[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR316.34]

[Page 177]
 
                        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 D--Orphan-drug Exclusive Approval
 
Sec. 316.34  FDA recognition of exclusive approval.

    (a) FDA will send the sponsor (or, the permanent-resident agent, if 
applicable) timely written notice recognizing exclusive approval once 
the marketing application for a designated orphan-drug product has been 
approved. The written notice will inform the sponsor of the requirements 
for maintaining orphan-drug exclusive approval for the full 7-year term 
of exclusive approval.
    (b) When a marketing application is approved for a designated orphan 
drug that qualifies for exclusive approval, FDA will publish in its 
publication entitled ``Approved Drug Products with Therapeutic 
Equivalence Evaluations'' information identifying the sponsor, the drug, 
and the date of termination of the orphan-drug exclusive approval. A 
subscription to this publication and its monthly cumulative supplements 
is available from the Superintendent of Documents, Government Printing 
Office, Washington, DC 20402-9325.