PA-27-037-Revised-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of The Director, National Institutes of Health (OD)

Office of AIDS Research (OAR)

National Eye Institute (NEI)

National Human Genome Research Institute (NHGRI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of General Medical Sciences (NIGMS)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Center for Complementary and Integrative Health (NCCIH)

National Cancer Institute (NCI)

Tribal Health Research Office (THRO)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE Project)

Applicants should carefully note which ICOs participate in this announcement and refer to NIH Institute, Center, and Office Grants & Funding Profiles for ICO-specific missions, interest areas, priorities, and funding considerations.

Funding Opportunity Title

Predoctoral to Postdoctoral Transition Award (Parent F99/K00 - Clinical Trial Not Allowed)

Activity Code

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

Announcement Type

New

Related Notices

Funding Opportunity Number (FON)

PA-27-037

Companion Notice of Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.310, 93.172, 93.867, 93.173, 93.121, 93.T21, 93.213, 93.855, 93.113, 93.273, 93.865, 93.242, 93.853, 93.398, 93.846, 93.866, 93.286, 93.THR, 93.279, 93.859

Funding Opportunity Purpose

The purpose of this award is to support promising graduate students as they complete their doctoral research training and transition into mentored postdoctoral career development opportunities in research areas relevant to the missions of participating NIH Institutes and Centers.

This Notice of Funding Opportunity (NOFO) does not allow fellowship candidates to propose to lead an independent clinical trial, but does allow candidates to propose research experience in a clinical trial led by a sponsor or co-sponsor.

Funding Opportunity Goal(s)

NIH's mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.

Key Dates

Posted Date

June 16, 2026

Open Date (Earliest Submission Date)

July 08, 2026

The following table includes NIH standard due dates marked with an asterisk.

August 08, 2026 *

August 08, 2026 *

Not Applicable

April 2027

December 08, 2026 *

December 08, 2026 *

Not Applicable

July 2027

April 08, 2027 *

April 08, 2027 *

Not Applicable

December 2027

August 08, 2027 *

August 08, 2027 *

Not Applicable

April 2028

December 08, 2027 *

December 08, 2027 *

Not Applicable

July 2028

April 08, 2028 *

April 08, 2028 *

Not Applicable

December 2028

August 08, 2028 *

August 08, 2028 *

Not Applicable

April 2029

December 08, 2028 *

December 08, 2028 *

Not Applicable

July 2029

April 08, 2029 *

April 08, 2029 *

Not Applicable

December 2029

All applications are due by 5:00 PM local time of applicant organization.

Fellowship candidates 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 09, 2029

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Table of Contents

Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Funding Opportunity Description Section II. Award Information Other Award Budget Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall goal of the NIH fellowship, research training, and career development programs is to help ensure a highly trained, heterogeneous pool of scientists is available across appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. NIH fellowships support the training of predoctoral and postdoctoral scientists, dual-degree investigators, and senior researchers. More information about these fellowships is available on the NIH Research Training and Career Development website.

Note: This Notice of Funding Opportunity (NOFO) does not allow candidates to propose leading an independent clinical trial. However, candidates may propose research experience in a clinical trial led by a sponsor or co-sponsor.

Purpose The purpose of the Predoctoral to Postdoctoral Transition Award (Parent F99/K00) is to support promising graduate students as they complete their doctoral research training and transition to mentored postdoctoral career development opportunities in research areas relevant to the mission of participating NIH Institutes and Centers (ICs), preparing them to become productive, independent researchers.

Award Structure The F99/K00 provides up to 5 years of support across two consecutive phases.

A K00 award will be made only to support a PD/PI who has successfully completed F99-supported training, secured a postdoctoral appointment, and, in coordination with the applicant institution, submitted to NIH a strong research and career development plan to be carried out in a supportive and rigorous research environment. Candidates are expected to obtain a postdoctoral position at an institution other than the one where they conducted their doctoral research.

