Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration (FDA)

NOTE:  The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.  Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA.

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

Office of Regulatory Affairs (ORA)

Funding Opportunity Title

Development and Maintenance of Human and Animal Food Rapid Response Teams (U2F) Clinical Trials Not Allowed

Activity Code

U2F Food Safety Capacity and Infrastructure Building

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-FD-23-019

Companion Funding Opportunity

None

Assistance Listing Number(s)

93.103  

Funding Opportunity Purpose

The purpose of this FOA is to develop and maintain Rapid Response Teams (RRTs) to facilitate long-term improvements and innovation to the national integrated food safety system by unifying and coordinating federal/state/local human and animal food (HAF) emergency response efforts including:

1) Strengthening the link among epidemiology, lab and environmental health/regulatory components;

2) Improving States' regulatory and surveillance HAF protection programs to include using Incident Command System (ICS)/National Incident Management System (NIMS) principles and a Unified Command structure to conduct integrated responses to all-hazards HAF emergencies, rapidly identifying and removing tainted food from commerce, and conducting root cause investigations to inform future prevention efforts; and

3) Addressing supporting components, such as training, data sharing, data analysis, communications, continuous process improvement, and development of best practices and other resources to support national response capacity/capability development.

Key Dates
Posted Date

January 26, 2023

Open Date (Earliest Submission Date)

January 26, 2023

Letter of Intent Due Date(s)

March 14, 2023

Application Due Date(s)

April 14, 2023, by 11:59 PM Eastern Time.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date. 

 

Late applications will not be accepted for this FOA.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May 2023

Advisory Council Review

Not Applicable

Earliest Start Date

July 2023

Expiration Date

April 15, 2023

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. 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.


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.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. 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.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. 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. Funding Opportunity Description

    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 Rapid Response Teams (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), their corresponding 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

    The RRT milestones/objectives below must be achieved each grant year. These RRT milestones/objectives are in aligned 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 of team members, and development of 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 must include ICS elements and standing up and 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 shall be shared with 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 are optional based on the state program funding tier as described below.

    Maintenance and Continuous Program Improvement (All Sub-Parts Required)

    1. Maintain the RRT: SOPs must 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: Must Have 2 Distinct Projects Per Year; Level 2 RRTs: Must Have 1 Project Per Year; Level 1 RRTs: No Requirement)

    1. Mentor a voluntary RRT (must be assigned by 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, District-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 is Required for all RRTs; Level 3 RRTs: Must Have 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: 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 (All Sub-Parts Required)

    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.

    Applicants must review and address these yearly RRT milestones/objectives within their application and provide mid-year and end-of-year progress report updates each grant year.

    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.

    Section II. Award Information
    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    New

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    Clinical Trial?

    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 for two (2) additional year(s) contingent upon annual appropriations, availability of funding and satisfactory recipient performance.

    FDA/ORA intends to commit up to $8,025,000 for fiscal year 2023 to fund up to 25 awards not to exceed $360,000 in total costs (direct plus indirect), per award in support of this program.

    Award Budget

    Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

    YR 01: $360,000

    YR 02: $360,000

    YR 03: $360,000

    Applicants must refer to Section III Eligibility Information to determine which funding track they should apply for: RRT Development or RRT Maintenance and the funding limits.

    Award Project Period

    The scope of the proposed project should determine the project period. The maximum project period is 3 years.

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    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. RRT partner recipients of subawards must agree to document how the subawards are 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.

    Applicants are encouraged to apply for cooperative agreement assistance that reflects their jurisdiction’s needs both in terms of amounts of funding and number of project years. 

    Funding Track 1: RRT Development

    Received less than three (3) years funding under a past RRT/FFM cooperative agreement or have never received 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

    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 FDA or agree to complete a 20.88 agreement with FDA by the end of grant year one (June 30, 2024)

    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 FDA or agree to complete a 20.88 agreement with FDA by the end of grant year one (June 30, 2024).
    Funding Track 2: RRT Maintenance

    Previously received more than three (3) years RRT funding under a past FFM/RRT cooperative agreements.

    RRT Maintenance Funding Criteria:

    Manufactured Food

    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 FDA or agree to complete a 20.88 agreement with FDA by the end of grant year one (June 30, 2024)

    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

    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) 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.

    Required Registrations

    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.

    • 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.
    • o   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. 
    • o   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 full SAM and 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 his/her 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 FDA 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.

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

    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.

     

    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 FOA. 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
    2. Content and Form of Application Submission

    It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    Letter of Intent

    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), email 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:

    Janelle Fundersburg, Grants Management Specialist
    Email: Janelle.fundersburg@fda.hhs.gov

    A technical session will be held for prospective applicants in February/March 2023. 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. 

