[Federal Register Volume 79, Number 201 (Friday, October 17, 2014)]
[Proposed Rules]
[Pages 62378-62379]
[FR Doc No: 2014-24491]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2014-0529; FRL-9915-52-Region 9]

Revisions to the California State Implementation Plan, California
Air Resources Board--Consumer Products

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the California Air Resources Board Portion of the
California State Implementation Plan (SIP). These revisions concern
volatile organic compound (VOC) emissions from consumer products. We
are proposing to approve a local rule that regulates these emission
sources under the Clean Air Act (CAA or the Act).

DATE:  Any comments on this proposal must arrive by November 17, 2014.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2014-0529, by one of the following methods:
    1. Federal eRulemaking Portal: www.regulations.gov. Follow the on-
line instructions.
    2. Email<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and

should not be submitted through www.regulations.gov or email.
www.regulations.gov is an ``anonymous access'' system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send email directly to EPA, your email
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: Generally, documents in the docket for this action are
available electronically at www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California 94105-3901.
While all documents in the docket are listed at www.regulations.gov,
some information may be publicly available only at the hard copy
location (e.g., copyrighted material, large maps), and some may not be
publicly available in either location (e.g., CBI). To inspect the hard
copy materials, please schedule an appointment during normal business
hours with the contact listed in the FOR FURTHER INFORMATION CONTACT
section.

FOR FURTHER INFORMATION CONTACT: Stanley Tong, EPA Region IX, (415)
947-4122<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This proposal addresses the following local
rule:

                             Table 1--Submitted California Air Resources Board Rule
----------------------------------------------------------------------------------------------------------------
                                                                 Filed with California
          Regulation                       Amended                 Secretary of State         Submitted to EPA
----------------------------------------------------------------------------------------------------------------
Subchapter 8.5--Consumer        March 15, 2013..............  April 25, 2013.............  May 28, 2014.
 Products; Article 2--Consumer
 Products.
----------------------------------------------------------------------------------------------------------------

    In the Rules and Regulations section of this Federal Register, we
are approving this local rule in a direct final action without prior
proposal because we believe these SIP revisions are not controversial.
If we receive adverse comments, however, we will publish a timely
withdrawal of the direct final rule and address the comments in
subsequent action based on this proposed rule. Please note that if we
receive adverse comment on an amendment, paragraph, or section of this
rule and if that provision may be severed from the remainder of the
rule, we may adopt as final those provisions of the rule that are not
the subject of an adverse comment.
    We do not plan to open a second comment period, so anyone
interested in commenting should do so at this time. If we do not
receive adverse comments, no further activity is planned. For further
information, please see the direct final action.

    Dated: August 5, 2014.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2014-24491 Filed 10-16-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 200 (Thursday, October 16, 2014)]
[Notices]
[Pages 62129-62130]
[FR Doc No: 2014-24580]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-1437-002.
    Applicants: Tampa Electric Company.
    Description: Supplement to June 30, 2014 Triennial Market Power
Update of Tampa Electric Company.
    Filed Date: 10/7/14.
    Accession Number: 20141007-5234.
    Comments Due: 5 p.m. ET 10/28/14.

    Docket Numbers: ER14-1711-005.
    Applicants: TC Ravenswood, LLC.
    Description: Tariff Amendment per 35.17(b): Oil Burn Rate Schedule
to be effective 10/7/2014.
    Filed Date: 10/7/14.
    Accession Number: 20141007-5162.
    Comments Due: 5 p.m. ET 10/28/14.

    Docket Numbers: ER14-1711-006.
    Applicants: TC Ravenswood, LLC.
    Description: Tariff Amendment per 35.17(b): Clarification of 10/7/
14 Amendment to Restart 60 day clock effective 5/1/14 to be effective
5/1/2014.
    Filed Date: 10/8/14.
    Accession Number: 20141008-5092.
    Comments Due: 5 p.m. ET 10/29/14.

    Docket Numbers: ER14-1822-003.
    Applicants: New York Independent System Operator, Inc.
    Description: Tariff Amendment per 35.17(b): Amendment Unexecuted
TCR Minimum Oil Burn Agreement to be effective 5/1/2014.
    Filed Date: 10/7/14.
    Accession Number: 20141007-5168.
    Comments Due: 5 p.m. ET 10/28/14.

    Docket Numbers: ER14-2469-001.
    Applicants: NorthWestern Corporation.
    Description: Compliance filing per 35: Additional Changes to
Pending Order No 792 Compliance Filing (Montana) to be effective 7/22/
2014.
    Filed Date: 10/8/14.
    Accession Number: 20141008-5083.
    Comments Due: 5 p.m. ET 10/29/14.

    Docket Numbers: ER14-2532-001.
    Applicants: Tampa Electric Company.
    Description: Compliance filing per 35: Amendment of Compliance
Filing Under Order No. 792 to be effective 8/1/2014.
    Filed Date: 10/7/14.
    Accession Number: 20141007-5220.
    Comments Due: 5 p.m. ET 10/28/14.

    Docket Numbers: ER14-2544-001.
    Applicants: PacifiCorp.
    Description: Compliance filing per 35: OATT EIM Attachment T
Revisions Compliance Filing to be effective 10/1/2014.
    Filed Date: 10/8/14.
    Accession Number: 20141008-5094.
    Comments Due: 5 p.m. ET 10/29/14.

    Docket Numbers: ER14-2548-003.
    Applicants: Ocean State Power.
    Description: Tariff Amendment per 35.17(b): Third Amendment to
Notice of Succession to be effective 7/1/2014.
    Filed Date: 10/8/14.
    Accession Number: 20141008-5093.
    Comments Due: 5 p.m. ET 10/29/14.

    Docket Numbers: ER15-58-000.
    Applicants: Palo Duro Wind Interconnection Services, LLC.
    Description: Baseline eTariff Filing per 35.1: Palo Duro Wind
Interconnection Services, LLC MBR Application to be effective 12/6/
2014.
    Filed Date: 10/7/14.
    Accession Number: 20141007-5209.
    Comments Due: 5 p.m. ET 10/28/14.

    Docket Numbers: ER15-59-000.
    Applicants: ITC Midwest LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): CIAC
Agreement with CIPCO to be effective 12/8/2014.
    Filed Date: 10/7/14.
    Accession Number: 20141007-5210.
    Comments Due: 5 p.m. ET 10/28/14.

    Docket Numbers: ER15-60-000.
    Applicants: Footprint Power Salem Harbor Development LP.
    Description: Application for Deferral of Capacity Supply Obligation
of Footprint Power Salem Harbor Development LP.
    Filed Date: 10/7/14.
    Accession Number: 20141007-5242.
    Comments Due: 5 p.m. ET 10/28/14.

    Docket Numbers: ER15-61-000.
    Applicants: PJM Interconnection, L.L.C., American Transmission
Systems, Incorporated.
    Description: Compliance filing per 35: per 35.13(a)(2)(iii):
Opinion No. 533 Compliance Filing--ATSI under EL11-54-002 to be
effective 1/1/2015.
    Filed Date: 10/8/14.
    Accession Number: 20141008-5091.
    Comments Due: 5 p.m. ET 10/29/14.

