NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

An application may be submitted by an African institution or by a domestic (U.S.) institution that demonstrates collaboration with an African institution. Collaboration should be documented by joint publications, grants or previous research training activities.

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program.

The applicant institution and their partners must collectively have a strong and high-quality research program in the area(s) proposed under this FOA and must have the requisite faculty, staff, potential trainees and facilities on site to conduct the proposed institutional program. In many cases, it is anticipated that the proposed program will complement other ongoing career development programs occurring at the applicant institution and that a substantial number of program faculty will have active research projects in which participating trainees may gain relevant experiences consistent with their research interests and goals.

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 foreign institutions are limited to academic and other non-profit institutions in Africa. Applicants may propose partners from all types of organizations in Africa, the U.S., or other countries, including for-profit and government entities.

Applicant Organizations

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

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research training program as the Training Program Director/Principal Investigator (Training PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

The PD/PI(s) should be established investigators in data science and/or the other scientific areas in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI(s) will be responsible for the selection and appointment of trainees to the approved research training program, and for the overall direction, management, administration, and evaluation of the program. The PD/PI(s) will be expected to monitor and assess the program and submit all documents and reports as required. The PD/PI(s) have responsibility for the day to day administration of the program and are responsible for appointing members of the Training Advisory Committee and using their recommendations to modify the overall direction, management, administration, and evaluation of the program.

At least one PD/PI must be affiliated with the African institution(s) where the proposed research training program will be established and must have citizenship in an African country. Other Multiple PD/PI(s) with relevant expertise from partner institutions in Africa, the U.S. or other high-income country institutions are encouraged. Multiple PDs/PIs should have a documented history of collaboration relevant to the proposed research training program.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Program faculty should have strong records as researchers, including recent publications and successful competition for research support in the area of the proposed research training program. Program faculty should also have a record of research training, including successful, former trainees who have established productive careers relevant to the NIH mission. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as mentors.

For the purposes of this program, data science health research is interdisciplinary and includes three major scientific areas: (1) computer science/ informatics; (2) statistics/mathematics; and (3) biomedical sciences/public health. It anticipated that the training program will have a sufficient number of mentors in all three areas and will utilize the idea of multiple mentorship. The primary PD(s)/PI(s) must ensure that the appropriate faculty work collaboratively and in a sustained manner across scientific disciplines and organizational lines to jointly mentor trainees.

To the extent possible, faculty mentors should have research and/or research training experience in the African country/countries where training will occur.

Trainees must be citizens of African countries and affiliated with African institutions leading or collaborating in the application.

All trainees are required to pursue their research training full time, normally defined as 40 hours per week, or as specified by the sponsoring institution in accordance with its own policies. Appointments are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the awarding unit, or when trainees are appointed to approved, short-term training positions.

Predoctoral and master's trainees must be enrolled in a program leading to a PhD or master's degree or in an equivalent degree program. Health-professional students who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs, are also eligible.

Postdoctoral trainees must have received a Ph.D., M.D., D.D.S., or comparable doctoral degree from an accredited domestic or foreign institution. Comparable doctoral degrees include, but are not limited to, the following: D.M.D., DC, DO, DVM., OD, DPM, ScD, EngD, DrPH, DNSc, DPT, PharmD, ND (Doctor of Naturopathy), DSW, PsyD, as well as a doctoral degree in nursing research. Documentation by an authorized official of the degree-granting institution certifying all degree requirements have been met prior to the beginning date of the training appointment is acceptable. Individuals in postgraduate clinical training, who wish to interrupt their studies for a year or more to engage in full-time research training before completing their formal training programs, are also eligible.

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Training (T) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter 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:

Laura Povlich, Ph.D.

Fogarty International Center (FIC)
Telephone: 301-827-2227
Email: [email protected]

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

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

Follow all instructions provided in the SF424 (R&R) Application. Include the applicant institution and all collaborating institutions where research training will be supported.

