Preparation for International Conference on Harmonization Meetings in Brussels, Belgium; Public Meeting; Correction, 57111-57112 [E8-23120]
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Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices
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.
jlentini on PROD1PC65 with NOTICES
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
VerDate Aug<31>2005
18:22 Sep 30, 2008
Jkt 214001
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
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
57111
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.
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 https://www.fda.gov/cder/
meeting/ICH_20081021.htm.
E:\FR\FM\01OCN1.SGM
01OCN1
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.
jlentini on PROD1PC65 with NOTICES
ACTION:
Notice.
VerDate Aug<31>2005
18:22 Sep 30, 2008
Jkt 214001
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).
The agreement became effective
August 28, 2008.
FOR FURTHER INFORMATION CONTACT:
Randy Levin, Director for Health and
DATES:
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
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
E:\FR\FM\01OCN1.SGM
01OCN1
]]>Agencies
[Federal Register Volume 73, Number 191 (Wednesday, October 1, 2008)]
[Notices]
[Pages 57111-57112]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-23120]
-----------------------------------------------------------------------
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: https://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 https://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
