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Federal Register / Vol. 71, No.

147 / Tuesday, August 1, 2006 / Notices 43489

This meeting is the first of several received on the Internet at http:// recurrence of VTE in patients with
planned by FDA to discuss aspects of www.fda.gov/ohrms/dockets/. cancer. On September 7, 2006, the
the AFSS relative risk ranking model Dated: July 24, 2006. committee will discuss NDA 21–660,
during the model’s development by the Jeffrey Shuren, ABRAXANNE (paclitaxel protein-bound
agency. To determine the relative risks particles for injectible suspension)
Assistant Commissioner for Policy.
of chemical, physical, and biological (albumin-bound), Abraxis Bioscience,
contaminants in animal feed, [FR Doc. E6–12266 Filed 7–31–06; 8:45 am]
Inc., including trial design issues for
information about the health BILLING CODE 4160–01–S
adjuvant treatment of node-positive
consequences posed by the contaminant breast cancer.
(represented by a health consequence
DEPARTMENT OF HEALTH AND Procedure: Interested persons may
scoring) is combined with information
HUMAN SERVICES present data, information, or views,
about the amount of the contaminant in
animal feed (represented by an exposure orally or in writing, on issues pending
Food and Drug Administration before the committee. Written
scoring). This meeting will describe the
methods used by the agency to develop Oncologic Drugs Advisory Committee; submissions may be made to the contact
the animal and human health Notice of Meeting person on or before August 22, 2006.
consequence scoring for feed Oral presentations from the public will
contaminants. At one or more AGENCY: Food and Drug Administration, be scheduled between approximately 10
subsequent meetings, FDA will present HHS. a.m. to 10:30 a.m., and 2:30 p.m. to 3
information about exposure of animals ACTION: Notice. p.m. on September 6, 2006, and between
and humans to contaminants in feed approximately 10 a.m. to 10:30 a.m. on
This notice announces a forthcoming
and information about how health September 7, 2006. Time allotted for
meeting of a public advisory committee
consequence scoring is combined with each presentation may be limited. Those
of the Food and Drug Administration
exposure scoring to determine the desiring to make formal oral
(FDA). The meeting will be open to the
relative risks of contaminants in animal presentations should notify the contact
public.
feed. person and submit a brief statement of
Name of Committee: Oncologic Drugs
II. Meeting Advisory Committee. the general nature of the evidence or
General Function of the Committee: arguments they wish to present, the
We are holding the meeting in an To provide advice and names and addresses of proposed
effort to gather further information from recommendations to the agency on participants, and an indication of the
you, our stakeholders, on changes to FDA’s regulatory issues. approximate time requested to make
AFSS that will help minimize risks to Date and Time: The meeting will be their presentation before August 22,
animal and human health associated held on September 6, 2006, from 8 a.m. 2006.
with animal feed. Prior to the public to 5 p.m. and September 7, 2006, from
meeting, FDA will place in the docket Persons attending FDA’s advisory
8 a.m. to 12 noon.
(found in brackets in the heading of this Location: Hilton, Washington DC/ committee meetings are advised that the
document) two documents, entitled Silver Spring, Maryland Ballrooms, agency is not responsible for providing
‘‘List of Potentially Hazardous 8727 Colesville Rd., Silver Spring, MD. access to electrical outlets.
Contaminants in Animal Feed and Feed Contact Person: Johanna M. Clifford, FDA welcomes the attendance of the
Ingredients’’ and ‘‘Determining Health Center for Drug Evaluation and Research public at its advisory committee
Consequence Scoring for Feed (HFD–21), Food and Drug meetings and will make every effort to
Contaminants.’’ The documents will Administration, 5600 Fishers Lane (for accommodate persons with physical
summarize the agency’s methods for express delivery, 5630 Fishers Lane, rm. disabilities or special needs. If you
assigning animal and human health 1093), Rockville, MD 20857, 301–827– require special accommodations due to
consequence scoring to physical, 7001, FAX: 301–827–6776, email: a disability, please contact Johanna
chemical, and biological contaminants cliffordj@cder.fda.gov, or FDA Advisory Clifford at least 7 days in advance of the
that may be present in animal feed. Committee Information Line, 1–800– meeting.
Details of these methods will be 741–8138 (301–443–0572 in the
discussed at the meeting. A draft agenda Washington, DC area), code Notice of this meeting is given under
for the meeting will also be placed in 3014512542. Please call the Information the Federal Advisory Committee Act (5
the docket prior to the meeting. Line for up-to-date information on this U.S.C. app. 2).
III. Comments meeting. Dated: July 18, 2006.
Agenda: On September 6, 2006, the Randall W. Lutter,
If you would like to submit written committee will discuss two new drug
Associate Commissioner for Policy and
comments to the docket, please send applications (NDAs): (1) NDA 21–874,
Planning.
you comments to the Division of proposed trade name GENASENSE
[FR Doc. E6–12270 Filed 7–31–06; 8:45 am]
Dockets Management (see ADDRESSES). (oblimersen sodium) Injection, Genta,
Submit a single copy of electronic Inc., proposed indication for the BILLING CODE 4160–01–S

comments or two paper copies of any treatment of patients with chronic


written comments, except that lymphocytic leukemia in combination
individuals may submit one copy. with fludarabine and
Comments are to be identified with the cyclophosphamide; and (2) NDA 020–
docket number found in brackets in the 287, FRAGMIN (dalteparin sodium),
rwilkins on PROD1PC63 with NOTICES

heading of this document. Received Pfizer, Inc., proposed indication for the
comments may be seen in the Division extended treatment of symptomatic
of Dockets Management between 9 a.m. venous thromboembolism (VTE),
and 4 p.m., Monday through Friday. proximal deep vein thrombosis, and/or
You can view comments FDA has pulmonary embolism to reduce the

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