    Docket Numbers: ER15-62-000.
    Applicants: PacifiCorp.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Tri-
State NITSA Rev 5 to be effective 10/1/2014.
    Filed Date: 10/8/14.
    Accession Number: 20141008-5096.
    Comments Due: 5 p.m. ET 10/29/14.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 8, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-24580 Filed 10-15-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 89 (Thursday, May 8, 2014)]
[Notices]
[Pages 26499-26501]
[FR Doc No: 2014-10575]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2013-0002 (Notice No. 14-6)]

Information Collection Activities

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
Department of Transportation (DOT).

ACTION: Notice and request for comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, this
notice announces that the Information Collection Requests (ICR)
abstracted below will be forwarded to the Office of Management and
Budget (OMB) for review and comments. The ICRs describe the nature of
the information collections and their expected burden. A Federal
Register Notice with a 60-day comment period soliciting comments on
these collections of information was published in the Federal Register
on February 12, 2014 [79 FR 8535] under Docket No. PHMSA-2013-0002
(Notice No. 14-1). PHMSA did not receive any comments in response to
February 12, 2014 notice.

DATES: Interested persons are invited to submit comments on, or before
June 9, 2014.

ADDRESSES: Interested parties are invited to submit comments regarding
this notice. Comments should refer to the information collection by
title and/or OMB Control Number. Send comments regarding the burden
estimate, including suggestions for reducing the burden, to OMB,
Attention: Desk Officer for PHMSA, 725 17th Street NW., Washington, DC
20503. Comments are invited on: (1) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; (2) the accuracy of the Department's estimate of the burden of
the proposed information collection; (3) ways to enhance the quality,
utility and clarity of the information to be collected; and (4) ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology. A comment to OMB is most effective if OMB
receives it within 30 days of publication.

FOR FURTHER INFORMATION CONTACT: Steven Andrews or T. Glenn Foster,
Standards and Rulemaking Division (PHH-12), U.S. Department of
Transportation, Pipeline and Hazardous Materials Safety Administration,
1200 New Jersey Avenue SE., East Building, 2nd Floor, Washington, DC
20590-0001, Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Section 1320.8 (d), Title 5, Code of Federal
Regulations requires Federal agencies to provide interested members of
the public and affected agencies an opportunity to comment on
information collection and recordkeeping requests. This notice
identifies information collection requests that PHMSA will be
submitting to OMB for renewal and extension. These information
collections are contained in 49 CFR parts 107, 130, 171, 173, 176, 177,
178, and 180 of the Hazardous Materials Regulations (HMR; 49 CFR parts
171-180). PHMSA has revised burden estimates, where appropriate, to
reflect current reporting levels or adjustments based on changes in
proposed or final rules published since the information collections
were last approved. The following information is provided for each
information collection: (1) Title of the information collection,
including former title if a change is being made; (2) OMB Control
Number; (3) abstract of the information collection activity; (4)
description of affected persons; (5) estimate of total annual reporting
and recordkeeping burden; and (6) frequency of collection. PHMSA will
request a three-year term of approval for each information collection
activity and, when approved by OMB, publish notice of the approvals in
the Federal Register.
    PHMSA requests comments on the following information collections:
    Title: Requirements for Cargo Tanks.
    OMB Control Number: 2137-0014.
    Summary: This information collection consolidates and describes the
information collection provisions in Parts 107, 178, and 180 of the HMR
involving the manufacture, qualification, maintenance, and use of all
specification cargo tank motor vehicles. It also includes the
information collection and recordkeeping requirements for persons who
are engaged in the manufacture, assembly, requalification, and
maintenance of Department of Transportation (DOT) specification cargo
tank motor vehicles. The types of information collected include:
    (1) Registration Statements: Cargo tank manufacturers and
repairers, and cargo tank motor vehicle assemblers are required to be
registered with DOT by furnishing information relative to their
qualifications to perform the functions in accordance with the HMR. The

registration statements are used to identify these persons in order for
DOT to ensure they possess the knowledge and skills necessary to
perform the required functions, and that they are performing the
specified functions in accordance with the applicable regulations.
    (2) Requalification and maintenance reports: These reports are
prepared by persons who requalify or maintain cargo tanks. This
information is used by cargo tank owners, operators and users, and DOT
compliance personnel to verify that the cargo tanks are requalified,
maintained, and are in proper condition for the transportation of
hazardous materials.
    (3) Manufacturers' data reports, certificates, and related papers:
These reports are prepared by cargo tank manufacturers and certifiers,
and are used by cargo tank owners, operators, users and DOT compliance
personnel to verify that a cargo tank motor vehicle was designed and
constructed to meet all requirements of the applicable specification.
    Affected Public: Manufacturers, assemblers, repairers,
requalifiers, certifiers, and owners of cargo tanks.

Annual Reporting and Recordkeeping Burden

    Number of Respondents: 41,366.
    Total Annual Responses: 132,600.
    Total Annual Burden Hours: 101,507.
    Frequency of Collection: On occasion.
    Title: Hazardous Materials Incident Reports.
    OMB Control Number: 2137-0039.
    Summary: This information collection is applicable upon occurrence
of incidents as prescribed in Sec. Sec.  171.15 and 171.16. A Hazardous
Materials Incident Report, DOT Form F 5800.1, must be completed by a
person in physical possession of a hazardous material at the time a
hazardous material incident occurs in transportation, such as a release
of materials, serious accident, evacuation, or closure of a major
transportation artery. Incidents meeting criteria in Sec.  171.15 also
require a telephonic report. This information collection enhances the
Department's ability to evaluate the effectiveness of its regulatory
program, determine the need for regulatory changes, and address
emerging hazardous materials transportation safety issues. The
requirements apply to all interstate and intrastate carriers engaged in
the transportation of hazardous materials by rail, air, water, and
highway.
    Affected Public: Shippers and carriers of hazardous materials.

Annual Reporting and Recordkeeping Burden

    Number of Respondents: 1,781.
    Total Annual Responses: 17,810.
    Total Annual Burden Hours: 23,746.
    Frequency of collection: On occasion.
    Title: Flammable Cryogenic Liquids.
    OMB Control Number: 2137-0542.
    Summary: Provisions in Sec.  177.840(a)(2) specify certain safety
procedures and documentation requirements for drivers of motor vehicles
transporting flammable cryogenic liquids. This information allows the
driver to take appropriate remedial actions to prevent a catastrophic
release of the flammable cryogenics should the temperature of the
material begin to rise excessively or if the travel time will exceed
the safe travel time. These requirements are intended to ensure a high
level of safety when transporting flammable cryogenics due to their
extreme flammability and high compression ratio when in a liquid state.
    Affected Public: Carriers of cryogenic materials.

Annual Reporting and Recordkeeping Burden

    Total Respondents: 65.
    Total Annual Responses: 18,200.
    Total Annual Burden Hours: 1,213.
    Frequency of collection: On occasion.
    Title: Container Certification Statement.
    OMB Control Number: 2137-0582.
    Summary: Shippers of explosives, in freight containers or transport
vehicles by vessel, are required to certify on shipping documentation
that the freight container or transport vehicle meets minimal
structural serviceability requirements. This requirement is intended to
ensure an adequate level of safety for transport of explosives aboard
vessel and consistency with similar requirements in international
standards.
    Affected Public: Shippers of explosives in freight containers or
transport vehicles by vessel.

