80 FR 41506 - Preparation for International Cooperation on Cosmetics Regulation

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 135 (July 15, 2015)

Page Range		41506-41507
FR Document		2015-17248

Federal Register, Volume 80 Issue 135 (Wednesday, July 15, 2015)

[Federal Register Volume 80, Number 135 (Wednesday, July 15, 2015)]
[Notices]
[Pages 41506-41507]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-17248]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Preparation for International Cooperation on Cosmetics Regulation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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    The Food and Drug Administration (FDA or we) is announcing a public 
meeting entitled ``International Cooperation on Cosmetics Regulation 
(ICCR)--Preparation for ICCR-9 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-9 
meeting that will be held November 4-6, 2015, in Brussels, Belgium.
    Date and Time: The public meeting will be held on September 10, 
2015, 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 (first floor), 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: 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 August 27, 2015.
    If you need special accommodations due to a disability, please 
contact Maria Rossana (Rosemary) Cook by September 3, 2015.

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 August 27, 2015, 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: 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. Written requests are to be sent 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: 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.

[[Page 41507]]

    ICCR is a voluntary international group of cosmetics regulatory 
authorities from the United States, Japan, the European Union, Canada, 
and Brazil. 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 Commission Directorate-General for 
Internal Market, Industry, Entrepreneurship, and Subject Matter 
Experts; the Ministry of Health, Labor, and Welfare of Japan; the 
Brazilian Health Surveillance Agency; 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 September 3, 
2015. We may use the information that you provide to us during the 
public meeting to help us prepare for the November 4-6, 2015, ICCR-9 
meeting.

    Dated: July 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17248 Filed 7-14-15; 8:45 am]
BILLING CODE 4164-01-P

41506 Federal Register / Vol. 80, No. 135 / Wednesday, July 15, 2015 / Notices

respondents to provide contact data for Respondents: JSA study participants Annual Burden Estimates
possible longer-term follow-up. and program staff.

EXTENSION OF PREVIOUSLY APPROVED INFORMATION COLLECTIONS
Total Annual Number of Average Annual
Instrument number of number of responses per burden hours burden hours
respondents respondents respondent per response

Baseline Information Form ................................................... 6,400 3,200 1 .2 640
Implementation Study Site Visits ......................................... 600 300 1 1 300
JSA Staff Survey .................................................................. 440 220 1 .33 73

PROPOSED NEW INFORMATION COLLECTIONS
Total Annual Number of Average Annual
Instrument number of number of responses per burden hours burden hours
respondents respondents respondent per response

6 Month Follow-Up Survey .................................................. 6,400 3,200 1 .333 1,066
Contact Update Form .......................................................... 6,400 3,200 11 .033 1,162

