[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR99.303]

[Page 453]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 99_DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED 
 
     Subpart D_FDA Action on Submissions, Requests, and Applications
 
Sec.  99.303  Extension of time for completing planned studies.

    (a) Upon review of a drug or device manufacturer's proposed 
protocols and schedules for conducting studies needed for the submission 
of a supplemental application for a new use, FDA may, with or without a 
request for an extension from the manufacturer, determine that such 
studies cannot be completed and submitted within 36 months. The agency 
may exercise its discretion in extending the time period for completing 
the studies and submitting a supplemental application. Extensions under 
this paragraph are not subject to any time limit, but shall be made 
before the manufacturer begins the studies needed for the submission of 
a supplemental application for the new use.
    (b) The manufacturer may, after beginning the studies needed for the 
submission of a supplemental application for a new use, request in 
writing that FDA extend the time period for conducting studies needed 
for the submission of a supplemental application for a new use and 
submitting a supplemental application to FDA. FDA may grant or deny the 
request or, after consulting the manufacturer, grant an extension 
different from that requested by the manufacturer. FDA may grant a 
manufacturer's request for an extension if FDA determines that the 
manufacturer has acted with due diligence to conduct the studies needed 
for the submission of a supplemental application for a new use and to 
submit such a supplemental application to FDA in a timely manner and 
that, despite such actions, the manufacturer needs additional time to 
complete the studies and submit the supplemental application. Extensions 
under this paragraph shall not exceed 24 months.
    (c) If FDA extends the time period for completing the studies and 
submitting a supplemental application under paragraph (a) of this 
section after the manufacturer has submitted a certification under Sec.  
99.201(a)(4)(ii)(B), or if FDA grants a manufacturer's request for an 
extension under paragraph (b) of this section, the manufacturer shall 
submit a new certification under Sec.  99.201(a)(4)(ii)(B) that sets 
forth the timeframe within which clinical studies will be completed and 
a supplemental application will be submitted to FDA.