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.

Components of Participating Organizations

Agency for Healthcare Research and Quality (AHRQ)

Funding Opportunity Title

Advancing Evidence into Practice through Shared, Interoperable Clinical Decision Support Resources (U18)

Activity Code

U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PA-18-792

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

 93.226

Funding Opportunity Purpose

 This Funding Opportunity Announcement (FOA) invites U18 cooperative agreement applications for innovative research on disseminating evidence into practice through shared, interoperable clinical decision support (CDS) resources.

Key Dates
Posted Date

May 21, 2018

Open Date (Earliest Submission Date)

 August 28, 2018

Letter of Intent Due Date(s)

Not Applicable.

Application Due Date(s)

Standard dates apply), by 5:00 PM local time of applicant organization.  

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

AIDS Application Due Date(s)

Not applicable.

Scientific Merit Review

Generally, four months after receipt date.

Advisory Council Review

Not applicable.

Earliest Start Date

Generally, four months after peer review date.

Expiration Date

January 28, 2020

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 U18 cooperative agreement applications for innovative research on disseminating evidence into practice through shared, interoperable clinical decision support (CDS) resources.

    Background

    CDS provides patient-specific information and knowledge, enabled by health IT, to clinicians, patients, or other individuals to enhance health and health care (Mardon et al., 2014). CDS includes processes and mechanisms that aim to deliver the right information, to the right person, using the right format, in the right channel, and at the right time during workflow (often referred to as the "5 Rights" framework; Osheroff, 2009). Well-implemented, electronic CDS can improve health care processes (Lobach, 2012).

    AHRQ has a long history of making significant investments in CDS as a means to advance research evidence into clinical practice. Despite widespread adoption of electronic health records (EHRs), challenges remain about how to best leverage health IT, including CDS, to improve health care quality. In 2017, the National Academy of Medicine (NAM) released a special publication, “Optimizing Strategies for Clinical Decision Support,” which outlined thirteen priorities for collaborative action (NAM, 2017). These priorities include creating a national CDS repository, developing a multi-stakeholder CDS learning community, and establishing an investment program for CDS research. AHRQ is beginning to address some of these priorities with support from the Patient-Centered Outcomes Research Trust Fund.

    In 2016, AHRQ convened the Patient-Centered CDS Learning Network (PCCDS LN) as a cooperative agreement grant to RTI International (see https://www.healthit.ahrq.gov/ahrq-funded-projects/patient-centered-outcomes-research-clinical-decision-support-learning-network#h=learning network). The PCCDS LN is a multi-stakeholder learning community that informs and connects a wide variety of perspectives to address the challenges and opportunities of translating evidence, including patient-centered outcomes research findings, into patient-centered CDS.

    In 2017, AHRQ launched a repository for CDS knowledge artifacts known as CDS Connect (see https://cds.ahrq.gov/cdsconnect). CDS Connect is a platform for hosting CDS and making CDS more shareable, standards-based, and publicly-available. CDS Connect currently includes CDS from a variety of clinical domains such as cholesterol management, opioids and pain management, and diabetes. In addition, CDS Connect includes an open-source and freely-available CDS authoring tool. The authoring tool enables non-technical users to develop interoperable CDS logic according to the HL7 Clinical Quality Language (CQL) standard. CQL harmonizes the logic shared by both CDS and electronic clinical quality measures (eCQMs), and the Centers for Medicare & Medicaid Services recently announced its use for programs that require eCQMs. (CMS, 2017)

    Shareable, interoperable CDS tools and resources, are meant to reduce the burden of developing and implementing CDS from scratch. Currently, health care systems translate clinical practice guidelines and other evidence-based recommendations into CDS in siloed fashion, leaving opportunities to share lessons learned and to build on collective experience and knowledge unrealized. Research is needed on how to best leverage shareable, interoperable CDS resources as means of making CDS development and implementation more efficient, thereby making it easier to advance evidence into practice through CDS.

