Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

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

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

Announcement Type
Reissue of RFA-CA-21-059
Related Notices

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

Funding Opportunity Announcement (FOA) Number
RFA-CA-22-041
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.398
Funding Opportunity Purpose

The purpose of the NCI Predoctoral to Postdoctoral Fellow Transition Award (F99/K00) is to encourage and retain outstanding graduate students recognized by their institutions for their high potential and strong interest in pursuing careers as independent cancer researchers. The award will facilitate the transition of talented graduate students into successful cancer research postdoctoral appointments and provide opportunities for career development activities relevant to their long-term career goals of becoming independent cancer researchers.

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

Key Dates

Posted Date
August 18, 2022
Open Date (Earliest Submission Date)
October 18, 2022
Letter of Intent Due Date(s)

Not Applicable

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
November 18, 2022 Not Applicable Not Applicable March 2023 May 2023 July 2023

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

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

No late applications will be accepted for this Funding Opportunity Announcement.

Expiration Date
November 19, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

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

The objective of the NCI Predoctoral to Postdoctoral Fellow Transition Award (F99/K00) is to identify and encourage outstanding graduate students who are recognized by their institutions as having high potential and strong interest in pursuing careers as independent cancer researchers, and then to facilitate their successful transition to postdoctoral positions.

The F99/K00 award is intended for individuals who require 1-2 years to complete their Ph.D. dissertation research training (F99 phase) before transitioning to mentored postdoctoral research training (K00 phase). Consequently, applicants are expected to propose an individualized research training plan for the next 1-2 years of dissertation research training and a plan for 3-4 years of mentored postdoctoral research and career development activities that will prepare them for independent cancer-focused research careers.

The F99/K00 award is meant to provide up to 6 years of support in two phases. The initial (F99) phase will provide support for 1-2 years of dissertation research (final experiments, dissertation preparation, and selection of a postdoctoral mentor). The second (K00) phase will provide up to 4 years of mentored postdoctoral research and career development support, contingent upon successful completion of the doctoral degree requirements and securing a cancer-focused postdoctoral position at a new institution. The two award phases are intended to be continuous in time meaning gaps are not permitted between the completion of the PhD requirements (i.e acceptance of the PhD thesis by the institution and not when the degree is conferred) and the start of the K00 phase. A K00 award will be made only to a PD/PI who has successfully completed the F99-supported training, secured a cancer-focused postdoctoral appointment, and provided NCI with a strong research and career development plan.

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

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New

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

Clinical Trial?

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

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NCI intends to commit $1.1 M to fund up to 24 awards in FY2023.

Award Budget

For the F99 phase, award budgets are composed of stipends, tuition and fees, and institutional allowance, as described below. For the K00 phase, award budgets are composed of salary and fringe benefits, other program-related expenses (These funds may be used for the following expenses: (a) tuition and fees related to career development; (b) research-related expenses, such as supplies, equipment and technical personnel; c) travel to research meetings or training; and (d) statistical services including personnel and computer time), and indirect costs, as described below.

Award Project Period

For the F99/K00 award, 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.

Other Award Budget Information

Stipends (F99)/Salary (K00)

ALLOWABLE COSTS: F99 PHASE

Stipends are provided as a subsistence allowance to help defray living expenses during the research training experience.

The stipend level for F99 predoctoral fellows is the same as for the F31 Ruth L. Kirschstein National Research Service Award (NRSA) fellows. See https://researchtraining.nih.gov/programs/fellowships

ALLOWABLE COSTS: K00 PHASE

NCI will contribute up to $60,000 in the first year toward the salary of the career award recipient. This will be increased to $63,300 for the second year, to $66,600 for the third year, and to $69,900 for a fourth year.

Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide.

The total salary, however, may not exceed the legislatively mandated salary cap if the source of the funds is federal. See: http://grants.nih.gov/grants/policy/salcap_summary.htm

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 https://researchtraining.nih.gov/resources/policy-notices

Institutional Allowance (F99)/Other Program-Related Expenses (K00)

ALLOWABLE COSTS: F99 PHASE

The applicant should request an institutional allowance to help defray the cost of fellowship expenses such as health insurance, research supplies, equipment, books, and travel to scientific meetings. The annual institutional allowance level for the F99 phase is the same as that provided for the F31 Ruth L. Kirschstein National Research Service Award (NRSA) awards (see https://researchtraining.nih.gov/programs/fellowships). In addition, the application budget should include an additional $1,500 in the first year of the F99 award to defray the travel costs to attend a mandatory NCI-sponsored conference.

