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

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

 

Rapid Response Teams (RRTs) are multi-agency, multi-disciplinary teams that operate using Incident Command System (ICS)/National Incident Management System (NIMS) principles and a Unified Command structure to respond to human and animal food emergencies. The desired outcome of RRT development is to minimize the time between agency notification of a human or animal food incident and implementation of effective control measures. Human and animal food incident means: all hazards, farm to fork, outbreaks, natural disasters, potential tampering/intentional adulteration, positive samples, recalls, and radiological preparedness. RRTs take three years to fully develop, which is termed 'RRT Development'. RRTs may apply for up to $300k for each grant year in development. After three years in development, RRTs transition to 'RRT Maintenance' where criteria-based data is used to put RRTs into one of three funding tiers (Level 1-$150k, Level 2-$225k, Level 3-$300k). See additional information under Section III Eligibility Information.

This cooperative agreement is to support development and maintenance of RRTs. Applicants must refer to Section III Eligibility Information to determine which funding track they should apply for: RRT Development or RRT Maintenance.

Applicants should take sustainability into account when designing projects proposed under this cooperative agreement to maximize the longevity of resulting outcomes, resources, and program infrastructure beyond the end of the project period.

The RRT Program supports development and maintenance/continued operations of multi-jurisdictional, multi-disciplinary Rapid Response Teams (RRTs) for program improvement and requires extensive cooperation and coordination among State programs (human and animal food regulatory programs, laboratory, epidemiology, emergency management)and corresponding to the FDA Division Office and the Office of Partnerships. Incident response and surveillance work conducted by the RRT, including investigations, tracebacks, environmental assessments, sample collection, laboratory analyses, and recalls are considered within scope for this cooperative agreement.

For more information on the RRT Program, please visit this website Rapid Response Teams- Program Information

Listed below are RRT yearly milestones/objectives that applicants should review and address within their application. In addition, a successful applicant shall provide mid-year and end-of-year progress report updates each grant year. These RRT milestones/objectives are in alignment with the RRT Program 6 Year Plan (2023-2029) and the RRT Capacity Building Process and Mentorship Framework. 

Yearly objectives for RRT Development:

1. Complete the RRT Capacity Building Process and Mentorship Framework phases 1 and 2, including: developing the RRT structure (inclusive of human and animal food regulatory, epidemiology, and laboratory partners), holding quarterly meetings, training team members, and developing standard operating procedures.

2. Complete development of an RRT sustainability plan and provide updates in progress reports.

3. Conduct at least one joint training addressing a common need among RRT member agencies/partners (e.g., Epi-Ready, Environmental Sampling, Tracebacks etc.)

4. Complete a capability assessment review each year and develop an improvement plan based on the results of the assessment.

5. Participate in an RRT workgroup to improve capability assessments.

6. Conduct at least one planned, joint exercise with all RRT partners to focus on improving response capabilities identified as needing improvement (e.g., Tracebacks, Sampling, Environmental Assessments, Recalls etc.). The exercise should include ICS elements and standing up an Incident Management Team to manage the incident.

7. Conduct at least one presentation (oral or poster) about the development of the RRT or documenting a specific investigation (in years 2 and 3).

8. Complete after-action reviews and summary reports in a timely way for exercises and responses to significant real incidents. At least one after-action report should be shared with the FDA each grant year.

Yearly objectives for RRT Maintenance:

 

Only RRTs led by manufactured food programs will be eligible for maintenance funding because they have already received three years of RRT development funding under previous cooperative agreements. Since the RRT maintenance funding is tiered, some goals may not apply based on the state program funding tier as described below.

Maintenance and Continuous Program Improvement (Applies to All Sub-Parts )

1. Maintain the RRT: SOPs should be current and fit for use, execute the training plan, maintain the team, equip the team, complete at least one exercise each grant year, develop and maintain an improvement plan based on investigation findings.

2. Complete after-action reviews for RRT responses, activations, and exercises per RRT SOPs. Incorporate findings into the improvement plan.

3. Complete and submit a capability assessment review and develop an improvement plan based on the results of the assessment. Participate in workgroup to revise capability assessments.

