[Federal Register Volume 77, Number 51 (Thursday, March 15, 2012)]
[Proposed Rules]
[Pages 15323-15327]
[FR Doc No: 2012-6222]

-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Parts 100 and 165

[Docket No. USCG-2012-0123]
RIN 1625-AA08, AA00

Special Local Regulations and Safety Zone; War of 1812
Bicentennial Commemorations, Chesapeake Bay and Port of Baltimore, MD

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard proposes to establish temporary special local
regulations and safety zone in the Chesapeake Bay and Port of
Baltimore, Maryland for War of 1812 Bicentennial Commemorations
activities. This action is necessary to provide for the safety of life
on navigable waters before, during, and after War of 1812 Bicentennial
Commemorations events being planned for Baltimore, Maryland. This
action will restrict vessel traffic in portions of the Inner Harbor,
the Northwest Harbor, the Patapsco River, and the Chesapeake Bay.

DATES: Comments and related material must be received by the Coast
Guard on or before April 16, 2012. Requests for public meetings must be
received by the Coast Guard on or before March 30, 2012.

ADDRESSES: You may submit comments identified by docket number USCG-
2012-0123 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) 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.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section

below for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Mr. Ronald Houck, Sector Baltimore Waterways
Management Division, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

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.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2012-0123), 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 (via 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 via www.regulations.gov, 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,
click on the ``submit a comment'' box, which will then become
highlighted in blue. In the ``Document Type'' drop down menu select
``Proposed Rule'' and insert ``USCG-2012-0123'' in the ``Keyword'' box.
Click ``Search'' then click on the balloon shape in the ``Actions''
column. 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.

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,
click on the ``read comments'' box, which will then become highlighted
in blue. In the ``Keyword'' box insert ``USCG-2012-0123'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
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. We have an
agreement with the Department of Transportation to use the Docket
Management Facility.

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).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one on or before March 30, 2012 using one of the four
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.

Basis and Purpose

    The U.S. Department of the Navy is sponsoring War of 1812
Bicentennial Commemorations in the Chesapeake Bay and Port of
Baltimore, Maryland. Planned events include the scheduled arrival of
U.S. and foreign naval vessels, public vessels, tall ships and other
vessels beginning on June 12, 2012 and the scheduled departure of those
vessels ending on June 20, 2012. The Coast Guard anticipates a large
spectator fleet for these events. Operators should expect significant
vessel congestion along the arrival and departure routes. The purpose
of these regulations is to promote maritime safety and protect
participants and the boating public in the Port of Baltimore and the
waters of the Chesapeake Bay immediately prior to, during, and after
the scheduled events. The regulations will provide for clear passage of
participating vessels, a safety buffer around the participating vessels
while they are in transit for the benefit of participants and
spectators. The regulations will impact the movement of all vessels
operating in specified waters of the Chesapeake Bay, Patapsco River,
Northwest Harbor and the Inner Harbor.
    It may be necessary for the Coast Guard to establish additional
safety or security zones in addition to these regulations to safeguard
dignitaries and certain vessels participating in the event. If the
Coast Guard deems it necessary to establish such zones at a later date,
the details of those zones will be announced separately via the Federal
Register, Local Notice to Mariners, Safety Voice Broadcasts, and any
other means available.
    With the arrival of War of 1812 Bicentennial Commemorations
participants and spectator vessels in the Port of Baltimore for this
event, it will be necessary to curtail normal port operations to some
extent. The Coast Guard will attempt to minimize interference while
still ensuring the safety of life on the navigable waters immediately
before, during, and after the scheduled events.

