Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

 

Components of Participating Organizations

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Opportunity Title
KUH Predoctoral to Postdoctoral Fellow Transition Award (F99/K00 - Independent Clinical Trial Not Allowed)
Activity Code

F99/K00  Pre-doc to Post-doc Transition Award/Post-doctoral Transition Award

Announcement Type
Reissue of RFA-DK-19-032
Related Notices

NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022

Funding Opportunity Announcement (FOA) Number
RFA-DK-21-033
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.847
Funding Opportunity Purpose

The purpose of the Kidney, Urology or Hematology (KUH) Predoctoral to Postdoctoral Transition Award (F99/K00) is to recruit truly exceptional graduate students, who are currently not involved in Kidney, Urology or Hematology (K, U or H) research, and provide them a stable transition into a postdoctoral research experience focused on K, U, or H research. Strong candidates will bring novel approaches and diverse perspectives from fields including, but not limited to, engineering, statistics, data science, imaging, biochemistry, neuroscience and genetics. Graduate students who are already involved in K, U, or H research are not eligible for this F99/K00 award and are instead encouraged to apply for the Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31, PA-21-051). Prospective applicants are strongly encouraged to contact the NIDDK Program Official early in the process to discuss eligibility and program goals.

This Funding Opportunity Announcement (FOA) does not allow applicants to propose to lead an independent clinical trial, but does allow applicants to propose research experience in a clinical trial led by a sponsor or co-sponsor.

Key Dates

Posted Date
March 17, 2022
Open Date (Earliest Submission Date)
July 01, 2022
Letter of Intent Due Date(s)

Not Applicable

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
August 01, 2022 August 01, 2022 Not Applicable October 2022 January 2023 April 2023
November 30, 2022 November 30, 2022 Not Applicable February 2023 May 2023 July 2023
March 30, 2023 March 30, 2023 Not Applicable June 2023 October 2023 December 2023
August 01, 2023 August 01, 2023 Not Applicable October 2023 January 2024 April 2024
November 30, 2023 November 30, 2023 Not Applicable February 2024 May 2024 July 2024
April 02, 2024 April 02, 2024 Not Applicable June 2024 October 2024 December 2024
August 01, 2024 August 01, 2024 Not Applicable October 2024 January 2025 April 2025
December 03, 2024 December 03, 2024 Not Applicable February 2025 May 2025 July 2025
April 01, 2025 April 01, 2025 Not Applicable June 2025 October 2025 December 2025

All applications are due 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.

Expiration Date
April 02, 2025
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Fellowship (F) instructions in the SF424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Innovation requires novel approaches and diverse perspectives, yet opportunities for recruiting new talent into Kidney (K), Urologic (U), or Hematologic (H) diseases research are limited. The goal of this program is to recruit the best and brightest graduate students – who are currently not involved in K, U or H research and transition them to postdoctoral research focused on K, U or H research It is expected that this program will be attractive to:

  1. Exceptional graduate students who are currently in fields like (but not limited to) engineering, statistics, data science, imaging, biochemistry, neuroscience or genetics and want to apply their expertise and skills to make a positive impact on KUH research, and
  2. Existing KUH mentors who are looking for a way to recruit a talented graduate student into their laboratory and fund their postdoctoral research experience.
     

The F99/K00 award is intended for individuals who require up to 2 years to complete their Ph.D. dissertation research training (F99 phase) and provide them with a stable transition into mentored postdoctoral research training (K00 phase) for up to 4 years. While the F99 phase cannot include K, U or H research, the K00 phase must focus on K, U or H research. It is anticipated that successful completion of this phased award will make the individual highly competitive for a subsequent NIDDK award (e.g., K99/R00, K01, R01).

The two award phases are intended to be sequential and continuous in time. A K00 award will be made only to a PD/PI who has successfully completed the F99 phase, identified a K, U, or H-focused postdoctoral project and mentor(s), and provided the NIDDK with a strong research and career development plan for the K00 phase.

This Funding Opportunity Announcement (FOA) does not allow applicants to propose to lead an independent clinical trial but does allow applicants to propose research experience in a clinical trial led by a mentor or co-mentor.

