Drawbridge Operation Regulations; Pinellas Bayway Structure “E” (SR 679) Bridge, Gulf Intracoastal Waterway, mile 113, St. Petersburg Beach, Pinellas County, FL, 68116-68118 [E7-23412]
Download as PDF
<![CDATA[
68116
§ 211.103
Federal Register / Vol. 72, No. 232 / Tuesday, December 4, 2007 / Proposed Rules
Calculation of yield.
Actual yields and percentages of
theoretical yield shall be determined at
the conclusion of each appropriate
phase of manufacturing, processing,
packaging, or holding of the drug
product. Such calculations shall either
be performed by one person and
independently verified by a second
person, or, if the yield is calculated by
automated equipment under § 211.68,
be independently verified by one
person.
13. Section 211.110 is amended by
revising paragraph (a) introductory text
and by adding paragraph (a)(6) to read
as follows:
§ 211.110 Sampling and testing of inprocess materials and drug products.
(a) To assure batch uniformity and
integrity of drug products, written
procedures shall be established and
followed that describe the in-process
controls, and tests, or examinations to
be conducted on appropriate samples of
in-process materials of each batch. Such
control procedures shall be established
to monitor the output and to validate
the performance of those manufacturing
processes that may be responsible for
causing variability in the characteristics
of in-process material and the drug
product. Such control procedures shall
include, but are not limited to, the
following, where appropriate:
*
*
*
*
*
(6) Bioburden testing.
*
*
*
*
*
14. Section 211.113 is amended by
revising paragraph (b) to read as follows:
§ 211.113 Control of microbiological
contamination.
*
*
*
*
(b) Appropriate written procedures,
designed to prevent microbiological
contamination of drug products
purporting to be sterile, shall be
established and followed. Such
procedures shall include validation of
all aseptic and sterilization processes.
15. Section 211.160 is amended by
revising paragraph (b)(1) to read as
follows:
mstockstill on PROD1PC66 with PROPOSALS
*
*
*
*
(b) * * *
(1) Determination of conformity to
applicable written specifications for the
acceptance of each lot within each
shipment of components, drug product
containers, closures, and labeling used
in the manufacture, processing, packing,
or holding of drug products. The
specifications shall include a
description of the sampling and testing
procedures used. Samples shall be
VerDate Aug<31>2005
17:10 Dec 03, 2007
Jkt 214001
§ 211.182
RIN 1625–AA09
Equipment cleaning and use log.
A written record of major equipment
cleaning, maintenance (except routine
maintenance such as lubrication and
adjustments), and use shall be included
in individual equipment logs that show
the date, time, product, and lot number
of each batch processed. If equipment is
dedicated to manufacture of one
product, then individual equipment logs
are not required, provided that lots or
batches of such product follow in
numerical order and are manufactured
in numerical sequence. In cases where
dedicated equipment is employed, the
records of cleaning, maintenance, and
use shall be part of the batch record.
The persons performing and doublechecking the cleaning and maintenance
(or, if the cleaning and maintenance is
performed using automated equipment
under § 211.68, just the person verifying
the cleaning and maintenance done by
the automated equipment) shall date
and sign or initial the log indicating that
the work was performed. Entries in the
log shall be in chronological order.
17. Section 211.188 is amended by
revising paragraph (b)(11) to read as
follows:
Batch production and control
*
General requirements.
*
DEPARTMENT OF HOMELAND
SECURITY
§ 211.188
records.
*
§ 211.160
representative and adequately
identified. Such procedures shall also
require appropriate retesting of any
component, drug product container, or
closure that is subject to deterioration.
*
*
*
*
*
16. Section 211.182 is revised to read
as follows:
*
*
*
*
(b) * * *
(11) Identification of the persons
performing and directly supervising or
checking each significant step in the
operation, or if a significant step in the
operation is performed by automated
equipment under § 211.68, the
identification of the person checking the
significant step performed by the
automated equipment.
*
*
*
*
*
Dated: November 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–23292 Filed 12–3–07; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00011
Fmt 4702
Sfmt 4702
Coast Guard
33 CFR Part 117
[Docket No. USCG–2007–0096]
Drawbridge Operation Regulations;
Pinellas Bayway Structure ‘‘E’’ (SR
679) Bridge, Gulf Intracoastal
Waterway, mile 113, St. Petersburg
Beach, Pinellas County, FL
Coast Guard, DHS.
Notice of proposed rulemaking.
