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

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

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 transition (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. The two award phases are intended to be continuous in time. 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.

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

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

• Eligible Agencies of the Federal Government

Other

• None

F99 Eligibility: Domestic institution/organization types listed above that grant PhD or equivalent research degrees (e.g., DrPH, ScD) are eligible to submit an application. 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 NIH Intramural Programs and other Federal laboratories, are eligible to submit K00 transition phase applications on behalf of F99 awardees. There is no limit on the number of K00 awardees that an organization may sponsor.

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

Applicant Organizations

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

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

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

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

Any applicant fellow with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her sponsor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.

An applicant may be a citizen or a noncitizen national of the United States, have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status), or be a non-U.S. citizen with a valid U.S. visa. 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. 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.

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 begins a postdoctoral position or completes all doctoral dissertation requirements before an F99 award is issued, the applicant must forfeit both the F99 and the K00 awards.

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

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

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

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

Individuals may not exceed the aggregate limit of support shown above in the Award Project Period (see Section II. Award Information).

F99 awardees are required to pursue their research training on a full-time basis, normally defined as 40 hours per week or as specified by the sponsoring institution in accordance with its own policies.

K00 awardees are required to have a full-time appointment at the applicant institution, and to commit a minimum of 9 person months (or 75% of their full-time appointment at the applicant instititution) to their career development and research training. K00 awardees may engage in other duties (e.g., other research, training, clinical and teaching activities) as part of the remaining 25% effort not covered by the award, as long as such duties do not interfere with or detract from the proposed career development program.

Before submitting the application, the applicant must identify an F99 sponsor(s) who will supervise the proposed dissertation research training experience. The primary sponsor should be the applicant's primary dissertation research advisor and be committed both to the applicant s research training and to direct supervision of his/her research. The sponsor should have a successful track record of mentoring predoctoral students. Applicants may identify more than one sponsor, i.e., a team of sponsors, if this is deemed advantageous for providing expert advice in all aspects of the research and training program. When there is a sponsor team, one individual must be identified as the primary sponsor who will coordinate the applicant s training program. The applicant must work with the sponsor(s) in preparing the application.

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Fellowship (F) instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

Letter of Intent

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

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

Descriptive title of proposed activity

Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)

Names of other key personnel

Participating institution(s)

Number and title of this funding opportunity

The letter of intent should be sent to:

Michele McGuirl, Ph.D.
Cancer Training Branch
National Cancer Institute (NCI),
Telephone: 240-276-5421
Fax: 240-276-5659
Email: [email protected]

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

Instructions for Application Submission

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

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

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

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

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

This letter is limited to 2 pages.

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.

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

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

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

Fellowship Applicant Section

Applicant s Background and Goals for Fellowship Training

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

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:

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.

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.

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.

Approach

Provide an overview of the dissertation research, including the background, goal, rationale and hypotheses of the research project(s). The Approach for this Aim should be organized into two sections:

1. A progress report on the dissertation research project thus far, including the approaches used, research outcomes obtained, and important methodologies learned;

2. A detailed research proposal for the work to be completed in the F99 phase, including experimental design, anticipated results, potential problems, alternative strategies, and potential follow-up studies.

Specific Aim 2:

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.

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:

• 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.
• 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.

Institutional Environment and Commitment to Training Section

Description of Institutional Environment and Commitment to Training

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

Follow the instructions for F31 applications.

Appendix

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

PHS Human Subjects and Clinical Trials Information

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

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record. If gaining research experience in a clinical trial led by a sponsor/co-sponsor, provide the sponsor s ClinicalTrials.gov identifier (i.e., NCT number).

Study Record: PHS Human Subjects and Clinical Trials Information

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

• Do not complete Section 4 Protocol Synopsis information or Section 5 Other Clinical Trial-related Attachments.

Delayed Onset Study

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

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

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

The F99/K00 award may not be held concurrently with another federally sponsored fellowship or career development award, or a similar federal award that provides a stipend or salary, or otherwise duplicates provisions of this award.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:
All PD(s)/PI(s) and sponsor(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research 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 proposed training and the potential to lead to a productive, independent research career.

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

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

Fellowship Applicant

• Are the applicant’s academic record, prior training and research experience of high quality?
• Does the applicant have the potential to develop into an independent and productive
• researcher in biomedical, behavioral or clinical science?
• Does the applicant demonstrate commitment to a career as an independent 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 research investigator?

