Cooperative Agreement for Long Term Data Collection on Antimicrobial Use in Animals (RFA-FD-24-031) is sponsored by FDA Center for Veterinary Medicine (CVM). Cooperative Agreement for Long Term Data Collection on Antimicrobial Use in Animals (RFA-FD-24-031) is a grant from the FDA Center for Veterinary Medicine (CVM) that funds long-term data collection on antimicrobial use in animals to support veterinary medicine and antimicrobial …

Expired RFA-FD-24-031: Cooperative Agreement for Long Term Data Collection on Antimicrobial Use in Animals (U01) Clinical Trial Not Allowed 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) U.S. Food and Drug Administration ( FDA ) NOTE: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Where this Notice of Funding Opportunity (NOFO) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this NOFO. The FDA does not follow the NIH Page Limitation Guidelines or the NIH Review Criteria.

Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Peer Review Process.

of Participating Organizations Center for Veterinary Medicine ( CVM ) Funding Opportunity Title Cooperative Agreement for Long Term Data Collection on Antimicrobial Use in Animals (U01) Clinical Trial Not Allowed Research Project Cooperative Agreements 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 Funding Opportunity Number (FON) Companion Notice of Funding Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose FDA announces the availability of fiscal year (FY) 2024 funds to support one or more projects to 1) collect antimicrobial use data from diverse animal sectors, including domestic livestock, poultry, companion animals (dogs, cats, and horses), and minor species (e.g., fish, sheep, goats) and 2) contribute to the development of data collection frameworks, including providing data and expertise as resources and a public-private partnership frameworks are established.

This grant will support the continued advancement of FDA's initiatives to support antimicrobial stewardship in veterinary settings.

It will also support the National Action Plan objectives to engage the animal health community and relevant stakeholders to advance strategies intended to improve understanding of antimicrobial use and foster antimicrobial stewardship in Open Date (Earliest Submission Date) March 11, 2024 (for May 12, 2024 application due date); March 11, 2025 (for May 12, 2025 application due date).

Letter of Intent Due Date(s) April 11, 2024 (for May 12, 2024 application due date); April 11, 2025 (for May 12, 2025 application due date). By 11:59 PM Eastern Time. 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.

Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants. gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date. applications will not be accepted for this NOFO.

AIDS Application Due Date(s) It is critical that applicants follow the Research (R) Instructions in How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . 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 I.

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

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

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

Notice of Funding Opportunity Description Antimicrobial resistance is recognized as a growing global health threat requiring coordinated antimicrobial use stewardship actions across multiple sectors, including human, animal, and environmental health.

Insights into what drugs are being used, how much of the drugs are being used, and how they are being used are vital to guiding stewardship efforts and furthering our understanding of the relationship between antimicrobial drug use and resistance. However, the accessibility of antimicrobial use data in animals is limited and therefore, it remains a key data gap for veterinary and animal production settings within the United States.

Antimicrobial use data includes the collection and analysis of information about the amount of antimicrobial prescribing, authorizing, administering, and delivering for administration in a defined animal species or population.

Antimicrobial use data is ideally collected as close to the point of actual administration to the animal or population of animals as possible, along with information about appropriate contextual information for the use of In 2018, FDA CVM released 'Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2019-2023.'

This plan outlined CVM's intended focus on supporting antimicrobial stewardship along three key goals: 1) align antimicrobial drug product use with the principles of antimicrobial stewardship, 2) foster stewardship of antimicrobials in veterinary settings, and 3) enhance monitoring of antimicrobial resistance and antimicrobial drug use in animals.

In 2023, FDA CVM released its next 5-Year Plan for Fiscal Years 2023-2028 outlining ongoing and additional actions related to these three key goals in supporting antimicrobial stewardship in veterinary As part of its strategy to address the third goal of enhanced monitoring of antimicrobial drug use data in animals, FDA CVM funded four cooperative agreements for antimicrobial use data collection in food-producing animals (two (2) grants funded since 2016) and in companion animals (two (2) grants funded since 2020).

These pilot data collection efforts were intended to provide baseline information on antimicrobial use practices in animals and important information on methodologies to help optimize long-term strategies for collecting and reporting such data.

Some of these groups published a series of papers in a 2020 describing the first few years of data collection (in one issue of the journal, Zoonoses and Public Health ), and other publications are reported in the scientific literature since then, and are also listed on the FDA CVM website .

