Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Rules and Regulations 48415 

FDA has determined that special 

controls, in combination with the 

general controls, address these risks to 

health and provide reasonable assurance 

of safety and effectiveness. In order for 

a device to fall within this classification, 

and thus avoid automatic classification 

in class III, it would have to comply 

with the special controls named in this 

final order. The necessary special 

controls appear in the regulation 

codified by this order. This device is 

subject to premarket notification 

requirements under section 510(k). 

III. Analysis of 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. 

IV. 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. 

List of Subjects in 21 CFR Part 862 

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 862 is 

amended as follows: 

PART 862—CLINICAL CHEMISTRY 

AND CLINICAL TOXICOLOGY 

DEVICES 

■ 1. The authority citation for part 862 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 862.3652 to subpart D to read 

as follows: 

§ 862.3652 Organophosphate test system. 

(a) Identification. An 

organophosphate test system is a device 

intended to measure organophosphate 

metabolites quantitatively in human 

urine from individuals who have signs 

and symptoms consistent with 

cholinesterase poisoning. The data 

obtained by this device is intended to 

aid in the confirmation and 

investigation of organophosphate 

exposure. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) The distribution of these devices is 

limited to laboratories with experienced 

personnel who are trained to measure 

and evaluate organophosphate exposure 

and guide public health response. 

(2) Analytical testing must 

demonstrate the device has appropriate 

performance characteristics, including 

adequate precision and accuracy across 

the measuring range and near medical 

decision points. 

Dated: October 13, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–22590 Filed 10–17–17; 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 MICHAEL 

MONSOOR (DDG 1001) 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 October 18, 

2017 and is applicable beginning 

October 3, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Lieutenant Commander Kyle Fralick, 

(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 MICHAEL MONSOOR (DDG 1001) 

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 

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

location of the forward masthead light at 

a height not less than 6 meters above the 

hull; Annex I, paragraph 2(g) pertaining 

to the placement of sidelights above the 

hull of the vessel; Rule 30(a)(i) and 

Annex I, paragraph 2(k) pertaining to 

the vertical separation between anchor 

lights, and the location of the forward 

anchor light at a height of not less than 

6 meters above the hull; Annex I, 

paragraph 3(a), pertaining to the 

horizontal separation between the 

forward and after masthead lights; 

Annex I, paragraph 2(i)(iii), pertaining 

to the vertical spacing of task lights; and 

Annex I, paragraph 3(c), pertaining to 

the task lights placed at a horizontal 

distance of not less than 2 meters from 

the fore and aft centerline of the vessel. 

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 

alphanumerical order by vessel number, 

an entry for USS MICHAEL MONSOOR 

(DDG 1001); 


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48416 Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Rules and Regulations 

■ b. In Table Three, adding in 

alphanumerical order by vessel number, 

an entry for USS MICHAEL MONSOOR 

(DDG 1001); 

■ c. In Table Four, under paragraph 15, 

adding in alphanumerical order by 

vessel number, an entry for USS 

MICHAEL MONSOOR (DDG 1001); 

■ d. In Table Four, under paragraph 19, 

adding in alphanumerical order by 

vessel number, an entry for USS 

MICHAEL MONSOOR (DDG 1001); 

■ e. In Table Four, under paragraph 22 

adding, in alphanumerical order by 

vessel number, an entry for USS 

MICHAEL MONSOOR (DDG 1001); and 

■ f. In Table Five, adding, in 

alphanumerical order by vessel number, 

an entry for USS MICHAEL MONSOOR 

(DDG 1001). 

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 1 

*******

USS MICHAEL MONSOOR ................................................................................................................. DDG 2.33 

* * * * * * * 

* * * * * 

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 

relationship of 

aft light to 

forward light 

in meters 

2(K) annex 1 

USS MICHAEL MONSOOR ............... DDG 1001 .................... .................... .................... ........................ ........................ 5.3 2.99 below. 