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

Project Summary/Abstract. Provide an abstract of the entire application. Include the objectives, rationale and design of the research training program, as well as key activities in the training plan. Indicate the planned duration of appointments, the projected number of trainees including their levels (i.e., master's, predoctoral, postdoctoral, faculty), and intended trainee outcomes. Identify all collaborating institutions.

Other Attachments. A plan must be provided for the appointment of a Training Advisory Committee to monitor progress of the training program. The composition, roles, responsibilities, and desired expertise of committee members, frequency of committee meetings, and other relevant information should be included. Describe how the Advisory Committee will evaluate the overall effectiveness of the program. Potential Advisory Committee members should not be invited to participate in the application and should not be named in the application. 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.

Follow all instructions provided in the SF424 (R&R) Application. If applicable, include at least one person as key personnel from each collaborating institution who will serve as the primary collaborator for that training location.

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

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

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

• Use the Other Personnel section to submit costs for salary support for administrative staff.
• Use the Travel section to submit costs for key personnel and faculty travel including biannual DS-I Africa meetings.
• Use the Participant/Trainee Support Costs section to submit costs for Trainees and training-related expenses. Include health insurance under Training Related Expenses (not in Tuition/Fees/Health Insurance). Do not use the Subsistence category. Provide details of trainees and training related expenses in the budget justification and identify by name any continuing trainees.
• Use the Other Direct Costs section to submit costs for other direct costs related to training activities. Describe fully in the budget justification

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

• Training Program
• Faculty, Trainees, and Training Record
• Other Training Program Sections
• Appendix - Note that the Appendix should only be used in circumstances covered in the NIH policy on appendix materials or if the FOA specifically instructs applicants to do so.

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

Particular attention must be given to the required Training Data Tables. For this FOA, applicants should use the tables listed under New International Training. Applicants should summarize, in the body of the application, key data from the tables that highlight the characteristics of the applicant pool, faculty mentors, the educational and career outcomes of participants, and other factors that contribute to the overall environment of the proposed program.

Training Program

Program Plan

A. Background (In addition to the instructions in the SF424 (R&R) Application Guide):

Applications should document the existing data science research capacity at the African institution(s) where a new data science research training capacity will be established. Measurable parameters of increased research capacity expected as a result of the proposed research training activities at the end of the grant period should be defined.

Institutions with existing related research training programs must explain what distinguishes the proposed program from the others, how their proposed program will synergize with the others, if applicable, and demonstrate that the pool of faculty, potential trainees, and resources are robust enough to support an additional program.

For applications that propose a partnership training model, applicants should describe any prior research and/or research training collaboration between partners or other activities that demonstrate the ability of partners to successfully coordinate the proposed training program.

B. Program Plan

a. Program Administration (In addition to the instructions in the SF424 (R&R) Application Guide):

Applicants should describe how the proposed research training program relates to and/or integrates with the existing organizational structure of the applicant institution as well as the structure of partner institutions, where applicable. Additionally, applicants should describe how program leadership will manage any administrative barriers to interdepartmental and/or multi-institutional teaching, training, and or/mentoring activities.

Applicants should describe how decisions regarding the components of the proposed research training program will be made in consultation with the proposed faculty and Training Advisory Committee.

Applicants should describe plans for how all mentored research projects under this award will receive independent scientific review through procedures established by the applicant institution and Training Advisory Committee. In addition, applicants should describe how trainees who conduct mentored research involving human subjects will receive education in the protection of human subjects. Trainee research must receive annual approval from an institutional (or ethical) review board or committee at the applicant institution and, if different, at the institution in which the research is being conducted.

