Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Dental and Craniofacial Research (NIDCR)

Funding Opportunity Title

NIDCR Dentist Scientist Career Transition Award for Intramural Investigators (K22)

Activity Code

K22 Career Transition Award

Announcement Type

Reissue of PAR-12-004

Related Notices
  • March 18, 2016 - This PAR has been reissued as PAR-16-140.
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)
  • NOT-OD-16-012 - Implementing Rigor and Transparency in NIH & AHRQ Career Development Award Applications (November 18, 2015)
Funding Opportunity Announcement (FOA) Number

PAR-15-084

Companion Funding Opportunity

None

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

93.121

Funding Opportunity Purpose

The purpose of the NIDCR Dentist Scientist Career Transition Award for Intramural Investigators (K22) program is to provide highly qualified dentists in NIH Intramural postdoctoral fellowship positions with an opportunity to receive further mentored research experience in the NIH Intramural program, and then to provide them with independent funding to facilitate the transition of their research programs as new investigators at extramural institutions.

Key Dates
Posted Date

January 8, 2015

Open Date (Earliest Submission Date)

January 12, 2015

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

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

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

AIDS Application Due Date(s)

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

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

Scientific Merit Review
Advisory Council Review
Earliest Start Date
Expiration Date

New Date May 10, 2016 per issuance of PAR-16-140. (Original Expiration Date: January 8, 2018)

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Table of Contents

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

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

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

The objective of the Career Transition Award (K22) is to provide support to outstanding, newly trained basic or clinical investigators to develop their independent research skills through a two phase program; an initial period involving an intramural appointment at the NIH and a final period of support at an extramural institution. The award is intended to facilitate the establishment of a record of independent research by the candidate in order to sustain or promote a successful, independent research career.

The goal of the NIDCR Career Transition Award (K22) is to provide support to outstanding, newly trained basic or clinical investigators to develop their independent research skills through a two phase program, an initial period involving an intramural appointment at the NIH and a final period of support at an extramural institution. The award is intended to facilitate the establishment of a record of independent research by the candidate in order to sustain or promote a successful, independent research career. This FOA supports the NIDCR Strategic Plan 2104-2019, Goal 4:" Ensure that a strong research workforce is dedicated to improving dental, oral, and craniofacial health."

To achieve this goal, the program is structured to provide two years of mentored research training in an NIH intramural laboratory (Phase 1) followed by three years of K22 funding (Phase 2) to conduct biomedical research as an independent scientist at an extramural sponsoring institution/organization to which the individual has been recruited, has been offered, and has accepted a tenure-track full-time assistant professor position (or equivalent). The K22 award, used to support Phase 2, allows the individual to continue to work toward establishing his/her own independent research program and prepare an application for research grant support, such as an R01, or equivalent grant support.

The K22 application should describe the research activities planned during both the mentored and independent phases of the program (up to 5 years). The application will be peer reviewed and assigned an overall impact score. Successful candidates (i.e., whose application has received a fundable overall impact score) will receive an approval letter from the NIDCR to initiate the intramural NIH research training (Phase 1). The approval letter will include the terms and conditions to activate the K22 award at an extramural institution/organization (Phase 2).

A transition application from the extramural institution/organization on behalf of the K22 awardee will be required to begin the activation process. Activation of the extramural phase of the award is not automatic. Approval to activate the extramural phase will be based on an administrative review of the transition application by the NIDCR, and will consider the success of the awardee’s research performance progress during the intramural phase and the satisfactory response to the programmatic requirements of the K22, which include achieving an independent tenure-track (or equivalent) position at an extramural institution. The details of the transition application process are described in Section VI. Award Administration Information.

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New
Resubmission

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

Funds Available and Anticipated Number of Awards

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

Award Budget

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

Award Project Period

The total project period may not exceed 5 years (two years intramural, plus three years extramural).

