Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	Fogarty International Center (FIC) National Institute of Mental Health (NIMH)
Funding Opportunity Title	Limited Competition: Training Programs for Critical HIV Research Infrastructure for Low- and Middle-Income Country Institutions (G11)
Activity Code	G11- Extramural Associate Research Development Award (EARDA)
Announcement Type	Reissue of PAR-12-069
Related Notices	May 23, 2016 - This PAR has been reissued as PAR-16-280. June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications. May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
Funding Opportunity Announcement (FOA) Number	PAR-13-215
Companion Funding Opportunity	PAR-13-126, D43, International Research Training Grants PAR-13-214, D71, International Research Training Planning Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.989, 93.242
Funding Opportunity Purpose	The purpose of this FOA is to encourage U.S. institutions with research collaborations at low-and middle-income country (LMIC) institutions to submit applications for training programs to strengthen the leadership and expertise in selected critical research infrastructure areas at their collaborating LMIC institutions. This FOA can only support training related to technical expertise, administration and financial management in support of one of these six areas: Dedicated research offices; Offices of research integrity; Ethics committees for protection of human subjects; Committees for animal care and use in research; Health sciences libraries (library and information science); and Information and communications technology systems (ICT) - (expertise to keep these systems up-to-date and functioning)

Posted Date	April 25, 2013
Open Date (Earliest Submission Date)	June 24, 2013
Letter of Intent Due Date(s)	30 days before the application due date
Application Due Date(s)	July 24, 2013, July 24, 2014, July 30, 2015, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	July 24, 2013, July 24, 2014, July 30, 2015 by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Scientific Merit Review	October/November 2013, October/November 2014, October/November 2015
Advisory Council Review	January 2014, January 2015, January 2016
Earliest Start Date	April 2014, April 2015, April 2016
Expiration Date	July 31, 2015
Due Dates for E.O. 12372	Not Applicable

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 human capacity to contribute to the ability of institutions in eligible low- and middle-income countries (LMIC) to conduct HIV-related research on the evolving HIV-related epidemics in their country and to compete independently for research funding. See http://data.worldbank.org/about/country-classifications/country-and-lending-groups for the countries defined as low-and middle-income.

The Fogarty HIV Research Training Program encourages applications under three different Funding Opportunity Announcements (FOAs). This FOA (G11) encourages applications from U.S. institutions to support training to develop and strengthen leadership and expertise in six specific research infrastructure areas at an LMIC institution with which the U.S. applicant institution has on-going HIV research collaborations. This training is expected to strengthen the HIV research capacity of the specified LMIC institution. Applicants interested in other areas of scientific research training should consult the D71, PAR-13-214 and D43, PAR-13-126 FOAs.

FIC, with co-funding from other NIH Institutes, Centers and Offices, has provided 25 years of support to HIV research through two HIV research training programs, the AIDS International Training and Research Program (AITRP) and the International Clinical, Operations and Health Services Research Training Award for AIDS TB program (ICOHRTA AIDS TB (ICOHRTA AIDS TB). Awards under these two programs have supported research training of LMIC individuals who have participated in important HIV research, conducted at LMIC institutions and 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, to address HIV/TB co-infection, and to prevent HIV infection through behavior change, microbicides, and antiretroviral drugs, have been facilitated through partnerships with LMIC scientists and supported by the FIC research training programs. Continued investment in training to strengthen research and research capacity at LMIC institutions is needed to address the on-going HIV epidemic in LMICs.

Efforts to implement research findings within the context of increased provision of HIV prevention, care and treatment services in LMICs over the past ten years have led to the emergence of new research issues, such as combination HIV prevention interventions, better linking of newly diagnosed individuals into care programs, and integration of HIV programs with other health services. As LMICs implement HIV prevention, care and treatment programs for their populations, these and other, yet undefined, research issues will need evidence-based solutions.

Because the social context of an LMIC will influence the research designed to answer these evolving research questions, LMIC institutions and their researchers, who intimately understand the social context of their country and with the research capacity to design and conduct the research, are best positioned to conduct the most relevant research, disseminate the results in-country, and influence policymakers, program managers and medical/public health practice.

