[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: 21CFR5.28]

[Page 41-42]
 
                        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. 5.28  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 (21 U.S.C. 335, 344(b), and 381(a)); section 6 of the Fair Packaging 
and Labeling Act (15 U.S.C. 1455) (21 U.S.C. 145); section 9(b) of the 
Federal Caustic Poison Act (44 Stat. 1406; see also Public Law 86-613, 
section 19 formerly section 18); 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:
    (1) The Director and Deputy Director, Center for Food Safety and 
Applied Nutrition (CFSAN); and the Director of Regulations and Policy, 
CFSAN.
    (2) The Director and Deputy Director, the Directors, Office of 
Review Management and Office of Pharmaceutical Science, Center for Drug 
Evaluation and Research (CDER); the Associate Director for Regulatory 
Policy and the Associate Director for Medical Policy, 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 Directors for Science and for 
Regulations and Policy, Center for Devices and Radiological Health 
(CDRH).
    (4) The Director and Deputy Director, Center for Veterinary Medicine 
(CVM).
    (5) The Director and Deputy Directors, Center for Biologics 
Evaluation and Research (CBER), and the Directors and Deputy Directors, 
Office of Blood Research and Review, Office of Vaccines Research and 
Review, Office of Therapeutics Research and Review, and Office of 
Compliance and Biologics Quality, CBER.

[[Page 42]]

    (6) Regional Food and Drug Directors.
    (7) District Directors.
    (8) The Director, St. Louis Branch.
    (b) The Director and Deputy Directors for Science and for 
Regulations Policy, CDRH, are authorized to hold hearings, and to 
designate other officials to hold informal hearings, under section 
360(a) of the PHS 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 under 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 
of Food and Drugs (Commissioner).
    (2) The Director and Deputy Director, CFSAN.
    (3) The Director and Deputy Director, Center for Drug Evaluation and 
Research (CDER); the Directors, Office of Review Management and Office 
of Pharmaceutical Science, CDER; the Associate Director for Regulatory 
Policy and the Associate Director for Medical Policy, 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 for Science and for 
Regulations Policy, CDRH.
    (5) The Director and Deputy Director, CVM.
    (6) The Director and Deputy Directors, Center for Biologics 
Evaluation and Research (CBER), and the Directors and Deputy Directors, 
Office of Blood Research and Review, Office of Vaccines Research and 
Review, Office of Therapeutics Research and Review, and Office of 
Compliance and Biologics Quality, 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.
    (d) These officials may not further redelegate this authority.