50082 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations 

TABLE 1—NON-EEG PHYSIOLOGICAL SIGNAL BASED SEIZURE MONITORING SYSTEM RISKS AND MITIGATION MEASURES— 

Continued 

Identified risks Mitigation measures 

Incorrect alerts, including: 

• Missing a seizure—device fails to identify physiological signal 

that is associated with a seizure; or.

• False alarm—device mistakenly identifies a physiological signal 

as being associated with a seizure.

Clinical performance testing; 

Non-clinical performance testing; 

Software verification, validation, and hazard analysis; 

Labeling; and 

Training. 

FDA has determined that special 

controls, in combination with the 

general controls, address these risks to 

health and provide reasonable assurance 

of the 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) of the 

FD&C Act. 

At the time of classification, non-EEG 

physiological signal based seizure 

monitoring systems are for prescription 

use only. Prescription devices are 

exempt from the requirement for 

adequate directions for use for the 

layperson under section 502(f)(1) of the 

FD&C Act (21 U.S.C. 352(f)(1)) and 21 

CFR 801.5, as long as the conditions of 

21 CFR 801.109 are met. 

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, and the collections of 

information in 21 CFR part 801, 

regarding labeling have been approved 

under OMB control number 0910–0485. 

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 part 882 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 882.1580 to subpart B to read 

as follows: 

§ 882.1580 Non-electroencephalogram 

(EEG) physiological signal based seizure 

monitoring system. 

(a) Identification. A nonelectroencephalogram (non-EEG) 

physiological signal based seizure 

monitoring system is a noninvasive 

prescription device that collects 

physiological signals other than EEG to 

identify physiological signals that may 

be associated with a seizure. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) The technical parameters of the 

device, hardware and software, must be 

fully characterized and include the 

following information: 

(i) Hardware specifications must be 

provided. Appropriate verification, 

validation, and hazard analysis must be 

performed. 

(ii) Software, including any 

proprietary algorithm(s) used by the 

device to achieve its intended use, must 

be described in detail in the Software 

Requirements Specification (SRS) and 

Software Design Specification (SDS). 

Appropriate software verification, 

validation, and hazard analysis must be 

performed. 

(2) The patient-contacting 

components of the device must be 

demonstrated to be biocompatible. 

(3) The device must be designed and 

tested for electrical, thermal, and 

mechanical safety and electromagnetic 

compatibility (EMC). 

(4) Clinical performance testing must 

demonstrate the ability of the device to 

function as an assessment aid for 

monitoring for seizure-related activity in 

the intended population and for the 

intended use setting. Performance 

measurements must include positive 

percent agreement and false alarm rate. 

(5) Training must be provided for 

intended users that includes 

information regarding the proper use of 

the device and factors that may affect 

the collection of the physiologic data. 

(6) The labeling must include health 

care professional labeling and patientcaregiver labeling. The health care 

professional and the patient-caregiver 

labeling must include the following 

information: 

(i) A detailed summary of the clinical 

performance testing, including any 

adverse events and complications. 

(ii) Any instructions technicians and 

clinicians should convey to patients and 

caregivers regarding the proper use of 

the device and factors that may affect 

the collection of the physiologic data. 

(iii) Instructions to technicians and 

clinicians regarding how to set the 

device threshold to achieve the 

intended performance of the device. 

Dated: October 24, 2017. 

Lauren Silvis, 

Chief of Staff. 

[FR Doc. 2017–23516 Filed 10–27–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG 2017–0162] 

RIN 1625–AA09 

Drawbridge Operation Regulation; 

Nanticoke River, Seaford, DE 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is modifying 

the operating schedule that governs the 

SR 13 Bridge across the Nanticoke 

River, mile 39.6, in Seaford, Delaware 

(DE). This modification will require the 


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Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations 50083 

bridge to open on signal every Saturday 

and Sunday during the winter season, if 

at least 24 hours notice is given. This 

action is necessary to balance bridge 

operations and maintenance with the 

existing needs of navigation. 

DATES: This rule is effective November 

29, 2017. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to http://

www.regulations.gov. Type USCG– 

2017–0162 in the ‘‘SEARCH’’ box and 

click ‘‘SEARCH.’’ Click on Open Docket 

Folder on the line associated with this 

rulemaking. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email Mr. Martin A. Bridges, Fifth Coast 

Guard District (dpb), at (757) 398–6422, 

email Martin.A.Bridges@uscg.mil. 

SUPPLEMENTARY INFORMATION section 

below for instructions on submitting 

comments. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

§ Section 

U.S.C. United States Code 

II. Background Information and 

Regulatory History 

On July 5, 2017, we published a 

notice of proposed rulemaking entitled, 

‘‘Drawbridge Regulation; Nanticoke 

River, Seaford, DE’’ in the Federal 

Register (see 82 FR 127). We did not 

receive any comments on the proposed 

rule. 

