[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: 21CFR99.401]

[Page 451-452]
 
                        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. 99.401  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 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

[[Page 452]]

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.