[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.109]

[Page 51]
 
                        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. 5.109  Issuance of written notices concerning patent information, current good manufacturing practices and false or misleading labeling of new drugs.

    (a) The following officials are authorized to perform all the 
functions of the Commissioner of Food and Drugs under Sec. 505(e) of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e)) 
regarding the issuance of written notices.
    (1) The Director, the Deputy Director, and the Directors, Office of 
Review Management and Office of 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 Associate Director for Medical Policy, and the Director and 
Deputy Director, Division of Scientific Investigations, Office of 
Medical Policy, CDER.
    (7) The Director and Deputy Directors, Center for Biologics 
Evaluation and Research (CBER), the Director and Deputy Directors, 
Office of Compliance and Biologics Quality (OCBQ), CBER, and the 
Directors, Division of Case Management, Division of Inspections and 
Surveillance, and Division of Manufacturing and Product Quality, OCBQ, 
CBER.
    (8) The Director and Deputy Directors for Science and for 
Regulations and Policy, Center for Devices and Radiological Health 
(CDRH), and the Director and Deputy Directors of the Office of Device 
Evaluation, CDRH.
    (9) Regional Food and Drug Directors.
    (10) District Directors.
    (b) These officials may not further redelegate this authority.