81 FR 23308 - Preparation for International Cooperation on Cosmetics Regulation
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 76 (April 20, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 76 (April 20, 2016)
| Page Range | 23308-23309 | |
| FR Document | 2016-09143 |
[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)] [Notices] [Pages 23308-23309] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-09143] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1024] Preparation for International Cooperation on Cosmetics Regulation 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-10 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-10 meeting that will be held July 12-14, 2016, in Bethesda, MD. Date and Time: The public meeting will be held on June 15, 2016, from 2 p.m. to 4 p.m. Location: This meeting will be held at the Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., Wiley Auditorium, College Park, MD 20740. Contact Person: Maria Rossana (Rosemary) Cook, Office of Cosmetics and Colors, Food and Drug Administration, 4300 River Rd., College Park, MD 20740, [email protected], or FAX: 301-436-2975. [[Page 23309]] 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 June 1, 2016. If you need special accommodations due to a disability, please contact Maria Rossana (Rosemary) Cook at least 7 days in advance of the meeting. SUPPLEMENTARY INFORMATION: You may present proposals for future ICCR agenda items, 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 June 1, 2016, 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. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://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. A transcript will also be available in either hardcopy or on CD- ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's Web site at http://www.fda.gov. The Purpose of the Multilateral Framework on the ICCR: 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 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. Agenda: 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 June 8, 2016. We may use the information that you provide to us during the public meeting to help us prepare for the July 12-14, 2016, ICCR-10 meeting. Dated: April 13, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-09143 Filed 4-19-16; 8:45 am] BILLING CODE 4164-01-P
![23308 Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices
confidential information that you or a provide this information on the cover it satisfies the requirements of the
third party may not wish to be posted, sheet and not in the body of your applicable statutes and regulations.
such as medical information, your or comments and you must identify this
III. Paperwork Reduction Act of 1995
anyone else’s Social Security number, or information as ‘‘confidential.’’ Any
confidential business information, such information marked as ‘‘confidential’’ This guidance refers to previously
as a manufacturing process. Please note will not be disclosed except in approved collections of information
that if you include your name, contact accordance with 21 CFR 10.20 and other found in FDA regulations. These
information, or other information that applicable disclosure law. For more collections of information are subject to
identifies you in the body of your information about FDA’s posting of review by the Office of Management and
comments, that information will be comments to public dockets, see 80 FR Budget (OMB) under the Paperwork
posted on http://www.regulations.gov. 56469, September 18, 2015, or access Reduction Act of 1995 (44 U.S.C. 3501–
• If you want to submit a comment the information at: http://www.fda.gov/ 3520). The collections of information in
with confidential information that you regulatoryinformation/dockets/ 21 CFR 514.80 have been approved
do not wish to be made available to the default.htm. under OMB control number 0910–0284.
public, submit the comment as a Docket: For access to the docket to IV. Electronic Access
written/paper submission and in the read background documents or the
manner detailed (see ‘‘Written/Paper electronic and written/paper comments Persons with access to the Internet
Submissions’’ and ‘‘Instructions’’). received, go to http:// may obtain the guidance at either http://
www.regulations.gov and insert the www.fda.gov/AnimalVeterinary/
Written/Paper Submissions GuidanceComplianceEnforcement/
docket number, found in brackets in the
Submit written/paper submissions as heading of this document, into the GuidanceforIndustry/default.htm or
follows: ‘‘Search’’ box and follow the prompts http://www.regulations.gov.
• Mail/Hand delivery/Courier (for
and/or go to the Division of Dockets Dated: April 13, 2016.
written/paper submissions): Division of
Management, 5630 Fishers Lane, Rm. Leslie Kux,
Dockets Management (HFA–305), Food
1061, Rockville, MD 20852. Associate Commissioner for Policy.
and Drug Administration, 5630 Fishers
Submit written requests for single [FR Doc. 2016–09141 Filed 4–19–16; 8:45 am]
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments copies of the guidance to the Policy and BILLING CODE 4164–01–P
submitted to the Division of Dockets Regulations Staff (HFV–6), Center for
Management, FDA will post your Veterinary Medicine, Food and Drug
comment, as well as any attachments, Administration, 7519 Standish Pl., DEPARTMENT OF HEALTH AND
except for information submitted, Rockville, MD 20855. Send one self- HUMAN SERVICES
marked and identified, as confidential, addressed adhesive label to assist that
if submitted as detailed in office in processing your requests. See Food and Drug Administration
‘‘Instructions.’’ the SUPPLEMENTARY INFORMATION section [Docket No. FDA–2016–N–1024]
Instructions: All submissions received for electronic access to the guidance
must include the Docket No. FDA– document. Preparation for International
2015–D–3056 for ‘‘Distributor Labeling FOR FURTHER INFORMATION CONTACT: Cooperation on Cosmetics Regulation
for New Animal Drugs.’’ Received Dorothy McAdams, Center for AGENCY: Food and Drug Administration,
comments will be placed in the docket Veterinary Medicine, Division of HHS.
and, except for those submitted as Surveillance (HFV–210), Food and Drug
ACTION: Notice of meeting.