Expectations Predoctoral students applying for the F99/K00 award are expected to propose an individualized research training plan for the final 1 to 2 years of predoctoral training, as well as a broad outline of up to 3 years of mentored postdoctoral research and career development activities that will prepare them for a productive, independent scientific research career in a biomedically relevant field.

The mentored research training and career development experience is expected to provide:

The F99/K00 award is intended for individuals who require at least 12 months of mentored research training in the F99 phase before transitioning to the K00 phase. Accordingly, individuals should propose a well-conceived plan for 1 to 2 years of substantive mentored predoctoral research training that will help them become competitive for postdoctoral research positions. An individual who cannot provide a compelling rationale for at least one year of additional mentored predoctoral research training at the time of award is not a competitive candidate for this fellowship.

Additional Information Because of the differences in individual Institute, Center, and Office (ICO) program requirements for this announcement, prospective candidates are strongly encouraged to consult the NIH Research Training and Career Development website to make sure that their application is appropriate for the requirements of one of the participating NIH ICOs.

Supported PD/PIs who can justify the need for additional mentored career development training beyond the K00 may work with their institutions to apply for additional NIH mentored career development awards.

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

Section II. Award Information

Funding Instrument

Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

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

Resubmission

The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

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

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

Note: Applications may propose activities involving human subjects that are not deemed clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

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

Award Project Period

Individuals may receive up to 5 years of aggregate Kirschstein-NRSA support at the predoctoral level (up to 6 years for dual degree training, e.g., MD/PhD), and up to 3 years of aggregate Kirschstein-NRSA support at the postdoctoral level, including any combination of support from institutional training grants (e.g., T32) and an individual fellowship award.

Effective for applications submitting to December 8, 2026 receipt date and after per NOT-OD-26-091- Individuals may receive up to five years of aggregate support across both phases, including up to two years at the F99 predoctoral level and up to three years at the K00 postdoctoral level.

Other Award Budget Information

Stipends

Effective for applications submitting to December 8, 2026 receipt date and after per NOT-OD-26-091- Stipends are provided as a subsistence allowance to help defray living expenses during the research training experience. See https://researchtraining.nih.gov/resources/policy-notices.

F99 Phase: Stipends are provided as a subsistence allowance to help defray living expenses during the research training experience. The stipend amount for F99 predoctoral fellows is the same as that for Ruth L. Kirschstein National Research Service Award (NRSA) predoctoral trainees and fellows. For details, see NRSA policy notices on the NIH Fiscal Policies website.

Award recipients in the NIH intramural program will be supported by intramural funds provided by the NIH Institute or Center (IC) intramural laboratory in which they are conducting their research.

K00 Phase: The participating NIH Institutes and Centers will provide salary and fringe benefits for the K00 award recipient. Candidates are encouraged to visit the NIH Research Training and Career Development website and consult with program officials from participating NIH institutes and centers for IC-specific award budget information. Further guidance on budgeting for career development salaries is provided in the How to Apply - Application Guide.

Tuition and Fees

Fellowship awards will contribute to the combined cost of tuition and fees at the rate in place at the time of award. See NIH Fiscal Policies.

Institutional Allowance

F99 Phase: The application 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). For details, see the NIH Fiscal Policies website.

K00 Phase: Research development support may be requested to the level provided by the awarding NIH Institutes and Centers. Candidates should visit the NIH Research Training and Career Development webpage and consult with program officials for IC-specific, programmatic and budgetary information. Further guidance on budgeting for research development support is provided in the How to Apply - Application Guide. These funds may be used for the following expenses: (a) tuition and fees related to career development activities; (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.

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

Indirect Costs

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

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 NIH Fiscal Policies website.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Federal Governments

Eligible Agencies of the Federal Government

Other None

F99 Eligibility: All institution/organization types listed above that grant PhD or equivalent research degrees (e.g., EngD, DNSc, DrPH, DSW, PharmD, ScD) are eligible to serve as a sponsoring institution. The sponsoring institution must have staff and facilities available on site to provide a suitable environment for performing high-quality research training. The training should occur in an environment that has appropriate human and technical resources and is demonstrably committed to training in the field(s) proposed by the candidate. All organizations with the appropriate resources and commitment are encouraged to apply. Multiple applications from an institution are allowed.

