48764 Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Rules and Regulations 

sequences from patients suspected of 

meningitis or encephalitis. A device to 

detect and identify microbial pathogen 

nucleic acids in cerebrospinal fluid is 

intended to aid in the diagnosis of 

meningitis or encephalitis when used in 

conjunction with clinical signs and 

symptoms and other clinical and 

laboratory findings. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Premarket notification 

submissions must include detailed 

device description documentation, 

including the device components, 

ancillary reagents required but not 

provided, and a detailed explanation of 

the methodology, including primer/ 

probe sequence, design, and rationale 

for sequence selection. 

(2) Premarket notification 

submissions must include detailed 

documentation from the following 

analytical studies: Analytical sensitivity 

(limit of detection), inclusivity, 

reproducibility, interference, cross 

reactivity, and specimen stability. 

(3) Premarket notification 

submissions must include detailed 

documentation from a clinical study. 

The study, performed on a study 

population consistent with the intended 

use population, must compare the 

device performance to results obtained 

from well-accepted comparator 

methods. 

(4) Premarket notification 

submissions must include detailed 

documentation for device software, 

including, but not limited to, software 

applications and hardware-based 

devices that incorporate software. 

(5) The Intended Use statement in the 

device labeling must include a 

statement that the device is intended to 

be used in conjunction with standard of 

care culture. 

(6) A detailed explanation of the 

interpretation of results and acceptance 

criteria must be included in the device’s 

21 CFR 809.10(b)(9) compliant labeling. 

(7) The device labeling must include 

a limitation stating that the negative 

results do not preclude the possibility of 

central nervous system infection. 

(8) The device labeling must include 

a limitation stating that device results 

are not intended to be used as the sole 

basis for diagnosis, treatment, or other 

patient management decisions. 

(9) The device labeling must include 

a limitation stating that positive results 

do not mean that the organism detected 

is infectious or is the causative agent for 

clinical symptoms. 

(10) As part of the risk management 

activities performed as part of your 21 

CFR 820.30 design controls, you must 

document an appropriate end user 

device training program that will be 

offered as part of your efforts to mitigate 

the risk of failure to correctly operate 

the instrument. 

Dated: October 13, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–22769 Filed 10–19–17; 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 (72 COLREGS), to reflect that 

the Deputy Assistant Judge Advocate 

General (DAJAG) (Admiralty and 

Maritime Law) has determined that 

certain vessels of the VIRGINIA SSN 

Class are vessels of the Navy which, due 

to their special construction and 

purpose, cannot fully comply with 

certain provisions of the 72 COLREGS 

without interfering with their special 

function as a naval ships. The intended 

effect of this rule is to warn mariners in 

waters where 72 COLREGS apply. 

DATES: This rule is effective October 20, 

2017 and is applicable beginning 

September 30, 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 

certain vessels of the SSN Class are 

vessels of the Navy which, due to their 

special construction and purpose, 

cannot fully comply with the following 

specific provisions of 72 COLREGS 

without interfering with their special 

function as a naval ship: Rule 23(a) and 

Annex I, paragraph 2(a)(i), pertaining to 

the vertical placement of the masthead, 

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

pertaining to the masthead light being 

above and clear of all other lights and 

obstructions; Rule 30 (a), Rule 21(e), and 

Annex I, paragraph 2(k), pertaining to 

the vertical separation of the anchor 

lights, vertical placement of the forward 

anchor light above the hull, and the arc 

of visibility of all around lights; Rule 23 

(a) and 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 these vessels in 

a manner differently from that 

prescribed herein will adversely affect 

these vessels’ ability to perform their 

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 INDIANA (SSN 789); 

■ b. In Table Three, adding, in alpha 

numerical order, by vessel number, an 

entry for USS INDIANA (SSN 789); and 

■ c. In Table Four: 

■ i. In paragraph 25, adding, in alpha 

numerical order, by vessel number, an 

entry for USS INDIANA (SSN 789); and 

■ ii. In paragraph 26, adding, in alpha 

numerical order, by vessel number, an 

entry for USS INDIANA (SSN 789). 

The additions read as follows: 

§ 706.2 Certifications of the Secretary of 

the Navy under Executive Order 11964 and 

33 U.S.C. 1605. 

* * * * * 


nlaroche on DSK9F9SC42PROD with RULES
Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Rules and Regulations 48765 

TABLE ONE

Vessel Number 

Distance in meters of 

forward masthead light 

below minimum 

required height 

§ 2(a)(i) Annex I 

*******

USS INDIANA ..................................................................... SSN 789 ............................................................................. 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 

relationship 

of aft light 

to forward 

light in 

meters 2(K) 

annex 1 

*******

USS INDIANA .................................................... SSN 789 .... .................... .................... 206.0° 4.37 11.05 2.8 0.30 

*******

* * * * * 

* * * * * 

25. * * * 

TABLE FOUR

Vessel Number 

Distance in meters of 

masthead light below 

the submarine 

identification lights 

*******

USS INDIANA ..................................................................... SSN 789 ............................................................................. 0.81 

26. * * * 

Vessel Number 

Obstruction angle relative to ship’s 

headings 

Forward anchor 

light 

Aft anchor 

light 

*******

USS INDIANA ...................................................... SSN 789 ............................................................... 172° to 188° .......... 359° to 1°. 


nlaroche on DSK9F9SC42PROD with RULES
48766 Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Rules and Regulations 

* * * * * 

Approved: September 30, 2017. 

A.S. Janin, 

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

Judge Advocate, General (Admiralty and 

Maritime Law Division). 

Dated: October 10, 2017. 

A.M. Nichols, 

Lieutenant Commander, Judge Advocate 

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

Liaison Officer. 

