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.

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

PURPOSE

The purpose of this Funding Opportunity Announcement (FOA) is to invite applications that propose creating patient safety learning laboratories or that propose using existing patient safety learning laboratories for new research projects. These learning laboratories will create a multidisciplinary research team and employ a prescribed systems engineering methodology in order to develop, implement, and evaluate innovative solutions to pressing patient safety problems associated with diagnosis and/or treatment, including issues related to inequities in care.

Overview

The progress cited in the patient safety literature during the past 20 years bears witness to the commitment, intellectual vigor, and skillful execution of many individuals and organizations in reducing harms to patients and creating safer health care environments. Well known to the research community are the improved understanding and advances that have been made in infection control, medication safety, health information technology, teamwork, and safety culture. As journal editorials have noted, no one is completely satisfied with the extent of progress. As fine as the achievements have been, they are not the norm. Much of the progress has occurred at well-resourced and culturally receptive institutions. Further efforts are needed for improvements to be more widespread and better integrated into the fabric and structure of clinical work nationwide.

Despite the eager endorsement of systems thinking by many health care advocates, there remains a scarcity of effort of actually engaging the design and engineering disciplines in diagnostic and patient safety projects. In 2005, the National Academy of Engineering and the Institute of Medicine drew from the combined talent in the engineering and health care communities to produce a consensus report and collection of papers entitled Building a Better Delivery System A New Engineering/Health Care Partnership. In 2014, the President's Council of Advisors on Science and Technology (PCAST) issued a report calling for accelerated improvement in health care delivery and lower costs through systems engineering (Report to the President: Better Health Care and Lower Costs: Accelerating Improvements through Systems Engineering). The impact of these reports has been limited.

The present PA provides an opportunity for applicants to be proactive and engage with others not just within the allied health care disciplines, but beyond in the architecture, design, and engineering communities as well. Assuming a steady effort and strong system of care focus, such teams increase the likelihood of becoming truly transdisciplinary and generating innovative designs that have the potential to alter the status quo and shape a safer future rather than simply layering a new safety practice on top of the existing system.

Objectives and Scope

AHRQ seeks applications that identify the diagnostic or treatment setting along with the salient issues and harms of major focus for which new and innovative approaches are needed. To achieve robust improvements and broader system-wide impacts, more than a singular safety issue or harm must be addressed. A focus on closely-related threats and harms is needed to provide the foundation for subsequent design and development efforts that undergo repeated testing, revision, and integration as a working system. The efficacy of the integrated working system needs to be evaluated in a realistic simulated or clinical setting. While applicants will choose the areas of diagnosis or treatment upon which to focus, those that carry a high burden of harm and cost are of special interest to AHRQ.

This FOA provides new or experienced investigators who have interests in improving patient safety by reducing diagnostic and treatment harms with the opportunity to pursue funding in these areas, and also allows flexibility to address emerging and long-standing concerns. For example the FOA encourages focus on current pressing issues such as: telehealth, provider burnout, integration across healthcare settings and the continuum of care, and resiliency of healthcare systems in the wake of a crisis. This FOA provides a unique opportunity for investigators who have an interest in testing novel approaches to solving persistent healthcare issues, such as but not limited to, patient falls, medication safety, sepsis (early detection and treatment), and association(s) between workforce safety and patient safety. This FOA encourages the development of new concepts of operations (CONOPS) and/or artifacts to be used by a system. The above examples also apply to the existing PSLLs that submit applications for new research projects responsive to this program announcement.

Promoting equity is an important societal goal. AHRQ intends that research funded by the agency contribute to this goal by addressing equity. AHRQ encourages applicants responding to this FOA to consider whether there are equity issues in their proposed projects and, where relevant, to address these issues in the proposed research plan.

While applicants will select the area of diagnostic or treatment focus they consider of high significance, this FOA requires applicants to us a flexible five-phase systems engineering methodology. These five phases -- problem analysis, design, development, implementation, and evaluation -- are a simplification of the successive phases that larger-scale systems engineering projects entail.

