NCI Special Notes

Funded K99/R00 Grants

Submitting an Application

Peer Review Process

Frequently Asked Questions

NCI Staff Contacts

Introduction

The goal of the Pathway to Independence Award (PI) is to facilitate receiving an R01 award earlier in an investigator's research career and ultimately to increase and maintain a strong legion of new and talented NIH-supported independent investigators.

The PI award provides up to five years of support composed of two phases. The initial phase will provide 1-2 years of mentored support for highly promising, postdoctoral research scientists. The initial phase is followed by up to 3 years of independent support contingent on securing an independent research position. Award recipients will be expected to compete successfully for independent R01 support from the NIH during the career transition award period.

The PI Award is limited to researcher's holding doctoral degrees who have less than 5 years of research experience since their doctoral degree and are still in a mentored position. The initial application for the mentored phase may be submitted on behalf of the candidate (principal investigator) by any domestic for-profit or non-profit institution/organization such as universities, colleges, hospitals and laboratories, and eligible agencies of the Federal government, including NIH intramural laboratories. Foreign institutions are not eligible to apply.

The subsequent application for the independent phase may be submitted on behalf of the awardee (principal investigator) by any domestic for-profit or non-profit institution/organization such as universities, colleges, hospitals and laboratories at which the awardee has been recruited. Agencies of the Federal government (including NIH intramural laboratories) and foreign institutions are not eligible to apply for the independent phase of the PI award.

Applicants may submit only one PI Award application, and may not simultaneously submit applications or have awards pending for any other PHS career development award (K-series mechanisms). Up to two revisions of an application will be accepted. Pathway to Independence Awards are neither renewable nor transferable from one principal investigator to another.

The K99 phase of the award provides support in the form of salary (up to $75,000 per year plus fringe benefits), research development support (up to $30,000 for expenses such as tuition/fees, books, supplies/equipment, and travel to meetings), ancillary personnel support, and 8 percent facilities and administrative costs (formerly called indirect costs). The total cost for the independent investigator R00 phase may not exceed $249,000 per year. This amount includes salary, fringe benefits, research support allowance and applicable indirect costs.

UPDATE: The K99 mentored phase salary is now capped for competing awards issued after January 1, 2009 at $100,000 per year for a 75% effort (9 person-months) commitment. Please see http://grants.nih.gov/grants/guide/notice-files/NOT-CA-09-022.html for further salary details.

Program Announcement

New Electronic PA required for February 12, 2009 Grant Submission: PA-09-036 NIH Pathway to Independence Award (K99/R00) ¹

This replaces PA-07-297 NIH Pathway to Independence (PI) Award (K99/R00) ²

Use of Model Systems

The proposed research may include model systems, including animal models. However, at some point during the grant period, the proposed research must include work on human cancer. Work developing or refining model systems will be supported only if the proposed research objectives actively test the relevance of the model to human cancer.

Data Sharing

Under the NIH Data Sharing Policy, grantees are expected to engage in a timely release of final data sets that have been generated with NIH support for use by other researchers, provide a Data Sharing Plan that will achieve this objective, OR state why data sharing is not possible or appropriate. No Data Sharing Plan is required for the mentored phase of the K99 mechanism because it supports career development. However, during the un-mentored, independent phase of the grant (R00 award), grantees are responsible to share the data and provide an acceptable Data Sharing Plan to the NIH as part of their NIH grant support.

The K99/R00- Howard Temin Pathway to Independence Award in Cancer Research is for outstanding junior scientists in laboratory- based cancer research who are committed to developing research programs in understanding human biology and human disease as they relate to the etiology, pathogenesis, prevention, diagnosis, and treatment of human cancer. This award provides support for a period of one or two years in a mentored environment, followed by a transition to the equivalent of an independent, tenure-track faculty position to develop an independent research program. The K99 provides support for up to 2 years for salary (up to $75,000 plus fringe benefits, per year) and research development support (up to $30,000 per year) during the mentored phase, while the ROO provides up to 3 years of support for the independent phase (up to $249,000 total cost, per year). The K99/K00 requires a minimum of 9 person-months (75% total professional effort) commitment toward the research and career development objectives of the award. Grant applications must include proposals for both phases and the K99R00 is nonrenewable.

See the NCI Funded Research Portfolio ³ for a current list of K99/R00 awards.

In submitting a competing K99/R00 Howard Temin Award, the applicant must use the PHS 398 Form (Revised 11/2007) ⁴, and should download the instructions and the Research Career Development Award form files. Refer to Section III of the instructions, "Preparing an Individual CDA Application". It is suggested that you print, if possible, the pages of PHS 398 Form (Revised 11/2007) ⁴ and carefully review all pages, especially the section titled "NOTABLE CHANGES MADE TO PHS 398. This section contains information to facilitate the completion of your application.

