[Federal Register: March 7, 2008 (Volume 73, Number 46)]
[Notices]
[Page 12455]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07mr08-91]
 
 
[[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.
 
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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 http://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 http://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