Key features of the five-phase methodology:

Problem analysis. Defining the problem thoroughly provides the foundation upon which all subsequent efforts are based. Too often, insufficient time and resources are given to the analysis phase, resulting in an incomplete understanding of system issues. The problem analysis will likely entail repeated trips to the clinical setting where records, risk assessments, and relevant documents can be reviewed, where clinical processes and procedures can be observed, where equipment and technology can be examined, and where front-line staff, unit leaders, and other stakeholders can be interviewed. Project teams need to learn about the requirements and preferences of patients, providers, and other stakeholders as well as a myriad of socio-technical factors (e.g., facility design features, equipment and technology, work processes and flow, and organizational, cultural, and contextual characteristics) that shape the clinical experience, and if neglected, can facilitate harm. Based on consultation with engineering members of the team, activities may include requirement analysis, development of concept of operations and use cases, fishbone diagrams, root cause analysis, and decision support trees, to name a few. The problem analysis enables the team to set clear and specific goals to bound and scope the problem, to inform metrics that will be used to verify expected workflow processes and system performance, and to give the team a purposeful sense of direction.

Design. Establishing design objectives is another early and critical phase of project work to be undertaken. Such objectives address what needs to be accomplished by the new system as informed by the problem analysis, goals, and necessary tasks to be performed. In high level design, the idea is to capture ideas and differing perspectives from diverse team members, taking advantage of techniques used by leading design firms such as design workshops, brainstorming, living in the future, rapid prototyping, storyboarding, or foam-board mock-ups to arrive at high level capabilities of the system. The rapid prototypes undergo further testing, revision, and development and a feasible evaluation scheme is developed to determine which designs are likely to hold promise and deserve subsequent development. Detailed design lends greater specificity to the high level capabilities in terms of mapping out core and interdependent functions of the system along with inputs and expected outputs. By using block and flow diagrams, computer models, prototype graphical user interfaces, and other tools, design teams lend greater clarity to the allocation of functions and tasks to humans, hardware, and software. Usability considerations and needs for standardization, interoperability, and redundancy should inform the design process. Plans for integrating devices and separate components into a working system are formulated during this phase as well.

Development. Specific development activities depend, in large measure, on the system under development. During this phase, a considerable amount of testing and evaluation of subsystem components with representative users can be expected. The transdisciplinary team of clinicians, architects, designers, engineers, human factors specialists, and end users working together help ensure not only that system requirements and design specifications are fulfilled, but human considerations in terms of cognitive, perceptual and physical capabilities of patients and providers also are taken into account. As the clinical processes, software and hardware components are created or acquired, they need to undergo individual testing as well as interdependent subsystem formative testing with small groups of representative users for the purpose of improving their effectiveness and working relationships. The selection of subsystems for development and integration has considerable impact on the very real constraints of time, resources and budget. While system development projects proceed in a phase-based forward moving direction, repeated testing in conjunction with new insights and practical constraints may necessitate a two-steps forward, one-step backward progression where previous requirements and functions arrived at in the design phase may need redefinition. It is less costly in terms of resources encumbered and schedule slips to make changes at the earlier phases of design rather than proceed through development and then make the changes. The end goal of the development phase is completion of system components and integration of these components into an overall working system.

Implementation. Given completion of the development phase, the implementation phase affords the opportunity to evaluate the full and integrated complement of facility design features; equipment, tools and technology; new tasks, procedures and workflow patterns; providers, patients and family members; and organizational policy and contextual variables, all functioning together. The implementation phase can be considered a full dress rehearsal to discover what is missing or has not been considered. What are the "bugs and glitches" that still need to be addressed? The project team should be able to verify whether the integrated system is working as intended. Testing the integrated system in this fashion may reveal important socio-technical factors that have been unrecognized and neglected. Of concern are any system vulnerabilities or unintended consequences that may expose patients to new harms or further the work burden of providers. Full-dress rehearsal testing continues until a point of diminishing returns is reached for discovering and correcting system vulnerabilities.

Evaluation. After the integrated system has undergone implementation, its effectiveness can be more rigorously evaluated under realistic conditions. As will be relevant to the particular project proposed, evaluation needs to take into account the simulated or clinical sites utilized; the overall methodology; the extent and associated timelines of the evaluation; specific patient safety process and outcome measures to be captured; system performance metrics to be captured; safeguards for ensuring data reliability, confidentiality, and anonymity of subjects/units; any sampling and recruitment strategies; roles served by research, data collection, technical, and provider personnel; interface design, usability, and related human factors and work-systems issues identified; agreements reached with host site; equipment, tools, supplies to be utilized; organizational constraints; data analysis methods anticipated; and any travel or logistical needs identified. The conduct of the evaluation of the integrated system should be of sufficient scope and duration to enable a full and realistic assessment.

