	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Part 52

	[EPA-R03-OAR-2008-0746; FRL-       ]

	Approval and Promulgation of Air Quality Implementation Plans;

West Virginia; Revised Motor Vehicle Emission Budgets for

the Parkersburg 8-Hour Ozone Maintenance Area

AGENCY:     Environmental Protection Agency (EPA).

ACTION:     Direct final rule.

SUMMARY:  EPA is taking direct final action to approve revisions to the
West Virginia State Implementation Plan (SIP).  The revision amends the
8-hour ozone maintenance plan for the Parkersburg area.  This revision
amends the maintenance plans' 2009 and 2018 motor vehicle emissions
budgets (MVEBs) by reallocating a portion of the plans' safety margins,
which results in an increase in the MVEBs.  The revised plan continues
to demonstrate maintenance of the

8-hour national ambient air quality standard (NAAQS) for ozone.  EPA is
approving this SIP revision to the West Virginia maintenance plan for
Parkersburg in accordance with the requirements of the Clean Air Act
(CAA).

DATES:  This rule is effective on [Insert date 60 days after publication
in the Federal Register]  without further notice, unless EPA receives
adverse written comment by [Insert date 30 days after publication in the
Federal Register].  If EPA receives such comments, it will publish a
timely withdrawal of the direct final rule in the Federal Register and
inform the public that the rule will not take effect.

ADDRESSES:  Submit your comments, identified by Docket ID Number
EPA-R03-OAR-2008-0746 by one of the following methods:

 www.regulations.gov.  Follow the on-line instructions for submitting
comments.

     B.    E-mail<EMAIL_ADDRESS>
     C.    Mail:   EPA-R03-OAR-2008-0746, Carol Febbo, Chief, Energy,
Radiation and Indoor Environment Branch, Mailcode 3AP23, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.

     D.   Hand Delivery: At the previously-listed EPA Region III
address.  Such deliveries are only accepted during the Docket(s normal
hours of operation, and special arrangements should be made for
deliveries of boxed information.

Instructions:  Direct your comments to Docket ID No
EPA-R03-OAR-2008-0746.  EPA's policy is that all comments received 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 information claimed to
be Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov or
e-mail.  The www.regulations.gov website is an (anonymous access(
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment.  If you
send an e-mail comment directly to EPA without going through
www.regulations.gov, your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet.  If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit.  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:  All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute.  Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form.  Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103.  Copies of the State submittal
are available at the West Virginia Department of Environmental
Protection, Division of Air Quality, 601 57th Street SE, Charleston,
West Virginia 25304.

FOR FURTHER INFORMATION CONTACT: Megan Goold<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

Background

On May 8, 2007 (72 FR 25967) EPA redesignated the Parkersburg area of
West Virginia to attainment for the 8-hour ozone NAAQS.  For the
Parkersburg area, the redesignation included approval of an 8-hour ozone
maintenance plan, identifying on-road MVEBs for VOCs and NOX, which are
ozone precursors, used for transportation planning and conformity
purposes.  Subsequently, after the SIP approval by EPA, West Virginia
discovered that the MVEBs which were included in the previously approved
maintenance plan did not provide a sufficient buffer to account for
unforseen future growth or significant changes in the planning
assumption data which was used in developing the original MVEBs in its
September 2006 submission.

II.	Summary of SIP Revision

2009 and 2018 Motor Vehicle Emission Budgets

On August 25, 2008, the State of West Virginia submitted to EPA a formal
revision to its State Implementation Plan (SIP).  The SIP revision
proposes new MVEBs to reflect the reallocation of a portion of the
differences (“safety margins”) between the total base year and total
projected 2009 and 2018 emissions, thus producing an increase in the
MVEBs.  The base year is 2004 for the Parkersburg area.  By increasing
the MVEBs, the West Virginia Department of Environmental Protection
(WVDEP) is ensuring that transportation conformity can be demonstrated
in the Parkersburg area.  The August 25, 2008 submittal, while
increasing the MVEBs, still ensures maintenance of the NAAQS for ozone
for the Parkersburg area.

Tables 1 and 2 and the discussion that follows describe the basis of the
new MVEBs for the Parkersburg area.

Table 1.-- Parkersburg Area Reallocation of Safety Margin to the MVEBs

    Current MVEBs in the Approved Maintenance Plan

(Tons/Day)

2004 Base Year         2009 Projection     2018 Projection

        VOC                      4.00                              3.0
                     1.9

       NOX                       5.66                              4.1
                     2.0

                            Proposed MVEBs in the Revised Maintenance
Plan

(Tons/Day)

                                 2004 Base Year         2009 Projection
   2018 Projection

         VOC                      4.00			    3.8
2.4

         NOX                      5.66	                            5.5
                     2.7

Table 2.-- Parkersburg Area Total Emissions (Point, Area and Mobile)
Before and After Reallocation of Safety Margin to the MVEBs

(Tons/Day)

                                    Current Total Emissions in the
Approved Maintenance Plan

                                        2004 Base Year         2009
Projection     2018 Projection

   VOC                                16.7
14.0                        13.6

   NOX                               15.2
11.8                         9.4

Proposed Total Emissions in the Revised Maintenance Plan

                                    2004 Base Year         2009
Projection     2018 Projection

   VOC                                16.7
14.8                        14.1

    NOX                               15.2
13.2                        10.1

For the Parkersburg, West Virginia 8-hour ozone maintenance area
addressed herein, the WVDEP recalculated the 2009 and 2018 MVEBs using
revised planning data which became available after the original
maintenance plan was submitted to EPA on September 8, 2006.  The 2009
and 2018 MVEBs for VOCs and NOX emissions listed above in Table 1 under
the Proposed MVEBs in the Revised Maintenance Plan section will serve as
the new MVEBs for transportation conformity planning.

As shown in Table 1, above, WVDEP has proposed reallocating a portion of
the previous safety margin into the MVEBs for both VOCs and NOX.  The
remaining surplus emissions have been reserved as residual safety
margins in the total maintenance budgets to ensure continued maintenance
of the 8-hour ozone NAAQS.

