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Part 1114
FEDERAL · 21 CFR
Part 1114 — Premarket Tobacco Product Applications
21 sections · Title 21: Food and Drugs
§ 1114.1
Scope.
§ 1114.3
Definitions.
§ 1114.5
Application submission.
§ 1114.7
Required content and format.
§ 1114.9
Amendments.
§ 1114.11
Withdrawal by applicant.
§ 1114.13
Change in ownership of an application.
§ 1114.15
Supplemental applications.
§ 1114.17
Resubmissions.
§ 1114.25
Communication between FDA and applicants.
§ 1114.27
Review procedure.
§ 1114.29
FDA action on an application.
§ 1114.31
Issuance of a marketing granted order.
§ 1114.33
Issuance of a marketing denial order.
§ 1114.35
Withdrawal of a marketing granted order.
§ 1114.37
Temporary suspension of a marketing granted order.
§ 1114.39
Postmarket changes.
§ 1114.41
Reporting requirements.
§ 1114.45
Record retention.
§ 1114.47
Confidentiality.
§ 1114.49
Electronic submission.