NARMS Cooperative Agreement Program to Strengthen Antibiotic Resistance Surveillance in Retail Food Specimens

NARMS Cooperative Agreement Program to Strengthen Antibiotic Resistance Surveillance in Retail Food Specimens is sponsored by U.S. Department of Health and Human Services; U.S. Food and Drug Administration. The funding opportunity supports antimicrobial resistance surveillance in retail food specimens for fiscal year 2025, aiming to improve detection, data collection, and analysis to inform public health actions.

PAR-25-014: NARMS Cooperative Agreement Program to Strengthen Antibiotic Resistance Surveillance in Retail Food Specimens 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 Notice of Funding Opportunity (NOFO) may differ from those used by the NIH.

Where this NOFO provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this NOFO. 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 Objective Review Process.

Components of Participating Organizations Center for Veterinary Medicine ( CVM ) Funding Opportunity Title NARMS Cooperative Agreement Program to Strengthen Antibiotic Resistance Surveillance in Retail Food Specimens U01 Research Project Cooperative Agreements Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3. Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), builds upon the National Antimicrobial Resistance Monitoring System (NARMS) which was initiated in 1996 as one of the key activities in a national action plan to combat antibiotic resistance threats.

The purpose of this FOA is to protect and promote public health by enhancing, strengthening, and sustaining antibiotic resistance surveillance in retail food specimens within the NARMS program. The NARMS cooperative agreement is intended to improve the detection of antibiotic resistance among bacteria in food commodities, as well as expand to new sites to expand the scope of sampling.

Measurable outcomes of the program will be in alignment with the NARMS Objectives. Funding Opportunity Goals The FOA is intended to maintain and improve the detection of antibiotics resistance among bacteria in food commodities by funding new and existing sites to conduct routine sampling and testing of retail food commodities.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) July 23, 2025 for August 11, 2025 application due date. March 2, 2026 for April 1, 2026 application due date. March 1, 2027 April 1, 2027 application due date.

All applications are due by 11:59 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

AIDS Application Due Date(s) September 1, 2025 for August 11, 2025 application due date. July 1, 2026 for April 1, 2026 application due date. July 1, 2027 April 1, 2027 application due date.

Required Application Instructions Conformance to all requirements, both in the the Research (R) Instructions How to Apply - Application Guide and in the NOFO, is required and strictly enforced.

Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV of this NOFO or an applicable related Notice posted to the Guide for Grants and Contracts . When the program-specific instructions deviate from those in the How to Apply - Application Guide , follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners.

You must use one of these submission options to access the application forms for this opportunity. 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 Announcement Section 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 The National Antimicrobial Resistance Monitoring System (NARMS) is a U.S. public health surveillance system that tracks antibiotic resistance in enteric bacteria from humans, retail meats, and food animals.

It was established in 1996 and is a collaboration of the U.S. Food and Drug Administration (FDA), the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Department of Agriculture (USDA), and State and Local Public Health Departments.

The NARMS program helps promote and protect public health by providing information about trends in bacterial resistance, how resistant infections differ from susceptible infections, and the impact of interventions designed to limit the spread of resistance.

NARMS is a resource for providing data for animal antibiotics, including post-approval safety monitoring of new animal drugs, and helps assess the risks associated with new animal drugs as well as older antimicrobial agents. The primary bacteria under surveillance are Salmonella , Campylobacter , Escherichia coli , Enterococcus , Vibrio , and Aeromonas . This FOA is limited to the retail food surveillance portion of the NARMS program.

Antimicrobial drugs have been widely used in human and veterinary medicine for more than 80 years, with tremendous benefits to both human and animal health. The development of resistance to these medicines poses a serious public health threat.

Antimicrobial drug use creates selective evolutionary pressure that enables antimicrobial resistant bacteria to increase in numbers and thus increases the opportunity for individuals to become infected by resistant bacteria. When antimicrobial drugs are used in food-producing animals, they can enrich for populations of resistant strains that reach humans via the food supply.

FDA announces the availability of fiscal year (FY) 2025 funds to enhance and strengthen antibiotic resistance surveillance in retail food specimens within the National Antimicrobial Resistance Monitoring System (NARMS). This cooperative agreement with the NARMS retail food surveillance program will enable research and investigations for the collection of critical data to help inform public health stakeholders.