    References:

    CMS. (2017). CMS Announces Transition of Electronic Clinical Quality Measures to Clinical Quality Language for the CY2019 Reporting/Performance Periods Retrieved from https://ecqi.healthit.gov/ecqms/ecqm-news/cms-announces-transition-electronic-clinical-quality-measures-clinical-quality-0

    Lobach D, Sanders GD, Bright TJ, Wong A, Dhurjati R, Bristow E, Bastian L, Coeytaux R, Samsa G, Hasselblad V, Williams JW, Wing L, Musty M, Kendrick AS. Enabling Health Care Decisionmaking Through Clinical Decision Support and Knowledge Management. Evidence Report No. 203. (Prepared by the Duke Evidence-based Practice Center under Contract No. 290-2007-10066-I.) AHRQ Publication No. 12-E001-EF. Rockville, MD:  Agency for Healthcare Research and Quality. April 2012.

    Mardon R, Mercincavage L, Johnson M, et al. Findings and Lessons From AHRQ’s Clinical Decision Support Demonstration Projects. (Prepared by Westat under Contract No. HHSA 290-2009-00023I). AHRQ Publication No. 14-0047-EF. Rockville, MD: Agency for Healthcare Research and Quality. June 2014.

    National Academy of Medicine. (2017). Optimizing Strategies for Clinical Decision Support. Retrieved from https://nam.edu/optimizing-strategies-clinical-decision-support/ Osheroff JA, ed. Improving medication use and outcomes with clinical decision support: a step-by-step guide. Chicago, IL: HIMSS, 2009.

    Objectives and Scope

    The goal of this funding opportunity is to conduct innovative research on broadly disseminating Patient-Centered Outcomes Research (PCOR) findings into clinical practice through CDS. Further, this opportunity aims to assist users of health IT focused on CDS through developing and building upon shareable, interoperable CDS resources such as those available on CDS Connect. Ultimately, AHRQ desires to have the CDS resources developed through these awards to be publicly-available, interoperable, and shareable on CDS Connect for further innovation, evaluation, and use in the field. Since AHRQ desires to support innovation through this funding opportunity, a wide range of applicants, including for-profit private institutions, are encouraged to respond (see Section III below).

    Highly responsive applications will include:

    1. Use of the CDS authoring tool to develop:

    • Computable guideline recommendations that use the CQL standard. Guidelines are currently written in text-based form and need to be translated into computable form for integration and implementation in EHRs. Using the CDS authoring tool to write recommendations can accelerate the translation of guidelines into CDS and can ensure the CDS is consistent with guideline authors’ intentions. Research is needed on how a CDS authoring tool can make guidelines more computable, thus expediting their dissemination through EHRs and other health IT.
    • CDS as part of patient-facing apps that can integrate with EHRs and other health IT (e.g., CDS that triggers a risk assessment questionnaire completed by patients and displays results and recommendations to providers).
    • CDS based on PCOR findings that can be posted to the CDS repository for sharing and dissemination to other sites. The CDS may take various forms, such as:
    • CDS aimed towards not just physicians at the point of care but towards other members of the care team (e.g., nurses, care coordinators, population health managers, community health workers)
    • SMART on FHIR apps that use the CQL generated by the CDS authoring tool; or

    2. Use of the repository and the CDS artifacts already available through CDS Connect, such as:

    • Building additional functionality or new ways to present the CDS to end-users
    • Implementing and evaluating CDS in new sites and settings
    • Developing and sharing methods for accessing CDS from the repository
    • Using application programming interfaces (APIs) to integrate with other health IT (e.g., CDS services that automate updates when artifacts on CDS Connect change)
    • Finding innovative ways to incorporate patient or caregiver preferences in the CDS
     Proposed applications must:
    • Incorporate the "5 Rights" framework of delivering the right information, to the right person(s), using the right format, in the right channel, and at the right time during workflow (Osheroff, 2009);
    • Assess usability and incorporate user-centered design
    • Incorporate Clinical Quality Language (CQL) and other HL7 standards, if appropriate, for developing and integrating their CDS with EHRs and other health IT.
    • Describe the PCOR finding including appropriate citations, level of evidence that forms the basis for the proposed CDS
    • Identify project staff who will become active members of the AHRQ PCCDS Learning Network to share experiences and learn from others across the CDS community
    Proposed applications are encouraged to:
    • Build on tools and resources currently available through CDS Connect, such as the authoring tool or CDS artifacts available on the repository
    • Use resources available through the PCCDS LN, such as the Analytic Framework for Action, which represents a life cycle of patient-centered CDS, including prioritizing, authoring, implementing, and measuring CDS interventions.
    • Collaborate with the PCCDS LN and other efforts aimed at sharing and disseminating best practices across the CDS community

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

    Section II. Award Information
    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, AHRQ scientific or program staff will assist, guide, coordinate, or participate in project activities.