The PHS 398 Form (Revised 11/2007) ⁴ is also available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, Office of Extramural Research, NIH, Phone (301) 435-0714, Fax (301) 480-0525, E-mail: GrantsInfo@nih.gov.

Application Receipt Dates and Review Schedule

If the application receipt date falls on a weekend, the application must be postmarked by the application receipt date and received at the Center for Scientific Review (CSR) by the following Monday.

If the application receipt date falls on a holiday, (but not on a weekend), the application must be postmarked by the application receipt date and received at CSR by the following day.

* Start dates are determined by the availability of NCI funds and may not occur until well after the earliest possible start date.

Upon receipt, applications will be reviewed by the Center for Scientific Review (CSR) and the National Cancer Institute (NCI) for completeness and conformance to all eligibility requirements and special provisions and requirements. Incomplete or ineligible applications will be returned to the applicant without further consideration.

Those applications judged to be complete and eligible will be evaluated, according to the review criteria listed in the Program Announcement, by Subcommittee F ⁵ convened by the Division of Extramural Activities of the NCI. Applications will receive a second level review by the National Cancer Advisory Board (NCAB) to determine if the application meets the broad program needs and priorities of the NCI and the National Cancer Program.

For review criteria for the K99/R00 grant mechanism, see the Review Criteria ⁶ section of the Program Announcement.

1. Do postgraduate clinical training experiences count toward the 5-year research training eligibility limit?
   No. Time spent conducting postgraduate clinical training that does not involve research is not considered as part of the 5-year research training eligibility limit. Only time dedicated to research activities would count toward the 5-year limit. Therefore, applicants with postgraduate clinical training experience remain eligible and are encouraged to apply for the Pathway to Independence award.

2. Will Pathway to Independence (PI) Award recipients be considered "new investigators" when applying for NIH R01 support?
   Yes. New investigators can check "Yes" in the "New Investigator" box when applying for NIH R01 support if the principal investigator has not previously served as such on any Public Health Service (PHS)-supported research project other than a Pathways to Independence Award (K99/R00), a small grant (R03), an Academic Research Enhancement Award (R15), an exploratory/developmental grant (R21), or mentored career development awards for persons at the beginning of their research career (K01, K08, K22, K23, and K25). Current or past recipients of Independent Scientist and other non-mentored career awards (K02, K05, K24, and K26) are not considered new investigators.

3. Does postgraduate research work conducted outside of the United States count toward the 5-year research training eligibility limit?
   Yes. Time spent conducting postgraduate research, whether inside or outside of the United States, is considered as part of the 5-year research training eligibility limit.

4. What is meant by "at the time of initial application or resubmission?"
   Applicants must have fewer than 5 years of postgraduate research experience at the time the initial application or resubmission application is postmarked for delivery to the NIH.

5. How should potential reviewer concerns regarding overlap with the mentor's line of research during the K99 phase of the award be addressed?
   Candidates are strongly encouraged to include in their research plan: 1) a description of the mentor's research describing how it relates to his or her proposed research plan, and 2) details of potential overlap and synergism.

6. Are applicants with greater than 5 years of research training experience who have changed research directions or disciplines eligible to apply?
   In unusual circumstances, exceptions to the 5-year limit may be approved, e.g., where significant changes in fields of study have occurred, such as moving from physical science to life science research, or from engineering to behavioral research, exceptions to the five year limit can be made. Such unique exceptions will be considered on a case by case basis and will require concurrence of NIH program staff of the Institute or Center (IC) most likely to be assigned the application for potential funding. IC concurrence must be obtained prior to submission and a statement describing the circumstances must be included in the application.

For a more complete and up to date listing of Questions and Answers, please see the NIH's K99/R00 Questions and Answers Resources page ⁷.

For additional information regarding policies and/or guidance in preparing an application for the K99/R00 Award, contact:

Ms. Nancy C. Lohrey, M.S., MT-ASCP
Program Director
Telephone: (301) 496-8580
Fax: (301) 402-4472
E-mail: Lohreyn@mail.nih.gov

For information regarding fiscal and/or budget issues, contact:

Grants Administration Branch
Phone: (301) 496-3179
Fax: (301) 496-8601

For information regarding referral and review issues, contact:

Referral Officer
Division of Extramural Activities
Phone: (301) 594-1403
Fax: (301) 402-0275