Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title

The NCI Transition Career Development Award (K22)

Activity Code

K22 Transition Career Development Award

Announcement Type

Reissue of PAR-12-121

Related Notices

  • May 26, 2016 - This PAR has been reissued as PAR-16-293.
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)
  • NOT-OD-16-012 - Implementing Rigor and Transparency in NIH & AHRQ Career Development Award Applications (November 18, 2015)
  • January 13, 2015 - See Notice NOT-CA-15-010.

Funding Opportunity Announcement (FOA) Number

PAR-15-056

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.398

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) represents the continuation of an NCI program to facilitate the transition of investigators in mentored, non-independent cancer research positions to independent faculty cancer research positions. This goal is achieved by providing protected time through salary and research support for the initial 3 years of the first independent tenure-track faculty position, or its equivalent, beginning at the time when the candidate starts a tenure-track faculty position.

Key Dates

Posted Date

December 10, 2014

Open Date (Earliest Submission Date)

January 12, 2015

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Advisory Council Review

Earliest Start Date

Expiration Date

New Date May 26, 2016 per issuance of PAR-16-293. (Original Expiration Date: November 13, 2017)

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, includingSupplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

  1. Part 1. Overview Information
  2. Part 2. Full Text of the Announcement
    1. Section I. Funding Opportunity Description
    2. Section II. Award Information
    3. Section III. Eligibility Information
    4. Section IV. Application and Submission Information
    5. Section V. Application Review Information
    6. Section VI. Award Administration Information
    7. Section VII. Agency Contacts
    8. Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs. In addition to this opportunity, 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. These other programs may be more suitable for particular candidates. NIH also supports non-mentored career development programs for independent investigators.More information about Career programs may be found at the NIH Extramural Training Mechanisms website.

Doctoral-level investigators pursuing careers in all fields of cancer research often require extended periods of mentored research training beyond their original doctoral degrees (e.g., MD, MD/PhD, or PhD). Postdoctoral investigators who have no more than 4 years of postdoctoral research training experience at the time of initial application have access to the NIH Pathway to Independence Award in Cancer Research (K99/R00) for this purpose. However, because of the prolonged training experiences often needed for biomedical researchers, there is a wealth of talented new investigators still in mentored, non-independent positions who have more than 4 years of postdoctoral training in cancer research. These include investigators at domestic extramural institutions/organizations, as well as investigators working in Federal research groups. Many such investigators need additional protected time to develop successful independent research programs.

The objective of the NCI Transition Career Development Award (K22) is to provide support to mentored, non-independent investigators in transitioning to their first independent tenure-track faculty cancer research positions, or their equivalent, with an enhanced probability of success for obtaining independent NIH or other research project grant support. Candidates in mentored, non-independent cancer research positions may apply, and if successful, must obtain tenure-track faculty, or equivalent, positions, and NCI approval before awards will be issued.

The NCI K22 award will provide up to 3 years of support for the most promising and exceptionally talented mentored, non-independent investigators. This period of support is to allow the investigator to work towards establishing his/her own independent research program and to prepare an application for research grant support (R01 or equivalent). 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.

The candidate submits a K22 application from the institution where he/she currently pursues mentored, non-independent research training. The application will be peer reviewed and assigned an overall impact score. Successful candidates (i.e. whose application has been selected for funding) will receive a Letter of Intent to Commit Funds from NCI that will include the terms and conditions to issue/activate the K22 award. In order to issue/activate the K22 award, the candidate will need to first secure a tenure-track faculty position within 12 months of the receipt of the Letter of Intent to Commit Funds. Once the faculty position has been secured, the candidate will submit updated information about the K22 application with the support of the awardee institution. The awardee institution can be the same as the submitting institution or it can be different. The updated information of the transition to a tenure-track faculty position at the awardee institution will be evaluated by NCI staff to ensure that all programmatic requirements are met prior to the issuance/activation of the K22 award. The details of the requirements for the issuance/activation of the K22 award are described in Section VI.

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Award budgets are composed of salary and other program-related expenses, as described below.

Award Project Period

The total project period may not exceed 3 years.