    Page Limitations

    All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

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

    Instructions for Application Submission

    The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

    SF424(R&R) Cover

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

    11. 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.    

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    SF424(R&R) Senior/Key Person Profile

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

    R&R Budget

    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 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. 
    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

    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 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.

    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.

    Appendix:

    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.
    PHS Human Subjects and Clinical Trials Information

    When involving human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed 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.

    PHS Assignment Request Form

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

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

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

    4. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

    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. eRA Commons 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. Late applications will not be accepted for this FOA.

    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 SF424 (R&R) Application Guide.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

    All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement and 45 CFR 75, 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.

    Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

    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 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. 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 FDA. See Section III of this FOA 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 assigned Grants Management Specialist and responsiveness by components of participating organizations, FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

     

    Post Submission Materials

    Post-submission materials are those submitted after submission of the grant application but prior to objective review. They are not intended to correct oversights or errors discovered after submission of the application. FDA accepts limited information between the time of initial submission of the application and the time of objective review.  Applicants must contact the assigned Grants Management Specialist to receive approval, prior to submitting any post submission materials. Acceptance and/or rejection of any post submission materials is at the sole discretion of the FDA. Any inquiries regarding post submission materials should be directed to the assigned Grants Management Specialist.

    Section V. Application Review Information
    1. Criteria

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

    Scored Review Criteria

    Reviewers will consider each of the review criteria below in the determination of scientific/technical merit.

    RRT Development Scored Criteria

    Effective Use of Grant Funds (10 Points): 

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

    Established Relationships (40 points): 

    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?

    RRT Effectiveness (50 points): 

    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 FDA regulated commodities) where there were illnesses or distribution/processing/production of the contaminated product in the state?

    RRT Maintenance Scored Criteria

    Effective Use of Grant Funds (10 Points):

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

    Established Relationships (40 points): 

    Does the applicant demonstrate mature, 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: FDA District 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.

    RRT Effectiveness (50 points): 

    Does the applicant adequately demonstrate the impact/benefit/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?

    Additional Review Considerations

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

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the  categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

    For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the 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.

    Inclusion of Women, Minorities, and Individuals Across the Lifespan 

    When the proposed project involves human subjects and/or 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.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    Biohazards

    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.

    Resubmissions

    Not Applicable

    Renewals

    Not Applicable

    Revisions

    Not Applicable

    Select Agent Research

    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).

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

    Authentication of Key Biological and/or Chemical Resources:

    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.

    2. Review and Selection Process

    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 FOA.

    Applications will compete for available funds with all other recommended applications submitted in response to this FOA. 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.
    3. Anticipated Announcement and Award Dates

    Successful applicants will be notified of additional information that may be required or 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.

    Section VI. Award Administration Information
    1. Award Notices

    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.5. Funding Restrictions and in the Notice of Award. 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 FOA will be subject to terms and conditions found in the HHS Grants Policy Statement, this FOA, and Notice of Award.   

    Institutional Review Board or Independent Ethics Committee Approval: For projects that involve Human Subjects and/or Clinical Trials Research, Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in FDA-funded studies, the recipient must provide FDA copies of documents related to all major changes in the status of ongoing protocols.

    2. Administrative and National Policy Requirements

    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.

    Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy).  This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities.  The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS.  Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

    HHS recognizes that 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 FDA grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

    Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.   

    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), FDA 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 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all FDA grants and cooperative agreements.

    FDA considers the sharing of research resources developed through FDA-sponsored research an important means to enhance the value and further the advancement of research. When research resources have been developed with FDA funds and the associated research findings published, those findings must be made readily available to the scientific community.

    Upon acceptance for publication, scientific researchers must submit the author’s final manuscript of the peer-reviewed scientific publication resulting from research supported in whole or in part with FDA funds to the NIH National Library of Medicine's (NLM) PubMed Central (PMC). FDA defines the author's final manuscript as the final version accepted for journal publication, which includes all modifications from the publishing peer review process. The PMC archive is the designated repository for these manuscripts for use by the public, health care providers, educators, scientists, and FDA. Please see the FDA Public Access Policy.

    Termination provisions in 2 CFR 200.340 (a) (1-4) are applicable to awards issued under this Notice of Funding Opportunity.

    Additional terms and conditions regarding FDA regulatory and ORA programmatic requirements may be part of the Notice of Award.

    Standard Terms and Conditions of Award

    Reporting Requirements:

    All FDA grants require both Financial and Performance reporting.

