Part I Overview Information

Department of Health and Human Services

Participating Organization
National Institutes of Health (NIH), (

Components of Participating Organizations
National Cancer Institute (NCI), (
National Eye Institute (NEI), (
National Heart, Lung, and Blood Institute (NHLBI), (
National Human Genome Research Institute (NHGRI), (
National Institute on Aging (NIA), (
National Institute on Alcohol Abuse and Alcoholism (NIAAA), ( /)
National Institute of Allergy and Infectious Diseases (NIAID), (
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), (
National Institute of Biomedical Imaging and Bioengineering (NIBIB), (
National Institute of Child Health and Human Development (NICHD), (
National Institute on Deafness and Other Communication Disorders (NIDCD), (
National Institute of Dental and Craniofacial Research (NIDCR), (
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (
National Institute on Drug Abuse (NIDA), (
National Institute of Environmental Health Sciences (NIEHS), (
National Institute of General Medical Sciences (NIGMS), (
National Institute of Mental Health (NIMH), (
National Institute of Neurological Disorders and Stroke (NINDS), (
National Institute of Nursing Research (NINR), (
National Library of Medicine (NLM), (
Fogarty International Center (FIC), (
National Center for Complementary and Alternative Medicine (NCCAM), (
National Center on Minority Health and Health Disparities (NCMHD), (
National Center for Research Resources (NCRR), (
Title: NIH Pathway to Independence (PI) Award (K99/R00)

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of the NIH Pathway to Independence (PI) Award (K99/R00) previously issued as PA-06-133.  It includes clarification of Eligible Individuals, Award Information, Submission Requirements, Review Criteria, and Award Administration.  Relevant Notices issued since PA-06-133 have been incorporated into this announcement.

Updates: The following updates relating to this announcement have been issued:

NOTE: Prospective applicants are encouraged to see the extensive list of Pathway to Independence Award Questions and Answers regarding general issues, fiscal issues, citizenship issues, eligibility issues (individual and institutional), review issues, transition to the independent phase issues, and evaluation.

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2007 the NIH will gradually transition each research grant mechanism to electronic submission through and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications using those mechanisms electronically using For more information and an initial timeline, see NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts ( ). Specific funding opportunity announcements will also clearly indicate if submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site ( for the most current information when preparing a grant application.

Program Announcement Number: PA-07-297

Catalog of Federal Domestic Assistance Number(s)
93.213, 93.389, 93.172, 93.233, 93.837, 93.838, 93.839, 93.271, 93.855, 93.856, 93.173, 93.121, 93.847, 93.848, 93.849, 93.279, 93.859, 93.281, 93.361, 93.853, 93.894, 93.879, 93.989, 93.308, 93.867, 93.866, 93.846, 93.865, 93.286, 93.398  

Key Dates
Release Date: January 12, 2007
Letters of Intent Receipt Date(s): Not required       
Application Receipt Dates(s): Standard dates, please see for details
Peer Review Date(s): Standard dates, please see for details
Council Review Date(s): Standard dates, please see for details
Earliest Anticipated Start Date: Standard dates, please see for details
Additional Information To Be Available Date (URL Activation Date): Not applicable
Expiration Date: January 8, 2009 (per PA-09-036) - Previously: January 8, 2010 (per NOT-OD-07-093) - Originally: January 3, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The primary, long-term goal of the Pathway to Independence (PI) Award program is to increase and maintain a strong cohort of new and talented NIH-supported independent investigators.  The PI award program is designed to facilitate a timely transition from a mentored postdoctoral research position to a stable independent research position with independent NIH or other independent research support at an earlier stage than is currently the norm. 

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
   1. Research Objectives

Section II. Award Information
   1. Mechanism(s) of Support
   2. Funds Available
   3.  Transition from K99 Phase to R00 Phase of Award

Section III. Eligibility Information
   1. Eligible Applicants
     A. Eligible Institutions
     B. Eligible Individuals
   2.Cost Sharing or Matching
   3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
   1. Address to Request Application Information
   2. Content and Form of Application Submission
   3. Submission Dates and Times
     A. Submission, Review and Anticipated Start Dates
       1. Letter of Intent
     B. Sending an Application to the NIH
     C. Application Processing
   4. Intergovernmental Review
   5. Funding Restrictions
   6.Other Submission Requirements
   7.  Application Contents

Section V. Application Review Information
   1. Criteria
   2. Review and Selection Process
     A. Additional Review Criteria
     B. Additional Review Considerations
     C. Sharing Research Data
     D. Sharing Research Resources
   3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
   1. Award Notices
   2. Administrative and National Policy Requirements
   3. Reporting
   4.  Activating the Independent Phase of the Pathway to Independence Award (R00)

Section VII. Agency Contact(s)
   1. Scientific/Research Contact(s)
   2. Peer Review Contact(s)
   3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Career Objectives

Background and Objective

The primary goal of this initiative is to assist investigators in transitioning to a stable independent research position with NIH or other independent research funding.