ALLOWABLE COSTS: K00 PHASE

NCI will contribute $3,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities. In addition, the application budget should include an additional $1,500 in the first year of the K00 award to defray the travel costs to attend a mandatory NCI-sponsored conference. 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.

ALLOWABLE COSTS: F99 PHASE

NCI does not separately reimburse indirect costs (also known as Facilities & Administrative [F&A] Costs) for fellowships. Costs for administering the F99 awards are part of the Institutional Allowance. See https://researchtraining.nih.gov/resources/policy-notices

ALLOWABLE COSTS: K00 PHASE

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

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

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

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

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

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

Governments

  • Eligible Agencies of the Federal Government
Other
  • None

F99 Eligibility: Domestic institution/organization types listed above that grant PhD or equivalent research degrees (e.g., Dr.P.H., Sc.D.) are eligible to submit an application. One F99 application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

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

Foreign Institutions

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

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

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

Required Registrations

Applicant Organizations

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

  • System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • Unique Entity Identifier (UEI) A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any applicant fellow with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her sponsor and organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

An applicant must be a citizen or a noncitizen national of the United States, or has 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. 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. NCI may request verifying information as part of the pre-award process.

The applicant must have a baccalaureate degree and be currently enrolled as a graduate student in the third or fourth year of a mentored PhD or equivalent research degree program (e.g., DrPH, ScD) in the biomedical, behavioral, or clinical sciences at a domestic institution. F99 eligibility is determined from the date of enrollment as a graduate student at the PhD institution and includes the time spent to earn a MS degree unless there was a major change in research area and a change in research mentor. The applicant must be at the dissertation research stage of training at the time of award, and must show evidence of high academic performance in the sciences and commitment to a career as an independent cancer research scientist.

Exceptions:

  • If a 2nd-year student is expected to graduate within 2 years, an exception may be requested. Applicants may check with the Program Official prior to the selection of the nominee. If granted, the exception should be explained in the Nomination Letter.
  • If a 5th-year student took a documented and extended Leave of Absence, an exception may be requested. Applicants may check with the Program Official prior to the selection of the nominee. If granted, the exception should be explained in the Nomination Letter.

Potential candidates are encouraged to discuss their individual situation with the NCI Scientific Program Contact prior to seeking institutional nomination.

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, AuD). Students matriculated in a dual-degree program (e.g. MD/PhD, DO/PhD, DDS/PhD, or DVM/PhD) are not eligible for the F99/K00 program.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Each eligible institution, whether identified by a single UEI number or by multiple UEI numbers for schools/colleges/divisions within the institution, is eligible to submit one application per due date.

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

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review.
Duration of Support

F99 recipients 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 recipients are required to have a full-time appointment at the applicant institution, and to commit a minimum of 9 person months (75%) of their full-time appointment at the applicant institution to their career development and mentored research. K00 recipients 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

Before submitting the application, the applicant must identify an F99 sponsor(s) who will supervise the proposed dissertation research training experience. The primary sponsor should be an active investigator in the area of the proposed research training and be committed both to the applicant’s research training and to direct supervision of the applicant's research. The primary sponsor must document the availability of sufficient research funds and facilities for high-quality research training. 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 training program. The applicant must work with the sponsor(s) in preparing the 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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Instructions for Application Submission

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

Instructions for Application Submission
SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

Other Project Information

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

Other Attachments: The application must include the following information:

Institutional Nomination Letter

The institutional nomination letter must include a description of the nomination process, including how eligible students are informed/solicited and how faculty evaluation/selection is conducted. The nominee is to be selected based on faculty evaluation of an applicant’s potential and desire to become a successful independent cancer researcher.

The letter must confirm the eligibility of the applicant. If an exception to the number of years in the PhD program was requested and granted, this should be explained in the letter.

Exceptions:

  • If a 2nd-year student is expected to graduate within 2 years, an exception may be requested. Applicants may check with the Program Official prior to the selection of the nominee. If granted, the exception should be explained in the Nomination Letter.
  • If a 5th-year student took a documented and extended Leave of Absence, an exception may be requested. Applicants may check with the Program Official prior to the selection of the nominee. If granted, the exception should be explained in the Nomination Letter.

