Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

Agency for Healthcare Research and Quality (AHRQ)

NOTE:  The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.  Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA.

Components of Participating Organizations

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

Funding Opportunity Title

Novel, High-Impact Studies Evaluating Health System and Healthcare Professional Responsiveness to COVID-19 (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

March 26, 2020 - Notice of Intent: New funding opportunity announcement to support novel, high-impact studies evaluating health system and healthcare professional responsiveness to COVID-19

Notice Number:   NOT-HS-20-008

March 26, 2020 - Notice of Intent: Revision supplements to existing AHRQ grants and cooperative agreements to address health system responsiveness to COVID-19  

Notice Number:  NOT-HS-20-007

April 6, 2020 - Reminder: Flexibilities Available to AHRQ Recipients and Applicants Directly Impacted by the Novel Coronavirus (COVID-19) Due to Loss of Operations

Notice Number:  NOT-HS-20-010

March 10, 2020 - Reminder: FORMS-F Grant Application Forms & Instructions Must be Used for Due Dates On or After May 25, 2020—New Grant Application Instructions Now Available
Notice Number: NOT-OD-20-077

January 27, 2020 - OMB Approval for Grant Application and Related Forms Underway Continue to Use Current Forms (FORMS-E) through May 24, 2020
Notice Number: NOT-OD-20-047

January 15, 2020 Salary Limitation on AHRQ FY2020 Grants, Cooperative Agreements, and Contracts
Notice Number: NOT-HS-20-006

January 10, 2020 - AHRQ Guide Notice on Implementation of the Use of a Single Institutional Review Board (IRB) for Cooperative Research at 45 CFR 46.114 (b). See Notice NOT-HS-20-005.

November 22, 2019 - New NIH "FORMS-F" Grant Application Forms and Instructions Coming for Due Dates on or after May 25, 2020. See Notice NOT-OD-20-026.

January 11, 2019 - AHRQ Implementation of Final Rule on the Federal Policy for the Protection of Human Subjects (Common Rule). See Notice NOT-HS-19-008.

January 11, 2019 - AHRQ Announces Change in Grant Recipient Purchasing of Identifiable CMS Data, effective FY2019. See Notice NOT-HS-19-007.

Funding Opportunity Announcement (FOA) Number

RFA-HS-20-003

Companion Funding Opportunity

Not Applicable.

Assistance Listings (formerly called the Catalog of Federal Domestic Assistance (CFDA))

 93.226 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites R01 grant applications for funding to support novel, high-impact studies evaluating the responsiveness of healthcare delivery systems, healthcare professionals, and the overall U.S. healthcare system to the COVID-19 pandemic.

AHRQ is interested in funding critical research focused on evaluating topics such as effects on quality, safety, and value of health system response to COVID-19; the role of primary care practices and professionals during the COVID-19 epidemic; understanding how the response to COVID-19 affected socially vulnerable populations and people with multiple chronic conditions; and digital healthcare including innovations and challenges encountered in the rapid expansion of telehealth response to COVID-19.

AHRQ encourages multi-method, rapid-cycle research with the ability to: produce and disseminate initial findings (e.g. observations, lessons learned, or findings) within 6 months after award and then regularly throughout the remainder of the award period.

Key Dates

 

Posted Date

May 14, 2020

Open Date (Earliest Submission Date)

May 14, 2020

Letter of Intent Due Date(s)

June 1, 2020

Application Due Date(s)

June 15, 2020 

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

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

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

Expedited

Advisory Council Review

Not applicable

Earliest Start Date

September 30, 2020

Expiration Date

June 16, 2020

Due Dates for E.O. 12372

Not applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV and follow the AHRQ Grants Policy and Guidance found on the AHRQ website at http://www.ahrq.gov/funding/policies/foaguidance/index.html. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


Table of Contents

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

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


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

Purpose:

This Funding Opportunity Announcement (FOA) invites R01 grant applications for funding to support novel, high-impact studies evaluating the responsiveness of healthcare delivery systems, healthcare professionals, and the overall U.S. healthcare system to the COVID-19 pandemic.

AHRQ is interested in funding critical research focused on evaluating topics such as: effects on quality, safety, and value of health system response to COVID-19; the role of primary care practices and professionals during the COVID-19 epidemic; how the response to COVID-19 affected socially vulnerable populations and people with multiple chronic conditions; and implementation of digital healthcare, including innovations and challenges encountered in the rapid expansion of telehealth response to COVID-19.

