82_FR_17078 82 FR 17012 - Preparation for International Cooperation on Cosmetics Regulation Eleventh Annual Meeting; Public Meeting

82 FR 17012 - Preparation for International Cooperation on Cosmetics Regulation Eleventh Annual Meeting; Public Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 66 (April 7, 2017)

Page Range17012-17013
FR Document2017-06938

The Food and Drug Administration (FDA or we) is announcing a public meeting entitled ``International Cooperation on Cosmetics Regulation (ICCR)--Preparation for ICCR-11 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-11 meeting that will be held July 12-14, 2017, in Brasilia, Brazil.

Federal Register, Volume 82 Issue 66 (Friday, April 7, 2017)
[Federal Register Volume 82, Number 66 (Friday, April 7, 2017)]
[Notices]
[Pages 17012-17013]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-06938]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


Preparation for International Cooperation on Cosmetics Regulation 
Eleventh Annual Meeting; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing a 
public meeting entitled ``International Cooperation on Cosmetics 
Regulation (ICCR)--Preparation for ICCR-11 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

[[Page 17013]]

help us prepare for the ICCR-11 meeting that will be held July 12-14, 
2017, in Brasilia, Brazil.

DATES: The public meeting will be held on May 25, 2017, from 2 p.m. to 
4 p.m. See the SUPPLEMENTARY INFORMATION section for registration date 
and information.

ADDRESSES: The public meeting will be held at the Food and Drug 
Administration, Center for Food Safety and Applied Nutrition, 5001 
Campus Dr., Wiley Auditorium (first floor), College Park, MD 20740.

FOR FURTHER INFORMATION CONTACT: Jonathan Hicks, Office of Cosmetics 
and Colors, Food and Drug Administration, 5001 Campus Dr. (HFS-125), 
College Park, MD 20740, email: [email protected], 240-402-
1375.

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 global consumer protection. 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-11 meeting that will be held July 12-14, 2017, in Brasilia, 
Brazil.
    ICCR is a voluntary international group of cosmetics regulatory 
authorities from Brazil, Canada, the European Union, Japan, and the 
United States of America. 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: The Brazilian Health Surveillance Agency; Health Canada; the 
European Commission Directorate-General for Internal Market, Industry, 
Entrepreneurship, and Small and Medium-sized Enterprises; the Ministry 
of Health, Labor, and Welfare of Japan; and FDA. 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.

II. Topics for Discussion at the Public Meeting

    We will make the agenda for the public meeting available on the 
Internet at http://www.fda.gov/Cosmetics/InternationalActivities/ICCR/default.htm. Depending on the number of requests for oral 
presentations, we intend to have an agenda available by May 18, 2017.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, send registration 
information (including your name, title, affiliation, address, email, 
and telephone), to Jonathan Hicks by May 11, 2017. If you would like to 
listen to the meeting by phone, please submit a request for a dial-in 
number by May 11, 2017. If you need special accommodations due to a 
disability, please contact Jonathan Hicks by May 18, 2016.
    Requests for Oral Presentations: If you wish to make an oral 
presentation, you should notify Jonathan Hicks by May 11, 2017, and 
submit a brief statement of the general nature of the evidence or 
arguments that you wish to present, your name, title, affiliation, 
address, email, and telephone, and indicate the approximate amount of 
time you need to make your presentation. You may present proposals for 
future ICCR agenda items, data, information, or views, in person or in 
writing, on issues pending at the public meeting. There will be no 
presentations by phone. Time allotted for oral presentations may be 
limited to 10 minutes or less for each presenter.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov. It may also be viewed at the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20850.

    Dated: April 3, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-06938 Filed 4-6-17; 8:45 am]
 BILLING CODE 4164-01-P



                                               17012                             Federal Register / Vol. 82, No. 66 / Friday, April 7, 2017 / Notices

                                               Management, FDA will post your                          FOR FURTHER INFORMATION CONTACT:                      approximate time requested to make
                                               comment, as well as any attachments,                    Lauren D. Tesh, Center for Drug                       their presentation on or before April 7,
                                               except for information submitted,                       Evaluation and Research, Food and                     2017. Time allotted for each
                                               marked and identified, as confidential,                 Drug Administration, 10903 New                        presentation may be limited. If the
                                               if submitted as detailed in                             Hampshire Ave., Bldg. 31, rm. 2417,                   number of registrants requesting to
                                               ‘‘Instructions.’’                                       Silver Spring, MD 20993–0002, 301–                    speak is greater than can be reasonably
                                                  Instructions: All submissions received               796–9001, FAX: 301–847–8533,                          accommodated during the scheduled
                                                                                                       AMDAC@fda.hhs.gov, or FDA Advisory                    open public hearing session, FDA may
                                               must include the Docket No. FDA–
                                                                                                       Committee Information Line, 1–800–                    conduct a lottery to determine the
                                               2017–N–1813 for ‘‘Antimicrobial Drugs
                                                                                                       741–8138 (301–443–0572 in the                         speakers for the scheduled open public
                                               Advisory Committee; Notice of Meeting;
                                                                                                       Washington, DC area). A notice in the                 hearing session. The contact person will
                                               Establishment of a Public Docket;
                                                                                                       Federal Register about last minute                    notify interested persons regarding their
                                               Request for Comments.’’ Received
                                                                                                       modifications that impact a previously                request to speak by April 10, 2017.
                                               comments will be placed in the docket                                                                            Persons attending FDA’s advisory
                                               and, except for those submitted as                      announced advisory committee meeting
                                                                                                       cannot always be published quickly                    committee meetings are advised that the
                                               ‘‘Confidential Submissions,’’ publicly                                                                        Agency is not responsible for providing
                                                                                                       enough to provide timely notice.
                                               viewable at https://www.regulations.gov                                                                       access to electrical outlets.
                                                                                                       Therefore, you should always check the
                                               or at the Division of Dockets                                                                                    FDA welcomes the attendance of the
                                                                                                       Agency’s Web site at http://
                                               Management between 9 a.m. and 4 p.m.,                                                                         public at its advisory committee
                                                                                                       www.fda.gov/AdvisoryCommittees/
                                               Monday through Friday.                                                                                        meetings and will make every effort to
                                                                                                       default.htm and scroll down to the
                                                  • Confidential Submissions—To                        appropriate advisory committee meeting                accommodate persons with disabilities.
                                               submit a comment with confidential                      link, or call the advisory committee                  If you require accommodations due to a
                                               information that you do not wish to be                  information line to learn about possible              disability, please contact Lauren D. Tesh
                                               made publicly available, submit your                    modifications before coming to the                    at least 7 days in advance of the
                                               comments only as a written/paper                        meeting.                                              meeting.
                                               submission. You should submit two                                                                                FDA is committed to the orderly
                                                                                                       SUPPLEMENTARY INFORMATION                             conduct of its advisory committee
                                               copies total. One copy will include the                    Agenda: The committee will discuss
                                               information you claim to be confidential                                                                      meetings. Please visit our Web site at
                                                                                                       the development of antibacterial drugs                http://www.fda.gov/Advisory
                                               with a heading or cover note that states                that treat a single species of bacteria
                                               ‘‘THIS DOCUMENT CONTAINS                                                                                      Committees/AboutAdvisoryCommittees/
