[Federal Register: March 25, 2009 (Volume 74, Number 56)]
[Proposed Rules]
[Page 12769-12774]
[DOCID:fr25mr09-48]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2009-0106]
RIN 1625-AA08

Special Local Regulation for Marine Events; Temporary Change of
Dates for Recurring Marine Events in the Fifth Coast Guard District

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to temporarily change the enforcement
period of special local regulations for recurring marine events in the
Fifth Coast Guard District. These regulations apply to only five
recurring marine events that conduct on water activities such as power
boat races, swimming competitions, and harbor celebrations. Special
local regulations are necessary to provide for the safety of life on
navigable waters during the event. This action is intended to restrict
vessel traffic in portions of the Chester River, MD; Rappahannock
River, VA; Elizabeth River, Southern Branch, VA; North Atlantic Ocean,
Ocean City, MD; and Pasquotank River during each event.

DATES: Comments and related material must either be submitted to our
online docket via http://www.regulations.gov on or before April 24,
2009 or reach the Docket Management Facility by that date.

ADDRESSES: You may submit comments identified by docket number USCG-
2009-0106 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
instructions on submitting comments, see the ``Public Participation and
Request for Comments'' portion of the SUPPLEMENTARY INFORMATION section
below.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call Dennis Sens, Project Manager, Fifth Coast Guard District,
Prevention Division, at<PHONE_NUMBER> or e-mail at
<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-2009-0106),

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, or by fax, mail or
hand delivery, but please use only one of these means. We recommend
that you include your name and a mailing address, an e-mail address, or
a phone number in the body of your document so that we can contact you
if we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
select the Advanced Docket Search option on the right side of the
screen, insert ``USCG-2009-0106'' in the Docket ID box, press Enter,
and then click on the balloon shape in the Actions column. If you
submit your comments by mail or hand delivery, submit them in an
unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit them by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period 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,
select the Advanced Docket Search option on the right side of the
screen, insert USCG-2009-0106 in the Docket ID box, press Enter, and
then click on the item in the Docket ID column. You may also visit
either 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; or the Fifth Coast
Guard District, Prevention Division, 431 Crawford Street, Portsmouth,
VA 23704, between 10 a.m. and 2 p.m., Monday through Friday, except
Federal holidays. We have an agreement with the Department of
Transportation to use the Docket Management Facility.

Privacy Act

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

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one to the Docket Management Facility at the address under
ADDRESSES explaining why one would be beneficial. If we determine that
one would aid this rulemaking, we will hold one at a time and place
announced by a later notice in the Federal Register.

Background and Purpose

    Marine events are frequently held on the navigable waters within
the boundary of the Fifth Coast Guard District. The on-water activities
that typically comprise marine events include sailing regattas,
powerboat races, swim races and holiday parades. For a description of
the geographical area of each Coast Guard Sector--Captain of the Port
Zone, please see 33 CFR 3.25.
    This regulation proposes to temporarily change the enforcement
period of special local regulations for recurring marine events within
the Fifth Coast Guard District. This proposed regulation applies to
five marine events in 33 CFR 100.501, Table to Sec.  100.501.
    Annually, the District of Columbia Aquatics Club sponsors the
``Maryland Swim for Life,'' on the waters of the Chester River near
Chestertown, MD. The regulation at 33 CFR 100.501 is effective annually
for the Maryland Swim for Life marine event. The event is an open water
swimming competition held on the waters of the Chester River, near
Chestertown, Maryland. Approximately 150 swimmers will start from
Rolph's Wharf and swim up-river 2.5 miles then swim downriver returning
back to Rolph's Wharf. A large fleet of support vessels accompany the
swimmers. Therefore, to ensure the safety of participants and support
vessels, 33 CFR 100.501 would be enforced for the duration of the
event. Under provisions of 33 CFR 100.501, from 5:30 a.m. to 2:30 p.m.
on July 11, 2009, vessels may not enter the regulated area unless they
receive permission from the Coast Guard Patrol Commander. Vessel
traffic may be allowed to transit the regulated area only when the
Patrol Commander determines it is safe to do so.
    On June 6, 2009, the Rappahannock River Boaters Association (RRBA)
will sponsor the ``2009 RRBA Spring Radar Shootout,'' on the waters of
the Rappahannock River near Layton, Virginia. The regulation at 33 CFR
100.501 is effective annually for this river boat race marine event.
The event consists of approximately 35 powerboats participating in
high-speed competitive races, traveling along a 3-mile straight line
racecourse. Participating boats race individually within the designated
course. A fleet of spectator vessels is anticipated to gather nearby to
view the competition. Due to the need for vessel control during the
event, vessel traffic will be temporarily restricted to provide for the
safety of participants, spectators and transiting vessels. The
regulation at 33 CFR 100.501 would be enforced for the duration of the
event. Under provisions of 33 CFR 100.501, from 12 p.m. to 5 p.m. on
June 6, 2009, or rain date June 7, 2009, vessels may not enter the
regulated area unless they receive permission from the Coast Guard
Patrol Commander.
    Norfolk Festevents Ltd., Norfolk, VA sponsors the annual ``Norfolk
Harborfest Celebration,'' on the waters of the Elizabeth River between
Norfolk and Portsmouth, VA. The regulation at 33 CFR 100.501 is
effective annually for the Norfolk Harborfest marine event. This annual
celebration of Norfolk Harbor consists of a variety of on the water
activities that include an Opening Ceremony--Parade of Sail; jet ski,
water ski, wake board demonstrations; Fire boat demonstrations; Lazy
Lizzie Anything That Floats Parade and Race; Dinghy Parade; Search and
Rescue demonstrations by USCG & USN; and Quick and Dirty Boat Race.
Evening pyrotechnic displays ``fireworks'' will be fired from barge(s)
on the Elizabeth River as part of the Harborfest celebration. A large
fleet of spectator vessels is anticipated to view the Harborfest
activities. Therefore, to ensure the safety of participants, spectators
and transiting vessels, 33 CFR 100.501 would be enforced for the
duration of the event. Under provisions of 33 CFR 100.501, from 9 a.m.
July 3, 2009 to 11 p.m. on July 5, 2009, vessels may not enter the
regulated area unless they receive permission from the Coast Guard
Patrol Commander. Vessel traffic will be allowed to transit the
regulated area between on the water events, when the Patrol Commander
determines it is safe to do so.
    The Offshore Performance Association (OPA) Racing LLC annually
sponsors the ``Offshore Grand Prix,'' on the waters of the North
Atlantic Ocean near Ocean City, MD. The regulation at 33 CFR 100.501 is
effective annually for the Ocean City Offshore race marine event. The
event is conducted on the waters of the North Atlantic Ocean along the
shoreline near Ocean City, MD. The event consists of approximately 50
V-hull and twin-hull

inboard hydroplanes racing in heats counter-clockwise around an oval
race course. A fleet of spectator vessels is anticipated to gather
nearby to view the competition. Therefore, to ensure the safety of
participants, spectators and transiting vessels, 33 CFR 100.501 would
be enforced for the duration of the event. Under provisions of 33 CFR
100.501, from 10 a.m. May 30, 2009 to 5 p.m. on May 31, 2009, vessels
may not enter the regulated area unless they receive permission from
the Coast Guard Patrol Commander. Due to the need for vessel control
during the event, vessel traffic will be temporarily restricted to
provide for the safety of participants, spectators and transiting
vessels.
    The Carolina Cup Regatta, Inc. annually sponsors a power boat race
on the waters of the Pasquotank River near Elizabeth City, NC. The
regulation at 33 CFR 100.501 is effective annually for this power boat
race marine event. The event consists of approximately 25 inboard
hydroplanes racing in counter clockwise heats around an oval race
course. A fleet of spectator vessels is anticipated to gather nearby to
view the competition. Therefore, to ensure the safety of participants,
spectators and transiting vessels, 33 CFR 100.501 will be enforced for
the duration of the event. Under provisions of 33 CFR 100.501, from 9
a.m. May 16, 2009 to 5 p.m. on May 17, 2009, vessels may not enter the
regulated area unless they receive permission from the Coast Guard
Patrol Commander. Due to the need for vessel control during the event,
vessel traffic will be temporarily restricted to provide for the safety
of participants, spectators and transiting vessels.

Discussion of Proposed Rule

    The Coast Guard proposes to temporarily suspend the regulations at
33 CFR 100.501 by changing the date of enforcement in the table to
Sec.  100.501. The Coast Guard proposes to temporarily change the
enforcement period of special local regulations for recurring marine
events within the Fifth Coast Guard District. This regulation applies
to five marine events listed in the Table to Sec.  100.501 and are
listed as follows.

Chester River, Chestertown, MD

    The Table to Sec.  100.501, event No. 21 establishes the
enforcement date for the Maryland Swim for Life. This regulation
proposes to temporarily change the enforcement date from ``June--3rd
Saturday or July--3rd Saturday'' to the second Saturday in July,
holding the marine event on July 11, 2009. The District of Columbia
Aquatics Club, which is the sponsor for this event, intends to hold
this event annually; however, they have changed the date of the event
for 2009 so that it is outside the scope of the existing enforcement
period. Due to the need for vessel control while swimmers are in the
water along the Chester River, vessel traffic would be temporarily
restricted to provide for the safety of participants, spectators and
transiting vessels.

Rappahannock River, Layton, VA

    The Table to Sec.  100.501, event No. 40 establishes the
enforcement date for the ``2009 RRBA Spring Radar Shootout''. This
regulation proposes to temporarily change the enforcement date from
``June--last Saturday'' to the first Saturday in June, holding the
marine event on June 6, 2009. The temporary special local regulations
will be enforced from 12 p.m. to 5 p.m. on June 6, 2009, and will
restrict general navigation in the regulated area during the event. The
Rappahannock River Boaters Association (RRBA), which is the sponsor for
this event, intends to hold this event annually; however, they have
changed the date of the event for 2009 so that it is outside the scope
of the existing enforcement period. Except for participants and vessels
authorized by the Coast Guard Patrol Commander, no person or vessel
will be allowed to enter or remain in the regulated area. These
regulations are needed to control vessel traffic during the event to
enhance the safety of participants, spectators and transiting vessels.

Elizabeth River, Norfolk, VA

    The Table to Sec.  100.501, event No. 37 establishes the
enforcement date for Norfolk Harborfest. This regulation proposes to
temporarily change the enforcement date from ``June--1st Friday,
Saturday and Sunday'' to the first Friday, Saturday and Sunday in July,
holding the marine event on July 3, through July 5, 2009. The Norfolk
Festevents Ltd., which is the sponsor for this event, intends to hold
this event annually; however, they have changed the date of the event
for 2009 so that it is outside the scope of the existing enforcement
period. Due to the need for vessel control during various on water
activities along the Elizabeth River, vessel traffic would be
temporarily restricted to provide for the safety of participants,
spectators and transiting vessels.

