27124 Federal Register / Vol. 78, No. 90 / Thursday, May 9, 2013 / Proposed Rules 

Children,’’ Cancer Epidemiology, Biomarkers 

& Prevention, vol. 17, pp. 2318–2324, 2008. 

49. Karagas, M.R., V.A. Stannard, L.A. 

Mott, et al., ‘‘Use of Tanning Devices and 

Risk of Basal Cell and Squamous Cell Skin 

Cancers. Journal of the National Cancer 

Institute, vol. 94, pp. 224–226, 2002. 

50. Lever, L.R. and C.M. Lawrence, 

‘‘Nonmelanoma Skin Cancer Associated With 

Use of a Tanning Bed,’’ New England Journal 

of Medicine, vol. 332, pp. 1450–1451, 1995. 

51. Parr, C.L., A. Hjarta ̊ker, P. Laake, et al., 

‘‘Recall Bias in Melanoma Risk Factors and 

Measurement Error Effects: A Nested CaseControl Study Within the Norwegian Women 

and Cancer Study,’’ American Journal of 

Epidemiology, vol. 169, pp. 257–266, 2009. 

52. Ting, W., K. Schultz, N.N. Cac, et al., 

‘‘Tanning Bed Exposure Increases the Risk of 

Malignant Melanoma’’ International Journal 

of Dermatology, vol. 46, pp.1253–1257, 2007. 

53. Westerdahl, J., H. Olsson, A. Ma ̊sba ̈ck, 

et al., ‘‘Use of Sunbeds or Sunlamps and 

Malignant Melanoma in Southern Sweden,’’ 

American Journal of Epidemiology, vol. 140, 

pp. 691–699, 1994. 

List of Subjects in 21 CFR Part 878 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act, and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

21 CFR part 878 be amended as follows: 

PART 878—GENERAL AND PLASTIC 

SURGERY DEVICES 

■ 1. The authority citation for 21 CFR 

part 878 continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Section 878.4635 is revised to read 

as follows: 

§ 878.4635 Sunlamp product. 

(a) Identification. An electronic 

product that includes one or more 

ultraviolet (UV) lamps and a fixture 

intended for irradiation of any part of 

the living human body, by UV radiation 

with wavelengths in air between 200 

and 400 nanometers, to induce skin 

tanning. This definition includes 

tanning beds, tanning booths, and UV 

lamps (bulbs) sold separately. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Conduct performance testing that 

demonstrates the following: 

(i) Sunlamp products meet 

appropriate output performance 

specifications such as wavelengths, 

energy density, and lamp life; and 

(ii) Safety features, such as timers to 

limit UV exposure and alarms, function 

properly. 

(2) Demonstrate that sunlamp 

products are mechanically safe to 

prevent user injury. 

(3) Demonstrate software verification, 

validation, and hazard analysis. 

(4) Demonstrate that sunlamp 

products are biocompatible. 

(5) Demonstrate that sunlamp 

products are electrically safe and 

electromagnetically compatible in their 

intended use environment. 

(6) Labeling must bear all information 

required for the reasonable assurance of 

safe and effective use of the device. 

(i) The warning statement below must 

appear on all sunlamp product fixtures. 

This statement must be permanently 

affixed or inscribed on the product 

when fully assembled for use so as to be 

legible and readily accessible to view by 

the person who will be exposed to UV 

radiation immediately before the use of 

the product. It shall be of sufficient 

durability to remain legible throughout 

the expected lifetime of the product. It 

shall appear on a part or panel 

displayed prominently under normal 

conditions of use so that it is readily 

accessible to view whether the tanning 

bed canopy (or tanning booth door) is 

open or closed when the person who 

will be exposed approaches the 

equipment and the text shall be at least 

10 millimeters (height). Labeling on the 

device must include the following 

statement: 

‘‘Attention: This sunlamp product should 

not be used on persons under the age of 18 

years.’’ 

