80_FR_35963 80 FR 35843 - Regattas and Marine Parades; Great Lakes Annual Marine Events

80 FR 35843 - Regattas and Marine Parades; Great Lakes Annual Marine Events

DEPARTMENT OF HOMELAND SECURITY
Coast Guard

Federal Register Volume 80, Issue 120 (June 23, 2015)

Page Range35843-35844
FR Document2015-15408

The Coast Guard will enforce various special local regulations for annual regattas and marine parades in the Captain of the Port Detroit zone from 9 a.m. on June 26, 2015 through 7 p.m. on August 23, 2015. Enforcement of these regulations is necessary and intended to ensure safety of life on the navigable waters immediately prior to, during, and immediately after these regattas or marine parades. During the aforementioned period, the Coast Guard will enforce restrictions upon, and control movement of, vessels in a specified area immediately prior to, during, and immediately after regattas or marine parades.

Federal Register, Volume 80 Issue 120 (Tuesday, June 23, 2015) 
[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Rules and Regulations]
[Pages 35843-35844]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-15408]


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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2013-0103]
RIN 1625-AA08


Regattas and Marine Parades; Great Lakes Annual Marine Events

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce various special local regulations 
for annual regattas and marine parades in the Captain of the Port 
Detroit zone from 9 a.m. on June 26, 2015 through 7 p.m. on August 23, 
2015. Enforcement of these regulations is necessary and intended to 
ensure safety of life on the navigable waters immediately prior to, 
during, and immediately after these regattas or marine parades. During 
the aforementioned period, the Coast Guard will enforce restrictions 
upon, and control movement of, vessels in a

[[Page 35844]]

specified area immediately prior to, during, and immediately after 
regattas or marine parades.

DATES: The regulations in 33 CFR 100.914, 100.915, 100.918, 100.919, 
and 100.920 will be enforced at specified dates and times between June 
26, 2015 and August 23, 2015.

