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The FDA's Cooperative Agreement Program for States and Territories to Implement a National Produce Safety Program (U2F) Clinical Trials Not Allowed

ID: PAR-21-174 • Type: Posted
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Description

  1. Background
  2. To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA) has established science-based minimum standards for the safe growing, harvesting, packing, and holding of produce raw agricultural commodities grown for human consumption. FDA established these standards in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, referred to as the Produce Safety Rule under 21 CFR Part 112, as part of the implementation of the FDA Food Safety Modernization Act (FSMA). Additionally, FSMA explicitly recognizes that all food safety agencies need to work together in an integrated way to achieve our public health goals.
  3. FDA initiated a partnership with state and territory agencies in 2016 through June 2021 via the cooperative agreements under PAR-16-137. That Cooperative Agreement Program provided technical and financial assistance to state and territorial agencies to develop and implement multi-faceted Produce Safety Programs that support implementation of the Produce Safety Rule and the FDA Food Safety Modernization Act (FSMA).
  4. Program Structure
  5. Grantee agencies of this cooperative agreement program (CAP) will establish and maintain a Produce Safety Program within their jurisdiction with the overarching purpose to enhance produce safety and achieve high rates of compliance with the FDA's Produce Safety Rule. The objectives of this CAP are holistically intended to guide grantee Produce Programs that are focused on quality and national consistency.
  6. Grantees are to choose one of three Program Path options. The Program Path selected by the grantee primarily distinguishes how they choose to accomplish a Produce Safety regulatory program.
  7. Objectives are outlined according to Program Path.
  8. Objectives for Assessment and Planning; Program Administration; Education, Outreach, and Technical Assistance; and Farm Inventory are applicable to all grantees, as outlined.
  9. All applicants MUST choose only one Program Path (A, B, or C)
  10. PATH A: Jurisdictions that will not conduct produce safety inspections (non-regulatory programs) but will complete other applicable program objectives. Path A grantees are responsible for completing all items under Program Objectives 1, 2, 3, and 4.
  11. PATH B: Jurisdictions that will conduct produce safety inspections under FDA's authority and will complete other applicable program objectives. Path B grantees are responsible for completing all items under Program Objectives 1, 2, 3, 4, 5, 6, and 7.
  12. PATH C: Jurisdictions that will conduct produce safety inspections under their own authority and will complete other applicable program objectives. Path C grantees are responsible for completing all items under Program Objectives 1, 2, 3, 4, 5, 6, and 7.
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Overview

Agency
Food and Drug Administration (FDA) [HHS]
Category of Funding
Agriculture
Consumer Protection
Food and Nutrition
Funding Instruments
Cooperative Agreement
Grant Program (CFDA)
93.103 - Food and Drug Administration Research
Grant Category
Discretionary
Cost Sharing / Matching Requirement
False
Source
Grants.gov
On 2/18/21 Food and Drug Administration posted grant opportunity PAR-21-174 for The FDA's Cooperative Agreement Program for States and Territories to Implement a National Produce Safety Program (U2F) Clinical Trials Not Allowed with funding of $35.0 million. The grant will be issued under grant program 93.103 Food and Drug Administration Research. It is expected that 56 total grants will be made.

Timing

Posted Date
Feb. 18, 2021, 12:00 a.m. EST
Closing Date
March 1, 2023, 12:00 a.m. EST Past Due
Closing Date Explanation
This FOA has multi-application due dates: April 23, 2021, by 11:59 PM Eastern Time; March 1, 2022, by 11:59 PM Eastern Time; March 1, 2023, by 11:59 PM Eastern Time
Last Updated
March 11, 2021, 3:39 p.m. EST
Version
7
Archive Date
March 2, 2023

Eligibility

Eligible Applicants
State governments
Additional Info
State Governments U.S. Territory or Possession American Samoa (AS) Commonwealth of the Northern Mariana Islands (CNMI) Guam (GU) Puerto Rico (PR) Virgin Islands (VI) Washington District of Columbia (DC) This opportunity is available only to state and territory government agencies with actual or potential regulatory oversight and responsibility over their respective jurisdiction’s farms, produce commodities, and activities covered under FDA's Produce Safety Rule (21 CFR Part 112).Only one application is allowed per state or territory. Jurisdictions interested in involving multiple state or territory entities within their jurisdiction are required to internally coordinate and choose one entity to apply

Award Sizing

Ceiling
$12,500,000
Floor
Not Listed
Estimated Program Funding
$35,000,000
Estimated Number of Grants
56

Contacts

Contact
Gordana Zuber Grant Management Specialist
Contact Email
gordana.zuber@fda.hhs.gov   Profile
Contact Phone
(301) 348-1747
Additional Information
Full Announcement for PAR-20-174 on NIH Guide for Grants and Contracts
Additional Information Site
https://grants.nih.gov/grants/guide/pa-files/PAR-21-174.html

Documents

Posted documents for PAR-21-174

Grant Awards

Grants awarded through PAR-21-174

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