OFFICE OF REGIONAL OPERATIONS


 Division of Emergency & Investigational Operations (HFC-130)


a.  Provides coordinative direction, assistance, and
    management for field domestic and foreign investigative
    activities; serves as the Agency focal point for
    Headquarters/field relationships on investigational and
    inspection problems, programs, and operations; develops and
    recommends related policy and procedures.


b.  Develops and/or reviews policy and procedures for
    investigating and evaluating the compliance of regulated
    domestic and foreign industries with laws and regulations
    administered by the Agency; coordinates, develops, and
    maintains field guidance manuals on investigational and
    inspectional procedures.


c.  Identifies the need for investigational and inspectional
    training programs for field personnel.  Participates in the
    design, implementation, and presentation of training and
    career development programs for field investigational staffs
    and related personnel.


d.  Manages a program providing the field expert investigational
    technical advice and assistance.


e.  Manages the Agency foreign inspection program.


f.  Manages and coordinates field acquisition and utilization of
    major investigational and inspectional equipment. 


g.  Coordinates activities with other Federal organizations
    through interagency agreements and informal working
    relationships.


h.  Coordinates and provides facts regarding epidemiological
    investigations and other potential imminent dangers to
    public health on a 24-hour, seven-day-a-week basis to
    Headquarters, regional, and district personnel.


i.  Coordinates the Agency's epidemiological investigations
    program with other Federal agencies, private associations,
    State and local governments, and foreign governmental health
    agencies in conformance with policy of national and
    international scope.


j.  Recommends and coordinates epidemiological investigational
    practices and procedures. 


k.  Reviews Action Memoranda for all FDA-initiated recalls and
    all Class I recalls to assure proper evaluation of proposed
    actions.  Consults with appropriate ORA contacts when
    appropriate to ensure that recall recommendations comply
    with agency policy.  Makes recommendations to the Associate
    Commissioner For Regulatory Affairs regarding concurrence,
    nonconcurrence, or alternatives.


l.  Serves as focal point within the Agency for guidance on
    recall plans and procedures.  Directs and coordinates field
    activities in support of all product recalls; maintains
    liaison with other Agency components, industry, and other
    Government agencies to ensure proper implementation and
    completion of recall plans and activities.


m.  Directs and coordinates the emergency preparedness and civil
    defense programs; coordinates Headquarters and field efforts
    during periods of natural disaster or national emergency.





[SMG 1121.33 & 34]


[5-1-92 & 5-12-89]


[No Expiration Date]
[FDA