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 under three different Funding Opportunity Announcements (FOAs). This FOA (G11) encourages applications for infrastructure development training programs to strengthen one of the six infrastructure functions critical to support HIV research at LMIC institutions. Applicants interested in scientific research training should consult D43 FOA (PAR-16-279). A third FOA (D71), (PAR-16-281), provides the option for a planning grant to LMIC institutions prior to an application for the research training.

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 six research 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, and 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 limited to these six functions:

• 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.
• 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.
• 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.
• 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.
• 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.
• Information and communications technology systems (ICT) for research- Computer systems that provide, coordinate, and manage information technology, and advance computational science.

In previous competitions of this program, LMIC institutions were not eligible to apply to the G11 FOA, but this restriction is now lifted. Another change is that the beneficiary of the training supported through this G11 FOA is expanded to include an LMIC institution that is a site in an established HIV research network.

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 institutional or at LMIC Network site(s) level) to provide more meaningful monitoring and evaluation of individual awards and of the program as a whole.

This program FOA provides opportunities for a U.S or LMIC institution to collaborate with their partners, including an established HIV Research Network with LMIC sites, to fill gaps in training in a particular research infrastructure function that will strengthen the HIV research capacity at the proposed LMIC institution. Applicants should design training programs for LMIC scientists and staff at LMIC institution so that trainees can strengthen the selected research infrastructure function at the LMIC institution. If the LMIC institution is a LMIC Network site, the training should strengthen the selected function at the institutional level and not focus solely at the network site level. 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 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 many cases, it is anticipated that the proposed program will complement ongoing efforts to strengthen the infrastructure function at the LMIC institution(s) and, if relevant, as an LMIC Network site. Proposed training should be designed to be synergistic and not duplicative of these programs.

It is anticipated that some LMIC institutions could serve as training sites in the selected infrastructure function for other LMIC institutions. Faculty and staff from these more advanced LMIC institutions 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 with their own institution as the beneficiary of the training to further strengthen its own capacity; a LMIC institution as applicant with another LMIC institution 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.

Training models may be innovative, but must be appropriate to the context of the LMIC institution. Training should take place at the most appropriate site. Training sites may be proposed at institutions other than the applicant or LMIC institution named in the application, including those in high-income countries. Innovative approaches, topics for training, 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 LMIC Network sites, identified in the application.

Applicants are encouraged to review the NIH HIV/AIDS Research Priorities, the NIH Plan for HIV-Related Research for the year they are applying, available at http://www.oar.nih.gov/strategicplan, and the FIC Strategic Plan to inform their proposed training plan.

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.

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)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Non-domestic (non-U.S.) Entities (Foreign Institutions) in LMICs

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 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). Other High Income Country (HIC) Faculty and institutions may be named as partners and serve as training sites.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

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 infrastructure training program 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).

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 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).

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.

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.

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: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

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.

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

All instructions in the SF424 (R&R) Application Guide must be followed. Include the applicant institution, the LMIC institution or LMIC Network sites, and any other participating institutions, both U.S. and foreign as performance sites.

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

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.

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

• 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 with the following additional modifications:

• 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.

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

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

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

Specific Aims - The specific aims page should:

• Identify the research infrastructure function and the LMIC institution and, if relevant, the Network and network site at the LMIC institution, for the proposed training.
• State concisely the goals of the proposed training and summarize the expected outcome(s), including the impact that the results of the proposed training will exert on the high priority HIV research capacity of the LMIC institution.
• List succinctly the specific objectives of proposed training.

Research Strategy: The Research Strategy section must be used to upload the Capacity Building Strategy, which must include the following information:

1. Significance

• Provide the rationale for the selection of the specific research infrastructure function.
• Describe the current level of capacity in the selected infrastructure function at the LMIC institution and describe how training will further strengthen that research infrastructure function at the proposed training sites.
• Describe the current HIV research collaborations among the applicant institution, LMIC institution, if relevant the Network, and other participating institution(s) ), and, if relevant, the HIV research Network.
• Describe how the selected infrastructure function currently supports the HIV research at the LMIC institution.
• Identify gaps in that support, and describe how further training will strengthen the LMIC institutional support to HIV research that is considered "high priority" by the LMIC and the NIH.
• 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.
• Describe the institutional support and commitment to the goals of the training program by the applicant, LMIC institution, other partnering institutions and, if relevant, the Network.

