[Federal Register: July 21, 2009 (Volume 74, Number 138)]
[Rules and Regulations]
[Page 35802-35803]
[DOCID:fr21jy09-16]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket Number USCG-2009-0591]

Drawbridge Operation Regulations; Illinois Waterway, Beardstown,
IL

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, Eighth Coast Guard District has issued a
temporary deviation from the regulation governing the operations of the
Burlington Northern Santa Fe Railroad Bridge, Mile 88.8, at Beardstown,
Illinois across the Illinois Waterway. The deviation is necessary to
allow time for upgrade of the lift drive mechanism which only can be
done when the bridge is in the closed-to-navigation position. This
deviation allows the bridge to remain closed-to-navigation during the
60-hour period July 27-29, 2009.

DATES: This deviation is effective from 8 a.m., July 27 to 8 p.m., July
29, 2009.

ADDRESSES: Documents mentioned in this preamble as being available in
docket are part of docket USCG-2009-0591 and are available online by
going to www.regulations.gov, selecting the Advanced Docket Search
option on the right side of the screen, inserting USCG-2009-0591 in the
docket ID box, pressing Enter, and then clicking on the item on the
Docket ID column. They are also available for inspection or copying at
the 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, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Roger K. Wiebusch, Bridge Administrator, Coast Guard;
telephone<PHONE_NUMBER> or<EMAIL_ADDRESS>If you have
questions on viewing the docket, call Renee V. Wright, Program Manager,
Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Burlington Northern Santa Fe Railway
Company requested a temporary deviation for the Burlington Northern
Santa Fe (BNSF) Railroad Bridge, mile 88.8, at Beardstown, Illinois
across the Illinois Waterway. It has a vertical clearance of 19.6 feet
above normal pool

in the closed position. The BNSF Railroad Bridge currently operates in
accordance with 33 CFR 117.393(a) which requires that the bridge be
maintained in the open-to-navigation position; closing only when a
train needs to transit the bridge.
    The deviation period is from 8 a.m., July 27 to 8 p.m., July 29,
2009 when the draw span will be maintained in the closed-to-navigation
position. During this time the lift drive mechanism will be
inoperative. The draw span will not be returned to its fully open
position until the lift drive mechanism is fully operational on August
2, 2009. During the period July 30-August 2, 2009 span openings will be
coordinated with rail traffic closures and efforts to return the bridge
to normal operations. Both commercial vessels and recreational
watercraft use the waterway. Most commercial vessels can not pass
underneath the bridge while it is in the closed position. Only vessels
having a low-clearance profile will be able to pass under the span
while in the closed position. There are no alternate routes for vessels
transiting this section of the Illinois Waterway. Minimal impact to
navigation is expected.
    In accordance with 33 CFR 117.393(a), the drawbridge shall return
to its normal operating schedule immediately at the end of the
designated time period. This deviation from the operating regulations
is authorized under 33 CFR 117.35(c).

    Dated: June 6, 2009.
Roger K. Wiebusch,
Bridge Administrator.
[FR Doc. E9-17196 Filed 7-20-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 84, Number 231 (Monday, December 2, 2019)]
[Notices]
[Page 65986]
[FR Doc No: 2019-25946]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4590]

Morton Grove Pharmaceuticals, Inc., et al.; Withdrawal of
Approval of 21 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 21 abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.

