21 CFR 314.1 - Scope of this part.

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§ 314.1 Scope of this part.
(a) This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of applications and abbreviated applications to market a new drug under section 505 of the Federal Food, Drug, and Cosmetic Act, as well as amendments, supplements, and postmarketing reports to them.
(b) This part does not apply to drug products subject to licensing by FDA under the Public Health Service Act (58 Stat. 632 as amended (42 U.S.C. 201 et seq.)) and subchapter F of chapter I of title 21 of the Code of Federal Regulations.
(c) References in this part to regulations in the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.
[50 FR 7493, Feb. 22, 1985, as amended at 57 FR 17981, Apr. 28, 1992; 64 FR 401, Jan. 5, 1999]

Title 21 published on 2013-04-01

no entries appear in the Federal Register after this date.

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 314 after this date.

  • 2013-12-27; vol. 78 # 249 - Friday, December 27, 2013
    1. 78 FR 78796 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Correction and Extension of Comment Period
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule; correction and extension of comment period.
      FDA is extending the comment period on the proposed rule published November 13, 2013, at 78 FR 67985, and on information collection issues under the Paperwork Reduction Act of 1995. Submit either electronic or written comments on the proposed rule by March 13, 2014. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by February 11, 2014 (see the “Paperwork Reduction Act of 1995” section of the proposed rule).
      21 CFR Parts 314 and 601