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Grant Analysis

Purpose & Target

The NHLBI Career Transition Award (K22) aims to support highly qualified postdoctoral fellows and doctoral-level researchers currently training within the NHLBI Division of Intramural Research. Its core objective is to facilitate their transition to independent junior investigator positions at extramural institutions. The grant provides a two-phase support model: a mentored intramural phase (up to two years) followed by an independent extramural phase (three years). Applicants must propose to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary study to an existing trial. This is a SECTOR-SPECIFIC grant focused on biomedical, behavioral, and clinical research relevant to heart, lung, and blood diseases. The geographic scope is limited to the United States (including U.S. Territories and Possessions), as foreign organizations are not eligible to apply. This is a recurring grant opportunity, reissued from PAR-22-040, with multiple application deadlines each year until its expiration date.

Financial Structure

Total Award Period: Five years (up to two years intramural, plus three years extramural).
Intramural Phase Salary: Support during the intramural phase is based on the candidate's postdoctoral experience, commensurate with NHLBI intramural salary structure, and provided by the candidate's laboratory or branch.
Intramural Phase Research Expenses: Including personnel, consultants, equipment, supplies, and travel, these are negotiated with the NHLBI intramural laboratory chief based on the nature and scope of the research.
Extramural Phase Total Cost: May not exceed $249,000 per year and $747,000 for the three-year period. This amount includes salary, fringe benefits, research support allowance, and applicable Facilities & Administrative (F&A) costs.
Extramural Phase Salary: The total salary provided may not exceed the legislatively mandated NIH salary cap.
Indirect Costs (F&A): Reimbursed at 8% of modified total direct costs for the extramural phase.
Cost Sharing: Not required.
Financial Guarantees: Extramural institutions must demonstrate a commitment to the candidate by providing protected research time, space, and supplemental funds (including salary) in the form of a startup package. This startup package must be comparable to that given to other newly hired faculty and cannot be offset by K22 funds.
Eligible Costs: Salary, fringe benefits, research support allowance, F&A costs (extramural phase). Personnel, consultants, equipment, supplies, travel (intramural phase).
Ineligible Costs: Salary for mentors, secretarial, and administrative assistants is not allowed.

Eligibility Requirements

Individual Eligibility (Program Director/Principal Investigator)

Current Training Status: Must be an NHLBI postdoctoral fellow or other doctoral-level NHLBI researcher currently in training within the NHLBI Division of Intramural Research.
Prospective Trainees: Individuals accepted to an intramural NHLBI postdoctoral position may apply once their intramural appointment begins.
Time in Research: Must have no more than 5 years of full-time research experience in the NHLBI Division of Intramural Research as of the due date for a new application.
Citizenship: By the time of award, must be a U.S. citizen, non-citizen national, or lawfully admitted for permanent residence (Green Card holder).
Doctoral Degree: Must hold a clinical or research doctorate (e.g., PhD, MD, DO, DDS, DVM, ScD, PharmD, or equivalent).
Postdoctoral Experience: Must have postdoctoral research experience demonstrating potential for highly productive research.
Full-time Research: Must commit 100% full-time effort to research during the intramural phase.
Extramural Appointment: To obtain support for the extramural phase, must have a full-time formal tenure-track (or equivalent) appointment offer at the academic institution that is the applicant institution.
Exclusion Criteria: Not eligible if holding non-mentored and independent positions (e.g., staff scientist, Assistant Clinical Investigator, Lasker Clinical Research Scholars, Stadtman Investigator, or other tenure-track equivalent positions).
Prior Awards: Not eligible if they have a pending application for any other PHS career development award, an NIH institute-specific K22, or a Pathway to Independence Award (K99/R00).
Prior Grant PI: Not eligible if they have been or are currently a PD/PI on an NIH research grant (e.g., R03, R21, R01) or a subproject leader on an NIH multicomponent grant, or an equivalent NIH or non-NIH award.
Clinical Trial Focus: Must propose to serve as the lead investigator of an independent clinical trial, clinical trial feasibility study, or a separate ancillary study to an existing trial.

