[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: 21CFR99.203]



[Page 449]

 

                        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.''