234 Federal Register / Vol. 83, No. 2 / Wednesday, January 3, 2018 / Rules and Regulations 

of Food and Drugs, 21 CFR part 864 is 

amended as follows: 

PART 864—HEMATOLOGY AND 

PATHOLOGY DEVICES 

■ 1. The authority citation for part 864 

continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Add § 864.1865 to subpart B to read 

as follows: 

§ 864.1865 Cervical intraepithelial 

neoplasia (CIN) test system. 

(a) Identification. A cervical 

intraepithelial neoplasia (CIN) test 

system is a device used to detect a 

biomarker associated with CIN in 

human tissues. The device is indicated 

as an adjunct test and not to be used as 

a stand-alone device. The test results 

must be interpreted in the context of the 

patient’s clinical history including, but 

not limited to, prior and current cervical 

biopsy results, Papanicolaou (Pap) test 

results, human papillomavirus (HPV) 

test results, and morphology on 

hematoxylin and eosin (H&E) stained 

sections. This device is not intended to 

detect the presence of HPV. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Premarket notification 

submissions must include the following 

information: 

(i) The indications for use must 

specify the biomarker that is intended to 

be identified and its adjunct use (e.g., 

adjunct to examination of H&E stained 

slides) to improve consistency in the 

diagnosis of CIN. 

(ii) Summary of professional society 

recommendations, as applicable. 

(iii) A detailed device description 

including: 

(A) A detailed description of all test 

components, including all provided 

reagents and required, but not provided, 

ancillary reagents. 

(B) A detailed description of 

instrumentation and equipment, 

including illustrations or photographs of 

non-standard equipment or manuals. 

(C) If applicable, detailed 

documentation of the device software, 

including, but not limited to, standalone software applications and 

hardware-based devices that incorporate 

software. 

(D) A detailed description of 

appropriate positive and negative 

controls that are recommended or 

provided. 

(E) Detailed specifications for sample 

collection, processing, and storage. 

(F) A detailed description of 

methodology and assay procedure. 

(G) A description of the assay cutoff 

(the medical decision point between 

positive and negative) or other relevant 

criteria that distinguishes positive and 

negative results, including the rationale 

for the chosen cutoff or other relevant 

criteria and results supporting 

validation of the cutoff. 

(H) Detailed specification of the 

criteria for test results interpretation and 

reporting. 

(iv) Detailed information 

demonstrating the performance 

characteristics of the device, including: 

(A) Analytical specificity studies such 

as, but not limited to, antibody 

characterization (e.g., Western Blot, 

peptide inhibition analysis), studies 

conducted on panels of normal tissues 

and neoplastic tissues, interference by 

endogenous and exogenous substances 

as well as cross-reactivity, as applicable. 

(B) Device analytical sensitivity data 

generated by testing an adequate 

number of samples from individuals 

with the target condition including limit 

of blank, limit of detection, and limit of 

quantification, as applicable. 

(C) Device precision/reproducibility 

data to evaluate within-run, betweenrun, between-day, between-lot, betweensite, between-reader, within-reader and 

total precision, as applicable, using a 

panel of samples covering the device 

measuring range and/or the relevant 

disease categories (e.g. No CIN, CIN1, 

CIN2, CIN3, cervical cancer) and testing 

in replicates across multiple, 

nonconsecutive days. 

(D) Device robustness/guardbanding 

studies to assess the tolerance ranges for 

various critical test and specimen 

parameters. 

(E) Device stability data, including 

real-time stability and shipping stability 

under various storage times, 

temperatures, and freeze-thaw 

conditions. 

(F) Data from a clinical study 

demonstrating clinical validity using 

well-characterized prospectively or 

retrospectively obtained clinical 

specimens, as appropriate, 

representative of the intended use 

population. The study must evaluate the 

consistency of the diagnosis of CIN, for 

example, by comparing the levels of 

agreements of diagnoses rendered by 

community pathologists to those 

rendered by a panel of expert 

pathologists. Agreement for each CIN 

diagnostic category (e.g., No CIN, CIN1, 

CIN2, CIN3, cancer) and for alternate 

diagnostic categories (e.g., No CIN, low 

grade squamous intraepithelial lesion 

(LSIL)-histology, high grade squamous 

intraepithelial lesion (HSIL)-histology, 

cancer) between reference diagnosis by 

expert pathologist and community 

pathologist must be evaluated, as 

applicable. In addition, agreements for 

CIN binary categories as ≥CIN2 (i.e., 

CIN2 or CIN3 or cancer) and ≤CIN1 (i.e., 

No CIN or CIN1) between reference 

diagnosis by expert pathologist with 

H&E staining and community 

pathologist with H&E staining and 

agreements for alternate CIN binary 

categories as ≥HSIL-histology (i.e., HSILhistology or cancer) and ≤LSIL-histology 