If the applicant is not a U.S. Citizen, U.S. National, or permanent resident, the sponsoring 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 must be provided by the head of the graduate program and be signed by this individual. If the applicant is being jointly nominated, the program head of the second institution should also sign. This letter is limited to 2 pages.

Foreign component justification should be attached here.

No other attachments are allowed.

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

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

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

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

Biographical Sketch

Applicant


Applicant must include the start date (month and year) of all education/training experiences.
In the "Personal Statement" section, applicants are encouraged to account for and describe factors that may have affected past productivity.
Under the section "Scholastic Performance," applicants should list undergraduate courses, but should not include undergraduate grades. Graduate courses and grades must be included

PHS Fellowship Supplemental Form

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

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

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

Fellowship Applicant Section

Applicant’s Background and Goals for Fellowship Training

This section should address both the F99 phase and the K00 phase.

Doctoral Dissertation and Research Experience

  • Include a description of how the combination of past research experiences and the F99/K00 plans contribute to achieving the long-term career goal.

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, 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. If the K00 research direction is markedly different from the F99 research area, describe efforts and/or plans during the F99 phase training that provide preparation for the K00 research. Include a strategy for identifying a K00 mentor.

Activities Planned Under This Award

  • Describe the scientific and professional development activities planned for each phase and explain how the 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:

A. Specific Aims

All applicants must use these two Specific Aims:

  • Specific Aim 1: The Dissertation Research Project.
    • Provide a detailed description of 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.

B. Research Strategy

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.

Applicants should address the Significance and Approach for each Specific Aim individually and address the Scored Review Criteria indicated in Section V.1.

Specific Aim 1:

  • Significance
    • Provide an overview of the dissertation research, including the scientific question being addressed and its potential impact on the dissertation research field.
    • Describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project.
    • Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.
    • Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.
  • Approach

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 that encompasses rigor and reproducibility, anticipated results, potential problems, alternative strategies, and potential follow-up studies.

Specific Aim 2:

  • Significance
    • Explain the significance of the K00 research direction. Describe a specific scientific question or observation that will be investigated. Explain how this question or observation is related to the applicant’s research interests and how this work will help advance this research direction.
    • Describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project.
    • Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.
    • Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.
  • Approach
    • Provide 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.

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

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

  • Follow the F31-specific instructions for Sections A through E. Additionally, in Section E the sponsor(s) should provide an assessment of the applicant’s qualifications and potential for transitioning to the postdoctoral phase (K00) and becoming a productive, independent researcher.
  • The Sponsor should also describe the roles and responsibilities that both he/she and the fellow are undertaking, including contributions to the research plan, the portion of the research ideas and plan that originated with the candidate, and the relationship between the proposed research plan and funded or unfunded research projects previously devised by the sponsor.
  • If the applicant is proposing to gain experience in a clinical trial as part of his or her research training, the sponsor or co-sponsor must include a statement to document leadership of the clinical trial including source of funding, NCT#, and appropriate expertise to guide the applicant in any proposed clinical trials research experience. The individual receiving support for the clinical trial (i.e., the sponsor/primary mentor or a co-sponsor) is the responsible individual of record for oversight of the trial though fellows can take part in all components of a clinical trial. Oversight includes (but is not limited to): interacting with relevant Institutional Review Board (IRB) staff; reviewing all informed consent documents; reporting potential serious adverse events; and maintaining responsibility for patient safety. However, the fellow can gain experience in all these components in conjunction with the mentor or individual leading the trial.

Institutional Environment and Commitment to Training Section

Description of Institutional Environment and Commitment to Training

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

Appendix

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

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

Delayed Onset Study

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

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

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

Applicants must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. Applications lacking the appropriate required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Reference Letter link and not through Grants.gov.

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

The F99/K00 award may not be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or otherwise duplicates provisions of this award. Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

For this particular announcement, note the following:

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

Overall Impact

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

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

  • How strong is the applicant’s research experience?
  • Does the applicant have the potential to develop into an independent and productive researcher?
  • Does the applicant demonstrate commitment to a career as an independent cancer researcher 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 cancer research investigator?
  • Does the research project reflect a significant contribution of the applicant to the originality of the project idea, approach and/or hypotheses relative to the career stage of the applicant?

F99 Phase

  • Are the sponsor(s ) research qualifications (including recent publications) and track record of mentoring individuals at a similar stage appropriate for the needs of the candidate?
  • Is there evidence of a match between the research and clinical interests (if applicable) of the candidate and the sponsor(s)? Do(es) the sponsor(s) demonstrate an understanding of the candidate’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 candidate’s proposed research project and training for the duration of the research component of the fellowship?
  • If a team of sponsors is proposed, is the team structure well justified for the mentored training plan, and are the roles of the individual members appropriate and clearly defined?
  • Are the qualifications of any collaborator(s) and/or consultant(s), including their complementary expertise and previous experience in fostering the training of fellows, appropriate for the proposed project?
  • Does the sponsor's research and training record, as well as mentoring statement, indicate that the candidate will receive outstanding training in the proposed research area and have the opportunity to publish high quality papers and present research data at national meetings as the project progresses?
  • 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 sponsor(s) to guide the applicant during the clinical trial research experience?

K00 Phase

  • Does the applicant describe what type of mentor(s) will help achieve their long term career goals?
  • How well does the applicant describe the desired characteristics, experience and expertise of their future mentor(s) during the K00 phase? Applicants do not have to name any specific mentor(s) for the K00 phase.

F99 Phase

  • Is the proposed research project of high scientific quality, and is it well integrated with the proposed research training plan?
  • Is the prior research that serves as the key support for the proposed project rigorous?
  • Has the applicant included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project?
  • Has the applicant presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
  • Has the applicant presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
  • Based on the sponsor’s description of his/her active research program, is the candidate’s proposed research project sufficiently distinct from the sponsor’s funded research for the candidate’s career stage?
  • Is the research project consistent with the candidate’s stage of research development, and relevant to the candidate's research career objectives? (Dissertation research does not have to be cancer focused)
  • Is the proposed time frame feasible to accomplish the proposed dissertation research training and transition to the career development phase?
  • Have the applicant and/or sponsor(s) outlined feasible research milestones for the transition from the fellowship phase of the award to the career development phase?
  • Does the training plan provide adequate opportunities to present and publish research findings and meet with scientists in the community at national meetings as the work progresses?
  • Will the training plan provide the professional skills needed for the candidate to transition to the next stage of his/her research career?

K00 Phase

  • Does the applicant describe a general direction of research for their postdoctoral phase? This is not a specific project, but rather an explanation of the basis of the applicant’s interest in cancer research and a description of an overall research direction.
  • Is the research plan outlined for the career development K00 phase appropriate to the applicant’s anticipated stage of development and serve as a vehicle for developing the research skills described in the career development plan?

  • Are the proposed research project and training plan likely to provide the candidate with the requisite individualized and mentored experiences in order to obtain appropriate skills for a research career?
  • Does the training plan take advantage of the candidate’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 proposed training in the fellowship phase have the potential to serve as a sound foundation for transition to the career development phase?
  • Have the applicant and sponsor(s) outlined appropriate milestones in terms of professional and career skills for transition to the career development phase of the award?
  • Are adequate plans described for monitoring and evaluating the applicant’s research and career development progress throughout the training period?

F99 Phase

  • Are the research facilities, resources (e.g., equipment, laboratory space, computer time, subject populations, clinical training settings) and training opportunities (e.g. seminars, workshops, professional development opportunities) for the fellowship phase adequate and appropriate?
  • Is the institutional environment for the candidate’s scientific development of high quality?
  • Is there appropriate institutional commitment to fostering the applicant’s mentored training, in the fellowship phase of the award?

K00 Phase

  • Does the applicant adequately describe in general terms the anticipated research facilities, resources and training opportunities including the types of faculty capable of productive collaboration, for the transition to the career development phase of the award?
  • Do the anticipated research facilities, resources and training opportunities described for the career development phase match the research program anticipated in that phase?
  • Is the type of institutional environment the candidate plans to join for scientific development during the K00 phase of high quality?
Additional Review Criteria

These additional review criteria elements apply only to the F99 phase project and not the K00 phase project.

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

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

This review criterion applies only to the F99 project and not to the K00 project.

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.

This review criterion applies only to the F99 project and not to the K00 project.

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.

This review criterion applies only to the F99 project and not to the K00 project.

Not Allowed.

Not Allowed

Not Allowed

Additional Review Considerations

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

All applications for support under this FOA must include a plan to fulfill NIH requirements for Instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the candidate, including any prior instruction or participation in RCR as appropriate for the candidate’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the sponsor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019 and NOT-OD-22-055.

