[Federal Register: May 1, 2008 (Volume 73, Number 85)]
[Notices]
[Page 24075-24076]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01my08-55]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Dermatologic and Ophthalmic 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: Dermatologic and Ophthalmic 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 June 17, 2008, from 8
a.m. to 5 p.m., and June 18, 2008, from 8 a.m. to 2 p.m.
Location: Food and Drug Administration, Center for Drug Evaluation
and Research, Advisory Committee Conference Room, rm. 1066, 5630
Fishers Lane, Rockville, MD.
Contact Persons: Yvette Waples or John Lauttman, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093),
Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail:
yvette.waples@fda.hhs.gov, or FDA Advisory Committee Information Line,
1-800-741-8138 (301-443-0572 in the Washington, DC area), code
3014512534. 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 hotline/phone line to learn
about possible modifications before coming to the meeting.
Agenda: On June 17, 2008, the committee will discuss biologic
licensing application (BLA) 125261, ustekinumab, a human monoclonal
antibody, Centocor, Inc., proposed for the treatment of moderate to
severe psoriasis. On June 18, 2008, the committee will discuss
supplemental biologic licensing application (sBLA) 103795/5350,
etanercept, a lyophilized powder for subcutaneous injection, Immunex
Corp., proposed for the treatment of moderate to severe psoriasis in
the pediatric population.
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/ohrms/dockets/ac/acmenu.htm, click on
the year 2008 and 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 June
3, 2008. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 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 May 27, 2008. 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 May 28,
2008.
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
[[Page 24076]]
disabilities or special needs. If you require special accommodations
due to a disability, please contact Yvette Waples or John Lauttman 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/oc/advisory/
default.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: April 22, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-9549 Filed 4-30-08; 8:45 am]
BILLING CODE 4160-01-S