[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: 21CFR99.201]
[Page 449-451]
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
Subpart C Manufacturer's Submissions, Requests, and Applications
Sec. 99.201 Manufacturer's submission to the agency.
(a) Sixty days before disseminating any written information
concerning the safety, effectiveness, or benefit of a new use for a drug
or device, a manufacturer shall submit to the agency:
(1) An identical copy of the information to be disseminated,
including any information (e.g., the bibliography) and statements
required under Sec. 99.103;
(2) Any other clinical trial information which the manufacturer has
relating to the effectiveness of the new use, any other clinical trial
information that the manufacturer has relating to the safety of the new
use, any reports of clinical experience pertinent to the safety of the
new use, and a summary of such information. For purposes of this part,
clinical trial information includes, but is not limited to, published
papers and abstracts, even if not intended for dissemination, and
unpublished manuscripts, abstracts, and data analyses from completed or
ongoing investigations. The reports of clinical experience required
under this paragraph shall include case studies, retrospective reviews,
epidemiological studies, adverse event reports, and any other material
concerning adverse effects or risks reported for or associated with the
new use. If the manufacturer has no knowledge of clinical trial
information relating to the safety or effectiveness of the new use or
reports of clinical experience pertaining to the safety of the new use,
the manufacturer shall provide a statement to that effect;
(3) An explanation of the manufacturer's method of selecting the
articles for the bibliography (e.g., the databases or sources and
criteria (i.e., subject headings/keywords) used to generate the
bibliography and the time period covered by the bibliography); and
(4) If the manufacturer has not submitted a supplemental application
for the new use, one of the following:
(i) If the manufacturer has completed studies needed for the
submission of a supplemental application for the new use:
[[Page 450]]
(A) A copy of the protocol for each completed study or, if such
protocol was submitted to an investigational new drug application or an
investigational device exemption, the number(s) for the investigational
new drug application or investigational device exemption covering the
new use, the date of submission of the protocol(s), the protocol
number(s), and the date of any amendments to the protocol(s); and
(B) A certification stating that, ``On behalf of [insert
manufacturer's name], I certify that [insert manufacturer's name] has
completed the studies needed for the submission of a supplemental
application for [insert new use] and will submit a supplemental
application for such new use to the Food and Drug Administration no
later than [insert date no later than 6 months from date that
dissemination of information under this part can begin]''; or
(ii) If the manufacturer has planned studies that will be needed for
the submission of a supplemental application for the new use:
(A) The proposed protocols and schedule for conducting the studies
needed for the submission of a supplemental application for the new use.
The protocols shall comply with all applicable requirements in parts 312
of this chapter (investigational new drug applications) and 812 of this
chapter (investigational device exemptions). The schedule shall include
the projected dates on which the manufacturer expects the principal
study events to occur (e.g., initiation and completion of patient
enrollment, completion of data collection, completion of data analysis,
and submission of the supplemental application); and
(B) A certification stating that, ``On behalf of [insert
manufacturer's name], I certify that [insert manufacturer's name] will
exercise due diligence to complete the clinical studies necessary to
submit a supplemental application for [insert new use] and will submit a
supplemental application for such new use to the Food and Drug
Administration no later than [insert date no later than 36 months from
date that dissemination of information under this part can begin or no
later than such time period as FDA may specify pursuant to an extension
granted under Sec. 99.303(a)];'' or
(iii) An application for exemption from the requirement of a
supplemental application; or
(5) If the manufacturer has submitted a supplemental application for
the new use, a cross-reference to that supplemental application.
(b) The manufacturer's attorney, agent, or other authorized official
shall sign the submission and certification statement or application for
exemption. If the manufacturer does not have a place of business in the
United States, the submission and certification statement or application
for exemption shall contain the signature, name, and address of the
manufacturer's attorney, agent, or other authorized official who resides
or maintains a place of business in the United States.
(c) The manufacturer shall send three copies of the submission and
certification statement or application for exemption to FDA. The outside
of the shipping container shall be marked as ``Submission for the
Dissemination of Information on an Unapproved/New Use.'' The
manufacturer shall send the submission and certification statement or
application for exemption to the appropriate FDA component listed in
paragraphs (c)(1) through (c)(3) of this section.
(1) For biological products and devices regulated by the Center for
Biologics Evaluation and Research, the Advertising and Promotional
Labeling Staff (HFM-602), Center for Biologics Evaluation and Research,
Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448;
(2) For human drug products, biological products, and devices
regulated by the Center for Drug Evaluation and Research, the Division
of Drug Marketing, Advertising, and Communications (HFD-42), Center for
Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857; or
(3) For medical devices, the Promotion and Advertising Policy Staff
(HFZ-302), Office of Compliance, Center for Devices and Radiological
Health, Food and Drug Administration, 2098 Gaither Rd., Rockville, MD
20850.
[[Page 451]]
(d) The 60-day period shall begin when FDA receives a manufacturer's
submission, including, where applicable, a certification statement or an
application for an exemption.
[63 FR 64581, Nov. 20, 1998, as amended at 70 FR 14980, Mar. 24, 2005]
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