Preparation for International Cooperation on Cosmetics Regulations Meetings in Washington, DC; Public Meeting, 31699-31700 [E8-12338]

Download as PDF Federal Register / Vol. 73, No. 107 / Tuesday, June 3, 2008 / Notices please submit your registration as soon as possible. Course space will be filled in order of receipt of registration. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site is not guaranteed but may be possible on a space available basis on 31699 the day of the public workshop, beginning at 8 a.m. The cost of registration at the site is $200, payable to: ‘‘The University of Arkansas.’’ If you need special accommodations due to a disability, please contact Steven C. Seideman (see Contact) at least 7 days in advance. Registration Form Instructions: To register, please complete the following form and submit along with a check or money order for $150, payable to the ‘‘The University of Arkansas.’’ Mail to: Institute of Food Science & Engineering, University of Arkansas, 2650 North Young Ave., Fayetteville, AR 72704. Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121), as an outreach activity by a government agency to small businesses. The goal of this public workshop is to present information that will enable manufacturers and regulated industry to better comply with labeling requirements, especially in light of growing concerns about obesity and food allergens. Information presented will be based on agency position as articulated through regulations guidance. Topics to be discussed at the workshop include: (1) Mandatory label elements, (2) nutrition labeling requirements, (3) health and nutrition claims, (4) the Food Allergen Labeling and Consumer Protection Act of 2004, and (5) special labeling issues such as exemptions. FDA expects that participation in this public workshop will provide regulated industry with greater understanding of the regulatory and policy perspectives on food labeling and increase voluntary compliance. DEPARTMENT OF HEALTH AND HUMAN SERVICES Name: Affiliation: Mailing Address: City/State/Zip Code: Phone: Fax: E-mail: Special Accommodations Required: Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Course handouts may be requested at cost through the Freedom of Information Office (HFI–35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A–16, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page. This public workshop is being held in response to the large volume of food labeling inquiries from small food manufacturers and startups originating from the area covered by the FDA Dallas District Office. The SWR SBR presents these workshops to help achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393(f)), which include working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. This is consistent with the purposes of the SBR Program, which are in part to respond to industry inquiries, develop educational materials, and sponsor workshops and conferences to provide firms, particularly small businesses, with firsthand working knowledge of FDA’s requirements and compliance policies. This workshop is also consistent with the Small Business ebenthall on PRODPC60 with NOTICES SUPPLEMENTARY INFORMATION: VerDate Aug<31>2005 14:18 Jun 02, 2008 Jkt 214001 Dated: May 27, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–12301 Filed 6–2–08; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 Food and Drug Administration [Docket No. FDA–2008–N–0306] Preparation for International Cooperation on Cosmetics Regulations Meetings in Washington, DC; 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 ‘‘International Cooperation on Cosmetics Regulations (ICCR)—Preparation for ICCR Meetings in Washington, DC’’ to provide information and receive comments on the International Cooperation on Cosmetics Regulations (ICCR) as well as the upcoming meetings in Washington, DC. The topics to be discussed are the topics for discussion at the forthcoming ICCR steering committee meeting. The purpose of the meeting is to solicit public input prior to the next steering committee and expert working group meetings in Washington, DC, the week of July 28, 2008, at which the action items from the first ICCR meeting are to be discussed. DATES: The meeting will be held on June 19, 2008, from 3 p.m. to 4:30 p.m. Send E:\FR\FM\03JNN1.SGM 03JNN1 31700 Federal Register / Vol. 73, No. 107 / Tuesday, June 3, 2008 / Notices registration information and requests to make a presentation by June 16, 2008. ADDRESSES: The meeting will be held at 5600 Fishers Lane, 3rd fl., Chesapeake Conference Room, Rockville, MD 20857. For security reasons, all attendees must preregister 3 days prior to the meeting and are asked to arrive no later than 2:50 p.m. because attendees will be escorted from the front entrance of 5600 Fishers Lane to the Chesapeake Conference Room. Comment Submissions: Submit written comments to the Divsion of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Tammie Bell, Office of International Programs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, FAX: 301–827– 0003, e-mail: Tammie.Bell2@fda.hhs.gov. SUPPLEMENTARY INFORMATION: ebenthall on PRODPC60 with NOTICES I. Background The purpose of the multilateral framework on the ICCR is to pave the way for the removal of regulatory obstacles to international trade while maintaining the highest level of global consumer protection. ICCR is a voluntary international group of cosmetics regulatory authorities from the United States, Japan, the European Union, and Canada. These regulatory authority members will enter into constructive dialogue with their relevant cosmetics’ industry trade associations. Currently, the ICCR members are Health Canada; the European Commission Directorate General for Enterprise and Industry; the Ministry of Health, Labor, and Welfare of Japan; and the U.S. Food and Drug Administration. All decisions made by the members of ICCR will be made by consensus and will be compatible with the laws, policies, rules, regulations, and directives of the respective administrations and governments. Members will implement and/or promote actions or documents within their own jurisdictions and seek convergence of regulatory policies and practices. Successful implementation will require input from stakeholders. II. Registration and Requests for Oral Presentations Send registration information (including name, title, firm name, address, telephone, and fax number), written material and requests to make oral presentations, to the contact person VerDate Aug<31>2005 14:18 Jun 02, 2008 Jkt 214001 (Tammie.Bell2@fda.hhs.gov) (see DATES). If you need special accommodations due to a disability, please contact Tammie Bell at least 7 days in advance. 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 4 p.m. and 4:30 p.m. Time allotted for oral presentations may be limited to 10 minutes. Those desiring to make oral presentations should notify the contact person (Tammie.Bell2@fda.hhs.gov) (see DATES) 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. III. Transcripts Please be advised that as soon as a transcript is available, it will be accessible at https://www.fda.gov/ohrms/ dockets/ac/acmenu.htm. It may be viewed at the Division of Dockets Management (see ADDRESSES). A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (HFI–35), Office of Management Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6–30, Rockville, MD 20857. IV. Comments Interested persons may submit written or electronic comments to the Division of Dockets Management (see ADDRESSES). 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 Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at https://www.regulations.gov. PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 V. Electronic Access The agenda for the public meeting will be made available via the internet at https://www.cfsan.fda.gov/~lrd/ vidtel.html Dated: May 28, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–12338 Filed 6–2–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301/ 496–7057; fax: 301/402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Immunotoxins With Deletions in Domain II That Remove Immunogenic Epitopes With Minimal Loss of Cytotoxic Activity Description of Technology: Anti-CD22 immunotoxins consist of a disulfidelinked FV (VH/VL) antibody fragment recombinantly linked to a toxic moiety capable of killing cells. In particular, a 38-kDa active fragment of Pseudomonas exotoxin A (PE38) containing three specific domains (domain Ib, domain II and domain III) has been used successfully in these immunotoxins. These immunotoxins have been shown to have activity against various forms of cancer, such as hairy cell leukemia and chronic lymphocytic leukemia, and are E:\FR\FM\03JNN1.SGM 03JNN1