Other Award Budget Information

Salary

NIH will contribute up to $ 100,000 per year toward the salary of the career award recipient.

The total salary requested must be based on a full-time staff appointment. The 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 of equivalent qualifications, rank, and responsibilities in the department concerned. Confirmation of salary may be required prior to the issuance of an award. Fringe benefits, based on the awardee institution’s rate and the percent of effort, are provided in addition to salary.

The awardee 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 PHS funds be used for salary supplementation. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the career award.

Other Program-Related Expenses

NIH will contribute up to $50,000 per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.

Salary for mentors, secretarial and administrative assistants, etc. is not allowed.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

NIH grant policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government, including the NIH intramural program
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization 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. Multiple PDs/PIs are not allowed.

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status .

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Such individuals may also be eligible for the NCI Transition Career Development Award to Promote Diversity (K22) supported by the Center to Reduce Cancer Health Disparities through the PAR-15-063 FOA and are advised to contact the NCI Scientific/Research Contact for PAR-15-063 "NCI Transition Career Development Award to Promote Diversity" for eligibility information.

Postdoctoral Investigators:

At the time of the initial application submission (or resubmission), candidates for this award must (1) have earned a terminal clinical or research doctorate (including PhD, MD, DO, DC, ND, DDS, DMD, DVM, ScD, DNS, PharmD, or equivalent doctoral degree) or a combined research doctorate/clinical degree; (2) have at least 2 years of postdoctoral, or its equivalent, training in cancer research at the time of submission of the initial application (e.g., postdoctoral fellow, postdoctoral associate, clinical fellow, clinical associate, or equivalent); (3) have no more than a total of 8 years of mentored, non-independent research training experience after the terminal clinical or research doctorate at the time of initial application or subsequent resubmission; (4) have not already obtained an individual career development award or research project grant (except R03) from the Federal Government; and (5) have not already had or have a tenure-track faculty position, or its equivalent.

Clinicians:

Following clinical training or fellowship training periods, clinicians (including those with MD, DDS, DVM degrees and other licensed professionals) may obtain clinical faculty positions that denote 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 K22 award and should contact the NCI Scientific/Research Contact listed in Section VII 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 development awards available for physician scientists.

Other Candidates:

Some institutions appoint postdoctoral fellows in positions with other titles (e.g., research associate, instructor, or equivalent) although they are still in mentored, non-independent training positions. Candidates in such positions are encouraged to obtain confirmation of their eligibility before they begin to prepare their applications. It is incumbent upon the candidate to provide evidence that he/she is in a mentored, non-independent position.

NIH Intramural Candidates:

Mentored, non-independent investigators in NIH intramural laboratories and other eligible agencies of the Federal Government are eligible to apply for the NCI K22 award.

Individuals are NOT eligible for the NCI K22 award if they:

  • Have less than 2 years of postdoctoral training in cancer research at the time of initial application; or
  • Have more than a total of 8 years of mentored, non-independent research training after the terminal clinical or research doctorate at the time of initial application or resubmission; or
  • Have currently or have previously held an independent research faculty or tenure-track faculty position, or its equivalent, in academia, industry, or elsewhere; or
  • Have an application pending for any other PHS career development award, including a Pathway to Independence Award (K99/R00); or
  • Have currently or have previously held another NIH career development award (e.g., K01, K07, K08, K18, K22, K23, K25, K99, K99/R00); or
  • Have been an independent principal investigator on an NIH research project grant (e.g., R01, R21; P01) or a subproject leader on a Program Project (P01) or Center Grant (P50), or a non-NIH research grant equivalent to these grants/awards; or
  • Have currently or have previously held other peer-reviewed NIH (except R03) or non-NIH research grants over $100,000 in direct costs per year; or
  • Have no affiliation with a domestic extramural institution or Federal institution at the time of initial application or resubmission.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct. An individual may not have another competing NIH career development application or an NIH research project grant (e.g., R01, R21) application pending review concurrently.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

  • To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
  • Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
  • Of an application with a changed grant activity code.

