Contracts

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.

Contract Programs

Click the links below to learn more about these various contract programs:

• Animal Food Safety Contract Program
• Human Food Inspection Contract Program, Including Egg Safety Inspections 
• Medical Device Inspection Contract Program
• MQSA Inspection Contract Program
   

FMD-76 Contact Monitoring Program

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 applies 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. 

Field Management Directive 76 (FMD-76) and its appendices can be accessed through the links below:

• FMD-76 Revision 05, dated 08/22/2023  
• Appendix A: Instructions for Evaluating Contract Inspections
• Appendix B: Human Field Inspection Audit (FORM FDA 3610H)
• Appendix B.2: Instructions for Reporting Human Food Contract Audits
• Appendix C: Animal Food Safety Inspection Audit Form (FORM FDA 3610A)
• Appendix C.1: Instructions for Completing the Animal Food Safety Inspection Audit Form
• Appendix C.2: Instructions for Reporting Animal Food Contract Audits
• Appendix D: Instructions for Conducting Joint Audit Inspections, Verification Audits for State Auditors, and Joint Inspections
• Appendix H: State Implementation Agreement and Year-End Evaluation
• Appendix I: Request for Audit Reduction Form and Instructions
• Appendix J: Corrective Action Plan for Program and Performance Factors
• HF 3610-H Summary Sheet 

Compiled data related to the previous year’s audits under FMD-76 can be viewed here.