Department of Health and Human Services

Part 1. Overview Information

Key Dates

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




Table of Contents

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

Section I. Notice of 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. Notice of Funding Opportunity Description

 

PURPOSE

The mission of the Agency for Healthcare Research and Quality (AHRQ) is to produce evidence to make healthcare safer, higher quality, and 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 the evidence is understood and used.

The purpose of this Notice of Funding Opportunity (NOFO) is to conduct research on patient-centered clinical decision support (PC CDS), a nascent area within the larger field of CDS. Through the AHRQ-funded Patient Centered Outcomes Research (PCOR) CDS Initiative and the CDS Innovation Collaborative specifically, PC CDS resources are now publicly available for interested researchers to further build upon, develop, and test, in real-world settings. Innovative research is needed to understand how to make traditional, clinician-facing CDS more patient-centered, while also engaging patients, families, and caregivers in a co-design process to design and implement these tools.

BACKGROUND

Clinical decision support refers to digital tools that are used to help inform patient care. Patient-centered clinical decision support (PC CDS), in contrast to traditional clinician-facing CDS, is CDS that focuses on the patient, or their caregiver, and facilitates their active involvement in healthcare decision-making with their clinicians. PC CDS uses information from patient-centered outcomes research findings and/or patient-specific information and has the potential to be transformative by enabling higher-quality care delivery and improved outcomes. PC CDS can also support shared decision making (SDM), which AHRQ defines as a collaborative process in which patients and clinicians work together to make healthcare decisions informed by evidence, the care team's knowledge and experience, and the patient's values, goals, preferences, and circumstances. PC CDS can also support shared care planning enabling patients, caregivers, and clinicians to work together to tailor a clinical plan to align with a given patients priorities and goals. PC CDS is a developing field and has the potential to increase the quality and experience of patient care.

AHRQ’s CDS Initiative is supported by the Patient Centered Outcomes Research Trust Fund (PCOR TF) and is guided by AHRQ’s PCOR TF strategic framework (https://www.ahrq.gov/pcor/strategic-framework/index.html). Since 2016, AHRQ’s PCOR CDS Initiative has been building tools, concepts, frameworks, and conducting pilot projects. Much of AHRQ’s recent effort has focused on patient-centered CDS, and several past projects have generated resources that could be highly useful to the developing PC CDS field. Examples of these projects include AHRQ’s PC CDS Learning Network and CDS Connect, as well as a project that assessed the current state and future directions with PC CDS. Additional information for CDS projects is available on the PCOR CDS Initiative webpage.

AHRQ’s most recent PC CDS project, the CDS Innovation Collaborative, or CDSiC, is a multi-component stakeholder-driven initiative that produced a rich set of resources and tested concepts around different aspects of PC CDS. As part of the CDSiC, four workgroups were formed, each around a specific area of PC CDS, with the charge to create products (e.g., frameworks, guides, checklists) that could be used in the clinical field to establish or measure use of PC CDS. These products could address clinical workflows or the development of CDS technologies, among other areas related to PC CDS. During the first two years of the CDSiC, these workgroups created numerous products that addressed PC CDS in different areas. These areas included CDS outcomes, trust and patient-centeredness, and scaling and dissemination. One workgroup also focused on the existing standards and regulatory frameworks that could impact the future uptake and use of PC CDS. Applicants can examine, using these products and tools, how PC CDS can support shared decision making and care planning among individuals with complex needs including older adults, people living with multiple chronic conditions, frailty, disabilities, and/or socioeconomic disadvantage and how this may foster the delivery of person-centered care. They may also study strategies to scale and spread effective tools including use in lower resourced and safety net instituions.