DATES: Approval is withdrawn as of January 2, 2020.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980<EMAIL_ADDRESS>SUPPLEMENTARY INFORMATION: The
applicants listed in the table have informed FDA that these drug
products are no longer marketed and have requested that FDA withdraw
approval of the applications under the process described in Sec.
314.150(c) (21CFR 314.150(c)). The applicants have also, by their
requests, waived their opportunity for a hearing. Withdrawal of
approval of an application or abbreviated application under Sec.
314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
       Application No.                 Drug               Applicant
------------------------------------------------------------------------
ANDA 040759..................  Phenytoin Sodium      Morton Grove
                                Capsules,             Pharmaceuticals,
                                30milligrams (mg)     Inc., 6451 Main
                                (Extended).           St., Morton Grove,
                                                      IL 60053.
ANDA 062349..................  Nystatin Oral         G&W Laboratories,
                                Suspension, 100,000   Inc., 301 Helen
                                units/milliters       St., South
                                (mL).                 Plainfield, NJ
                                                      07080.
ANDA 062483..................  Griseofulvin V        Valeant
                                (griseofulvin         Pharmaceuticals
                                microsize) Oral       North America,
                                Suspension, 125 mg/   LLC, 400 Somerset
                                5 mL.                 Corporate Blvd.,
                                                      Bridgewater, NJ
                                                      08807.
ANDA 063264..................  Amikacin Sulfate      Hospira, Inc., 275
                                Injection USP,        North Field Dr.,
                                Equivalent to (EQ)    Bldg. H1, Lake
                                250 mg base/mL.       Forest, IL 60045.
ANDA 072655..................  Amantadine            G&W Laboratories,
                                Hydrochloride (HCl)   Inc.
                                Syrup USP, 50 mg/5
                                mL.
ANDA 074176..................  Cimetidine HCl Oral   Do.
                                Solution, EQ 300 mg
                                base/5 mL.
ANDA 075366..................  Sotalol HCl Tablets   Upsher-Smith
                                USP 80 mg, 120 mg,    Laboratories, LLC,
                                160 mg, and 240 mg.   6701 Evenstad Dr.,
                                                      Maple Grove, MN
                                                      55369.
ANDA 075887..................  Fluvoxamine Maleate   Do.
                                Tablets, 25 mg, 50
                                mg, and 100 mg.
ANDA 076709..................  Fentanyl Extended-    Actavis
                                Release Film, 25      Laboratories UT,
                                micrograms (mcg)/     Inc., Subsidiary
                                hr, 50 mcg/hr, 75     of Teva
                                mcg/hr, 100 mcg/hr.   Pharmaceuticals
                                                      USA, Inc, 577
                                                      Chipeta Way, Salt
                                                      Lake City, UT
                                                      84108.
ANDA 076841..................  Mesalamine Enema, 4   G&W Laboratories,
                                grams (gm)/60 mL.     Inc.
ANDA 077062..................  Fentanyl Extended-    Mayne Pharma LLC,
                                Release Film, 25      1240 Sugg Parkway,
                                mcg/hr, 50 mcg/hr,    Greenville, NC
                                75 mcg/hr, and 100    27834.
                                mcg/hr.
ANDA 078426..................  Zolpidem Tartrate     Morton Grove
                                Tablets, 5 mg and     Pharmaceuticals
                                10 mg.                Inc.
ANDA 078653..................  Ranitidine HCl        Do.
                                Tablets USP, EQ 150
                                mg base.
ANDA 078701..................  Ranitidine HCl        Do.
                                Tablets USP, EQ 150
                                mg base and EQ 300
                                mg base.
ANDA 078884..................  Ranitidine HCl        Do.
                                Tablets USP, EQ 75
                                mg base.
ANDA 087811..................  Phrenilin             Bausch Health US,
                                (acetaminophen and    LLC.
                                butalbital)
                                Tablets, 325 mg/50
                                mg.
ANDA 088761..................  Prometh VC Plain      G&W Laboratories,
                                (promethazine HCl     Inc.
                                and phenylephrine
                                HCl) Syrup, 5 mg/
                                5mL, and 6.25 mg/5
                                mL.
ANDA 088762..................  Prometh w/            Do.
                                Dextromethorphan
                                (promethazine HCl
                                and
                                dextromethorphan
                                hydrobromide)
                                Syrup, 6.25 mg/5 mL
                                and 15 mg/5 mL.
ANDA 090786..................  Carbidopa,            Morton Grove
                                Entacapone, and       Pharmaceuticals
                                Levodopa Tablets,     Inc.
                                12.5 mg/200 mg/50
                                mg.
ANDA 091267..................  Donepezil HCl         Do.
                                Tablets, 5 mg and
                                10 mg.
ANDA 201947..................  Morphine Sulfate      VistaPharm, Inc.,
                                Oral Solution, 10     7265 Ulmerton Rd.,
                                mg/5 mL and 20 mg/5   Largo, FL 33771.
                                mL.
------------------------------------------------------------------------
Do = Ditto.

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
January 2, 2020. Approval of each entire application is withdrawn,
including any strengths or products inadvertently missing from the
table. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on January 2, 2020 may continue to be dispensed until
the inventories have been depleted or the drug products have reached
their expiration dates or otherwise become violative, whichever occurs
first.

