[Federal Register: October 18, 2007 (Volume 72, Number 201)]
[Notices]
[Page 59098-59099]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18oc07-53]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Cardiovascular and Renal Drugs Advisory Committee; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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: Cardiovascular and Renal 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 December 11 and 12,
2007, from 8 a.m. to 5 p.m.
Location: Sheraton College Park Hotel, 4095 Powder Mill Rd.,
Beltsville, MD, 301-937-4422.
Contact Person: Cathy A. Miller, 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: Cathy.Miller1@fda.hhs.gov, or
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572
in the Washington, DC area), code 3014512533. 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 December 11, 2007, the committee will discuss new drug
application (NDA) 22-034, vernakalant hydrochloride injection, 20
milligrams (mg) per milliliter (ml), Astellas Pharma U.S., Inc., for
the proposed indication of use for conversion of atrial fibrillation to
normal sinus rhythm. On December 12, 2007, the committee will discuss
NDA 22-123, PULZIUM (tedisamil sesquifumarate) IV solution 2 mg per ml,
Solvay Pharmaceuticals, Inc., for the proposed indication of use for
conversion of atrial fibrillation or atrial flutter to normal sinus
rhythm.
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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2007 and 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
November 27, 2007. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on both days for the
corresponding agenda. 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
November 16, 2007. 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 November 20,
2007.
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 John Lauttman 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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/advisory/default.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).
[[Page 59099]]
Dated: October 11, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-20512 Filed 10-17-07; 8:45 am]
BILLING CODE 4160-01-S