Annual Reporting and Recordkeeping Burden

    Annual Respondents: 650.
    Annual Responses: 890,000.
    Annual Burden Hours: 14,908.
    Frequency of collection: On occasion.
    Title: Response Plans for Shipments of Oil.
    OMB Control Number: 2137-0591.
    Summary: In recent years, several major oil discharges damaged the
marine environment of the United States. Under authority of the Federal
Water Pollution Control Act, as amended by the Oil Pollution Act of
1990, PHMSA issued regulations in 49 CFR Part 130 that require
preparation of written spill response plans.
    Affected Public: Carriers that transport oil in bulk, by motor
vehicle or rail.

Annual Reporting and Recordkeeping Burden

    Annual Respondents: 8,000.
    Annual Responses: 8,000.
    Annual Burden Hours: 10,560.
    Frequency of collection: On occasion.
    Title: Hazardous Materials Security Plans.
    OMB Control Number: 2137-0612.
    Summary: To assure public safety, shippers and carriers must take
reasonable measures to plan and implement procedures to prevent
unauthorized persons from taking control of, or attacking, hazardous
materials shipments. Part 172 of the HMR requires persons who offer or
transport certain hazardous materials to develop and implement written
plans to enhance the security of hazardous materials shipments. The
security plan requirements, as prescribed in Sec.  172.800(b) applies
to specific types of shipments. Such shipments include but are not
limited to shipments greater than 3,000 kg (6,614 pounds) for solids or
3,000 liters (792 gallons) for liquids and gases in a single packaging
such as a cargo tank motor vehicle, portable tank, tank car, or other
bulk container; any quantity of a Division 1.1, 1.2, or 1.3 material; a
large bulk quantity of a Division 2.1 material; or any quantity of a
poison by inhalation material. A security plan will enable shippers and
carriers to reduce the possibility that a hazardous materials shipment
will be used as a weapon of opportunity by a terrorist or criminal.
    Affected Public: Shippers and carriers of hazardous materials in
commerce.

Annual Reporting and Recordkeeping Burden

    Number of Respondents: 54,999.
    Total Annual Responses: 54,999.
    Total Annual Burden Hours: 427,719.
    Frequency of collection: On occasion.
    Title: Inspection and Testing of Meter Provers.
    OMB Control Number: 2137-0620.
    Summary: This information collection and recordkeeping burden
results from the requirements pertaining to the use, inspection, and
maintenance of mechanical displacement meter provers (meter provers)
used to check the accurate flow of liquid hazardous materials into bulk
packagings, such as portable tanks and cargo tank motor vehicles, under
the HMR. These meter provers are used to ensure that the

amount of liquid hazardous materials being measured during load and
unloading of bulk packagings is accurate. These meter provers consist
of a gauge and several pipes that always contain small amounts of the
liquid hazardous material in the pipes as residual material, and,
therefore, must be inspected and maintained in accordance with the HMR
to ensure they are in proper calibration and working order. These meter
provers are not subject to the specification testing and inspection
requirements in Part 178. However, these meter provers must be visually
inspected annually and hydrostatic pressure tested every five years in
order to ensure they are properly working as specified in Sec.  173.5a
of the HMR. Therefore, this information collection requires that:
    (1) Each meter prover must undergo and pass an external visual
inspection annually to ensure that the meter provers used in the flow
of liquid hazardous materials into bulk packagings are accurate and in
conformance with the performance standards in the HMR.
    (2) Each meter prover must undergo and pass a hydrostatic pressure
test at least every five years to ensure that the meter provers used in
the flow of liquid hazardous materials into bulk packagings are
accurate and in conformance with the performance standards in the HMR.
    (3) Each meter prover must successfully complete the test and
inspection and must be marked in accordance with 173.5a.
    (4) Each owner must retain a record of the most recent visual
inspection and pressure test until the meter prover is requalified.
    Affected Public: Owners of meter provers used to measure liquid
hazardous materials flow into bulk packagings such as cargo tanks and
portable tanks.

Annual Reporting and Recordkeeping Burden

    Number of Respondents: 50.
    Total Annual Responses: 250.
    Total Annual Burden Hours: 175.
    Frequency of collection: On occasion.
    Title: Requirements for United Nations (UN) Cylinders.
    OMB Control Number: 2137-0621.
    Summary: This information collection and recordkeeping burden is
the result of efforts to amend the HMR to adopt standards for the
design, construction, maintenance, and use of cylinders and multiple-
element gas containers (MEGCs) based on the standards contained in the
United Nations (UN) Recommendations on the Transport of Dangerous
Goods. Aligning the HMR with the UN Recommendations promotes
flexibility, permits the use of technological advances for the
manufacture of the pressure receptacles, provides for a broader
selection of pressure receptacles, reduces the need for special
permits, and facilitates international commerce in the transportation
of compressed gases. Information collection requirements address
domestic and international manufacturers of cylinders that request
approval by the approval agency for cylinder design types. The approval
process for each cylinder design type includes review, filing, and
recordkeeping of the approval application. The approval agency is
required to maintain a set of the approved drawings and calculations
for each design it reviews and a copy of each initial design type
approval certificate approved by the Associate Administrator for not
less than 20 years.
    Affected Public: Fillers, owners, users, and retesters of UN
cylinders.

Annual Reporting and Recordkeeping Burden

    Number of Respondents: 50.
    Total Annual Responses: 150.
    Total Annual Burden Hours: 900.
    Frequency of collection: On occasion.

    Dated: May 5, 2014.
Charles E. Betts,
Director, Standards and Rulemaking Division.
[FR Doc. 2014-10575 Filed 5-7-14; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 80, Number 115 (Tuesday, June 16, 2015)]
[Notices]
[Page 34400]
[FR Doc No: 2015-14736]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Commision Staff Attendance

    The Federal Energy Regulatory Commission hereby gives notice that
members of its staff may attend the following meeting related to the
transmission planning activities of the Southwest Power Pool, Inc.
(SPP).
    Special SPP Board of Directors/Members Committee Teleconference
    June 15, 2015 (10:00 a.m.-11:00 a.m. CDT)
    The call in information for the above-referenced meeting is:
    Teleconference: Dial In:<PHONE_NUMBER> Passcode: 157403
    The above-referenced meeting is open to the public.
    Further information may be found at www.spp.org.
    The discussions may address matters at issue in the following
proceedings:
    Docket No. ER13-366, Southwest Power Pool, Inc.
    Docket No. ER13-367, Southwest Power Pool, Inc.
    Docket No. ER15-509, Southwest Power Pool, Inc.
    For more information, contact Jay Sher, Office of Energy Market
Regulation, Federal Energy Regulatory Commission at<PHONE_NUMBER> or
<EMAIL_ADDRESS>
    Dated: June 8, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-14736 Filed 6-15-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 182 (Tuesday, September 20, 2011)]
[Rules and Regulations]
[Pages 58105-58108]
[FR Doc No: 2011-24051]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0857]
RIN 1625-AA11

Regulated Navigation Area; Saugus River, Lynn, MA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a Regulated Navigation Area
(RNA) on the navigable waters of the Saugus River in Lynn,
Massachusetts. This temporary rule allows the Coast Guard to suspend
all vessel traffic within the regulated area to allow for stabilization
operations that could pose a safety hazard to vessels operating in the
area. This temporary rule is necessary to enhance vessel safety, marine
environmental protection, and provide for the safety of life on the
navigable waters during the removal of a damaged section of the Energy
Systems Pipeline Bridge at Mile 2.3 of the Saugus River.

