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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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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).

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER K - TOBACCO PRODUCTS
 
PART 1107EXEMPTION REQUESTS AND SUBSTANTIAL EQUIVALENCE REPORTS
 

Subpart A - Exemptions
   § 1107.1 - Exemptions.
   § 1107.3 - Recordkeeping.

Subpart B - General
   § 1107.10 - Scope.
   § 1107.12 - Definitions.

Subpart C - Substantial Equivalence Reports
   § 1107.16 - Submission of a substantial equivalence report.
   § 1107.18 - Required content and format of an SE Report.
   § 1107.19 - Comparison information.
   § 1107.20 - Amendments.
   § 1107.22 - Withdrawal by applicant.
   § 1107.24 - Change in ownership of an SE Report.

Subpart D - FDA Review
   § 1107.40 - Communications between FDA and applicants.
   § 1107.42 - Review cycles.
   § 1107.44 - FDA action on an SE Report.
   § 1107.46 - Issuance of an order finding a new tobacco product substantially equivalent.
   § 1107.48 - Issuance of an order denying marketing authorization.
   § 1107.50 - Rescission of order.

Subpart E - Miscellaneous
   § 1107.58 - Record retention.
   § 1107.60 - Confidentiality.
   § 1107.62 - Electronic submission.

Authority: 21 U.S.C. 371, 374, 387e(j), 387i, 387j; Pub. L. 117-103, 136 Stat. 49.
Source: 76 FR 38974, July 5, 2011, unless otherwise noted.

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