Prospective applicants are strongly encouraged to contact the NIDDK Program Official, listed in Section VII Agency Contact(s) Scientific/Research Contact(s), early in the process to discuss eligibility and program goals.

See Section VIII. Other Information for award authorities and regulations.

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

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose independent clinical trials.

 

Note: Applicants may propose to gain experience in a clinical trial led by a sponsor/co-sponsor as part of their research training.

 

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIDDK intends to commit $250,000 in Fiscal Years 2023, 2024 and 2025 to fund up to 6 awards each year.

Award Budget

For the F99 phase, award budgets are composed of stipends, tuition and fees, institutional allowance, and some travel costs as described below. For the K00 phase, award budgets are composed of salary and fringe benefits, research and career development support, indirect costs, and travel costs, as described below.

Award Project Period

For the F99/K00 award, individuals may receive up to 6 years of combined support for both phases, which includes up to 2 years in the F99 fellowship phase and up to 4 years in the K00 career development phase.

Other Award Budget Information

Stipends

F99 PHASE: Stipends are provided as a subsistence allowance to help defray living expenses during the research training experience. The stipend level for F99 predoctoral fellows is the same as for the F31 Ruth L. Kirschstein National Research Service Award (NRSA) fellows. See https://researchtraining.nih.gov/resources/policy-notices.

K00 PHASE: NIDDK will contribute up to $53,760 in the first year toward the salary of the career award recipient. This will be increased to $54,144 for the second year, $54,540 for the third year, and $56,712 for the fourth year. Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide. The total salary, however, may not exceed the legislatively mandated salary cap. See: http://grants.nih.gov/grants/policy/salcap_summary.htm.

Institutional Allowance

F99 PHASE: The applicant should request an institutional allowance to help defray the cost of fellowship expenses such as health insurance, research supplies, equipment, books, and travel to scientific meetings. The annual institutional allowance level for the F99 phase is the same as that provided for the F31 Ruth L. Kirschstein National Research Service Award (NRSA) awards (see https://researchtraining.nih.gov/resources/policy-notices), plus a one-time additional $2,000 to defray travel costs to an institution to meet the proposed mentor and to discuss and prepare a postdoctoral research and career development strategy.

K00 PHASE: The NIDDK will contribute up to $14,500 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities. These costs may be used for the following expenses: (a) tuition and fees related to career development; (b) research expenses, such as supplies, equipment and technical personnel; c) travel to research meetings or training; and (d) statistical services including personnel and computer time. In addition, the NIDDK will provide $2,000 in the first year of the K00 award to defray travel costs to attend a mandatory NIDDK K Awardees Workshop.

Salary for mentors, secretarial and administrative assistants, etc. is not allowed.

Indirect Costs

ALLOWABLE COSTS

F99 PHASE: Fellowship awards do not include a separate reimbursement for indirect costs (also known as Facilities & Administrative [F&A] Costs). Instead, costs for administering fellowships are covered by the Institutional Allowance. See https://researchtraining.nih.gov/resources/policy-notices

K00 PHASE: Indirect Costs are reimbursed at 8% of modified total direct costs.

Stipend levels, as well as funding amounts for tuition and fees and the institutional allowance are announced annually in the NIH Guide for Grants and Contracts, and are also posted on the Ruth L. Kirschstein National Research Service Award (NRSA) webpage.

 

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Governments

  • None
Other
  • None

F99 Eligibility: Domestic institution/organization types listed above that grant PhD or equivalent research degrees (e.g., Dr.P.H., Sc.D.) are eligible to submit an application. There is no limit on the number of F99 applications that an organization may sponsor.

K00 Eligibility: Domestic institution/organization types listed above, including Federal laboratories, are eligible to submit K00 transition phase applications on behalf of F99 awardees. There is no limit on the number of K00 awardees that an organization may sponsor. Note that if the F99 awardee accepts a postdoctoral position in the NIH intramural research program, the postdoctoral phase will be supported directly by NIH intramural funds and the K00 will not be awarded, since NIH intramural scientists are not eligible for NIH extramural grant awards.

Foreign Institutions

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

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

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

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.

  • 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.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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 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.

All PD(s)/PI(s) must be registered with ORCiD. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Eligible Individuals (Program Director/Principal Investigator)

Any applicant fellow with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) 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. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019. Multiple PDs/PIs are not allowed.

Exceptional graduate students from a diverse and broad range of scientific disciplines including, but not limited to, engineering, statistics, data science, imaging, biochemistry, neuroscience and genetics are encouraged to apply. The applicant must have a baccalaureate degree, have completed their candidacy exam, and be at the dissertation research stage of training at the time of award. The applicant must be within two years of completing their mentored PhD or equivalent research degree program (e.g., Dr.PH, ScD) at the time of the application. The current dissertation research topic cannot be focused on K, U, or H research. Applications which propose K, U, or H research for the F99 phase are ineligible for this F99/K00 award and will be administratively withdrawn. Graduate students who are already involved in K, U, or H research are instead encouraged to apply for the Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31, PA-21-051).

An applicant may be a citizen or a noncitizen national of the United States, 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), or be a non-U.S. citizen with a valid U.S. visa at the time of the award is made. For applications submitted on behalf of non-U.S. citizens with valid U.S. visas, the visa status during each phase of the F99/K00 award must allow the PD/PI to conduct the proposed research at the applicant institution. For the F99 phase of the award, the applicant F99 institution is responsible for determining and documenting that the applicant's visa will allow the applicant to remain in the U.S. to complete the F99 phase of the award, and that there are no known obstacles that would prevent the applicant from obtaining a visa for the K00 phase. For the K00 phase of the award, the U.S. institution at which the K00 phase of the award will be conducted is responsible for determining and documenting, in the transition application, that the PD/PI's visa will allow the PD/PI to remain in the U.S. for the duration of the K00 award. NIDDK may request verifying information as part of the pre-award process.

The F99/K00 award may not be used to support studies leading to the MD, DDS, or other clinical, health-professional degree (e.g., DC, DMD, DNP, DO, DPM, DVM, ND, OD, or AuD). Students matriculated in a dual-degree program (e.g. MD/PhD, DO/PhD, DDS/PhD or DVM/PhD) are not eligible for the F99/K00 program.

If an applicant completes all doctoral dissertation requirements or begins a postdoctoral position before an F99 award is issued, neither the F99 nor the K00 will be awarded.

Individuals who receive F99/K00 support remain eligible and are encouraged to apply for subsequent individual career development awards (e.g. K01, K08, K23) and Pathway to Independence awards (K99/R00) provided they meet program eligibility.

Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of fellowship and career development awards are encouraged to apply for an extramural LRP award. Individuals are only eligible to apply for and receive LRPs after the granting of their doctoral level degree.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. 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.
Duration of Support

Individuals may receive up to 6 years combined support for both phases, which includes up to 2 years in the F99 fellowship phase and up to 4 years in the K00 career development phase

Level of Effort

F99 awardees 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. K00 awardees are required to have a full-time appointment at the applicant institution, and to commit a minimum of 9 person months (75%) of their full-time appointment at the applicant institution to their career development and mentored research. K00 awardees may engage in other duties (e.g., other research, training, clinical and teaching activities) as part of the remaining 25% effort not covered by the award, as long as such duties do not interfere with or detract from the proposed career development program.

Sponsor

F99 sponsor(s)

Before submitting the application, the applicant must identify an F99 sponsor(s) who will supervise the proposed dissertation research training 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 primary sponsor must document the availability of sufficient research funds and facilities for high-quality research training. The sponsor should also have a successful track record of mentoring predoctoral students. Applicants may 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. When there is a sponsor team, one individual must be identified as the primary sponsor who will coordinate the applicant’s overall training program. The applicant must work with the primary sponsor in preparing the application.

The F99 sponsor(s) should provide support and guidance to the applicant during the search for a postdoctoral research position and transition to the postdoctoral career development phase (K00).

K00 mentor(s)

It is strongly encouraged that the applicant identifies a future post-doctoral phase (K00) mentor(s) before submitting the application. While t is not necessary for the post-doctoral project to be fully developed at the time of application submission, the K00 mentor is expected to work with the applicant in addressing how their graduate research experience can be leveraged to address a K, U or H-related research direction.

If a K00 mentor is not identified at the time of application submission, the F99 sponsor is expected to work with the applicant to address a strategy of identifying a K00 mentor and address how the graduate research experience can be potentially leveraged to address a K, U or H-related research direction.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the Fellowship (F) 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.

Page Limitations
All page limitations described in the SF424 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.

Instructions for Application Submission
SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

Other Project Information

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

Fellowship Applicant Eligibility Certification Letter

Applicants must attach a letter from the institution certifying their eligibility for this program. The certification letter must be on institutional letterhead and scanned so that an institutional official signature is visible.

The letter must confirm that the applicant has a baccalaureate degree, completed their candidacy exam, and that they are at the dissertation research stage of training at the time of award.

If the applicant is not a U.S. Citizen, U.S. National, or permanent resident, the mentoring institution must give assurance that the candidate's visa provides sufficient time to complete the F99 phase of the award at a U.S. institution, and that there are no known obstacles (e.g., home country requirement) to the candidate obtaining a visa at the time of the K00 transition. 

Certification Letter: The filename "Certification Letter.pdf" should be used for this attachment and will be the name used for the bookmark in the electronic application in eRA Commons. No other attachments are allowed.  Applications that lack the Certification Letter are considered incomplete and will not be peer reviewed.

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

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

IMPORTANT REMINDER: The personal profile associated with the eRA Commons username entered in the Credential field for the PD/PI (fellowship applicant) must include an ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help

PHS Fellowship Supplemental Form

The PHS Fellowship Supplemental Form is comprised of the following sections:

  • Fellowship Applicant
  • Research Training Plan
  • Sponsor(s), Collaborator(s), and Consultant(s);
  • Institutional Environment & Commitment to Training
  • Other Research Training Plan Sections
  • Additional Information
  • Budget
  • Appendix

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

Fellowship Applicant Section

Applicant’s Background and Goals for Fellowship Training

F99 sponsor(s) Before submitting the application, the applicant must identify an F99 sponsor(s) who will supervise the proposed dissertation research training 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 primary sponsor must document the availability of sufficient research funds and facilities for high-quality research training. The sponsor should also have a successful track record of mentoring predoctoral students. Applicants may 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. When there is a sponsor team, one individual must be identified as the primary sponsor who will coordinate the applicant’s overall training program. The applicant must work with the primary sponsor in preparing the application. The F99 sponsor(s) should provide support and guidance to the applicant during the search for a postdoctoral research position and transition to the postdoctoral career development phase (K00).

K00 mentor(s) It is strongly encouraged that the applicant identifies a future post-doctoral phase (K00) mentor(s) before submitting the application. While t is not necessary for the post-doctoral project to be fully developed at the time of application submission, the K00 mentor is expected to work with the applicant in addressing how their graduate research experience can be leveraged to address a K, U or H-related research direction. If a K00 mentor is not identified at the time of application submission, the F99 sponsor is expected to work with the applicant to address a strategy of identifying a K00 mentor and address how the graduate research experience can be potentially leveraged to address a K, U or H-related research direction.

Research Training Plan

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

Specific Aims

All applicants must use the following Specific Aims:

Specific Aim 1 (F99 phase): The Dissertation Research Project (not within the mission of KUH). Provide a detailed description of the non-KUH research to be completed in the F99 phase.

Specific Aim 2 (K00 phase): The Postdoctoral Research Direction (within the mission of KUH). With guidance from the K00 mentor (or the F99 sponsor if a K00 mentor has not yet been identified at the time of application), identify a K, U or H research direction to be pursued during the K00 phase. More information about the K, U or H research programs can be found at the NIDDK/KUH website.

Research Strategy

Applicants should address the Significance and Approach for each Specific Aim individually.

