Preparation for International Cooperation on Cosmetics Regulation; Public Meeting, 20662-20663 [2013-07949]

Download as PDF 20662 Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued No. of respondents No. of responses per respondent Total annual responses Average burden per response .............................. .............................. .............................. .............................. 21 CFR Section Total ................................................ 1 There Total hours 18,200 are no capital costs or operating and maintenance costs associated with this collection of information. Section 571.1(c) Complex Category: For a food additive petition with complex chemistry, manufacturing, efficacy, and/or safety issues, the estimated time requirement per petition is approximately 10,000 hours. An average of one petition of this type is received on an annual basis, resulting in a burden of 10,000 hours. Section 571.1(c) Moderate Category: For a food additive petition without complex chemistry, manufacturing, efficacy, or safety issues, the estimated time requirement per petition is approximately 3,000 hours. An average of one petition of this type is received on an annual basis, resulting in a burden of 3,000 hours. Section 571.6: For a food additive petition amendment, the estimated time requirement per petition is approximately 1,300 hours. An average of four petitions of this type is received on an annual basis, resulting in a burden of 5,200 hours. TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1 No. of responses per respondent No. of respondents 21 CFR Section Average burden per response Total annual responses Total hours Investigation Food Additive Files 570.17 moderate category ..................... 570.17 complex category ....................... 9 4 1 1 9 4 1,500 5,000 13,500 20,000 Total ................................................ .............................. .............................. .............................. .............................. 33,500 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Section 570.17 Moderate Category: For an investigational food additive file without complex chemistry, manufacturing, efficacy, or safety issues, the estimated time requirement per file is approximately 1,500 hours. An average of nine files of this type is received on an annual basis, resulting in a burden of 13,500 hours. Section 570.17 Complex Category: For an investigational food additive file with complex chemistry, manufacturing, efficacy, and/or safety issues, the estimated time requirement per file is approximately 5,000 hours. An average of four files of this type is received on an annual basis, resulting in a burden of 20,000 hours. Dated: April 1, 2013. Peter Lurie, Acting Associate Commissioner for Policy and Planning. [FR Doc. 2013–07892 Filed 4–4–13; 8:45 am] mstockstill on DSK4VPTVN1PROD with NOTICES BILLING CODE 4160–01–P VerDate Mar<15>2010 18:50 Apr 04, 2013 Jkt 229001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Preparation for International Cooperation on Cosmetics Regulation; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting. The Food and Drug Administration (FDA or we) is announcing a public meeting entitled, ‘‘International Cooperation on Cosmetics Regulation (ICCR)—Preparation for ICCR–7 Meeting.’’ The purpose of the meeting is to invite public input on various topics pertaining to the regulation of cosmetics. We may use this input to help us prepare for the ICCR–7 meeting that will be held in Japan on July 8 to 10, 2013. DATES: Date and Time: The meeting will be held on May 8, 2013, from 2 p.m. to 4 p.m. Location: The meeting will be held at the Food and Drug Administration, University Station Building, 4300 River Rd., Conference Room 3172 (third floor), College Park, MD 20740. PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 Contact Person: If you intend to participate in the meeting, you should register with Maria Rossana (Rosemary) Cook, Office of Cosmetics and Colors, Food and Drug Administration, 4300 River Rd., College Park, MD 20740, by email: maria.cook@fda.hhs.gov or Fax: 301–436–2975. Registration and Requests for Oral Presentations: Send registration information (including your name, title, firm name, address, telephone number, fax number, and email address), written material, and requests to make an oral presentation, to the contact person by April 22, 2013. If you need special accommodations due to a disability, please contact Maria Rossana (Rosemary) Cook (see Contact Person) by May 1, 2013. You 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 or less for each presenter. If you wish to make an oral presentation, you should notify the contact person by April 22, 2013, and submit a brief statement of the general nature of the evidence or arguments that you wish to present, your name, address, telephone number, fax number, and email address, and indicate the approximate amount of time you need to make your presentation. E:\FR\FM\05APN1.SGM 05APN1 mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Notices Transcripts: As soon as a transcript is available, it will be accessible at https:// www.regulations.gov. It also 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. You should send written requests for a hardcopy or CD–ROM transcript to the Division of Freedom of Information, (ELEM–1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. 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 and public advocacy groups. Currently, the ICCR members are: Health Canada; the European Directorate General for Health and Consumers; the Ministry of Health, Labor and Welfare of Japan; and the U.S. Food and Drug Administration. All decisions made by consensus 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 need input from stakeholders. You 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 or less for each presenter. If you wish to make an oral presentation, you should notify the contact person by April 22, 2013, and submit a brief statement of the general nature of the evidence or arguments that you wish to present, your name, address, telephone number, fax number, and email address, and indicate the approximate time you need to make your presentation. If you need special accommodations due to a disability, please contact Maria Rossana (Rosemary) Cook (see Contact Person) by May 1, 2013. We will make the agenda for the public meeting available on the Internet at: https://www.fda.gov/Cosmetics/ InternationalActivities/Conferences MeetingsWorkshops/International VerDate Mar<15>2010 17:14 Apr 04, 2013 Jkt 229001 CooperationonCosmeticsRegulations ICCR/default.htm. We may use the information that you provide to us during the public meeting to help us prepare for the July 8 to 10, 2013 ICCR– 7 meeting. Dated: April 1, 2013. Peter Lurie, Acting Associate Commissioner for Policy and Planning. [FR Doc. 2013–07949 Filed 4–4–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. 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: Vaccines and Related Biological Products 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 8, 2013, from 1 p.m. to approximately 4 p.m. Location: Rockwall II, Conference Room 1033, 5515 Security Lane, Rockville, MD 20852. The public is welcome to attend the meeting at the specified location where a speakerphone will be provided. Public participation in the meeting is limited to the use of the speakerphone in the conference room. Contact Person: Donald W. Jehn or Denise Royster, Center for Biologics Evaluation and Research (HFM–71), 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). 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 at https:// www.fda.gov/AdvisoryCommittees/ PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 20663 default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: On May 8, 2013, the committee will meet in open session to hear updates of the research programs in the Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. 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 meeting link. Procedure: On May 8, 2013, from 1 p.m. to approximately 3:20 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 1, 2013. Oral presentations from the public will be scheduled between approximately 2:20 p.m. and 3:20 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 April 23, 2013. 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 April 24, 2013. Closed Committee Deliberations: On May 8, 2013, from approximately 3:20 p.m. to approximately 4 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 E:\FR\FM\05APN1.SGM 05APN1

