[Federal Register: November 1, 2006 (Volume 71, Number 211)]
[Notices]
[Page 64284-64285]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01no06-90]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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:
karen.kirchberg@fda.hhs.gov.
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 CDER_330CATS@cder.fda.gov 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