Federal and State Integration Activities to Advance Cooperation and Regulatory Standards Among Animal Food Safety Regulatory Programs (RFA FD 25 022)

Federal and State Integration Activities to Advance Cooperation and Regulatory Standards Among Animal Food Safety Regulatory Programs (RFA FD 25 022) is sponsored by Food and Drug Administration (FDA). This opportunity supports mission-aligned projects and measurable outcomes.

Expired RFA-FD-25-022: Federal and State Integration Activities to Advance Cooperation and Regulatory Standards Among Animal Food Safety Regulatory Programs 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 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 Human Foods Program ( HFP ) Funding Opportunity Title Federal and State Integration Activities to Advance Cooperation and Regulatory Standards Among Animal Food Safety Regulatory Programs Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3. Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose This Notice of Funding Opportunity is issued to announce the availability of a cooperative agreement to be awarded under a Limited Competition.

The purpose is to provide a funding opportunity for national feed associations to advance and promote a national animal food safety system by building inter-agency collaboration, improving states' regulatory and surveillance protection programs, and promoting the Animal Feed Regulatory Program Standards (AFRPS).

Effective leveraging of animal food safety resources and harmonization requires collaboration with relevant initiatives, including those of federal partners, national initiatives and associations, and state partners.

Funding Opportunity Goals The goal of the cooperative agreement program is to facilitate long-term improvements to the national animal food safety system and achieve integration of the system by building inter-agency collaboration, improving states' regulatory and surveillance protection programs, and promoting the Animal Feed Regulatory Program Standards (AFRPS).

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 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) 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. 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 Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM) and Human Food Program (HFP), is announcing the availability of a cooperative agreement to be awarded under a Limited Competition.

The FDA anticipates the availability for one year of funding with the possibility of two years of additional, non-competitive support, dependent on performance and continued availability of federal funds.

Only national associations and organizations representing state animal food regulatory programs as a primary purpose and primarily consisting of membership from state animal food regulatory program directors and staff including, but not limited to AFRPS enrollees, are eligible to apply for this funding opportunity. Further eligibility restrictions apply. Please see Section III.

The primary goal of this cooperative agreement program is to facilitate long-term improvements to the national animal food safety system by strengthening interagency collaboration, improving states' regulatory and surveillance protection programs for animal foods, and providing education, outreach, and promotion of the AFRPS. The FDA Food Safety Modernization Act (FSMA) gave the FDA a new public health mandate.

The law applies to human food, as well as to animal food including animal food for pets. FSMA directed the FDA to establish standards for adoption of modern animal food safety prevention practices by those who grow, process, transport, and store food.

Congress recognized the more than 3,000 state, local, territorial, and tribal government agencies involved in food safety, including animal food safety, must be fully integrated in FDA's work to fulfill FSMA's mandate to protect consumers with an animal food safety system based on prevention and risk.

This national integrated animal food safety system ensures the quality, consistency, and effectiveness of state and federal efforts to protect the animal food supply. Effective leveraging of resources and harmonization of efforts will require extensive cooperation and coordination with the FDA, national organizations and initiatives, state regulatory programs, and other regulatory animal food safety stakeholders.

The AFRPS establish a uniform foundation for the design and management of state programs responsible for the regulation of animal food. The elements of the AFRPS describe best practices of a high-quality regulatory program. Implementation of these program standards will help the FDA and state agencies better direct their regulatory activities at reducing animal food hazards in facilities that manufacture, process, pack, or hold foods.

The primary objectives of this cooperative agreement are: 1) Support the advancement of the AFRPS and future revisions of the AFRPS as part of a system of continuous improvement to ensure the standards are modernized and support the needs of animal food regulatory programs; 2) Identify, develop, deliver, promote, and assist with attendance of animal food safety training programs to support implementation of AFRPS, as well as training and stakeholder support for provisions of FSMA; 3) Support the efforts of federal and state government agencies to build and expand a national integrated animal food safety system; and 4) Establish and improve existing systems for the sharing, promotion, and collaboration of best practices, guidance documents, sampling plans, procedures, memorandums of understanding, and other tools to facilitate and encourage mutual reliance between federal and state animal food regulatory programs and public health agencies.

