21 CFR Part 1114
PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS
- PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter K—Tobacco Products
- Subpart A—General Provisions
- § 1114.1 Scope.
- § 1114.3 Definitions.
- Subpart B—Premarket Tobacco Product Applications
- § 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.
- Subpart C—FDA Review
- § 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.
- Subpart D—Postmarket Requirements
- § 1114.39 Postmarket changes.
- § 1114.41 Reporting requirements.
- Subpart E—Miscellaneous
- § 1114.45 Record retention.
- § 1114.47 Confidentiality.
- § 1114.49 Electronic submission.
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