Title 21-FOOD AND DRUGS is composed of nine volumes. The parts in these volumes are arranged in the following order: Parts 1-99, 100-169, 170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300-end. The first eight volumes, containing parts 1-1299, comprise Chapter I-Food and Drug Administration, Department of Health and Human Services. The ninth volume, containing part 1300 to end, includes Chapter II-Drug Enforcement Administration, Department of Justice, and Chapter III-Office of National Drug Control Policy. The contents of these volumes represent all current regulations codified under this title of the CFR as of April 1, 2000.

Redesignation tables for Chapter I-Food and Drug Administration appear in the Finding Aids section for the volumes containing parts 170-199 and 500-599.

For this volume, Lisa N. Morris was Chief Editor. The Code of Federal Regulations publication program is under the direction of Frances D. McDonald, assisted by Alomha S. Morris.

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Drugs

(This book contains parts 1 to 99)

Part

CHAPTER I —Food and Drug Administration, Department of
Health and Human Services

1

CROSS REFERENCES: Food Safety and Inspection Service, Department of Agriculture: 9 CFR chapter III.

Federal Trade Commission: See Commercial Practices, 16 CFR chapter I.

U.S. Customs Service, Department of the Treasury: See Customs Duties, 19 CFR chapter I. Internal Revenue Service, Department of the Treasury: See Internal Revenue, 26 CFR chapter I.

Bureau of Alcohol, Tobacco, and Firearms, Department of the Treasury: See Alcohol, Tobacco Products and Firearms, 27 CFR chapter I.

Electronic records; electronic signatures
Formal evidentiary public hearing

.....

Public hearing before a public board of inquiry
Public hearing before a public advisory committee
Public hearing before the Commissioner

Regulatory hearing before the Food and Drug Ad-
ministration

113

117

134

139

165

168

Civil money penalties hearings

173

20

Standards of conduct and conflicts of interest
Public information

186

.......

188

Protection of privacy

217

25

Environmental impact considerations

233

Mutual recognition of pharmaceutical good manu-
facturing practice reports, medical device qual-
ity system audit reports, and certain medical de-
vice product evaluation reports: United States
and The European Community
Protection of human subjects

Financial disclosure by clinical investigators
Institutional Review Boards

58

Good laboratory practice for nonclinical labora

tory studies

297

60

Patent term restoration

311