To explain how the safety margins are determined and allocated, the VOC
emissions for the Parkersburg area may be used as an example.  In Table
2, listed under the Current Total Emissions in the Approved Maintenance
Plan section, the total 2004 base year VOC emissions are 16.7 tons/day
(tpd), which is the maximum amount of VOC emissions consistent with
maintenance of the 8-hour ozone NAAQS. The total projected 2009
emissions are 14.0 tpd, which provides a 2.7 tpd VOC safety margin
(i.e., the ozone NAAQS would continue to be maintained if total VOC
emissions increased as much as 2.7 tpd above the projected 2009
emissions of 14.0 tpd).  In the Proposed Total Emissions in the Revised
Maintenance Plan section, the total projected emissions for 2009 would
be increased by 0.8 tpd through the increase in the allowable mobile
emissions for VOC while still leaving a safety margin of 1.9 tpd.
Therefore, even with the reallocation of some of the current safety
margin into the MVEBs, the State of West Virginia has left a safety
margin for any other unforseen growth.

III.	Final Action

EPA is approving West Virginia's August 25, 2008 SIP revision submittal
which amends the

8-hour ozone maintenance plan for the Parkersburg area.  These revisions
amend the maintenance plans' 2009 and 2018 MVEBs to reflect the
reallocation of a portion of the plans' safety margins which results in
an increase in the MVEBs.  EPA is approving this SIP revision to the
maintenance plan for the Parkersburg area because the August 25, 2008
submittal continues to demonstrate maintenance of the 8-hour ozone NAAQS
as even after reallocation of a portion of the safety margin a
sufficient safety margin still exists to demonstrate continued
attainment.

EPA notes that the D.C. Circuit issued a decision on July 11, 2008,
vacating the Clean Air Interstate Rule (CAIR).  North Carolina v. EPA,
531 F.3d 896 (D.C. Cir. 2008).  EPA’s CAIR modeling was included in
the last Parkersburg maintenance plan effective June 17, 2007 (72 FR
25967, May 8, 2007) as a supplemental analysis however, EPA’s approval
of that maintenance plan was based on permanent and enforceable measures
(as instructed in the Calcagni memorandum, September 4, 1992).  These
permanent and enforceable measures are sufficient to provide for
continued maintenance even without any CAIR reductions.  EPA did note in
the approval that, in addition to permanent and enforceable measures,
further emissions reductions in the nonattainment area (specifically
Washington County, OH) are largely attributable to CAIR, but these
reductions are not needed to demonstrate maintenance in the area.
Therefore, EPA’s approval of the August 25, 2008 SIP revision is not
impacted by the DC Circuit Court decision as even without any CAIR
reductions the area continues to demonstrate maintenance after
reallocation of a portion of the safety margin.

EPA is publishing this rule without prior proposal because the Agency
views this as a noncontroversial amendment and anticipates no adverse
comment, since no significant adverse comments were received on the SIP
revision at the State level.  However, in the (Proposed Rules( section
of today's Federal Register, EPA is publishing a separate document that
will serve as the proposal to approve the SIP revision if adverse
comments are filed. This rule will be effective on [Insert date 60 days
after publication in the Federal Register] without further notice unless
EPA receives adverse comment by [Insert date 30 days after publication
in the Federal Register].

If EPA receives adverse comment, EPA will publish a timely withdrawal in
the Federal Register informing the public that the rule will not take
effect.  EPA will address all public comments in a subsequent final rule
based on the proposed rule. EPA will not institute a second comment
period on this action.  Any parties interested in commenting must do so
at this time.

IV. Statutory and Executive Order Reviews

A.   General Requirements

Under the Clean Air Act, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations.  42 U.S.C. 7410(k); 40 CFR 52.02(a).  Thus, in
reviewing SIP submissions, EPA’s role is to approve state choices,
provided that they meet the criteria of the Clean Air Act.  Accordingly,
this action merely approves state law as meeting Federal requirements
and does not impose additional requirements beyond those imposed by
state law.  For that reason, this action:

is not a "significant regulatory action” subject to review by the
Office of Management and Budget under Executive Order 12866 (58 FR
51735, October 4, 1993);

does not impose an information collection burden under the provisions of
the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

is certified as not having a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.);

does not contain any unfunded mandate or significantly or uniquely
affect small governments, as described in the Unfunded Mandates Reform
Act of 1995 (Public Law 104-4);

does not have Federalism implications as specified in Executive Order
13132 (64 FR 43255, August 10, 1999);

is not an economically significant regulatory action based on health or
safety risks subject to Executive Order 13045 (62 FR 19885, April 23,
1997);

is not a significant regulatory action subject to Executive Order 13211
(66 FR 28355, May 22, 2001);

is not subject to requirements of Section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note)
because application of those requirements would be inconsistent with the
Clean Air Act; and

does not provide EPA with the discretionary authority to address, as
appropriate, disproportionate human health or environmental effects,
using practicable and legally permissible methods, under Executive Order
12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by
Executive Order 13175

(65 FR 67249, November 9, 2000), because the SIP is not approved to
apply in Indian country located in the state, and EPA notes that it will
not impose substantial direct costs on tribal governments or preempt
tribal law.

B.   Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating the
rule must submit a rule report, which includes a copy of the rule, to
each House of the Congress and to the Comptroller General of the United
States.  EPA will submit a report containing this action and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register.  A major rule cannot
take effect until 60 days after it is published in the Federal Register.
 This action is not a “major rule” as defined by 5 U.S.C. 804(2).

C.  Petitions for Judicial Review

Under section 307(b)(1) of the Clean Air Act, petitions for judicial
review of this action must be filed in the United States Court of
Appeals for the appropriate circuit by [Insert date 60 days from date of
publication of this document in the Federal Register].  Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for

the purposes of judicial review nor does it extend the time within
which a petition for judicial review may be filed, and shall not
postpone the effectiveness of such rule or action.  This action to
revise the MVEBs for the Parkersburg 8-hour Ozone Maintenance Plan may
not be challenged later in proceedings to enforce its requirements.
(See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

October 20, 2008						/s/

_________________
__________________________

Dated:                                				Donald S. Welsh,

                                      				Regional Administrator,

                                      				Region III.

40 CFR Part 52 is amended as follows:

PART 52 - [AMENDED]

1.  The authority citation for 40 CFR part 52 continues to read as
follows:

               Authority:  42 U.S.C. 7401 et seq.