AGENCY:
ACTION:
SUMMARY: The Coast Guard proposes to
change the drawbridge regulation of the
Pinellas Bayway Structure ‘‘E’’ (SR 679)
Bridge, Gulf Intracoastal Waterway, mile
113, St. Petersburg Beach, Pinellas
County, Florida. This rule is needed to
provide vehicular traffic relief during
heavy vehicular traffic periods flowing
into a nearby county park while still
meeting the reasonable needs of
mariners.
Comments and related material
must reach the Coast Guard on or before
January 18, 2008.
ADDRESSES: You may submit comments
identified by Coast Guard docket
number USCG–2007–0096 to the Docket
Management Facility at the U.S.
Department of Transportation. To avoid
duplication, please use only one of the
following methods:
(1) Online: https://
www.regulations.gov.
(2) Mail: Docket Management Facility
(M–30), U.S. Department of
Transportation, West Building, Ground
Floor, Room W12–140, 1200 New Jersey
Avenue, SE., Washington, DC 20590–
0001.
(3) Hand delivery: Room W12–140 on
the Ground Floor of the West Building,
1200 New Jersey Avenue, SE.,
Washington, DC 20590, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays. The telephone
number is 202–366–9329.
(4) Fax: 202–493–2251.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this proposed
rule, call Michael Lieberum, Seventh
Coast Guard District, Bridge Branch,
telephone number 305–415–6744. If you
have questions on viewing or submitting
material to the docket, call Renee V.
Wright, Program Manager, Docket
Operations, telephone 202–366–9826.
SUPPLEMENTARY INFORMATION:
DATES:
E:\FR\FM\04DEP1.SGM
04DEP1
Federal Register / Vol. 72, No. 232 / Tuesday, December 4, 2007 / Proposed Rules
Public Participation and Request for
Comments
We encourage you to participate in
this rulemaking by submitting
comments and related materials. All
comments received will be posted,
without change, to https://
www.regulations.gov and will include
any personal information you have
provided. We have an agreement with
the Department of Transportation (DOT)
to use the Docket Management Facility.
Please see DOT’s ‘‘Privacy Act’’
paragraph below.
mstockstill on PROD1PC66 with PROPOSALS
Submitting Comments
If you submit a comment, please
include the docket number for this
rulemaking (USCG–2007–0096),
indicate the specific section of this
document to which each comment
applies, and give the reason for each
comment. We recommend that you
include your name and a mailing
address, an e-mail address, or a phone
number in the body of your document
so that we can contact you if we have
questions regarding your submission.
You may submit your comments and
material by electronic means, mail, fax,
or delivery to the Docket Management
Facility at the address under ADDRESSES;
but please submit your comments and
material by only one means. If you
submit them by mail or delivery, submit
them in an unbound format, no larger
than 81⁄2 by 11 inches, suitable for
copying and electronic filing. If you
submit them by mail and would like to
know that they reached the Facility,
please enclose a stamped, self-addressed
postcard or envelope. We will consider
all comments and material received
during the comment period. We may
change this proposed rule in view of
them.
Viewing Comments and Documents
To view comments, as well as
documents mentioned in this preamble
as being available in the docket, go to
https://www.regulations.gov at any time,
click on ‘‘Search for Dockets,’’ and enter
the docket number for this rulemaking
(USCG–2007–0096) in the Docket ID
box, and click enter. You may also visit
the Docket Management Facility in
Room W12–140 on the ground floor of
the DOT West Building, 1200 New
Jersey Avenue, SE., Washington, DC
20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal
holidays.
Privacy Act
Anyone can search the electronic
form of all comments received into any
of our dockets by the name of the
individual submitting the comment (or
VerDate Aug<31>2005
17:10 Dec 03, 2007
Jkt 214001
signing the comment, if submitted on
behalf of an association, business, labor
union, etc.). You may review the
Department of Transportation’s Privacy
Act Statement in the Federal Register
published on April 11, 2000 (65 FR
19477), or you may visit https://
DocketsInfo.dot.gov.
Public Meeting
We do not now plan to hold a public
meeting. But you may submit a request
for a meeting by writing to the Bridge
Branch, Seventh Coast Guard District at
the address under ADDRESSES explaining
why one would be beneficial. If we
determine that one would aid this
rulemaking, we will hold one at a time
and place announced by a later notice
in the Federal Register.
