[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR99.303]



[Page 451]

 

                        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 

DRUGS, BIOLOGICS, AND DEVICES--Table of Contents

 

     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.