Estimated Total Annual Burden DEPARTMENT OF HEALTH AND presentation, to the contact person by
Hours: 3,241. HUMAN SERVICES August 27, 2015.
In compliance with the requirements If you need special accommodations
Food and Drug Administration due to a disability, please contact Maria
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Rossana (Rosemary) Cook by September
Administration for Children and [Docket No. FDA–2015–N–0001] 3, 2015.
Families is soliciting public comment Preparation for International SUPPLEMENTARY INFORMATION: You may
on the specific aspects of the Cooperation on Cosmetics Regulation present proposals for future ICCR
information collection described above. agenda items, data, information, or
Copies of the proposed collection of AGENCY: Food and Drug Administration, views, orally or in writing, on issues
information can be obtained and HHS. pending at the public meeting. Time
comments may be forwarded by writing ACTION: Notice of meeting. allotted for oral presentations may be
to the Administration for Children and limited to 10 minutes or less for each
Families, Office of Planning, Research The Food and Drug Administration presenter. If you wish to make an oral
and Evaluation, 370 L’Enfant (FDA or we) is announcing a public presentation, you should notify the
Promenade SW., Washington, DC 20447, meeting entitled ‘‘International contact person by August 27, 2015, and
Attn: OPRE Reports Clearance Officer. Cooperation on Cosmetics Regulation submit a brief statement of the general
Email address: OPREinfocollection@ (ICCR)—Preparation for ICCR–9 nature of the evidence or arguments that
acf.hhs.gov. All requests should be Meeting.’’ The purpose of the meeting is you wish to present, your name,
identified by the title of the information to invite public input on various topics address, telephone number, fax number,
collection. pertaining to the regulation of and email address, and indicate the
cosmetics. We may use this input to approximate amount of time you need
The Department specifically requests help us prepare for the ICCR–9 meeting
comments on (a) whether the proposed to make your presentation.
that will be held November 4–6, 2015,
collection of information is necessary in Brussels, Belgium. Transcripts: As soon as a transcript is
for the proper performance of the Date and Time: The public meeting available, it will be accessible at
functions of the agency, including will be held on September 10, 2015, http://www.regulations.gov. It may also
whether the information shall have from 2 p.m. to 4 p.m. be viewed at the Division of Dockets
practical utility; (b) the accuracy of the Location: This meeting will be held at Management (HFA–305), Food and Drug
agency’s estimate of the burden of the the Food and Drug Administration, Administration, 5630 Fishers Lane, rm.
proposed collection of information; (c) Center for Food Safety and Applied 1061, Rockville, MD 20850. A transcript
the quality, utility, and clarity of the Nutrition, 5100 Paint Branch Pkwy., will also be available in either hardcopy
information to be collected; and (d) Wiley Auditorium (first floor), College or on CD–ROM, after submission of a
ways to minimize the burden of the Park, MD 20740. Freedom of Information request. Written
collection of information on Contact Person: Maria Rossana requests are to be sent to the Division
respondents, including through the use (Rosemary) Cook, Office of Cosmetics of Freedom of Information, (ELEM–
of automated collection techniques or and Colors, Food and Drug 1029), Food and Drug Administration,
other forms of information technology. Administration, 4300 River Rd., College 12420 Parklawn Dr., Element Bldg.,
Consideration will be given to Rockville, MD 20857.
mstockstill on DSK4VPTVN1PROD with NOTICES

Park, MD 20740, email: maria.cook@
comments and suggestions submitted fda.hhs.gov, or FAX: 301–436–2975. The Purpose of the Multilateral
within 60 days of this publication. Registration and Requests for Oral Framework on the ICCR: The purpose of
Presentations: Send registration the multilateral framework on the ICCR
Karl Koerper,
information (including your name, title, is to pave the way for the removal of
Reports Clearance Officer. firm name, address, telephone number, regulatory obstacles to international
[FR Doc. 2015–17264 Filed 7–14–15; 8:45 am] fax number, and email address), written trade while maintaining global
BILLING CODE 4184–01–P material, and requests to make an oral consumer protection.

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Federal Register / Vol. 80, No. 135 / Wednesday, July 15, 2015 / Notices 41507