4. Submit a Sustainability Assessment, which describes the following: 1) Resources critical to RRT operations and program maintenance; 2) Current funding source for each resource (State, Federal, etc.); 3) Approximate dollar value of each resource; 4) Contingency plans and impact on each resource should Federal RRT funds cease.

RRT Innovation, Integration, and National Capacity/Capability Development (Level 3 RRTs: 2 Distinct Projects Per Year; Level 2 RRTs: 1 Project Per Year; Level 1 RRTs: No Project Per Year Necessary)

1. Mentor a voluntary RRT (assigned by the FDA Office of Partnerships (OP)) in RRT development.

2. Develop and execute an inter-RRT project/collaboration, aimed at any RRT-related topic of mutual interest. Examples include: Regional RRT meetings, Division-wide RRT collaboration, multi-RRT After Action Reports (AAR)/improvement plans, identifying and proposing solutions to regional/national needs/gaps (surveillance, response or prevention; training; exercise; data sharing), and working with relevant partners to propose outreach, education, legislative and other activities to prevent incident/contamination recurrence.

3. Develop and execute a specific project aimed at enhancing/improving collaboration with local health departments during RRT responses and activations, or with another RRT partner that has historically not been involved in your RRT (e.g., FSIS, a new food/feed commodity area, law enforcement, emergency management; which partners meet this criterion will largely depend on how your RRT is structured).  

4. Develop and execute a training-related project.

5. Participate in individual, multi-state or national initiatives to undertake innovative approaches to response and/or create and provide tools and resources to help others enhance their ability to effectively respond to food/feed contamination incidents.

Gathering and Sharing Data to Support Prevention (Number 3 Applies to all RRTs; Level 3 RRTs: 1 Project Per Year Selected from Other Sub-Parts; Level 1 & 2 RRTs: No Requirement)

1. Address gaps in procedures or training necessary to support conducting environmental assessments/root cause investigations (assessments geared at identifying contributing factors and environmental antecedents that led to a food or feed contamination event).

2. Share investigation findings with industry, or work with relevant partners to propose recommendations for industry or other preventive measures based on findings from environmental assessments. Examples include: organizing/hosting workshop or trainings for industry, developing and providing written guidelines/best practices or other resources to industry, publishing articles in trade journals, leveraging State Food Protection Task Force events, and speaking at industry events.

3. Work with RRT member agencies/partners to capture and report environmental assessment data to national reporting systems, such as: the FDA’s Farm Investigation Questionnaire for on-farm/produce related microbiological contamination events, and CDC’s National Outbreak Reporting System for any human foodborne illness outbreak. Use of the FDA Environmental Assessment Process Overview in conducting environmental assessments is encouraged.

4. Work with RRT member agencies/partners to capture and report environmental assessment data to CDC’s National Environmental Assessment Reporting System (NEARS) for outbreaks linked to food service establishments.

5. Collaborate with regulatory partners to suggest and implement prevention-focused improvements in routine inspection and sampling activities based on lessons learned and findings from past environmental assessments and investigations.  Examples include: revision of inspection/investigation questionnaires or protocols, implementation of or changes to surveillance sampling schedules, revision of sampling protocols, and changes in risk classification of firm inventory.

Communicating RRT Impact (Applies to All Sub-Parts )

 

1. Conduct at least two presentations per year (oral or poster) documenting a specific RRT investigation or other activity and share a copy of the presentation within the RRT Program Workgroup in FoodSHIELD. At least one of these two presentations must be at a regional or national meeting (a RRT Face to Face (F2F) Meeting presentation cannot count as your regional/national meeting presentation).

2. Present at least once per year on the national RRT monthly teleconference and present a poster at the national RRT F2F meeting to share investigation or project outcomes, as well as emerging or nascent stage lessons learned and best practices with other RRTs.

3. Prepare and post at least one report per year of a significant investigation, successful prevention effort, or other RRT action taken to protect public health on a Food Protection Task Force webpage, a state agency webpage or other public webpage and notify RRT Program Coordinators to allow cross-linking from the FDA RRT webpage. RRT authorship on a peer reviewed journal article is acceptable for this goal.

