[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: 21CFR5.30]

[Page 39-40]
 
                        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. 5.30  Hearings.

    (a) The following officials are authorized to designate officials to 
hold informal hearings that relate to their assigned functions under 
sections 305, 404(b), and 801(a) of the Federal Food, Drug, and Cosmetic 
Act; section 6 of the Fair Packaging and Labeling Act; section 9(b) of 
the Federal Caustic Poison Act; and section 5 of the Federal Import Milk 
Act. Officials so designated are delegated authority vested in the 
Secretary of Agriculture by 7 U.S.C. 2217 (43 Stat. 803) to administer 
to take from any person an oath, affirmation, affidavit, or deposition 
for use in any prosecution or proceeding under, or in enforcement of, 
any law as cited in this part:

[[Page 40]]

    (1) The Director and Deputy Directors, Center for Food Safety and 
Applied Nutrition (CFSAN), and the Director, Office of Policy, Planning, 
and Strategic Initiatives, CFSAN.
    (2) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER); the Directors of the Offices of Drug 
Evaluation I, II, III, IV, and V, Office of Review Management, CDER; and 
the Director and Deputy Director, Office of Compliance, CDER.
    (3) The Director and Deputy Director, Center for Devices and 
Radiological Health (CDRH).
    (4) The Director and Deputy Director, Center for Veterinary Medicine 
(CVM).
    (5) The Director and Deputy Director, Center for Biologics 
Evaluation and Research (CBER), and the Directors and Deputy Directors 
of the Offices of Biological Product Review, Biologics Research, and 
Compliance, CBER.
    (6) Regional Food and Drug Directors.
    (7) District Directors.
    (8) The Director, St. Louis Branch.
    (b) The Director and Deputy Directors, CDRH, are authorized to hold 
hearings, and to designate other officials to hold informal hearings, 
under section 360(a) of the Public Health Service Act.
    (c) The following officials are authorized to serve as the presiding 
officer, and to designate other Food and Drug Administration employees 
to serve as the presiding officer, at a regulatory hearing and to 
conduct such a hearing pursuant to the provisions of part 16 of this 
chapter. An official can serve as the presiding officer in a particular 
hearing only if he or she satisfies the requirements of Sec. 16.42(b) of 
this chapter with respect to the action that is the subject of the 
hearing. Such officials are delegated authority vested in the Secretary 
of Agriculture by 7 U.S.C. 2217 (43 Stat. 803) to administer or to take 
from any person an oath, affirmation, or deposition for use in any 
prosecution or proceeding under, or in enforcement of, any law as cited 
in this part:
    (1) The Chief Mediator and Ombudsman, Office of the Ombudsman, 
Office of the Senior Associate Commissioner, Office of the Commissioner.
    (2) The Director and Deputy Directors, CFSAN.
    (3) The Director, Deputy Center Director for Review Management, and 
Deputy Center Director for Pharmaceutical Science, CDER; the Directors 
of the Offices of Drug Evaluation I, II, III, IV, and V, Office of 
Review Management, CDER; and the Director and Deputy Director, Office of 
Compliance, CDER.
    (4) The Director and Deputy Directors, CDRH.
    (5) The Director and Deputy Director, CVM.
    (6) The Director and Deputy Director, CBER, and the Directors and 
Deputy Directors of the Offices of Biological Product Review, Biologics 
Research, and Compliance, CBER.
    (7) Regional Food and Drug Directors.
    (8) District Directors.
    (9) The Director, St. Louis Branch.
    (10) Such other FDA official as is designated by the Commissioner by 
memorandum in the proceeding.

[48 FR 8440, Mar. 1, 1983, as amended at 48 FR 56946, Dec. 27, 1983; 49 
FR 14932, 14936, Apr. 16, 1984; 51 FR 32452, Sept. 12, 1986; 54 FR 8316, 
Feb. 28, 1989; 54 FR 9034, Mar. 3, 1989; 59 FR 42491, Aug. 18, 1994; 62 
FR 2554, Jan. 17, 1997; 62 FR 67270, Dec. 24, 1997; 65 FR 34962, June 1, 
2000]