Subpart XX ( West Virginia

2.  In ( 52.2520, the table in paragraph (e) is amended by revising the
entry for the 8-Hour Ozone

Maintenance Plan for the Parkersburg-Marietta, WV-OH Area to read as
follows:

( 52.2520  	Identification of plan.

*	*	*	*	*

(e)* * *

Name of non-regulatory SIP revision

Applicable geographic area

State submittal date

EPA approval date

Additional explanation

*     *     *     *     *     *     *

8-Hour Ozone

Maintenance Plan for

the Parkersburg-Marietta, WV-OH

Area

Wood County

09/08/06

5/8/07

72 FR 2967

08/25/08

[Insert Federal Register publication date] [Insert page number where the
document begins]	Reallocation of emissions from the existing “safety
margin” to increase the available motor vehicle emission budgets for
highway vehicles.

*     *     *     *     *     *     *

*	*	*	*	*

 EPA filed a petition for rehearing with the Court of Appeals for the
District of Columbia Circuit on September 24, 2008.

 PAGE

 PAGE  12


[Federal Register: December 1, 2008 (Volume 73, Number 231)]
[Notices]
[Page 72814-72817]
[DOCID:fr01de08-83]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2007-0042]

Application for the Containerized Cargo Ship ATLANTIC COMPASS,
Review for the Inclusion in the Shipboard Technology Evaluation
Program; Final Environmental Assessment and Finding of No Significant
Impact

AGENCY: Coast Guard, DHS.

ACTION: Notice of availability.

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

SUMMARY: The Coast Guard announces the availability of the Final
Environmental Assessment (FEA) and Finding of No Significant Impact
(FONSI) that evaluated the potential environmental impacts resulting
from accepting the vessel the ATLANTIC COMPASS into the Shipboard
Technology Evaluation Program (STEP). Under the STEP, the ATLANTIC
COMPASS will be using and testing the Ecochlor TM Inc.
Ballast Water Treatment System (BWTS), as the vessel operates in U.S.
waters.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this notice as being available in the docket,
are part of the docket USCG-2007-0042. These documents are 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 20590-0001,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. You can also find all docketed documents on the Federal
Document Management System at http://www.regulations.gov, United States
Coast Guard docket number USCG-2007-0042.
    You may submit comments identified by docket number USCG-2007-0042
using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
assessment please contact LCDR Brian Moore at<PHONE_NUMBER> or 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: This document has been tiered off the
Programmatic Environmental Assessment (PEA) for STEP dated December 8,
2004 (69 FR 71068, Dec 8,

2004), and was prepared in accordance with the National Environmental
Policy Act of 1969 (Section 102 (2)(c)), as implemented by the Council
of Environmental Quality regulations (40 CFR parts 1500-1508) and Coast
Guard Commandant Instruction M16475.1D. From these documents, the Coast
Guard has prepared an FEA and FONSI for accepting the ATLANTIC COMPASS
into the STEP.
    Response to Comments: The Coast Guard requested comments on the
Draft Environmental Assessment (DEA) when the Notice of Availability
and Request for Public Comments was published in the Federal Register
on April 4, 2008 (73 FR 18543, Apr. 4, 2008). The Coast Guard received
31 substantive comments total from 4 agencies. The Coast Guard has
responded to all of the comments that were within the scope of the DEA.
    One commenter requested a description of the circumstances under
which ballast is discharged without any treatment.
    These circumstances are described in 33 CFR 151.2030(b). The Coast
Guard has determined that in order to keep the FEA concise this
background information should not be included in the document.
    One commenter asked for clarification regarding the statement ``* *
* treatment system is expected to have no impact on water quality,
biological resources * * *''. The commenter asked how there could be no
impact when residuals (biocides) would be released.
    The Coast Guard acknowledges this comment, but disagrees with the
inference. This paragraph refers strictly to the effects of the BWT
system as it pertains to coastal barrier systems, and, as such, we
conclude there will be no impact on water quality as it affects coastal
barrier systems. The overall effects of residuals on water quality are
discussed elsewhere in the FEA.
    One commenter asked under what circumstances a vessel would be
granted a safety waiver.
    The circumstances in which a safety waiver can be used are
described in 33 CFR 151.2030(b). The Coast Guard has determined that in
order to keep the FEA concise, this background information should not
be included in the FEA.
    One commenter requested examples of accuracy and precision related
to the target final concentration of the automated system (i.e., does
it produce a 5.0 ppm concentration every time or is there some
variation involved?).
    The Coast Guard has determined that the initial dosage values that
have been proposed by the applicant are based solely upon laboratory
results using validated Environmental Protection Agency (EPA) methods.
The STEP program is intended to provide the sort of detailed
information requested by the commenter. As of now, only laboratory
values have been established. Gathering actual shipboard examples of
dosing parameters is a primary goal of the STEP.
    One commenter requested clarification regarding the statement ``* *
* that chlorite reacts with metals.'' The commenter asked which metals
would cause a reaction and if processes have been developed to assess
vessel damage.
    The Coast Guard has determined that the clarification of potential
for metal reactions with the treatment chemicals is outside the scope
of this FEA, which is narrowly focused on the potential for impacts to
the environment. The Coast Guard, the ship's owner/operator,
classification society, and flag administration are also monitoring the
ship's structure under different laws, rules, and regulations.
    One commenter asked how long it would take chlorate to decompose
and if chlorate and chlorite have an impact on organisms.
    The Coast Guard has determined that the degradation rate of
chlorate is similar to that of chlorite, but was not included because
it is such a small fraction of the degradation products of
ClO2. Both chlorate and chlorite are biocides.
    One commenter requested estimated water residency times for the
harbors.
    The system manufacturer has not provided the Coast Guard with any
information about harbor water residency times (for the chemical
residuals associated with this system). However, the Coast Guard
believes that based on the non-persistent nature of the ClO2
and the long residence time associated with this vessel's voyages, that
the amount of residual available for discharge is negligible and should
not present an accumulation hazard.
    One commenter requested clarification regarding the statement
``residual chemical levels are thought to be below applicable EPA and
state discharge standards.'' The commenter asked if there were any data
to support this statement and what the preliminary testing levels and
standards were.
    The Coast Guard has determined that there are no known state or
Federal standards for discharge of ClO2, or its degradation
products, into marine waters. However, the reported discharge
concentrations of these residuals are not detected when held beyond
five days and up to 1.5 ppm when held between one and two days. These
levels are below the levels associated with significant toxicity to
aquatic organisms, even before the dilution effects of discharge into
unconfined waters.
    One commenter asked what sodium sulfate concentrations were
produced and if they would be toxic. The commenter also asked if there
was any information available regarding sodium sulfate and its effects.
    The Coast Guard has determined that sulfates in several forms are
common constituents of seawater. The EcochlorTM system is
expected to introduce ~5 ppm sulfate against a background of ~2600 ppm
sulfate. The impact of this additional load is expected to be
negligible.
    One commenter requested that a description of the planktonic
communities and potential indirect effects on fisheries should be
included in the document. The commenter also suggested including a map
of the ports.
    The Coast Guard disagrees with the suggestion of including a map of
the harbor locations. Each port is part of a major metropolitan area of
the same name and easily located on any map, chart or Web mapping
service. Information on plankton and fisheries is included in the FEA.
    One commenter asked if the chlorite residues from the Ecochlor
TM system could impact small marine invertebrates, the food
source for the endangered piping plover.
    The Coast Guard has consulted with the U.S. Fish and Wildlife
Services which has stated that accepting the ATLANTIC COMPASS into the
STEP is not likely to adversely affect any listed species including the
piping plover, if the ship operates in accordance with its application.
    One commenter stated that there was an introduction to Baltimore
Harbor, but not Portsmouth Harbor.
    The Coast Guard agrees with this comment and has added introductory
information about Portsmouth Harbor to the FEA.
    One commenter stated that the biological surveys in the section
Benthos, Baltimore Harbor are out-dated (conducted in 1975 and 1983).
The commenter requested that more recent data be provided.
    The Coast Guard agrees with this comment and has updated this
section.
    One commenter stated that the benthic index of biological integrity
information seemed out of place. The commenter suggested that the
information be removed or described in more detail. The commenter also
requested that information about dominant species be included.