    Dated: November 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25946 Filed 11-29-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 130 (Monday, July 8, 2013)]
[Proposed Rules]
[Pages 40651-40654]
[FR Doc No: 2013-16252]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0322]
RIN 1625-AA11

Regulated Navigation Area; Special Buzzards Bay Vessel
Regulation, Buzzards Bay, MA

AGENCY: Coast Guard, DHS.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Coast Guard is seeking comments and feedback on how best
to enhance environmental protections and navigation safety outlined in
the Special Buzzards Bay regulations. Specifically, the Coast Guard is
seeking comments related to potential modifications of the current
mandatory pilotage, escort tug, and Vessel Movement Reporting System
(VMRS) Buzzards Bay requirements. The Coast Guard intends to use this
input to propose new requirements on barges carrying 5,000 or more
barrels of oil or other hazardous material.

DATES: Comments and related material must be received by the Coast
Guard on or before October 7, 2013.
    Requests for public meetings must be received by the Coast Guard on
or before July 29, 2013.

ADDRESSES: Documents mentioned in this preamble are part of Docket
Number USCG-2011-0322. To view documents mentioned in this preamble as
being available in the docket, go to http://www.regulations.gov, type
the docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on
``Open Docket Folder'' on the line associated with this rulemaking. You
may also visit the Docket Management Facility in Room W12-140 on the
ground floor of the Department of Transportation West Building, 1200
New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    You may submit comments, identified by docket number, using any one
of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: 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. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>. See the
``Public Participation and Request for Comments'' portion of the
SUPPLEMENTARY INFORMATION section below for further instructions on
submitting comments. To avoid duplication, please use only one of these
three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. John J. Mauro, Waterways Management Division, U.S.
Coast Guard First District,<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Barbara Hairston, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

AIS Automatic Identification System
ANPRM Advanced Notice of Proposed Rulemaking
AWO American Waterways Operators
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
MOSPA Massachusetts Oil Spill Prevention and Response Act
RCP Responsible Carrier Program
RNA Regulated Navigation Area
RA Technical Risk Assessment
VMRS Vessel Movement Reporting System

A. Executive Summary

    Having weighed sometimes competing, but fundamentally important
goals of environmental protection, concerns of the local community,
judicious use of public funds, restrained exercise of governmental
regulation, facilitation of maritime commerce, and the standardization
of safety regulations to avoid the fragmentation of regulatory regimes
as a vessel transits across State

or regional boundaries, we now seek to develop the next phase of
comprehensive, balanced, and effective risk mitigation measures for
Buzzards Bay. In particular, we want to update the following areas:
     Federal Pilotage. The Coast Guard believes laden tank
barges transiting Buzzards Bay and carrying 5,000 or more barrels of
oil or other hazardous material should be under the direction and
control of an independent pilot regardless of whether those tank barges
are single or double hull.
     Reporting and participation requirements of the VMRS
Buzzards Bay. The Coast Guard believes amending the reporting and
participation requirements of the VMRS Buzzards Bay to focus on that
population of marine traffic that is laden with 5,000 or more barrels
of oil or hazardous material, rather than all marine traffic, will
enhance navigation safety and marine environmental protection. The
intent is that the VMRS will still be manned on a 24 x 7 basis.
     Escort Tugs. The Coast Guard believes that under certain
conditions (e.g. adverse weather, equipment limitations), double hull
tank barges laden with 5,000 or more barrels of oil or hazardous
material may require a tug escort. Single-hull tank barges will
continue to require tug escorts under all circumstances. The Coast
Guard notes that single hull tank barges are to be phased out January
1, 2015.

B. 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 http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation. You may submit your comments and material online at
http://www.regulations.gov, or by fax, mail, or hand delivery, but
please use only one of these means. If you submit a comment online, it
will be considered received by the Coast Guard when you successfully
transmit the comment. If you fax, hand deliver, or mail your comment,
it will be considered as having been received by the Coast Guard when
it is received at the Docket Management Facility. We recommend that you
include your name and a mailing address, an email address, or a
telephone number in the body of your document so that we can contact
you if we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number in the ``SEARCH'' box and click ``SEARCH.''
Click on ``Submit a Comment'' on the line associated with this
rulemaking.
    If you submit your comments by mail or hand 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 comments 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 and may change the rule
based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number in the ``SEARCH'' box and click ``SEARCH.''
Click on Open Docket Folder on the line associated with this
rulemaking. You may also visit the Docket Management Facility in Room
W12-140 on the ground floor of the Department of Transportation West
Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

3. Privacy Act

    Anyone can search the electronic form of 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 a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one on or before July 29, 2013, using one of the methods
specified under ADDRESSES. Please explain why you believe a public
meeting 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.

