1. CFR › Title 21 › Chapter I › Subchapter D › Part 316

21 CFR Part 316 - ORPHAN DRUGS

Authority:
21 U.S.C. 360aa, 360bb, 360cc, 360dd, 371.
Source:
57 FR 62085, Dec. 29, 1992, unless otherwise noted.
Editorial Note:
Nomenclature changes to part 316 appear at 69 FR 13717, Mar. 24, 2004.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

§ 360aa - Recommendations for investigations of drugs for rare diseases or conditions

§ 360bb - Designation of drugs for rare diseases or conditions

§ 360cc - Protection for drugs for rare diseases or conditions

§ 360dd - Open protocols for investigations of drugs for rare diseases or conditions

§ 371 - Regulations and hearings

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 316 after this date.

  • 2014-12-23; vol. 79 # 246 - Tuesday, December 23, 2014
    1. 79 FR 76888 - Policy on Orphan-Drug Exclusivity; Clarification
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notification; clarification on policy.
      Effective December 23, 2014.
      21 CFR Part 316