[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: 21CFR99.401]
[Page 454-455]
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. 99.401 Corrective actions and cessation of dissemination of
information.
(a) FDA actions based on post dissemination data. If FDA receives
data after a manufacturer has begun disseminating information on a new
use and, based on that data, determines that the new use that is the
subject of information disseminated under this part may not be effective
or may present a significant risk to public health, FDA shall consult
the manufacturer and, after such consultation, take appropriate action
to protect the public health. Such action may include ordering the
manufacturer to cease disseminating information on the new use and to
take appropriate corrective action.
(b) FDA actions based on information disseminated by a manufacturer.
If FDA determines that a manufacturer is disseminating information that
does not comply with the requirements under this part, FDA may:
(1) Provide to the manufacturer an opportunity to bring itself into
compliance with the requirements under this part if the manufacturer's
noncompliance constitutes a minor violation of these requirements; or
(2) Order the manufacturer to cease dissemination of information and
to take corrective action. FDA shall issue such an order only after it
has:
(i) Provided notice to the manufacturer regarding FDA's intent to
issue an order to cease dissemination; and
(ii) Provided to the manufacturer an opportunity for a meeting. FDA
need not provide an opportunity for a meeting if the manufacturer
certified that it will submit a supplemental application for the new use
within 6 months of the date that dissemination can begin and the
noncompliance involves a failure to submit such supplemental
application.
(c) FDA actions based on a manufacturer's supplemental application.
FDA may
[[Page 455]]
order a manufacturer to cease disseminating information under this part
and to take corrective action if:
(1) In the case of a manufacturer that has submitted a supplemental
application for the new use, FDA determines that the supplemental
application does not contain adequate information for approval of the
new use;
(2) In the case of a manufacturer that has certified that it will
submit a supplemental application for the new use within 6 months, the
manufacturer has not, within the 6-month period, submitted a
supplemental application for the new use;
(3) In the case of a manufacturer that has certified that it will
submit a supplemental application for the new use within 36 months or
within such time as FDA has determined to be appropriate under Sec.
99.303(a) or (b), such manufacturer has not submitted the supplemental
application within the certified time, or FDA, after an informal
hearing, has determined that the manufacturer is not acting with due
diligence to initiate or complete the studies necessary to support a
supplemental application for the new use; or
(4) In the case of a manufacturer that has certified that it will
submit a supplemental application for the new use within 36 months or
within such time as FDA has determined to be appropriate under Sec.
99.303(a) or (b), the manufacturer has discontinued or terminated the
clinical studies that would be necessary to support a supplemental
application for a new use.
(d) Effective date of orders to cease dissemination. An order to
cease dissemination of information shall be effective upon date of
receipt by the manufacturer, unless otherwise stated in such order.
(e) Cessation of dissemination by a noncomplying manufacturer. A
manufacturer that begins to disseminate information in compliance with
this part, but subsequently fails to comply with this part, shall
immediately cease disseminating information under this part. A
manufacturer that discontinues, terminates, or fails to conduct with due
diligence clinical studies that it certified it would complete under
Sec. 99.201(a)(4)(ii) shall be deemed not in compliance with this part.
A manufacturer shall notify FDA immediately if it ceases dissemination
under this paragraph.
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