DATES: This rule is effective in the CFR on September 20, 2011 until 5
p.m. on November 9, 2011. This rule is effective with actual notice for
purposes of enforcement from 8 a.m. on September 12, 2011 until 5 p.m.
on November 9, 2011.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2011-0857 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-0857 in the
``Keyword'' box, and then clicking ``Search.'' 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
temporary rule, call or e-mail Mr. Mark Cutter, U.S. Coast Guard Sector
Boston Waterways Management Division, Coast Guard; telephone 617-223-
4000, e-mail<EMAIL_ADDRESS>or Lieutenant Junior Grade Isaac
Slavitt, Coast Guard First District Waterways Management Branch,
telephone<PHONE_NUMBER>, e-mail<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:

Regulatory Information

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedures Act (APA), 5 U.S.C. 553(b). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule; notice and comment is impracticable because
immediate action is necessary to ensure the safety of the public in the
vicinity of construction operations being conducted in the Saugus
River.
    Serious damage to this pipeline bridge was caused during Tropical
Storm Irene, which passed through Boston on 28 August, 2011. Currently,
the pipeline is leaning over precariously and is in danger of
collapsing. Two phases of work are needed for this pipeline:
stabilization (which may include removal of the damaged segment), and
then full removal at a later date. This rule addresses only emergency
stabilization efforts. A separate rule will be promulgated with normal
notice and comment periods for the longer term full repair project.
    On September 1, 2011, General Electric, the pipeline operators,
advised that the Energy Systems Pipeline bridge demolition project
would require periodic closures of the Saugus River at mile 2.3 to
remove the damaged piping support structure. The hazard that the
damaged portion of the Energy Systems Pipeline bridge poses to the
navigational channel necessitates that all mariners comply with this
RNA. Immediate action is needed to control vessels operating in the
restricted waterway in order to facilitate repairs and to protect the
maritime public from the hazards associated with the stabilization of
this damaged structure. Publishing a NPRM and waiting 30 days for
comment would be contrary to the public interest since immediate action
is needed to restrict

vessel traffic to effect repairs and to protect the maritime public
from the hazards associated with removal of the damaged section of the
structure, including falling debris and the use of heavy machinery.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective fewer than 30 days after
publication in the Federal Register. Any delay would be both
impracticable and contrary to the public interest. Immediate action is
necessary for the reasons discussed above, supporting good cause under
5 U.S.C. 553(b)(B).

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 determined
to have hazardous conditions and in which vessel traffic can be
regulated in the interest of safety. See 33 U.S.C. 1231 and Department
of Homeland Security Delegation No. 0170.1.
    The purpose of this temporary rule is to facilitate the removal of
the damaged piping support structure for the Energy Systems Pipeline
Bridge located at approximately mile 2.3 of the Saugus River in Lynn,
MA. Establishing this temporary rule will allow the necessary
stabilization work to be completed and will protect the maritime public
from the hazards associated with the demolition of this damaged
structure. This structure is in danger of collapse and its
stabilization allows for the future safe transit of vessels in the
area.

Discussion of Rule

    This action is intended to prohibit vessel traffic on a portion of
the Saugus River, when necessary for the safety of navigation, while
work is done on the Energy Systems Pipeline Bridge on the Saugus River
in Lynn, MA. The regulated area encompasses all waters within 100 yards
of either side of the Energy Systems Pipeline Bridge. The Coast Guard
may close the area described in this rule to all vessel traffic during
any circumstance, planned or unforeseen, that poses a threat to
waterway users operating in the area. Complete waterway closures will
be made with as much advance notice as possible.
    The project consists of stabilization, cutting and removal of
damaged abandoned pipeline and associated steel support structure.
Demolition operations will temporarily block the navigable channel due
to positioning of a barged-based lifting crane, a deck barge, and an
associated towing vessel.
    Entry into this RNA during a closure is prohibited unless
authorized by the Sector Boston Captain of the Port (COTP). In the
event of an emergency, all construction equipment shall be removed from
the channel to allow for emergency vessels to pass. Any violation of
this rule is punishable by, among others, civil and criminal penalties,
in rem liability against the offending vessel, and the initiation of
suspension or revocation proceedings against Coast Guard-issued
merchant-mariner credentials.
    The Captain of the Port (COTP) Boston will cause notice of
enforcement, suspension of enforcement, or closure of the waterway to
be made by all appropriate means for the widest distribution among the
affected segments of the public. Such means of notification may
include, but are not limited to, Broadcast Notice to Mariners and Local
Notice to Mariners.

Regulatory Analyses

    We developed this temporary final 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.

Executive Order 12866 and Executive Order 13563

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, 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 economic impact of this rule will be severely limited for the
following reasons: (1) The actual waterway restriction imposed by this
RNA is expected to last no longer than 12 hours at a time; (2)
demolition work that restricts the navigational channel will be
scheduled when there is limited demand for this navigational channel;
and (3) advance notification will be made to the maritime community via
Local Notice to Mariners, Broadcast Notice to Mariners, and on the
Internet at http://homeport.uscg.mil/boston.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this 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 rule will
not have a significant economic impact on a substantial number of small
entities. This rule will affect the following entities, some of which
may be small entities: the owners or operators of vessels intending to
transit in a portion of the Saugus River during periods of construction
until the Energy Systems Pipeline bridge has been structurally
stabilized. Several small marinas up-river from the damaged pipeline
may also be affected.
    This rule will not have a significant economic impact on a
substantial number of small entities for the following reasons:
although the regulated navigation area will apply to the entire width
of the Saugus River navigational channel, restriction of vessel traffic
will be limited to not more than 12 hours at a time and response to
traffic demand will be coordinated in advance by the Captain of the
Port Boston in consultation with the harbormaster of Lynn, MA. Before
the effective period, we will issue maritime advisories widely
available to users of the waterway. Additionally, because of the
dangerous and unstable nature of the damaged pipeline, many vessel
operators may have independently reached the conclusion that it is too
dangerous to pass underneath. Therefore, the inherent danger of the
damaged pipeline is probably already preventing vessel operators from
passing through.
    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 offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of federal
employees who enforce, or otherwise determine compliance with, federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The

Ombudsman evaluates these actions annually and rates each agency's
responsiveness to small business. If you wish to comment on actions by
employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). 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 rule calls 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 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 rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

Taking of Private Property

    This rule will 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 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 rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does 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 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 rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this 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 concluded
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded, under figure 2-1, paragraph (34)(g), of
the Instruction. This rule involves the establishment of a RNA. An
environmental analysis checklist and a categorical exclusion
determination will be available in the docket where indicated under
ADDRESSES.

List of Subjects in 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 amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1226, 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, 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T01-0857 to read as follows:

Sec.  165.T01-0857  Regulated Navigation Area; Saugus River, Lynn MA.

    (a) Regulated Area. The following area is a regulated navigation
area: all waters within 100 yards of either side of the Energy Systems
Pipeline Bridge at approximately mile 2.3 of the Saugus River in
position 42[deg]26'56'' N, 070[deg] 58'31'' W, in Lynn, MA. All
geographic coordinates are North American Datum of 1983 (NAD 83).
    (b) Regulations.
    (1) The general regulations contained in 33 CFR 165.13 apply.
    (2) No vessel may enter or transit through the regulated area
during enforcement periods without the express permission of the
Captain of the Port (COTP) Boston.
    (3) Vessels transiting through the RNA with COTP permission are
required to do so at reduced speed so as to produce no wake. Vessels
transiting through the RNA with COTP permission must still remain at
least 150 feet away from all demolition equipment.
    (c) Effective Period. This rule is effective from 8 a.m. on
September 12, 2011 until 5 p.m. on November 9, 2011.
    (d) Enforcement Period. This rule will be enforced when necessary
for construction operations. The COTP Boston will cause notice of
enforcement periods to be made by reasonable means, which may include
but are not limited to a Broadcast Notice to Mariners.

