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Prospective investigators seeking to obtain treatment use of designated orphan drugs may do so as provided in subpart I of this chapter.
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