‘‘Confidential Submissions,’’ publicly Administration, 7519 Standish Pl.,
viewable at http://www.regulations.gov Rockville, MD 20855, 240–402–5763, The Food and Drug Administration
or at the Division of Dockets email: dorothy.mcadams@fda.hhs.gov. (FDA or we) is announcing a public
Management between 9 a.m. and 4 p.m., SUPPLEMENTARY INFORMATION: meeting entitled ‘‘International
Monday through Friday. Cooperation on Cosmetics Regulation
• Confidential Submissions—To I. Background
(ICCR)—Preparation for ICCR–10
submit a comment with confidential In the Federal Register of September Meeting.’’ The purpose of the meeting is
information that you do not wish to be 10, 2015 (80 FR 54568), FDA published to invite public input on various topics
made publicly available, submit your the notice of availability for a draft pertaining to the regulation of
comments only as a written/paper guidance entitled ‘‘Distributor Labeling cosmetics. We may use this input to
submission. You should submit two for New Animal Drugs’’ giving help us prepare for the ICCR–10 meeting
copies total. One copy will include the interested persons until November 9, that will be held July 12–14, 2016, in
information you claim to be confidential 2015, to comment on the draft guidance. Bethesda, MD.
with a heading or cover note that states FDA received no comments on the draft Date and Time: The public meeting
‘‘THIS DOCUMENT CONTAINS guidance. The guidance announced in will be held on June 15, 2016, from 2
CONFIDENTIAL INFORMATION.’’ The this notice finalizes the draft guidance p.m. to 4 p.m.
Agency will review this copy, including dated September 2015. Location: This meeting will be held at
the claimed confidential information, in the Food and Drug Administration,
its consideration of comments. The II. Significance of Guidance Center for Food Safety and Applied
second copy, which will have the This level 1 guidance is being issued Nutrition, 5100 Paint Branch Pkwy.,
claimed confidential information consistent with FDA’s good guidance Wiley Auditorium, College Park, MD
Lhorne on DSK5TPTVN1PROD with NOTICES
redacted/blacked out, will be available practices regulation (21 CFR 10.115). 20740.
for public viewing and posted on http:// The guidance represents the current Contact Person: Maria Rossana
www.regulations.gov. Submit both thinking of FDA on distributor labeling (Rosemary) Cook, Office of Cosmetics
copies to the Division of Dockets for new animal drugs. It does not and Colors, Food and Drug
Management. If you do not wish your establish any rights for any person and Administration, 4300 River Rd., College
name and contact information to be is not binding on FDA or the public. Park, MD 20740, maria.cook@
made publicly available, you can You can use an alternative approach if fda.hhs.gov, or FAX: 301–436–2975.
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![Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices 23309
Registration and Requests for Oral consensus will be compatible with the ADDRESSES: You may submit comments
Presentations: Send registration laws, policies, rules, regulations, and as follows:
information (including your name, title, directives of the respective
Electronic Submissions
firm name, address, telephone number, administrations and governments.
fax number, and email address), written Members will implement and/or Submit electronic comments in the
material, and requests to make an oral promote actions or documents within following way:
presentation, to the contact person by their own jurisdictions and seek • Federal eRulemaking Portal: http://
June 1, 2016. convergence of regulatory policies and www.regulations.gov. Follow the
If you need special accommodations practices. Successful implementation instructions for submitting comments.
due to a disability, please contact Maria will need input from stakeholders. Comments submitted electronically,
Rossana (Rosemary) Cook at least 7 days Agenda: We will make the agenda for including attachments, to http://
in advance of the meeting. the public meeting available on the www.regulations.gov will be posted to
Internet at http://www.fda.gov/ the docket unchanged. Because your
SUPPLEMENTARY INFORMATION: You may
Cosmetics/InternationalActivities/ICCR/ comment will be made public, you are
present proposals for future ICCR
default.htm. Depending on the number solely responsible for ensuring that your
agenda items, data, information, or
of requests for oral presentations, we comment does not include any
views, orally or in writing, on issues
intend to have an agenda available by confidential information that you or a
pending at the public meeting. Time
June 8, 2016. We may use the third party may not wish to be posted,
allotted for oral presentations may be
information that you provide to us such as medical information, your or
limited to 10 minutes or less for each
during the public meeting to help us anyone else’s Social Security number, or
presenter. If you wish to make an oral
prepare for the July 12–14, 2016, ICCR– confidential business information, such
presentation, you should notify the
10 meeting. as a manufacturing process. Please note
contact person by June 1, 2016, and
that if you include your name, contact
submit a brief statement of the general Dated: April 13, 2016.
