[Federal Register Volume 73, Number 44 (Wednesday, March 5, 2008)]
[Notices]
[Page 11928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-4157]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Oncologic Drugs Advisory Committee; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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The Food and Drug Administration (FDA) is announcing an amendment
to the notice of a meeting of the Oncologic Drugs Advisory Committee.
This meeting was announced in the Federal Register of January 25, 2008
(73 FR 4580). The amendment is being made to reflect a change in the
Date and Time, Agenda, and Procedure portions of the document. There
are no other changes.
FOR FURTHER INFORMATION CONTACT: 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:
[email protected], 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.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 25, 2008,
FDA announced that a meeting of the Oncologic Drugs Advisory Committee
would be held on March 12 and 13, 2008.
On page 4580, in the third column, the Date and Time portion of the
meeting is amended to read as follows:
Date and Time: The meeting will be held on March 12 and 13, 2008,
from 8 a.m. to 4 p.m.
On page 4580, beginning in the third column, the Agenda portion of
the meeting is amended to read as follows:
Agenda: On March 12, 2008, the committee will discuss 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 (ITP) who are nonsplenectomized 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. 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.
On page 4581, beginning in the first column, the Procedure portion
of the meeting is amended to read as follows:
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 1 p.m. to 2 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: February 26, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-4157 Filed 3-4-08; 8:45 am]
BILLING CODE 4160-01-S