It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV 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.

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

Purpose

The Agency for Healthcare Research and Quality (AHRQ) hereby notify grantees holding active AHRQ research grants and cooperative agreements, (except R13s, T32s, F32s), that funds may be available for competitive revisions to meet immediate needs to help address timely health system and healthcare professional response to the COVID-19 public health crisis. This FOA does not include grants that were previously funded under FOAs supported by Patient Centered Outcome Research Trust Fund (PCOR TF) dollars (please see FOA number PA-20-072, which is directed towards those grants).

It is expected that competitive revision supplement requests will capitalize on the expertise of grant personnel and the institutional environment to expand the specific aims of the on-going research to develop high-impact new knowledge concerning COVID-19.

Funding will be available in Fiscal Year 2020.

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

These projects are authorized by 42 U.S.C. 299a, which provides that AHRQ shall conduct and support research, support demonstration projects, and disseminate information on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness, and value of health care services.

All applications submitted and AHRQ grants made in response to this FOA are subject to 45 CFR Part 75 (Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards; http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75) , 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 organizations administering an eligible parent award may apply for a supplement under this announcement. Applicant must follow the eligibility requirement of the parent grant.

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations (for Cooperative Agreements Only)

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

Governments

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

This announcement is for supplements to existing projects (except R13s, T32s, F32s). This FOA does not include grants that were previously funded under FOAs supported by Patient Centered Outcome Research Trust Fund (PCOR TF) dollars please see FOA number PA-20-072, which is directed towards those grants).

To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment (inclusive of an existing or planned first no-cost extension or existing second no-cost extension).

AHRQ's authorizing legislation does not allow for-profit organizations to be eligible to lead applications under research grant mechanisms. For-profit organizations may participate in research grant projects as members of consortia or as subcontractors only.

For profit organizations are eligible to lead applications under cooperative agreements.

Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only. Applications submitted by for-profit organizations or foreign institutions will not be reviewed. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the grantee and what substantive role the applicant organization will play. Justification can be provided in the Specific Aims or Research Strategy section of the PHS398 Research Plan Component sections of the SF424 (R&R) application. There is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities.

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.

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. (See also https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-010.html)
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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.

Individual(s) must hold an active AHRQ grant or cooperative agreement active, (except R13s, T32s, F32s, which are not eligible, and grants that were previously funded under FOAs supported by PCORTF dollars).

The research proposed in the supplement must be accomplished within the competitive segment of the active award (inclusive of an existing or planned first no-cost extension or an existing second no-cost extension). 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) but must be submitted by the parent award organization. Do not use this 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. See also AHRQ's NOT-HS-16-018 related to Multiple PD/PI via https://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-018.html.

This FOA does not require cost sharing.

While there is no cost sharing requirement included in this FOA, 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.

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.

For competitive revision supplements submitted in response to this FOA, please submit all applications by May 29, 2020 by 5:00 PM local time of applicant organization.

In order to ensure identification, tracking, and appropriate review of their applications, all applicants MUST follow these special instructions:

• Applicants should begin the Introduction to the Revision Application section by stating: This application is being submitted in response to "PA-20-070".
• Applicants MUST insert the unique identifier "PA-20-070" in the beginning of the Project Title of their application. [Note: AHRQ limits the Project Title to 200 characters (including spaces and punctuation)]. Please see SF 424 (R&R) regarding title Project Title Requirements.
• Applicants must follow instructions in SF 424 (R&R) Form Box 4a (Federal Identifier) where applicant will enter IC (i.e., HS) and Serial number of the funded AHRQ Grant that the competitive revision is linked to.

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.

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

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

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 FOA to do otherwise.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

Select Revision in the Type of Application field.

This FOA 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 FOA.

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

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

Ensure to follow instructions in SF 424 (R&R) Form Box 4a (Federal Identifier) where applicant will enter IC (i.e., HS) and Serial number of the funded AHRQ Grant that the competitive revision is linked to.

All instructions in the SF424 (R&R) Application Guide and this FOA 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.

All instructions in the SF424 (R&R) Application Guide and this FOA 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.

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

Only include funds requested for the additional supplement activities.

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

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

In addition to describing the research plan to be conducted with supplemental funding, the applicant should describe how the proposed work will affect the original project. The revision supplement may not exceed 12 months including the original period of performance and/or that of an existing or planned first-time no cost extension. If the project is in a second no-cost extension, the revision supplement may not extend beyond the current end of the project.

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:

Not applicable.

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.

When involving NIH-defined 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 FOA, 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.

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

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.

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

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.

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.

This initiative is not subject to intergovernmental review.