[FR Doc. 2017–22578 Filed 10–19–17; 8:45 am] 

BILLING CODE 3810–FF–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R05–OAR–2017–0157; FRL–9969–87– 

Region 5] 

Air Plan Approval; Wisconsin; 

Regional Haze Progress Report 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is approving the regional 

haze progress report under the Clean Air 

Act as a revision to the Wisconsin State 

Implementation Plan (SIP). Wisconsin 

has satisfied the progress report 

requirements of the Regional Haze Rule. 

Wisconsin has also met the 

requirements for a determination of the 

adequacy of its regional haze plan with 

its negative declaration submitted with 

the progress report. 

DATES: This direct final rule will be 

effective December 19, 2017, unless EPA 

receives adverse comments by 

November 20, 2017. If adverse 

comments are received, EPA will 

publish a timely withdrawal of the 

direct final rule in the Federal Register 

informing the public that the rule will 

not take effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R05– 

OAR–2017–0157 at http://

www.regulations.gov or via email to 

aburano.douglas@epa.gov. For 

comments submitted at Regulations.gov, 

follow the online instructions for 

submitting comments. Once submitted, 

comments cannot be edited or removed 

from Regulations.gov. For either manner 

of submission, EPA may publish any 

comment received to its public docket. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. Multimedia 

submissions (audio, video, etc.) must be 

accompanied by a written comment. 

The written comment is considered the 

official comment and should include 

discussion of all points you wish to 

make. EPA will generally not consider 

comments or comment contents located 

outside of the primary submission (i.e., 

on the web, cloud, or other file sharing 

system). For additional submission 

methods, please contact the person 

identified in the FOR FURTHER

INFORMATION CONTACT section. For the 

full EPA public comment policy, 

information about CBI or multimedia 

submissions, and general guidance on 

making effective comments, please visit 

http://www2.epa.gov/dockets/ 

commenting-epa-dockets. 

FOR FURTHER INFORMATION CONTACT: 

Gilberto Alvarez, Environmental 

Scientist, Attainment Planning and 

Maintenance Section, Air Programs 

Branch (AR–18J), Environmental 

Protection Agency, Region 5, 77 West 

Jackson Boulevard, Chicago, Illinois 

60604, (312) 886–6143, 

alvarez.gilberto@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document whenever 

‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean 

EPA. This supplementary information 

section is arranged as follows: 

I. Background 

II. Requirements for the Regional Haze 

Progress Report SIPs and Adequacy of 

Determinations 

III. What is EPA’s analysis? 

IV. What action is EPA taking? 

V. Statutory and Executive Order Reviews 

I. Background 

States are required to submit a 

progress report every five years that 

evaluates progress towards the 

Reasonable Progress Goals (RPGs) for 

each mandatory Class I Federal area 

within the State and in each mandatory 

Class I Federal area outside the State 

which may be affected by emissions 

from within the State. See 40 CFR 

51.308(g). States are also required to 

submit, at the same time as the progress 

report, a determination of the adequacy 

of the State’s existing regional haze SIP. 

See 40 CFR 51.308(h). The first progress 

report is due five years after the 

submittal of the initial regional haze 

SIP. 

Wisconsin submitted its regional haze 

plan on January 18, 2012. EPA approved 

Wisconsin’s regional haze plan into its 

SIP on August 7, 2012, 77 FR 46952. 

Wisconsin submitted its five-year 

progress report on March 17, 2017. This 

is a report on progress made in the first 

implementation period towards RPGs 

for Class I areas outside of Wisconsin. 

Wisconsin does not have any Class I 

areas within its borders. This progress 

report SIP included a determination that 

Wisconsin’s existing regional haze SIP 

requires no substantive revision to 

achieve the established regional haze 

visibility improvement and emissions 

reduction goals for 2018. EPA is 

proposing to approve Wisconsin’s 

progress report on the basis that it 

satisfies the applicable requirements of 

the rule at 40 CFR 51.308. 

II. Requirements for the Regional Haze 

Progress Report SIPs and Adequacy of 

Determinations 

Under 40 CFR 51.308(g), states must 

periodically (every five years) submit a 

regional haze progress report that 

address the seven elements found in 40 

CFR 51.308(g). 

Under 40 CFR 51.308(h), states are 

required to submit, at the same time as 

the progress report, a determination of 

the adequacy of their existing regional 

haze SIP and to take one of four possible 

listed actions based on information in 

the progress report. 

III. What is EPA’s analysis? 

The Regional Haze Rule provides the 

required elements for five-year progress 

reports in 40 CFR 51.308(g). EPA finds 

that Wisconsin satisfied the 40 CFR 

51.308(g) requirements with its progress 

report. EPA finds that, with its negative 

declaration, Wisconsin also satisfied the 

requirements for the determination of 

adequacy provided in 40 CFR 51.308(h). 

The following sections discuss the 

information provided by Wisconsin in 

the progress report submission, along 

with EPA’s analysis and determination 

of whether the submission met the 

applicable requirements of § 51.308. 

1. Status of Implementation of all 

Measures Included in the Regional Haze 

SIP 

In its progress report, Wisconsin 

summarizes the status of the emissions 

reduction measures that were included 

in its 2012 regional haze SIP. 

Specifically, the report addresses the 

status of the on-the-books emissions 

reduction measures. The measures 

include applicable Federal programs 

(e.g., Clean Air Interstate Rule—CAIR, 

Cross State Pollution Rule—CSAPR, onand off-highway mobile source rules, 

area source rules, point sources, Title IV 

programs, nitrogen oxides (NOX) SIP 

Call, Maximum Achievable Control 

Technology (MACT) standards, Federal 

and State consent agreements, and 

Federal and State control strategies for 

electric generating units (EGUs)). This 

summary includes a discussion of the 

benefits associated with each measure. 


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