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Federal Register / Vol. 73, No.

46 / Friday, March 7, 2008 / Notices 12455

DEPARTMENT OF HEALTH AND ICCR will operate on a consensus II. Comments


HUMAN SERVICES basis whereby all decisions of the Interested persons may submit to the
representatives of the regulatory Division of Dockets Management (see
Food and Drug Administration members and subsequent actions must ADDRESSES) written or electronic
[Docket No. FDA–2008–N–0138] (formerly be taken by consensus. Members agree comments regarding this document.
Docket No. 2007N–0313) to take steps as appropriate to Submit a single copy of electronic
implement the items that have reached comments or two paper copies of any
Outcome of Meeting of the consensus within the boundaries of mailed comments, except that
International Cooperation on Cosmetic their legal and institutional constraints. individuals may submit one paper copy.
Regulation, September 26–28, 2007; In this respect, they agree to promote Comments are to be identified with the
Availability the documents reflecting the consensus docket number found in brackets in the
within their own jurisdictions and to heading of this document. Received
AGENCY: Food and Drug Administration, seek convergence of regulatory policies
HHS. comments may be seen in the Division
and practices. of Dockets Management between 9 a.m.
ACTION: Notice. The members’ responsibilities will and 4 p.m., Monday through Friday.
SUMMARY: The Food and Drug
include providing overall strategic Please note that on January 15, 2008,
Administration (FDA) is announcing the guidance and direction to activities of the FDA Web site transitioned to the
availability of the International ICCR; defining subject areas for ICCR Federal Dockets Management System
Cooperation on Cosmetic Regulation activities and deciding on future topics (FDMS). FDMS is a Government-wide,
(ICCR) Outcome of Meeting, September for activity; exchanging information on electronic docket management system.
26–28, 2007. This notice is in keeping regulatory, trade, and market Electronic submissions will be accepted
with an FDA/ICCR commitment to developments of interest; determining by FDA through FDMS only.
transparency as well as providing policies related to the ICCR process,
administration, and external III. Electronic Access
opportunity for public comment.
communications; appointing ad-hoc Persons with access to the Internet
DATES: To ensure that the agency
working groups to carry out technical may obtain the outcome of meeting
considers your comment on this ICCR work as needed; adopting guidelines
outcome of meeting, please submit document at http://www.fda.gov/ohrms/
and policy statements, including those dockets/default.htm.
written or electronic comments on the developed by the ad-hoc working
outcome of meeting by July 2, 2008. groups; and taking on any other
Dated: February 29, 2008.
ADDRESSES: Submit written comments initiatives that contribute to achieving Jeffrey Shuren,
to the Division of Dockets Management ICCR objectives. Assistant Commissioner for Policy.
(HFA–305), Food and Drug It is recognized that successful [FR Doc. E8–4476 Filed 3–6–08; 8:45 am]
Administration, 5630 Fishers Lane, rm. implementation requires the input of a BILLING CODE 4160–01–S
1061, Rockville, MD 20852. Submit constructive dialogue with the
electronic comments to http:// cosmetics’ industry trade associations
www.regulations.gov. and other relevant stakeholders, hence DEPARTMENT OF HEALTH AND
FOR FURTHER INFORMATION CONTACT: the scheduling of this public meeting. HUMAN SERVICES
Michelle Limoli, Office of the The industry trade associations of
Office of Inspector General
Commissioner, Office of International each region will gather input in order to
Programs (HFG–1), Food and Drug represent all affected industry sectors on Office of the Secretary; Statement of
Administration, 5600 Fishers Lane, rm. specific issues at ICCR meetings. Well in Organization, Functions, and
15A–55, Rockville, MD 20857. advance of ICCR meetings (to allow Delegations of Authority
SUPPLEMENTARY INFORMATION: adequate time for preparation), industry
will suggest items for priority actions to This notice amends Part A (Office of
I. Background be consider by ICCR members. During the Secretary), chapter AF of the
ICCR is a voluntary international the ICCR meeting, industry trade Statement of Organization, Functions,
group of cosmetics regulatory associations will enter in a constructive and Delegations of Authority for the
authorities from the United States, dialogue with the members and give Department of Health and Human
Japan, the European Union, and Canada. their opinion and directions for future Services (HHS) to reflect a title change
It should be noted that the definition work. and adjusted responsibilities within the
and regulatory classification of According to specific needs, on an ad- Office of Inspector General’s (OIG)
‘‘cosmetics’’ in the different countries/ hoc and temporary basis members may Office of Evaluation and Inspections
regions is not identical. For this reason, establish ICCR working groups with a (OEI) to better reflect the current work
ICCR will consider some U.S. over-the- precise mandate. Working groups are environment and responsibilities with
counter drugs that are regulated as created primarily for the purpose of regard to (1) oversight activities of the
‘‘cosmetics’’ outside the United States. developing proposed guidelines and State Medicaid Fraud Control Units, and
ICCR members are: FDA; the Ministry of policy statements for adoption by the (2) coordinative efforts within the
Health, Labor, and Welfare of Japan; the members. The working group Technical Support unit with the Chief
European Commission Directorate participants are appointed by consensus Information Officer for technology
General Enterprise; and Health Canada. of the members. Outside technical support and compliance on information
This multilateral framework was created experts may be invited on an as-needed security requirements. Chapter AF was
to identify ways to remove regulatory basis. last amended on December 21, 2006 (71
sroberts on PROD1PC70 with NOTICES

obstacles among the regions, while ICCR will meet at least once per year, FR 76676).
maintaining the highest level of global but may alter the frequency of meetings As amended, sections AFE.10 and
consumer protection. The first group if considered necessary to ensure AFE.20 of Chapter AF now read as
meeting occured in Brussels, Belgium, progress. The venue of meetings rotates follows:
September 26–28, 2007. among the territory of the four members. * * * * *

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