Discussion of Proposed Rule

    The War of 1812 Bicentennial Commemorations vessels are scheduled
to arrive in the Captain of the Port (COTP) Baltimore Zone, as
described in 33 CFR 3.25-15, beginning on June 12, 2012, following a
route that includes specified waters of the Chesapeake Bay, Patapsco
River, Northwest Harbor and the Inner Harbor. The War of 1812
Bicentennial Commemorations vessels are scheduled to depart the COTP
Baltimore Zone, ending on June 20, 2012, following a route that
includes specified waters of the Inner Harbor, Northwest Harbor,
Patapsco River and the Chesapeake Bay. The safety of War of 1812
Bicentennial Commemorations vessels and spectators requires that
spectator craft be kept at a safe distance from these routes during
these vessel movements.
    The Coast Guard proposes establishing special local regulations for
the area in the Port of Baltimore through which the vessels will pass
for the War of 1812 Bicentennial Commemorations arrival on June 13,
2012 and the War of 1812 Bicentennial Commemorations

departure on June 19, 2012. In addition to establishing special local
regulations, we propose to establish temporary moving safety zones
around War of 1812 Bicentennial Commemorations vessels greater than 100
feet in length overall, while operating in the navigable waters of the
Chesapeake Bay or its tributaries, north of the Maryland--Virginia
border and south of latitude 39[deg]35'00'' N. This action is necessary
to ensure the safety of participants and spectators immediately prior
to, during, and following the War of 1812 Bicentennial Commemorations
activities.
    The regulations contained within this proposed rule are not
intended to effect existing Naval Vessel Protection Zone regulations
described in Title 33 CFR Part 165 (Subpart G).

Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    Executive Orders 12866, Regulatory Planning and Review, and 13563,
Improving Regulation and Regulatory Review, direct agencies to assess
the costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. 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. The primary impact of
this proposed rule would be on vessels wishing to transit the affected
waterways during the War of 1812 Bicentennial Commemorations vessels
arrival beginning on June 12, 2012 and their departure ending on June
20, 2012. Although this proposed rule would prevent traffic from
transiting a portion of the Inner Harbor, Northwest Harbor, Patapsco
River and the Chesapeake Bay during these events, that restriction is
limited in duration, affects only a limited area, and would be well
publicized to allow mariners to make alternative plans for transiting
the affected area. Moreover, the magnitude of the event itself would
severely hamper or prevent transit of the waterway, even absent this
proposed rule, which is designed to ensure it is conducted in a safe
and orderly fashion.

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. This proposed rule would affect the following
entities, some of which might be small entities: The owners or
operators of vessels intending to operate or anchor in portions of the
Inner Harbor, the Northwest Harbor and Patapsco River, and the
Chesapeake Bay, in Maryland. The regulations would not have a
significant impact on a substantial number of small entities for the
following reasons: The restrictions are limited in duration, affect
only limited areas, and will be well publicized to allow mariners to
make alternative plans for transiting the affected areas. Moreover, the
magnitude of the event itself will severely hamper or prevent transit
of the waterway, even absent these regulations designed to ensure it is
conducted in a safe and orderly fashion.
    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
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 Commander, Coast Guard Sector
Baltimore, 2401 Hawkins Pont Road, Building 70, Baltimore, Maryland,
21226-1791, Attention to: Waterways Management Division. The Coast
Guard will not retaliate against small entities that question or
complain about this proposed 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 (adjusted for
inflation) 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 cause 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 Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide 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 one of a category
of actions which do not individually or cumulatively have a significant
effect on the human environment.
    This proposed rule involves establishing special local regulations
issued in conjunction with a marine event, as described in figure 2-1,
paragraph (34)(h), of the Instruction. Under figure 2-1, paragraph
(34)(h), of the Instruction, an environmental analysis checklist and
categorical exclusion determination are not required for this proposed
rule. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this proposed
rule.
    Additionally, this proposed rule is categorically excluded, under
figure 2-1, paragraph (34)(g), of the Instruction. This rule also
involves establishing a temporary safety zone. A preliminary
environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects

33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.
    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR parts 100 and 165 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

    1. The authority citation for part 100 continues to read as
follows:

    Authority:  33 U.S.C. 1233.

    2. Add Sec.  100.35T05-0123 to read as follows:

Sec.  100.35T05-0123  Special Local Regulations for Marine Events; War
of 1812 Bicentennial Commemorations, Chesapeake Bay and Port of
Baltimore, MD.

