[Federal Register: May 1, 2008 (Volume 73, Number 85)]
[Page 24075-24076]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of 

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


    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 
    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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 
the year 2008 and scroll down to the appropriate advisory committee 
    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, 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 

[[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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/advisory/default.htm for procedures on public conduct during advisory committee 
    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]