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.

Program Announcement

PA-07-297 NIH Pathway to Independence (PI) Award (K99/R00) ¹

Grants awarded by NCI under this announcement will be funded as Howard Temin Pathway to Independence Awards in Cancer Research.

The candidate's research proposal must include research on the etiology, pathogenesis, prevention, diagnosis, control and treatment of HUMAN cancer. The proposed research may involve model systems, including animal models. However, at some point during the grant period, the proposed research must include work on human cancer (includes human cancer cells or tissues).

Candidates must be able to identify an individual with extensive experience in human cancer research who can serve as a mentor for the initial mentored phase of this award.

In the mentored phase, NCI will support salaries up to $75,000, plus applicable fringe benefits, and up to $30,000 for research support costs for a 12-month budget period.

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.

#	Grant Number	Principal Investigator Name	Project Title	Institution
1	1K99CA127462-01	BEHBOD, FARIBA	Role of Cancer Stem Cells in Malignant Progression of Ductal Carcinoma in Situ.	BAYLOR COLLEGE OF MEDICINE
2	1K99CA129640-01	CHAN, KEITH SYSON	Identification and characterization of bladder cancer stem cells	STANFORD UNIVERSITY
3	1K99CA125994-01A1	COVERT, MARKUS W	Combining Computational and Experimentation to Interrogate NF-kappaB Signaling	STANFORD UNIVERSITY
4	1K99CA127134-01	DAI, MUSHUI	Dissection of the feedback inhibition of c-Myc by L11	INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
5	1K99CA126186-01	HE, LIN	Functions of microRNAs in lymphomagenesis	COLD SPRING HARBOR LABORATORY
6	1K99CA126026-01A1	KOBAYASHI, SUSUMU	Role of EGFR mutations and new therapeutics in lung cancer	BETH ISRAEL DEACONESS MEDICAL CENTER
7	1K99CA126980-01	LI, ZHE	Breast cancer stem cells and their cellular origin	CHILDREN'S HOSPITAL BOSTON
8	1K99CA126147-01	MCMAHON, PAMELA	Developing approaches for modeling genomic and proteomic profiles in lung cancer	MASSACHUSETTS GENERAL HOSPITAL
9	1K99CA129070-01	MEDAROVA, ZDRAVKA O.	Target-Specific Imaging and Delivery of siRNA to Tumors	MASSACHUSETTS GENERAL HOSPITAL
10	1K99CA127599-01	QUARLES, CHRISTOPHER CHAD	Quantitative MRI Assessment of Tumor Hypoxia and Angiogenesis	VANDERBILT UNIVERSITY
11	1K99CA129174-01	ROHATGI, RAJAT	Biochemical Mechanisms of Hedgehog Signaling	STANFORD UNIVERSITY
12	1K99CA127772-01	SILVA, JOSE M	Genetic approaches to next-generation breast cancer therapy	COLD SPRING HARBOR LABORATORY
13	1K99CA129172-01	STEGH, ALEXANDER H.	The Role of Bcl2L12 in the Genesis of Malignant Glioma	DANA-FARBER CANCER INSTITUTE
14	1K99CA126839-01	TANNOUS, BAKHOS A	Imaging and therapy of tumors using biotinylated cell surface docking sites	MASSACHUSETTS GENERAL HOSPITAL
15	1K99CA127361-01	VARGO-GOGOLA, TRACY	P190-B RhoGAP regulates the microenvironment in the developing mammary gland	BAYLOR COLLEGE OF MEDICINE
16	1K99CA126182-01A1	VERMA, SUBHASH C.	Understanding the mechanism of KSHV latent DNA replication	UNIVERSITY OF PENNSYLVANIA
17	1K99CA126160-01A1	WANG, QIANBEN	Genome-Wide Analysis of Transcription Factor Function in Prostate Cancer	DANA-FARBER CANCER INSTITUTE
18	1K99CA125892-01	WANG, SHIZHEN EMILY	Crosstalk TGFbeta and HER2 (ErbB2) Signaling in Mammary Tumorigenesis	VANDERBILT UNIVERSITY
19	1K99CA125937-01	XIN, LI	Characterization of prostatic stem cells and prostate cancer-initiating cells	UNIVERSITY OF CALIFORNIA LOS ANGELES
20	1K99CA126173-01	ZHANG, YOU-WEI	Roles of the Checkpoint Kinase Chk1 in Cancer Biology and Therapy	SALK INSTITUTE FOR BIOLOGICAL STUDIES

Submitting an Application

In submitting a competing K99/R00 Howard Temin Award, the applicant must use the PHS 398 Form (Revised 9/2004) ², 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 9/2004) ² 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 9/2004) ² 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 a peer review group 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 section of the Program Announcement: PA-07-297 NIH Pathway to Independence (PI) Award (K99/R00) ¹

Questions and Answers

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 ³.

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