Preparation for International Cooperation on Cosmetics Regulations; Public Meeting, 18767-18768 [2011-7966]

Download as PDF Federal Register / Vol. 76, No. 65 / Tuesday, April 5, 2011 / Notices srobinson on DSKHWCL6B1PROD with NOTICES interim final regulation with comment period in the Federal Register (75 FR 24450), implementing the program as of June 1, 2010. Section 1102(e) of the Affordable Care Act appropriates funding of $5 billion for the temporary program, which ends no later than January 1, 2014. To participate in the program, an employment-based plan must submit an application to the Secretary. A copy of the application can be found at https://www.errp.gov. Section 1102(f) of the Affordable Care Act grants the Secretary the authority to stop taking applications for participation in the program based on the availability of funding under section 1102(e) of the Affordable Care Act. The ERRP interim final regulation also grants the Secretary such authority (75 FR 24456). II. Provisions of the Notice Based on the amount of the $5 billion in appropriated program funding that remains available and the rate at which it is being disbursed, we are announcing, under section 1102(f) of the Affordable Care Act, that we will no longer accept applications for the program after May 5, 2011. We have projected the availability of program funding based on the rate at which appropriated funds are currently being used to reimburse plan sponsors, and we have concluded that we have approved a sufficient number of applications to exhaust the program funding. Applications were first accepted by the ERRP on June 29, 2010, and therefore, plan sponsors have so far had 9 months to submit applications if desired. As a result of this agency action, any program applications that CMS receives after May 5, 2011 will not be accepted for processing. Applications must be received in the program’s Intake Center on or before May 5, 2011, to be accepted for processing. A copy of the application, as well as information on how to complete and send it, and where to send it, can be found on https:// www.errp.gov. Merely postmarking an application before this date will not be sufficient. We will post additional information about the mechanics of not accepting such applications for processing, such as how we will respond upon receiving such an application, on https://www.errp.gov. We note that our decision to no longer accept applications after May 5, 2011, is based on the actual availability of remaining appropriated ERRP funds and the rate at which we have been disbursing reimbursement, as opposed to the projected amounts of ERRP reimbursements that applicants listed in their ERRP applications. Should circumstances related to the availability VerDate Mar<15>2010 15:18 Apr 04, 2011 Jkt 223001 of ERRP funding change, we may decide it is appropriate to resume accepting ERRP applications. If this occurs, we will provide such notice in the Federal Register. III. Collection of Information Requirements This document does not impose information collection and recordkeeping requirements. So, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995. Authority: 42 U.S.C. 18002(f). Dated: March 29, 2011. Donald M. Berwick, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2011–7934 Filed 3–31–11; 4:15 pm] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Preparation for International Cooperation on Cosmetics Regulations; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. The Food and Drug Administration (FDA) is announcing a public meeting entitled ‘‘International Cooperation on Cosmetics Regulations (ICCR)—Preparation for ICCR–5 Meeting in Paris, France’’ to provide information and receive comments on the International Cooperation on Cosmetics Regulations (ICCR) as well as the upcoming meetings in Paris, France. 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 Paris, France scheduled on June 28 through July 1, 2011. DATES: Date and Time: The public meeting will be held on April 26, 2011, from 2 p.m. to 4 p.m. Location: The public meeting will be held at the Washington Theater room at the Hilton Washington DC/Rockville Hotel & Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: All participants must register with Kimberly Franklin, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire SUMMARY: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 18767 Ave., Silver Spring, MD 20993–0002, email: Kimberly.Franklin@fda.hhs.gov, or Fax: 301–595–7937. 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 by April 22, 2011. If you need special accommodations due to a disability, please contact Kimberly Franklin (see Contact Person) 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. Time allotted for oral presentations may be limited to 10 minutes. Those desiring to make oral presentations should notify the contact person by April 22, 2011, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses, telephone number, fax, and e-mail of proposed participants, and an indication of the approximate time requested to make their presentation. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https:// www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. 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, 12420 Parklawn Dr., Rockville, MD 20857. SUPPLEMENTARY INFORMATION: 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 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 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 consensus will be compatible with the laws, policies, rules, regulations, and directives of the respective administrations and governments. Members will implement and/or E:\FR\FM\05APN1.SGM 05APN1 18768 Federal Register / Vol. 76, No. 65 / Tuesday, April 5, 2011 / Notices promote actions or documents within their own jurisdictions and seek convergence of regulatory policies and practices. Successful implementation will require input from stakeholders. The agenda for the public meeting will be made available on the Internet at https://www.fda.gov/Cosmetics/ InternationalActivities/Conferences MeetingsWorkshops/International CooperationonCosmeticsRegulations ICCR/default.htm. Dated: March 30, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–7966 Filed 4–4–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0002] Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. srobinson on DSKHWCL6B1PROD with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Cellular, Tissue, and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on May 31, 2011, from 2:30 p.m. to 6:15 p.m. Location: National Institutes of Health (NIH) Campus, 29 Lincoln Dr., Bldg. 29B, Conference Rooms A and B, Bethesda, MD 20892. The public is welcome to attend the meeting at NIH, Building 29B, Conference Rooms A and B, where a speakerphone will be provided. Public participation in the meeting is limited to the use of the speakerphone in the conference room. Important information about transportation and directions to the NIH campus, parking, and security procedures is available on the Internet at https://www.nih.gov/about/visitor/ index.htm. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) Visitors must show two forms of identification, one of VerDate Mar<15>2010 15:18 Apr 04, 2011 Jkt 223001 which must be a government-issued photo identification such as a Federal employee badge, driver’s license, passport, green card, etc. Detailed information about security procedures is located at https://www.nih.gov/about/ visitorsecurity.htm. Due to the limited available parking, visitors are encouraged to use public transportation. Contact Person: Gail Dapolito or Sheryl Clark (HFM–71), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301–827–0314, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On May 31, 2011, the committee will meet in open session to hear brief overviews of research programs in the Laboratory of Biochemistry, Division of Therapeutic Proteins, Center for Drug Evaluation and Research; and the Laboratory of Cell Biology, the Laboratory of Molecular and Developmental Immunology, the Laboratory of Molecular Oncology, Division of Monoclonal Antibodies, Center for Drug Evaluation and Research. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee link. Procedure: On May 31, 2011, from 2:30 p.m. to approximately 5:15 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before May 24, 2011. Oral presentations from PO 00000 Frm 00056 Fmt 4703 Sfmt 9990 the public will be scheduled between approximately 4:15 p.m. and 5:15 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before May 16, 2011. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by May 17, 2011. Closed Committee Deliberations: On May 31, 2011, from 5:15 p.m. to 6:15 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss a report of intramural research programs and make recommendations regarding personnel staffing decisions. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Gail Dapolito at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: March 30, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–7968 Filed 4–4–11; 8:45 am] BILLING CODE 4160–01–P E:\FR\FM\05APN1.SGM 05APN1

