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