In the event that a clinical trial may be proposed, provide documentation of the PD/PI(s) expertise, experience, and ability to oversee the organization, management and implementation of the clinical trial, including any feasibility or ancillary study, proposed by trainee(s).

b. Program Faculty (In addition to the instructions in the SF424 (R&R) Application Guide):

Describe the specific role of each proposed faculty mentor in the proposed research training program. Briefly describe any relevant research, including any current research collaborations with the PD(s)/PI(s) or other faculty, and research training record, in particular, for trainees from Africa. Applicants should explain how the relevant research grant support and activities of the PD(s)/PI(s) and proposed faculty mentors may contribute to the proposed data science research training plan.

If any mentors will supervise a trainee proposing to either lead a clinical trial, or gain research experience in a clinical trial, provide documentation of his/her expertise, experience, and ability to provide guidance in the organization, management and implementation of the proposed clinical trial, ancillary, or feasibility study and help him/her to meet the study timelines

c. Proposed Training (In addition to the instructions in the SF424 (R&R) Application Guide):

The research training proposed should instill advanced data science expertise and research leadership capabilities through rigorous and innovative didactic, practicum and mentored research activities designed to address the health needs of African countries. Applicants should describe in detail the research masters, doctoral, postdoctoral, and faculty development research training proposed, including the scientific focus, faculty, institutional location and duration for curriculum components, practicum experiences and mentored trainee research. The numbers of trainees expected to participate in each training component should be stated. While new curriculum should be developed, as described below, the plans described must include details for how trainees will be recruited in the first year of the award and trained either at an African institution or through a partnership model.

Applicants should include plans that describe new curriculum and courses that will be developed, which should expose trainees to the basic concepts and working knowledge in the three scientific areas of data science health research (computer science/informatics, statistics/mathematics, and biomedical science/public health). It is incumbent on the applicant to define a set of core concepts that graduating students will master, even if their research projects are highly specialized. Applicants are expected to work with the other DS-I Africa Research Training PIs and Coordinating Center to develop methods for curriculum harmonization or standardization.

Since data science is an interdisciplinary field with applications that cut across academia, private sector, and government, applicants are strongly encouraged to incorporate elements into their training program that foster interdisciplinary and cross-sectoral collaboration, including: team science approaches to problem-based learning; applied research experiences or internships in a variety of academic, industrial, government, or other relevant settings; and joint mentorship of trainees by mentors with expertise in diverse scientific areas and multisectoral experience.

If a partnership structure is proposed, applications should describe how each collaborating institution will contribute to the specific objectives of the research training plan including how the African institution(s) will gain the data science training capacities initially provided by partners to eventually establish a sustainable training program.

Applicants should describe how the proposed application meets the objectives of the DS-I Africa program described earlier in this funding opportunity, including incorporation of FAIR principles in data science training. Applicants should discuss how the program will integrate with the DS-I Africa Open Data Science Platform and Coordinating Center in the sharing of data resources, including educational material.

Applicants are encouraged to include plans for strengthening the associated skills and knowledge necessary for long-term research career sustainability, such as scientific writing and presentation, grant writing, and expertise in research administration and management of intellectual property. Training in English as a second language may be supported, if needed. Applicants are encouraged to develop plans to foster the creation of Individual Development Plans for each student.

Research training by interactive distance learning technology may be proposed, if appropriate and sustainable for the African trainees and institutions involved. Applicants should describe the availability of distance learning facilities, equipment, internet connectivity, and technical support.

Applicants should provide specific milestones during the requested grant period to meet the proposed research training objectives. A timeline should be included.

In the event that a clinical trial may be proposed, provide documentation of the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the clinical trial, including any feasibility or ancillary study, proposed by trainees.

d. Training Program Evaluation (In addition to the instructions in the SF424 (R&R) Application Guide):

In the evaluation plan provided, included metrics for evaluating improvements in institutional capacity at the African institution(s).

e. Trainee Candidates (In addition to the instructions in the SF424 (R&R) Application Guide):

Applicants should describe plans for how the most qualified African trainees from diverse scientific fields will be recruited for the proposed research training programs. The specific criteria and decision-making process for selecting trainees should be delineated. Strategies that will be used to retain trainees in master's and doctoral degree programs and postdoctoral mentored research projects as well as facilitate sustainable biomedical data science research and training careers in African institutions should be characterized.