FIC decided to consolidate the two FIC HIV research training programs in FY2013 into a new program, Fogarty HIV Research Training Program. This new program is designed to focus each individual award on specific research capacity at an identified LMIC institution. The new program will move beyond simple output indicators (number and type of people trained) to outcome indicators (increased research capacity at an institutional level) for more meaningful monitoring and evaluating both of individual awards and of the program as a whole. This FOA complements the other two FOAs, which are focused on scientific research training, by supporting training that addresses six research infrastructure areas considered critical to successful high quality research. It provides opportunities for U.S. institutions and their LMIC institutional research partner to collaborate to identify gaps in capacity and to design training to bring the partner LMIC institution to the next level of capacity in a critical research infrastructure area. Research infrastructure training programs will maximize previous FIC and other NIH research and research training investments in LMIC institutions, will further strengthen the LMIC institution's research and research training capabilities, and will provide additional and more accessible research infrastructure training opportunities to others in their own country and in other LMICs.

This FOA under the Fogarty HIV Research Training Program can only support training related to technical expertise, administration and financial management in these six areas:

• dedicated research offices;
• offices of research integrity;
• ethics committees for protection of human subjects;
• committees for animal care and use in research;
• health sciences libraries (library and information science); and
• information and communications technology systems (ICT) - (expertise to keep these systems up to date and functioning)

Each individual application will need to:

• identify one research infrastructure area for which the proposed training will be focused at one specific LMIC institution;
• provide rationale for the selection of that area as important for further research capacity development at the LMIC institution;
• describe the current level of capacity in that area at LMIC institution and justify the need for more training; and
• describe the increased capacity in that research infrastructure area that will result at the end of the three-year funding period and define measures that can be used to demonstrate the increased capacity.

The proposed training is expected to raise the LMIC institution to the next level of capacity in the research infrastructure area. In some cases, it is anticipated that the proposed program will complement other ongoing research infrastructure training programs occurring at the LMIC institution. The applicant should describe any other related research infrastructure programs at the LMIC institution, regardless of the source of funding, and explain what distinguishes the proposed training program from the other training programs, how their program will synergize with the others, if applicable, and make it clear that the pool of training staff, potential trainees, and resources are robust enough to support additional programs.

Proposed programs can support a mix 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 research infrastructure area at the LMIC institution identified in the application. Only individuals who are or are expected to be associated with that LMIC institution are eligible for training under this FOA

Emphasis should be on training that provides the theoretical and applied depth needed by an individual or by a group of individuals in the LMIC institution to support capacity in the specific research infrastructure area that will be maintained at a level of high quality after the training. Over time, it is anticipated that some of the LMIC institutions could reach a level of capacity that they could serve as training sites in their defined research infrastructure area for other LMIC institutions, and existing staff at LMIC institutions are eligible for further training to achieve that goal.

Training should be appropriate to the context of the LMIC institution, and training sites may include institutions other than the applicant or LMIC institution named in the application. Innovative approaches and topics for training, such as a practicum, collaborative exchanges, leadership training, organizational planning, career development planning, mediation/negotiation training, are encouraged. Distance learning with sufficient mentoring and support at the LMIC institution can be an option. Training-related projects must be conducted or involve data from the LMIC or the LMIC institution identified in the application.

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.

Applicants are encouraged to review the FIC Strategic Plan at http://www.fic.nih.gov/About/Pages/Strategic-Plan.aspx and the NIH Plan for HIV-Related Research for the year they are applying, available at http://www.oar.nih.gov/strategicplan/. Applicants are also encouraged to explore research training in topics of interest to PEPFAR (http://www.pepfar.gov/) and the U.S. Global Health Initiative (http://www.ghi.gov/).

See Frequently Asked Questions (FAQs) for the Fogarty HIV Research Training Program for more information.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Resubmission The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	Application budgets are limited to $92,000 direct costs per year. Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees and expenditures for equipment), rather than on the basis of a negotiated rate agreement. Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004. Facilities and administrative costs are limited to 8% for all awards and sub-awards.
Award Project Period	Three years

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)

Eligible U.S. institutions must demonstrate active and strong HIV-related collaborations with the LMIC institution named in the application. The applicant institution must have a strong and high quality research infrastructure program in the area proposed under this FOA and must have the requisite training staff and facilities to conduct the proposed training program.

The applicant institution must assure support for the proposed program. Both the applicant institution and LMIC institution named in an application must demonstrate institutional commitment to the proposed training by identifying a tangible means of support. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

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

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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 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. Women and 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 program infrastructure area 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) will be expected to monitor and assess the program and submit all documents and reports as required.

