Preparation for International Conference on Harmonization Steering Committee and Expert Working Group Meetings in Cincinnati, OH; Regional Public Meeting, 20690 [2011-8816]
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20690
Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: April 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–8817 Filed 4–12–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Preparation for International
Conference on Harmonization Steering
Committee and Expert Working Group
Meetings in Cincinnati, OH; Regional
Public Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSKH9S0YB1PROD with NOTICES
ACTION:
Notice of public meeting.
The Food and Drug Administration
(FDA) is announcing a public meeting
entitled ‘‘Preparation for ICH Steering
Committee and Expert Working Group
Meetings in Cincinnati, Ohio’’ to
provide information and receive
comments on the International
Conference on Harmonization (ICH) as
well as the upcoming meetings in
Cincinnati, OH. 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 Group meetings in
Cincinnati, OH, scheduled on June 11
through 17, 2011, at which discussion of
the topics underway and the future of
ICH will continue.
Date and Time: The public meeting
will be held on May 19, 2011, from 2
p.m. to 4 p.m.
Location: The public meeting will be
held at the Washington Theater room at
the Hilton Washington DC/Rockville
Hotel & Executive Meeting Center, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: All participants must
register with Kimberly Franklin, Office
of the Commissioner, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002, email: Kimberly.Franklin@fda.hhs.gov, or
FAX: 301–595–7937.
Registration and Requests for Oral
Presentations: Send registration
VerDate Mar<15>2010
18:37 Apr 12, 2011
Jkt 223001
information (including name, title, firm
name, address, telephone, and fax
number), written material, and requests
to make oral presentations to the contact
person (see Contact Person) by May 16,
2011.
Interested persons may present data,
information, or views orally or in
writing, on issues pending at the public
meeting. Public oral presentations will
be scheduled between approximately
3:30 p.m. and 4 p.m. Time allotted for
oral presentations may be limited to 10
minutes. Those desiring to make oral
presentations should notify the contact
person (see Contact Person) by May 16,
2011, and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses, telephone
number, fax, and email of proposed
participants, and an indication of the
approximate time requested to make
their presentation.
If you need special accommodations
due to a disability, please contact
Kimberly Franklin (see Contact Person)
at least 7 days in advance.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD. A transcript will
also be available in either hardcopy or
on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information, 12420
Parklawn Dr., Rockville, MD 20857.
SUPPLEMENTARY INFORMATION: 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
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
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. (FDA has verified
the Web site addresses in this
document, but FDA is not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.)
The agenda for the public meeting
will be made available on the Internet
at https://www.fda.gov/Drugs/
NewsEvents/ucm248489.htm.
Dated: April 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–8816 Filed 4–12–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
International Consortium of
Orthopedic Registries; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘International Consortium of
Orthopedic Registries (ICOR).’’ The
E:\FR\FM\13APN1.SGM
13APN1
]]>Agencies
[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Page 20690]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8816]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Preparation for International Conference on Harmonization
Steering Committee and Expert Working Group Meetings in Cincinnati, OH;
Regional Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``Preparation for ICH Steering Committee and Expert
Working Group Meetings in Cincinnati, Ohio'' to provide information and
receive comments on the International Conference on Harmonization (ICH)
as well as the upcoming meetings in Cincinnati, OH. 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 Group
meetings in Cincinnati, OH, scheduled on June 11 through 17, 2011, at
which discussion of the topics underway and the future of ICH will
continue.
Date and Time: The public meeting will be held on May 19, 2011,
from 2 p.m. to 4 p.m.
Location: The public meeting will be held at the Washington Theater
room at the Hilton Washington DC/Rockville Hotel & Executive Meeting
Center, 1750 Rockville Pike, Rockville, MD 20852.
Contact Person: All participants must register with Kimberly
Franklin, Office of the Commissioner, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, e-mail:
Kimberly.Franklin@fda.hhs.gov, or FAX: 301-595-7937.
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 presentations
to the contact person (see Contact Person) by May 16, 2011.
Interested persons may present data, information, or views orally
or in writing, on issues pending at the public meeting. Public oral
presentations will be scheduled between approximately 3:30 p.m. and 4
p.m. Time allotted for oral presentations may be limited to 10 minutes.
Those desiring to make oral presentations should notify the contact
person (see Contact Person) by May 16, 2011, and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses, telephone number, fax, and email
of proposed participants, and an indication of the approximate time
requested to make their presentation.
If you need special accommodations due to a disability, please
contact Kimberly Franklin (see Contact Person) at least 7 days in
advance.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information, 12420 Parklawn
Dr., Rockville, MD 20857.
SUPPLEMENTARY INFORMATION: 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. (FDA has verified the Web site addresses
in this document, but FDA is not responsible for any subsequent changes
to the Web sites after this document publishes in the Federal
Register.)
The agenda for the public meeting will be made available on the
Internet at https://www.fda.gov/Drugs/NewsEvents/ucm248489.htm.
Dated: April 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8816 Filed 4-12-11; 8:45 am]
BILLING CODE 4160-01-P
