[Federal Register Volume 73, Number 46 (Friday, March 7, 2008)]
[Notices]
[Page 12455]
From the Federal Register Online via the Government Publishing 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.

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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