    (a) Definitions. (1) ``Captain of the Port Baltimore'' means the
Commander, Coast Guard Sector Baltimore or any Coast Guard
commissioned, warrant, or petty officer who has been authorized by the
Captain of the Port Baltimore to act on his behalf.
    (2) ``Official Patrol Vessel'' includes all U. S. Coast Guard,
public, state, county or local law enforcement vessels assigned and/or
approved by Commander, Coast Guard Sector Baltimore.
    (3) ``War of 1812 Bicentennial Commemorations Vessel'' includes all
vessels participating in War of 1812 Bicentennial Commemorations
activities under the auspices of the U.S. Department of Homeland
Security Application for Marine Event submitted for the War of 1812
Bicentennial Commemorations activities in Baltimore, Maryland and
approved by the Captain of the Port Baltimore.
    (4) ``War of 1812 Bicentennial Commemorations arrival'' is the
movement of War of 1812 Bicentennial Commemorations vessels in orderly
succession as they navigate designated routes in the Chesapeake Bay in
Maryland and in the Port of Baltimore while inbound to Baltimore,
Maryland on June 13, 2012.
    (5) ``War of 1812 Bicentennial Commemorations departure'' is the
movement of War of 1812 Bicentennial Commemorations vessels in orderly
succession as they navigate designated routes in the Port of Baltimore
and in the Chesapeake Bay in Maryland while outbound from Baltimore,
Maryland on June 19, 2012.
    (b) Regulated areas. The following regulated areas are established
as special local regulations during the War of 1812 Bicentennial
Commemorations in Baltimore, Maryland. All coordinates reference Datum
NAD 1983.
    (1) ``Arrival Area''. All waters of the Patapsco River, Northwest
Harbor and Inner Harbor enclosed by:

------------------------------------------------------------------------
              Latitude                            Longitude
------------------------------------------------------------------------
39[deg]15'41'' N                     076[deg]34'48'' W, to
39[deg]15'05'' N                     076[deg]34'44'' W, and
39[deg]14'08'' N                     076[deg]33'38'' W, to
39[deg]12'46'' N                     076[deg]32'03'' W, to
39[deg]10' 25'' N                    076[deg]31'01'' W, to
39[deg]12'06'' N                     076[deg]29'43'' W, to
39[deg]13'22'' N                     076[deg]31'16'' W, to
39[deg]15'40'' N                     076[deg]33'34'' W.
------------------------------------------------------------------------

     (2) ``Departure Area''. All waters of the Patapsco River,
Northwest Harbor and Inner Harbor enclosed by:

------------------------------------------------------------------------
              Latitude                            Longitude
------------------------------------------------------------------------
39[deg]15'41'' N                     076[deg]34'48'' W, to
39[deg]15'05'' N                     076[deg]34'44'' W, and
39[deg]14'08'' N                     076[deg]33'38'' W, to
39[deg]12'46'' N                     076[deg]32'03'' W, to
39[deg]10'25'' N                     076[deg]31'01'' W, to
39[deg]12'06'' N                     076[deg]29'43'' W, to
39[deg]13'22'' N                     076[deg]31'16'' W, to
39[deg]15'40'' N                     076[deg]33'34'' W.
------------------------------------------------------------------------

    (c) Special Local Regulations. (1) All persons and vessels within
the regulated areas must operate in strict conformance with any
directions given by the Captain

of the Port Baltimore and leave the regulated areas immediately if the
Captain of the Port Baltimore so orders.
    (2) Unless otherwise directed by the Captain of the Port Baltimore,
all vessels within the regulated areas shall be operated at the minimum
speed necessary to maintain safe course.
    (3) Persons desiring to transit the regulated area must first
obtain authorization from the Captain of the Port Baltimore. To seek
permission to transit the regulated areas, the Captain of the Port
Baltimore and his designated representatives can be contacted at
telephone number<PHONE_NUMBER> or on Marine Band Radio, VHF-FM channel
16 (156.8 MHz). All Coast Guard vessels enforcing these regulated areas
can be contacted on marine band radio VHF-FM channel 16 (156.8 MHz).
    (4) The Captain of the Port Baltimore will publish a notice in the
Fifth Coast Guard District Local Notice to Mariners and will notify the
public of any changes in the status of the regulated areas by a Marine
Safety Radio Broadcast on VHF-FM marine band radio, channel 22A (157.1
MHZ).
    (d) Effective dates: This rule is effective from June 13, 2012
through June 19, 2012.
    (e) Enforcement periods: (1) ``Arrival Area''. Paragraph (b)(1) of
this section will be enforced from 9 a.m. until 9 p.m. on June 13,
2012.
    (2) ``Departure Area''. Paragraph (b)(2) of this section will be
enforced from 6:30 a.m. until 3 p.m. on June 19, 2012.