Sponsors, Collaborators, and Consultants

• Are the research qualifications (including recent publications) of the sponsor(s) in the fellowship phase, and track record of mentoring individuals at a similar stage, appropriate for the needs of the applicant?
• Is there evidence of a match between the research interests of the applicant and the sponsor(s) in the fellowship phase? Do the sponsor(s) demonstrate an understanding of the applicant’s training needs as well as the ability and commitment to assist in meeting these needs?
• Is there evidence of adequate research funds to support the applicant’s proposed research project and training for the duration of the fellowship phase?
• 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?
• Have the applicant and sponsor(s) described an appropriate set of qualifications and characteristics for the mentor in the career development phase of the award?
• 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?

Research Training Plan

• Is the proposed research project of high scientific quality, and is it well integrated with the proposed research training plan?
• Is the research project consistent with the applicant’s stage of research development, and relevant to his/her research career objectives?
• Is the proposed timeframe feasible to accomplish the proposed 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?
• Is the research plan outlined for the career development phase appropriate to the applicant’s anticipated stage of development and as a vehicle for developing the research skills described in the career development plan?
• If proposed, will the clinical trial experience contribute to the proposed project and/or the applicant’s research training?

Training Potential/Development Plan

• Do the proposed research project and training plan have the potential to provide the applicant with the requisite individualized and mentored experiences that will develop his/her knowledge, research, and professional skills?
• Does the training plan take advantage of the applicant s strengths and address gaps in needed skills? Does the training plan document a clear need for, and value of, the proposed training for the applicant?
• Does the training plan in the fellowship phase provide an appropriate foundation for transition to the career development phase of the award?
• 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?

Institutional Environment & Commitment to Training

• Are the research facilities, resources (e.g. equipment, laboratory space, computer resources, subject populations), and training opportunities (e.g. seminars, workshops, professional development opportunities) for the fellowship phase of the award adequate and appropriate?
• Is the intellectual environment for the applicant’s scientific development in the fellowship phase of the award of high quality?
• Is there appropriate institutional commitment to fostering the applicant’s mentored training toward his/her research career goals, in the fellowship phase of the award?
• Does the applicant describe adequate and appropriate research facilities, resources and training opportunities including the types of faculty capable of productive collaboration, for the transition to the career development phase of the award? Do the research facilities, resources and training opportunities described for the career development phase match the research program anticipated in that phase?

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

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six 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 six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

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 children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Training in the Responsible Conduct of Research

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan.

Budget and Period of Support

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

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

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

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

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

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

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

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

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

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

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

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

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

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.

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 encouraged to apply for postdoctoral positions at departments and institutions different from where they conducted their doctoral research. It is important for all applicants, but especially so for applicants who intend to stay at the predoctoral phase institution for the postdoctoral phase, to provide a plan by which they will separate from their Ph.D. sponsor.

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. 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 is ended.

Prospective applicants are strongly encouraged to contact the NCI Program Official as soon as a plan to assume a postdoctoral position develops, and not later than 4 months prior to the end of the F99 phase of the award.

An eligible K00 institution and mentor must have appropriate infrastructure to support the proposed research program and a history of external research funding. Foreign institutions are not eligible. Applicants may apply for 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, since NIH intramural scientists are not eligible for NIH extramural grant awards.

The K00 postdoctoral phase institution must submit the materials on behalf of the candidate for the K00 award, no later than 10 weeks prior to the proposed start of the K00 Award. The institution's Authorized Organizational Representative will email the application in PDF format 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, tuition and fees, other program related expenses, 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 less than 3 pages;
• A new Mentor, Co-Mentor, Consultant, Collaborators Section that includes a plan for transitioning the candidate to the next stage of his/her career by the end of the project award period. The mentor should describe previous experience as a mentor, including type of mentoring (e.g., graduate students, career development awardees, postdoctoral students), number of persons mentored, and career outcomes. If the primary mentor has limited training experience, a co-mentor with a strong, successful track record as a mentor should be included; If the candidate is proposing to gain experience in a clinical trial as part of his or her research training, the mentor or co-mentor must include a statement to document leadership of the clinical trial including source of funding, NCT# and appropriate expertise to guide the candidate in any proposed clinical trials research experience.
• An updated Environment and Institutional Commitment to the Candidate Section;
• An 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 Children (as appropriate);
• Updated Other Research Plan Sections (as appropriate), including:
• Vertebrate Animals;
• Select Agent Research;
• Resource Sharing Plans;
• Authentication of Key Biological and/or Chemical Resources; and
• Updated Biohazards.

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. A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of the K00 phase of the award, as described in the NIH Grants Policy Statement.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually. The report is due two months before the beginning date of the next budget period and must include information describing the current year's progress as well as the research and training plans for the coming year.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Michele McGuirl, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5421
Email: [email protected]

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: [email protected]

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

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