[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.33]

[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--General Redelegations of Authority
 
Sec. 5.33  Issuance of reports of minor violations.

    (a) The following officials are authorized to perform all the 
functions of the Commissioner of Food and Drugs (Commissioner) under 
section 309 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 336) 
(the act) regarding the issuance of written notices or warnings:
    (1)(i) The Director and Deputy Directors, Center for Biologics 
Evaluation and Research (CBER).
    (ii) The Director and Deputy Directors, Office of Compliance and 
Biologics Quality, CBER.
    (2)(i) The Director and Deputy Directors for Science and for 
Regulations and Policy, Center for Devices and Radiological Health 
(CDRH).
    (ii) The Director and Deputy Director, Office of Compliance, CDRH.
    (iii) For medical devices assigned to their respective divisions, 
the Division Directors, Office of Compliance, CDRH.
    (iv) The Director and Deputy Director, Office of Surveillance and 
Biometrics (OSB), CDRH, and the Director and Deputy Director, Division 
of Surveillance Systems (DSS), OSB, CDRH.
    (3)(i) The Director and Deputy Director, Center for Food Safety and 
Applied Nutrition, (CFSAN).
    (ii) The Director of Regulations and Policy, CFSAN.
    (iii) The Director, Office of Field Programs, CFSAN.
    (iv) The Director, Division of Enforcement and Programs, Office of 
Field Programs, CFSAN.
    (4)(i) The Director and Deputy Director, Center for Veterinary 
Medicine (CVM).
    (ii) The Director and Deputy Director, Office of Surveillance and 
Compliance, CVM.
    (iii) The Director, Division of Compliance, Office of Surveillance 
and Compliance, CVM.
    (5)(i) The Director, the Deputy Director, the Associate Director for 
Regulatory Policy, and the Directors, Office of Review Management and 
Office of Pharmaceutical Science, Center for Drug Evaluation and 
Research (CDER).
    (ii) The Director and Deputy Director, Office of Compliance, CDER.
    (iii) The Associate Director for Medical Policy, CDER.
    (iv) The Director, Division of Drug Marketing, Advertising, and 
Communications, Office of Medical Policy, CDER.
    (6)(i) Regional Food and Drug Directors.
    (ii) District Directors.
    (iii) Chiefs of District Compliance Branches.
    (iv) The Director, St. Louis Branch.
    (v) The Director, Northeast Regional Laboratory, Northeast Region.
    (vi) The Director, Southeast Regional Laboratory, Southeast Region.
    (vii) The Director, Winchester Engineering and Analytical Center.
    (viii) The Director, National Forensic Chemistry Center.
    (ix) The Director, Arkansas Regional Laboratory.

[[Page 47]]

    (b) The following officials are authorized to perform all the 
functions of the Commissioner under section 539(d) of the act (21 U.S.C. 
360pp(d)) regarding the issuance of written notices or warnings:
    (1) The Director and Deputy Directors for Science and for 
Regulations and Policy, Center for Devices and Radiological Health 
(CDRH).
    (2) The Director and Deputy Director, Office of Compliance, CDRH.
    (3) For medical devices assigned to their respective divisions, the 
Division Directors, Office of Compliance, CDRH.
    (4) The Director and Deputy Director, Office of Surveillance and 
Biometrics (OSB), CDRH, and the Director and Deputy Director, Division 
of Surveillance Systems (DSS), OSB, CDRH.
    (5) Regional Food and Drug Directors; District Directors; the 
Director, St. Louis Branch; the Director, Northeast Regional Laboratory, 
Northeast Region; the Director, Southeast Regional Laboratory, Southeast 
Region; the Director, Winchester Engineering and Analytical Center; the 
Director, National Forensic Chemistry Center, and the Director, Arkansas 
Regional Laboratory when such functions relate to:
    (i) Assemblers of diagnostic x-ray systems, as defined in 
Sec. 1020.30(b) of this chapter; and
    (ii) Manufacturers of sunlamp products and ultraviolet lamps 
intended for use in any sunlamp product as defined in Sec. 1040.20(b) of 
this chapter.
    (c) These officials may not further redelegate these authorities.