One of the most challenging transitions in any research career is the transition from postdoctoral trainee to independent scientist. Recent reports from the National Research Council of the National Academies of Science (Bridges to Independence: Fostering the Independence of New Investigators in Biomedical Research, and Advancing the Nation’s Health Needs: NIH Research Training Programs) have highlighted the need for enhanced efforts to foster the transition of postdoctoral scientists from mentored environments to independence.

NIH believes that the creativity and innovation of new independent investigators in their early career stages play an integral role in addressing our Nation’s biomedical, behavioral, and clinical research needs.  However, the average age of first-time (new) Principal Investigators obtaining R01 research funding from the NIH has risen to 42 years for Ph.D. degree holders and 44 years for M.D. and M.D./Ph.D. degree holders.  The intent of the Pathway to Independence Program is to help alleviate this trend and to assist new investigators in transitioning to stable independent research positions at an earlier age and with an enhanced probability of success in obtaining independent NIH or other independent research support. 

In addition to this initiative, NIH Institutes and Centers (ICs) support a variety of other mentored career development programs designed to foster the transition of new investigators to research independence, which may be more suitable for particular applicants.  Information describing all NIH Career Development Award programs can be found at the K Kiosk - Information about NIH Career Development Awards.

Nature of the career/research transition opportunity

The PI award will provide up to 5 years of support consisting of two phases.  The initial mentored phase will provide support for up to 2 years for the most promising and exceptionally talented new investigators who have no more than 5 years of postdoctoral research training experience at the time of initial application or subsequent resubmission(s).  This initial phase of mentored support will allow the candidate time to obtain additional training, complete research, publish results, and bridge to an independent research position.   The candidate must propose a research project that will be pursued during the K99 phase and transition into an independent project during the R00 phase of the award.  The candidate and mentor(s) together will be responsible for all aspects of the mentored (K99 phase) career development and research program.  An individual may submit an application from an extramural or intramural sponsoring institution/organization that has a rich and extensive research program in the area of interest as well as the faculty, facilities and resources to support the proposed research endeavor.  The individual must select an appropriate mentor with a track record of funded research related to the selected research topic and experience as a supervisor and mentor. The sponsoring institution must ensure that the candidate has the protected time needed to conduct the proposed research.

Following the mentored phase, the individual may request up to 3 years of support to conduct research as an independent scientist at an extramural sponsoring institution/organization to which the individual has been recruited, been offered and has accepted a tenure-track full-time assistant professor position (or equivalent).  This support is to allow the individual to continue to work toward establishing his/her own independent research program and prepare an application for regular research grant support (R01).  Support for the independent phase, however, is not automatic and is contingent upon being accepted by an appropriate extramural institution and the successful NIH programmatic review of the individual’s mentored phase of the award.

See Section VIII, Other Information – Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the combination K99/R00 funding mechanism.  As an applicant, the candidate and his/her mentor(s) are jointly responsible for planning, directing, and executing the proposed mentored phase of the research project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions. The applicant should follow the instructions for budget information described in the PHS 398, Section III, providing only the total direct costs requested for each year and the entire proposed period of support and budget justification information. 

2. Funds Available

The PI award has two phases: a mentored phase of up to 2 years at an eligible extramural sponsoring institution/organization or NIH intramural laboratory followed by an independent scientist phase of up to 3 years sponsored by an extramural institution/organization to which the individual has been recruited.   Individuals who receive mentored phase support and are subsequently recruited to positions at NIH intramural laboratories will not receive the independent scientist phase of the award.