Organizational Eligibility (Applicant Institution for Extramural Phase)

Intramural Phase Application: Only the NHLBI intramural program can submit applications on behalf of intramural candidates for the mentored phase.
Extramural Phase Application: The application for the independent phase must be submitted by an extramural institution.
Eligible Extramural Institution Types:
- Higher Education Institutions (Public/State Controlled, Private)
- Nonprofits (501(c)(3) IRS Status and others)
- For-Profit Organizations (Small Businesses, Other than Small Businesses)
- Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal Governments)
- Federal Governments (Eligible Agencies, U.S. Territory or Possession)
- Other (Independent School Districts, Public Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations).
Geographic Restrictions: Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic components of U.S. Organizations are not eligible. Foreign components as defined by NIH Grants Policy Statement are not allowed.
Required Registrations: Applicant organizations must complete and maintain active registrations with the System for Award Management (SAM), Unique Entity Identifier (UEI), eRA Commons, and Grants.gov prior to submission.
Institutional Environment: The extramural institution must demonstrate a strong, well-established record of research and career development activities and faculty qualified to serve as mentors. They must provide protected research time, space, and a sufficient startup package comparable to other faculty newly hired into tenure-track or equivalent positions.

Application Process

Application Process and Submission

Submission System: Applications must be submitted electronically through Grants.gov using the NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
Applicant: For the intramural phase, the NHLBI intramural program submits on behalf of candidates. For the independent extramural phase, the extramural institution submits the application.
Application Due Dates: Multiple deadlines annually. The latest application due date is June 12, 2027, by 5:00 PM local time of the applicant organization. Applicants are encouraged to apply early.
Expiration Date: The Funding Opportunity Announcement (NOFO) expires on July 13, 2027.
Reference Letters: Candidates must follow instructions for reference letter submission, which is a separate process directly through eRA Commons. Applications without required reference letters will not be reviewed.
System Requirements: All PD(s)/PI(s) must have an eRA Commons account and an ORCID ID linked to their profile. Organizations must be registered with SAM, UEI, eRA Commons, and Grants.gov.

Required Documentation and Materials

Application Package: SF424(R&R) forms, including Cover, Project/Performance Site Locations, Other Project Information, Project Summary/Abstract, Senior/Key Person Profile Expanded, R&R Budget.
PHS 398 Forms: Cover Page Supplement, Career Development Award Supplemental Form.
Career Development Award Supplemental Form Sections: Candidate Section (background, career goals, plan for career development), Research Plan Section (spanning both phases, including clinical trial details), Mentor, Co-Mentor, Consultant, Collaborators Section (statements from mentors and collaborators), Environmental and Institutional Commitment to the Candidate Section (statements from NHLBI Scientific Director and extramural institution).
Other Plans: Data Management and Sharing Plan (required for all research generating scientific data), PHS Human Subjects and Clinical Trials Information (if applicable).

Review and Selection Process

Evaluation: Applications are evaluated for scientific and technical merit by a Scientific Review Group and receive a written critique.
Funding Decisions: Based on scientific and technical merit, availability of funds, and relevance to program priorities.

Post-Award Requirements and Compliance

Reporting: Recipients are required to submit the Research Performance Progress Report (RPPR) annually, including a Mentor’s Report for mentored awards. A final RPPR and financial report are required for closeout.
Transition to Extramural Phase: Not automatic. Requires successful research program during intramural phase, NHLBI progress review, and a full-time formal tenure-track (or equivalent) appointment offer at an extramural institution. The extramural phase application is submitted by the extramural institution no later than 3 months prior to the proposed activation date.
Data Management and Sharing: Recipients must adhere to the approved Data Management and Sharing Plan.
ClinicalTrials.gov: If applicable, the responsible party must register and submit results information for clinical trials.
IRB/IEC Approval: Recipient institutions must ensure all protocols are reviewed by their IRB or IEC.
Data and Safety Monitoring: Required for human biomedical and behavioral intervention studies.
IND/IDE Requirements: Clinical research projects involving investigational interventions must be performed under FDA IND or IDE.
Accountability Reporting: Recipients are required to report information about first-tier subawards (FFATA) and maintain currency of information in SAM regarding civil/criminal/administrative proceedings (Section 872 of PL 110-417).