Predicted Project Impact Statement

Applicants are required to submit a predicted project impact statement, which will be evaluated in the determination of scientific merit in terms of the proposed project's significance. Please note that this scored review criterion is different from the Overall Impact in Section V. External stakeholders often ask about the impact that AHRQ’s funded research is having in terms of making health care safer, higher quality, and higher value. Given increasing use of data visualization, infographics, extrapolation, modeling, and predictive and sensitivity analytic techniques to better portray the potential value and benefits resulting from research (e.g., impact on health outcomes), applicants must describe - recognizing the necessary precautions and the early stage nature of the request - the techniques and projections that could be used to best show the impact their proposed research aims could have. Applicants must include in this statement an estimate of potential impact based on the identified techniques. The Predicted Project Impact Statement is limited to one page, and should be included in Appendix A. Applications that fail to include a predicted project impact statement will not be accepted for review.

Recipients of awards under this FOA must provide annual and final reports of performance in achieving the FOA objective (see section VI.3. Reporting).

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

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; https://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75)), the HHS Grants Policy Statement (see https://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of Award.

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)

Governments

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

Other

• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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.

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.

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 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.
• o 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.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active 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.

Please note that for applications with due dates of January 25, 2022, and after, all individuals listed in the SF424 R&R Senior/Key Person Profile (Expanded) Form will be required to have an eRA Commons username (Commons ID). See NOT-OD-21-109 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-109.html) for details.

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. If more than one PD/PI is proposed, one of the PDs/PIs must be from an appropriate clinical domain while another PD/PI must be from an engineering domain (e.g. systems engineering, design engineering, or architecture.

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.

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).

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

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.

Not Applicable.

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

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.

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

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

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

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

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.

Applicants who propose the use of identifiable Centers for Medicare and Medicaid Services (CMS) data are advised to review NOT-HS-19-007 (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-19-007.html) for important changes to how applicants are to budget for the cost of this data.

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

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

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

• Introduction is limited to 1 page. An introduction is required for resubmission applications, and not allowed for new or renewal applications)
• Specific Aims is limited to 1 page.
• Research Strategy section, tables, graphs, figures, diagrams, charts, is limited to 12 pages.

Research Strategy:

• A. Applicants must describe how the prescribed five-phase methodology would be used in the proposed research approach/strategy.

B. As part of the research strategy, the following must be clearly stated 1) Formation of a multidisciplinary research team, 2) Healthcare practice setting(s) involved, 3) Targeted patient population.

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:

• 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:

• Appendix A: Applicants must include a one-page Predicted Project Impact Statement in Appendix A. External stakeholders often ask about the impact that AHRQ’s funded research is having in terms of making health care safer, higher quality, and higher value. Given increasing use of data visualization, infographics, extrapolation, modeling, and predictive and sensitivity analytic techniques in moving to better portray the potential value and benefits resulting from research findings (e.g., impact on health outcomes), applicants must describe - recognizing the necessary precautions and the early stage nature of the request - the techniques and projections that could be used to best show the impact their proposed research aims could have. Applicants are to include in this statement an estimate of potential impact based on the identified techniques. The predicted project impact statement will be evaluated in the determination of scientific merit in terms of the proposed project's significance. Please note that this scored review criterion is different from the Overall Impact in Section V.
• Appendix B: Applicants must include the following information in appendix B: 1) An Evaluation Plan, 2) A Dissemination Plan, and 3) A Project Timeline (use each phase as a milestone). Appendix B is limited to no more than 3 (three) pages. In the evaluation plan, applicant must specify all of the minority and/or vulnerable populations that will be included in the study and are encouraged to describe how evaluation plans will demonstrate how inequities/disparities are addressed by the initiative. For more information on priority and vulnerable populations requirements see Section IV.7. below.

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.

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

For details regarding IRB approval, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). Applicant should also be aware of the AHRQ policy for use of single IRB for cooperative research, 45 CFR 46.114 (b) https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-005.html.

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

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

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.