(i.e., No CIN or LSIL-histology) between 

reference diagnosis by an expert 

pathologist with H&E + [biomarker 

specified in paragraph (b)(1)(i) of this 

section] and a community pathologist 

with H&E + [biomarker specified in 

paragraph (b)(1)(i) of this section] must 

be evaluated and compared, as 

applicable. 

(G) The staining performance of the 

device as determined by the community 

pathologists during review of the study 

slides must be evaluated. The staining 

performance criteria assessed must 

include overall staining acceptability, 

background staining acceptability, and 

morphology acceptability, as applicable. 

(H) Appropriate training requirements 

for users, including interpretation 

manual, as applicable. 

(I) Identification of risk mitigation 

elements used by the device, including 

a description of all additional 

procedures, methods, and practices 

incorporated into the instructions for 

use that mitigate risks associated with 

testing. 

(2) The device’s 21 CFR 809.10(b) 

compliant labeling must include a 

detailed description of the protocol, 

including the information described in 

paragraph (b)(1)(ii) of this section, as 

applicable, and a detailed description of 

the performance studies performed and 

the summary of the results, including 

those that relate to paragraph (b)(1)(ii) of 

this section, as applicable. 

Dated: December 27, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–28342 Filed 1–2–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF STATE 

22 CFR Parts 35, 103, 127, and 138 

[Public Notice 10236] 

RIN 1400–AE50 

Department of State 2018 Civil 

Monetary Penalties Inflationary 

Adjustment 

AGENCY: Department of State. 

ACTION: Final rule. 


jstallworth on DSKBBY8HB2PROD with RULES
Federal Register / Vol. 83, No. 2 / Wednesday, January 3, 2018 / Rules and Regulations 235 

SUMMARY: This final rule is issued to 

adjust the civil monetary penalties 

(CMP) for regulatory provisions 

maintained and enforced by the 

Department of State. The revised CMP 

adjusts the amount of civil monetary 

penalties assessed by the Department of 

State based on the December 2017 

guidance from the Office of 

Management and Budget. The new 

amounts will apply only to those 

penalties assessed on or after the 

effective date of this rule, regardless of 

the date on which the underlying facts 

or violations occurred. 

DATES: This final rule is effective on 

January 3, 2018. 

FOR FURTHER INFORMATION CONTACT: 

Alice Kottmyer, Attorney-Adviser, 

Office of Management, kottmyeram@

state.gov. ATTN: Regulatory Change, 

CMP Adjustments, (202) 647–2318. 

SUPPLEMENTARY INFORMATION: The 

Federal Civil Penalties Inflation 

Adjustment Act of 1990, Public Law 

101–410, as amended by the Debt 

Collection Improvement Act of 1996, 

Public Law 104–134, required the head 

of each agency to adjust its CMPs for 

inflation no later than October 23, 1996 

and required agencies to make 

adjustments at least once every four 

years thereafter. The Federal Civil 

Penalties Inflation Adjustment Act 

Improvements Act of 2015, Section 701 

of Public Law 114–74 (the 2015 Act) 

further amended the 1990 Act by 

requiring agencies to adjust CMPs, if 

necessary, pursuant to a ‘‘catch-up’’ 

adjustment methodology prescribed by 

the 2015 Act, which mandated that the 

catch-up adjustment take effect no later 

than August 1, 2016. Additionally, the 

2015 Act required agencies to make 

annual adjustments to their respective 

CMPs in accordance with guidance 

issued by the Office of Management and 

Budget (OMB). 

Based on these statutes, the 

Department of State (the Department) 

published a final rule on June 8, 2016, 

to implement the ‘‘catch-up’’ provisions. 

See 81 FR 36791. The Department 

published its first annual update to its 

CMPs in January 2017. See 82 FR 3168. 

