Preparation for International Cooperation on Cosmetics Regulations Meeting in Brussels, Belgium; Notice of Public Meeting, 45250-45251 [07-3954]
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45250
Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Notices
Lane, Rockville, MD 20857, 301–827–
1482.
SUPPLEMENTARY INFORMATION: In the
Federal Register of May 25, 2006 (71 FR
30142), the agency announced that the
proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0445. The
approval expires on January 31, 2010. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
Dated: August 6, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–15740 Filed 8–10–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0304]
Preparation for International
Conference on Harmonization
Meetings in Yokohama, Japan; Public
Meeting
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
ACTION:
Notice of meeting.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public meeting entitled ‘‘Preparation for
ICH meetings in Yokohama, Japan’’ to
provide information and receive
comments on the International
Conference on Harmonization (ICH) as
well as the upcoming meetings in
Yokohama, Japan. 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
Yokohama, Japan, October 27 through
November 1, 2007, at which discussion
of the topics underway and the future of
ICH will continue.
Date and Time: The meeting will be
held on Wednesday, October 10, 2007,
from 12:30p.m. to 3 p.m.
Location: The meeting will be held at
5600 Fishers Lane, 3rd floor, Conference
Room D and E, Rockville, MD 20857.
For security reasons, all attendees are
VerDate Aug<31>2005
16:19 Aug 10, 2007
Jkt 211001
asked to arrive no later than 12:20 p.m.,
as you will be escorted from the front
entrance of 5600 Fishers Lane to
Conference Room D and E.
Contact Person: All participants must
register with Tammie Bell, Office of the
Commissioner, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, by e-mail:
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 presentations, to the
contact person by October 8, 2007.
If you need special accommodations
due to a disability, please contact
Tammie 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–16, Rockville, MD 20857,
approximately 15 working days after the
meeting at a cost of 10 cents per page.
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 Manufacturers
Association; the Centers for Drug
Evaluation and Research and Biologics
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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. Oral presentations from the
public will be scheduled between
approximately 4:30 p.m. and 5 p.m.
Time allotted for oral presentations may
be limited to 10 minutes. Those desiring
to make oral presentations should notify
the contact person by April 2, 2007, and
submit a brief statement of the general
nature of the evidence or arguments
they which 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.
The agenda for the public meeting
will be made available via the internet
at https://www.fda.gov/cder/meeting/
ICH_20060508.htm.
Dated: August 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–15803 Filed 8–10–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0313]
Preparation for International
Cooperation on Cosmetics
Regulations Meeting in Brussels,
Belgium; Notice of 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
International Cooperation on Cosmetics
E:\FR\FM\13AUN1.SGM
13AUN1
jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Notices
Regulations (ICCR) Meeting in Brussels,
Belgium’’ to provide information on the
process and receive comments on issues
that may be relevant to discussions
being held at the ICCR meeting in
Brussels, Belgium. The purpose of the
meeting is to solicit public input prior
to the first meeting of this group in
Brussels on September 27, 2007.
Date and Time: The meeting will be
held on Tuesday, August 28, 2007, from
2 p.m. to 3:30 p.m.
Location: The meeting will be held at
5600 Fishers Lane, 3rd fl., Chesapeake
Conference Room, Rockville, MD 20857.
For security reasons, all attendees must
preregister and are asked to arrive no
later than 1:50 p.m., as you will be
escorted from the front entrance of 5600
Fishers Lane to the Chesapeake
Conference Room.
Contact Person: All participants must
register with Michelle Limoli, Office of
the Commissioner, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, by e-mail:
michelle.limoli@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), and written material and
requests to make oral presentations, to
the contact person by August 21, 2007.
If you need special accommodations
due to a disability, please contact
Michelle Limoli 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.
6–30, Rockville, MD 20857,
approximately 15 working days after the
meeting at a cost of 10 cents per page.
