[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: 21CFR316.28]

[Page 183]
 
                        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 C--Designation of an Orphan Drug
 
Sec. 316.28  Publication of orphan-drug designations.

    Each month FDA will update a publically available list of drugs 
designated as orphan drugs. A cumulative, updated list of all designated 
drugs will be provided annually. These will be placed on file at the FDA 
Dockets Management Branch, and will contain the following information:
    (a) The name and address of the manufacturer and sponsor;
    (b) The generic name and trade name, if any, of the drug and the 
date of the granting of orphan-drug designation;
    (c) The rare disease or condition for which orphan-drug designation 
was granted; and
    (d) The proposed indication for use of the drug.