[Federal Register Volume 76, Number 183 (Wednesday, September 21, 2011)]
[Rules and Regulations]
[Pages 58401-58403]
[FR Doc No: 2011-24140]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0575]
RIN 1625-AA00

Safety Zone; Swim Around Charleston, Charleston, SC

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary moving safety zone
during the Swim Around Charleston, a swimming race occurring on waters
of the Wando River, the Cooper River, Charleston Harbor, and the Ashley
River, in Charleston, South Carolina. The Swim Around Charleston is
scheduled to take place on Sunday, October 23, 2011. The temporary
safety zone is necessary for the safety of the swimmers, participant
vessels, spectators, and the general public during the event. Persons
and vessels are prohibited from entering, transiting through, anchoring
in, or remaining within the safety zone unless authorized by the
Captain of the Port Charleston or a designated representative.

DATES: This rule is effective from 10 a.m. until 4 p.m. on October 23,
2011.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2011-0575 and are available online by going to
http://www.regulations.gov, inserting USCG-2011-0575 in the ``Keyword''
box, and then clicking ``Search.'' This material is also available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary final rule, call or e-mail Ensign John R. Santorum, Sector
Charleston Office of Waterways Management, Coast Guard; telephone 843-
740-3184, e-mail<EMAIL_ADDRESS>If you have questions on
viewing the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On July 1, 2011, we published a notice of proposed rulemaking
(NPRM) entitled Safety Zone; Swim Around Charleston, Charleston, SC in
the Federal Register (76 FR 38586). We received no comments on the
proposed rule. No public meeting was requested, and none was held.

Basis and Purpose

    The legal basis for the rule is the Coast Guard's authority to
establish regulated navigation areas and other limited access areas: 33
U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33
CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L. 107-295, 116 Stat. 2064;
Department of Homeland Security Delegation No. 0170.1.
    The purpose of the rule is to ensure the safety of the swimmers,
participant vessels, spectators, and the general public during the Swim
Around Charleston.

Discussion of Comments and Changes

    The Coast Guard did not receive any comments to the proposed rule,
and no changes were made to the regulatory text.

Discussion of Rule

    On Sunday, October 23, 2011, the Swim Around Charleston is
scheduled to take place on the waters of the Wando River, the Cooper
River, Charleston Harbor, and the Ashley River, in Charleston, South
Carolina. The Swim Around Charleston will consist of a 10-mile swim
that starts at Remley's Point on the Wando River, crosses the main
shipping channel of Charleston Harbor, and finishes at the General
William B. Westmoreland Bridge on the Ashley River.
    This rule establishes a temporary moving safety zone of a 75-yard
radius around the Swim Around Charleston participant vessels that are
officially associated with the swim on the waters of the Wando River,
the Cooper River, Charleston Harbor, and the Ashley River, in
Charleston, South Carolina. The temporary safety zone will be enforced
from 10 a.m. until 4 p.m. on October 23, 2011. Persons and vessels are
prohibited from entering, transiting through, anchoring in, or
remaining within the safety zone unless authorized by the Captain of
the Port Charleston or a designated representative. Persons and vessels
desiring to enter, transit through, anchor in, or remain within the
safety zone may contact the Captain of the Port Charleston by telephone
at<PHONE_NUMBER>, or a designated representative via VHF radio on
channel 16, to request authorization.

Regulatory Analyses

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

Executive Order 12866 and Executive Order 13563

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, and does not require an
assessment of potential costs and benefits under section 6(a)(3) of
that Order. The Office of Management and Budget has not reviewed it
under that Order.
    The economic impact of this rule is not significant for the
following reasons: (1) The safety zone will only be enforced for a
total of six hours; (2) the safety zone will move with the participant
vessels so that once the swimmers clear a portion of the waterway, the
safety zone will no longer be enforced in that portion of the waterway;
(3) although persons and vessels may not enter, transit through, anchor
in, or remain within the safety zone without authorization from the
Captain of the Port Charleston or a designated representative, they may
operate in the surrounding area during the enforcement period; (4)
persons and vessels may still enter, transit through, anchor in, or
remain within the safety zone if authorized by the Captain of the Port
Charleston or a designated representative; and (5) the Coast Guard will
provide advance notification of the safety zone to the local maritime
community by Local Notice to Mariners and Broadcast Notice to Mariners.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit

organizations that are independently owned and operated and are not
dominant in their fields, and governmental jurisdictions with
populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule may affect the following entities, some of which
may be small entities: the owners or operators of vessels intending to
enter, transit through, anchor in, or remain within that portion of the
Wando River, the Cooper River, Charleston Harbor, and the Ashley River
in Charleston, South Carolina encompassed within the safety zone from
10 a.m. until 4 p.m. on October 23, 2011. For the reasons discussed in
the Executive Order 12866 and Executive Order 13563 section above, this
rule will not have a significant economic impact on a substantial
number of small entities.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM 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 Standards

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

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded, under figure 2-1, paragraph (34)(g), of
the Instruction. This rule involves establishing a temporary safety
zone that will be enforced for a total of six hours. An environmental
analysis checklist and a categorical exclusion determination are
available in the docket where indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

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

0
2. Add a temporary Sec.  165.T07-0575 to read as follows:

Sec.  165.T07-0575  Safety Zone; Swim Around Charleston, Charleston,
SC.

    (a) Regulated Area. The following regulated area is a moving safety
zone: all waters within a 75-yard radius around Swim Around Charleston
participant vessels that are officially associated with the swim. The
Swim Around Charleston swimming race consists of a 10-mile course that
starts at Remley's Point on the Wando River in approximate position
32[deg]48'49'' N, 79[deg]54'27'' W, crosses the main shipping channel
of Charleston Harbor, and finishes at the General William B.
Westmoreland Bridge on the Ashley River in approximate position
32[deg]50'14'' N, 80[deg]01'23'' W. All coordinates are North American
Datum 1983.
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, state, and local officers designated by or assisting the
Captain of the Port Charleston in the enforcement of the regulated
area.
    (c) Regulations.
    (1) All persons and vessels are prohibited from entering,
transiting through, anchoring in, or remaining within the regulated
area unless authorized by the Captain of the Port Charleston or a
designated representative.
    (2) Persons and vessels desiring to enter, transit through, anchor
in, or remain within the regulated area may contact the Captain of the
Port Charleston by telephone at<PHONE_NUMBER>, or a designated
representative via VHF radio on channel 16, to request authorization.
If authorization to enter, transit through, anchor in, or remain within
the regulated area is granted by the Captain of the Port Charleston or
a designated representative, all persons and vessels receiving such
authorization must comply with the instructions of the Captain of the
Port Charleston or a designated representative.
    (3) The Coast Guard will provide notice of the regulated area by
Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene
designated representatives.
    (d) Effective Date. This rule is effective from 10 a.m. until 4
p.m. on October 23, 2011.

    Dated: September 7, 2011.
M.F. White,
Captain, U.S. Coast Guard, Captain of the Port Charleston.
[FR Doc. 2011-24140 Filed 9-20-11; 8:45 am]
BILLING CODE 9110-04-P


