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

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

Not Applicable

Generally, four months after the receipt date. 

It is critical that applicants follow the Multi-Project (M) 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.
   
   



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of 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 & Objectives

The overarching objective of this NOFO is to develop a National Coordinating Center (NCC) to support the recipients of AHRQ's State-based Healthcare Extension Cooperatives to Accelerate Implementation of Actionable Knowledge into Practice (U19) (referred to as Cooperatives) to accelerate the dissemination and implementation of Patient-Centered Outcomes Research (PCOR) evidence into healthcare delivery through improvements in healthcare policy, payment, and practice and to reduce healthcare disparities especially among people who receive Medicaid, are uninsured, and other people who are medically underserved.

This NOFO will fund a recipient to provide guidance, technical assistance, expertise, coordination, and evidence-based resources for the Cooperatives. The NCC will convene learning networks for Cooperatives to promote learning from successes and challenges, as well as their facilitators and barriers, and to spread effective practices and troubleshoot persistent issues from each Cooperative. The NCC will provide communications and dissemination expertise. The NCC will also collaborate with AHRQ and the NEC to support the Cooperatives. Cooperatives will collaborate with the NEC, AHRQ program staff, and other Cooperatives to share approaches, methods, and data through the coordination of the NCC.

AHRQ’s Healthcare Extension Service will consist of the NCC, recipients of the NOFO State-based Healthcare Extension Cooperatives to Accelerate Implementation of Actionable Knowledge into Practice (U19) and the NOFO National Evaluation Center (NEC) for AHRQ's Healthcare Extension Service: State-based Solutions to Healthcare Improvement (U19).

This is one of three related NOFOs and applicants are strongly encouraged to review the other two NOFOs to prepare applications for this NOFO.

Background on Healthcare Extension and National Coordinating Center

It can take a long time for new findings from PCOR to be implemented in healthcare delivery and there can be tremendous variation within and across healthcare delivery organizations and states in the quality and consistency of the delivery of evidence-based care. As seen in AHRQ’s National Healthcare Quality and Disparities Reports, the United States often struggles to deliver high-quality, evidence-based care, particularly for people with lower income and from certain racial and ethnic groups and geographic areas who receive their care from safety net healthcare delivery organizations.

Barriers to the dissemination and implementation of PCOR evidence into healthcare delivery include: (1) policies and payment structures that do not align with implementing evidence-based care; (2) health information technology that does not produce real time information that can be used for quality improvement and does not facilitate data sharing across healthcare settings; (3) workforce issues such as shortages, inefficiencies, and lack of training; (4) limited coordination and technical support for practice transformation; and (5) limited connections between healthcare delivery organizations and other sectors, such as public health and community organizations. These challenges occur across the healthcare delivery system, and especially affect more resource-challenged safety net healthcare delivery organizations.

A promising path to accelerate the dissemination and implementation of patient-centered healthcare delivery improvements is to build relationships and implementation capacity within and across organizations. At the state level, there needs to be coordination and alignment of improvement efforts through a systematic process inclusive of affected stakeholders, including but not limited to Medicaid agencies, managed care organizations, safety net healthcare delivery organizations, clinicians and staff, patients, and community-based organizations. On a more local level, improvements also may include delivering targeted support to local healthcare delivery organizations, improving the processes of healthcare delivery, and providing training, education, and other types of assistance to organizations, clinicians, and staff.

AHRQ's Healthcare Extension Service, modeled after the U.S. Department of Agriculture Cooperative Extension System and incorporating principles from learning health systems, proposes to help healthcare policy, payment, and delivery organizations overcome implementation barriers and improve the quality of healthcare services for medically underserved people through state- or system- and local-level, evidence-based improvements.

AHRQ's Healthcare Extension Service is aligned with AHRQ's mission to produce evidence that improves healthcare making it safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used to improve care. The NCC's structure and function detailed below are intended to address AHRQ’s Patient Centered Outcomes Research Trust Fund Strategic Framework’s mission, goals, vision, and priorities. This includes the development of learning networks to bring together the Cooperatives to accelerate the uptake of evidence-based improvements, and by providing resources to enhance understanding of how to increase adoption and spread of improvements.

