17500 Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices 

Dated: April 8, 2009. 

Carlton Duncan, 

Deputy Chief Operating Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–8632 Filed 4–14–09; 8:45 am] 

BILLING CODE 3410–16–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice of Annual Meeting 

The Vessel Sanitation Program, 

National Center for Environmental 

Health, Centers for Disease Control and 

Prevention (CDC), announces the 

following meeting: 

Name: Vessel Sanitation Program: 

Annual Program Status Update and 

Experience to Date with Program 

Operations. 

Time and Date: 9 a.m. to 4 p.m., June 

12, 2009. 

Location: Auditorium, Port Everglades 

Administration Building, 1850 Eller 

Drive, Fort Lauderdale, Florida 33316. 

Status: The meeting is open to the 

public, but space is limited. The 

meeting room can accommodate 

approximately 100 persons. Annual 

attendees normally include cruise ship 

industry officials, private sanitation 

consultants, and other interested 

parties. 

Meeting Objectives 

CDC staff will update attendees on the 

current status of program topics, 

including but not limited to the 

following: 

• 2008 Program Review. 

• Proposed revisions to the Vessel 

Sanitation Program Operations Manual 

2005. 

• Proposed revisions to the Vessel 

Sanitation Program Construction 

Guidelines 2005. 

• Updates on cruise ship outbreaks. 

An official record of this meeting will 

remain open for 15 days (through June 

27, 2009) so that additional materials or 

comments may be submitted and made 

part of the record. 

Advanced registration is encouraged. 

You may contact Stephanie Lawrence to 

register in advance or to receive 

additional information about the 

meeting. Ms. Lawrence can be reached 

by phone (770–488–3141), fax (770– 

488–4127), or e-mail 

(slawrence@cdc.gov). Please provide 

your name, title, company name, 

mailing address, telephone number, fax 

number, and e-mail address when 

contacting Ms. Lawrence. 

Dated: April 8, 2009. 

Carlton Duncan, 

Deputy Chief Operating Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–8631 Filed 4–14–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0178] 

Preparation for International 

Conference on Harmonisation 

Meetings in Yokohama, Japan; Public 

Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting entitled ‘‘Preparation for 

ICH meetings in Yokohama, Japan’’ to 

provide information and receive 

comments on the International 

Conference on Harmonisation (ICH) as 

well as the upcoming meetings in 

Yokohama, Japan. The topics to be 

discussed are the topics for discussion 

at the forthcoming ICH Steering 

Committee Meeting. The purpose of the 

meeting is to solicit public input prior 

to the next Steering Committee and 

Expert Working Groups meetings in 

Yokohama, Japan, scheduled for June 6 

through 11, 2009, at which discussion of 

the topics underway and the future of 

ICH will continue, as well as provide 

comprehensive updates of the various 

ICH topics. 

Date and Time: The meeting will be 

held on May 6, 2009, from 2:30 p.m. to 

5 p.m. 

Location: The meeting will be held in 

the Washington Room at the Hilton 

Washington DC/Rockville Hotel & 

Executive Meeting Center, 1750 

Rockville Pike, Rockville, MD 20852. 

For security reasons, all attendees are 

asked to arrive no later than 2:15 p.m. 

Contact Person: All participants must 

register with Tammie Jo Bell, Office of 

the Commissioner (HFG–1), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, e-mail: 

Tammie.Bell2@fda.hhs.gov, or FAX: 

301–827–0003. 

Registration and Requests for Oral 

Presentations: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number), written material and requests 

to make oral presentation, to the contact 

person by April 29, 2009. 

If you need special accommodations 

due to a disability, please contact 

Tammie Jo Bell (see Contact Person) at 

least 7 days in advance. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at http://www.fda.gov/ 

ohrms/dockets/ac/acmenu.htm. It may 

be viewed at the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD. A transcript will 

also be available in either hardcopy or 

on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (HFI–35), Office 

of Management Programs, Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. 

SUPPLEMENTARY INFORMATION: The ICH 

was established in 1990 as a joint 

regulatory/industry project to improve, 

through harmonization, the efficiency of 

the process for developing and 

registering new medicinal products in 

Europe, Japan and the United States 

without compromising the regulatory 

obligations of safety and effectiveness. 

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 medical product 

development among regulatory 

agencies. ICH was organized to provide 

an opportunity for harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. ICH is concerned with 

harmonization 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 

Association; the Japanese Ministry of 

Health, Labor and Welfare; the Japanese 

Pharmaceutical Manufactures 

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 


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