Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

Agency for Healthcare Research and Quality (AHRQ)

NOTE:  The 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.

Also note that AHRQ has different page limits than NIH for the application Research Strategy, which can be found within each individual FOA.

Components of Participating Organizations

Agency for Healthcare Research and Quality (AHRQ)  https://www.ahrq.gov/)

Funding Opportunity Title

Using Innovative Digital Healthcare Solutions to Improve Quality at the Point of Care (R21/R33 - Clinical Trial Optional)

Activity Code

R21/R33 Phased Innovation Award

Announcement Type

New

Funding Opportunity Announcement (FOA) Number

PA-21-164

Companion Funding Opportunity

Agency for Healthcare Research and Quality

Assistance Listing Number(s)

 93.226

Funding Opportunity Purpose

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.  

Key Dates

 

Posted Date

February 9, 2021

Open Date (Earliest Submission Date)

 February 9, 2021

Letter of Intent Due Date(s)

Not Applicable.

Application Due Date(s)

Standard dates apply.   

All applications are due by 5:00 PM local time of the applicant organization

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

AIDS Application Due Date(s)

Not applicable.

Scientific Merit Review

Generally, four months after receipt date.

Advisory Council Review

Not applicable.

Earliest Start Date

Generally, four months after the peer review date

Expiration Date

 July 18, 2024   

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this 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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information


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

    Purpose

    This Funding Opportunity Announcement (FOA) invites applications for research projects that test promising digital healthcare interventions aimed at improving the quality of 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.

    Background

    The digital healthcare ecosystem is rapidly evolving, and there is a need to build the evidence base on how digital healthcare innovations can be effectively, efficiently, and safely deployed at the point of care, which is considered any location where patient care is provided (e.g., clinic, the bedside, home or ambulance). The prolific emergence of new technological innovations used by multiple members of the healthcare team as well as caregivers in healthcare settings is transforming care delivery models and impacting care delivery and patient care experiences.  

    The use of evidence-based, technology-driven, point of care process solutions has the potential to revolutionize the way care is delivered. The use of these solutions can improve productivity, reduce errors, enhance safety, and increase opportunities for patient engagement and shared decision-making.

    Artificial Intelligence (AI), Patient-Centered Digital Healthcare Technologies (PC-DHT), and Clinical Decision Support Systems (CDSS) are among the digital healthcare solutions that are being used to support efficient healthcare delivery, enhance patient engagement, advance the quality of care, and mitigate safety risks. For example, health-related AI applications are used to improve care processes and provide AI-based diagnostic and treatment recommendations (Yu, Beam, & Kohane, 2018). PC-DHT such as mobile health applications, wearables, invisibles, and sensors are being used to improve care and patient experiences (Kabelac, et al., 2019). PC-DHT is used to capture patient-generated data, provide timely health information to inform decisions, facilitate shared decision-making, and promote self-care activities. Digital CDSS tools are used to link clinicians with health knowledge to assist with clinical decision making at the point of care (Baig, Gholamhosseini, Moqeem, Mirza, & Lindén, 2017). Research is needed to understand how these technologies impact health outcomes, the delivery and quality of care, and patient experiences.

    Health services research that explores the use of innovative patient-centric digital healthcare solutions to improve services at the point of care aligns with the Department of Health and Human Services (DHHS) priority to increase the value derived from healthcare spending while delivering whole person 360-degree care.

    Objective and Scope

    The overarching objective of this FOA is to improve the quality of healthcare services delivery at the point of care. This FOA aims to support phased exploratory and developmental research projects that test promising digital healthcare interventions intended to improve quality at the point of care.

    Research should be designed to test promising digital healthcare solutions that enable or facilitate technology-driven, point of care process solutions that use advanced analytics, patient-centered clinician and patient facing digital healthcare technologies, or clinical decision support systems to improve quality and health outcomes at the point of care. A theoretical framework should inform the research study and incorporate the use of care models when appropriate.