Other Award Budget Information
Salary

Intramural Phase 1:

Support for the intramural phase is provided by the candidate's NIH intramural laboratory or branch. Support for the intramural phase may not exceed two years in duration The salary support will be consistent with that provided by the NIH intramural program for other investigators in the same position and with similar levels of postdoctoral experience.

Extramural Phase 2:

Support for the extramural phase will be provided to the extramural institution. Support for the extramural phase may not exceed three years in duration. The total cost for the extramural phase may not exceed $249,000 per year, including salary, fringe benefits, research support allowance, and applicable facilities and administrative (F&A) costs (see “Indirect Costs” below)..

The total salary requested must be based on a full-time staff appointment. The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned.

The sponsoring 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

Intramural Phase 1:

Research-related expenses for the intramural phase is provided by the candidate's NIH intramural laboratory or branch.

Extramural Phase 2:

Total expenses for the extramural phase may not exceed $249,000 per year, including salary, fringe benefits, research support allowance, and applicable facilities and administrative (F&A) costs (see “Indirect Costs” below).

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

Indirect Costs

For the extramural phase, Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs. F&A costs are included in the total cost limitation.

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Eligible Applicant Organizations for Phase 1 (mentored, intramural)

For Phase 1, only NIH intramural laboratories are eligible to apply on behalf of the intramural candidate.

Eligible Applicant Organizations for Phase 2 (independent, extramural)

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • 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

NIH intramural laboratories are eligible to apply for the mentored phase of the K22 mechanism on behalf of intramural candidates. They are not eligible to apply for the independent phase.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are  allowed.

Required Registrations

Applicant Organizations

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

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

Specific information is available for intramural candidates on the Electronic Submission Intranet – link available only to users internal to NIH)

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her mentor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Multiple PDs/PIs are not allowed.

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

Candidates for this award must have earned a clinical dental doctoral degree (DDS, DMD or equivalent), or a combined dental and research doctoral degree (PhD or equivalent), and must be in an NIH intramural postdoctoral fellowship position at the time of applicaton. The candidate

must have postdoctoral research experience, during which the potential for highly productive basic or clinical research was demonstrated. During the intramural phase of the award, the candidate will spend full time on research in an intramural NIH laboratory.

Individuals are eligible for a K22 award if they have been the PD/PI of an NIH R03 or R21 grant or a PHS or non-Federal award that duplicates the specific aims or research goals of an R03 or R21 grant. Individuals are NOT eligible to apply if they have pending an application for any other PHS career development award, an NIH institute-specific K22, or a Pathway to Independence Award (K99/R00). Individuals are not eligible to apply if they have been or are currently a PD/PI on an NIH research grant (such as R01, R29, P01) or a subproject leader on a Program Project (P01) or Center Grant (P50), or a non-NIH equivalent to these grants/awards.

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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

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

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

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

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

K22 award recipients are expected to apply for NIH or other independent research grant support during the extramural phase of the award. Recipients may hold concurrent research support and under certain circumstances salary support from the final two years of their K22 award and a competing NIH research project grant when recognized as the PD/PI or subproject Director of the research project grant. See NOT-OD-08-065.

Level of Effort

Modify effort level as appropriate for different K awards, and leave note for OEP to edit accordingly.

Intramural Phase 1 (mentored): The candidate must have a “full-time” appointment in an NIH Intramural Scientific Program and commit 100% of full time professional effort to the  mentored research experience.

Extramural Phase 2 (independent): At the time of award for the independent extramural phase, the candidate must have a “full-time” appointment at an eligible institution. Phase 2 awardees are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their research 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. 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

Mentor(s)

Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities for high-quality research. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research career development program. In such cases, one individual must be identified as the principal mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate’s career stage.

Institutional Environment

Both Phase 1 and Phase 2 applicant institutions must have strong, well-established records of research and career development activities and faculty qualified to serve as mentors, collaborators and/or consultants in biomedical, behavioral, or clinical research.

Section IV. Application and Submission Information
1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

Other Project Information

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

Project Summary/Abstract

Include a description of your current intramural research and the research you propose to continue in the independent extramural phase.