In 2021, FDA CVM asked the Reagan Udall Foundation for FDA to seek input from a variety of affected stakeholders on a draft framework exploring public-private partnerships to track antimicrobial use data in food producing animals in the United States. The Foundation conducted this outreach under a cooperative agreement with the FDA, the results of which are summarized in a report outlining the draft framework.

The report includes information about antimicrobial use data standardization and protection of data confidentiality; it also summarizes stakeholder input and public comments about potential objectives, membership, organizational structure, and financing for a potential public-private partnership.

The report describes a potential framework, supported in part by public and private resources, that includes a Data Repository Coordinator, Data Partners, and a Steering Committee. Antimicrobial use data collection projects funded under this Notice of Funding Opportunity would function to collect data in a manner similar to that envisioned for the "data partners" outlined in the report referenced above.

Grantees would be expected to contribute to the development of data collection frameworks, including providing data and expertise as resources and public-private partnership framework becomes Antimicrobial use data in animals is critical to foster antimicrobial stewardship in veterinary settings. A key data gap is the limited availability of antimicrobial use data in animals.

Development of a long-term strategy is needed to successfully implement a functional and efficient infrastructure for ongoing collection of antimicrobial use data from across diverse veterinary and animal Building upon prior antimicrobial use data collection efforts, including exploration of a potential framework for establishing public-private partnership to collect and analyze antimicrobial use data, the purpose of the 1) Gather, summarize, and report information about antimicrobial use in domestic animals from diverse veterinary or animal production 2) Contribute to and support long-term data collection efforts that are under development within the United States, including potential public-private partnership frameworks and national data repositories or dashboards intended to securely store, analyze, and report antimicrobial use data.

Applicant should identify and characterize specific antimicrobial use data gaps or challenges to data collection in one or more population(s) of animal species or species subsector(s), including domestic livestock (e.g., beef cattle, dairy cattle, swine), poultry (e.g., layer chickens, broiler chickens, turkeys), companion animals (e.g., dogs, cats, horses), or other minor species (e.g., fish, sheep, goats).

Applicant shall collect and report detailed summary information on available antimicrobial drug use data and contextual information (e.g., antimicrobial drug name or identifier, dosing information, or indication for use) from the identified animal population(s) (e.g., animal demographic information, population numbers, or weights at time of treatment) using methodologies that are standard or appropriate to that sector.

Applicant shall collect data in a manner that protects disclosure of nonpublic information, such as raw data containing identifying information or other confidential business information.

Applicant shall characterize the extent to which the collected data are representative of the animal species sector or animal species subsector Applicant shall produce annual summary reports of the quantitative and qualitative antimicrobial use data collected (which does not include raw data), such as detailed descriptions of the data collection methodology, analysis of trends, and information that provides essential context to interpretation of the data (e.g., information about data source/record type, type of veterinary setting, epidemiological Applicant shall also make annual summary data available to the public, such as, for use to inform antimicrobial stewardship programs or to Applicant shall contribute summary antimicrobial use data and technical support to public-private partnerships/collaborations for long-term data collection that are under development in the United States, including through contributing data to national data repository or dashboard, as those resources or infrastructure For FY 2024, proposals to collect antimicrobial use data from domestic livestock or poultry sectors will be prioritized.

In FY 2025, proposals to collect antimicrobial use data collection from companion animal or minor species sectors will be prioritized.

FDA is requesting proposals describing the following activities and detailed information about how applicants intend to accomplish them: Characterize and address data gaps and specific challenges to the collection of antimicrobial use data from an identified animal population, sector, Propose methods and strategies for data collection and standardization of antimicrobial use data from across diverse data sources from the identified animal population, sector, or subsector; Propose methods and strategies to ensure data confidentiality and maintain anonymization of identifying data extracted from records (e.g., producer treatment records, veterinary prescription records); Summarize the collected antimicrobial use data using standardized formats that are appropriate to the studied animal population, sector, or subsector, including analyses of trends and contextual information pertinent to accurate interpretation of the data; Make collected antimicrobial use data and summary information, such as analysis of trends, available to the public using a variety of appropriate outlets, such as peer-reviewed scientific literature or public-facing dashboards; Collaborate with and contribute to public-private partnership efforts working towards development of a national data repository or dashboard(s) across animal or veterinary sectors to collect and report antimicrobial use data, including collaboration with animal health organizations, veterinary practices, animal producer groups, universities, and federal or state partners who are involved in those efforts; and Propose methodologies to provide aggregated and anonymized antimicrobial use data which will be made available for input to a national database repository or dashboard in future years, as resources or national infrastructure VIII.

Other Information for award authorities and regulations. Section II. Award Information Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement.

Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI. 2 for additional information about the substantial involvement for Application Types Allowed and the SF424 (R&R) Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. Not Allowed: Only accepting applications that do not determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications.

Award(s) will provide one (1) year of support and include future recommended support for four (4) additional year(s) contingent upon annual appropriations, availability of funding and satisfactory recipient FDA intends to fund an estimate of 3 awards, corresponding to a total of $600,000, for fiscal year 2024.

FDA intends to fund an estimate of 2 additional awards, corresponding to a total of $1,000,000 for fiscal It is anticipated that awards will be made in fiscal year 2024 and 2025, not to exceed $200,000 in total costs (direct plus indirect), Future year amounts will depend on annual appropriations. The first year of grant funding will prioritize proposals specifically targeting data collection in domestic livestock and poultry species.

FDA encourages proposals targeting data collection in companion animal and minor species to apply, starting in FY2025. Application budgets are not limited but need to reflect the actual needs of the proposed project. Application budgets should not exceed the following in total costs (direct and indirect): The scope of the proposed project should determine the project period.

The maximum project period is five FDA grants policies as described Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

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 FDA 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 For-Profit Organizations (Other than Small Businesses) 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 Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) are Non-domestic (non-U.S.) components of U.S. Organizations are not eligible Foreign components, as defined in the HHS Grants Policy Statement , are not allowed.

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.

Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference HHS Grants Policy Statement Section 2. 3. 9.

2 Electronically Submitted Applications for additional information. Award Management (SAM) Applicants must complete and maintain an active registration, 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. and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.

gov registration process. The same UEI must be used for all registrations, as well as on the grant application. - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.

gov registration; 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. Applicants must have an active SAM registration in order to complete the Grants.

gov 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 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 their organization to develop an application for 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) This NOFO does not require cost sharing as defined in the HHS Grants Policy Statement Section 1. 2 Definition of Terms . 3.

Additional Information Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per HHS Grants Policy Statement .

This means that the FDA 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.

An application that has substantial overlap with another application pending appeal of initial peer review (see HHS Grants Policy Statement ). For Fiscal Year 2024, FDA intends to fund For Fiscal Year 2025, FDA intends to an additional two (2) Section IV. Application and Submission Information 1.

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

gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system 2. Content and Form of Application It is critical that applicants follow the Research (R) Instructions to Apply - Application Guide , except where instructed in this notice of funding opportunity to do otherwise.

Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: Katherine Huebner via [email protected] All page limitations described in the How to Apply Application Guide of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the How to Apply Application Guide and should be used for preparing an application to 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 must 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 must All instructions in the SF424 (R&R) Application Guide must All instructions in the SF424 (R&R) Application Guide must PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by FDA) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or FDA-defined 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 Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must does NOT apply to a study that can be described but will not start immediately 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 Management See Part 1. Section III. 1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.

gov 4. Submission Dates and Times Part I. Overview Information contains information about Key Dates and times.

Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day. Organizations must submit applications to Grants.

gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , FDA’s electronic system for grants administration. FDA 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 HHS Grants Policy Statement . 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. This initiative is not subject to intergovernmental All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement . Pre-award costs are allowable only as described in the HHS 7.

Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications 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, 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 form . Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA.

See Section III of this NOFO for information on registration requirements. The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the assigned grants management specialist and responsiveness by components of participating organizations , FDA.

Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed Post Submission Materials Post-submission materials are those submitted after submission of the grant application but prior to objective review. They are not intended to correct oversights or errors discovered after submission of the application.

FDA accepts limited information between the time of initial submission of the application and the time of objective review. Applicants must contact the assigned Grants Management Specialist to receive approval, prior to submitting any post submission materials. Acceptance and/or rejection of any post submission materials is at the sole discretion of the FDA.

Any inquiries regarding post submission materials should be directed to the assigned Grants Management Specialist Only the review criteria described below will be considered Applications submitted to the FDA in support of the HHS mission are evaluated for scientific and technical merit through the FDA Reviewers will consider each of the review criteria below in the determination of scientific/technical merit.

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?

How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Investigator(s) (30 Points) 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)?

If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate 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 vertebrate animals If the project involves human subjects and/or FDA-defined clinical research, are the plans to address 1) the protection of human subjects 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?

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 Additional Review Criteria As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores For FY 2024, proposals to collect antimicrobial use data collection in domestic livestock or poultry sectors will be prioritized.

In FY 2025, proposals to collect antimicrobial use data collection in companion animal or minor species will be prioritized.

Protections for Human Subjects 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