information, or other information that
nature of the evidence or arguments that Leslie Kux, identifies you in the body of your
you wish to present, your name, Associate Commissioner for Policy. comments, that information will be
address, telephone number, fax number, [FR Doc. 2016–09143 Filed 4–19–16; 8:45 am] posted on http://www.regulations.gov.
and email address, and indicate the
BILLING CODE 4164–01–P • If you want to submit a comment
approximate amount of time you need
with confidential information that you
to make your presentation.
do not wish to be made available to the
Transcripts: Please be advised that as DEPARTMENT OF HEALTH AND public, submit the comment as a
soon as a transcript is available, it will HUMAN SERVICES written/paper submission and in the
be accessible at http://
manner detailed (see ‘‘Written/Paper
www.regulations.gov. It may also be Food and Drug Administration Submissions’’ and ‘‘Instructions’’).
viewed at the Division of Dockets
Management (HFA–305), Food and Drug [Docket No. FDA–2013–N–0375]
Written/Paper Submissions
Administration, 5630 Fishers Lane, Rm. Submit written/paper submissions as
1061, Rockville, MD 20850. A transcript Agency Information Collection follows:
will also be available in either hardcopy Activities; Proposed Collection; • Mail/Hand delivery/Courier (for
or on CD–ROM, after submission of a Comment Request; Agreement for written/paper submissions): Division of
Freedom of Information request. The Shipment of Devices for Sterilization Dockets Management (HFA–305), Food
Freedom of Information office address is and Drug Administration, 5630 Fishers
available on the Agency’s Web site at AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852.
http://www.fda.gov. HHS. • For written/paper comments
The Purpose of the Multilateral ACTION: Notice. submitted to the Division of Dockets
Framework on the ICCR: The purpose of Management, FDA will post your
the multilateral framework on the ICCR SUMMARY: The Food and Drug comment, as well as any attachments,
is to pave the way for the removal of Administration (FDA) is announcing an except for information submitted,
regulatory obstacles to international opportunity for public comment on the marked and identified, as confidential,
trade while maintaining global proposed collection of certain if submitted as detailed in
consumer protection. information by the Agency. Under the ‘‘Instructions.’’
ICCR is a voluntary international Paperwork Reduction Act of 1995 (the Instructions: All submissions received
group of cosmetics regulatory PRA), Federal Agencies are required to must include the Docket No. FDA–
authorities from Brazil, Canada, the publish notice in the Federal Register 2013–N–0375 for ‘‘Agency Information
European Union, Japan, and the United concerning each proposed collection of Collection Activities; Proposed
States of America. These regulatory information, including each proposed Collection; Comment Request;
authority members will enter into extension of an existing collection of Agreement for Shipment of Devices for
constructive dialogue with their information, and to allow 60 days for Sterilization.’’ Received comments will
relevant cosmetics industry trade public comment in response to the be placed in the docket and, except for
associations and public advocacy notice. This notice solicits comments on those submitted as ‘‘Confidential
groups. Currently, the ICCR members information collection requirements Submissions,’’ publicly viewable at
are: The Brazilian Health Surveillance relating to shipment of nonsterile http://www.regulations.gov or at the
Lhorne on DSK5TPTVN1PROD with NOTICES
Agency; Health Canada; the European devices that are to be sterilized Division of Dockets Management
Commission Directorate-General for elsewhere or are shipped to other between 9 a.m. and 4 p.m., Monday
Internal Market, Industry, establishments for further processing, through Friday.
Entrepreneurship, and Small and labeling, or repacking. • Confidential Submissions—To
Medium-sized Enterprises; the Ministry DATES: Submit either electronic or submit a comment with confidential
of Health, Labor, and Welfare of Japan; written comments on the collection of information that you do not wish to be
and FDA. All decisions made by information by June 20, 2016. made publicly available, submit your
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Document Created: 2016-04-20 01:52:08
Document Modified: 2016-04-20 01:52:08
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of meeting. | |
| FR Citation | 81 FR 23308 |
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