Part 1. Overview Information

Key Dates

It is critical that applicants follow the instructions in the Career Development (K) Instructions in the How to Apply - Application Guide except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Other Award Budget Information
Section III. Eligibility Information
1. Eligible Applicants
Section IV. Application and Submission Information
Other Project Information
PHS 398 Career Development Award Supplemental Form
Mentor, Co-Mentor, Consultant, Collaborators Section
Letters of Support from Collaborators, Contributors and Consultants
Environmental and Institutional Commitment to the Candidate
PHS Human Subjects and Clinical Trials Information
Section V. Application Review Information
Career Development Plan/Career Goals and Objectives
Research Plan
Mentor, Co-Mentor, Consultant, Collaborator(s)
Environment & Institutional Commitment to the Candidate
Study Timeline for Clinical Trials
Section VI. Award Administration Information
1. Award Notices
Transition to the Independent Phase
Section VII. Agency Contacts
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. NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals. More information about Career programs may be found at the NIH Research Training and Career Development 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., M.D., M.D./Ph.D., or Ph.D.). These investigators perform their research training at domestic extramural institutions/organizations, as well as in Federal research groups. Many of these 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 who have had at least 2 years of postdoctoral cancer research training, but, no more than a total of 8 years of mentored, non-independent training experience after the terminal research doctorate or clinical degree may apply, and if selected for funding, must obtain tenure-track faculty, or equivalent, positions before awards will be issued.

The NCI K22 award will provide up to 3 years of support. The K22 award period is intended to enable the investigator to establish a productive independent cancer research program and to generate preliminary data for a subsequent R01 or equivalent grant application submission. NCI believes that the creativity and innovation of new independent cancer research investigators in their early career stages play an integral role in addressing our Nation’s biomedical, behavioral, and clinical cancer research needs.

The candidate submits a K22 application from the institution where he/she currently pursues mentored, non-independent research training. 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 or equivalent position at a domestic extramural institution that is not an agency of the Federal Government 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 updated information about 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.

 NIH defines a clinical trial as "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." (NOT-OD-15-015).

Non-Responsive Applications

Applications with one or more of the characteristics listed below will be considered non-responsive and will not be reviewed:

• Applications that are merely cancer-related or not highly related to the mission of the NCI.
• Applications in which the candidate has more than a total of 8 years of mentored, non-independent research training experience after the terminal research doctorate or clinical degree at the time of application submission or resubmission unless the candidate received prior approval from the Program Director before application submission; or
• Applications in which the candidate currently holds or previously held an independent research faculty or tenure-track faculty position, or its equivalent, in academia, industry or elsewhere; or
• Applications in which the candidate has an application pending review for any other PHS career development award, including a Pathway to Independence Award (K99/R00); or
• Applications in which the candidate currently holds or previously held another NIH career development award (e.g. K01, K07, K08, K18, K22, K23, K99, K99/R00) (except K00) or other peer-reviewed NIH (except R03) or non-NIH research grants over $100,000 in direct costs per year; or
• Applications in which the candidate has been an independent PD/PI on NIH research grants (e.g. R01, R21, P01), or a sub-project leader on a Program Project (P01) or Center Grant (P50), or a non-NIH research grant equivalent to these grants/awards; or
• Applications in which the candidate does not have an affiliation with a domestic extramural institution or Federal institution at the time of initial application or resubmission.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Other Award Budget Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

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)

Local 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)

Federal Governments

• 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

The applicant institution may be private (profit or nonprofit) or public. NIH intramural and other eligible Federal laboratories are eligible to submit K22 applications. However, NIH intramural laboratories and other agencies of the Federal Government are not eligible to be the awardee institution.

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 allowed. 

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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – 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.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. 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 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.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) and who has at least 2 years of postdoctoral cancer research training, but, no more than a total of 8 years of mentored, non-independent research experience after the terminal research doctorate or clinical degree is invited to work with their organization to develop an application for support. Parental, medical, or other well-justified leave for personal or family situations of generally less than 12 months duration is not included in the 8-year eligibility limit, nor is clinical training with no research involvement (e.g., full-time residency training). Part-time postdoctoral research training, related to personal or family situations or occurring during a research residency or fellowship, will be pro-rated accordingly. 

Individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women 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) and are advised to contact the NCI Center to Reduce Cancer Health Disparities. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019. 

