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 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 § 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 § 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 § 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.