Part 1. Overview Information

Key Dates

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

Other Award Budget Information

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

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

• 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.

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

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

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

Applicant Organizations

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

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

• 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.

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.

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.

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.

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

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

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

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.

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

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.

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.

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.

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.

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.

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.

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.

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:

• Federal-wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

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.

• For information on an institution's specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal conscience protections and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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.

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: 301-480-7075

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

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

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

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.

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.