III. Legal Authority and Need for Rule 

The Coast Guard is issuing this rule 

under authority 33 U.S.C. 499. The US 

13 Bridge across the Nanticoke River, 

Mile 39.6, in Seaford, DE, owned and 

operated by the Delaware Department of 

Transportation, has a vertical clearance 

of 3 feet above mean high water in the 

closed-to-navigation position. There is a 

monthly average of three bridge 

openings on Saturdays and Sundays, 

from 7:30 a.m. to 3:30 p.m., from 

November 1 through March 31, which 

allow one or more vessels to transit 

through the bridge during each opening. 

The bridge is normally maintained in 

the closed position, due to the volume 

of vehicular traffic crossing the bridge. 

The current operating schedule is 

published in 33 CFR 117.243(b). The 

Coast Guard’s authority to make a 

permanent change to a drawbridge 

operating schedule is contained in 33 

CFR 117.8. 

The Nanticoke River is used 

predominately by recreational vessels 

and pleasure craft. The three-year 

average number of bridge openings, 

maximum number of bridge openings, 

and weekend bridge openings between 

7:30 a.m. and 3:30 p.m., by month and 

overall for 2014 through 2016, as drawn 

from the data contained in the bridge 

tender logs provided by the Delaware 

Department of Transportation, is 

presented below. 

Month Average 

openings 

Maximum 

openings 

Proposed weekends— 

average openings 

7:30 a.m.–3:30 p.m. 

January .......................................................................................................................... 11 31 3 

February ......................................................................................................................... 1 3 1 

March ............................................................................................................................. 21 53 4 

April ................................................................................................................................ 72 91 N/A 

May ................................................................................................................................ 138 192 N/A 

June ............................................................................................................................... 150 168 N/A 

July ................................................................................................................................. 280 175 N/A 

August ............................................................................................................................ 198 223 N/A 

September ..................................................................................................................... 144 214 N/A 

October .......................................................................................................................... 51 66 N/A 

November ...................................................................................................................... 8 13 5 

December ...................................................................................................................... 1 4 1 

Monthly .......................................................................................................................... 89 223 3 

Daily ............................................................................................................................... 3 7 <1 

IV. Discussion of Comments, Changes 

and the Final Rule 

The Delaware Department of 

Transportation has requested to modify 

the operating regulation for the bridge, 

due to the limited number of requested 

openings of the bridge on Saturday and 

Sunday, from 7:30 a.m. to 3:30 p.m., 

from November 1 through March 31, 

over a period of approximately the past 

three years. The data presented in the 

table above demonstrate that the 

requested modification may be 

implemented with minimal impact to 

navigation. The modification requested 

will require the bridge to open on signal 

on Saturday and Sunday; from 7:31 a.m. 

to 3:29 p.m., from November 1 through 

March 31, if at least 24 hours notice is 

given. All other provisions of 33 CFR 

117.243 (b) will remain the same. 

The Coast Guard provided a comment 

period of 60 days and received zero 

comments on the proposed rule. 

V. Regulatory Analysis 

We developed this rule after 

considering numerous statutes and 

Executive Orders related to rulemaking. 

Below we summarize our analyses 

based on a number of these statutes and 

Executive Orders, and we discuss First 

Amendment rights of protesters. 

A. Regulatory Planning and Review 

Executive Orders 12866 and 13563 

direct agencies to assess the costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits. 

Executive Order 13771 directs agencies 

to control regulatory costs through a 

budgeting process. This rule has not 

been designated a ‘‘significant 

regulatory action,’’ under Executive 

Order 12866. Accordingly, it has not 

been reviewed by the Office of 

Management and Budget (OMB) and 

pursuant to OMB guidance it is exempt 

from the requirements of Executive 

Order 13771. 

This is not considered a significant 

regulatory action. This determination is 

based on the findings that: (1) The 

potential impact is small, given the 

limited number of vessels requiring a 

bridge opening during the time frame of 

the proposed modification, and (2) 

vessels will be able to transit through 

the bridge during the time frame of the 

proposed modification, given the bridge 

will open on signal, if at least 24 hours 

notice is given. 


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50084 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Rules and Regulations 

B. Impact on Small Entities 

The Regulatory Flexibility Act of 1980 

(RFA), 5 U.S.C. 601–612, as amended, 

requires federal agencies to consider the 

potential impact of regulations on small 

entities during rulemaking. The term 

‘‘small entities’’ comprises small 

businesses, not-for-profit organizations 

that are independently owned and 

operated and are not dominant in their 

fields, and governmental jurisdictions 

with populations of less than 50,000. 

