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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
BackgroundTo 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.FDA initiated a partnership with state and territory agencies in 2016 through June 2021 via the cooperative agreements under PAR-16-13 7. 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).Program StructureGrantee 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.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.Objectives are outlined according to Program Path.Objectives for Assessment and Planning; Program Administration; Education, Outreach, and Technical Assistance; and Farm Inventory are applicable to all grantees, as outlined.
All applicants MUST choose only one Program Path (A, B, or C) 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. 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. 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.
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.FDA initiated a partnership with state and territory agencies in 2016 through June 2021 via the cooperative agreements under PAR-16-13 7. 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).Program StructureGrantee 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.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.Objectives are outlined according to Program Path.Objectives for Assessment and Planning; Program Administration; Education, Outreach, and Technical Assistance; and Farm Inventory are applicable to all grantees, as outlined.
All applicants MUST choose only one Program Path (A, B, or C) 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. 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. 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.
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Estimated Funding: $35,000,000
Office: Food and Drug Administration
Estimated Funding: $35,000,000
Who's Eligible
Obtain Full Opportunity Text:
Full Announcement for PAR-20-174on NIH Guide for Grants and Contracts
Additional Information of Eligibility:
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
Full Opportunity Web Address:
https://grants.nih.gov/grants/guide/pa-files/PAR-21-174.html
Contact:
Agency Email Description:
gordana.zuber@fda.hhs.gov
Agency Email:
Date Posted:
2021-02-18
Application Due Date:
Archive Date:
2023-03-02
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