Agencies

[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Notices]
[Pages 20662-20663]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07949]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Preparation for International Cooperation on Cosmetics 
Regulation; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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

    The Food and Drug Administration (FDA or we) is announcing a public 
meeting entitled, ``International Cooperation on Cosmetics Regulation 
(ICCR)--Preparation for ICCR-7 Meeting.'' The purpose of the meeting is 
to invite public input on various topics pertaining to the regulation 
of cosmetics. We may use this input to help us prepare for the ICCR-7 
meeting that will be held in Japan on July 8 to 10, 2013.

DATES: Date and Time: The meeting will be held on May 8, 2013, from 2 
p.m. to 4 p.m.
    Location: The meeting will be held at the Food and Drug 
Administration, University Station Building, 4300 River Rd., Conference 
Room 3172 (third floor), College Park, MD 20740.
    Contact Person: If you intend to participate in the meeting, you 
should register with Maria Rossana (Rosemary) Cook, Office of Cosmetics 
and Colors, Food and Drug Administration, 4300 River Rd., College Park, 
MD 20740, by email: maria.cook@fda.hhs.gov or Fax: 301-436-2975.
    Registration and Requests for Oral Presentations: Send registration 
information (including your name, title, firm name, address, telephone 
number, fax number, and email address), written material, and requests 
to make an oral presentation, to the contact person by April 22, 2013.
    If you need special accommodations due to a disability, please 
contact Maria Rossana (Rosemary) Cook (see Contact Person) by May 1, 
2013.
    You 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 or less for each presenter. 
If you wish to make an oral presentation, you should notify the contact 
person by April 22, 2013, and submit a brief statement of the general 
nature of the evidence or arguments that you wish to present, your 
name, address, telephone number, fax number, and email address, and 
indicate the approximate amount of time you need to make your 
presentation.

[[Page 20663]]

    Transcripts: As soon as a transcript is available, it will be 
accessible at https://www.regulations.gov. It also 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. You should send written requests for a 
hardcopy or CD-ROM transcript to the Division of Freedom of 
Information, (ELEM-1029), Food and Drug Administration, 12420 Parklawn 
Dr., Element Bldg., Rockville, MD 20857.
    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 and 
public advocacy groups. Currently, the ICCR members are: Health Canada; 
the European Directorate General for Health and Consumers; the Ministry 
of Health, Labor and Welfare of Japan; and the U.S. Food and Drug 
Administration. All decisions made by consensus 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 need input from stakeholders.
    You 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 or less for each presenter. 
If you wish to make an oral presentation, you should notify the contact 
person by April 22, 2013, and submit a brief statement of the general 
nature of the evidence or arguments that you wish to present, your 
name, address, telephone number, fax number, and email address, and 
indicate the approximate time you need to make your presentation. If 
you need special accommodations due to a disability, please contact 
Maria Rossana (Rosemary) Cook (see Contact Person) by May 1, 2013.
    We will make the agenda for the public meeting available on the 
Internet at: https://www.fda.gov/Cosmetics/InternationalActivities/ConferencesMeetingsWorkshops/InternationalCooperationonCosmeticsRegulationsICCR/default.htm. We may 
use the information that you provide to us during the public meeting to 
help us prepare for the July 8 to 10, 2013 ICCR-7 meeting.

    Dated: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07949 Filed 4-4-13; 8:45 am]
BILLING CODE 4160-01-P

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