Drug Safety and Risk Management Advisory Committee; Amendment of Notice, 24449 [05-9228]
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Federal Register / Vol. 70, No. 88 / Monday, May 9, 2005 / Notices
Dated: May 4, 2005.
Debbie Powell,
Director, Office of Operations and
Discretionary Grant Programs,
Administration on Developmental
Disabilities.
[FR Doc. 05–9225 Filed 5–6–05; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2000P–1439] (formerly Docket
No. 00P–1439)
Iceberg Industries Corp.; Revocation
of Temporary Permit for Market
Testing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
revocation of a temporary permit issued
to Iceberg Industries Corp. to market test
products designated as ‘‘Borealis Iceberg
Water’’ because there is no evidence
that the company is operational, and the
need for the permit no longer exists.
FOR FURTHER INFORMATION CONTACT:
Loretta 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 a notice
published in the Federal Register of
September 7, 2000 (65 FR 54283), FDA
issued a temporary permit to Iceberg
Industries Corp., 16 Forest Rd., suite
300, St. John’s, Newfoundland, Canada,
A1C2B9, to market test products
identified as ‘‘iceberg water,’’ a name
that is not permitted under the U.S.
standard of identity for bottled water in
§ 165.110 (21 CFR 165.110). The agency
issued the permit to facilitate market
testing of products whose labeling
differs from the requirements of the
standard of identity for bottled water
issued under section 401 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
341). The permit covered limited
interstate market testing of products that
deviated from the standard for bottled
water in § 165.110 in that they were
identified as ‘‘iceberg water’’ rather than
as ‘‘bottled water’’ or one of the other
names specified in § 165.110(a)(2). The
test product met all the requirements of
the standard with the exception of this
deviation.
On September 28, 2001, Iceberg
Industries Corp. requested that its
temporary permit be extended to allow
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17:20 May 06, 2005
Jkt 205001
for additional time for the market testing
of its products under the permit in order
to gain additional information in
support of its petition. In the Federal
Register of June 27, 2002 (67 FR 43325),
FDA announced that it was extending
the temporary permit issued to Iceberg
Industries Corp. to market test products
designated as ‘‘Borealis Iceberg Water.’’
The extension allowed the permit
holder to continue to collect data on
consumer acceptance of products while
the agency considered the petition to
amend the standard of identity for
bottled water, which was submitted by
the permit holder. Under the extension,
FDA invited interested persons to
participate in the market test under the
conditions that applied to Iceberg
Industries Corp., except for the
designated area of distribution. No one
accepted the invitation to participate in
the market test. In March 2004, FDA
attempted to contact Iceberg Industries
Corp. to discuss some issues regarding
its petition at the telephone number
listed in its petition. The telephone
number was no longer in service.
Attempts to reach the applicant by letter
were unsuccessful. Therefore, under 21
CFR 130.17(g)(3), FDA is revoking the
Iceberg Industries Corp.’s temporary
permit because the need no longer
exists.
Dated: May 3, 2005.
Barbara Schneeman,
Director, Office of Nutritional Products,
Labeling and Dietary Supplements, Center for
Food Safety and Applied Nutrition.
[FR Doc. 05–9233 Filed 5–6–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Drug Safety and Risk Management
Advisory Committee; Amendment of
Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of meeting of the Drug Safety
and Risk Management Advisory
Committee. This meeting was
announced in the Federal Register of
April 14, 2005 (70 FR 19763). The
amendment is being made to reflect a
change in the Date and Time portion of
the document. The start time for each
day of the meeting will be changed.
There are no other changes.
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24449
FOR FURTHER INFORMATION CONTACT:
Shalini Jain, Center for Drug Evaluation
and Research (HFD–21), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
7001, FAX: 301–827–6776, e-mail:
jains@cder.fda.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington DC area), code 3014512535.
Please call the Information Line for upto-date information on this meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of April 14, 2005, FDA
announced that a meeting of the Drug
Safety and Risk Management Advisory
Committee would be held on May 18
and 19, 2005, from 8:30 a.m. to 5 p.m.
On page 19763, in the third column, the
Date and Time portion of the meeting
notice is amended to read as follows:
Date and Time: The meeting will be
held on May 18 and 19, 2005, from 8
a.m. to 5 p.m.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: May 3, 2005.
Lester M. Crawford,
Acting Commissioner of Food and Drugs.
[FR Doc. 05–9228 Filed 5–6–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Advisory Committee on Special
Studies Relating to the Possible LongTerm Health Effects of Phenoxy
Herbicides and Contaminants (Ranch
Hand Advisory Committee); Notice of
Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Advisory
Committee on Special Studies Relating
to the Possible Long-Term Health Effects
of Phenoxy Herbicides and
Contaminants (Ranch Hand Advisory
Committee).
General Function of the Committee:
To advise the Secretary of Health and
Human Services (the Secretary) and the
Assistant Secretary for Health
concerning its oversight of the conduct
of the Ranch Hand study by the U.S. Air
E:\FR\FM\09MYN1.SGM
09MYN1
Agencies
[Federal Register Volume 70, Number 88 (Monday, May 9, 2005)]
[Notices]
[Page 24449]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9228]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Drug Safety and Risk Management Advisory Committee; Amendment of
Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing an amendment
to the notice of meeting of the Drug Safety and Risk Management
Advisory Committee. This meeting was announced in the Federal Register
of April 14, 2005 (70 FR 19763). The amendment is being made to reflect
a change in the Date and Time portion of the document. The start time
for each day of the meeting will be changed. There are no other
changes.
FOR FURTHER INFORMATION CONTACT: Shalini Jain, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093),
Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail:
jains@cder.fda.gov, or FDA Advisory Committee Information Line, 1-800-
741-8138 (301-443-0572 in the Washington DC area), code 3014512535.
Please call the Information Line for up-to-date information on this
meeting.
SUPPLEMENTARY INFORMATION: In the Federal Register of April 14, 2005,
FDA announced that a meeting of the Drug Safety and Risk Management
Advisory Committee would be held on May 18 and 19, 2005, from 8:30 a.m.
to 5 p.m. On page 19763, in the third column, the Date and Time portion
of the meeting notice is amended to read as follows:
Date and Time: The meeting will be held on May 18 and 19, 2005,
from 8 a.m. to 5 p.m.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Dated: May 3, 2005.
Lester M. Crawford,
Acting Commissioner of Food and Drugs.
[FR Doc. 05-9228 Filed 5-6-05; 8:45 am]
BILLING CODE 4160-01-S