Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 8377 [05-3180]
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Federal Register / Vol. 70, No. 33 / Friday, February 18, 2005 / Notices
to demonstrate the effectiveness of
antiseptic products used in health care
settings. The discussion will also focus
on related public health issues, trial
design, and statistical issues. The
background material will become
available no later than the day before
the meeting and will be posted under
the Nonprescription Drugs Advisory
Committee (NDAC) on FDA’s Web site
at https://www.fda.gov/ohrms/dockets/
ac/acmenu.htm. (Click on the year 2005
and scroll down to NDAC).
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 by March 16, 2005. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. on March 23, 2005.
Time allotted for each presentation may
be limited. Those desiring to make
formal oral presentations should notify
the contact person before March 16,
2005 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.
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 LaNise Giles,
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: February 10, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–3115 Filed 2–17–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting
AGENCY: Food and Drug Administration,
HHS.
VerDate jul<14>2003
15:41 Feb 17, 2005
Jkt 205001
ACTION: Notice.
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: Vaccines and
Related Biological 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 March 15, 2005, from 8:30 a.m.
to approximately 5:40 p.m.
Location: Holiday Inn Select
Bethesda, 8120 Wisconsin Ave.,
Bethesda, MD.
Contact Person: Christine Walsh or
Denise Royster, 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
3014512391. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: The committee will review
safety and immunogenicity for two
Tetanus Toxoid, Reduced Diptheria
Toxoid and Acellular Pertussis Vaccine,
Absorbed (Tdap) vaccines. In the
morning the committee will review
safety and immunogenicity data for a
Tdap vaccine manufactured by
GlaxoSmithKline Biologicals. In the
afternoon the committee will review
safety and immunogenicity data for a
Tdap vaccine manufactured by Aventis
Pasteur Ltd.
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 by March 8, 2005. Oral
presentations from the public will be
scheduled between approximately 11:10
a.m. and 11:40 a.m., and approximately
4:10 p.m. and 4:40 p.m. Time allotted
for each presentation may be limited.
Those desiring to make formal oral
presentations should notify the contact
person before March 8, 2005, 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.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
PO 00000
Frm 00041
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8377
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 Christine
Walsh or Denise Royster 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: February 10, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–3180 Filed 2–17–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0043]
Blood Pressure Measurement Devices
(Sphygmomanometers)—Accuracy;
Draft Revised Compliance Policy
Guide; Availability
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft revised guidance
for FDA staff and industry entitled
‘‘Compliance Policy Guide (CPG) Sec.
310.210 Blood Pressure Measurement
Devices (Sphygmomanometers)—
Accuracy (CPG 7124.23).’’ This draft
CPG provides guidance concerning
accuracy and exhaust rate criteria for
sphygmomanometers. This draft
guidance is being issued for public
comment only and will not be
implemented until a final CPG is
announced in the Federal Register.
DATES: Submit written or electronic
comments on the draft guidance by May
19, 2005.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Compliance Policy (HFC–
230), Office of Regulatory Affairs, Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, or FAX your
request to 240–632–6861. Submit
written comments on the draft guidance
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
E:\FR\FM\18FEN1.SGM
18FEN1
]]>Agencies
[Federal Register Volume 70, Number 33 (Friday, February 18, 2005)]
[Notices]
[Page 8377]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-3180]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Vaccines and Related Biological 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). The meeting will
be open to the public.
Name of Committee: Vaccines and Related Biological 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 March 15, 2005, from
8:30 a.m. to approximately 5:40 p.m.
Location: Holiday Inn Select Bethesda, 8120 Wisconsin Ave.,
Bethesda, MD.
Contact Person: Christine Walsh or Denise Royster, 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 3014512391. Please call the
Information Line for up-to-date information on this meeting.
Agenda: The committee will review safety and immunogenicity for two
Tetanus Toxoid, Reduced Diptheria Toxoid and Acellular Pertussis
Vaccine, Absorbed (Tdap) vaccines. In the morning the committee will
review safety and immunogenicity data for a Tdap vaccine manufactured
by GlaxoSmithKline Biologicals. In the afternoon the committee will
review safety and immunogenicity data for a Tdap vaccine manufactured
by Aventis Pasteur Ltd.
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 by March 8, 2005.
Oral presentations from the public will be scheduled between
approximately 11:10 a.m. and 11:40 a.m., and approximately 4:10 p.m.
and 4:40 p.m. Time allotted for each presentation may be limited. Those
desiring to make formal oral presentations should notify the contact
person before March 8, 2005, 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.
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 Christine Walsh or
Denise Royster 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: February 10, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-3180 Filed 2-17-05; 8:45 am]
BILLING CODE 4160-01-S
