[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: 21CFR5.101]

[Page 68-69]
 
                        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. 5.101  Termination of exemptions for new drugs for investigational 
use in human beings.

    (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 Directors, Center for Biologics 
Evaluation and Research (CBER).
    (2) The Director, the Deputy Director, and the Directors, Office of 
Review Management and Pharmaceutical Science, Center for Drug Evaluation 
and Research (CDER).
    (3) The Director and Deputy Directors for Science and for 
Regulations and Policy, Center for Devices and Radiological Health 
(CDRH).
    (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 and Deputy 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 Directors and Deputy Directors, Office of Blood Research and 
Review (OBRR), OVRR, and Office of Therapeutics Research and Review 
(OTRR), CBER.
    (4) The Directors and Deputy Directors of the Division of Blood 
Applications, OBRR, the Division of Vaccines and Related Products 
Applications, OVRR, and the Division of Application Review and Policy, 
OTRR, CBER.
    (5) The Director and Deputy Directors, Office of Device Evaluation 
(ODE), CDRH.
    (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 and Deputy 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 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.

[[Page 69]]

    (4) The Directors and Deputy Directors of the Division of Blood 
Applications, OBRR, the Division of Vaccines and Related Products 
Applications, OVRR, and the Division of Application Review and Policy, 
OTRR, CBER.
    (5) The Director and Deputy Directors, ODE, CDRH.
    (d) These officials may not further redelegate these authorities.