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
Effective Date: July 8, 2011
1. OFFICE OF BLOOD RESEARCH AND REVIEW (DKKBD).
A. Plans and conducts research related to the development, manufacture, testing and activities of biological blood products, including those related to AIDS and those prepared by genetic engineering and synthetic procedures, in order to develop and maintain a scientific base for establishing standards designed to ensure the continued safety, purity, potency and effectiveness of biological blood products.
B. Performs functions regarding blood components, blood derivatives and analogous products, and diagnostic test kits related to the blood supply and/or AIDS.
C. Plans and conducts research on the preparation, preservation, characteristics, action, and safety of blood and blood products; the methods of evaluating safety, purity, potency, and efficacy of such products; the therapeutic uses of such products; the problems concerned with products; and the testing and use of diagnostic reagents employed in grouping and typing blood, and screening for markers of infectious diseases.
D. Develops policy and procedures governing the pre-market approval review and evaluation of biological blood products in keeping with the provisions of the PHS Act and applicable provisions of the FD&C Act.
E. Review, evaluates, and takes appropriate action on investigational new drug applications (INDs) related to biological blood products and amendments or supplements to these applications. Actions include, but are not limited to, approval or disapproval of research plans and protocols, modifications, and restrictions.
F. Performs the investigational device exemption (IDE) review process for devices related to biological blood products regulated by the Office, and develops related policy.
G. Reviews, evaluates, and takes appropriate action on product applications submitted by manufacturers of biological blood products, including labeling, and proposes written and reference standards for biological blood products regulated by the Office.
H. Reviews, evaluates, and takes appropriate action on establishment license applications submitted by blood and plasma establishments and on registration and product listing forms required by Section 510d of the FD&C Act.
I. In cooperation with other Center components, as appropriate, tests products submitted for release by manufacturers.
J. In coordination with the Office of Establishment Licensing and Product Surveillance, evaluates clinical experience and reports of adverse events as necessary.
K. Participates in inspections of manufacturing facilities for compliance with applicable standards.
L. Reviews, evaluates, and takes appropriate action on recommendations concerning denial of license applications for products.
M. Administers applicable provisions of the FD&C Act as they pertain to pre-market clearance or review of certain devices and drugs that are under the jurisdiction of the Office.
N. Cooperates with other Agency components and outside organizations on a variety of issues related to these products.
2. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this Office were approved by the Secretary of Health and Human Services on July 8, 2011.
|STATUS (I, R, C)||DATE APPROVED||LOCATION OF CHANGE HISTORY||CONTACT||APPROVING OFFICIAL|
|Initial||04/09/2010||N/a||OC/OA/OM/OMP||Commissioner of Food and Drugs|
|Revision||07/08/2011||N/a||OMPT/CBER/OM||Secretary of Health and Human Services|