49104 Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Rules and Regulations 

(H) Specimen stability data, including 

stability under various storage times, 

temperatures, freeze-thaw, and transport 

conditions where appropriate; 

(I) Method comparison data generated 

by comparison of the results obtained 

with the device to those obtained with 

a legally marketed predicate device with 

similar indication of use. Patient 

samples from the intended use 

population covering the device 

measuring range must be used; 

(J) Specimen matrix comparison data 

if more than one specimen type or 

anticoagulant can be tested with the 

device. Samples used for comparison 

must be from patient samples covering 

the device measuring range; 

(K) A description of how the assay 

cut-off (the medical decision point 

between positive and negative) was 

established and validated as well as 

supporting data; 

(L) Clinical performance must be 

established by comparing data generated 

by testing samples from the intended 

use population and the differential 

diagnosis groups with the device to the 

clinical diagnostic standard. The 

diagnosis of Type 1 diabetes mellitus 

must be based on clinical history, 

physical examination, and laboratory 

tests, such as one or more pancreatic or 

insulin autoantibody test. Because the 

intended use population for Type 1 

diabetes mellitus includes subjects less 

than 18 years old, samples from 

representative numbers of these subjects 

must be included. Representative 

numbers of samples from all age strata 

must also be included. The differential 

diagnosis groups must include, but not 

be limited to the following: Type 2 

diabetes mellitus; metabolic syndrome; 

latent autoimmune diabetes in adults; 

other autoimmune diseases such as 

celiac disease (without a concomitant 

diagnosis of Type 1 diabetes mellitus), 

systemic lupus erythematosus, 

rheumatoid arthritis, and Hashimoto’s 

thyroiditis; infection; renal disease; and 

testicular cancer. Diseases for the 

differential groups must be based on 

established diagnostic criteria and 

clinical evaluation. For all samples, the 

diagnostic clinical criteria and the 

demographic information must be 

collected and provided. The clinical 

validation results must demonstrate 

clinical sensitivity and clinical 

specificity for the test values based on 

the presence or absence of Type 1 

diabetes mellitus. The data must be 

summarized in tabular format 

comparing the interpretation of results 

to the disease status; and 

(M) Expected/reference values 

generated by testing an adequate 

number of samples from apparently 

healthy normal individuals. 

(iii) Identification of risk mitigation 

elements used by the device, including 

description of all additional procedures, 

methods, and practices incorporated 

into the directions for use that mitigate 

risks associated with testing. 

(2) Your 21 CFR 809.10(a) compliant 

label and 21 CFR 809.10(b) compliant 

labeling must include warnings relevant 

to the assay including: 

(i) A warning statement that reads, 

‘‘The device is for use by laboratory 

professionals in a clinical laboratory 

setting’’; 

(ii) A warning statement that reads, 

‘‘The test is not a stand-alone test but an 

adjunct to other clinical information. A 

diagnosis of Type 1 diabetes mellitus 

should not be made on a single test 

result. The clinical symptoms, results 

on physical examination, and laboratory 

tests (e.g., serological tests), when 

appropriate, should always be taken 

into account when considering the 

diagnosis of Type 1 diabetes mellitus 

and Type 2 diabetes mellitus’’; 

(iii) A warning statement that reads, 

‘‘Absence of Zinc T8 autoantibody does 

not rule out a diagnosis of Type 1 

diabetes mellitus’’; and 

(iv) A warning statement that reads, 

‘‘The assay has not been demonstrated 

to be effective for monitoring the stage 

of disease or its response to treatment.’’ 

(3) Your 21 CFR 809.10(b) compliant 

labeling must include a description of 

the protocol and performance studies 

performed in accordance with 

paragraph (b)(1)(ii) of this section and a 

summary of the results. 

Dated: October 18, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–22995 Filed 10–23–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2017–0048] 

RIN 1625–AA09 

Drawbridge Operation Regulation; 

Reynolds Channel, Lawrence, NY 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is modifying 

the operating schedule that governs the 

Atlantic Beach Bridge across Reynolds 

Channel, mile 0.4 at Lawrence, New 

York. This action is necessary to allow 

for an unexpected delay in the 

reconstruction and painting of the 

bascule leaves. A temporary deviation 

was previously granted for a length of 

180 days. As the Coast Guard may not 

approve extensions beyond that allotted 

timeframe nor approve back-to-back or 

sequential deviations, it is necessary to 

issue this rule in order to allow the 

bridge owner to complete the remaining 

work items. 