Key Terms for this NOFO

For purposes of this NOFO, the following definitions apply:

Behavioral Health: an umbrella term that includes mental health and substance use conditions, life stressors and crises, stress-related physical symptoms, and health behaviors.

Cooperatives:  See State-based Healthcare Extension Cooperatives below.

Evidence-based, patient-centered, healthcare delivery improvement ("Evidence-based improvement"): Consistent with Brownson and colleagues (1), evidence-based, patient-centered, healthcare delivery improvements are defined as healthcare delivery interventions, programs, education, training, practices, processes, guidelines, and policies with some evidence of effectiveness in improving health outcomes that are meaningful for patients and their caregivers. This includes clinical evidence, evidence on how best to deliver healthcare that is potentially generalizable beyond specific health conditions or healthcare delivery circumstances (e.g., management strategies, models of care), or evidence-based policies.

Healthcare delivery organization: an organization of people, institutions, and resources that is responsible for the delivery of healthcare services to meet the healthcare needs of a target population. For the purposes of this NOFO, healthcare delivery organizations include but are not limited to health systems, hospitals, ambulatory care practices (including primary care practices and specialty practices), managed care organizations, pre-hospital services, community-based organizations that provide healthcare services, and skilled nursing facilities.

Healthcare Extension Agent(s): Individual(s) who provides external support to improve the healthcare delivery system to improve population health. Healthcare extension agents work to achieve the goals of the Cooperative. Examples of healthcare extension agents include education and training professionals; health IT advisors; human factors, systems engineering or task analysis experts; implementation experts; practice facilitators and coaches.

Learning Network of State-based Healthcare Extension Cooperatives ("Learning Networks"): Learning networks convened by the National Coordinating Center that consists of key members from each of the State-based Healthcare Extension Cooperatives. These learning networks are intended to facilitate mutual learning across all Cooperatives, identify common barriers and facilitators to the provision of evidence-based improvements, and provide technical assistance to members of the Cooperatives.

Safety Net Healthcare Delivery Organizations: Healthcare delivery organizations that provide a significant level of healthcare and health-related services to medically underserved people, including people who are uninsured, receive Medicaid, people made vulnerable by poverty, and others. Examples of safety net organizations include Community Health Centers, Federally Qualified Health Centers (and look-alikes), CMS Rural Health Clinics, Safety Net Hospitals, Indian Health Service providers, pre-hospital service organizations, and primary care practices that serve these populations.

State-based Healthcare Extension Cooperatives (“Cooperatives”): State-level entities that serve as a coordinating entity for supporting the identification and delivery of patient-centered improvements within the State based on PCOR evidence.

Technical Assistance:  Support to Cooperatives to establish state-based health extension services including identifying and disseminating evidence-based tools and resources, providing or identifying subject matter expertise (individuals or organizations), or resources needed for Cooperatives to achieve their goals. 

Reference:

1) Brownson RC, Shelton RC, Geng EH, Glasgow RE. Revisiting concepts of evidence in implementation science. Implement Sci. 2022 Apr 12;17(1):26. doi: 10.1186/s13012-022-01201-y. PMID: 35413917; PMCID: PMC9004065

NOFO Requirements

The central role of the NCC will be to provide the Cooperatives with a wide range of support, resources, and collaborative guidance, and to convene the Cooperatives to facilitate mutual learning in real time. The NCC will also fill a key role as a liaison among the Cooperatives and the NEC to facilitate coordination and communications across all the Healthcare Extension Service recipients. Specifically, the NCC will focus on 4 main areas: 1) technical assistance, 2) learning networks, 3) communications/dissemination and 4) leadership and project management.

Technical Assistance to Cooperatives

The NCC must:

Assess each Cooperatives’ needs and preferences for technical assistance (TA) content and mode of delivery on an ongoing basis to establish customized TA approaches for each Cooperative. AHRQ anticipates that the level of TA required by each Cooperative will vary considerably depending on the current skills, experiences, and resources of the Cooperative.