North Atlantic Ocean, Ocean City, MD

    The Table to Sec.  100.501, event No. 38 establishes the
enforcement date for the Ocean City Maryland Offshore Grand Prix. This
regulation proposes to temporarily change the enforcement date from
``June--1st Friday and Saturday'' to the last Saturday and Sunday in
May, holding the marine event on May 30 and 31, 2009. The Offshore
Performance Association (OPA) Racing LLC, which is the sponsor for this
event, intends to hold this event annually; however, they have changed
the date of the event for 2009 so that it is outside the scope of the
existing enforcement period. Due to the need for vessel control while
high performance power boats race along the shoreline at Ocean City,
MD, vessel traffic would be temporarily restricted to provide for the
safety of participants, spectators and transiting vessels.

Pasquotank River, Elizabeth City, NC

    The Table to Sec.  100.501, event No. 54 establishes the
enforcement date for the Carolina Cup Regatta. This regulation proposes
to temporarily change the enforcement date from ``June--2nd Saturday
and Sunday'' to the third Saturday and Sunday in May, holding the
marine event on May 16 and 17, 2009. The Carolina Cup Regatta Inc.,
which is the sponsor for this event, intends to hold this event
annually; however, they have changed the date of the event for 2009 so
that it is outside the scope of the existing enforcement period. Due to
the need for vessel control while high performance power boats race
along the Pasquotank River near Elizabeth City, NC, vessel traffic
would be temporarily restricted to provide for the safety of
participants, spectators and transiting vessels.
    Except for persons or vessels authorized by the Coast Guard Patrol
Commander, no person or vessel may enter or remain in the regulated
areas during the effective period. The regulated area is needed to
control vessel traffic during the event to enhance the safety of
participants and transiting vessels.
    In addition to notice in the Federal Register, the maritime
community will be provided extensive advance notification via the Local
Notice to Mariners, and marine information broadcasts so mariners can
adjust their plans accordingly.

Regulatory Analyses

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

Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
and does not require an assessment of potential costs and benefits
under section 6(a)(3) of that Order. The Office of Management and
Budget has not reviewed it under that Order.
    Although this proposed rule prevents traffic from transiting a
portion of certain waterways during specified events, the effect of
this regulation will not be significant due to the limited duration
that the regulated area will be in effect and the extensive advance
notifications that will be made to the maritime community via marine
information broadcasts, local radio stations and area newspapers so
mariners can adjust their plans accordingly. Additionally, this
rulemaking does not change the permanent regulated areas that have been
published in 33 CFR 100.501, Table to Sec.  100.501. In some cases
vessel traffic may be able to transit the regulated area when the Coast
Guard Patrol Commander deems it is safe to do so.

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 would affect the following
entities, some of which might be small entities: the owners or
operators of vessels intending to transit or anchor in the areas where
marine events are being held. This regulation will not have a
significant impact on a substantial number of small entities because it
will be enforced only during marine events that have been permitted by
the Coast Guard Captain of the Port. The Captain of the Port will
ensure that small entities are able to operate in the areas where
events are occurring when it is safe to do so. In some cases, vessels
will be able to safely transit around the regulated area at various
times, and, with the permission of the Patrol Commander, vessels may
transit through the regulated area. Before the enforcement period, the
Coast Guard will issue maritime advisories so mariners can adjust their
plans accordingly.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

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

Collection of Information

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

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this proposed rule
under that Order and have determined that it does not have implications
for federalism.

Unfunded Mandates Reform Act

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

Taking of Private Property

    This proposed rule would not 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 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 Directive 0023.1 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 made a
preliminary determination that this action is one of a category of
actions which do not individually or cumulatively have a significant
effect on the human environment. Therefore, this rule is categorically
excluded, under section 2.B.2. Figure 2-1, paragraph 34(h), of the
Instruction and neither an environmental assessment nor an
environmental impact statement is required. This rule involves
implementation of regulations within 33 CFR Part 100 that apply to
organized marine events on the navigable waters of the United States
that may have potential for negative impact on the safety or other
interest of waterway users and shore side activities in the event area.
The category of water activities includes but is not limited to sail
boat regattas, boat parades, power boat racing, swimming events, crew
racing, and sail board racing. Under figure 2-1, paragraph (34)(h), of
the Instruction, an ``Environmental Analysis Check List'' and a
``Categorical Exclusion Determination'' are not required for this rule.
We seek any comments or information that may lead to 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 WATERS

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

    Authority: 33 U.S.C. 1233.

    2. In the Table to Sec.  100.501, suspend line Nos. 21, 37, 38, 40
and 54 from May 15, 2009 to July 15, 2009; and
    a. From 5:30 a.m. to 2:30 p.m., on July 11, 2009, add line No. 58;
    b. From 12 p.m. to 5 p.m., on June 6, 2009, add line No. 59;
    c. From 9 a.m., July 3, 2009 to 11 p.m., July 5, 2009, add line No.
60;
    d. From 10 a.m., May 30, 2009 to 5 p.m., May 31, 2009, add line No.
61; and
    e. From 9 a.m., May 16, 2009 to 5 p.m., May 17, 2009, add line No.
62.
    The additions read as follows:

Sec.  100.501-T05-0106  Special Local Regulations; Marine Events in the
Fifth Coast Guard District.