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0.430238141 0.00050826 0 0.516285769 0.00042355 0 0.430238141 0 0 0 0 0 0 0.015240185 0 9.390625342 0.015240185 0 9.390625342 0.016389159 0 9.136824658 0.018730468 0 9.136824658 0 0 0 0 0 0 0 0 0 0 0 0 0.00103675 0 1.190600513 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.00138131 0 1.586292319 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.001015669 0 1.18971926 0 0 0 0 0 0 0 0 0 0.000355805 0 0.408213016 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.000992136 0 1.13936631 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.000574011 0 0.659192596 0.000574011 0 0.659192596 0 0 0 0 0 0 0.000574011 0 0.659192596 0.001572223 0 1.805536188 0.001572223 0 1.805536188 0 0 0 0 0 0 0.00077868 0 0.912118054 0.000906579 0 1.061934618 0 0 0 0.000422067 0 0.484700431 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.000952693 0 0.870999521 0 0 0 0 0 0 0 0 0 0 0 0 0.001743309 0 2.00201098 0.002193827 0 2.519384669 0.002742284 0 3.14923089 0.003447443 0 3.959033205 0 0 0 0 0 0 0 0 0 0.0017 0 1.9142 0 0 0 0 0 0 0 0 0 0.000957037 0 1.099058227 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.001419085 0 1.629673008 0 0 0 0 0 0 0 0 0 0 0 0 1.5877 2.0398 697.9702 1.6914 1.9899 680.887 2.509 8.998 1533.0338 0.27960571 1.462590233 136.4866543 0.369399974 1.912 178.4274 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.001521933 0 1.392764656 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.005173619 0 1.115031349 0.000951908 0 1.115031349 0.3765 1.3469 125.6892 0.279322241 1.349404884 125.9243729 0.291883623 1.349404884 125.9243729 2.3041 6.6458 1364.3987 2.1082 4.4396 1396.9109 2.6772 7.9828 2237.0719 3.687400518 7.320116705 1556.988281 3.535563632 7.018694681 1492.875839 3.660745555 7.267202074 1545.733343 3.654623721 6.463939951 1374.879549 4.197398415 7.423946589 1579.072889 3.8612 6.4137 1364.1923 0 0 0 0 0 0 2.96361549 5.010850926 1028.730414 2.025949853 4.917024528 1009.467803 2.850952739 6.919324546 1420.541083 8.2463 23.9335 3275.7035 0.344246793 0 396.1029543 0.344246793 0 396.1029543 0 0 0 1.2207402 5.183416719 642.7693539 1.203481566 5.183416719 642.7693539 3.992477838 20.63586656 2558.949692 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.500904729 1.251083799 266.1031218 0.704 3.9712 370.583 0.737568113 4.396647205 410.2883503 0.985331927 7.020452795 655.1378497 0 0 0 0.040171492 0.1092022 16.59132209 0.040171492 0.1092022 16.59132209 0.040171492 0.1092022 16.59132209 0.040171492 0.1092022 16.59132209 0.040171492 0.1092022 16.59132209 0.040171492 0.1092022 16.59132209 0 0 0 0 0 0 0.060257238 0.163803301 24.88698313 1.502943794 5.541861409 1835.069754 3.750087787 9.722144799 3219.281853 4.834423531 12.18254017 4033.989545 4.021828866 12.30197683 4073.538462 0 0 0 0 0 0 0 0 0 2.633303396 2.07183073 1198.163736 5.100496604 4.01296927 2320.746664 0 0 0 1.35344552 2.66311202 874.144956 1.405928628 3.040739061 998.0979743 1.375671114 2.975298183 976.6175359 1.554884158 2.921618568 958.9976371 0 0 0 0 0 0 0 0 0 6.0827 17.2452 3668.0526 0 0 0 0 0 0 0 0 0 0.798714974 0 772.0761542 1.678459003 0 1622.478875 1.377866772 0 1230.6115 1.426307401 0 1273.875186 1.704504056 0 1647.655271 0.15051847 0 440.2432639 0.388837915 0 446.0196336 2.587037158 0 1663.09201 1.405356867 0 1255.16377 0.793546765 0 910.2441502 0.424826548 0 2761.360309 1.792478433 0 1359.481823 3.513392169 0 3137.909425 1.229687259 0 1098.268299 1.180499769 0 1054.337567 1.405356867 0 1255.16377 1.86417757 0 1413.861096 3.513392169 0 3137.909425 1.756696084 0 1568.954713 0.82564716 0 737.4087149 0.945388788 0 1176.716028 3.904961749 0 2510.327563 1.841028495 0 2111.766428 0.761094341 0 735.7102484 0.662281266 0 1937.070361 1.496078752 0 