Combating Antibiotic-Resistant Bacteria (CARB)

Combating Antibiotic-Resistant Bacteria (CARB) is sponsored by BARDA. Advances late-stage development of antibiotics, diagnostics, and alternatives to address critical AMR threats with global relevance.

PA-22-047: Large Research Projects for Combating Antibiotic-Resistant Bacteria (CARB) (R01) 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. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) Agency for Healthcare Research and Quality 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 has different page limits than NIH for the application Research Strategy, which can be found within each individual of Participating Organizations Agency for Healthcare Research Center for Quality Improvement and Patient Safety ( CQuIPS ) Funding Opportunity Title Large Research Projects for Combating Antibiotic-Resistant Bacteria (CARB) (R01) 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 June 13, 2023 - Notice of Clarification for PA-21-264, PA-21-265, PA-22-047, and PA-22-048.

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 .

NOT-HS-22-006 Notice of Change to Large Research Projects for Combating Antibiotic-Resistant Bacteria (CARB) (R01) 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 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, Agency for Healthcare Research and Quality (AHRQ) Multiple Program Director/Principal Investigator Policy applied to Healthcare-Associated Infection (HAI) Prevention and Combating Antibiotic-Resistant Bacteria (CARB) FOAs Multiple Program Director/Principal Investigator Policy Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Agency for Healthcare Research and Quality PA-22-048 , R18 Large Health Services Research Demonstration and Dissemination Projects for Combating Antibiotic-Resistant Bacteria (CARB) Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) invites applications for grant funding to conduct Large Health Services Research Projects (R01) focused on Combating Antibiotic-Resistant Bacteria (CARB) Open Date (Earliest Submission Date) Letter of Intent Due Date(s) The first standard due date for this FOA is February 5, 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 receipt date Generally, four months after the peer review date It is critical that applicants follow the Research (R) Instructions (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 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 There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. 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 Full Text of Announcement Section I.

Funding Opportunity This Funding Opportunity Announcement (FOA) solicits applications for grant funding to conduct Large Health Services Research Projects (R01) focused on Combating Antibiotic-Resistant Bacteria (CARB) in the following ways: by promoting appropriate antibiotic use, reducing the transmission of resistant bacteria, and preventing healthcare-associated infections (HAIs) in the first place.

Antibiotic resistance (AR), which has been noted since soon after the discovery of penicillin, has become a national and international threat. The Centers for Disease Control and Prevention (CDC) estimates that more than 2. 8 million antibiotic-resistant infections occur in the United States each year, and more than 35,000 people die as a result.

In 2014, the White House called for a national effort for Combating Antibiotic-Resistant Bacteria (CARB). The National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB NAP) was released in March 2015, 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 ). The first and third goals of the CARB NAP are particularly relevant to AHRQ's mission.

The first goal of the CARB NAP focuses on slowing the emergence of resistant bacteria and preventing the spread of resistant infections, and the third goal of the NAP includes improving the use of diagnostic tests in clinical care directed to potential resistant infections. The Department has also 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 . AHRQ’s CARB-related activities contribute significantly to achieving the goals of both the CARB NAP and the HAI NAP.

A complementary FOA ( PA-22-048 ) highlights the research areas of interest for R18 applications related to CARB. AHRQ is interested in supporting AR research in all settings targeted in the CARB NAP and the HAI NAP, including acute care hospitals, long-term care, and ambulatory care settings, as well as transitions between care settings.

AHRQ notes that methods of combating AR and conducting antibiotic stewardship are less-well-developed in long-term care and ambulatory settings than in the inpatient hospital setting. Additional research in these areas is especially needed.

AHRQ aims to support research in all It should be noted that AR blurs the distinction between community-acquired infections and HAIs since AR bacteria that emerge in the community tend to be transmitted in due time to healthcare settings. AR is not confined to specific healthcare settings.