Applicants responding to this NOFO must propose to use the resources developed by AHRQ's PCOR CDS Initiative, or any of the many products developed by the ongoing CDSiC, to further explore their usefulness, impact, and practical application in real-world settings. For example, CDSiC products that could be used may include the Taxonomy of Patient Preferences, Integration of Patient-Centered CDS into Shared Decision Making, Approaches to Measuring Patient-Centered CDS Workflow and Lifeflow Impacts, or the PC CDS Performance Measurement Inventory User Guide. Links to and descriptions of the products are available on the CDSiC Stakeholder Center webpage (https://cdsic.ahrq.gov/cdsic/cdsic-stakeholder-community-outreach-center ) The CDSiC's Innovation Center (https://cdsic.ahrq.gov/cdsic/innovation-center) developed a comprehensive report around measurement of PC CDS and created two pilot dashboards that can help clinicians understand and use Patient Generated Health Data. Additional information on other PCOR CDS projects is available at https://cds.ahrq.gov/about.

Examples of Highly Responsive Projects include:

• A community hospital with a large priority population, selects from the CDSiC portfolio of projects generated by the Trust and Patient-Centeredness workgroup. The recipient selects the source credibility product from the Trust and Patient Centeredness workgroup and conducts a study to understand how their population perceives the information they receive from within their existing electronic health record (EHR) system. Patients provide input, and the approach is assessed against existing CDS tools, as well as the definition of PC CDS as defined by the CDSiC, to assess their level of patient-centeredness.
• A small startup company is developing applications (apps) to help patients improve their healthcare. The startup leverages two products from the CDSiC standards and regulatory frameworks workgroup: Advancing Standardized Representations for Patient Preferences to Support Patient-Centered Clinical Decision Support and an Environmental Scan that reveals opportunities to evolve standards and regulatory frameworks to advance PC CDS. The company works with a patient advocacy organization to co-design the patient-facing PC CDS app, uses standards to leverage existing patient generated health data (PGHD), and incorporates a final assessment as to the level of patient-centeredness of their technology.
• A primary care physician group is working to reduce clinician burnout with the goal of improving patient outcomes. The group looks at the CDSiC’s Taxonomy of Patient Preferences and assesses how they can incorporate these concepts into restructured workflows. The group then also uses CDSiC’s product called Approaches to Patient-Centered CDS Workflow and Lifeflow Impact, which provides a framework to help identify the optimal point for a patient-centered CDS tool’s deployment in a patient’s lifeflow. Their study will also assess how increased patient-centeredness in their CDS tools do not inadvertently have a negative impact on clinician workflows or experience.

All projects are encouraged to:

Incorporate Clinical Quality Language (CQL) and other HL7 standards into their project design, if appropriate for developing, integrating, (or modifying) their CDS with their EHR system or other health information technology (Health IT) components to become more patient-centered.

OBJECTIVES AND SCOPE

This NOFO aims to support innovative collaborative research to understand how clinical decision support tools in real-world settings can be improved to become more patient centered. Recipients will become part of an existing community of researchers who have an interest in PC CDS including AHRQ, the CDSiC, and other researchers.

Interested applicants may include health information technology experts, patient advocates and representatives, clinicians, electronic health record developers, policymakers, payors, as well as leaders from research and academic medical institutions.

 

All projects must:

• Utilize one or more of the products from the CDSiC or the PCOR CDS Initiative, which are available on the project website: cdsic.ahrq.gov, or another resource available from the PCOR CDS Initiative (cds.ahrq.gov), which includes the PC CDS Learning Network, CDS Connect, or AHRQ's Evaluation project that assessed the current state and future directions with PC CDS;
• If CDSiC products are used specifically, applicants must identify if any other frameworks are being used to evaluate the performance of their PC CDS (e.g., RE-AIM or other);
• Apply the definition of patient-centered CDS (available here: https://cdsic.ahrq.gov/cdsic/patient-centered-clinical-cds-infographic) and describe the degree to which each of the 4 elements are incorporated into the patient-centered CDS tool: knowledge, patient data, delivery, and use.
• Apply an equity lens, consistent with AHRQ's PCOR Strategic Framework.
• Apply at least 1 of the 4 priorities from AHRQ's PCOR Strategic Framework.
• Include meaningful and substantial participation from patients and/or patient representatives in the co-design, implementation, and evaluation of their research, to also be reflected in the proposed budget.
• Fully describe their research ecosystem.
• If developing or extending a digital tool, be mobile friendly to be more accessible to a broader population (for example, a patient-facing portal, website, etc.).
• If the research or tool will be incorporated into an EHR system, the facility must have a mature, functioning EHR system (e.g., the facility is not planning any significant system upgrade or migration). Otherwise, an alternative means to test and evaluate the selected CDS product can be described.
• If the research strategy intends to modify an existing clinical workflow that is currently clinician-focused, to become a patient-centric or patient-facing approach, then the strategy must include an evaluation component to characterize the performance of the PC CDS tool versus the previous clinician-facing workflow.
• If the proposed project plans to promote implementation of SDM, it should align with AHRQ’s definition of SDM (available here: https://www.ahrq.gov/sdm/about/index.html) and include at least one validated measure of SDM in its evaluation.

Applicants are encouraged to consider use of open-source tools developed through the Multiple Chronic Conditions Electronic Care Plan project to improve interoperability of data for people living with MCCs. Such tools include SMART on FHIR care planning applications, FHIR data standards, and value sets from common clinical terminologies. The tools are available on the Agency for Healthcare Research and Quality's (AHRQ) eCare Plan webpage. https://ecareplan.ahrq.gov/

 

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. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed

New

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 NOFO.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s)

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

AHRQ intends to invest up to $6 Million over 2 years to support up to 6 awards. The number of awards is contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

Future year funding is contingent upon the availability of funds for each year of support.

Award Budget

The total costs (direct and indirect) for a project awarded under this NOFO will not exceed $500,000 in any given year and $1,000,000 million for the entire project period. Applications requesting more than $500,000 total costs in any one year will not undergo peer review.

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 project period may not exceed 2 years.

These projects are being funded pursuant to 42 USC 299b-37 which authorizes AHRQ to make these awards to support the agency's dissemination of comparative clinical effectiveness research findings and to assist users of health information technology focused on CDS to promote the timely incorporation of such findings into clinical practices.

All applications submitted and AHRQ grants made in response to this NOFO 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)

For-Profit Organizations

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

Local 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)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

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 recipient 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 Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 via https://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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration 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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women 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.

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/organization 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.

• The PD(s)/PI(s) will have the primary responsibility for conducting research in accordance with the terms and conditions in 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 regularly scheduled (e.g., 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 CDS Innovation Collaborative (CDSiC), which is held in the Washington, DC area.
2. Cost Sharing

This NOFO does not require cost sharing.

While there is no cost sharing requirement included in this NOFO, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project. This information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request.

3. Additional Information on Eligibility
Number of Applications

Applicant organizations may submit 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 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.

 

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

2. Content and Form of Application Submission

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows AHRQ staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this notice of funding opportunity

The letter of intent should be sent to:

James Swiger, MBE
Center for Evidence and Practice Improvement
Agency for Healthcare Research and Quality
clinicaldecisionsupport@ahrq.hhs.gov

Page Limitations

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

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

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

Study budgets should provide appropriate levels of funding for patients, families, and caregivers commensurate with the roles and the level of effort they will provide to the research, if applicable.

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.

 

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

The research strategy must include all elements noted under the section "Objectives and Scope."

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: Data Management Plan should NOT be submitted under Other Plans attachment, it is to be submitted under Resource Sharing plan as per AHRQ DMP policy.

Submission of a data management plan is required. AHRQ applicants are reminded to refer to NOT-HS-20-011: The Agency for Healthcare Research and Quality Data Management Plan Policy (https:/grants.nih.gov/grants/guide/notice-/NOT-HS-20-011.html for additional information on how to incorporate their data management plan into the resource sharing plan.