1569.609642 0.503516011 0 3272.839548 2.0149 0 1274.3418 1.060178478 0 1216.086185 0.24137872 0 1568.954721 1.756696084 0 1568.954713 2.459374518 0 2196.536598 3.513392169 0 3137.909425 0.454900264 0 1330.512975 1.157557933 0 1118.950948 1.34557302 0 1201.769043 2.214057143 0 2785.416057 0.945388788 0 1176.716028 2.440601093 0 1568.954727 3.513392169 0 3137.909425 3.513392169 0 3137.909425 0.8786 0 767.1309 1.030534985 0 1182.097326 0.174580288 0 200.253713 0.880942751 0 746.8822654 1.1067 0 988.4415 0.476128059 0 546.1464901 3.864731385 0 3451.700368 1.0232 0 1129.3612 1.36640013 0 1522.6286 1.792478433 0 1359.481823 1.660542857 0 2089.062043 0.0238 0 27.3073 0.24137872 0 1568.954721 1.964536609 0 1754.582803 0.878269622 0 741.3050032 1.728642379 0 1465.580294 1.86161487 0 1578.31724 1.756696084 0 1568.954713 1.512622061 0 1882.745644 1.0258 0 1176.7161 3.864731385 0 3451.700368 0.231870372 0 265.9718983 2.152916832 0 1922.830469 0.5275 0 656.6075 0.864965596 0 695.619659 1.932365693 0 1725.850184 0.214694788 0 246.2702762 0.547921253 0 686.5472576 0.576967775 0 462.3155276 0.125332177 0 100.4267724 0.0549 0 49.0197 1.588989018 0 1419.172019 0.288907094 0 258.0312761 0.5995 1.0607 266.3822 2.6663 4.2183 1202.8018 0.1502 0 144.0825 0.060173218 0 64.00902865 0.646826087 0 749.2951304 0.031432658 0 32.05658698 0.203460693 0 216.4305281 0.186792192 0 190.0268139 0.104100009 0 108.7786 1.105925501 0 1145.070946 0.216299978 0 260.9392 0.344973913 0 399.6240696 0.267407769 0 272.0383861 0.031432658 0 32.05658698 0.157282616 0 158.6354672 0.460802292 0 477.112894 0.256787945 0 258.9966812 0.044206416 0 45.33254725 0.0658 0 64.7492 0.3184 0 305.3523 0.410860712 0 414.39469 0.4818 0 526.7492 0.0332 0 32.37459048 0.147456734 0 152.6761261 0.031432658 0 32.05658698 0.171044776 0 194.2474925 0.1525 0 159.3557 0.112986696 0 113.9585397 0.2319 0 240.0339 0.300866089 0 320.0451432 0.002067375 0 2.018949026 0.0007 0 0.8001 0.166 0 161.8729524 0.875524355 0 906.5144986 0.3881 0 449.5771 0.065863042 0 64.76078178 0.065863042 0 64.76078178 0.404172948 0 414.4690034 0.003173771 0 3.619577049 0.107358439 0 110.093329 0.03215 0 28.48965 0.203201023 0 207.2345017 0.626691117 0 648.8735358 0.384749589 0 388.5646907 0.0664 0 64.74918095 0.002526792 0 2.467604365 0.050521619 0 51.80862543 0.014426231 0 16.45262295 0.03215 0 28.48965 0.203201023 0 207.2345017 0.3443 0 362.8751 0.385181917 0 388.4950218 0.083 0 80.93647619 0.001263396 0 1.233802183 0.151564856 0 155.4258763 0.019955224 0 22.66220746 0.0333 0 35.1166 2.73526E 05 0 0.032004954 0.563511315 0 659.3587787 0.076461332 0 89.46661632 0.000114137 0 0.667692418 2.35142706 0 13755.64737 0.319058803 0 1866.466733 8.44724E 05 0 0.494166373 1.740281429 0 10180.70324 0.236134099 0 1381.392195 0.771225424 0 902.3285296 0.416210583 0 486.9635663 2.764695944 0 3234.675553 1.488268055 0 1741.263558 0.668303858 0 781.9394849 0.184796142 0 216.2181151 0.24291454 0 284.2031668 0.87848546 0 1027.803233 1.119610682 0 6549.838747 0.309589318 0 1811.129653 0.172122366 0 201.3953009 0.240889859 0 281.8581149 0.194768036 0 227.8923312 0.000819739 0 0.959152983 0.109283092 0 127.8589619 0.088359275 0 103.3785275 0.000371886 0 0.435099429 0.078085746 0 91.35871117 2.2567 0 2640.337 1.2277 0 7181.7741 2.4788 0 14501.0884 0.052888779 0 61.87706091 0.703611221 0 823.1877391 0.228615516 0 267.4767128 0.017184484 0 20.10558718 0.124419621 0 145.5572089 0.241390923 0 282.4007083 0.007465458 0 8.733760445 0.007638242 0 8.935899238 0.032685756 0 38.23872313 0.073574562 0 430.4277932 0.017193432 0 100.5854556 0.543363031 0 3178.796353 0.280064475 0 1638.440384 0.016804499 0 98.3101141 0.0894 0 104.6215 0.1371 0 160.4652 0.043354571 0 50.72607817 0.000765918 0 0.896146264 0.058241445 0 68.14414343 