[Federal Register Volume 73, Number 191 (Wednesday, October 1, 2008)]
[Notices]
[Pages 57111-57112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-23120]


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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.

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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: [email protected] 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: [email protected] 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.


[[Page 57112]]


    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