C. Regulatory History and Information

    The Oil Pollution Act of 1990 (OPA 90) resulted in sweeping changes
to the way oil and chemical transportation is conducted in the United
States and throughout the world. This wide-ranging legislation required
changes in virtually every aspect of the oil transportation industry.
It involved new construction requirements, operational changes,
response planning, licensing and manning mandates, and increased
liability limits.
    One significant pollution prevention standard in OPA 90 was the
requirement that new tank barges and vessels be of double- hull
construction. This provision also required that existing single-hull
tank vessels (including barges) be retrofitted with a double hull or be
phased out of operation entirely by January 1, 2015.
    In 1998, in response to the January 1996 grounding of a single-hull
tank barge off Moonstone Beach in Rhode Island that resulted in the
release of approximately 880,000 gallons of 2 fuel oil, the
Coast Guard established an RNA for the navigable waters of the First
Coast Guard District. The RNA required any single-hull tank barge
carrying petroleum as bulk cargo to be accompanied by an escort or
assist tug unless towed by a tug equipped with twin-screws and two
engines independent of each other and capable of maintaining control of
the tank barge in the event of a loss of one of the engines. It also
stipulated that the escort or assist tug must be of sufficient
capability to push or tow the tank barge promptly away from danger, and
noted that the use of double-hull barges would remove the need for
twin-screw, twin-engine tugs.
    In response to the April 2003 grounding of the oil-laden barge B-
120, which spilled approximately 98,000 gallons of No. 6 oil into
Buzzards Bay, the Coast Guard undertook several studies and
assessments, facilitated public discussion and ultimately implemented
additional measures to improve navigation safety and protect the marine
environment. Those measures included aids-to-navigation improvements
and adoption of a voluntary recommended vessel route (``green lanes'')
in 2004, followed in 2007 by an updated RNA that contained requirements
for escort tugs, federally licensed pilots, and creation of a VMRS;
these enhancements were accompanied by widely expanded use of AIS.
These changes were intended to reduce the navigation and environmental
risks associated with tank barges laden with

5,000 or more barrels of petroleum product or other hazardous material.
    Since 2007, the American Waterways Operators (AWO) Responsible
Carrier Program (RCP) and the emerging Coast Guard Towing Vessel
Inspection Program have also served to reduce the likelihood of a
material or human factor-related incident through vessel design and
equipment standards, maintenance programs, staffing and certification
programs, and compliance programs. For more information about the Coast
Guard Towing Vessel Inspection Program, see the notice of proposed
rulemaking published at 76 FR 49976. For more information about the AWO
RCP, please see their Web site: http://www.americanwaterways.com/commitment_safety/index.html.

D. Basis and Purpose

    Under the Ports and Waterways Safety Act, the Coast Guard has the
authority to establish RNAs in defined water areas that are hazardous
or in which hazardous conditions are determined to exist. See 33 U.S.C.
1231 and Department of Homeland Security Delegation No. 0170.1.
    In 2012, the Coast Guard and Massachusetts Department of
Environmental Protection (Mass DEP) contracted with the Homeland
Security Systems Engineering Development Institute (HS-SEDI) to provide
a technical risk assessment (RA) and evaluation of measures to further
reduce the level of potential risk of an oil spill in Buzzards Bay and
the Cape Cod Canal (The RA will be provided in the docket).
    The RA noted that double-hull tank barge requirements, which become
fully effective in January 2015, have increasingly resulted in a
significant reduction in the probability of an oil spill after a marine
incident that culminated in a collision, allision, or grounding. The
double hull requirement is noted as one of the primary contributors to
risk reduction in Buzzards Bay.
    The purpose of this proposed rulemaking is to provide for safety on
the navigable waters in the regulated area.