Data from investigations conducted by applicants will assist in developing pre-approval safety evaluation of new animal antibiotics, determining parameters for the antimicrobial use in veterinary medicine, and the ability of public health actors to provide information to promote interventions to reduce resistance among foodborne bacteria.

This cooperative agreement will address NARMS programmatic needs to implement effective surveillance and response for antibiotic resistance as recommended in the National Strategy for Combating Antibiotic-Resistant Bacteria (CARB). The chief goal of the NARMS food surveillance program is to monitor for antimicrobial resistance among enteric bacteria in raw retail meat commodities.

This cooperative agreement will address NARMS programmatic needs to implement effective surveillance and response for antibiotic resistance as recommended in the National Strategy for Combating Antibiotic-Resistant Bacteria (CARB). The chief goal of the NARMS food surveillance program is to improve the detection of and surveillance for antimicrobial resistance among enteric bacteria in raw retail meat commodities. 1.

Applicant will be able to research, collect and process samples within the time frame described in the FDA protocol and guidelines 2. Applicant will be able to perform microbiological tests, as described in the project protocol, of the total samples required by the FDA 3. Applicant will be able to use microbiological results from the project to analyze quality assurance practices 4.

Applicant will be able to integrate surveillance activities with FDA 5. Applicant will be able to exchange relevant and complete surveillance data with FDA and their local public health agencies 6. Applicant will be able to use data to inform program and policy development 7.

Applicant will be able to employ data for education on current and emerging hazards 8. Applicant will be able to support awareness of antimicrobial resistance among the public 9. Applicant will be able to identify foodborne illness outbreaks and coordinate outbreak investigations with the local and state public health agencies as well as the FDA 10.

Applicant will be able to analyze antimicrobial resistance data for their catchment area over time 11.

Applicant will be able to defend their jurisdictions involvement in protecting and promoting the public's health Specific activities supported by this cooperative agreement include but are not limited to those listed below: Actively participate in NARMS conference calls and working groups Implement the NARMS sampling and laboratory protocols to ensure standardized methodologies.

Implement standardized data collection and isolate transmission protocols. Provide FDA with a list of sampling areas that meet the NARMS sampling requirements. Collect fresh retail meat at a minimum of 2 non-consecutive days per month from pre-selected retail locations.

Perform microbiological tests on fresh retail meat samples for Salmonella and Campylobacter. Option to perform microbiological tests on fresh retail meat samples for Escherichia coli and Enterococcus Perform microbiological tests on seafood samples for Enterococcus , Aeromonas , and Vibrio. Perform microbiological tests on fresh retail meat samples for other organisms as specified in ad hoc pilot studies.

Culture other fresh retail food samples for bacteria specified by NARMS. Provide serotype and/or species identifications for isolates when available. Conduct whole genome sequencing and other molecular testing of isolates cultured from fresh retail foods, including seafood, for the NARMS program.

Send isolates to the FDA on a monthly basis for further evaluation. Submit sequences to the National Center for Biotechnology Information (NCBI) as soon as possible or within 60 days of testing. Submit and adhere to the NARMS data use policy agreement Specific activities that are NOT supported by this cooperative agreement include but are not limited to those listed below: 1.

Collection and testing of meats and/or food products not specified in the sampling assignment 2. Isolation of organisms other than those agreed to or specified in pilot study programs FDA staff is substantially involved in the NARMS retail food surveillance program activities beyond routine grant monitoring which include but are not limited to the activities listed below: 1.

Provide general coordination for all NARMS retail food surveillance sites and the overall NARMS network 2. Develop, facilitate, and participate in collaborative multi-site relationships as needed to support the successful completion of the program activities 3. Provide scientific consultation and technical assistance as necessary in the operation of the NARMS retail food surveillance program 4.

Facilitate the development of protocols, procedure manuals, and training of applicants 5. Perform confirmatory bacterial identifications and antimicrobial susceptibility testing 6. Perform whole genome sequencing and other molecular characterization of select NARMS isolates 7.