    Accordingly, this FOA is focused on three research areas of interest. Examples of research projects responsive to this FOA include but are not limited to:

    Use advanced analytics to improve quality at the point of care.

    • Projects that will test innovative digital healthcare solutions that integrate the use of artificial intelligence (AI) (e.g., Natural Language Processing, Machine Learning) during the provision of healthcare services at the point of care. Such applications should assess and evaluate AI’s impact on practice workflow and quality of care
    • Projects that apply machine learning against large health data sets to improve care delivery and quality at the point of care.
    • Use innovative, patient-centered, clinician and patient facing digital healthcare technologies to improve patient experiences and healthcare services delivery at the point of care
    • Projects that explore understanding how the use of patient-centered digital healthcare technologies (e.g., wearables, sensors, mhealth solutions) impacts patient outcomes, experiences, and healthcare services delivery at the point of care. Such applications should assess and evaluate the technology implementation’s impact on practice workflow and quality of care.

    Of particular interest is (1) testing innovative digital healthcare technologies that facilitate information sharing and shared decision-making between patients and providers, and (2) evaluating the use of novel digital solutions for patients with multiple chronic conditions.

    Use evidence-based knowledge and patient-data to augment support for clinical decision-making at the point of care.

    • Projects that will test innovative digital clinical decision-making tools that incorporate the use of patient-generated data and patient-reported outcomes at the point of care.
    • Projects that evaluate a digital point of care solution that combines the use of natural language processing (NLP) with a decision support tool in order to turn unstructured clinical data into knowledge and facilitate the advancement of the knowledge into practice.
    • Enabling clinicians and health system decision makers to effectively and efficiently use standardized computable biomedical knowledge to support clinical decision making is also an interest area.  Applications that explore digital healthcare innovations in support of this interest area are welcome.

    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.

    Phased Innovation Award

    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.

    Applications proposing only R21 or R33 activities alone will not be accepted. 

    Preliminary data are not required for this mechanism, but may be included if available.

    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.

    All projects must:

    • Describe the healthcare practice setting(s) for the research;
    • Describe the patient population(s) impacted by the research;
    • Describe the digital healthcare intervention and the problem indicating its readiness for an exploratory/developmental research project;
    • Describe how performance will be measured (expected standards, outcomes, baselines, indicators, etc).
    • Describe all users of the digital healthcare solution or system;
    • Describe how the solution should be expected to reduce (or at least not exacerbate) disparities;
    • Evaluate the reliability, validity, and usability of the digital healthcare solution used at the point of care;
    • Describe how the digital healthcare intervention will be incorporated into the clinical workflow;
    • Describe how technology modifications, systems, or tools will be designed from the outset to be easily adopted by other providers and teams in the organization and how the project will be designed to scale across the organization and beyond to other, similar organizations;
    • Clearly demonstrate how the resulting innovation can be sustained and adopted by other settings;
    • Develop an innovative and leading-edge dissemination strategy that will be implemented during the second phase of the grant;
    • Evaluate and report (as applicable):
    • ·    Improvement in the quality of care and reduction in adverse events;
    • ·    Improvement in patient experience;
    • ·    Reduction in provider burden; and
    • ·    Unintended patient safety events.
    • Provide a detailed project timeline that shows major milestones.

    Recipients of awards under this FOA must provide annual and final reports of performance in achieving the FOA objective to develop projects that test promising digital healthcare interventions aimed at improving the quality of healthcare services delivery at the point of care. (see section VI.3. Reporting).

    References:

    Baig, M. M., Gholamhosseini, H., Moqeem, A. A., Mirza, F., & Lindén, M. (2017). Clinical decision support systems in hospital care using ubiquitous devices: Current issues and challenges. Health Informatics Journal, 25(3), 1091–1104. doi: 10.1177/1460458217740722.

    HHS Secretary Priorities. US Department of Health and Human Services; July 23, 2018. Available from: https://www.hhs.gov/about/leadership/secretary/priorities/index.html#value-based-healthcare.

