Required Application Instructions

It is critical that applicants follow the 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

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-16-279). 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 in six research infrastructure functions described in PAR-16-280.

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.

In previous competitions of this program, an LMIC institution was required to have a planning grant award before submitting an application for funding of a training program in response to the D43 FOA. LMIC institutions now have the option to apply for a planning grant in response to this FOA or for a research training award to the D43 FOA. Another change is that the beneficiary of the training supported through the D43 is expanded to include LMIC sites in an established HIV research network.

The FIC, with co-funding from other NIH Institutes, Centers and Offices (I/C/O), 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 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 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 or at LMIC sites within an established HIV research network. An established HIV Research Network (referred to as "the Network" in these FOAS) is defined as multiple research institutions, with a group of researchers from each institution that are collaboratively working towards a common HIV research agenda, that are formally organized and funded for such collaboration. This FOA will not support the establishment of a new HIV Research Network. The network sites located in LMICs for an established HIV research network are referred to as "LMIC Network sites" in these FOAs.

The Fogarty HIV Research Training Program is designed to move beyond simple output indicators (number and type of people trained) to outcome indicators (increased research capacity at an LMIC institution or at LMIC Network site(s) to provide more meaningful monitoring and evaluation of individual awards and of the program as a whole.

The program provides opportunities for U.S and LMIC institutions to collaborate with their partners, including HIV Research Networks with LMIC sites, to fill gaps in training in a particular area that will strengthen HIV research capacity at the proposed LMIC institutions or Network sites. Applicants should design HIV research training programs for LMIC scientists and staff at LMIC institutions or Network sites so that trainees can address both long-standing and emerging HIV research questions. This approach will allow applicants to be more responsive to research needs at an LMIC institution(s) and 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 from the LMIC or, if relevant, from the LMIC Network sites, to be recruited for a future research training program.
• Design research training approaches that address the selected HIV scientific focus.
• Organize and submit an application in response to D43 FOA.

Applicants are encouraged to review the NIH HIV/AIDS Research Priorities, the NIH Plan for HIV-Related Research for the year they are applying, and the FIC Strategic Plan to inform the planning process proposed.

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to 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 information. U.S., other High Income Country (HIC) or ineligible LMIC Faculty and institutions may be named as partners and serve as future training sites.

Applications that propose to plan research training to support a Network and LMIC Network sites should be submitted by one of their LMIC Network site institutions.

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 planning process and future planned program. If relevant, the Network and Network sites are expected to demonstrate commitment and tangible support to the proposed planning process and future training program.

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) (formerly CCR) 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 and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

International applicants may obtain more information on the registrations required for grants.gov and eRA Commons at: https://grants.nih.gov/grants/ElectronicReceipt/files/Tips_for_International_Applicants.pdf.
https://grants.nih.gov/grants/ElectronicReceipt/files/international_support.pdf
https://grants.nih.gov/grants/ElectronicReceipt/files/international_qa.pdf
https://grants.nih.gov/grants/ElectronicReceipt/preparing_grantsgov_reg.htm

Guidance for International Applicants Blocked from Registration Websites: NOT-OD-11-090.

An NIH supported webinar on Electronic Submission of Grant Applications for Foreign Institutions can be found at https://grants.nih.gov/grants/webinar_docs/webinar_20120927.htm.

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 and, if relevant, the HIV Research Network. 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.

The PD(s)/PI(s) on a planning grant (D71) award under the Fogarty HIV Research Training Program is expected to be the PD(s)/PI(s) on the respective D43 application.

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 and scientifically 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).

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

Dr. Geetha Bansal
Telephone: 301-496-1492
Fax: 301-402-0779
Email: geetha.bansal@nih.gov

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. Include the applicant institution and all of the partnering institutions in the planning process, both foreign and U.S., as performance sites.

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. If relevant, include the name of the Network and the names of the LMIC Network sites. Provide a short description of the planning process to be used.

