Requirements Document.pdf

Food and Drug Administration (FDA)

Center for Food Safety and Applied Nutrition (CFSAN)

Statement of Work

ELISA kit procurement for on-going work on allergens detection

BACKGROUND

The detection of undeclared food allergens and gluten are necessary for the regulatory enforcement of the Food Allergen Consumer Protection Act of 2004 (FALCPA) and the Gluten-Free Regulation issued by the FDA on August 5, 2013. The methods currently being employed by the FDA involve the use of analyte specific ELISA technology to detect seven of the eight major food allergens; namely, egg, gluten/wheat, milk, peanut, tree nut (almond, hazelnut, and walnut), crustacean shellfish, and soy protein. The most sensitive of these methods are those developed by MIoBS (Morinaga Institutes of Biological Sciences, Inc.)

with limits of detection (LOD values) of 0.3 g/mL. These MIoBS ELISA Test Kits have been demonstrated to be reliable in multi-laboratory validation studies, analyses conducted in support of regulatory actions taken by the FDA, and research and development efforts conducted by the Center for Food Safety and Applied Nutrition.

This contract is designed to facilitate development of the methods and establishment of reference materials used for food allergen and gluten detection by providing required MIoBS ELISA test kits.

Further, the contract makes it possible to acquire MIoBS ELISA test kits with maximum shelf-life and minimal kit-to-kit variability, two features critical to the success of the project.

OBJECTIVE

This contract is designed to facilitate development of the methods used for food allergen and gluten detection by providing required MIoBS ELISA test kits. Further, the contract makes it possible to acquire MIoBS ELISA test kits with maximum shelf-life and minimal kit-to-kit variability, two features critical to the success of the project.

Requirements

• On a quarterly basis, the vendor shall provide up to seven (7) ELISA Test Kits. The specifics of which test kits (e.g., gluten, casein, peanut, egg, etc.) will be made at the time the quarterly order is placed.

• The Vendor shall provide FDA with the test kits for an analyte from multiple lots. This will be stipulated when the order is placed for the quarter. Otherwise, it is understood that all test kits for a specific analyte would be from the same lot with maximum shelf-life.

• Whether the receipt of the test kits should be in multiple or a single shipment will be specified by the

FDA at the time the order is placed for the quarter.

Delivery The vendor is responsible for delivery of the MIoBs ELISA Test Kits specified above. It is understood, that delivery of the ELISA Test Kits to the FDA may take up to 8 weeks from the date the order is placed. Any additional delay must be approved by the FDA. Fixed unit pricing includes packaging/handling and shipping costs.

PERIOD OF PERFORMANCE

The period of performance for this contract shall be ONE YEAR (with NO Option year renewals) from date of award. Anticipated date of award shall be September 15, 2024.

Project Officer

LCDR Chung Y. Cho Food and Drug Administration CPK1 Rm2E018 HFS-716 5001 Campus Drive College Park, MD 20740

Tel: 240-402-2044 E-mail: Chung.Cho@fda.hhs.gov

Commented [BT1]: This shall be included on stand alone justification document in detail