Background and Purpose
The Pinellas Bayway Structure ‘‘E’’
(SR 679) Bridge, Gulf Intracoastal
Waterway, mile 113, St. Petersburg
Beach, Pinellas County, Florida,
currently opens on signal; except that,
from 9 a.m. to 7 p.m. the draw need
only open on the hour, 20 minutes after
the hour, and 40 minutes after the hour.
The bridge provides vehicular access
into and out of a popular county park.
At the request of Florida State
Representative Frishe’s office, who is
acting on behalf of local citizens, the
Coast Guard is proposing this regulation
that will require the Pinellas Bayway
‘‘E’’ Bridge to open on signal, except
that from 7 a.m. to 9 p.m. the bridge will
open on the hour and half-hour. Public
vessels of the United States, tugs with
tows and vessels in distress shall be
allowed to pass on signal.
Discussion of Proposed Rule
Under this proposed rule, the draw of
the Pinellas Bayway Structure ‘‘E’’
Bridge would be required to open on
signal, except that from 7 a.m. to 9 p.m.
the bridge would only need to open on
the hour and half-hour. The draw would
be required to open, upon proper signal,
for the passage of tugs with tows, public
vessels of the United States and vessels
in a situation where a delay would
endanger life or property.
This proposed rule is expected to
provide vehicular traffic relief during
heavy traffic periods by allowing two
openings an hour instead of the current
three openings an hour.
Regulatory Evaluation
This proposed rule is not a
‘‘significant regulatory action’’ under
section 3(f) of Executive Order 12866,
Regulatory Planning and Review, and
does not require an assessment of
potential costs and benefits under
PO 00000
Frm 00012
Fmt 4702
Sfmt 4702
68117
section 6(a)(3) of that Order. The Office
of Management and Budget has not
reviewed it under that Order. It is not
‘‘significant’’ under the regulatory
policies and procedures of the
Department of Homeland Security.
We expect the economic impact of
this proposed rule to be so minimal that
a full Regulatory Evaluation is
unnecessary, because the rule would
allow for scheduled bridge openings of
this drawbridge and all waterway
restrictions or closure times would be
published with adequate time for
mariners to plan accordingly.
Small Entities
Under the Regulatory Flexibility Act
(5 U.S.C. 601–612), we have considered
whether this proposed rule would have
a significant economic impact on a
substantial number of small entities.
The term ‘‘small entities’’ comprises
small businesses, not-for-profit
organizations that are independently
owned and operated and are not
dominant in their fields, and
governmental jurisdictions with
populations of less than 50,000.
The Coast Guard certifies under 5
U.S.C. 605(b) that this proposed rule
would not have a significant economic
impact on a substantial number of small
entities, as the rule will allow for
scheduled bridge openings.
This proposed rule would affect the
following entities, some of which may
be small entities: The owners or
operators of vessels needing to transit
the Gulf Intracoastal Waterway in the
vicinity of the Pinellas Bayway
Structure ‘‘E’’ Bridge, persons intending
to drive over the bridge, and nearby
business owners. The revision to the
opening schedule would not have a
significant impact on a substantial
number of small entities. Vehicle traffic
and small business owners in the area
may benefit from the improved traffic
flow that regularly scheduled openings
will offer this area. Although bridge
openings would be less frequent, vessel
traffic would still be able to transit the
Gulf Intracoastal Waterway on the hour
and half-hour between 7 a.m. until 9
p.m.
If you think that your business,
organization, or governmental
jurisdiction qualifies as a small entity
and that this rule would have a
significant economic impact on it,
please submit a comment (see
ADDRESSES) explaining why you think it
qualifies and how and to what degree
this rule would economically affect it.
Assistance for Small Entities
Under section 213(a) of the Small
Business Regulatory Enforcement
E:\FR\FM\04DEP1.SGM
04DEP1
68118
Federal Register / Vol. 72, No. 232 / Tuesday, December 4, 2007 / Proposed Rules
Fairness Act of 1996 (Pub. L. 104–121),
we want to assist small entities in
understanding this proposed rule so that
they can better evaluate its effects on
them and participate in the rulemaking.
If the rule would affect your small
business, organization, or governmental
jurisdiction and you have questions
concerning its provisions or options for
compliance please contact the Seventh
Coast Guard District Bridge Branch at
the address under ADDRESSES. The Coast
Guard will not retaliate against small
entities that question or complain about
this rule or any policy or action of the
Coast Guard.
