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Grant Analysis

Purpose & Target

This grant aims to support early-stage postdoctoral researchers in their transition to independent, tenure-track faculty positions, fostering a strong cohort of new, NCI-supported investigators. - Target recipients are individual postdoctoral fellows with research/clinical doctoral degrees. - This is a SECTOR-SPECIFIC grant, focused on cancer research. - Geographic scope is limited to U.S. institutions. - Key filtering criteria include individual's postdoctoral experience (no more than 2 years), lack of prior independent faculty/research positions, and the research not involving leading an independent clinical trial. - This is a recurring grant opportunity with multiple application cycles annually until its expiration.

Financial Structure

K99 Phase Salary: Up to $100,000 per year towards the career award recipient's candidate.
K99 Phase Research Development Costs: Up to $30,000 per year for tuition, fees, research-related expenses (supplies, equipment, technical personnel), and travel to meetings/training.
R00 Phase Total Cost: May not exceed $249,000 per year. This amount includes salary, fringe benefits, research costs, and applicable indirect costs.
Indirect Costs (K99 extramural): Reimbursed at 8% of modified total direct costs.
Indirect Costs (R00 phase): Reimbursed at the extramural sponsoring institution’s indirect cost rate.
Eligible Costs (K99 research development): tuition and fees related to career development; research-related expenses (supplies, equipment, technical personnel); travel to research meetings or training; statistical services.
Ineligible Costs (K99 research development): Salary for mentors, secretarial and administrative assistants.
Matching Fund/Cost Sharing: Not required.
Financial Reporting: Annual Research Performance Progress Report (RPPR), financial statements.
Financial Sustainability: Institutions must provide a startup and salary package for the R00 phase equivalent to that given to a newly hired faculty member without a grant. R00 funds cannot offset typical startup packages.
Currency: USD (implied by NIH/NCI context).

Eligibility Requirements

Organizational Eligibility

Higher Education Institutions (Public/State Controlled, Private)
Nonprofits (with/without 501(c)(3) IRS Status)
For-Profit Organizations (Small Businesses, Other)
Governments (State, County, City/Township, Special District, Indian/Native American Tribal (Federally Recognized/Other), Eligible Agencies of Federal Government, U.S. Territory or Possession)
Other: Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations (other than Federally recognized tribal governments), Faith-based or Community-based Organizations, Regional Organizations)
Note: Eligible agencies of the Federal government (e.g., NIH intramural program) are only eligible for the K99 (mentored) phase, not the R00 (independent) phase.
Must be based in the U.S. (Foreign Institutions or non-domestic components of U.S. Organizations are not eligible to apply).
Must have a strong, well-established record of research and career development activities.
Must have faculty qualified to serve as mentors.
For the R00 phase, the institution must have appropriate infrastructure to support the proposed research and a history of external research funding.

Individual Eligibility (Program Director/Principal Investigator)

Must be a postdoctoral fellow with a research or clinical doctoral degree (e.g., PhD, MD, DO, DDS, DVM, ScD, DNS, PharmD or equivalent).
Must have no more than 2 years of postdoctoral research experience as of the application due date (exceptions for childbirth/leave).
Must be in a mentored, postdoctoral training position; if independence is achieved before K99 award, neither phase will be made.
Clinicians in clinical faculty positions that denote clinical independence but not research independence may be eligible.
No citizenship requirement, but visa status must allow research in U.S. for duration of both phases.
Must commit a minimum of 75% of full-time professional effort (9 person-months) to career development.
Must identify a primary mentor (or mentoring team) who is an active investigator and committed to the candidate's development.
Exclusion Criteria:
- Currently or previously held an independent research faculty or tenure-track faculty position (or equivalent) in academia, industry, or elsewhere.
- More than 2 years of related postdoctoral research training at the time of initial application or resubmission.
- Been an independent PD/PI on NIH research grants (e.g., R01, R03, R21), NIH career development awards (e.g., K01, K07, K08, K23, K25), or other peer-reviewed NIH or non-NIH research grants over $100,000 direct costs per year, or Project Leaders on sub-projects of program project (P01) or center (P50) grants or equivalent.
Research proposed must not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. (Experience in a mentor-led clinical trial is allowed).

Application Process

Application Deadlines

Latest application due date: October 14, 2026 by 5:00 PM local time of applicant organization.
If a due date falls on a weekend or Federal holiday, the deadline is extended to the next business day.

Application Procedure

Pre-application: Strong encouragement to confirm eligibility with NCI. Letter of Intent is not applicable. Pre-application webinar is anticipated.
Submission Systems: Applicants must use NIH ASSIST, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Registrations: Applicant organizations must complete and maintain active registrations with System for Award Management (SAM), obtain a Unique Entity Identifier (UEI), register with eRA Commons, and Grants.gov. PD/PIs must have an eRA Commons account and link to a valid ORCID ID. Registrations can take 6 weeks or more and must be completed prior to submission.
Review and Correction: Applicants are encouraged to apply early to allow time for corrections. Errors found during submission must be corrected and a changed/corrected application resubmitted by the due date.