Mentored Phase of the Pathway to Independence Award Program (K99)

The total cost per year for the initial mentored phase generally should not exceed $90,000 at either an NIH intramural or an extramural sponsoring institution site, but may be higher in the case of individuals with exceptional salary needs.  Salary and fringe benefits may be requested up to the level provided by other Mentored Career Awards offered by the awarding Institute or Center.  Please contact the relevant IC for information:  Research support costs will be provided up to $20,000 for a 12 month budget period.  Some ICs may offer higher research support costs.  Because the nature and scope of the proposed research career development program will vary from application to application and the amounts provided for salary by the participating ICs are not uniform, it is anticipated that the size and duration of each award will also vary.  Although the financial plans of the ICs provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. 

Candidates (intramural or extramural) are required to commit a minimum of 75% of full-time professional effort (i.e. minimum of 9 person-months) to pursuit of their career development and research experience during the mentored phase.  This experience may also include activities such as completing research publications and searching for an independent research position.   Candidates may engage in teaching and/or clinical duties as part of the 25% maximum of the applicant’s full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program.

Intramural: Mentored candidates in the NIH intramural program will be supported by intramural funds provided by the NIH Institute/Center intramural laboratory in which they are conducting their research. Budget details for the mentored phase will be negotiated with the sponsoring intramural laboratory Institute/Center and salary will be consistent with that offered new scientists in similar positions.

Extramural: Mentored candidates in an extramural sponsoring institution/organization will be supported by NIH extramural funds. Salary must be consistent with levels provided to scientists in similar positions at the institution.  Fringe benefits should be requested based on the sponsoring institution’s rate. Research expenses may include (a) tuition and fees related to career development; (b) supplies, equipment and technical personnel; c) travel to research meetings or training; and (d) statistical services including personnel and computer time.    F&A costs will be provided at 8% of modified direct costs to extramural sponsoring institutions, only.

The extramural sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale. However, supplementation may not be from Federal funds unless specifically authorized by the Federal program from which such funds are derived.  In no case may additional PHS funds beyond those provided in the K99 award be used for salary supplementation.  Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of this award. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale.  The total salary paid from NIH funds, however, may not exceed the legislatively mandated salary cap.

Independent Investigator Phase of the Pathway to Independence Award Program (R00)

The total cost for the independent investigator phase may not exceed $249,000 per year. This amount includes salary, fringe benefits, research support allowance and applicable F&A costs.  F&A costs will be reimbursed at the extramural sponsoring institution’s F&A rate. Facilities and administrative costs requested by consortium participants are included in the total cost limitation.

The salary requested should be based on the person months effort to be devoted to the R00 project, as is the case for other research grant awards.  The applicant is required to devote a total of 75% of their full-time, 12 month professional effort to research (i.e., a full-time 9 person months).  See eligibility below.  However, it may not be feasible to support this entire effort through the R00 project alone.  Recipients of the R00 phase awards may devote effort to other research projects and may reduce effort on the PI award if they receive additional independent research support.  Please note that a reduction of time devoted to a project by 25% or more from the level in an approved application will require NIH prior approval as described in the NIH Grants Policy Statement

Applicable to both Mentored and Independent Phases

For information regarding NIH policy on determining full-time professional effort for career awards see NOT-OD-04-056. The requested salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members with equivalent qualifications, rank, and responsibilities in the department concerned.  If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be related appropriately to the existing salary structure.  Confirmation of salary is required prior to the issuance of an award.  Fringe benefits based on the sponsoring institution’s rate and the percent of effort are provided in addition to the salary.

Candidates who have VA appointments may not consider part of the VA effort toward satisfying the “full time” requirement at the applicant institution (see: NOT-OD-04-056). Candidates with VA appointments should contact the staff person in the relevant NIH Institute or Center prior to preparing an application to discuss their eligibility. 

3.  Transition from K99 Phase to R00 Phase Award

Transition from the mentored phase (intramural NIH or extramural institution) to the extramural independent scientist phase is NOT automatic and is subject to review of the awardee’s research training/career development accomplishments and an evaluation of the materials submitted in support of the R00 phase application.  The candidate must be accepted by an extramural institution in a tenure-track, full-time assistant professor (or equivalent) position in order to activate the extramural support phase.  Information on materials to be submitted is located in Section VI.4 Activating the Extramural Independent Investigator Phase of the Pathway to Independence Award (R00).