    Financial Reporting:

    A. Financial Expenditure Reports

    A required Federal Financial Report (FFR) must be submitted annually. All annual FFRs must be submitted electronically using the Payment Management System (PMS). This includes all initial FFRs being prepared for submission and any revised FFRs being submitted or re-submitted to FDA. Paper expenditure/FFR reports will not accepted.

    Annual FFRs must be submitted for each budget period no later than 90 days after the end of the calendar quarter in which the budget period ended. The reporting period for an annual FFR will be that of the budget period for the particular grant; however, the actual submission date is based on the calendar quarter. If a grant is under expanded authorities, the grantee must indicate the carryover amount in Section 12. Remarks of the annual FFR.

    Performance Progress Reporting:

    When multiple years (more than one budget period) are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually as required in the Notice of Award. Annual RPPRs must be submitted using the RPPR module in eRA Commons.  The annual RPPR must include a detailed budget.  Annual RPPRs are due no later than 60 days prior to the start of the next budget period.

    Failure to submit timely reports may affect future funding. Additional Financial and Performance Progress reports may be required for this award. Any additional reporting requirements will be listed under Section IV – Special Terms and Condition of the Notice of Award.

    Salary Caps:

    None of the funds in this award shall be used to pay the salary of an individual at a rate in excess

    of the current Executive Level II of the Federal Executive Pay Scale.

    Certificates of Confidentiality – 42 U.S.C. 241(d)

    Recipients are responsible for complying with all requirements to protect the confidentiality of identifiable, sensitive information that is collected or used in biomedical, behavioral, clinical, or other research (including research on mental health and research on the use and effect of alcohol and other psychoactive drugs) funded wholly or in part by the Federal Government.  See 42 U.S.C. 241(d).  All research funded by FDA, in whole or in part, that is within the scope of these requirements is deemed to be issued a “Certificate of Confidentiality” through these Terms and Conditions.   Certificates issued in this manner will not be issued as a separate document. 

    Recipients are expected to ensure that any investigator or institution not funded by FDA who receives a copy of identifiable, sensitive information protected by these requirements, understand they are also subject to the requirements of 42 U.S.C. 241(d).  Recipients are also responsible for ensuring that any subrecipient that receives funds to carry out part of the FDA award involving a copy of identifiable, sensitive information protected by these requirements understand they are also subject to subsection 42 U.S.C. 241(d).

    Acknowledgment of Federal Support:

    When issuing statements, press releases, publications, requests for proposal, bid solicitations and other documents --such as tool-kits, resource guides, websites, and presentations (hereafter “statements”)--describing the projects or programs funded in whole or in part with FDA federal funds, the recipient must clearly state:

    1. the percentage and dollar amount of the total costs of the program or project funded with federal money; and,

    2. the percentage and dollar amount of the total costs of the project or program funded by non-governmental sources.

    When issuing statements resulting from activities supported by FDA financial assistance, the recipient entity must include an acknowledgement of federal assistance using one of the following statements.

    If the FDA Grant or Cooperative Agreement is NOT funded with other non-governmental sources:

    This [project/publication/program/website, etc.] [is/was] supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $XX with 100 percent funded by FDA]/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

    If the FDA Grant or Cooperative Agreement IS partially funded with other nongovernmental sources:

    This [project/publication/program/website, etc.] [is/was] supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $XX with XX percentage funded by FDA/HHS and $XX amount and XX percentage funded by non-government source(s). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

    The federal award total must reflect total costs (direct and indirect) for all authorized funds (including supplements and carryover) for the total competitive segment up to the time of the public statement.  Any amendments by the recipient to the acknowledgement statement must be coordinated with FDA.  If the recipient plans to issue a press release concerning the outcome of activities supported by FDA financial assistance, it should notify FDA in advance to allow for coordination.

    Additional prior approval requirements pertaining to Acknowledgement of Federal Support, publications, press statements, etc. may be required, and if applicable, will be listed under Section IV – Special Terms and Condition of the Notice of Award.

    Prior Approval:

    All prior approval requests must be submitted using the Prior Approval module in eRA Commons.  Any requests involving budgetary issues must include a new proposed budget and a narrative justification of the requested changes. If there are any questions regarding the need or requirement for prior approval for any activity or cost, the grantee is to contact the assigned Grants Management Specialist prior to expenditure of funds.

