2026 FDA U.S. Human Food Inspection Program - Notice of Intent to Sole Source

The program meets the criteria set forth in 41 U.S.C. 253(c) (5). In accordance with 21 U.S.C. 301, Federal food, Drug and Cosmetic Act, the inspection services can be obtained only from State, Local, Tribal Territorial organizations possessing the authority necessary to conduct regulatory food safety inspections. Contractors must meet the following special requirements:

(1) possess legal authority under state and territorial law necessary to gain access to any regulated private commercial establishment for the unique purpose of conducting regulatory inspections and investigations to determine compliance with the human food safety inspections provision of the Federal Food, Drug, and Cosmetics Act at any geographical location within the state;

(2) have trained personnel experienced with the inspectional procedures and evidence development techniques necessary to assess the conformance of an establishment with the federal law or comparable state and territorial requirements;

(3) demonstrate experience with state and territorial regulatory procedures for correcting violative practices. Only governmental organizations have the unique qualification to perform this kind of activity. Competition does not exist for this program. Within any state, its legislature designates the governmental organizations which have the authority and resources to accomplish a program. The prospective contractors for this solicitation are those designated state and territorial organizations.

This program meets the requirements of the congressional mandate expressed in 31 U.S.C. § 1502(a), commonly referred to as the bona fide needs rule, which provides that fixed period appropriations are only available for the legitimate needs arising during the period of availability for which they were made.