4. For each revision cycle of the RRT Manual, participate in at least one aspect of RRT Manual revision. Options include: review chapters to verify content or identify content requiring revision (at least 3 chapters), participate in the national review (review at least 3 chapters), and participate in a chapter committee (at least 1 committee). This goal may not be applicable during each year of the cooperative agreement.

Legislation/other references of authority

National Integrated Food Safety System:

http://www.fda.gov/ForFederalStateandLocalOfficials/ProgramsInitiatives/default.htm

http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/UCM183650.pdf

Food Safety Modernization Act:

http://www.fda.gov/Food/GuidanceRegulation/FSMA/

Full text of the law: http://www.fda.gov/food/guidanceregulation/fsma/ucm247548.htm   

PERFORMANCE MEASURES:

Consistent with the Uniform Guidance, codified at 2 CFR Part 200, an emphasis will be placed on the applicant’s ability to measure progress and track performance using objective, proven, and measurable data.  As such, applicants will propose how they will develop and implement a performance measurement system, plan, and/or process and will carefully consider the Scored Review Criteria listed in Section V of this announcement when submitting their application.

See Section VIII. Other Information for award authorities and regulations.

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

Governments

State Governments

This opportunity is only available to state human and animal food regulatory programs listed below.

Manufactured food regulatory programs, retail food regulatory programs, produce regulatory programs, and animal food regulatory programs that meet the eligibility criteria below may apply for funding under this cooperative agreement. Competition is limited to these programs. Only one application is allowed per state/territory. Jurisdictions interested in involving multiple state/territory entities (within their jurisdiction) should internally coordinate and choose one (1) entity to apply. Eligible state human and animal food regulatory programs should discuss who is best suited to lead development of new RRTs. States that have existing RRTs should continue to maintain their RRTs using the existing manufactured food program lead team and infrastructure developed through prior RRT cooperative agreement investments.

Applicants will be categorized under one of two (2) funding tracks: RRT Development or RRT Maintenance (see eligibility criteria and funding ceilings (maximum amount that may be requested). Within each funding track the applicant may apply for $20,000 in additional funding to subaward to RRT partners. Applicant may apply for up to 3 subawards ($60,000 total) for RRT partners. Applicants applying for subawards for RRT partners must provide within their application how RRT partner recipients will document how the subawards will be used to assist the RRT in meeting program milestones/objectives. This includes information related to the overall RRT budget and Capability Assessment submissions. Progress updates on subaward funded activities must be included in mid-year and end-of-year progress reports.

Applications should reflect a jurisdiction’s needs both in terms of amounts of funding and number of project years. 

To be eligible under the RRT Development track, an applicant must have received less than three (3) years funding under a past RRT/Manufactured Food Regulatory Program Standards (MFRPS) Flexible Funding Model (FFM) cooperative agreement or have never received funding under a RRT cooperative agreement.

Applicants may request up to $300,000/year for this funding option.

 

RRT Development Track
Eligible RRTs receive up to $300,000 per year	Max of 3 years of funding
$20,000 (up to 3 subawards)*
*Subject to availability of federal funds

 

 

 

 

 

To apply for RRT Development, the state human or animal food regulatory program must meet the following eligibility criteria:

Manufactured Food Program eligibility requirements:

Must be in conformance with the Manufactured Food Regulatory Program Standards (MFRPS)

https://www.fda.gov/federal-state-local-tribal-and-territorial-officials/regulatory-program-standards/manufactured-food-regulatory-program-standards-mfrps

• Must have a 20.88 agreement with the FDA or agree to complete a 20.88 agreement with the FDA by the end of grant year one (June 30, 2025)
• Retail Food Program eligibility requirements:
• Retail food code adoptions (must have adopted one of the latest 3 versions); https://www.fda.gov/food/fda-food-code/adoption-fda-food-code-state-and-territorial-agencies-responsible-oversight-restaurants-and-retail 
• Must be in conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS): https://www.fda.gov/food/voluntary-national-retail-food-regulatory-program-standards/listing-jurisdictions-enrolled-voluntary-national-retail-food-regulatory-program-standards

Produce Program eligibility requirements:

• Only Path C grantee agencies may apply
• Must be enrolled in the Produce Regulatory Program Standards (when available)
• Must have a 20.88 agreement with the FDA or agree to complete a 20.88 agreement with the FDA by the end of grant year one (June 30, 2025)

Animal Food Program eligibility requirements: 

• Must be in implementation with the Animal Food Regulatory Program Standards (AFRPS) per last audit. Must have a 20.88 agreement with the FDA or agree to complete a 20.88 agreement with the FDA by the end of grant year one (June 30, 2025).