    Dated: September 9, 2011.
D. A. Neptun,
Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District.
[FR Doc. 2011-24051 Filed 9-19-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 79 (Monday, April 25, 2016)]
[Notices]
[Pages 24107-24108]
[FR Doc No: 2016-09450]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-P-3299]

Determination That THALITONE (Chlorthalidone USP) Tablets, 15
Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that THALITONE (chlorthalidone USP) tablets, 15 milligrams
(mg), were not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for

chlorthalidone USP tablets, 15 mg, if all other legal and regulatory
requirements are met.

FOR FURTHER INFORMATION CONTACT: Christopher Koepke, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6214, Silver Spring, MD 20993-0002, 240-
402-3543.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    THALITONE (chlorthalidone USP) tablets, 15 mg, are the subject of
NDA 19-574, held by Citron Pharma LLC, and initially approved on
December 20, 1988. THALITONE is indicated for the management of
hypertension either alone or in combination with other antihypertensive
drugs. Chlorthalidone is indicated as an adjunctive therapy in edema
associated with congestive heart failure, hepatic cirrhosis, and
corticosteroid and estrogen therapy. Chlorthalidone has also been found
useful in edema due to various forms of renal dysfunction such as
nephrotic syndrome, acute glomerulonephritis, and chronic renal
failure.
    THALITONE (chlorthalidone USP) tablets, 15 mg, are currently listed
in the ``Discontinued Drug Product List'' section of the Orange Book.
    Clinipace Worldwide submitted a citizen petition dated September 9,
2015 (Docket No. FDA-2015-P-3299), under 21 CFR 10.30, requesting that
the Agency determine whether THALITONE (chlorthalidone USP) tablets, 15
mg, were withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information, FDA has determined under Sec.  314.161
that THALITONE (chlorthalidone USP) tablets, 15 mg, were not withdrawn
for reasons of safety or effectiveness. The petitioner has identified
no data or other information suggesting that THALITONE (chlorthalidone
USP) tablets, 15 mg, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of THALITONE (chlorthalidone USP) tablets, 15
mg, from sale. We have also independently evaluated relevant literature
and data for possible postmarketing adverse events. We have reviewed
the available evidence and determined that this drug product was not
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list THALITONE
(chlorthalidone USP) tablets, 15 mg, in the ``Discontinued Drug Product
List'' section of the Orange Book. The ``Discontinued Drug Product
List'' delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to THALITONE (chlorthalidone USP)
tablets, 15 mg, may be approved by the Agency as long as they meet all
other legal and regulatory requirements for the approval of ANDAs. If
FDA determines that labeling for this drug product should be revised to
meet current standards, the Agency will advise ANDA applicants to
submit such labeling.

    Dated: April 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09450 Filed 4-22-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 86 (Friday, May 5, 2017)]
[Notices]
[Pages 21227-21228]
[FR Doc No: 2017-09120]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL17-68-000]

Linden VFT, LLC v. PJM Interconnection, L.L.C.; Notice of
Complaint

    Take notice that on April 28, 2017, pursuant to sections 206 and
306 of the Federal Power Act, 16 U.S.C. 824e and 825e, and Rules 206
and 215 of the Federal Energy Regulatory Commission's (Commission)
Rules of Practice and Procedure, 18 CFR 385.206 and 385.215, Linden
VFT, LLC (Linden VFT or Complainant) filed a formal complaint against
PJM Interconnection, L.L.C. (PJM or Respondent) alleging that (i) PJM
does not have the authority to reallocate certain costs associated with
Regional Transmission Expansion Plan projects b2436 and b2437 (BLC),
(ii) PJM did not reallocate such cost using a methodology contained in
the PJM Open Access Transmission Tariff, (iii) the PJM BLC cost
reallocations are unjust, unreasonable and unduly discriminatory and
preferential, all as more fully explained in the complaint.
    Complainant certifies that copies of the complaint were served on
the contacts for Respondent as listed on the Commission's list of
Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to

intervene, and protests must be served on the Complainant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on May 18, 2017.

    Dated: May 1, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-09120 Filed 5-4-17; 8:45 am]
BILLING CODE 6717-01-P


ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 124, Subpart H
[EPA-HQ-XXX-XXX-XXXX; FRL-XXXX-XX]
RIN XXXX-XXXX
Strengthening Transparency and Validity in Regulatory Science
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed Rule.
SUMMARY: This notice proposes a regulation intended to strengthen the transparency and validity of EPA regulatory science. The proposed regulation provides that EPA shall ensure that the regulatory science underlying its actions is publicly available in a manner sufficient for independent validation. When EPA develops regulations, including regulations for which the public is likely to bear the cost to comply, using public resources, EPA should require that the underlying scientific information is available to the public. In this notice, EPA solicits comment on this proposal and how it can best be promulgated and implemented in light of existing law and prior policies calling for increasing public access to data and influential scientific information used to inform federal regulation.
DATES: Comments must be received on or before [Insert date 30 days after publication date].
ADDRESSES: Submit your comments, identified by Docket ID No. EPA - HQ - XXXX - XXXX, at http:// www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/ commenting-epa-dockets.
FOR FURTHER INFORMATION, CONTACT: EPA, Office of the Science Advisor, 1200 Pennsylvania Avenue NW, Washington, DC 20460.
SUPPLEMENTARY INFORMATION:
Submitting CBI. Do not submit information that you consider to be CBI electronically through http://www.regulations.gov or email. Send or deliver information identified as CBI to only the following address: OAQPS Document Control Officer (Room C404-02), Environmental Protection Agency, Research Triangle Park, North Carolina 27711; Attn: Docket ID No. EPA - HQ - OAR - 2017 - 0545.

      Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. If you submit a CD-ROM or disk that does not contain CBI, mark the outside of the disk or CD-ROM clearly that it does not contain CBI. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 Code of Federal Regulations (CFR) part 2.

Organization of This Document. The following outline is provided to aid in locating information in this preamble.

 General Information
 Does this Action Apply to Me?
 What action is the Agency taking?
 What is the Agency's Authority for taking this action?
 Background
 Request for Comment
 Statutory and Executive Orders

 General Information
       A.  Does this action apply to me?
 This proposed regulation does not directly regulate any entity outside the federal government. However, any entity interested in EPA's regulations may be interested in this proposal. This proposal may be of particular interest to entities that conduct research and other scientific activity that is likely to be relevant to EPA's regulatory activity.
      B.  What action is the agency taking?
This notice solicits information and comment from the public on a proposed regulation intended to issue to strengthen the transparency and validity of EPA regulatory science. The proposed regulation provides that EPA shall ensure that the regulatory science underlying its actions is publicly available in a manner sufficient for validation. In this notice, EPA solicits comment on this proposal and how it can best be implemented in light of existing law and prior statements of policy that have called for increasing public access to data and influential scientific information used to inform federal regulation. EPA has not previously implemented these policies and guidance in a robust and consistent manner. This proposal will help ensure that EPA is pursuing its mission of protecting public health and the environment in a manner that the public can trust and understand.

