Large Health Services Research Demonstration and Dissemination Projects for Prevention of Healthcare-Associated Infections (R18)

Large Health Services Research Demonstration and Dissemination Projects for Prevention of Healthcare-Associated Infections (R18) is sponsored by Agency for Healthcare Research and Quality (AHRQ). This Funding Opportunity Announcement invites grant applications for funding to conduct Large Health Services Research Demonstration and Dissemination Projects that propose to address strategies for the prevention of healthcare-associated infections.

Expired PA-21-264: Large Health Services Research Demonstration and Dissemination Projects for Prevention of Healthcare-Associated Infections (R18) This notice has expired. For NIH, in limited situations, applications may be accepted on a case-by-case basis for a short period after expiration to accommodate NIH late or continuous submission policies . Contact the eRA Service Desk for any submission issues.

Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1. Overview Information Participating Organization(s) Agency for Healthcare Research and Quality ( AHRQ ) NOTE: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA. Also note that AHRQ may have different page limits than NIH for the application Research Strategy, which will be identified within each individual FOA under the page limitation section.

of Participating Organizations Center for Quality Improvement and Patient Safety (CQuIPS) Funding Opportunity Title Large Health Services Research Demonstration and Dissemination Projects for Prevention of Healthcare-Associated Infections Research Demonstration and Dissemination Project March 20, 2026 - Notice of Early Expiration PA-21-264 -- Large Health Services Research Demonstration and Dissemination Projects for Prevention of Healthcare-Associated Infections (R18).

See Notice NOT-HS-26-019 March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 August 28, 2024 - Notice to Extend Expiration Dates for PA-21-264 and PA-21-265. See Notice NOT-HS-24-022 . June 13, 2023 - Notice Title.

See Notice NOT-HS-23-014 . NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available November 17, 2022 - AHRQ Announces Interest in Healthcare Associated Infections and Combating Antibiotic Resistant Bacteria Research.

See Notice NOT-HS-23-003 NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018 .

August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. See Notice NOT-OD-21-169 . August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements.

See Notice NOT-OD-21-170 . April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109 .

October 21, 2021 - Large Research Projects for Combating Antibiotic-Resistant Bacteria (CARB) (R01). See Announcement PA-22-047 October 21, 2021 - Large Health Services Research Demonstration and Dissemination Projects for Combating Antibiotic-Resistant Bacteria (CARB)(R18).

See Announcement PA-22-048 Requirement for eRA Commons IDs to All Senior/Key Personnel Policy on the Inclusion of Priority Populations in Research Limitation on AHRQ FY2021 Grants, Cooperative Agreements, and Contracts Guide Notice on Exception to the Use of the Single IRB Review Requirements During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Changes to the Biographical Sketch and Other Support Format Page for Due Dates on or after May 25, 2021 NOT-OD-21-095 - Extending the Special Exception to the NIH/AHRQ/NIOSH Post-Submission Material Policy During the COVID-19 Pandemic: January 2022 Council to the HHS Notice of Award (NoA) Beginning October 1, 2020 Agency for Healthcare Research and Quality Data Management Plan Policy FORMS-F Grant Application Forms & Instructions Must be Used for Due Dates On or After May 25, 2020 New Grant Application Instructions Now Available Limitation on AHRQ FY2020 Grants, Cooperative Agreements, and Contracts Guide Notice on Implementation of the Use of a Single Institutional Review Board (IRB) for Cooperative Research at 45 CFR 46.

114 (b) Announces Change in Grant Recipient Purchasing of Identifiable CMS Data, Multiple Program Director/Principal Investigator Policy Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Agency for Healthcare Research and Quality ( AHRQ ) Research Projects for Prevention of Healthcare-Associated Infections (R01) Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) issued by AHRQ invites grant applications for funding to conduct Large Health Services Research Demonstration and Dissemination Projects (R18) that propose to address strategies and approaches for prevention and reduction of Healthcare-Associated Infections (HAIs).

This FOA describes the broad areas of HAI research for which funds are available to support Health Services Research Demonstration and Dissemination Projects.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) The first standard due date for the FOA is September 25, All applications are due by 5:00 PM local time of Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. AIDS Application Due Date(s) Generally, four months after peer review date.

New Date March 20, 2026 per issuance of NOT-HS-26-019 . (Original Expiration 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 . 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.

