[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR316.2]

[Page 174]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 316_ORPHAN DRUGS--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 316.2  Purpose.

    The purpose of this part is to establish standards and procedures 
for determining eligibility for the benefits provided for in section 2 
of the Orphan Drug Act, including written recommendations for 
investigations of orphan drugs, a 7-year period of exclusive marketing, 
and treatment use of investigational orphan drugs. This part is also 
intended to satisfy Congress' requirements that FDA promulgate 
procedures for the implementation of sections 525(a) and 526(a) of the 
act.