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e-CFR data is current as of August 4, 2020

Title 21Chapter IIPart 1316


TITLE 21—Food and Drugs

CHAPTER II—DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE

PART 1316—ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES

rule

Subpart A—ADMINISTRATIVE INSPECTIONS

§1316.01
Scope of subpart A.
§1316.02
Definitions.
§1316.03
Authority to make inspections.
§1316.04
Exclusion from inspection.
§1316.05
Entry.
§1316.06
Notice of inspection.
§1316.07
Requirement for administrative inspection warrant; exceptions.
§1316.08
Consent to inspection.
§1316.09
Application for administrative inspection warrant.
§1316.10
Administrative probable cause.
§1316.11
Execution of warrants.
§1316.12
Refusal to allow inspection with an administrative warrant.
§1316.13
Frequency of administrative inspections.
rule

Subpart B—PROTECTION OF RESEARCHERS AND RESEARCH SUBJECTS

§1316.21
Definitions.
§1316.22
Exemption.
§1316.23
Confidentiality of identity of research subjects.
§1316.24
Exemption from prosecution for researchers.
rule

Subpart C—ENFORCEMENT PROCEEDINGS

§1316.31
Authority for enforcement proceeding.
§1316.32
Notice of proceeding; time and place.
§1316.33
Conduct of proceeding.
§1316.34
Records of proceeding.
rule

Subpart D—ADMINISTRATIVE HEARINGS

§1316.41
Scope of subpart D.
§1316.42
Definitions.
§1316.43
Information; special instructions.
§1316.44
Waiver or modification of rules.
§1316.45
Filings; address; hours.
§1316.46
Inspection of record.
§1316.47
Request for hearing.
§1316.48
Notice of appearance.
§1316.49
Waiver of hearing.
§1316.50
Appearance; representation; authorization.
§1316.51
Conduct of hearing and parties; ex parte communications.
§1316.52
Presiding officer.
§1316.53
Time and place of hearing.
§1316.54
Prehearing conference.
§1316.55
Prehearing ruling.
§1316.56
Burden of proof.
§1316.57
Submission of documentary evidence and affidavits and identification of witnesses subsequent to prehearing conference.
§1316.58
Summary of testimony; affidavits.
§1316.59
Submission and receipt of evidence.
§1316.60
Objections; offer of proof.
§1316.61
Exceptions to rulings.
§1316.62
Interlocutory appeals from rulings of the presiding officer.
§1316.63
Official transcript; index; corrections.
§1316.64
Proposed findings of fact and conclusions of law.
§1316.65
Report and record.
§1316.66
Exceptions.
§1316.67
Final order.
§1316.68
Copies of petitions for judicial review.

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