                                                                                                       when the target species infrequently                  ucm111462.htm for procedures on
                                               CONFIDENTIAL INFORMATION.’’ The                         causes infections; examples of such
                                               Agency will review this copy, including                                                                       public conduct during advisory
                                                                                                       drugs include those that are only active              committee meetings.
                                               the claimed confidential information, in                against Pseudomonas aeruginosa or
                                               its consideration of comments. The                                                                               Notice of this meeting is given under
                                                                                                       Acinetobacter baumannii.                              the Federal Advisory Committee Act (5
                                               second copy, which will have the                           FDA intends to make background
                                               claimed confidential information                                                                              U.S.C. app. 2).
                                                                                                       material available to the public no later
                                               redacted/blacked out, will be available                 than 2 business days before the meeting.                Dated: April 3, 2017.
                                               for public viewing and posted on                        If FDA is unable to post the background               Janice M. Soreth,
                                               https://www.regulations.gov. Submit                     material on its Web site prior to the                 Associate Commissioner for Special Medical
                                               both copies to the Division of Dockets                  meeting, the background material will                 Programs.
                                               Management. If you do not wish your                     be made publicly available at the                     [FR Doc. 2017–06901 Filed 4–6–17; 8:45 am]
                                               name and contact information to be                      location of the advisory committee                    BILLING CODE 4164–01–P
                                               made publicly available, you can                        meeting, and the background material
                                               provide this information on the cover                   will be posted on FDA’s Web site after
                                               sheet and not in the body of your                       the meeting. Background material is                   DEPARTMENT OF HEALTH AND
                                               comments and you must identify this                     available at http://www.fda.gov/                      HUMAN SERVICES
                                               information as ‘‘confidential.’’ Any                    AdvisoryCommittees/Calendar/
                                               information marked as ‘‘confidential’’                                                                        Food and Drug Administration
                                                                                                       default.htm. Scroll down to the
                                               will not be disclosed except in                         appropriate advisory committee meeting                [Docket No. FDA–2017–N–0001]
                                               accordance with 21 CFR 10.20 and other                  link.
                                               applicable disclosure law. For more                        Procedure: Interested persons may                  Preparation for International
                                               information about FDA’s posting of                      present data, information, or views,                  Cooperation on Cosmetics Regulation
                                               comments to public dockets, see 80 FR                   orally or in writing, on issues pending               Eleventh Annual Meeting; Public
                                               56469, September 18, 2015, or access                    before the committee. All electronic and              Meeting
                                               the information at: https://www.gpo.gov/                written submissions submitted to the
                                               fdsys/pkg/FR-2015-09-18/pdf/2015-                                                                             AGENCY:    Food and Drug Administration,
                                                                                                       Docket (see the ADDRESSES section) on                 HHS.
                                               23389.pdf.                                              or before April 10, 2017, will be                     ACTION:   Notice of public meeting.
                                                  Docket: For access to the docket to                  provided to the committee. Oral
                                               read background documents or the                        presentations from the public will be                 SUMMARY:   The Food and Drug
                                               electronic and written/paper comments                   scheduled between approximately 1:30                  Administration (FDA or we) is
                                               received, go to https://                                p.m. and 2:30 p.m. Those individuals                  announcing a public meeting entitled
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                                               www.regulations.gov and insert the                      interested in making formal oral                      ‘‘International Cooperation on
                                               docket number, found in brackets in the                 presentations should notify the contact               Cosmetics Regulation (ICCR)—
                                               heading of this document, into the                      person and submit a brief statement of                Preparation for ICCR–11 Meeting.’’ The
                                               ‘‘Search’’ box and follow the prompts                   the general nature of the evidence or                 purpose of the meeting is to invite
                                               and/or go to the Division of Dockets                    arguments they wish to present, the                   public input on various topics
                                               Management, 5630 Fishers Lane, rm.                      names and addresses of proposed                       pertaining to the regulation of
                                               1061, Rockville, MD 20852.                              participants, and an indication of the                cosmetics. We may use this input to


