NOTEThe policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH. Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA.
The Agency for Healthcare Research and Quality's (AHRQ) mission is to produce evidence to make health care safer, of higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used.
This FOA invites applications that propose research projects that test promising digital healthcare interventions aimed at improving quality of care and healthcare services delivery at the point of care. This FOA will use the Phased Innovation Award (R21/R33) mechanism to provide up to 2 years of R21 support for initial developmental activities, and up to 3 years of R33 support for expanded activities.
Transition to the R33 phase is not guaranteed for all grants awarded under this FOA. Continuation from the R21 phase to the R33 phase will be determined by AHRQ staff based on progress achieved in the R21 phase and factors such as program priorities and availability of funds.
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 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
When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
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
It is acceptable for applicants to propose research that crosses the research categories of interest mentioned above. For example, an applicant may propose to study an innovation that integrates AI with a clinical decision support solution that incorporates patient-reported outcomes at the point of care.
This FOA will use the Phased Innovation Award Mechanism (R21/R33) to provide up to 2 years of R21 support for initial developmental activities and up to an additional 3 years of R33 support for expanded activities.
Proposed projects must include both an R21 phase, with milestone-driven developmental activities, and an R33 phase with expanded activities that will build on the initial developmental phase to achieve the aims of the entire award.
Prior to funding an application, AHRQ staff will contact the applicant to discuss the proposed milestones. AHRQ staff and the applicant organization will negotiate and agree on a final set of milestones, which will be incorporated into the terms and conditions of the award and will be the basis for judging the success of the R21 work.
Three months prior to the end of the R21 phase, awardees will submit a package, endorsed by an authorized institutional official, that requests transition to the R33 phase. This package will include a progress report that describes progress made toward each of the initial milestones, and a clear description of whether the original R33 proposed aims will remain intact or be modified based on the results of the R21 phase. Materials will be reviewed by AHRQ program staff and then, if selected to continue into the R33 phase, the R21 grant will be transitioned to an R33 award without the need to submit a new grant application.
Decisions on transitioning to the R33 phase will be based on the original R21/R33 peer review recommendations, successful completion of the originally described milestones, program priorities, and availability of funds. Transition to the R33 phase is not guaranteed for all grants awarded under this FOA. If R21 awardees are not ready to submit an R33 transition package prior to the end of the R21 award, a no-cost extension for up to one year may be requested, during which time awardees may submit an R33 transition package. This one-year no cost extension period will not count against the 5-year limit for the entire R21/R33 award, but will count as the one grantee-initiated no-cost extension allowed under expanded authorities. A subsequent no-cost extension of the R33, if awarded, would require AHRQ prior approval.
Funds may be used only for those expenses that are directly related and necessary to the project and must be expended in compliance with applicable OMB Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards (45 CFR Part 75) and the HHS Grants Policy Statement.
The duration of the entire R21/R33 award may not exceed 5 years. The R21 phase may not exceed 2 years of support. The R33 phase may not exceed 3 years of support. Transition to the R33 phase is not guaranteed for all grants awarded under this FOA. Continuation from the R21 phase to the R33 phase will be determined by AHRQ staff based on progress achieved in the R21 phase and factors such as program priorities and availability of funds.
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; -bin/text-idx?node=pt45.1.75)), the HHS Grants Policy Statement (see ), and the terms and conditions set forth in the Notice of Award.
AHRQ's authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism. For-profit organizations may participate in projects as members of consortia or as subcontractors only. 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.
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.
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.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide. The AHRQ multiple PDs/PIs policy can be found at -files/NOT-HS-16-018.html.
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.
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