[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: 21CFR5.38]

[Page 46-47]
 
                        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. 5.38  Issuance of written notices concerning patent information, current good manufacturing practices and false or misleading labeling of new drugs, new animal drugs, and feeds bearing or containing new animal drugs.

    (a) The following officials are authorized to perform all the 
functions of the Commissioner of Food and Drugs under section 505(e) of 
the Federal Food, Drug, and Cosmetic Act (the act) regarding the 
issuance of written notices.
    (1) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER).
    (2) The Director and Deputy Director, Office of Compliance, CDER.
    (3) The Director and Deputy Director, Division of Labeling and 
Nonprescription Drug Compliance, Office of Compliance, CDER.
    (4) The Director and Deputy Director, Division of Manufacturing and 
Product Quality, Office of Compliance, CDER.
    (5) The Director and Deputy Director, Division of Prescription Drug 
Compliance and Surveillance, Office of Compliance, CDER.
    (6) The Director and Deputy Director, Division of Scientific 
Investigations, Office of Compliance, CDER.
    (7) Regional Food and Drug Directors.

[[Page 47]]

    (8) District Directors.
    (b) The following officials are authorized to perform all the 
functions of the Commissioner of Food and Drugs under sections 512(e) 
and 512 (m)(4)(B)(ii) and (m)(4)(B)(iii) of the act regarding the 
issuance of written notices.
    (1) The Director and Deputy Director, Center for Veterinary Medicine 
(CVM).
    (2) The Director and Deputy Director, Office of Surveillance and 
Compliance, CVM.
    (3) The Director, Division of Compliance, Office of Surveillance and 
Compliance, CVM.
    (4) Regional Food and Drug Directors.
    (5) District Directors.

[57 FR 18823, May 1, 1992, as amended at 62 FR 2555, Jan. 17, 1997]