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                                                                                 Federal Register / Vol. 82, No. 66 / Friday, April 7, 2017 / Notices                                                  17013

                                               help us prepare for the ICCR–11 meeting                 at http://www.fda.gov/Cosmetics/                        Effective Date: April 7, 2017.
                                               that will be held July 12–14, 2017, in                  InternationalActivities/ICCR/                           Applicability Date: The correction
                                               Brasilia, Brazil.                                       default.htm. Depending on the number                  notice is applicable for the Findings of
                                               DATES: The public meeting will be held                  of requests for oral presentations, we                Research Misconduct notice published
                                               on May 25, 2017, from 2 p.m. to 4 p.m.                  intend to have an agenda available by                 on June 8, 2016.
                                               See the SUPPLEMENTARY INFORMATION                       May 18, 2017.                                         FOR FURTHER INFORMATION CONTACT: Ms.
                                               section for registration date and                                                                             Karen Gorirossi at 240–453–8800.
                                                                                                       III. Participating in the Public Meeting
                                               information.                                                                                                  SUPPLEMENTARY INFORMATION:
                                                                                                          Registration: To register for the public
                                               ADDRESSES: The public meeting will be                                                                         I. Background
                                                                                                       meeting, send registration information
                                               held at the Food and Drug                               (including your name, title, affiliation,                In FR Doc. 2016–13541 of June 8,
                                               Administration, Center for Food Safety                  address, email, and telephone), to                    2016 (81 FR 36932–36933), there was a
                                               and Applied Nutrition, 5001 Campus                      Jonathan Hicks by May 11, 2017. If you                typographical error involving one of the
                                               Dr., Wiley Auditorium (first floor),                    would like to listen to the meeting by                papers cited in the notice. The error is
                                               College Park, MD 20740.                                 phone, please submit a request for a                  identified and corrected in the
                                               FOR FURTHER INFORMATION CONTACT:                        dial-in number by May 11, 2017. If you                Correction of Errors section below.
                                               Jonathan Hicks, Office of Cosmetics and                 need special accommodations due to a
                                               Colors, Food and Drug Administration,                   disability, please contact Jonathan Hicks             II. Correction of Errors
                                               5001 Campus Dr. (HFS–125), College                      by May 18, 2016.                                         In FR Doc. 2016–13541 of June 8,
                                               Park, MD 20740, email: jonathan.hicks@                     Requests for Oral Presentations: If you            2016 (81 FR 36932–36933), make the
                                               fda.hhs.gov, 240–402–1375.                              wish to make an oral presentation, you                following correction:
                                               SUPPLEMENTARY INFORMATION:                              should notify Jonathan Hicks by May                      1. On page 36932, third column, in FR
                                               I. Background                                           11, 2017, and submit a brief statement                Doc. 2016–13541, second to last
                                                                                                       of the general nature of the evidence or              paragraph, line 5, change ‘‘August’’ to
                                                  The purpose of the multilateral                      arguments that you wish to present,                   ‘‘December’’ so that the text reads
                                               framework on the ICCR is to pave the                    your name, title, affiliation, address,               ‘‘falsified twenty-four (24) fluorescent
                                               way for the removal of regulatory                       email, and telephone, and indicate the                image panels by drawing staining in
                                               obstacles to international trade while                  approximate amount of time you need                   Photoshop and falsely labeling them in
                                               maintaining global consumer protection.                 to make your presentation. You may                    Figures 5B, 5C, 5D, 5E, 7A, 7B, 7D, 8A,
                                               The purpose of the meeting is to invite                 present proposals for future ICCR                     8B, 9A, and 9B in the December 2015
                                               public input on various topics                          agenda items, data, information, or                   Development paper and included some
                                               pertaining to the regulation of                         views, in person or in writing, on issues             of the same images in four (4) figures in
                                               cosmetics. We may use this input to                     pending at the public meeting. There                  the ASCB 2015 poster and in two (2)
                                               help us prepare for the ICCR–11 meeting                 will be no presentations by phone. Time               figures in the MARZ 2015 poster’’
                                               that will be held July 12–14, 2017, in                  allotted for oral presentations may be                  Dated: March 30, 2017.
                                               Brasilia, Brazil.                                       limited to 10 minutes or less for each