* * * * *
    Table To Sec.  100.501.--All coordinates listed in the Table to
Sec.  100.501 Reference Datum NAD 1983.

----------------------------------------------------------------------------------------------------------------
    Number             Date                Event               Sponsor                     Location
----------------------------------------------------------------------------------------------------------------
                                     Coast Guard Sector Baltimore--COTP Zone
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
58...........  July 11, 2009......  Maryland Swim for    District of          The waters of the Chester River
                                     Life.                Columbia Aquatics    from shoreline to shoreline,
                                                          Club.                bounded on the south by a line
                                                                               drawn at latitude 39[deg]10'16''
                                                                               N, near the Chester River Channel
                                                                               Buoy 35 (LLN-26795) and bounded
                                                                               on the north at latitude
                                                                               39[deg]12'30'' N by the Maryland
                                                                               S.R. 213 Highway Bridge.
----------------------------------------------------------------------------------------------------------------
                                   Coast Guard Sector Hampton Roads--COTP Zone
----------------------------------------------------------------------------------------------------------------
59...........  June 6, 2009; rain   RRBA Spring Radar    Rappahannock River   The waters of the Rappahannock
                date: June 7, 2009.  Shootout.            Boaters              River, adjacent to Layton, VA,
                                                          Association (RRBA).  from shoreline to shoreline,
                                                                               bounded on the west by a line
                                                                               running along longitude
                                                                               076[deg]58'30'' W, and bounded on
                                                                               the east by a line running along
                                                                               longitude 076[deg]56'00'' W.

60...........  July 3, 2009-July    Norfolk Harborfest.  Norfolk Festevents,  The waters of the Elizabeth River
                5, 2009.                                  Ltd.                 and its branches from shore to
                                                                               shore, bounded to the northwest
                                                                               by a line drawn across the Port
                                                                               Norfolk Reach section of the
                                                                               Elizabeth River between the
                                                                               northern corner of the landing at
                                                                               Hospital Point, Portsmouth,
                                                                               Virginia, latitude
                                                                               36[deg]50'51.'' N, longitude
                                                                               076[deg]18'09.0'' W and the north
                                                                               corner of the City of Norfolk
                                                                               Mooring Pier at the foot of
                                                                               Brooks Avenue located at latitude
                                                                               36[deg]51'00.0'' N, longitude
                                                                               076[deg]17'52.0'' W; bounded on
                                                                               the southwest by a line drawn
                                                                               from the southern corner of the
                                                                               landing at Hospital Point,
                                                                               Portsmouth, Virginia, at latitude
                                                                               36[deg]50'50.0'' N, longitude
                                                                               076[deg]18'10.0'' W, to the
                                                                               northern end of the eastern most
                                                                               pier at the Tidewater Yacht
                                                                               Agency Marina, located at
                                                                               latitude 36[deg]50'29.0'' N,
                                                                               longitude 076[deg]17'52.0'' W;
                                                                               bounded to the south by a line
                                                                               drawn across the Lower Reach of
                                                                               the Southern Branch of the
                                                                               Elizabeth River, between the
                                                                               Portsmouth Lightship Museum
                                                                               located at the foot of London
                                                                               Boulevard, in Portsmouth,
                                                                               Virginia at latitude
                                                                               36[deg]50'10.0'' N, longitude
                                                                               076[deg]17'47.0'' W, and the
                                                                               northwest corner of the Norfolk
                                                                               Shipbuilding & Drydock, Berkley
                                                                               Plant, Pier No. 1, located at
                                                                               latitude 36[deg]50'08.0'' N,
                                                                               longitude 076[deg]17'39.0'' W;
                                                                               and to the southeast by the
                                                                               Berkley Bridge which crosses the
                                                                               Eastern Branch of the Elizabeth
                                                                               River between Berkley at latitude
                                                                               36[deg]50'21.5'' N, longitude
                                                                               076[deg]17'14.5'' W, and Norfolk
                                                                               at latitude 36[deg]50'35.0'' N,
                                                                               longitude 076[deg]17'10.0'' W.
61...........  May 30, 2009-May     Ocean City Maryland  Offshore             The waters of the Atlantic Ocean
                31, 2009.            Offshore Grand       Performance          commencing at a point on the
                                     Prix.                Association, OPA     shoreline at latitude
                                                          Racing, LLC.         38[deg]25'42'' N, longitude
                                                                               075[deg]03'06'' W; thence east
                                                                               southeast to latitude
                                                                               38[deg]25'30'' N, longitude
                                                                               075[deg]02'12'' W, thence south
                                                                               southwest parallel to the Ocean
                                                                               City shoreline to latitude
                                                                               38[deg]19'12'' N, longitude
                                                                               075[deg]03'48'' W; thence west
                                                                               northwest to the shoreline at
                                                                               latitude 38[deg]19'30'' N,
                                                                               longitude 075[deg]05'00'' W. The
                                                                               waters of the Atlantic Ocean
                                                                               bounded by a line drawn from a
                                                                               position along the shoreline near
                                                                               Ocean City, MD at latitude
                                                                               38[deg]22'25.2'' N, longitude
                                                                               075[deg]03'49.4'' W, thence
                                                                               easterly to latitude
                                                                               38[deg]22'00.4'' N, longitude
                                                                               075[deg]02'34.8'' W, thence
                                                                               southwesterly to latitude
                                                                               38[deg]19'35.9'' N, longitude
                                                                               075[deg]03'35.4'' W, thence
                                                                               westerly to a position near the
                                                                               shoreline at latitude
                                                                               38[deg]20'05'' N, longitude
                                                                               075[deg]04'48.4'' W, thence
                                                                               northerly along the shoreline to
                                                                               the point of origin.
----------------------------------------------------------------------------------------------------------------
                                  Coast Guard Sector North Carolina--COTP Zone
----------------------------------------------------------------------------------------------------------------
62...........  May 16, 2009-May     Carolina Cup         The Carolina Cup     The waters of the Pasquotank
                17, 2009.            Regatta.             Regatta Inc.         River, adjacent to Elizabeth
                                                                               City, NC, from shoreline to
                                                                               shoreline, bounded on the west by
                                                                               the Elizabeth City Draw Bridge
                                                                               and bounded on the east by a line
                                                                               originating at a point along the
                                                                               shoreline at latitude
                                                                               36[deg]17'54'' N, longitude
                                                                               076[deg]12'00'' W, thence
                                                                               southwesterly to latitude
                                                                               36[deg]17'35'' N, longitude
                                                                               076[deg]12'18'' W at Cottage
                                                                               Point.
----------------------------------------------------------------------------------------------------------------