       C.  What is the agency's authority for taking this action?
The Agency proposes to take this action under its authority to promulgate regulations necessary to carry out the Agency's functions under the statutes it administers, including that provided under Clean Air Act § 301(a); Clean Water Act § 501; Safe Drinking Water Act § 1450(a)(1); Resource Conservation and Recovery Act § 2002(a)(1); Comprehensive Environmental Response, Compensation, and Liability Act § 115, as delegated to the Administrator via Executive Order 12580; Emergency Planning and Community Right-To-Know Act § 328; Federal Insecticide, Fungicide, and Rodenticide Act § 25(a)(1); Toxic Substances Control Act, as amended, § 26(h). This action is consistent with requirements in the Administrative Procedure Act to ensure public participation in the rulemaking process.  As noted in Section III below, EPA solicits comment on whether additional or alternative sources of authority are appropriate bases for this proposed regulation.

 Background
Sound science must serve as the foundation of EPA's regulatory actions. Enhancing transparency and validity of the scientific information relied upon by EPA strengthens the integrity of EPA's regulatory actions, and better informs the public about the science used in the regulatory process. EPA must apply the best available science to its regulatory decision-making in a way that complies with federal transparency and data integrity laws, and that ensures independence, objectivity, transparency, clarity, and reproducibility. Although these standards are important in all scientific endeavors, they are of paramount importance when the government relies on science to inform its regulatory decisions that will bind members of the public. When EPA develops regulations using public resources, including regulations for which the public is likely to bear the cost to comply, EPA should require that the underlying scientific information is available to the public. This proposed rule will ensure that there is transparency in the preparation, identification, and use of science in policymaking.
This action follows basic principles of proper administration, including the requirements in the Administrative Procedure Act and programmatic statutes that EPA administers to disclose to the public the bases for agency rules and to rationally execute and adequately explain agency actions.  This proposed rule is also consistent with Executive Orders 13777 and 13783, and builds upon prior EPA actions, data access and sharing policies of other federal agencies, as well as policies or recommendations of third party organizations and major scientific journals.
Today, EPA is proposing to establish a clear policy for transparency and validity of the scientific information used for regulation. With this notice, EPA is soliciting public comment on a proposed regulation designed to ensure all future EPA final agency actions are based on transparent, reproducible science. This proposed regulation is intended to provide a mechanism to increase access to EPA regulatory science while protecting sensitive information. This action will ensure that the best available science that provides the justification for regulation includes information that is truly available for validation.
Regulatory determinations based on science should describe and document any assumptions and methods used, and should address variability, uncertainty, the degree of independent verification and peer review. EPA expects that regulatory decisions will be based on the weight of the publicly available scientific evidence and consider all information in a transparent and integrative framework. Particularly for EPA programs that evaluate information to determine whether a causal relationship exists between a pollutant/chemical and a specific effect, EPA should utilize a weight of evidence approach that considers and integrates all lines of evidence in a consistent manner and make determinations on the totality of the evidence. Where available and appropriate, EPA will use peer-reviewed information, standardized test methods, consistent data evaluation procedures, and good laboratory practices to ensure transparent, understandable, and reproducible scientific assessments. While the scientific community has identified some fundamental issues with peer review in recent years, EPA's regulatory science should be consistent with its 2015 Peer Review Handbook and the Office of Management and Budget's Final Information Quality Bulletin for Peer Review.

EPA has not consistently followed previous EPA policy that encouraged the use of non-proprietary data and models.  EPA's regulatory science will be based on transparent data and model alternatives.
Transparency and validity in regulatory science addresses many potential issues for key studies, including identifying confounders and inconsistent findings in the data. Despite growing empirical evidence of non-linearity in the concentration-response function for specific pollutants and health effects, EPA has often based its assessments on a default model that assumes a linear, no-threshold dose response. To address these complex relationships, EPA should give greater weight to high quality studies that explore: a broad class of parametric concentration-response models with a robust set of potential confounding variables; nonparametric models that incorporate fewer assumptions; various threshold models across the exposure range; and geographic consistency that addresses spatial heterogeneity in many key studies.

Across EPA programs, much of the science that informs regulatory actions is developed outside the Agency. In the era of "big data" as well as the "replication crisis" across scientific disciplines (in which a significant proportion of published research may be false or not reproducible), it is the charge of regulators to ensure that key findings are valid and credible. Using scientific information that can be independently validated will lead to better outcomes, and strengthen public confidence in the health and environmental protections underpinning EPA's regulatory actions.
This proposed regulation is intended to apply prospectively to final agency actions. The Agency's offices should, however, be guided by this policy to the maximum extent practicable during ongoing regulatory action, even where such research has already been generated, solicited, or obtained.
This action focuses on ensuring that the information used in regulation is publicly available in a manner sufficient for independent validation. These requirements are consistent with recent activities in the scientific community and reflect definitions of research reproducibility across scientific disciplines. Considering the breadth of scientific information used in various EPA programs, the requirements for availability may differ. These mechanisms may range from, consistent with requirements for many scientific journals, deposition in public data repositories to, for certain types of information, controlled-access in federal research data centers for secondary research use by the public.
Implementation of this proposed rule will be consistent with the definition of "research data" in Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, exemptions in P.L. 89-487, and other applicable federal laws. EPA believes that concerns about access to confidential or private information are without merit. Nothing in the proposed rule compels the disclosure of any information. Other federal agencies have developed tools and methods to de-identify private information for a variety of disciplines. The National Academies have noted that simple data masking, coding, and de-identification techniques have been developed over the last half century and that "Nothing in the past suggests that increasing access to research data without damage to privacy and confidentiality rights is beyond scientific reach."

 Request for Comment
EPA solicits comment on all aspects of the proposed regulation and the bases articulated for it above. Specifically, EPA believes that it has identified appropriate sources of statutory authority for this proposed regulation in Section I(c) above, and solicits public comment on whether additional or alternative sources of authority are appropriate bases for this proposed regulation. EPA further believes that a generally applicable regulatory provision of the type proposed here is the appropriate vehicle to establish and implement the policies articulated in Section II above, in the interests of consistency, predictability, and transparency across the functions that EPA performs.
EPA solicits comment on whether alternative or additional regulatory or other policy vehicles are appropriate to establish and implement these policies, and whether further regulatory or other policy vehicles at the programmatic or statutory level would be appropriate as alternative or additional steps the agency may take to further the policies articulated in Section II above.
EPA solicits comment on the effects of this proposed rule on individual EPA programs, including whether certain activities are appropriate to be excepted (§ 124.222) or if other requirements would affect implementation (§ 124.223).
Although the proposed regulatory text (at proposed § 124.218) would impose requirements specifically on final agency action, EPA solicits comment on whether and to what extent these requirements, or other provisions and policies, should apply to other stages of the rulemaking process, including proposed rules, as well as to other types of agency actions and promulgations, such as guidance. EPA also solicits comments on whether and how EPA should apply these principles to EPA-funded science that does not provide the basis for regulation. EPA also solicits suggestions for a platform that would enable the Agency to implement this proposed regulation.
Furthermore, EPA seeks comment related to whether and how EPA, when utilizing a weight of evidence approach for regulatory determinations, whether and how EPA should give greater weight to scientific information that is more transparent and/or independently validated. EPA seeks comment on how to address a circumstance in which EPA has a statutory requirement to make a determination for which scientific information publicly available in a manner sufficient for independent validation does not exist. EPA also solicits comment on how EPA can build upon other federal agencies' policies regarding data access and data sharing in order to ensure consistency and confidentiality.
 Statutory and Executive Orders Reviews
A.	Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review
This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review. Any changes made in response to OMB recommendations have been documented in the docket.
B.	Executive Order 13771: Reducing Regulations and Controlling Regulatory Costs
This action is not expected to be an Executive Order 13771 regulatory action because it relates to "agency organization, management or personnel."
C. Paperwork Reduction Act (PRA)
This action does not contain any information collection activities and therefore does not impose an information collection burden under the PRA.
D. Regulatory Flexibility Act (RFA)
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities.
E. Unfunded Mandates Reform Act (UMRA)
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531 - 1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.
F. Executive Order 13132: Federalism