 

Appendix:

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

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

 

The Federal awarding agency may not make a Federal award to an applicant until the applicant has complied with all applicable unique entity identifier and SAM requirements and, if an applicant has not fully complied with the requirements by the time the Federal awarding agency is ready to make a Federal award, the Federal awarding agency may determine that the applicant is not qualified to receive a Federal award and use that determination as a basis for making a Federal award to another applicant

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 How to Apply 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.

Add additional information about funding restrictions. If any of these restrictions become part of the terms of award, that must be stated in Section VI.1.

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. 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 form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier 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-f/general-forms-f.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.

Letters of support:

In some scenarios, it may be appropriate for applicants to include letters of support from:

• Personnel who have agreed to participate in and collaborate as part of the proposed project (e.g., IT leadership at a participating site).
• A clinical site collaborator (since fully described research should ideally include a facility with a mature, functioning EHR system), or where there is otherwise a justification for an alternative means to test and evaluate the selected CDS.
• A patient group or patient advocacy organization that endorses the research.

A clinical site collaborator (since fully described research should ideally include a facility with a mature, functioning EHR system), or where there is otherwise a justification for an alternative means to test and evaluate the selected CDS product.

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

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

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.

Please be sure that you observe the total cost, project period, and page number limitations specified above for this NOFO. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Priority Populations

AHRQ is committed to the inclusion of priority populations in health services research. The overall portfolio of health services research that AHRQ conducts and supports shall include the populations specifically named in AHRQ’s authorizing legislation: inner city; rural; low income; minority; women; children; elderly; and those with special health care needs, including those who have disabilities, need chronic care, or need end-of-life health care. 42 U.S.C. 299(c)(1). AHRQ also includes in its definition of priority populations those groups identified in Section 2(a) of Executive Order 13985 as members of underserved communities: Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality.

AHRQ will broadly implement this inclusion policy across the research that AHRQ supports and conducts so that the portfolio of research is inclusive of all populations. AHRQ intends that these populations be included in studies such that the research design explicitly allows conduct of valid analyses. The policy applies to all grant applications. Investigators should review the document entitled, AHRQ Policy on the Inclusion of Priority Populations, which is available at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-21-015.html. Applicants under this NOFO must consider and discuss including priority populations in research design as specified in this Notice.

Public Access to AHRQ-Funded Scientific Publications

Investigators should review the document titled AHRQ Announces new Policy for Public Access to AHRQ-Funded Scientific Publications , which is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-008.html). For all research arising from AHRQ support, this policy requires that AHRQ-funded authors submit an electronic version of the author’s final peer-reviewed accepted manuscript to the National Library of Medicine's PubMed Central (PMC) to be made publicly available within 12 months of the publisher’s date of publication.

 

AHRQ Data Management Plan Policy

Investigators should review the document titled AHRQ Data Management Plan (DMP) Policy, which is available at (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-011.html). This policy requires applicants for AHRQ new/competing grants and research contracts to include a DMP for managing, storing and disseminating the primary data, samples, physical collections, and other supporting materials created or gathered in the course of research funded by AHRQ, or state why data management is not possible, as a component of their grant application or research contract proposal. 

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data should describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools also will be provided; whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Data Confidentiality

The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied. Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it. There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute. 42 USC 299c-3(d). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected (see NOT-HS-18-012: Confidentiality in AHRQ-Supported Research). The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine-readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by recipient under this RFA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164. 

The recipient should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules if applicable (see HIPAA website in prior paragraph) and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

Sharing Research Resources: Rights in Data

Unless otherwise provided in grant awards, AHRQ recipients may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers.  In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits.  Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on recipients to publish research results in peer-reviewed journals and to market grant-supported products.  AHRQ requests that recipients notify the Office of Communications (OC) when an AHRQ-funded research article has been accepted for publication in a peer-reviewed journal. Researchers should submit manuscripts that have been accepted for publication in a peer-reviewed journal to JournalPublishing@ahrq.hhs.gov at least four to six weeks in advance of the journal’s expected publication date. 