Establish TA protocols, including guidelines about types and volume of TA that Cooperatives can expect to receive, and communication and engagement mechanisms to provide TA and to facilitate collaboration, learning and sharing.

Identify and disseminate available evidence-based tools and resources (e.g., implementation strategies, protocols for identifying PCOR evidence, etc.) based on best practices from individual Cooperatives to share with all Cooperatives or on topic areas chosen by Cooperatives.

Provide or identify subject matter expertise (individuals or organizations), or resources needed to achieve Cooperatives’ initiatives. The NCC will draw on the NEC’s methodological expertise for TA related to data and measurement.

Provide TA to the Cooperatives on the following topics: 1. Disseminating and implementing PCOR evidence into healthcare delivery improvement; 2. Creating and running a Multistakeholder Council, for example identifying and recruiting key stakeholders or drafting bylaws or governance documents; 3. Assisting with identifying PCOR evidence and evidence-based tools and resources related to topic areas chosen by Cooperatives, and 4. Communicating and disseminating results to multiple audiences.

Document, track and report to AHRQ on all TA activities. The NCC will use information from AHRQ Program Officials and individual Cooperatives to compile, summarize, produce, and share brief descriptive reports on the status of Cooperative activities.

In addition to the required TA content, applicants may propose other TA topics and strategies.

Learning Networks

The NCC must:

Organize, convene, and facilitate learning networks to bring together representatives from each Cooperative to share best practices, identify common challenges, engage in problem solving and learn from each other as well as external experts.

Establish a learning network that includes all Cooperatives.

Establish smaller learning networks for subsets of Cooperative participants based on project role (e.g., Principal Investigator (PI), evaluation lead, etc.), by topic area or based on the needs of the Cooperatives.

Convene a work group to discuss harmonizing data and measurement across the Cooperatives, in collaboration with subject matter experts from the NEC.

Convene a Federal Interagency Workgroup with the purpose of: (1) identifying information about Federal initiatives including state initiatives that have federal investment that would inform the Cooperatives, and possibly enhance alignment across initiatives and reduce duplication, and (2) reviewing reports from the Cooperatives about successes that could be spread and barriers that could be addressed through sharing with Federal partners. Federal workgroup participants may include The Centers for Medicare & Medicaid Services (CMS), Health Resources and Services Administration (HRSA), The Substance Abuse and Mental Health Services Administration (SAMHSA), The Centers for Disease Control and Prevention (CDC) or other federal agencies with knowledge of relevant state-based quality improvement work.

Identify subject matter experts (individuals or organizations) from across the Cooperatives, the NEC or external experts to lead learning network discussions and presentations.

Assess each Cooperatives’ needs and preferences for learning network structure (e.g., 60-minute format, didactic vs. case approach), content and mode of communication on an ongoing basis in order to adapt strategies to maximize engagement and learning.

Convene the learning networks using various formats, such as in-person and virtual meetings or webinars and provide logistics support and produce summary reports of these meetings.

Create a process for collecting and synthesizing feedback from TA activities to share implementation progress and adaptations with the Cooperatives in real time.

Plan and implement an annual Healthcare Extension Service 2 day in-person meeting at AHRQ or other federal building(s) in the Washington D.C. area. This meeting would include Cooperative, NCC, and NEC recipients.

Communications and Dissemination

The NCC must:

Create and implement an evidence-based communications and dissemination plan to promote Cooperatives’ work and to develop dissemination materials that can be used and adapted by individual Cooperatives. The plan should identify key audiences and strategies for reaching each of these audiences.

Provide Healthcare Extension Service content for posting on AHRQ's website, including recommendations for web page layout.  Examples of content may include descriptive information on State-based Healthcare Extension Cooperative recipients as well as data, resources and information developed by AHRQ, the NCC, Cooperatives, or the NEC.