2. Innovation

• Describe strategies that will be used to engage trainees in training-related research infrastructure activities that will directly benefit the on-going priority HIV research at the LMIC institution.
• 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 LMIC Network sites and other HIV Research Networks with LMIC sites.

3. Approach

• If multiple PD(s)/PI(s) are involved in the training program, describe how the training program and trainees will benefit from the arrangement.
• Describe how the leadership and professional staff at the LMIC institution, and, if relevant, the Network site at the LMIC institution were involved in the development of the application.
• 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 the LMIC key collaborator, professional staff at the LMIC institution, other participating institutions, and the TAC.
• Provide a three-year training implementation plan that describes and provides the rationale for the type of training, topics of the training and the expected candidates for each type of training included.
• Describe courses and research infrastructure project opportunities that will be available to trainees.
• Describe a plan for providing mentoring that will support trainees while in courses and conducting training-related projects.
• Describe the criteria, recruitment and selection procedures for trainees to ensure that trainees have appropriate prior training and experience, are likely to complete the training, and to contribute to the increased capacity of the LMIC institution in the selected infrastructure function.
• Describe the role of the LMIC institution and their professional staff in the recruitment and selection of trainees. Describe recruitment efforts to attract women and other populations who are under-represented in the proposed infrastructure function in that LMIC to apply for training opportunities.
• Describe the pool of potential trainees. Identify any potential trainees from existing LMIC institution staff and why they would be recruited.
• Describe a plan for retaining students after completion of training.
• Describe the increased capacity in the function expected at the end of the three-year funding period and how it will strengthen high priority HIV research capacity at the LMIC institution
• Describe an evaluation plan that will assess the quality and effectiveness of the training over the three-year period. Include a process to obtain feedback from current and former trainees
• Include measures in the evaluation plan that can be used to demonstrate increased capacity in the infrastructure function at the end of and beyond the three-year funding period. Describe how the data will be collected and monitored over time.
• For renewal applications, highlight how the training program evolved in response to changes in relevant technical knowledge, educational practices, and evaluation of the training program.

Letters of Support: The application should include letters of support from institutional leaders and leaders of the research infrastructure function proposed for training of the LMIC institution, of partner institutions and, if relevant, from Network Leadership. 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.

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

• Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

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.

Not applicable for this FOA.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

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

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

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

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.

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.

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. 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.

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 for the project to exert a sustained, powerful 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 scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical infrastructural barrier to progress in HIV research at the LMIC institution? If the aims of the project are achieved, how will HIV research capacity at the LMIC institution be improved? Does the proposed program provide training for the infrastructure function that will be sustained at the higher level beyond the project period?

Does the PD(s)/PI(s) have the technical and administrative background, expertise, and experience to provide strong leadership, direction, management, and administration to the proposed training program? Does the PD(s)/PI(s) plan to commit sufficient time to the program to ensure its success? Does the history of collaborations among the PD(s)/PI(s) and training staff/mentors at the participating institutions provide a strong foundation for the proposed training?

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?

Has the applicant described innovative strategies for trainees to engage in the infrastructure function proposed to support HIV research at LMIC institution?

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

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

Does the program have 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 and beyond the three-year funding period? Is the proposed method to monitor the long-term impact of training in the proposed function on the HIV research capacity at the LMIC institution adequate?

If relevant, will the training approach result in expected increased capacity in the infrastructure function that will enable the proposed training sites to become future training sites for other LMIC institutions or other HIV Research Networks and their LMIC sites?

Will the scientific and administrative environment for the training proposed contribute to its success? Are the institutional support, equipment and other physical resources available from the applicant and LMIC institution(s) and, if relevant, Network adequate for the training proposed?

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?

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.

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

For Renewals, the committee will consider the progress made in the last funding period.

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.

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

Not Applicable

Not Applicable

Not Applicable

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 on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the FIC Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds. Relevance of the proposed project to program priorities, 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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

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

A final progress report, 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.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons 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 CenterTelephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Dr. Geetha Bansal
Fogarty International Center (FIC)
Telephone: 301-496-1492
Email: [email protected]

Shoshana Kahana
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-2261
Email: [email protected]

Joan Romaine
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-594-6230
Email: [email protected]

Robert Freund PH.D
Center for Scientific Review (CSR)
Telephone: 301-435-1050
Email:[email protected]

Kasima Brown
Fogarty International Center (FIC)
Telephone: 301-496-5710
Email: [email protected]

Pamela Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-253-8729
Email: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

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

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