[Federal Register Volume 72, Number 155 (Monday, August 13, 2007)]
[Pages 45250-45251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-3954]



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 

[[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: 
[email protected] 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 
    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]