Drawbridge Operation Regulations; Knapps Narrows, MD, 61738-61739 [05-21322]
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61738
Federal Register / Vol. 70, No. 206 / Wednesday, October 26, 2005 / Rules and Regulations
mutation detection system they intend
to market.
expenditure that would meet or exceed
this amount.
II. What Is the Environmental Impact of
This Rule?
The agency has determined under 21
CFR 25.34(b) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
IV. Does This Final Rule Have
Federalism Implications?
III. What Is the Economic Impact of
This Rule?
FDA has examined the impacts of the
final rule under Executive Order 12866
and the Regulatory Flexibility Act (5
U.S.C. 601–612), and the Unfunded
Mandates Reform Act of 1995 (Public
Law 104–4). Executive Order 12866
directs agencies to assess all costs and
benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety,
and other advantages; distributive
impacts; and equity). The agency
believes that this final rule is not a
significant regulatory action as defined
by the Executive order and so it not
subject to review under the Executive
order.
The Regulatory Flexibility Act
requires agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. Because classification of this
device into class II will relieve
manufacturers of the cost of complying
with the premarket approval
requirements of section 515 of the act
(21 U.S.C. 360e), and may permit small
potential competitors to enter the
marketplace by lowering their costs, the
agency certifies that the final rule will
not have a significant economic impact
on a substantial number of small
entities.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and tribal governments, in the aggregate,
or by the private sector, of $100,000,000
or more (adjusted annually for inflation)
in any one year.’’ The current threshold
after adjustment for inflation is $115
million using the most current (2003)
Implicit Price Deflator for the Gross
Domestic Product. FDA does not expect
this final rule to result in any 1-year
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FDA has analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. FDA has
determined that the rule does not
contain policies that have substantial
direct effects on the States, on the
relationship between the National
Government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Accordingly, the
agency has concluded that the rule does
not contain policies that have
federalism implications as defined in
the Executive order and, consequently,
a federalism summary impact statement
is not required.
V. How Does This Rule Comply with
the Paperwork Reduction Act of 1995?
FDA concludes that this rule contains
no collections of information. Therefore,
clearance by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995 (the PRA) (44
U.S.C. 3501–3520) is not required.
FDA also concludes that the special
controls guidance document identified
by this rule contains information
collection provisions that are subject to
review and clearance by OMB under the
PRA. Elsewhere in this issue of the
Federal Register, FDA is publishing a
notice announcing the availability of the
draft guidance entitled ‘‘Class II Special
Controls Guidance Document: CFTR
Gene Mutation Detection Systems.’’
VI. What References are on Display?
The following reference has been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
1. Petition from Tm Bioscience Corp.,
dated April 4, 2005.
List of Subjects in 21 CFR Part 866
Biologics, Laboratories, Medical
devices.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 866 is
amended as follows:
PART 866—IMMUNOLOGY AND
MICROBIOLOGY DEVICES
1. The authority citation for 21 CFR
part 866 continues to read as follows:
I
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Fmt 4700
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Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
I 2. Add § 866.5900 to subpart F to read
as follows:
§ 866.5900 Cystic fibrosis transmembrane
conductance regulator (CFTR) gene
mutation detection system.
(a) Identification. The CFTR gene
mutation detection system is a device
used to simultaneously detect and
identify a panel of mutations and
variants in the CFTR gene. It is intended
as an aid in confirmatory diagnostic
testing of individuals with suspected
cystic fibrosis (CF), carrier
identification, and newborn screening.
This device is not intended for standalone diagnostic purposes, prenatal
diagnostic, pre-implantation, or
population screening.
(b) Classification. Class II (special
controls). The special control is FDA’s
guidance document entitled ‘‘Class II
Special Controls Guidance Document:
CFTR Gene Mutation Detection
System.’’ See § 866.1(e) for the
availability of this guidance document.
Dated: October 17, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. 05–21348 Filed 10–25–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[CGD05–05–124]
RIN 1625–AA–09
Drawbridge Operation Regulations;
Knapps Narrows, MD
Coast Guard, DHS.
Notice of temporary deviation
from regulations.
AGENCY:
ACTION:
SUMMARY: The Commander, Fifth Coast
Guard District, has approved a
temporary deviation from the
regulations governing the operation of
the Route 33/Knapps Narrows Bridge, at
mile 0.4, across Knapps Narrows, at
Tilghman, Maryland. This deviation
allows the drawbridge to remain closedto-navigation each day from 9 p.m. to 5
a.m., beginning on Monday, October 24
until Friday, October 28, 2005, to
facilitate mechanical repairs.
DATES: The deviation is effective from 9
p.m. to 5 a.m. from October 24 until
October 28, 2005.
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Federal Register / Vol. 70, No. 206 / Wednesday, October 26, 2005 / Rules and Regulations
[COTP St. Petersburg 05–120]
assets on scene who will also provide
notice of the safety zone to mariners.
