FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
OFFICE OF GLOBAL REGULATORY OPERATIONS AND POLICY
OFFICE OF REGULATORY AFFAIRS
OFFICE OF OPERATIONS
Effective Date: 08/07/2012
1. OFFICE OF OPERATIONS (DLLRI)
A. Provides direction and counsel to Regional Food and Drug Directors (RFDDs) in the implementation of policies and guidelines that form the framework for management of Agency global (domestic, U.S. border/port and international) operational activities.
B. Evaluates the overall management and capabilities of the Agency’s field organization; initiates action to improve the management of global field activities.
C. Develops, issues, and approves proposals and instructions affecting global field activities. Develops, clears, issues and maintains guidance to the field in the Investigations Operations Manual.
D. Stimulates awareness within the Agency of the need for prompt and positive action to assure compliance by regulated industries; works to assure an effective and uniform balance between regulatory compliance and Agency responsiveness to consumer needs.
E. Resolves appeals when proposed compliance actions are disapproved by the Centers or the Office of the Chief Counsel.
F. Provides direction, assistance, management, and oversight of Agency import operations, including investigational and compliance activities. Serves as the Agency focal point for Headquarters/field relationships on all import programs, operations, and problems.
G. Provides strategic leadership and support for high quality, collaborative, scientific activities that advance regulatory science and address important public health issues concerning FDA regulated products, including their evaluation, quality, safety and effectiveness.
H. Directs and coordinates ORA’s emergency preparedness and response activities.
I. Participates, where appropriate, in international harmonization activities.
2. AUDIT STAFF (DLLRI1)
A. Conducts audits of domestic and international regulatory partners to measure their performance against program standards. Audits include reviews of regulatory systems and more specifically the inspection, investigation, sample collection and analysis, enforcement, response, recovery, and/or outreach components of these regulatory systems.
B. Coordinates with other ORA units on the development of training and certification programs for regulatory partners.
C. Develops program standards and associated audit programs that may apply to international and/or State regulatory partners and ORA.
D. Represents ORA and coordinates ORA participation on Agency workgroups responsible for comparability assessments and equivalence determinations of foreign regulatory partners.
3. AUTHORITY AND EFFECTIVE DATE
The functional statements for this Office were approved by the Commissioner of Food and Drugs on August 7, 2012.