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

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

R&R Budget

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

Phase 1: In the initial application, an itemized budget is not required for the K22 intramural phase (Phase 1, up to two years). Support for the intramural phase is provided by the candidate's NIH intramural laboratory or branch. Although the Direct and Indirect Costs should specify $0, the applicant should indicate 12 person-months effort for him/herself for each project period during this phase.

Phase 2: In the initial application, an itemized budget is not required for the K22 independent phase (Phase 2). The applicant should indicate a minimum of 9 person-months effort for him/herself for each project period during this phase. The exact amount of direct and indirect costs does not need to be specified, however, a line item in section F: Other Direct Costs titled ‘Independent Phase’ requesting $249,000 should be added for each period during this phase.  At the time of transition to the independent K22 phase, the applicant extramural institution will submit a detailed budget for the Phase 2 K22 project period.

PHS 398 Cover Page Supplement

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

PHS 398 Career Development Award Supplemental Form

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

Candidate Information

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

Candidate’s Background

  • Describe the candidate’s commitment to a career in a biomedical or behavioral research field relevant to the mission of the NIDCR.
  • For individuals in postdoctoral and similar positions (i.e., still in training), describe current training and research efforts of the candidate.
  • Describe prior training and research efforts, and how they relate to the objectives and long-term career plans of the candidate.
  • Provide evidence of the candidate's potential to develop into a successful independent investigator. Usually this is evident from publications, prior research interests and experience, and letters of reference.

Career Goals and Objectives

  • Describe a systematic plan that shows a logical progression from prior research and training experiences to the research and training experiences that will occur during the K22 award period and then to independent investigator status.
  • Candidates should select a mentor with whom the candidate can consult in preparing and submitting the application for the NIH intramural mentored phase of the award. Candidates may work with their current mentor, or with another intramural investigator, provided the research experience proposed in this application will enhance the candidate’s scientific career.

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

  • The candidate and the mentor are jointly responsible for the preparation of the career development plan. A timeline, including publications, is strongly encouraged. The mentor in consultation with the applicant, may form a mentoring team (or an advisory committee) to assist with the development of the program of study or to monitor the candidate's progress through the career development program.
  • The career development plan must be tailored to the needs of the individual candidate, incorporating the candidate's goals , current activities, prior experience, and the ultimate goal of achieving independence as a researcher.
  • Include a plan to obtain the necessary research experience to launch an independent research career. Suggested activities include, but are not limited to, those designed to improve skills and understanding in grant writing, clinical trials methodology, research design and management, statistical analysis, and bioethics
  • Candidates must justify the need for both the mentored phase and the independent phase, and must provide a convincing case that the proposed period of support (1-2 years as a mentored scientist followed by up to 3 years as an independent scientist) will substantially enhance his/her career and/or will allow the pursuit of a novel or promising approach to a particular research problem.
  • The candidate and intramural mentor must describe a plan, including a timeline with milestones, for evaluation of the candidate's progress during the intramural mentored phase and plans for the transition to the independent extramural phase.

Training in the Responsible Conduct of Research

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

 

Statements and Letters of Support

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

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

  • The candidate must name a primary mentor (sponsor), who, together with the candidate, is responsible for the planning, direction, and execution of the program. The candidate may also identify co-mentors as appropriate to the goals of the program.
  • The mentor(s) should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training individuals in postdoctoral positions who have gone on to become independent investigators.
  • The application must include a statement from the mentor providing: (1) information on his/her research qualifications and previous experience as a research supervisor; (2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period, including how the candidate’s scientific and professional independence will be promoted; (3) a description of the elements of the planned research career development, including any formal course work; and (4) a plan for transitioning the candidate to move from the mentored stage of his/her career to the independent research investigator status during the project period of the award.
  • The mentor(s) must agree to provide annual evaluations of the candidate’s progress as required in the annual progress report.