Specific Aim 1 (F99 phase): Dissertation Research Project (not within the mission of KUH):

Significance

  • Provide an overview of the non-KUH dissertation research, including the scientific question being addressed and its potential impact on the dissertation research field.

  • Describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project.

  • Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.

  • Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.

Approach

Provide an overview of the dissertation research, including the background, goal, rationale, and hypotheses of the research project(s). The Approach for this Aim should be organized into two sections:

1. A progress report on the dissertation research project thus far, including the approaches used, research outcomes obtained, and important methodologies learned;

2. A detailed research proposal for the work to be completed in the F99 phase, including experimental design, anticipated results, potential problems, alternative strategies, and potential follow-up studies.

Specific Aim 2 (K00 phase): Postdoctoral Research Direction (within the mission of KUH):

Significance

Explain the significance of the proposed K00 research direction. Describe a specific question or observation that might be investigated. Explain how this question or observation is related to the applicant's research interests and how it builds on skills acquired in the F99 phase. Explain how this work will advance K, U or H research.

Approach

While it is recognized that the actual approach and experimental detail may change from the time of application and activation of the K00 phase of the award, the applicants should provide the anticipated specific aims and the description of how the research might be conducted, including approaches and methodologies to be used, anticipated results, challenges that might arise and how to address them. Explain the relationship between the approaches used in the F99 dissertation project to the proposed K00 project.

If the applicant is proposing to gain experience in a clinical trial as part of his or her research training, describe the relationship of the proposed research project to the clinical trial.

Sponsor(s), Collaborator(s), and Consultant(s)

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

  • F99 sponsor(s): Follow the F31-specific instructions for Sections A through E.
  • K00 mentor(s): If mentor(s) have been identified at the time of application, Sections A through E should also be completed by the mentor(s). If K00 mentor(s) have not been identified at he time of application, describe the strategy for identifying a K00 mentor(s).

  • Additionally, in Section E., both the F99 Sponsor(s) and K00 Mentor(s) (if one has been identified) should provide an assessment of the applicant's qualifications and potential for transitioning to the postdoctoral phase (K00) and for becoming a productive, independent researcher.

  • The Sponsor should also describe the roles and responsibilities that both he/she and the fellow are undertaking, including contributions to the research plan, the portion of the research ideas and plan that originated with the candidate.

  • If the applicant is proposing to gain experience in a clinical trial as part of his or her research training, the sponsor or co-sponsor must include a statement to document leadership of the clinical trial including source of funding, NCT# and appropriate expertise to guide the applicant in any proposed clinical trials research experience. The individual receiving support for the clinical trial (i.e., the sponsor/primary mentor or a co-sponsor) is the responsible individual of record for oversight of the trial though fellows can take part in all components of a clinical trial. Oversight includes (but is not limited to): interacting with relevant Institutional Review Board (IRB) staff; reviewing all informed consent documents; reporting potential serious adverse events; and maintaining responsibility for patient safety. However, the fellow can gain experience in all these components in conjunction with the mentor or individual leading the trial.

Institutional Environment and Commitment to Training Section

Description of Institutional Environment and Commitment to Training

  • Follow the SF424 (R&R) Application Guide instructions for F31 applications.

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 the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

  • Do not provide an NCT# in Section 1, item 1.5. See instruction for Sponsor(s), Collaborator(s), and Consultant(s) above.
  • Do not complete Section 4 – Protocol Synopsis information or Section 5 – Other Clinical Trial-related Attachments.

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). 

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

PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
Reference Letters

Applicants must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. 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.

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

The F99/K00 award 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.