Applicants who propose the use of identifiable 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 Part 1. Overview Information Part 2. Full Text of the Announcement I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Funding Opportunity This Funding Opportunity Announcement (FOA) invites grant applications for funding to conduct Large Health Services Research Demonstration and Dissemination Projects (R18) that propose to address strategies and approaches for prevention and reduction of Healthcare-Associated Infections (HAIs).

This FOA describes the broad areas of HAI research for which funds are available to support Health Services Research Demonstration and HAIs are infections that patients acquire during the course of receiving treatment for other conditions within a healthcare setting. These infections are a significant cause of preventable illness and death in the United States. At any given time, about 1 in every 31 hospital patients has an HAI.

Tens of thousands of patients lose their lives from HAIs each year, and these infections impose billions of dollars in excess costs For these reasons, the prevention of HAIs is a top priority for the U.S. Department of Health and Human Services (HHS). The Department published the National Action Plan to Prevent Healthcare-Associated Infections (HAI NAP), which is available at: http://www. hhs.

gov/ash/initiatives/hai/actionplan/index. html . In 2015, the White House announced the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB NAP), and in 2020, the CARB NAP was updated for 2020-2025 (available at: https://www.

hhs. gov/sites/default/files/carb-national-action-plan-2020-2025. pdf ).

AHRQ’s HAI-related activities contribute significantly to achieving the goals of both the HAI NAP and the CARB NAP. It should be noted that, in addition to this R18 FOA and the companion R01 FOA for HAI prevention (PA-21-265), AHRQ has also published a set of FOAs to invite applications focused on CARB issues of combating antibiotic resistance and promoting antibiotic stewardship.

Applications that are primarily focused on HAI prevention should be submitted in response to the HAI FOAs. Applications for proposed projects that are primarily focused on CARB issues should be submitted in response to the CARB FOAs. It will be helpful for applicants to follow this guidance.

However, because prevention of HAIs is intimately connected to achieving the aims of the CARB NAP, AHRQ will consider applications on HAI prevention and/or CARB issues responsive if submitted to either set of FOAs.

AHRQ collaborates with other HHS Agencies to prevent and reduce HAIs and has funded initiatives in all of the settings identified in the HAI NAP: Acute care hospitals; ambulatory settings, such as ambulatory surgical centers, outpatient care clinics and offices, and hemodialysis centers/end-stage renal disease facilities; and long-term care settings.

AHRQ projects have addressed a variety of HAI types, prominently among them: central line-associated bloodstream infection (CLABSI), catheter-associated urinary tract infection (CAUTI), surgical site infection (SSI), ventilator-associated pneumonia (VAP), methicillin-resistant Staphylococcus aureus (MRSA), and AHRQ intends to continue supporting research and demonstration projects that address more effective ways to prevent HAIs and promote the wide-scale adoption of evidence-based approaches.

This FOA announces the availability of funds to support Large Health Services Research Demonstration and Dissemination Projects, using the R18 mechanism, in the following broad areas of HAI research: Demonstration, dissemination, and evaluation of strategies and approaches for prevention and reduction of HAIs.

Research regarding adoption and implementation (including sustainment and spread/scale-up) of evidence-based approaches for prevention of AHRQ is interested in R18 projects directed to any of the healthcare settings acute care hospitals, ambulatory care settings, and long-term care settings as scientifically warranted.

AHRQ is interested in all aspects of HAI prevention, including, but not limited to, ambulatory care, ambulatory surgery, long-term care, linkage between the various settings of care to improve tracking and prevention of HAIs, antibiotic stewardship, multidrug-resistant organisms, C. diff, and prevention of respiratory viral HAIs.

AHRQ is interested in HAI research conducted in under-resourced A companion FOA (PA-21-265) announces the availability of funds to support Large Research Projects, using the R01 mechanism, in the following broad areas of HAI research: Determination of the clinical efficacy and effectiveness of preventive interventions, including unintended adverse consequences.

Characterization and assessment of relevant epidemiological aspects of HAIs, including but not limited to patient risk factors, clinical presentation, and sources of antibiotic-resistant organisms involved in the In AHRQ’s research funding framework, R01 projects on HAIs are intended to produce evidence to determine the effectiveness of interventions to prevent HAIs or to identify the epidemiological factors associated with HAIs, whereas R18 projects on HAIs are intended to take interventions that have been shown to be effective on a small scale or in a particular setting and to demonstrate and disseminate their application more widely or to explore issues of implementation and adoption.

