Document ID: FDA-2009-N-0664-0118
Agency: fda
Document Type: Notice
Title: Oncologic Drugs Advisory Committee; Notice of Meeting
Posted Date: 2009-11-17T05:00Z

[Federal Register: November 17, 2009 (Volume 74, Number 220)]
[Notices]               
[Page 59193-59194]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17no09-72]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

 
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 17, 2009, from 
8 a.m. to 1 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 
620 Perry Pkwy., Gaithersburg, MD. The hotel phone number is 301-977-
8900.
    Contact Person: Nicole Vesely, 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, 301-827-6793, fax: 301-827-6776, e-mail: 
nicole.vesely@fda.hhs.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area), code 
3014512542. 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 17, 2009, the committee will discuss new drug 
application (NDA) 022-555, proposed

[[Page 59194]]

trade name HEXVIX (hexaminolevulinate as hydrochloride) Kit, for the 
preparation of HEXVIX solution for intravesical use, by Photocure ASA. 
The product is a diagnostic imaging agent that becomes visible when 
illuminated by blue light, a special type of light that causes the 
agent to appear a certain (fluorescent) color. The agent is proposed 
for administration into the bladder to help in the examination of the 
bladder wall with a cystoscope, a surgical instrument used to detect 
some types of cancer. The proposed indication (use) for this product is 
for blue light cystoscopy performed with the Karl Storz Photodynamic 
Diagnosis (PDD) system (equipment that produces blue light) as an 
adjunct to white light cystoscopy in the detection of non-muscle 
invasive papillary cancer of the bladder.
    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 
December 9, 2009. Oral presentations from the public will be scheduled 
between approximately 11 a.m. and 12 noon. 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 December 1, 2009. 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 December 2, 2009.
    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: November 10, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27493 Filed 11-16-09; 8:45 am]

BILLING CODE 4160-01-S