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Regulations last checked for updates: Nov 22, 2024
Title 21 - Food and Drugs last revised: Nov 19, 2024
All Titles
Title 21
Chapter I
Part 10
Subpart B - Subpart B—General Administrative Procedures
§ 10.20 - Submission of documents to Dockets Management Staff; computation of time; availability for public disclosure.
§ 10.25 -
§ 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.
authority:
5 U.S.C. 551-558
,
701
;
15 U.S.C. 1451-1461
;
21 U.S.C. 141-149
,
321
,
467f
,
679
,
821
,
1034
;
28 U.S.C. 2112
;
42 U.S.C. 201
,
262
,
263b
,
264
source:
44 FR 22323, Apr. 13, 1979, unless otherwise noted.
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