Special Local Regulation; U.S. Nationals Waterski Racing Championship; Mission Bay, San Diego, CA, 49610 [E8-19532]
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Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Rules and Regulations
(6) For purposes of paragraph (f)(2) of
this section, information will be
considered newly acquired if it consists
of data, analyses, or other information
not previously submitted to the agency,
which may include (but are not limited
to) data derived from new clinical
studies, reports of adverse events, or
new analyses of previously submitted
data (e.g., meta-analyses) if the studies,
events or analyses reveal risks of a
different type or greater severity or
frequency than previously included in
submissions to FDA.
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Dated: August 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–19572 Filed 8–21–08; 8:45 am]
PART 814—PREMARKET APPROVAL
OF MEDICAL DEVICES
Special Local Regulation; U.S.
Nationals Waterski Racing
Championship; Mission Bay, San
Diego, CA
6. The authority citation for 21 CFR
part 814 continues to read as follows:
I
Authority: 21 U.S.C. 351, 352, 353, 360,
360c–360j, 371, 372, 373, 374, 375, 379, 379e,
381.
7. Section 814.3 is amended by adding
paragraph (o) to read as follows:
I
§ 814.3
Definitions.
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(o) Newly acquired information means
data, analyses, or other information not
previously submitted to the agency,
which may include (but are not limited
to) data derived from new clinical
studies, reports of adverse events, or
new analyses of previously submitted
data (e.g., meta-analyses) if the studies,
events or analyses reveal risks of a
different type or greater severity or
frequency than previously included in
submissions to FDA.
8. Section 814.39 is amended by
revising paragraphs (d)(1) introductory
text and (d)(2)(i) to read as follows:
I
§ 814.39
PMA supplements.
yshivers on PROD1PC62 with RULES
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(d)(1) After FDA approves a PMA, any
change described in paragraph (d)(2) of
this section to reflect newly acquired
information that enhances the safety of
the device or the safety in the use of the
device may be placed into effect by the
applicant prior to the receipt under
§ 814.17 of a written FDA order
approving the PMA supplement
provided that:
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(2) * * *
(i) Labeling changes that add or
strengthen a contraindication, warning,
precaution, or information about an
adverse reaction for which there is
reasonable evidence of a causal
association.
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BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG–2008–0424]
Coast Guard, DHS.
Notice of enforcement of
regulation.
AGENCY:
ACTION:
SUMMARY: The Coast Guard will enforce
the U.S. Nationals Waterski Racing
Championship special local regulation
on Mission Bay from 8 a.m. on October
10, 2008 through 5 p.m. on October 12,
2008. This action is necessary to
provide for the safety of the
participants, crew, spectators,
participating vessels, and other vessels
and users of the waterway. During the
enforcement period, no person or vessel
may enter the special local regulation
without permission of the Captain of the
Port.
DATES: The regulations in 33 CFR
100.1101 will be enforced from 8 a.m.
on October 10, 2008 through 5 p.m. on
October 12, 2008.
FOR FURTHER INFORMATION CONTACT:
Petty Officer Kristen Beer, USCG,
Waterways Management, U.S. Coast
Guard Sector San Diego at (619) 278–
7233.
SUPPLEMENTARY INFORMATION: The Coast
Guard will enforce the special local
regulation for the U.S. Nationals
Waterski Racing Championship in 33
CFR 100.1101 on October 10, 2008, from
8 a.m. to 7 p.m., October 11, 2008, from
8 a.m. to 7 p.m., and October 12, 2008,
from 8 a.m. to 7 p.m.
Under the provisions of 33 CFR
100.1101, a vessel may not enter the
regulated area, unless it receives
permission from the COTP. Spectator
vessels may safely transit outside the
regulated area but may not anchor,
block, loiter in, or impede the transit of
participants or official patrol vessels.
The Coast Guard may be assisted by
other Federal, State, or local law
enforcement agencies in enforcing this
regulation.
PO 00000
Frm 00020
Fmt 4700
Sfmt 4700
This notice is issued under authority
of 33 CFR 100.1101(a) and 5 U.S.C.