DATES: This rule is effective without 

actual notice from October 24, 2017 

until 11:59 p.m. on November 13, 2017. 

For the purposes of enforcement, actual 

notice will be used from 12:01 on 

October 14, 2017 until October 24, 2017. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to http://

www.regulations.gov, type USCG–2017– 

0048 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 interim rule, 

call or email James M. Moore, Bridge 

Management Specialist, U.S. Coast 

Guard; telephone 202–372–1518, email 

James.M.Moore2@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

DHS Department of Homeland Security 

FR Federal Register 

OMB Office of Management and Budget 

NPRM Notice of Proposed Rulemaking 

§ Section 

U.S.C. United States Code 

II. Background Information and 

Regulatory History 

On April 6, 2017, we published a 

temporary deviation entitled, 

‘‘Drawbridge Operation Regulation; 

Atlantic Beach Bridge, Reynolds 

Channel, Lawrence, NY’’ in the Federal 

Register (see 82 FR 06735). Although we 

did not request public comments, 

outreach conducted with mariners 

utilizing the waterway indicated no 

objections to the temporary deviation. 

No complaints have been submitted 

during the current temporary deviation. 

The Coast Guard is issuing this 

temporary interim rule without prior 

notice and opportunity to comment 

pursuant to authority under section 4(a) 

of the Administrative Procedure Act 

(APA) (5 U.S.C. 553(b)). This provision 

authorizes an agency to issue a rule 

without prior notice and opportunity to 

comment when the agency for good 

cause finds that those procedures are 

‘‘impracticable, unnecessary, or contrary 


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Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Rules and Regulations 49105 

to the public interest.’’ Under 5 U.S.C. 

553(b), the Coast Guard finds that good 

cause exists for not publishing a notice 

of proposed rulemaking (NPRM) with 

respect to this rule because it is 

impracticable. Due to unanticipated 

difficulties and delays impacting the 

schedule and pace of bascule leaf 

reconstruction and painting, additional 

time is required to finalize and complete 

the work necessary to restore the bridge 

to full operational capacity. We must 

modify the operation schedule of the 

bridge by October 15, 2017 to allow the 

completion of bascule leaf 

reconstruction and painting. Due to the 

circumstances of this repair project, we 

lack sufficient time to provide a 

reasonable comment period and then 

consider those comments before issuing 

the modification. 

We are issuing this rule and under 5 

U.S.C. 553(d)(3), and for the reasons 

stated above, the Coast Guard finds that 

good cause exists for making it effective 

in less than 30 days after publication in 

the Federal Register. 

III. Legal Authority and Need for the 

Rule 

The Coast Guard is issuing this rule 

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

Coast Guard is modifying the operating 

schedule that governs the Atlantic 

Beach Bridge across Reynolds Channel, 

mile 0.4, at Lawrence, New York. The 

Atlantic Beach Bridge is a double-leaf 

bascule bridge offering mariners a 

vertical clearance of 25 feet at mean 

high water and 30 feet at mean low 

water in the closed position. Work 

platforms installed underneath the 

bascule spans have reduced the 

available vertical clearance to 21.5 feet 

at mean high water in the closed 

position and to 26.5 feet at mean low 

water in the closed position. 

The existing drawbridge regulations 

are listed at 33 CFR 117.799(e). The 

Nassau County Bridge Authority, the 

bridge owner, has requested this 

modification as additional time is 

required to complete the final 

reconstruction and painting of the 

bascule leaves. 

The Nassau County Bridge Authority 

has also requested that the Atlantic 

Beach Bridge be allowed to open on 

signal only one of two bascule spans for 

bridge openings with the understanding 

that dual lift-span operations will occur 

for vessels requiring such an opening 

provided a 48 hour advance notice, and 

receipt of 24 hour advance 

confirmation, from 7 a.m. Monday 

through 6 p.m. Friday. The bridge will 

operate normally and open fully upon 

signal on weekends from 6 p.m. Friday 

through 7 a.m. Monday. 

The bridge generally opens four times 

per week for routine passage of towing 

vessels with tank barges or dry cargo 

barges. The bulk of remaining vessel 

traffic is recreational not requiring an 

opening in order to proceed through the 

draw. Vessels that can pass under the 

bridge without an opening may do so at 

all times. The bridge will be able to 

open for emergencies and there is an 

alternate route for vessels unable to pass 

through the bridge when in the closed 

position. 

