Iceberg Water Deviating From Identity Standard; Temporary Permit for Market Testing, 67093-67094 [2010-27518]
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67093
Federal Register / Vol. 75, No. 210 / Monday, November 1, 2010 / Notices
Number of
responses per
respondent
Number of
respondents
Respondents (forms listed in parentheses)
Average
burden per
response
(in hours)
Total burden
(in hours)
General national sample of adults age 18+ (consent form) ............................
General national sample of adults age 18+ (full survey) ................................
1,650
1,500
1
1
2/60
25/60
55
625
Total ..........................................................................................................
........................
........................
........................
770
Carol Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–27487 Filed 10–29–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Joint Meeting of the Anesthetic and
Life Support Drugs Advisory
Committee and the Drug Safety and
Risk Management Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
mstockstill on DSKH9S0YB1PROD with NOTICES
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 Committees: Anesthetic and Life
Support Drugs Advisory Committee and the
Drug Safety and Risk Management Advisory
Committee.
General Function of the Committees: To
provide advice and recommendations to the
Agency on FDA’s regulatory issues.
Date and Time: The meeting will be held
on December 2, 2010, from 8 a.m. to 4:30
p.m.
Location: The Marriott Inn and Conference
Center, University of Maryland University
College, The Ballroom, 3501 University Blvd.
East, Adelphi, MD. The hotel telephone
number is 301–985–7300.
Contact Person: Kalyani Bhatt, Center for
Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire
Ave., Bldg. 31, rm. 2417, Silver Spring, MD
20993–0002, 301–796–9001, FAX: 301–847–
8533, e-mail: kalyani.bhatt@fda.hhs.gov, or
FDA Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), codes 3014512529 or
3014512535. Please call the Information Line
for up-to-date information on this meeting. A
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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 and call the appropriate advisory
committee hot line/phone line to learn about
VerDate Mar<15>2010
16:44 Oct 29, 2010
Jkt 223001
possible modifications before coming to the
meeting.
Agenda: On December 2, 2010, the
committees will begin with a closed session
from 8 a.m. to 9:15 a.m. Following the closed
session, from 9:15 a.m. to 4:30 p.m., the
meeting will be open to the public. The
committees will discuss new drug
application (NDA) 201655, Oxymorphone
HCl Extended-Release Tablets, Endo
Pharmaceuticals, Inc., and its safety for the
proposed indication of relief of moderate to
severe pain in patients requiring continuous,
around-the-clock opioid treatment for an
extended period of time. The extendedrelease characteristics of this formulation are
purportedly less easily defeated than other
formulations of controlled-release
oxymorphone.
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 link.
Procedure: On December 2, 2010, from 9:15
a.m. to 4:30 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 November 17, 2010. Oral
presentations from the public will be
scheduled between approximately 1 p.m. and
2 p.m. Those desiring to make 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
November 8, 2010. 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 November 9, 2010.
Closed Presentation of Data: On December
2, 2010, from 8 a.m. to 9:15 a.m., the meeting
will be closed to permit discussion and
review of trade secret and/or confidential
information (5 U.S.C. 552b(c)(4)). During this
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session, the committee will discuss
confidential protocol and methodology.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee meetings
and will make every effort to accommodate
persons with physical disabilities or special
needs. If you require special accommodations
due to a disability, please contact Kalyani
Bhatt at least 7 days in advance of the
meeting.
FDA is committed to the orderly conduct
of its advisory committee meetings. Please
visit our Web site at https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/ucm111462.htm
for procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under the
Federal Advisory Committee Act (5 U.S.C.
app. 2).
Dated: October 26, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–27457 Filed 10–29–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–P–0517]
Iceberg Water Deviating From Identity
Standard; Temporary Permit for Market
Testing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a temporary permit has been issued
to Iceberg Canada Corp., to market test
a product designated as ‘‘GLACE Rare
Iceberg Water’’ that deviates from the
U.S. standard of identity for bottled
water. The purpose of the temporary
permit is to allow the applicant to
measure consumer acceptance of the
product, identify mass production
problems, and assess commercial
feasibility.
DATES: This permit is effective for 15
months, beginning on the date the
SUMMARY:
E:\FR\FM\01NON1.SGM
01NON1
67094
Federal Register / Vol. 75, No. 210 / Monday, November 1, 2010 / Notices
permit holder introduces or causes the
introduction of the test product into
interstate commerce, but not later than
February 1, 2011.
