[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.203]

[Page 53]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents
 
            Subpart D--Biologics; Redelegations of Authority
 
Sec. 5.203  Issuance and revocation of licenses for the propagation or manufacture and preparation of biological products.

    (a) The following officials are authorized to issue licenses under 
section 351 of the PHS Act (42 U.S.C. 262) for the propagation or 
manufacture and preparation of biological products as specified in the 
PHS Act, and to revoke such licenses at the manufacturer's request:
    (1) The Director and Deputy Directors, Center for Biologics 
Evaluation and Research (CBER).
    (2) Directors and Deputy Directors, Office of Blood Research and 
Review, Office of Vaccines Research and Review, Office of Therapeutics 
Research and Review, and Office of Compliance and Biologics Quality, 
CBER.
    (b) These officials may not further redelegate this authority.