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.

{'United States Code': [{'Title': '21', 'Section': '360aa', 'headtext': ' Recommendations for investigations of drugs for rare diseases or conditions', 'cleanpath': '/uscode/text/21/360aa'}, {'Title': '21', 'Section': '360bb', 'headtext': ' Designation of drugs for rare diseases or conditions', 'cleanpath': '/uscode/text/21/360bb'}, {'Title': '21', 'Section': '360cc', 'headtext': ' Protection for drugs for rare diseases or conditions', 'cleanpath': '/uscode/text/21/360cc'}, {'Title': '21', 'Section': '360dd', 'headtext': ' Open protocols for investigations of drugs for rare diseases or conditions', 'cleanpath': '/uscode/text/21/360dd'}, {'Title': '21', 'Section': '371', 'headtext': ' Regulations and hearings', 'cleanpath': '/uscode/text/21/371'}], 'Statutes at Large': [], 'Public Laws': [], 'Presidential Documents': []}