Plans should include details for the recruitment of women, individuals with disabilities, individuals from disadvantaged backgrounds, and individuals from racial or ethnic groups underrepresented in the biomedical, behavioral and clinical sciences in the African context.

In the event that a clinical trial may be proposed, discuss the potential of prospective trainees to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study.

f. Institutional Environment and Commitment to the Program (In addition to the instructions in the SF424 (R&R) Application Guide):

Details on the institutional environment and commitment to the program (as instructed in the SF424 Guide) should be provided for each institution where training will take place in the proposed application.

Sustainability: Dedicated funds for DS-I Africa by the NIH Common Fund will provide 5 to 10 years of support. Beyond that, any support for continuation of the research training programs and research careers initiated under the auspices of DS-I Africa will be dependent on other funding. Applicants should discuss the future sustainability of their research training program beyond the 5-years of funding provided by these awards and how the research training program will contribute to success in continuing the research efforts of its participants. This section of the application should refer to relevant letters of support.

g. Qualifications of Trainee Candidates and Admissions and Completion Records

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

Faculty, Trainees, and Training Record

In addition to the instructions in the SF424 (R&R) Application Guide

Letters of Support: Applications should include a letter of support from the appropriate institutional or organizational official (University or Medical School President, Dean or Director, or the head research administrator, company leader, government representative, or equivalent) from the applicant and all collaborating organizations to substantiate the organizations' commitment to the proposed DS-I Africa Training Program. Each organization should state its commitment to overcoming any administrative obstacles to the implementation of the proposal, such as accommodation for participation by multiple schools at a university or collaboration with other institutions within or outside of the applicant’s country. Appropriate organizational commitment to the program includes the provision of adequate staff, facilities, and resources needed for the success of the planned program. It should also address commitment to DS-I Africa policies and procedures, including collaborating and sharing data and resources with the DS-I Africa Consortium and Open Data Science Platform, as appropriate. Where applicable, the letter should also address corporate interests and commitment to the proposed research project and any applicable in-kind support. The letter should also briefly discuss the institution's plans for sustaining the Research Training Program.

Faculty who agree to serve as faculty/mentors should provide letters indicating their willingness to participate and specific contribution to the training proposed.

The programmatic activities of this initiative will support national and international collaborations. Where relevant and attainable, letters of support from the related national ministries such as the Ministry of Science, Ministry of Health and/or Ministry of Education for each African country with a programmatic component are strongly encouraged. The letter should briefly describe the national policy concerning scientific research and health funding priorities.

Plan for Instruction in the Responsible Conduct of Research

Individuals are required to comply with the instructions for Plan for Instruction in the Responsible Conduct of Research as provided in the SF424 (R&R) Application Guide.

Subject Matter

Applicants are encouraged to incorporate instruction related to contemporary ethical, legal, and social issues specifically related to data science health research in Africa.

Appendix

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to theSF424 (R&R) Application Guide instructions.

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement. Any additional costs associated with the decision to allow research elective credit for short-term research training are not allowable charges on an institutional training grant.

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the proposed training program will prepare individuals for successful, productive scientific research careers and thereby exert a sustained influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

