Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

Agency for Healthcare Research and Quality (AHRQ)

Components of Participating Organizations

N/A

Funding Opportunity Title

Competitive Revision Supplements to Existing AHRQ Grants and Cooperative Agreements to Enhance Workforce Diversity in Health Services Research

Activity Code

Competitive revision requests may be submitted electronically for active AHRQ awards, excluding R13 and R36 awards.

Applicants should apply to this PA, using the activity code of the grant type mechanism of the parent grant for which they are requesting a supplement.

Announcement Type

New

Related Notices

September 12, 2024 - Notice to Extend Expiration Dates for PA-22-175 Competitive Revision Supplements to Existing AHRQ Grants and Cooperative Agreements to Enhance Workforce Diversity in Health Services Research. See Notice NOT-HS-24-024

RFA-HS-24-004 - State-based Healthcare Extension Cooperatives to Accelerate Implementation of Actionable Knowledge into Practice (U19)

July 10, 2024 - Implementing and Evaluating Patient-Centered Clinical Decision Support Strategies in Real-World Settings(U18). See Announcement RFA-HS-24-003

March 29, 2024 - Research to Advance the Science of Primary Care (R01). See Notice PA-24-205

January 25, 2024 - Evaluation and Coordinating Center for the AHRQ/PCORI Learning Health System Embedded Scientist Training and Research Centers (U18). See Announcement RFA-HS-24-002

August 22, 2023 - AHRQ Understanding and Improving Diagnostic Safety in Ambulatory Care: Incidence and Contributing Factors (R01). See Announcement PA-23-291

August 22, 2023 - AHRQ Improving Diagnostic Safety in Ambulatory Care: Strategies and Interventions (R18). See Announcement PA-23-290

January 11, 2023 - AHRQ Announces Interest in Research on Climate Change and Healthcare. See Notice NOT-HS-23-006

NOT-OD-23-012 - Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available

NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022

NOT-OD-22-018 Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available

NOT-OD-21-169- New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022

NOT-OD-21-170- Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice.

NOT-OD-21-109- Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel

NOT-OD-21-170- Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements

NOT-OD-21-109 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel

NOT-OD-21-073 Upcoming Changes to the Biographical Sketch and Other Support Format Page for Due Dates on or after May 25, 2021

NOT-HS-21-016 Notice of Updated AHRQ Policy for Late Application Submission for Active Peer Review or National Advisory Council Service

NOT-HS-21-015 - AHRQ Policy on the Inclusion of Priority Populations in Research

NOT-HS-21-014-Special Emphasis Notice (SEN): AHRQ Announces Interest in Health Services Research to Advance Health Equity

NOT-OD-21-109 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel

NOT-HS-21-015 - AHRQ Policy on the Inclusion of Priority Populations in Research

NOT-HS-21-007 - Salary Limitation on AHRQ FY2021 Grants, Cooperative Agreements, and Contracts

NOT-HS-21-002 - AHRQ Guide Notice on Exception to the Use of the Single IRB Review Requirements During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

NOT-OD-21-095 - Extending the Special Exception to the NIH/AHRQ/NIOSH Post-Submission Material Policy During the COVID-19 Pandemic: January 2022 Council

NOT-HS-20-017 - Changes to the HHS Notice of Award (NoA) Beginning October 1, 2020

NOT-HS-20-011 - The Agency for Healthcare Research and Quality Data Management Plan Policy

NOT-HS-20-005 - AHRQ Guide Notice on Implementation of the Use of a Single Institutional Review Board (IRB) for Cooperative Research at 45 CFR 46.114 (b)

NOT-HS-19-007 - AHRQ Announces Change in Grant Recipient Purchasing of Identifiable CMS Data, effective FY2019

NOT-HS-16-018 - AHRQ Multiple Program Director/Principal Investigator Policy

Funding Opportunity Announcement (FOA) Number

PA-22-175

Companion Funding Opportunity

None

Assistance Listing Number(s)

93.226

Add information from NIHGPS record. IC should make sure that NIHGPS record is correct, and that each participating IC/component has provided an Assistance Listing Number.

Funding Opportunity Purpose

The objective of this NOFO is to notify Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) holding specific types of research grants (activity codes listed above) that funds are available for competitive revisions to enhance the diversity of the research workforce by recruiting and supporting students, post doctorates, and eligible investigators from diverse backgrounds, including those from groups that have been shown to be underrepresented in health services research. This opportunity is also available to PD(s)/PI(s) of research grants who are or become disabled and need additional support to accommodate their disability in order to continue to work on the research project.

Key Dates
Posted Date

May 11, 2022

Open Date (Earliest Submission Date)

April 26, 2022

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

June 26, October 26, February 26 by 5:00 PM local time of applicant organization.

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Generally, four months after receipt date.

Advisory Council Review

Not Applicable

Earliest Start Date

Generally, four months after peer review date.

Expiration Date

New Date March 1, 2028 per NOT-HS-24-024 (Prior Date March 1, 2025).

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) 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 and follow the AHRQ Grants Policy and Guidance found on the AHRQ website at http://www.ahrq.gov/funding/policies/foaguidance/index.html.

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.

Applicants who propose the use of identifiable CMS data are advised to review NOT-HS-19-007 (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-19-007.html) for important changes to how applicants are to budget for the cost of this data.


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.


  4. 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

    This competitive revision program has the following goals: 1) To enhance the number of health services researchers from diverse backgrounds, including those from groups that have been shown to be underrepresented in health services research and 2) To facilitate continued research involvement of PD(s)/PI(s) who are or become disabled and who need additional support to accommodate their disability in order to continue to work on the research project. These goals are consistent with the federal government-wide commitment to fostering equity and diversity outlined the Executive Order On Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (January 20, 2021; https://www.whitehouse.gov/briefing-room/presidential-actions/2021/01/20/executive-order-advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government/) and support AHRQ’s commitment to building a research workforce representing the diversity of American society. While AHRQ encourages applicants with diverse backgrounds to work with their organization to develop applications for training, career development, and research funding support, more can be done to further diversify the health services research workforce.

    An April 2021 Report from the National Science Foundations (NSF) (see https://ncses.nsf.gov/pubs/nsf21321/report) and a 2018 article on the health services research workforce (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6149355/) provide evidence that while workforce diversity has improved over time, further work should be done to help ensure the health service research enterprise better reflects the diversity of the Nation. A diverse workforce can help to ensure many different perspectives in a variety of research settings and ensure research agenda priority. Increased faculty diversity can also increase recruitment and retention of students of diverse backgrounds.

    Application Information:

    AHRQ recipients with active research grants and cooperative agreements (excluding R13 and R36 awards) and career development (Ks) awards) may submit competitive revision applications. The project period of the proposed revision award must be within the approved project period of the parent award and may not exceed the end date of the parent award. Competing revision applications will not be accepted in the final year of the parent grant. Budget requests should reflect the actual needs of the proposed project, depending on the effort and career level of the candidate. Funding requests for large research grant (e.g., R01, R18) supplements are limited by AHRQ to 20 percent of the approved Federal direct costs, plus associated indirect costs, for the project period or $100,000 direct costs, plus associated indirect costs, whichever is less.

    The Agency plans to provide funding each fiscal year to support competitive revision awards. The amount of funding is dependent upon the availability of funds. Competing revisions are for one budget period.

    Funds will not be awarded for activities performed prior to the funding decision nor for activities to be performed beyond the approved project period end date.

    For the purposes of this program candidates to be supported by revision funding 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).

    Institutions are encouraged to diversify their student, postdoctoral and faculty populations to enhance the participation of individuals that are underrepresented at the national level in health services research. While there are different ways to identify the above populations of interest, some examples include those listed below:

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

    Section II. Award Information
    Funding Instrument

    The funding instrument will be the same as the parent award.

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

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, AHRQ scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    Competitive revision applications will be accepted for active AHRQ research grants and cooperative agreements, except R13 and R36 awards.

    Funds Available and Anticipated Number of Awards

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

    Award Budget

    Award budget is contingent upon activity code and the dollar amount of the parent award.

    For all other active AHRQ research grants and cooperative agreements not listed above, (except R13 and R36 awards), funding requests are limited by AHRQ to 20 percent of the approved Federal direct costs plus associated indirect costs for the project period or $100,000 direct costs plus associated indirect costs, whichever is less. Budget requests are not to exceed 12 months.

    Funds may be used only for those expenses that are directly related and necessary to the project and must be expended in compliance with applicable OMB Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards (45 CFR Part 75) and the HHS Grants Policy Statement.

    Award Project Period

    The project and budget periods must be within the currently approved project period for the existing parent award.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    All organizations administering an eligible parent award may apply for a competing revision under this announcement. Eligible awards include active research grants and cooperative agreements (excluding R13 and R36 awards).

    This announcement is for competing revisions to existing projects. To be eligible, the parent award must be active, and the research proposed in the competing revision must be accomplished within the competitive segment. All additional costs must be within the objectives of the peer reviewed and approved project.

    IMPORTANT: The research proposed by the AHRQ recipient in the competing revision application must be within the original objectives of the AHRQ-supported grant project.

    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.

    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. Since administrative supplements are made against active grants and cooperative agreements, many of these registrations may already be in place. 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.

    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. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.
    • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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.
      • NOT-OD-21-170- Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements

    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)

    Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award. Individuals are encouraged to work with their organizations to develop applications for support.

    For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the recipient institution of the parent award. Do not use this administrative supplement application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more information. The AHRQ multiple PDs/PIs policy can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-018.html.