Prepare tools and resources (e.g., implementation strategies, protocols for identifying PCOR evidence, etc.) based on best practices from individual Cooperatives for posting on AHRQ’s website, and where applicable, on AHRQ’s Tools for Change. Work with AHRQ to ensure that all resources prepared for posting align with AHRQ’s Publishing and Communications Guidelines, including compliance with requirements of Section 508 of the ADA, and acquire permissions to post content from external organizations on AHRQ’s website if required. These tools and resources should be posted on the AHRQ website throughout the life of the grant. 

Promote collaboration and support communication among Healthcare Extension Service participants – including the state Cooperatives, NEC recipient, and AHRQ staff.

Develop, maintain, and manage a web-based platform appropriate for intra-team communications and resource document sharing.

Leadership and Project Management

The NCC must:

Lead and manage all activities of the NCC and maintain documentation (tracking and reporting) of all activities, including preparing quarterly progress reports and meeting at least monthly with the AHRQ Program Officials.

Serve as a liaison between AHRQ, the Cooperatives and the NEC, ensuring cooperation, collaboration, and participation across the Cooperatives and the NEC in developing learning networks.

Lead outreach to the Cooperatives to participate in TA activities, working groups, meetings, etc.

Engage with national/state partners and professional and community-based organizations invested in patient-centered healthcare delivery improvements to identify potential resources, support or partners for Cooperatives.

An Evaluation Liaison must be identified to serve as a coordinator with the National Evaluation Center (NEC).

Conduct at least two site visits to each Cooperative over the course of the grant period to build and nurture relationships, observe real-time barriers and facilitators, and foster strong working relationships, all of which are facilitated by in-person connections.

Cooperate and collaborate with the NEC to participate in a process and effectiveness evaluation of NCC services and activities, including but not limited to technical assistance services and convening functions.

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

Investigators proposing clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

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.

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

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 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.

Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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.

• 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.

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 How to Apply - Application Guide.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide. The AHRQ multiple PDs/PIs policy can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-018.html.  

A single PD/PI, or the multiple PD(s)/PI(s) combined, must devote at least 25% minimum full-time effort (FTE); i.e., at least 10 hours per week in each given year of the project. If multiple PD(s)/PI(s) are proposed, each PD/PI must devote at least 10% minimum FTE (i.e., at least 4 hours per week). If any effort is in-kind, this should be explained in the budget justification, and a letter of support from an authorized institutional official is required. 

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. 

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity (NOFO) to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most AHRQ opportunities. 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 funding opportunity

The letter of intent should be sent to:

Jenny Schnaier, MA
Center for Evidence Practice and Improvement
Agency for Healthcare Research and Quality
EMAIL: AHRQ_HES@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 including the following page limits.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required, maximum of 1
• Supporting Healthcare Extension Cooperatives Core:  required, maximum of 1

Pre-application Technical Assistance (TA) Webinars

AHRQ encourages applicants to check the following webpage for resources for this NOFO:   AHRQ’s Healthcare Extension Service Initiative | Agency for Healthcare Research and Quality.  AHRQ encourages applicants to take advantage of any TA webinars that may be held by AHRQ program staff. Participation is optional and is not required to apply. Information about a TA webinar will be published through the NIH Guide for Grants and Contracts and posted on the AHRQ website.

Overall Component

When preparing the application, use Component Type ‘Overall’.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

Complete entire form.

Use Component Type 'Overall'.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Overall. Applications must also describe:

• The overall focus of the NCC and proposed activities.
• How the activities (technical assistance, learning networks, communications/dissemination and leadership and project management) contribute individually and collectively to achieve the goals of this NOFO.
• The applicant's experience and capacity to engage in the proposed work, including connections with key subject matter expert individuals and organizations.

PHS 398 Cover Page Supplement (Overall)

Complete entire form. Use Component Type 'Overall'.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons, (Technical Assistance Lead, Learning Networks Lead, Communication-Dissemination Lead, and Evaluation Liaison) that are working in the components and describe key personnel roles and associated activities.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

A single PD/PI, or the multiple PD(s)/PI(s) combined, must devote at least 25% minimum full-time effort in each given year of the project. If multiple PD(s)/PI(s) are proposed, each PD/PI must devote at least 10% minimum FTE (i.e., at least 4 hours per week).