Agencies

[Federal Register Volume 73, Number 107 (Tuesday, June 3, 2008)]
[Notices]
[Pages 31699-31700]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-12338]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0306]


Preparation for International Cooperation on Cosmetics 
Regulations Meetings in Washington, DC; 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 ``International Cooperation on Cosmetics Regulations 
(ICCR)--Preparation for ICCR Meetings in Washington, DC'' to provide 
information and receive comments on the International Cooperation on 
Cosmetics Regulations (ICCR) as well as the upcoming meetings in 
Washington, DC. The topics to be discussed are the topics for 
discussion at the forthcoming ICCR steering committee meeting. The 
purpose of the meeting is to solicit public input prior to the next 
steering committee and expert working group meetings in Washington, DC, 
the week of July 28, 2008, at which the action items from the first 
ICCR meeting are to be discussed.

DATES: The meeting will be held on June 19, 2008, from 3 p.m. to 4:30 
p.m. Send

[[Page 31700]]

registration information and requests to make a presentation by June 
16, 2008.

ADDRESSES: The meeting will be held at 5600 Fishers Lane, 3rd fl., 
Chesapeake Conference Room, Rockville, MD 20857. For security reasons, 
all attendees must preregister 3 days prior to the meeting and are 
asked to arrive no later than 2:50 p.m. because attendees will be 
escorted from the front entrance of 5600 Fishers Lane to the Chesapeake 
Conference Room.
    Comment Submissions: Submit written comments to the Divsion of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Tammie Bell, Office of International 
Programs, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, FAX: 301-827-0003, e-mail: Tammie.Bell2@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    The purpose of the multilateral framework on the ICCR is to pave 
the way for the removal of regulatory obstacles to international trade 
while maintaining the highest level of global consumer protection.
    ICCR is a voluntary international group of cosmetics regulatory 
authorities from the United States, Japan, the European Union, and 
Canada. These regulatory authority members will enter into constructive 
dialogue with their relevant cosmetics' industry trade associations. 
Currently, the ICCR members are Health Canada; the European Commission 
Directorate General for Enterprise and Industry; the Ministry of 
Health, Labor, and Welfare of Japan; and the U.S. Food and Drug 
Administration. All decisions made by the members of ICCR will be made 
by consensus and will be compatible with the laws, policies, rules, 
regulations, and directives of the respective administrations and 
governments. Members will implement and/or promote actions or documents 
within their own jurisdictions and seek convergence of regulatory 
policies and practices. Successful implementation will require input 
from stakeholders.

II. Registration and Requests for Oral Presentations

    Send registration information (including name, title, firm name, 
address, telephone, and fax number), written material and requests to 
make oral presentations, to the contact person 
(Tammie.Bell2@fda.hhs.gov) (see DATES).
    If you need special accommodations due to a disability, please 
contact Tammie Bell at least 7 days in advance.
    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 4 
p.m. and 4:30 p.m. Time allotted for oral presentations may be limited 
to 10 minutes. Those desiring to make oral presentations should notify 
the contact person (Tammie.Bell2@fda.hhs.gov) (see DATES) 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.

III. Transcripts

    Please be advised that as soon as a transcript is available, it 
will be accessible at https://www.fda.gov/ohrms/dockets/ac/acmenu.htm. 
It may be viewed at the Division of Dockets Management (see ADDRESSES). 
A transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to Division of Freedom of Information (HFI-35), Office 
of Management Programs, Food and Drug Administration, 5600 Fishers 
Lane, rm. 6-30, Rockville, MD 20857.

IV. Comments

    Interested persons may submit written or electronic comments to the 
Division of Dockets Management (see ADDRESSES). 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 Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at https://www.regulations.gov.

V. Electronic Access

    The agenda for the public meeting will be made available via the 
internet at https://www.cfsan.fda.gov/~lrd/vidtel.html

    Dated: May 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-12338 Filed 6-2-08; 8:45 am]
BILLING CODE 4160-01-S

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