Acceptance into the PI Award Program does not imply a commitment on the part of the NIH to consider the awardee for a tenure-track position at an NIH intramural laboratory.  The primary intent of this program is to develop outstanding researchers who will pursue extramural research careers related to the mission of the NIH awarding component that provided the support for the program.  However, awardees may wish to apply for available tenure-track positions at the NIH.  The award will be terminated if the candidate is offered and accepts such a position.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

Eligible applicant organizations for the PI award include domestic for-profit or non-profit institutions/organizations, or public or private institutions, such as universities, colleges, hospitals and laboratories, and eligible agencies of the federal government.  NIH intramural laboratories are eligible to apply for this mechanism on behalf of intramural candidates.  Foreign institutions are not eligible to apply.

The applicant institution will be the mentored phase K99 institution.  All institution/organization types listed above are eligible for both the mentored and independent phase, with one exception: ineligible agencies of the Federal government, such as the NIH intramural program, are eligible only for the mentored phase.

For non-U.S. citizen/permanent residents, the applicant U.S. institution for each phase of the application (K99 or R00) is responsible for determining and documenting in the application that the applicant investigator’s visa will allow him or her to remain in this country long enough to (a) transition to an independent research career in the U.S. during the proposed mentored (K99) phase and/or (b) be productive on the research project in the U.S. for the duration of the proposed independent research (R00) phase. 

If a grant is awarded on the basis of this information and the individual's visa does not allow for such a stay, NIH may terminate the grant (see "Administrative Requirements—Changes in Project and Budget” and "Administrative Requirements—Enforcement Actions—Suspension, Termination, and Withholding of Support.”)  NIH will not intercede on behalf of non-citizens whose stay in the United States may be limited by their visa status. 

1.B. Eligible Individuals

U.S. citizens and non-U.S. citizens with the skills, knowledge, and resources necessary to carry out the proposed research are invited 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.

This award is intended for and limited to postdoctoral scientists who are in mentored training positions and do not have sufficient research experience or institutional authority to lead an independent research program.

At time of submission (or any resubmissions), applicants must:

Individuals are NOT eligible if they:

Ph.D. applicants in positions other than postdoctoral fellow positions

It is recognized that some institutions appoint postdoctoral fellows in positions with other titles although they are still in non-independent training positions.  Applicants in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications.  It is incumbent upon the applicant to provide evidence that the position he/she is in complies with the intent of this eligibility requirement. Evidence for non-independence may include:  

Conversely, evidence for independence, and therefore lack of eligibility, includes:

Clinicians (including those with M.D., D.D.S, D.V.M. and other licensed professionals) in positions not designated as postdoctoral positions

Following clinical training or fellowship training periods, clinicians often obtain a clinical faculty position that denotes independence in clinical responsibilities but not in research. A clinical faculty member who does not hold an independent research faculty position may be eligible for the K99/R00 award, and should contact a Program Director at the relevant NIH Institute for guidance. Clinicians in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications.      Such individuals may also wish to consider other career awards available for junior faculty development.  See: K Kiosk - Information about NIH Career Development Awards.

Applicants are strongly encouraged to consult with the scientific/research contact person listed in Section VII of this announcement prior to the submission of an application to discuss eligibility and program requirements (

2. Cost Sharing or Matching

Not applicable.

3. Other-Special Eligibility Criteria

A candidate for the PI award may not simultaneously submit or have an application pending for any other NIH fellowship, career award or research award. Ineligible individuals include current and former principal investigators on NIH research grants (e.g. R01, R03, R21), comparable individual NIH career development awards (e.g., K01, K07, K08, K23, K25), equivalent non-PHS peer-reviewed career development awards, or non-PHS peer-reviewed research grants over $100,000 direct costs per year, or project leaders on sub-projects of program project (P01) or center (P50) grants.   

PI award recipients are expected to apply for NIH or other independent research grant support during the independent phase of the award.  Recipients of a PI award may hold concurrent research support, and under certain circumstances (see Funds Available above) salary support from their PI Award and a competing NIH research project grant when recognized as a Principal Investigator or subproject Director of the research project grant; see NOT-OD-04-007.

Section IV. Application and Submission Information

1. Address to Request Application Information           

The PHS 398 application instructions are in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact Grants Info., Telephone (301) 435-0714, Email:

Telecommunications for the hearing impaired: TTY 301-451-0088.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a Dun &Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the D&B Website. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the “YES” box must be checked.  Applicants should use the substitute Table of Contents for Career Development Awards, and report their citizenship status in the appropriate box at the bottom of that page. 

