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 Career Transition Award
Announcement Type	Reissue of PAR-09-089
Related Notices	December 10, 2014 - This PAR has been reissued as PAR-15-056. June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. November 27, 2013 (NOT-OD-14-027) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after January 25, 2014. Forms-C applications are required for due dates on or after January 25, 2014.
Funding Opportunity Announcement (FOA) Number	PAR-12-121
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.398
FOA 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.

Posted Date	March 15, 2012
Open Date (Earliest Submission Date)	May 12, 2012
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date(s)	Standard dates apply
Expiration Date	New Date: December 11, 2014. This PAR has been reissued as PAR-15-056. May 8, 2015
Due Dates for E.O. 12372	Not Applicable http://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch10.htm#construction_grants_intergovernmental_review

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, especially Supplemental 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.

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

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. More information about career development 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 5 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 5 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) program is to support 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.

The NCI K22 award will provide up to 3 years of support for the most promising and exceptionally talented mentored, non-independent investigators who (1) have earned a terminal clinical or research doctorate; (2) have at least 2 years of postdoctoral training in cancer research at the time of submission of the initial application; (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 from the Federal Government; and (5) do not already have a full-time tenure-track assistant professor faculty position, or its equivalent. 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.

Funding Instrument	Grant
Application Types Allowed	New Resubmission The OER Glossary and the SF 424 (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.

Salary	NIH will contribute $100,000 per year toward the salary of the career award recipient. The total salary requested must be based on a full-time 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. 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 $50,000 per year toward the research 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 advisors, 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.

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

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 and other Federal laboratories
• 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

The submitting institution may be private (profit or nonprofit) or public, including the NIH intramural programs and other Federal laboratories.

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.
http://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch16.htm#_Toc271265275

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

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. 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-12-062 FOA and are advised to contact the appropriate NCI Scientific Research Agency Contact listed in Section VII of the PAR-12-062 FOA for eligibility information. Multiple Principal Investigators 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).

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 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 from the Federal Government; and (5) have not already had or have a full-time tenure-track assistant professor faculty position, or its equivalent.

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 appropriate Program Director at the NCI 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 junior faculty development.

Some institutions appoint postdoctoral fellows in positions with other titles, 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.

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 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, R29); or
• Have currently or have previously held other peer-reviewed NIH (except R03) or non-NIH research grants or career development awards 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.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed. An individual may not have two or more competing NIH career development applications or an NIH career development award application and an NIH research project grant (e.g., R01, R21, R29) application pending review concurrently. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

At the time of award, the candidate must have a full-time appointment at the awardee institution. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the awardee institution. Candidates with VA appointments should contact the Program Director at NCI 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.

Candidates must be able to commit a minimum of 9 calendar months (75% of full-time professional effort) conducting research and career development activities associated with this award. The remaining 25% effort can be divided among other research, clinical, and teaching activities only if these activities are consistent with the goals of the NCI K22 award. For information regarding NIH policy on determining full-time professional effort for career development awards, see NOT-OD-04-056.

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.

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.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, 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.

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure all appropriate optional components are completed.

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

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

Candidate’s Background (Component of Candidate Information)

• 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.
• Describe the candidate’s commitment to a career in a biomedical or behavioral research field relevant to the mission of the NIH.

Career Goals and Objectives (Component of Candidate Information)

• 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, and then to independent investigator status; (2) justifies the need for further career development to become an independent investigator; (3) utilizes the relevant research and educational resources of the institution; and (4) describes the candidate's current, as well as long-term, research and career objectives.

Career Development/Training Activities During Award Period (Component of Candidate Information)

• The candidate is responsible for the preparation of the career development plan. A timeline, including a publication plan, is strongly encouraged.
• Provide a description of the career development plan, incorporating consideration of the candidate's goals and prior experience. Include a plan to obtain the necessary research experience to launch an independent career.
• The career development plan must be tailored to the needs of the individual candidate with the ultimate goal of achieving independence as a researcher.
• Although not required, an advisory committee may be formed to assist with the development of the program of study and to monitor the candidate’s progress during the career development program.
• 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 research problem.

Training in the Responsible Conduct of Research (Component of Candidate Information)

Individuals are required to comply with the instructions for Training in the Responsible Conduct of Research as described in Chapter 7 of the SF424 (R&R) Application Guide.

Statements by Consultants and Contributors (Component of Statements of Support)

• Signed statements must be provided by all consultants/collaborators confirming their participation in the project and describing their specific roles. Collaborators and consultants are generally not directly involved in the development of the career of the candidate as an independent investigator.
• Collaborators and consultants should document the appropriate expertise in the proposed areas of consulting/collaboration and provide their biographical sketches.
• Any other opportunities for the candidate's professional growth should also be documented in these statements.

