[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.
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