Project Narrative: Include the selected scientific area for which HIV 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. If relevant, include the name of the Network and the names of the LMIC Network sites. Describe the public health relevance of the future increased HIV research capacity to the LMIC institution or, if relevant, LMIC Network sites.

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

Include at least one person at each U.S. and foreign participating institutions as senior/Key Personnel and identify their role in the planning process.

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 request costs for key personnel and faculty travel
• Use the Other Direct Costs" section to request costs related to other activities for the planning process.

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

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

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

Training Program

Program Plan

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

• If relevant, identify the HIV Research Network and describe how it meets the definition of an established HIV Research Network. Include link to Network website, if available.
• 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 or Network and LMIC Network sites 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 Administration - In addition to the instructions in the SF424 (R&R) Application Guide:

• Describe the decision-making process during the planning period.

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, 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.
• Identify any existing research training programs at the LMIC institution or LMIC Network sites 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-16-279) as they prepare their planning grant application to this FOA.
• The applicant should describe a step-wise process to meet the objectives of the planning grant (see Section I).

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

• Describe a monitoring and 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 recruit and select trainees.

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, other partner institutions, and, if relevant, by the Network and LMIC Network sites. 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.
• Attach a PDF file that states Not applicable to this FOA for the Plan for Instruction in the Responsible Conduct of Research

Participating Faculty biosketches

Participating faculty and mentors should include a Personal Statement in their Biosketch that reflects their contribution and willingness to participate in the proposed planning and, if relevant, future training program.

Data Tables

Not required for this FOA.

Letters of Support

The application should include letters of support from institutional leaders of applicant, partnering institutions, and, if relevant, from Network Leadership to provide evidence that the leadership of the LMIC institution (and Network, if relevant), support the development of a future research training program.

The Personal Statements from key personnel and participating faculty members and mentors will be used in place of individual letters of support to confirm their roles.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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. .

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

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 our Post Submission Application Materials policy.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research 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 planning process will lead to a future training program that will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, and on the HIV- research capacity in LMIC institutions or LMIC Network sites in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of the merit of the training program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the context of proposed short-term training. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Training Program and Environment

Does the 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 the planning activities defined in the application address the objectives of the planning grant FOA?

Does the applicant propose a realistic plan for developing an application to the D43 FOA in the Fogarty HIV Training Program? Does the applicant propose creative approaches to develop a HIV research training program? 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 and, if relevant, Network and Network sites, 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 collaborations among the PD(s)/PI(s), the faculty and staff at the applicant and participating institutions, and, if relevant, within the Network?

Does the Training PD(s)/PI(s) plan to commit sufficient time 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?

Preceptors/Mentors

Do the faculty and mentors have appropriate expertise, experience, and track records of past mentoring and training to contribute to the research training program planning process?

Trainees

Does there seem to be an adequate pool of candidates for the future training program? Are 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?

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.

Recruitment Plan to Enhance Diversity

Not Applicable

Training in the Responsible Conduct of Research

Not Applicable

Select Agent Research

Not Applicable

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the 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. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 http://www.hhs.gov/ocr/civilrights/understanding/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.

Awards made primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required, as described in the NIH Grants Policy Statement.

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 Progress Report 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.

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 eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

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

Shoshana Kahana
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-2261
Email: kahanas@mail.nih.gov

Joan Romaine
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-594-6230
Email: Joan.romaine@nih.gov

David Stoff
National Institute of Mental Health (NIMH)
Telephone: 240-627-3876
Email: dstoff@mail.nih.gov

Robert Freund PH.D
Center for Scientific Review (CSR)
Telephone: 301-435-1050
Email:freundr@csr.nih.gov

Kasima Brown
Fogarty International Center (FIC)
Telephone: 301-496-5710
Email: kasima.brown@nih.gov

Pamela Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-253-8729
Email: pfleming@nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: rr46w@nih.gov

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.