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
REGIONAL FIELD OFFICE, SOUTHWEST, DALLAS, TX
Effective Date: 08/07/2012
1. REGIONAL FIELD OFFICE, SOUTHWEST REGION - DALLAS, TX (DLLRW).
A. Provides managerial direction to the Agency's field programs to achieve compliance with the laws and regulations for which the Agency is responsible through appropriate voluntary correction or regulatory action.
B. Manages resource allocations, money, and people.
C. Manages a field management information system.
D. Coordinates Agency activities with related operations of the PHS Regional Health Administrator and the Department's Regional Director.
E. Develops and maintains cooperative relationships with State, local, and other Federal agencies; serves on interagency councils; encourages improved State and local consumer protection programs pertinent to Agency-enforced laws and regulations.
F. Assists State and local cooperative officials in the development of uniform legislation, codes, and regulations.
G. Represents the Agency, or provides policy and direction for Agency representation, in dealing with public and private organizations, such as governmental agencies, volunteer agencies, educational institutions, industry and professional associations, and the local media within the Region.
H. Plans and evaluates program activities; measures accomplishments against annual field workplan objectives; initiates management and program analyses; manages a Quality Assurance Program; and advises Headquarters regarding strategy changes needed to reach existing or modified objectives.
I. Advises Headquarters on new or emerging problems and trends, future program needs and priorities; State legislative activities; manpower, equipment, financial needs, and long-range planning.
J. Coordinates emergency activities by maintaining liaison with Department components, and other Federal departments and agencies and by providing assistance to States and localities in the event of a national disaster or other emergency.
K. Advises, commissions, and certifies State personnel; and monitors and evaluates State programs in milk, shellfish, food service sanitation, and radiation safety.
L. Determines the acceptability of items, subject to the Agency's jurisdiction, for entry into this country through examination of available records, inspection of the product or by sampling and laboratory examination of the product followed by release, detention, and/or rejection.
M. Conducts investigations and inspections, and analyzes samples of foods, drugs, and other commodities for which the Agency has regulatory responsibility.
N. Conducts administrative hearings on alleged violations, and initiates appropriate enforcement action.
O. Recommends legal action to Headquarters, to the Office of the Chief Counsel, or to the responsible U.S. attorney (when such direct reference is authorized), and assists in implementing approved action.
P. Detains medical devices and, in cooperation with USDA, detains meat, poultry, or egg products that may be violative.
Q. Manages recalls and performs follow-up activities to assess recall effectiveness and prevent recurrences.
R. Conducts research to develop and refine analytical methodology and to explore new systems of analysis; maintains liaison with scientists and scientific bodies with interest pertinent to laboratory activities.
S. Manages, evaluates, and audits the program aspects of Federal-State contracts.
T. Manages an equal employment opportunity and career development and training program.
U. Conducts consumer affairs, and information programs.
V. Provides formal mechanisms for receiving consumer input into Agency planning and priority-setting systems.
W. Directs a freedom of information program consistent with Agency policy.
X. Maintains liaison with the medical community to share the Agency's position on pertinent issues, and to obtain feedback regarding the concerns of physicians and other health-related scientists.
Y. Conducts a small business representative program.
Z. Maintains working liaison with the Center for Devices and Radiological Health.
AA. Maintains working liaison for state radiation programs in the eleven Southwest Region states.
BB. Provides technical assistance and training for the region and members of industry.
CC. Conducts field tests for diagnostic x-ray equipment, x-ray units, microwave ovens, and sunlamp (tanning) products.
DD. Inspects laser product manufacturers, and laser use in medicine and entertainment.
EE. Partners with other federal agencies such as NASA, Bureau of Prisons, Department of Energy, and the Coast Guard by providing field tests and consulting services for their x-ray programs, and Federal Emergency Management Agency in disaster preparedness operations.
FF. Provides regional guidance for all program activities, including budget and fiscal, contracts and procurement, personnel management, and the management of facilities, services and supplies.
GG. Maintains working Liaison with other Federal offices providing support services to the Agency.
HH. Oversees and coordinates manpower and table of organization for the Region.
II. Directs and coordinates budget projects for the Region; recommends distribution of operating funds and monitors expenditures.
JJ. Plans, coordinates, and conducts management studies and surveys and program analyses for all areas of regional management including issues regarding organization structure and other program activities.
KK. Coordinates the internal security, safety, and emergency preparedness programs.
LL. Serves as focal point for ORA and Center program managers for administrative areas.
MM. Provides direction of the agency's affirmative and equal employment programs.
NN. Manages the regional office cooperative education and stay-in school programs.
OO. Develops and implements regional Quality Systems Management Program.
PP. Directs the regional small business program.
QQ. Directs the regional career development and training program.
RR. Partnership development with States and cooperating officials.
SS. Coaches the State Cooperative Programs' team consisting of Food, Shellfish, and Milk specialists.
2. STATE COOPERATIVE PROGRAMS STAFF (DLLRW1).
Cooperative State-FDA functions include all areas of the Agency's responsibility, but this staff is generally limited to Food Service, Milk, and Shellfish Sanitation.
A. Coordinates and evaluates State program activities for conformity with State-FDA guidelines and certify State personnel. Prepares, as appropriate, State program evaluation reports, meets with State program officials to provide technical and administrative consultations, and maintains cooperative relationships with State counterpart agencies.
B. Inspects establishments subject to laws and regulations enforced by the Agency; collects samples for laboratory analysis; performs field analyses and prepares reports on findings of each inspection. Analyzes inspectional and analytical findings relative to compliance or noncompliance and determine appropriate follow up. Makes recommendations to firm and/or State program officials when voluntary corrective action is appropriate.
C. Manages, evaluates, and audits the program aspects of Federal/State contracts and programs that are applicable to the special program area. Performs special investigations, studies, and evaluations, including foreign program evaluations, epidemiological investigations of food poisonings, and technical assistance projects requested by State officials.
D. Plans, schedules, and controls inspection and evaluation operations; and formulates, implements, and coordinates investigation and evaluation workplans.
E. Provides counsel and training regarding inspectional techniques and technical developments to other Federal agencies; to State, local, and foreign counterpart agencies; and to industry under the cooperative State-FDA program.
3. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this Region were approved by the Commissioner of Food and Drugs, effective August 7, 2012.