On December 15, 2017, OMB notified 

agencies that the annual cost-of-living 

adjustment multiplier for 2018, based 

on the Consumer Price Index, is 

1.02041. Additional information may be 

found in OMB Memorandum M–18–03, 

at: https://www.whitehouse.gov/wpcontent/uploads/2017/11/M-18-03.pdf. 

This final rule amends Department 

CMPs for fiscal year 2018. 

Overview of the Areas Affected by This 

Rule 

Within the Department of State (Title 

22, Code of Federal Regulations), this 

rule affects four areas: 

(1) Part 35, which implements the 

Program Fraud Civil Remedies Act of 

1986 (PFCRA), codified at 31 U.S.C. 

3801–3812; 

(2) Part 103, which implements the 

Chemical Weapons Convention 

Implementation Act of 1998 (CWC Act); 

(3) Part 127, which implements the 

penalty provisions of sections 38(e), 

39A(c), and 40(k) of the Arms Export 

Control Act (AECA) (22 U.S.C. 2778(e), 

2779a(c), 2780(k)); and 

(4) Part 138, which implements 

Section 319 of Public Law 101–121, 

codified at 31 U.S.C. 1352, and prohibits 

recipients of federal contracts, grants, 

and loans from using appropriated 

funds for lobbying the Executive or 

Legislative Branches of the federal 

government in connection with a 

specific contract. 

Specific Changes to 22 CFR Made by 

This Rule 

I. Part 35 

The PFRCA, enacted in 1986, 

authorizes agencies, with approval from 

the Department of Justice, to pursue 

individuals or firms for false claims. 

Applying all previous adjustments in 

accordance with the 2015 Act, the 

maximum liabilities under the PFRCA 

were $10,957, up to a maximum of 

$328,734. Applying the 2018 multiplier 

(1.02041) provided by OMB, the new 

maximum liabilities are as follows: 

$11,181 up to a maximum of $335,443. 

II. Part 103 

The CWC Act provided domestic 

implementation of the Convention on 

the Prohibition of the Development, 

Production, Stockpiling, and Use of 

Chemical Weapons and on Their 

Destruction. The penalty provisions of 

the CWC Act are codified at 22 U.S.C. 

6761. Applying all previous adjustments 

in accordance with the 2015 Act, the 

maximum amounts were as follows: 

Prohibited acts related to inspections, 

$36,849; for Recordkeeping violations, 

$7,370. 

Applying the 2018 multiplier 

(1.02041) provided by OMB, the new 

maximum amounts are as follows: 

Prohibited acts related to inspections, 

$37,601; for Recordkeeping violations, 

$7,520. 

III. Part 127 

The Assistant Secretary of State for 

Political-Military Affairs is responsible 

for the imposition of CMPs under the 

International Traffic in Arms 

Regulations (ITAR), which is 

administered by the Directorate of 

Defense Trade Controls (DDTC). 

(1) AECA section 38(e): 

Applying all previous adjustments in 

accordance with the 2015 Act, the 

maximum penalty under 22 U.S.C. 

2778(e), or Section 38(e) of the AECA, 

was $1,111,908. Applying the 2018 

multiplier (1.02041) provided by OMB, 

the new maximum penalty under 22 

U.S.C. 278(e) is $1,134,602. 

(2) AECA section 39A(c): 

Applying all previous adjustments in 

accordance with the 2015 Act, the 

maximum penalty for 22 U.S.C. 

2779a(c), or Section 39A(c) of the 

AECA, was $808,458. Applying the 

2018 multiplier (1.02041) provided by 

OMB, the new maximum penalty for 22 

U.S.C. 2779a(c) is $824,959. 

(3) AECA section 40(k): 

Applying all previous adjustments in 

accordance with the 2015 Act, the 

maximum penalty for 22 U.S.C. 2780(k), 

or Section 40(k) of the AECA, was 

$962,295 per violation. Applying the 

2018 multiplier (1.02041) provided by 

OMB, the new maximum penalty per 

violation is $981,935. 

IV. Part 138 

Section 319 of Public Law 101–121, 

codified at 31 U.S.C. 1352, provides 

penalties for recipients of federal 

contracts, grants, and loans who use 

appropriated funds to lobby the 

Executive or Legislative Branches of the 

federal government in connection with 

a specific contract, grant, or loan. Any 

person who violates that prohibition is 

subject to a civil penalty. The statute 

also requires each person who requests 

or receives a federal contract, grant, 

cooperative agreement, loan, or a federal 

commitment to insure or guarantee a 

loan, to disclose any lobbying; there is 

a penalty for failure to disclose. 

