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Dated: October 11, 2007. FDA intends to make background Dated: October 11, 2007.
Randall W. Lutter, material available to the public no later Randall W. Lutter,
Deputy Commissioner for Policy. than 2 business days before the meeting. Deputy Commissioner for Policy.
[FR Doc. E7–20512 Filed 10–17–07; 8:45 am] If FDA is unable to post the background [FR Doc. E7–20511 Filed 10–17–07; 8:45 am]
BILLING CODE 4160–01–S
material on its Web site prior to the BILLING CODE 4160–01–S
meeting, the background material will
be made publicly available at the
DEPARTMENT OF HEALTH AND location of the advisory committee DEPARTMENT OF HEALTH AND
HUMAN SERVICES meeting, and the background material HUMAN SERVICES
will be posted on FDA’s Web site after
Food and Drug Administration the meeting. Background material is Food and Drug Administration
available at http://www.fda.gov/ohrms/
Peripheral and Central Nervous dockets/ac/acmenu.htm, click on the Science Board to the Food and Drug
System Drugs Advisory Committee; year 2007 and scroll down to the Administration; Amendment of Notice
Notice of Meeting appropriate advisory committee link. AGENCY: Food and Drug Administration,
AGENCY: Food and Drug Administration, Procedure: Interested persons may HHS.
HHS. present data, information, or views, ACTION: Notice.
ACTION: Notice. orally or in writing, on issues pending
before the committee. Written The Food and Drug Administration
This notice announces a forthcoming submissions may be made to the contact (FDA) is announcing an amendment to
meeting of a public advisory committee person on or before November 21, 2007. the notice of meeting of the Science
of the Food and Drug Administration Oral presentations from the public will Board to the Food and Drug
(FDA). The meeting will be open to the be scheduled between approximately 1 Administration (Science Board). This
public. p.m. and 2 p.m. Those desiring to make meeting was originally announced in
Name of Committee: Peripheral and formal oral presentations should notify the Federal Register of October 2, 2007
Central Nervous System Drugs Advisory the contact person and submit a brief (72 FR 56078). The amendment is being
Committee. statement of the general nature of the made to reflect a change in the Date and
General Function of the Committee: evidence or arguments they wish to Time and Procedure portions of the
To provide advice and present, the names and addresses of document. There are no other changes.
recommendations to the agency on proposed participants, and an FOR FURTHER INFORMATION CONTACT:
FDA’s regulatory issues. indication of the approximate time Carlos Peña, Office of the
Date and Time: The meeting will be requested to make their presentation on Commissioner, Food and Drug
held on December 6, 2007, from 8 a.m. or before November 7, 2007. Time Administration (HF–33), 5600 Fishers
to 5 p.m. allotted for each presentation may be Lane, Rockville, MD, 20857, 301–827–
Location: Sheraton College Park limited. If the number of registrants 6687, carlos.Peña@fda.hhs.gov, or FDA
Hotel, The Ballroom, 4095 Powder Mill requesting to speak is greater than can Advisory Committee Information Line,
Rd., Beltsville, MD. The hotel telephone be reasonably accommodated during the 1–800–741–8138 (301–443–0572 in the
number is 301–937–4422. scheduled open public hearing session, Washington, DC area), code
Contact Person: Darrell Lyons, Center FDA may conduct a lottery to determine 3014512603.
for Drug Evaluation and Research (HFD– the speakers for the scheduled open SUPPLEMENTARY INFORMATION: In the
21), Food and Drug Administration, public hearing session. The contact Federal Register of October 2, 2007,
5600 Fishers Lane (for express delivery, person will notify interested persons FDA announced that a meeting of the
5630 Fishers Lane, rm. 1093) Rockville, regarding their request to speak by Science Board would be held on
MD 20857, 301–827–7001, FAX: 301– November 8, 2007. October 30, 2007. On page 56078,
827–6776, e-mail: Persons attending FDA’s advisory beginning in the second column, the
darrell.lyons@fda.hhs.gov, or FDA committee meetings are advised that the Date and Time and Procedure portions
Advisory Committee Information Line, agency is not responsible for providing of the document are amended to read as
1–800–741–8138 (301–443–0572 in the access to electrical outlets. follows:
Washington, DC area), code Date and Time: The meeting will be
FDA welcomes the attendance of the
3014512543. Please call the Information held on December 3, 2007, from 8 a.m.
public at its advisory committee
Line for up-to-date information on this to 5:30 p.m.
meetings and will make every effort to
meeting. A notice in the Federal Procedure: Interested persons may
accommodate persons with physical
Register about last minute modifications present data, information, or views,
disabilities or special needs. If you
that impact a previously announced orally or in writing, on issues pending
require special accommodations due to
advisory committee meeting cannot before the committee. Written
a disability, please contact Darrell Lyons
always be published quickly enough to submissions may be made to the contact
at least 7 days in advance of the
provide timely notice. Therefore, you person on or before November 26, 2007.
meeting.
should always check the agency’s Web Oral presentations from the public will
site and call the appropriate advisory FDA is committed to the orderly be scheduled between approximately 4
committee hot line/phone line to learn conduct of its advisory committee p.m. and 5 p.m. Those desiring to make
about possible modifications before meetings. Please visit our Web site at formal oral presentations should notify
coming to the meeting. http://www.fda.gov/oc/advisory/ the contact person and submit a brief
mstockstill on PROD1PC66 with NOTICES
Agenda: The committee will discuss default.htm for procedures on public statement of the general nature of the
new drug application (NDA) 21–894, conduct during advisory committee evidence or arguments they wish to
tetrabenazine, Prestwick meetings. present, the names and addresses of
Pharmaceuticals, Inc., for the proposed Notice of this meeting is given under proposed participants, and an
indication to treat chorea associated the Federal Advisory Committee Act (5 indication of the approximate time
with Huntington’s disease. U.S.C. app. 2). requested to make their presentation on
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59100 Federal Register / Vol. 72, No. 201 / Thursday, October 18, 2007 / Notices
or before November 16, 2007. Time Federal holidays. The telephone number considered. You may submit your
allotted for each presentation may be is 202–366–9329. comments and material by electronic
limited. If the number of registrants (3) Fax to: Docket Management means, mail, fax, or delivery to the
requesting to speak is greater than can Facility: 202–493–2251. Docket Management Facility at the
be reasonably accommodated during the The Docket Management Facility address under ADDRESSES; but please
scheduled open public hearing session, maintains the public docket for this submit them by only one means. If you
FDA may conduct a lottery to determine notice. Comments and material received submit them by mail or delivery, submit
the speakers for the scheduled open from the public, as well as documents them in an unbound format, no larger
public hearing session. The contact mentioned in this notice as being than 81⁄2 by 11 inches, suitable for
person will notify interested persons available in the docket, will become part copying and electronic filing. If you
regarding their request to speak by of this docket and will be available for submit them by mail and would like to
November 19, 2007. inspection or copying at room W12–140 know that they reached the Facility,
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relating to the advisory committees. p.m., Monday through Friday, except during the comment period. We may
Federal holidays. You may also find this change the documents supporting this
Dated: October 12, 2007.
docket on the Internet at http:// collection of information or even the
Randall W. Lutter,
www.regulations.gov. underlying requirements in view of
Deputy Commissioner for Policy. them.
A copy of the complete ICR is
[FR Doc. E7–20550 Filed 10–17–07; 8:45 am] available through this docket on the Viewing comments and documents:
BILLING CODE 4160–01–S Internet at http://www.regulations.gov. Go to http://www.regulations.gov to
Additionally, copies are available from view documents mentioned in this
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