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).

Postdoctoral Investigators:

At the time of the initial application submission (or resubmission), candidates for this award must (1) have earned a terminal clinical degree or research doctorate (including Ph.D., M.D., D.O., D.C., N.D., D.D.S., D.M.D., D.V.M., Sc.D., D.N.S., Pharm.D., 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 (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 degree or research doctorate; (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 held an independent research faculty or tenure-track faculty position, or its equivalent, in academia, industry or elsewhere.

Individuals are eligible for a K22 award if they have been, or currently are, the PD/PI of an NIH R03 or a PHS or non-Federal award that does not duplicate the specific aims or research goals of an R03 grant.  

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 from the NCI K22 Scientific/Research Contact listed in Section VII 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 if requested.

Clinicians:

Time spent in clinical training is not counted for the 8-year postdoctoral research experience limit. Following clinical training or fellowship training periods, clinicians (including those with M.D., D.D.S., D.V.M. 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 as well.

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 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 8 years of mentored, non-independent research training after the terminal research or clinical doctorate at the time of initial application or resubmission; or
• Have currently or previously held an independent research faculty or tenure-track faculty position, or its equivalent, in academia, industry or elsewhere; or
• Have an application pending review 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, K99, K99/R00) (except K00) or other peer-reviewed NIH (except R03) or non-NIH research grants over $100,000 in direct costs per year; or
• Have been an independent PD/PI on NIH research grants (e.g. R01, R21, P01), or a sub-project leader on a Program Project (P01) or Center Grant (P50), or a non-NIH research grant equivalent to these grants/awards; or
• Have no affiliation with a domestic extramural institution or Federal institution at the time of initial application or resubmission.

 The following is provided as an aid to distinguish independent from non-independent positions. However, it is not sufficient merely to cite one or more of the following items to document eligibility.

Evidence for non-independence may include:

• The candidate’s salary is paid by another investigator(s).
• The candidate's research is entirely funded by another investigator's grants.
• The candidate’s research is conducted entirely in another investigator’s assigned space.
• According to institutional policy, the candidate cannot hire postdoctoral fellows or technical staff or be the responsible supervisor of graduate students.
• According to institutional policy, the candidate is not allowed to submit an application as the PD/PI of an NIH research project grant application (e.g., R01, P01).
• The candidate lacks other rights and privileges of faculty, such as attendance at faculty meetings.

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

• The candidate has a full-time faculty position.
• The candidate received a start-up package for support of their independent research.
• The candidate has research space dedicated to their own research.
• The candidate may attend faculty meetings, be the responsible supervisor for graduate students, and/or hire technical support or postdoctoral fellows.
• The candidate is eligible to apply for independent research funding as the PD/PI of an NIH research project grant.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definitions of Terms. 

3. Additional Information on Eligibility

Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a different candidate.

NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. An individual may not have two or more competing NIH career development applications pending review concurrently. In addition, 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Candidates may submit research project grant (RPG) applications concurrently with the K22 application. However, any concurrent RPG application may not have substantial scientific and/or budgetary overlap with the K22 career award application. But, if the RPG award is issued before the K22 award is issued, the K22 award will not be issued. K22 award recipients are encouraged to obtain funding from NIH or other Federal sources either as a PD/PI on a competing research grant award or cooperative agreement, or as project leader on a competing multi-project award as described in NOT-OD-18-157.

At the time of award, the candidate must have a “full-time” appointment at the academic 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 program of career development. 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 staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility.

After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances.  See NOT-OD-18-156  and NIH Grants Policy Statement, Section 12.3.6.4 Temporary Adjustments to the Percent Effort Requirement for more details.

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 sub-project Director of the research project grant. See NOT-OD-08-065.

The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified in biomedical, behavioral, or clinical research to collaborate with the applicant.

Section IV. Application and Submission Information

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Career Development (K) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity 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 How to Apply - Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply - Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

Other Project Information

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

Project Summary/Abstract

Include a description of your current research and the research you propose to do in the independent K22 award.

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

All instructions in the SF424 (R&R) Application Guide must be followed.

Specific for this NOFO

The K22 award is a non-mentored career development award. Inclusion of a current or future mentor/co-mentor as Senior/Key Personnel is not allowed.

IMPORTANT REMINDER: The personal profile associated with the eRA Commons username entered in the Credential field for the PD/PI (candidate) must include an ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Career Development Award Supplemental Form

The PHS 398 Career Development Award Supplemental Form is comprised of the following sections:

• Candidate
• Research Plan
• Other Candidate Information
• Mentor, Co-Mentor, Consultant, Collaborators
• Environment & Institutional
• Commitment to the Candidate
• Other Research Plan Sections
• Appendix

All instructions in the SF424 (R&R) Application Guide must be followed.

Candidate Section

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

Candidate Information and Goals for Career Development

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.
• Describe the candidate's research efforts to this point in their research career, including any publications, prior research interests and experiences.
• 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 reference letters from at least 3 well-established scientists.
• Present evidence of the candidate's ability to interact and collaborate with other scientists.

In addition, for applications proposing independent clinical trials:

• Describe the candidate's prior clinical trials research efforts, research interests and experience.
• Describe the candidate's ability to organize, manage, and implement the proposed clinical trial, feasibility or ancillary clinical trial.

Career Goals and Objectives​

• Describe a systematic plan: (1) that shows a logical progression from prior research and training experiences to the research and career development experiences that will occur during the career award period and then to independent investigator status; and (2) that justifies the need for further career development to become an independent investigator. 

• Describe the candidate's immediate and long-term research and career goals and objectives under this award, explaining how the award will contribute to their attainment. Candidates are encouraged to provide a timeline for accomplishing these goals.
• If currently supported by an institutional training grant or individual fellowship award (such as provided through the Ruth L. Kirschstein NRSA program), describe the candidate’s current research training or fellowship program.

In addition, for applications proposing independent clinical trials:

• Describe the training that the candidate already received or will receive in courses such as: data management, epidemiology, study design (including statistics), hypothesis development, drug development, etc., as well as the legal and ethical issues associated with research on human subjects and clinical trials.

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

• A systematic plan should be presented for obtaining the biomedical, behavioral, or clinical science background, research experience, and career development activities necessary for 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 professional development skills such as grant-writing, communication, leadership, and laboratory management.
• The career development plan must be specifically tailored to meet the needs of the candidate as an independent cancer 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 is encouraged to include a timeline, including plans to submit a subsequent research project grant application (R01 or equivalent) prior to the end of the second year of support.
• Although not required, an advisory committee may be formed to monitor the candidate's progress during the career development program. No signed statements, letters of support or NIH biographical sketches for members of any advisory committee, if any, are allowed. If the exact composition of an advisory committee is not known at the time of application submission, general roles and contributions of future committee members can be discussed.

Research Plan Section

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

Research Strategy

• A sound research project that is consistent with the candidate’s level of research development and objectives of their career development plan must be provided.
• The research description should demonstrate the quality of the candidate’s research thus far, and also the novelty, significance, creativity and approach, as well as the ability of the candidate to successfully perform the research.

In addition, for applications proposing independent clinical trials:

• Applicants proposing a clinical trial, ancillary or feasibility study should describe the planned analyses and statistical approach and how the expected analytical approach is suited to the available resources, proposed study design, scope of the project, and methods used to assign trial participants and deliver interventions.
• If proposing an ancillary study to an ongoing clinical trial, provide a brief description of its relationship to the larger clinical trial.
• If proposing a feasibility study, to begin to address a clinical question, provide justification why this is warranted and how it will contribute to the overall goals of the research project including planning and preliminary data for future, larger scale clinical trials.
• Describe the proposed timelines for the proposed clinical trial, feasibility or ancillary study, including any potential challenges and solutions (e.g., enrollment shortfalls or inability to attribute causal inference to the results of an intervention when performing a small feasibility study).
• Describe how the proposed clinical trial or ancillary study will test the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy (This would not apply to a feasibility study).
  
   

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). See SF424 (R&R) Application Guide for instructions.