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
G.	Executive Order 13175: Consultation and Coordination with Indian Tribal Governments
This action does not have tribal implications as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action.
H.	Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of "covered regulatory action" in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
I. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use
This action is not a "significant energy action" because it is not likely to have a significant adverse effect on the supply, distribution or use of energy.
J. National Technology Transfer and Advancement Act (NTTAA)
This rulemaking does not involve technical standards.
K.	Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations
The EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard.
L. Congressional Review Act (CRA)
This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a "major rule" as defined by 5 U.S.C. 804(2).

 List of Subjects in 40 CFR Part 124: Environmental protection, Administrative practice and procedure, Air pollution control, Hazardous waste, Indians-lands, Reporting and recordkeeping requirements, Water pollution control, Water supply.

Dated: __________________________________.

________________________________________

For the reasons set forth in the preamble, EPA proposes to amend 40 CFR part 124 [as follows:

PART 124 - PROCEDURES FOR DECISIONMAKING

      Authority: The authority citation for Part 124 is amended to read as follows:
Resource Conservation and Recovery Act, 42 U.S.C. 6901 et seq.; Safe Drinking Water Act, 42 U.S.C. 300f et seq.; Clean Water Act, 33 U.S.C. 1251et seq.; Clean Air Act, 42 U.S.C. 7401et seq.; Comprehensive Environmental Response, Compensation, and Liability Act, 42 U.S.C. 9601 et seq.; Emergency Planning and Community Right-To-Know Act, 42 U.S.C. 11001 et seq.; Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq.; Toxic Substances Control Act, 15 U.S.C. 2601 et seq.

xx. Add subpart H, consisting of sections 124.215 through 124.223, to part 124 to read as follows:
Subpart H  -  Strengthening Transparency and Validity in Regulatory Science

Sec.

§ 124.215	What is the purpose of this subpart?
§ 124.216.	What definitions apply to this subpart?
§ 124.217.	How do the provisions of this subpart apply?
§ 124.218.	What requirements apply to EPA's use of studies in taking final action?
§ 124.219.	What requirements apply to EPA's regulatory determinations and decisions that 			are based on science?
§ 124.220.	How do requirements address use of certain EPA models and default assumptions?
§ 124.221.	What role does independent peer review play in EPA decision making?
§ 124.222.	How is EPA to account for cost under this subpart?
§ 124.223.	May EPA grant exceptions to this subpart?
§ 124.224.	What other requirements apply under this subpart?

Subpart H  -  Strengthening Transparency and Validity in Regulatory Science

§ 124.215.	What is the purpose of this subpart?

      This subpart directs EPA to ensure that the regulatory science underlying its actions is publicly available in a manner sufficient for independent validation.

§ 124.216.	What definitions apply to this subpart?

	As used in this subpart, all terms not defined herein shall have the meaning given them in the Act or in subpart A; and the following terms shall have the specific meanings given them.

	Regulatory science means scientific information, including assessments, models, criteria documents, and regulatory impact analyses, that provide the basis for EPA final agency action.

	Research data means "research data" as that term is defined in Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.

§ 124.217.	How do the provisions of this subpart apply?

	The provisions of this section apply regardless of the source of funding or identity of the party conducting the regulatory science. The provisions of this section do not apply to physical objects (like laboratory samples), drafts, and preliminary analyses.

§ 124.218.	What requirements apply to EPA's use of studies in taking final action?

	EPA shall clearly identify all studies (or other regulatory science) relied upon when it takes final agency action. The Agency shall ensure that the scientific and technical information supporting these studies will be publicly available in a manner sufficient for independent validation. Information "publicly available in a manner sufficient for independent validation" consists of information necessary for the public to understand, assess, and replicate findings. This includes, for example: data and associated protocols necessary to understand, assess, and extend conclusions; computer codes and models involved in the creation and analysis of such information; recorded factual materials; and detailed descriptions of how to access and use such information. The provisions of this section apply to regulatory science regardless of who funded or conducted the underlying research.

§ 124.219.	What requirements apply to EPA's regulatory determinations and decisions that are based on science?

	Regulatory determinations based on science should describe and document any assumptions and methods used, and should address variability, uncertainty, the degree of independent verification and peer review. EPA expects that regulatory decisions be based on the weight of the publicly available scientific evidence and consider all information in a transparent and integrative framework. Particularly for EPA programs that evaluate information to determine whether a causal relationship exists between a pollutant/chemical and a specific effect, EPA should utilize a weight of evidence approach that considers and integrates all lines of evidence in a consistent manner and make determinations on the totality of the evidence. Where available and appropriate, EPA will use peer-reviewed information, standardized test methods, consistent data evaluation procedures, and good laboratory practices to ensure transparent, understandable, and reproducible scientific assessments.

§ 124.220. 	How do requirements address use of certain EPA models and default assumptions?

      Transparency in regulatory science addresses issues associated with EPA's reliance on certain default models and assumptions, including the use of a default model that assumes a linear, no-threshold dose response despite growing empirical evidence of non-linearity in the concentration-response function for specific pollutants or chemicals and health effects. EPA shall give greater weight to high quality studies that explore: a broad class of parametric concentration-response models with a robust set of potential confounding variables; nonparametric models that incorporate fewer assumptions; various threshold models across the exposure range; and geographic consistency that addresses spatial heterogeneity in many key studies.

§ 124.221.	What role does independent peer review play in EPA decision making?

	EPA shall conduct independent peer review on influential scientific information that Agency intends to disseminate to the public or use as the basis for regulation.

§ 124.222.	How is EPA to account for cost under this subpart?

	EPA shall implement the provisions of this subpart in a manner that minimizes costs.

§ 124.223.	May EPA grant exceptions to this subpart?

	Yes. The Administrator may grant exemptions to the provisions of this section on a case-by-case basis.

§ 124.224.	What other requirements apply under this subpart?

	EPA shall implement the provisions of this section consistent with the definition of "research data" in Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, exemptions in P.L. 89-487, and other applicable federal laws. Where appropriate, data sharing agreements and state-of-the-art data-masking techniques may be employed to facilitate access to information. The provisions of this section do not create any right or benefit, substantive or procedural, enforceable at law or equity by a party against the United States, EPA, its officers or employees, or any other person.


[Federal Register: March 9, 2009 (Volume 74, Number 44)]
[Rules and Regulations]
[Page 9956-9958]
[DOCID:fr09mr09-4]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2009-0063]
RIN 1625-AA00

Safety Zone; Coast Guard Air Station San Francisco Airborne Use
of Force Judgmental Training Flights

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone in the
navigable waters of the San Pablo Bay, CA for training purposes. This
safety zone is established to ensure the safety of the public and
participating crews from potential hazards associated with fast-moving
Coast Guard smallboats taking part in the exercise. Unauthorized
persons or vessels are prohibited from entering into, transiting
through, or remaining in the safety zone without permission of the
Captain of the Port San Francisco or his designated representative.