For the same reasons, under 5 U.S.C.
553(d)(3), the Coast Guard finds that
good cause exists for making this rule
effective less than 30 days after
publication in the Federal Register.
RIN 1625–AA00
Background and Purpose
Materials referred to in this
document are available for inspection or
copying at Commander (obr), Fifth Coast
Guard District, Federal Building, 1st
Floor, 431 Crawford Street, Portsmouth,
VA 23704–5004 between 8 a.m. and 4
p.m., Monday through Friday, except
Federal holidays. The telephone number
is (757) 398–6422. Commander (obr),
Fifth Coast Guard District maintains the
public docket for this temporary
deviation.
DEPARTMENT OF HOMELAND
SECURITY
Bill
H. Brazier, Bridge Management
Specialist, Fifth Coast Guard District, at
(757) 398–6422.
AGENCY:
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
The Route
33/Knapps Narrows Bridge, a basculetype drawbridge, has a vertical
clearance in the closed position to
vessels of 7 feet, at mean high water.
Covington Machine and Welding, Inc.
(CMW), is the contractor engaged to
perform these repairs for the Maryland
State Highway Administration (SHA),
the bridge owner. CMW, on behalf of
SHA, requested a temporary deviation
from the operating regulations for the
Route 33/Knapps Narrows Bridge, set
out in 33 CFR 117.5, that requires to
bridge to open promptly and fully for
the passage of vessels when a request to
open is given.
CMW requested the temporary
deviation to close the Route 33/Knapps
Narrow Bridge to navigation to facilitate
replacing leaking oil seals in the main
drive gear reducer and the hydraulic
braking system of the draw span. The
lift span will be locked in the closed-tonavigation position each day from 9
p.m. to 5 a.m. beginning on Monday,
October 24, 2005 until and including
Friday, October 28, 2005. At all other
times, the bridge will operate in
accordance with 33 CFR 117.5.
The Coast Guard has informed the
known users of the waterway of the
closure periods for the bridge so that
these vessels can arrange their transits
to minimize any impact caused by the
temporary deviation.
In accordance with 33 CFR 117.35(c),
this work will be performed with all due
speed in order to return the bridge to
normal operation as soon as possible.
This deviation from the operating
regulations is authorized under 33 CFR
117.35.
SUPPLEMENTARY INFORMATION:
Dated: October 18, 2005.
Waverly W. Gregory, Jr.,
Chief, Bridge Administration Branch, Fifth
Coast Guard District.
[FR Doc. 05–21322 Filed 10–25–05; 8:45 am]
BILLING CODE 4910–15–P
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61739
Coast Guard
33 CFR Part 165
Safety Zone Regulation; Tampa Bay,
FL
ACTION:
Coast Guard, DHS.
Temporary final rule.
SUMMARY: The Coast Guard is
establishing a temporary safety zone on
the waters of Tampa Bay, Florida, in the
vicinity of the Clearwater Memorial
bascule bridge. This safety zone is being
established to protect mariners from the
hazards associated with the blasting
demolition of the concrete portions of
the Clearwater Memorial bascule bridge.
This rule is necessary to provide for the
safety of life on the navigable waters of
the United States.
DATES: This rule is effective from 9:30
a.m. on October 4, 2005 through 2 p.m.
on November 8, 2005.
ADDRESSES: Documents indicated in this
preamble as being available in the
docket are part of docket [COTP St.
Petersburg 05–120] and are available for
inspection or copying at Coast Guard
Sector St. Petersburg, Prevention
Department, 155 Columbia Drive,
Tampa, Florida 33606–3598 between
7:30 a.m. and 4 p.m., Monday through
Friday, except Federal holidays.
FOR FURTHER INFORMATION CONTACT:
Lieutenant Junior Grade Jennifer
Andrew at Coast Guard Sector St.
Petersburg, Prevention Department,
(813) 228–2191 Ext 8203.
SUPPLEMENTARY INFORMATION:
Regulatory Information
We did not publish a notice of
proposed rulemaking (NPRM) for this
regulation. Under 5 U.S.C. 553(b)(B), the
Coast Guard finds that good cause exists
for not publishing an NPRM. The
necessary details for the blasting
demolition of the Clearwater Memorial
bascule bridge were not provided with
sufficient time remaining to publish an
NPRM. Publishing a NPRM and
delaying its effective date would be
contrary to the public interest since
immediate action is needed to minimize
potential danger to the public during the
blasting demolition of the Clearwater
Memorial bascule bridge. The Coast
Guard will issue a broadcast notice to
mariners to advise mariners of the
restriction along with Coast Guard
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PCL construction was contracted to
build a fixed bridge to replace the
Clearwater Memorial Causeway Bridge
and remove the existing bridge. The
fixed bridge was completed early
September and the removal of the
bascule bridge was commenced on
September 12, 2005. On September 13,
2005 PCL contacted Coast Guard Sector
St. Petersburg Prevention Department to
discuss blasting the large concrete
portions of the bascule bridge directly
adjacent to the navigation channel along
with the concrete counterweights for the
metal bridge leafs. PCL will conduct two
separate blasts on two different days to
break up the concrete into smaller
sections for removal. The first blast will
be conducted tentatively on October 5,
2005, at approximately 7:30 a.m. This
first blast will fracture the main
concrete vertical portions adjacent to
the channel from the top to three feet
above the waterline. The second blast
will be conducted tentatively on
October 26, 2005, at approximately 7:30
a.m. This second and final blast will
fracture the remaining three feet and the
16 feet of bridge below the waterline.