    Established Investigators Who Are or Become Disabled: Established investigators (PDs/PIs) on an AHRQ research, program project, or center grant who are or become disabled during the current project period may request funds for reasonable accommodations to permit completion of the currently funded research project. Any currently funded PD(s)/PI(s) on an AHRQ research project grant, cooperative agreement, program project grant, or center grant may request support for special equipment, an assistant, or other modifications to facilitate reasonable accommodation to a disabling injury or illness that has occurred during the current project period.

    2. Cost Sharing

    This FOA does not require cost sharing.

    While there is no cost sharing requirement included in this NOFO, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project. This information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request.

    3. Additional Information on Eligibility
    Number of Applications

    Applicant organizations may submit competing revision applications for more than one grant or cooperative agreement, provided that each is sufficiently distinct from any other application currently under consideration by AHRQ but may not submit more than one competing revision application per award.

    The AHRQ will not accept duplicate or highly overlapping applications under review at the same time.

    Eligible Candidates for the Competitive Revision Program

    For the purpose of this announcement, institutions are encouraged to identify candidates who will enhance diversity on a national basis. In addition, it is recognized that underrepresentation can vary from setting to setting; individuals from groups that can be demonstrated convincingly to be underrepresented by the recipient institution should be encouraged to participate in this program (see Section I Description). The strength of the institution’s description of how the candidate furthers the goals of the program in the Candidate Eligibility Statement will be considered along with all other aspects of the proposed experience (see Review Criteria in Section V. Application Review Information).

    Competing revision awards under this announcement are limited to citizens or non-citizen nationals of the United States or to individuals who have been lawfully admitted for permanent residence in the United States (i.e., in possession of a Permanent Resident Card, Form I-551). This program may not be used to provide technical support to AHRQ-supported investigators.

    Note: PD(s)/PI(s) should encourage candidates to submit applications for fellowships, career development awards, research grants, and other sources of independent support before the competing revision period ends.

    All organizations administering an eligible parent award may apply for a competing revision under this announcement. Eligible awards include active research grants and cooperative agreements (excluding R13 and R36 awards).

    This announcement is for competing revision to existing projects. To be eligible, the parent award must be active and the research proposed in the competing revision must be accomplished within the competitive segment.

    PD(s)/PI(s) are encouraged to consider administrative supplements under this program for candidates at the following career levels:

    High School Students: The purpose of this program is to provide high school students who have expressed an interest in the health-related sciences with an opportunity to obtain a meaningful experience in health services research to stimulate their interest in research careers in biomedical, behavioral, clinical or social sciences. Any eligible high school student who is currently enrolled and in good standing at their high school and is interested in these areas of science is encouraged to participate in this program.

    Undergraduate Students: As part of this supplement program, undergraduate students with a demonstrated interest in or desire to pursue research training in health-related sciences, may participate in a research project during the summer months and/or the academic year. This experience is separate from any requirement of the regular academic program. The student may be affiliated with either the applicant institution or another academic institution. Any eligible undergraduate student interested in health services research is encouraged to participate in this program.

    Baccalaureate and Master's Degree Holders: This supplement will provide opportunities for baccalaureate or master's degree holders who have demonstrated an interest in and wish to pursue research training in health-related sciences while applying for admission to graduate or medical school. The duration of the program is normally 1 year, but the research experience can be extended for an additional year if evidence is provided to show that the candidate is actively pursuing entry into a graduate or a health professions school. Students who plan to attend medical, dental or other professional schools are encouraged to use this program to gain research experience.

    Graduate (Predoctoral) and Health Professional Students: The objective of this program is to support graduate/health professional (e.g., PhD, MD, DDS, etc.) students in biomedical, behavioral, clinical or social sciences, and health professional students who wish to develop their research capabilities. However, because this program is not intended to provide an alternative or additional means of supporting individuals who receive support from an AHRQ research grant, a Ruth L. Kirschstein National Research Service Award (Kirschstein-NRSA), or any other PHS funding mechanism, students who are supported by an institutional Kirschstein-NRSA may not be transferred to supplemental support prior to completion of the expected period of training on the program. In addition, individuals may not be transferred to a supplement to increase the availability of funds to the parent grant for other uses.

    Individuals in Postdoctoral Training: These supplements support individuals in the postdoctoral research phase of their training who wish to participate as researchers in ongoing research projects and career development experiences in preparation for an independent career in health services research. This experience must serve as a means of assisting the postdoctoral researcher's development into a productive researcher in health services research. Because this program is not intended to provide an alternative or additional means of supporting individuals who receive support from PHS funding mechanisms, individuals in postdoctoral training who are supported by an institutional Kirschstein-NRSA may not be transferred to supplemental support prior to the completion of their expected period of training in the program. In addition, individuals may not be transferred to a supplement to increase the availability of funds to the parent grant for other uses. The individual in postdoctoral training may be affiliated with either the applicant institution or some other institution.

    Investigators Developing Independent Research Careers: These supplements provide either short or long-term research support for faculty members who wish to participate in ongoing research projects while further developing their own research potential, to enhance their research skills and establish an independent research career.

    1. Short-term Investigator Research Supplement: This supplement provides short-term support for faculty members to conduct full-time research in the biomedical, behavioral, clinical or social sciences for three to five months each year during the summer or another portion of the academic year, over a maximum period of four years.

    2. Long-term Investigator Research Supplement: This supplement provides long-term research support for faculty members to conduct research in the biomedical, behavioral, clinical or social sciences. Support is usually provided for up to two years at a minimum of 9 person months (equivalent to 75% effort) during each 12-month period.

    In either case (1 or 2 above), the investigator may be affiliated with the applicant institution or some other institution. The investigator must have a doctoral degree, be beyond the level of a research trainee (post-residency and specialty training), and typically be employed at the junior faculty level (instructor or assistant professor). An individual who has received previous funding from AHRQ as an independent PD/PI on a research grant (e.g., R01), as the project leader on a component of a program project or center grant (e.g., P01, P50), or as PD/PI on an individual research career development award (e.g., K01, K02, and K08), is not eligible. However, individuals appointed as Scholars on Institutional Career Development Award (K12) are eligible for this supplement program, following the completion of their expected career development appointment. Applications for faculty-level supplements must convincingly demonstrate the need for the mentored research experience in establishing the candidate as an independent investigator.

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

    Applicants must prepare applications using current forms in accordance with the Application Guide.

    The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

    All forms must be completed for the supplemental activities only and must not reflect funding or activities for the previously awarded parent award.

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

    Page Limitations

    All page limitations applicable to the parent award as described in the Application Guide and the Table of Page Limits for the activity code of the parent award must be followed, with the following exceptions or additional requirements, and/or except where instructed in a this NOFO to do otherwise.

    Application Submission

    Administrative supplement requests must be submitted through Grants.gov using electronic submission processes.

    Instructions for Electronic Application Submission through Grants.gov

    Use the Apply button(s) in Part I of this announcement to access the application forms package posted at Grants.gov. If presented with more than one form package, use the Competition ID and Competition Titles provided to determine the most appropriate application forms package for your situation.

    Prepare applications using the SF424 (R&R) forms associated with the chosen package. Please note that some forms marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional forms, with the following additional guidance:

    • SF424 R&R Cover form: Select Revision in the Type of Application field.
    • R&R Other Project Information form: If applicable, attach PDF documents in the Other Attachments field indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the recipient institution. Name the documents IACUC Documentation.pdf and/or IRB Documentation.pdf . Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement.
    • Project/Performance Site Location(s) form: Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.
    • Sr/Key Person Profile (Expanded) form: List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.
    • Budget forms (e.g., R&R Budget, PHS 398 Training Budget): Only include funds requested for the additional supplement activities.
    • Research Plan form (e.g., PHS 398 Research Plan form, PHS 398 Research Training Program Plan): At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project. Other sections should also be included if they are being changed by the proposed supplement activities.

    SF424(R&R) Cover

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

    Enter the Federal Identifier of parent grant on box 4a. The applicant will enter IC (i.e., HS) and serial number of the funded AHRQ Grant that the competitive revision is linked to.

    This NOFO number must be included in box 4b (Agency Routing Identifier) on the application face page to be considered under the revision Policy Notice and this NOFO.

    In field 8. Type of Application, select Revision.

    Ensure that the proposed project start and end dates in field 12 are within the current approved project period of the parent grant.

    Proposed projects may not extend into a planned no-cost extension beyond the original project period end date.

    To be eligible, the parent award must be active and the research proposed in the competing revision must be accomplished within the original competitive segment. Competitive Revision Supplements will not be accepted in the final budget period of the parent award.

    SF424(R&R) Project/Performance Site Locations

    All instructions in the SF424 (R&R) Application Guide and this NOFO must be followed with the following additional instructions: Include the primary site where the proposed competing revision activities will be performed. If a portion of the proposed competing revision activities will be performed at any other site(s), identify the locations in the fields provided.

    SF424(R&R) Other Project Information

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

    SF424(R&R) Senior/Key Person Profile

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

    List the PD/PI as the first person (regardless of their role on the competing revision activities). List the candidate as the second person, and in the field Role on Project enter Candidate. List any other individuals directly involved in activities related to the competing revision, including mentors; include a biographical sketch for each. The candidate’s biographical sketch should include information to address evidence of achievements or interest in health services research, any sources of current funding, and a statement outlining the candidate’s research objectives and career goals.

    For competing revision to parent awards that include multiple PDs/PIs, do not use this competing revision application to add, delete, or change the PDs/PIs listed on the parent award.

    R&R Budget

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

    Budget Component: Special Instructions for AHRQ applications

    AHRQ is not using the Modular Grant Application and Award Process. Applicants applying for funding from AHRQ are to ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R). Applications submitted in the Modular format will not be reviewed.

    Applicants who propose the use of identifiable Centers for Medicare and Medicaid Services (CMS) data are advised to review NOT-HS-19-007 (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-19-007.html) for important changes to how applicants are to budget for the cost of this data.

