Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 57111 

marketing of the products subject to 

those NDAs. Additional ANDAs that 

refer to these products may also be 

approved by the agency if they comply 

with relevant legal and regulatory 

requirements. If FDA determines that 

labeling for these drug products should 

be revised to meet current standards, the 

agency will advise ANDA applicants to 

submit such labeling. 

Dated: September 24, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–23035 Filed 9–30–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0484] 

Preparation for International 

Conference on Harmonization 

Meetings in Brussels, Belgium; Public 

Meeting; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

correction to the notice of a public 

meeting entitled ‘‘Preparation for 

International Conference on 

Harmonization Meetings in Brussels, 

Belgium; Public Meeting.’’ This meeting 

was announced in the Federal Register 

of September 16, 2008 (73 FR 53428). 

The correction is being made to reflect 

changes in the Summary, Date and 

Time, Location, Contact Person, 

Background, and Agenda portions of the 

document. 

FOR FURTHER INFORMATION CONTACT: 

Tammie Jo Bell, Office of the 

Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, by email: 

Tammie.Bell2@fda.hhs.gov or fax: 301– 

827–0003. 

SUPPLEMENTARY INFORMATION: The FDA 

is correcting a notice published in the 

Federal Register of September 16, 2008 

(73 FR 53428), announcing a meeting 

entitled ‘‘Preparation for International 

Conference on Harmonization Meetings 

in Brussels, Belgium.’’ This corrected 

notice is being published in its entirety: 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting entitled ‘‘Preparation for 

International Conference on 

Harmonization Meetings in Brussels, 

Belgium’’ to provide information and 

receive comments on the International 

Conference on Harmonization (ICH) as 

well as the upcoming meetings in 

Brussels, Belgium. 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 

Brussels, Belgium, November 10 to 13, 

2008, 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 Tuesday, October 21, 2008, 

from 2:30 p.m. to 5:30 p.m. 

Location: The meeting will be held at 

5600 Fishers Lane, 3rd floor, Conference 

Rooms D and E, Rockville, MD 20857. 

For security reasons, all attendees are 

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

as you will be escorted from the front 

entrance of 5600 Fishers Lane to 

Conference Rooms D and E. 

Contact Person: All participants must 

register with Tammie Jo Bell, Office of 

the Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, by email: 

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 October 14, 2008. 

If you need special accommodations 

due to a disability, please contact 

Tammie Jo Bell at least 7 days in 

advance. 

Transcripts: Transcripts of the 

meeting may be requested in writing 

from the Freedom of Information Office 

(HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

12A–66, Rockville, MD 20857, 

approximately 15 working days after the 

meeting at a cost of 10 cents per page. 

Background: 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 

Associations; 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 

representatives from each of the ICH 

sponsors and Health Canada, the 

European Free Trade Area and the 

World Health Organization. The ICH 

process has achieved significant 

harmonization of the technical 

requirements for the approval of 

pharmaceuticals for human use in the 

three ICH regions. 

The current ICH process and structure 

can be found at the following Web site: 

http://www.ich.org. 

Interested persons may present data, 

information, or views orally or in 

writing, on issues pending at the public 

meeting. Time allotted for oral 

presentations may be limited to 10 

minutes. Those desiring to make oral 

presentations should notify the contact 

person by October 14, 2008, and submit 

a brief statement of the general nature of 

the evidence or arguments they wish to 

present, the names and addresses, 

phone number, fax, and email of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation. 

Agenda: The agenda for the public 

meeting will be made available via the 

internet at http://www.fda.gov/cder/ 

meeting/ICH_20081021.htm. 


jlentini on PROD1PC65 with NOTICES
57112 Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 

Dated: September 26, 2008. 

Jeffrey Shuren, 

Asssociate Commissioner for Policy and 

Planning. 

[FR Doc. E8–23120 Filed 9–30–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0043] 

[FDA No. 225–08–8004] 

Memorandum of Agreement Between 

the Food and Drug Administration, the 

National Cancer Institute, a Part of the 

National Institutes of Health, and the 

CRIX International Association 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration FDA) is providing 

notice of a memorandum of agreement 

(MOA) between FDA, the National 

Cancer Institute (NCI) and CRIX 

International Association. The purpose 

of the MOA is to establish a publicprivate partnership to pilot the use of a 

nonprofit organization to manage the 

production instance of the Federal 

Investigator Registry of Biomedical 

Information Research Data (FIREBIRD) 

system as a vehicle for secure, rapid and 

efficient electronic exchange of clinical 

investigator credentialing information 

among clinical investigators at trial 

sites, sponsors (including NCI), and 

FDA; and to continue the development 

of FIREBIRD to fulfill the requirements 

of FDA and sponsors (including the 

NCI). 

DATES: The agreement became effective 

August 28, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Randy Levin, Director for Health and 

Regulatory Data Standards (HF–18), 

Food and Drug Administration, 

5600 Fishers Lane, Rockville, MD 

20857, 301–827–7784; 

George Komatsoulis, Chief Operating 

Officer, Center for Bioinformatics, 

National Cancer Institute, 8800 

Rockville Pike, Bethesda, MD 

20892–8505, 301–451–2881; and 

James L. Bland, Project Officer, CRIX 

International Association, 1195 

Freedom Dr., Reston, VA 20190, 

703–577–8788. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 20.108(c), 

which states that all written agreements 

and MOUs between FDA and others 

shall be published in the Federal 

Register, the agency is publishing notice 

of this MOA. 

Dated: September 24, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

BILLING CODE 4160–01–S 


jlentini on PROD1PC65 with NOTICES