Title 21 published on 2013-04-01
The following are only the Rules published in the Federal Register after the published date of Title 21.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
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.
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.
§ 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
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 316 after this date.