[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: 21CFR99.403]
[Page 455-456]
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 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
[[Page 456]]
paragraph (d) of this section, the manufacturer must, within 60 days of
being 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.
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