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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2018]
[CITE: 21CFR316]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE
 
PART 316ORPHAN DRUGS
 

Subpart E--Open Protocols for Investigations

Sec. 316.40 Treatment use of a designated orphan drug.

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

[74 FR 40945, Aug. 13, 2009]

Authority: 21 U.S.C. 360aa, 360bb, 360cc, 360dd, 371.
Source: 57 FR 62085, Dec. 29, 1992, unless otherwise noted.

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