[Federal Register Volume 71, Number 211 (Wednesday, November 1, 2006)]
[Notices]
[Pages 64284-64285]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-17959]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0478]


Marketed Unapproved Drugs; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop on issues related to the application process for seeking 
approval for marketed unapproved drugs. This will be a 1-day workshop 
involving FDA staff and representatives from businesses currently 
marketing unapproved drugs. The purpose of the workshop is to provide 
clarification and direction to businesses on how to seek approval to 
legally market drugs through the new drug application (NDA) and 
abbreviated new drug application (ANDA) processes and how to legally 
market drugs through compliance with the over-the-counter (OTC) 
monographs.

DATES: The public workshop will be held on January 9, 2007, from 9 a.m. 
to 4 p.m. Registration is open until November 15, 2006. Submit requests 
for specific discussion topics by November 15, 2006.

ADDRESSES: The public workshop will be held in the Center for Drug 
Evaluation and Research Advisory Committee conference room, 5630 
Fishers Lane, rm. 1066, Rockville, MD. The agenda for the meeting will 
be posted at http://www.fda.gov/cder/drug/unapproved_drugs.
    Submit topics by mail to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit topics electronically to http://www.fda.gov/dockets/ecomments. Submit two paper copies of any mailed 
topics, except that individuals may submit one paper copy. All requests 
for discussion topics should be identified with the docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Karen Kirchberg, Center for Drug 
Evaluation and Research (HFD-330), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-8916, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 9, 2006 (71 FR 33466), FDA 
announced the availability of a guidance entitled ``Marketed Unapproved 
Drugs--Compliance Policy Guide'' (the Marketed Unapproved Drugs CPG). 
The guidance describes how FDA intends to exercise its enforcement 
discretion with regard to drugs marketed in the United States that do 
not have required FDA approval for marketing. The guidance explains 
that FDA intends to continue to give priority to enforcement actions 
involving unapproved drugs that have potential safety risks, lack 
evidence of effectiveness, and constitute health fraud, among other 
categories. The Marketed Unapproved Drugs CPG also explains how the 
agency intends to address those situations in which a company obtains 
approval to sell a drug that other companies have sold without FDA 
approval for some time. In the Marketed Unapproved Drugs CPG, FDA 
encourages companies to comply with the drug approval requirements of 
the Federal Food, Drug, and Cosmetic Act.
    Following the publication of the Marketed Unapproved Drugs CPG, a 
number of drug companies have contacted FDA seeking clarification about 
how to obtain approval to legally market their unapproved drug products 
and whether applications for marketing are subject to user fees, among 
other issues. The agency is committed to working with companies to 
facilitate the process of ensuring that products are safe and effective 
and meet appropriate standards for manufacturing and labeling.

II. Scope of the Public Workshop

    As part of FDA's goal to ensure that all marketed drugs comply with 
appropriate FDA requirements to ensure their safety and efficacy, FDA 
is holding a public workshop to educate businesses on the drug 
application and OTC monograph processes and to discuss issues of 
interest to participants.
    Topics for discussion include the following: (1) The various routes 
for legal marketing--NDAs, ANDAs, and OTC monographs; (2) application 
processes; (3) user fee applicability and waivers; and (4) market 
exclusivity for newly-approved drugs. The information provided during 
registration will help us determine additional topics for discussion 
and how to further focus the workshop.

III. Participation in the Public Workshop

A. Registration

    Register via e-mail to [email protected] by providing 
complete contact information for each attendee (including name, title, 
affiliation, e-mail address, and phone number(s)) by November 15, 2006. 
Please indicate ``Workshop--Unapproved Products'' in the ``subject'' 
line of the e-mail. FDA intends to respond to registration requests by 
e-mail after November 15, 2006. There is no registration fee to attend. 
Space is limited; therefore, interested parties are encouraged to 
register early and FDA may need to limit the number of attendees from 
each firm or organization. If you need special accommodations due to a 
disability, please e-mail your request at least 7 days before the 
meeting.

B. Suggested Topics

    If you would like to request discussion of a specific topic for the 
workshop, submit it to the Division of Dockets Management (see 
ADDRESSES) using the docket number, found in brackets in the heading of 
this document, by November 15, 2006. We may not be able to include all 
submitted topics in the workshop agenda.

C. Parking, Transportation, and Security

    Limited visitor parking is available for a fee, and the Twinbrook 
Metro station is within walking distance. Early arrival is encouraged, 
as there will be security screening. Workshop participants will be 
asked for government-issued picture identification by the security 
officers.

IV. Transcripts

    Following the workshop, transcripts will be available for review at 
the

[[Page 64285]]

Division of Dockets Management (see ADDRESSES), Monday through Friday 
between 9 a.m. and 4 p.m. You may also request a copy of the transcript 
from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, 
approximately 15 working days after the public workshop at a cost of 10 
cents per page.

    Dated: October 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-17959 Filed 10-31-06; 8:45 am]
BILLING CODE 4160-01-S