7. Other Submission Requirements and Information

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

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

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

Important reminders:

All PD(s)/PI(s) and sponsor(s) must include their eRA Commons ID in the Credential fieldof the Senior/Key Person Profile form. 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 unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies.  CDEs are data elements that have been identified and defined for use in multiple data sets across different studies.  Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records.  NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository).  NIH has established a “Common Data Element (CDE) Resource Portal" (https://cde.nlm.nih.gov/home) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection.  The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research.  Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

Post Submission Materials

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.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

  • A fellowship application has a research project that is integrated with the training plan. The review will emphasize the applicant’s potential for a productive career, the applicant’s need for the proposed training, and the degree to which the research project and training plan, the sponsor(s), and the environment will satisfy those needs. The review will also evaluate the research and career development plans for the K00 phase, emphasizing the need for the career development and the potential to lead to a productive, independent research career focused on K, U or H diseases.
Overall Impact

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, a productive 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.

 
  • Are the applicant’s academic record, research and scientific experience of high quality and appropriate for the F99/K00 fellowship?
  • How likely will the proposed research project and training plan provide the candidate with the requisite individualized and mentored experiences that will develop his/her knowledge, research, and professional skills?
 

F99

  • How appropriate are the F99 sponsor(s’) research qualifications (including recent publications) and track record of mentoring individuals at a similar stage for training the candidate?
  • How appropriate is  the sponsor(s) understanding of the candidate’s training needs as well as their ability and commitment to assist in meeting these needs?
  • Is there evidence of a match between the research and clinical interests (if applicable) of the candidate and the sponsor(s)?
  • Is there evidence of adequate research funds to support the applicant’s proposed research project and training for the duration of the fellowship (F99) phase?
  • If a team of F99 sponsors is proposed, how appropriate is the justification for the team structure and the roles of the individual members?
  • How appropriate are the qualifications of any collaborator(s) and/or consultant(s), including their complementary expertise and previous experience in fostering the training of fellows, for the proposed project?

K00

  • If K00 mentor(s) has been identified at the time of application, how appropriate are their research qualifications and track record of mentoring?
  • If K00 mentor(s) has not been identified at the time of application, how appropriate is the strategy for identifying a K00 mentor(s) and how likely is it that this strategy can identify a strong mentor who is capable of guiding the candidate's transition into KUH research and successfully completing the proposed work?
  • If the applicant is proposing to gain experience in a clinical trial as part of his or her research training, is there evidence of the appropriate expertise, experience, resources, and ability on the part of the mentor(s) to guide the applicant during the clinical trial research experience?
 

F99

  • Is the proposed F99 research project of high scientific quality, and how well is it integrated with the proposed research training plan?
  • How rigorous is the prior research that serves as the key support for the proposed project?
  • How appropriate are the plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project?
  • How appropriate are the strategies to ensure a robust and unbiased approach for the work proposed?
  • How adequate are the plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
  • Is the F99 research project consistent with the applicant’s stage of research development and relevant to his/her research career objectives?
  • How feasible is the proposed time frame for accomplishing the proposed F99 research training and transitioning to the K00 career development phase?

K00

  • Is the proposed K00 research project aligned with the mission of KUH?
  • How appropriate is the K00 proposed research for developing the applicant’s research skills?
  • How appropriate is the proposed K00 research project for meeting the applicant’s long-term career goals?
  • How well do the specific aims and the proposed approach address the research question being asked in the K00 phase?
  • How well is the relationship between the approaches used in the F99 dissertation project to the proposed K00 project described?
  • If proposed, will the clinical trial experience contribute to the proposed project and/or the applicant’s research training?
 
  • Does the training plan document a clear need for, and value of, the proposed training?
  • How well does the training plan take advantage of the applicant’s strengths and addresses gaps in needed skills?
  • How readily can the doctoral project and research experience be leveraged and applied to a research question within the mission of KUH?
  • How appropriate is the applicant’s commitment to a research career in K, U, or H in the future?
  • How well will the training the F99/K00 fellowship prepare the applicant for achieving their long-term career goals?
  • How adequate are the plans for monitoring and evaluating the applicant's research and career development progress throughout the training period?
 
  • How adequate are the research facilities, resources (e.g., equipment, laboratory space, computer resources, subject populations) and training opportunities (e.g. seminars, workshops, professional development opportunities) for the F99 and K00 phase of the award?
  • How appropriate is the institutional commitment to fostering the applicant’s mentored training toward his/her research career goals in the F99 and K00 fellowship phase of the award?
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.

