Preparation for International Cooperation on Cosmetics Regulation, 41506-41507 [2015-17248]
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41506
Federal Register / Vol. 80, No. 135 / Wednesday, July 15, 2015 / Notices
respondents to provide contact data for
possible longer-term follow-up.
Respondents: JSA study participants
and program staff.
Annual Burden Estimates
EXTENSION OF PREVIOUSLY APPROVED INFORMATION COLLECTIONS
Total
number of
respondents
Instrument
Baseline Information Form ...................................................
Implementation Study Site Visits .........................................
JSA Staff Survey ..................................................................
Annual
number of
respondents
6,400
600
440
Number of
responses per
respondent
3,200
300
220
1
1
1
Average
burden hours
per response
Annual
burden hours
.2
1
.33
640
300
73
PROPOSED NEW INFORMATION COLLECTIONS
Total
number of
respondents
Instrument
mstockstill on DSK4VPTVN1PROD with NOTICES
6 Month Follow-Up Survey ..................................................
Contact Update Form ..........................................................
Estimated Total Annual Burden
Hours: 3,241.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: OPRE Reports Clearance Officer.
Email address: OPREinfocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on (a) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Karl Koerper,
Reports Clearance Officer.
[FR Doc. 2015–17264 Filed 7–14–15; 8:45 am]
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Annual
number of
respondents
6,400
6,400
3,200
3,200
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.
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
PO 00000
Frm 00033
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Number of
responses per
respondent
1
11
Average
burden hours
per response
Annual
burden hours
.333
.033
1,066
1,162
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.
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
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. 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.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 80, No. 135 / Wednesday, July 15, 2015 / Notices
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 DirectorateGeneral 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 https://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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: HHS–0990–0279–60D]
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request
Office of the Assistant
Secretary for Health, HHS.
AGENCY:
ACTION:
approve, and have continuing oversight
of research involving human subjects.
The Office for Human Research
Protections (OHRP) and the Food and
Drug Administration (FDA) are
requesting a three-year extension of the
OMB No. 0990–0279, Institutional
Review Board (IRB) Registration Form.
This form was modified in 2009 to be
consistent with IRB registration
requirements, 45 CFR part 46, subpart E
and 21 CFR 56.106 that were adopted in
July 2009 OHRP and FDA, respectively.
Need and Proposed Use of the
Information: The information collected
through the Institutional Review Board
registration collection requirements is
the minimum necessary to satisfy the
registration requirements of Section 491
(a) of the Public Health Service Act, 45
CFR part 46, subpart E and 21 CFR
56.106.
Likely Respondents: Institutions or
organizations operating IRBs that review
human subjects research conducted or
supported by HHS, or, in the case of
FDA’s regulations, IRBs in the United
States that review clinical investigations
regulated by FDA under sections 505(i)
or 520(g) of the Federal Food, Drug and
Cosmetic Act; and, IRBs in the United
States that review clinical investigations
that are intended to support
applications for research or marketing
permits for FDA-regulated products.
Burden Statement: The burden
estimates for the IRB registration form
include those approved by OMB in
March 2015 under Control Number
0990–0263, the Assurance
Identification/IRB Certification/
Declaration of Exemption form (former
Optional Form 310). Those burden
estimates are not included as part of the
burden estimate presented below.
Notice.
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary, Department of Health and
Human Services (HHS), announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). The ICR is for extending
the use of the approved information
collection assigned OMB control
number 0990–0279, which expires on
August 31, 2015. Prior to submitting
that ICR to OMB, OS seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on the ICR must be
received on or before September 14,
2015.
SUMMARY:
Submit your comments to
Information.CollectionClearance@
hhs.gov or by calling (202) 690–6162.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
document identifier 0990–0279 for
reference.
Information Collection Request Title:
Institutional Review Board Form—OMB
No. 0990–0279, Assistant Secretary for
Health, Office for Human Research
Protections.
Abstract: Section 491(a) of Public Law
99–158 states that the Secretary of HHS
shall by regulation require that each
entity applying for HHS support (e.g., a
grant, contract, or cooperative
agreement) to conduct research
involving human subjects submit to
HHS assurances satisfactory to the
Secretary that it has established an
institutional review board (IRB) to
review the research in order to ensure
protection of the rights and welfare of
the human research subjects. IRBs are
boards, committees, or groups formally
designated by an entity to review,
ADDRESSES:
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
mstockstill on DSK4VPTVN1PROD with NOTICES
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
IRB Registration 0990–0279 ...........................................................................
5,900
500
2
2
1
1
11,800
1,000
Total ..........................................................................................................
........................
........................
........................
12,800
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]]>Agencies
[Federal Register Volume 80, Number 135 (Wednesday, July 15, 2015)]
[Notices]
[Pages 41506-41507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17248]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 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. 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 https://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]
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