[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: 21CFR316.26]

[Page 182]
 
                        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. 316.26  Amendment to orphan-drug designation.

    (a) At any time prior to approval of a marketing application for a 
designated orphan drug, the sponsor holding designation may apply for an 
amendment to the indication stated in the orphan-drug designation if the 
proposed change is due to new and unexpected findings in research on the 
drugs, information arising from FDA recommendations, or unforeseen 
developments in treatment or diagnosis of the disease or condition.
    (b) FDA will grant the amendment if it finds that the initial 
designation request was made in good faith and that the amendment is 
intended to conform the orphan-drug designation indication to the 
results of unanticipated research findings, to unforeseen developments 
in the treatment or diagnosis of the disease or condition, or to changes 
based on FDA recommendations, and that, as of the date of the submission 
of the amendment request, the amendment would not result in exceeding 
the prevalence or cost recovery thresholds in Sec. 316.21 (a)(1) or 
(a)(2) upon which the drug was originally designated.