[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR99.403]

[Page 452-453]
 
                        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 DRUGS, BIOLOGICS, AND DEVICES--Table of Contents
 
      Subpart E--Corrective Actions and Cessation of Dissemination
 
Sec. 99.403  Termination of approvals of applications for exemption.

    (a) FDA may, at any time, terminate the approval of an application 
for an exemption from the requirement to file a supplemental application 
if:
    (1) The application for an exemption had been deemed to be approved 
because the agency had not acted on the application within 60 days after 
its receipt by FDA;
    (2) The manufacturer is disseminating written information on the new 
use; and
    (3) FDA determines that it would be economically and ethically 
possible for the manufacturer to conduct the clinical studies needed to 
submit a supplemental application for the new use.
    (b) If FDA terminates a deemed approval of an application for an 
exemption under paragraph (a) of this section, FDA also may:
    (1) Order the manufacturer to cease disseminating information; and
    (2) Order the manufacturer to take action to correct the information 
that has been disseminated if FDA determines that the new use described 
in the disseminated information would pose a significant risk to public 
health.
    (c) FDA shall notify the manufacturer if it terminates the deemed 
approval of an application for an exemption under paragraph (a) of this 
section. If FDA also issues an order to cease dissemination of 
information, the manufacturer shall comply with the order no later than 
60 days after its receipt.
    (d) FDA may, at any time, terminate the approval of an application 
for an exemption from the requirement to file a supplemental application 
for a new use if, after consulting with the manufacturer that was 
granted such exemption, FDA determines that the manufacturer no longer 
meets the requirements for an exemption on the basis that it is 
economically prohibitive or unethical to conduct the studies needed to 
submit a supplemental application for the new use.
    (e) If FDA terminates an approval of an application for an exemption 
under paragraph (d) of this section, the manufacturer must, within 60 
days of being

[[Page 453]]

notified by FDA that its exemption approval has been terminated, file a 
supplemental application for the new use that is the subject of the 
information being disseminated under the exemption, certify, under 
Sec. 99.201(a)(4)(i) or (a)(4)(ii) that it will file a supplemental 
application for the new use, or cease disseminating the information on 
the new use. FDA may require a manufacturer that ceases dissemination of 
information on the new use to undertake corrective action.