Source: http://www.law.cornell.edu/cfr/text/21/316?quicktabs_7=0
Timestamp: 2013-12-05 20:43:33
Document Index: 350944803

Matched Legal Cases: ['art 316', 'art 316', 'art 316', '§ 316', '§ 316', '§ 316', '§ 316', '§ 316', '§ 316', 'art 316', 'art 316', '§ 360', '§ 360', '§ 360', '§ 360', '§ 371']

21 CFR Part 316 - ORPHAN DRUGS | Title 21 - Food and Drugs | Code of Federal Regulations | LII / Legal Information Institute
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21 CFR Part 316 - ORPHAN DRUGS
There is 1 rule appearing in the Federal Register for 21 CFR 316. Select the tab below to view, or View eCFR (GPOAccess)
SUBPART A — General Provisions (§§ 316.1 - 316.4)
SUBPART B — Written Recommendations for Investigations of Orphan Drugs (§§ 316.10 - 316.14)
SUBPART C — Designation of an Orphan Drug (§§ 316.20 - 316.30)
SUBPART D — Orphan-drug Exclusive Approval (§§ 316.31 - 316.36)
SUBPART E — Open Protocols for Investigations (§§ 316.40 - 316.40)
SUBPART F — Availability of Information (§§ 316.50 - 316.52)
21 U.S.C. 360aa, 360bb, 360cc, 360dd, 371.
57 FR 62085, Dec. 29, 1992, unless otherwise noted.
Nomenclature changes to part 316 appear at 69 FR 13717, Mar. 24, 2004.
Title 21 published on 2013-04-01The 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.2013-06-12; vol. 78 # 113 - Wednesday, June 12, 201378 FR 35117 - Orphan Drug Regulations
typeregulations.gov FR Doc.2013-13930 RIN0910-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 SummaryThe 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.United States CodeUSC : 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 2013-04-01The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 316 after this date.2013-06-12; vol. 78 # 113 - Wednesday, June 12, 201378 FR 35117 - Orphan Drug Regulations