Evaluation Criteria

Overall Impact

Reviewers assess the 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: Assessment of the candidate’s background, prior training, research potential (evidenced by publications, experience, reference letters), commitment to a research career, and ability to organize/implement proposed clinical trials.
Career Development Plan/Career Goals and Objectives/Plan to Provide Mentoring: Evaluation of the systematic plan showing progression to independent investigator status, justification for further career development, and inclusion of training activities (e.g., data management, ethics).
Research Plan: Evaluation of the proposed research across both intramural and extramural phases, including scientific significance, innovation, approach, and how mentored research leads to independent research. This includes proposed timelines, challenges, and solutions for the clinical trial.
Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s): Assessment of the primary NHLBI intramural mentor’s qualifications, track record of mentoring, commitment to the candidate’s development, and the plan for supervision and promoting independence. Evaluation of any co-mentors and their expertise.
Environment & Institutional Commitment to the Candidate: Assessment of the NHLBI intramural environment’s suitability for the candidate’s development and research. For the extramural phase, evaluation of the institution’s commitment (protected time, space, startup funds) to support the candidate’s independent research and career progression to R01-equivalent funding.

Additional Review Criteria (Not Scored, but Impact Overall)

Study Timeline for Clinical Trials: Detailed evaluation of timelines, potential challenges, and solutions for the proposed clinical trial.
Protections for Human Subjects: Adequacy of plans for human subject protection.
Inclusion of Women, Minorities, and Individuals Across the Lifespan: Compliance with NIH policies on inclusion.
Vertebrate Animals: If applicable, assessment of animal use plans.
Biohazards: If applicable, assessment of biohazard management plans.
Resubmissions/Renewals/Revisions: Evaluation of how previous reviews were addressed.

Additional Review Considerations (Not Scored)

Training in Responsible Conduct of Research (RCR): Evaluation of the RCR training plan (format, subject matter, faculty participation, duration, frequency) as ACCEPTABLE or UNACCEPTABLE (minimum 8 contact hours required, not solely online).
Select Agent Research: Assessment of plans for handling select agents.
Resource Sharing Plans: Review of proposed data and resource sharing plans.
Authentication of Key Biological and/or Chemical Resources: Plans for ensuring validity of resources.
Budget and Period of Support: Justification and reasonableness of the proposed budget and duration.

Compliance & Special Requirements

Regulatory Compliance

NIH Grants Policy Statement: All awards are subject to the terms, conditions, and cost principles outlined in the NIH Grants Policy Statement.
Nondiscrimination Laws: Recipients must comply with all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690).
SAM.gov: Compliance with SAM.gov requirements regarding integrity and performance information.
E.O. 12372: This initiative is not subject to intergovernmental review.

Data Protection and Privacy

Data Management and Sharing Plan: Required for all applications planning research that generates scientific data. Must be attached in FORMS-H application packages and implemented upon approval.

Ethical Standards

Responsible Conduct of Research (RCR): All applications must include a plan to fulfill NIH requirements for RCR instruction, including minimum contact hours and specific subject matter.
Human Subjects Protections: Compliance with regulations for research involving human subjects, including IRB/IEC approval and data and safety monitoring.

Risk Management

Pre-Award Costs: Allowable only as described in the NIH Grants Policy Statement.

Unique Aspects and Challenges

Two-Phase Award: The grant has a distinct two-phase structure (mentored intramural, independent extramural), with a non-automatic transition requiring specific reviews and a confirmed independent faculty appointment.
Intramural Requirement: The initial phase explicitly requires the candidate to be an NHLBI intramural postdoctoral fellow or researcher.
Clinical Trial Requirement: This specific NOFO is exclusively for applicants proposing to lead an independent clinical trial, feasibility study, or ancillary study. Applicants not proposing a clinical trial must apply to the companion NOFO (PAR-24-209).
Mentorship: Strong emphasis on mentorship throughout the intramural phase and continued guidance for career development during the extramural phase.
Institutional Commitment: The extramural institution must provide substantial commitment, including protected research time and a competitive startup package, which is reviewed by NHLBI staff before activating the independent phase.
Level of Effort: Candidates are required to commit a minimum of 75% of full-time professional effort (9 person-months) to their career development program, especially during the extramural phase.
Career Path Focus: Specifically intended to develop scientists for careers in the extramural biomedical research community, not for internal NHLBI tenure-track positions, though not precluded from applying.

Technology Specifications

NIH ASSIST, eRA Commons, Grants.gov: Required electronic platforms for application submission and management.

Grant Details