Collection of Information
This proposed rule would call for no
new collection of information under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501–3520).
Federalism
A rule has implications for federalism
under Executive Order 13132,
Federalism, if it has a substantial direct
effect on State or local governments and
would either preempt State law or
impose a substantial direct cost of
compliance on them. We have analyzed
this proposed rule under that Order and
have determined that it does not have
implications for federalism.
Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act
of 1995 (2 U.S.C. 1531–1538) requires
Federal agencies to assess the effects of
their discretionary regulatory actions. In
particular, the Act addresses actions
that may result in the expenditure by a
State, local, or tribal government, in the
aggregate, or by the private sector of
$100,000,000 or more in any one year.
Though this proposed rule would not
result in such an expenditure, we do
discuss the effects of this rule elsewhere
in this preamble.
Taking of Private Property
mstockstill on PROD1PC66 with PROPOSALS
This proposed rule would not affect a
taking of private property or otherwise
have taking implications under
Executive Order 12630, Governmental
Actions and Interference with
Constitutionally Protected Property
Rights.
Civil Justice Reform
This proposed rule meets applicable
standards in sections 3(a) and 3(b)(2) of
Executive Order 12988, Civil Justice
Reform, to minimize litigation,
eliminate ambiguity, and reduce
burden.
VerDate Aug<31>2005
17:10 Dec 03, 2007
Jkt 214001
Protection of Children
We have analyzed this proposed rule
under Executive Order 13045,
Protection of Children from
Environmental Health Risks and Safety
Risks. This rule is not an economically
significant rule and would not create an
environmental risk to health or risk to
safety that might disproportionately
affect children.
Indian Tribal Governments
This proposed rule does not have
tribal implications under Executive
Order 13175, Consultation and
Coordination with Indian Tribal
Governments, because it would not have
a substantial direct effect on one or
more Indian tribes, on the relationship
between the Federal Government and
Indian tribes, or on the distribution of
power and responsibilities between the
Federal Government and Indian tribes.
Energy Effects
We have analyzed this proposed rule
under Executive Order 13211, Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use. We have
determined that it is not a ‘‘significant
energy action’’ under that order because
it is not a ‘‘significant regulatory action’’
under Executive Order 12866 and is not
likely to have a significant adverse effect
on the supply, distribution, or use of
energy. The Administrator of the Office
of Information and Regulatory Affairs
has not designated it as a significant
energy action. Therefore, it does not
require a Statement of Energy Effects
under Executive Order 13211.
Technical Standards
The National Technology Transfer
and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use
voluntary consensus standards in their
regulatory activities unless the agency
provides Congress, through the Office of
Management and Budget, with an
explanation of why using these
standards would be inconsistent with
applicable law or otherwise impractical.
Voluntary consensus standards are
technical standards (e.g., specifications
of materials, performance, design, or
operation; test methods; sampling
procedures; and related management
systems practices) that are developed or
adopted by voluntary consensus
standards bodies.
This proposed rule does not use
technical standards. Therefore, we did
not consider the use of voluntary
consensus standards.
PO 00000
Frm 00013
Fmt 4702
Sfmt 4702
Environment
We have analyzed this proposed rule
under Commandant Instruction
M16475.lD which guides the Coast
Guard in complying with the National
Environmental Policy Act of 1969
(NEPA)(42 U.S.C. 4321–4370f), and
have made a preliminary determination
that this action is not likely to have a
significant effect on the human
environment because it simply
promulgates the operating regulations or
procedures for drawbridges. We seek
any comments or information that may
lead to the discovery of a significant
environmental impact from this
proposed rule.
List of Subjects in 33 CFR Part 117
Bridges.
For the reasons discussed in the
preamble, the Coast Guard proposes to
amend 33 CFR part 117 as follows:
PART 117—DRAWBRIDGE
OPERATION REGULATIONS
1. The authority citation for part 117
continues to read as follows:
Authority: 33 U.S.C. 499; 33 CFR 1.05–1(g);
Department of Homeland Security Delegation
No. 0170.1.
2. Revise § 117.287(d)(4) to read as
follows:
*
*
*
*
*
§ 117.287
Gulf Intracoastal Waterway.
(d)(4) Pinellas Bayway Structure ‘‘E’’
(SR 679) bridge, mile 113.0 at St.
Petersburg Beach. The draw shall open
on signal, except that from 9 a.m. to 7
p.m. the draw need open only on the
hour and 30 minutes past the hour.
