[Federal Register: January 25, 2008 (Volume 73, Number 17)]
[
Notices]
[Page 4580-4581]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ja08-80]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 March 12, 2008, from 8
a.m. to 5 p.m. and on March 13, 2008, from 8 a.m. to 4 p.m.
Location: Holiday Inn, The Ballrooms, 2 Montgomery Village Ave.,
Gaithersburg, MD, 301-948-8900.
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 March 12, 2008, the committee will discuss: (1) Biologic
license application (BLA) 125268, proposed trade name NPLATE
(romiplostim), Amgen Inc., proposed indication for the treatment of
thrombocytopenia in adults with chronic immune (idiopathic)
thrombocytopenia purpura who are nonspelenectomized and have had an
inadequate response or are intolerant to corticosteroids and/or
immunoglobulins; or patients who are splenectomized and have an
inadequate response to splenectomy, and (2)
[[Page 4581]]
supplemental biologics license application (sBLA) 103949/5153,
PEGINTRON (peginterferon alfa-2b), Schering Corp., proposed indication
for adjuvant treatment of melanoma. On March 13, 2008, the committee
will discuss the cumulative data, including recent study results, on
the risks of erythropoeisis-stimulating agents when administered to
patients with cancer. Agents to be discussed include ARANESP
(darbepoetin alfa), EPOGEN (epoetin alfa), PROCRIT (epoetin alfa,
Amgen, Inc.), and MIRCERA (methoxy polyethylene glycol-epoetin beta,
Hoffman-La Roche Inc.). This is a followup to the May 10, 2007,
Oncologic Drugs Advisory Committee Meeting.
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
February 27, 2008. Oral presentations from the public will be scheduled
between approximately 10:30 a.m. to 11 a.m., and 3:30 p.m. to 4 p.m. on
March 12, 2008, and between approximately 1 p.m. to 2 p.m. on March 13,
2008. 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
February 19, 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 February 20,
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 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/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: January 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-1295 Filed 1-24-08; 8:45 am]
BILLING CODE 4160-01-S