NIH Intramural Programs and other Federal laboratories are eligible to submit applications for the F99 phase (see note below).

K00 Eligibility: All institution/organization types listed above, with the exclusion of Federal laboratories, are eligible to submit K00 transition phase applications on behalf of individuals receiving support from F99 awards. There is no limit on the number of K00 awardees that an organization may sponsor.

Note: If the F99 candidate accepts a postdoctoral position in the NIH intramural research program or another federal agency, the postdoctoral phase will then be supported directly by the federal agency offering the postdoctoral position. The K00 will not be awarded, as federal employees are not eligible for NIH extramural grants. These postdoctoral scholars are invited to continue to participate in any relevant programmatic opportunities offered by the participating NIH Institutes and Centers.

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

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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.

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Required Registrations

Applicant Organizations Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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 applicant organizations should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

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. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

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. 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 candidate(s) 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 their sponsor and organization to develop an application for support. Multiple PDs/PIs are not allowed.

The candidate must be currently enrolled in a PhD or equivalent research degree program (e.g., EngD, DNSc, DrPH, DSW, PharmD, ScD) in the biomedical, behavioral, or clinical sciences at an eligible institution.

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

At the time of award, the candidate must be in the dissertation research stage of training and is expected to require 1–2 years to complete their Ph.D. dissertation research training (F99 phase) before transitioning to mentored postdoctoral research training (K00 phase). If an individual begins a postdoctoral position or completes all Ph.D. dissertation requirements before an F99 award is made, neither the F99 award nor the K00 award will be issued.

Clinical Training and Health Professional Degrees Candidates must be enrolled in a research doctoral degree program that does not require post-degree clinical training. The Parent F99/K00 award may not be used to support studies leading to a MD, DDS, or other clinical, health-professional degree (e.g., DC, DMD, DNP, DO, DPM, DVM, ND, OD, AuD, PharmD, clinical PhD). The F99 and K00 phases are intended to be contiguous in time and cannot accommodate clinical training.

Dual-Degree Programs Students matriculated in a dual-degree program (e.g. MD/PhD, DO/PhD, DDS/PhD, or DVM/PhD) who seek support for both dissertation research training and clinical training are not eligible for the F99/K00 program because the F99/K00 does not support the clinical training component. Exceptions may be considered if there is no gap between the doctoral research training and postdoctoral phase, i.e., there is no clinical training period between completion of the PhD and the start of the postdoctoral research position. Students matriculated in a dual-degree program without a gap between the completion of the PhD and the postdoctoral phase should contact the appropriate IC program officer for approval prior to submitting an application. Alternatively, such students may apply for the Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral MD/PhD or Other Dual-Doctoral Degree Fellowship (Parent F30) to support both dissertation research training and clinical training.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 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 (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Concurrent support from multiple NIH/PHS individual fellowships and/or dissertation awards are prohibited.

Duration of Support

See Award Project Period in Section II. Award Information.

Level of Effort

F99 Phase: At the time of award, individuals are required to pursue their research training on a full-time basis, normally defined as 40 hours per week or as specified by the sponsoring organization in accordance with its own policies.

K00 Phase: Individuals receiving support under a K00 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 professional effort 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.

Sponsor

F99 Phase: The primary sponsor should be an active investigator in the area of the proposed research training and be committed both to the candidate's research training and to direct supervision of their research. The primary sponsor must document the availability of sufficient research funds and facilities for the proposed research training. The primary sponsor can be an independent investigator at any career stage, including an early-stage investigator. Regardless of career stage, the primary sponsor must demonstrate a commitment to ensuring the candidate receives tailored training that will facilitate their skills development and career advancement. The candidate must work with the primary sponsor(s) in preparing the application.