552(a). In addition to this notice in the
Federal Register, the Coast Guard will
provide the maritime community with
extensive advance notification of this
enforcement period via the Local Notice
to Mariners, marine information
broadcasts, local radio stations and area
newspapers. If the COTP or his
designated representative determines
that the regulated area need not be
enforced for the full duration stated in
this notice, he or she may use a
Broadcast Notice to Mariners to grant
general permission to enter the
regulated area.
Dated: August 8, 2008.
T.H. Farris,
Captain, U.S. Coast Guard, Captain of the
Port Sector San Diego.
[FR Doc. E8–19532 Filed 8–21–08; 8:45 am]
BILLING CODE 4910–15–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG–2008–0769]
Oregon Symphony Celebration
Fireworks Display, Portland, OR
Coast Guard, DHS.
Notice of enforcement of
regulation.
AGENCY:
ACTION:
SUMMARY: The Coast Guard will enforce
the ‘‘Oregon Symphony Celebration
Fireworks Display safety zone on the
Willamette River’’; from 8:30 p.m.
through 11:30 p.m. on August 28, 2008.
This action is necessary to provide a
safe display for the public and to keep
them clear of the fall out area of the
fireworks. During the enforcement
period, no person or vessel may enter
the safety zone without permission of
the Captain of the Port Portland or his
designated representative.
DATES: The regulations in 33 CFR
165.1315(a)(7) will be enforced from
8:30 p.m. through 11:30 p.m. on August
28, 2008.
FOR FURTHER INFORMATION CONTACT: BM2
Joshua Lehner, Sector Portland
Waterways Management at (503) 247–
4015.
The Coast
Guard will enforce the safety zone for
the Oregon Symphony Celebration
Fireworks Display in 33 CFR
165.1315(a)(7) on August 28, 2008 from
8:30 p.m. to 11:30 p.m.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\22AUR1.SGM
22AUR1
]]>Agencies
[Federal Register Volume 73, Number 164 (Friday, August 22, 2008)]
[Rules and Regulations]
[Page 49610]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-19532]
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DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 100
[Docket No. USCG-2008-0424]
Special Local Regulation; U.S. Nationals Waterski Racing
Championship; Mission Bay, San Diego, CA
AGENCY: Coast Guard, DHS.
ACTION: Notice of enforcement of regulation.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard will enforce the U.S. Nationals Waterski
Racing Championship special local regulation on Mission Bay from 8 a.m.
on October 10, 2008 through 5 p.m. on October 12, 2008. This action is
necessary to provide for the safety of the participants, crew,
spectators, participating vessels, and other vessels and users of the
waterway. During the enforcement period, no person or vessel may enter
the special local regulation without permission of the Captain of the
Port.
DATES: The regulations in 33 CFR 100.1101 will be enforced from 8 a.m.
on October 10, 2008 through 5 p.m. on October 12, 2008.
FOR FURTHER INFORMATION CONTACT: Petty Officer Kristen Beer, USCG,
Waterways Management, U.S. Coast Guard Sector San Diego at (619) 278-
7233.
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the special
local regulation for the U.S. Nationals Waterski Racing Championship in
33 CFR 100.1101 on October 10, 2008, from 8 a.m. to 7 p.m., October 11,
2008, from 8 a.m. to 7 p.m., and October 12, 2008, from 8 a.m. to 7
p.m.
Under the provisions of 33 CFR 100.1101, a vessel may not enter the
regulated area, unless it receives permission from the COTP. Spectator
vessels may safely transit outside the regulated area but may not
anchor, block, loiter in, or impede the transit of participants or
official patrol vessels. The Coast Guard may be assisted by other
Federal, State, or local law enforcement agencies in enforcing this
regulation.
This notice is issued under authority of 33 CFR 100.1101(a) and 5
U.S.C. 552(a). In addition to this notice in the Federal Register, the
Coast Guard will provide the maritime community with extensive advance
notification of this enforcement period via the Local Notice to
Mariners, marine information broadcasts, local radio stations and area
newspapers. If the COTP or his designated representative determines
that the regulated area need not be enforced for the full duration
stated in this notice, he or she may use a Broadcast Notice to Mariners
to grant general permission to enter the regulated area.
Dated: August 8, 2008.
T.H. Farris,
Captain, U.S. Coast Guard, Captain of the Port Sector San Diego.
[FR Doc. E8-19532 Filed 8-21-08; 8:45 am]
BILLING CODE 4910-15-P
