[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR99.203]

[Page 454]
 
                        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 C--Manufacturer's Submissions, Requests, and Applications
 
Sec. 99.203  Request to extend the time for completing planned studies.

    (a) A manufacturer may request, prior to or at the time of making a 
submission to FDA under Sec. 99.201, that FDA extend the 36-month time 
period for completing the studies and submitting a supplemental 
application for the new use that is the subject of the information to be 
disseminated. Such request must set forth the reasons that such studies 
cannot be completed and submitted in a supplemental application within 
36 months.
    (b) A manufacturer who has certified that it will complete the 
studies necessary to submit a supplemental application for a new use 
within a specified period of time from the date that dissemination of 
information under this part can begin under Sec. 99.201(a)(4)(ii), but 
later finds that it will be unable to complete such studies and submit a 
supplemental application within that time period may request an 
extension of time from FDA. The manufacturer, in its request for 
extension, shall identify the product, the new use, and shall:
    (1) Describe the study or studies that cannot be completed on time 
and explain why the study or studies cannot be completed on time;
    (2) Describe the current status of the incomplete study or studies 
and summarize the work conducted, including the dates on which principal 
events concerning the study or studies occurred; and
    (3) Estimate the additional time needed to complete the studies and 
submit a supplemental application. The requested extension shall not 
exceed an additional 24 months.
    (c) The manufacturer shall send three copies of the request for 
extension to the same FDA office that received the manufacturer's 
initial submission and certification statement. The outside of the 
envelope shall be marked as ``Request for Time Extension--Dissemination 
of Information on an Unapproved Use.''