Mentor, Co-Mentor, Consultant, Collaborators Section

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

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

Not Applicable. The candidate must include a short statement indicating that this is a non-mentored career development award in this section sub-heading of the online application

Letters of Support from Collaborators, Contributors and Consultants

• Signed statements must be provided by all collaborators, contributors, and/or consultants confirming their participation in the project and describing their specific roles. Collaborators and contributors should provide their NIH biosketches. Consultants do not need to provide their biographical sketches as consultants are generally not directly involved in the development of the career of the candidate as an independent investigator. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration.
• Advisory committee members (if applicable): The composition of an advisory committee, if any, should be described only in general terms. No signed statements, letters of support or NIH biographical sketches of members of a proposed advisory committee are allowed. 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. The main purpose of an advisory committee would be to monitor the candidate's progress during the career development program. An advisory committee should not be a mentoring committee.
• Current and/or past mentors and co-mentors should be advised not to submit letters of support, since this is an independent award. Instead, current and/or past mentors and co-mentors should submit only letters of reference into eRA Commons.

Environmental and Institutional Commitment to the Candidate

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

Description of Institutional Environment

• 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 the candidate's development into a productive, independent investigator and to meeting the requirements of this award. It should be clear that the institutional commitment to the candidate is not contingent upon receipt of this career award. This statement is typically signed by the Department Chair or Dean in extramural institutions and by the Division Chief in the NIH intramural program.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix:

Limited items are allowed in the Appendix.  Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

Reference Letters

Candidates must carefully follow the SF424 (R&R) Application Guide, including the time period for when reference letters will be accepted. 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 https://public.era.nih.gov/commonsplus/public/reference/submitReferenceLetter.era and not through Grants.gov. 

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and Times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply - Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

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

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - 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 How to Apply - Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. 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. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - 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 and responsiveness by NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following: Reviewers should evaluate the candidate’s potential for developing an independent research program that will make important contributions to the field, taking into consideration the years of research experience and the likely value of the proposed research career development as a vehicle for developing a successful, independent research program.

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.

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?
• What is the quality of the candidate's pre- and postdoctoral research training, with respect to development of appropriate scientific and technical expertise?
• 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?
• Considering the years of postdoctoral research experience to date, what is the candidate's record of research productivity, including the quality of peer-reviewed scientific publications?
• Is the candidate committed to a successful 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 3 well-established scientists address the candidate’s potential for becoming a successful independent cancer research investigator?

In addition, for applications proposing independent clinical trials:

• Does the candidate have the potential to organize, manage, and implement the proposed clinical trial, feasibility or ancillary study?
• Does the candidate have training (or plans to receive training) in data management and statistics including those relevant to clinical trials?

Career Development Plan/Career Goals and Objectives

• Are the content, scope, phasing, and duration of the career development plan appropriate for an early stage independent investigator?
• Are there adequate plans for monitoring and evaluating the candidate’s research and career development progress?
• Are appropriate timelines planned for the candidate's progress?
• Does the candidate demonstrate they have received training or will participate in courses such as: data management, epidemiology, study design (including statistics), hypothesis development, drug development, etc., as well as the legal and ethical issues associated with research on human subjects if applicable?

Research Plan

• Is the prior research that serves as the key support for the proposed project rigorous?
• Has the candidate included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project?
• Are the proposed research question, design, and methodology of significant scientific and technical merit?
• Are the scientific and technical merits of the research question, design, and methodology appropriate in the context of the candidate's prior training and experience?
• Is the proposed research project appropriate as a vehicle for development of the research skills described in the career development plan?
• Is the proposed research plan relevant to the candidate’s research career objectives?
• Has the candidate presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
• Has the candidate presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
• To what extent is the proposed research likely to foster the career of the candidate as a successful independent investigator in cancer research?

In addition, for applications proposing independent clinical trials:

• Are the scientific rationale and need for a clinical trial, feasibility or ancillary study well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?
• If proposing a small feasibility study, is the study warranted and will it contribute to planning and preliminary data needed for design of future larger scale clinical trials?
• Is the clinical trial or ancillary study necessary for testing the safety, efficacy or effectiveness of an intervention, or in the case of a feasibility study necessary to establish feasibility of a future clinical trial?
• Is the study design justified and relevant to the clinical, biological, and statistical hypothesis(es) being tested?
• Are the plans to standardize, assure quality of, and monitor adherence to, the protocol and data collection or distribution guidelines appropriate?
• Are planned analyses and statistical approaches appropriate for the proposed study design and methods that are used to assign participants and deliver interventions, if interventions are delivered?
• For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

• If proposed, will the clinical trial experience contribute to the research project?

Mentor, Co-Mentor, Consultant, Collaborator(s)

• Is adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration?
• Are the combined expertise, roles and responsibilities of any involved consultants, and/or collaborators likely to enhance the candidate’s career development?
• 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?
• Are the proposed collaborations with other active investigators and other opportunities for professional growth appropriate and of high quality?