The PD(s)/PI(s) must include relevant staff and training staff expected to facilitate the proposed training program and contribute to its ability to bring the LMIC institution to the next level of capacity in the specific program infrastructure area.

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

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Current AITRP and Phase II ICOHRTA AIDS TB award institutions are not eligible to submit applications under this FOA until the last year of their current AITRP or Phase II ICOHRTA AIDS TB project period.

Applicants must download 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, 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:

Jeanne McDermott
Program Officer
Division of International Training and Research
Fogarty International Center, NIH
Bldg. 31, Rm. B2-C39
31 Center Dr. MSC 2220
Bethesda MD 20892-2220 U.S.A
Telephone: 301-496-1492
Email: [email protected]

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

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

Proposed Project Start and Ending Dates: Use the "Earliest Anticipated Start Dates" given in this FOA as the Proposed Project Start Date.

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

Include the applicant institution, the identified LMIC institution in the application 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 additional instructions:

Foreign Award or With Foreign Component: Check YES and list the foreign countries in 6a for all of the performance sites listed in SF 424 (R&R) Project/Performance Site Locations Component.

Project Summary/Abstract: Provide an abstract for the entire application, including the long-term goals and objectives of the program, key elements of the training plan, and a brief description of planned training program. Include the country and name of the LMIC institution and the specified research infrastructure area for which training is being proposed. Include the rationale and design of the training program, the expected increased research capacity and the measures the applicant will use to demonstrate that increased capacity.

Project Narrative: Include the name of the LMIC and the LMIC institution, the specified research infrastructure area for which training is being proposed, and describe the public health relevance of the increased research capacity to the LMIC.

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

In addition to naming a Senior/Key Person, include the name of one person at the LMIC institution who will serve as the main collaborator, 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.

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

• Use Section A to submit costs for Senior/Key personnel. The salary for the PD/PI, other key personnel, training faculty and administrative staff must be commensurate with the salary structure and benefits at the institution where they are employed and within the limits described at http://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 Section B to enter salary support for administrative staff. Do not include trainees in this section; Use Section E for trainee expenses.
• The administrative, training or teaching responsibilities and time commitment for personnel receiving salary should be thoroughly described and justified.
• Use Section D to submit costs for key personnel and faculty travel for training responsibilities and to attend necessary meetings. Funds may be requested for round-trip economy airfare on U.S. carriers (to the maximum extent possible) and lodging and per diem. PDs/PIs are expected to attend the network meeting, normally in the U.S., and may also budget for grant administrators, other faculty, collaborators and trainees to attend. Include trainee travel in Section E.
• Use Section E for trainee and training-related expenses:
  • Funds for tuition and academic fees at the U.S. or a foreign institution may be requested. Include health insurance under Training Related Expenses category rather than in the Tuition/Fees/health insurance category.
  • Stipends are provided 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 travel expenses.
  • Funds may be requested for round-trip economy class airfare on U.S. carriers (to the maximum extent possible). Funds may be requested for lodging and per diem for short-term trainees. Trainee travel to attend scientific meetings and workshops that the institution determines to be necessary for the individual s research training experience is an allowable trainee expense. Funds may be requested to support participation in international conferences and meetings in which current or former trainees will present training-related information.
  • Do not use Subsistence category.
  • Use Other for other trainee-related expenses. Applicants are encouraged to budget adequate professional development opportunities for trainees, including international conference attendance. Training-related expenses (e.g., books, computers, and courses for software, English language proficiency, etc.) may be included but must be described in the budget justification. Funds for self-only or family medical insurance may be requested.
  • Applicants may include cost to support mentored in-country training projects of up to $5,000 direct costs/project/trainee for medium- or long-term trainees upon completion of their didactic training. Support for only one project per trainee is allowed.
• Use Section F for other direct costs and describe fully in budget justification. Applications may include costs for short- term courses and describe in budget justification. Equipment, software and other non-training expenses are not allowed.

Provide details of trainees and training expenses in the budget narrative.

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:

Specific Aims:

• Include the research infrastructure area for which training is being proposed and identify the LMIC institution for which the training is being proposed.
• Describe the proposed training program, including the goals, objectives, and how the program will meet the objectives outlined in this FOA, to bring the LMIC institution to the next level of capacity in the specified research infrastructure area.