    R&R Subaward Budget

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

    Only include funds requested for the additional competing revision activities.

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan Form

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

    Introduction: 1 page limit. The applicant should describe the nature of the competitive revision and how it will influence the specific aims, research design, and methods of the current grant.

    Research Strategy: Please use the standard page limit of the parent grant activity code. The research strategy must include a summary or abstract of the funded parent award or project. In addition, the narrative portion of the request should discuss the following:

    • Include a description of how the candidate's proposed research activities relate to one or more aims of the parent project.
    • Provide evidence of a focus on the enhancement of the research capability of the candidate and that the research experience is intended to provide opportunities for career development as a productive researcher, including a discussion of the mentorship, career development and research activities designed to contribute to a career in health services research.

    Letters of Support: Include as the first letter a Candidate Eligibility Statement. The candidate eligibility statement should be a signed statement from an institutional official establishing the eligibility of the candidate for support under this program. The statement must include clearly presented information on citizenship of the candidate and a description of how the appointment of this specific candidate would further the goals of this this program, consistent with the underrepresented groups defined above.

    Resource Sharing Plan:

    Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    AHRQ applicants are reminded to refer to NOT-HS-20-011: The Agency for Healthcare Research and Quality Data Management Plan Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-011.html) for additional information on how to incorporate the required data management plan into the resource sharing plan.

    Appendix:

    Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

    See NIH/NIOSH/AHRQ New Policy Appendix Guide located at NOT-OD-18-126.

    PHS Human Subjects and Clinical Trials Information

    When involving human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide and this NOFO, 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.

    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). A Delayed Onset study is one in which human subjects research is anticipated within the period of award but definite plans are not yet known and cannot be described in the application.

    For details regarding IRB approval, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). Applicant should also be aware of the AHRQ policy for use of single IRB for cooperative research, 45 CFR 46.114 (b) https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-005.html.

    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 electronic 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). 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. AHRQ 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.

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

    For electronic application submission, information on the submission process and a definition of on-time submission are provided in the SF424(R&R) Application Guide.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

    For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf.

    Revision funds will not be awarded for activities performed prior to the funding decision nor for activities to be performed beyond the approved project period end date.

    Add additional information about funding restrictions. If any of these restrictions become part of the terms of award, that must be stated in Section VI.1.

    Supplements for Established Investigators Who Are or Become Disabled

    Support will be limited to items that will permit the investigator to complete the remaining years of a currently funded research project. This might include: salary support for an individual who can assist the Established Investigator in meeting the goals of the research project, specialized equipment, or modifications of the working environment. In all cases, the requested support must be consistent with the type of disability and the nature of the approved research. The total amount of support requested under this supplement must be reasonable in relationship to the direct costs of the parent award and the Established Investigator's role and effort on the project. In future competing applications, funds for continuation of the accommodations provided under this supplement must be requested in the parent grant application and may NOT be requested as a research supplement.

    Reasonable Accommodations: As part of these awards, funds may be requested to make changes or adjustments to the research setting that will make it possible for a qualified individual with a disability to perform the essential functions associated with his/her role on the project. The accommodations requested under this program must be directly related to the performance of the proposed role on the research project and must be appropriate to the disabilities of the individual. Some types of accommodations that might be provided under these awards include: specialized equipment, assistive devices, and personnel such as readers, interpreters, or assistants. In all cases, the total funds for accommodations requested from the supplement must be reasonable in relationship to the direct costs of the parent grant and the nature of the supplement award.

    High School Students: The salary for a high school student, whether full- or part-time, should be consistent with institutional salary policies. Institutional salary rates for high school students that exceed the hourly minimum wage must be justified. Students are expected to devote sufficient effort to the research project and related activities during the period of support to gain insight into the process of scientific discovery. Support for at least three months is encouraged during any one year. This may include a combination of full-time summer experience and part-time experience during the school year. PD(s)/PI(s) are encouraged to seek high school students who will devote at least two years to this program (i.e., equivalent to two three-month, full-time periods). Exceptions to the latter will be considered, depending on the circumstances of the applicant, the parent grant, and the specific request.

    Undergraduate Students: The salary for an undergraduate student should be consistent with institutional salary policies. Institutional rates for undergraduate salary that exceed $12 per hour must be justified. An additional amount of $200 per month for supplies and travel may also be requested. Students are expected to devote the equivalent of at least three months of full-time effort to the research project and related activities in any one year; in most cases, the period of support for any individual should last at least two years. Exceptions to these requirements will be considered, depending on the circumstances of the applicant, the parent grant, and the specific request.

    Baccalaureate and Master's Degree Holders: The salary for baccalaureate and master's degree holders should be reasonable and consistent with the institutional salary policies and cannot exceed the compensation allowed for graduate students. Additional funds up to $3,000 per year may be requested to support supplies and travel for the candidate.