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?

In addition, for applications proposing independent clinical trials:

• Are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
• Does the application adequately address the ability to conduct the trial feasibility or the ancillary study at the proposed site(s) or centers? If applicable, are there plans to add or drop enrollment centers, as needed, appropriate?
• If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

Study Timeline for Clinical Trials 

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative databases, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? 

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 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 Individuals Across the Lifespan

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 individuals of all ages (including children and older adults) 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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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.

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 score.

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Training in the Responsible Conduct of Research

All applications for support under this NOFO 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 candidate, including any prior instruction or participation in RCR as appropriate for the candidate’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).

Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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), in accordance with NIH peer review policies and practices, 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 appropriate national Advisory Council or Board.

• 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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

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.

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO 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 the K22 candidate has secured a tenure-track faculty position, or equivalent, and an awardee institution has been identified by the candidate and approved by the NCI. The NCI will initially notify candidates who have tentatively selected for funding with a Letter of Intent to Commit Funds. Selected candidates will then have up to 12 months from the issue date of the letter to accept an appointment at 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.), and at which the candidate is expected to establish their own independent research program. No funds will be issued for use while the candidate occupies a mentored, non-independent position at the submitting institution or awardee institution.

In the Request to Activate the K22 Award, the awardee institution must:

• 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, including a high-quality research environment with key faculty members and other investigators capable of productive collaboration with the candidate.
• Provide detailed budget pages for a non-modular budget.
• Provide updated Protections for Human Subjects (as appropriate).
• Provide updated Vertebrate Animals (as appropriate).
• Updated DMS plan.

The awardee institution must also 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 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 and provide assurance that K22 funds will not be used to offset the start-up package or to offset the institutional commitment to provide salary for tenure-track, or equivalent, assistant professors who have been recently hired without grant support.
• The institution must provide a statement with assurances that the candidate will be able to devote a minimum of 75% effort (9 calendar months) in the conduct of research and career development activities proposed in the K22 application, 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, including laboratory and office space, and for which the sizes should be indicated.

In addition, the new awardee institution must also provide a revised budget according to the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions. This information should be provided through the Change of Grantee Organization (Type 7 Parent Program Announcement) if the candidate changes institutions or through "just-in-time" procedures if the candidate obtains a tenure-track faculty, or equivalent, position at the applicant (or submitting) institution.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NOFO.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm.

Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Institutional Animal Care and Use Committee (IACUC) Approval: Grantee institutions must ensure that protocols for vertebrate animal studies are reviewed by their Office of Laboratory Animal Welfare (OLAW).  

Specific to applications proposing clinical trials, ancillary or feasibility studies 

Additionally, NCI may specify any special reporting requirements for the proposed clinical trial to be included under NCI-specific terms and conditions in the NoA. 

For example: If the proposed clinical trial has elevated risks, NCI may require closer programmatic monitoring and it may be necessary to require the awardee to provide more frequent information and data as a term of the award (e.g., to clarify issues, address and evaluate concerns, provide documentation). All additional communications and information related to programmatic monitoring must be documented and incorporated into the official project file.

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, Recipients, and Activities, including of note, but not limited to:

• Federal-wide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions. 

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website. 

HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.”

Transition to the Independent Phase

Not Applicable.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients 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. For mentored awards, the Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

A final RPPR, 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. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement. 

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

5. Evaluation

In carrying out its stewardship of human resource-related programs, 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.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Sonia B. Jakowlew, Ph.D. (for PIs with last names beginning with A-M)
National Cancer Institute (NCI)
Telephone: 240-276-5630
Email: [email protected]

Michael Schmidt, Ph.D. (for PIs with last names beginning with N-Z)
National Cancer Institute (NCI)
Telephone: 240-276-5630
Email: [email protected]

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]

Amy Bartosch
National Cancer Institute (NCI)
Telephone: 240-276-6375
Email: [email protected]

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.

Please note that the NIH Loan Repayment Programs (LRPs) are a set of programs to attract and retain promising early-stage investigators in research careers by helping them to repay their student loans. Recipients of career development awards are encouraged to consider applying for an extramural LRP award.

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 Part 75 and 2 CFR Part 200.