Research Strategy (Capacity Building Strategy):

Use the directions below for Research Strategy (Capacity building Strategy) in place of the instructions in the 424 Application Guide:

a) Significance

• Describe why the specific research infrastructure area was selected for the particular LMIC institution identified in the application. Identify areas of mutual interest with the priorities of the LMIC, the LMIC institution and co-sponsoring NIH Institutes or Centers identified on this FOA.
• Describe the existing resources that already exist at the applicant and participating institutions that will contribute to the success of the proposed training program. Identify research infrastructure gaps in important resources necessary for HIV research and describe how these gaps could be filled by the proposed training.

b) Investigators

• Describe how the LMIC institutional leadership and relevant professional staff from the LMIC institution were involved in the planning, decision-making and development of the application.
• Describe the prior and current HIV research collaborations among the applicant institution, LMIC institution and other participating institution(s), and how they demonstrate strong partnerships that will support the proposed training. in the application.
• Describe the qualifications of the PD(s)/PI(s) to provide leadership for the proposed training program, including relevant scientific or professional background and relevant training experience.
• Indicate the level of effort and activities for which the PD(s)/PI(s) will be responsible.
• Provide a short description of the expertise for each of the professional staff from all participating institutions that is relevant to their role in the proposed training plan. Applications should include descriptions of the roles and bio-sketches for relevant faculty, mentors and other teaching staff expected to participate in the proposed training
• If multiple PD(s)/PI(s) are involved in the training program, applicants must describe how the training program and trainees will benefit from the arrangement and include the required Leadership Plan. See Section III.1.B and Section IV.2 in this FOA for NIH multiple PD(s)/PI(s) instructions: Multiple Principal Investigators, and information in Section 8.7.10 of the Research Training Program Plan Component Instructions.

c) Innovation

• Describe innovative strategies that will be used to engage trainees in training-related research infrastructure activities that relate to on-going HIV research at the LMIC institution.
• Describe how the training approach and /or the resulting expected increased capacity in the critical research infrastructure area will expand the expectations of the LMIC institution in its research capacity.

d) Approach

• Indicate how the proposed program relates to prior and current training activities, relevant to the specified research infrastructure area, by others at the LMIC institution, regardless of funding source. Describe how the proposed training will leverage and support, but not duplicate, the current training activities.
• 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 and following courses and while conducting training-related projects relevant to the specified research infrastructure area.
• Describe the plans for the integration of the proposed training with other relevant capacity building activities at the LMIC institution.
• Describe the criteria, recruitment and selection procedures for trainees defined in the three-year training implementation plan. Describe the role of the LMIC institution professional staff in the process. Criteria should include a list of standards that will be used to ensure that trainees have appropriate prior training and experience, are likely to complete the training, and are likely to contribute to the increased capacity of the LMIC institution in the specified research infrastructure area. Identify potential trainees from existing LMIC institution staff and why they would be recruited.
• Describe a plan for retaining students in the program until completion.
• Define measures that can be used to demonstrate increased capacity at the end of the three-year funding period in the specific research infrastructure area for which the training program is proposed.
• Describe how the data for those measures will be collected and how they will be monitored over the three-year period.
• Describe the mechanism to be used to annually review the capacity measures, the progress of the trainees and other indications of the effectiveness of your training program. Describe the roles of the professional staff at the LMIC institution and all other participating institutions, of current and former trainees in the review process.

e) Environment

• Include short descriptions of all of the on-going HIV research at the LMIC institution, regardless of funding source, and describe how the training in the specified research infrastructure area will support this research.
• Describe the institutional support and commitment to the goals of the training program by the applicant and LMIC institutions. The application should include a description of support (financial and otherwise) to be provided to the proposed program. This could include, for example, space, shared laboratory facilities and equipment, funds for curriculum development, release time for the PD(s)/PI(s) and/or participating training and professional staff, support for additional trainees in the program, or any other creative ways to improve the climate for the establishment and growth of the training program.
• 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 collaborator and other participating partners.

The following attachments of the Research Plan form are not applicable to this FOA:

Inclusion Enrollment Report, Progress Report Publication List, Protection of Human Subjects, Inclusion of Women and Minorities, Targeted/Planned Enrollment Table, Inclusion of Children, Vertebrate Animals, and Select Agent Research

Letters of Support: The application should include letters of support that describe how the proposed training program will collaborate with other training programs and relevant on-going HIV research at the institution. The application should include letters of support from officials at LMIC government that describe how they will support and collaborate with the proposed training program, as well as letters of institutional commitment.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

• Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) 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.