DATES: This safety zone is effective from 9 a.m. on February 10, 2009,
until 10 p.m. on March 20, 2009.

ADDRESSES: Comments and materials received from the public, as well as
documents indicated in this preamble as being available in the docket,
are part of docket USCG-2009-0063 and are available online at http://
www.regulations.gov, selecting the Advanced Docket Search option on the
right side of the screen, inserting USCG-2009-0063 in the Docket ID
box, pressing Enter, and then clicking on the item in the Docket ID
column. This material is also available for inspection or copying at
two locations: 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, and Coast Guard Sector
San Francisco, 1 Yerba Buena Island, San Francisco, California 94130,
between 9 a.m. and 4 p.m., Monday through Friday, except Federal
holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call Lieutenant Junior Grade Megan Clifford, U.S. Coast
Guard Sector San Francisco, at<PHONE_NUMBER>. If you have questions on
viewing the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    Due to the dynamic availability of Coast Guard assets to conduct
this training, the Coast Guard is issuing this final rule without prior
notice and opportunity to comment pursuant to authority under section
(a)(1) of the Administrative Procedure Act (APA) (5 U.S.C. 553). This
provision creates a military function exception to the advance
publication requirements. Because of the potential hazards posed by
this exercise, the safety zone is necessary to provide for the safety
of the public, participating vessels and crews, and other vessels
transiting the area. For the safety concerns noted, it is in the public
interest to have these regulations in effect during the event.
    Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause
exists for not publishing a notice of proposed rulemaking (NPRM) with
respect to this rule because any delay in the effective date of this
rule would expose mariners to the potential hazards posed by the
exercises. For the same reasons as above, under 5 U.S.C. 553(d)(3), the
Coast Guard finds that good cause exists for making this rule effective
less than 30 days after publication in the Federal Register.

Background and Purpose

    U.S. Coast Guard Air Station San Francisco will be conducting
airborne use of force judgmental training flights with observers from
the Coast Guard Aviation Training Center and Coast Guard Headquarters,
on February 10, and March 5 through 20, 2009 (excluding Saturdays and
Sundays), in the waters of San Pablo Bay. The exercises are designed to
train and test Coast Guard aviation personnel in the judgmental
decision-making process necessary to safely and effectively employ use
of force from a helicopter

during homeland security incidents. The training will generally involve
the use of Coast Guard helicopters to intercept fast-moving, evasive
smallboats on the water. The helicopter crews will fire weapons at the
smallboats using blank ammunition and catch bags to ensure that
cartridges and other debris do not fall to the water. This safety zone
is issued to establish a temporary restricted area in San Pablo Bay
around the training site.

Discussion of Rule

    The Coast Guard is establishing a temporary safety zone in the
navigable waters of San Pablo Bay. During the exercises the safety zone
applies to the navigable waters, from the surface to the seafloor,
defined by enclosing an area between the following points:
38[deg]05'11'' N, 122[deg]22'10'' W; 38[deg]03'44'' N, 122[deg]20'12''
W; 38[deg]00'41'' N, 122[deg]25'28'' W; and 38[deg]01'45'' N,
122[deg]26'38'' W (NAD 83).
    The effect of the temporary safety zone will be to restrict
navigation in the vicinity of the exercise.
    Except for persons or vessels authorized by the Coast Guard Patrol
Commander, no person or vessel may enter or remain in the restricted
area. These regulations are intended to keep the public a safe distance
away from the participating smallboats and to ensure the safety of
transiting vessels.

Regulatory Analyses

    We developed this 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

    This 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.
    Although this rule restricts access to the waters encompassed by
the safety zone, the effect of the rule will not be significant because
the safety zone is in an area of San Pablo Bay not heavily used by
commercial traffic and because local waterway users will be notified
via Broadcast Notice to Mariners to ensure minimum impact. The entities
most likely to be affected are pleasure craft engaged in recreational
activities.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this 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 rule will
not have a significant economic impact on a substantial number of small
entities.
    This rule may affect owners and operators of pleasure craft engaged
in recreational activities and sightseeing. This rule will not have a
significant economic impact on a substantial number of small entities
for several reasons: (i) Vessel traffic can pass safely around the
area, (ii) vessels engaged in recreational activities and sightseeing
have ample space outside of the effected portion of the San Pablo Bay
to engage in these activities, (iii) this rule will encompass only a
small portion of the waterway for limited periods of time, and (iv) the
maritime public will be advised in advance of and during the
enforcement of this safety zone via Broadcast Notice to Mariners.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). 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 rule calls 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 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 rule will not result in such an expenditure, we
do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not effect 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 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 rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does 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 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 rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 5100.1 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 concluded
under the Instruction that there are no factors in this case that would
limit the use of a categorical exclusion under section 2.B.2 of the
Instruction. Therefore, this rule is categorically excluded, under
figure 2-1, paragraph (34)(g), of the Instruction, from further
environmental documentation because this temporary rule establishes a
safety zone.
    An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

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

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1226, 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.

0
2. Add temporary Sec.  165-T11-149 to read as follows:

Sec.  165-T11-149  Safety Zone; Coast Guard Air Station San Francisco
Airborne Use of Force Judgmental Training Flights.

    (a) Location. This temporary safety zone is established for the
navigable waters of the San Pablo Bay, from the surface to the
seafloor, defined by enclosing an area between the following points:
38[deg]05'11'' N, 122[deg]22'10'' W; 38[deg]03'44'' N, 122[deg]20'12''
W; 38[deg]00'41'' N, 122[deg]25'28'' W; and 38[deg]01'45'' N,
122[deg]26'38'' W (NAD 83).
    (b) Definitions. As used in this section, ``Designated
representative'' means a Coast Guard Patrol Commander, including a
Coast Guard coxswain, petty officer, or other officer operating a Coast
Guard vessel or a Federal, State, or local officer assisting the
Captain of the Port (COTP) San Francisco in the enforcement of the
safety zone.
    (c) Regulations. (1) Under the general regulations in Sec.  165.23
of this title, entry into, transiting, or anchoring within this safety
zone is prohibited unless authorized by the COTP or the COTP's
designated representative.
    (2) The safety zone is closed to all vessel traffic, except as may
be permitted by the COTP or the COTP's designated representative.
    (3) Vessel operators desiring to enter or operate within the safety
zone must contact the COTP or the COTP's representative to obtain
permission to do so. Vessel operators given permission to enter or
operate in the safety zone must comply with all directions given to
them by the COTP or the COTP's designated representative. Persons and
vessels may request permission to enter the safety zone by contacting
the Patrol Commander on VHF-16 or through the Coast Guard Command
Center at telephone<PHONE_NUMBER>.
    (d) Enforcement period. This temporary rule will be enforced from 9
a.m. to 5 p.m. on February 10, 2009, and from 10 a.m. to 10 p.m. on
March 5-6, 9-13, and 16-20, 2009.

    Dated: February 9, 2009.
P.M. Gugg,
Captain, U.S. Coast Guard, Captain of the Port, San Francisco.
[FR Doc. E9-4894 Filed 3-6-09; 8:45 am]

BILLING CODE 4910-15-P


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