Please note that applications responding to this announcement must include at least three sealed letters of reference attached to the face page of the original application.  Applications submitted without the required number of reference letters will be considered incomplete and will be returned without review.  Current postdoctoral mentor(s), other proposed mentors for this award, and/or anyone else participating in the application should not be used to provide one of the 3 required references.

2. Submission Dates and Times

See Section IV.3.A for details.

3. A. Submission, Review and Anticipated Start Dates
Application Receipt Date(s): Standard dates, please see for details
Peer Review Date: Standard dates, please see for details
Council Review Date: Standard dates, please see for details
Earliest Anticipated Start Date: Standard dates, please see for details

3. A.1. Letter of Intent

A letter of intent is not required for this funding opportunity.  However, applicants are encouraged to contact the scientific research/program contact at the relevant awarding component (See Section VII and, prior to submitting an application, to discuss issues of eligibility and review the specific provisions of this award.

3. B. Sending an Application to the NIH

Applications must be prepared using the research grant application forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies of the application and any appendix materials (NOT-OD-07-018) in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see NOT-OD-03-040).

3. C. Application Processing

Applications must be submitted on or before the application receipt/submission dates described above (Section IV.3.A.) and at Submission Dates/Deadlines. Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review (CSR).   Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Information on the status of an application should be checked by the applicant in the eRA Commons.

4. Intergovernmental Review  

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Ruth L. Kirschstein National Research Service Award (NRSA) recipients that are selected for PI award funding must terminate their NRSA support prior to receiving support from the PI award. 

Pre-award costs are allowable. A grantee may, at his/her own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement.

6. Other Submission Requirements

Applicants should follow the instructions in the PHS 398 application for Individual Research Career Development Awards (Section III) and complete all the required sections with the following modifications: 

Section D. Basic Administrative Data

Complete ALL sections with the following modifications:

Section F. Career Development Plan

Complete ALL the sections with the following modifications:

In addition to the Supplementary Instructions in the PHS 398 for Research Career Awards (Instructions, Part III), and the modifications stated above, applicants should consider the following when preparing the application.

Prospective applicants should contact the scientific/research contact at the targeted NIH awarding component (see Section VII; to discuss eligibility and determine actions necessary to initiate the process.  If the applicant is planning an NIH intramural laboratory for the mentored phase, a mentor will need to be selected with whom the candidate can consult in preparing and submitting the application for the intramural mentored phase of the award.  Individuals working at an NIH laboratory may work with their current mentor, or with another intramural investigator, provided the research experience proposed in this application will enhance the candidate’s scientific career. Candidates planning to be sponsored by an extramural institution should consult with the proposed mentor prior to contacting the NIH scientific/research staff to discuss the proposed research training/career development plan for the mentored phase and the research plan to be presented in the application for the subsequent independent scientist phase. In any case, both the candidate and the mentor must collaborate closely in preparing the application and follow the appropriate instructions.

7. Application Contents


Career Development Plan

Research Plan


Environment and Institutional Commitment to the Candidate

Training in the Responsible Conduct of Research

Applications must include a description of a program to receive formal or informal instruction in scientific integrity and the responsible conduct of research. Applications without plans for instructions in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. Applicants must follow the application instructions found on page 49 of the PHS-398 application package and refer to the NIH's Bioethics Resources on the Web  for additional guidance.

Document prior instruction in or proposed plans to obtain instruction in the responsible conduct of research in terms of subject matter and duration of instruction.  An award cannot be made if an application lacks this component.

Letters of Reference

Include with the application three or more sealed independent letters of reference from well-established scientists, other than the mentor(s) or any others involved in the application, which address the application content areas and any other evidence that the candidate has a high potential for becoming a successful candidate for this transition award program.  The mentor(s) may also submit letters of reference, but these letters will be considered independently of the three required reference letters.  All sealed letters of reference should be attached to the face page of the application.


Stop SignIMPORTANT NOTE: NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review.  See

Applicants must follow the specific instructions on Appendix materials as described in the PHS 398 Application (See

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Plan for Sharing Research Data

A plan for sharing research data is not required.

Sharing Research Resources

NIH policy expects that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication: NIH Grants Policy Statement: Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Research Resource.Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025)

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines (see also: Submission and Assignment Process).

Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group in accordance with the review criteria stated below. 

