Oncologic Drugs Advisory Committee; Notice of Meeting, 42903-42904 [E9-20379]
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42903
Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices
than 18 years who are current
participants in any pregnancy registry
for a chronic condition; and
(3) Health Care Providers: to include
a mix of health care providers
(including specialists, obstetriciangynecologists, and primary care
providers) some who have participated
in a pregnancy registry and some who
have not participated in a pregnancy
registry.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Annual Frequency
per
Response
No. of
Respondents
60
Total Annual
Responses
1
Hours per
Response
1
Total Hours
1.0
Total
60.0
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The study will involve about 60
respondents and take approximately 1
hour each to complete. These estimates
are based on the Contractor’s extensive
experience with mental models
research.
Dated: August 18, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–20407 Filed 8–24–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Peripheral and Central Nervous
System Drugs Advisory Committee;
Notice of Meeting
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.
pwalker on DSK8KYBLC1PROD with NOTICES
60.0
Name of Committee: Peripheral and
Central Nervous System 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 October 14, 2009, from 8 a.m. to 5 p.m.
Location: The Inn and Conference Center,
University of Maryland University College
(UMUC), Marriott Conference Centers, 3501
University Blvd. East, Adelphi, MD. The
hotel telephone number is 301–985–7300.
Contact Person: Diem-Kieu Ngo, 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:
diem.ngo@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–741–
VerDate Nov<24>2008
00:41 Aug 25, 2009
Jkt 217001
8138 (301–443–0572 in the Washington, DC
area), code 3014512543. 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: The committee will discuss new
drug application (NDA) 22–250, with the
proposed trade name AMAYA (fampridine)
10 milligram (mg) tablets, manufactured by
Acorda Therapeutics, Inc. The proposed
indication for this new drug product is to
improve walking ability in individuals with
multiple sclerosis (MS). MS is a neurological
disease that may cause a wide variety of
possible symptoms, including in some
patients difficulty in walking.
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 https://
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
September 29, 2009. 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 September 21,
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
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
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 September 22, 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 Diem-Kieu
Ngo 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 https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/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: August 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–20380 Filed 8–24–09; 8:45 am]
BILLING CODE 4160–01–S
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.
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.
E:\FR\FM\25AUN1.SGM
25AUN1
pwalker on DSK8KYBLC1PROD with NOTICES
42904
Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices
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 October 5, 2009, from 8 a.m. to 5 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: The committee will discuss the
following topics:
(1) Supplemental biologics license
application (sBLA) 103949/5153.0,
PEGINTRON (peginterferon alfa-2b)
injection, manufactured by Schering Corp.
The proposed indication (use) for this
product is as an adjuvant (additional)
treatment for melanoma, a kind of skin
cancer. The primary treatment for melanoma
that is metastatic (has spread) to the lymph
nodes is surgery to remove both the original
cancer and lymph nodes surrounding the
cancer. PEGINTRON’s proposed use is as a
treatment in addition to, or as an ‘‘adjuvant,’’
to surgery.
(2) New drug application (NDA) 022–465,
proposed trade name VOTRIENT (pazopanib)
tablets, manufactured by GlaxoSmithKline.
The proposed indication (use) for this
product is for the treatment of patients with
advanced renal cell carcinoma, a form of
kidney cancer.
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 https://
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
September 21, 2009. Oral presentations from
the public will be scheduled between
approximately 10:30 a.m. and 11 a.m., and
between approximately 3:30 p.m. and 4 p.m.
Those desiring to make formal oral
VerDate Nov<24>2008
22:52 Aug 24, 2009
Jkt 217001
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
September 11, 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 September 14, 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 https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/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: August 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–20379 Filed 8–24–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Board
of Scientific Counselors, NIA.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
evaluation of individual intramural
programs and projects conducted by the
National Institute on Aging, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, NIA.
Date: October 20–21, 2009.
Closed: October 20, 2009, 8 a.m. to 8:30
a.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Open: October 20, 2009, 8:30 a.m. to 11:55
a.m.
Agenda: Committee Discussion.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Closed: October 20, 2009, 11:55 a.m. to 1
p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Open: October 20, 2009, 1 p.m. to 2:30 p.m.
Agenda: Committee Discussion.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Closed: October 20, 2009, 2:30 p.m. to 2:45
p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Open: October 20, 2009, 2:45 p.m. to 3:15
p.m.
Agenda: Committee Discussion.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Closed: October 20, 2009, 3:15 p.m. to 4:15
p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Closed: October 21, 2009, 8 a.m. to 8:30
a.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
E:\FR\FM\25AUN1.SGM
25AUN1
]]>Agencies
[Federal Register Volume 74, Number 163 (Tuesday, August 25, 2009)]
[Notices]
[Pages 42903-42904]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20379]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
[[Page 42904]]
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 October 5, 2009, from
8 a.m. to 5 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: The committee will discuss the following topics:
(1) Supplemental biologics license application (sBLA) 103949/
5153.0, PEGINTRON (peginterferon alfa-2b) injection, manufactured by
Schering Corp. The proposed indication (use) for this product is as
an adjuvant (additional) treatment for melanoma, a kind of skin
cancer. The primary treatment for melanoma that is metastatic (has
spread) to the lymph nodes is surgery to remove both the original
cancer and lymph nodes surrounding the cancer. PEGINTRON's proposed
use is as a treatment in addition to, or as an ``adjuvant,'' to
surgery.
(2) New drug application (NDA) 022-465, proposed trade name
VOTRIENT (pazopanib) tablets, manufactured by GlaxoSmithKline. The
proposed indication (use) for this product is for the treatment of
patients with advanced renal cell carcinoma, a form of kidney
cancer.
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 https://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
September 21, 2009. Oral presentations from the public will be
scheduled between approximately 10:30 a.m. and 11 a.m., and between
approximately 3:30 p.m. and 4 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 September 11, 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 September 14,
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 https://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: August 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20379 Filed 8-24-09; 8:45 am]
BILLING CODE 4160-01-S