* * * * * * * 

* * * * * 

* * * * * 

15. * * * 

TABLE FOUR

Vessel Number 

Horizontal distance from the fore 

and aft centerline of the vessel in the 

athwartship direction 

*******

USS MICHAEL MONSOOR ....................................................................................... DDG 1001 FWD Lower: 10.33 meters. 

FWD Middle: 10.31 meters. 

FWD Upper: 10.30 meters. 

AFT Lower: 11.05 meters. 

AFT Middle: 11.05 meters. 

AFT Upper: 11.05 meters. 

* * * * * * * 

1On DDG 1000, the ship does not have a traditional mast. To achieve the effect of a ‘‘single, all-around light,’’ multiple sets of task lights are 

embedded into each of the four faces of the ship’s superstructure. Except when viewing the ship from dead ahead, dead astern or broadside, 

two deckhouse surfaces are visible; consequently, two sets of task lights are visible simultaneously. Because the deckhouse surfaces are sloped, 

unless the lights are viewed dead-on, the three task lights do not present as being in a vertical line. 

* * * * * 19. * * * 


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Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Rules and Regulations 48417 

Vessel Number Distance in meters of sidelights above 

maximum allowed height 

USS MICHAEL MONSOOR ....................................................................................... DDG 1001 2.23 PORT. 

2.52 STBD. 

* * * * * * * 

* * * * * 22. * * * 

Vessel Number 

Vertical Separation of the task light array 

is not equally spaced, the separation between the middle and lower task light exceed the separation between the upper 

and middle light by 

*******

USS MICHAEL MONSOOR ....................................................................................... DDG 1001 FWD: 0.01 meter. 

AFT: 0.00 meter. 

PORT: 0.17 meter. 

STBD: 0.24 meter. 

* * * * * * * 

* * * * * 

TABLE FIVE

Vessel Number 

Masthead 

lights not 

over all 

other lights 

and 

obstructions; 

annex I, 

sec. 2(f) 

Forward 

masthead 

light not in 

forward 

quarter 

of ship; 

annex I, 

sec. 3(a) 

After 

masthead 

light less 

than 1⁄2 ship’s 

length aft of 

forward 

masthead 

light; 

annex I, 

sec.3(a) 

Percentage 

horizontal 

separation 

attained 

*******

USS MICHAEL MONSOOR .............................................. DDG 1001 X X X 77.2 

*******

Approved: October 3, 2017. 

A.S. Janin, 

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

Judge Advocate, General (Admiralty and 

Maritime Law). 

Dated: October 10, 2017. 

A.M. Nichols, 

Lieutenant Commander, Judge Advocate 

General’s Corps, U.S. Navy,Federal Register 

Liaison Officer. 

[FR Doc. 2017–22577 Filed 10–17–17; 8:45 am] 

BILLING CODE 3810–FF–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket Number USCG–2017–0858] 

RIN 1625–AA08 

Special Local Regulation; Clinch River, 

Oak Ridge, TN 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a special local regulation 

for all navigable waters of the Clinch 

River from mile marker (MM) 49.5 to 

MM 54.0. This action is necessary to 

provide for the safety of life on these 

navigable waters near Oak Ridge, TN 

during the Secret City Head Race. Entry 

into, transiting through, or anchoring 

within this regulated area is prohibited 

unless authorized by the Captain of the 

Port Sector Ohio Valley (COTP) or a 

designated representative. 

DATES: This rule is effective from 6 a.m. 

through 6 p.m. on October 21, 2017. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to http://

www.regulations.gov, type USCG–2017– 

0858 in the ‘‘SEARCH’’ box and click 

‘‘SEARCH.’’ Click on Open Docket 

Folder on the line associated with this 

rule. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call 

Petty Officer Vera Max, Marine Safety 

Detachment Nashville, U.S. Coast 

Guard; telephone 615–736–5421, email 

MSDNashville@uscg.mil. 

SUPPLEMENTARY INFORMATION: 


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