The PD/PI(s) should have demonstrated leadership and management skills.

The activities on this award demand complex management and coordination as many different entities will ultimately participate in the collaboration. Therefore, Program Director(s)/Principal Investigator(s) must commit and sustain sufficient effort throughout the award to manage this complex entity.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover. 

Travel requirement: Applicants must budget for at least two key personnel to travel to the Washington, DC area once each year to meet with AHRQ staff, and any invited guests for a two-day meeting.

The budget should provide a breakout of travel costs for site visits, annual meetings, and conference presentations. 

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific Aims:

Describe the aims of the proposed U54 National Coordinating Center. Summarize the expected outcome(s) of the U54 as a whole, including the impact that the results of the proposed NCC will have on the Healthcare Extension Service.  Briefly describe how the U54 is structured and how the activities fit into the overall goals. 

Research Strategy:

This section should summarize the structure and overall strategy of the NCC and approach to establishing and managing relationships with, and support services for the Cooperatives and NEC.  This includes descriptions of the following:

• The overall concept of the NCC should be conveyed by providing a concise and overall vision for the proposed NCC.
• Describe why the proposed NCC is important in the context of the known challenges for development of the Healthcare Extension Service program.
• Explain how the components of the NCC, including key personnel, will interact to form a multi-disciplinary team focused on support of the Healthcare Extension Service.
• Describe how the NCC will cooperate and collaborate with the Cooperatives and the NEC.
• Succinctly describe specific expertise of the Overall PDs/PIs that makes them appropriate for their associated roles on the NCC team, without duplicating information in biosketches.
• For the Overall PD(s)/PI(s), describe prior experience leading a national coordinating center or support network providing collaborative guidance, TA, collection of evidence-based resources, and subject matter expertise. Describe how this selected team has experience engaging with national/state partners and professional and community-based organizations invested in delivery of evidence-based, patient-centered healthcare delivery improvements to people receiving care from safety-net healthcare delivery organizations.
• Describe operational or work teams that will carry out the work of the NCC, and how their skills complement each other to contribute to the overall team, including staffing, contracting, and hiring plans.
• Collaboration with AHRQ: Describe plans to engage with AHRQ on key activities and decisions.
• Provide a detailed project timeline, including when all major aspects of the proposed work will be initiated, conducted and completed. 

Letters of Support:

Submit only with Overall Component. Letters of support from partner organizations and entities should specify the nature of collaboration and their role in the NCC. Applications must include letter(s) of support from an institutional official that endorses the proposed NCC and describes the available institutional resources that will support the activities of the NCC. Letters should include, in part, a description of the planned activities, duration of the partnership, and any in-kind support. Letters from individuals who will serve as consultants or collaborators on the project, but with no specified levels of efforts, should also be included. Do not include letters from individuals who will be supported by the grant who are named in the application. Do not include letters from individuals or organizations that are not directly contributing to the project (i.e., general letters of support for the project). 

Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - 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-files/NOT-HS-20-011.html) for additional information on how to incorporate their data management plan into the resource sharing plan. 

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - 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 How to Apply- Application Guide must be followed.

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 (Overall)

All instructions in the How to Apply- Application Guide must be followed.

Supporting Healthcare Extension Cooperatives Core

When preparing your application, use Component Type ‘Support HC Ext Coops Core' Component.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Supporting Healthcare Extension Cooperatives)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Supporting Healthcare Extension Cooperatives)

Research & Related Other Project Information (Supporting Healthcare Extension Cooperatives)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Supporting Healthcare Extension Cooperatives)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Supporting Healthcare Extension Cooperatives)

In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.

Budget (Supporting Healthcare Extension Cooperatives)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Supporting Healthcare Extension Cooperatives)

Specific Aims: Describe the approach to establishing and managing the NCC, including the following activities: 1) technical assistance, 2) learning networks, 3) communications/dissemination, and 4) leadership and project management.   

