U18FD007901

ISU VET-LIRN INFRASTRUCTURE GRANT PROPOSAL - PROJECT SUMMARY

The proposed work is for a cooperative agreement between the Iowa State University Veterinary Diagnostic Laboratory (ISU-VDL) and the FDA Center for Veterinary Medicine Vet-LIRN program to provide support in the following areas:

1) To participate in FDA/Vet-LIRN sanctioned sample analysis for chemical contaminants.
2) To provide analytical data to support potential regulatory use.
3) To participate in additional projects such as small scale methods development, method validation, and matrix extension for analysis of chemical contaminants.
4) To participate in the Vet-LIRN AMR monitoring program as a source laboratory.

These activities are designed to support the FDA in strengthening coordination of veterinary diagnostic laboratory efforts in enhancing the national food safety system.

The ISU-VDL is a full-service laboratory, fully accredited by the AAVLD, which provides cutting-edge diagnostic services to the state of Iowa and beyond. The case load at the ISU-VDL is unique in the nation because it is predominantly food-animal related. Iowa is a major food animal producing state. The laboratory is not only the first line of defense in the area of food safety to food animal producers across the country, but is also heavily engaged in protection of companion animal health.

This project will specifically address issues related to chemical contamination leading to animal illnesses or death. A significant amount of our food animal products from Iowa are exported overseas to the EU and Asia markets which are sensitive to food safety. Participation in this cooperative agreement program will not only benefit the FDA, but the lab and the state of Iowa as well because all aspects of this project add value to our product, namely, accurate and timely analysis of test results to protect animal and human health from chemical contaminants.

The ISU-VDL is well-equipped and staffed to positively impact the needs of the FDA as outlined in the FOA. Specifically, we have the necessary infrastructure to support training, participate in quality assurance processes and proficiency tests, and share data to support national capacity development. We will quickly and accurately test diagnostic samples to assist the FDA in case investigations. As members and long-term participants in the Food Emergency Response Network (FERN) and also as founding members of Vet-LIRN, we have demonstrated that we have the infrastructure to report out results accurately and efficiently. The quality of our work product is overseen by an independent quality assurance unit.

In summary, we have the resources and infrastructure to deliver our work product in a timely manner. We are ready to collaborate with the FDA on this grant if the application is successful.

Iowa State University Of Science And Technology

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.

93.103 - Food and Drug Administration Research

FDA Office of Acquisition and Grant Services (OAGS) [HHS - FDA]

Food and Drug Administration (FDA) [HHS]

Ames, Iowa 500110001 United States

Single Zip Code

CVM Vet-LIRN Veterinary Diagnostic Laboratory Program (U18) Clinical Trials (PAR-22-063)

Amendment Since initial award the total obligations have increased 200% from $45,900 to $137,700.