* * * * *

    Dated: March 16, 2009.
Neil O. Buschman,
Captain, U.S. Coast Guard, Commander, Fifth Coast Guard District,
Acting.
 [FR Doc. E9-6424 Filed 3-24-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 78, Number 209 (Tuesday, October 29, 2013)]
[Notices]
[Page 64496]
[FR Doc No: 2013-25579]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9902-14-OAR]

Acid Rain Program: Notice of Annual Adjustment Factors for Excess
Emissions Penalty

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of annual adjustment factors for excess emissions
penalty.

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

SUMMARY: The Acid Rain Program under title IV of the Clean Air Act
provides for automatic excess emissions penalties in dollars per ton of
excess emissions for sources that do not meet their annual Acid Rain
emissions limitations. This notice states the dollars per ton excess
emissions penalty amounts, which must be adjusted for each compliance
year commensurate with changes in the Consumer Price Index (CPI), for
compliance years 2013 and 2014.

FOR FURTHER INFORMATION CONTACT: Robert L. Miller, Clean Air Markets
Division (6204J), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460, at<PHONE_NUMBER> or
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Acid Rain Program under title IV of the
Clean Air Act limits annual sulfur dioxide and nitrogen oxide emissions
of fossil fuel-fired utility units. Under the Acid Rain Program,
affected sources must hold enough allowances to cover their sulfur
dioxide emissions, and certain coal-fired sources must meet an emission
limit for nitrogen oxides. Under 40 CFR 77.6, sources that do not meet
these requirements must pay a penalty without demand to the
Administrator based on the number of excess tons emitted times $2,000
as adjusted by an annual adjustment factor, which must be published in
the Federal Register.
    The annual adjustment factor for adjusting the penalty for excess
emissions of sulfur dioxide and nitrogen oxides under 40 CFR 77.6(b)
for compliance year 2013 is 1.8489. This value is derived using the CPI
for 1990 and 2012 (defined respectively at 40 CFR 72.2 as the CPI for
August of the year before the specified year for all urban consumers)
and results in an automatic penalty of $3,698 per excess ton of sulfur
dioxide or nitrogen oxides emitted for 2013.
    The annual adjustment factor for adjusting the penalty for such
excess emissions under 40 CFR 77.6(b) for compliance year 2014 is
1.8770. This value is derived using the CPI for 1990 and 2013 and
results in an automatic penalty of $3,754 per excess ton of sulfur
dioxide or nitrogen oxides emitted for 2014.

    Dated: September 30, 2013.
Reid P. Harvey,
Director, Clean Air Markets Division, Office of Atmospheric Programs,
Office of Air and Radiation.
[FR Doc. 2013-25579 Filed 10-28-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 25 (Tuesday, February 9, 2021)]
[Rules and Regulations]
[Pages 8713-8714]
[FR Doc No: 2021-02427]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 271

[EPA-R05-RCRA-2020-0275; FRL-10017-08-Region 5]

Illinois: Final Authorization of State Hazardous Waste Management
Program Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final authorization.

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

SUMMARY: The Environmental Protection Agency (EPA) is granting Illinois
final authorization for changes to its hazardous waste program under
the Resource Conservation and Recovery Act (RCRA). The Agency published
a Proposed Rule on July 30, 2020 and provided for public comment. No
adverse comments were received on the proposed revisions. No further
opportunity for comment will be provided.

