Notice: Meetings: Cardiovascular and Renal Drugs Advisory Committee

59098 Federal Register / Vol. 72, No.
201 / Thursday, October 18, 2007 / Notices
Dated: October 11, 2007. DEPARTMENT OF HEALTH AND than 2 business days before the meeting.
James D. Seligman, HUMAN SERVICES If FDA is unable to post the background
Chief Information Officer, Centers for Disease material on its Web site prior to the
Control and Prevention. Food and Drug Administration meeting, the background material will
[FR Doc. E7–20592 Filed 10–17–07; 8:45 am] be made publicly available at the
Cardiovascular and Renal Drugs location of the advisory committee
BILLING CODE 4163–18–P Advisory Committee; Notice of Meeting meeting, and the background material
AGENCY: Food and Drug Administration, will be posted on FDA’s Web site after
DEPARTMENT OF HEALTH AND HHS. the meeting. Background material is
HUMAN SERVICES ACTION: Notice. available at http://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
Food and Drug Administration This notice announces a forthcoming year 2007 and scroll down to the
meeting of a public advisory committee appropriate advisory committee link.
of the Food and Drug Administration
[Docket No. 2000D–0084] (formerly 00D– (FDA). The meeting will be open to the Procedure: Interested persons may
0084) public. present data, information, or views,
Name of Committee: Cardiovascular orally or in writing, on issues pending
Agency Information Collection and Renal Drugs Advisory Committee. before the committee. Written
Activities; Announcement of Office of General Function of the Committee: submissions may be made to the contact
Management and Budget Approval; To provide advice and person on or before November 27, 2007.
Guidance for Industry on Special recommendations to the agency on Oral presentations from the public will
Protocol Assessment FDA’s regulatory issues. be scheduled between approximately 1
Date and Time: The meeting will be p.m. and 2 p.m. on both days for the
AGENCY: Food and Drug Administration, held on December 11 and 12, 2007, from corresponding agenda. Those desiring to
HHS. 8 a.m. to 5 p.m. make formal oral presentations should
Location: Sheraton College Park notify the contact person and submit a
ACTION: Notice. Hotel, 4095 Powder Mill Rd., Beltsville, brief statement of the general nature of
MD, 301–937–4422. the evidence or arguments they wish to
SUMMARY: The Food and Drug Contact Person: Cathy A. Miller, present, the names and addresses of
Administration (FDA) is announcing Center for Drug Evaluation and Research proposed participants, and an
that a collection of information entitled (HFD–21), Food and Drug indication of the approximate time
‘‘Guidance for Industry on Special Administration, 5600 Fishers Lane (for requested to make their presentation on
Protocol Assessment’’ has been express delivery, 5630 Fishers Lane, rm. or before November 16, 2007. Time
approved by the Office of Management 1093), Rockville, MD 20857, 301–827– allotted for each presentation may be
and Budget (OMB) under the Paperwork 7001, FAX: 301–827–6776, e-mail: limited. If the number of registrants
Reduction Act of 1995. Cathy.Miller1@fda.hhs.gov, or FDA requesting to speak is greater than can
Advisory Committee Information Line, be reasonably accommodated during the
FOR FURTHER INFORMATION CONTACT:
1–800–741–8138 (301–443–0572 in the scheduled open public hearing session,
Karen L. Nelson, Office of the Chief Washington, DC area), code
Information Officer (HFA–250), Food FDA may conduct a lottery to determine
3014512533. Please call the Information the speakers for the scheduled open
and Drug Administration, 5600 Fishers Line for up-to-date information on this
Lane, Rockville, MD 20857, 301–827– public hearing session. The contact
meeting. A notice in the Federal person will notify interested persons
4816. Register about last minute modifications regarding their request to speak by
that impact a previously announced November 20, 2007.
SUPPLEMENTARY INFORMATION: In the
advisory committee meeting cannot
Federal Register of June 22, 2007 (72 FR always be published quickly enough to Persons attending FDA’s advisory
34470), the agency announced that the provide timely notice. Therefore, you committee meetings are advised that the
proposed information collection had should always check the agency’s Web agency is not responsible for providing
been submitted to OMB for review and site and call the appropriate advisory access to electrical outlets.
clearance under 44 U.S.C. 3507. An committee hot line/phone line to learn FDA welcomes the attendance of the
agency may not conduct or sponsor, and about possible modifications before public at its advisory committee
a person is not required to respond to, coming to the meeting. meetings and will make every effort to
a collection of information unless it Agenda: On December 11, 2007, the accommodate persons with physical
displays a currently valid OMB control committee will discuss new drug disabilities or special needs. If you
number. OMB has now approved the application (NDA) 22–034, vernakalant require special accommodations due to
information collection and has assigned hydrochloride injection, 20 milligrams a disability, please contact John
OMB control number 0910–0470. The (mg) per milliliter (ml), Astellas Pharma Lauttman at least 7 days in advance of
approval expires on October 31, 2010. A U.S., Inc., for the proposed indication of the meeting.
copy of the supporting statement for this use for conversion of atrial fibrillation to
FDA is committed to the orderly
information collection is available on normal sinus rhythm. On December 12,
conduct of its advisory committee
the Internet at http://www.fda.gov/ 2007, the committee will discuss NDA
meetings. Please visit our Web site at
ohrms/dockets. 22–123, PULZIUM (tedisamil
http://www.fda.gov/oc/advisory/
sesquifumarate) IV solution 2 mg per
default.htm for procedures on public
mstockstill on PROD1PC66 with NOTICES
Dated: October 12, 2007. ml, Solvay Pharmaceuticals, Inc., for the
Jeffrey Shuren, proposed indication of use for conduct during advisory committee
conversion of atrial fibrillation or atrial meetings.
Assistant Commissioner for Policy.
[FR Doc. E7–20549 Filed 10–17–07; 8:45 am] flutter to normal sinus rhythm. Notice of this meeting is given under
BILLING CODE 4160–01–S
FDA intends to make background the Federal Advisory Committee Act (5
material available to the public no later U.S.C. app. 2).
VerDate Aug<31>2005 21:55 Oct 17, 2007 Jkt 214001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\18OCN1.SGM 18OCN1
Federal Register / Vol. 72, No. 201 / Thursday, October 18, 2007 / Notices 59099
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
VerDate Aug<31>2005 21:55 Oct 17, 2007 Jkt 214001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\18OCN1.SGM 18OCN1

Notice: Meetings: Cardiovascular and Renal Drugs Advisory Committee

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59098 Federal Register / Vol. 72, No.

201 / Thursday, October 18, 2007 / Notices

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