[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: 21CFR99.201]



[Page 447-449]

 

                        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 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unpublished manuscripts, abstracts, and data analyses from completed or 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 448]]



    (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 449]]



    (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]