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Enhancing State Programs within the NCDA & CS by advancing efforts to maintain Manufactured Foods Regulatory Program Standards, Rapid Response Team, and Food Protection Task Force Programs.

Award Number: U18FD006384
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 – Preventive Controls Implementation Expansion in North Carolina The Preventive Controls Implementation Expansion Supplement is intended to augment the current processes and procedures in place for training, auditing, program improvement, infrastructure development, PC inspection, compliance implementation strategies, legislative research, rulemaking, policy analysis, outreach, joint work planning, and enforcement. The goal for training is to continue developing a fully trained staff to conduct preventive control (PC) inspections. This will be accomplished by hiring a training/outreach coordinator to provide risk based inspection methodology training to the field inspection staff. The goal for the auditing is to maintain consistency and proficiency in conducting PC inspections. This will be accomplished by incorporating PC audits into existing Manufactured Food Regulatory Program Standard (MFRPS) Standard 4 – Inspection Audit Program. Program Improvement and Infrastructure development will be evaluated during the 3 year grant period to determine if enhancements are needed to equipment and/or IT processes. The goals for PC inspection and compliance implementation strategies are to incrementally increase contract and initiate non-contract PC inspections. This will be accomplished by utilizing the training/outreach coordinator to teach the field staff risk based preventive controls methodology for conducting PC inspections. The compliance specialist would serve as an internal compliance specialist for PC inspections and external resource for industry. A workgroup will be developed to evaluate the feasibility and resources needed to adopt the Intentional Adulteration and Sanitary Transportation rules within the 3 year grant period to address legislative research, rulemaking, and policy analysis section. The goals for outreach are to educate the small and medium firms regarding the PC rule and inspection compliance with firms under inspection. The training/outreach coordinator will provide training on the PC rule to small and medium industry firms. The compliance specialist will provide guidance information for industry regarding critical and chronic violations documented on observation sheets during PC inspections. Joint workplanning and enforcement activities between NCDA&CS FDPD and FDA are collaborative efforts and will be realized through formal and informal communications. These communications will address contract expectations, joint inspection planning, joint complaint follow up and other PC related situations regarding the interest of public health safety.


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: 2023 ( Subtotal = $0 )
2023	2022	NORTH CAROLINA DEPARTMENT OF AGRICULTURE & CONSUMER SERVICES	2 W EDENTON ST	RALEIGH	NC	27601	WAKE	USA	Flexible Funding Model - Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs	000	5	5/12/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $385,000 )
2022	2022	NORTH CAROLINA DEPARTMENT OF AGRICULTURE & CONSUMER SERVICES	2 W EDENTON ST	RALEIGH	NC	27601	WAKE	USA	Flexible Funding Model - Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs	000	5	7/4/2022	NON-COMPETING CONTINUATION	$385,000
														Subtotal = $385,000

Issue Date FY: 2021 ( Subtotal = $308,500 )
2021	2021	NORTH CAROLINA DEPARTMENT OF AGRICULTURE & CONSUMER SERVICES	2 W EDENTON ST	RALEIGH	NC	27601	WAKE	USA	Flexible Funding Model - Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs	001	4	7/29/2021	NON-COMPETING CONTINUATION	$308,500
2021	2020	NORTH CAROLINA DEPARTMENT OF AGRICULTURE & CONSUMER SERVICES	2 W EDENTON ST	RALEIGH	NC	27601	WAKE	USA	Flexible Funding Model - Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs	000	3	11/5/2020	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $308,500

Issue Date FY: 2020 ( Subtotal = $385,000 )
2020	2020	NORTH CAROLINA DEPARTMENT OF AGRICULTURE & CONSUMER SERVICES	2 W EDENTON ST	RALEIGH	NC	27601	WAKE	USA	Flexible Funding Model - Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs	002	3	8/31/2020	SUPPLEMENT FOR EXPANSION	$150,000
2020	2020	NORTH CAROLINA DEPARTMENT OF AGRICULTURE & CONSUMER SERVICES	2 W EDENTON ST	RALEIGH	NC	27601	WAKE	USA	Flexible Funding Model - Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs	001	3	7/7/2020	NON-COMPETING CONTINUATION	$235,000
2020	2019	NORTH CAROLINA DEPARTMENT OF AGRICULTURE & CONSUMER SERVICES	2 W EDENTON ST	RALEIGH	NC	27601	WAKE	USA	Flexible Funding Model - Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs	000	2	12/19/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $385,000

Issue Date FY: 2019 ( Subtotal = $235,000 )
2019	2019	NORTH CAROLINA DEPARTMENT OF AGRICULTURE & CONSUMER SERVICES	2 W EDENTON ST	RALEIGH	NC	27601	WAKE	USA	Flexible Funding Model - Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs	000	2	6/19/2019	NON-COMPETING CONTINUATION	$235,000
														Subtotal = $235,000

Issue Date FY: 2018 ( Subtotal = $235,000 )
2018	2018	NORTH CAROLINA DEPARTMENT OF AGRICULTURE & CONSUMER SERVICES	2 W EDENTON ST	RALEIGH	NC	27601	WAKE	USA	Flexible Funding Model - Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs	000	1	8/29/2018	NEW	$235,000
														Subtotal = $235,000

Grand Total All Awards = $1,548,500

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Enhancing State Programs within the NCDA & CS by advancing efforts to maintain Manufactured Foods Regulatory Program Standards, Rapid Response Team, and Food Protection Task Force Programs.

Award Number: U18FD006384

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

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