Allergenic Products Advisory Committee; Notice of Meeting, 51197 [E6-14295]
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Federal Register / Vol. 71, No. 167 / Tuesday, August 29, 2006 / Notices
The burden is based on the number of
applications received in the last 3 years.
Dated: August 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–14267 Filed 8–28–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Allergenic Products Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Allergenic
Products 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 13, 2006 from 12
noon to approximately 3:45 p.m.
Location: National Institutes of
Health, Bldg. 29B, Conference Rooms A
and B, Bethesda, MD.
Contact Person: Gail Dapolito or Jane
Brown, Center for Biologics Evaluation
and Research (HFM–71), Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852, 301–827–0314 or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014512388. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: On September 13, 2006, the
committee will discuss a proposed
strategy for the reclassification of
Category IIIA allergenic products. The
committee will also receive an update of
the research program of the Laboratory
of Immunobiochemistry, Division of
Bacterial, Parasitic and Allergenic
Products, Center for Biologics
Evaluation and Research.
Procedure: On September 13, 2006,
from 12 noon to approximately 3:15 pm,
the meeting is open to the public.
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 6, 2006. Oral presentations
from the public will be scheduled
VerDate Aug<31>2005
17:07 Aug 28, 2006
Jkt 208001
between approximately 1:45 pm and
2:45 pm. 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 6, 2006.
Closed Committee Deliberations: On
September 13, 2006 from approximately
3:15 pm to 3:45 p.m., the meeting will
be closed to permit discussion where
disclosure would constitute a clearly
unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). The
committee will discuss individual
research programs in the Office of
Vaccines Research and Review.
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 Gail Dapolito
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: August 23, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E6–14295 Filed 8–28–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Cardiovascular and Renal Drugs
Advisory Committee; Amendment of
Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
amendment to the notice of meeting of
the Cardiovascular and Renal Drugs
Advisory Committee. This meeting was
originally announced in the Federal
Register of August 1, 2006 (71 FR
43487). The amendment is being made
to reflect changes in the Agenda portion
of the document. The word
‘‘TRASYOL’’ should read
‘‘TRASYLOL’’. In the same paragraph,
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51197
the word ‘‘apportioning’’ should read
‘‘aprotinin’’. There are no other changes.
FOR FURTHER INFORMATION CONTACT:
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.
In the
Federal Register of August 1, 2006, FDA
announced that the Cardiovascular and
Renal Drugs Advisory Committee would
meet on September 21, 2006, from 8
a.m. to 5 p.m., and the committee would
discuss clinical data for aprotinin
injection (trade name, TRASYLOL), an
approved product, new drug application
(NDA) 020–304, Bayer
Pharmaceuticals). On page 43487, in the
third column, the Agenda portion of the
document is amended to read as
follows:
Agenda: The committee will discuss
clinical data for aprotinin injection
(trade name, TRASYLOL), 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 aprotinin
injection (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 Web site at
https://www.fda.gov/ohrms/dockets/ac/
acmenu.htm under the heading
‘‘Cardiovascular and Renal Drugs
Advisory Committee’’ (Click on the year
2006 and scroll down to the above
named committee meeting.)
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
SUPPLEMENTARY INFORMATION:
Dated: August 23, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and
Planning.
[FR Doc. E6–14294 Filed 8–28–06; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\29AUN1.SGM
29AUN1
]]>Agencies
[Federal Register Volume 71, Number 167 (Tuesday, August 29, 2006)]
[Notices]
[Page 51197]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14295]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Allergenic Products 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). At least one
portion of the meeting will be closed to the public.
Name of Committee: Allergenic Products 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 13, 2006 from
12 noon to approximately 3:45 p.m.
Location: National Institutes of Health, Bldg. 29B, Conference
Rooms A and B, Bethesda, MD.
Contact Person: Gail Dapolito or Jane Brown, Center for Biologics
Evaluation and Research (HFM-71), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852, 301-827-0314 or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 3014512388. Please call the Information Line
for up-to-date information on this meeting.
Agenda: On September 13, 2006, the committee will discuss a
proposed strategy for the reclassification of Category IIIA allergenic
products. The committee will also receive an update of the research
program of the Laboratory of Immunobiochemistry, Division of Bacterial,
Parasitic and Allergenic Products, Center for Biologics Evaluation and
Research.
Procedure: On September 13, 2006, from 12 noon to approximately
3:15 pm, the meeting is open to the public. 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 6, 2006. Oral presentations from
the public will be scheduled between approximately 1:45 pm and 2:45 pm.
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 6, 2006.
Closed Committee Deliberations: On September 13, 2006 from
approximately 3:15 pm to 3:45 p.m., the meeting will be closed to
permit discussion where disclosure would constitute a clearly
unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The
committee will discuss individual research programs in the Office of
Vaccines Research and Review.
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 Gail Dapolito 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: August 23, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-14295 Filed 8-28-06; 8:45 am]
BILLING CODE 4160-01-S