DATES: This final authorization is effective February 9, 2021.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R05-RCRA-2020-0275. All documents in the docket are
listed on the http://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g., 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 electronically
through http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jean Gromnicki, Illinois Regulatory
Specialist, U.S. EPA Region 5, LL-17J, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

A. What changes to Illinois' hazardous waste program is EPA authorizing
with this action?

    On August 7, 2019, Illinois submitted a complete program revision
application seeking authorization of changes to its hazardous waste
program in accordance with 40 CFR 271.21. EPA published a Proposed Rule
on July 30, 2020 and requested public comment. EPA received two
comments which were generally supportive of this state authorization
action. EPA now makes a final decision that Illinois' hazardous waste
program revisions that are being authorized are equivalent to,
consistent with, and no less stringent than the Federal program, and
therefore satisfy all of the requirements necessary to qualify for
final authorization. For a list of State rules being authorized with
this Final Authorization, please see the Proposed Rule published in the
July 30, 2020, Federal Register at 85 FR 45834.

B. What is codification and is EPA codifying the Illinois' hazardous
waste program as authorized in this rule?

    Codification is the process of placing citations and references to
the State's statutes and regulations that comprise the State's
authorized hazardous waste program into the Code of Federal
Regulations. EPA does this by adding those citations and references to
the authorized State rules in 40 CFR part 272. EPA is not codifying the
authorization of Illinois' revisions at this time. However, EPA
reserves the ability to amend 40 CFR part 272, subpart O for the
authorization of Illinois' program changes at a later date.

C. Statutory and Executive Order Reviews

    This final authorization revises Illinois' authorized hazardous
waste management program pursuant to Section 3006 of RCRA and imposes
no requirements other than those currently imposed by State law. For
further information on how this authorization complies with applicable
executive orders and statutory provisions, please see the Proposed Rule
published in the July 30, 2020, Federal Register at 85 FR 45834. 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 document
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 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). This
final action will be effective February 9, 2021.

List of Subjects in 40 CFR Part 271

    Environmental protection, Administrative practice and procedure,
Confidential business information, Hazardous waste, Hazardous waste
transportation, Indian lands, Intergovernmental relations, Penalties,
Reporting and recordkeeping requirements.

    Authority: This action is issued under the authority of sections
2002(a), 3006, and 7004(b) of the Solid Waste Disposal Act as
amended, 42 U.S.C. 6912(a), 6926, and 6974(b).

Cheryl Newton,
Acting Regional Administrator.
[FR Doc. 2021-02427 Filed 2-8-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: April 15, 2008 (Volume 73, Number 73)]
[Rules and Regulations]
[Page 20173-20175]
[DOCID:fr15ap08-11]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2007-0145]
RIN 1625-AA00

Safety Zone; Colorado River, Parker, AZ

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone within
in the Lake Moolvalya region on the navigable waters of the Colorado
River in Parker, Arizona for the Bluewater Resort and Casino `Spring
Classic' Boat Race. This temporary safety zone is necessary to provide
for the safety of the participants, crew, spectators, participating
vessels and other vessels and users of the waterway. Persons and
vessels are prohibited from entering into, transiting through, or
anchoring within this safety zone unless authorized by the Captain of
the Port, or his designated representative.

DATES: This rule is effective from 6 a.m. on April 11, 2008, through 6
p.m on April 13, 2008.

ADDRESSES: Comments and material received from the public, as well as
documents indicated in this preamble as being available in the docket,
are part of docket CG-2007-0145 and are available for inspection or
copying at U.S. Coast Guard Sector San Diego, 2710 N. Harbor Drive, San
Diego, CA 92101-1064 between 8 a.m. and 3 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: MST3 Kristen Beer, Waterways
Management, U.S. Coast Guard Sector San Diego, CA at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On February 7, 2008, we published a notice of proposed rulemaking
(NPRM) entitled Safety Zone; Colorado River, Parker, AZ in the Federal
Register (73 FR 7229). We received no comments on the proposed rule. No
public hearing was requested, and none was held.
    Under 5 U.S.C. 553(d)(3), good cause exists for making this rule
effective less than 30 days after publication in the Federal Register.
Delaying this rule would be contrary to the public interest of ensuring
the safety of spectators and vessels during this event and immediate
action is necessary to prevent possible loss of life or property.

Background and Purpose

    The Southern California Speedboat Club is sponsoring the Bluewater
Resort and Casino `Spring Classic' Boat Race, which is held on the Lake
Moolvalya region on the Colorado River in Parker, Arizona. This
temporary safety zone is necessary to provide for the safety of the
participants, crew, spectators, sponsor vessels, and other users of the
waterway. This event involves powerboats racing along a circular track.
The size of the boats varies from 12 to 22 feet. Approximately 85 boats
will participate in this event. The sponsor will provide two water
rescue and two patrol vessels to patrol this event.

Regulatory Evaluation

    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. We expect the economic impact of this
proposed rule to be so minimal that a full Regulatory Evaluation is
unnecessary.
    This determination is based on the size and location of the safety
zone. Commercial vessels will be hindered by the safety zone.
Recreational vessels will not be allowed to transit through the
designated safety zone during the specified times.

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 and operators of pleasure craft
engaged in recreational activities and sightseeing in a portion of the
Lower Colorado River from 6 a.m. on April 11, 2008, through 6 p.m. on
April 13, 2008. This safety zone will not have a significant economic
impact on a substantial number of small entities because the rule will
be in effect for only 12 hours for a period of three (3) days. Before
the effective period, we will submit an inclusion in the Local 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 offered to assist small
entities in understanding the rule so that they could 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 Standard

    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.
    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 Commandant Instruction M16475.lD,
which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have concluded 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. A final ``Environmental Analysis Check
List'' and a final ``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, 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; 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 new Sec.  165.T11-001 to read as follows:

Sec.  165.T11-001  Safety Zone; Colorado River, Parker, AZ.