Applying all previous adjustments in 

accordance with the 2015 Act, the 

maximum penalties for both improper 

expenditures and failure to disclose, 

was: For first offenders, a penalty of 

$18,936; for others, not less than 

$19,246, and not more than $192,459. 

Applying the 2018 multiplier (1.02041) 

provided by OMB, the new maximums 

are: For first offenders, $19,322; for 

others, not less than $19,639, and not 

more than $196,387. 

Summary 


jstallworth on DSKBBY8HB2PROD with RULES
236 Federal Register / Vol. 83, No. 2 / Wednesday, January 3, 2018 / Rules and Regulations 

Citation in 22 CFR Old penalty 2018 penalty 

§ 35.3 .................................................................. $10,957 up to $328,734 ................................... $11,181 up to $335,443. 

§ 103.6 Prohibited Acts ...................................... $36,849 ............................................................ $37,601. 

§ 103.6 Recordkeeping Violations ...................... $7,370 .............................................................. $7,520. 

§ 127.10(a)(1)(i) .................................................. $1,111,908 ....................................................... $1,134,602. 

§ 127.10(a)(1)(ii) ................................................. $808,458 .......................................................... $824,959. 

§ 127.10(a)(1)(iii) ................................................ $962,295 .......................................................... $981,935. 

§ 138.400 First Offenders ................................... $18,936 ............................................................ $19,322. 

§ 138.400 ............................................................ $19,246 up to $192,459 ................................... $19,639 up to $192,549. 

2018 multiplier: 1.02041 

Effective Date of Penalties 

The revised CMP amounts will go into 

effect on the date this rule is published. 

All violations for which CMPs are 

assessed on or after the effective date of 

this rule, regardless of whether the 

violation occurred before the effective 

date, will be assessed at the adjusted 

penalty level. 

Future Adjustments and Reporting 

The 2015 Act directed agencies to 

undertake an annual review of CMPs 

using a formula prescribed by the 

statute. Annual adjustments to CMPs are 

made in accordance with the guidance 

issued by OMB. As in this rulemaking, 

the Department of State will publish 

notification of annual inflation 

adjustments to CMPs in the Federal 

Register no later than January 15 of each 

year, with the adjusted amount taking 

effect immediately upon publication. 

Regulatory Analysis and Notices 

Administrative Procedure Act 

The Department of State is publishing 

this rule using the ‘‘good cause’’ 

exception to the Administrative 

Procedure Act (5 U.S.C. 553(b)), as the 

Department has determined that public 

comment on this rulemaking would be 

impractical, unnecessary, or contrary to 

the public interest. This rulemaking is 

mandatory; it implements Public Law 

114–74. In addition, the Department of 

State finds good cause for this rule to be 

effective upon publication, as Congress 

has mandated that the penalty 

adjustments be effective on or before 

January 15th. See 5 U.S.C. 553(d)(3). 

Regulatory Flexibility Act 

Because this rulemaking is exempt 

from 5 U.S.C. 553, a Regulatory 

Flexibility Analysis is not required. 

Unfunded Mandates Reform Act of 1995 

This rule does not involve a mandate 

that will result in the expenditure by 

State, local, and tribal governments, in 

the aggregate, or by the private sector, of 

$100 million or more in any year and it 

will not significantly or uniquely affect 

small governments. Therefore, no 

actions were deemed necessary under 

the provisions of the Unfunded 

Mandates Reform Act of 1995. 

Small Business Regulatory Enforcement 

Fairness Act of 1996 

This rule is not a major rule within 

the meaning of the Small Business 

Regulatory Enforcement Fairness Act of 

1996. 

Executive Orders 12372 and 13132 

This amendment will not have 

substantial direct effects 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. Therefore, in 

accordance with Executive Order 13132, 

it is determined that this amendment 

does not have sufficient federalism 

implications to require consultations or 

warrant the preparation of a federalism 

summary impact statement. 

Executive Orders 12866, 13563, and 

13771 

The Department believes that benefits 

of the rulemaking outweigh any costs, 

and there are no feasible alternatives to 

this rulemaking. It is the Department’s 

position that this rulemaking is not an 

economically significant rule under the 

criteria of Executive Order 12866, and is 

consistent with the provisions of 

Executive Order 13563. This rule is not 

an E.O. 13771 regulatory action because 

this rule is not significant under E.O. 