Regulations applicable to AHRQ recipients concerning intangible rights and copyright can be found at 45 CFR 75.322.

Section V. Application Review Information

1. Criteria

The mission of AHRQ is to produce evidence to make healthcare 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/nofoguidance/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 NOFO 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 NOFO will not be reviewed.  Only the review criteria described below will be considered in the review process.

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? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

• How will the project increase our knowledge regarding best practices for using PC CDS in real-world settings?
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 multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

• Does the team have specific expertise and a track record in clinical decision support, health IT, testing, implementation, and evaluation?
• Does the project have sufficient participation from patients and/or patient representatives to be considered meaningful and substantial with respect to CDS co-design, implementation, and evaluation?
• Does the PD/PI 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/organization proposing multiple PDs/PIs, regardless of the number of PDs/PIs proposed, does each PD/PI devote a minimum of 10% annual full-time effort (i.e., at least 4 hours per week) in each year of the project?
• 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 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?

• If the research strategy intends to modify an existing clinician-focused clinical workflow to become a patient-centric or patient-facing approach, does the strategy include an evaluation component to characterize the performance of the PC CDS tool versus the previous clinician-facing workflow?
• If the proposed project plans to promote implementation of SDM, does it align with AHRQ’s definition of SDM (available here: https://www.ahrq.gov/sdm/about/index.html) and include at least one validated measure of SDM in its evaluation?
Approach

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

 

• Has the applicant used one or more products from the CDSiC, or the PCOR CDS Initiative (applicants should identify the specific product used)?
• If CDSiC products are used, has the applicant identified if any other frameworks are being used to evaluate the performance of their PC CDS (e.g., RE-AIM or other)?
• Has the applicant applied the definition of PC CDS and described the degree to which each of the 4 elements of the PC CDS definition are incorporated into the PC CDS tool (e.g. knowledge, patient data, delivery, or use)?
• Has the applicant been consistent with AHRQ’s PCOR Strategic Framework by applying an equity lens to the research plan and the framework overall?
• Has the applicant applied at least 1 of the 4 elements from AHRQ's PCOR Strategic Framework?
  • These elements include: (1) High quality safe care that is aligned with national priorities; (2) Prevention and improved care of patients with chronic conditions including multiple chronic conditions; (3) Primary care transformation; (4) Patient, family provider, and community experience of care that enhances trust in the healthcare system.
• Has the applicant included meaningful and substantial participation from patients and/or patient representatives in the co-design, implementation, and evaluation of their research, to also be reflected in the proposed budget?
• If the applicant is developing or extending a digital tool, have they employed a mobile-friendly approach to be more accessible to a broader population (for example, a patient-facing portal, website, etc.)?
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?

• Have the applicants fully described their research ecosystem?
• If the research or tool will be incorporated into an EHR system, has the applicant shown that their facility has a mature, functioning EHR system (e.g., the facility is not planning any significant system upgrade or migration)?
  • Otherwise, have they provided an alternative means to test and evaluate the selected CDS product?

 

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.

Data Management Plan

The reviewers will comment on whether the Data Management Plan is reasonable.

Protections for Human Subjects

If the project involves human subjects and/or clinical research, are there plans to address

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

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.

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.

Inclusion of Priority Populations

Peer reviewers will assess the adequacy of plans to address the needs of AHRQ priority populations. 

Peer reviewers must include their assessment of the proposed inclusion plan for priority populations in evaluating the overall scientific and technical merit of the application and assigning the impact score.

In evaluating the overall impact of the application, the review groups will:

• Evaluate the application for the presence or absence of the inclusion plan based on the proposed research objectives.
• Evaluate the adequacy of the proposed plan for the inclusion of priority populations.
• Evaluate the proposed justification for the exclusion of priority populations when a requirement for inclusion is described as inappropriate with respect to the purpose of the research.
• Evaluate the plans for outreach and recruitment of study participants, including priority populations, where appropriate.
• Evaluate the proposed plan for study design, execution, and outcome assessments so that study results will be relevant to one or more priority populations, where appropriate.
• Assess the plan as being acceptable or unacceptable with regard to the appropriateness of the inclusion or exclusion of priority populations in the proposed research.
Degree of Responsiveness

Reviewers will assess how well the application addresses the purpose and objectives of this NOFO. How responsive is the application to the special eligibility criteria, including the project requirements, noted in the NOFO?