    (a) Location. The following area is a temporary safety zone: The
portion of the Colorado River from Headgate Dam to 0.5 nautical miles
north of Bluewater Marina, Parker, Arizona.
    (b) Enforcement Period. This safety zone will be enforced each day
from 6 a.m. to 6 p.m. from April 11, 2008, through April 13, 2008. If
the need for the safety zone ends before the scheduled termination
time, the Captain of the Port will cease enforcement of this safety
zone.
    (c) Definitions. The following definition applies to this section:
Designated representative, means any commissioned, warrant, and petty
officers of the Coast Guard on board Coast Guard, Coast Guard
Auxiliary, and local, State, and Federal law enforcement vessels who
have been authorized to act on the behalf of the Captain of the Port,
New York.
    (d) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into, transit through, or anchoring
within this zone by all vessels is prohibited, unless authorized

by the Captain of the Port, or his designated representative.
    (2) Mariners requesting permission to transit through the safety
zone may request authorization to do so from the Patrol Commander. The
Patrol Commander may be contacted via VHF-FM channel 16.
    (3) All persons and vessels shall comply with the instructions of
the Coast Guard Captain of the Port or the designated representative.
    (4) Upon being hailed by U.S. Coast Guard patrol personnel by
siren, radio, flashing light, or other means, the operator of a vessel
shall proceed as directed.
    (5) The Coast Guard may be assisted by other Federal, State, or
local agencies.

    Dated: March 17, 2008.
C.V. Strangfeld,
Captain, U.S. Coast Guard, Captain of the Port.
[FR Doc. E8-7937 Filed 4-14-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 85, Number 199 (Wednesday, October 14, 2020)]
[Notices]
[Pages 65038-65039]
[FR Doc No: 2020-22662]

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

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: ER18-2317-004.
    Applicants: Meadow Lake Wind Farm V LLC.
    Description: Compliance filing: Informational Filing Pursuant to
Schedule 2 of the PJM OATT & Request for Waiver to be effective N/A.
    Filed Date: 10/6/20.
    Accession Number: 20201006-5101.
    Comments Due: 5 p.m. ET 10/27/20.

    Docket Numbers: ER19-468-003.
    Applicants: California Independent System Operator Corporation.
    Description: Compliance filing: 2020-10-07 Order No. 841--Third
Compliance Filing to be effective 12/3/2019.
    Filed Date: 10/7/20.
    Accession Number: 20201007-5082.
    Comments Due: 5 p.m. ET 10/28/20.

    Docket Numbers: ER19-585-002.
    Applicants: Quilt Block Wind Farm LLC.
    Description: Compliance filing: Informational Filing Pursuant to
Schedule 2 of the MISO OATT & Waiver Request to be effective N/A.
    Filed Date: 10/6/20.
    Accession Number: 20201006-5099.
    Comments Due: 5 p.m. ET 10/27/20.

    Docket Numbers: ER20-1802-000.
    Applicants: Entergy Louisiana, LLC.
    Description: Entergy Louisiana, LLC submits tariff filing per
35.19a(b): Refund Report_SRMPA to be effective N/A.
    Filed Date: 10/7/20.
    Accession Number: 20201007-5058.
    Comments Due: 5 p.m. ET 10/28/20.

    Docket Numbers: ER21-35-000.
    Applicants: Tri-State Generation and Transmission Association, Inc.
    Description: Sec.  205(d) Rate Filing: Amendment to Tri-State Rate
Schedule FERC No. 244 to be effective 10/8/2020.
    Filed Date: 10/7/20.
    Accession Number: 20201007-5002.
    Comments Due: 5 p.m. ET 10/28/20.

    Docket Numbers: ER21-36-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original WMPA, Service
Agreement No. 5820; Queue No. AF2-290 to be effective 9/9/2020.
    Filed Date: 10/7/20.
    Accession Number: 20201007-5003.
    Comments Due: 5 p.m. ET 10/28/20.

    Docket Numbers: ER21-37-000.
    Applicants: Techren Solar II LLC.
    Description: Tariff Cancellation: Cancellation of Rate Schedule
Tariff to be effective 10/8/2020.
    Filed Date: 10/7/20.
    Accession Number: 20201007-5041.
    Comments Due: 5 p.m. ET 10/19/20.

    Docket Numbers: ER21-38-000.
    Applicants: AEP Texas Inc.
    Description: Sec.  205(d) Rate Filing: AEPTX-Starr Solar Ranch
Generation Interconnection Agreement to be effective 10/1/2020.
    Filed Date: 10/7/20.
    Accession Number: 20201007-5051.
    Comments Due: 5 p.m. ET 10/28/20.

    Docket Numbers: ER21-39-000.
    Applicants: Wabash Valley Power Association, Inc.
    Description: Sec.  205(d) Rate Filing: Compliance Filing of Amended
Distributed Generation Policy D-11 to be effective 12/7/2020.
    Filed Date: 10/7/20.
    Accession Number: 20201007-5054.
    Comments Due: 5 p.m. ET 10/28/20.

    Docket Numbers: ER21-40-000.
    Applicants: ConocoPhillips Company.
    Description: Compliance filing: WECC Cost Justification Filing to
be effective N/A.