12866. 

Executive Order 12988 

The Department of State has reviewed 

the proposed amendment in light of 

Executive Order 12988 to eliminate 

ambiguity, minimize litigation, establish 

clear legal standards, and reduce 

burden. 

Executive Order 13175 

The Department of State has 

determined that this rulemaking will 

not have tribal implications, will not 

impose substantial direct compliance 

costs on Indian tribal governments, and 

will not preempt tribal law. 

Accordingly, Executive Order 13175 

does not apply to this rulemaking. 

Paperwork Reduction Act 

This rulemaking does not impose or 

revise any information collections 

subject to 44 U.S.C. Chapter 35. 

List of Subjects 

22 CFR Part 35 

Administrative practice and 

procedure, Claims, Fraud, Penalties. 

22 CFR Part 103 

Administrative practice and 

procedure, Chemicals, Classified 

information, Foreign relations, Freedom 

of information, International 

organization, Investigations, Penalties, 

Reporting and recordkeeping 

requirements. 

22 CFR Part 127 

Arms and munitions, Exports. 

22 CFR Part 138 

Government contracts, Grant 

programs, Loan programs, Lobbying, 

Penalties, Reporting and recordkeeping 

requirements. 

For the reasons set forth above, 22 

CFR parts 35, 103, 127, and 138 are 

amended as follows: 

PART 35—PROGRAM FRAUD CIVIL 

REMEDIES 

■ 1. The authority citation for part 35 

continues to read as follows: 

Authority: 22 U.S.C. 2651a; 31 U.S.C. 3801 

et seq.; Pub. L. 114–74, 129 Stat. 584. 

§ 35.3 [Amended] 

■ 2. In § 35.3: 

■ a. Remove ‘‘$10,957’’ and add in its 

place ‘‘$11,181’’, wherever it occurs. 

■ b. In paragraph (f), remove ‘‘$328,734’’ 

and add in its place ‘‘$335,443’’. 


jstallworth on DSKBBY8HB2PROD with RULES
Federal Register / Vol. 83, No. 2 / Wednesday, January 3, 2018 / Rules and Regulations 237 

PART 103—REGULATIONS FOR 

IMPLEMENTATION OF THE CHEMICAL 

WEAPONS CONVENTION AND THE 

CHEMICAL WEAPONS CONVENTION 

IMPLEMENTATION ACT OF 1998 ON 

THE TAKING OF SAMPLES AND ON 

ENFORCEMENT OF REQUIREMENTS 

CONCERNING RECORDKEEPING AND 

INSPECTIONS 

■ 3. The authority citation for part 103 

continues to read as follows: 

Authority: 22 U.S.C. 2651a; 22 U.S.C. 6701 

et seq.; Pub. L. 114–74, 129 Stat. 584. 

§ 103.6 [Amended] 

■ 4. Amend § 103.6 by removing 

‘‘$36,849’’ and adding in its place 

$37,601’’ in paragraph (a)(1), and 

removing ‘‘$7,370’’ and adding in its 

place ‘‘$7,520’’ in paragraph (a)(2). 

PART 127—VIOLATIONS AND 

PENALTIES 

■ 5. The authority citation for part 127 

continues to read as follows: 

Authority: Sections 2, 38, and 42, Pub. L. 

90–629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 

2791); 22 U.S.C. 401; 22 U.S.C. 2651a; 22 

U.S.C. 2779a; 22 U.S.C. 2780; E.O. 13637, 78 

FR 16129; Pub. L. 114–74, 129 Stat. 584. 

§ 127.10 [Amended] 

■ 6. Section 127.10 is amended as 

follows: 

■ a. In paragraph (a)(1)(i), remove 

‘‘$1,111,908’’ and add in its place 

‘‘$1,134,602’’; 

■ b. In paragraph (a)(1)(ii), remove 

‘‘$808,458’’ and add in its place 

‘‘$824,959’’; and 

■ c. In paragraph (a)(1)(iii), remove 

‘‘$962,295’’ and add in its place 

‘‘$981,935.’’ 

PART 138—RESTRICTIONS ON 

LOBBYING 

■ 7. The authority citation for part 138 

continues to read as follows: 

Authority: 22 U.S.C. 2651a; 31 U.S.C. 

