[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: 21CFR99.301]



[Page 450-451]

 

                        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 D_FDA Action on Submissions, Requests, and Applications

 

Sec.  99.301  Agency action on a submission.





    (a) Submissions. Within 60 days after receiving a submission under 

this part, FDA may:

    (1) Determine that the manufacturer does not comply with the 

requirements under this part and that, as a result, the manufacturer 

shall not disseminate any information under this part;

    (2) After providing the manufacturer notice and an opportunity for a 

meeting, determine that the information submitted regarding a new use 

fails to provide data, analyses, or other written matter that is 

objective and balanced and:

    (i) Require the manufacturer to disseminate additional information, 

including information that the manufacturer has submitted to FDA or, 

where appropriate, a summary of such information or any other 

information that can be made publicly available, which, in the agency's 

opinion:

    (A) Is objective and scientifically sound;

    (B) Pertains to the safety or effectiveness of the new use; and

    (C) Is necessary to provide objectivity and balance; and



[[Page 451]]



    (ii) Require the manufacturer to disseminate an objective statement 

prepared by FDA that is based on data or other scientifically sound 

information available to the agency and bears on the safety or 

effectiveness of the drug or device for the new use; and

    (3) Require the manufacturer to maintain records that will identify 

individual recipients of the information that is to be disseminated when 

such individual records are warranted due to special safety 

considerations associated with the new use.

    (b) Protocols/Studies. Within 60 days after receiving a submission 

under this part, FDA shall:

    (1) If the manufacturer has planned studies that will be needed for 

the submission of a supplemental application for the new use, review the 

manufacturer's proposed protocols and schedule for completing such 

studies and determine whether the proposed protocols are adequate and 

whether the proposed schedule for completing the studies is reasonable. 

FDA shall notify the manufacturer of its determination; or

    (2) If the manufacturer has completed studies that the manufacturer 

believes would be an adequate basis for the submission of a supplemental 

application for the new use, conduct a review of the protocols submitted 

for such studies to determine whether they are adequate. FDA shall 

notify the manufacturer of its determination.