(ii) Manufacturers of sunlamp 

products shall provide or cause to be 

provided in the user instructions for a 

sunlamp product as well as all catalogs, 

specification sheets, and descriptive 

brochures intended for consumers in 

which sunlamp products are offered for 

sale, and on all consumer-directed Web 

pages on which sunlamp products are 

offered for sale, the following 

contraindication and warning 

statements: 

(A) ‘‘Contraindication: This sunlamp 

product is contraindicated for use on 

persons under the age of 18 years.’’ 

(B) ‘‘Contraindication: This sunlamp 

product must not be used if skin lesions 

or open wounds are present.’’ 

(C) ‘‘Warning: This sunlamp product 

should not be used on individuals who 

have had skin cancer or have a family 

history of skin cancer.’’ 

(D) ‘‘Warning: Persons repeatedly 

exposed to ultraviolet sunlamp products 

should be regularly evaluated for skin 

cancer.’’ 

(iii) Manufacturers of sunlamp 

products shall provide validated 

instructions on cleaning and 

disinfection of sunlamp products 

between uses in the user instructions. 

(c) Sunlamp products are subject to 

the electronic product performance 

standard at § 1040.20 of this chapter. 

Dated: May 2, 2013. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–10982 Filed 5–6–13; 4:15 pm] 

BILLING CODE 4160–01–P 

DEPARTMENT OF DEFENSE 

Department of the Army, Corps of 

Engineers 

33 CFR Part 334 

Pacific Ocean Off the Kekaha Range 

Facility at Barking Sands, Island of 

Kauai, Hawaii; Danger Zone 

AGENCY: U.S. Army Corps of Engineers, 

DoD. 

ACTION: Notice of proposed rulemaking 

and request for comments. 

SUMMARY: The Corps of Engineers is 

proposing to amend its regulations to 

establish a new danger zone in waters 

of the Pacific Ocean off the Kekaha 

Range Facility, Barking Sands, Island of 

Kauai, Hawaii. The proposed 

amendment is necessary for the Hawaii 

Army National Guard to continue small 

arms training operations at the Kekaha 

Range Facility and to protect the public 

from potentially hazardous conditions 

which may exist as a result of that use. 

The proposed amendment would 

prohibit, on an intermittent basis, 

vessels from entering a six mile wide 

section of the Pacific Ocean that 

narrows to a 0.7 mile wide section along 

the shoreline fronting the Kekaha Range 

Facility without first obtaining 

permission from the Commanding 

Officer of Kekaha Range Facility. 

DATES: Written comments must be 

submitted on or before June 10, 2013. 

ADDRESSES: You may submit comments, 

identified by docket number COE– 

2013–0004, by any of the following 

methods: 

Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Email: david.b.olson@usace.army.mil. 

Include the docket number COE–2013– 

0004, in the subject line of the message. 

Mail: U.S. Army Corps of Engineers, 

Attn: CECW–CO–R (David B. Olson), 

441 G Street NW., Washington, DC 

20314–1000. 

Hand Delivery/Courier: Due to 

security requirements, we cannot 

receive comments by hand delivery or 

courier. 

Instructions: Direct your comments to 

docket number COE–2013–0004. All 


tkelley on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 78, No. 90 / Thursday, May 9, 2013 / Proposed Rules 27125 

comments received will be included in 

the public docket without change and 

may be made available on-line at 

http://www.regulations.gov, including 

any personal information provided, 

unless the commenter indicates that the 

comment includes information claimed 

to be Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. Do 

not submit information that you 

consider to be CBI, or otherwise 

protected, through regulations.gov or 

email. The regulations.gov Web site is 

an anonymous access system, which 

means we will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an email directly to the 

Corps without going through 

regulations.gov, your email address will 

be automatically captured and included 

as part of the comment that is placed in 

the public docket and made available on 

the Internet. If you submit an electronic 

comment, we recommend that you 

include your name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If we cannot read your 

comment because of technical 

difficulties and cannot contact you for 

clarification, we may not be able to 

consider your comment. Electronic 

comments should avoid the use of any 

special characters, any form of 

encryption, and be free of any defects or 

viruses. 

Docket: For access to the docket to 

read background documents or 

comments received, go to 

www.regulations.gov. All documents in 

the docket are listed. Although listed in 

the index, some information is not 

publicly available, such as 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. 

FOR FURTHER INFORMATION CONTACT: Mr. 

David Olson, Headquarters, Operations 

and Regulatory Community of Practice, 

Washington, DC at 202–761–4922, or 

Mr. Farley Watanabe, Corps of 

Engineers, Honolulu District, Regulatory 

Branch, at 808–835–4305 or by email at 

farley.k.watanabe@usace.army.mil. 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

The purpose of this regulatory action 

is to establish a new danger zone in 

waters of the Pacific Ocean off the 

Kekaha Range Facility at Barking Sands, 

Island of Kauai, Hawaii. 

The Corps authority to establish this 

danger zone is Section 7 of the Rivers 

and Harbors Act of 1917 (40 Stat 266; 

33 U.S.C. 1) and Chapter XIX of the 

Army Appropriations Act of 1919 (40 

Stat 892; 33 U.S.C. 3). 

Background 

Pursuant to its authorities in Section 

7 of the Rivers and Harbors Act of 1917 

(40 Stat. 266; 33 U.S.C. 1) and Chapter 

XIX of the Army Appropriations Act of 

1919 (40 Stat. 892; 33 U.S.C. 3), the 

Corps of Engineers is proposing to 

amend the regulations at 33 CFR part 

334 to establish a new danger zone in 

the waters of the Pacific Ocean off the 

Kekaha Range Facility at Barking Sands, 

Island of Kauai, Hawaii. 

Procedural Requirements 

a. Review Under Executive Order 12866 

This proposed rule is issued with 

respect to a military function of the 

Defense Department and the provisions 

of Executive Order 12866 do not apply. 

b. Review Under the Regulatory 

Flexibility Act 

This proposed rule has been reviewed 

under the Regulatory Flexibility Act 

(Pub. L. 96–354) which requires the 

preparation of a regulatory flexibility 

analysis for any regulation that will 

have a significant economic impact on 

a substantial number of small entities 

(i.e., small businesses and small 

governments). Unless information is 

obtained to the contrary during the 

public notice comment period, the 

Corps expects that the establishment of 

this danger zone would have practically 

no economic impact on the public, no 

anticipated navigational hazard, or 

interference with existing waterway 

traffic. This proposed rule if adopted, 

will have no significant economic 

impact on small entities. 

c. Review Under the National 

Environmental Policy Act 

Due to the administrative nature of 

this action and because there is no 

intended change in the use of the area, 

the Corps expects that this regulation, if 

adopted, will not have a significant 

impact to the quality of the human 

environment and, therefore, preparation 

of an environmental impact statement 

will not be required. An environmental 

assessment will be prepared after the 

public notice period is closed and all 

comments have been received and 

considered. After it is prepared, it may 

be reviewed at the District office listed 

at the end of the FOR FURTHER

INFORMATION CONTACT section, above. 

d. Unfunded Mandates Act 

This proposed rule does not impose 

an enforceable duty among the private 

sector and, therefore, it is not a Federal 

private sector mandate and it is not 

subject to the requirements of either 

Section 202 or Section 205 of the 

Unfunded Mandates Act. We have also 

found under Section 203 of the Act, that 

small governments will not be 

significantly and uniquely affected by 

this rulemaking. 

List of Subjects in 33 CFR Part 334 

Danger zones, Marine safety, 

Navigation (water), Restricted areas, 

Waterways. 

For the reasons set out in the 

preamble, the Corps proposes to amend 

33 CFR part 334 as follows: 

PART 334—DANGER ZONE AND 

RESTRICTED AREA REGULATIONS 

■ 1. The authority citation for part 334 

continues to read as follows: 

Authority: 40 Stat. 266 (33 U.S.C. 1) and 

40 Stat. 892 (33 U.S.C. 3). 

■ 2. Add § 334.1395 to read as follows: 

§ 334.1395 Pacific Ocean off the Kekaha 

Range Facility at Barking Sands, Island of 

Kauai, Hawaii; danger zone. 