Training Program and Environment

• Are the research facilities and research environment conducive to preparing trainees for successful careers as biomedical data scientists in Africa?
• Are the objectives, design and direction of the proposed research training program likely to ensure effective training?
• Do the courses and research experiences provide opportunities for trainees to acquire state-of-the-art scientific knowledge, methods, and tools that are relevant to the goals of the training program?
• Does the program provide appropriate inter- or multidisciplinary or multisectoral research training opportunities?
• Is the proposed training program likely to ensure trainees will be well prepared for research-intensive and research-related data science careers in Africa?
• Is the level of institutional commitment to the training program at all proposed training sites, including administrative and research training support, sufficient to ensure the success of the program?
• Is it clear how the proposed training program is distinguished from other externally funded training programs at the applicant or partner institutions?
• Does the program adequately address the objectives of DS-I Africa? Does the training program include sufficient plans to incorporate FAIR (Findable, Accessible, Interoperable, Reuseable) principles in the proposed data science training?
• If clinical trials may be proposed by trainee(s), are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? Does the application adequately address the capability and ability to conduct the trial feasibility or ancillary study at the proposed site(s) or centers? If applicable, are there plans to add or drop enrollment centers, as needed, appropriate? If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial? If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

In addition, for this FOA:

• If a partnership training model is proposed, is there sufficient evidence (including a history of past collaboration) that the partners will be able to successfully coordinate to carry out the training program and establish research capacity at the African institution(s)?
• Are appropriate plans in place to ensure that any gaps in faculty expertise at the African institution(s) are addressed by additional faculty development training during the grant period?
• If distance learning approaches are proposed, are sufficient facilities, equipment, internet connectivity and technical support available at the African institutions involved to ensure success?
• Are plans for independent scientific review (and ethical review if human subjects involved) of mentored trainee research adequate?
• Is the future sustainability of the research training program addressed appropriately, including relevant letters of support?

Training Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))

• Does the PD/PI have the scientific background, data science expertise, and administrative and training experience in Africa to provide strong leadership, direction, management, and administration of the proposed research training program?
• Does the PD/PI plan to commit sufficient effort to ensure the program s success?
• For applications designating multiple PDs/PIs:
• Is a strong justification provided that the multiple PD/PI leadership approach will benefit the training program and the trainees?
• Is a strong and compelling leadership approach evident, including the designated
• roles and responsibilities, governance, and organizational structure consistent with and justified by the aims of the training program and the complementary expertise of the PDs/PIs?
• With regard to the proposed leadership for the training program, do the PD/PI(s) have the expertise, experience, and ability to oversee the organization, management and implementation of the proposed clinical trial?

In addition, for this FOA:

• Is leadership sufficiently strong to develop and maintain close collaborations across participating departments and partner organizations, if applicable?

Preceptors/Mentors

• Are sufficient numbers of experienced preceptors/mentors with appropriate expertise and funding available to support the number and level of trainees proposed in the application?
• Do the preceptors/mentors have strong records as researchers, including recent publications and successful competition for research support in areas directly related to the proposed research training program?
• Do the preceptors/mentors have strong records of training individuals from Africa at the level of trainees proposed in the program? Are appropriate plans in place to ensure that preceptors lacking sufficient research training experience are likely to provide strong and successful mentoring?
• If the program will support clinical trial research experience for the trainees, do the mentor(s) who will supervise the trainee(s) have the expertise, experience, resources, and ability to provide appropriate guidance and help the trainee(s) to meet the timelines?
• Do the preceptors/mentors who will supervise the trainee(s) have the expertise, experience, and ability to provide guidance in the organization, management and implementation of a clinical trial, ancillary, or feasibility study and help him/her to meet timelines?

In addition, for this FOA:

• Do the preceptors'/mentors' expertise collectively cover all the areas that are critical to biomedical data science, such as computer science/ informatics; statistics/mathematics; and biomedical sciences/public health?

Trainees

• Is a recruitment plan proposed with strategies likely to attract well-qualified African trainees from diverse disciplines for the training program?
• Is there a competitive applicant pool of sufficient size and quality, at each of the proposed levels (master's, predoctoral, or postdoctoral), to ensure a successful training program?
• Are there well-defined and justified selection criteria as well as retention strategies?
• Do prospective trainees have the potential to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study?
• Are there plans to provide instruction in data management and statistics including those relevant to clinical trials to the prospective trainees?