Letters of Support from Collaborators, Contributors and Consultants

  • Signed statements must be provided by all collaborators and/or consultants confirming their participation in the project and describing their specific roles. Collaborators and consultants generally do not need to provide their biographical sketches. However, information should be provided clearly documenting the appropriate expertise in the proposed areas of consulting/collaboration. Collaborators/consultants are generally not directly involved in the development of the career of the candidate as an independent investigator. 

Environmental and Institutional Commitment to the Candidate

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

Description of Institutional Environment

  • Document the quality of the research environment, the strengths and extent of the research programs in the NIH Intramural Research Program that are related to the candidate's area of research interest, and the key scientists and other researchers capable of productive collaboration with the candidate. Any unique features of the research environment, such as collaborative arrangements or subject populations, should be described
  • Describe the scientific environment including the resources and facilities that will be available to the candidate during the intramural Phase 1 of the K22.

Institutional Commitment to the Candidate’s Research Career Development

  • The Scientific Director of the NIH Intramural Research Program must provide a statement of commitment to the candidate that the Intramural laboratory or branch will ensure that the required effort of the candidate will be devoted directly to the proposed research training, career development, and research activities , and will facilitate the candidate’s transition to a faculty position in the extramural community. Assurance must be provided that the candidate will be provided  with the appropriate facilities and other resources necessary to facilitate his/her transition to an extramural institution.

Research Plan

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

Research Strategy

  • The research plan must span both phases of the award. The candidate should clearly indicate the research planned for each phase. This narrative should describe what the candidate will accomplish during the mentored phase research that will enable him/her to launch an independent research program (i.e., what does the candidate still need to accomplish during the mentored phase in order to compete successfully once independence is achieved).
  • Describe a sound research project that is consistent with the candidate’s level of research experience and the objectives of his/her continued career advancement.
  • The project 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 candidate's ability to carry out the proposed research.

Appendix

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

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

Letters of Reference

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

3. Submission Dates and Times

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

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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

6. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

 

Post Submission Materials

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

Section V. Application Review Information

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

1. Criteria

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

Overall Impact

Reviewers should provide their assessment of the likelihoodthat the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in a health-related field, taking into consideration the criteria below in determining the overall impact score.

Scored Review Criteria

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

Candidate
  • Does the candidate have the potential for becoming a successful independent investigator who will contribute significantly to a chosen health-related research field?
  • Will the research experiences in the intramural mentored phase prepare the candidate to implement successfully the independent phase research project?
  • Is there evidence that the candidate is committed to a career in a biomedical, behavioral, or clinical research field relevant to the mission of the NIDCR?
  • Do the letters of reference from at least three well-established scientists address the candidate's potential for becoming an independent investigator who will contribute significantly to a chosen health-related research field?
  • Based on the candidate’s demonstrated capacity to conduct independent research, evidence of past and present research productivity (contributions to the scientific literature), prior training, proposed career development plan, and the referees’ evaluations, is the candidate likely to continue to make significant contributions to the field?
Career Development Plan/Career Goals and Objectives/Plan to Provide Mentoring
  • To what extent are the plans for evaluating the awardee's progress adequate and appropriate for guiding the candidate towards a successful transition to the independent phase of the award?
  • Is the timeline planned for the transition to the independent phase of the award appropriate for the candidate’s current stage of scientific and professional development and the career development proposed for that phase of the award?
  • What is the likelihood that the plan will contribute substantially to the scientific development of the candidate leading to scientific independence?
  • Is the career development plan consistent with the candidate’s prior research experience and current research career goals?
  • Are the content, phasing, and proposed 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 scientific independence?
Research Plan
  • Is the proposed research project appropriate for the candidate’s stage of research development and as a vehicle for development of the research skills described in the career development plan?
  • Are the scientific and technical merits of the research question, design, and methodology appropriate in the context of prior training and experience? 
  • Is the proposed research relevant to stated career objectives?
  • Is the proposed independent phase research scientifically sound and a logical extension of the Intramural mentored phase research?
  • Is the proposed research significant and of high quality? Does it have high potential for advancing the field of study?? 
  • Is there strong potential for the proposed independent phase research project to foster the career of the candidate as an independent investigator in biomedical research?

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

  • Are the qualifications of the mentor(s) in the area of the proposed research appropriate?
  • Does the mentor(s) adequately address the candidate’s potential and his/her strengths and areas needing improvement?
  • Is there adequate description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate?
  • Is the mentor’s description of the elements of the research career development activities, including formal course work, adequate?
  • Is there evidence of the mentor's, consultant’s, and/or collaborator’s previous experience in fostering the development of independent investigators?
  • Is there evidence of the mentor's current research productivity and peer-reviewed support?
  • Are there adequate plans for monitoring and evaluating the career development awardee’s progress toward independence?
  • Does the mentor have a comprehensive plan to support the proposed mentored career development activities and research plans as well as the candidate’s efforts to transition to independence? Is this plan adequate and appropriate?
  • Is adequate information provided that clearly documents expertise in the proposed area(s) of consulting/collaboration?
  • Have the proposed consultant(s) and collaborator(s) provided evidence of commitment to the candidate and the candidate’s project?
  • Do the proposed consultant(s)/collaborator(s) provide the required expertise for successful conduct of the research project? 

Environment & Institutional Commitment to the Candidate

  • Are there adequate and appropriate research facilities and educational opportunities, including collaborating faculty at the NIH?
  • Are there unique features of the intramural scientific environment that benefit the candidate's proposed careeer development and research plan; e.g., useful collaborative arrangements or subject populations?
  • Does the application document a high-quality intramural research environment and a strong, well established intramural research program related to the candidate's areas of scientific interest interest and needs for professional development?
  • Based on the statement of the Scientific Director of the sponsoring NIH intramural program, is there clear commitment to ensure that the required effort of the candidate will be devoted directly to the proposed research training, career development, and research activities?
  • Is there  a strong commitment to facilitate the candidate's transition to a research faculty position in the extramural community?
Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Training in the Responsible Conduct of Research

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

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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

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

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

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

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

Section VI. Award Administration Information
1. Award Notices

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

There will not be a formal Notice of Award (NoA) associated with the mentored phase of the K22 award conducted in the NIH intramural program. The NIDCR will transmit to the successful candidate an approval letter that will include the terms and conditions of the NIH intramural K22 award, as well as expectations for the transition to the independent Phase 2 of the award.

A formal Notice of Award (NoA) will be provided as part of the extramural phase of the K22 award conducted at a domestic, sponsoring extramural institution/organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the

awarding component to the grantee business official.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants. More specifically, for K Awards, visit the Research Career Development (“K”) Awardees section of the NIH Grants Policy Statement.

Transition to the Independent Phase

Transition from the intramural phase (Phase 1) to the extramural phase (Phase 2) is intended to be continuous in time. Support for Phase 2 is not automatic and is contingent upon the K22 awardee obtaining an appropriate extramural position at an eligible institution, an appropriate start-up package, and the successful NIDCR programmatic review of the tenure-track (or equivalent) faculty position the candidate has accepted and the institutional commitment to the candidate. In order to submit a independent Phase 2 application, individuals must have been offered and accepted a research faculty position at an eligible institution that has both appropriate infrastructure to support the proposed research program and a history of external research funding.

To avoid potential problems, candidates are strongly encouraged to contact their NIDCR Program Official as soon as plans to apply for, or assume, an independent position develop. At that time, individuals should discuss plans for transition to, and the transitionapplication for, the Phase 2 award. The application for the Phase 2 award should be submitted no later than 2 months prior to the proposed start date of the Phase 2 award.