Level of Effort

At the time of award, the candidate must have a "full-time" appointment at the awardee institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their career development and research training. Candidates may engage in other duties as part of the remaining 25% of their 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.

Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the Scientific/Research Contact listed in Section VII prior to preparing an application to discuss their eligibility. Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.

Special Requirements:

NCI K22 award recipients are expected to apply for NIH or other independent research project grant support (R01 or equivalent) prior to the end of the 2nd year of support. Recipients may hold concurrent research support, and, under certain circumstances, salary support from the final 2 years of their K22 award and a competing NIH research project grant when recognized as the PD(s)/PI(s) or subproject Director of the research project grant. See NOT-OD-08-065.

Institutional Environment

The applicant institution must have a strong, well-established record of research and career development activities.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the "Apply for Grant Electronically" button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Page Limitations

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF 424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), must be followed.

Other Project Information

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), must be followed.

Project Summary/Abstract: Include a description of your current research and the research you propose to perform in the independent K22 award.

SF424(R&R) Senior/Key Person Profile Expanded

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), must be followed.

R&R Budget

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), must be followed, with the following additional instructions:

B A preliminary budget for research expenses for all three years is required as part of the application.

  • For the period of support, indicate the total period of support being requested: 3 years.
  • For Senior/Key personnel, list the name of the PD/PI only.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), must be followed.

PHS 398 Career Development Award Supplemental Form

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), must be followed, with the following additional instructions:

Candidate Information

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Candidate’s Background

  • Describe the candidate’s commitment to a career in a biomedical or behavioral research field relevant to the mission of the NCI.
  • Describe prior training and research efforts, and how they relate to the objectives and long-term career plans of the candidate.
  • Provide evidence of the candidate’s potential to develop into a successful independent investigator. Usually this is evident from publications, prior research interests and experience, and letters of reference.

Career Goals and Objectives

  • Describe a systematic plan that (1) shows a logical progression from prior research and training experiences to the research and career development activities that will occur during the K22 award period and then to independent investigator status; (2) justifies the need for further career development to become an independent investigator; and (3) describes the candidate's current, as well as long-term, research and career objectives.
  • If currently supported by an institutional or individual Ruth L. Kirschstein NRSA, describe the candidate’s current research training or fellowship program.

Candidate’s Plan for Career Development/Training Activities During Award Period

  • The candidate is responsible for the preparation of the career development plan. A timeline, including a publication plan, is strongly encouraged.
  • A systematic plan should be presented for obtaining biomedical, behavioral, or clinical science background, research experience, and career development activities necessary to launch the stated independent research career. Describe current activities and how they relate to the candidate’s career development plans and career goals. Describe proposed activities, e.g., those that will lead to new and/or enhanced research skills and knowledge, as well as related skills such as grant-writing, communication, leadership, and laboratory management.
  • The career development plan must be tailored to the needs of the individual candidate with the ultimate goal of achieving independence as a researcher.
  • The candidate must justify the need for the K22 award and must provide a convincing case that the proposed period of support (3 years) will substantially enhance his/her career and allow the pursuit of a novel or promising approach to a particular cancer research problem.
  • The candidate must discuss plans to apply for NIH or other independent research project grant support (R01 or equivalent) prior to the end of the 2nd year of support.
  • Although not required, an advisory committee may be formed to monitor the candidate’s progress during the career development program. If the exact composition of an advisory committee is not known at the time of submission, general roles and contributions of future committee members can be discussed.

Training in the Responsible Conduct of Research

  • All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR).
  • The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019.
  • Applications lacking a Plan for Instruction in the Responsible Conduct of Research will not be reviewed.

Statements and Letters of Support

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), must be followed, with the following additional instructions:

Plans and Statements of Mentor and Co-mentor(s)

  • The NCI Transition Career Development Award is not a mentored award. Candidates must include a statement indicating that this is a transition award with no mentor or co-mentors in this section sub-heading.