    Graduate (Predoctoral) and Health Professional Students: AHRQ will provide salary support in addition to other necessary expenses, such as supplies and travel, to enable the individual to participate as a graduate research assistant in a funded research project. AHRQ will provide compensation that (1) conforms to the established, consistently applied salary and wage policies of the institution and (2) reflects the percentage of time devoted to the AHRQ-funded project. For graduate students this compensation may include tuition remission paid as, or in lieu of, wages provided that the student is in a bona fide employer-employee relationship with the institution for the work performed, and payment is made explicitly for performance of necessary work. The total amount requested for salary, tuition and fringe benefits cannot exceed the amount allowable for a first-year postdoctoral fellow (i.e., level zero) at the same institution performing comparable work (see NIH Guide announcement, http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-02-017.html). Additional funds up to $4,000 per year may be requested to support supplies and travel for the candidate.

    Individuals in Postdoctoral Training: AHRQ will provide support for salary and fringe benefits in addition to other necessary expenses, such as travel and supplies, to enable the candidate to participate as a postdoctoral research associate on the funded research project. The requested annual salary must be in accordance with the salary structure of the recipient institution, consistent with the level of effort. Requested salary may not exceed the maximum allowable NRSA stipend level for postdoctoral fellows (with comparable levels of experience) in effect at the time of appointment (see: https://grants.nih.gov/training/nrsa.htm). Fringe benefits are provided in addition to salary, and should be in accordance with the fringe benefits provided to other postdoctorates at the recipient institution. The supplement budget may include up to $6,000 per year to support supplies and travel for the candidate.

    Investigators Developing Independent Research Careers: The requested salary and fringe benefits for an investigator should be consistent with the level of support provided by AHRQ Career Development Awards. Salary and fringe benefits must be in accordance with the salary structure of the recipient institution and must be consistent with the level of effort. Additional funds of up to $10,000 per year may be requested for supplies and travel for the candidate. Equipment may be purchased but requires prior approval. The maximum period of support for any investigator is usually two years.

    Initial and Continued Funding

    In most cases, during the first budget period for the supplement, funds will be provided as an administrative supplement to the parent grant. In subsequent years, continued funding for the supplement is contingent on continued funding of the parent grant and cannot extend beyond the current competitive segment of the parent grant and the availability of funds.

    In Renewal (Type 2) applications, funds for continuation of support of the supplemental award will depend on the successful renewal of the parent grant and will be handled as follows:

    Funds for the continuation of support for students must be requested as a new diversity supplement. The request must be submitted promptly in anticipation of a renewal award to avoid an interruption of support. Additional time may be considered for individuals with disabilities but must be well justified.

    Funds for continued support for a postdoctoral researcher or an investigator must be requested by name in the parent grant application at the time of renewal and may not be requested as a research supplement. Postdoctoral researchers and investigators are expected to be fully integrated in the research laboratory when considered for continuation of support.

    7. Other Submission Requirements and Information

    Applications must be submitted using the instructions specified above. Paper applications will not be accepted.

    Applicants must complete all required registrations prior to submission. 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:
    For applications submitted electronically on the SF424 (R&R) Application forms, 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 eRA 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 unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

    • NOT-OD-21-170- Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements

    See more tips for avoiding common errors.

    The applicant should pay particular attention to the SF424 (R&R) application guide instructions (https://grants.nih.gov/grants/how-to-apply-application-guide/forms-g/general-forms-g.pdf) concerning letters of support. Letters of support, recommendation, or affirmation from any entity or individual not directly participating in the project should not be included.

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

    Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see https://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.

    Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

    Recipients of awards under this NOFO must include the progress report of the revision award with, but clearly delineated from, the progress report of the parent award. The revision award progress report must report on the performance in achieving the NOFO objective to enhance the diversity of the health services research workforce by supporting students, post doctorates, and eligible early-career investigators from underrepresented backgrounds, including those from groups that have been shown to be nationally underrepresented in health services research.

    Warning: Please be sure that you observe the total cost, project period, and page number limitations specified above for this NOFO. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

    Priority Populations

    AHRQ is committed to the inclusion of priority populations in health services research. The overall portfolio of health services research that AHRQ conducts and supports shall include the populations specifically named in AHRQ’s authorizing legislation: inner city; rural; low income; minority; women; children; elderly; and those with special health care needs, including those who have disabilities, need chronic care, or need end-of-life health care. 42 U.S.C. 299(c)(1). AHRQ also includes in its definition of priority populations those groups identified in Section 2(a) of Executive Order 13985 as members of underserved communities: Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality.

    AHRQ will broadly implement this inclusion policy across the research that AHRQ supports and conducts so that the portfolio of research is inclusive of all populations. AHRQ intends that these populations be included in studies such that the research design explicitly allows conduct of valid analyses. The policy applies to all grant applications. Investigators should review the document entitled, AHRQ Policy on the Inclusion of Priority Populations, which is available at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-21-015.html. Applicants under this NOFO must consider and discuss including priority populations in research design as specified in this Notice.