SUPPLEMENTARY INFORMATION: The ICCR
is a voluntary international group of
cosmetics regulatory authorities from
the United States, Japan, the European
Union, and Canada. It should be noted
that the definition and regulatory
classification of ‘‘cosmetics’’ in the
different countries/regions is not
identical. For this reason, the ICCR will
consider some U.S. over-the-counter
drugs that are regulated as ‘‘cosmetics’’
outside the United States. ICCR
members are: the Food and Drug
Administration of the United States of
America; the Ministry of Health, Labour,
and Welfare of Japan; the European
Commission Directorate General
Enterprise; and Health Canada. This
multilateral framework was created to
identify ways to remove regulatory
obstacles among the regions, while
VerDate Aug<31>2005
16:19 Aug 10, 2007
Jkt 211001
maintaining the highest level of global
consumer protection. The first meeting
of the group will occur in Brussels,
Belgium, September 27, 2007.
The ICCR will operate on a consensus
basis whereby all decisions of the
representatives of the regulatory
members and subsequent actions must
be taken by consensus. Members agree
to take steps as appropriate to
implement the items that have reached
consensus within the boundaries of
their legal and institutional constraints.
In this respect, they agree to promote
the documents reflecting the consensus
within their own jurisdictions and to
seek convergence of regulatory policies
and practices.
The members’ responsibilities will
include providing overall strategic
guidance and direction to activities of
ICCR; defining subject areas for ICCR
activities and deciding on future topics
for activity; exchanging information on
regulatory, trade, and market
developments of interest; determining
policies related to the ICCR process,
administration, and external
communications; appointing ad-hoc
working groups to carry out technical
work as needed; adopting guidelines
and policy statements, including those
developed by the ad-hoc working
groups; and taking on any other
initiatives that contribute to achieving
ICCR objectives.
It is recognized that successful
implementation requires the input of a
constructive dialogue with the
cosmetics’ industry trade associations
and other relevant stakeholders, hence
the scheduling of this public meeting.
The industry trade associations of
each region will gather input in order to
represent all affected industry sectors on
specific issues at ICCR meetings. Prior
to ICCR meetings, well in advance to
allow adequate time for preparation,
industry will suggest items for priority
actions to be consider by ICCR
members. During the ICCR meeting,
industry trade associations will enter in
a constructive dialogue with the
members and give their opinion and
directions for future work.
According to specific needs, ICCR
working groups may be established with
a precise mandate on an ad-hoc and
temporary basis by the members.
Working groups are created primarily
for the purpose of developing proposed
guidelines and policy statements for
adoption by the members. The working
group participants are appointed by
consensus of the members. Outside
technical experts may be invited on an
as-needed basis.
The ICCR will meet at least once per
year, but may alter the frequency of
PO 00000
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Fmt 4703
Sfmt 4703
45251
meetings if considered necessary to
ensure progress. The venue of meetings
rotates among the territory of the four
members.
Interested persons may present data,
information, or views orally or in
writing, on issues pending at the public
meeting. Oral presentations from the
public will be scheduled between
approximately 3 p.m. and 3:30 p.m.
Time allotted for oral presentations may
be limited by the numbers requesting to
speak; however no more than 10
minutes will be allotted per speaker.
Those desiring to make oral
presentations should notify the contact
person by August 24, 2007, 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 e-mail of
proposed participants, and an
indication of the approximate time
requested to make their presentation.
Dated: August 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–3954 Filed 8–9–07; 1:38 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission of OMB Review; Comment
Request; Drug Accountability Record
Summary: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute, the National
Cancer Institute (NIH) will publish
periodic summaries to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection
Title: Drug Accountability Record
(Form NIH 2564).
Type of Information Collection
Request: Extension, with no Changes
OMB No. 0925–0240, Expiration Date
11/30/07.
Need and Use of Information
Collection: Food and Drug
Administration (FDA) regulations
require investigators to establish a
record of the receipt, use and
disposition of all investigational agents.
The National Cancer Institute, (NCI) as
a sponsor investigational drug trials, has
the responsibility to assure the FDA that
investigators in its clinical trials
program are maintaining systems for
drug accountability. In order to fulfill
E:\FR\FM\13AUN1.SGM
13AUN1
]]>Agencies
[Federal Register Volume 72, Number 155 (Monday, August 13, 2007)]
[Notices]
[Pages 45250-45251]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-3954]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0313]
Preparation for International Cooperation on Cosmetics
Regulations Meeting in Brussels, Belgium; Notice of 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 International Cooperation on
Cosmetics
[[Page 45251]]
Regulations (ICCR) Meeting in Brussels, Belgium'' to provide
information on the process and receive comments on issues that may be
relevant to discussions being held at the ICCR meeting in Brussels,
Belgium. The purpose of the meeting is to solicit public input prior to
the first meeting of this group in Brussels on September 27, 2007.
