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
DIVISION OF FOOD AND FEED PROGRAM OPERATIONS AND INSPECTIONS
Effective Date: 08/07/2012
1. DIVISION OF FOOD AND FEED PROGRAM OPERATIONS AND INPECTIONS (DLLRICB)
A. Serves as the Agency focal point for coordinating, directing, and assisting the field and headquarters (HQ) with domestic and international food and feed investigative activities.
B. Serves as operational food and feed liaison to FDA’s foreign offices; provides inspectional and technical assistance to FDA’s field and foreign offices.
C. Coordinates international food and feed regulatory activities. Participates in harmonization efforts with other FDA components and national and international governments.
D. 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.
E. Serves as subject matter experts on field operations relative to foods and feeds on internal cross Agency committees, workgroups and task forces.
F. Assists with foodborne outbreak and feed related emergency response activities.
2. FOOD AND FEED PROGRAM OPERATIONS AND INPECTIONS (DLLRICB1)
A. Serves as the Agency focal point for coordinating, directing, and assisting the field and headquarters with food and feed investigative activities.
B. Creates reviews, clears and/or issues field assignments. Serves as technical point of contact for these assignments and monitors outcomes of assignments.
C. Develops, reviews, and recommends procedures and guidance for investigating and evaluating the compliance of regulated food and feed facilities with laws and regulations administered by the Agency.
D. Provides inspectional and technical assistance to FDA field and foreign offices.
E. Performs food and feed inspections.
F. 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.
G. Monitors emerging issues and advancements in technology and recommends and coordinates implementation into the Agency’s food and feed investigative activities.
3. FOOD AND FEED INPECTION BRANCH (DLLRICB2)
A. Manages the foreign food and feed inspection cadre.
B. Performs food and feed inspections.
C. Monitors emerging issues and advancements in food and feed technology.
4. FOOD AND FEED TRIP PLANNING BRANCH (DLLRICB3)
A. Manages and oversees the planning and trip coordination for food inspections and investigative activities conducted by field and headquarter personnel.
B. Provides international trip planning coordination and support for non-regulatory food and feed travel by ORA management and staff.
C. In coordination with the Office of Medical Products and Tobacco Operations, Medical Products and Tobacco Trip Planning Branch, develops and reviews policies and procedures governing foreign regulatory and non-regulatory trips; provides relevant and current information to travelers regarding safety concerns and precautions.
5. AUTHORITY AND EFFECTIVE DATE
The functional statements for this Office were approved by the Commissioner of Food and Drugs on August 7, 2012.