    The Coast Guard agrees and the section has been simplified to
improve readability and consistency with other sections including
discussion of dominant species.
    One commenter asked if there were any wetlands in Portsmouth
harbor.
    The Coast Guard has determined that wetlands in Portsmouth harbor
are typical for the Chesapeake and that they are described in the FEA.
    One commenter asked if there were any planktivorous fish that may
be indirectly affected by potential impacts on planktonic communities.
    The Coast Guard believes that the analysis of ecosystems conducted
in the PEA includes the potential direct and indirect impacts upon all
fish species, including plankton eaters. This analysis has concluded
that the range of impacts resulting from the preferred alternative runs
from not significant to potentially beneficial based on the probability
that the BWMS under evaluation may prevent the introduction of non-
indigenous species which could have very significant adverse impacts on
the ecosystems under study, including plankton eaters.
    One commenter asked for the average salinity and turbidity values
for the Newark Bay, what levels were considered low for dissolved
oxygen and requested that a list of the toxic pollutants in the
Chesapeake Bay be included in the document.
    The Coast Guard disagrees that the additional water body
characterization information requested by the commenter is necessary to
make a determination about whether to accept the ATLANTIC COMPASS into
the STEP because the Coast Guard has determined that ambient turbidity,
dissolved oxygen, and toxic pollutant levels are not relevant to the
degradation pathways for the potential treatment residuals. For the
same reason, the Coast Guard declines to include a list of toxic
pollutants in the Chesapeake Bay in the document.
    One commenter stated that the potential impact of chlorite is
underestimated and the toxicity of chlorite is not mentioned in the
document. The commenter stated that according to http://
www.pesticideinfo.org, chlorite causes serious sub-lethal effects
including carcinogenicity and reproductive, developmental, and
neurological toxicity. The commenter also stated that it is inadequate
to only examine the LC50 of chlorite and that the
LC50 is too extreme of an endpoint to determine whether or
not the biological resources will be impacted.
    Due to the non-persistent nature of the chemicals, the Coast Guard
believes that all treatment residues will have degraded to levels
sufficiently safe for discharge for the purposes of making a decision
about STEP acceptance. Physical and chemical analysis of the treated
ballast water is a primary goal of the STEP.
    One commenter asked for clarification regarding the statement ``the
potential impacts from this action will primarily be to the planktonic
community''. The commenter stated that out of 13 studies that were
listed in Addendum F, only 3 were performed on plankton, and had
LC50 well below the value for ``compiled toxicity levels''
reported in the text (``The compiled toxicity levels are mostly greater
than * * * 75,000 ug/L for chlorite * * *'').
    Based on the extended residence times that the biocide will be
stored in the vessel ballast tanks, the Coast Guard has determined that
all treatment residues will have degraded to levels sufficiently safe
for discharge for the purposes of making a decision about STEP
acceptance. Physical and chemical analysis of the treated ballast water
is a primary goal of the STEP.
    One commenter stated that the link for EPA Aquire (Addendum F) was
broken, and the previous studies need to be properly referenced. The
commenter also stated that the table is not reader friendly, and it is
unclear whether the algae species tested were not affected by chlorite
exposure because chlorite is not toxic to algae, or because the
concentrations administered were low.
    The Coast Guard was not able to replicate the difficulty locating
the EPA Aquire database. The Coast Guard appreciates the time and
expertise the EPA has placed into its toxicity database. However, the
Coast Guard is not an appropriate agent for making changes to an EPA
work product. The data show that algae are not being affected by
chlorite. Since the evaluated dosages include the expected maximum
discharge concentrations, the negligible impact conclusion is
supported.
    One commenter asked how chlorite, chlorate, and chlorine dioxide
impact biological resources. The commenter also stated that a
discussion of the local planktonic communities should be included in
the document.
    The Coast Guard has determined that the treatment chemical--
chlorine dioxide--and its initial degradation products are toxic to
biological organisms. That is why they are proposed for use as ballast
water treatments. The applicant has provided bench top data that show
the residuals of these biocides are small enough and dilute quickly
enough upon discharge from the ship that they are not likely to have a
long term or cumulative adverse impact on the receiving water. However,
characterization and assessment of the effluent is a principal goal of
the STEP and these values will be used to determine further suitability
of the BWTS for use in U.S. waters. The use of the pesticide info.org
report is not directly relevant as that information is based on human
exposures which are not likely to occur since the water will be
discharged directly to the sea in industrial harbors.
    One commenter asked what the typical port pH values were. The
commenter also asked what would cause a drop in pH.
    The Coast Guard disagrees that the information requested by the
commenter is necessary, because of the de minimis volumes on water
discharge into the unconfined industrial port waters. Therefore, the
requested information is not needed to make a determination whether to
accept the ATLANTIC COMPASS into the STEP. Characterization of the
effluent is a primary component of the STEP.
    One commenter asked for clarification regarding the statement ``* *
* the discharge pH will still generally be near neutrality * * * not
likely pose a significant negative impact.''
    The Coast Guard has determined that the actual impact from a single
ship discharging into a harbor is too small to have other than a
negligible impact to the harbor itself and no measurable impact on the
larger coastal environment.
    One commenter asked what the chlorine (gas) emission limits were.
The commenter also asked if it was harmful and if testing for
Cl2 will be conducted.
    The Coast Guard has determined that none of the degradation
pathways for chlorine dioxide include formation of elemental chlorine
(Cl2, a gas at normal temperature); the end product of
degradation is chloride ion (Cl-), a harmless and ubiquitous
component of seawater.
    One commenter asked if there were any long term impacts from
chlorite. The commenter stated that chlorite decomposition appears to
take between 70-200 days and that this amount of time and the
continuous discharges from the vessel (described as every 35 days for a
round trip voyage), may result in a build up of chlorite levels in the
harbor depending on circulation patterns.
    The applicant has provided bench top data that show the residuals
of these biocides are very small and dilute below the no observable
effect concentration

