U01FD008398
Cooperative Agreement
Overview
Grant Description
Continuing to support and enhance an integrated food safety system through implementation of program standards, data sharing, collaboration, and state training and equipment grants.
- AFDO 2024 Alliance to support the activities of the integrated food safety system (IFSS), including the Grade A Milk Safety and National Shellfish Sanitation Programs.
Application: Project summary
The Association of Food and Drug Officials (AFDO) will direct and implement the activities under this cooperative agreement which will facilitate FDA’s implementation of the Food Safety Modernization Act (FSMA), help increase mutual reliance between agencies, help develop a nationally integrated food safety system (IFSS), and strengthen manufactured food, Grade A milk and shellfish sanitation programs, thereby improving public health protection of the food supply.
AFDO has been representing state regulatory food programs since 1896.
The principal investigator and project staff assigned to this project include former state food program managers that have extensive experience developing state food safety programs, implementing programmatic change to achieve conformance with the requirements of the MFRPS, and collaborating with FDA to achieve a national IFSS.
Major activities conducted under this cooperative agreement include but are not limited to:
• Providing oversight and support to the Manufactured Food Regulatory Program Alliance (MFRPA) to support state continuous improvement in the implementation of the Manufactured Food Regulatory Program Standards (MFRPS);
• In collaboration with a joint advisory group, providing subaward funding for training and equipment to state and territorial Grade A milk and molluscan shellfish regulatory programs;
• Conducting research and surveys on the capabilities of state manufactured food programs;
• Researching and developing mechanisms to enhance data sharing;
• Maintaining and enhancing the secure online MFRPA portal for sharing information and data related to best practices, guidance documents, procedures, and other critical tools;
• Maintaining and enhancing directories for subject matter experts, food process authorities, and directories of state and local regulatory officials, to improve interagency communication and provide access to key contacts necessary for inter-agency collaboration in an IFSS;
• Collaborating to develop, deliver, and support state attendance at food safety and defense training programs, including annual meetings for the MFRPA and Rapid Response Teams (RRT), as well as web-based and face-to-face training courses designed to increase core regulatory and scientific knowledge; and
• Researching methods to further promote food safety related regulatory careers with colleges and universities and developing opportunities for experiential learning.
- AFDO 2024 Alliance to support the activities of the integrated food safety system (IFSS), including the Grade A Milk Safety and National Shellfish Sanitation Programs.
Application: Project summary
The Association of Food and Drug Officials (AFDO) will direct and implement the activities under this cooperative agreement which will facilitate FDA’s implementation of the Food Safety Modernization Act (FSMA), help increase mutual reliance between agencies, help develop a nationally integrated food safety system (IFSS), and strengthen manufactured food, Grade A milk and shellfish sanitation programs, thereby improving public health protection of the food supply.
AFDO has been representing state regulatory food programs since 1896.
The principal investigator and project staff assigned to this project include former state food program managers that have extensive experience developing state food safety programs, implementing programmatic change to achieve conformance with the requirements of the MFRPS, and collaborating with FDA to achieve a national IFSS.
Major activities conducted under this cooperative agreement include but are not limited to:
• Providing oversight and support to the Manufactured Food Regulatory Program Alliance (MFRPA) to support state continuous improvement in the implementation of the Manufactured Food Regulatory Program Standards (MFRPS);
• In collaboration with a joint advisory group, providing subaward funding for training and equipment to state and territorial Grade A milk and molluscan shellfish regulatory programs;
• Conducting research and surveys on the capabilities of state manufactured food programs;
• Researching and developing mechanisms to enhance data sharing;
• Maintaining and enhancing the secure online MFRPA portal for sharing information and data related to best practices, guidance documents, procedures, and other critical tools;
• Maintaining and enhancing directories for subject matter experts, food process authorities, and directories of state and local regulatory officials, to improve interagency communication and provide access to key contacts necessary for inter-agency collaboration in an IFSS;
• Collaborating to develop, deliver, and support state attendance at food safety and defense training programs, including annual meetings for the MFRPA and Rapid Response Teams (RRT), as well as web-based and face-to-face training courses designed to increase core regulatory and scientific knowledge; and
• Researching methods to further promote food safety related regulatory careers with colleges and universities and developing opportunities for experiential learning.