    Application Types Allowed

    New

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

    Clinical Trial?

    Not applicable

    Funds Available and Anticipated Number of Awards

    The number of awards is contingent upon funds availability and the submission of a sufficient number of meritorious applications. Future year amounts will depend on funding availability.

    Award Budget

    The total costs (direct and indirect) for a project awarded under this FOA will not exceed $500,000 in any given year or $1 million for the entire project period.

    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 Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards (45 CFR Part 75) and the HHS Grants Policy Statement.

    Award Project Period

     The project period may not exceed 2 years. 

    This project is authorized by Section 937 of the Public Health Service Act (42 U.S.C. 299b-37) and is funded through the Patient-Centered Outcomes Research Trust Fund. Section 937(a) requires AHRQ to broadly disseminate research findings published by the Patient-Centered Outcomes Research Institute (PCORI) and other government-funded research relevant to comparative clinical effectiveness research. Section 937(b) provides that AHRQ, in consultation with relevant medical and clinical associations, shall assist users of health IT focused on CDS to promote the timely incorporation of research findings disseminated under Section 937(a) into clinical practices and to promote the ease of use of such incorporation. 

    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.

    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)

    For-profit private institutions

    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

    Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as consortia or as subcontractors only. Applications submitted by 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.
    Foreign components, as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) may participate in projects as member of consortia or as subcontractors only.  

    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 (https://www.sam.gov/portal/SAM/#1) (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.
    • 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 a 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(s)/Principal Investigator(s))

    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/are 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.

    The PD/PI is required to devote a minimum of 20% annual full-time effort (i.e. at least 8 hours per week) in each year of the project. For institutions/organizations proposing multiple PDs/PIs, regardless of the number of PDs/PIs proposed, each PD/PI is required to devote a minimum of 10% annual full-time effort (i.e. at least 4 hours per week) in each year of the project.

    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. 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

    2. Cost Sharing

    This FOA does not require cost sharing.

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

    AHRQ will not accept duplicate or highly overlapping applications under review at the same time.  This means that 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-14-074).
    Section IV. Application and Submission Information
    1. Requesting an Application Package

    Buttons to access the online ASSIST system or to download application forms 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, including Supplemental Grant Application Instructions 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.

    For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

    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.

    • Research Strategy section is limited to 12 pages, which also includes:
    • Implementation Plan section is limited to 2 pages, and
    • Evaluation Plan section is limited to 2 pages.
    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 should 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.

    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 using shared, interoperable CDS resources as a means of disseminating and implementing evidence into clinical practice. Specifically, applicants must address the following elements:

    • How any CDS being developed meets the “Five Rights” framework
    • How health IT standards for CDS specification and services (e.g., CQL, FHIR) will be leveraged
    • What tools will be used to create shareable, standards-based, interoperable CDS resources. If the AHRQ CDS authoring tool will be used for this purpose, so state.
    • If the AHRQ CDS authoring tool is not being used, then how other tools will be used to create similar shareable, standards-based, interoperable CDS resources?
    • How the applicant plans to engage in ongoing activities of the PCCDS Learning Network
    • The evidence-based practice that the CDS is meant to disseminate and implement (including the strength of recommendation and level of evidence, if applicable, and appropriate citations)
    • How any CDS being implemented is patient-centered and focused on outcomes
    • How the project will be completed within the time period of 2 years, including CDS development, testing, validation, and additional phases where necessary. Please include a detailed timeline that shows major milestones.
    • How principles and standards for user-centered design will be incorporated into the methods, including citations and applicable frameworks
    • How the outputs of the project will be disseminated and shared. Describe all platforms that will be used. AHRQ plans to work with grantees to disseminate grantees' material (e.g., CDS artifacts and implementation guidance) on CDS Connect (see Special Requirements section).
    • What intellectual property considerations, if any, are applicable to developing and sharing the CDS once developed
    • Grant applications must include a detailed project timeline that shows major milestones.
    Project Administration:
    • Grant applications must fully address the administration of the project. This is especially crucial for teams necessitating 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