The application should detail how the following grant objectives and supporting activities will be achieved.

Specific activities (or outputs) of this cooperative agreement are intended to be: 1) Building, or using and enhancing existing, on-line program portals, to serve as a learning exchange, subject matter expert registry, topical index of regulatory guidance, regulatory updates, and other information that impacts animal food regulatory programs.

Suggested outputs include maintenance and continuous updating of online portals, publications, and other resources; 2) Providing support to revise the AFRPS using established processes and other initiatives that advance an integrated animal food safety system by: Encouraging involvement from state animal food program managers to assist in technical guidance solutions, implementing changes, and increased sharing of best practices for the AFRPS, Scheduling and hosting meetings (in-person and remote), recruiting members, recording meeting minutes, and other duties necessary to support the revision and maintenance of the AFRPS, Maintaining a repository of all documents created, such as meeting minutes, suggested changes to the AFRPS, and position statements, and Hosting of at least one annual meeting (face-to-face or virtual) to assist state animal food regulatory programs in achieving implementation of the AFRPS including, but not limited to, scheduling, meeting facilities, invitations, registration, materials, and audio-visual (AV) needs and support.

Grantee will work to ensure the meeting facilities and arrangements are adequate to support the agenda. Feedback should be elicited from attendees through onsite evaluation forms, online surveys, or a combination of the two to identify strengths and implement opportunities for improvement in future meetings.

Travel assistance may also be provided to states interested in enrolling in the AFRPS; 3) Providing administrative support to additional conferences and seminars the grantee identifies that will support the advancement of an integrated animal food safety system including, but not limited to, scheduling, meeting facilities, invitations, registration, materials, AV needs, on-site support during the meeting, and travel assistance to attendees.

The grantee will work to ensure the meeting facilities and arrangements are adequate to support the agenda.

Feedback should be elicited from attendees through onsite evaluation forms, online surveys, or a combination of the two to identify strengths and implement opportunities for improvement in future meetings; 4) Supporting the training needs associated with the implementation of the AFRPS and best practices in animal food safety by identifying, developing, delivering, and promoting animal food safety training programs, such as basic and advanced inspector training seminars and other training for regulators, as well as training to support animal food safety education and outreach for regulators, industry, and consumers; 5) In support of FSMA, working with the FDA to establish, participate, and promote operational partnerships that assist in building an integrated national animal food safety system.

Operational partnerships may include other national associations and alliances, 6) Providing financial support for animal food regulatory programs to develop, host, and attend training courses, meetings, conferences, and other events that support building an integrated animal food safety system.

Examples include the annual AFRPS meetings, AFRPS revision meetings, training courses that support implementation of the AFRPS, and meetings that support a national integrated food safety system. 7) Establishing a system for continuous improvement of all activities being performed under this cooperative agreement.

The grantee should actively request feedback from all stakeholders on activities being performed under this cooperative agreement. The feedback solicited should then be used to identify and implement improvements for future activities. Other program objectives and activities may be supported upon mutual agreement between FDA and the grantee.

Applicants are strongly encouraged to identify additional activities that will support the goals and objectives of this cooperative agreement. Baseline data, targets, and performance measures and outcomes for each activity should be included in the application. The applicant should also suggest the reporting criteria for each activity.

To promote information sharing, applicants must hold an information sharing agreement with the FDA under 21 CFR 20. 88(e) or be able to obtain an agreement prior to the start date of the award. Information sharing is limited to pre-decisional information only and only for the purpose outlined in this award.

Historically, the animal food supply has encountered risks and emergencies of significant national concern. To provide safe animal food to consumers, efforts have been undertaken at all levels, including consumers, industry, regulators, and even international organizations, to identify and implement improvements to the animal food safety system.