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.

Resubmissions

Not applicable

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.

2. Review and Selection Process

Applications that are complete and responsive to the NOFO 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 NOFO will not be reviewed.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Responsiveness to goals and objectives of the NOFO.
• 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 Division of Grants Management staff will request "Just-In-Time" information from the applicant. Just-In-Time information generally consists of information on other support, any additional information necessary to address administrative and budgetary issues, and certification of IRB approval of the project's proposed use of human subjects. For details regarding IRB approval, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). Applicant should also be aware of the AHRQ policy for use of single IRB for cooperative research, 45 CFR 46.114 (b) https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-005.html.

If all administrative and programmatic issues are resolved, a formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the AHRQ grants management officer is the authorizing document and will be sent via email to the e-mail address designated by the recipient organization during the eRA Commons registration process.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk.

Any application awarded in response to this NOFO will be subject to the UEI, SAM Registration, and Transparency Act requirements.

Individual awards are based on the application submitted to, and as approved by, the AHRQ and are subject to the AHRQ-specific terms and conditions identified in the NoA. 

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, and the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of Award.

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

Successful applicants under this NOFO agree that where award funding involves: Implementing, acquiring, or upgrading health IT for activities by any funded entity; Recipients and subrecipients are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity. Visit https://www.ecfr.gov/current/title- 45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

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

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR Part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If you receive an award, HHS may terminate it if any of the conditions in 2 CFR 200.340(a)(1)-(4) are met. No other termination conditions apply.

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

If you receive an award, you must follow all applicable nondiscrimination laws. You agree to this when

you register in SAM.gov. You must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website.

Below are available HHS resources on Health Literacy:

• Health.gov: Health Literate Care Model
• AHRQ: Health Literacy Universal Precautions Toolkit

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), AHRQ awards will be subject to the Federal Recipient Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all AHRQ grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

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

Terms and Conditions of Cooperative Agreement 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, and other DHHS, PHS, and AHRQ grant administration policy statements. 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 recipient is anticipated during the performance of the activities. Under a cooperative agreement, the AHRQ purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipient 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 recipient and AHRQ as described in the NOFO. Cooperative activities are intended to strengthen the individual recipient 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.

Activities conducted under this award that involve the collection of information e.g., conducting surveys or requesting responses to uniform questions from nine or more persons, establishments or other entities, with certain exceptions, are currently required to be cleared by OMB under the Paperwork Reduction Act (PRA) (44 USC 3501-3521). PRA review and approval is required in cooperative agreements if AHRQ has significant input or control over the data collection activity. Submissions for clearance under the PRA are through AHRQ and HHS. Therefore, impacted recipients should include the time in their proposed timelines to develop materials and receive necessary clearances. It typically takes at least 6 months from date of initial submission to AHRQ and sometimes much longer if submissions are incomplete or the justification for the proposed data collection plans are questioned during the clearance process. Information collection that requires PRA clearance may not begin until recipients receive written notification via e-mail from AHRQ that clearance has been obtained. Detailed information on the PRA can be found at Paperwork Reduction Act (PRA) of 1995 | Guidance Portal (hhs.gov).

Program Director/Principal Investigator (PD/PI) Responsibilities

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 recipients.

The PD(s)/PI(s) must participate in regularly scheduled (e.g., monthly) teleconferences with the AHRQ program official and/or other AHRQ personnel as appropriate.