Description of Institutional Environment (Component of Environment and Institutional Commitment to the Candidate)

• The submitting institution must describe the scientific environment, including the faculty, resources, and facilities that will be available to the candidate in securing a tenure-track assistant professor faculty position, or its equivalent, in a domestic academic institution.

Institutional Commitment to the Candidate’s Research Career Development (Component of Environment and Institutional Commitment to the Candidate)

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

Research Strategy (Component of Research Plan)

• A sound research project that is consistent with the candidate s level of research development and objectives of his/her career development plan must be provided.
• The research 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.

The NCI K22 award consists of three years of support and is based on a successful application.

Budget Component (Section 4.7): A preliminary budget for research expenses for all three years will be required as part of the application. If the application receives a meritorious score after being reviewed for scientific merit and then is favorably reviewed by the National Cancer Advisory Board for relevance to the mission of the NCI, a Letter of Intent to Commit Funds will be issued to the candidate. He/she will then have up to 12 months to identify and secure a tenure-track assistant professor faculty position, or its equivalent, in a domestic academic institution. Upon securing a tenure-track faculty position, or its equivalent, an updated application with a revised budget will be submitted by the new sponsoring institution to the NCI. Detailed instructions for submitting a revised budget will be included with the Letter of Intent to Commit Funds. NCI will review the new updated application to ensure that all programmatic requirements have been met prior to issuance of the award.

General Guidance for Budget for the Application Process:

• The SF424 (R&R) Detailed Budget component should be used with the instructions found in Part I.4.7 (R&R Budget Component) of the Application Guide. However, for K22 applications, only limited budget information is required and candidates will also need to follow the special instructions in Part I.7.4 of the SF 424 (R&R) [Supplemental Instructions for Career Development Awards], noting the special instructions that modify Section 4.7.
• In budget section A (Senior/Key Persons), include base salary, person months, and requested salary and fringe benefit information for only the candidate. Base salary and requested salary and fringe benefits should reflect actual levels. Any adjustments based on NCI policy limits will be made at the time of the award. Sections B-E should be left blank. If a dollar amount is required, enter 0 (zero) in the appropriate box. The total Research Development Support amount requested for each year will be entered in Section F, Materials and Supplies. In Section H enter Modified Total Direct Costs under Indirect Cost Type. The Indirect Cost rate is 8% of modified total direct cost. The Indirect Cost amount should be entered under Funds Requested. Totals for Sections F, G, and H will be calculated automatically for each year as well as for the Cumulative Budget. Within the direct cost limitation for research development support, provide a detailed description with justification for all equipment, supplies, and personnel that will be used to help achieve the career development and research objectives of this award.

Complete all sections using the general guidance above with the following modifications:

• 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.
• The maximum direct cost budget for research costs is $50,000 for each year.

• Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when letters of reference will be accepted. Applications lacking the appropriate, required reference letters will not be reviewed (more details in NOT-OD-11-036). 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.
• Candidates must arrange to have at least three, but no more than five, letters submitted on their behalf in the NIH eRA Commons web site.
• The letters should be from established scientists (referees) and address the qualities of the candidate, as well as his/her potential for becoming an independent investigator.
• The referees should not be involved in directly supporting the performance of the research project described in the application, but should be familiar with the candidate's qualifications, training, and interests.
• Each letter should address the following issues as appropriate: (1) The adequacy of the candidate's scientific background for the proposed research and career goals; (2) The quality of the candidate's scientific productivity and achievements (e.g., publications, intellectual contributions to the research environment); (3) The candidate's ability to work with other scientists in various interactive situations (e.g., seminars, journal clubs), on collaborative research projects, and with support staff (e.g., technicians, nurses, secretaries, etc.); (4) Evidence of the candidate's originality and innovativeness in pursuing a research problem; and (5) The candidate's potential to develop, establish, and manage an independent research program.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. 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 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.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF 424 (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.

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 SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD(s)/PI(s) 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 Central Contractor Registration (CCR). 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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

Reviewers should provide their assessment of the likelihood for the candidate to maintain a strong research program, taking into consideration the criteria below in determining the overall impact/priority score.

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 quality of 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?
• What is the scientific productivity during the postdoctoral period of cancer research training?
• 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?
• Does the candidate have an ability to interact and collaborate with other scientists?
• 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 & Objectives

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

Research 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 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?
• Is the proposed research relevant to the 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?
• If appropriate, are there adequate plans for the protection of human and animal subjects and for the safety of the research environment and conformance with the NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research and Inclusion of Children Participating in Research Involving Human Subjects?

