Anesthetic and Life Support Drugs Advisory Committee; Notice of Meeting, 61132-61133 [05-20970]
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Federal Register / Vol. 70, No. 202 / Thursday, October 20, 2005 / Notices
FEDERAL RESERVE SYSTEM
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The application also will be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Additional information on all bank
holding companies may be obtained
from the National Information Center
Web site at https://www.ffiec.gov/nic/.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than November 15,
2005.
Federal Reserve Bank of Atlanta
(Andre Anderson, Vice President) 1000
Peachtree Street, NE., Atlanta, Georgia
30303:
1. Security Bank Corporation, Macon,
Georgia, to merge with Rivoli BanCorp,
Inc., and thereby indirectly acquire
Rivoli Bank and Trust, Macon, Georgia.
A. Federal Reserve Bank of St. Louis
(Glenda Wilson, Community Affairs
Officer) 411 Locust Street, St. Louis,
Missouri 63166-2034:
1. Farmers Capital Bank Corporation,
Frankfort, Kentucky; to acquire 100
percent of the voting shares of Citizens
Bancorp, Inc., Newport, Kentucky, and
thereby indirectly acquire Citizens Bank
of Northern Kentucky, Newport,
Kentucky.
In connection with this application,
Citizens Acquisition Subsidiary Corp.,
Frankfort, Kentucky has applied to
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become a bank holding company by by
merging with Citizens Bancorp, Inc.,
and thereby acquire Citizens Bank of
Northern Kentucky, Inc., Newport,
Kentucky.
Applicants also have applied to
acquire Citizens Financial Services,
Newport, Kentucky and thereby engage
in securities brokerage and financial
planning services, pursuant to section
225.28(b)(6) and (7) of Regulation Y.
Federal Reserve Bank of Dallas (W.
Arthur Tribble, Vice President) 2200
North Pearl Street, Dallas, Texas 752012272:
1. New Waggoner Inc., Vernon, Texas;
to become a bank holding company by
acquiring 100 percent voting shares of
Waggoner National Bancshares, Inc.,
Vernon, Texas, and indirectly acquiring
and Vernon Bancshares, Inc.,
Wilmington, Delaware, and The
Waggoner National Bank of Vernon,
Vernon,Texas.
Board of Governors of the Federal Reserve
System, October 14, 2005.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E5–5782 Filed 10–19–05; 8:45 am]
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telephone (202) 690–7100; or Marjorie
S. Greenberg, Executive Secretary,
NCVHS, National Center for Health
Statistics, Centers for Disease Control
and Prevention, 3311 Toledo Road,
Room 2402, Hyattsville, Maryland
20782, telephone (301) 458–4245.
Information also is available on the
NCVHS home page of the HHS Web site:
https://www.ncvhs.hhs.gov/, where
further information including an agenda
will be posted when available.
Should you require reasonable
accommodation, please contact the CDC
Office of Equal Employment
Opportunity on (301) 458–4EEO (4336)
as soon as possible.
Dated: October 14, 2005.
James Scanlon,
Deputy Assistant Secretary for Planning and
Evaluation (OSDP), Office of the Assistant
Secretary for Planning and Evaluation.
[FR Doc. 05–20991 Filed 10–19–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Anesthetic and Life Support Drugs
Advisory Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Committee on Vital and Health
Statistics: Meeting
Pursuant to the Federal Advisory
Committee Act, the Department of
Health and Human Services (HHS)
announces the following advisory
committee meeting.
Name: National Committee on Vital
and Health Statistics (NCVHS),
Subcommittee on Privacy and
Confidentiality.
Time and Date: October 21, 2005, 9
a.m.–5 p.m.
Place: Hubert H. Humphrey Building,
Room 443E, 200 Independence Avenue,
SW., Washington, DC 20201.
Status: Open.
Purpose: The purpose of this working
session will be to discuss a letter and
report to the HHS Secretary on Privacy
and the National Health Information
Network.
Contact Person for More Information:
Substantive program information as
well as summaries of meetings and a
roster of committee members may be
obtained from Maya A. Bernstein, Lead
Staff for Subcommittee on Privacy and
Confidentiality, Office of the Assistant
Secretary for Planning and Evaluation,
434E Hubert H. Humphrey Building,
200 Independence Avenue, SW., 20201;
PO 00000
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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: Anesthetic and
Life Support 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 November 10, 2005, from 9 a.m.
to 5 p.m.
Location: Food and Drug
Administration, Center for Drug
Evaluation and Research Advisory
Committee Conference Room, rm. 1066,
5630 Fishers Lane, Rockville, MD.
Contact Person: Victoria FerrettiAceto, 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:
ferrettiv@cder.fda.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
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Federal Register / Vol. 70, No. 202 / Thursday, October 20, 2005 / Notices
3014512529. Please call the Information
Line for up-to-date information on this
meeting. When available, background
materials for this meeting will be posted
one business day prior to the meeting on
the FDA Web site at https://www.fda.gov/
ohrms/dockets/ac/acmenu.htm. (Click
on the year 2005 and scroll down to
Anesthetic and Life Support Drugs
Advisory Committee).
