The F99/K00: Answers to Frequently Asked Questions for PA-27-037

Career Stage

At the time of application, you must be:

• A predoctoral candidate in a biomedical, behavioral, or clinical research doctoral degree program.
• Enrolled at a domestic (US) institution.
• Within 1-2 years from completion of the doctoral degree at the time of award. The F99 phase will not be extended, nor will the K00 phase be postponed, except under rare and unforeseen circumstances.
• At the dissertation stage at the time of award. This means you have passed the requirements set by your institution for advancement to the Ph.D. candidacy stage.
• If you complete the Ph.D. degree requirements or begin a postdoctoral position before an award is made, neither the F99 nor the K00 award will be made.
   

Degree Program

You must be enrolled in a Ph.D. program or other research doctoral program (e.g., DrPH, ScD). Students enrolled in the following programs are NOT eligible for the F99/K00 award:

• Dual-degree programs, even if the degrees are completed in separate phases.
• Professional doctorate or clinical practice degree programs.
• Any degree program that requires an extended internship following the research degree.

Research Area

NCI supports all areas of cancer research.

• The K00 phase MUST be cancer-focused.
• The F99 dissertation research must be in a biomedical, behavioral, or clinical research area that prepares you for a future career in cancer research.

Citizenship

• By the time of award, the F99 candidate must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e. possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status).
• The candidate does not require citizenship or a green card to apply. Citizenship or green card is required at the time of award issuance.

Not required

Although foreign institutions are not eligible, foreign components are allowed.

• An applicant risks losing the F99 award if all requirements for funding are not met in a timely manner.
• This includes termination of another fellowship immediately prior to the issuance of the F99/K00 award and providing all other information requested by NCI.
   

F31 applicants and current awardees are eligible for the F99/K00 award.

• Only one fellowship award may be active at any given time. F31 awardees must terminate the F31 award prior to accepting the F99/K00 award.
• The NIH does not allow 2 overlapping applications to be “pending review” at the same time. “Pending review” covers the time from when an application has been submitted until the release of its Summary Statement. For example, you may not submit an F99 application and an F31 application for December due dates that are in the same review cycle.
• The F99/K00 is not an NRSA fellowship. Having prior NRSA support does not impact the years of support that may be requested for the F99/K00. Similarly, having an F99/K00 award does not impact any eligibility for future NRSA support.
• Neither the F99 phase nor the K00 phase may be held concurrently with another federally sponsored fellowship or similar Federal award that provides a stipend or salary, or otherwise duplicates the provisions of this award.

• Your primary F99 sponsor is not strictly required to have peer-reviewed, cancer-related research grant at the time of application or award. However, the sponsor must demonstrate the availability of research resources, scientific and technical expertise, and mentorship experience to effectively mentor you. These are included in the NOFO review criteria.
•  The roles of any co-sponsors should be clearly described in the application.

• F99 awardees may not transition to the K00 phase until at least the end of their first year of funding.
• The F99/K00 award is intended to facilitate successful transition to the postdoctoral career stage. Consequently, a requirement for the K00 phase award is successful completion of the doctoral dissertation degree and subsequent transition to a cancer-focused, mentored postdoctoral research position.
• Applicants are expected 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 and, except in unusual circumstances, NCI will not extend the F99 phase or delay the start of the K00 phase.
• To begin the K00 phase of the grant, individuals must have been offered and accepted a postdoctoral appointment to carry out cancer-focused research.
• When the K00 phase of the award begins, the F99 phase of the award ends.
• A transition application is required for the K00 phase. Prospective applicants must contact the F99 NCI Program Official as soon as a plan to assume a postdoctoral position develops and at least 9 months prior to the end of the F99 phase of the award to allow adequate time for NCI approval of the sponsor and the project and for development of a complete application. This will also ensure the transition to the K00 phase takes place without interruption in funding.

Use the Fellowship (F31-specific) section of the SF424 (R&R) application package for guidance, except where the instructions in the NOFO, i.e., the Notice of Funding Opportunity PA-27-037 -- Predoctoral to Postdoctoral Transition Award (Parent F99/K00 - Clinical Trial Not Allowed), tell you to do something else.
This guidance is listed in the order it appears in the Fellowship Instructions of the Application Guide. Please pay special attention to the following sections that deviate significantly from the F31 application:

• Fellowship Applicant Section – follow the instructions in the NOFO.
• Specific Aims – follow the instructions in the NOFO.
• Research Strategy Section – follow the instructions in the NOFO.

