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, NORTHEAST REGION, JAMAICA, NY
WINCHESTER ENGINEERING AND ANALYTICAL CENTER
Effective Date: 08/07/2012
1. WINCHESTER ENGINEERING AND ANALYTICAL CENTER (DLLRNE).
A. Serves as a national resource for engineering and analytical chemistry associated with problems in compliance testing and methods development and required field investigations and inspections.
B. Provides specialized engineering and analytical services for project activities relating to electronic product radiation, medical devices, pharmaceuticals, radiopharmaceuticals, radionuclides in food, and the biological and microbiological safety of radiopharmaceuticals.
C. Serves as the focal point for Agency field activities related to Nuclear Regulatory Commissioner licensing; for the purchase, servicing, use, storage, and disposal of radiological materials; and for the coordination of the Agency's Radiation Safety Program.
D. Provides chemical, physical, and microanalytical support for domestic and import program operations for which the Agency has authorized regulatory responsibility.
E. Provides training services in the operational aspects of electronic product testing, radiopharmaceutical testing, radiological safety, automated drug analysis, and other related compliance program areas.
F. Maintains liaison with national and international scientists and scientific bodies; other Federal, state, and local government officials; and industry personnel having interests pertinent to Center activities.
G. Develops and operates procedures for automated analyses of drugs, radiopharmaceuticals, and radionuclides in foods.
H. Develops and operates engineering evaluation and compliance testing procedures for consumer and industrial products, medical devices, and other electronic, electro-mechanical, and mechanical products and devices.
I. Conducts research to develop and refine analytical methodology and to explore new systems of analysis.
J. Provides facility and administrative services to all employees stationed at the Center.
K. Manages and evaluates program activities, continuously measures accomplishments against annual field workplan objectives, and advises the Regional Food and Drug Director regarding strategy changes needed to reach objectives or the need to adjust objectives.
L. Plans, schedules, and controls branch operations in coordination with other Agency components to which services are provided.
M. Provides administrative management support for program and operational activities, including budget, fiscal, procurement, management analysis, space and personnel management, and management of services and supplies.
N. Provides overall engineering services in design, operation, and maintenance of all environmental support systems, plants, buildings, grounds, and related equipment to support Center programs.
O. Monitors the operation of the facility to efficiently implement, operate, maintain, and conserve energy systems and resources at the Center.
P. Provides design specifications and cost data, and fabricates and modifies prototype and unique or specialized scientific equipment that is usually not available from outside sources for Center research projects and for other Agency operational laboratories.
Q. ;Maintains working liaison with other Federal offices providing support services to the Agency.
R. Coordinates the equal employment opportunity, internal security, safety, and emergency preparedness programs.
2. ANALYTICAL BRANCH (DLLRNE2).
A. Plans, schedules, and manages analytical operations; and formulates, implements, and coordinates laboratory workplans with Agency components being serviced.
B. Performs laboratory analysis of samples to:
1. Assess their compliance with laws and regulations enforced by the Agency.
2. Obtain information through national surveillance programs for the purpose of identifying potential problems or trends.
C. Provides evidence and court testimony regarding analytical findings as required.
D. Conducts research to develop and refine methods used in the analysis of samples and to explore new systems of analysis. Develops and evaluates methods for the rapid and accurate analysis of large numbers of drugs, employing combinations of complex instruments in automated systems of original design.
E. Tests samples of radiopharmaceuticals to determine compliance with official compendia, NDA specifications, or other standards. Develops methods and carries out analysis of samples of foods to determine the level of radionuclide contamination.
F. Evaluates the validity of proposed analytical methods to insure integrity of radiopharmaceuticals; devises new methods for the examination of individual radiopharmaceuticals which present analytical problems.
G. Assists investigators during inspections and investigations relating to manufacturing facilities to evaluate compliance with appropriate standards, Current Good Manufacturing Practice Regulations, and other regulations and requirements.
H. Assists official certification laboratories in testing reference standard radiopharmaceuticals for compliance with specifications.
I. Operates a quality control program to assure the reliability of analytical results obtained in the Agency and other specific laboratories to whom delegated regulatory responsibility has been given.
J. Serves as a resource in scientific knowledge and provides expert advice and training regarding laboratory techniques and technological developments to scientific bodies and institutions; other Federal, State, and local agencies; foreign counterpart agencies; and industry.
K. Serves as a resource for all Agency field activities relating to Nuclear Regulatory Commission licenses. Services radioactive detectors and provides technical support for the purchase, use, storage, and disposal of radioactive materials. Provides training and coordinates the Agency's Radiation Safety Program.
L. Participates in nationwide training programs for investigators assigned to radiopharmaceutical compliance activities.
M. Provides court testimony in areas of expertise.
3. ENGINEERING BRANCH (DLLRNE3).
A. Plans, schedules, and controls branch operations; and formulates, implements, and coordinates workplans with Agency components being serviced.
B. Provides nationwide consultation on the operation, performance and compliance testing, and evaluation of consumer and industrial products, medical devices, and other electronic, electro-mechanical, and mechanical products and devices (e.g., pacemakers, defibrillators, x-ray machines, microwave ovens, television receivers, etc.).
C. Serves as a national resource in scientific knowledge, biomedical engineering methodology, and techniques applicable to solving problems pertinent to consumer and industrial products, medical devices, and other products and devices.
D. Conducts research to develop and refine testing methodology used in the examination of products in its area of scientific specialty.
E. Reviews proposed test and evaluation methods for appropriateness, ease of use, reproducibility, accuracy, etc., and recommends modifications or new methods, as required.
F. Conducts tests and evaluations of consumer and industrial products, medical devices, and other products and devices obtained in planned surveillance programs or submitted for examination by district offices, the Center for Devices and Radiological Health, or other agencies, to assure compliance with appropriate specifications and standards.
G. Cooperates with other appropriate agencies in collaborative study programs of consumer and industrial products, medical devices, and other products and devices.
H. Conducts research to determine the significance of defects in consumer and industrial products, medical devices, and other products and devices.
I. Prepares and conducts nationwide compliance workshops on electronic products, medical devices, and other standards for manufacturers, assemblers, and appropriate State and Federal control agency personnel.
J. Participates in nationwide training programs for investigators assigned to electronic product and device compliance activities.
K. Provides expert advice and training regarding engineering techniques and technological developments to other Federal, State, and local agencies; foreign counterpart agencies; and to industry.
L. Assists investigators during inspections and investigations relating to manufacturing facilities to evaluate compliance with appropriate standards, Current Good Manufacturing Practice Regulations, and other regulations and requirements.
M. Provides court testimony regarding engineering test results, as required.
N. Performs tests and evaluations of medical devices procured by the Department of Defense.
O. Implements an effective internal quality assurance program.
4. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this District Office were approved by the Commissioner of Food and Drugs, effective August 7, 2012.