[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: 21CFR99.301]

[Page 452-453]
 
                        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 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 453]]

    (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.