Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting, 3912 [2011-1264]
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3912
Federal Register / Vol. 76, No. 14 / Friday, January 21, 2011 / Notices
Dated: January 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–1270 Filed 1–20–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Peripheral and Central Nervous
System Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
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: 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 March 10, 2011, from 8 a.m. to
5 p.m.
Location: Hilton Washington DC/
Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The
hotel telephone number is 301–589–
5200.
Contact Person: Diem-Kieu Ngo,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., WO31–2417, Silver Spring, MD
20993–0002, 301–796–9001, FAX: 301–
847–8533, e-mail:
diem.ngo@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. 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 10, 2011, the
committee will discuss, in general, the
use of historical-controlled trials for the
VerDate Mar<15>2010
13:45 Jan 20, 2011
Jkt 223001
approval of anticonvulsant
monotherapy for seizures of partial
origin for antiepileptic drug products
that are already approved for adjunctive
therapy. The committee will also
discuss how this may specifically apply
to the approval of the supplemental new
drug application 022115/S–011,
LAMICTAL XR (lamotrigine extendedrelease tablets), sponsored by
SmithKline Beecham Corp. d/b/a
GlaxoSmithKline, for monotherapy in
patients 13 years of age and older with
partial seizures who are receiving
therapy with a single antiepileptic drug.
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 February 24, 2011.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making 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
15, 2011. 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 16, 2011.
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
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
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/
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: January 18, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–1264 Filed 1–20–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Advisory Committee for
Pharmaceutical Science and Clinical
Pharmacology; 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: Advisory Committee
for Pharmaceutical Science and Clinical
Pharmacology.
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 2, 2011, from 7:15 a.m. to 3 p.m.
Location: Hyatt Regency Dallas at Reunion,
Landmark Ballroom, 300 Reunion Blvd.,
Dallas, TX 75207. The hotel phone number
is 214–651–1234.
Contact Person: Yvette Waples, Center for
Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire
Ave., Bldg. 31, rm. 2417, Silver Spring, MD
20993–0002, 301–796–9001, FAX: 301–847–
8540, e-mail: yvette.waples@fda.hhs.gov, or
FDA Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), and follow prompts to
the desired center or product area. 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
E:\FR\FM\21JAN1.SGM
21JAN1
]]>Agencies
[Federal Register Volume 76, Number 14 (Friday, January 21, 2011)]
[Notices]
[Page 3912]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1264]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
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.
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 March 10, 2011, from 8
a.m. to 5 p.m.
Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The hotel telephone number is 301-
589-5200.
Contact Person: Diem-Kieu Ngo, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., WO31-
2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533, e-
mail: diem.ngo@fda.hhs.gov, or FDA Advisory Committee Information Line,
1-800-741-8138 (301-443-0572 in the Washington, DC area), and follow
the prompts to the desired center or product area. 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 10, 2011, the committee will discuss, in general,
the use of historical-controlled trials for the approval of
anticonvulsant monotherapy for seizures of partial origin for
antiepileptic drug products that are already approved for adjunctive
therapy. The committee will also discuss how this may specifically
apply to the approval of the supplemental new drug application 022115/
S-011, LAMICTAL XR (lamotrigine extended-release tablets), sponsored by
SmithKline Beecham Corp. d/b/a GlaxoSmithKline, for monotherapy in
patients 13 years of age and older with partial seizures who are
receiving therapy with a single antiepileptic drug.
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
February 24, 2011. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making 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 15, 2011. 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 16, 2011.
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/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: January 18, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-1264 Filed 1-20-11; 8:45 am]
BILLING CODE 4160-01-P
