Outcome of Meeting of the International Cooperation on Cosmetic Regulation, September 26-28, 2007; Availability, 12455 [E8-4476]
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Federal Register / Vol. 73, No. 46 / Friday, March 7, 2008 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0138] (formerly
Docket No. 2007N–0313)
Outcome of Meeting of the
International Cooperation on Cosmetic
Regulation, September 26–28, 2007;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the International
Cooperation on Cosmetic Regulation
(ICCR) Outcome of Meeting, September
26–28, 2007. This notice is in keeping
with an FDA/ICCR commitment to
transparency as well as providing
opportunity for public comment.
DATES: To ensure that the agency
considers your comment on this ICCR
outcome of meeting, please submit
written or electronic comments on the
outcome of meeting by July 2, 2008.
ADDRESSES: Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Michelle Limoli, Office of the
Commissioner, Office of International
Programs (HFG–1), Food and Drug
Administration, 5600 Fishers Lane, rm.
15A–55, Rockville, MD 20857.
SUPPLEMENTARY INFORMATION:
sroberts on PROD1PC70 with NOTICES
I. Background
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,
ICCR will consider some U.S. over-thecounter drugs that are regulated as
‘‘cosmetics’’ outside the United States.
ICCR members are: FDA; the Ministry of
Health, Labor, 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 group
meeting occured in Brussels, Belgium,
September 26–28, 2007.
VerDate Aug<31>2005
18:46 Mar 06, 2008
Jkt 214001
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. Well in
advance of ICCR meetings (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, on an adhoc and temporary basis members may
establish ICCR working groups with a
precise mandate. 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.
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.
PO 00000
Frm 00089
Fmt 4703
Sfmt 4703
12455
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Web site transitioned to the
Federal Dockets Management System
(FDMS). FDMS is a Government-wide,
electronic docket management system.
Electronic submissions will be accepted
by FDA through FDMS only.
III. Electronic Access
Persons with access to the Internet
may obtain the outcome of meeting
document at https://www.fda.gov/ohrms/
dockets/default.htm.
Dated: February 29, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–4476 Filed 3–6–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
Office of the Secretary; Statement of
Organization, Functions, and
Delegations of Authority
This notice amends Part A (Office of
the Secretary), chapter AF of the
Statement of Organization, Functions,
and Delegations of Authority for the
Department of Health and Human
Services (HHS) to reflect a title change
and adjusted responsibilities within the
Office of Inspector General’s (OIG)
Office of Evaluation and Inspections
(OEI) to better reflect the current work
environment and responsibilities with
regard to (1) oversight activities of the
State Medicaid Fraud Control Units, and
(2) coordinative efforts within the
Technical Support unit with the Chief
Information Officer for technology
support and compliance on information
security requirements. Chapter AF was
last amended on December 21, 2006 (71
FR 76676).
As amended, sections AFE.10 and
AFE.20 of Chapter AF now read as
follows:
*
*
*
*
*
E:\FR\FM\07MRN1.SGM
07MRN1
]]>Agencies
[Federal Register Volume 73, Number 46 (Friday, March 7, 2008)]
[Notices]
[Page 12455]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-4476]
[[Page 12455]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0138] (formerly Docket No. 2007N-0313)
Outcome of Meeting of the International Cooperation on Cosmetic
Regulation, September 26-28, 2007; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the International Cooperation on Cosmetic Regulation
(ICCR) Outcome of Meeting, September 26-28, 2007. This notice is in
keeping with an FDA/ICCR commitment to transparency as well as
providing opportunity for public comment.
DATES: To ensure that the agency considers your comment on this ICCR
outcome of meeting, please submit written or electronic comments on the
outcome of meeting by July 2, 2008.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Michelle Limoli, Office of the
Commissioner, Office of International Programs (HFG-1), Food and Drug
Administration, 5600 Fishers Lane, rm. 15A-55, Rockville, MD 20857.
SUPPLEMENTARY INFORMATION:
I. Background
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, ICCR will consider some U.S. over-the-
counter drugs that are regulated as ``cosmetics'' outside the United
States. ICCR members are: FDA; the Ministry of Health, Labor, 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 group meeting occured in Brussels, Belgium, September 26-28,
2007.
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. Well in advance of ICCR meetings (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, on an ad-hoc and temporary basis
members may establish ICCR working groups with a precise mandate.
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.
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.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.
III. Electronic Access
Persons with access to the Internet may obtain the outcome of
meeting document at https://www.fda.gov/ohrms/dockets/default.htm.
Dated: February 29, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-4476 Filed 3-6-08; 8:45 am]
BILLING CODE 4160-01-S