    For grant awards not covered under Expanded Authorities, Carryover and No Cost Extension (NCE) requests will require prior approval.  All Carryover and NCE requests should be submitted using the Prior Approval module in eRA Commons.  ****Please review the section on Expanded Authorities to determine if this award is covered/not covered under Expanded Authorities and whether prior approval is needed for carryover and no cost extension requests.****

    The following activities require prior approval from FDA on all awards:

    1.         Change in Grantee Organization

    2.         Significant Rebudgeting

    3.         Change in Scope or Objectives

    4.         Deviation from Terms and Conditions of Award

    5.         Change in Key Personnel which includes replacement of the PD/PI or other key personnel as specified on the NoA.

    6.         Disengagement from the project for more than three months, or a 25 percent reduction in time devoted to the project, by the approved PD/PI. No individual may be committed to more than 100% professional time and effort. In the event that an individual's commitment exceeds 100%, the grantee must make adjustments to reduce effort. For FDA-sponsored projects, significant reductions in effort (i.e., in excess of 25% of the originally proposed level of effort) for the PD/PI and key personnel named on named on this Notice of Award must receive written prior approval from FDA.

    Additional prior approval requirements may be required for this award, and if applicable, will be listed under Section IV – Special Terms and Condition of the Notice of Award.

    Audits and Monitoring:

    Audit Requirements:

    1.         Recipients of Federal funds are subject to annual audit requirements as specified in 45 CFR 75.501 (https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=8040c4036b962cc9d75c3638dedce240&ty=HTML&h=L&r=PART&n=pt45.1.75#se45.1.75_1501). Grantees should refer to this regulation for the current annual Federal fund expenditure threshold level which requires audit.

    2.         Foreign recipients are subject to the same audit requirements as for-profit organizations (specified in 45 CFR 75.501(h) through 75.501(k).

    3.         For-profit and foreign entities can email their audit reports to AuditResolution@hhs.gov or mail them to the following address:

    U.S. Department of Health and Human Services

    Audit Resolution Division, Room 549D

    Attention: Robin Aldridge, Director

    200 Independence Avenue, SW

    Washington, DC 20201

    Monitoring:

    Recipients are responsible for managing the day-to-day operations of grant-supported activities using their established controls and policies, as long as they are consistent with Federal, DHHS and FDA requirements. However, to fulfill their role in regard to the stewardship of Federal funds, FDA monitors our grants to identify potential problems and areas where technical assistance might be necessary. This active monitoring is accomplished through review of reports and correspondence from the recipient, audit reports, site visits, and other information available to FDA.

    1.         Desk review: FDA grants monitoring specialists will periodically reach out to recipients to request information for the completion of desk reviews. Requested information may include:

    •          Policies and procedures

    •          List of grant expenditures

    •          Accounting records

    •          Supporting documents (e.g., invoices, receipts, paystubs, timesheets, contracts, etc.)

    •          Financial statements

    •          Audit reports

    •          Other related documentation

    2.         Site visits: FDA will conduct site visits when necessary and will notify the recipient with reasonable advance notice of any such visit(s).

    3.         Foreign entities: All Foreign entities are subject to the same monitoring requirements as domestic entities.  Foreign entities covered under immunity Executive Orders will provide supporting documents for monitoring requirements unless such an action is a violation of the Executive Orders. Recipients may discuss with the FDA to come up with an alternate approach to satisfy the award monitoring requirements.

    All recipients will make reasonable efforts to resolve issues found, including audit findings. Successful resolutions to issues are important as they are part of the grant performance review. All recipients are responsible for submitting all requested information in an expeditious manner.  Failure to submit timely reports and/or respond to inquiries from FDA may affect future funding or enforcement actions, including withholding, or conversion to a reimbursement payment method.

    Financial Conflict of Interest (FCOI):

    This award is subject to the Financial Conflict of Interest (FCOI) regulation at 42 CFR Part 50 Subpart F.

    Closeout Requirements (when applicable):

    A Final Research Performance Progress Report (FRPPR), Final Invention Statement HHS-568 (if applicable), Tangible Personal Property Report SF-428 (if applicable), and Statement of Disposition of Equipment (if applicable) must be submitted within 120 days after the expiration date of the project period.  All closeout documents must be submitted electronically in eRA Commons.

    The Final Federal Financial Report (FFR SF-425), must be submitted in PMS and indicate the exact balance of unobligated funds and may not reflect unliquidated obligations. There must be no discrepancies between the Final FFR expenditure data and FFR cash transaction data in the Payment Management System (PMS). The expended funds reported on the Final FFR must exactly match the disbursements and the charge advances in PMS.  It is the recipient's responsibility to reconcile reports submitted to PMS and to the FDA.

    Program Income:

    The grantee is required to report any Program Income generated during the Project Period of this grant. Except for royalty income generated from patents and inventions, the amount and disposition of Program Income must be identified on lines 10 (l), (m), (n), and (o) of the grantee’s Federal Financial Report (FFR) SF-425.

