61132 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 http://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 

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 75201- 

2272: 

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] 

BILLING CODE 6210–01–S 

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; 

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: 

http://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] 

BILLING CODE 4151–05–M 

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 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 

Federal Register / Vol. 70, No. 202 / Thursday, October 20, 2005 / Notices 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 http://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] 

BILLING CODE 4160–01–S 

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. 

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. 

ADDRESSES: 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 http:// 

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 selfaddressed 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: 

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.