    Filed Date: 10/7/20.
    Accession Number: 20201007-5065.
    Comments Due: 5 p.m. ET 10/28/20.

    Docket Numbers: ER21-41-000.
    Applicants: La Joya Wind, LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization, Request for Related Waivers to be effective 11/1/
2020.
    Filed Date: 10/7/20.
    Accession Number: 20201007-5076.
    Comments Due: 5 p.m. ET 10/28/20.

    Docket Numbers: ER21-42-000.
    Applicants: Tenaska Power Services Co.
    Description: Compliance filing: Filing re Certain Spot Sales at
Prices Exceeding West-Wide Soft Cap--Aug. 2020 to be effective N/A.
    Filed Date: 10/7/20.
    Accession Number: 20201007-5079.
    Comments Due: 5 p.m. ET 10/28/20.

    Docket Numbers: ER21-43-000.
    Applicants: Exelon Generation Company, LLC.
    Description: Compliance filing: WECC Soft Offer Cap to be effective
N/A.
    Filed Date: 10/7/20.
    Accession Number: 20201007-5081.
    Comments Due: 5 p.m. ET 10/28/20.

    Docket Numbers: ER21-44-000.
    Applicants: Altavista Solar, LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Tariff
Application to be effective 10/15/2020.
    Filed Date: 10/7/20.
    Accession Number: 20201007-5083.
    Comments Due: 5 p.m. ET 10/28/20.

    Docket Numbers: ER21-45-000.
    Applicants: Calvert Cliffs Nuclear Power Plant, LLC.
    Description: Compliance filing: Baseline Filing to be effective 12/
6/2020.
    Filed Date: 10/7/20.
    Accession Number: 20201007-5085.
    Comments Due: 5 p.m. ET 10/28/20.

    Docket Numbers: ER21-45-001.
    Applicants: Calvert Cliffs Nuclear Power Plant, LLC.
    Description: Compliance filing: Informational Filing Regarding
Transfer of Ownership to be effective N/A.
    Filed Date: 10/7/20.
    Accession Number: 20201007-5110.
    Comments Due: 5 p.m. ET 10/28/20.

    Docket Numbers: ER21-46-000.
    Applicants: Mercuria Energy America, LLC.
    Description: Compliance filing: Explanation for Bilateral Spot
Sales in the West to be effective N/A.
    Filed Date: 10/7/20.
    Accession Number: 20201007-5088.
    Comments Due: 5 p.m. ET 10/28/20.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by 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 7, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-22662 Filed 10-13-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Notices]
[Pages 52441-52443]
[FR Doc No: 2016-18714]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0453]

Deciding When To Submit a 510(k) for a Software Change to an
Existing Device; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Deciding When to
Submit a 510(k) for a Software Change to an Existing Device.'' FDA is
issuing this draft guidance document to clarify when a software change
in a legally marketed medical device would require that a manufacturer
submit a premarket notification (510(k)) to FDA. This draft guidance is
not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by November 7, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:

     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2011-D-0453 for ``Deciding When to Submit a 510(k) for a Software
Change to an Existing Device.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Deciding When to Submit a 510(k) for a Software Change to an Existing
Device'' to the Office of the Center Director, Guidance and Policy
Development, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002; or to the Office of Communication, Outreach and
Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Linda Ricci, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1314, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-
7911.

SUPPLEMENTARY INFORMATION:

I. Background

    A premarket notification (510(k)) is required when a legally
marketed device subject to 510(k) requirements is about to be
significantly changed or modified in design, components, method of
manufacture, or intended use. Significant changes or modifications are
those that could significantly affect the safety or effectiveness of
the device, or those that constitute major changes or modifications in
the intended use of the device (21 CFR 807.81(a)(3)). This guidance,
when finalized, will aid manufacturers of medical devices who intend to
make a software modification to a 510(k)-cleared device or a
preamendments device subject to 510(k) (i.e., ``existing devices'')
during the process of deciding whether the software modification
exceeds the regulatory threshold of Sec.  807.81(a)(3) for submission
and clearance of a new 510(k).
    This draft guidance specifically addresses software design and
technology modifications. This draft guidance does not apply to
software for which the Agency has stated in guidance that it does not
intend to enforce compliance with applicable regulatory controls (see,
e.g., ``Mobile Medical Applications: Guidance for Industry and FDA
Staff,'' issued February 9, 2015, available on the Internet at http://www.fda.gov/downloads/MedicalDevices/.../UCM263366.pdf).
    Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of the guidance document entitled ``Deciding When to
Submit a 510(k) for a Change to an Existing Device,'' to aid
manufacturers of medical devices who intend to make non-software
changes to an existing device during the process of deciding whether
the modification exceeds the regulatory threshold of Sec.  807.81(a)(3)
for submission and clearance of a new 510(k).

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on when to submit
a 510(k) for a software change to an existing device. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov. Persons unable to download
an electronic copy of ``Deciding When to Submit a 510(k) for a Software
Change to an Existing Device'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 1500055 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 820 are approved under OMB
control number 0910-0073; the collections of information in 21 CFR part
807, subpart E are approved under OMB control number 0910-0120; the
collections of information in 21 CFR part 803 are approved under OMB
control number 0910-0437; and the collections of information in 21 CFR
parts 801 are approved under OMB control number 0910-0485.

    Dated: August 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18714 Filed 8-5-16; 8:45 am]
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