As part of the initial merit review, all applications:

Applicants can check the status of their application at each stage and receive the written critique through the eRA Commons.

The following will be considered in making funding decisions:

The goal of the PI award is to facilitate a new investigator’s transition from a postdoctoral status to an independent scientist with the ability to successfully compete for an R01 award.  In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research and career development plans will have a substantial impact on the pursuit of these goals:


Career Development Plan

Research Plan


Environment and Institutional Commitment to the Candidate

Training in the Responsible Conduct of Research

2. A. Additional Review Criteria:

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:

Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, adequacy of the proposed protection will be assessed.

2. B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research transition award program. The priority score should not be affected by the evaluation of the budget.

2. C. Sharing Research Data

A plan for sharing research data is not required.  

2. D. Sharing Research Resources

NIH policy expects that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. NIH Grants Policy Statement and Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice. Investigators responding to this FOA should include a plan addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the resource sharing plans with the Principal Investigator before recommending funding of an application. The final version of the resources sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report. (PHS 2590). See Section VI.3. Reporting.  

3. Anticipated Announcement and Award Dates

Earliest Anticipated Start Date: Standard dates, please see for details

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the applicant (Principal Investigator) will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General..

There will not be a formal Notice of Award (NoA) associated with the mentored phase of the PI Award conducted in the NIH intramural program.  The awarding Institute will transmit to the successful applicant an approval letter which will include the terms and conditions of the NIH intramural K99 award, as well as expectations for the transition to the independent phase (R00) of the award.

A formal NoA will be provided as part of the extramural mentored phase of the PI Award conducted at a domestic, sponsoring extramural institution/organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. 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..


In carrying out its stewardship of human resource-related program, the NIH may request information essential to an assessment of the effectiveness of this program.  Accordingly, recipients are hereby notified that they 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.

Changes in Research Program

A change in the specified scientific area of the research component requires prior approval of the awarding NIH institute or center.  A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed research plan.  The new research plan will be evaluated by staff of the awarding NIH component to ensure that the plan remains within the overall scope of the original peer-reviewed research program.  If the new plan does not satisfy this requirement, staff could recommend that the award be terminated.

Change of program/transfer of sponsoring institution

A change of sponsoring institution will be permitted only when all of the terms and benefits attributable to the original award can be assured.  Consultation with the NIH Institute or Center scientific/research staff responsible for the programmatic management of the award is strongly encouraged when a change of institution is being considered.  A change may be made without peer review, provided the PI plans no significant change in research and career development objectives and the facilities and resources at the new organization will allow for successful performance of the project. If these conditions or other programmatic or administrative requirements are not met, the NIH awarding office may disapprove the request and, if appropriate, terminate the award.

3. Reporting

Pathway to Independence Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form PHS 2590 annually and financial statements as required in the NIH Grants Policy Statement.

The mentored phase progress report must also include Sections a through f as described in the general PHS 2590 instructions, as well as sections g through j as described in Section IV of the 2590 instructions. Evaluation of the awardee’s progress will depend on the following:

A final progress report, invention statement, and Financial Status Report are required upon the conclusion or termination of an award.

4.  Activating the Independent Phase of the Pathway to Independence Award (R00)

Transition from the mentored phase to the independent phase is intended to be continuous in time and except in unusual circumstances, the K99 phase will not be extended beyond the 2 year limit. To activate the independent phase of the grant, individuals must have been offered and accepted a tenure-track, full time assistant professor position (or equivalent) at an eligible institution with appropriate infrastructure to support the proposed research program and a history of external research funding.  Applicants are free to apply for independent phase positions within the NIH intramural research program (IRP). However, should the individual accept such a position in the IRP, the independent phase of the award will not be activated.  This is because NIH intramural scientists are supported directly by NIH intramural funds and are not eligible for NIH extramural grant awards.  Such outcomes are not inconsistent with the goals of the PI award initiative.

The application for the R00 phase of the award must be submitted no later than 2 months prior to the proposed activation date of the R00 award by the R00 phase grantee organization. However, to avoid potential problems in activation, applicants are strongly encouraged to contact NIH program officials as soon as plans to assume an independent position develop, and not later than 6 months prior to the termination of the K99 phase of the award to discuss plans for transition to, and the application for, the R00 phase. This is especially important if the applicant has any question about the acceptability of a specific independent position for  the R00 phase of the award.

