationale for the assembling of the key personnel and collaborators identified in this planning grant?
• Does the Training PD(s)/PI(s) plan to commit sufficient effort to the planning process to ensure its success and submission of an application to the D43 FOA?

For applications designating multiple PDs/PIs:

• Is a strong justification provided that the multiple PD/PI leadership approach will benefit the planning process for a future training program?
• Is a strong and compelling leadership approach evident for the roles and responsibilities of the PD(s)/PI(s) in the governance, and organizational structure proposed for the HIV research training planning process?

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?

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.

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 Children

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.

Resubmissions

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.

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.

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 training plan.

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

As part of the scientific peer review, all applications:

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the 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. Program priorities are as articulated in the NIH HIV/AIDS Research Priorities, the NIH Plan for HIV-Related Research for the year they are applying, and the FIC Strategic Plan
• Consideration of programmatic and geographic distribution.
• Interests of participating organizations and components

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.

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 grantee’s business official.

Awardees 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 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, awardees 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 grantee 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.

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

eRA Commons Help 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: [email protected] (preferred method of contact)
Telephone: 301-945-7573

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

Mark Rubert, PhD
Scientific Review Officer
Center for Scientific Review (CSR)
Telephone: 301-806-6596
Email: [email protected]

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

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

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