To be eligible under the RRT Maintenance track, an applicant must have previously received more than three (3) years RRT funding under a past FFM/RRT cooperative agreements.

RRT Maintenance Funding Criteria:

Criteria-based data was used to tier Manufactured Food Programs into three funding levels (Level 1-$150k, Level 2-$225k, or Level 3-$300k). Criteria-based data used: state population, FSMA High Risk Firm Count + Non-High-Risk Firms= state total, and count of multi-state outbreaks the state is involved in (average over past 10 years per CDC's National Outbreak Reporting System (NORS)).

RRT Maintenance Track
Level I $150,000	Level II $225,000	Level III $300,000
$20,000 (up to 3 subawards)*
*Subject to availability of federal funds

Program eligibility requirement:

 

Must be in conformance with Manufactured Food Regulatory Program Standards (MFRPS) per the last audit

Must have a 20.88 agreement with the FDA or agree to complete a 20.88 agreement with the FDA by the end of grant year one (June 30, 2025)

Eligible applicants can apply for optional funding of up to 3 subawards of $20,000 each ($60k

total/RRT) to subaward to response partners.

Manufactured Food Program- RRT Maintenance Funding Ceiling Table
RRT Level 1 Eligible for up to $150,000	RRT Level 2 Eligible for up to $225,000	RRT Level 3 Eligible for up to $300,000
Mississippi	Connecticut	California
Rhode Island	Georgia	Florida
West Virginia	Indiana	Michigan
	Iowa	Minnesota
	Kansas	New York
	Kentucky	Pennsylvania
	Maryland	Texas
	Massachusetts	Wisconsin
	Missouri
	North Carolina
	South Carolina
	Utah
	Virginia
	Washington

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 HHS Grants Policy Statement, are not allowed.

Applicant Organizations

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 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 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.
• 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.

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. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This NOFO does not require cost sharing as defined in the HHS Grants Policy Statement.

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 2.3.7.4 Submission of Resubmission Application. 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 (A1) application.
• 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

 

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.

Applicants must download the application package associated with the Track (RRT Maintenance or RRT Development) they are applying for by referencing the COMPETITION ID field. The COMPETITION ID field will state:

• RRT Development
• RRT Maintenance

It is critical that applicants follow 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 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 IC 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:

Terrin Brown
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: Terrin.Brown@fda.hhs.gov

A technical session will be held for prospective applicants in February/March 2024. The conference call information will be provided to prospective applicants that submit a letter of intent.  The technical session will provide an overview of the submission requirements and allow prospective applicants an opportunity to ask questions regarding the application process.  Participation in the technical session is optional, but strongly encouraged. 

All page limitations described in the How to Apply Application Guide and the Table of Page Limits must be followed.

For this specific FOA, the Research Strategy section is limited to 30 pages.

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 SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Descriptive Title of Applicant's Project: Applicants must include the Track Name (RRT Maintenance or RRT Development) and State Organization Name/Abbreviation in the Project Title.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.
• If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission.  This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.
• If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed.  MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract.  MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward and subcontract in excess of $25,000.
• RRT budget information should include personnel (e.g., human and animal food regulatory, epidemiologist, lab etc.), supplies and equipment, travel, training, and any budgeting for special projects and contractors.
• Budgets should take into consideration sending at least 2 key RRT personnel to an annual face-to-face meeting (as determined by the FDA/OP) and at least 1 person representing the RRT to the biennial Integrated Foodborne Outbreak Response Management (InFORM) conference (held in odd number years) and the Regional PulseNet/OutbreakNet meetings (held in non-InFORM years).
• RRT partner programs that receive subaward funding must develop a budget and send at least one (1) representative to the RRT Annual meeting. 