Loretta
A. Carey, Center for Food Safety and
Applied Nutrition (HFS–820), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301–
436–2371.
FURTHER INFORMATION CONTACT:
In
accordance with 21 CFR 130.17
concerning temporary permits to
facilitate market testing of foods
deviating from the requirements of the
standards of identity issued under
section 401 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 341), FDA
is giving notice that a temporary permit
has been issued to Iceberg Canada Corp.,
5335 J. Armand Bombardier, St-Hubert
(Quebec), Canada J3Z 1G4.
This permit covers limited interstate
marketing tests of products identified as
‘‘GLACE Rare Iceberg Water’’ that
deviate from the U.S. standard of
identity for bottled water (§ 165.110 (21
CFR 165.110)) in that the source of the
water is an iceberg. The test product
meets all the requirements of the
standard with the exception of the
source definition. The purpose of this
temporary permit is to allow the
applicant to measure consumer
acceptance of the product, identify mass
production problems, and assess
commercial feasibility.
This permit provides for the
temporary marketing of 153,090 cases of
the 24 x 250 milliliter bottles and
515,900 cases of the 12 x 700 milliliter
bottles totaling 668,990 cases. The total
fluid quantity covered by this
application is 5,252,100 liters (1,387,458
gallons). The test product will be
manufactured for Iceberg Canada Corp.,
5335 J. Armand Bombardier, St-Hubert
(Quebec), Canada J3Z 1 G4. Iceberg
Canada Corp. will distribute the test
products throughout the United States.
The information panel of the labels will
bear nutrition labeling in accordance
with 21 CFR 101.9. The bottled water
must be manufactured in accordance
with the quality standards in
§ 165.110(b) and the requirements for
processing and bottling of bottled
drinking water in 21 CFR part 129. This
permit is effective for 15 months,
beginning on the date the permit holder
introduces or causes the introduction of
the product into interstate commerce,
but not later than (see DATES).
mstockstill on DSKH9S0YB1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
16:44 Oct 29, 2010
Jkt 223001
Dated: October 26, 2010.
Barbara Schneeman,
Director, Office of Nutrition, Labeling and
Dietary Supplements, Center for Food Safety
and Applied Nutrition.
[FR Doc. 2010–27518 Filed 10–29–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HOMELAND
SECURITY
Customs and Border Protection
Agency Information Collection
Activities: CBP Regulations Pertaining
to Customs Brokers
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: 60-Day Notice and request for
comments; Extension of an existing
collection of information: 1651–0034.
AGENCY:
As part of its continuing effort
to reduce paperwork and respondent
burden, CBP invites the general public
and other Federal agencies to comment
on an information collection
requirement concerning the: CBP
Regulations Pertaining to Customs
Brokers (19 CFR Part 111). This request
for comment is being made pursuant to
the Paperwork Reduction Act of 1995
(Pub. L. 104–13; 44 U.S.C. 3505(c)(2)).
DATES: Written comments should be
received on or before January 3, 2011, to
be assured of consideration.
ADDRESSES: Direct all written comments
to U.S. Customs and Border Protection,
Attn: Tracey Denning, Regulations and
Rulings, Office of International Trade,
799 9th Street, NW., 7th Floor,
Washington, DC 20229–1177.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be directed to Tracey Denning,
U.S. Customs and Border Protection,
Regulations and Rulings, Office of
International Trade, 799 9th Street, NW,
7th Floor, Washington, DC 20229–1177,
at 202–325–0265.
SUPPLEMENTARY INFORMATION: CBP
invites the general public and other
Federal agencies to comment on
proposed and/or continuing information
collections pursuant to the Paperwork
Reduction Act of 1995 (Pub. L. 104–13;
44 U.S.C. 3505(c)(2)). The comments
should address: (a) Whether the
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 estimates of the burden of the
collection of information; (c) ways to
SUMMARY:
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Sfmt 4703
enhance the quality, utility, and clarity
of the information to be collected; (d)
ways to minimize the burden including
the use of automated collection
techniques or the use of other forms of
information technology; and (e) the
annual costs burden to respondents or
record keepers from the collection of
information (a total capital/startup costs
and operations and maintenance costs).
The comments that are submitted will
be summarized and included in the CBP
request for Office of Management and
Budget (OMB) approval. All comments
will become a matter of public record.
In this document CBP is soliciting
comments concerning the following
information collection:
Title: CBP Regulations Pertaining to
Customs Brokers (19 CFR Part 111).