• As part of the Cooperative Agreement, PIs will be required to be an active stakeholder in AHRQ's CDS
• Innovation Collaborative, a separately funded learning collaborative. Active participation means that PIs may, based on expertise and interest, be a workgroup member or a key informant on specific
• Issues or products, may present to various committees including the steering or planning
• committees, or co-author on products, manuscripts, and posters. Applicants must indicate a commitment to participate in these activities as well as collaborate with other recipients.

The PD(s)/PI(s) must attend the annual conference of the CDSiC, which is held in the Washington, DC 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.

Cooperative activities are intended to strengthen individual projects and at the same time generate collaboration across the projects. By being an active participant in the CDS Innovation Collaborative, recipients will have the benefit of additional input, feedback, and expertise from a diverse array of stakeholders, as well as a source of cutting-edge knowledge and thought leadership in the area of patient-centered clinical decision support. PIs will also learn how to apply PCOR CDS Initiative (or CDSiC) resources appropriately in conducting their research.

Specific cooperative aims and activities in carrying out individual projects may be shared among the recipients and the AHRQ Program Officials, and other stakeholders in the CDSiC. AHRQ staff will also provide advice and support to the recipient and will assist in the cooperative work of the project beyond the usual program stewardship for grants.

The AHRQ Program Official will maintain regular 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. The Program Official, in coordination with the recipient, will also disseminate project findings to research and policy audiences. Progress will be reviewed quarterly. 

AHRQ will:

• Coordinate recipients' communication and participation in the CDSiC.
• Conduct regular regularly scheduled (e.g., monthly) teleconferences with recipients.
• Review the development of project timelines and plans and assess progress.
• Work closely with recipients to facilitate communication, information sharing and collaboration.
• Work closely with recipients to trouble-shoot dissemination challenges and assist with dissemination of findings.
• Facilitate conference calls and annual with recipients.
• Work closely with grant recipients and other federal partners 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

Applicants must commit to collaborating with AHRQ and other recipients needed to share information and develop common resources as noted above. Recipients and AHRQ will also participate in periodic meetings including teleconferences and annual in-person meetings.

3. Reporting

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.

Recipients 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 4/30/2023, the annual FFR is due 9/30/2023 (90 days after the end of the calendar quarter of 6/30/2023).

A final Progress Report, final Federal Financial Report, and Final Invention Statement are required when an award ends.  All final reports are due within 120 days of the project period end date.  For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/funding/grant-mgmt/index.html#Closeout.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable AHRQ grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the 2 CFR Part 170 (https://www.ecfr.gov/current/title-2/subtitle-A/chapter-I/part-170) for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Program planning and performance reporting requirements:

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

APPLYING PC CDS:

• Performance measures: Assess the level of patient centeredness by applying the definition of patient-centered CDS, and providing an assessment as to how much each of the 4 elements are incorporated into their tool.
• Timeline: By the end of year 2

OUTCOMES:

• Performance measures: Success in implementing the planned CDS within the environment; if applicable, when modifying an existing workflow, the details should be captured in an evaluation.
• Timeline: By the end of year 2.

IMPACT:

• Performance measures: Degree of direct patient involvement or feedback; overall usefulness of the PC CDS tool; generalizability;
• Timeline: By the end of year 2.

 

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: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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



Scientific/Research Contact(s)

There must be a contact for all participating ICs.

James Swiger, MBE
Center for Evidence and Practice Improvement
Agency for Healthcare Research and Quality
clinicaldecisionsupport@ahrq.hhs.gov

Peer Review Contact(s)

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


Xavier Bogle, PhD
Division of Scientific Review
Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
Email: DSR@ahrq.hhs.gov

Financial/Grants Management Contact(s)

There must be a contact for all participating ICs.

Janene Dyson
Division of Grants Management
Telephone: 301-427-1491
Email: Janene.Dyson@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 (https://www.ahrq.gov/funding/policies/hhspolicy.

Authority and Regulations

This program is described in the Assistance Listings (formerly called the Catalog of Federal Domestic Assistance) at https://sam.gov/content/home 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/funding/policies/hhspolicy/index.html