In addition, for this FOA:

• Is a recruitment plan proposed with strategies likely to successfully recruit and retain women, individuals with disabilities, individuals from disadvantaged backgrounds, and/or individuals from racial or ethnic groups underrepresented in the biomedical, behavioral and clinical sciences in the African context?

Training Record

• Have the applicants demonstrated success in training students/postdoctorates in similar training programs?
• Have trainees in similar training programs been productive in terms of research accomplishments, publication of research conducted during the training period, and subsequent training appointments and fellowship or career development awards?
• How successful are the trainees from similar training programs in achieving productive scientific careers as evidenced by successful competition for research science positions in industry, academia, government or other research venues; grants; receipt of honors, awards, or patents; high-impact publications; promotion to scientific leadership positions; and/or other such measures of success?
• Does the program propose a rigorous evaluation plan to assess the quality and effectiveness of the training? Are effective mechanisms in place for obtaining feedback from current and former trainees?

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

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research..

Vertebrate Animals

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

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Recruitment Plan to Enhance Diversity

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the specific characteristics of the training program, the level of trainee experience, and the particular circumstances of the trainees, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework and/or real-time discussion groups, including face-to-face interaction? (A plan involving only on-line instruction is not acceptable.); 2) Subject Matter Does the plan include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics? 3) Faculty Participation - Does the plan adequately describe how faculty will participate in the instruction? 4) Duration of Instruction - Does the plan meet the minimum requirements for RCR, i.e., at least eight contact hours of instruction? 5) Frequency of Instruction Does the plan meet the minimum requirements for RCR, i.e., at least once during each career stage (undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty levels) and at a frequency of no less than once every four years?

Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee.

Select Agent Research

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

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by 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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the Fogarty International Center 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.
• Relevance of the proposed project to the goals of DS-I Africa
• Relevance of proposed project to priorities of co-funding components
• Commitment to compliance with DS-I Africa procedures
• Consideration of programmatic and geographic distribution

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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides 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/fact-sheet-guidance/index.html and https://www.lep.gov. 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 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• 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.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

Awardee and Principal Investigator Primary Responsibilities

• Planning, directing, and executing all aspects of the proposed research training program, including any modification of its design, management, evaluation, preparation and submission of publications, and collaboration with other faculty, unless otherwise provided for in these terms;
• Providing effective leadership and management of all activities under the award;
• Developing programmatic goals, timelines, and milestones, reporting of progress to NIH biannually, and ensuring that the outputs produced meets the quality standards agreed to at the beginning of the project by the DS-I Africa Consortium;
• Assuring compliance with all applicable DHHS/NIH policies for conduct of research and clinical trials as well as host country regulations for protection of human subjects and conduct of clinical research;
• Ensuring collaboration with the DS-I Africa Open Data Science Platform, that data resources developed as part of this project are shared according to DS-I Africa policies, and that results are published in a timely manner;
• Working in close coordination, cooperation, and participation with NIH staff for scientific and technical management of the project, described further under NIH Responsibilities;
• Agreeing to the governance of the Consortium through the Steering Committee, including adherence to DS-I Africa policies and procedures; and
• Serving as active members of the DS-I Africa Steering Committee, attending Steering Committee meetings, and participating directly or by proxy on relevant DS-I Africa Working Groups, both remotely through regular teleconferences and in-person at biannual DS-I Africa Consortium Meetings.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH Responsibilities

NIH staff (including, but not limited to, Project Scientists, Program Officers, Intramural Scientists, and Program Analysts) have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.