Letters of Support from Collaborators, Contributors and Consultants

  • Signed statements must be provided by each collaborator, contributor and/or consultant confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided that clearly documents expertise in the proposed area(s) of collaboration/consultation. Any other opportunities for the candidate’s professional growth should also be documented in these statements.
  • Advisory Committee members: The composition of an advisory committee, if any, should be described only in general terms. No signed statements or biographical sketches of members of the proposed advisory committee are expected or needed. Candidates will not be expected to know the exact composition of an advisory committee, if any, until they identify awardee institutions if selected for an award.

Environmental and Institutional Commitment to the Candidate

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), must be followed, with the following additional instructions:

Description of Institutional Environment

  • Due to the nature of this award, the candidate may not have identified a sponsoring awardee institution at the time of submitting the K22 application. Describe the submitting institution’s scientific environment, including the resources and facilities that will be available to the candidate in securing a tenure-track faculty position, or its equivalent, in a domestic academic institution.

Institutional Commitment to the Candidate’s Research Career Development

  • The submitting institution must provide a statement of commitment to assist in the candidate’s development into a productive, independent investigator and in his/her progression to a tenure-track faculty position, or its equivalent.

Research Plan

All instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series), must be followed, with the following additional instructions:

Research Strategy

  • A sound research project description that is consistent with the candidate’s level of research development and objectives of his/her career development plan must be provided.
  • The research project description should demonstrate not only the quality of the candidate’s research thus far, but also the novelty, significance, creativity and approach, as well as the ability of the candidate to successfully perform the proposed research.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Letters of Reference

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted (letters are due by the application due date as described in the NOT-OD-11-079). Applications lacking the appropriate, required reference letters will not be reviewed. This is a separate process from submitting an application electronically. Reference letters are submitted directly through the eRA Commons Submit Referee Information link and not through Grants.gov.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

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.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

Important Update: See NOT-OD-16-012 and NOT-OD-16-006 for updated review language for applications for due dates on or after January 25, 2016.

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers should provide their assessment of 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, taking into consideration the criteria below in determining the overall impact score.

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

Candidate

  • Does the candidate have the potential for becoming a successful independent investigator who will contribute significantly to the cancer research field?
  • Will the research and career development experiences prepare the candidate for independence?
  • What is the scientific productivity during the postdoctoral period of cancer research training in terms of research experience(s), didactic experiences, and other experiences (e.g., special skills, perspectives, techniques), and has it enhanced the candidate's ability to pursue an independent cancer research career?
  • Is the candidate committed to an independent research career that will be focused on problems clearly relevant to cancer?
  • Does the candidate have the potential ability to successfully manage an independent cancer research project?
  • Do the letters of reference from at least three established scientists address the candidate’s potential for becoming an independent cancer research investigator?

Career Development Plan/Career Goals and Objectives

  • What is the likelihood that the plan will contribute substantially to the scientific development of the candidate and lead to scientific independence?
  • Are the content, scope, phasing, and duration of the career development plan appropriate when considered in the context of prior training/research experience and the stated career development and research objectives for achieving research independence?
  • Are there adequate plans for monitoring and evaluating the candidate’s research and career development progress?
  • Are the candidate's prior training and research experience appropriate for this award?

Research Plan

  • Is the proposed research project appropriate for the candidate’s stage of research development and as a vehicle for development of the research skills described in the career development plan?
  • Are the scientific and technical merits of the research question, design, and methodology appropriate in the context of prior training and experience?
  • Is the proposed research relevant to stated career objectives?
  • To what extent is the proposed research likely to foster the career of the candidate as an independent investigator in cancer research?

Consultant(s), Collaborator(s)

  • Is adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration?
  • Have the proposed consultant(s) and collaborator(s) provided evidence of commitment to the candidate and the candidate’s project?
  • Do the proposed consultant(s)/collaborator(s) provide the required expertise for successful conduct of the research project?