 

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.

 

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

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

 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

 

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.

 

Not Allowed

 

Not Allowed

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.

 

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 candidate, including any prior instruction or participation in RCR as appropriate for the candidate’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 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.

 

Not Applicable.

 

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).

 

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

 

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

 

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 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 will receive a written critique.

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.

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 National Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKAC). 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.
  • Doctorate training that brings new skill sets into the KUH biomedical research mission.

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. 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.

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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.

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

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, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, 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 (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

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.

Institutional allowances and No-Cost Extensions

Carry-over of unspent funds is not permitted between the first and second years of the F99 phase or from a partially completed year in the F99 phase into the K00 phase. Provisions for No-Cost Extensions do not apply.

The K00 postdoctoral phase institution must submit the materials on behalf of the candidate for the K00 award, no later than 12 weeks prior to the proposed start of the K00 award. The institution's Authorized Organizational Representative will email the application in PDF format using PHS 398 (https://grants.nih.gov/grants/funding/phs398/phs398.html) to the NIDDK Scientific/Research Contact listed in Section VII. The K00 application will be evaluated by NIDDK program staff for completeness and responsiveness to the program. Candidates who are not approved to transition will receive written notification from the awarding component communicating the rationale for the disapproval. This notification typically will be sent within 60 days of receipt of the K00 application. Although the financial plans of NIDDK provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds. Instructions for the K00 Transition Award F99 awardees wishing to submit a K00 transition application must follow the Career Development (K) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise, as described here. The K00 Transition Application will include the following components:
  • A new cover page signed by the K00 phase institutional representative;
  • A Final Progress Report for the F99 phase;
  • A final evaluation statement by the F99 primary mentor;
  • Updated Project Summary and Abstract, Project Narrative, Bibliography & References Cited, Facilities & Other Resources, and Equipment sections;
  • Biographical sketches;
  • Detailed budget pages for a non-modular budget: K00 budgets consist of salary and fringe benefits, other program-related expenses (These funds may be used for the following expenses: (a) tuition and fees related to career development; (b) research-related expenses, such as supplies, equipment and technical personnel; c) travel to research meetings or training; and (d) statistical services including personnel and computer time, and indirect costs, as described in Part II, Section II of this funding opportunity announcement. Combined cost of tuition and fees in an amount equal to 60% of the level requested by the applicant institution, up to $4,500 per year Other costs are not allowed;
  • Updated sections of the PHS Career Development Award Supplemental Form, which should include:
    • A new candidate Section;
    • An updated Research Plan section: the Specific Aims should be updated to reflect current plans for the K00 phase and the updated Research Strategy should be described in less than 3 pages;
    • A new Mentor, Co-Mentor, Consultant, Collaborators Section that includes a plan for transitioning the candidate to the next stage of his/her career by the end of the project award period. The mentor should describe previous experience as a mentor, including type of mentoring (e.g., graduate students, career development awardees, postdoctoral students), number of persons mentored, and career outcomes. If the primary mentor has limited training experience, a co-mentor with a strong, successful track record as a mentor should be included. If the candidate is proposing to gain experience in a clinical trial as part of his or her research training, the mentor or co-mentor must include a statement to document leadership of the clinical trial including source of funding, NCT# and appropriate expertise to guide the candidate in any proposed clinical trials research experience.
    • An updated Description of Institutional Environment;
    • An Institutional Commitment to Candidate's Research Career Development: If the candidate is not a U.S. Citizen or Permanent Resident, the mentoring institution must include information about the candidate's visa status and an assurance that the candidate's visa provides sufficient time to complete the K00 phase of the award at a U.S. institution;
    • Updated Protections for Human Subjects and Inclusion of Women, Minorities and Children (as appropriate);
    • Updated Other Research Plan Sections (as appropriate), including: Vertebrate Animals;
    • Select Agent Research, Resource Sharing Plans, Authentication of Key Biological and/or Chemical Resources, and Updated Biohazards