K00 Phase: Candidates are not required to identify a sponsor for the K00 phase at the time of the initial F99/K00 application.

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 NOFO. 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 applicant organizations and fellowship candidates follow the Fellowship (F) instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the How to Apply - 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 How to Apply - Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply - Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

Effective for applications submitting to December 8, 2026 receipt date and after per NOT-OD-26-091- The Certification Letter is not required.

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

All instructions in the How to Apply - 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 candidate) 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

Specific to this NOFO, the following additional instructions apply:

Biographical Sketch:

PD/PI (fellowship candidate)

PHS Fellowship Supplemental Form

All instructions in the How to Apply - Application Guide must be followed.

Candidate Section

Goals, Preparedness, and Potential All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions:

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

A. Overall Training Goals Describe the long-term research and career goals and explain how the F99/K00 will enable the attainment of those goals. For each phase, describe how the proposed research training and career development plan will enhance the candidate's knowledge, technical expertise, and professional skills, keeping in mind existing strengths as well as any gaps in existing skills. Candidates are encouraged to discuss their alignment with the mission(s) of at least one participating NIH Institute/Center (IC). Consult IC Strategic Plans and the NIH Research Training and Career Development website for information on IC missions and areas of interest.

B. Candidate's Preparedness

C. Candidate's Self-Assessment In addition to two to four specific areas of development during the F99 phase, include two to four specific areas of development during the K00 phase to attain the stated research training and career goals.

D. Scientific Perspective Address the scientific perspective of both phases of the F99/K00. Go beyond the information addressed in the Scientific Foundation and Rationale section of the Research Training Plan to demonstrate the significance of your specific research interests and goals in addressing key gaps in the broader scientific field.

Research Training Plan

Research Training Project Specific Aims and Strategy All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Training Activities and Timeline The plan and timeline must cover both the F99 and K00 phases of the award. The research training plan activities should not just be a list of activities; provide justification for planned activities based on your goals, strengths, and weaknesses identified in the candidate's self-assessment.

Research Training Project - Specific Aims All candidates must use these two Specific Aims:

Specific Aim 1: The Dissertation Research Project.

Provide a detailed description of the overall dissertation research project, what has been accomplished to date (preliminary data may be included), and the research to be completed in the F99 phase.

Specific Aim 2: The Postdoctoral Research Direction.

Identify the research direction to be pursued for the K00 phase.

Research Training Project - Strategy Candidates should individually address the Scientific Foundation and Rationale and Approach for each Specific Aim and address the Scored Review Criteria indicated in Section V.1.

Specific Aim 1:

Scientific Foundation and Rationale

Approach The approach for this aim should be organized into two sections:

Specific Aim 2:

Scientific Foundation and Rationale

Approach Provide a general description of how the research will be conducted, including approaches and methodologies to be used, anticipated results, challenges that might arise and how to address them. Career and professional development skills to be acquired should also be detailed.

Commitment to Candidate, Mentoring and Training Environment

C. Commitment to the Candidate's Research Training Plan Include a description of how the sponsor(s) promote(s) the development of candidate skills in approaches to rigorous experimental design, methods of data collection, data analysis, interpretation, and reporting as well as ethically sound and responsible scientific research.

D. Research Training Environment When describing opportunities for professional development and intellectual interactions, do not just list available opportunities, but indicate which opportunities the candidate will participate in during the research training period and how they will further the candidate's scientific development.

E. Candidate's Potential In this section, the sponsor should address both the candidate's potential for successful completion of the F99 and K00 phases and for becoming an independent investigator.

Clinical Trial Training (If proposed) If the candidate 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 candidate 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.

Other Plan(s) A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix

Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the How to Apply - Application Guide; any instructions provided here are in addition to the How to Apply - 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 How to Apply - 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

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).

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

Reference Letters

Applicant organizations must carefully follow the How to Apply - 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 2. 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. contains information about Key Dates and times. Applicant organizations 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). Applicant organizations 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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

Information on the…