ICCR is a voluntary international ACTION: Notice. approve, and have continuing oversight
group of cosmetics regulatory of research involving human subjects.
authorities from the United States, SUMMARY: In compliance with section
3506(c)(2)(A) of the Paperwork The Office for Human Research
Japan, the European Union, Canada, and Protections (OHRP) and the Food and
Brazil. These regulatory authority Reduction Act of 1995, the Office of the
Secretary, Department of Health and Drug Administration (FDA) are
members will enter into constructive
Human Services (HHS), announces requesting a three-year extension of the
dialogue with their relevant cosmetics
industry trade associations and public plans to submit an Information OMB No. 0990–0279, Institutional
advocacy groups. Currently, the ICCR Collection Request (ICR), described Review Board (IRB) Registration Form.
members are: Health Canada; the below, to the Office of Management and This form was modified in 2009 to be
European Commission Directorate- Budget (OMB). The ICR is for extending consistent with IRB registration
General for Internal Market, Industry, the use of the approved information requirements, 45 CFR part 46, subpart E
Entrepreneurship, and Subject Matter collection assigned OMB control and 21 CFR 56.106 that were adopted in
Experts; the Ministry of Health, Labor, number 0990–0279, which expires on July 2009 OHRP and FDA, respectively.
and Welfare of Japan; the Brazilian August 31, 2015. Prior to submitting Need and Proposed Use of the
Health Surveillance Agency; and FDA. that ICR to OMB, OS seeks comments Information: The information collected
All decisions made by consensus will be from the public regarding the burden through the Institutional Review Board
compatible with the laws, policies, estimate, below, or any other aspect of
registration collection requirements is
rules, regulations, and directives of the the ICR.
the minimum necessary to satisfy the
respective administrations and DATES: Comments on the ICR must be registration requirements of Section 491
governments. Members will implement received on or before September 14, (a) of the Public Health Service Act, 45
and/or promote actions or documents 2015.
within their own jurisdictions and seek CFR part 46, subpart E and 21 CFR
ADDRESSES: Submit your comments to 56.106.
convergence of regulatory policies and
practices. Successful implementation Information.CollectionClearance@ Likely Respondents: Institutions or
will need input from stakeholders. hhs.gov or by calling (202) 690–6162. organizations operating IRBs that review
Agenda: We will make the agenda for FOR FURTHER INFORMATION CONTACT: human subjects research conducted or
the public meeting available on the Information Collection Clearance staff, supported by HHS, or, in the case of
Internet at http://www.fda.gov/ Information.CollectionClearance@ FDA’s regulations, IRBs in the United
Cosmetics/InternationalActivities/ICCR/ hhs.gov or (202) 690–6162. States that review clinical investigations
default.htm. Depending on the number SUPPLEMENTARY INFORMATION: When regulated by FDA under sections 505(i)
of requests for oral presentations, we submitting comments or requesting or 520(g) of the Federal Food, Drug and
intend to have an agenda available by information, please include the Cosmetic Act; and, IRBs in the United
September 3, 2015. We may use the document identifier 0990–0279 for States that review clinical investigations
information that you provide to us reference. that are intended to support
during the public meeting to help us Information Collection Request Title:
prepare for the November 4–6, 2015, applications for research or marketing
Institutional Review Board Form—OMB
ICCR–9 meeting. permits for FDA-regulated products.
No. 0990–0279, Assistant Secretary for
Dated: July 9, 2015. Health, Office for Human Research Burden Statement: The burden
Leslie Kux, Protections. estimates for the IRB registration form
Associate Commissioner for Policy. Abstract: Section 491(a) of Public Law include those approved by OMB in
99–158 states that the Secretary of HHS March 2015 under Control Number
[FR Doc. 2015–17248 Filed 7–14–15; 8:45 am]
shall by regulation require that each 0990–0263, the Assurance
BILLING CODE 4164–01–P
entity applying for HHS support (e.g., a Identification/IRB Certification/
grant, contract, or cooperative Declaration of Exemption form (former
DEPARTMENT OF HEALTH AND agreement) to conduct research Optional Form 310). Those burden
HUMAN SERVICES involving human subjects submit to estimates are not included as part of the
HHS assurances satisfactory to the burden estimate presented below.
[Document Identifier: HHS–0990–0279–60D] Secretary that it has established an
institutional review board (IRB) to
Agency Information Collection
review the research in order to ensure
Activities; Proposed Collection; Public
protection of the rights and welfare of
Comment Request
the human research subjects. IRBs are
AGENCY: Office of the Assistant boards, committees, or groups formally
Secretary for Health, HHS. designated by an entity to review,

ESTIMATED ANNUALIZED BURDEN TABLE
Average
Number of
Number of burden per Total burden
Form name responses per
respondents response hours
respondent (in hours)
mstockstill on DSK4VPTVN1PROD with NOTICES

IRB Registration 0990–0279 ........................................................................... 5,900 2 1 11,800
500 2 1 1,000

Total .......................................................................................................... ........................ ........................ ........................ 12,800

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Document Created: 2015-12-15 13:32:17
Document Modified: 2015-12-15 13:32:17

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		80 FR 41506

80 FR 41506 - Preparation for International Cooperation on Cosmetics Regulation

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 135 (July 15, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration