[Federal Register Volume 75, Number 204 (Friday, October 22, 2010)]
[Notices]
[Pages 65362-65363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-26651]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Oncologic Drugs Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Oncologic Drugs Advisory Committee
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on December 1, 2010, from 8
a.m. to 5 p.m.
Location: FDA White Oak Campus, Bldg 31, the Great Room, White Oak
Conference Center (rm. 1503), 10903 New Hampshire Ave., Silver Spring,
MD 20993-0002. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You'', click on ``White Oak Conference Center Parking
and Transportation Information for FDA Advisory Committee Meetings''.
Contact Person: Nicole Vesely, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-
8533, e-mail: [email protected], or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 301-451-2542. Please call the Information Line for up-to-
date information on this meeting. A notice in the Federal Register
about last minute modifications that impact a previously announced
advisory committee meeting cannot always be published quickly enough to
provide timely notice. Therefore, you should always check the Agency's
Web site and call the appropriate advisory committee hot line/phone
line to learn about possible modifications before coming to the
meeting.
Agenda: On December 1, 2010, the committee will discuss
supplemental new drug applications (sNDAs) 021-319/S-024, trade name
AVODART (dutasteride) Soft Gelatin Capsules,
[[Page 65363]]
manufactured by SmithKline Beecham Corp. d/b/a (doing business as)
GlaxoSmithKline and 020-180/S-034, trade name PROSCAR (finasteride)
Tablets, manufactured by Merck & Co., Inc. The proposed indication
(use) for AVODART (dutasteride) is for reduction in the risk of
prostate cancer in men at increased risk of developing the disease. The
population at increased risk of prostate cancer includes men with an
elevated serum prostate-specific antigen (PSA) or men otherwise
determined to be at increased risk based on other associated risk
factors such as age, race, and family history. There is no proposed
expansion of the indication for PROSCAR (finasteride); however, in
light of the Prostate Cancer Prevention Trial (PCPT) which demonstrated
a statistically significant reduction in the 7-year period prevalence
of prostate cancer with finasteride (PROSCAR) treatment, and which
reported an imbalance in high Gleason grade prostate cancers
(indicating more aggressive cancers) in the finasteride treatment arm
vs. placebo, the efficacy and safety of both products for use in
prostate cancer risk reduction will be examined.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
November 16, 2010. Oral presentations from the public will be scheduled
between approximately 2:30 p.m. to 3:30 p.m. Those desiring to make
formal oral presentations should notify the contact person and submit a
brief statement of the general nature of the evidence or arguments they
wish to present, the names and addresses of proposed participants, and
an indication of the approximate time requested to make their
presentation on or before November 8, 2010. Time allotted for each
presentation may be limited. If the number of registrants requesting to
speak is greater than can be reasonably accommodated during the
scheduled open public hearing session, FDA may conduct a lottery to
determine the speakers for the scheduled open public hearing session.
The contact person will notify interested persons regarding their
request to speak by November 9, 2010.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Nicole Vesely at
least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: October 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-26651 Filed 10-21-10; 8:45 am]
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