Factors that contribute to AR in one setting affect others as well, whether through inappropriate use of antibiotics across settings or transmission of resistant infections from one setting to Consistent with AHRQ’s mission to improve the delivery of healthcare, AHRQ will fund grants that address AR, in the following areas of Areas of interest include but are not limited to: Improving the appropriateness of antibiotic selection and use in all healthcare settings, including but not limited to identifying and modifying factors influencing prescriber decisions about the use and choice of The role of new and existing diagnostics, including rapid diagnostics, in improving antibiotic use, including how diagnostics should be integrated into clinicians decision making about antibiotic use.

The role of the patient’s perceptions and preferences and patient engagement in influencing antibiotic use. Developing improved methods for conducting antibiotic stewardship, particularly in ambulatory and long-term care settings, including multidisciplinary approaches to antibiotic stewardship Developing electronic health record-based approaches to antibiotic stewardship in and across various settings.

Promoting the implementation of antibiotic stewardship programs in long-term care, ambulatory, and hospital settings, including but not limited to identifying and overcoming barriers to implementation. the transmission of resistant organisms.

Areas of interest include but are not limited to: Approaches to preventing the transmission of AR organisms, including regional approaches that span hospital, long-term care, and Developing new methods, improving existing methods, and improving implementation of decolonization with or without screening. Reducing transmission of Clostridioides difficile (C. diff) and multidrug-resistant organisms (MDROs).

Combating C. diff and MDROs, including but not limited to carbapenem-resistant Enterobacteriaceae (CRE)/ Klebsiella pneumoniae carbapenemase (KPC), methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE), and extended spectrum beta-lactamase-producing the basic R01 funding announcement focused on prevention of HAIs.

This FOA announces the availability of funds to support Large Research Projects, using the R01 mechanism, that address the following aspects of the CARB research areas noted above: Determination of the clinical efficacy and effectiveness of CARB-related interventions, including unintended adverse consequences.

Characterization and assessment of relevant epidemiological aspects related to improving antibiotic use, reducing transmission of resistant organisms, and preventing healthcare-associated infections.

A companion FOA ( PA-22-048 ) 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 CARB research: Demonstration, dissemination, and evaluation of strategies and approaches focused on promoting appropriate antibiotic use, reducing transmission of resistant organisms, and preventing healthcare-associated Research regarding adoption and implementation (including sustainment and spread/scale-up) of evidence-based approaches for promoting appropriate antibiotic use, reducing transmission of resistant organisms, and preventing healthcare-associated infections.

In AHRQ’s research funding framework, R01 projects on CARB are intended to produce evidence to determine the effectiveness of interventions that are CARB-related or to identify epidemiological factors, whereas R18 projects on CARB 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.

It should be noted that, in addition to the CARB FOAs for R01 and R18 applications, AHRQ has published a set of FOAs that solicit R01 and R18 applications focused on preventing HAIs. Applications for proposed projects that are primarily focused on CARB issues should be submitted in response to the CARB FOAs. Applications that are primarily focused on HAI prevention should be submitted in response to the HAI 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 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 CARB 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 objective to support large research grants for combating antibiotic-resistant bacteria (see section VI. 3. Reporting ).

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

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 to and necessary to the project and must be expended in compliance with the applicable Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards (45 CFR 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 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 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 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 to apply. 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 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) 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 to 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 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. This FOA does not require cost sharing.

While there is no cost sharing requirement included in this FOA, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project.

Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project.

This information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request. 3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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

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

gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the Research (R) Instructions (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 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: 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: The reviewers will comment on whether the Data Management 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.

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).

All instructions in the SF424 (R&R) Application Guide must be followed. For details regarding IRB approval, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" ( https://grants. nih.

gov/grants/guide/notice-files/not-hs-00-003. html ). Applicant should also be aware of the AHRQ policy for use of single IRB for cooperative research, 45 CFR 46.

114 (b) https://grants. nih. gov/grants/guide/notice-files/NOT-HS-20-005.

html . PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide 3. Unique Entity Identifier and System for Award Management (SAM) See Part 1.

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

Applications that miss the due date and time are subjected to the NIH Policy on Late Application 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 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.

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

Section III. Eligibility Information contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide .

If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII .

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.

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 . 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-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