E. Discussion of the Proposed Rule

    The Coast Guard plans to use the results of this RA to evaluate the
current level of federal regulation for Buzzards Bay and the Cape Cod
Canal, and to determine whether changes are necessary to the VMRS,
federal pilots, and/or tug escort system requirements in order to
enhance safety in the marine environment and further reduce the
potential for oil spills.
    VMRS: We believe that the current regulations regarding the VMRS
need revision, in that the majority of vessels currently monitored do
not pose significant threats of pollution incidents. As currently
written, the regulations direct watch stander focus from the higher
risk population of oil and hazardous cargo laden tank barges to the
much broader population of nearly ALL vessels transiting in Buzzards
Bay. In addition, in a comparative ranking of measures that would
mitigate risk of an oil spill, the RA ranked the VMRS as one of the
less effective options for preventing spills in Buzzards Bay.
Therefore, we believe that the public would be best served if the VMRS
were to focus specifically on the highest risk vessels that transit
Buzzards Bay, (oil laden tank barges carrying 5,000 or more barrels of
petroleum or other hazardous cargo) rather than ALL vessels.
    Certain classes of vessels that frequent Buzzards Bay and are
currently subject to the VMRS regulations, such as commercial fishing
vessels and ferries, usually have a maximum capacity of 250 barrels of
petroleum (primarily for fuel). This is well below the 5,000-barrel
threshold considered to be a significant threat to the environment as
defined in the 2007 regulations that implemented several navigation
safety measures in Buzzards Bay and established the VMRS. (See 72 FR
50052.)
    More than 20,000 commercial cargo vessels, tankers, tugs, barges,
passenger vessels, and commercial fishing vessels pass through Buzzards
Bay each year, along with thousands of smaller recreational boats. Of
those, roughly 600 are tank barges laden with 5,000 or more barrels of
petroleum or other hazardous material. When viewed in combination with
the increased measures already implemented along with those that we
propose to put in place (including mandatory pilotage and condition-
based tug escorts), the need for this additional control for tank
barges laden with LESS than 5,000 barrels of petroleum or other
hazardous material is no longer necessary and counter-productive as it
diffuses watch stander attention from the higher risk target
population.
    Changing certain reporting and participation requirements of the
Buzzards Bay VMRS to more closely focus monitoring activity on tank
barges laden with 5,000 or more barrels of petroleum or other hazardous
material would reduce reporting and participation on certain other
classes of vessels, and permit marine controllers to focus more closely
on the intended vessel population--tank barges laden with 5,000 or more
barrels of petroleum product or other hazardous material--thereby
reducing costs and improving navigation safety in Buzzards Bay.
What changes to the VMRS Buzzards Bay reporting and participation
requirements are being considered by the Coast Guard?
    Only tank barges laden with 5,000 or more barrels of petroleum or
other hazardous material (both single hull and double hull) would be
required to submit intentions and position reports, and would be
actively monitored as they transited through Buzzards Bay by the VMRS
control center at the Cape Cod Canal. All other classes of vessels
(such as ferries and commercial fishing vessels) that currently
participate in the VMRS in either an ``active'' or ``passive'' capacity
(per the VMRS User Manual) would be exempt from VMRS requirements and
would not be actively monitored by the VMRS control center.
What would not change from the current VMRS Buzzards Bay reporting and
participation requirements?
    1. All vessels subject to the Bridge-To-Bridge Radiotelephone Act
(i.e., primarily commercial vessels, including ferries and commercial
fishing vessels, but not including recreational vessels) would still be
required to monitor the VMRS radio frequency (channel 13 VHF-FM) at all
times while operating within the VMRS area and respond promptly when
hailed. (See Pub. L. 92-63; 85 Stat. 164; 33 U.S.C. 1201-1208; 33 CFR
26; 47 CFR 80.1001-80.1023; 46 CFR 7).
    2. All vessels (including recreational vessels) would still be
required to observe the Inland Rules of the Road (See Pub. L. 96-591;
94 Stat. 3415; 33 U.S.C. 2001-2038; 33 CFR 84-90).
    3. All current reporting and participation requirements for tank
barges laden with 5,000 or more barrels of petroleum or other hazardous
material will continue to be in effect.
    4. VMRS Buzzards Bay Control will continue to be staffed and
operated by U.S. Army Corps of Engineers, Cape Cod Canal.
    Federal Pilots: The existing regulation states that each single
hull tank barge transiting Buzzards Bay carrying 5,000 or more barrels
of oil or other hazardous material must be under the direction and
control of a pilot, who is not a member of the crew, operating under a
valid, appropriately endorsed, Federal first class pilots license
issued by the Coast Guard. Pilots are required to embark, direct, and
control from the primary tug during transits of Buzzards Bay. The new
regulation would extend this requirement to double hulls as well