*
*
*
*
*
Dated: November 21, 2007.
William Lee,
CAPT, USCG, Acting D7 District Commander.
[FR Doc. E7–23412 Filed 12–3–07; 8:45 am]
BILLING CODE 4910–15–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R07–OAR–2007–1055; FRL–8502–1]
Approval and Promulgation of
Implementation Plans; State of
Missouri; General Conformity
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
SUMMARY: EPA is proposing to approve
a revision to the Missouri State
Implementation Plan (SIP) to amend the
E:\FR\FM\04DEP1.SGM
04DEP1
]]>Agencies
[Federal Register Volume 72, Number 232 (Tuesday, December 4, 2007)]
[Proposed Rules]
[Pages 68116-68118]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23412]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG-2007-0096]
RIN 1625-AA09
Drawbridge Operation Regulations; Pinellas Bayway Structure ``E''
(SR 679) Bridge, Gulf Intracoastal Waterway, mile 113, St. Petersburg
Beach, Pinellas County, FL
AGENCY: Coast Guard, DHS.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard proposes to change the drawbridge regulation
of the Pinellas Bayway Structure ``E'' (SR 679) Bridge, Gulf
Intracoastal Waterway, mile 113, St. Petersburg Beach, Pinellas County,
Florida. This rule is needed to provide vehicular traffic relief during
heavy vehicular traffic periods flowing into a nearby county park while
still meeting the reasonable needs of mariners.
DATES: Comments and related material must reach the Coast Guard on or
before January 18, 2008.
ADDRESSES: You may submit comments identified by Coast Guard docket
number USCG-2007-0096 to the Docket Management Facility at the U.S.
Department of Transportation. To avoid duplication, please use only one
of the following methods:
(1) Online: https://www.regulations.gov.
(2) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
(3) Hand delivery: Room W12-140 on the Ground Floor of the West
Building, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The
telephone number is 202-366-9329.
(4) Fax: 202-493-2251.
FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call Michael Lieberum, Seventh Coast Guard District, Bridge
Branch, telephone number 305-415-6744. If you have questions on viewing
or submitting material to the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone 202-366-9826.
SUPPLEMENTARY INFORMATION:
[[Page 68117]]
Public Participation and Request for Comments
We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to https://www.regulations.gov and will include any
personal information you have provided. We have an agreement with the
Department of Transportation (DOT) to use the Docket Management
Facility. Please see DOT's ``Privacy Act'' paragraph below.
Submitting Comments
If you submit a comment, please include the docket number for this
rulemaking (USCG-2007-0096), indicate the specific section of this
document to which each comment applies, and give the reason for each
comment. We recommend that you include your name and a mailing address,
an e-mail address, or a phone number in the body of your document so
that we can contact you if we have questions regarding your submission.
You may submit your comments and material by electronic means, mail,
fax, or delivery to the Docket Management Facility at the address under
ADDRESSES; but please submit your comments and material by only one
means. If you submit them by mail or delivery, submit them in an
unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit them by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period. We may change this
proposed rule in view of them.
Viewing Comments and Documents
To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to https://www.regulations.gov at
any time, click on ``Search for Dockets,'' and enter the docket number
for this rulemaking (USCG-2007-0096) in the Docket ID box, and click
enter. You may also visit the Docket Management Facility in Room W12-
140 on the ground floor of the DOT West Building, 1200 New Jersey
Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
Privacy Act
Anyone can search the electronic form of all comments received into
any of our dockets by the name of the individual submitting the comment
(or signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review the Department of
Transportation's Privacy Act Statement in the Federal Register
published on April 11, 2000 (65 FR 19477), or you may visit https://
DocketsInfo.dot.gov.
Public Meeting
We do not now plan to hold a public meeting. But you may submit a
request for a meeting by writing to the Bridge Branch, Seventh Coast
Guard District at the address under ADDRESSES explaining why one would
be beneficial. If we determine that one would aid this rulemaking, we
will hold one at a time and place announced by a later notice in the
Federal Register.
Background and Purpose
The Pinellas Bayway Structure ``E'' (SR 679) Bridge, Gulf
Intracoastal Waterway, mile 113, St. Petersburg Beach, Pinellas County,
Florida, currently opens on signal; except that, from 9 a.m. to 7 p.m.
the draw need only open on the hour, 20 minutes after the hour, and 40
minutes after the hour. The bridge provides vehicular access into and
out of a popular county park.