The use of explosives and the proximity
of the concrete bridge structure to the
navigable channel present a hazard to
mariners transiting the area. This safety
zone is being established to ensure the
safety of life on the navigable waters of
the United States.
Discussion of Rule
The safety zone will extend out from
the Clearwater Memorial Causeway
bascule Bridge in a 1,000 foot radius.
Vessels and persons not under contract
or employees of PCL are prohibited from
entering, anchoring or transiting within
this zone unless authorized by the
Captain of the Port St. Petersburg or his
designated representative. This safety
zone is effective from 7:30 a.m. on
October 4, 2005, through 2 p.m. on
November 8, 2005. The Coast Guard
does not know the exact dates that this
safety zone will be enforced at this time.
Coast Guard Sector St. Petersburg will
give notice of the enforcement of the
safety zone by issuing a Broadcast
Notice to Mariners beginning 24 to 48
hours before the blasting is scheduled to
begin. On-scene notice will be provided
by local Coast Guard and Pinellas
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Agencies
[Federal Register Volume 70, Number 206 (Wednesday, October 26, 2005)]
[Rules and Regulations]
[Pages 61738-61739]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-21322]
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DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 117
[CGD05-05-124]
RIN 1625-AA-09
Drawbridge Operation Regulations; Knapps Narrows, MD
AGENCY: Coast Guard, DHS.
ACTION: Notice of temporary deviation from regulations.
-----------------------------------------------------------------------
SUMMARY: The Commander, Fifth Coast Guard District, has approved a
temporary deviation from the regulations governing the operation of the
Route 33/Knapps Narrows Bridge, at mile 0.4, across Knapps Narrows, at
Tilghman, Maryland. This deviation allows the drawbridge to remain
closed-to-navigation each day from 9 p.m. to 5 a.m., beginning on
Monday, October 24 until Friday, October 28, 2005, to facilitate
mechanical repairs.
DATES: The deviation is effective from 9 p.m. to 5 a.m. from October 24
until October 28, 2005.
[[Page 61739]]
ADDRESSES: Materials referred to in this document are available for
inspection or copying at Commander (obr), Fifth Coast Guard District,
Federal Building, 1st Floor, 431 Crawford Street, Portsmouth, VA 23704-
5004 between 8 a.m. and 4 p.m., Monday through Friday, except Federal
holidays. The telephone number is (757) 398-6422. Commander (obr),
Fifth Coast Guard District maintains the public docket for this
temporary deviation.
FOR FURTHER INFORMATION CONTACT: Bill H. Brazier, Bridge Management
Specialist, Fifth Coast Guard District, at (757) 398-6422.
SUPPLEMENTARY INFORMATION: The Route 33/Knapps Narrows Bridge, a
bascule-type drawbridge, has a vertical clearance in the closed
position to vessels of 7 feet, at mean high water.
Covington Machine and Welding, Inc. (CMW), is the contractor
engaged to perform these repairs for the Maryland State Highway
Administration (SHA), the bridge owner. CMW, on behalf of SHA,
requested a temporary deviation from the operating regulations for the
Route 33/Knapps Narrows Bridge, set out in 33 CFR 117.5, that requires
to bridge to open promptly and fully for the passage of vessels when a
request to open is given.
CMW requested the temporary deviation to close the Route 33/Knapps
Narrow Bridge to navigation to facilitate replacing leaking oil seals
in the main drive gear reducer and the hydraulic braking system of the
draw span. The lift span will be locked in the closed-to-navigation
position each day from 9 p.m. to 5 a.m. beginning on Monday, October
24, 2005 until and including Friday, October 28, 2005. At all other
times, the bridge will operate in accordance with 33 CFR 117.5.
The Coast Guard has informed the known users of the waterway of the
closure periods for the bridge so that these vessels can arrange their
transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(c), this work will be performed
with all due speed in order to return the bridge to normal operation as
soon as possible. This deviation from the operating regulations is
authorized under 33 CFR 117.35.
Dated: October 18, 2005.
Waverly W. Gregory, Jr.,
Chief, Bridge Administration Branch, Fifth Coast Guard District.
[FR Doc. 05-21322 Filed 10-25-05; 8:45 am]
BILLING CODE 4910-15-P