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Animal Feed Regulatory Program Standards (AFRPS) Maintenance and the Enhancement of Current Good Manufacturing Practices (cGMP) and Preventive Controls for Animal Food Regulatory (PCAF) Activities

Award Number: U18FD007200
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: KDA (KNOWLEDGE/DEVELOPMENT/APPLICATION)

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Project Summary/Abstract Animal Feed Regulatory Program Standards (AFRPS) Maintenance and the Enhancement of Current Good Manufacturing Practices (cGMP) and Preventive Controls for Animal Food (PCAF) Regulatory Activities FOA: PAR-20-13 Development and Maintenance of the Animal Feed Regulatory Program Standards with Optional Coordinated Preventive Control Regulatory Activities and Capacity Building (U18) Clinical Trial Not Allowed The Louisiana Department of Agriculture & Forestry’s (LDAF), Office of Animal Health & Food Safety (AHFS), Feed Program Division is currently finalizing year 5 of the Animal Feed Regulatory Program Standards (AFRPS) Development and Implementation Grant (RFA-FD-15-021) and expects to be found in full conformance during the program’s final FDA audit scheduled for August 2020. The LDAF AHFS Feed Program plans to move forward with the maintenance phase of the FDA AFRPS Program and enroll in the Preventive Controls (PC) Funding Opportunity to support the FDA Preventive Controls Initiative. The Feed Program plans to maintain FDA Contract work for feed related activities while annually increasing the capability and capacity to conduct all comprehensive inspections covered under 21 CFR Part 507. The LDAF AHFS Feed Program will support the LDAF Agricultural Chemistry Laboratory by providing trained personnel for sample collection allowing the Laboratory to enhance its scope and capacity. The Feed Program plans to identify and train a qualified field inspection trainer for comprehensive inspections which include Current Good Manufacturing Practices (cGMP) and Preventive Controls for Animal Food (PCAF). The program will enhance its outreach program by identifying outreach venues and developing outreach materials that pertain to PCAF regulation. The Feed Program plans to move forward with the State Auditor Program by moving towards Phase 2 and 3. The program plans to participate in and help develop capabilities to share regulatory data with the FDA through IT interface platforms such as the National Food Safety Data Exchange (NFSDX). The program will continue to work with the FDA to evaluate an enhance data collection and enforcement strategies, especially as it pertains to cGMP and PCAF compliance. The Feed Program will continue to support the FDA by providing current firm inventories categorized by risk. Finally, The LDAF AHFS Feed Program with develop a sound Exit Strategy by year 5 that will outline how the program will sustain required resources for program enhancement and implementation, advancements in cGMP/PC regulatory work activities and maintain full conformance with the AFRPS. Maintaining full conformance with the AFRPS will assist both Louisiana and the Food and Drug Administration (FDA) to better direct their regulatory activities toward preventing feed manufacturing compliance issues and increasing food safety and Public Health within the United States.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $450,000 )
2024	2024	AGRICULTURE & FORESTRY, LOUISIANA DEPARTMENT OF	5825 FLORIDA BLVD	BATON ROUGE	LA	70806	EAST BATON ROUGE	USA	Food and Drug Administration Research	000	5	8/6/2024	NON-COMPETING CONTINUATION	$450,000
														Subtotal = $450,000

Issue Date FY: 2023 ( Subtotal = $374,265 )
2023	2023	AGRICULTURE & FORESTRY, LOUISIANA DEPARTMENT OF	5825 FLORIDA BLVD	BATON ROUGE	LA	70806	EAST BATON ROUGE	USA	Food and Drug Administration Research	000	4	7/12/2023	NON-COMPETING CONTINUATION	$374,265
														Subtotal = $374,265

Issue Date FY: 2022 ( Subtotal = $204,805 )
2022	2022	AGRICULTURE AND FORESTRY, LOUISIANA DEPARTMENT OF	5825 FLORIDA BLVD # 2000	BATON ROUGE	LA	70806	EAST BATON ROUGE	USA	Food and Drug Administration Research	000	3	6/27/2022	NON-COMPETING CONTINUATION	$204,805
														Subtotal = $204,805

Issue Date FY: 2021 ( Subtotal = $279,775 )
2021	2021	AGRICULTURE AND FORESTRY, LOUISIANA DEPARTMENT OF	5825 FLORIDA BLVD # 2000	BATON ROUGE	LA	70806	EAST BATON ROUGE	USA	Food and Drug Administration Research	000	2	7/26/2021	NON-COMPETING CONTINUATION	$279,775
2021	2021	AGRICULTURE AND FORESTRY, LOUISIANA DEPARTMENT OF	5825 FLORIDA BLVD # 2000	BATON ROUGE	LA	70806	EAST BATON ROUGE	USA	Food and Drug Administration Research	001	2	8/26/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $279,775

Issue Date FY: 2020 ( Subtotal = $450,000 )
2020	2020	AGRICULTURE AND FORESTRY, LOUISIANA DEPARTMENT OF	5825 FLORIDA BLVD # 2000	BATON ROUGE	LA	70806	EAST BATON ROUGE	USA	Food and Drug Administration Research	002	1	9/12/2020	NEW	$450,000
2020	2020	AGRICULTURE AND FORESTRY, LOUISIANA DEPARTMENT OF	5825 FLORIDA BLVD # 2000	BATON ROUGE	LA	70806	EAST BATON ROUGE	USA	Food and Drug Administration Research	000	1	9/4/2020	NEW	$450,000
2020	2020	AGRICULTURE AND FORESTRY, LOUISIANA DEPARTMENT OF	5825 FLORIDA BLVD # 2000	BATON ROUGE	LA	70806	EAST BATON ROUGE	USA	Food and Drug Administration Research	001	1	9/9/2020	NEW	-$450,000
														Subtotal = $450,000

Grand Total All Awards = $1,758,845

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Animal Feed Regulatory Program Standards (AFRPS) Maintenance and the Enhancement of Current Good Manufacturing Practices (cGMP) and Preventive Controls for Animal Food Regulatory (PCAF) Activities

Award Number: U18FD007200

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: KDA (KNOWLEDGE/DEVELOPMENT/APPLICATION)

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