[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: 21CFR316.24]

[Page 181]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 316_ORPHAN DRUGS--Table of Contents
 
                 Subpart C_Designation of an Orphan Drug
 
Sec. 316.24  Granting orphan-drug designation.

    (a) FDA will grant the request for orphan-drug designation if none 
of the reasons described in Sec. 316.25 for requiring or permitting 
refusal to grant such a request applies.
    (b) When a request for orphan-drug designation is granted, FDA will 
notify the sponsor in writing and will publicize the orphan-drug 
designation in accordance with Sec. 316.28.