[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: 21CFR99.203]
[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
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.''
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