21 CFR Part 316 - ORPHAN DRUGS | US Law | LII / Legal Information Institute

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 09-Jun-2018 03:51

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

79 FR 76888 - Policy on Orphan-Drug Exclusivity; Clarification

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2014-29920
RIN
Docket No.	FDA-2011-N-0583

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Notification; clarification on policy.

Effective December 23, 2014.

21 CFR Part 316

Summary

The Food and Drug Administration (FDA) is publishing this document to clarify its policy regarding certain aspects of orphan-drug exclusivity. This document is being published because of a recent court decision interpreting provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Orphan Drug Act.

2013-06-12; vol. 78 # 113 - Wednesday, June 12, 2013

78 FR 35117 - Orphan Drug Regulations

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-13930
RIN	0910-AG72
Docket No.	FDA-2011-N-0583

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final rule.

This rule is effective August 12, 2013.

21 CFR Part 316

Summary

The Food and Drug Administration (FDA) is issuing final regulations amending the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. These amendments are intended to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued.