Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Rules and Regulations 15165 

MedWatch if they experience any 

adverse events with this device. 

Æ The anticipated number of device 

uses prior to failure. 

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 not necessary to provide reasonable 

assurance of the safety and effectiveness 

of the device. Therefore, this device 

type is exempt from premarket 

notification requirements. Persons who 

intend to market this type of device 

need not submit to FDA a premarket 

notification, prior to marketing the 

device, which contains information 

about the limited output transcutaneous 

piezoelectric stimulator for skin 

reactions associated with insect bites 

they intend to market. 

II. Environmental Impact 

The Agency has determined under 21 

CFR 25.34(b) that this action is of a 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 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, and the collections of 

information in 21 CFR part 801, 

regarding labeling have been approved 

under OMB control number 0910–0485. 

IV. References 

The following references have been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday, and are available 

electronically at http://

www.regulations.gov. 

1. DEN100024: De Novo Request per 513(f)(2) 

from Ecobrands, Ltd., dated September 8, 

2010. 

2. DEN130019: De Novo Request per 513(f)(2) 

from Tecnimed S.r.l., dated February 14, 

2013. 

List of Subjects in 21 CFR Part 882 

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 882 is 

amended as follows: 

PART 882—NEUROLOGICAL DEVICES 

■ 1. The authority citation for 21 CFR 

part 882 continues to read as follows: 

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

360j, 371. 

■ 2. Add § 882.5894 to subpart F to read 

as follows: 

§ 882.5894 Limited output transcutaneous 

piezoelectric stimulator for skin reactions 

associated with insect bites. 

(a) Identification. A limited output 

transcutaneous piezoelectric stimulator 

for skin reactions associated with insect 

bites is a device intended to alleviate 

skin reactions associated with insect 

bites via cutaneous, piezoelectric 

stimulation at the local site of the bite. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Appropriate testing to characterize 

the electrical output specifications of 

the device (i.e., total charge delivered, 

maximum instantaneous output current, 

maximum instantaneous output voltage, 

pulse duration, charge density) must be 

conducted. 

(2) Mechanical bench testing must 

demonstrate that the device will 

withstand the labeled number duration 

of uses. 

(3) All elements of the device that 

may contact the patient must be 

assessed to be biocompatible. 

(4) Labeling must include: 

(i) Validated instructions which 

addresses the following: 

(A) Identification of areas of the body 

which are appropriate and not 

appropriate for contact with the device. 

(B) Whether use of the device in 

conjunction with flammable materials 

(e.g., insect repellent) is appropriate. 

(C) Use of the device on or near 

implanted devices. 

(D) How to identify the correct type of 

skin condition. 

(ii) Technical parameters of the device 

(maximum output voltage 

(instantaneous), maximum output 

current (instantaneous), and pulse 

duration). 

(iii) Language to direct end users to 

contact the device manufacturer and 

MedWatch if they experience any 

adverse events with this device. 

(iv) The anticipated number of device 

uses prior to failure. 

Dated: March 17, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–06499 Filed 3–20–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF DEFENSE 

Department of the Navy 

32 CFR Part 706 

Certifications and Exemptions Under 

the International Regulations for 

Preventing Collisions at Sea, 1972 

AGENCY: Department of the Navy, DoD. 

ACTION: Final rule. 

SUMMARY: The Department of the Navy 

(DoN) is amending its certifications and 

exemptions under the International 

Regulations for Preventing Collisions at 

Sea, 1972, as amended (72 COLREGS), 

to reflect that the Deputy Assistant 

Judge Advocate General 

(DAJAG)(Admiralty and Maritime Law) 

has determined that USS JOHN 

WARNER (SSN 785) is a vessel of the 

Navy which, due to its special 

construction and purpose, cannot fully 

comply with certain provisions of the 72 

COLREGS without interfering with its 

special function as a naval ship. The 

intended effect of this rule is to warn 

mariners in waters where 72 COLREGS 

apply. 

DATES: This rule is effective March 23, 

2015 and is applicable beginning 

January 28, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Commander Theron R. Korsak, 

(Admiralty and Maritime Law), Office of 

the Judge Advocate General, Department 

of the Navy, 1322 Patterson Ave. SE., 

Suite 3000, Washington Navy Yard, DC 

20374–5066, telephone 202–685–5040. 

SUPPLEMENTARY INFORMATION: Pursuant 

to the authority granted in 33 U.S.C. 

1605, the DoN amends 32 CFR part 706. 

This amendment provides notice that 

the DAJAG (Admiralty and Maritime 

Law), under authority delegated by the 

Secretary of the Navy, has certified that 

USS JOHN WARNER (SSN 785) is a 

vessel of the Navy which, due to its 

special construction and purpose, 

cannot fully comply with the following 

specific provisions of 72 COLREGS 

without interfering with its special 

function as a naval ship: Annex I, 

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15166 Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Rules and Regulations 

paragraph 2(a)(i), pertaining to the 

vertical placement of the masthead 

light; Annex I, paragraph 2(f)(i), 

pertaining to Virginia class submarine 

masthead light location below the 

submarine identification lights; Annex I, 

paragraph 2(k), pertaining to the vertical 

separation of the anchor lights and 

vertical placement of the forward 

anchor light above the hull; Rule 30(a) 

and Rule 21(e), pertaining to arc of 

visibility of the forward and after anchor 

lights; Annex I, paragraph 3(b), 

pertaining to the location of the 

sidelights; and Rule 21(c), pertaining to 

the location and arc of visibility of the 

sternlight. The DAJAG (Admiralty and 

Maritime Law) has also certified that the 

lights involved are located in closest 

possible compliance with the applicable 

72 COLREGS requirements. 

Moreover, it has been determined, in 

accordance with 32 CFR parts 296 and 

701, that publication of this amendment 

for public comment prior to adoption is 

impracticable, unnecessary, and 

contrary to public interest since it is 

based on technical findings that the 

placement of lights on this vessel in a 

manner differently from that prescribed 

herein will adversely affect the vessel’s 

ability to perform its military functions. 

List of Subjects in 32 CFR Part 706 

Marine safety, Navigation (water), 

Vessels. 

For the reasons set forth in the 

preamble, the DoN amends part 706 of 

title 32 of the Code of Federal 

Regulations as follows: 

PART 706—CERTIFICATIONS AND 

EXEMPTIONS UNDER THE 

INTERNATIONAL REGULATIONS FOR 

PREVENTING COLLISIONS AT SEA, 

1972 

■ 1. The authority citation for part 706 

continues to read as follows: 

Authority: 33 U.S.C. 1605. 

■ 2. Section 706.2 is amended by: 

■ a. In Table One, adding, in alpha 

numerical order, by vessel number, an 

entry for USS JOHN WARNER (SSN 

785); 

■ b. In Table Three, adding, in alpha 

numerical order, by vessel number, an 

entry for USS JOHN WARNER (SSN 

785); 

■ c. In Table Four, under paragraph 25, 

adding, in alpha numerical order, by 

vessel number, an entry for USS JOHN 

WARNER (SSN 785); and 

■ d. In Table Four, paragraph 26, 

adding, in alpha numerical order, by 

vessel number, an entry for USS JOHN 

WARNER (SSN 785). 

The additions read as follows: 

§ 706.2 Certifications of the Secretary of 

the Navy under Executive Order 11964 and 

33 U.S.C. 1605. 

* * * * * 

TABLE ONE

Vessel Number 

Distance in meters of 

forward masthead light 

below minimum required 

height. 

§ 2(a)(i), Annex I 

*******

USS JOHN WARNER ......................................................... SSN 785 ............................................................................. 2.76 

*******

* * * * * 

TABLE THREE

Vessel Number 

Masthead 

lights arc of 

visibility; rule 

21(a) 

Side lights 

arc of visibility; rule 

21(b) 

Stern light 

arc of visibility; rule 

21(c) 

Side lights 

distance 

inboard of 

ship’s sides 

in meters 

3(b) annex 1 

Stern light, 

distance forward of stern 

in meters; 

rule 21(c) 

Forward 

anchor light, 

height above 

hull in 

meters; 2(K) 

annex 1 

Anchor 

lights relation-ship of 

aft light to 

forward light 

in meters 

2(K) annex 

1 

*******

USS JOHN WARNER.SSN 785 .... ...................... ...................... 206.4° 4.37 11.05 2.8 0.30 below. 

*******

* * * * * 25. * * * 

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Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Rules and Regulations 15167 

TABLE FOUR

Vessel Number 

Distance in meters of 

masthead light below 

the submarine 

identification lights 

*******

USS JOHN WARNER ......................................................... SSN 785 ............................................................................. 0.81 

26. * * * 

Obstruction angle relative to 

ship’s heading 

Vessel Number Forward Anchor 

Light Aft Anchor Light 

*******

USS JOHN WARNER ............................................ SSN 785 ................................................................. 172° to 188° 359° to 1° 

* * * * * 

Approved: January 28, 2015. 

A.B. Fischer, 

Captain, JAGC, U.S. Navy, Deputy Assistant 

Judge Advocate, General (Admiralty and 

Maritime Law). 

Dated: March 11, 2015. 

N.A. Hagerty-Ford, 

Commander, Office of the Judge Advocate 

General, U.S. Navy, Federal Register Liaison 

Officer. 

[FR Doc. 2015–06298 Filed 3–20–15; 8:45 am] 

BILLING CODE 3810–FF–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket No. USCG–2015–0062] 

Special Local Regulation; Annual 

Marine Events on the Colorado River, 

Between Davis Dam (Bullhead City, 

Arizona) and Headgate Dam (Parker, 

Arizona) Within the San Diego Captain 

of the Port Zone 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

the 2015 Lake Havasu Desert Storm 

marine event special local regulations 

from 8 a.m. through 3 p.m. on April 25, 

2015. This annual marine event occurs 

on the navigable waters of the Colorado 

River in Lake Havasu, Arizona. This 

action is necessary to provide for the 

safety of the participants, crew, 

spectators, safety vessels, and general 

users of the waterway. During the 

enforcement period, persons and vessels 

are prohibited from entering into, 

transiting through, or anchoring within 

this regulated area unless authorized by 

the Captain of the Port, or his 

designated representative. 

DATES: The regulations in 33 CFR 

100.1102, Table 1, Item 4 will be 

enforced from 8 a.m. through 3 p.m. on 

April 25, 2015. If the event is delayed 

by inclement weather, these regulations 

will also be enforced from 8 a.m. 

through 3 p.m. on April 26, 2015. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this document, 

call or email Petty Officer Nick 

Bateman, Waterways Management, U.S. 

Coast Guard Sector San Diego, CA; 

telephone 619–278–7656, D11-PFMarineEventsSanDiego@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the Special Local 

Regulations in Lake Havasu for the 2015 

Desert Storm Shootout in 33 CFR 

100.1102, Table 1, Item 4 from 8 a.m. 

through 3 p.m. on April 25, 2015. If the 

event is delayed by inclement weather, 

these regulations will also be enforced 

from 8 a.m. through 3 p.m. on April 26, 

2015. 

Under provisions of 33 CFR 100.1102, 

persons and vessels are prohibited from 

entering into, transiting through, or 

anchoring within the regulated area, 

unless authorized by the Coast Guard 

Captain of the Port or his designated 

representative. Persons or vessels 

desiring to enter into or pass through 

the special local regulations may request 

permission from the Captain of the Port 

or a designated representative. If 

permission is granted, all persons and 

vessels shall comply with the 

instructions of the Captain of the Port or 

his designated representative. Spectator 

vessels may safely transit outside the 

regulated area but may not anchor, 

block, loiter, or impede the transit of 

participants or official patrol vessels. 

The Coast Guard may be assisted by 

other Federal, State, or Local law 

enforcement agencies in enforcing this 

regulation. 

This document is issued under 

authority of 33 CFR 100.1102 and 5 

U.S.C. 552(a). In addition to this 

document in the Federal Register, the 

Coast Guard will provide the maritime 

community with extensive advance 

notification of this enforcement period 

via the Local Notice to Mariners, 

Broadcast Notice to Mariners, and local 

advertising by the event sponsor. 

If the Captain of the Port Sector San 

Diego or his designated representative 

determines that the regulated area need 

not be enforced for the full duration 

stated on this document, he or she may 

use a Broadcast Notice to Mariners to 

grant general permission to enter the 

regulated area. 

Dated: March 6, 2015. 

J.A. Janszen, 

Commander, U.S. Coast Guard, Acting, 

Captain of the Port San Diego. 

[FR Doc. 2015–06603 Filed 3–20–15; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2015–0129] 

RIN 1625–AA00 

Safety Zone, Delaware River; Marcus 

Hook, PA 

AGENCY: Coast Guard, DHS. 

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