    Examples of Program Income include (but are not limited to): fees for services performed during the grant or sub-grant period, proceeds from sale of tangible personal or real property, usage or rental fees, patent or copyright royalties, and proceeds from the sale of products and technology developed under the grant.

    Any Program Income generated during the Project Period of this grant by the grantee or sub-grantee will be treated as identified below.

    Treatment of Program Income:

    Prohibition on certain telecommunications and video surveillance services or equipment:

    (a) As described in CFR 200.216, recipients and subrecipients are prohibited to obligate or spend grant funds (to include direct and indirect expenditures as well as cost share and program) to:

    (1) Procure or obtain,

    (2) Extend or renew a contract to procure or obtain; or

    (3) Enter into contract (or extend or renew contract) to procure or obtain equipment, services, or systems that use covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. As described in Pub. L. 115-232, section 889, covered telecommunications equipment is telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (or any subsidiary or affiliate of such entities).

    i. For the purpose of public safety, security of government facilities, physical security surveillance of critical infrastructure, and other national security purposes, video surveillance and telecommunications equipment produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities).

    ii. Telecommunications or video surveillance services provided by such entities or using such equipment.

    iii. Telecommunications or video surveillance equipment or services produced or provided by an entity that the Secretary of Defense, in consultation with the Director of the National Intelligence or the Director of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise, connected to the government of a covered foreign country.

    Other:

    This award is subject to the requirements of 2 CFR Part 25 for institutions to maintain an active registration in the System of Award Management (SAM). Should a consortium/subaward be issued under this award, a requirement for active registration in SAM must be included.

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts with cumulative total value greater than $10,000,000 must report and maintain information 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 the Federal Awardee Performance and Integrity Information System (FAPIIS)). Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75.

    You must administer your project in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes taking reasonable steps to provide meaningful access to persons with limited English proficiency and providing programs that are accessible to and usable by persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/providerobligations/index.html and  https://www.hhs.gov/civil-rights/forindividuals/nondiscrimination/index.html.

    Special Terms and Conditions of Award

    Additional Reporting Requirements:

    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.

    Cooperative Agreement Terms and Conditions of Award

    In addition to meeting the yearly milestones/objectives, recipients must 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 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, provide updates in the RPPR on how the funding was used, and send at least one (1) representative to the RRT Annual meeting.  RRTs must participate in the FoodSHIELD workgroup, RRT monthly conference calls, sharing best practices, and other RRT Program activities identified by OP.

    3. Reporting

    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. RRTs must provide a mid-year report describing status of completing milestones/objectives as well.

    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 terms and conditions of award and the HHS Grants Policy Statement. FDA FOAs outline intended goals and objectives. Post award, FDA will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), 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 FDA 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.

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 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 45 CFR Part 75 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

    Section VII. Agency Contacts

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

    Application Submission Contacts

    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://grants.nih.gov/support/index.html(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

    Program Contact(s)

    Hunter Herrman, Management and Program Analyst

    Office of Management (OM)

    Food and Drug Administration

    Telephone 240-402-3102

    Email: Hunter.Herrman@fda.hhs.gov

    Jocelyn T. Ramos

    Office of Regulatory Affairs

    Office of Partnerships (OP), Division of Partnership Investments and Agreements

    U.S. Food and Drug Administration

    Telephone: 510-337-6894

    Email: Jocelyn.Ramos@fda.hhs.gov

    James R. Betz, MPH, CPH

    Office of Regulatory Affairs

    Office of Partnerships (OP), Division of Partnership Investments and Agreements

    U.S. Food and Drug Administration

    Telephone: 843-642-6190

    Email: James.Betz@fda.hhs.gov

    Objective Review Contact(s)

    Janelle Fundersburg

    Office of Acquisitions, Grants, and Services (OAGS)

    Division of Grants, Agreements, and Acquisitions Support

    U.S. Food and Drug Administration

    Telephone: 301-796-2533

    Email: Janelle.Fundersburg@fda.hhs.gov

    Financial/Grants Management Contact(s)

    Janelle Fundersburg

    Office of Acquisitions, Grants, and Services (OAGS)

    Division of Grants, Agreements, and Acquisitions Support

    U.S. Food and Drug Administration

    Telephone: 301-796-2533

    Email: Janelle.Fundersburg@fda.hhs.gov

    Section VIII. Other Information

    All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement, Notice of Award, and 45 CFR 75, 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 .

    Authority and Regulations

    Awards are made under the authorization of section 1009 of the Federal Food, Drug, and Cosmetic Act (21 USC 399) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.

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