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45250 Federal Register / Vol. 72, No.

155 / Monday, August 13, 2007 / Notices

Lane, Rockville, MD 20857, 301–827– asked to arrive no later than 12:20 p.m., Evaluation and Research, FDA; and the
1482. as you will be escorted from the front Pharmaceutical Research and
SUPPLEMENTARY INFORMATION: In the entrance of 5600 Fishers Lane to Manufacturers of America. The ICH
Federal Register of May 25, 2006 (71 FR Conference Room D and E. Secretariat, which coordinates the
30142), the agency announced that the Contact Person: All participants must preparation of documentation, is
proposed information collection had register with Tammie Bell, Office of the provided by the International
been submitted to OMB for review and Commissioner, Food and Drug Federation of Pharmaceutical
clearance under 44 U.S.C. 3507. An Administration, 5600 Fishers Lane, Manufacturers Associations (IFPMA).
agency may not conduct or sponsor, and Rockville, MD 20857, by e-mail: The ICH Steering Committee includes
a person is not required to respond to, Tammie.Bell2@fda.hhs.gov or fax: 301– representatives from each of the ICH
a collection of information unless it 827–0003. sponsors, and Health Canada, the
displays a currently valid OMB control Registration and Requests for Oral European Free Trade Area, and the
number. OMB has now approved the Presentations: Send registration World Health Organization. The ICH
information collection and has assigned information (including name, title, firm process has achieved significant
OMB control number 0910–0445. The name, address, telephone, and fax harmonization of the technical
approval expires on January 31, 2010. A number), written material and requests requirements for the approval of
copy of the supporting statement for this to make oral presentations, to the pharmaceuticals for human use in the
information collection is available on contact person by October 8, 2007. three ICH regions.
the Internet at http://www.fda.gov/ If you need special accommodations The current ICH process and structure
ohrms/dockets. due to a disability, please contact can be found at the following Web site:
Tammie Bell at least 7 days in advance. http://www.ich.org.
Dated: August 6, 2007. Transcripts: Transcripts of the Interested persons may present data,
Jeffrey Shuren, meeting may be requested in writing information, or views orally or in
Assistant Commissioner for Policy. from the Freedom of Information Office writing, on issues pending at the public
[FR Doc. E7–15740 Filed 8–10–07; 8:45 am] (HFI–35), Food and Drug meeting. Oral presentations from the
BILLING CODE 4160–01–S Administration, 5600 Fishers Lane, rm. public will be scheduled between
12A–16, Rockville, MD 20857, approximately 4:30 p.m. and 5 p.m.
approximately 15 working days after the Time allotted for oral presentations may
DEPARTMENT OF HEALTH AND meeting at a cost of 10 cents per page. be limited to 10 minutes. Those desiring
HUMAN SERVICES SUPPLEMENTARY INFORMATION: The ICH to make oral presentations should notify
was established in 1990 as a joint the contact person by April 2, 2007, and
Food and Drug Administration submit a brief statement of the general
regulatory/industry project to improve,
[Docket No. 2007N–0304] through harmonization, the efficiency of nature of the evidence or arguments
the process for developing and they which to present, the names and
Preparation for International registering new medicinal products in addresses, phone number, fax, and e-
Conference on Harmonization Europe, Japan, and the United States mail of proposed participants, and an
Meetings in Yokohama, Japan; Public without compromising the regulatory indication of the approximate time
Meeting obligations of safety and effectiveness. requested to make their presentation.
In recent years, many important The agenda for the public meeting
AGENCY: Food and Drug Administration,
initiatives have been undertaken by will be made available via the internet
regulatory authorities and industry at http://www.fda.gov/cder/meeting/
ACTION: Notice of meeting. ICH_20060508.htm.
associations to promote international
SUMMARY: The Food and Drug harmonization of regulatory Dated: August 7, 2007.
Administration (FDA) is announcing a requirements. FDA has participated in Jeffrey Shuren,
public meeting entitled ‘‘Preparation for many meetings designed to enhance Assistant Commissioner for Policy.
ICH meetings in Yokohama, Japan’’ to harmonization and is committed to [FR Doc. E7–15803 Filed 8–10–07; 8:45 am]
provide information and receive seeking scientifically based harmonized
comments on the International technical procedures for pharmaceutical
Conference on Harmonization (ICH) as development. One of the goals of
well as the upcoming meetings in harmonization is to identify and then DEPARTMENT OF HEALTH AND
Yokohama, Japan. The topics to be reduce differences in technical HUMAN SERVICES
discussed are the topics for discussion requirements for medical product
at the forthcoming ICH Steering development among regulatory Food and Drug Administration
Committee Meeting. The purpose of the agencies. ICH was organized to provide
an opportunity for harmonization [Docket No. 2007N–0313]
meeting is to solicit public input prior
to the next Steering Committee and initiatives to be developed with input
Preparation for International
Expert Working Groups meetings in from both regulatory and industry
Cooperation on Cosmetics
Yokohama, Japan, October 27 through representatives. ICH is concerned with
Regulations Meeting in Brussels,
November 1, 2007, at which discussion harmonization among three regions: The
Belgium; Notice of Public Meeting
of the topics underway and the future of European Union, Japan, and the United
ICH will continue. States. The six ICH sponsors are the AGENCY: Food and Drug Administration,
Date and Time: The meeting will be European Commission; the European HHS.
held on Wednesday, October 10, 2007, Federation of Pharmaceutical Industries ACTION: Notice of meeting.
jlentini on PROD1PC65 with NOTICES

from 12:30p.m. to 3 p.m. Associations; the Japanese Ministry of

Location: The meeting will be held at Health, Labor and Welfare; the Japanese SUMMARY: The Food and Drug
5600 Fishers Lane, 3rd floor, Conference Pharmaceutical Manufacturers Administration (FDA) is announcing a
Room D and E, Rockville, MD 20857. Association; the Centers for Drug public meeting entitled ‘‘Preparation for
For security reasons, all attendees are Evaluation and Research and Biologics International Cooperation on Cosmetics

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