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, however, pre-award costs will be allowed for the supplement portion of the project. A grantee may, at its own risk and without AHRQ prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the revision supplement award if such costs are necessary to conduct the project and would be allowable under the grant, if awarded, without AHRQ prior approval.

For Career Awards (e.g., K01, K08, K12): These awards will not be made under expanded authorities, however, pre-award costs will be allowed for the supplement portion of the project. A grantee may, at its own risk and without AHRQ prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the revision supplement award if such costs are necessary to conduct the project and would be allowable under the grant, if awarded, without AHRQ prior approval..

For Research Grants (e.g., R01, R03, R21, R18): Pre-award costs are allowable. A grantee may, at its own risk and without AHRQ prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the revision supplement award if such costs are necessary to conduct the project and would be allowable under the grant, if awarded, without AHRQ prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain AHRQ approval before incurring the cost. AHRQ prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a revision supplement award imposes no obligation on AHRQ either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project.

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 AHRQ. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. 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/how-to-apply-application-guide/forms-d/general-forms-d.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 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.

Applicants are required to follow the instructions for post-submission materials, as described NOT-OD-19-083 and NOT-OD-20-061.Any instructions provided here are in addition to the instructions in the policy.

Priority Populations

AHRQ supports research, evaluations, and demonstration projects concerning the delivery of health care in inner-city and rural areas (including frontier areas), and health care for priority populations. Priority populations include low income groups, minority groups, women, children, the elderly, and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. 42 USC 299(c). Women and members of minority groups are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate, e.g. because of the lack of connection between the study and the health of women or particular minorities. 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-03-010.html. Applicants under this FOA should consider and discuss including priority populations in the 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.

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 grantees under this RFA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164.

The grantee 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 grantees 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 grantees to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ requests that grantees 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 grantees concerning intangible rights and copyright can be found at 45 CFR 75.322.

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 FOA will be evaluated for scientific and technical merit 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 FOA 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.

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 research.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project and responsiveness to the immediate need to help address timely health system and healthcare professional response to the COVID-19 public health crisis, in accordance with this FOA. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive care transitions? Does the project address an important problem or a critical barrier related to the COVID-19 pandemic?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Investigators are in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant variables, such as sex, for studies human subjects?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project proposed, reviewers will evaluate the following additional items and their responsiveness to the immediate need to help address timely health system and healthcare professional response to the COVID-19 public health crisis, but will not give separate scores for these items:

How well does the proposed research plan align with AHRQ’s mission and research priorities?

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 FOA. How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA?

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.

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.

Reviewers will assess the adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups). Reviewers will assess the adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.7 Other Submission Requirements ).

Resubmissions

Not applicable.

Renewals

Not applicable.

Revisions

See criteria outlined above in Overall Impact section.

Additional Review Considerations

Not Applicable.

Applications that are complete and responsive to the FOA 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 FOA 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 FOA.
• Relevance and fit within AHRQ research priorities, as well as overall programmatic and geographic balance of the proposed project to program priorities.

Not Applicable.

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).

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.

Awardees 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 FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the OER Glossary link or the AHRQ web site at https://www.ahrq.gov/funding/grant-mgmt/index.html.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Post-Award Grants Management portion of the AHRQ website: https://www.ahrq.gov/funding/grant-mgmt/index.html#terms. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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 grantees 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.

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. This includes ensuring programs are accessible to persons with limited English proficiency. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please 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 further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please 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. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf.

Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html

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 FOA.

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.

Recipients may be required to submit interim progress reports to AHRQ.

If applicable, detailed instructions on additional reporting requirements will be provided with the grant award.

Grantees 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). 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 4/30/2018, the annual FFR is due 9/30/2018 (90 days after the end of the calendar quarter of 6/30/2018).

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable 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 (https://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 Appendix XII to 45 CFR Part 75, 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 Award Term and Conditions for Recipient Integrity and Performance Matter.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten 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: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

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

Francis D. Chesley, Jr., M.D.
Director, Office of Extramural Research, Education, and Priority Populations
Director, Office of Minority Health
Acting Director, Division of Scientific Review
Agency for Healthcare Research and Quality
e-mail: Grant_Queries@ahrq.hhs.gov

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

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

This program is described in the Assistance Listings (formerly called the Catalog of Federal Domestic Assistance) at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

These projects are authorized by 42 U.S.C. 299a, which provides that AHRQ shall conduct and support research, support demonstration projects, and disseminate information on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness, and value of health care services.

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 https://www.ahrq.gov/funding/policies/hhspolicy/index.html.