Required Documentation and Materials

Institutional Nomination Letter: Written and signed by the head of the candidate's postdoctoral department/program, limited to 2 pages. Must identify one of four scientific areas (Cancer Data Science, Cancer Control Science, Molecular/Precision Cancer Prevention, Other Cancer Research) and affirm the candidate is the institution's sole nominee in this area for the specified due date.
SF424(R&R) Forms: Includes Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile Expanded, and R&R Budget.
PHS 398 Cover Page Supplement.
PHS 398 Career Development Award Supplemental Form: Sections include Candidate (Information and Goals for Career Development, Candidate’s Background, Career Goals and Objectives, Plan for Career Development/Training Activities), Research Plan (spanning K99/R00 phases), Mentor/Co-Mentor/Consultant/Collaborators (statements from each), and Environment & Institutional Commitment.
Data Management and Sharing Plan: Required for due dates on or after January 25, 2023.
PHS Human Subjects and Clinical Trials Information form: If human subjects are involved (Section 4 and 5 are not completed for this NOFO).
PHS Assignment Request Form.
Reference Letters: Submitted directly through eRA Commons 'Submit Referee Information' link.
Appendix: Limited items allowed.

Project Implementation Timeline & Reporting Obligations

Project Duration: Total period may not exceed 5 years (K99 phase up to 2 years; R00 phase up to 3 years).
Level of Effort: Candidate must commit a minimum of 75% full-time professional effort (9 person-months) to career development.
Transition to R00 Phase: Intended to be continuous. Requires candidate to secure an independent tenure-track (or equivalent) faculty position by the end of the K99 phase. R00 application submitted by the R00 phase institution no later than 2 months prior to proposed activation date.
Reporting: Annual Research Performance Progress Report (RPPR), final RPPR for closeout, financial statements, Federal Subaward Reporting System (FSRS) for subawards, SAM for integrity and performance matters.
Mentor's Report: Annual evaluation statement of candidate’s progress required from primary mentor during K99 phase.

Post-Award Requirements & Compliance

Compliance with NIH Grants Policy Statement terms and conditions.
Adherence to Federal-wide Standard Terms and Conditions for Research Grants.
Compliance with HHS Assurance of Compliance regarding non-discrimination and federal conscience laws.
Implementation of the approved Data Management and Sharing Plan.
IRB/IEC approval for protocols involving human subjects.
FAPIIS reporting requirements.

Evaluation Criteria

Overall Impact

Likelihood that the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in a health-related field.

Scored Review Criteria

Candidate:
- Potential to become a highly successful, independent investigator based on prior research, training, track record, and referee evaluations.
- Quality and originality of prior research and the current application.
- Record of research productivity, including peer-reviewed publications, considering years of postdoctoral experience.
- Quality of pre- and postdoctoral research training in developing scientific and technical expertise.
- Likelihood of achieving an independent, tenure-track position within the K99 phase timeline.
Career Development Plan/Career Goals and Objectives/Plan to Provide Mentoring:
- Appropriateness and justification of content and duration for candidate’s development stage and career goals.
- Extent to which the plan enhances/augments prior training and skills.
- Likelihood of contributing substantially to scientific/professional development and facilitating transition to independence.
- Adequacy of plans for evaluating K99 recipient's progress and guiding transition to R00.
- Appropriateness of timeline for transition to independence.
- Contribution of proposed clinical trial experience (if any) to research career development.
Research Plan:
- Rigor of prior research supporting the proposed project.
- Strategies to ensure a robust and unbiased approach, and plans to address relevant biological variables (e.g., sex).
- Significance and scientific soundness of K99 phase research and its appropriateness for developing research skills and a successful R00 program.
- Significance, scientific soundness, and logical extension of the R00 phase research from the K99 phase.
- Evidence of long-term viability of the proposed R00 phase research plan.
- Does the R00 project address an innovative hypothesis or challenge existing paradigms?
- Does it develop or employ novel concepts, approaches, methodologies, tools, or technologies?
- Extent to which the R00 research fosters the candidate’s career as an independent investigator.
- Contribution of proposed clinical trial experience (if any) to the research project.
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s):
- Mentor's track record in training independent researchers, research qualifications, scientific stature, and mentoring experience.
- Adequacy of supervision and commitment to applicant's career development.
- Mentor's plan addressing training needs and fostering transition to independence, including clear separation of candidate's research.
- Appropriateness of consultants/collaborators' research qualifications and their commitment (via letters of support).
- Appropriateness of Advisory Committee members' qualifications and commitment (via letters of support).
- For clinical trial experience, evidence of mentor's expertise to guide applicant.
Environment & Institutional Commitment to the Candidate:
- Quality and appropriateness of the institutional environment for candidate’s development during K99 phase.
- Adequacy of research facilities, educational opportunities, and collaborating faculty for candidate’s goals.
- Evidence of strong institutional commitment to fostering candidate’s development and preparation for independence.
- Assurance that 9 person-months (75%) effort will be devoted to research/career development.