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

    1. The authority citation for part 165 continues to read as
follows:

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

    2. Add Sec.  165.T05-0123 to read as follows:

Sec.  165.T05-0123  Safety Zone; War of 1812 Bicentennial
Commemorations, Chesapeake Bay and Port of Baltimore, MD.

    (a) Definitions. (1) ``Captain of the Port Baltimore'' means the
Commander, U.S. Coast Guard Sector Baltimore, Maryland.
    (2) ``Designated Representative'' means any Coast Guard
commissioned, warrant, or petty officer who has been authorized by the
Captain of the Port Baltimore to assist in enforcing the safety zone
described in paragraph (b) of this section.
    (3) ``War of 1812 Bicentennial Commemorations Vessels'' includes
all vessels participating in War of 1812 Bicentennial Commemorations
activities under the auspices of the U.S. Department of Homeland
Security Application for Marine Event submitted for the War of 1812
Bicentennial Commemorations activities in Baltimore, Maryland and
approved by the Captain of the Port Baltimore.
    (b) Regulated areas. The following locations are a moving safety
zone: (1) All waters within 500 yards of any War of 1812 Bicentennial
Commemorations vessel which is greater than 100 feet in length overall,
while operating in the navigable waters of the Chesapeake Bay or its
tributaries, north of the Maryland-Virginia border and south of
latitude 39[deg]35'00'' N.
    (2) All waters within 100 yards of any War of 1812 Bicentennial
Commemorations vessel which is greater than 100 feet in length overall,
while operating in the navigable waters of the Chesapeake Bay or its
tributaries, north of the Maryland-Virginia border and south of
latitude 39[deg]35'00'' N.
    (c) Regulations. The general safety zone regulations found in 33
CFR 165.23 apply to the safety zone created by this temporary section,
Sec.  165.T05.0123. (1) All persons are required to comply with the
general regulations governing safety zones found in 33 CFR 165.23.
    (2) The Navigation Rules shall apply while within the safety zone
described in paragraph (b).
    (3) Persons and vessels intending to transit the area of the safety
zone described in paragraph (b)(1) of this section shall operate at the
minimum speed necessary to maintain a safe course, unless required to
maintain speed by the Navigation Rules, and shall proceed as directed
by the Captain of the Port Baltimore or his designated representative.
    (4) Entry into or remaining in the area of the safety zone
described in paragraph (b)(2) of this section is prohibited unless
authorized by the Captain of the Port Baltimore or his designated
representative. Persons desiring to transit the area of the safety zone
described in paragraph (b)(2) of this section must first request
authorization from the Captain of the Port Baltimore or his designated
representative. To seek permission to transit the area, the Captain of
the Port Baltimore and his designated representatives can be contacted
at telephone number<PHONE_NUMBER> or on Marine Band Radio, VHF-FM
channel 16 (156.8 MHz). The Coast Guard vessels enforcing this section
can be contacted on Marine Band Radio, VHF-FM channel 16 (156.8 MHz).
Upon being hailed by a U.S. Coast Guard vessel, or other Federal,
State, or local agency vessel, by siren, radio, flashing lights, or
other means, the operator of a vessel shall proceed as directed. If
permission is granted, all persons and vessels must comply with the
instructions of the Captain of the Port Baltimore or his designated
representative and proceed at the minimum speed necessary to maintain a
safe course while within the zone, unless required to maintain speed by
the Navigation Rules.
    (5) The Captain of the Port Baltimore will notify the public of any
changes in the status of this zone by a Marine Safety Radio Broadcast
on Marine Band Radio VHF-FM channel 22A (157.1 MHZ).
    (6) The U.S. Coast Guard may be assisted in the patrol and
enforcement of the zone by Federal, State, and local agencies.
    (d) Effective dates: This section is effective from June 12, 2012
through June 20, 2012.
    (e) Enforcement periods: This section will be enforced from 6 p.m.
on June 12, 2012 until 9 p.m. on June 13, 2012, and from 6 a.m. on June
19, 2012 until 5 a.m. on June 20, 2012.