Research Strategy:

Proposed Project Description

Applicants must describe the proposed approach and associated evidence-based strategies or best practices for developing a TA program, convening learning networks, providing communications and dissemination support and leadership and project management for the NCC, including the elements listed below and any additional elements necessary to fully understand how grant funding will be used.  Applicants must describe approaches and strategies based on the most current evidence available in the field. Applicants must describe how they will advance health equity as it relates to their work supporting the Cooperatives.

Technical Assistance Approach

.  The plan must:

• Describe specific activities, strategies and formats that will be used to provide TA on topics related to:
  • Implementing, monitoring, and improving extension services.
  • Creating and convening a multistakeholder council.
  • Identifying patient-centered outcomes research and other relevant evidence and evidence-based tools and resources related to topic areas chosen by Cooperatives.
• Discuss potential challenges, barriers and solutions to providing TA to multiple Cooperatives with differing stakeholders, initiatives, and state healthcare environments.
• Describe how Cooperatives’ TA needs will be assessed and provided – both to individual Cooperatives and collectively across Cooperatives.
• Describe how subject matter expertise (individuals or organizations) will be identified and engaged to lead TA offerings by topic.
• Discuss an overall approach for establishing guidelines about types and volume of TA Cooperatives can expect to receive and for tracking and summarizing TA requests for AHRQ.
• Describe how information from AHRQ POs and individual Cooperatives will be used to provide and share brief descriptive reports on the status of Cooperative activities.
• Describe how PCOR and other relevant evidence, tools and resources will be identified and disseminated across Cooperatives.

Learning Networks Approach

• Describe the approach for convening and facilitating learning networks to foster relationships across the Cooperatives’ participants and engage them in peer-to-peer learning, sharing and problem solving around common challenges.
• Describe how subject matter experts (individuals or organizations) from across the Cooperatives, the NEC or external experts will be identified and engaged to lead learning network discussions and presentations.
• Describe the approach for assessing Cooperatives’ needs and preferences for learning network content and activities.
• Describe the process for providing systematic rapid cycle feedback to Cooperatives generated from TA, and input from healthcare extension agents and stakeholders to guide the work of the Cooperatives.
• Discuss how participants will be identified for the Federal Interagency Workgroup.

Communications and Dissemination Approach

• Describe an evidence-based approach for creating a communications and dissemination plan to promote the Cooperatives’ work through diverse channels (e.g., blogs, listserv messages, etc.) to multiple audiences and that can be used and adapted by individual Cooperatives and AHRQ.
• Describe the process for identifying and designing content to be developed about the Healthcare Extension Service for AHRQ’s website and include examples of types of content and intended audiences.
• Describe the approach for preparing tools and resources that support the Cooperatives’ work for posting on AHRQ’s website and Tools for Change and how this approach will align with AHRQ’s Publishing and Communications Guidelines and requirements for Section 508 of the ADA.
• Describe a plan for supporting communications across the entire project's participants (Cooperatives, NEC, and AHRQ staff) that includes maintaining a web portal for document sharing.

Leadership and Project Management Approach

• Describe the plan for providing leadership and management of all activities described in this NOFO, including how activities will be tracked and reported to AHRQ.
• Describe current or previous experience serving as the lead in a national coordinating or support network capacity providing collaborative guidance, TA, subject matter expertise and collection of evidence-based resources.
• Describe the approach for coordinating activities between the Cooperatives, the NEC and AHRQ.
• Describe the plan for ensuring collaboration and participation in the learning networks.
• Describe experience engaging with national/state partners and professional and community-based organizations invested in patient-centered healthcare delivery improvements.
• Describe the approach for conducting periodic site visits to each Cooperative over the course of the grant period.

Letters of Support: Submit only with the Overall Component.

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:

 A 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-files/NOT-HS-20-011.html) for additional information on how to incorporate their data management plan into the resource sharing plan. 

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

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.   

PHS Human Subjects and Clinical Trials Information (Supporting Healthcare Extension Cooperatives)

When involving human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, 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 a 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 

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. 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) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. AHRQ and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 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 Grants Policy Statement can be found at http://www.ahrq.gov/funding/grants/policies/hhspolicy.html.

Grant funds may NOT be used for the purchase of food of any kind (refreshments, meals, etc.). AHRQ will not award funds to support the cost of food.