Additional Review Criteria (not scored)

Protections for Human Subjects: Justification for involvement, protection against risks, potential benefits, importance of knowledge, data/safety monitoring. For exempt research, justification for exemption, human subjects involvement/characteristics, and material sources.
Inclusion of Women, Racial and Ethnic Minorities, and Individuals Across the Lifespan: Evaluation of proposed inclusion/exclusion plans based on scientific goals and research strategy.
Vertebrate Animals: Description of procedures, justification for use/species, interventions to minimize discomfort, justification for euthanasia method (if applicable).
Biohazards: Assessment of potential hazards and adequacy of proposed protections.

Additional Review Considerations (not scored, no impact on overall score)

Resource Sharing Plans: Reasonableness of sharing plans or rationale for not sharing.
Training in the Responsible Conduct of Research (RCR): Adequacy of proposed RCR training (format, subject matter, faculty participation, duration, frequency). Rated as 'ACCEPTABLE' or 'UNACCEPTABLE'.
Select Agent Research: Information on select agent use, registration, monitoring, biosafety, biocontainment, and security.
Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity of resources.
Budget and Period of Support: Whether budget and requested period are fully justified and reasonable.

Compliance & Special Requirements

Regulatory and Ethical Compliance

Human Subjects/Animal Welfare: Compliance with 45 CFR Part 46 for human subjects; evaluation of vertebrate animal use per AVMA Guidelines.
Data Management and Sharing: Adherence to NIH Policy for Data Management and Sharing for applicable awards (due dates on or after Jan 25, 2023). A Data Management and Sharing Plan is required.
Responsible Conduct of Research (RCR): All applications must include a plan for RCR instruction, including at least 8 contact hours in specific formats (no online-only), broad subject matter, faculty participation (including mentor), and instruction frequency.
Non-Discrimination: Recipient organizations must complete an HHS Assurance of Compliance form, agreeing to administer programs without discrimination based on race, color, national origin, age, sex, and disability, and comply with federal conscience laws. This includes ensuring meaningful access for Limited English Proficient individuals and effective communication with persons with disabilities.
Work Environment: Adherence to policies ensuring a safe and respectful work environment, free of sexual harassment.
Federal Awardee Performance and Integrity Information System (FAPIIS): Recipients must report and maintain currency of information regarding civil, criminal, and administrative proceedings if cumulative Federal award value is over $10,000,000.
Prohibited Telecommunications: Compliance with prohibition on certain telecommunications and video surveillance services or equipment.

Unique Aspects and Challenges

Independent Clinical Trial Prohibition: This NOFO specifically excludes projects where the candidate leads an independent clinical trial, clinical trial feasibility study, or ancillary clinical trial. This is a critical filtering criterion.
Dual-Phase Award: The K99 (mentored) and R00 (independent) phases are distinct but intended to be continuous, requiring successful transition to an independent faculty position for R00 activation.
Strict Postdoctoral Experience Limit: Candidates must generally have no more than 2 years of postdoctoral research experience, with specific, limited exceptions (childbirth, well-justified leaves).
Institutional Nomination: A unique requirement is the institutional nomination letter affirming the candidate as the sole nominee in a specific scientific area for a given due date. This indicates internal institutional competition and selection.
Separation from Mentor: A strong emphasis is placed on the candidate’s plan to achieve scientific independence from their mentor(s) during the K99 phase and for the R00 research program to be clearly separate.
R00 Activation Contingency: The R00 phase is not automatically awarded; it's contingent on satisfactory K99 progress and securing an appropriate independent tenure-track (or equivalent) faculty position, along with NIH approval of the institutional commitment.

Strategic Opportunities

This grant is ideal for highly promising postdoctoral researchers who are near-ready for independence and can demonstrate a clear path to becoming an independent investigator with a relatively short additional period of mentored training.
Strong alignment with NCI's specific scientific areas (cancer control, prevention, data sciences) provides a competitive edge.
Opportunity to establish a robust independent research program with significant initial funding and mentorship.

Risk Tolerance

The grant's structure requires significant commitment from both the candidate and the institution, and successful transition to an independent position is a key condition for the second phase, introducing a degree of risk regarding securing that position.

Grant Details