Key Dates

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 an AHRQ Notice published in 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 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 provided in this NOFO 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.




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 Agency for Healthcare Research and Quality (AHRQ) hereby notifies recipients holding active AHRQ awards, (except R13s, and R36s), that funds may be available for administrative supplements to provide additional funding to currently funded grants to meet increased costs that are within the scope of the approved project, but that were unforeseen when the new or competing renewal application was awarded. Applications for administrative supplements are considered prior approval requests and will be routed directly to the Grants Management Officer of the parent award.

Applications must be responsive to AHRQ’s mission, which 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 with other partners to make sure that the evidence is understood and used. Within the mission, AHRQ’s specific priority areas of focus are detailed here: https://www.ahrq.gov/funding/policies/foaguidance/index.html.

Although requests for administrative supplements may be submitted through this NOFO, there is no guarantee that funds will be available for any specific grant. All applicants are encouraged to discuss potential requests with the assigned Program Official .

It is expected that funding will be available in Fiscal Year 2022.

Application Information:

AHRQ recipients with active research grants and cooperative agreements (excluding R13 and R36 awards) may submit applications for Administrative supplements for Grants to Enhance Health Services Research. The project period of the proposed supplement must be within the approved project period of the parent award. The supplement project cannot exceed the end date of the parent award. Supplement applications will not be accepted in the final year of the parent grant. Budget requests should reflect actual needs. Funding requests for large research grant (e.g., R01, R18, U18) supplements are limited by AHRQ to 20 percent of the approved Federal direct costs for the project period or $100,000 total costs, whichever is less. Small research grant (R03) administrative supplement total cost requests are limited by AHRQ to 10 percent of the approved Federal direct costs for the project period.

Supplements are for one budget period. Supplemental funds will not be awarded for activities performed prior to the issuance of the supplement award NOA nor for activities to be performed beyond the approved project period end date.

The Agency plans to allocate funding each fiscal year to support administrative supplements. The amount of the set-aside is dependent upon the availability of funds.

AHRQ may publish Notices that guide applicants to submit administrative supplement applications using this NOFO, including Special Emphasis Notices (SEN) or Notices of Special Interest (NOSI). Such notices may include specific requirements and instructions supplementing the instructions found in this NOFO. Be sure to follow specific Notice instructions if applying for consideration for administrative supplement funding, and include the Notice number in the Agency Routing Identifier field (box 4B) of the SF424 (R&R) Form.

Recipients of awards under this NOFO must provide annual and final reports of performance in achieving the NOFO objective to enhance health services research (See section VI.3. Reporting).

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.

Application Types Allowed

Administrative supplement applications to active AHRQ research grants and cooperative agreements (except R13 and R36 grants).

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

Clinical Trial?

Optional

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

For R03 projects, administrative supplement total cost budgets are limited to 10% of direct costs of the R03 project period.

For eligible AHRQ research grants and cooperative agreements, (except R13s and R36s, which are not eligible), funding requests are limited by AHRQ to 20 percent of the approved Federal direct costs for the project period or $100,000 total costs, whichever is less. Supplement budget requests are not to exceed 12 months.

Supplemental funds may not be requested to restore costs that were not allowed during initial negotiation of the award.

Funds may be used only to meet increased costs that are within the scope of the approved award, but were unforeseen when the competing application was submitted. These expenses must be 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.

Applicants must demonstrate that existing project funds cannot be re-budgeted in order to cover the expense(s) for which supplemental funds are requested.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

All organizations administering an eligible parent award may apply for an administrative supplement under this announcement.

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

IMPORTANT: The research proposed by the AHRQ recipient in the administrative supplement application must be within the original scope of the AHRQ-supported grant project.

This announcement is for supplements to existing projects (except R13 and R36 applications.

To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment.

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. 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) 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, applicant organizations 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 to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Individual(s) must hold an active AHRQ 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.

2. Cost Sharing

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

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

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 NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

All applications must be submitted electronically using one of the submission methods listed in Part 1 of this NOFO and must be in response to this NOFO.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide except where instructed in this Notice of Funding Opportunity announcement to do otherwise. Conformance to these 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 described in the SF424 Application Guide and the Table of Page Limits for the activity code of the parent award must be followed except where instructed in this NOFO to do otherwise.

Instructions for Application Submission

Administrative supplement requests must be submitted through Grants.gov using NIH ASSIST, Grants.gov Workspace, or institutional system-to-system (S2S) solutions. 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. The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide 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 administrative supplement is linked to.

If the administrative supplement application is in response to an AHRQ Notice (SEN or NOSI) enter the Notice number in the Agency Routing Identifier field (box 4B) of the SF424 (R&R) Form.

In field 8. Type of Application, select Revision.

Ensure that the proposed supplement project start and end dates in field 12 are within the current approved project period of the parent grant, and are not in the final budget period of the award.

To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment.

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 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.

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 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. For supplements to parent awards that include multiple PDs/PIs, do not use this supplement 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.

Only include funds requested for the additional supplement activities. Supplemental funds may not be requested to restore costs that were not allowed during initial negotiation of the award.

In the Budget Justification, clearly explain how the funds requested will be used to meet increased costs that are within the scope of the approved award, but were unforeseen when the competing application was submitted. Demonstrate that existing project funds cannot be re-budgeted in order to cover the expense(s) for which supplemental funds are requested.

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 supplement activities. Supplemental funds may not be requested to restore costs that were not allowed during initial negotiation of the award.

In the Budget Justification, clearly explain how the funds requested will be used to meet increased costs that are within the scope of the approved award, but were unforeseen when the competing application was submitted. Demonstrate that existing project funds cannot be re-budgeted in order to cover the expense(s) for which supplemental funds are requested.