FOR FURTHER INFORMATION CONTACT: If you have questions on this 
document, call or email Petty Officer First Class Todd Manow, 
Prevention Department, U.S. Coast Guard Sector Detroit, 110 Mount 
Elliot Ave., Detroit MI, 48207; telephone (313)568-9580, email 
[email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the following 
special local regulations listed in 33 CFR part 100, Safety of Life on 
Navigable Waters, on the following dates and times, which are listed in 
chronological order:
    (1) Sec.  100.919 International Bay City River Roar, Bay City, MI. 
This special local regulation will be enforced from 9 a.m. to 6 p.m. on 
June 26, 27, and 28, 2015. A regulated area is established to include 
all waters of the Saginaw River bounded on the north by the Liberty 
Bridge, located at 43[deg]36.3' N, 083[deg]53.4' W, and bounded on the 
south by the Veterans Memorial Bridge, located at 43[deg]35.8' N, 
083[deg]53.6' W. In case of rain on any of the race days, this special 
local regulation may be enforced an additional day on June 29, 2015 
from 9 a.m. until 6 p.m.
    (2) Sec.  100.920 Tug Across the River, Detroit, MI. This special 
local regulation will be enforced from 6 p.m. to 6:45 p.m. on July 10, 
2015. A regulated area is established to include all waters of the 
Detroit River, Detroit, Michigan, bounded on the south by the 
International boundary, on the west by 083[deg]03' W, on the east by 
083[deg]02' W, and on the north by the U.S. shoreline. This position is 
located on the Detroit River in front of Hart Plaza, Detroit, MI.
    (3) Sec.  100.914 Trenton Rotary Roar on the River, Trenton, MI. 
This special local regulation will be enforced from 8 a.m. to 8 p.m. on 
July 17, 18, and 19, 2015. The regulated area is established to include 
all waters of the Detroit River, Trenton, Michigan, bounded by an east/
west line beginning at a point of land at the northern end of Elizabeth 
Park in Trenton, MI, located at position 42[deg]8.2' N; 083[deg]10.6' 
W, extending east to a point near the center of the Trenton Channel 
located at position 42[deg]8.2' N; 083[deg]10.4' W, extending south 
along a north/south line to a point at the Grosse Ile Parkway Bridge 
located at position 42[deg]7.7' N; 083[deg]10.5' W, extending west 
along a line bordering the Grosse Ile Parkway Bridge to a point on land 
located at position 42[deg]7.7' N; 083[deg]10.7' W, and along the 
shoreline to the point of origin. This area is in the Trenton Channel 
between Trenton and Grosse Isle, MI.
    (4) Sec.  100.915 St. Clair River Classic Offshore Race, St. Clair, 
MI. This special local regulation will be enforced from 10 a.m. to 7 
p.m. each day from July 20, 2015 through July 26, 2015. A regulated 
area is established to include all waters of the St. Clair River, St. 
Clair, Michigan, bounded by latitude 42[deg]52'00'' N to the north; 
latitude 42[deg]49'00'' N to the south; the shoreline of the St. Clair 
River on the west; and the international boundary line on the east.
    Special Local Regulations:
    (1) In accordance with Sec.  100.901, entry into, transiting, or 
anchoring within these regulated areas is prohibited unless authorized 
by the Coast Guard patrol commander (PATCOM). The PATCOM may restrict 
vessel operation within the regulated area to vessels having particular 
operating characteristics.
    (2) Vessels permitted to enter this regulated area must operate at 
a no wake speed and in a manner that will not endanger race 
participants or any other craft.
    (3) The PATCOM may direct the anchoring, mooring, or movement of 
any vessel within this regulated area. A succession of sharp, short 
signals by whistle or horn from vessels patrolling the area under the 
direction of the PATCOM shall serve as a signal to stop. Vessels so 
signaled shall stop and shall comply with the orders of the PATCOM. 
Failure to do so may result in expulsion from the area, a Notice of 
Violation for failure to comply, or both.
    (4) If it is deemed necessary for the protection of life and 
property, the PATCOM may terminate at any time the marine event or the 
operation of any vessel within the regulated area.
    (5) In accordance with the general regulations in Sec.  100.35 of 
this part, the Coast Guard will patrol the regatta area under the 
direction of a designated Coast Guard Patrol Commander (PATCOM). The 
PATCOM may be contacted on Channel 16 (156.8 MHz) by the call sign 
``Coast Guard Patrol Commander.''
    (6) The rules in this section shall not apply to vessels 
participating in the event or to government vessels patrolling the 
regulated area in the performance of their assigned duties.
    This document is issued under authority of 33 CFR 100.35 and 5 
U.S.C. 552(a). If the Captain of the Port determines that any of these 
special local regulations need not be enforced for the full duration 
stated in this document, he may suspend such enforcement and notify the 
public of the suspension via a Broadcast Notice to Mariners.

    Dated: June 8, 2015.
Scott B. Lemasters,
Captain, U. S. Coast Guard, Captain of the Port Detroit.
[FR Doc. 2015-15408 Filed 6-22-15; 8:45 am]
 BILLING CODE 9110-04-P

Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Rules and Regulations 35843 TABLE 1—VIBRATOR FOR CLIMAX CONTROL OF PREMATURE EJACULATION RISKS AND MITIGATION MEASURES Identified risk Mitigation measures Pain or Discomfort due to Misuse of Device ........................................... Labeling. Burns ........................................................................................................ Electrical and Thermal Safety Testing Labeling. Electrical Shock ........................................................................................ Electrical Safety Testing Labeling. Adverse Skin Reactions ........................................................................... Biocompatibility Testing. Patient Injury due to Device Breakage or Failure .................................... Mechanical Safety Testing Labeling. Interference With Other Devices/Electrical Equipment ............................ Electromagnetic Compatibility Testing Labeling. FDA believes that the following found in other FDA regulations. These vibratory effects of the device on the special controls, in combination with collections of information are subject to penis. the general controls, address these risks review by the Office of Management and (b) Classification. Class II (special to health and provide reasonable Budget (OMB) under the Paperwork controls). The special controls for this assurance of the safety and Reduction Act of 1995 (44 U.S.C. 3501– device are: effectiveness: 3520). The collections of information in (1) The labeling must include specific • The labeling must include specific part 807, subpart E, regarding premarket instructions regarding the proper instructions regarding the proper notification submissions have been placement and use of the device. placement and use of the device. approved under OMB control number (2) The portions of the device that • The portions of the device that 0910–0120, and the collections of contact the patient must be contact the patient must be information in 21 CFR part 801, demonstrated to be biocompatible. demonstrated to be biocompatible. regarding labeling have been approved (3) Appropriate analysis/testing must • Appropriate analysis/testing must under OMB control number 0910–0485. demonstrate electromagnetic demonstrate electromagnetic compatibility safety, electrical safety, IV. References compatibility safety, electrical safety, and thermal safety of the device. and thermal safety of the device. The following references have been (4) Mechanical safety testing must • Mechanical safety testing must placed on display in the Division of demonstrate that the device will demonstrate that the device will Dockets Management (HFA–305), Food withstand forces encountered during withstand forces encountered during and Drug Administration, 5630 Fishers use. use. Lane, rm. 1061, Rockville, MD 20852, Dated: June 16, 2015. Section 510(m) of the FD&C Act and may be seen by interested persons between 9 a.m. and 4 p.m., Monday Leslie Kux, provides that FDA may exempt a class through Friday, and are available Associate Commissioner for Policy. II device from the premarket notification electronically at http:// [FR Doc. 2015–15328 Filed 6–22–15; 8:45 am] requirements under section 510(k) of the FD&C Act, if FDA determines that www.regulations.gov. BILLING CODE 4164–01–P premarket notification is not necessary 1. DEN130047: De Novo Request per to provide reasonable assurance of the 513(f)(2) from Auris Medtech Europe Ltd., safety and effectiveness of the device. dated November 21, 2013. DEPARTMENT OF HOMELAND For this type of device, FDA has 2. Amendment to De Novo Request from SECURITY determined that premarket notification Auris Medtech Europe Ltd., dated June 17, 2014. Coast Guard is necessary to provide reasonable assurance of the safety and effectiveness List of Subjects in 21 CFR Part 876 of the device. Therefore, this device 33 CFR Part 100 Medical devices. type is not exempt from premarket Therefore, under the Federal Food, [Docket No. USCG–2013–0103] notification requirements. Persons who Drug, and Cosmetic Act and under RIN 1625–AA08 intend to market this type of device authority delegated to the Commissioner must submit to FDA a premarket of Food and Drugs, 21 CFR part 876 is Regattas and Marine Parades; Great notification, prior to marketing the amended as follows: Lakes Annual Marine Events device, which contains information about the vibrator for climax control of PART 876—GASTROENTEROLOGY– AGENCY: Coast Guard, DHS. premature ejaculation they intend to UROLOGY DEVICES ACTION: Notice of enforcement of market. regulation. ■ 1. The authority citation for 21 CFR II. Environmental Impact part 876 continues to read as follows: SUMMARY: The Coast Guard will enforce The Agency has determined under 21 Authority: 21 U.S.C. 351, 360, 360c, 360e, various special local regulations for CFR 25.34(b) that this action is of a type 360j, 360l, 371. annual regattas and marine parades in that does not individually or ■ 2. Republish § 876.5025 to read as the Captain of the Port Detroit zone from cumulatively have a significant effect on follows: 9 a.m. on June 26, 2015 through 7 p.m. the human environment. Therefore, on August 23, 2015. Enforcement of neither an environmental assessment § 876.5025 Vibrator for climax control of these regulations is necessary and mstockstill on DSK4VPTVN1PROD with RULES nor an environmental impact statement premature ejaculation. intended to ensure safety of life on the is required. (a) Identification. A vibrator for navigable waters immediately prior to, climax control of premature ejaculation during, and immediately after these III. Paperwork Reduction Act of 1995 is used for males who suffer from regattas or marine parades. During the This final order establishes special premature ejaculation. It is designed to aforementioned period, the Coast Guard controls that refer to previously increase the time between arousal and will enforce restrictions upon, and approved collections of information ejaculation using the stimulating control movement of, vessels in a VerDate Sep<11>2014 16:21 Jun 22, 2015 Jkt 235001 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 E:\FR\FM\23JNR1.SGM 23JNR1