Agencies

[Federal Register Volume 76, Number 65 (Tuesday, April 5, 2011)]
[Notices]
[Pages 18767-18768]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7966]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


Preparation for International Cooperation on Cosmetics 
Regulations; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting entitled ``International Cooperation on Cosmetics Regulations 
(ICCR)--Preparation for ICCR-5 Meeting in Paris, France'' to provide 
information and receive comments on the International Cooperation on 
Cosmetics Regulations (ICCR) as well as the upcoming meetings in Paris, 
France. 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 Paris, France scheduled on June 28 
through July 1, 2011.

DATES:  Date and Time: The public meeting will be held on April 26, 
2011, from 2 p.m. to 4 p.m.
    Location: The public meeting will be held at the Washington Theater 
room at the Hilton Washington DC/Rockville Hotel & Executive Meeting 
Center, 1750 Rockville Pike, Rockville, MD 20852.
    Contact Person: All participants must register with Kimberly 
Franklin, Office of the Commissioner, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993-0002, e-mail: 
Kimberly.Franklin@fda.hhs.gov, or Fax: 301-595-7937.
    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 by April 22, 2011.
    If you need special accommodations due to a disability, please 
contact Kimberly Franklin (see Contact Person) 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. Time allotted 
for oral presentations may be limited to 10 minutes. Those desiring to 
make oral presentations should notify the contact person by April 22, 
2011, and submit a brief statement of the general nature of the 
evidence or arguments they wish to present, the names and addresses, 
telephone number, fax, and e-mail of proposed participants, and an 
indication of the approximate time requested to make their 
presentation.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at https://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD. 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, 12420 Parklawn 
Dr., Rockville, MD 20857.

SUPPLEMENTARY INFORMATION: 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 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 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 consensus will be compatible with the laws, 
policies, rules, regulations, and directives of the respective 
administrations and governments. Members will implement and/or

[[Page 18768]]

promote actions or documents within their own jurisdictions and seek 
convergence of regulatory policies and practices. Successful 
implementation will require input from stakeholders.
    The agenda for the public meeting will be made available on the 
Internet at https://www.fda.gov/Cosmetics/InternationalActivities/ConferencesMeetingsWorkshops/InternationalCooperationonCosmeticsRegulationsICCR/default.htm.

    Dated: March 30, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-7966 Filed 4-4-11; 8:45 am]
BILLING CODE 4160-01-P

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