CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER K - TOBACCO PRODUCTS

PART 1114 PREMARKET TOBACCO PRODUCT APPLICATIONS

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.

Authority: 21 U.S.C. 371, 374, 387a, 387i, 387j; Pub. L. 117-103, 136 Stat. 49.
Source: 86 FR 55412, Oct. 4, 2021, unless otherwise noted.