FDA Regulated Products Sampling Services

Background
The U.S. Food and Drug Administration (FDA) is responsible for ensuring the safety and efficacy of food, drugs, medical devices, and other products in the United States. The sample collection process is a critical component of the FDA's regulatory oversight activities.

The FDA collects samples of regulated products ready for consumption or sale, as well as in-process and raw ingredient samples, to monitor and evaluate these products for potential adulterants or to verify the accuracy of product labeling. The results of sample collection and testing will be used by the FDA to ensure product safety and quality, expand knowledge through surveillance, and make regulatory decisions such as pursuing voluntary recalls.

Work Details
The contractor will provide FDA Regulated Products Sampling Services which include:
- Collecting samples as part of FDA’s surveillance sampling program to gather data on FDA-regulated products.
- Aiding FDA’s sampling efforts for items offered for import during import status or after release.
- Providing a reliable and consistent stream of samples for analysis to FDA laboratories.

Sample collection involves taking physical samples from warehouses, distributors, retail locations, ports of entry, or other designated holding facilities for laboratory analysis. The products sampled may be produced domestically or imported into the U.S., including those originally produced in the U.S. before being exported and re-imported.

Period of Performance
The anticipated period of performance is five (5) years with an initial ordering period starting from July 1, 2025, through June 30, 2026, followed by additional ordering periods extending annually until June 30, 2030.

Place of Performance
The contract will be performed nationwide across various locations including warehouses, distributors, retail locations, ports of entry, or other designated holding facilities.