[Federal Register: August 1, 2006 (Volume 71, Number 147)]
[Notices]
[Page 43487-43488]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01au06-60]
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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 September 21, 2006, from
8 a.m. to 5 p.m.
Location: Food and Drug Administration, CDER Advisory Committee
Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
Contact Person: Cathy Groupe, 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: 301-827-6778, e-mail: Cathy.Groupe@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.
Agenda: The committee will discuss clinical data for aprotinin
injection (trade name, TRASYOL), an approved product, new drug
application (NDA) 020-304, Bayer Pharmaceuticals) with the indication
for prophylactic use to reduce perioperative blood loss and the need
for blood transfusion in patients undergoing cardiopulmonary bypass in
the course of coronary artery bypass graft surgery. This discussion
follows a February 8, 2006, FDA Public Health Advisory for the use of
apportioning injection (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/drug/advisory/aprotinin.htm).
The background material for this meeting will be posted 1 business day
before the meeting on FDA's Website 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
under the heading ``Cardiovascular and Renal
Drugs Advisory Committee.'' (Click on the
[[Page 43488]]
year 2006 and scroll down to the above named committee meeting.)
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 13, 2006. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 p.m. Time allotted for
each presentation may be limited. 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 13, 2006.
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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: July 18, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-12269 Filed 7-31-06; 8:45 am]
BILLING CODE 4160-01-S