    Public Access to AHRQ-Funded Scientific Publications

    Investigators should review the document titled AHRQ Announces new Policy for Public Access to AHRQ-Funded Scientific Publications , which is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-008.html). For all research arising from AHRQ support, this policy requires that AHRQ-funded authors submit an electronic version of the author’s final peer-reviewed accepted manuscript to the National Library of Medicine's PubMed Central (PMC) to be made publicly available within 12 months of the publisher’s date of publication.

    AHRQ Data Management Plan Policy

    Investigators should review the document titled AHRQ Data Management Plan (DMP) Policy, which is available at (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-011.html). This policy requires applicants for AHRQ new/competing grants and research contracts to include a DMP for managing, storing and disseminating the primary data, samples, physical collections and other supporting materials created or gathered in the course of research funded by AHRQ, or state why data management is not possible, as a component of their grant application or research contract proposal.

    Plan for Sharing Research Data

    The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data should describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools also will be provided; whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

    The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

    Data Confidentiality

    The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied. Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it. There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute. 42 USC 299c-3(d). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected (see NOT-HS-18-012: Confidentiality in AHRQ-Supported Research). The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine-readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by recipient under this RFA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164.

    The recipient should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

    Sharing Research Resources: Rights in Data

    Unless otherwise provided in grant awards, AHRQ recipients may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers. In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on recipients to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ requests that recipients notify the Office of Communications (OC) when an AHRQ-funded research article has been accepted for publication in a peer-reviewed journal. Researchers should submit manuscripts that have been accepted for publication in a peer-reviewed journal to JournalPublishing@ahrq.hhs.gov at least four to six weeks in advance of the journal’s expected publication date.

    Regulations applicable to AHRQ recipients concerning intangible rights and copyright can be found at 45 CFR 75.322.

    Post Submission Materials

    Not Applicable

    Section V. Application Review Information
    1. Criteria

    The mission of AHRQ is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work with the U.S. Department of Health and Human Services (HHS) and other partners to make sure that the evidence is understood and used.

    AHRQ's priority areas of focus are available at https://www.ahrq.gov/funding/policies/foaguidance/index.html.

    Applications that are complete and responsive to the NOFO will be evaluated for overall impact within the original objectives of the award by an appropriate objective group convened in accordance with standard AHRQ peer-review procedures that are described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive applications or applications not following instructions given in this NOFO will not be reviewed. Only the review criteria described below will be considered in the review process.

    • Administrative Criteria: Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, National Institutes of Health, and for responsiveness by AHRQ.
    • Merit Review Criteria: Merit Review Criteria, as described below, will be considered in the review process.

    Overall Impact

    Overall Impact

    Reviewers will consider the ability of the proposed competing revision activities to increase or preserve the parent award’s overall impact within the original objectives of award as well as the potential for the competing revision to advance the training and career development of the candidate. Factors to be considered include:

    • appropriateness/fit of the request to the original objectives of the parent project;
    • adequacy and appropriateness of plans for organizing and carrying out the integral part of the project;
    • qualifications, and research training, and relevant experience of the candidate;
    • reasonableness of budget and the time frame relative to the proposed work;
    • ability of the recipient to complete the additional work within the approved project period;
    • adequacy of mentorship experience and career development for the candidate;
    • evidence that the competing revision will enhance candidates research capabilities, knowledge and skill sets, and advance their career goals

    In addition, each of the following criteria will be evaluated as applicable for the proposed competing revision.

    Scored Review Criteria

    Reviewers will consider each of the review criteria listed in the parent NOFO 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. For example, a project that by its nature is not innovative may be essential to advance a field.

    Additional Review Criteria

    n/a

    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.

    For details regarding IRB approval, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). Applicant should also be aware of the AHRQ policy for use of single IRB for cooperative research, 45 CFR 46.114 (b) https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-005.html.

    Inclusion of Priority Populations

    Peer reviewers will assess the adequacy of plans to address the needs of AHRQ priority populations.

    Peer reviewers must include their assessment of the proposed inclusion plan for priority populations in evaluating the overall scientific and technical merit of the application and assigning the impact score.

    In evaluating the overall impact of the application, the review groups will:

    • Evaluate the application for the presence or absence of the inclusion plan based on the proposed research objectives.
    • Evaluate the adequacy of the proposed plan for the inclusion of priority populations.
    • Evaluate the proposed justification for the exclusion of priority populations when a requirement for inclusion is described as inappropriate with respect to the purpose of the research.
    • Evaluate the plans for outreach and recruitment of study participants, including priority populations, where appropriate.
    • Evaluate the proposed plan for study design, execution and outcome assessments so that study results will be relevant to one or more priority populations, where appropriate.
    • Assess the plan as being acceptable or unacceptable with regard to the appropriateness of the inclusion or exclusion of priority populations in the proposed research.