Environment & Institutional Commitment to the Candidate

  • Are there adequate and appropriate research facilities and educational opportunities, including collaborating faculty at the submitting institution to help the candidate secure a tenure-track faculty position, or its equivalent, in a domestic academic institution?
  • Is there appropriate commitment from the submitting institution to assist the candidate in career progression to a tenure-track faculty position, or its equivalent?
  • Is there appropriate commitment from the submitting institution to assist in the candidate’s development into a productive, independent investigator?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: (1) risk to subjects, (2) adequacy of protection against risks, (3) potential benefits to the subjects and others, (4) importance of the knowledge to be gained, and (5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: (1) the justification for the exemption, (2) human subjects involvement and characteristics, and (3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; (2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; (3) adequacy of veterinary care; (4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and (5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Training in the Responsible Conduct of Research

All applications for support under this FOA must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). Taking into account the level of experience of the applicant, including any prior instruction or participation in RCR as appropriate for the applicant’s career stage, the reviewers will evaluate the adequacy of the proposed RCR training in relation to the following five required components: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the mentor(s) and other faculty involvement in the fellow’s instruction; 4) Duration of Instruction - the number of contact hours of instruction (at least eight contact hours are required); and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE, and the summary statement will provide the consensus of the review committee. See also: NOT-OD-10-019.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including (1) the Select Agent(s) to be used in the proposed research, (2) the registration status of all entities where Select Agent(s) will be used, (3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and (4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genome Wide Association Studies (GWAS)/ Genomic Data Sharing Plan.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NCI in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

  • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
  • Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Council. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

There will not be a formal Notice of Award (NoA) for applications until an awardee institution has been identified by the candidate and approved by the NCI. The NCI will initially notify candidates who have successfully competed for funding with a Letter of Intent to Commit Funds. Selected candidates will then have up to 12 months from the date of the letter to accept an appointment in a domestic academic institution that has offered a position at the tenure-track faculty level, or its equivalent (e.g., Assistant Professor, Assistant Member, Laboratory Head, Principal Investigator, etc.), at which the candidate is expected to establish his/her own independent research program, prepare applications for regular (non-career development) research project funding, and act as a PI(s)/PD(s) on such independent research projects. No funds will be issued for use while the candidate occupies a mentored, non-independent position at the submitting institution or awardee institution.

Before the NCI issues the NoA, the awardee institution will need to provide a description of the institutional environment for the following:

  • Describe the institution’s scientific environment, including the resources and facilities that will be available to the candidate to perform the proposed research plan.
  • Describe how the institutional research environment is particularly suited for the development of the candidate's research career and the pursuit of the proposed research plan and progression to independence.
  • The institution must document a strong, well-established research and career development program related to the candidate's area of interest, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.

The awardee institution will also need to provide a description of the institutional commitment to the candidate's career development for the following:

  • The institution must provide a statement of commitment to the candidate’s development into a productive, independent investigator, and to meeting the requirements of the award.
  • The institution must provide a clear statement that describes the commitment to the career progression of the candidate (e.g., tenure-track faculty position).
  • The institution must provide a statement that the institutional commitment to the candidate is not contingent upon receipt of this career award.
  • The institution must describe the start-up package and salary to be provided and document how it is equivalent to those provided to recent newly hired tenure-track faculty who do not have K22 awards.
  • The institution must provide a statement with assurances that the candidate will be able to spend a minimum of 75% effort (9 calendar months) in the conduct of research and career development activities associated with this award, with the remaining 25% effort devoted to other research, clinical, and teaching activities.
  • The institution must provide the candidate with the appropriate facilities and other resources to perform the proposed research plan, including laboratory and office space, and for which the asizes should be indicated.

In addition, the candidate and the new awardee institution will also need to provide a revised budget according to the the instructions in the SF424 (R&R) Application Guide, including Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ("K" Series).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. 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. More information is provided at Award Conditions and Information for NIH Grants. More specifically, for K Awards, visit the Research Career Development ("K") Awardees section of the NIH Grants Policy Statement.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

4. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants 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.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Sonia B. Jakowlew, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5630
Email: jakowles@mail.nih.gov

Peer Review Contact(s)

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.gov

Financial/Grants Management Contact(s)

Arina Kramer
National Cancer Institute (NCI)
Telephone: 240-276-6327
Email: kramerav@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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 Part 52 and 45 CFR Parts 74 and 92.

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