    Letters of Support:
    • Applicants must include letters of support from stakeholder organizations (e.g., professional medical societies, patient/family representative organizations, provider organizations) who have agreed to participate in and collaborate as part of the proposed project.
    • AHRQ encourages collaboration with stakeholder organizations that focus on racial or ethnic minority health issues' thus leading to more widely used CDS and greater uptake of evidence-based research findings in clinical practice for diverse populations (e.g., CDS delivered to a professional society's membership);
    • Letters of support, recommendation, or endorsement should NOT be included from any entity or individual who is not directly participating in the proposed project. These types of letters may impede the review and/or selection process.
    PHS Human Subjects and Clinical Trials Information

    When involving human subject 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

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

    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 2. 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.

    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 Grants Policy Statement can be found at http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf.

    These awards will not be made under expanded authorities, therefore pre-award costs are not allowable without AHRQ prior approval.

    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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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.

    Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH and for responsiveness by AHRQ.  Applications that are incomplete 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

    Applicants are required to follow the instructions for post-submission materials, as described in the policy NOT-OD-16-130. 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.  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 Federal purposes, and to authorize others to do so. In accordance with AHRQ's research dissemination mandate, such products and materials will be made available to the public and the health care community. AHRQ purposes may include but are not limited to making project materials, databases, results, and algorithms available for verification or replication by other researchers.   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.

    Other Special Requirements

    The PD/PI is required to devote a minimum of 20% annual full-time effort (i.e. at least 8 hours per week) in each year of the project. For institutions/organizations proposing multiple PDs/PIs, regardless of the number of PDs/PIs proposed, each PD/PI is required to devote a minimum of 10% annual full-time effort (i.e. at least 4 hours per week) in each year of the project

     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. 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

    The PD/PI will be expected to meet with AHRQ program staff by teleconference on at least a monthly basis at mutually agreeable times.

    Grantees will be expected to collaborate with other grantees and/or contractors taking part in AHRQ's overall PCOR CDS initiative, including an external evaluator of the entire AHRQ PCOR CDS initiative.

    Applicants should anticipate that some dissemination activities will be conducted in cooperation with AHRQ contractors responsible for monitoring project progress and/or updating content on the Health IT Web site, http://healthit.ahrq.gov.  Awardees are required to cooperate fully with AHRQ staff and contractors in promoting their work and findings.  Activities that the awardee may engage in with AHRQ contractors for the duration of the grant may include:

    • Reviewing a project description or “profile” that a contractor develops for publication on the Health IT Web site and providing timely feedback; and
    • Sharing information on any grant outputs (e.g., publications, survey instruments) for inclusion in AHRQ output repositories, as appropriate, so that the contractor(s) can update the project profile on an annual basis.

    Applicants must describe how the outputs of the project will be disseminated and shared, describing all platforms that will be used. In addition, AHRQ plans to work with grantees to publish project outputs (e.g., CDS artifacts and accompanying material) on CDS Connect, in accordance with the rights in data acquired by the agency pursuant to the terms of the grant award.  (Reference the section, "Sharing Research Resources:  Rights in Data" included in this announcement).]

    Project staff are expected to become active members of the AHRQ PCCDS Learning Network to share experiences and learn from others across the CDS community

    Applicants must budget for the PD/PI to attend the PCCDS LN annual conference, which takes place in the Washington, D.C area. For institutions/organizations proposing multiple PDs/PIs, a maximum of two PDs/PIs may attend.

    Grantees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information

    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:

    • Research to improve health care patient safety.
    • Harnessing data and technology to improve health care quality and patient outcomes and to provide a 360-degree view of the patient.
    • Research to increase accessibility and affordability of health care by examining innovative market approaches to care delivery and financing.

