[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: 21CFR5.202]

[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. 5.202  Issuance of notices of opportunity for a hearing on proposals 
for denial of approval of applications for licenses, suspension of 
licenses, or revocation of licenses and certain notices of revocation of 
licenses.

    (a) The Director and Deputy Directors, Center for Biologics 
Evaluation and Research are authorized to issue:
    (1) Notices of opportunity for a hearing on proposals to deny 
approval or filing of applications for biologics licenses under 
Sec. 601.4(b) of this chapter.
    (2) Notices of opportunity for a hearing on proposals to revoke 
biologics licenses under Sec. 601.5(b) of this chapter.
    (3) Notices of revocation, at the manufacturer's request, of 
biologics licenses under Secs. 601.5(a) and 601.8 of this chapter.
    (4) Notices of revocation when the manufacturer has waived the 
opportunity for hearing under Sec. 601.7(a) of this chapter.
    (5) Notice of biologics license suspensions under Sec. 601.6 of this 
chapter.
    (b) These officials may not further redelegate these authorities.