Preparation for International Conference on Harmonization Meetings in Brussels, Belgium; Public Meeting, 53428 [E8-21573]
Download as PDF
<![CDATA[
53428
Federal Register / Vol. 73, No. 180 / Tuesday, September 16, 2008 / Notices
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: September 10, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–21574 Filed 9–15–08; 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
AGENCY:
Food and Drug Administration,
HHS.
ebenthall on PROD1PC60 with NOTICES
ACTION:
Notice of meeting.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public meeting entitled ‘‘Preparation for
ICH 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.
Date and Time: The meeting will be
held on Tuesday, October 21, 2008,
from 3 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 2:45 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.bell@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.
VerDate Aug<31>2005
13:43 Sep 15, 2008
Jkt 214001
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.
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
The current ICH process and structure
can be found at the following Web site:
https://www.ich.org.
Dated: September 9, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–21573 Filed 9–15–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Use of Razoxane for the Treatment of
Alzheimer’s Disease
Description of Technology:
Abnormalities in the metabolism of the
transition metals, iron and copper, have
been demonstrated to play a crucial role
in the pathogenesis of various
neurodegenerative diseases, including
Alzheimer’s disease (AD) and
Parkinson’s disease (PD). Excessive iron
accumulation in the brain occurs in
both AD and PD. High levels of reactive
iron can increase oxidative stressinduced neuronal vulnerability,
increase the toxicity of environmental or
endogenous toxins, and accelerate
hallmark pathologies of these diseases.
As an example among many, the
expression level of amyloid-b precursor
protein (APP) that generates the AD
neurotoxic peptide, amyloid-b (Ab), is
E:\FR\FM\16SEN1.SGM
16SEN1
]]>Agencies
[Federal Register Volume 73, Number 180 (Tuesday, September 16, 2008)]
[Notices]
[Page 53428]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-21573]
-----------------------------------------------------------------------
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
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``Preparation for ICH 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.
Date and Time: The meeting will be held on Tuesday, October 21,
2008, from 3 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 2:45 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.bell@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: https://www.ich.org.
Dated: September 9, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21573 Filed 9-15-08; 8:45 am]
BILLING CODE 4160-01-S