    As part of this mission, applications submitted to AHRQ to support health services research 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 peer 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 initial merit review, all applications will:

    • Undergo a selection process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score;
    • Receive a written critique.
    • Merit Review Criteria:  Merit Review Criteria, as described below, will be considered in the review process.
    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?
    • Does the project address an important problem or a critical barrier to using shared, interoperable CDS resources to improve evidence-based care in clinical practice?
    • Is there a strong scientific premise for the project?
    • 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 this field?
    • How will the project increase our knowledge regarding best practices for contributing to and using shared, interoperable CDS resources?
    • Will the project advance the field of patient-centered CDS?
    Investigator(s)
    • Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project?
    • If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?
    • If the project is collaborative or includes multi-PDs/PIs, do the investigators have complementary and integrated expertise; are their leadership approaches, governance and organizational structures appropriate for the project?
    • Does the team have specific expertise in standards that support CDS specification (e.g., CQL) and services (e.g., FHIR)?
    • The PD/PI is required to devote a minimum of 20% annual full-time effort (i.e. at least 8 hours per week) in each year of the project. For institutions/organizations proposing multiple PDs/PIs, regardless of the number of PDs/PIs proposed, each PD/PI is required to devote a minimum of 10% annual full-time effort (i.e. at least 4 hours per week) in each year of the project.
    • Is the minimum effort level requirement of the PD(s)/PI(s) being met?
    • Are the proposed levels of effort for all key personnel appropriate for carrying out the project successfully?
    Innovation

    Does the application challenge and seek to shift current research, technical, 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?

    • Will the project lead to new CDS technologies or new types of CDS services?
    • How innovative is the CDS itself in terms of technology, platform, interaction with intended user audience, or envisioned use by clinicians, patients, or other members of the care team?
    Approach
    • 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 biological variables, such as sex, for human subjects? 
    • Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?
    • Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?
    • Are potential problems and alternative strategies presented?

    For projects developing CDS:

    • Is the CDS based on appropriate PCOR findings?

    For all projects:

    • Does the project leverage CQL or other applicable standards to ensure interoperability? 
    • Does the project incorporate the Five Rights CDS framework?
    • Does the applicant plan to engage in ongoing activities of the PC-CDS Learning Network?
    • Can the project realistically be completed in 2 years? Is the approach realistic to be completed and demonstrate impact within the proposed timeframe?
    • Does the project incorporate user-centered design in its methods?
    • Will the intended platform for sharing and disseminating outputs of the project contribute to the goals of the FOA?
    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? 

    • Are letters of support included for collaborating organizations?
    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.

    •   How innovative is the use of authoring tools and CDS artifacts?
    Protections for Human Subjects

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

    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.

    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

    N/A

    Revisions

    N/A

    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 will be evaluated for scientific and technical merit by an appropriate Scientific Review Group in accordance with the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons

    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). 

    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 grant and cooperative agreement awards are subject to 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), 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 (NoA). As necessary, additional Terms and Conditions will be incorporated into the NoA.

    A standard term and condition of award will be included in the Notice of Award (NoA) that states:  “in any grant-related activity in which family, marital, or household consideration are, by statute or regulation, relevant for purposes of determining beneficiary eligibility or participation, grantees must treat same-sex spouses, marriages, and households on the same terms as opposite-sex spouses, marriages, and households, respectively. By “same-sex spouses,” HHS means individuals of the same sex who have entered into marriages that are valid in the jurisdiction where performed, including any of the 50 states, the District of Columbia, or a U.S. territory or in a foreign country, regardless of whether or not the couple resides in a jurisdiction that recognizes same-sex marriage.  By “same-sex marriages,” HHS means marriages between two individuals validly entered into in the jurisdiction where performed, including any of the 50 states, the District of Columbia, or a U.S. territory or in a foreign country, regardless of whether or not the couple resides in a jurisdiction that recognizes same-sex marriage.  By “marriage,” HHS does not mean registered domestic partnerships, civil unions or similar formal relationships recognized under the law of the jurisdiction of celebration as something other than a marriage.”

    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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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. HHS provides general 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. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/index.html Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/. l. 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 o or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations.