The Coast Guard received zero 

comments from the Small Business 

Administration on this rule. The Coast 

Guard certifies under 5 U.S.C. 605(b) 

that this rule will not have a significant 

economic impact on a substantial 

number of small entities. While some 

owners or operators of vessels intending 

to transit the bridge may be small 

entities, for the reasons stated in section 

V.A above, this rule will not have a 

significant economic impact on any 

vessel owner or operator. 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Pub. L. 104–121), 

we want to assist small entities in 

understanding this rule. If the rule 

would affect your small business, 

organization, or governmental 

jurisdiction and you have questions 

concerning its provisions or options for 

compliance, please contact the person 

listed in the FOR FURTHER INFORMATION

CONTACT, above. 

Small businesses may send comments 

on the actions of Federal employees 

who enforce, or otherwise determine 

compliance with, Federal regulations to 

the Small Business and Agriculture 

Regulatory Enforcement Ombudsman 

and the Regional Small Business 

Regulatory Fairness Boards. The 

Ombudsman evaluates these actions 

annually and rates each agency’s 

responsiveness to small business. If you 

wish to comment on actions by 

employees of the Coast Guard, call 1– 

888–REG–FAIR (1–888–734–3247). The 

Coast Guard will not retaliate against 

small entities that question or complain 

about this rule or any policy or action 

of the Coast Guard. 

C. Collection of Information 

This rule calls for no new collection 

of information under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). 

D. Federalism and Indian Tribal 

Government 

A rule has implications for federalism 

under Executive Order 13132, 

Federalism, if it has a substantial direct 

effect on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. We have 

analyzed this rule under that Order and 

have determined that it is consistent 

with the fundamental federalism 

principles and preemption requirements 

described in Executive Order 13132. 

Also, this rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not have a substantial 

direct effect on one or more Indian 

tribes, on the relationship between the 

Federal Government and Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. We 

received zero comments on this rule. 

E. Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 (adjusted for inflation) or 

more in any one year. Though this 

proposed rule will not result in such an 

expenditure, we do discuss the effects of 

this proposed rule elsewhere in this 

preamble. We received zero comments 

on this rule. 

F. Environment 

We have analyzed this rule under 

Department of Homeland Security 

Management Directive 023–01 and 

Commandant Instruction M16475.lD, 

which guides the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have made a determination that this 

action is one of a category of actions 

which do not individually or 

cumulatively have a significant effect on 

the human environment. This rule 

simply promulgates the operating 

regulations or procedures for 

drawbridges. This action is categorically 

excluded from further review, under 

figure 2–1, paragraph (32)(e), of the 

Instruction. A preliminary Record of 

Environmental Consideration and a 

Memorandum for the Record are not 

required for this rule. 

G. Protest Activities 

The Coast Guard respects the First 

Amendment rights of protesters. 

Protesters are asked to contact the 

person listed in the FOR FURTHER

INFORMATION CONTACT section to 

coordinate protest activities so that your 

message can be received without 

jeopardizing the safety or security of 

people, places or vessels. 

List of Subjects in 33 CFR Part 117 

Bridges. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 117 as follows: 

PART 117—DRAWBRIDGE 

OPERATION REGULATIONS 

■ 1. The authority citation for part 117 

continues to read as follows: 

Authority: 33 U.S.C. 499; 33 CFR 1.05–1; 

Department of Homeland Security Delegation 

No. 0170.1. 

■ 2. Revise § 117.243(b) to read as 

follows: 

§ 117.243 Nanticoke River. 

* * * * * 

(b) The draw of the SR 13 Bridge, mile 

39.6, in Seaford shall: 

(1) Open on signal, except from 6 p.m. 

to 8 a.m., from April 1 through October 

31; from November 1 through March 31, 

Monday to Friday and on Saturday and 

Sunday from 3:30 p.m. to 7:30 a.m., if 

at least four hours notice is given. 

(2) Open on signal, on Saturday and 

Sunday, from 7:31 a.m. through 3:29 

p.m., from November 1 through March 

31, if at least 24 hours notice is given. 

Dated: October 10, 2017. 

M.L. Austin, 

Rear Admiral, U.S. Coast Guard, Commander, 

Fifth Coast Guard District. 

[FR Doc. 2017–23559 Filed 10–27–17; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0155; FRL–9968–12] 

Hexythiazox; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends an 

existing tolerance for residues of the 

ovicide/miticide hexythiazox in/on hop, 

dried cones, by increasing the current 

tolerance from 2.0 parts per million 

(ppm) to 20 ppm. Gowan Company 

requested modification of this tolerance 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

October 30, 2017. Objections and 

requests for hearings must be received 


nlaroche on DSK9F9SC42PROD with RULES