Agenda: The meeting will be open to
the public from 9 a.m. to 10 a.m., unless
public participation does not last that
long, from 10 a.m. to 5 p.m., the meeting
will be closed to permit discussion and
review of trade secret and/or
confidential information.
Procedure: On November 10, 2005,
from 9 a.m. to 10 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 November 3, 2005. Oral
presentations from the public will be
scheduled between approximately 9:15
a.m. to 10:15 a.m. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before November 3, 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 Presentation of Data: On
November 10, 2005, from 10 a.m. to 5
p.m., the meeting will be closed to
permit discussion and review of trade
secret and/or confidential information
(5 U.S.C. 552b(c)(4)).
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 Victoria
Ferretti-Aceto 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: October 12, 2005.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. 05–20970 Filed 10–19–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D–0378]
International Conference on
Harmonisation; Guidance on S7B
Nonclinical Evaluation of the Potential
for Delayed Ventricular Repolarization
(QT Interval Prolongation) by Human
Pharmaceuticals; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Submit written comments
on the 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.
Submit written requests for single
copies of the guidance to the Division of
Drug Information (HFD–240), Center for
Drug Evaluation and Research, Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, or the Office
of Communication, Training and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 1401 Rockville Pike,
Rockville, MD 20852–1448. The
guidance may also be obtained by mail
by calling the Center for Biologics
Evaluation and Research (CBER) Voice
Information System at 1–800–835–4709
or 301–827–1800. Send one self-
ADDRESSES:
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addressed adhesive label to assist the
office in processing your requests.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: John
Koerner, Center for Drug Evaluation
and Research (HFD–110), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–
594–5338.
Regarding the ICH: Michelle Limoli,
Office of International Programs
(HFG–1), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–
4480.
SUPPLEMENTARY INFORMATION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled ‘‘S7B
Nonclinical Evaluation of the Potential
for Delayed Ventricular Repolarization
(QT Interval Prolongation) by Human
Pharmaceuticals.’’ The guidance was
prepared under the auspices of the
International Conference on
Harmonisation of Technical
Requirements for Registration of
Pharmaceuticals for Human Use (ICH).
The guidance describes a nonclinical
testing strategy for assessing the
potential of a test substance to delay
ventricular repolarization and includes
information concerning nonclinical
assays and an integrated risk
assessment. The guidance is intended to
facilitate the nonclinical assessment of
the effects of pharmaceuticals on
ventricular repolarization and
proarrhythmic risk.
DATES: Submit written or electronic
comments on agency guidances at any
time.
PO 00000
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I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies.
ICH was organized to provide an
opportunity for tripartite harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products among three
regions: The European Union, Japan,
and the United States. The six ICH
sponsors are the European Commission;
the European Federation of
Pharmaceutical Industries Associations;
the Japanese Ministry of Health, Labour,
and Welfare; the Japanese
Pharmaceutical Manufacturers
Association; the Centers for Drug
Evaluation and Research and Biologics
Evaluation and Research, FDA; and the
Pharmaceutical Research and
Manufacturers of America. The ICH
Secretariat, which coordinates the
preparation of documentation, is
provided by the International
Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
The ICH Steering Committee includes
representatives from each of the ICH
sponsors and the IFPMA, as well as
observers from the World Health
Organization, Health Canada, and the
European Free Trade Area.
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]]>Agencies
[Federal Register Volume 70, Number 202 (Thursday, October 20, 2005)]
[Notices]
[Pages 61132-61133]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20970]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Anesthetic and Life Support Drugs 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: Anesthetic and Life Support 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 November 10, 2005, from
9 a.m. to 5 p.m.
Location: Food and Drug Administration, Center for Drug Evaluation
and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers
Lane, Rockville, MD.
Contact Person: Victoria Ferretti-Aceto, 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: ferrettiv@cder.fda.gov,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code
[[Page 61133]]
3014512529. Please call the Information Line for up-to-date information
on this meeting. When available, background materials for this meeting
will be posted one business day prior to the meeting on the FDA Web
site at https://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the
year 2005 and scroll down to Anesthetic and Life Support Drugs Advisory
Committee).
Agenda: The meeting will be open to the public from 9 a.m. to 10
a.m., unless public participation does not last that long, from 10 a.m.
to 5 p.m., the meeting will be closed to permit discussion and review
of trade secret and/or confidential information.
Procedure: On November 10, 2005, from 9 a.m. to 10 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
November 3, 2005. Oral presentations from the public will be scheduled
between approximately 9:15 a.m. to 10:15 a.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before November 3, 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 Presentation of Data: On November 10, 2005, from 10 a.m. to
5 p.m., the meeting will be closed to permit discussion and review of
trade secret and/or confidential information (5 U.S.C. 552b(c)(4)).
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 Victoria Ferretti-
Aceto 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: October 12, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. 05-20970 Filed 10-19-05; 8:45 am]
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