    Kabelac, Z., Tarolli, C. G., Snyder, C., Feldman, B., Glidden, A., Hsu, C.-Y., … Katabi, D. (2019). Passive Monitoring at Home: A Pilot Study in Parkinson Disease. Digital Biomarkers, 3(1), 22–30. doi: 10.1159/000498922

    Yu, K.-H., Beam, A. L., & Kohane, I. S. (2018). Artificial intelligence in healthcare. Nature Biomedical Engineering, 2(10), 719–731. doi: 10.1038/s41551-018-0305-z.

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

    Section II. Award Information

     

    Funding Instrument

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

    Application Types Allowed

    New
    Resubmission (only of applications originally submitted to this FOA)

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    Funds Available and Anticipated Number of Awards

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

    Future year amounts will depend on annual appropriations.

    Award Budget

    In the R21 phase, the combined budget for total costs (direct and indirect) for the two-year period may not exceed $275,000.  No more than $200,000 total costs may be budgeted in either year of the R21 phase.

    In the R33 phase, the combined budget for total costs (direct and indirect) for the three-year period may not exceed $750,000.  No more than $300,000 total costs may be budgeted in any given year.

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

    Award Project Period

    The 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; https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75)), the HHS Grants Policy Statement (see https://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of Award.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    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)

    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

    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations

    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.

    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.

    • 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)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons.  Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 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.

    Eligible Individuals (Program Director/Principal Investigator)

    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 https://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-018.html.

    A single PD/PI, or the multiple PD(s)/PI(s) combined, must devote at least 20% minimum full-time effort (i.e. at least 8 hours per week) in each given year of the project.

    2. Cost Sharing

    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.

    3. Additional Information on Eligibility
    Number of Applications

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

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

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
    • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-18-197).
    Section IV. Application and Submission Information
    1. Requesting an Application Package

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

    2. Content and Form of Application Submission

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

    Letter of Intent

    Not applicable.

    Page Limitations

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

    Instructions for Application Submission

    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.

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    SF424(R&R) Senior/Key Person Profile

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

    R&R or Modular Budget

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

    Budget Component: Special Instructions for AHRQ applications

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

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

    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

    Applicants should describe their approach to test promising digital healthcare interventions aimed at improving quality of care and care delivery using advanced analytics, innovative patient-centered digital health technologies, or clinician decision support tools at the point of care.

    The Research Strategy must include a description of both the R21 and R33 phases in the single Research Strategy attachment.

    In describing this approach, applicants must address the following elements:

    Describe the healthcare practice setting(s) for the research;

    Describe the patient population(s) impacted by the research;

    Describe all users of the digital healthcare solution or system;

    Describe how the solution should be expected to reduce (or at least not exacerbate) disparities;

    Describe the digital healthcare intervention and the problem indicating its readiness for an exploratory/developmental research project; and

    Describe how the digital healthcare intervention will be incorporated into the clinical workflow.

    Evaluation:

    Applicants are to describe their approach to test the innovative intervention(s). Applicants should consider a wide range of scientific methods, including quantitative, qualitative, and other novel methods. The study design and analytical plan should be well-justified and consistent with the specific aims and study type. In describing this plan, applicants must also address the following elements:

    Applicants must evaluate the reliability, validity, and usability of the digital healthcare solution used at the point of care.

    Applicants must describe how the research will measure the following:

    Improvement in the quality of care and reduction in adverse events;

    Evaluate and report on unintended patient safety events.

    Sustainability and Scalability:

    Applicants are to describe how technology modifications, systems, or tools will be designed from the outset to be sustainable and easily adopted by other providers and teams in the organization and how the project will be designed to scale across the organization and beyond to other, similar organizations.

    Milestones:

    Grant applications must include a detailed project timeline that shows major milestones.

    Include a specific section labeled "Milestones". Milestones should be clearly-described, feasible, well-developed, quantifiable, and scientifically justified to transition to the R33 phase. A discussion of the milestones relative to the progress of the R21 phase and the implications of successful completion of the milestones for the R33 phase should be included.

