Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Library of Medicine (NLM)
National Center for Complementary and Alternative Medicine (NCCAM)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

Special Note: Because of the differences in individual Institute and Center (IC) program requirements for this FOA, prospective applicants are strongly encouraged to consult the Table of IC-Specific Information, Requirements and Staff Contacts, to make sure that their application is responsive to the requirements of one of the participating NIH ICs.

Funding Opportunity Title

Ruth L. Kirschstein National Research Service Award Individual Predoctoral Fellowship to Promote Diversity in Health-Related Research (Parent F31 - Diversity)

Activity Code

F31 Predoctoral Individual National Research Service Grant Award

Announcement Type

Reissue of PA-11-112

Related Notices

  • August 29, 2014- See Notice NOT-OD-14-129. eRA Commons Username Required for Sponsor in Individual Fellowship Grant Applications to NIH and AHRQ.
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • May 20, 2014 - See Notice NOT-OD-14-095. Notice of Clarification Regarding the Additional Educational Information Required.

Funding Opportunity Announcement (FOA) Number

PA-14-148

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.853; 93.351; 93.846; 93.839; 93.838; 93.837; 93.233; 93.866; 93.361; 93.307; 93.121; 93.172; 93.273; 93.859; 93.879; 93.867; 93.847; 93.856; 93.855; 93.398; 93.286; 93.865; 93.173; 93.865; 93.213; 93.242; 93.113; 93.279

Funding Opportunity Purpose

The purpose of this Kirschstein-NRSA predoctoral fellowship (F31) award is to enhance the diversity of the health-related research workforce by supporting the research training of predoctoral students from population groups that have been shown to be underrepresented in the biomedical, behavioral, or clinical research workforce. Such individuals include those from underrepresented racial and ethnic groups, those with disabilities, and those from disadvantaged backgrounds. Through this award program, promising predoctoral students will obtain individualized, mentored research training from outstanding faculty sponsors while conducting well-defined research projects in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers. The proposed mentored research training is expected to clearly enhance the individual’s potential to develop into a productive, independent research scientist.   

Key Dates
Posted Date

March 7, 2014

Open Date (Earliest Submission Date)

March 8, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, 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)

Standard AIDS dates apply, 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

Standard dates apply

Advisory Council Review

Not Applicable for Fellowships

Earliest Start Date

Standard dates apply

Expiration Date

January 8, 2017

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Individual Fellowship 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.


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Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

The overall goal of the NIH Ruth L. Kirschstein National Research Service Award (NRSA) program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs.  In order to accomplish this goal, NRSA training programs are designed to train individuals to conduct research and to prepare for research careers. More information about NRSA programs may be found at the Ruth L. Kirschstein National Research Service Award (NRSA) website.

The purpose of the Kirschstein-NRSA Individual Predoctoral Fellowship to Promote Diversity in Health-Related Research (F31) is to provide support for mentored research training leading to the PhD or equivalent research degree, the combined MD/PhD degree, or another formally combined health professional degree and research doctoral degree in the biomedical, behavioral, or clinical sciences by individuals from diverse population groups. This fellowship program will enhance the diversity of the biomedical, behavioral, and clinical research workforce in the United States by providing opportunities for academic institutions to identify and recruit students from diverse population groups to seek graduate degrees in health-related research and apply for this fellowship. The goal of this program is to enhance the number of scientists from diverse population groups who are well prepared for research careers in the biomedical, behavioral, and clinical sciences. 

This Kirschstein-NRSA predoctoral fellowship award will enable promising predoctoral students to obtain individualized, mentored research training from outstanding faculty sponsors while conducting well-defined research projects in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers.

Applicants for this Kirschstein-NRSA F31 award are expected to propose a well-defined research project and training plan within the mission of the participating Institutes and Centers. The training plan should reflect the applicant’s research project, which may be his/her dissertation research project, and facilitate and clearly enhance the individual’s potential to develop into a productive, independent research scientist. The training plan should document the need for, and the anticipated value of, the proposed mentored research and training in relationship to the individual’s research career goals.  

It is expected that the mentored research training experience will provide:

Although applicants may apply at any time, applications are encouraged once an applicant has identified a specific research project that will be undertaken in the sponsor’s laboratory.  This often occurs in the second year of a PhD program. 