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.

Pursuant to its authorizing legislation, see 42 U.S.C. 299(c), AHRQ conducts and supports research for AHRQ priority populations (see Section IV. 7 for a list of priority populations).

AHRQ is interested in HAI research that includes a focus on priority populations such that meaningful subgroup analysis can be conducted and results stratified by priority population can be produced.

Recipients of awards under this FOA must provide annual and final reports of performance in achieving the FOA objectives to support large health services research demonstration and dissemination projects to prevent healthcare-associated infections (see section VI. 3. VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

Future year funding is contingent upon the availability of funds for each year of support. The total costs (direct and indirect) for each project awarded under this FOA will not exceed $500,000 in any given year and $2. 5 million for the entire project period.

Funds may be used only for those expenses that are directly related and necessary to the project and must be expended in compliance with applicable OMB Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards (45 CFR Part 75) and the HHS Grants Policy Statement . The project period may not exceed 5 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 All applications submitted and AHRQ grants made in response to this FOA are subject to 45 CFR Part 75 (Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards; http://www.

ecfr. gov/cgi-bin/text-idx? node=pt45.

1. 75 ) , the HHS Grants Policy Statement (see http://www. ahrq.

gov/funding/policies/hhspolicy/index. html ), and the terms and conditions set forth in the Notice of Award. Section III.

Eligibility Information 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 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 Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based 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 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 Non-domestic (non-U.S.) components of U.S. Organizations are not eligible 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) 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. 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. 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.

must have an active DUNS number and SAM registration in order to complete the 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. Note: Targeting due dates on or after January 25, 2022, all individuals listed on the R&R Senior/Key Person Profile (Expanded) Form are required to have an eRA Commons username (Commons ID).

See https://grants. nih. gov/grants/guide/notice-files/NOT-OD-21-109.

html . Eligible Individuals (Program Director/Principal 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 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% annual full-time effort (i.e. at least 8 hours per week) in each given year of the project.

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. Information on Eligibility 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. See NOT-OD-18-197 .

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 A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution. It is critical that applicants follow the Research (R) Instructions (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 For information on Application Submission and Receipt, Asked Questions Application Guide, Electronic Submission of Grant All page limitations described in the SF424 Application Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an All instructions in the SF424 (R&R) Application Guide SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide Budget Component: Special Instructions for AHRQ 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.

All instructions in the SF424 (R&R) Application Guide PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Not to exceed 12 The introduction is limited to one page and is only allowed for resubmission applications. The Specific Aims are limited to 1 page.

The Research Strategy section, including tables, graphs, figures, diagrams, charts, and dissemination plan is limited to 12 pages. All applications should include a Dissemination Plan as part of the research strategy, and it is suggested to be two pages or less.

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the 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 the required data management plan into the resource sharing plan. Only limited Appendix materials are allowed. 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 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 Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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 ). Applicants 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 PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide 3. Unique Entity Identifier and System for Award See Part 2.

for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4. Submission Dates and Times Part I.

Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next 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. are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E. O.

12372) This initiative is not subject to intergovernmental For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www. hhs.

gov/sites/default/files/grants/grants/policies-regulations/hhsgps107. pdf . Pre-award costs are allowable.

A grantee may, at its own risk and without AHRQ prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs are necessary to conduct the project and would be allowable under the grant, if awarded, without AHRQ prior approval.

If specific expenditures would otherwise require prior approval, the grantee must obtain AHRQ approval before incurring the cost. AHRQ prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on AHRQ either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred.

AHRQ expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. 7.

Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted. Applicants must complete all required registrations before the application due date.

Section III. Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission 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 .

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.

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. for avoiding common errors.

The applicant should pay particular attention to the SF424 (R&R) application guide instructions (https://grants. nih. gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.

pdf) concerning letters of support. Letters of support, recommendation, or affirmation from any entity or individual not directly participating in the project should not be included. Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH and responsiveness by AHRQ Applications that are incomplete or non-compliant will not be reviewed.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see https://grants. nih. gov/grants/guide/notice-files/NOT-HS-00-003.

html ). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

In addition to the annual Research Performance Progress Report (RPPR) that is required of grants with multiple years of funding, awards under this FOA carry the requirement to submit semiannual progress reports to the AHRQ Research Reporting System (ARRS). Quarterly conference calls with the AHRQ Program Official for the grant may also be required at the discretion of the Program Official.

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