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.

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

Interdisciplinary research is increasingly being recognized as the foundation for the development of new scientific knowledge and discovery. Many research programs currently funded by the NIDDK/Division of Kidney, Urologic and Hematologic Diseases (KUH) require expertise from a variety of scientific disciplines, yet opportunities for recruiting new talent and innovative approaches to science of interest to the KUH research communities are limited. Thus, the goal of the KUH Predoctoral to Postdoctoral Fellow Transition Award (F99/K00) aims to attract graduate students from a diverse and broad range of scientific disciplines, including (but not limited to) engineering, statistics, data science, imaging, biochemistry and genetics, who are recognized by their institutions for their high potential and recruit them to pursue a career in research on Kidney (K), Urologic (U), or Hematologic (H) diseases. More information about the current KUH research programs can be found at the NIDDK/KUH website.

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.

Prospective applicants are strongly encouraged to contact the NIDDK Program Official prior to initiating plans for application submission.

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.

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

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.

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

• Eligible Agencies of the Federal Government

F99 Eligibility: Domestic institution/organization types listed above that grant PhD or equivalent research degrees (e.g., DrPH, ScD) are eligible to submit an application. Only one F99 application per institution is allowed per receipt date, as defined in Section III.3. Eligibility Information.

K00 Eligibility: Domestic institution/organization types listed above, including NIH Intramural Programs and other 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.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

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

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

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

Any 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. 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, 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 and must show evidence of extremely high academic performance in the sciences. 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 adminstratively 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-19-195).

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 application submission. 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, in the nomination letter, 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 the applicant begins a postdoctoral position or completes all doctoral dissertation requirements before an F99 award is issued, the applicant becomes ineligible for an award.

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.

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

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

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

Only one competitive F99/R00 application per institution (normally identified by having a unique DUNS number or NIH IPF number) per receipt date is allowed. There is no institutional limit on the number of awards for the K00 phase.

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.

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 (or 75% of their full-time appointment at the applicant institution) to their career development and research training. 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.

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 the applicant's primary dissertation research advisor and be committed both to the applicant's research training and to direct supervision of his/her research.

The sponsor should 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.

K00 mentor(s)

It is strongly encouraged that the applicant identifies a future post-doctoral phase (K00) mentor(s) before submitting the application. It 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 the graduate research experience can be leveraged to address a K, U or H-related research direction. If however a 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.

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

It is critical that applicants follow the 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.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed activity
Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
Names of other key personnel
Participating institution(s)
Number and title of this funding opportunity

The letter of intent should be sent to:

John F. Connaughton, PH.D.
Chief, Scientific Review Branch
Telephone: 301-584-7797
Email: NIDDKLetterofIntent@mail.nih.gov

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

Instructions for Application Submission

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

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

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

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

Other Attachments:

Institutional Nomination Letter

The application must be accompanied by an Institutional Nomination letter (limited to 2 pages). 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. The Institutional Nomination letter must also certify that the candidate is within two years of completing doctoral training at the time of application.

The institutional nomination letter must include a description of a rigorous nomination process, including how eligible students were informed about the program, identified, and solicited and how the faculty evaluation and selection was conducted. The nominee is to be selected based on faculty evaluation of an applicant's potential and desire to become a successful independent researcher in K, U, or H science.

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.

The letter should include the name of the primary sponsor and an affirmation of the institution's commitment to the applicant's training and research career goals. If the applicant's dissertation research involves another institution, a joint nomination letter may be submitted.

The letter should be provided by the head of the graduate program and be signed by this individual and the institution's Authorized Organizational Representative. If the applicant is being jointly nominated, the program head of the second institution should also sign.

The filename "Institutional Nomination 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.

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

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, with the following additional instructions:

Fellowship Applicant Section

Applicant s Background and Goals for Fellowship Training

This section should address both phases of the F99/K00.

A. Doctoral Dissertation and Research Experience

Describe how the current doctoral project and research experience, which is not within the mission of KUH (F99) will be leveraged for identifying and pursuing a post-doctoral research question within the mission of KUH (K00).

B. Training Goals and Objectives

Describe the long-term career goal and explain how the F99/K00 will enable the attainment of that goal. For each phase (F99 and K00), describe how the proposed research training and career development plan will enhance the applicant's knowledge, technical expertise, and professional skills, keeping in mind existing strengths as well as any gaps in existing skills. Describe efforts and/or plans during the F99 phase that will prepare for the K00 transition. If a K00 mentor has not been identified prior to application submission, include a strategy for identifying a K00 mentor.

C. Activities Planned Under This Award

Describe the scientific and professional development activities planned for each phase (F99 and K00) and explain how these activities will facilitate the transition to each subsequent career stage. Include a timeline with scientific, professional development, and career milestones.

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 KUH 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.

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. 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 a general 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) has been identified at the time of application, Sections A through E should also be completed by the 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.
• 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.

Institutional Environment and Commitment to Training Section

Description of Institutional Environment and Commitment to Training

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

Follow the 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 a Delayed Onset Study record. If gaining research experience in a clinical trial led by a sponsor/co-sponsor, provide the sponsor s ClinicalTrials.gov identifier (i.e., NCT number).

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.

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

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.