OMB Number: 1651–0034.
Form Numbers: CBP Forms 3124 and
3124E.
Abstract: The information contained
in part 111 of the CBP regulations
governs the licensing and conduct of
customs brokers. Specifically, an
individual who wishes to take the
broker exam would complete CBP Form
3124E, ‘‘Application for Customs Broker
License Exam’’; or to apply for a broker
license, CBP Form 3124, ‘‘Application
for Customs Broker License’’ must be
completed. The procedures to request a
local or national broker permit can be
found in 19 CFR 111.19, and a triennial
report is required under 19 CFR 111.30.
The information collected from customs
brokers is provided for by 19 U.S.C.
1641. CBP Forms 3124 and 3124E may
be found at https://www.cbp.gov/xp/
cgov/toolbox/forms/. Further
information about the customs broker
exam and how to apply for it may be
found at https://www.cbp.gov/xp/cgov/
trade/trade_programs/broker/broker_
exam/notice_of_exam.xml.
Current Actions: This submission is
being made to extend the expiration
date with no change to the burden hours
or to this collection of information.
Type of Review: Extension (without
change).
Affected Public: Businesses,
Individuals.
CBP Form 3124E, ‘‘Application for
Customs Broker License Exam’’
Estimated Number of Respondents:
2,300.
Total Number of Estimated Annual
Responses: 2,300.
Estimated Time per Response: 1 hour.
Estimated Total Annual Burden
Hours: 2,300.
Estimated Total Annual Cost to the
Public: $466,000.
E:\FR\FM\01NON1.SGM
01NON1
]]>Agencies
[Federal Register Volume 75, Number 210 (Monday, November 1, 2010)]
[Notices]
[Pages 67093-67094]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-27518]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-P-0517]
Iceberg Water Deviating From Identity Standard; Temporary Permit
for Market Testing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
temporary permit has been issued to Iceberg Canada Corp., to market
test a product designated as ``GLACE Rare Iceberg Water'' that deviates
from the U.S. standard of identity for bottled water. The purpose of
the temporary permit is to allow the applicant to measure consumer
acceptance of the product, identify mass production problems, and
assess commercial feasibility.
DATES: This permit is effective for 15 months, beginning on the date
the
[[Page 67094]]
permit holder introduces or causes the introduction of the test product
into interstate commerce, but not later than February 1, 2011.
FURTHER INFORMATION CONTACT: Loretta A. Carey, Center for Food Safety
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 301-436-2371.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 130.17 concerning
temporary permits to facilitate market testing of foods deviating from
the requirements of the standards of identity issued under section 401
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341), FDA is
giving notice that a temporary permit has been issued to Iceberg Canada
Corp., 5335 J. Armand Bombardier, St-Hubert (Quebec), Canada J3Z 1G4.
This permit covers limited interstate marketing tests of products
identified as ``GLACE Rare Iceberg Water'' that deviate from the U.S.
standard of identity for bottled water (Sec. 165.110 (21 CFR 165.110))
in that the source of the water is an iceberg. The test product meets
all the requirements of the standard with the exception of the source
definition. The purpose of this temporary permit is to allow the
applicant to measure consumer acceptance of the product, identify mass
production problems, and assess commercial feasibility.
This permit provides for the temporary marketing of 153,090 cases
of the 24 x 250 milliliter bottles and 515,900 cases of the 12 x 700
milliliter bottles totaling 668,990 cases. The total fluid quantity
covered by this application is 5,252,100 liters (1,387,458 gallons).
The test product will be manufactured for Iceberg Canada Corp., 5335 J.
Armand Bombardier, St-Hubert (Quebec), Canada J3Z 1 G4. Iceberg Canada
Corp. will distribute the test products throughout the United States.
The information panel of the labels will bear nutrition labeling in
accordance with 21 CFR 101.9. The bottled water must be manufactured in
accordance with the quality standards in Sec. 165.110(b) and the
requirements for processing and bottling of bottled drinking water in
21 CFR part 129. This permit is effective for 15 months, beginning on
the date the permit holder introduces or causes the introduction of the
product into interstate commerce, but not later than (see DATES).
Dated: October 26, 2010.
Barbara Schneeman,
Director, Office of Nutrition, Labeling and Dietary Supplements, Center
for Food Safety and Applied Nutrition.
[FR Doc. 2010-27518 Filed 10-29-10; 8:45 am]
BILLING CODE 4160-01-P