This initiative is not subject to intergovernmental review.

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.

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 NIH. See Section III of this FOA for information on registration requirements.

Please note that for applications with due dates of January 25, 2022, and after, all individuals listed in the SF424 R&R Senior/Key Person Profile (Expanded) Form will be required to have an eRA Commons username (Commons ID). See NOT-OD-21-109 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-109.html) for details.

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-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 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.

Special requirements and information

1. Applicants should submit letters of support from health system leaders that address their system’s commitment to using transdisciplinary teams and incorporating systems engineering methods as part of a learning health system, including application and spread of the results achieved from the work of this grant.

2. The PD(s)/PI(s) of the Learning Laboratory must be identified and be responsible for the combined planning, technical, financial and administrative functions of the grant. A minimum of 20% cumulative effort amongst all named PD(s)/PI(s) in each given year of the project must be devoted to the Laboratory, supported either through the grant or provided "in-kind." If any effort is "in-kind," this should be explained in the budget justification, and a letter of support from an authorized institutional official is required. If MPIs are proposed, one must be from a clinical domain and the other must be from an engineering domain.

3. Funds requested for equipment, hardware, and software must be clearly identified and well justified. In no case should these costs exceed 20% of the total cost budget for a given year.

4. Applicants must budget for up to two key members of the Laboratory to travel to Washington, DC each year to meet with AHRQ staff, other Laboratory members, and any invited guests for a full day meeting to inform participants of progress and accomplishments, discuss anticipated directions and approaches, and expand opportunities for further learning.

5. Applicants who have active awards funded under RFAs RFA-HS-14-005, RFA-HS-15-001, RFA-HS-18-v001, or RFA-HS-19-001 must ensure that the project proposed under this new FOA does not contain programmatic or budgetary overlap with their existing award. Resubmissions are allowed only for applications originally submitted in response the current FOA, and not for applications that were first submitted to prior RFAs for AHRQ's Patient Safety Learning Lab. When switching from an RFA submission to a PA submission, the subsequent application must be submitted as a new application. For additional information please see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-197.html.

Applicants are required to follow the instructions for post-submission materials, as described in https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-197.htm and https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-179.html as applicable. - Any instructions provided here are in addition to the instructions in the policy.

Priority Populations

AHRQ’s authorizing legislation provides that AHRQ shall, in carrying out its mission, conduct and support research and evaluations, and support demonstration projects, with respect to the delivery of health care in inner-city and rural areas (including frontier areas); and health care for priority populations, which 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 U.S.C. 299(c)(1). AHRQ was also directed to establish a process to ensure that these requirements are reflected in the overall portfolio of research conducted and supported by the Agency. 42 U.S.C. 299(c)(2).

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. AHRQ also includes in its definition of priority populations those groups identified in Section 2(a) of Executive Order 13985 as members of underserved communities: Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality.

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

Public Access to AHRQ-Funded Scientific Publications

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

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.

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.

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.

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 detailed here: https://www.ahrq.gov/funding/policies/foaguidance/index.html. As part of this mission, applications are submitted to AHRQ to support health services research which are evaluated for scientific and technical merit through the AHRQ peer review system.

Applications that are complete and responsive to the 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.

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).

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.

• Does the project address closely related diagnostic or patient safety harms that occur in a healthcare system? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
• Does the predicted project impact statement directly relate to the stated problem? Is the impact attainable through the proposed study? Does the impact involve affecting harms caused by a patient safety concern(s) in reducing various levels of harm, costs associated with harm or improvement in quality of treatment?
• Has the applicant considered the impact of equity on the problem or the project?

• Are the PD(s)/PI(s), collaborators, and other researchers well-suited to the project? If early stage investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Do the investigators and key project personnel have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
• If more than one PD/PI is proposed, is one of the PDs/PIs from an appropriate clinical domain while another PD/PI is from an engineering domain?
• Does the investigative team include appropriate and proportional expertise (e.g., clinicians, architects, designers, engineers, human factors specialists, end users, and other appropriate personnel) to accomplish the proposed research objectives? Does the single PI, or do the co-PD/PIs combined, have at least 20% minimum full-time effort in each given year of the project?