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

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 Managment. 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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

For this particular announcement, note the following:

The research infrastructure training program proposed should be evaluated for its expected ability to bring the LMIC institution to the next level of capacity in the critical research infrastructure area proposed in the application. The applicant should provide a clear rationale for the selection of the research infrastructure area as critical to the research capacity of the LMIC institution. The applicant should describe how the proposed training will build or strengthen the LMIC institutional capacity in the proposed research infrastructure area. While the applicant can and should collaborate and leverage other efforts at the designated LMIC institution, regardless of funding source, the application will need to demonstrate that the proposed training is distinct and not duplicative of other efforts at the LMIC institution in that research infrastructure area.

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 capacity in research infrastructure areas at LMIC institutions, 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.

Significance

Does the project address an important problem or a critical barrier to progress in the at the LMIC institution? If the aims of the project are achieved, how will research capacity at the LMIC institution be improved? Does the proposed program provide training that will support research capacity that will be maintained at a higher level of quality after the project period?

Investigator(s)

Does the history of collaborations among the training staff/mentors at the participating institutions provide a strong platform for the proposed training? Does the PD(s)/PI(s) have the technical background, expertise, and experience to provide strong leadership, direction, management, and administration to the proposed research infrastructure training program? Does the PD(s)/PI(s) plan to commit sufficient time to the program to ensure its success? Are sufficient numbers of experienced professional staff and mentors with appropriate expertise and funding available to support the proposed training program? Do the professional staff/mentors have strong records as professionals in areas directly related to the proposed training program? Do the training staff and mentors have strong records of training individuals from LMICs?

Innovation

Has the applicant described innovative strategies for trainees to be engaged in the specified research infrastructure area in relation to HIV-related research at LMIC institution? Will the training approach and /or the resulting expected increased capacity in the critical research infrastructure area expand the expectations of the LMIC institution in its research capacity?

Approach

Does the design of the proposed training (the objectives, design, direction and mix of short-, medium- and long- term training) provide an effective training program in the specified research infrastructure area? Does the proposed training program take advantage of the LMIC institution’s research infrastructure and of previous and current investments and support from FIC, NIH, and other organizations? Does the proposed training appear to be distinct and not duplicative of training or efforts in the specified research administration area being provided by others at the LMIC institution? Is a recruitment plan proposed with strategies to attract appropriate and high quality trainees? Are there well-defined and justified selection criteria and retention strategies?

How well has the applicant defined measures that can be used to demonstrate increased capacity in the particular research infrastructure area at the end of the three-year funding period? Does the program have a rigorous evaluation plan to assess the quality and effectiveness of the training over the three-year period? How adequate is the proposed method to monitor the long-term impact of the training experience on the subsequent research capacity at the LMIC institution? Are effective mechanisms in place for obtaining feedback from current and former trainees?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available from both the applicant and LMIC institutions to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is sufficient administrative and training support provided for the program? Do the application and PD/PI demonstrate true partnership with the LMIC institution and key collaborator 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.

Protections for Human Subjects

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Not Applicable

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Not Applicable

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the FIC Advisory Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities, as articulated in the FIC Strategic Plan http://www.fic.nih.gov/About/Pages/Strategic-Plan.aspx, the relevant NIH Plan for HIV-Related Research available at http://www.oar.nih.gov/strategicplan/, and the U.S. Global Health Initiative (http://www.ghi.gov/), including PEPFAR (http://www.pepfar.gov).
• Consideration of program 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.

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement. Awards providing funds for mentored projects by medium- or long-term trainees must report on the trainees and mentors selected for funding, the status of the projects, and any resulting publications. Grantees will be requested to enter information annually concerning long- term trainees into CareerTrac, a database to track the training history and accomplishments of trainees over time. The database will be made available to grantees after the award is made.

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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

Jeanne McDermott
Fogarty International Center (FIC)
Telephone: 301-496-1492
Email: [email protected]

Dr. Willo Pequegnat
National Institute of Mental Health (NIMH)
Telephone: 301-443-1187
Email: [email protected]

Hilary D. Sigmon, Ph.D., R.N.
Center for Scientific Review (CSR)
Telephone: 301-357-9236
Email: [email protected]

Kasima Brown
Fogarty International Center (FIC)
Telephone: 301-496-1670
Email: [email protected]

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
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 63.