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

See more tips for avoiding common errors.

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

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" (http://cde.nih.gov/) 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.

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

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

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.

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

• Has the applicant described how the F99 graduate research experience (outside of the KUH mission) can be leveraged to address a K, U, or H-relevant research direction in the K00 phase?
• Are the applicant’s academic record and research experience of high quality?
• Does the applicant have the potential to develop into an independent and productive K, U, or H researcher?
• Does the applicant demonstrate commitment to a research career in the future?
• Do the letters of reference provide evidence that the applicant has both a strong commitment to, and high potential for, becoming an independent research investigator?

Sponsors, Collaborators, and Consultants

• Are the research qualifications of the F99 sponsor(s) in the fellowship phase and their track record of mentoring appropriate for mentoring the applicant?
• Do(es) the F99 sponsor(s) demonstrate an understanding of the applicant s training needs as well as the ability and commitment to assist in meeting these needs?
• 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, is the team structure well justified and are the roles of the individual members appropriate and clearly defined?
• If K00 mentor(s) has been identified at the time of application, are the research qualifications of the K00 mentor(s) and their track record of mentoring appropriate for mentoring the applicant?
• If K00 mentor(s) have not been identified at the time of application, have the applicant and sponsor(s) described an appropriate set of qualifications and characteristics of a potential mentor?
• 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?

Research Training Plan

• Is the proposed F99 research project of high scientific quality, and is it well integrated with the proposed research training plan?
• Is the F99 research project consistent with the applicant’s stage of research development and relevant to his/her research career objectives?
• Is the proposed time frame feasible to accomplish the proposed F99 research training and transition to the K00 career development phase?
• Have the applicant and mentor(s) outlined feasible research milestones for the transition from the F99 fellowship phase of the award to the K00 career development phase?
• Is the research plan outlined for the K00 career development phase appropriate to the applicant's anticipated stage of development and as a vehicle for developing the research skills described in the career development plan?
• Is the strategy for identifying a K00 mentor (if not already identified at the time of application submission) capable of guiding the candidate's transition to K, U, or H research described?
• If proposed, will the clinical trial experience contribute to the proposed project and/or the applicant’s research training?

Training Potential

• Do the proposed research project and training plan have the potential to provide the applicant with the requisite individualized and mentored experiences that will develop his/her knowledge, research, and professional skills?
• Does the training plan take advantage of the applicant s strengths and address gaps in needed skills? Does the training plan document a clear need for, and value of, the proposed training?
• Does the training plan in the F99 fellowship phase provide an appropriate foundation for transition to the K00 career development phase of the award?
• Have the applicant and mentor(s) outlined appropriate milestones in terms of professional and career skills for transition to the K00 career development phase of the award?
• Are adequate plans described for monitoring and evaluating the applicant's research and career development progress throughout the F99 training period?

Institutional Environment & Commitment to Training

• Does the institutional nomination letter include a description of a rigorous nomination process, including how eligible students were informed about the program, identified, and solicited and how the faculty evaluation and selection were conducted?
• 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 fellowship phase of the award adequate and appropriate?
• Is the institutional environment for the applicant’s scientific development in the F99 fellowship phase of high quality?
• Is there appropriate institutional commitment to fostering the applicant’s mentored training toward his/her research career goals in the F99 fellowship phase of the award?
• Does the applicant describe adequate and appropriate research facilities, resources and training opportunities including the types of faculty capable of productive collaboration, for the transition to the K00 career development phase of the award? Are the research facilities, resources and training opportunities anticipated for the K00 career development phase matching with the research program anticipated in that phase?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

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

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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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.

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

Not Allowed

Revisions

Not Allowed

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 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

Not applicable

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) Genomic Data Sharing Plan.

Budget and Period of Support

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

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

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

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by NIDDK. 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.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Grantee 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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

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 for this F99/K00 awarde F99 phase.

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. 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 have been offered and accepted a postdoctoral appointment to carry out K-, U-, or H-focused research. Upon starting the K00 phase of the award, the F99 phase of the award is terminated.

Prospective applicants are strongly encouraged to contact the NIDDK Program Official 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.

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. These materials will be reviewed by the appropriate NIDDK staff. The institution's Authorized Organizational Representative will email the application in PDF format using PHS 398 form 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 the Funding Opportunity Announcement to do otherwise, as described here.

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.

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, 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 program related expenses, and indirect costs, as described in Part II, Section II of the Funding Opportunity Announcement. 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 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

When multiple years are involved, awardees 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.

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.

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

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

eRA 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: 301-945-7573

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

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

Cindy Roy, Ph.D. for Hematology-focused research
National Institutes of Diabetes and Digestive and Kidney diseases (NIDDK)
Telephone: 301-594-8805
Email: cindy.roy@nih.gov

Peter Kozel, Ph.D. for Hematology-focused research
National Institutes of Diabetes and Digestive and Kidney diseases (NIDDK)
Telephone: 301-594-4721
Email: kozelp@mail.nih.gov

Jill Bradshaw, Senior Grants Management Specialist
National Institutes of Diabetes and Digestive and Kidney diseases (NIDDK)
Telephone: 301-827-1230
Email: jill.bradshaw@nih.gov

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 63A and 45 CFR Part 75.