FAR 46.408—Single-agency assignments of Government contract quality assurance.
Plain-English Summary
FAR 46.408 assigns government-wide responsibility for quality assurance support for certain commodity acquisitions to specific civilian agencies with subject-matter expertise. It covers three product categories: drugs, biologics, and other medical supplies; food other than seafood; and seafood. For each category, the rule identifies the cognizant federal office responsible for providing quality assurance support: the Food and Drug Administration for drugs, biologics, and other medical supplies; the Department of Agriculture for food except seafood; and the National Marine Fisheries Service of the Department of Commerce for seafood. The section also tells agencies that need this support to request it directly from the cognizant office rather than routing the request through another channel. In practice, this provision helps ensure that inspections, surveillance, and other quality assurance activities are performed by the agency with the most relevant technical expertise and statutory responsibility, reducing duplication and improving product safety and compliance.
Key Rules
FDA covers medical supplies
For drugs, biologics, and other medical supplies, government-wide quality assurance support is assigned to the Food and Drug Administration. Agencies buying these items should look to FDA as the cognizant office for support.
USDA covers most food
For food acquisitions other than seafood, the Department of Agriculture is the designated source of quality assurance support. This means USDA is the lead office for quality assurance support on these commodities.
NMFS covers seafood
For seafood acquisitions, the National Marine Fisheries Service of the Department of Commerce provides the quality assurance support. Seafood is treated separately from other food because it falls under a different cognizant authority.
Request support directly
Agencies needing quality assurance support for these supplies should request it directly from the cognizant office. The rule is intended to streamline coordination and avoid unnecessary intermediaries.
Responsibilities
Agencies
Identify whether the acquisition involves drugs, biologics, other medical supplies, food, or seafood, then request quality assurance support directly from the correct cognizant office.
Food and Drug Administration
Provide government-wide quality assurance support for acquisitions of drugs, biologics, and other medical supplies.
Department of Agriculture
Provide government-wide quality assurance support for acquisitions of food, except seafood.
National Marine Fisheries Service, Department of Commerce
Provide government-wide quality assurance support for acquisitions of seafood.
Practical Implications
Contracting teams must classify the commodity correctly before seeking quality assurance support, because the responsible office depends on the item being bought.
A common pitfall is treating seafood as ordinary food; FAR 46.408 separates seafood from other food and assigns it to NMFS, not USDA.
Agencies should contact the cognizant office directly early in the acquisition process so quality assurance support can be built into inspection and acceptance planning.
This section is about support assignment, not the full quality assurance process; contracting officers still need to apply the rest of FAR Part 46 and the contract’s inspection and acceptance terms.
Misrouting requests can delay procurement actions, especially for time-sensitive or regulated products such as medical supplies and perishable foods.
Official Regulatory Text
(a) Government-wide responsibility for quality assurance support for acquisitions of certain commodities is assigned as follows: (1) For drugs, biologics, and other medical supplies-the Food and Drug Administration; (2) For food, except seafood-the Department of Agriculture. (3) For seafood-the National Marine Fisheries Service of the Department of Commerce. (b) Agencies requiring quality assurance support for acquiring these supplies should request the support directly from the cognizant office.