See also: International Cooperation on Cosmetics Regulations Meeting in Brussels, Belgium on Septermber 26-28, 2007
[Federal Register: August 13, 2007 (Volume 72, Number 155)]
[Notices]
[Page 45250-45251]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13au07-79]
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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.
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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
