[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: 21CFR316.52]

[Page 185]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 316_ORPHAN DRUGS--Table of Contents
 
                  Subpart F_Availability of Information
 
Sec. 316.52  Availability for public disclosure of data and 
information in requests and applications.

    (a) FDA will not publicly disclose the existence of a request for 
orphan-drug designation under section 526 of the act prior to final FDA 
action on the request unless the existence of the request has been 
previously publicly disclosed or acknowledged.
    (b) Whether or not the existence of a pending request for 
designation has been publicly disclosed or acknowledged, no data or 
information in the request are available for public disclosure prior to 
final FDA action on the request.
    (c) Upon final FDA action on a request for designation, FDA will 
determine the public availability of data and information in the request 
in accordance with part 20 and Sec. 314.430 of this chapter and other 
applicable statutes and regulations.
    (d) In accordance with Sec. 316.28, FDA will make a cumulative list 
of all orphan drug designations available to the public and update such 
list monthly.
    (e) FDA will not publicly disclose the existence of a pending 
marketing application for a designated orphan drug for the use for which 
the drug was designated unless the existence of the application has been 
previously publicly disclosed or acknowledged.
    (f) FDA will determine the public availability of data and 
information contained in pending and approved marketing applications for 
a designated orphan drug for the use for which the drug was designated 
in accordance with part 20 and Sec. 314.430 of this chapter and other 
applicable statutes and regulations.