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy must address the following:

For RRT Development Applicants

Demonstrate adequate need for advanced capacity and capabilities to respond to all hazards HAF emergencies, as evidenced by: average number of natural disasters affecting HAF firm operations; average number of recalls of HAF commodities resulting from firms in the state or with distribution in the state (by class); average number of HAF outbreaks (especially those involving the FDA regulated commodities) where there were illnesses or distribution/processing/production of the contaminated product in the state.

Describe how the applicant agency plans to work with Federal/State/Local RRT member agencies/partners to develop, share and operationalize capacity/capabilities to rapidly respond to all-hazards HAF emergencies (with the ultimate goal of shortening the time between agency notification and implementation of effective control measures), as well as supporting surveillance and post-response/prevention activities.

For RRT Maintenance Applicants

Submit most recent RRT Capability Assessment Tool and Activity Table as appendix 1.

Demonstrate the impact/benefit/effectiveness of the RRT for real-life HAF incidents (outbreaks, natural disasters and other contamination events). Specifically, demonstrate that the RRT consistently: 1) utilizes the RRT in activation (ICS) mode to respond to real-life HAF contamination events; 2) conducts multi-agency/multi-disciplinary investigations, particularly on-site investigations and environmental assessments to document contributing factors and environmental antecedents; 3) documents lessons learned and other investigation findings in After Action Reviews.

Describe how lessons learned and investigation findings have been cycled back into process improvement or prevention efforts (e.g., training for investigators, updating procedures, outreach/education for industry, publishing investigation findings for academia, industry and other public health partners to learn from).

Describe steps taken or planned to shorten the time between agency notification of an incident and implementation of effective control measures.

As a part of your application (for RRT Development and RRT Maintenance Applicants), applicants should explain how they intend to measure performance if their application is funded. This should include Acceptable Quality Levels as well as Public Health Measures that are SMART:

Specific (specific, sensible, significant)

Measurable (meaningful, motivating)

Achievable (agreed, attainable)

Relevant (reasonable, realistic and resourced, results-based)

Time-Bound (time-based, time limited, time/cost limited, timely, time sensitive)

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide and the additional instructions below.

For RRT Maintenance Applicants:

• Submit most recent RRT Capability Assessment Tool and Activity Table as appendix 1.

When involving human subjects research, clinical research, and/or NIH-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 form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

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 SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

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

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, NIH’s electronic system for grants administration. NIH 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 2.3.9.2 Electronically Submitted Applications.

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.

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.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

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

Important reminders:

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 NIH. 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 Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

 

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Only the review criteria described below will be considered in the review process.

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.

Is the proposed budget relevant and impactful towards achieving the goals of the cooperative agreement?

Has the applicant established relationships with partners in other, relevant organizations (e.g.,

letters of support/commitment from animal food program, laboratory and epidemiology programs;

steps taken to date to establish a RRT structure/membership) to collaborate as a multi-

jurisdictional, multi-disciplinary RRT to respond to all hazards HAF emergencies?

Does the applicant have a plan in place to work with Federal/State/Local RRT member

agencies/partners to develop, share and operationalize capacity/capabilities to rapidly respond to

all-hazards HAF emergencies (with the ultimate goal of shortening the time between agency

notification and implementation of effective control measures), as well as supporting surveillance

and post-response/prevention activities? Does the applicant demonstrate adequate need for

advanced capacity and capabilities to respond to all hazards HAF emergencies, as evidenced by:

average number of natural disasters affecting HAF firm operations; average number of recalls of

HAF commodities resulting from firms in the state or with distribution in the state (by class);

average number of HAF outbreaks (especially those involving the FDA regulated commodities)

where there were illnesses or distribution/processing/production of the contaminated product in

the state?

Is the proposed budget relevant and impactful towards achieving the goals of the cooperative

agreement?