35844 Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Rules and Regulations specified area immediately prior to, located at position 42°7.7′ N; 083°10.7′ for the full duration stated in this during, and immediately after regattas W, and along the shoreline to the point document, he may suspend such or marine parades. of origin. This area is in the Trenton enforcement and notify the public of the DATES: The regulations in 33 CFR Channel between Trenton and Grosse suspension via a Broadcast Notice to 100.914, 100.915, 100.918, 100.919, and Isle, MI. Mariners. 100.920 will be enforced at specified (4) § 100.915 St. Clair River Classic Dated: June 8, 2015. dates and times between June 26, 2015 Offshore Race, St. Clair, MI. This special Scott B. Lemasters, and August 23, 2015. local regulation will be enforced from 10 a.m. to 7 p.m. each day from July 20, Captain, U. S. Coast Guard, Captain of the FOR FURTHER INFORMATION CONTACT: If Port Detroit. you have questions on this document, 2015 through July 26, 2015. A regulated area is established to include all waters [FR Doc. 2015–15408 Filed 6–22–15; 8:45 am] call or email Petty Officer First Class Todd Manow, Prevention Department, of the St. Clair River, St. Clair, BILLING CODE 9110–04–P U.S. Coast Guard Sector Detroit, 110 Michigan, bounded by latitude Mount Elliot Ave., Detroit MI, 48207; 42°52′00″ N to the north; latitude 42°49′00″ N to the south; the shoreline DEPARTMENT OF HOMELAND telephone (313)568–9580, email SECURITY Todd.M.Manow@uscg.mil. of the St. Clair River on the west; and the international boundary line on the Coast Guard SUPPLEMENTARY INFORMATION: The Coast east. Guard will enforce the following special Special Local Regulations: local regulations listed in 33 CFR part (1) In accordance with § 100.901, 33 CFR Part 165 100, Safety of Life on Navigable Waters, entry into, transiting, or anchoring [Docket Number USCG–2015–0496] on the following dates and times, which within these regulated areas is are listed in chronological order: RIN 1625–AA00 prohibited unless authorized by the (1) § 100.919 International Bay City Coast Guard patrol commander River Roar, Bay City, MI. This special Safety Zone; Black River Kayak-a-thon; (PATCOM). The PATCOM may restrict Black River, Lorain, OH local regulation will be enforced from 9 vessel operation within the regulated a.m. to 6 p.m. on June 26, 27, and 28, area to vessels having particular AGENCY: Coast Guard, DHS. 2015. A regulated area is established to operating characteristics. include all waters of the Saginaw River ACTION: Temporary final rule. (2) Vessels permitted to enter this bounded on the north by the Liberty regulated area must operate at a no wake SUMMARY: The Coast Guard is Bridge, located at 43°36.3′ N, 083°53.4′ speed and in a manner that will not establishing a temporary safety zone on W, and bounded on the south by the endanger race participants or any other Black River, Lorain, OH. This safety Veterans Memorial Bridge, located at craft. zone is intended to restrict vessels from 43°35.8′ N, 083°53.6′ W. In case of rain (3) The PATCOM may direct the a portion of the Black River during the on any of the race days, this special anchoring, mooring, or movement of Black River Kayak-a-thon. This local regulation may be enforced an any vessel within this regulated area. A temporary safety zone is necessary to additional day on June 29, 2015 from 9 succession of sharp, short signals by protect participants and mariners from a.m. until 6 p.m. whistle or horn from vessels patrolling the navigational hazards associated with (2) § 100.920 Tug Across the River, the area under the direction of the a paddle sport regatta. Detroit, MI. This special local regulation PATCOM shall serve as a signal to stop. DATES: This rule is effective from 7:45 will be enforced from 6 p.m. to 6:45 Vessels so signaled shall stop and shall