These awards will not be made under expanded authorities; therefore, pre-award costs are not allowable.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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 How to Apply - Application Guide. 

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH and 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 authors 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 application.

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 NOFO 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.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 Center proposed).

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 Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the Center 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 Center rigorous?  If the aims of the Center 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?

• Will successful implementation of the proposed NCC support new, sustainable capacity to increase the dissemination and implementation of PCOR evidence and evidence-based healthcare delivery improvements among the states.
• Will successful implementation of the 4 main areas of the NCC advance health care equity? 

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

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

• Are Key Personnel roles and associated activities clearly described?
• Is the PD/PI or multiple PDs/PIs, devoting at least 25% annual FTE in each given year of the project? Are the multiple PD(s)/PI(s) devoting at least 10% minimum FTE (i.e., at least 4 hours per week).
• To what extent do the proposed Key Personnel have relevant experience and expertise across the four primary NCC activities?
• To what extent do Key Personnel collectively have current or previous experience serving as leads in a national coordinating center or support network capacity?
• To what extent do Key Personnel collectively have experience engaging with national/state partners and professional and community-based organizations invested in patient-centered healthcare delivery improvements?  

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed Center? 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 Center 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 human subjects?

If the Center involves human subjects and/or clinical research, are the 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?

• To what extent does the overall approach demonstrate a clear understanding of the challenges to supporting Cooperatives with varying skills, experiences, and resources?
• How effective is the approach for developing and delivering TA to the Cooperatives?
• To what extent will the approach for convening and facilitating learning networks result in building meaningful relationships, peer-to-peer learning and problem solving among Cooperative participants?
• Is the approach for communicating and disseminating information to promote the Cooperatives’ work evidence-based, and how well does it describe multiple audiences for this work?
• Based on the proposed leadership and management plan, how likely is it that this applicant will be an effective leader of the NCC? 

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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 Center proposed? Will the Center benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

• To what extent do letters of support from collaborating organizations and individuals indicate substantial engagement and document specific contributions of the partner during the proposed collaboration? 

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Review Criteria - Scored - Supporting Healthcare Extension Cooperatives

• Does the approach for supporting the Healthcare Extension Cooperatives clearly describe strategies and activities to accomplish the goals and objectives of the NCC?
• Does the approach for supporting the Healthcare Extension Cooperatives fulfill the requirement to cooperate and collaborate with the Cooperatives and NEC?

Additional Review Criteria - Overall

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

Protections for Human Subjects

If the Center 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.

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 Center's 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 - Overall

As applicable for the Center 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.

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) or the rationale for not sharing the resources, is reasonable.

Data Management Plan

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

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 Center 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 their 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. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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.

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:

• HHS 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.

The following special terms of award are in addition to otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 75, and other HHS, 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, AHRQ's purpose is to support and stimulate 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 primary 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 awardees should include PRA review and approval time in their proposed timelines to develop materials and receive necessary clearances. It typically takes at least six 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 awardees 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).

Government and Principal Investigator (PI) Role Expectations for NCC Cooperative Agreement

Program Director/Principal Investigator (PD/PI) Responsibilities:

The PD(s)/PI(s) will have the primary responsibility for the NCC in accordance with the terms and conditions of the Notice of Award and cooperating with other key parties, including the AHRQ Program Official, other recipients, the Cooperatives, and the NEC.  This includes but is not limited to the following:

• Determine approaches, designing, and setting project milestones and implementing the project plan for the NCC.
• Share issues with AHRQ related to providing guidance and support to the Cooperatives. 
• Cooperate and collaborate with the Cooperatives as described in the section, "Overview of NOFO Requirements."
• Work collaboratively with the NEC including sharing information to contribute to the national evaluation of the Cooperatives and NCC.
• Participate in group activities, including program-wide meetings and communications.
• Provide logistical support for the entire program, including facilitating workgroup and other virtual and in-person meetings, and preparing concise summaries of meetings for distribution.
• Cooperate and collaborate with Cooperatives and NEC in the publication and dissemination of program results and the eventual release to the scientific and healthcare communities of methods, tools, results, and other resources.
• The PD(s)/PI(s) will participate in monthly virtual meetings with the AHRQ Program Official and/or other AHRQ personnel as appropriate. The PD(s)/PI(s) will attend an annual meeting with AHRQ and other recipients, which is held in the Washington, D.C. area, unless otherwise determined.
• In addition to the annual progress report, the recipient is required to submit quarterly progress reports to AHRQ.

