[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.72]

[Page 58]
 
                        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 B--Redelegations of Authority from the Commissioner of Food and 
                                  Drugs
 
Sec. 5.72  Authority to approve and to withdraw approval of a charge for investigational new drugs.

    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:
    (a) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (b) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER).

[55 FR 5445, Feb. 15, 1990, as amended at 62 FR 2556, Jan. 17, 1997]