• 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? If the project involves human subjects and/or clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
• Does the approach specifically describe the phases of problem analysis, design, development, implementation and evaluation? As appropriate, does the approach explicitly address: facility design, tools/technology, people (patients, family members, providers, and support staff), new procedures and workflow, and organizational contextual features?
• Has the applicant considered equity issues relevant to their project and, where equity issues have been identified, proposed a plan to address these issues?

• 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?

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?

Inclusion of Priority Populations

Peer reviewers will assess the adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups).

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 conducting peer review for scientific and technical merit, the peer 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.

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

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

For details regarding IRB approval, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). Applicant should also be aware of the AHRQ policy for use of single IRB for cooperative research, 45 CFR 46.114 (b) https://grants.nih.gov/grants/guide/notice-files/NOT-HS-20-005.html.

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?

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.

Resubmissions are allowed only for applications originally submitted in response this FOA, and not for applications that were first submitted to prior RFAs for AHRQ's Patient Safety Learning Lab. When switching between and RFA submission to a PA submission, the subsequent application must be submitted as a new application. For additional information please see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-197.html.

For Renewals, the committee will consider the progress made in the last funding period. Does the application describe the program’s accomplishments over the past funding period(s)? Is the program achieving its research objectives? Has the program evaluated the effectiveness of the research outcomes, and is there evidence that the evaluation outcomes are consistent with their predicted project impact statement? Are changes proposed that are likely to improve patient safety and/or quality of care during the next project period? Are the changes proposed that significantly transcend the past funding period's research scope?

Not Applicable.

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.

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.

• Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable, such as: Data Management Plan, Data Sharing Plan if applicable.
• 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

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.

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).

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

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

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.

All AHRQ grants awards 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), 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.

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.

AHRQ regulatory procedures that pertain to suspension and termination are specified in 45 CFR 75.371 through 75.375.

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.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to AHRQ grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. 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 https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.htmlhttps://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

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.

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 75.205 Federal awarding agency review of risk posed by applicants.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually unless specified otherwise in the terms of the award.

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

In addition to the annual progress report, recipients may be required to submit interim progress reports to AHRQ using the AHRQ Research Reporting System (ARRS). Detailed instructions on interim reporting requirements will be provided with the grant award.

Program Planning and Performance reporting requirements.

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

• Reach: What disciplines/team members were engaged in this project?
• Performance measures: Evidence of different disciplines (individuals working in different departments) engaged in this project.
• Timeline: Reach target by end of year 1

• Process: How closely was the five-phase methodology followed?
• Performance measures: 1. Assess if each phase was completed according to the project timeline. 2. For each phase the team used, describe the outcomes.
• Timeline: Report completion of phases and their outcomes in the next reporting period

• Impact: What results or quantitative measures of impact have been achieved?
• Performance measures: one or more health outcomes will be assessed for the evaluation.
• Timeline: Specific outcomes determined in year 1, updated predicted project impact statement by year 2 and 3, and final impact assessed by end of year 4.

• Reach: Who was reached by the project?
• Performance measures: Number of practices, clinicians, and patients reached as a result of implementation
• Timeline: Reach target by year 4

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

Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (https://www.ahrq.gov/funding/policies/hhspolicy/index.html). AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs is 90 days after the end of the calendar quarter in which the budget period ends. For example, if the budget period ends 4/30/2020, the annual FFR is due 9/30/2020 (90 days after the end of the calendar quarter of 6/30/2020).

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 to http://www.ahrq.gov/funding/grant-mgmt/index.html#Closeout.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for 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 (http://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.

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

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

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

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

Grants Info (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075

David Rodrick, PhD
Center for Quality Improvement and Patient Safety
Telephone: 301-427-1876
Email: David.Rodrick@ahrq.hhs.gov

Nghia Vo, M.D.
Division of Scientific Review
Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
Nghia.Vo@ahrq.hhs.gov

Anna Caponiti
Grants Management Specialist
Office of Management Services, Division of Grants Management
Agency for Healthcare Research and Quality
Telephone: 301-427-1402
Email: Anna.Caponiti@ahrq.hhs.gov

Recently issued AHRQ policy notices may affect your application submission. A full list of policy notices published by AHRQ is provided at https://www.ahrq.gov/funding/policies/polnotice/index.html.

Authority and Regulations

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

Awards are made under the authority of 42 USC 299 et seq., and in accordance with 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.