a.m. until 2:15 p.m. on June 27, 2015. p.m. on July 10, 2015. A regulated area comply with the orders of the PATCOM. is established to include all waters of ADDRESSES: Documents mentioned in Failure to do so may result in expulsion the Detroit River, Detroit, Michigan, this preamble are part of docket [USCG– from the area, a Notice of Violation for bounded on the south by the 2015–0496]. To view documents failure to comply, or both. International boundary, on the west by (4) If it is deemed necessary for the mentioned in this preamble as being 083°03′ W, on the east by 083°02′ W, protection of life and property, the available in the docket, go to http:// and on the north by the U.S. shoreline. PATCOM may terminate at any time the www.regulations.gov, type the docket This position is located on the Detroit marine event or the operation of any number in the ‘‘SEARCH’’ box and click River in front of Hart Plaza, Detroit, MI. vessel within the regulated area. ‘‘SEARCH.’’ Click on Open Docket (3) § 100.914 Trenton Rotary Roar on (5) In accordance with the general Folder on the line associated with this the River, Trenton, MI. This special regulations in § 100.35 of this part, the rulemaking. You may also visit the local regulation will be enforced from 8 Coast Guard will patrol the regatta area Docket Management Facility in Room a.m. to 8 p.m. on July 17, 18, and 19, under the direction of a designated W12–140 on the ground floor of the 2015. The regulated area is established Coast Guard Patrol Commander Department of Transportation West to include all waters of the Detroit (PATCOM). The PATCOM may be Building, 1200 New Jersey Avenue SE., River, Trenton, Michigan, bounded by contacted on Channel 16 (156.8 MHz) Washington, DC 20590, between 9 a.m. an east/west line beginning at a point of by the call sign ‘‘Coast Guard Patrol and 5 p.m., Monday through Friday, land at the northern end of Elizabeth Commander.’’ except Federal holidays. Park in Trenton, MI, located at position (6) The rules in this section shall not FOR FURTHER INFORMATION CONTACT: If 42°8.2′ N; 083°10.6′ W, extending east to apply to vessels participating in the you have questions on this rule, call LT a point near the center of the Trenton event or to government vessels Stephanie Pitts, Chief of Waterways mstockstill on DSK4VPTVN1PROD with RULES Channel located at position 42°8.2′ N; patrolling the regulated area in the Management, U.S. Coast Guard Marine 083°10.4′ W, extending south along a performance of their assigned duties. Safety Unit Cleveland; telephone 216– north/south line to a point at the Grosse This document is issued under 937–0128. If you have questions on Ile Parkway Bridge located at position authority of 33 CFR 100.35 and 5 U.S.C. viewing the docket, call Ms. Cheryl 42°7.7′ N; 083°10.5′ W, extending west 552(a). If the Captain of the Port Collins, Program Manager, Docket along a line bordering the Grosse Ile determines that any of these special Operations, telephone 202–366–9826 or Parkway Bridge to a point on land local regulations need not be enforced 1–800–647–5527. VerDate Sep<11>2014 16:21 Jun 22, 2015 Jkt 235001 PO 00000 Frm 00016 Fmt 4700 Sfmt 4700 E:\FR\FM\23JNR1.SGM 23JNR1


Document Created: 2018-02-22 11:15:31
Document Modified: 2018-02-22 11:15:31
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionNotice of enforcement of regulation.
DatesThe regulations in 33 CFR 100.914, 100.915, 100.918, 100.919, and 100.920 will be enforced at specified dates and times between June 26, 2015 and August 23, 2015.
ContactIf you have questions on this document, call or email Petty Officer First Class Todd Manow, Prevention Department, U.S. Coast Guard Sector Detroit, 110 Mount Elliot Ave., Detroit MI, 48207; telephone (313)568-9580, email [email protected]
FR Citation80 FR 35843 
RIN Number1625-AA08
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