AHRQ encourages multi-method, rapid-cycle research with the ability to: produce and disseminate initial findings (e.g. observations, lessons learned, or findings) within 6 months after award and then regularly throughout the remainder of the award period.

Background:

In January 2020, a novel coronavirus (SARS-CoV-2) was identified as the causative agent of a now global pandemic of respiratory disease, termed COVID-19. Information about the outbreak is changing rapidly and detailed guidance and epidemiology can be found on the Centers for Disease Control and Prevention website (https://www.cdc.gov/coronavirus/index.html) and other sources.

The outbreak of COVID-19 in the United States has exposed the vulnerability of our public health and healthcare delivery systems to contain and manage rapidly transmissible infectious diseases. The entire U.S. healthcare system including hospitals, health systems, primary and specialty care practices, long term care facilities, and healthcare professionals is under tremendous stress. The healthcare system is responding by rapidly adjusting many aspects of healthcare delivery.

There is an urgent need to evaluate the responsiveness of the U.S. healthcare system as a whole, as well as the effectiveness of the response to the COVID-19 pandemic by healthcare professionals and individual healthcare systems.

This AHRQ funding opportunity invites Large Research (R01) Project applications that focus on pertinent aspects of the responsiveness of the U.S. healthcare system to COVID-19 that are consistent with AHRQ's mission of producing evidence to make healthcare safer, higher quality, more ac­cessible, equitable and affordable, ensuring that the evidence is understood and used. 

Several organizations have identified high interest research questions that relate to the COVID-19 pandemic. For example, AHRQ participated in the development of the Priorities for Rapid-Cycle Evaluations developed by AcademyHealth.  In addition, the National Academies of Sciences, Engineering and Medicine has discussed a potential list of emerging infectious disease research topics. These, and other sources, may help to provide applicants with additional context, methods, and justification for their proposed research projects.

For two decades, AHRQ has funded research to improve the health and healthcare for all Americans, and through this funding opportunity, the agency seeks applications that can leverage lessons learned from previous research investments to the challenges resulting from the COVID-19 pandemic.

Objectives:

While AHRQ has identified the following areas of specific interest, these are not all inclusive and applicants may propose any health services research project related to the response to COVID-19 that may lead to improvement in US healthcare delivery.

This funding opportunity is open to relevant research in all healthcare settings, including hospitals, ambulatory care (especially primary care practices), pre-hospital care, long-term and nursing home care, home healthcare, pharmacy, and transitions of care between settings.

A. Research to Improve the Quality of Care Received and Patient Outcomes during and following the COVID-19 Pandemic

AHRQ is interested in research that evaluates how healthcare systems adjusted care delivery, management, decision-making, and operations in response to the COVID-19 pandemic.  The focus is not on the clinical questions of medications for treatment or ventilator settings, but on issues such as workforce deployment, space reallocation, communications between settings, and how decisions affected patient and workforce experience and outcomes.  In addition, there is interest in understanding how decisions and innovations made during the response can best inform operations in the future, both during normal times and in public health emergencies.  While there is interest in all settings of care, there is particular interest in research on changes, innovations, and unintended consequences in primary care. 

B. Research to Improve Healthcare Patient Safety during and following the COVID-19 Pandemic

The COVID-19 pandemic presents new challenges to patient and clinician safety, including antibiotic stewardship and prevention of healthcare-associated infections. AHRQ has supported and helped establish a strong foundation of scientific evidence regarding patient safety, and this FOA seeks to leverage and expand this foundation to address new threats. As with past patient safety research initiatives, relevant projects can be considered in three different stages:

  • Identification of risks, hazards, and harm to patients and clinicians.
  • Design, implementation, dissemination and spread, and evaluation of interventions to improve patient and clinician safety.
  • Establishment of strategies to sustain patient safety improvements such as culture, incident/event reporting, measurement, monitoring, and surveillance.

C.  Research to Understand How the Response to COVID-19 Affected Socially Vulnerable Populations and People with Multiple Chronic Conditions during and following the COVID-19 Pandemic

An additional area of interest is applications that evaluate how the responsiveness of the U.S. healthcare system to the COVID-19 pandemic by healthcare professionals and healthcare systems impacted socially vulnerable populations.  Socially vulnerable populations are those that, due to societal structures, face additional risk from the COVID-19 pandemic. These include, but are not limited to, racial and ethnic minorities other AHRQ Priority Populations (https://www.ahrq.gov/priority-populations/about/index.html), and people living with multiple chronic conditions.  This FOA seeks applications that examine social vulnerability specifically in the context of the COVID-19 pandemic, as well as applications that examine how to improve outcomes for populations with high social vulnerability, either through improvement in care delivery (including integration of social and medical care) or policies. Examination of intersectional dimensions that highlights the combined influences of vulnerabilities is encouraged. 

D. Research to Understand How Digital Healthcare Innovations Contributed to the Health System Response To COVID-19, Outcomes, and Unintended Consequences

The national response to COVID-19 involved an unprecedented expansion in the use of digital healthcare, including telehealth.  This FOA invites applications that seek to understand how digital healthcare innovations impacted, in a positive or negative way,  health system and healthcare professional innovation, as well as its role in identifying emerging best practices and answering questions such as how digital healthcare is best adapted to meet the needs of diverse patients, how policy and financing changes made telehealth more or less effective and sustainable, how telehealth solutions differed across settings, what type of workforce is needed to sustain digital healthcare innovations, and what types of training were needed for both patients and clinicians to allow digital solutions to be effective.

Expanded use of digital healthcare may not be without unintended consequences, which may positively or negatively affect quality of care. An area of interest is understanding its implications, for example, rapidly expanded use of telehealth could result in changes in risks for patient safety, such as increasing diagnostic errors.

Research Plans and Dissemination of Findings

AHRQ is interested in funding research that will have an important impact on healthcare practice and policy, both in the short and the long-term. Applicants are required to include a dissemination plan that describes how early research observations, lessons learned, or findings from the work will be disseminated within 6 months after award, then regularly throughout the remainder of the award period.  Applicants should present a plan for disseminating results during the proposed award period which does not rely on a no-cost extension.

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

Section II. Award Information
Funding Instrument

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

Application Types Allowed

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

Funds Available and Anticipated Number of Awards

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

AHRQ expects to make up to $5 million available to fund meritorious awards in FY2020.

Award Budget

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

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

Award Project Period

The project period may not exceed 2 years.   

These projects are authorized by 42 U.S.C. 299a, which provides that AHRQ shall conduct and support research, support demonstration projects, and disseminate information on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness, and value of health care services.

All applications submitted and AHRQ grants made in response to this FOA are subject to 45 CFR Part 75 (Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards; http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75) , the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of Award.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for AHRQ support as Public or Private Institutions of Higher Education:

o   Hispanic-serving Institutions

o   Historically Black Colleges and Universities (HBCUs)

o   Tribally Controlled Colleges and Universities (TCCUs)

o   Alaska Native and Native Hawaiian Serving Institutions

o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • 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

 AHRQ's authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism.  For-profit organizations may participate in projects as members of consortia or as subcontractors only.  Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only.  Applications submitted by for-profit organizations or foreign institutions will not be reviewed.  Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the grantee and what substantive role the applicant organization will play. Justification can be provided in the Specific Aims or Research Strategy section of the PHS398 Research Plan Component sections of the SF424 (R&R) application.  There is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities.

Foreign Institutions

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

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.

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

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

2. Cost Sharing

This FOA does not require cost sharing.

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

3. Additional Information on Eligibility
Number of Applications

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

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

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

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

2. Content and Form of Application Submission

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

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

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 staff to estimate the potential review workload and plan the review and ensure each application has the best chance of having appropriate peer-reviewers.

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 emailed to Grant_Queries@ahrq.hhs.gov.

Page Limitations

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

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

Budget Component:  Special Instructions for AHRQ applications

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

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

  • Introduction (not required) is limited to 1 page.
  • Specific Aims is limited to 1 page.
  • Research Strategy section, including tables, graphs, figures, diagrams, charts, the dissemination plan, and the timeline is limited to 12 pages.

In describing the research strategy, applicants must address:

  • How their research strategy and approach addresses the COVID-19 response;
  • Describe the evaluation approach, data sources, data collection, and analysis plan;
  • Describe the healthcare practice setting(s) for the research; and
  • Describe the patient population(s) impacted by the research.

The research strategy mush include a dissemination plan (recommended no longer than 2 pages):

Applicants are to describe their approach to disseminate early research findings (e.g. observations, lessons learned, or findings) within 6 months after award and then regularly throughout the remainder of the award period.  Applicants should present a plan for disseminating results during the proposed award period which does not rely on a no-cost extension. Applicants should consider applying innovative and leading edge dissemination strategies and methods that enhance the broader applicability, reproducibility, and scalability of the research findings.

The dissemination plan must describe how the team will effectively communicate and disseminate research evidence and findings to diverse audiences.

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

  • Describe the target audiences, materials that will be developed, and the strategy to evaluate the dissemination activities; and
  • Incorporate innovative and novel dissemination strategies and methods to communicate compelling stories, inform policy makers, and educate new audiences who may benefit from the knowledge.

Project Timeline (recommended no longer than 2 pages):

This section should accomplish the following:

  • Provide a project timeline showing the major scheduled milestones (events, activities, data gathering, analysis, and reporting) for the project. A more detailed Gantt chart may be included in the appendix.
  • The timeline should document how all aspects of the proposed work will be accomplished within 24 months. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Appendix:

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

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

  • See information listed above under Project Timeline.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. AHRQ and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf.

Pre-award costs are allowable. A grantee may, at its own risk and without AHRQ prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs are necessary to conduct the project and would be allowable under the grant, if awarded, without AHRQ prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain AHRQ approval before incurring the cost. AHRQ prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on AHRQ either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project.  

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to AHRQ. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

The applicant should pay particular attention to the SF424 (R&R) application guide instructions (https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf) concerning letters of support. Letters of support, recommendation, or affirmation from any entity or individual not directly participating in the project should not be included.

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

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

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described NOT-OD-19-083 and NOT-OD-20-061. Any instructions provided here are in addition to the instructions in the policy.

Priority Populations

AHRQ supports research, evaluations, and demonstration projects concerning the delivery of health care in inner-city and rural areas (including frontier areas), and health care for priority populations.  Priority populations include low income groups, minority groups, women, children, the elderly, and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. 42 USC 299(c). Women and members of minority groups are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate, e.g. because of the lack of connection between the study and the health of women or particular minorities.  Investigators should review the document entitled, “AHRQ Policy on the Inclusion of Priority Populations,” which is available at https://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html. Applicants under this FOA should consider and discuss including priority populations in the research design as specified in this Notice. 

Public Access to AHRQ-Funded Scientific Publications

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

Plan for Sharing Research Data

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

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

Data Confidentiality

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

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

Sharing Research Resources:  Rights in Data

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

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

Section V. Application Review Information
1. Criteria

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

AHRQ's priority areas of focus are available at https://www.ahrq.gov/funding/policies/foaguidance/index.html.

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate objective group convened in accordance with standard AHRQ peer-review procedures that are described in 42 CFR Part 67, Subpart A.  Incomplete and/or non-responsive applications or applications not following instructions given in this FOA will not be reviewed.  Only the review criteria described below will be considered in the review process.

Administrative Criteria: Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, National Institutes of Health, and for responsiveness by AHRQ.

Merit Review Criteria: Merit Review Criteria, as described below, will be considered in the review process.

 
Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance
  • Does the project address an important problem or a critical barrier related to the COVID-19 pandemic? Is there prior research that serves as the key support for the proposed project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive improvements in healthcare delivery in the U.S. in response to the COVID-19 pandemic or for future pandemics?   
Investigator(s)
  • Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project?
  • Do the investigators have appropriate experience and training and have they demonstrated an ongoing record of accomplishments that have advanced their fields?
  • If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
  • Is a single PD/PI, or are the multiple PD(s)/PI(s) combined, devoting at least 20% minimum full-time effort (i.e. at least 8 hours per week) in each given year of the project?
Innovation
  • Does the application propose innovative approaches to studying responsiveness to the COVID-19 pandemic? Does the application address an innovative hypothesis or critical barrier to understanding the response to the COVID-19 pandemic? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area, for example rapid cycle research and early dissemination of findings? 
Approach
  • Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented?
  • Does the project include a detailed project timeline so that early observations, findings or lessons learned can be disseminated and main research findings can be disseminated by the end of the 24 month project period? 
  • Does the dissemination plan include innovative approaches to disseminating research observations, findings or lessons learned in a way that can be shared within the first 6 months after award and then regularly throughout the remainder of the award period.  Does the applicant present a plan for disseminating results during the proposed award period which does not rely on a no-cost extension?
Environment
  • Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is the scientific and organizational environment strong enough to support completion of the project as described and according to the timeline?   
Additional Review Criteria