    Dated: February 26, 2012.
Mark P. O'Malley,
Captain, U.S. Coast Guard, Captain of the Port Baltimore.
[FR Doc. 2012-6222 Filed 3-14-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 235 (Wednesday, December 7, 2016)]
[Rules and Regulations]
[Pages 88099-88101]
[FR Doc No: 2016-29278]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2011-N-0146]

Third-Party Certification Body Accreditation for Food Safety
Audits: Model Accreditation Standards; Guidance for Industry and Food
and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a guidance for industry and FDA staff entitled ``Third-
Party Certification Body Accreditation for Food Safety Audits: Model
Accreditation Standards.'' The guidance contains FDA recommendations on
third-party certification body qualifications for accreditation to
conduct food safety audits and to issue food and/or facility
certifications under an FDA program required by the FDA Food Safety
Modernization Act (FSMA). The guidance is intended to describe the
standards for accreditation of third-party certification bodies as
required under the final rule entitled ``Accreditation of Third-Party
Certification Bodies to Conduct Food Safety Audits and to Issue
Certifications.'' In addition, this guidance discusses specific clauses
of ISO/IEC 17021: 2015 and industry practice that are currently being
used by third-party certification bodies and that FDA recommends
accreditation bodies consider as a model when making accreditation
decisions.

DATES: Submit either electronic or written comments on FDA guidances at
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2011-N-0146 for ``Third-Party Certification Body Accreditation for
Food Safety Audits: Model Accreditation Standards; Guidance for
Industry and Food and Drug Administration Staff.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the
Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Charlotte A. Christin, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry and
FDA staff entitled ``Third-Party Certification Body Accreditation for
Food Safety Audits: Model Accreditation Standards.'' We are issuing
this guidance consistent with our good guidance practices regulation
(21 CFR 10.115). The guidance represents the current thinking of FDA on
this topic. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
    In the Federal Register of July 24, 2015 (80 FR 44137), we made
available a draft guidance entitled ``Draft Guidance for Industry and
Food and Drug Administration Staff: Third-Party Auditor/Certification
Body Accreditation for Food Safety Audits: Model Accreditation
Standards'' and gave interested parties an opportunity to submit
comments by October 7, 2015, for us to consider before beginning work
on the final version of the guidance. Section 808 of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 384d) was added by
FSMA and directs FDA to establish a program for the recognition of
accreditation bodies that accredit third-party certification bodies to
conduct food safety audits and to issue food and/or facility
certifications that FDA may use in certain circumstances to facilitate
the entry of foods presented for import.

Section 808(b)(2) of the FD&C Act requires FDA to develop model
accreditation standards that recognized accreditation bodies shall use
to qualify third-party certification bodies for accreditation, and in
so doing, to look to existing standards for certification bodies (as of
the date of enactment of FSMA) to avoid unnecessary duplication of
efforts and costs. This guidance constitutes the model accreditation
standards referred to in section 808(b)(2) of the FD&C Act. The
guidance contains FDA recommendations on third-party certification body
qualifications for accreditation to conduct food safety audits and to
issue food and/or facility certifications under an FDA program required
by FSMA.
    FDA was guided in developing this guidance, in part, by the
National Technology Transfer and Advancement Act of 1995, which directs
Federal Agencies to use voluntary consensus standards in lieu of
government-unique standards, except where inconsistent with law or
otherwise impractical.
    In developing the guidance, FDA considered several voluntary
consensus standards for their relevance to the qualifications of third-
party certification bodies that would certify foreign food facilities
and/or their foods for conformance with the requirements of the FD&C
Act. FDA also sought to identify the standards most commonly used by
stakeholders (e.g., other governments, public and private accreditation
bodies, the food industry, and the international standards community)
in qualifying third-party certification bodies for conducting food
safety audits. As a result, FDA was guided in developing the model
accreditation standards guidance document by International Organization
for Standardization (ISO)/International Electrotechnical Commission
(IEC) ISO/IEC 17021: Conformity Assessment--Requirements for bodies
providing audit and certification management systems (2015) (ISO/IEC
17021:2015) and ISO/IEC 17065: Conformity Assessment--Requirements for
bodies certifying products, processes and services (2012) (ISO/IEC
17065:2012).
    We received several comments on the draft guidance and have
modified the final guidance where appropriate. We revised the guidance
for clarity and conformance with the final rule. We also updated
references to the ISO/IEC standards. The guidance announced in this
notice finalizes the draft guidance dated July 2015.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collection of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information regarding ``Accreditation of Third Party
Certification Bodies to Conduct Food Safety Audits and Issue
Certifications,'' have been approved under OMB control number 0910-
0750.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/FoodGuidances or http://www.regulations.gov.
Use the FDA Web site listed in the previous sentence to find the most
current version of the guidance.