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)/collaborator(s) provided evidence of commitment to the candidate and to 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

• Does the submitting institution provide an appropriate scientific environment, including the faculty, resources, and facilities that will be available to the candidate in securing a tenure-track assistant professor faculty position, or its equivalent, in a domestic academic institution?
• Does the submitting institution provide a statement that describes its commitment to assist the candidate in career progression to a tenure-track assistant professor position, or its equivalent?
• Does the submitting institution provide a statement of commitment in assisting in the candidate’s development into a productive, independent investigator?

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/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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.

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/priority score.

Training in the Responsible Conduct of Research

Taking into account the circumstances of the candidate, including level of experience, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g., lectures, coursework, and/or real-time discussion groups? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe the role of faculty involvement in the candidate’s instruction? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years? For detailed instructions, see NOT-OD-10-019. Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus of the review committee.

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).

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.

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

Applications for the NCI K22 award are submitted by an institution and the scientific merit of the application are first peer-reviewed and then reviewed by the National Cancer Advisory Board. If selected for funding, a Letter of Intent to Commit Funds is issued to the candidate, and he/she will have up to 12 months to identify and secure a tenure-track assistant professor faculty position, or its equivalent, in a domestic academic institution. Upon securing a tenure-track faculty position, or its equivalent, an updated application with a revised budget will be submitted by the new sponsoring institution to NCI. NCI will review the updated application to ensure that all programmatic requirements have been met prior to issuance of the award.

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/priority score.
• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the NCI. 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 Board. 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.

After the peer review of the application is completed, the PD(s)/PI(s) 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.

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.

There will not be a formal Notice of Award (NoA) for applications until an 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. 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 Assistant Professor level or an equivalent tenure-track faculty position (e.g., 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.

Before the NCI issues the NoA, the sponsoring 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 sponsoring 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 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 provide a startup package and salary equivalent to those provided to a newly hired tenure-track faculty member who does not have a K22 award.
• 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 only if these activities are consistent with the goals of the NCI K22 award.
• 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 amounts should be indicated.

In addition, the candidate and the new sponsoring institution will also need to provide a revised budget according to the following:

• The SF424 (R&R) Detailed Budget component should be used with the instructions found in Part I.4.7 (R&R Budget Component) of the Application Guide. However, for K22 applications, only limited budget information is required and candidates will also need to follow the special instructions in Part I.7.4 of the SF 424 (R&R) [Supplemental Instructions for Career Development Awards], noting the special instructions that modify Section 4.7.
• In budget section A (Senior/Key Persons), include base salary, person months and requested salary and fringe benefit information for only the candidate. Base salary, and requested salary and fringe benefits should reflect actual levels. Any adjustments based on NCI policy limits will be made at the time of the award. Sections B-E should be left blank. If a dollar amount is required, enter 0 (zero) in the appropriate box. The total Research Development Support amount requested for each year will be entered in Section F, Materials and Supplies. In Section H enter Modified Total Direct Costs under Indirect Cost Type. The Indirect Cost rate is 8% of modified total direct cost. The Indirect Cost amount should be entered under Funds Requested. Totals for Sections F, G, and H will be calculated automatically for each year as well as for the Cumulative Budget. Within the direct cost limitation for research development support, provide a detailed description with justification for all equipment, supplies and personnel that will be used to help achieve the career development and research objectives of this award.

Complete all sections using the general guidance above with the following modifications:

• List the name, role on project and percent effort for all project personnel (salaried or unsalaried).
• Identify all consultants by name and organizational affiliation and describe the services to be performed.
• Provide a brief narrative justification for any major budget items, other than personnel, that are requested for the conduct of the project. Describe specific resources committed by the institution to support the candidate’s research.
• Facilities and administration (F & A) costs will be calculated at the time of the award at eight percent of modified total direct costs (exclusive of tuition, fees, and equipment).

The NoA signed by the grants management officer is the authorizing document and will be sent via email to the awardee’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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, 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 sub-awards 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 Sub-award Reporting System (FSRS) available at www.fsrs.gov on all sub-awards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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.

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Sonia B. Jakowlew, Ph.D.
Program Director
Cancer Training Branch, Center for Cancer Training
National Cancer Institute (NCI)
National Institutes of Health
Branch Telephone: (240) 276-5630
Email: jakowles@mail.nih.gov

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Barbara Liesenfeld
Grants Management Specialist
Office of Grants Administration
National Cancer Institute (NCI)
National Institutes of Health
Telephone: (240) 276-6294
Email: liesenfb@mail.nih.gov

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.

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.