NIH Project Scientists roles include:

• Participating (with DS-I Africa investigators) in the group process of deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted;
• Attending Steering Committee meetings, serving on DS-I Africa Working Groups, and assisting in developing operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action;

NIH Program Officer roles include:

• Negotiating goals and milestones with the awardees as needed;
• Serving as liaisons between the awardees and the appropriate NIH Institute and Center National Advisory Councils and the NIH DS-I Africa Working Group made up of program staff that collectively manage the program;
• Attending Steering Committee meetings, serving on DS-I Africa Working Groups, and assisting in developing operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action;
• Convening external consultants to support NIH oversight of the DS-I Africa consortium?;
• Interacting with the PD(s)/PI(s) on a regular basis to monitor progress, which may include regular communication with the study leadership and staff, periodic site visits for discussion with the awardee research team, observation of data collection and management techniques, fiscal reviews, and other relevant stewardship matters; and
• Making recommendations for continued funding based on (a) overall research progress; (b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or (c) maintenance of high-quality research.
• Normal scientific and programmatic stewardship of the award and assignment in the award notice. The assigned NIH Program Official may not also serve as an NIH Project Scientist.
  

The government, via NIH Program Scientists, will have access to all data generated under this Cooperative Agreement and may periodically review and analyze the data for the preparation of internal reports related to the Cooperative Agreement.

An NIH intramural scientist may not serve as the PD/PI of a project awarded under this FOA but may participate as a collaborator or consultant. For applications that include NIH intramural components, the involvement of intramural scientists needs to be consistent with NIH policy ?-? https://oir.nih.gov/sourcebook/ethical-conduct/research-ethics/nih-policies/intramural-extramural-collaborations.

The NIH reserves the right to withhold funding or curtail studies in an individual award in the event of (a) substantive changes in the agreed-upon work scope with which NIH cannot concur, (b) human subject ethical issues that may dictate a premature termination; (c) or insufficient project progress.

Collaborative Responsibilities

A Steering Committee (SC) will serve as the governing board for awardees. All participants in the program are bound by the policies and procedures developed by the SC and adoption of such policies and procedures requires a majority vote. Membership on the SC will include the PI(s) of each award and associated NIH program officers and projects scientists. On voting matters, each funded project will have one vote for determining appropriate collaborative activities, with NIH providing final approval for consortium activities. The chair will be chosen by a majority vote of the SC, with years of service as chair determined by the committee. The chair, in collaboration with the associated program Coordinating Center staff, is responsible for preparing meeting agendas, for chairing meetings, and for approving minutes in a timely manner. NIH staff may not serve as Chair of the SC.

Steering Committee responsibilities include:

• Discussing progress in meeting the broad goals of various DS-I Africa projects (while maintaining appropriate project-specific protection of intellectual property) and of DS-I Africa as a whole;
• Developing recommendations for uniform procedures and policies necessary to meet the goals of the Consortium, for example for data quality measures and assessment as well as conventions for data sharing;
• Cooperating to ensure the timely and broad dissemination of lessons learned to inform researchers and health care systems engaged in data science for health discovery and innovation in Africa;
• Endorsing and overseeing progress and products of Working Groups within the Consortium; and
• Meeting twice a year in-person in conjunction with Consortium meetings and conducting regularly scheduled conference calls.
  
  

Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution and a Dispute Resolution Panel will be convened. The Panel will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. Continuation support will not be provided until the required forms are submitted and accepted.

Failure by the grantee institution to submit required forms in a timely, complete, and accurate manner may result in an expenditure disallowance or a delay in any continuation funding for the award.

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

Recipients are requested to annually update and maintain data on trainees in NIH's CareerTrac (https://careertrac.niehs.nih.gov/).

A final RPPR and the expenditure data portion of the Federal Financial Report are required for closeout of an award as described in the NIH Grants Policy Statement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

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

eRA Commons Help Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

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

Laura Povlich, Ph.D.

Fogarty International Center (FIC)
Telephone: 301-827-2227
Email: [email protected]

Seetha Bhagavan, Ph.D.

Center for Scientific Review (CSR)
Telephone: 301-237-9838
Email: [email protected]

Mollie Shea
Fogarty International Center (FIC)
Telephone: 301-451-6830
E-mail:[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.