0.13564536 0 158.7089207 0.009388356 0 10.98464321 0.075069579 0 87.83353798 0.010569556 0 12.36668104 0.103865215 0 121.5252492 0.133675766 0 156.4057269 0.028947253 0 33.8693857 0.418237272 0 489.3535043 0.032589264 0 38.13067769 0.231463103 0 270.8206281 0.002361567 0 2.763123287 0.179576677 0 210.1115377 0.320249098 0 374.7036163 0.092580792 0 541.5864433 0.059991356 0 350.9421821 0.52389575 0 3064.726826 1.059532102 0 6198.134748 0.248829776 0 1455.626164 1.026547489 0 6005.187189 0.334035519 0 1954.070166 0.041987215 0 245.6204813 0.525395384 0 3073.455582 0.170962106 0 1000.093364 0.0214894 0 125.7085942 0.127353111 0 744.9896595 1.0712 0 6266.247 0.258701548 0 1513.341529 0.066803886 0 390.7865873 0.13114083 0 767.1421586 0.004599308 0 26.90483882 0.428533939 0 2506.819972 0.025020489 0 146.363814 0.8601 0 1006.3324 0.1818 0 212.6848 1.5234 0 1782.3869 0.4641 0 542.9753 0.1032 0 603.9856 0.485721037 0 568.2996559 0.796711167 0 932.1619776 0.025978764 0 30.39547713 0.357520956 0 418.3039671 0.16388698 0 191.7498058 0.236135286 0 276.2812224 0.668588885 0 782.2573139 0.046556924 0 54.47218018 0.011917293 0 13.93681622 0.010000826 0 11.69558155 0.000696404 0 0.814417218 0.005347838 0 6.254090657 0.003532138 0 4.130699079 0.002451439 0 2.866864203 0.000388593 0 0.454444816 0.007265469 0 8.496686257 0.00470889 0 5.508995368 0.064803968 0 75.81504995 0.088041413 0 103.0008563 0.14441124 0 168.9486891 0.042801696 0 50.07429125 0.008438871 0 9.872751364 0.121187896 0 141.7793805 0.029706025 0 34.7534861 0.4195 0 2453.9288 0.6311 0 3692.1957 0.0337 0 196.9446 Total Mercury Emission ( Ton) 0.091799059 0.091799059 0 0 0 0 0 0 0 0 0 0.013964278 0 0 0 0 0 0 0 0.088112461 0.082321716 0 0 0 0 0 0 0 0 0 0 0.004522723 0.004522723 0.004522723 0.0167 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.005480447 0.005480447 0.005480447 0.0019 0.0019 0.000492553 0.000492553 0.000514895 0.004107913 0.00403274 0.004051434 0.004107913 0 0 0.0077 0.015451107 0.015624446 0.015624446 0.0155 0.057465823 0.0002 0 0 0 0 0 0.012321199 0.008403352 0.01 0.017813912 0 0 0 0 0 0 0.019500772 0.01 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.003016514 0.0029 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.004391548 0.005708452 0 0 0 0.014434323 0 0 0 0.006178801 0 0 0 0 0 0.003145374 0.003138303 0.003169232 0.0072 0.003170678 0.003110182 0.00313123 0.003400271 0.0056 0.0056 0.003458392 0.003458392 0.003383217 0 0 0 0 0 0 0.0016257 0.001613252 0.001661048 0 0 0 0 0.00906794 0.00906794 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.00393183 0.0117 0 0 0 0 0 0 0 0 0 0 0 0.014390124 0.014363945 0.008862614 0.006575342 0 0 0 0.007 0.003030449 0.002091987 0.0077 0.0636 0 0 0 0 0 0 0.0165 0.0123 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.0275 0 0 0.0026 0.0026 0.0026 0.0026 0.0141 0.013770398 0 0 0 0 0 0 0 0 0 0 0 0.001093717 0.002155845 0 0 0 0 0 0.002 0.0141 0 0 0 0 0 0.0039 0.0311 0.0311 0.02890041 0.1263 0.004232687 0.013767313 0 0 0 0 0 0 0 0 0 0 0 0.001392306 0.001392306 0 0 0 0 0 0 0 0 0 0 0 0 0 0.00295 0.00295 0.010337386 0.0328 0 0 0 0 0 0 0.0056 0.002310651 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.0028 0.004205679 0.00624736 0.00625264 0.007 0.007 0.0188 0.0096 0.0071 0.0043 0 0 0 0.0183 0 0 0 0 0.0639 0 0 0 0 0 0.000287519 0.000345023 0.000345023 0.0296 0 0 0 0 0 0 0 0 0 0 0 0 0.009424658 0.0205 0.1565 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.0195 0.030727018 0.0358 0 0 0.0475 0 0 0 0 0 0 0 0 0 0 0 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[Federal Register Volume 79, Number 181 (Thursday, September 18, 2014)]
[Rules and Regulations]
[Pages 56009-56011]
[FR Doc No: 2014-22254]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2014-N-1251]

Medical Devices; Immunology and Microbiology Devices;
Classification of Tryptase Test System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying tryptase
test system devices into class II (special controls). The Agency is
classifying the device into class II (special controls) because special
controls, in addition to general controls, will provide a reasonable
assurance of safety and effectiveness of the device.

DATES: This order is effective October 20, 2014. The classification was
applicable February 15, 2012.

FOR FURTHER INFORMATION CONTACT: Elizabeth Stafford, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5608, Silver Spring, MD 20993-0002, 301-
796-6184.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1).
Under the first procedure, the person submits a premarket notification
under section 510(k) of the FD&C Act for a device that has not
previously been classified and, within 30 days of receiving an order
classifying the device into class III under section 513(f)(1) of the
FD&C Act, the person requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a premarket
notification under section 510(k) and then a request for classification
under the first procedure, the person determines that there is no
legally marketed device upon which to base a determination of
substantial equivalence and requests a classification under section
513(f)(2) of the FD&C Act. If the person submits a request to classify
the device under this second procedure, FDA may decline to undertake
the classification request if FDA identifies a legally marketed device
that could provide a reasonable basis for review of substantial
equivalence with the device or if FDA determines that the device
submitted is not of ``low-moderate risk'' or that general controls
would be inadequate to control the risks and special controls to
mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device.