The extramural phase sponsoring institution will submit a transition application on behalf of the candidate using the PHS398 Application.forms. The application must include:

  • A new Form Page 1 (face page) signed by the Phase 2 institutional representative;
  • An updated Form Page 2 (project summary page) that reflects current plans for the Phase 2 award;
  • Form Page 3 (table of contents);
  • Form Pages 4 and 5 (Budget for Initial and Entire Proposed Project Periods): Detailed budget pages for a non-modular budget and narrative justification for all requested funds for each budget year, including:
    • The name, role on project, and level of effort for all project personnel (salaried and unsalaried) and a narrative justification for each person;
    • The name and organizational affiliation of all consultants and a description of the services to be performed;
  • Biographical Sketches for the PD/PI and any other Key Personnel;
  • A new Resources Format Page including a description of specific resources committed by the sponsoring institution to support the Candidate’s research; research facilities; and the availability of appropriate educational opportunities, including collaborating faculty, if appropriate.
  • Updated Specific Aims that reflect current plans for the Phase 2 project;
  • An updated Research Plan (not to exceed 5 pages);
  • A Letter of Institutional Commitment from the Department or Division Chairperson that describes the sponsoring institution's commitment to the candidate’s scientific independence (see additional details below);
  • Updated Protections for Human Subjects and Inclusion of Women, Minorities and Children, Planned Enrollment Report and Cumulative Inclusion Enrollment Report (as appropriate);
  • Updated Vertebrate Animals (as appropriate);
  • Updated Biohazards and Select Agents (as appropriate);
  • Letters of Support (e.g., Consultants): if previously unnamed consultants/collaborators are added, provide letters of commitment from these individuals;
  • Updated Resource Sharing Plan (as appropriate);
  • Updated plan for Instruction in the Responsible Conduct of Research; and
  • A new checklist.

Letter of Institutional Commitment: A letter of institutional commitment is required at the time of the Phase 2 application and is typically provided by the Department or Division Chairperson. This letter should satisfy the criteria described in the Career Development Award Section 7 of the SF424 Application Guide. The letter should describe the following:

A detailed description of the candidate’s position, responsibilities, and duties. The institution’s tenure-track policy should be defined, or a description should be provided of the equivalent arrangements for institutions without a formal tenure-track. The start-up and salary package and other evidence of institutional support must be described and must be comparable to that provided to other, recently hired faculty who did not have a grant at the time they were hired. K22 funds may not be used to offset the typical startup package or to offset the usual institutional commitment to provide salary for faculty who are hired without grant support.

Commitment to providing adequate resources, an appropriate institutional environment, and protected research time. Describe the quality and relevance of the institutional environment for the scientific and professional development of the candidate. In addition to space, facilities, resources, and other support needed to conduct the proposed research, the sponsoring institution must demonstrate a commitment to the candidate by providing a minimum of nine person-months (75% full-time professional effort) of protected research time for at least the duration of the K22 award. Consequently, teaching, clinical duties and other non-research activities should be reduced during the K22 award period.

Institutional commitment to fostering the candidate's career development including how the institution will foster and support the candidate's efforts to secure independent research grant (R01) support during the K22 award period. NIDCR will not make a K22 award if the institutional commitment is deemed inadequate.

These materials should be sent directly to the NIDCR. The original application plus one copy (preferably in PDF format) are to be are to be mailed or e-mailed directly to the NIDCR Financial/ Grants Management contact person listed in the PD/PI's eRA Commons account. The K22 transition application will be evaluated by extramural Program staff of the awarding component for completeness and responsiveness to the program.

Applicants who are approved to transition will receive a Notice of Award reflecting the dollar amount and the recipient organization. Candidates who are not approved to transition will receive written notification from the NIDCR communicating the rationale for the disapproval. This notification typically will be transmitted within 60 days of receipt of the Phase 2 application.

Although the financial plans of the NIDCR provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The Supplemental Instructions for Individual Career Development (K) RPPRs must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

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

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

4. Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program from databases and from participants themselves. Participants may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

Scientific/Research Contact(s)

Lynn Mertens King, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5006
Email: lynn.king@nih.gov

Janice Lee, DDS, MD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4591
Email: leejs2@mail.nih.gov

Peer Review Contact(s)

Yasaman Shirazi, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5593
Email: yasaman.shirazi@nih.gov.

Financial/Grants Management Contact(s)

Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.  

 

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