    Dissemination:

    Applicants are to describe their approach to disseminate research findings for both the R21 and R33 phases of the research grant. Applicants should consider applying innovative and leading edge dissemination strategies and methods that enhance the broader applicability, reproducibility, and scalability of the research findings.

    Applicants must submit a dissemination plan that describes how the team will effectively communicate and disseminate research evidence and findings to diverse audiences.

    Applicants should consider the following items when developing the dissemination plan:

    Describe the target audiences, materials that will be developed, plans to disseminate evidence, and the strategy to evaluate the dissemination activities; and

    Incorporate innovative and novel dissemination methods and strategies to communicate compelling stories, inform policy makers, and educate new audiences who may benefit from the knowledge.

    Project Administration:

    Grant applications must fully address the administration of the project. This is especially crucial for projects that require the coordination of multiple team members’ efforts across disciplines, institutions, and geographic regions.

    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:

    • Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

    Appendix:

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

    Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.  See NIH/NIOSH/AHRQ New Policy Appendix Guide located at NOT-OD-18-126.

    PHS Human Subjects and Clinical Trials Information

    When involving human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, 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). All instructions in the SF424 (R&R) Application Guide must be followed.

    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.

    PHS Assignment Request Form

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

     
    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 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. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

    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

    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 initial budget period of a new 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 competing or non-competing 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.  

    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 before the application due date. 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– 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 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-e/general-forms-e.pdf) concerning letters of support. Letters of support, recommendation, or affirmation from any entity or individual not directly participating in the project should not be included.

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

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

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

    Post Submission Materials

    Add modifications only if your FOA will deviate from the Policy by adding bullets describing the modification.

    Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-20-179 - Extending the Special Exception to the NIH/AHRQ/NIOSH Post-Submission Material Policy During the COVID-19 Pandemic: August/October 2021 Councils. 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.

    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. 

    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.

    Section V. Application Review Information
    1. Criteria

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

    AHRQ's priority areas of focus are detailed here: https://www.ahrq.gov/funding/policies/foaguidance/index.html.  As part of this mission, applications are submitted to AHRQ to support health services research which are evaluated for scientific and technical merit through the AHRQ peer review system.

    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.

    For this particular announcement, note the following:

    The R21/R33 phased innovation grant supports investigation of novel scientific ideas or new interventions, model systems, tools, or technologies that have the potential for significant impact on biomedical or behavioral and social sciences research. An R21/R33 grant application need not have preliminary data, extensive background material or preliminary information; however, they may be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.  Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding.  Reviewers will assign a single impact score for the entire application, which includes both the R21 and R33 phases.

    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).

    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? 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 improvements in the quality of care or healthcare delivery?  

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? Do the investigators have appropriate experience and training and have they demonstrated an ongoing record of accomplishments that have advanced their fields? 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?

    Is a single PD/PI, or are the multiple PD(s)/PI(s) combined, devoting at least 20% minimum full-time effort (i.e. at least 8 hours per week) in each given year of 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? If appropriate, 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?

    Specific to this FOA:

    Is there a unifying and testable hypothesis that transcends both R21 and R33 phases? Does the application provide clear milestones for the R21 phase and related scientific goals for the R33 phase? Are those milestones conducive to accomplishing the study aims? Are the goals of the R33 phase based, in part, on findings collected during the R21 phase? 

    Does the approach focus on testing promising interventions that improve quality of care and healthcare delivery services at the point of care? Are the reliability, validity, and usability of the digital healthcare solution used at the point of care evaluated? Does the approach measure improvement in the quality of care, patient experience and/or reductions in adverse events? Is the intervention designed with sustainability and scalability in mind? Is the dissemination plan well-described?  

    Does the project include a detailed project timeline? Is there an evaluation section included in the grant application and does the applicant adequately measure improvement in the quality of care and reduction in adverse events? Is there a dissemination plan that includes innovative approaches to disseminating evidence-based research findings to audiences that may benefit from the knowledge during each phase of the project?

    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? Is the scientific and organizational environment strong enough to support completion of the project as described and according to the timeline?  