At the request of Florida State Representative Frishe's office, who
is acting on behalf of local citizens, the Coast Guard is proposing
this regulation that will require the Pinellas Bayway ``E'' Bridge to
open on signal, except that from 7 a.m. to 9 p.m. the bridge will open
on the hour and half-hour. Public vessels of the United States, tugs
with tows and vessels in distress shall be allowed to pass on signal.
Discussion of Proposed Rule
Under this proposed rule, the draw of the Pinellas Bayway Structure
``E'' Bridge would be required to open on signal, except that from 7
a.m. to 9 p.m. the bridge would only need to open on the hour and half-
hour. The draw would be required to open, upon proper signal, for the
passage of tugs with tows, public vessels of the United States and
vessels in a situation where a delay would endanger life or property.
This proposed rule is expected to provide vehicular traffic relief
during heavy traffic periods by allowing two openings an hour instead
of the current three openings an hour.
Regulatory Evaluation
This proposed rule is not a ``significant regulatory action'' under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
and does not require an assessment of potential costs and benefits
under section 6(a)(3) of that Order. The Office of Management and
Budget has not reviewed it under that Order. It is not ``significant''
under the regulatory policies and procedures of the Department of
Homeland Security.
We expect the economic impact of this proposed rule to be so
minimal that a full Regulatory Evaluation is unnecessary, because the
rule would allow for scheduled bridge openings of this drawbridge and
all waterway restrictions or closure times would be published with
adequate time for mariners to plan accordingly.
Small Entities
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.
The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed
rule would not have a significant economic impact on a substantial
number of small entities, as the rule will allow for scheduled bridge
openings.
This proposed rule would affect the following entities, some of
which may be small entities: The owners or operators of vessels needing
to transit the Gulf Intracoastal Waterway in the vicinity of the
Pinellas Bayway Structure ``E'' Bridge, persons intending to drive over
the bridge, and nearby business owners. The revision to the opening
schedule would not have a significant impact on a substantial number of
small entities. Vehicle traffic and small business owners in the area
may benefit from the improved traffic flow that regularly scheduled
openings will offer this area. Although bridge openings would be less
frequent, vessel traffic would still be able to transit the Gulf
Intracoastal Waterway on the hour and half-hour between 7 a.m. until 9
p.m.
If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
Assistance for Small Entities
Under section 213(a) of the Small Business Regulatory Enforcement
[[Page 68118]]
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
rule would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance please contact the Seventh Coast Guard District
Bridge Branch at the address under ADDRESSES. The Coast Guard will not
retaliate against small entities that question or complain about this
rule or any policy or action of the Coast Guard.
Collection of Information
This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
Federalism
A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this proposed rule
under that Order and have determined that it does not have implications
for federalism.
Unfunded Mandates Reform Act
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 or more in any
one year. Though this proposed rule would not result in such an
expenditure, we do discuss the effects of this rule elsewhere in this
preamble.
Taking of Private Property
This proposed rule would not affect a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.
Civil Justice Reform
This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.
Protection of Children
We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.
Indian Tribal Governments
This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.
Energy Effects
We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.
Technical Standards
The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.
Environment
We have analyzed this proposed rule under Commandant Instruction
M16475.lD which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have
made a preliminary determination that this action is not likely to have
a significant effect on the human environment because it simply
promulgates the operating regulations or procedures for drawbridges. We
seek any comments or information that may lead to the discovery of a
significant environmental impact from this proposed rule.
List of Subjects in 33 CFR Part 117
Bridges.
For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 117 as follows:
PART 117--DRAWBRIDGE OPERATION REGULATIONS
1. The authority citation for part 117 continues to read as
follows:
Authority: 33 U.S.C. 499; 33 CFR 1.05-1(g); Department of
Homeland Security Delegation No. 0170.1.
2. Revise Sec. 117.287(d)(4) to read as follows:
* * * * *
Sec. 117.287 Gulf Intracoastal Waterway.
(d)(4) Pinellas Bayway Structure ``E'' (SR 679) bridge, mile 113.0
at St. Petersburg Beach. The draw shall open on signal, except that
from 9 a.m. to 7 p.m. the draw need open only on the hour and 30
minutes past the hour.
* * * * *
Dated: November 21, 2007.
William Lee,
CAPT, USCG, Acting D7 District Commander.
[FR Doc. E7-23412 Filed 12-3-07; 8:45 am]
BILLING CODE 4910-15-P