The NIH recognizes a unique and compelling need to promote diversity in the biomedical, behavioral and clinical sciences research workforce. The NIH expects that efforts to diversify the workforce to lead to:

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and thus to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences.

This announcement seeks to stimulate the participation of individuals from the following groups:

A.    Individuals from underrepresented racial and ethnic groups;

B.    Individuals with disabilities; and

C.    Individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research.

See Section III for additional information regarding eligibility for this program.

The Kirschstein-NRSA Individual Predoctoral Fellowship to Promote Diversity in Health-Related Research may provide up to five years of support for research training which leads to the PhD or equivalent research degree or up to six years of support for training leading to the combined MD/PhD degree or another, combined dual-doctoral degree in the biomedical, behavioral, or clinical sciences.

Special Note: Because of the differences in individual Institute and Center (IC) program requirements for this FOA, prospective applicants are strongly encouraged to consult the Table of IC-Specific Information, Requirements and Staff Contacts, to make sure that their application is responsive to the requirements of one of the participating NIH ICs.

Section II. Award 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
Renewal: Individual fellowship awards are generally not renewable. In rare cases in which fellowship awardees require further fellowship support, they should consult with NIH staff to obtain advice regarding submission of a renewal application.

The OER Glossary and the SF424 (R&R) Individual Fellowship 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

Award budgets are composed of stipends, tuition and fees, and institutional allowance, as described below.

Award Project Period

Individuals may receive up to 5 years of aggregate Kirschstein-NRSA support at the predoctoral level (up to 6 years for dual-degree training, e.g., MD/PhD), including any combination of support from institutional training grants (e.g., T32) and an individual fellowship award.

Other Award Budget Information
Stipends

Kirschstein-NRSA awards provide stipends as a subsistence allowance to help defray living expenses during the research and clinical training (when applicable) experiences.

The most recent stipend levels are described on the Kirschstein-NRSA webpage. NIH will adjust awards on the anniversary date of the award to ensure consistency with the stipend level in effect at that time.

Visit NIH Grants Policy Statement: Ruth L. Kirschstein National Research Service Awards for more information.

Tuition and Fees

NIH will contribute to the combined cost of tuition and fees at the rate in place at the time of award. The most recent tuition and fees levels are described on the Ruth L. Kirschstein National Research Service Award (NRSA) webpage. Visit NIH Grants Policy Statement: Ruth L. Kirschstein National Research Service Awards for more information.

Institutional Allowance

The applicant should request a Kirschstein-NRSA institutional allowance to help defray the cost of fellowship expenses such as health insurance, research supplies, equipment, books, and travel to scientific meetings. The most recent institutional allowance levels are described via a link on the Ruth L. Kirschstein National Research Service Award (NRSA) site. Requests for additional costs (such as to accommodate the disabilities of a fellow) must be explained in detail and justified in the application. Visit NIH Grants Policy Statement: Ruth L. Kirschstein National Research Service Awards for more information.

Indirect Costs

NIH does not separately reimburse indirect costs (also known as Facilitates & Administrative [F&A] Costs) for fellowships. Costs for administering fellowships are part of Institutional Allowance.

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.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Before submitting a fellowship application, the applicant must identify a sponsoring institution. The sponsoring institution must have staff and facilities available on site to provide a suitable environment for performing high-quality research training. The research training should occur in a strong research environment that has appropriate human and technical resources and is demonstrably committed to research training in the particular program proposed by the applicant. The sponsoring institution may be private (profit or nonprofit) or public, including the NIH Intramural Programs and other Federal laboratories.

An individual may request support for research training abroad. In such cases, the applicant is required to provide detailed justification for the foreign training, including the reasons why the facilities, the sponsor, or other aspects of the proposed experience are more appropriate than training in a domestic setting. The justification is evaluated in terms of the scientific advantages of the foreign training as compared to the training available domestically. Foreign training will be considered for funding only when the scientific advantages are clear.

Foreign Institutions

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.

Important Note: Foreign institutions are not eligible to apply for dual-degree training (e.g., MD/PhD).

Required Registrations

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.

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

All PD(s)/PI(s) [for fellowships, this is the applicant] 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. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any applicant with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) [for fellowships, this is the applicant] is invited to work with his/her sponsor and 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. Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).

The applicant must have identified a research project and sponsor, show evidence of high academic performance in the sciences, and a commitment to a career as an independent research scientist, or as an independent physician-scientist or other clinician-scientist (dual-degree training).  

The applicant must have a baccalaureate degree and be currently enrolled in a PhD or equivalent research degree program (e.g., EngD, DNSc, DrPH, DSW, PharmD, PsyD, ScD), a formally combined MD/PhD program, or other combined professional/clinical and research doctoral (e.g., DDS/PhD) in the biomedical, behavioral, or clinical sciences at a domestic institution. The Kirschstein-NRSA F31 may not be used to support studies leading to the MD, DDS, or other clinical, health-professional training (e.g., DC, DMD, DNP, DO, DPM, DVM, ND, OD, AuD).

The applicant must have a baccalaureate degree and be currently enrolled in a PhD or equivalent research degree program (e.g., EngD, DNSc, DrPH, DSW, PharmD, PsyD, ScD) in the biomedical, behavioral, or clinical sciences at a domestic or foreign institution. Alternatively, the applicant must have a baccalaureate degree and be currently enrolled in a formally combined MD/PhD program, or other combined professional/clinical and research doctoral (e.g., DDS/PhD) in the biomedical, behavioral, or clinical sciences at a domestic institution. The Kirschstein-NRSA F31 may not be used to support studies leading to only the MD, DDS, or other clinical, health-professional training (e.g., DC, DMD, DNP, DO, DPM, DVM, ND, OD, AuD).

Students matriculated in a dual-degree program (e.g., MD/PhD, DO/PhD, DDS/PhD, DVM/PhD) who seek support for both research and clinical training may apply either for this Kirschstein-NRSA F31 program or for the Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral MD/PhD or Other Dual-Doctoral Degree Fellowship (Parent F30) program.

For the purpose of this announcement, institutions are encouraged to identify applicants who will enhance diversity on a national or institutional basis. As indicated in Section I, the NIH is particularly interested in encouraging the recruitment and retention of the following classes of individuals:

A.    Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: African Americans, Hispanic Americans, American Indians, Alaska Natives, Native Hawaiians, and other Pacific Islanders. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution are eligible for support under this program.

B.    Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C.    Individuals from disadvantaged backgrounds, who are defined as:

1.    Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size; published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at HHS - Poverty Guidelines, Research, and Measurement. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professions Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2.    Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

Eligibility related to a disadvantaged background (C1 and C2) is most applicable to high school and perhaps to undergraduate candidates, but would be more difficult to justify for individuals beyond that level of academic achievement. Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background. Such decisions will be made on a case-by-case basis, based on appropriate documentation.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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:

Duration of Support

Individuals may not exceed the aggregate limit of NRSA support shown above in the Award Project Period (see Section II. Award Information). Applicant fellows must consider any prior NRSA research training in determining the duration of support requested. Information regarding previous Kirschstein-NRSA support must be included in the application and will be considered at the time of award.

Level of Effort

At the time of award, individuals are required to pursue their research training on a full-time basis, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies.

Sponsor

Before submitting the application, the applicant must identify a sponsor who will mentor and supervise the proposed mentored training and research experience. The primary sponsor should be an active investigator in the area of the proposed research training and be committed both to the applicant’s research training and to direct supervision of his/her research. The sponsor must document the availability of sufficient research funds and facilities for high-quality research training. The sponsor, or a member of the sponsor team, should have a successful track record of mentoring predoctoral students. Applicants are encouraged to identify more than one sponsor, i.e., a team of sponsors, if this is deemed advantageous for providing expert advice in all aspects of the research and training program. In such cases, one individual must be identified as the primary sponsor who will coordinate the applicant’s research and training program. The applicant must work with the sponsor(s) in preparing the application.

Applicants matriculated in a dual-degree program may also find a clinical training sponsor, in an area of clinical interest to the applicant, to be appropriate. This individual would meet regularly to help collaboratively mentor the applicant during the tenure of the award. In addition to the considerations stated above, a clinical sponsor must document the availability of facilities for high-quality clinical training and should have a successful track record of mentoring dual-degree students. If co-sponsors are proposed for a dual-degree applicant, it is expected that they will together coordinate and ensure integration of the applicant’s research and training program. 

Section IV. Application and Submission Information


1. Requesting an Application Package

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.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Individual Fellowship 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.

Page Limitations

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

Required and Optional Forms

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 the instructions in the SF424 (R&R) Individual Fellowship Application Guide to ensure you complete all appropriate “optional” forms.

Instructions for Application Submission

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

SF424(R&R) Cover Form

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

SF424(R&R) Project/Performance Site Locations Form

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

Other Project Information Form

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

Other Attachments

The following additional educational information is required and should be attached under Other Attachments:

A certification letter is required and should be attached under Other Attachments:

The filename provided for each “Other Attachment” will be the name used for the bookmark in the electronic application in eRA Commons.

SF424(R&R) Senior/Key Person Profile (Expanded) Form

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

PHS Fellowship Supplemental Form

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

Research Training Plan

Research Strategy

Applicants must describe a well-defined research project (typically hypothesis-driven) that is well-suited to his/her stage of career development. The applicant should describe the background leading to the proposed research, the significance of the research, the research approach (design and methods) for achieving the Specific Aims, the rationale for the proposed approach, potential pitfalls, and expected/alternative outcomes of the proposed studies. It may be beneficial to include pertinent preliminary data to demonstrate feasibility.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Responsible Conduct of Research

All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the instruction; 4) Duration of Instruction - the number of contact hours of instruction; and 5) Frequency of Instruction – instruction must occur during each career stage and at least once every four years. Document any prior instruction during the applicant’s current career stage, including the inclusive dates instruction was last completed. See also NOT-OD-10-019. Applications lacking a Plan for Instruction in the Responsible Conduct of Research will not be reviewed.

Additional Information

Goals for Fellowship Training and Career

Discuss how the proposed research project and activities enhance the applicant’s development and relate to the applicant’s career goals as a productive, independent research scientist. Discuss how the proposed research training plan will enhance his/her knowledge and technical and professional skills, and facilitate his/her transition to the next career stage.

Activities Planned Under This Award

The applicant’s research training plan, i.e. the activities planned under this award, should be individually tailored and well integrated with his/her research project. Describe the skills and techniques that the applicant intends to learn as well as any planned, non-research activities (e.g. those relating to professional development) during the award period. The applicant should provide a timeline for the proposed research training and related activities.

If the applicant is pursuing a dual degree, a timeline for the dual-degree program in which he/she is matriculated should be provided. On the timeline, indicate the percentage of time devoted to clinical- and research-related activities each year and indicate where, on this timeline, the applicant is at the time of application. This timeline will complement the applicant’s description of how he/she expects to divide his/her time between research and clinical training during each year of the award period.

Doctoral Dissertation and Other Research Experience

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

Sponsor and Co-Sponsor Information

The F31 fellowship supports a program of mentored research training from outstanding faculty sponsors. The sponsor(s) should describe their current research support and how this support relates to the applicant’s proposed research project. A contingency plan should be provided that describes how the applicant’s research training will be supported should there be a gap in the sponsor’s funding during the proposed award period. The role of the sponsor in the integrated research and training plan should be described. If a team of sponsors is proposed, this plan should describe the role of each sponsor and how they will communicate and coordinate their efforts to mentor the applicant effectively.

The training plan should be individualized for the applicant, keeping in mind the applicant’s strengths and any gaps in needed skills, and should be designed to enhance research training. The training plan should be coordinated with the applicant’s Research Strategy. The training plan should outline and justify new training opportunities, any relevant coursework, and professional development activities. Training in professional development skills, e.g. grant-writing and presentation skills, is strongly encouraged. The training plan should have the potential to facilitate the applicant’s transition to the next stage of his/her career. 

If the applicant is matriculated in a dual-degree program and is requesting support for both research and clinical training, the training plan should provide opportunities to integrate clinical experiences during the research training component; a smooth transition to the clinical training component; and should have the potential to facilitate the applicant’s transition to a residency or other program appropriate for his/her career goals.

The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computing resources, subject populations) should be described.

The sponsor and any co-sponsors are expected to provide an assessment of the applicant’s qualifications and potential for a career as a productive, independent researcher.

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. 

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Letters of Reference

Applicants must carefully follow the SF424 (R&R) Individual Fellowship Application Guide, including the time period for when letters of reference will be accepted (letters are due by the application due date as described in the Notice). It is important to note that neither the sponsor nor any co-sponsor of this application can be counted as a confidential reference. The sponsor/cosponsor's recommendation is included as part of the application. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Reference Letter link and not through Grants.gov.

Foreign Institutions

Foreign (non-U.S.) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Individual Fellowship Application Guide.

