[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: 21CFR5.44]

[Page 47-48]
 
                        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. 5.44  Export of unapproved drugs.

    (a) The following officials are authorized, under section 802(b) of 
the Federal Food, Drug, and Cosmetic Act, to approve or disapprove 
applications to export unapproved new drugs and biological products and 
to issue notices of receipt of such applications:
    (1) For human drugs assigned to their respective organizations:
    (i) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER).
    (ii) The Director and Deputy Director, Office of Compliance, CBER.
    (iii) The Director, Deputy Center Director for Review Management, 
and Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (iv) The Director and Deputy Director, Office of Compliance, CDER.
    (2) For new animal drugs assigned to their respective organizations:
    (i) The Director and Deputy Director, Center for Veterinary Medicine 
(CVM).
    (ii) The Director and Deputy Director, Office of New Animal Drug 
Evaluation, CVM.
    (b) The following officials are authorized, under section 802(f) of 
the Federal Food, Drug, and Cosmetic Act, to approve or disapprove an 
application to export a drug (including a biological product) to be used 
in the prevention or treatment of a tropical disease:
    (1) For human drugs assigned to their respective organizations:
    (i) The Director and Deputy Director, CBER.
    (ii) The Director and Deputy Director, Office of Compliance, CBER.
    (iii) The Director, Deputy Center Director for Review Management, 
and Deputy Center Director for Pharmaceutical Science, CDER.
    (iv) The Director and Deputy Director, Office of Compliance, CDER.
    (2) For veterinary drugs subject to their jurisdiction:
    (i) The Director and Deputy Director, CVM.
    (ii) The Director and Deputy Director, Office of New Animal Drug 
Evaluation, CVM.
    (c) The following officials are authorized, under section 351(h) of 
the Public

[[Page 48]]

Health Service Act, to approve or disapprove an application to export a 
partially processed biological product:
    (1) The Director and Deputy Director, CBER.
    (2) The Director and Deputy Director, Office of Compliance, CBER.

[52 FR 7269, Mar. 10, 1987, as amended at 54 FR 8317, Feb. 28, 1989; 62 
FR 2555, Jan. 17, 1997]