level upon discharge from the ship. The Coast Guard has determined that
they are not a long term or cumulative hazard on the receiving water
because of their non-persistent nature.
    One commenter stated that the information found in Appendix E
should be discussed in the body of the document. The commenter also
stated that the possibility of residual ClO2 discharge was
discussed in the Appendix, but the potential amounts of these
discharges should be discussed earlier in the document.
    The Coast Guard disagrees with this comment. The specific chemical
equations describing the outcome are beyond the scope of the FEA,
however, they are provided in the Appendix so that interested parties
may verify the conclusions on a scientific basis.
    One commenter stated that they did not object to the proposed
project, but if this program were to expand, they would recommend
review of the environmental assessment by the New Jersey Division of
Water Quality (NJDEP). The commenter also stated that if the
determination was made that a ship is a fixed pipe discharger, a
discharge permit should be required, and reporting requirements should
be imposed.
    The Coast Guard appreciates the comment and will inform NJDEP of
all applicable future STEP vessels.
    All of the commenters stated their support and approval for the
ATLANTIC COMPASS acceptance into the STEP, and recommended that the
application should be granted.
    The Coast Guard appreciates all of the comments and support for
including the ATLANTIC COMPASS into STEP. FINAL ENVIRONMENTAL
ASSESSMENT: The Final PEA for STEP identified and examined the
reasonable alternatives available to evaluate novel ballast water
management systems for effectiveness against nonindigenous species
(NIS) transportation by ships' ballast water.
    The FEA for acceptance of the ATLANTIC COMPASS into the STEP and
the subsequent operation of the experimental treatment system analyzed
the no action alternative and one action alternative that could fulfill
the purpose, and need of identifying suitable technologies capable of
preventing the transportation of NIS in ships ballast water.
Specifically, the FEA for the ATLANTIC COMPASS acceptance into the STEP
is tiered off of the PEA for the STEP, and considers the potential
impacts to the environment from the operation of the treatment system
on the ATLANTIC COMPASS, by examining the functioning of the system,
the operational practices of the vessel, and the potential affects on
discharge water quality.
    This notice is issued under authority of the National Environmental
Policy Act of 1969 (Section 102(2)(c)), as implemented by the Council
of Environmental Quality regulations (40 CFR parts 1500-1508) and Coast
Guard Commandant Instruction M16475.1D.

    Dated: November 21, 2008.
Brian M. Salerno,
Rear Admiral, U.S. Coast Guard, Assistant Commandant for Marine Safety,
Security and Stewardship.
[FR Doc. E8-28470 Filed 11-28-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 77, Number 57 (Friday, March 23, 2012)]
[Proposed Rules]
[Pages 16978-16981]
[FR Doc No: 2012-6980]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2012-0004]
RIN 1625-AA08

Special Local Regulation; Macy's Fourth of July Fireworks Display
Spectator Viewing Areas; Hudson River; New York, NY

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish a temporary special
local regulation (SLR) on the navigable waters of the Hudson River in
the vicinity of New York, NY for the Macy's Fourth of July Fireworks
Display. The temporary SLR is intended to restrict certain vessels from
portions of the Hudson River before, during, and immediately after the
fireworks event. This regulation is necessary to provide for the safety
of life on the navigable waters by controlling vessel movement and to
establish public viewing areas for the fireworks event.

DATES: Comments and related material must be received by the Coast
Guard on or before May 7, 2012. Requests for public meetings must be
received by the Coast Guard on or before April 13, 2012.

ADDRESSES: You may submit comments identified by docket number USCG-
2012-0004 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Ensign Kimberly Farnsworth, Coast Guard; telephone
(718) 354-4163, email<EMAIL_ADDRESS>If you have
questions on viewing or submitting material to the docket, call Renee
V. Wright, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2012-0004), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (via http://www.regulations.gov) or by fax, mail, or hand
delivery, but please use only one of these means. If you submit a
comment online via www.regulations.gov, it will be considered received
by the Coast Guard when you successfully transmit the comment. If you
fax, hand deliver, or mail your comment, it will be considered as
having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an email address, or a telephone number in the body
of your document so that we can contact you if we have questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number (USCG-2012-0004) in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking.

    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number (USCG-2012-0004) in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one using one of the four methods specified under
ADDRESSES. Please explain why you believe a public meeting would be
beneficial. If we determine that one would aid this rulemaking, we will
hold one at a time and place announced by a later notice in the Federal
Register.

Basis and Purpose

    The legal basis for the proposed SLR is 33 U.S.C. 1233; and
Department of Homeland Security Delegation No. 0170.1, which
collectively authorize the Coast Guard to define special local
regulations.
    The proposed temporary SLR is necessary to ensure the safety of
spectators and vessels from hazards associated with fireworks displays.
Based on the inherent hazards associated with fireworks, the Captain of
the Port (COTP) New York has determined that fireworks launches
proximate to water crafts pose a significant risk to public safety and
property. The combination of increased numbers of recreational vessels,
congested waterways, darkness punctuated by bright flashes of light,
and debris, especially burning debris falling on passing or spectator
vessels has the potential to result in serious injuries or fatalities.
The proposed rule will temporarily establish regulated areas designated
as spectator vessel viewing areas to restrict and control vessel
movement around the location of the fireworks launch platforms to
reduce the risk associated with the launch of fireworks.

Discussion of Proposed Rule

    Macy's is sponsoring their annual Fourth of July Fireworks Display
on the waters of the Hudson River in the vicinity of New York, NY. The
fireworks display will occur from approximately 9:20 p.m. until 9:50
p.m. on July 4, 2012. In order to coordinate the safe movement of
vessels within the area and to ensure that the area is clear of
unauthorized persons and vessels before, during, and immediately after
the fireworks launch, the proposed regulated areas will be enforced
from 7 p.m. until 11 p.m. on July 4, 2012.
    If the event is cancelled due to inclement weather, then the
proposed regulated areas will be enforced from 7 p.m. until 11 p.m. on
July 5, 2012.
    The Coast Guard will activate a pre-established safety zone under
33 CFR 165.160 (USCG-2010-1001), around the fireworks launch platforms.
The safety zone may be referred to as area CHARLIE, and its location is
defined in entry 1.1 of Table 1 to 33 CFR 165.160. Only fireworks
launch platforms and assist vessels will be allowed to enter into the
safety zone.
    To augment the existing safety zone around the fireworks launch
barges, the COTP New York will establish four limited access areas
within the boundaries of the special local regulation. Access to these
areas will be restricted to vessels of a certain size. The four
designated areas within the SLR are: (1) A ``spectator area''
designated ALPHA in which access is limited to vessels less than 20
meters in length (65.6ft); (2) ``spectator area'' designated BRAVO in
which access is limited to vessels greater than 20 meters in length
(65.6ft); (3) ``spectator area'' designated DELTA in which access is
limited to vessels greater than 20 meters in length (65.6ft); and (4) a
``spectator area'' designated ECHO in which access is limited to
vessels less than 20 meters in length (65.6ft).
    The geographic locations of regulated areas, and specific
requirements of this rule are contained in the regulatory text. Public
notifications will be made to the local maritime community prior to the
event through the Local Notice to Mariners, and Broadcast Notice to
Mariners.

Regulatory Analyses

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

Executive Order 12866 and Executive Order 13563

    This proposed 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.
    This determination is based on the limited time that vessels will
be restricted from the fireworks display area. The temporary special
local regulation will only be in effect for approximately four hours
during the evening hours. The Coast Guard does not expect significant
adverse impact to mariners from the regulated areas, because the event
has been extensively advertised in the public and affected mariners may
request authorization from the COTP New York or the designated
representative to transit the zone. Advance notification will be made
to the maritime community via Broadcast Notice to Mariners and Local
Notice to Mariners (LNM).

Impact on Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed
rule would not have a significant economic impact on a substantial
number of small entities.

    This rule will affect the following entities, some of which may be
small entities: The owners and operators of vessels intending to
transit or anchor in a portion of the Hudson River, in the vicinity of
New York, NY during the effective period.
    The temporary special local regulation will not have significant
economic impact on a substantial number of small entities for the
following reasons: This rule will be in effect for only four hours on a
single day during the late evening for this fireworks event. Although
the regulation will apply to the entire width of the river, traffic
will be allowed to pass through the area with the permission of the
COTP New York or the designated representative. Before the effective
period, the Coast Guard will issue maritime advisories widely available
to users of the waterway.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking process.
    If the rule would affect your small business, organization, or
governmental jurisdiction and you have questions concerning its
provisions or options for compliance, please contact 1-888-REG-FAIR (1-
888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on 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. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action appears to be
one of a category of actions which do not individually or cumulatively
have a significant effect on the human environment. A preliminary
environmental analysis checklist supporting this determination will be
available in the docket where indicated under ADDRESSES. This proposed
rule involves the establishment of a special local regulation to
regulate vessel traffic on a portion of the Hudson River during the
launching of fireworks. This rule appears to be categorically excluded,
under figure 2-1, paragraphs and (34)(h), of the Commandant
Instruction.
    We seek any comments or information that may lead to the discovery
of a significant environmental impact from this proposed rule.

List of Subjects in 33 CFR Part 100

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

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATER

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

    Authority:  33 U.S.C. 1233.

    2. Add Sec.  100.35T01-0004 to read as follows:

Sec.  100.35T01-0004  Macy's Fourth of July Fireworks Display Spectator
Viewing Areas; Hudson River; New York, NY.

