[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR99.403]



[Page 453-454]

 

                        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



[[Page 454]]



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.