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

  • How well does the proposed research plan align with AHRQ’s mission and research priorities?
  • Is the proposed research project’s approach to examine the response to COVID-19 pandemic likely to lead to findings that can contribute to significant improvements in US healthcare delivery?
Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Degree of Responsiveness

       Reviewers will assess how well the application addresses the purpose and objectives of this FOA.

How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA?

Budget and Period of Support

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

Inclusion of Priority Populations

Reviewers will assess the adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups).  Reviewers will assess the adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.7 “Other Submission Requirements”).

Privacy and Security Protections for Patients

Reviewers will assess the resources and processes to be used to address privacy and security issues in the development and implementation of the intervention.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations

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

 Not Applicable.    

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate Scientific Review Group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A.  Incomplete and/or non-responsive applications or applications not following instructions given in this FOA will not be reviewed.

As part of the scientific peer review, all applications:

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

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

The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Responsiveness to goals and objectives of the FOA.
  • Relevance and fit within AHRQ research priorities, as well as overall programmatic and geographic balance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information
1. Award Notices

If the application is under consideration for funding, AHRQ will request "Just-In-Time" information from the applicant.  Just-In-Time information generally consists of information on other support, any additional information necessary to address administrative and budgetary issues, and certification of IRB approval of the project's proposed use of human subjects.  For details regarding IRB approval, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). 

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

Awardees must comply with any funding restrictions described in Section  IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the AHRQ web site at https://www.ahrq.gov/funding/grant-mgmt/index.html.

2. Administrative and National Policy Requirements

All AHRQ grant and cooperative agreement awards are subject to OMB's Uniform Grant Guidance, HHS’s “Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards,” (http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75), and the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of Award.

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

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

Accessibility Provisions for All Grant Application Packages and Funding Opportunity Announcements.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex.  This includes ensuring programs are accessible to persons with limited English proficiency.  The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS.  Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html  or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations.

For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), AHRQ awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a 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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually unless specified otherwise in the terms of the award.   Grantees are required to submit expenditure data on the Federal Financial Report (FFR; SF 425) annually.

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

In addition to the annual progress report, recipients will be required to submit interim progress reports to AHRQ. Detailed instructions on additional reporting requirements will be provided with the grant award.

Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (https://www.ahrq.gov/funding/policies/hhspolicy/index.html). AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project.  However, the due date for annual FFRs is 90 days after the end of the calendar quarter in which the budget period ends.  For example, if the budget period ends 4/30/2018, the annual FFR is due 9/30/2018 (90 days after the end of the calendar quarter of 6/30/2018).

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable AHRQ grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the HHS Grants Policy Statement (https://www.ahrq.gov/funding/policies/hhspolicy/index.html) for additional information on this reporting requirement.

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)

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

Scientific/Research Contact(s)

Direct your questions about general FOA issues, including information on the inclusion of priority populations to:

William Freeman
Agency for Healthcare Research and Quality
Office of Extramural Research, Education and Priority Populations (OEREP)

Division of Priority Populations
Telephone: (301) 427-1320
Email: william.freeman@ahrq.hhs.gov

Robert McNellis
Agency for Healthcare Research and Quality
Center for Evidence and Practice Improvement (CEPI)
Division of Practice Improvement
Telephone: (301) 427-1888
Email: robert.mcnellis@ahrq.hhs.gov

Peer Review Contact(s)

Francis D. Chesley, Jr., M.D.
Director, Office of Extramural Research, Education, and Priority Populations
Director, Office of Minority Health
Acting Director, Division of Scientific Review
Agency for Healthcare Research and Quality
Email: Grant_Queries@ahrq.hhs.gov 

Financial/Grants Management Contact(s)

Office of Management Services 
Division of Grants Management
Agency for Healthcare Research and Quality
Email: GMI@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.  All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.  

Authority and Regulations

This program is described in the Assistance Listings (formerly called the Catalog of Federal Domestic Assistance) at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

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

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