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
OFFICE OF FOOD AND FEED OPERATIONS
Effective Date: 08/07/2012
1. OFFICE OF FOOD AND FEED OPERATIONS (DLLRIC)
A. Represents and makes decisions on behalf of Assistant Commissioner for Operations (ACO) relative to food/feed program investigatory operations including emergency response activities.
B. Coordinates and manages all domestic and foreign field investigatory operations related to foods and feed regulated by the Agency on behalf of the ACO.
C. Serves as the central point within the Agency through which Directorates and other Headquarters offices obtain field support services for food and feed activities.
D. Serves as the Agency focal point in coordinating, directing, and assisting the Field and Headquarters Offices with investigative food and feed activities.
E. Creates, reviews, clears and/or issues field assignments. Serves as technical point of contact for these assignments and monitors outcomes of assignments.
F. Develops, reviews, and recommends procedures for inclusion in the Agency’s various guidance manuals. Reviews policy documents relative to the investigation and evaluation of the compliance of regulated food and feed facilities with the laws and regulations administered by the Agency.
G. Provides technical assistance to FDA Field Offices regarding food and feed investigatory operations.
H. Manages the Food and Feed National Expert Program.
I. Serves as operational liaison for food and feed inspection programs to FDA’s Foreign Offices.
J. Coordinates international food and feed regulatory activities including the planning of all foreign food and feed inspections. Manages the foreign food and feed inspection cadre.
K. Participates in harmonization efforts with other FDA components and national and international governments.
L. Identifies and advocates for food and feed investigator training needs and, as subject matters experts, participate in the design, implementation, and presentation of training programs.
M. Monitors emerging issues, advancements in technology, and recommends and coordinates implementation into the Agency’s food and feed investigative activities.
N. Directs and coordinates ORA’s food and feed related emergency preparedness and response activities.
O. Serves as the liaison between law enforcement agencies and the ACO for the purpose of enforcing the Prior Notice regulation.
P. Serves as subject matter experts on field operations relative to foods and feeds on external and internal cross Agency committees, workgroups and task forces.
2. AUTHORITY AND EFFECTIVE DATE
The functional statements for this Office were approved by the Commissioner of Food and Drugs on August 7, 2012.