    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an
order on January 3, 2012, classifying the ImmunoCAP Tryptase into class
III, because it was not substantially equivalent to a device that was
introduced or delivered for introduction into interstate commerce for
commercial distribution before May 28, 1976, or a device which was
subsequently reclassified into class I or class II. On January 12,
2013, Phadia U.S., Inc. submitted a request for de novo classification
of the ImmunoCAP Tryptase under section 513(f)(2) of the FD&C Act. The
manufacturer recommended that the device be classified into class II.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request for de novo classification in order to classify the device
under the criteria for classification set forth in section 513(a)(1).
FDA classifies devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the request, FDA determined that the device
can be classified into class II with the establishment of special
controls. FDA believes these special controls, in addition to general
controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    The device is assigned the generic name tryptase test system, and
it is identified as a device that aids in the diagnosis of systemic
mastocytosis. It is intended for in vitro diagnostic use as an aid in
the clinical diagnosis of patients with a suspicion of systemic
mastocytosis in conjunction with other clinical and laboratory
findings.
    FDA has identified the following risks to health associated with
this type of device and the measures required to mitigate these risks
in Table 1:

       Table 1--Identified Risks to Health and Mitigation Measures
------------------------------------------------------------------------
      Identified risks to health              Mitigation measures
------------------------------------------------------------------------
False negative result................  Device description containing the
                                        information specified in the
                                        special control guideline.
                                       Analytical performance
                                        validation.
                                       Software.
                                       Clinical performance evaluation.
                                       Labeling.
False positive result................  Device description containing the
                                        information specified in the
                                        special control guideline.
                                       Analytical performance
                                        validation.
                                       Software.
                                       Clinical performance evaluation.
                                       Labeling.
Inappropriate use....................  Labeling.
------------------------------------------------------------------------

    FDA believes that the measures set forth in the special controls
guideline entitled ``Class II Special Controls Guideline: Tryptase Test
System as an Aid in the Diagnosis of Systemic Mastocytosis'' are
necessary, in addition to general controls, to mitigate the risks to
health described in table 1.
    Therefore, on February 15, 2012, FDA issued an order to the
petitioner classifying tryptase test system devices into class II. FDA
is codifying this device type by adding Sec.  866.5760.
    Following the effective date of this final classification order,
any firm submitting a 510(k) premarket notification for this device
type will need to comply with the special controls.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this type of device is not exempt from premarket
notification requirements. Persons who intend to market this type of
device must submit to FDA a premarket notification, prior to marketing
the device, which contains information about the tryptase test system
they intend to market.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that
refer to previously approved collections of information found in other
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 part 807, subpart E, regarding premarket notification
submissions have been approved under OMB control number 0910-0120; the
collections of information in 21 CFR part 820 have been approved under
OMB control number 0910-0073; and the collections of information in 21
CFR part 801 and 21 CFR 809.10 have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for 21 CFR part 866 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Add Sec.  866.5760 to subpart F to read as follows:

Sec.  866.5760  Tryptase test system.

    (a) Identification. A tryptase test system is a device that aids in
the diagnosis of systemic mastocytosis. It is intended for in vitro
diagnostic use as an aid in the clinical diagnosis of patients with a
suspicion of systemic mastocytosis in conjunction with other clinical
and laboratory findings.

    (b) Classification. Class II (special controls). The special
control is FDA's guideline entitled ``Class II Special Controls
Guideline: Tryptase Test System as an Aid in the Diagnosis of Systemic
Mastocytosis.'' For availability of the document, see Sec.  866.1(e).

    Dated: September 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22254 Filed 9-17-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)]
[Notices]
[Pages 8941-8942]
[FR Doc No: 2015-03335]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. DOT-NHTSA-2015-0012]

Notice and Request for Comments

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice and request for comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Request (ICR) abstracted below is being forwarded to the
Office of Management and Budget (OMB) for review and comments. A
Federal Register Notice with a 60-day comment period soliciting
comments on the following information collection was published on
December 5, 2014, 79 FR 72243-72244.

DATES: Comments must be submitted on or before March 23, 2015.