Important Note: Foreign institutions are not eligible to apply for dual-degree training (e.g., MD/PhD).

3. Submission Dates and Times

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.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The National Research Service Award (NRSA) policies apply to this program.  A Kirschstein-NRSA fellowship may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of this award.

Pre-award costs are generally not allowable for Fellowships.

6. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit 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.

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030. Because the Sponsor(s)’ funding is an important factor in the review of a Fellowship application, post-submission material that updates the Sponsor(s)’ funding information in the originally submitted application is allowed. Information on the Sponsor(s)’ funding information must not exceed 1 page, and is limited to the project title, funding source (e,g. NIH grant number), and a brief description of the Specific Aims and relevance to the fellowship application under review. The additional material is due no later than 30 days prior to the meeting of the review committee. See also: NOT-OD-12-022.

Section V. Application Review Information


1. Criteria

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:

Overall Impact/Merit

Reviewers will provide an overall impact score to reflect their assessment of the likelihood that the fellowship will enhance the candidate’s potential for, and commitment to, an independent scientific research career in a health-related field, in consideration of the scored and additional review criteria.

Scored Review Criteria

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.

Fellowship Applicant

Sponsors, Collaborators, and Consultants

Research Training Plan

Training Potential

Institutional Environment & Commitment to Training

Additional Review Criteria

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 six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

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 children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

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

Renewals

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

Revisions

Not Applicable

Additional Review Considerations

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.

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 level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the sponsor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction -  the total number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction – instruction must occur during each career stage and at least 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. See also: NOT-OD-10-019.

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

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 training.

2. Review and Selection Process

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

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

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information


1. Award Notices

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.

2. Administrative and National Policy Requirements

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.

The taxability of stipends is described in the NIH Grants Policy Statement.

Inventions and Copyrights

Fellowships funded primarily for educational purposes are exempted from the PHS invention requirements and thus invention reporting is not required. More details, including exceptions for fellows training at NIH, are provided in the NIH Grants Policy Statement.

Leave Policies

In general, NRSA fellows may receive stipends during the normal periods of vacation and holidays observed by individuals in comparable training positions at the sponsoring institution. For the purpose of these awards, however, the period between the spring and fall semesters is considered to be an active time of research and research training and is not considered to be a vacation or holiday. NRSA fellows may receive stipends for up to 15 calendar days of sick leave per year. Under exceptional circumstances, this period may be extended by the NIH awarding IC in response to a written request from an AOR. Other leave may be used for the medical conditions related to pregnancy and childbirth. NRSA fellows may receive stipends for up to 60 calendar days (equivalent to 8 work weeks) of parental leave per year for the adoption or the birth of a child when individuals in comparable training positions at the grantee organization have access to this level of paid leave for this purpose. Either parent is eligible for parental leave. The use of parental leave must be approved by the fellowship sponsor (see also: NOT-OD-08-064). A period of terminal leave is not permitted, and payment may not be made from fellowship funds for leave not taken. NRSA fellows requiring periods of time away from their research training experience longer than specified here, i.e., more than 15 calendar days of sick leave or more than 60 calendar days of parental leave, must seek approval from the NIH awarding component for an unpaid leave of absence. Approval for a leave of absence must be requested in advance by an AOR on behalf of the fellow.

3. Reporting

When multiple years are involved, awardees will be required to submit a Research Performance Progress Report (RPPR) annually. The report is due two months before the beginning date of the next budget period and must include information describing the current year's progress as well as the research project and training plan for the coming year.

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. 

Other Fellowship Reporting Requirements:
4. Evaluation

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.

Within ten years of making awards under this program, NIH will assess the program’s overall outcomes, gauge its effectiveness in enhancing diversity, and consider whether there is a continuing need for the program.  Upon the completion of this evaluation, NIH will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program. 

The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:

Section VII. Agency Contacts

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

Because of the difference in individual Institute and Center (IC) program requirements for this FOA, prospective applications are strongly encouraged to consult the Table of IC-Specific Information, Requirements and Staff Contacts, to make sure that their application is responsive to the requirements of one of the participating NIH ICs.

Application Submission Contacts

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

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Table of IC-Specific Information, Requirements and Staff Contacts

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Table of IC-Specific Information, Requirements and Staff Contacts

Section VIII. Other Information

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.

Authority and Regulations

Awards are made under the authorization of Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66.


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