The independent phase institution will submit an application on behalf of the candidate for the R00 award using the PHS 398.  The R00 application must include a new Face Page signed by the R00 phase institutional representatives, new project description page (Form page 2), budget pages (Form pages 3 and 4), biographical sketches  a new resources page, an updated research plan, and a new checklist.  The abstract and specific aims should be updated to reflect current plans for the R00 phase and the updated research plans should be briefly described in 2-3 pages.  A letter from the Department or Division Chairman describing the institution’s commitment to the candidate and plans for his/her career development should be submitted, as well as a  final evaluation statement by the K99 phase mentor, if not already provided.  These materials should be sent to the Grants Management Office of the Awarding Institute or Center.  Details are available at the NIH New Investigator Program website.  The R00 application will be evaluated by extramural program staff of the awarding component for completeness and responsiveness to the program.

The K99/R00 award is intended to facilitate the successful transition to independence. Consequently, a requirement for activation of the R00 phase is successful completion of this transition. Applicants are encouraged (but not required) to apply for independent positions at departments and institutions different from where they conducted their mentored research.  It is important for all applicants, but especially so for applicants who intend to stay at the mentored phase institution for the independent phase, to provide a plan by which they will separate from their mentor and advance to independence.  Awardees are also encouraged to include a plan and timeline for submitting an independent research grant application in a research area relevant to the mission of an NIH awarding component.

An institutional commitment agreement will be required at the time of activation of the independent phase of the award. This agreement should satisfy the criteria described in the CDA Section III (Part F.3.) of the PHS 398 application. In addition to space, facilities, resources, and other support needed to conduct the proposed research, the sponsoring institution must provide protected research time (minimum of 75% effort) at least for the duration of the R00 award. The start-up package and other institutional support should be comparable to that given to other recently hired faculty into tenure-track or equivalent positions.  Moreover, institutions may not require the use R00 funds to offset a typical startup package. The sponsoring institution should describe the candidate’s academic appointment, bearing in mind that it must be tenure-track or equivalent, and confirm that the appointment is not contingent on the transfer of the award to the institution. The independent phase institution must foster and support the awardee’s ability to apply for and secure independent research grant (R01) support.

Candidates may engage in limited teaching, administrative and clinical duties as part of the 25% effort not required by this grant award, as long as such non-research duties are minimal. In cases where salary commensurate with the required 75% effort cannot reasonably be covered by the $249,000 maximum total cost R00 phase award, grantee institutions may need to supplement the candidate’s salary so that the salary is consistent with salaries of individuals in comparable positions at the institution.  However, such supplements may not require applicants to engage in additional responsibilities that would interfere with the required 75% effort on the PI Award is not permitted.  NIH staff may review start-up packages and other commitments between the institution and candidate prior to activating the independent phase of the award. NIH will not activate the independent phase if the institutional commitment is deemed inadequate Applicants that are approved to transition will receive a Notice of Grant Award reflecting the new R00 grant mechanism, the dollar amount, and the new recipient organization (if applicable).

Candidates who are not approved to transition will receive written notification from the awarding component communicating the rationale for the disapproval.  This letter typically will be sent within 60 days of receipt of the R00 application.

Although the financial plans of the NIH Institute or Center provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Termination of the K99 award phase

If transition from the K99 phase at an extramural institution to the R00 phase occurs at the originally scheduled end date of the K99 award, then no specific steps to terminate the K99 award are necessary.  If the transition occurs prior to the scheduled end date, then a revised Notice of Award will be issued to terminate the K99 phase award.   Carry-over of unspent funds from a partially completed year in the K99 phase into the R00 phase will be permitted. 

Section VII. Agency Contacts

Information about the Pathway to Independence award program can be found in the NIH New Investigator website.  We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:


2. Peer Review Contacts:

Not applicable.

3. Financial or Grants Management Contacts:


Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals ( as mandated by the Health Research Extension Act of 1985 (, and the USDA Animal Welfare Regulations ( as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts,

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (; a complete copy of the updated Guidelines is available at The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding ( It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NHMS) system ( at Pub Med Central (PMC) an electronic version of the author’s final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH.  The author’s final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005.  The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings.  Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at and view the Policy or other Resources and Tools including the Author’s Manual (

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website ( provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for 2 years to the research. For further information, please see:

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS) - Government Made Easy

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, RealPlayer, Video or Flash files, see Help Downloading Files.