                                                  ICCR is a voluntary international                                                                          Kathryn Partin,
                                                                                                       presenter.
                                               group of cosmetics regulatory                                                                                 Director, Office of Research Integrity.
                                                                                                          Transcripts: Please be advised that as
                                               authorities from Brazil, Canada, the                    soon as a transcript of the public                    [FR Doc. 2017–07006 Filed 4–6–17; 8:45 am]
                                               European Union, Japan, and the United                   meeting is available, it will be accessible           BILLING CODE 4150–31–P
                                               States of America. These regulatory                     at https://www.regulations.gov. It may
                                               authority members will enter into                       also be viewed at the Division of
                                               constructive dialogue with their                        Dockets Management (HFA–305), Food                    DEPARTMENT OF HEALTH AND
                                               relevant cosmetics industry trade                       and Drug Administration, 5630 Fishers                 HUMAN SERVICES
                                               associations and public advocacy                        Lane, Rm. 1061, Rockville, MD 20850.
                                               groups. Currently, the ICCR members                                                                           National Institutes of Health
                                                                                                         Dated: April 3, 2017.
                                               are: The Brazilian Health Surveillance                                                                        Office of the Director, National
                                               Agency; Health Canada; the European                     Leslie Kux,
                                                                                                       Associate Commissioner for Policy.                    Institutes of Health; Notice of Meeting
                                               Commission Directorate-General for
                                               Internal Market, Industry,                              [FR Doc. 2017–06938 Filed 4–6–17; 8:45 am]               Pursuant to section 10(d) of the
                                               Entrepreneurship, and Small and                         BILLING CODE 4164–01–P                                Federal Advisory Committee Act, as
                                               Medium-sized Enterprises; the Ministry                                                                        amended (5 U.S.C. Appendix 2), notice
                                               of Health, Labor, and Welfare of Japan;                                                                       is hereby given of the meeting of the
                                               and FDA. All decisions made by                          DEPARTMENT OF HEALTH AND                              Council of Councils.
                                               consensus will be compatible with the                   HUMAN SERVICES                                           The meeting will be open to the
                                               laws, policies, rules, regulations, and                                                                       public as indicated below, with
                                               directives of the respective                            Office of the Secretary                               attendance limited to space available.
                                               administrations and governments.                                                                              Individuals who plan to attend and
                                                                                                       Findings of Research Misconduct;
                                               Members will implement and/or                                                                                 need special assistance, such as sign
                                                                                                       Correction
                                               promote actions or documents within                                                                           language interpretation or other
                                               their own jurisdictions and seek                        AGENCY:    Office of the Secretary, HHS.              reasonable accommodations, should
                                               convergence of regulatory policies and                  ACTION:   Correction of notice.                       notify the Contact Person listed below
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                                               practices. Successful implementation                                                                          in advance of the meeting. The open
                                               will need input from stakeholders.                      SUMMARY:   This document corrects an                  session will be videocast and can be
                                                                                                       error that appeared in the notice                     accessed from the NIH Videocasting and
                                               II. Topics for Discussion at the Public                 published in the June 8, 2016, Federal                Podcasting Web site (http://
                                               Meeting                                                 Register entitled ‘‘Findings of Research              videocast.nih.gov).
                                                  We will make the agenda for the                      Misconduct.’’                                            A portion of the meeting will be
                                               public meeting available on the Internet                DATES:                                                closed to the public in accordance with


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Document Created: 2017-04-06 23:49:30
Document Modified: 2017-04-06 23:49:30
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of public meeting.
DatesThe public meeting will be held on May 25, 2017, from 2 p.m. to 4 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information.
ContactJonathan Hicks, Office of Cosmetics and Colors, Food and Drug Administration, 5001 Campus Dr. (HFS-125), College Park, MD 20740, email: [email protected], 240-402- 1375.
FR Citation82 FR 17012 

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