so that all oil or hazardous material-laden tank barges carrying 5,000
or more barrels of petroleum or other hazardous material would require
pilots under all circumstances. The RA acknowledges that the
independent pilotage requirement proposed provides additional decision
support and experience on the tug when transiting Buzzards Bay, and
significantly reduces the probability of a human factor-induced
incident.
    Escort Tugs: The Coast Guard is considering establishing certain
thresholds, the exceedance of which would trigger the requirement for
an escort tug for double-hull tank barges laden with 5,000 or more
barrels of oil or hazardous material. These thresholds could be
expressed in terms of meteorological conditions such as wind speed,
wave height or visibility, or any other factors deemed appropriate,
such as equipment limitations or defects. Specifically, the Coast Guard
seeks the input of operators, pilots, industry associations,
regulators, members of the Area Committee, and concerned citizens on
the potential threshold conditions which would trigger the requirement
of an escort tug for double-hull tank barges laden with 5,000 or more
barrels of oil or hazardous material.
    Once these threshold conditions are fixed, industry would have the
flexibility to determine if the need to transit during these high-risk
periods is offset by the additional cost of the escort, or if a delay
in transit awaiting more favorable conditions is a better option.
    In a comparative ranking of measures that would mitigate risk of an
oil spill, the RA quotes a National Academy of Science study indicating
that double hulls result in a 75 to 83 percent reduction in the
probability of a spill, should a grounding, collision or allision
occur. Therefore, escort tugs would continue to accompany all single-
hulled tank barges laden with 5,000 or more barrels of petroleum or
other hazardous material through Buzzards Bay until single-hulled tank
barges are phased out January 1, 2015.

F. Information Requested

    This advance notice of proposed rulemaking invites public comment
on the merits, advantages, and disadvantages of changing certain vessel
reporting and participation requirements of the Buzzards Bay VMRS;
Federal Pilots, not a member of the crew, on board tugs towing both
single- and double-hulled tank barges; and Escort Tugs for double-hull
tank barges during adverse conditions.

G. Preliminary Regulatory Analysis

    This document is issued under authority of 5 U.S.C. 552(a) and 33
CFR 1.05-30.

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect 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. The U.S. Supreme Court, in the cases of United States v.
Locke, 529 U.S. 89 (2000) and Ray v. Atlantic Richfield Co., 435 U.S.
151 (1978) has ruled that certain categories of regulation issued
pursuant to the Ports and Waterways Safety Act of 1972, as amended, are
reserved exclusively to the Coast Guard, and that State regulation in
these areas is preempted. In general, only the federal government may
regulate the design, construction, alteration, repair, maintenance,
operation, equipping, personnel qualification, and manning of tank
vessels. Similarly, where the Coast Guard enacts regulations that
control vessel traffic or are otherwise intended to protect navigation
and the marine environment, or affirmatively determines that such
regulation is unnecessary or inappropriate, a State may not enact rules
that conflict with the Coast Guard's determination in that area,
including situations in which the State rules are identical to the
federal rules.
    As noted previously in our 2007 rulemaking (See 72 FR 50052), the
Coast Guard believes that State law is preempted on the subjects
discussed in this ANPRM, specifically with regard to the subjects of
vessel routing, manning, and tug escort requirements in Buzzards Bay.
    Nevertheless, the Coast Guard recognizes the key role State and
local governments may have in making regulatory determinations.
Sections 4 and 6 of Executive Order 13132 require that for any rules
with preemptive effect, the Coast Guard shall provide elected officials
of affected State and local governments and their representative
national organizations the notice and opportunity for appropriate
participation in any rulemaking proceedings, and to consult with such
officials early in the rulemaking process.
    Therefore, we invite affected State and local governments and their
representative national organizations to indicate their desire for
participation and consultation in this rulemaking process by submitting
comments to this notice. In accordance with Executive Order 13132, the
Coast Guard will provide a federalism impact statement to document (1)
the extent of the Coast Guard's consultation with State and local
officials that submit comments to this advanced notice of proposed
rulemaking, (2) a summary of the nature of any concerns raised by State
or local governments and the Coast Guard's position thereon, and (3)
the extent to which the concerns of State and local officials have been
met. We will also report to the Office of Management and Budget any
written communications with the States.

    Dated: May 30, 2013.
D.B. Abel,
Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District.
[FR Doc. 2013-16252 Filed 7-5-13; 8:45 am]
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