FOR FURTHER INFORMATION CONTACT: Walter Culbreath, Office of Chief
Information Officer, National Highway Traffic Safety Administration,
1200 New Jersey Ave., SE, W48-311, Washington, DC, 20590. Walter
Culbreath's phone number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must first publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulation (at 5CFR
1320.8(d), an agency must ask for public comment on the following:
    (i) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (ii) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (iii) How to enhance the quality, utility, and clarity of the
information to be collected;
    (iv) how to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g. permitting electronic
submission of responses.
    In compliance with these requirements, NHTSA asks for public
comments on the following proposed collection of information for which
the agency is seeking approval from:
    OMB Control Number: 2127-0682.
    Title: Generic Clearance for the Collection of Qualitative Feedback
on Agency Service Delivery.
    Type of Request: Extension of a currently approved collection.
    Abstract: The proposed information collection activity provides a
means to garner qualitative customer and stakeholder feedback in an
efficient, timely manner, in accordance with the Administration's
commitment to improving service delivery.
    This feedback will provide insights into customer or stakeholder
perceptions, experiences and expectations, provide an early warning of
issues with service, or focus attention on areas where communication,
training or changes in operations might improve delivery of products or
services. These collections will allow for ongoing, collaborative and
actionable communications between the Agency and its customers and
stakeholders. It will also allow feedback to contribute directly to the
improvement of program management.
    The solicitation of feedback will target areas such as: Timeliness,
appropriateness, accuracy of information, courtesy, efficiency of
service delivery, and resolution of issues with service delivery.
Responses will be assessed to plan and inform efforts to improve or
maintain the quality of service offered to the public. If this
information is not collected, vital feedback from customers and
stakeholders on the Agency's services will be unavailable.
    The Agency will only submit a collection for approval under this
generic clearance if it meets the following conditions:
     The collections are voluntary;
     The collections are low-burden for respondents (based on
considerations of

total burden hours, total number of respondents, or burden-hours per
respondent) and are low-cost for both the respondents and the Federal
Government;
     The collections are non-controversial and do not raise
issues of concern to other Federal agencies;
     Any collection is targeted to the solicitation of opinions
from respondents who have experience with the program or may have
experience with the program in the near future;
     Personally identifiable information (PII) is collected
only to the extent necessary and is not retained;
     Information gathered is intended to be used only
internally for general service improvement and program management
purposes and is not intended for release outside of the agency (if
released, the agency must indicate the qualitative nature of the
information);
     Information gathered will not be used for the purpose of
substantially informing influential policy decisions; and
     Information gathered will yield qualitative information;
the collections will not be designed or expected to yield statistically
reliable results or used as though the results are generalizable to the
population of study.
    Feedback collected under this generic clearance provides useful
information, but it does not yield data that can be generalized to the
overall population. This type of generic clearance for qualitative
information will not be used for quantitative information collections
that are designed to yield reliably actionable results, such as
monitoring trends over time or documenting program performance. Such
data uses require more rigorous designs that address: the target
population to which generalizations will be made, the sampling frame,
the sample design (including stratification and clustering), the
precision requirements or power calculations that justify the proposed
sample size, the expected response rate, methods for assessing
potential non-response bias, the protocols for data collection, and any
testing procedures that were or will be undertaken prior to fielding
the study. Depending on the degree of influence the results are likely
to have, such collections may still be eligible for submission for
other generic mechanisms that are designed to yield quantitative
results.
    As a general matter, information collections will not result in any
new system of records containing privacy information and will not ask
questions of a sensitive nature, such as sexual behavior and attitudes,
religious beliefs, and other matters that are commonly considered
private.
    Affected Public: Individuals and Households, Businesses and
Organizations, State, Local or Tribal Government.
    Frequency: Once per request.
    Estimated Total Annual Burden Hours: 20,204.
    Number of Respondents: 113,582.

ADDRESSES: Send comments regarding the burden estimate, including
suggestions for reducing the burden, to the Office of Management and
Budget, Attention: Desk Officer for the Office of the Secretary of
Transportation, 725 17th Street NW., Washington, DC 20503.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended; and 49 CFR 1:48.

Paul Mounkhaty,
ISSM/Chief Architect.
[FR Doc. 2015-03335 Filed 2-18-15; 8:45 am]
BILLING CODE 4910-59-P