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 administrative supplement 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 supplement request should discuss the following:

• describe the activities proposed in the administrative supplement and explain how the supplemental activities fit in the context of the parent project.

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

PHS Human Subjects and Clinical Trials Information form: This form is optional. Given that the proposed supplement should not change the scope of the awarded parent project, it will typically not be needed. If new recruitment or use of an additional existing dataset or resource is proposed in the supplement application, Section 2 should be revised and new Inclusion Enrollment Reports created, as well as other required sections, as appropriate for supplemental activities.

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, the electronic system for grants administration used by AHRQ. 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.

For Cooperative Agreements (e.g., U01, U18): These awards will not be made under expanded authorities

Pre-award costs will not be allowed for administrative supplements.

7. 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 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:

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. See Section III of this NOFO for information on registration requirements. Note: Targeting due dates on or after January 25, 2022, all individuals listed on the R&R Senior/Key Person Profile (Expanded) Form are required to have an eRA Commons username (Commons ID). See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-109.html.

The applicant organization must ensure that the UEI 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. Additional information may be found in the SF424 (R&R) Application Guide.

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/electronicreceipt/files/high-level-form-change-summary-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 for 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 AHRQ 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.

In addition to the annual Research Performance Progress Report (RPPR) that is required of grants with multiple years of funding, awards under this NOFO carry the requirement to submit semiannual progress reports to the AHRQ Research Reporting System (ARRS). Quarterly conference calls with the AHRQ Program Official for the grant may also be required at the discretion of the Program Official.

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.

Add any other Submission Requirements and Information, include heading (use Heading 4 and Heading 4 Indent styles) and description. Do not include information about the CONTENT and FORM of the application, which should instead be placed above in Section IV.2. Content and Form,

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.

Administrative Supplements do not receive peer review. Instead, the administrative criteria described below, will be considered in the administrative evaluation process.

AHRQ staff will evaluate requests for a supplement to determine its overall merit. The following general criteria will be used:

Budget and Period of Support

AHRQ staff will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed administrative supplement. AHRQ staff will ensure that the proposed supplement is for a maximum of 12 months, that the requested budget does not include a request to restore costs that were not allowed in the initial negotiation of the award, and that the request is within the parameters described by this NOFO.

Overall Impact

AHRQ staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award:

• Will the administrative supplement increase or preserve the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved?
• Will the administrative supplement increase or preserve the likelihood that the fellowship/career award will enhance the candidate's potential for, and commitment to, a productive, independent scientific research career in a health services research?
• Will the administrative supplement increase or preserve the likelihood for the candidate to maintain a strong research program?
• In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.
Protections for Human Subjects

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

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

Inclusion of 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?

Resubmissions

Not applicable.

Renewals

Not applicable.

Revisions

Not applicable.

Additional Review Considerations

Not Applicable.

Budget and Period of Support

Not applicable.

2. Review and Selection Process

Administrative supplement requests will undergo an administrative evaluation by AHRQ staff, but not a full peer review. Applications submitted for this funding opportunity will be assigned to the Program Official of the parent award and will be administratively evaluated using the criteria shown above.

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. Pre-award costs are not allowed.

Any application awarded in response to this NOFO will be subject to the UEI, 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 AHRQ grant and cooperative agreement awards are subject to OMB's Uniform Grant Guidance, HHS’s Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards, (http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75), and the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of Award.

All applicants will be subject to a term and condition that applies the terms of 48 CFR section 3.908 to the award, and requires that recipients inform their employees in writing of employee whistleblower rights and protections under 41U.S.C. 4712 in the predominant native language of the workforce.

As necessary, additional Terms and Conditions will be incorporated into the NoA.

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR Part 75, 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.

AHRQ regulatory procedures that pertain to suspension and termination are specified in 45 CFR 75.371 through 75.375.

There is a prohibition on certain telecommunications and video surveillance services or equipment that became effective on or after August 13, 2020.

Should you 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. 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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting your legal obligation to take reasonable steps to ensure meaningful access to your programs or activities by limited English proficient individuals. See https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on your specific legal obligations for serving qualified individuals with disabilities, including reasonable modifications and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html.
• For guidance on administering your program in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws, see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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
• or call 1-800-368-1019 or TDD 1-800-537-7697.
• Health Literacy Below are available HHS resources.
• HHS Health.gov: Health Literate Care Model
• AHRQ: Health Literacy Universal Precautions Toolkit

For additional guidance regarding how the provisions apply to AHRQ grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), AHRQ 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 Federal awarding agency review of risk posed by applicants. This provision will apply to all AHRQ 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 for the supplement must be included with, but clearly delineated from, the progress report for the parent award. The progress report must include information about the activities supported by the supplement. This information is submitted with the Research Performance Progress Report (RPPR) and financial statements as required in the HHS Grants Policy Statement. 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 appropriate budget period of the parent Federal Financial Report (FFR; SF 425). 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 4/30/2021, the annual FFR is due 9/30/2021 (90 days after the end of the calendar quarter of 6/30/2021).

A final Progress Report, final Federal Financial Report, and Final Invention Statement are required when an award ends. The final progress report for the supplement must be included with, but clearly delineated from, the final progress report for the parent award. The progress report must include information about the activities supported by the supplement. 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.

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)

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)

Direct your questions regarding program matters to the AHRQ staff associated with your current parent grant award.

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)

N/A

Financial/Grants Management Contact(s)

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

Or

Contact the Grants Management Specialist listed in the NoA.

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 42 U.S.C. 299b-37 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.