(a) The danger zone. All waters 

within the area bounded by a line 

connecting the following coordinates: 

beginning at a point on the shore at 

latitude 21°58′45′′ N, longitude 

159°45′32′′ W; thence easterly along the 

shoreline (shoreline is defined as the 

mean high water line and is 

coterminous with the federal property 

line) to a point at latitude 21°58′33′′ N, 

longitude 159°44′57′′ W; thence 

southeasterly to a point at latitude 

21°55′39′′ N, longitude 159°43′36′′ W; 

thence northwesterly to a point at 

latitude 21°57′50′′ N, longitude 

159°48′54′′ W; thence to point of 

beginning. All coordinates reference 

1983 North American Datum (NAD 83). 

(b) The regulations. (1) Weapons 

firing at the Kekaha Range Facility 

(KRF) may occur at any time between 7 

a.m. and 6 p.m., Monday through 

Sunday. Specific dates and hours for 

weapons firing, along with information 

regarding onshore warning signals, will 

be promulgated by the U.S. Coast 

Guard’s Local Notice to Mariners. 

Information on weapons firing 

schedules may also be obtained by 

calling the KRF Facility Manager, 

NGHI–OPS–TNG (G3) at 808–844–6731. 

(2) Whenever live firing is in progress 

during daylight hours, two large red 

triangular warning pennants will be 

flown at each of two highly visible and 


tkelley on DSK3SPTVN1PROD with PROPOSALS
27126 Federal Register / Vol. 78, No. 90 / Thursday, May 9, 2013 / Proposed Rules 

widely separated locations on the shore 

at the KRF. 

(3) Whenever any weapons firing is 

scheduled and in progress during 

periods of darkness, flashing red 

warning beacons will be displayed on 

the shore at the KRF. 

(4) Boaters will have complete access 

to the danger zone whenever there is no 

weapons firing scheduled, which will 

be indicated by the absence of any 

warning flags, pennants, or beacons 

displayed ashore. 

(5) The danger zone is not considered 

safe for boaters whenever weapons 

firing is in progress. Boaters shall 

expeditiously vacate the danger zone at 

best speed and by the most direct route 

whenever weapons firing is in progress. 

Weapons firing will be suspended as 

long as there is a vessel in the danger 

zone. Whenever a boater disregards the 

publicized warning signals that 

hazardous weapons firing is in progress, 

the boater will be personally requested 

to expeditiously vacate the danger zone 

by KRF personnel hailing the vessel on 

VHF channel 16 or contacting the vessel 

directly by surface craft. 

(6) Observation posts will be manned 

whenever any weapons firing is 

scheduled and in progress. Visibility 

will be sufficient to maintain visual 

surveillance of the entire danger zone 

and for an additional distance of 5 miles 

in all directions whenever weapons 

firing is in progress. 

(c) The enforcing agency. The 

regulations shall be enforced by the 

Commanding Officer, Kekaha Range 

Facility, Hawaiian Area, Barking Sands, 

Kauai, Hawaii and such agencies or 

persons as he or she may designate. 

Dated: May 3, 2013. 

Approved: 

James R. Hannon, 

Chief, Operations and Regulatory, Directorate 

of Civil Works. 

[FR Doc. 2013–11037 Filed 5–8–13; 8:45 am] 

BILLING CODE 3720–58–P 

DEPARTMENT OF DEFENSE 

Department of the Army, Corps of 

Engineers 

33 CFR Part 334 

East Bay, St. Andrews Bay and the 

Gulf of Mexico at Tyndall Air Force 

Base, Florida; Restricted Areas 

AGENCY: U.S. Army Corps of Engineers, 

DoD. 

ACTION: Notice of proposed rulemaking 

and request for comments. 

