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Compliance References
Regulatory Procedures Manual 2008
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3-1 - INTRODUCTION; OBJECTIVES

3-1 - INTRODUCTION; OBJECTIVES

This chapter describes the Food and Drug Administration’s (FDA) policies, procedures, and responsibilities for commissioning other government officials.  This chapter also sets out the circumstances for FDA consumer safety officials to accept state commissions.

FDA developed its commissioning program to make inter-agency cooperation more effective thereby increasing the amount of protection afforded to the American consumer.  FDA achieves its goal by:

  1. permitting commissioned Federal, state and local officials to operate under the Act, and,

  2. enabling those commissioned officials to effectively carry out their responsibilities by reviewing FDA information, such as draft policies, that is protected from disclosure to the public by a Freedom of Information Act (FOIA) provision.

FDA has two procedures for commissioning a state or local official--the traditional version (e.g., issuing credentials or a certificate), and another variation that is “streamlined” because it involves less paperwork.  The “streamlined” variation arises in the context of FDA contracts with state government agencies.  This chapter focuses on commissioning of state and local officials, with most of the attention devoted to the first variation of the commissioning procedure.

However, this chapter also briefly sets out references to FDA’s authority to commission officials from other Federal government Departments and agencies (Federal officials) under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002) (The BT Act).

FDA’s Office of Regulatory Affairs’ Division of Federal-State Relations (DFSR) (HFC-150) has primary responsibility for overseeing the implementation of FDA’s Commissioning Program.  For state or local officials, ORA Regional Food and Drug Directors (RFDDs) have primary responsibility for carrying out the Program.  For Federal officials the interagency Memorandum of Understanding (MOU) that is required by the BT Act should include provisions regarding the implementation of the commissioning procedures.  For that reason, this chapter will only briefly refer to those provisions.

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