IV. Discussion of the Rule 

The Coast Guard is issuing this rule, 

which permits a temporary deviation 

from the operating schedule that 

governs the Atlantic Beach Bridge 

across Reynolds Channel, mile 0.4, at 

Lawrence, New York. The rule is 

necessary to accommodate the 

completion of bascule leaf 

reconstruction and painting. This rule 

allows for single-leaf operations upon 

signal during the week, Monday through 

Friday. Dual lift-span operations will be 

provided for vessels requiring such an 

opening given 48 hours of advance 

notice and provided a 24 hour advance 

confirmation. The bridge will operate 

normally during weekends. 

V. Regulatory Analyses 

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 regulatory action 

determination is based on the ability of 

the majority of vessels to successfully 

transit through the draw of the bridge 

without an opening or with a single-leaf 

opening. Vessels requiring dual lift-span 

operations during the week may 

continue to transit the draw provided 

submission of advance notice. 

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 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 interim 

rule will not have a significant 

economic impact on any vessel owner 

or operator. Commercial mariners 

requiring dual lift-span operations 

during the week have been able to 

transit the draw following provision of 

advance notice. Single-leaf operations 

will be furnished on signal for those 

vessels requiring such an opening. 

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). 


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49106 Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Rules and Regulations 

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. 

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 rule 

will not result in such an expenditure, 

we do discuss the effects of this rule 

elsewhere in this preamble. 

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. In § 117.799, effective from 12:01 

a.m. on October 24, 2017, through 11:59 

p.m. on November 13, 2017, suspend 

paragraph (e)(1) and add paragraph 

(e)(4) to read as follows: 

§ 117.799 Long Island, New York Inland 

Waterway from East Rockaway Inlet to 

Shinnecock Canal. 

* * * * * 

(e) * * * 

(4) The Atlantic Beach Bridge will 

open only one of two bascule spans on 

signal for bridge openings from 7 a.m. 

Monday through 6 p.m. Friday. Dual 

lift-span operations will occur for 

vessels requiring such an opening 

provided a 48 hour advance notice and 

24 hour advance confirmation has been 

furnished from 7 a.m. Monday through 

6 p.m. Friday. The bridge will open 

fully on signal on weekends from 6 p.m. 

Friday through 7 a.m. Monday. 

* * * * * 

Dated: October 6, 2017. 

S.D. Poulin, 

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

First Coast Guard District. 

[FR Doc. 2017–23053 Filed 10–23–17; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2017–0890] 

RIN 1625–AA11 

Regulated Navigation Area; Beals 

Island Bridge Replacement, Moosabec 

Reach, Jonesport, ME 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule; request for 

comments. 

SUMMARY: The Coast Guard is 

establishing a temporary Regulated 

Navigation Area (RNA) for the navigable 

waters within 150-yards of the Beals 

Island Bridge between Jonesport, ME, 

and Beals Island, ME. The RNA is 

needed to protect personnel, vessels, 

and the marine environment from the 

potential hazards created by the 

demolition, subsequent removal, and 

replacement of the Beals Island Bridge. 

This RNA will establish speed and beam 

restrictions on vessels transiting the 

regulated area during bridge 

replacement operations. This rule will 

also allow the Coast Guard to prohibit 

vessel traffic through the RNA when 

necessary. 

DATES: This rule is effective without 

actual notice from October 24, 2017 

through January 31, 2021. For the 

purposes of enforcement, actual notice 

will be used from October 15, 2017, 

through October 24, 2017. 

Comments and related material must 

be received by the Coast Guard on or 

before January 22, 2018. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to http://

www.regulations.gov, type USCG–2017– 

0890 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 or 

email Mr. Craig Lapiejko, Waterways 

Management, First Coast Guard District; 

telephone (617) 223–8351, email 

Craig.D.Lapiejko@uscg.mil. You may 

also call or email Chief Petty Officer 

Chris Bains, Waterways Management 

Division, U.S. Coast Guard Sector 

Northern New England, telephone (207) 

347–5003, email Chris.D.Bains@

uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

COTP Captain of the Port 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

§ Section 

U.S.C. United States Code 

RNA Regulated Navigation Area 

MEDOT Maine Department of 

Transportation 

II. Background Information and 

Regulatory History 

On June 27, 2017, the U. S. Coast 

Guard District One Bridge Branch 


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