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 BLOOD RESEARCH AND REVIEW
DIVISION OF BLOOD APPLICATIONS
Effective Date: July 8, 2011
1. DIVISION OF BLOOD APPLICATIONS (DKKBDC).
A. Reviews, evaluates, and recommends appropriate action on blood and plasma product license applications/biologics license applications (PLAs/BLAs), establishment license applications (ELAs), and related supplements.
B. Conducts initial administrative and regulatory review of transfusion transmitted disease diagnostics and hematologic product license applications and supplements. Coordinates and facilitates management review of actions and policies proposed by Divisions with other Center components regarding license applications and amendments.
C. Directs and coordinates the IND review process with regard to blood and analogous products and certain other drugs, and coordinates the IDE review process for devices regulated by the Office. Develops related policy and coordinates the review of procedures for manufacturing and quality control testing of experimental products by other Office and Center components.
D. Directs and coordinates the approval process of new drug applications (NDAs) and medical device (PMA and 510(k)) submissions relating to the collection and/or use of blood-related and other products regulated by the Center.
E. Develops and maintains scientific programs to conduct review of factors affecting the safety and effectiveness of whole blood and blood components, red blood cells, plasma, and source leukocytes, and blood and plasma derivatives.
F. Develops and maintains scientific programs for the evaluation of blood grouping reagents and related in vitro diagnostic tests (except for infectious disease markers); medical devices; blood cell separators; and other equipment used for blood collection, processing, and quality control.
G. Develops and maintains, in coordination with other Center components, programs for the evaluation of computer software employed in the operation of blood establishments and the control of automated devices for the collection and processing of blood, blood components, and source plasma.
H. Maintains blood bank and plasmapheresis center establishment licensing records and coordinates licensing activities among Center components. Requests inspections of biological product firms prior to approval of licenses and participates in the review of findings to determine adherence with license applications.
I. Maintains the blood registration program and assists manufacturers in determining applicability of registration requirements.
J. Evaluates adverse experience reports and inspection results indicating regulatory violations and determines or advises on appropriate action. Conducts inspections of licensed and unlicensed blood establishments and manufacturing facilities.
K. Reviews regulations and guidelines setting forth administrative and regulatory applications for procedures in the biological licensing area.
L. Initiates the development of regulatory policies respecting blood establishments and blood component manufacturing.
M. Conducts or coordinates, for the Office, written and oral communication with sponsors/manufacturers. Coordinates, schedules, and conducts all meetings between sponsors/manufacturers and Office personnel.
N. Provides regulatory guidance and advice to other Agency components, governmental agencies, manufacturers, and consumers on applications for biologics and drugs and devices under the Center's jurisdiction. Provides consultation and serves as the primary source of information within the Agency on blood and analogous products. Maintains liaison with governmental and non-governmental organizations.
O. Cooperates with the Office of Therapeutics Research and Review in the regulatory review and management of matters related to Banked Human Tissues.
2. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this Division were approved by the Secretary of the Department of Health and Human Services on July 8, 2011.