[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: 21CFR5.71]

[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. 5.71  Termination of exemptions for new drugs for investigational use in human beings and in animals.

    (a) The following officials, for drugs under their jurisdiction, are 
authorized to perform all the functions of the Commissioner of Food and 
Drugs on the termination of exemptions for new drugs (including those 
that are biological products which are subject to the licensing 
provisions of the Public Health Service Act) for investigational use in 
human beings under Sec. 312.44 of this chapter and in animals under 
Sec. 312.160 of this chapter:
    (1) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER).
    (2) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (b) The following officials, for drugs under their jurisdiction, are 
authorized to terminate exemptions for new drugs for investigational use 
when sponsors fail to submit an annual progress report under 
Sec. 312.44(b)(1)(viii) of this chapter:
    (1) The Directors of the Offices of Drug Evaluation I, II, III, IV, 
and V, Office of Review Management, CDER.
    (2) 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.
    (3) The Director and Deputy Director, Office of Biological Product 
Review, CBER.
    (4) The Director and Deputy Director, Division of Biological 
Investigational New Drugs, Office of Biological Product Review.
    (c) The following officials, for drugs under their jurisdiction, are 
authorized to make the findings set forth in Sec. 312.44(b) of this 
chapter and to notify sponsors and invite correction before termination 
action on such exemptions:
    (1) The Directors of the Offices of Drug Evaluation I, II, III, IV, 
and V, Office of Review Management, CDER.
    (2) 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.
    (3) The Director and Deputy Director, Office of Biological Product 
Review, CBER.
    (4) The Director and Deputy Director, Division of Biological 
Investigational New Drugs, Office of Biological Product Review.
    (d) The following officials are authorized to perform all functions 
of the Commissioner of Food and Drugs with regard to the termination of 
new animal drugs for investigational use in animals under Sec. 511.1 of 
this chapter:
    (1) The Director and Deputy Director, Center for Veterinary Medicine 
(CVM).
    (2) The Director and Deputy Director, Office of New Animal Drug 
Evaluation, CVM.

[49 FR 14934, Apr. 16, 1984, as amended at 50 FR 14094, Apr. 10, 1985; 
52 FR 7829, Mar. 13, 1987; 54 FR 8318, Feb. 28, 1989; 55 FR 51688, Dec. 
17, 1990; 62 FR 2556, Jan. 17, 1997]