Does the applicant demonstrate, strong relationships with Federal/State/Local RRT member

agencies/partners and commitment from these member agencies/partners to collaborate as a

multi-jurisdictional, multi-disciplinary RRT to respond to all hazards HAF emergencies (e.g.,

letters of support/commitment, description of current level of engagement and working

relationship, etc.)? Particular importance should be stressed on relationships with core RRT

member agencies: the FDA Division Office, State Food Regulatory Programs (all commodity

areas), State Feed Regulatory Programs, State Epidemiology Programs and State Laboratory

Programs; as well as key auxiliary RRT member agencies: Local Agencies, State Veterinarian’s

Office/Board of Animal Health, etc.

Does the applicant adequately demonstrate the impact, benefit, and effectiveness of the RRT for

real-life HAF incidents (outbreaks, natural disasters and other contamination events)?

Specifically, does the RRT consistently: 1) utilize the RRT in activation (ICS) and response (non-

ICS) mode to respond to real-life HAF contamination events (e.g., number of responses and

activations); 2) conduct multi-agency/multi-disciplinary investigations, particularly on-site

investigations and environmental assessments to document contributing factors and

environmental antecedents (e.g., number of joint investigations); 3) document lessons learned

and other investigation findings in After Action Reviews (e.g., number of After Action Reports)?

Does the applicant describe how these lessons learned and investigation findings have been cycled

back into process improvement or prevention efforts (e.g., training for investigators, updating

procedures, outreach/education for industry, publishing investigation findings for academia,

industry and other public health partners to learn from)? Does the applicant describe steps taken

or planned to shorten the time between agency notification of an incident and implementation of

effective control measures?

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 these items.

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 committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the 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) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not Applicable

Not Applicable

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review Committee, using the stated review criteria.

As part of the objective review, all applications:

• Will receive a written critique.

Appeals of objective review will not be accepted for applications submitted in response to this NOFO.

Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by objective review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

Successful applicants will be notified of additional information that may be required for other actions leading to an award. The decision not to award a grant or to award a grant at a particular funding level, is discretionary and is not subject to appeal to any FDA or HHS official or board.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient’s business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found in the HHS Grants Policy Statement. 

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA.

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website.

HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Additional Reporting Requirements:

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the Notice of Award (NOA). All progress reports shall contain certain elements as applicable to their approved cooperative agreement and award.

All FDA grants require annual performance progress reporting. This award has additional performance reporting requirements as outlined below.

Performance

In addition to the annual RPPR, RRTs are required to submit a mid-year progress report describing status of completing each milestone/objective.

Progress updates on subaward funded activities must be included in mid-year and end-of-year progress reports.

Mid-Year and Annual Program reports are required. In accordance with 5 CFR 1320.5(b), the approved OMB CONTROL NUMBER: 0910-0909 will be displayed on all the required forms used by grantees to report information and data for this cooperative agreement program, including but not limited to: RRT Program Report (excel workbook)

In addition to meeting the yearly milestones/objectives, recipients should participate in initiatives supporting the RRT Program, including sending at least 2 key RRT personnel to an annual face-to-face meeting (as determined by the FDA/OP) and at least 1 person representing the RRT to the biennial Integrated Foodborne Outbreak Response Management (InFORM) conference (held in odd number years) and the Regional PulseNet/OutbreakNet meetings (held in non-InFORM years). RRT partner programs that receive subaward funding should develop a budget, provide updates in the RPPR on how the funding was used, and send at least one (1) representative to the RRT Annual meeting.  RRTs should participate in the FoodSHIELD workgroup, RRT monthly conference calls, sharing best practices, and other RRT Program activities identified by OP.

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the HHS Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

 

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Thanh Andrews
Office of Regulatory Affairs
Office of Partnerships (OP), Division of Partnership Investments and Agreements
U.S. Food and Drug Administration
Email: thanh.andrews@fda.hhs.gov

Laurie Keppley
Office of Regulatory Affairs
Office of Partnerships (OP), Division of Partnership Investments and Agreements
U.S. Food and Drug Administration
Email: laurie.keppley@fda.hhs.gov

Terrin Brown
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: Terrin.Brown@fda.hhs.gov)

Terrin Brown
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Email: Terrin.Brown@fda.hhs.gov

Recently issued policy notices may affect your application submission. A full list of policy notices published in the Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grantchans Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.