    (a) Regulated area. The regulated area includes all navigable
waters of the Hudson River bounded by a line drawn from the northern
most break-wall of the 79th Street Boat Basin, New York, NY,
approximate position 40[deg]47'11.70'' N, 073[deg]59'8.83'' W, then
west to a point on the shoreline of Guttenberg, NJ, approximate
position 40[deg]47'28.27'' N, 073[deg]59'46.39'' W, then south along
the New Jersey shoreline to a point in the vicinity of Port Imperial,
Weehawken, NJ approximate position 40[deg]46'35.43'' N,
074[deg]00'37.53'' W, then east to a point in the vicinity of Pier 99,
New York, NY approximate position 40[deg]46'16.98'' N,
073[deg]59'52.34'' W, then along the Manhattan shoreline north to the
point of origin and all navigable waters of the Hudson River bounded by
a line drawn from Maxwell Park, Hoboken, NJ, approximate location
40[deg]44'55.90'' N, 074[deg]01'24.94'' W, east to Chelsea Piers, New
York, NY approximate location 40[deg]44'48.97'' N, 074[deg]00'41.01''
W,, south along the Manhattan shore line to Pier 40 approximate
location 40[deg]43'46.43'' N, 074[deg]00'50.95'' W, and west to
Hoboken/New Jersey Transit Station, Hoboken, NJ approximate location
40[deg]43'50.38'' N, 074[deg]01'41.68'' W, and then north to the point
of origin. All geographic coordinates are North American Datum of 1983
(NAD 83). Within the overall regulated area defined in this paragraph
(a), the following are individually defined areas subject to specific
requirements:
    (1) Area ALPHA: All navigable waters of the Hudson River north of a
line drawn from a point in the vicinity of Riverwalk Place, Weehawken,
NJ, approximate position 40[deg]46'50.85'' N, 074[deg]00'19.52'' W,
east to a point in the vicinity of 64th Street, New York, NY,
approximate position 40[deg]46'34.38'' N, 073[deg] 59'30.98'' W, and
south of a line drawn from the shoreline of Guttenberg, NJ, approximate
position 40[deg]47'28.27'' N, 073[deg]59'46.39'' W, east to the
northern most break-wall of the 79th Street Boat Basin, New York, NY,
approximate position 40[deg]47'11.70'' N, 073[deg]59'8.83'' W. (NAD
83).
    (2) Area BRAVO: All navigable waters of the Hudson River north of a
line drawn from the ferry terminal at Port Imperial, Weehawken, NJ,
approximate position 40[deg]46'35.43'' N, 074[deg]00'37.53'' W, east to
a point in the vicinity of Pier 99, New York, NY, approximate position
40[deg]46'16.98'' N, 073[deg]59'52.34'' W, and south of a line drawn
from Riverwalk Place, Weehawken, NJ, approximate position
40[deg]46'51.01'' N, 074[deg]00'19.52'' W, east to a point in the
vicinity of 64th Street, New York, NY, approximate position
40[deg]46'34.38'' N, 073[deg]59'30.98'' W. (NAD 83).
    (3) Area DELTA: All navigable waters of the Hudson River north of a
line drawn to a point in the vicinity of Pier C Park, Hoboken, NJ, in
approximate position 40[deg]44'24.32'' N, 074[deg]01'32.98'' W, east to
Gansevoort Street, New York, NY, approximate position 40[deg]44'20.46''
N, 074[deg]00'37.28'' W, and south of a line drawn from in the vicinity
of Chelsea Piers, approximate position 40[deg]44'48.98'' N,
074[deg]00'41.06'' W, then west to a point in near Maxwell Park,
Hoboken, NJ, in approximate position 40[deg]44'55.91'' N,
074[deg]01'24.94'' W. (NAD 83).
    (4) Area ECHO: All navigable waters of the Hudson River north of a
line drawn Hoboken/New Jersey Transit Station approximate position
40[deg]43'50.38'' N, 074[deg]01'41.68'' W in Hoboken, NJ, east to Pier
40, New York, NY in approximate position 40[deg]43'46.43'' N,
074[deg]00'50.95'' W, and south of a line drawn from Pier C Park,
Hoboken, NJ, in approximate position 40[deg]44'24.32'' N,
074[deg]01'32.98'' W, east to Gansevoort Street, New York, NY,
approximate position 40[deg]44'20.46'' N, 074[deg]00'37.28'' W. (NAD
83).
    (b) Definitions. For purposes of this section ``Designated
representative'' is any Coast Guard commissioned, warrant, or petty
officer who has been designated by the Captain of the Port New York
(COTP) to act on the COTP's behalf.
    (c) Special local regulations. (1) In accordance with the general
regulations in section 100.35 of this part, entry into, transiting, or
anchoring within the regulated areas is prohibited, unless authorized
by the COTP or the designated representative.
    (2) Vessels are authorized by the COTP or the designated
representative to enter areas of this special location regulation in
accordance with the following restrictions:

    (i): Area ALPHA access is limited to vessels less than 20 meters
(65.6 ft) in length.
    (ii) Area BRAVO access is limited to vessels greater than 20
meters (65.6 ft) in length.
    (iii) Area DELTA access is limited to vessels greater than 20
meters (65.6 ft) in length.
    (iv) Area ECHO access is limited to vessels less than 20 meters
(65.6 ft) in length.

    (3) All persons and vessels in the regulated areas shall comply
with the instructions of the COTP or the designated representative.
    (4) Upon being hailed by a U.S. Coast Guard vessel by siren, radio,
flashing light or other means, the operator of a vessel shall proceed
as directed. The COTP or the designated representative can be reached
on VHF channel 16.
    (d) Effective period. This rule will be effective from 7 p.m. to 11
p.m. on July 4, 2012. If the fireworks display is postponed, this
section will be effective from 7 p.m. until 11 p.m. on July 5, 2012.

    Dated: February 27, 2012.
G.P. Hitchen,
Captain, U.S. Coast Guard, Acting Captain of the Port New York.
[FR Doc. 2012-6980 Filed 3-22-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 82 (Thursday, April 28, 2022)]
[Notices]
[Pages 25282-25284]
[FR Doc No: 2022-09070]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3758]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Expanded Access to
Investigational Drugs for Treatment Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by May 31, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0814. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Expanded Access to Investigational Drugs for Treatment Use

OMB Control Number 0910-0814--Revision

    This information collection supports Agency regulations in 21 CFR
part 312, subpart I, Expanded Access to Investigational Drugs for
Treatment Use; associated guidance; and Form FDA 3926, Individual
Patient Expanded Access Investigational New Drug Application (IND). The
regulations govern the use of investigational new drugs, biologics, and
approved drugs if availability is limited by a risk evaluation and
mitigation strategy, when the primary purpose is to diagnose, monitor,
or treat a patient's disease or condition. The goal of the expanded
access program is to facilitate the availability of such products to
patients with serious diseases or conditions when there is no
comparable or satisfactory alternative therapy to diagnose, monitor, or
treat the patient's disease or condition. The regulations provide that
certain criteria be met, establish content and format requirements for
associated reporting, and require that submissions include a cover
sheet.
    Although we continue to account for burden associated with the
submission of expanded access requests for individual patients, we are
revising the information collection to also account for burden
attendant to other expanded access submissions, including commercial
investigational new drug applications (INDs) that involve large groups
of patients enrolled for treatment use of the investigational drug
(Sec. Sec.  312.300 through 312.320 (21 CFR 312.300 through 312.320)),
currently approved under OMB control number 0910-0014. Because of FDA's
long history of facilitating expanded access to investigational drugs
for treatment use for patients with serious or immediately life-
threatening diseases or conditions, our efforts in this regard are
ongoing.
    Form FDA 3926 was developed to assist respondents to the
information collection. Form FDA 3926 requires the completion of data
fields that enable us to uniformly collect the minimum information
necessary from licensed physicians who want to request expanded access
as prescribed in the applicable regulations. To supplement the form
instructions, we issued guidance, most recently updated in October
2017, entitled ``Individual Patient Expanded Access Applications: Form
FDA 3926,'' available at https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/