Date and Time: The meeting will be held on Tuesday, August 28,
2007, from 2 p.m. to 3:30 p.m.
Location: The meeting will be held at 5600 Fishers Lane, 3rd fl.,
Chesapeake Conference Room, Rockville, MD 20857. For security reasons,
all attendees must preregister and are asked to arrive no later than
1:50 p.m., as you will be escorted from the front entrance of 5600
Fishers Lane to the Chesapeake Conference Room.
Contact Person: All participants must register with Michelle
Limoli, Office of the Commissioner, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, by e-mail:
michelle.limoli@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), and written material and requests to make oral
presentations, to the contact person by August 21, 2007.
If you need special accommodations due to a disability, please
contact Michelle Limoli 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. 6-30, Rockville, MD 20857,
approximately 15 working days after the meeting at a cost of 10 cents
per page.
SUPPLEMENTARY INFORMATION: The ICCR is a voluntary international group
of cosmetics regulatory authorities from the United States, Japan, the
European Union, and Canada. It should be noted that the definition and
regulatory classification of ``cosmetics'' in the different countries/
regions is not identical. For this reason, the ICCR will consider some
U.S. over-the-counter drugs that are regulated as ``cosmetics'' outside
the United States. ICCR members are: the Food and Drug Administration
of the United States of America; the Ministry of Health, Labour, and
Welfare of Japan; the European Commission Directorate General
Enterprise; and Health Canada. This multilateral framework was created
to identify ways to remove regulatory obstacles among the regions,
while maintaining the highest level of global consumer protection. The
first meeting of the group will occur in Brussels, Belgium, September
27, 2007.
The ICCR will operate on a consensus basis whereby all decisions of
the representatives of the regulatory members and subsequent actions
must be taken by consensus. Members agree to take steps as appropriate
to implement the items that have reached consensus within the
boundaries of their legal and institutional constraints. In this
respect, they agree to promote the documents reflecting the consensus
within their own jurisdictions and to seek convergence of regulatory
policies and practices.
The members' responsibilities will include providing overall
strategic guidance and direction to activities of ICCR; defining
subject areas for ICCR activities and deciding on future topics for
activity; exchanging information on regulatory, trade, and market
developments of interest; determining policies related to the ICCR
process, administration, and external communications; appointing ad-hoc
working groups to carry out technical work as needed; adopting
guidelines and policy statements, including those developed by the ad-
hoc working groups; and taking on any other initiatives that contribute
to achieving ICCR objectives.
It is recognized that successful implementation requires the input
of a constructive dialogue with the cosmetics' industry trade
associations and other relevant stakeholders, hence the scheduling of
this public meeting.
The industry trade associations of each region will gather input in
order to represent all affected industry sectors on specific issues at
ICCR meetings. Prior to ICCR meetings, well in advance to allow
adequate time for preparation, industry will suggest items for priority
actions to be consider by ICCR members. During the ICCR meeting,
industry trade associations will enter in a constructive dialogue with
the members and give their opinion and directions for future work.
According to specific needs, ICCR working groups may be established
with a precise mandate on an ad-hoc and temporary basis by the members.
Working groups are created primarily for the purpose of developing
proposed guidelines and policy statements for adoption by the members.
The working group participants are appointed by consensus of the
members. Outside technical experts may be invited on an as-needed
basis.
The ICCR will meet at least once per year, but may alter the
frequency of meetings if considered necessary to ensure progress. The
venue of meetings rotates among the territory of the four members.
Interested persons may present data, information, or views orally
or in writing, on issues pending at the public meeting. Oral
presentations from the public will be scheduled between approximately 3
p.m. and 3:30 p.m. Time allotted for oral presentations may be limited
by the numbers requesting to speak; however no more than 10 minutes
will be allotted per speaker. Those desiring to make oral presentations
should notify the contact person by August 24, 2007, 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 e-mail of
proposed participants, and an indication of the approximate time
requested to make their presentation.
Dated: August 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-3954 Filed 8-9-07; 1:38 pm]
BILLING CODE 4160-01-S