SF 424 (R&R) Form

• Start Date – refers to the start of the F99 phase.
• End Date – refers to the end of the K00 phase. NCI advises applicants to request 5 total years, even if they plan to transition to the K00 less than 2 years after the award.
• Estimated Project Funding – This is an estimate that covers both phases. See the NOFO.

R&R Other Project Information

• International Activities – Although foreign institutions are not allowed to apply, foreign components are permitted.
• Project Summary/Abstract – Address both phases.
• Project Narrative – Address both phases.

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

• Applicants are to use the Biographical Sketch Common Form.  Also see NOT-OD-26-018. 
• Manuscripts that are submitted or in preparation may be listed on the F99 applicant's biosketch but not on the biosketch of a Sponsor, Co-sponsor, or any other significant contributors.

PHS Fellowship Supplemental Form

You MUST follow the NOFO-specific instructions for all sections.

• Training in the Responsible Conduct of Research – in the Responsible Conduct of Research – required; limited to 1 page. Don’t forget to address each of the 5 required components:
  o    the format (face to face and online components)
  o    the topics covered (describe the course content)
  o    faculty participation (who participates in teaching the course)
  o    the duration (the NIH requires 8 hours of face-to-face time)
  o    the frequency (the NIH requires this to be repeated every 4 years and when you advance to a new career stage, i.e., the K00 phase)
• Sponsor and Co-Sponsor Statements
  • The 6-page limit is the total for the sponsoring team (not 6 pages per sponsor)
• Institutional Environment and Commitment to Training Section – follow the instructions given for F31 applications.
• Vertebrate Animals – include if applicable to the F99-phase research. Follow current NIH Guidelines and include a Vertebrate Animal Section in the application.
  • IACUC approval is needed before an award can be made, but not to submit the application.
• Resource Sharing Plan – include a plan that covers the F99 phase and addresses:
  • This is a REQUIRED element for all NIH Fellowship applications.
  • NIH policy requires that the results and accomplishments of the activities that it funds should be made available to the public.
  • The special guidance for research involving special topics such as Model Organisms.
  • Although Data Sharing and Genomic Data Sharing policies are not applicable to the F99 fellowship, reviewers often comment on whether fellowship applicants are aware of NIH policy. If you are doing work in these areas, NCI suggests that you add a brief description to show you are aware of the policies. If applicable, indicate that F99-generated data will be deposited as part of your sponsor’s funded research Genomic Data Sharing Policy.
• Authentication of Key Biological and/or Chemical Resources – If applicable to the F99 project, briefly describe methods to ensure the identity and validity of key biological and/or chemical resources used in the proposed studies.  A maximum of one page is suggested.
• Budget Section – use the F99 institution’s current graduate student and postdoctoral policies to estimate the costs for both phases, in conjunction with the Budget section of the NOFO, to estimate the total budget.
  • If an award is made, the NCI Grants Management Specialist will verify the tuition and fees for the F99 phase.
  • At the time of transition to the K00 phase, awardees will be asked to submit a new budget as part of the transition application.

Human Subjects and Clinical Trials Information

You, your sponsor, and your grants manager should read the instructions carefully.

• Include if applicable to the F99-phase research only, not the K00 phase.
• IRB approval is needed before an award can be made, but is not required to submit the application.
• Follow current NIH guidelines, PHS Human Subjects and Clinical Trials Information read the FAQs, and then include the Human Subjects section in your application.
• Use the Decision Tool below to determine if your research is human subjects research and what exemption applies if any: https://grants.nih.gov/policy/humansubjects/hs-decision.htm

Common mistakes involve the E4 exemption status and human specimens, cell lines or data. See the NIH OHRP website for guidance.

• If you answered “No” to the question “Are Human Subjects Involved” but are using human specimens and/or data, you must provide a justification for your claim that no human subjects are involved.

**An “investigator,” as it pertains to research involving human subjects, is defined as anyone involved in conducting the research. Individuals who provide coded information or specimens and collaborate on other activities related to the research are considered to be involved in the research and are therefore also considered to be investigators. Providers of data or samples who will be co-authors are also considered investigators. If any “investigator” has access to personally identifiable information, the work is categorized as Human Subjects Research.