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.

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-19-283). A third FOA (D71), (PAR-19-284), 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 Fogarty HIV Research Training 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 provide more accessible research infrastructure training opportunities to others in their own country and in other LMICs.

This FOA supports training related to technical expertise, administration and management 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 oversight - Administrative processes in place at an institution to promote research integrity, 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. 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.
5. 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.
6. Information and communications technology systems (ICT) for research- Computer systems that provide, coordinate, and manage information technology, and advance computational science.
7. 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.
8. 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.
9. Any area not mentioned above that justifiably will contribute to enhancing Institutional services that can support research activities

The Fogarty International Center (FIC), with co-funding from other NIH Institutes, Centers and Offices (ICOs), 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 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 (number and type of people trained, research products) to outcome indicators (including increased research capacity at an LMIC institution) to provide more meaningful evaluation of individual awards and of the program as a whole.

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 of why additional training is required.

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 U.S. institution as the applicant with an LMIC institution as beneficiary of the training; 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; 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.

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, practicum experiences, collaborative exchanges, leadership training, organizational planning, career development planning, and mediation/negotiation training, are encouraged. Distance learning with sufficient mentoring and support at the LMIC institution may be proposed. 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-15-137.html ), the NIH Plan for HIV-Related Research for the year they are applying, 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.

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

• Non-domestic (non-U.S.) Entities (Foreign Institutions)

An application may be submitted by a foreign institution in a low- or middle-income country (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.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.

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.

International applicants may obtain more information on the registrations required for grants.gov and eRA Commons at:

• https://grants.nih.gov/grants/Electronic Receipt/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 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 in 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 of 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).

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

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)

Faculty/Mentors

Proposed training staff and mentors should have expertise and experience relevant to the proposed training program. Mentors must be committed to continue their involvement throughout the total period of the mentee’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.

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

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: [email protected]

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, and, if relevant, the names of the Network and the Network site at the LMIC institution. Identify the research infrastructure function for which training is proposed, and how the increased capacity will strengthen the high priority 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 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 "high." Include the LMIC and name of the in-country institution and, if relevant, the names of the Network and the Network site at the LMIC 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 and, if relevant, LMIC Network sites. 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.

In addition:

1. • 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.
   • List all members of the Training Advisory Committee (TAC) as Senior/Key Personnel, select Other and list their role as TAC member .

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

• 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, such as recruitment and selection activities, as well as other program-related roles.
• 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. Medium- and long-term trainees may be paid a stipend comparable to their professional experience and institutional policy. Partial stipends for part time long-term 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 short term trainees should be covered by per diem and included under Trainee Travel. expenses
• Trainee Travel to participate in training experiences in other institutions or to attend scientific meetings and workshops that the training program determines to be necessary for the individual’s training. Awards may support travel for current or former 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 and 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, and identify, by name, any continuing trainees.

Specific Aims:

The specific aims page should:

1. List succinctly the specific objectives of the proposed training.
2. The specific aims page should identify the research support function and the LMIC institution that will benefit from the proposed training.
3. 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:

1. Significance:

1. Provide the rationale for the selection of the specific research support function.
2. 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.
3. Describe the current HIV research collaborations among the participating institutions.
4. Identify the research support gaps that will be addressed by this training program.
5. 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.

2. Investigator(s):

1. Describe the roles of the investigators and their qualifications to provide and sustain the required training.
2. 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.

3. Innovation:

1. 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).
2. 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.

4. Approach:

1. Describe the administrative structure of the training program and the distribution of responsibilities within, 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.
2. 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.
3. Describe courses and research support infrastructure project opportunities that will be available to trainees.
4. Describe a plan for providing mentoring that will support trainees while in courses and conducting training-related projects.
5. 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.
6. 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.
7. Describe the pool of potential trainees. Identify any potential trainees from existing LMIC institution staff and why they would be recruited.
8. Describe a plan for retaining trainees after completion of training.
9. 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
10. 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
11. 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.

5. Environment:

1. Describe the HIV and HIV-related scientific environment at the LMIC Institution and partnering LMIC institutions.
2. 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.
3. 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 with other research and training programs and 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.

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.

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.

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.

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 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. See Section III of this FOA for information on registration requirements.

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. 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 {[email protected]} when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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.

Significance

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?

Investigator(s)

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?

Innovation

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)?

Approach

1. 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?
2. Will the proposed recruitment, selection criteria and retention strategies engage and sustain the highest quality trainees?
3. 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?
4. If relevant, will the training approach result in expected increased capacity in the infrastructure function at the LMIC institution, and other participating LMIC institutions?

Environment

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 the application and PD(s)/PI(s) demonstrate equitable partnership with the LMIC institution(s) and key collaborator(s) in the planning, implementation and evaluation of the proposed training?

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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.

Vertebrate Animals

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.

Biohazards

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.

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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).

Authentication of Key Biological and/or Chemical Resources:

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.

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.

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.

• 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 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

1. • 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

3. Anticipated Announcement and Award Dates

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

1. Award Notices

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.

2. Administrative and National Policy Requirements

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.

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.

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.htmlhttps://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.

3. Reporting

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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In 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.

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: [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]

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.