[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.107]

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                        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 C--Human Drugs; Redelegations of Authority
 
Sec. 5.107  Extensions or stays of effective dates for compliance with certain labeling requirements for human prescription drugs.

    (a) The following officials are authorized to extend or stay an 
effective date in Sec. 201.59 of this chapter for compliance with 
certain labeling requirements for human prescription drugs.
    (1) For drugs assigned to their organizations:
    (i) The Director and Deputy Directors, Center for Biologics 
Evaluation and Research (CBER).
    (ii) The Directors and Deputy Directors, Office of Blood Research 
and Review (OBRR), Office of Vaccines Research and Review (OVRR), and 
Office of Therapeutics Research and Review (OTRR), CBER.
    (iii) The Directors and Deputy Directors of the Divisions in OBRR, 
OVRR, and OTRR, CBER.
    (2) For drugs assigned to their organizations:
    (i) The Director, the Deputy Director, and the Directors, Office of 
Review Management and Office of Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (ii) The Directors and Deputy Directors of the Offices of Drug 
Evaluation I, II, III, IV, and V, Office of Review Management, CDER.
    (iii) The Directors and Deputy Directors of the divisions in the 
Offices of Drug Evaluation I, II, III, IV, and V, Office of Review 
Management, CDER.
    (b) These officials may not further redelegate this authority.

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