1352; Pub. L. 114–74, 129 Stat. 584. 

§ 138.400 [Amended] 

■ 8. In § 138.400: 

■ a. Remove ‘‘$19,246’’ and ‘‘$192,459’’ 

and add in their place ‘‘$19,639’’ and 

‘‘$196,387’’, respectively, wherever they 

occur. 

■ b. In paragraph (e), remove ‘‘$18,936’’ 

and add in its place ‘‘$19,322’’. 

Jerry C. Drake, 

Acting Executive Director, Office of the Legal 

Adviser and Bureau of Legislative Affairs, 

Department of State. 

[FR Doc. 2017–28395 Filed 1–2–18; 8:45 am] 

BILLING CODE 4710–10–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Parts 100, 117, 147, and 165 

[USCG–2017–1008] 

2016 Quarterly Listings; Safety Zones, 

Security Zones, Special Local 

Regulations, Drawbridge Operation 

Regulations and Regulated Navigation 

Areas 

AGENCY: Coast Guard, DHS. 

ACTION: Notification of expired 

temporary rules issued. 

SUMMARY: This document provides 

notification of substantive rules issued 

by the Coast Guard that were made 

temporarily effective but expired before 

they could be published in the Federal 

Register. This document lists temporary 

safety zones, security zones, special 

local regulations, drawbridge operation 

regulations and regulated navigation 

areas, all of limited duration and for 

which timely publication in the Federal 

Register was not possible. 

DATES: This document lists temporary 

Coast Guard rules that became effective, 

primarily between April 2016 and June 

2016, unless otherwise indicated, and 

were terminated before they could be 

published in the Federal Register. 

ADDRESSES: Temporary rules listed in 

this document may be viewed online, 

under their respective docket numbers, 

using the Federal eRulemaking Portal at 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: For 

questions on this document contact 

Yeoman First Class David Hager, Office 

of Regulations and Administrative Law, 

telephone (202) 372–3862. 

SUPPLEMENTARY INFORMATION: Coast 

Guard District Commanders and 

Captains of the Port (COTP) must be 

immediately responsive to the safety 

and security needs within their 

jurisdiction; therefore, District 

Commanders and COTPs have been 

delegated the authority to issue certain 

local regulations. Safety zones may be 

established for safety or environmental 

purposes. A safety zone may be 

stationary and described by fixed limits 

or it may be described as a zone around 

a vessel in motion. Security zones limit 

access to prevent injury or damage to 

vessels, ports, or waterfront facilities. 

Special local regulations are issued to 

enhance the safety of participants and 

spectators at regattas and other marine 

events. Drawbridge operation 

regulations authorize changes to 

drawbridge schedules to accommodate 

bridge repairs, seasonal vessel traffic, 

and local public events. Regulated 

Navigation Areas are water areas within 

a defined boundary for which 

regulations for vessels navigating within 

the area have been established by the 

regional Coast Guard District 

Commander. 

Timely publication of these rules in 

the Federal Register may be precluded 

when a rule responds to an emergency, 

or when an event occurs without 

sufficient advance notice. The affected 

public is, however, often informed of 

these rules through Local Notices to 

Mariners, press releases, and other 

means. Moreover, actual notification is 

provided by Coast Guard patrol vessels 

enforcing the restrictions imposed by 

the rule. Because Federal Register 

publication was not possible before the 

end of the effective period, mariners 

were personally notified of the contents 

of these safety zones, security zones, 

special local regulations, regulated 

navigation areas or drawbridge 

operation regulations by Coast Guard 

officials on-scene prior to any 

enforcement action. However, the Coast 

Guard, by law, must publish in the 

Federal Register notice of substantive 

rules adopted. To meet this obligation 

without imposing undue expense on the 

public, the Coast Guard periodically 

publishes a list of these temporary 

safety zones, security zones, special 

local regulations, regulated navigation 

areas and drawbridge operation 

regulations. Permanent rules are not 

included in this list because they are 

published in their entirety in the 

Federal Register. Temporary rules are 

also published in their entirety if 

sufficient time is available to do so 

before they are placed in effect or 

terminated. 

The following unpublished rules were 

placed in effect temporarily during the 

period between June 2014–June 2016 

unless otherwise indicated. To view 

copies of these rules, visit 

www.regulations.gov and search by the 

docket number indicated in the list 

below. 


jstallworth on DSKBBY8HB2PROD with RULES