Analyze, interpret, and disseminate surveillance results 8. Coordinating and facilitating communications among NARMS retail food surveillance sites 9. Establish baseline studies of new commodities as needed Evaluation and Performance Measurement Strategy: Required performance measures for the project period are listed below.

Data will be reported on an annual basis and are used to indicate progress made toward program outcomes. The purpose of evaluation and performance measurement is to help FDA and NARMS Cooperative Agreement awardees: 1) Monitor the extent to which activities planned were successfully completed (e.g., Were activities implemented correctly?)

; 2) Demonstrate how capacity building activities contribute towards program outcomes (e.g., Were outcomes of interest achieved?) ; and 3) Inform decisions about future programming that drive continuous program improvement for more efficient and effective program performance (e.g., What and how could things be improved?)

Potential data sources will include awardee applications and progress reports (e.g., work plans, performance measures, and success stories). Below are evaluation questions to be addressed by the FOA during this project period: What are the major activities conducted by awardees that contributed towards achieving NARMS Retail Food Surveillance program outcomes?

What were the major outputs (milestones or deliverables) accomplished by awardees that contributed towards achieving NARMS Retail Food Surveillance program outcomes? To what extent were awardees proposed activities implemented as planned? To what extent were awardees able to collect and conduct microbiological tests on the assigned number of retail meat samples per month?

To what extent were awardees able to conduct sampling at least twice a month with a minimum of 6 days in between sampling periods? To what extent did awardees attend and participate in NARMS Retail Food Surveillance quarterly calls? To what extent were awardees able to meet submission of whole genome sequences to NCBI within 60 days See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Cooperative Agreement: A financial assistance 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 this NOFO.

Application Types Allowed The OER Glossary and the How to Apply - 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 propose clinical trials.

Need help 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 of four (4) additional year(s) contingent upon annual appropriations, availability of funding and satisfactory awardee performance. FDA/Center for Veterinary Medicine intends to fund up to $5,000,000, for fiscal year 2025 in support of this grant program.

Funding for future Fiscal Years will be contingent upon annual appropriations and program priorities. It is anticipated that up to 35 awards will be made, not to exceed $200,000 in total costs (direct and indirect), per award.

Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect): The total number of years of which federal support has been approved (project period) will be shown in the “Notice of Award. ” This information does not constitute a commitment by the federal government to fund the entire period.

The total project period comprises the initial competitive segment and any subsequent non-competitive continuation award (s). The scope of the proposed project should determine the project period. The maximum project period is five (5) years.

HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) 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 Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are not allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO). System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration.

SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.

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

gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants.

gov Applicants must have an active SAM registration in order to complete the Grants. gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

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

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with 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 How to Apply - Application Guide .

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required. This NOFO does not require cost sharing as defined in the HHS Grants Policy Statement .

3. Additional Information on Eligibility 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.

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 solution. 2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise.

Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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 FDA staff to estimate the potential review workload and plan the review. 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: Office of Acquisitions and Grants Services All page limitations described in the How to Apply - Application Guide and the Table 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 this NOFO. All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply - Application Guide must be followed. All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide .

Other Plan(s): 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 How to Apply - Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by the 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. Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide .

No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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 How to Apply - Application Guide , with the following additional instructions: If you answered "Yes" to the question “Are Human Subjects Involved?

” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed. PHS Assignment Request Form All instructions in the How to Apply - Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. 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.

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. No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission. Information on the submission process and a definition of on-time submission are provided in the How to Apply - Application Guide . 5.

Intergovernmental Review (E. O. 12372) This initiative is not subject to intergovernmental review.

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 Grants Policy Statement . 7.

Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply - 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 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 the 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 How to Apply - Application Guide . See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the assigned FDA Grants Management Specialist and responsiveness by components of participating organizations. Applications that 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. 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. Section V.

Application Review Information Only the review criteria described below will be considered in the review process. Applications submitted to the FDA in support of the FDA mission are evaluated for scientific and technical merit through the FDA objective review system.

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

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

Does the project address 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? 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 for the project?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?

Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project?

Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? If the project involves human subjects and/or FDA-defined clinical research, are the plans to address 1) the protection