    Additional Review Criteria

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

     
    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the 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.

    Degree of Responsiveness

    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

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

    Inclusion of Priority Populations

    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

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

    Renewals

    Not Applicable

    Revisions

    Not Applicable

    Additional Review Considerations

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

    Not Applicable

    2. Review and Selection Process

    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.

    Applications will compete for available funds with all other recommended applications submitted in response to this FOA.

    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.
    3. Anticipated Announcement and Award Dates

    After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

    Information regarding the disposition of applications is available in the HHS Grants Policy Statement (see https://www.ahrq.gov/funding/policies/hhspolicy/index.html).

    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.

    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 AHRQ web site at https://www.ahrq.gov/funding/grant-mgmt/index.html.

    2. Administrative and National Policy Requirements

    All AHRQ grants 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.

    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.

    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.

    HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.  For additional guidance regarding how the provisions apply to AHRQ grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

    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.

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

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), 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.” 

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually unless specified otherwise in the terms of the award.  

    For details regarding annual progress report submission, refer to https://www.ahrq.gov/funding/grant-mgmt/noncomp.html.  If instructions on the AHRQ website are different from the RPPR Instructions, follow the instructions on the AHRQ website. Annual progress reports are due 3 months before the start date of the next budget period of the award.

    In addition to the annual progress report, recipients may be required to submit interim progress reports to AHRQ using the AHRQ Research Reporting System (ARRS).  Detailed instructions on interim 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.

    Program Planning and Performance reporting requirement: describe how performance will be measured (expected standards, outcomes, baselines, indicators, etc.

    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 4/30/2019, the annual FFR is due 9/30/2019 (90 days after the end of the calendar quarter of 6/30/2019).

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

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for 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 (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 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 Matters.

    Program planning and performance reporting requirements.

    The overarching objective of this funding opportunity is to support research projects that test promising digital healthcare interventions aimed at improving the quality of healthcare services delivery at the point of care.

    Recipient performance will be measured based on success in the following Program goals:

    Reach: Who was reached by the project?

    Performance measures: Number of practices, clinicians, and patients using the digital healthcare solution.

    Timeline: reach target by year 2 for the R21 award and year 5 for the applications selected for expanded activities with the R33 award.

    Process: How were interventions implemented?

    Performance measures: Number and types of clinical/patient workflows (e.g., Medical, Nursing, Administrative, Allied Services, Patients) impacted by incorporating the digital healthcare intervention into practice.

    Timeline: reach target by year 2 for the R21 award and year 5 for the applications selected for expanded activities with the R33 award.

    Impact: Do health outcomes improve?

    Performance measures: One or more quality of care and reduction of adverse events measures will be developed and described for the evaluation.

    Timeline: reach target by year 2 for the R21 award and year 5 for the applications selected for expanded activities with the R33 award.

    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


    Grants Info (Questions regarding application instructions and process, finding NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Scientific/Research Contact(s)

    CDR Derrick L. Wyatt

    Agency for Healthcare Research and Quality
    Center for Evidence and Practice Improvement (CEPI)
    Division of Health Information Technology
    Telephone: 301-427-1505
    Email: DigitalHealthcareResearch@ahrq.hhs.gov (preferred method of contact)

    Peer Review Contact(s)

    Boris Aponte
    Agency for Healthcare Research and Quality
    Office of Extramural Research, Education and Priority Populations
    Division of Scientific Review
    Telephone: 301-427-1396
    Email: Boris.Aponte@AHRQ.hhs.gov

    Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

    Financial/Grants Management Contact(s)

    Brian Campbell
    Agency for Healthcare Research and Quality
    Office of Management Services
    Grants Management
    Telephone: (301) 427-1266
    Email: Brian.Campbell@ahrq.hhs.gov

    Section VIII. Other Information

    Recently issued AHRQ policy notices may affect your application submission. A full list of policy notices published by AHRQ is provided at https://www.ahrq.gov/funding/policies/polnotice/index.html.

    Authority and Regulations

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

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