[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.102]

[Page 69]
 
                        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. 5.102  Authority to approve and to withdraw approval of a charge 
for investigational new drugs.

    (a) The following officials, for drugs under their jurisdiction, are 
authorized to perform all the functions of the Commissioner of Food and 
Drugs to approve a charge and to withdraw approval to charge for 
investigational drugs in a clinical trial under an investigational new 
drug application under Sec. 312.7(d)(1) of this chapter:
    (1) The Director, the Deputy Director, and the Directors, Office of 
Review Management and the Office of Pharmaceutical Science, Center for 
Drug Evaluation and Research.
    (2) The Director and Deputy Directors, Center for Biologics 
Evaluation and Research.
    (b) These officials may not further redelegate this authority.