  • Transition to the Postdoctoral Career Development K00 Phase

    The F99/K00 award is intended to facilitate the successful transition from the non- K-, U-, or H predoctoral fellowship (F99) to the postdoctoral career stage (K00) and movement into a K-, U-, or H-focused research area. Consequently, a requirement for the K00 phase award is successful completion of the doctoral research degree and subsequent transition to a K-, U-, or H -focused, mentored postdoctoral research position. Applicants are strongly encouraged to “expand their skill set” and apply for postdoctoral positions at departments and institutions different from where they conducted their doctoral research. It is important for all applicants, but especially for those applicants who intend to stay at the predoctoral phase institution for the postdoctoral phase, to provide a plan by which they will separate from their Ph.D. mentor


    The transition from the predoctoral phase to the postdoctoral phase is intended to be sequential and continuous in time and, except in unusual circumstances, NIDDK will not extend the F99 phase.

    To begin the K00 award phase of the grant, individuals must a) have been offered and accepted a postdoctoral appointment to carry out K-, U-, or H-focused research and b) have received approval from NIA for the K00 transition (see below). Upon starting the K00 phase of the award, the F99 phase of the award is terminated.

    Prospective applicants are strongly encouraged to contact their NIDDK Program Official to discuss plans for transition to, and application for, the K00 phase as soon as a plan to assume a postdoctoral position develops, and not later than 6 months prior to the end of the F99 phase of the award.

    An eligible K00 institution and mentor must have appropriate infrastructure to support the proposed research program and a history of external research funding. Foreign institutions are not eligible. Applicants may apply for K-, U-, or H-focused postdoctoral positions within the NIH intramural research program (IRP). However, should the individual accept such a position in the IRP, the postdoctoral phase will be supported directly by NIH intramural funds and the K00 will not be awarded, since NIH intramural scientists are not eligible for NIH extramural grant awards. F99 fellows who accept a postdoctoral position in the IRP will be required to submit a final progress report and a final evaluation statement by the primary F99 mentor instead of a K00 application.

    Cooperative Agreement Terms and Conditions of Award

    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. Recipients must complete the "Inventions and Patents" section when submitting the K00 Research Performance Progress Report (RPPR).

    3. Reporting

    When multiple years are involved, recipients will be required to submit the 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 and training plans for the coming year.

    NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 200.301.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement. 

    Other Fellowship Reporting Requirements:

    • Individuals admitted to the United States as Permanent Residents must submit notarized evidence of legal admission prior to the award.
    • The fellowship award recipient has up to six months from the issue date on the Notice of Award to activate the award using the Kirschstein-NRSA Individual Fellowship Activation Notice (PHS 416-5). Under unusual circumstances, the activation period may be extended at the request of the fellow. Such a request must be countersigned by the sponsor and an authorized institutional official.
    • For the individual's initial 12 months of Kirschstein-NRSA postdoctoral support, a signed, original Payback Agreement Form (PHS 6031) must accompany the Activation Notice.
    • At the conclusion of a fellowship, the fellow must submit a Termination Notice (PHS 416-7) via xTrain to the NIH within 30 days of termination. Fellows with service payback requirements must notify the NIH of any change in address and submit Annual Payback Activities Certification Forms (PHS 6031-1) until the payback service obligation is satisfied

    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.

    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-637-3015

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Christine Maric-Bilkan, Ph.D. (for Kidney- and Urology-focused research)
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-435-0486
    Email: christine.maric-bilkan@nih.gov


    Shilpa Hattangadi, M.D. (for Hematology-focused research)
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-827-7442
    Email: shilpam.hattangadi@nih.gov

    Peer Review Contact(s)

    Xiaodu Guo, M.D., Ph.D.
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-594-4719
    Email: guox@niddk.nih.gov

    Financial/Grants Management Contact(s)

    Jill Bradshaw
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Telephone: 301-827-1230
    Email: jill.bradshaw@nih.gov

    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.

    Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of fellowship awards are encouraged to consider applying for an extramural LRP award and are eligible to apply once they have received their terminal level degree.

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 45 CFR Part 75 and 2 CFR Part 200.

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