individual-patient-expanded-access-applications-form-fda-3926. As
discussed in the guidance, Sec.  312.310(b) contains additional
submission requirements for individual patient expanded access
requests. These respondents may continue to use either Form FDA 3926 or
Form FDA 1571, Investigational New Drug Application (IND), for all
types of IND submissions to satisfy requirements in 21 CFR 312.23(a)
(approved under OMB control number 0910-0014). FDA considers a
completed Form FDA 3926 signed by the physician and checked in the box
in Field 10.a (Request for Authorization to use Form FDA 3926) to be a
waiver request in accordance with 21 CFR 312.10.
    We are proposing the following revisions to data elements in Form
FDA 3926 and will make corresponding revisions to the form
instructions:
     Reorder Field 8, ``Physician Name, Address, and Contact
Information'' to Field 1, and renumber remaining data fields
accordingly;
     Add ``Race and Ethnicity'' as an optional item under the
``Clinical Information/Brief Clinical History'' field;
     Add ``Request for Withdrawal'' under the ``Contents of
Submission'' field;
     Add technological enhancements to the electronic version
of Form FDA 3926 that utilize user-based selections to prompt required
data field entries. Currently, certain fields become grayed out if not
required for the submission type selected.
    Data elements in Sec. Sec.  312.315 and 312.320 continue to be
reported in Forms FDA 1571 and 1572, Statement of Investigator,
(approved under OMB control number 0910-0014).
    In the Federal Register of December 14, 2021 (86 FR 71069), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

             Table 1--Estimated Annual Reporting Burden--Center for Drug Evaluation and Research \1\
----------------------------------------------------------------------------------------------------------------
                                                 Number of
    Part 312, subpart I;         Number of     responses per   Total annual   Average burden per    Total hours
          activity              respondents     respondent       responses         response
----------------------------------------------------------------------------------------------------------------
Sec.  Sec.   312.310(b) and            1,204          2.4958           3,005  0.75..............           2,254
 312.305(b); submissions                                                      (45 minutes)......
 related to expanded access
 and treatment of an
 individual patient: Form
 FDA 3926.
Sec.   312.310(d);                     1,265           2.843           3,596  16................          57,536
 submissions related to
 emergency use of an
 investigational new drug:
 Form FDA 3926.
Sec.  Sec.   312.315(c) and               88            3.64             320  120...............          38,400
 312.305(b); submissions
 related to expanded access
 and treatment of an
 intermediate-size patient
 population \2\.
Sec.   312.320(b);                        20               7             140  300...............          42,000
 submissions related to a
 treatment IND or treatment
 protocol \2\.
                             -----------------------------------------------------------------------------------
    Total...................  ..............  ..............           7,061  ..................         140,190
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Data elements are reported in Forms FDA 1571 and 1572, approved under OMB control number 0910-0014.

          Table 2--Estimated Annual Reporting Burden--Center for Biologics Evaluation and Research \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
  Part 312, subpart I; activity      Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Sec.  Sec.   312.310(b) and                  118           1.305             154               8           1,232
 312.305(b); number of
 submissions related to expanded
 access and treatment of an
 individual patient: Form FDA
 3926...........................
Sec.   312.310(d); number of               1,591          4.2137           6,704              16         107,264
 submissions related to
 emergency use of an
 investigational new drug: Form
 FDA 3926.......................
Sec.  Sec.   312.315(c) and                   28               1              28             120           3,360
 312.305(b); number of
 submissions related to expanded
 access and treatment of an
 intermediate-size patient
 population \2\.................
Sec.   312.320(b); number of                  15               1              15             300           4,500
 submissions related to a
 treatment IND or treatment
 protocol \2\...................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............           6,901  ..............         116,356
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Data elements are reported in Forms FDA 1571 and 1572, approved under OMB control number 0910-0014.

    The information collection reflects an increase in 254,750 burden
hours and 11,568 responses annually since the last OMB review and
approval of the information collection. We attribute this to an
increase in the number of submissions.

    Dated: April 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09070 Filed 4-27-22; 8:45 am]
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[Federal Register Volume 76, Number 10 (Friday, January 14, 2011)]
[Notices]
[Pages 2746-2747]
[FR Doc No: 2011-717]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. FAA-2011-01]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number involved and must be received on or before February 3, 2011.

ADDRESSES: You may send comments identified by Docket Number FAA-2010-
1221 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.

     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Frances Shaver,<PHONE_NUMBER>, Office
of Rulemaking (ARM-207), Federal Aviation Administration, 800
Independence Avenue, SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC on January 11, 2011.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2010-1221.
    Petitioner: Indigenous Peoples Technology and Education Center,
Inc. (ITEC).
    Section of 14 CFR Affected: Sec.  21.190(c)(2).
    Description of Relief Sought: Petition for exemption from the
Federal Aviation Regulations, Sec.  21.190(c)(2) to permit an
additional weight allowance for a powered parachute (PPC) light-sport
aircraft (LSA) intended for both flight operations and operation on
public roadways, similar to the weight allowance for LSA intended for
operation on water. A roadable PPC has similar weight penalties to an
LSA intended for operation on water due to the additional equipment
required to make the vehicle roadworthy, and therefore a similar weight
allowance seems appropriate. This petition for exemption will allow
ITEC to issue a statement of compliance (FAA Form 8130-15) for each
ITEC ``Maverick'' PPC LSA for operation at the same weight prescribed
by 14 CFR 1.1 for LSA intended for operation on water.

[FR Doc. 2011-717 Filed 1-13-11; 8:45 am]
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