FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
OFFICE OF MEDICAL PRODUCTS AND TOBACCO
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
OFFICE OF THE CENTER DIRECTOR
Effective Date: July 8, 2011
A. Coordinates Center activities regarding planning and evaluation of programs, functional activities, and resource utilization.
B. Directs Center financial and budget activities.
C. Coordinates and manages Center extramural programs, including technical and administrative contracts and grant activities.
D. Provides information on biological review process to Center and Agency level management.
E. Coordinates the performance of organization and management studies for the Center and directs implementation of study recommendations.
F. Coordinates Center activities regarding planning, implementation and evaluating programs concerning budget and resource utilization of biotechnology and biomedical issues and the Center's User Fee programs.
G. Coordinates procurement activities with designated Program Managers in each Center Office.
A. Prepares notices and proposed and final rules related to the regulation of biological products for publication in the Federal Register.
B. Coordinates for the CBER the review of Federal Register documents prepared by other centers or by other agencies; consolidates the CBER comments and represents Center position to originating office.
C. Provides copies and interpretation of the regulations to persons in the Federal government, the regulated industry and the general public; and maintains historical archives of all Federal Register documents published by the CBER.
D. Advises the CBER staff concerning the administrative procedures for rulemaking, guidelines and other policy documents, hearings and delegations of authority.
E. Prepares advisory opinions and comments in response to requests from other Agency components, industry and trade organizations.
F. Develops policy in response to emerging or existing issues which affect the products and firms regulated by the CBER.
G. Coordinates with the Office of the Chief Counsel on initiation and publication of suspension and revocation actions.
A. Responsible for receiving, tracking and storing all of CBER's regulatory submissions.
B. Provides Life-cycle Records Management support services for the Center.
A. Administers and Directs Agency Bioinformatics Initiative within CBER.
B. Formulates Information Technology budget in accordance with OIM initiatives.
C. Represents CBER regarding standards development and Data Standards Committee according to International Standards Organization (ISO).
D. Directs Agency Enterprise Information Technology Initiative implementation within CBER.
A. Responsible for creating regulations to govern the CBER business processes and the development of work aids for the review cycle.
B. Develops training modules to cover business process aspects and supports reviewer training.
C. Develops and issues letter and review templates to be used by CBER reviewers.
A. Provides administrative management and oversight for CBER/OD activities and resource allocations. Advise the Center Director and senior Center management on administrative services and develop policies and procedures for these services.
B. Plans and directs office operations for financial and personnel management.
The functional statements for this Office were approved by the Secretary of Health and Human Services on Juy 8, 2011.