ORA’s Office of Partnerships manages various sole source and fixed price contract programs with states. Working collaboratively with our state partners through contracts, FDA is able to provide enhanced regulatory oversight of its regulated firms. We also manage a contract with a 3rd party to maintain milk drug residue testing data.
Click the links below to learn more about these various contract programs:
Field Management Directive 76 (FMD-76) is the document governing the Food and Drug Administration (FDA) Office of Regulatory Affairs' (ORA's) oversight of the state contract audit program. FMD-76 works in concert with several other ORA efforts to ensure that FDA's State partners have the capacity and capability to voluntarily support the FDA's regulatory oversight and enforcement of applicable sections the Food, Drug and Cosmetic Act and regulations toward the overarching goals of mutual reliance and a national integrated food safety system.
FMD-76 directly apples to contract inspections under: Human Food; Animal Food; Egg; Medical Device; and other State inspection programs. FMD-76 established the oversight of required audits of state-contract work being conducted on behalf of FDA.
Compiled data related to FMD-76 can be viewed here.