Contracts

The Office of Domestic Partnerships (ODP) 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.

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

SMG-8076 FDA State Contact Audit Program

Staff Manual Guide 8076 (SMG-8076) is the document governing the Food and Drug Administration (FDA) Human Food Program, Office of Domestic Partnerships (ODP) and the Office of Inspections and Investigations (OII) oversight of the audits of state contract regulatory inspections. SMG-8076 works in concert with several other FDA efforts to ensure that FDA's State partners have the capacity and capability to support the FDA's regulatory oversight and enforcement of applicable sections the Food, Drug and Cosmetic Act and regulations under contract. These goals also intersect with FDA efforts toward the overarching goals of mutual reliance and an integrated food safety system (IFSS). 

SMG-8076 directly applies to contract inspections under: Human Food; Animal Food; Egg; Medical Device; and other State inspection programs. SMG-8076 established the oversight of required audits of regulatory contract work being conducted, by the state or territory, on behalf of FDA. 

Staff Manual Guide 8076 (SMG-8076) and its appendices can be accessed through the links below:

• SMG-8076, FDA State Contract Audit Program, effective 11/7/2024
• 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) 
  (in XLXS)
• 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 H.1: Completion Guide for SMG 8076 Appendix H
• Appendix I: Request for Audit Reduction Form and Instructions
• Appendix J: Corrective Action Plan for Program and Performance Factors
• HF 3610-H Summary Sheet (in XLXS)

View compiled data related to the previous year’s audits under FMD-76.