AHRQ Responsibilities:

AHRQ staff have substantial programmatic involvement during the period of the cooperative agreement 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 projects. Specific cooperative aims and activities in carrying out individual projects may be shared among the Cooperatives grant recipients, the NEC, and AHRQ program officials.

AHRQ staff will provide advice and support to recipients and will assist in 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 troubleshoot implementation barriers and challenges, and confirm that projects are proceeding according to project timelines and plans. Progress will be reviewed quarterly.

AHRQ will:

• Work with the NCC PD(s)/PI(s) to ensure the objectives of the program are being met.  The dominant role and prime responsibility for the program resides with the PD(s)/PI(s), although specific tasks and activities will be shared among the PD(s)/PI(s) and the AHRQ Program Official.
• Provide the NCC with technical input, advice, and coordination; however, the role of the AHRQ staff will be to facilitate and not to direct activities.  It is anticipated that decisions in all activities will be reached by the NCC PD(s)/PI(s) and AHRQ staff will be given the opportunity to offer input to this process.
• Coordinate and facilitate between the NCC, State-based Healthcare Extension Cooperatives recipients, and NEC PD(s)/PI(s) when appropriate.
• Monitor and assess NCC progress towards meeting milestones and adherence to the strategic goals of the program; through a variety of means such as regular communications with NCC PD(s)/PI(s), periodic site visits, observation and review of project implementation plans, delivery of technical assistance and learning networks, and requests for additional reports or documentation.
• Assist in development, design, and coordination of activities and projects.
• Participate, as appropriate, in conference calls and technical assistance sessions that are conducted.
• Serve as participants in the planning of and attendance in any meetings conducted as part of project activities, as appropriate. Participation by staff from other federal agencies may also be appropriate and advantageous to facilitate the activities of the program.
• Review and provide input on written documents, including information and materials for the activities conducted, prior to submission for publication or public dissemination.
• Work closely with grant recipients and other federal partners to ensure dissemination of products and program findings.

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 staff and other Healthcare Extension Service and NEC recipients as described in Section I. 

NCC PD(s)/PI(s) will collaborate with AHRQ staff in determining the process of setting NCC priorities, deciding optimal technical assistance and learning network approaches, and contributing to the adjustment of approaches as warranted.

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.

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

The overarching objectives of these projects should be addressed through this reporting including progress with respect to:

Reach: Who was reached by this project?

Performance measures:

• How many technical assistance activities did the NCC provide for the Cooperatives?
• How many people/organizations participated in the NCC technical assistance activities?
• How many of the Cooperatives engaged with the NCC’s range of services?
• How many communication/dissemination activities did the NCC provide for the Cooperatives?
• Timeline: Annual report.

Process: What processes were evaluated, implemented, or improved because of this project?

Performance measures:

• How many learning networks were convened?
• What type of learning networks were convened?
• What evidence-based tools and resources did the NCC provide to facilitate the implementation of actionable knowledge in each Cooperative?
• Timeline: Annual report.

Impact: What was the impact of the implemented strategies?

Performance measures:

• How effective was the provision of technical assistance at improving the operations of each Cooperative?
• How many evidence-based tools and resources (e.g., implementation strategies, protocols for identifying PCOR evidence, etc.) based on best practices from individual Cooperatives were posted on AHRQ’s website?
• Timeline: Annual report.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: 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

Jenny Schnaier, MA
Center for Evidence and Practice Improvement
Agency for Healthcare Research and Quality
Email: AHRQ_HES@ahrq.hhs.gov

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

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

Janene Dyson 
Office of Management Services
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/index.html).

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