SUMMARY: The U.S. Army Corps of 

Engineers (Corps) is proposing to amend 

its regulations by revising an existing 

restricted area regulation and 

establishing six new restricted areas 

along the Tyndall Air Force Base (AFB) 

facility shoreline. Tyndall AFB is 

surrounded on three sides by water with 

approximately 129 miles of unprotected 

coastline. This includes several areas 

where the lack of security or lack of 

restriction on access to these areas 

leaves Tyndall AFB personnel and 

resources vulnerable to unauthorized 

activities. This amendment is necessary 

to implement an enhanced security plan 

for Tyndall AFB, which includes four 

new permanent restricted areas and the 

ability to activate two additional 

restricted areas as local and national 

intelligence threat evaluations dictate. 

DATES: Written comments must be 

submitted on or before June 10, 2013. 

ADDRESSES: You may submit comments, 

identified by docket number COE– 

2013–0003, by any of the following 

methods: 

Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Email: david.b.olson@usace.army.mil. 

Include the docket number, COE–2013– 

0003, in the subject line of the message. 

Mail: U.S. Army Corps of Engineers, 

Attn: CECW–CO (David B. Olson), 441 

G Street NW., Washington, DC 20314– 

1000. 

Hand Delivery/Courier: Due to 

security requirements, we cannot 

receive comments by hand delivery or 

courier. 

Instructions: Direct your comments to 

docket number COE–2013–0003. All 

comments received will be included in 

the public docket without change and 

may be made available on-line at 

http://www.regulations.gov, including 

any personal information provided, 

unless the commenter indicates that the 

comment includes information claimed 

to be Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. Do 

not submit information that you 

consider to be CBI, or otherwise 

protected, through regulations.gov or 

email. The regulations.gov Web site is 

an anonymous access system, which 

means we will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an email directly to the 

Corps without going through 

regulations.gov, your email address will 

be automatically captured and included 

as part of the comment that is placed in 

the public docket and made available on 

the Internet. If you submit an electronic 

comment, we recommend that you 

include your name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If we cannot read your 

comment because of technical 

difficulties and cannot contact you for 

clarification, we may not be able to 

consider your comment. Electronic 

comments should avoid the use of any 

special characters, any form of 

encryption, and be free of any defects or 

viruses. 

Docket: For access to the docket to 

read background documents or 

comments received, go to 

www.regulations.gov. All documents in 

the docket are listed. Although listed in 

the index, some information is not 

publicly available, such as 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. 

FOR FURTHER INFORMATION CONTACT: Mr. 

David Olson, Headquarters, Operations 

and Regulatory Community of Practice, 

Washington, DC at 202–761–4922 or Mr. 

Jon M. Griffin, U.S. Army Corps of 

Engineers, Jacksonville District, 

Regulatory Division, at 904–232–1680. 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

The purpose of this regulatory action 

is to establish four new permanent 

restricted areas in the waters 

surrounding Tyndall AFB to counter 

postulated threats against their 

personnel and equipment at those sites. 

Additionally, this regulatory action 

would establish two additional 

restricted areas which would be 

activated under conditions of heighten 

security risks and provide an 

administrative correction to the existing 

regulation at 33 CFR 334.660. 

The Corps authority to establish these 

restricted areas is Section 7 of the Rivers 

and Harbors Act of 1917 (40 Stat 266; 

33 U.S.C. 1) and Chapter XIX of the 

Army Appropriations Act of 1919 (40 

Stat. 892; 33 U.S.C. 3). 

Background 

Pursuant to its authorities in Section 

7 of the Rivers and Harbors Act of 1917 

(40 Stat 266; 33 U.S.C. 1) and Chapter 

XIX of the Army Appropriations Act of 

1919 (40 Stat 892; 33 U.S.C. 3) the Corps 

is proposing to revise the regulations at 

33 CFR part 334 by establishing a total 

of six new restricted areas in the waters 

surrounding Tyndall AFB. This 

amendment to the existing regulation 

will allow the Commander, Tyndall 


tkelley on DSK3SPTVN1PROD with PROPOSALS