    Degree of Responsiveness

    • How well does the proposed research plan align with AHRQ s mission and research priorities?
    • Reviewers will assess how well the application addresses the purpose and objectives of this NOFO. How responsive is the application to the special eligibility criteria, including the project requirements, noted in the NOFO?

    Budget and Period of Support

    The committee will evaluate whether the proposed budget is reasonable, and whether the requested period of support is appropriate in relation to the proposed research

    2. Review and Selection Process

    Applications that are complete and responsive to the NOFO will be evaluated for scientific and technical merit by an appropriate Scientific Review Group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive applications or applications not following instructions given in this NOFO will not be reviewed.

    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.

    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.
    • Responsiveness to goals and objectives of the NOFO.
    • Proposed plan to address health equity
    • Relevance and fit within AHRQ research priorities, as well as overall programmatic and geographic balance of the proposed project to program priorities.
    3. Anticipated Announcement and Award Dates

    Not Applicable

    Section VI. Award Administration Information
    1. Award Notices

    If the application is under consideration for funding, AHRQ will request "Just-In-Time" information from the applicant. Just-In-Time information generally consists of information on other support, any additional information necessary to address administrative and budgetary issues, and certification of IRB approval of the project's proposed use of human subjects. For details regarding IRB approval, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html) Applicant should also be aware of the AHRQ policy for use of single IRB for cooperative research, 45 CFR 46.114 (b) https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-005.html.

    If all administrative and programmatic issues are resolved, a formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the AHRQ grants management officer is the authorizing document and will be sent via email to the e-mail address designated by the recipient organization during the eRA Commons registration process.

    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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the AHRQ web site at

    https://www.ahrq.gov/funding/grant-mgmt/index.html.

    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:

    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.

    Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

    HHS recognizes that 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 FOA.

    Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

    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 45 CFR Part 75.205 and 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.

    Cooperative Agreement Terms and Conditions of Award

    Any supplements to Cooperative Agreements will be subject to the same Cooperative Agreement terms and conditions as the parent award.

    3. Reporting

    Reporting requirements will be specified in the terms and conditions of award as applicable to the supplemental activities. In most non-competing continuation applications, the progress report and budget for the supplement must be included with, but clearly delineated from, the progress report and budget for the parent award. The progress report must include information about the activities supported by the supplement even if support for future years is not requested. Continuation of support for the supplement activities in the remaining years of the competitive segment of the grant will depend upon satisfactory review by the AHRQ awarding component of progress for both the parent award and the supplement project, the research proposed for the next budget period, and the appropriateness of the proposed budget for the proposed effort. This information is submitted with the Research Performance Progress Report (RPPR) and financial statements as required in the HHS Grants Policy Statement. AHRQ NOFOs outline intended research goals and objectives. Post award, AHRQ will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR 200.301

    Recipients are required to submit expenditure data on the Federal Financial Report (FFR; SF 425) annually.

    Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425) of the parent grant. AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (https://www.ahrq.gov/funding/policies/hhspolicy/index.html). AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs is 90 days after the end of the calendar quarter in which the budget period ends. For example, if the budget period ends 4/30/2020, the annual FFR is due 9/30/2020 (90 days after the end of the calendar quarter of 6/30/2020).

    A final Progress Report, final Federal Financial Report, and Final Invention Statement are required when an award ends. All final reports are due within 90 days of the project period end date. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/funding/grant-mgmt/index.html#Closeout.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), 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 AHRQ 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 HHS Grants Policy Statement (http://www.ahrq.gov/funding/policies/hhspolicy/index.html) for additional information on this reporting requirement.

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 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 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

    Section VII. Agency Contacts

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

    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, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (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: support@grants.gov

    Scientific/Research Contact(s)
    General Questions

    Kathryn Roberts Marron, Ph.D.
    Division for Policy, Coordination and Analysis
    Office of Extramural Research, Education, and Priority Populations
    Agency for Healthcare Research and Quality, HHS
    Email: Kathryn.Marron@ahrq.hhs.gov

    Peer Review Contact(s)

    Director, Division of Scientific Review
    Office of Extramural Research, Education, and Priority Populations
    Agency for Healthcare Research and Quality
    e-mail: DSR@ahrq.hhs.gov

    Financial/Grants Management Contact(s)

    Office of Management Services
    Division of Grants Management
    Agency for Healthcare Research and Quality (AHRQ)
    Email address: GMI@ahrq.hhs.gov

    Section VIII. Other Information

    Recently issued AHRQ policy notices may affect your application submission. A full list of policy notices published by AHRQ is provided in the NIH Guide for Grants and Contracts. Notices can also be found at AHRQ Grants Policy Notices

    Authority and Regulations

    This program is described in the Assistance Listings (formerly called the Catalog of Federal Domestic Assistance) at https://beta.sam.gov/help/assistance-listing and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

    Awards are made under the authority of 42 USC 299 et seq., and in accordance with 45 CFR Part 75 and other referenced applicable statutes and regulations. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.

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