Funding Goals
TO ASSIST INSTITUTIONS AND ORGANIZATIONS, TO ESTABLISH, EXPAND, AND IMPROVE RESEARCH, DEMONSTRATION, EDUCATION AND INFORMATION DISSEMINATION ACTIVITIES, ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS), BIOLOGICS, BLOOD AND BLOOD PRODUCTS, THERAPEUTICS, VACCINES AND ALLERGENIC PROJECTS, DRUG HAZARDS, HUMAN AND VETERINARY DRUGS, CLINICAL TRIALS ON DRUGS AND DEVICES FOR ORPHAN PRODUCTS DEVELOPMENT, NUTRITION, SANITATION AND MICROBIOLOGICAL HAZARDS, MEDICAL DEVICES AND DIAGNOSTIC PRODUCTS, RADIATION EMITTING DEVICES AND MATERIALS, FOOD SAFETY AND FOOD ADDITIVES. THESE PROGRAMS ARE SUPPORTED DIRECTLY OR INDIRECTLY BY THE FOLLOWING CENTERS AND OFFICES: CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER), CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH), CENTER FOR VETERINARY MEDICINE (CVM), CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN), NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH (NCTR), THE OFFICE OF ORPHAN PRODUCTS DEVELOPMENT (OPD), THE CENTER FOR TOBACCO PRODUCTS (CTP), AND OFFICE OF REGULATORY AFFAIRS (ORA), AND THE OFFICE OF THE COMMISSIONER (OC). SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAMS: TO STIMULATE TECHNOLOGICAL INNOVATION, TO ENCOURAGE THE ROLE OF SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION BY MINORITY AND DISADVANTAGED PERSONS IN TECHNOLOGICAL INNOVATION. FUNDING SUPPORT FOR SCIENTIFIC CONFERENCES THAT ARE RELEVANT TO THE FDA SCIENTIFIC MISSION AND PUBLIC HEALTH ARE ALSO AVAILABLE.
Grant Program (CFDA)
Awarding Agency
Funding Agency
Place of Performance
York,
Pennsylvania
174011314
United States
Geographic Scope
Single Zip Code
Analysis Notes
Amendment Since initial award the End Date has been extended from 07/31/25 to 07/31/27 and the total obligations have increased 71% from $4,800,000 to $8,225,000.
Association Of Food & Drug Officials was awarded
Enhancing Integrated Food Safety System through AFDO 2024 Alliance
Cooperative Agreement U01FD008398
worth $8,225,000
from the FDA Office of Regulatory Affairs in August 2024 with work to be completed primarily in York Pennsylvania United States.
The grant
has a duration of 3 years and
was awarded through assistance program 93.103 Food and Drug Administration Research.
The Cooperative Agreement was awarded through grant opportunity Alliance to Support the Activities of the Integrated Food Safety System (IFSS), including the Grade “A” Milk Safety and National Shellfish Sanitation Programs (U01) Clinical Trials Not Allowed.
Status
(Ongoing)
Last Modified 9/5/25
Period of Performance
8/20/24
Start Date
7/31/27
End Date
Funding Split
$8.2M
Federal Obligation
$0.0
Non-Federal Obligation
$8.2M
Total Obligated
Activity Timeline
Transaction History
Modifications to U01FD008398
Additional Detail
Award ID FAIN
U01FD008398
SAI Number
U01FD008398-376004022
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Nonprofit With 501(c)(3) IRS Status (Other Than An Institution Of Higher Education)
Awarding Office
75FDA1 FDA Office of Acquisitions and Grants Services
Funding Office
75DLLR FDA OFFICE OF REGULATORY AFFAIRS
Awardee UEI
UFLXUY7KGRK1
Awardee CAGE
3L5M1
Performance District
PA-10
Senators
Robert Casey
John Fetterman
John Fetterman
Modified: 9/5/25