Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 3936 [05-1474]
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Federal Register / Vol. 70, No. 17 / Thursday, January 27, 2005 / Notices
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: January 19, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–1475 Filed 1–26–05; 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.
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: 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 February 16, 2005, from 8:30
a.m. to approximately 5 p.m., and on
February 17, 2005, from 8:30 a.m. to
approximately 2:05 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: On February 16, 2005, the
committee will review and discuss the
selection of strains to be included in the
influenza virus vaccine for the 20052006 season. On February 17, 2005, the
committee will hear updates on FDA
Critical Path Initiative and Research
Programs in the Center for Biologics
Evaluation and Research.
Procedure: On February 16, 2005,
from 8:30 a.m. to 5 p.m. and on
February 17, 2005, from 8:30 a.m. to
11:25 a.m., the meeting is open to the
VerDate jul<14>2003
17:20 Jan 26, 2005
Jkt 205001
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 by February
9, 2005. Oral presentations from the
public will be scheduled between
approximately 1 p.m. and 1:30 p.m. on
February 16, 2005, and approximately
8:45 a.m. and 9:15 a.m. on February 17,
2005. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before February 9, 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.
Closed Committee Deliberations: On
February 17, 2005, from approximately
12 noon to 2:05 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)) and to
permit discussion and review of trade
secret and/or confidential information
(5 U.S.C. 552b(c)(4)). The committee
will discuss individual Research
Programs in the Center for Biologics
Evaluation and Research and receive an
update on a product under review.
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 301–827–
0314 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: January 18, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–1474 Filed 1–26–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine; Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the second meeting of
the Commission on Systemic
Interoperability.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The mission of the Commission on
Systemic Interoperability is to submit a
report to the Secretary of Health and
Human Services and to Congress on a
comprehensive strategy for the adoption
and implementation of health care
information technology standards that
includes a timeline and prioritization
for such adoption and implementation.
In developing that strategy, the
Commission will consider: (1) The costs
and benefits of the standards, both
financial impact and quality
improvement; (2) the current demand
on industry resources to implement the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 and other electronic standards,
including HIPAA standards; and (3) the
most cost-effective and efficient means
for industry to implement the standards.
Name of Committee: Commission on
Systemic Interoperability (Teleconference).
Date: February 9, 2005.
Time: 3 p.m. to 4:30 p.m.
Agenda: Healthcare Information
Technology Standards.
Place: National Library of Medicine, NIH,
Conference Room B, Building 38, 2nd Floor,
8600 Rockville Pike, Bethesda, MD 20894.
Contact Person: Ms. Jane Griffith, Deputy
Director, National Library of Medicine,
National Institutes of Health, Building 38,
Room 2E17, Bethesda, MD 20894, (301) 496–
6661.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The comments should include
the name, address, telephone number and,
when applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
into the building by non-government
employees. Persons without a government
I.D. will need to show a photo I.D. and signin at the security desk upon entering the
building.
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]]>Agencies
[Federal Register Volume 70, Number 17 (Thursday, January 27, 2005)]
[Notices]
[Page 3936]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-1474]
-----------------------------------------------------------------------
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). At least one
portion of the meeting will be closed 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 February 16, 2005, from
8:30 a.m. to approximately 5 p.m., and on February 17, 2005, from 8:30
a.m. to approximately 2:05 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: On February 16, 2005, the committee will review and discuss
the selection of strains to be included in the influenza virus vaccine
for the 2005-2006 season. On February 17, 2005, the committee will hear
updates on FDA Critical Path Initiative and Research Programs in the
Center for Biologics Evaluation and Research.
Procedure: On February 16, 2005, from 8:30 a.m. to 5 p.m. and on
February 17, 2005, from 8:30 a.m. to 11:25 a.m., 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 by February 9, 2005. Oral
presentations from the public will be scheduled between approximately 1
p.m. and 1:30 p.m. on February 16, 2005, and approximately 8:45 a.m.
and 9:15 a.m. on February 17, 2005. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should
notify the contact person before February 9, 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.
Closed Committee Deliberations: On February 17, 2005, from
approximately 12 noon to 2:05 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)) and to
permit discussion and review of trade secret and/or confidential
information (5 U.S.C. 552b(c)(4)). The committee will discuss
individual Research Programs in the Center for Biologics Evaluation and
Research and receive an update on a product under review.
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 301-827-0314 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: January 18, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-1474 Filed 1-26-05; 8:45 am]
BILLING CODE 4160-01-S