Not Applicable

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

This review criterion applies only to the F99 project and not to the K00 project.

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.

This review criterion applies only to the F99 project and not to the K00 project.

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

This review criterion applies only to the F99 project and not to the K00 project.

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by Division of Extramural Activities at NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

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

Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

Inventions and Copyrights

F99 Phase:

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.

K00 Phase:

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

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.

Transition to the Postdoctoral Career Development K00 Phase

The F99/K00 award is intended to facilitate the successful transition to the postdoctoral career stage. Consequently, a requirement for the K00 phase award is successful completion of the doctoral research degree and subsequent transition to a cancer-focused, mentored postdoctoral research position. Applicants are strongly encouraged to apply for postdoctoral positions at institutions different from where they conducted their doctoral research.

The transition from the predoctoral phase to the postdoctoral phase is intended to be continuous in time (no gaps are allowed between the completion of the PhD requirements (acceptance of the PhD thesis by the institution and not when the degree is conferred) and the start of the K00 phase) and, except in unusual circumstances, NCI 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 cancer-focused research. Upon starting the K00 phase of the award, the F99 phase of the award ends.

Prospective applicants must contact the NCI Program Official as soon as a plan to assume a postdoctoral position develops, but not later than 9 months prior to the proposed start date of the K00 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 cancer-focused postdoctoral positions within the NIH intramural research program (IRP). However, should the individual accept such a position in the IRP, the postdoctoral phase will be supported directly by NIH intramural funds and the K00 will not be awarded, since NIH intramural scientists are not eligible for NIH extramural grant awards.

F99 fellows who accept a postdoctoral position in the IRP will be required to submit a final progress report and a final evaluation statement by the primary F99 mentor instead of a K00 application.

The K00 postdoctoral phase institution must submit the materials on behalf of the candidate for the K00 award, no later than 6 months prior to the proposed start date of the K00 Award. The institution's Authorized Organizational Representative will email the application in PDF format using PHS 398 (https://grants.nih.gov/grants/funding/phs398/phs398.html) to the NCI Scientific/Research Contact listed in Section VII. The K00 application will be evaluated by NCI 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 NCI provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Instructions for the K00 Transition Award

F99 awardees wishing to submit a K00 transition application must follow the Career Development (K) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise, as described here.

The K00 Transition Application will include the following components:

  • A new cover page signed by the K00 phase institutional representative;
  • A Final Progress Report for the F99 phase;
  • A final evaluation statement by the F99 primary sponsor;
  • Updated Project Summary and Abstract, Project Narrative, Bibliography & References Cited, Facilities & Other Resources, and Equipment sections;
  • Biographical sketches;
  • Detailed budget pages for a non-modular budget: K00 budgets consist of salary and fringe benefits, other program-related expenses (These funds may be used for the following expenses:
    • (a) tuition and fees related to career development;
    • (b) research-related expenses, such as supplies, equipment and technical personnel;
    • (c) travel to research meetings or training; and
    • (d) statistical services including personnel and computer time, and indirect costs, as described in Part II, Section II of this funding opportunity announcement.
  • 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 4 pages;
  • A new Mentor, Co-Mentor, Consultant, Collaborators Section that includes a plan for transitioning the candidate to the next stage of their 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 Environment and Institutional Commitment to the Candidate Section;
  • A Statement of Institutional Commitment to Candidate’s Research Career Development:
    • If the candidate is not a U.S. Citizen or permanent resident, the sponsoring 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 Individuals Across the Lifespan (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

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. In addition, for the K00 phase, a financial statement is required per the NIH Grants Policy Statement.

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.

For the K00 phase, a final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement

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

Other Fellowship Reporting Requirements:

  • Individuals admitted to the United States as Permanent Residents or as temporary U.S. visa holders must submit notarized evidence of legal admission prior to the award.

4. Evaluation

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

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

Scientific/Research Contact(s)

Dr. Mariam Eljanne
National Cancer Institute (NCI)
Telephone: 301-605-3200
Email: eljannem@mail.nih.gov

Peer Review Contact(s)

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov.

Financial/Grants Management Contact(s)

Amy Bartosch
National Cancer Institute (NCI)
Telephone: 240-276-6375
Email: bartoschar@mail.nih.gov

Section VIII. Other Information

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

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

Authority and Regulations

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

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