    Dated: December 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29278 Filed 12-6-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 55 (Thursday, March 21, 2019)]
[Notices]
[Pages 10498-10499]
[FR Doc No: 2019-05313]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2003-0085; FRL-9988-74-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NESHAP for Radionuclides (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), NESHAP for Radionuclides (EPA ICR
Number 1100.16, OMB Control Number 2060-0191) to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act. This is a proposed extension of the ICR,
which is currently approved through March 31, 2019. Public comments
were previously requested via the Federal Register on September 6, 2018
during a 60-day comment period. This notice allows for an additional 30
days for public comments. A fuller description of the ICR is given
below, including its estimated burden and cost to the public.

An agency may not conduct or sponsor and a person is not required to
respond to a collection of information unless it displays a currently
valid OMB control number.

DATES: Additional comments may be submitted on or before April 22,
2019.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2003-0085-0014, to (1) EPA online using www.regulations.gov (our
preferred method), by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW, Washington, DC 20460, and (2) OMB via email
to<EMAIL_ADDRESS>Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Jonathan P. Walsh, Radiation
Protection Division, Office of Radiation and Indoor Air, Mail Code
6608T, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number: 202-
343-2304; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: On December 15, 1989, pursuant to Section 112 of the
Clean Air Act as amended in 1977 (42 U.S.C. 1857), the Environmental
Protection Agency (EPA) promulgated National Emission Standards for
Hazardous Air Pollutants (NESHAP) to control radionuclide emissions
from several source categories. The regulations are codified at 40 CFR
part 61. Of the seven subparts (B, H, I, K, R, T and W) included in the
1989 rule, as currently amended, four apply to privately operated
facilities. In addition to requiring operational practices that limit
emissions, Subparts B, K, R, and W impose radionuclide dose and/or
emission limits, respectively, to underground uranium mines, elemental
phosphorous plants, phosphogypsum stacks, and uranium mill tailings
impoundments. Facilities must measure their radionuclide emissions,
perform analysis or calculations per EPA procedure, and report the
results to the EPA.
    Information collected is used by the EPA to ensure that public
health continues to be protected from the hazards of airborne
radionuclides by compliance with these standards. Compliance is
demonstrated through emissions testing and dose calculation when
appropriate.
    Form Numbers: None.
    Respondents/affected entities: The North American Industry
Classification System (NAICS) codes of facilities associated with the
activity of the respondents are: (1) Elemental Phosphorous--325180, (2)
Phosphogypsum Stacks--212392, (3) Underground Uranium Mines--212291,
and (4) Uranium Mill Tailings--212291.
    Respondent's obligation to respond: Mandatory (CAA, Sec, 112; 40
CFR part 61).
    Estimated number of respondents: 17 (total).
    Frequency of response: Annual, or one-time depending on the source
category and respondent activity.
    Total estimated burden: 1,880 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $447,850 (per year), includes $328,000
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is decrease of 1,898 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This decrease is due to a combination of factors.
Fewer facilities, particularly uranium mines, are currently active. The
only operating elemental phosphorus plant has obtained a waiver from
annual testing and reporting. Compared to previous estimates, the
current calculation assumes that fewer phosphogypsum stacks will
require radon tests in any given year. The current assumption
represents an upper bound on costs due to radon testing and reporting,
compared to the actual observed activities of these facilities.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2019-05313 Filed 3-20-19; 8:45 am]
 BILLING CODE 6560-50-P