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Electronic Code of Federal Regulations

e-CFR data is current as of February 19, 2020

Title 21Chapter ISubchapter APart 10


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A—GENERAL

PART 10—ADMINISTRATIVE PRACTICES AND PROCEDURES

rule

Subpart A—GENERAL PROVISIONS

§10.1
Scope.
§10.3
Definitions.
§10.10
Summaries of administrative practices and procedures.
§10.19
Waiver, suspension, or modification of procedural requirements.
rule

Subpart B—GENERAL ADMINISTRATIVE PROCEDURES

§10.20
Submission of documents to Division of Dockets Management; computation of time; availability for public disclosure.
§10.25
Initiation of administrative proceedings.
§10.30
Citizen petition.
§10.31
Citizen petitions and petitions for stay of action related to abbreviated new drug applications, certain new drug applications, or certain biologics license applications.
§10.33
Administrative reconsideration of action.
§10.35
Administrative stay of action.
§10.40
Promulgation of regulations for the efficient enforcement of the law.
§10.45
Court review of final administrative action; exhaustion of administrative remedies.
§10.50
Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.
§10.55
Separation of functions; ex parte communications.
§10.60
Referral by court.
§10.65
Meetings and correspondence.
§10.70
Documentation of significant decisions in administrative file.
§10.75
Internal agency review of decisions.
§10.80
Dissemination of draft Federal Register notices and regulations.
§10.85
Advisory opinions.
§10.90
Food and Drug Administration regulations, recommendations, and agreements.
§10.95
Participation in outside standard-setting activities.
§10.100
Public calendar.
§10.105
Representation by an organization.
§10.110
Settlement proposals.
§10.115
Good guidance practices.
rule

Subpart C—ELECTRONIC MEDIA COVERAGE OF PUBLIC ADMINISTRATIVE PROCEEDINGS; GUIDELINE ON POLICY AND PROCEDURES

§10.200
Scope.
§10.203
Definitions.
§10.204
General.
§10.205
Electronic media coverage of public administrative proceedings.
§10.206
Procedures for electronic media coverage of agency public administrative proceedings.

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