    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 http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    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 judgment 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.

    The following Terms and Conditions will be incorporated into the award statement and will be provided to the grant recipient at the time of award.

    Cooperative Agreement Terms and Conditions of Award

    The following special terms of award are in addition to otherwise applicable OMB administrative guidelines:  DHHS grant administration regulations at 45 CFR Parts 75 via http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75), and other DHHS, PHS, and AHRQ grant administration policy statements (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html).  AHRQ will use these procedures in evaluating and administering this cooperative agreement.

    The administrative and funding instrument used for this program is the cooperative agreement. A cooperative agreement is an "assistance" mechanism (rather than an "acquisition” mechanism), in which substantial AHRQ programmatic involvement with the grantee is anticipated during the performance of the activities.  Under the cooperative agreement, the AHRQ purpose is to support and stimulate the recipient's activities by involvement in and otherwise working jointly with the grantee in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.  Consistent with this concept, the dominant role and prime responsibility resides with the grant recipient and the PD(s)/PI(s) for the project as a whole, although specific tasks and activities may be shared between the grantee and AHRQ as described in the FOA. Cooperative activities are intended to strengthen the individual grantee activities through the facilitation of data sharing, data access and communications.

    All cooperative activities that include significant government involvement will require prior approval by AHRQ.

    Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) Rights and Responsibilities

    The grant recipient PD(s)/PI(s) will be responsible for:

    • The PD(s)/PI(s) will have the primary responsibility for conducting research in accordance with the terms and conditions of the Notice of Award, and cooperating with other key parties, including the AHRQ Program Official and other awardees.
    • The PD(s)/PI(s) will participate in monthly teleconferences with the program official and/or other AHRQ personnel as appropriate. The PD(s)/PI(s) will attend the annual conference of the PCCDS LN, which is held in the Washington, D.C. area.

    AHRQ Responsibilities

    AHRQ program staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

    Under the cooperative agreement, AHRQ’s purpose is to support and stimulate the recipient's activity by involvement in and otherwise working jointly with the grantee in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. 

    Cooperative activities are intended to strengthen individual projects and at the same time generate collaboration across the projects.  Specific cooperative aims and activities in carrying out individual projects may be shared among the awardees and the AHRQ program officials. 

    AHRQ staff will provide advice and support to the awardee, and will assist in the cooperative work of the project beyond the usual program stewardship for grants.

    The AHRQ program official will maintain contact with the PD(s)/PI(s) to consult on key project decisions, help to trouble-shoot implementation barriers/challenges, and confirm that projects are proceeding according to project timelines and plans. 

    AHRQ will:

    • Review the development of project timelines and project plans.
    • Work closely with grantees and other AHRQ contracts (e.g., MITRE) to ensure the CDS tools and products are shareable and interoperable.
    • Coordinate and facilitate collaboration with AHRQ CDS Connect partners.
    • Work closely with grantees and other federal partners (e.g., ONC) to ensure dissemination of products.

    Additionally, AHRQ program staff will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

    Collaborative Responsibilities

    When appropriate and feasible, AHRQ expects the grantee to work collaboratively with each other and with AHRQ to share information and develop common resources as noted above. Awardees and AHRQ will also participate in periodic meetings including monthly teleconferences and annual in-person meetings.

    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 anniversary of the award.

    In addition to the annual progress report, recipients may be required to submit quarterly 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).

    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 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 Matters.

    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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 submission, downloading forms and application packages)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Shafa Al-Showk
    Agency for Healthcare Research and Quality
    Email: ClinicalDecisionSupport@ahrq.hhs.gov

    Peer Review Contact(s)

    Boris Aponte, Ph.D.
    Agency of Healthcare Research & Quality (AHRQ)
    301-427-1396
    Boris.Aponte@ahrq.hhs.gov

    Financial/Grants Management Contact(s)

    Carol A Kauffman
    Agency for Healthcare Research and Quality
    Telephone:  301-427-1448
    Email:  carol.kauffman@ahrq.hhs.gov

    Section VIII. Other Information

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

     
    Authority and Regulations

    This program is described in the 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 the 45 C.F.R. 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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