[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: 21CFR5.37]

[Page 45-46]
 
                        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. 5.37  Issuance of reports of minor violations.

    (a) The following officials are authorized to perform all the 
functions of the Commissioner of Food and Drugs under section 309 of the 
Federal Food, Drug, and Cosmetic Act regarding the issuance of written 
notices or warnings:
    (1)(i) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER).
    (ii) The Director and Deputy Director, Office of Compliance, CBER.
    (2)(i) The Director and Deputy Directors, 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 Directors, Center for Food Safety and 
Applied Nutrition, (CFSAN).
    (ii) The Director, Office of Policy, Planning, and Strategic 
Initiatives, CFSAN.
    (iii) The Director, Office of Field Programs, CFSAN.

[[Page 46]]

    (iv) The Director, Division of Enforcement, 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, Deputy Center Director for Review Management, 
and Deputy Center Director for 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 Drug Evaluation I, Office of Review 
Management, 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.
    (b) The following officials are authorized to perform all the 
functions of the Commissioner of Food and Drugs under section 539(d) of 
the Federal Food, Drug, and Cosmetic Act regarding the issuance of 
written notices or warnings:
    (1) The Director and Deputy Directors, 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, OSB, CDRH, and the Director 
and Deputy Director, 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; and 
the Director, National Forensic Chemistry Center, 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.

[48 FR 8441, Mar. 1, 1983, as amended at 48 FR 56946, Dec. 27, 1983; 49 
FR 14933, 14936, Apr. 16, 1984; 51 FR 32452, Sept. 12, 1986; 54 FR 8317, 
Feb. 28, 1989; 55 FR 47053, Nov. 9, 1990; 57 FR 40318, Sept. 3, 1992; 59 
FR 42491, Aug. 18, 1994; 60 FR 15871, Mar. 28, 1995; 62 FR 2555, Jan. 
17, 1997; 62 FR 67271, Dec. 24, 1997; 64 FR 4965, Feb. 2, 1999]