Sample ahrq grant proposal

NOTE: The policies, guidelines, terms, and conditions stated in this Notice of Funding Opportunity (NOFO) may differ from those used by the NIH. Where this NOFO provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this NOFO. Also note that AHRQ may have different page limits than NIH for the application Research Strategy, which can be found within each individual NOFO.

AHRQ Small Health Services Research Grant Program (R03)

May 13, 2024 - Special Emphasis Notice: AHRQ Announces Interest in Health Services Research to Improve Care Delivery, Access, Quality, Equity, and Health Outcomes for Older Adults. See Notice NOT-HS-24-013

The purpose of this Notice of Funding Opportunity (NOFO) is to seek health services research grant applications focused on AHRQ research priorities, including improving healthcare quality and patient safety, improving healthcare delivery and practice improvement, and enhancing whole-person healthcare delivery. AHRQ supports research in all healthcare settings, including the hospital, long-term care, ambulatory care, home healthcare, pharmacy, and care transitions between settings. Research may involve many partners and other groups, including patients, families, clinicians, non-clinical healthcare staff, policymakers, payers, healthcare organizations, providers and accreditors, local and State governments, the Federal Government, and others.

February 6, 2024

Standard dates apply. The first application due date is June 16, 2024.

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.

Generally, four months after the receipt date

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV and follow the AHRQ Grants Policy and Guidance found on the AHRQ website at http://www.ahrq.gov/funding/policies/nofoguidance/index.html.

When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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

Background

The Agency for Healthcare Research and Quality (AHRQ) is the lead Federal agency charged with improving the quality of healthcare for all Americans. Providing high-quality care means providing safe, effective, and individualized care to meet the consumer’s desires but also accomplished promptly, efficiently, and equitably. AHRQ develops science-based knowledge, tools, and data to improve healthcare and help consumers, healthcare professionals, and policymakers make informed decisions.

Small research (R03) grants provide flexibility for initiating studies which are generally for preliminary or short-term projects. These grants are non-renewable. Some examples of the types of projects that R03 research supports include:

• Pilot or feasibility studies
• Secondary analysis of existing data
• Small, self-contained research projects
• Development of research methodology
• Development of new research technology

The AHRQ small grant is a mechanism for supporting discrete, well-defined health services research projects that realistically can be completed within two years (or less) within the budget constraints of the mechanism. Because the research strategy section of the application is limited to 6 pages, an R03 grant application may not contain the same level of detail as that found in an R01 application. Accordingly, appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.

The Small Research Grant (R03) is an award made by AHRQ to an institution/organization to support a discrete health services research project. The R03 research strategy proposed by the applicant institution/organization must be related to the mission and research interests of AHRQ, which are detailed below. Although the PD/PI is responsible for conducting and supervising the research, the actual applicant is the research institution/organization legally accountable for the performance of the award and the expenditure of funds.

AHRQ supports research in all healthcare settings, including the hospital, long-term care, ambulatory care, home healthcare, pharmacy, and care transitions between settings. Research may involve many partners and other groups, including patients, families, clinicians, non-clinical healthcare staff, policymakers, payers, healthcare organizations, providers and accreditors, local and State governments, the Federal Government, and others.

AHRQ Research Priority Areas

• Research to improve healthcare quality and patient safety
• Research to improve healthcare delivery and practice improvement
• Research to enhance whole-person healthcare delivery

AHRQ is interested in funding research that will have an important impact on health care practice and policy.

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

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

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

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

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

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

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.

Application budgets are limited to $100,000 total costs (including direct and indirect costs) for the entire project period, regardless of the length of the proposed project period.

An application with a budget that exceeds $100,000 total costs for the entire project period will not be reviewed

The scope of the proposed project should determine the project period. The project period may not exceed 2 years.

These projects are being funded pursuant to 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.

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)
• 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
• 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 recipient and what substantive role the applicant organization will play. Justification can be provided in the Specific Aims or Research Strategy section of the PHS398 Research Plan Component sections of the SF424 (R&R) application. There is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities.

Foreign Organizations

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

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

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.

• 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.

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

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

  Eligible Individuals (Program Director/Principal Investigator)

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

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

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

  2. Cost Sharing

  This NOFO does not require cost sharing.

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

  3. Additional Information on Eligibility Number of Applications

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

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

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  Section IV. Application and Submission Information 1. Requesting an Application Package 2. Content and Form of Application Submission

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

  Letter of Intent

  A letter of intent is NOT required for this funding opportunity.

  Page Limitations Instructions for Application Submission 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 instructions:

  • Introduction (required for a resubmission or revision application) is limited to 1 page.
  • Specific Aims is limited to 1 page.
  • Research Strategy section, including tables, graphs, figures, diagrams, and charts, is limited to 6 pages.

  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:

  • 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:

  Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

  PHS Human Subjects and Clinical Trials Information

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

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

  Study Record: PHS Human Subjects and Clinical Trials Information

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

  Delayed Onset Study

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

  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

  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. NIH 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.

  5. Intergovernmental Review (E.O. 12372) 6. Funding Restrictions

  Pre-award costs are allowable. A recipient 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 recipient 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 recipient to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the recipient'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 form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to AHRQ. See Section III of this NOFO for information on registration requirements.

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

  See more tips for avoiding common errors.

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

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

  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

  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.

  Public Access to AHRQ-Funded Scientific Publications

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

  AHRQ Data Management Plan Policy

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

  Plan for Sharing Research Data

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

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

  Data Confidentiality

  The 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

  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.

  As part of this mission, applications are submitted to AHRQ to support health services research which are evaluated for scientific and technical merit through the AHRQ peer review system.

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

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

  Overall Impact

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

  Scored Review Criteria

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

  Significance

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

  Investigator(s)

  Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

  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?

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

  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?

  Additional Review Criteria

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

  Data Management Plan

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

  Protections for Human Subjects

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

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

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

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

  Inclusion of Priority Populations

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

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

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

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

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

  Budget and Period of Support

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

  Resubmissions

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

  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.

  Resource Sharing 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.

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

  The following will be considered in making funding decisions:

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

  After the peer review of the application is completed, the PD/PI will be able to access 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.

  Section VI. Award Administration Information 1. Award Notices

  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.

  2. Administrative and National Policy Requirements

  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.

  • Health Literacy Below are available HHS resources.
  • 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.

  3. Reporting

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

  Recipients are required to submit expenditure data on the Federal Financial Report (FFR; SF 425) annually.

  Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement ( https://www.ahrq.gov/funding/policies/hhspolicy/index.html). AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs is 90 days after the end of the calendar quarter in which the budget period ends. For example, if the budget period ends 4/30/2023, the annual FFR is due 9/30/2023 (90 days after the end of the calendar quarter of 6/30/2023).

  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 achieving project aims.

  Section VII. Agency Contacts

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

  Application Submission Contacts

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

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

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

  Scientific/Research Contact(s) Peer Review Contact(s)

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

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

  Financial/Grants Management Contact(s)

  Office of Management Services
  Division of Grants Management
  Agency for Healthcare Research and Quality
  Telephone: 301-427-1025
  Email: kathryn.woolridge@ahrq.hhs.gov