- National Integrated Animal Food Safety System The FDA continues to work with its partners to create a national, fully Integrated Food Safety System (IFSS), which includes the national animal food safety system. This system is characterized by effective communication and efficient processes among federal and state partners in the animal food safety system.

Various initiatives, such as the Partnership for Food Protection, Food Protection Task Force Program, Preventive Controls Alliance, and federal cooperative agreements, work to engage partners across multiple sectors of the animal food safety system to collaborate and identify means to improve and optimize the nation's animal food safety system.

-FDA Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, provides the FDA with the tools to protect public health by strengthening the animal food safety system. FSMA allows the FDA to focus on the prevention of animal food safety problems by providing new enforcement authorities and risk-based animal food safety standards.

The expanded enforcement authorities include mandatory recalls, expanded administrative detention, suspension of facility registration, enhanced product tracing abilities, and additional recordkeeping requirements for high-risk animal foods. FSMA also give the FDA new tools to hold imported animal foods to the same standards as domestic animal foods.

FSMA directs the FDA to build an IFSS, including an integrated national animal food safety system, in partnership with state authorities, explicitly recognizing that all animal food safety agencies need to work together to achieve national public health goals.

FSMA identifies some key priorities in working with partners in areas, such as reliance on federal, state, and local agencies for inspections, improving foodborne illness surveillance, and enhancing state and local food safety and defense capabilities. The full text of the law can be accessed at: http://www. fda.

gov/Food/GuidanceRegulation/FSMA/default. htm 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 FDA intends to fund an estimate of $600,000 in fiscal year 2025 in support of this cooperative agreement. Future year amounts will depend on annual appropriations. It is anticipated that up to one (1) award will be made, not to exceed $600,000 in total costs (direct plus indirect), per award.

Application budgets are not limited but need to reflect the actual needs of the proposed project and 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 three (3) 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 This limited competition opportunity is only available to the following animal food safety training entities that collaborate with one or more institutes of higher education: National organizations and associations representing state animal food regulatory programs as a primary purpose and primarily consisting of membership from state animal feed regulatory program directors and staff, or government agencies including, but not limited to, AFRPS enrollees, and who collaborate with one or more institutions of higher education as defined in 21 USC 399(b).

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, please reference the HHS Grants Policy Statement for additional information 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 Only one application per institution (unique UEI) is allowed. 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. 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 .

A resource Sharing Plan is not required for this NOFO. 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. Applications that miss the due date and time are subjected to the FDA Policy on Late Application Submission.

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 . This award may only be used for activities associated with achieving the goals and objectives of the cooperative agreement and work proposed by the grantee.

Work proposed under this cooperative agreement may not be duplicated or funded by other cooperative agreements, contracts, or other funding mechanisms. Projects proposed under this cooperative agreement must remain distinct and separate from other projects and funding sources. The grantee must be able to account separately for fund expenditures.

1. Facilities and work covered under current contracts, cooperative agreements/grants, partnership funds, and other sources cannot be counted towards the fulfillment of the cooperative agreement and must remain distinct and separate from the cooperative agreement. The grantee must be able to account separately for fund expenditures other sources of FDA funding and these cooperative agreements.

2. Vehicle purchases are not permitted. 3.

Cooperative agreement funds may not be utilized for new building construction. 4. Food may not be purchased.

5. Clothing/uniforms may not be purchased. The funds provided under this NOFO shall be available to an eligible entity that receives a grant under this NOFO only to the extent such entity funds the food safety programs of such entity independently of any grant under this NOFO in each year of the grant at a level equal to the level of such funding in the previous year, increased by the Consumer Price Index.

Such non-Federal matching funds may be provided directly or through donations from public or private entities and may be in cash or in-kind, fairly evaluated, including plant, equipment, or services. Grant funds received under this NOFO shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this NOFO.

Additional funding restrictions may be part of the Notice of Award. 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 are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy . 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. Any instructions provided here are in addition to the instructions in the policy. 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? Investigator(s) (25 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 for the project?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the