[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR316.40]

[Page 185]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 316--ORPHAN DRUGS--Table of Contents
 
              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 Sec. 312.34 of this 
chapter.