Department of State 2018 Civil Monetary Penalties Inflationary Adjustment, 234-237 [2017-28395]
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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:
■
jstallworth on DSKBBY8HB2PROD with RULES
§ 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.
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(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
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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
Department of State.
Final rule.
AGENCY:
ACTION:
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Federal Register / Vol. 83, No. 2 / Wednesday, January 3, 2018 / Rules and Regulations
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.
SUMMARY:
This final rule is effective on
January 3, 2018.
DATES:
FOR FURTHER INFORMATION CONTACT:
Alice Kottmyer, Attorney-Adviser,
Office of Management, kottmyeram@
state.gov. ATTN: Regulatory Change,
CMP Adjustments, (202) 647–2318.
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.
jstallworth on DSKBBY8HB2PROD with RULES
SUPPLEMENTARY INFORMATION:
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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
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235
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
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236
Federal Register / Vol. 83, No. 2 / Wednesday, January 3, 2018 / Rules and Regulations
Citation in 22 CFR
Old penalty
§ 35.3 ..................................................................
§ 103.6 Prohibited Acts ......................................
§ 103.6 Recordkeeping Violations ......................
§ 127.10(a)(1)(i) ..................................................
§ 127.10(a)(1)(ii) .................................................
§ 127.10(a)(1)(iii) ................................................
§ 138.400 First Offenders ...................................
§ 138.400 ............................................................
2018 multiplier: 1.02041
$10,957 up to $328,734 ...................................
$36,849 ............................................................
$7,370 ..............................................................
$1,111,908 .......................................................
$808,458 ..........................................................
$962,295 ..........................................................
$18,936 ............................................................
$19,246 up to $192,459 ...................................
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).
2018 penalty
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.
jstallworth on DSKBBY8HB2PROD with RULES
Regulatory Flexibility Act
Because this rulemaking is exempt
from 5 U.S.C. 553, a Regulatory
Flexibility Analysis is not required.
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.
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
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.
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$11,181 up to $335,443.
$37,601.
$7,520.
$1,134,602.
$824,959.
$981,935.
$19,322.
$19,639 up to $192,549.
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’’.
■
E:\FR\FM\03JAR1.SGM
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Federal Register / Vol. 83, No. 2 / Wednesday, January 3, 2018 / Rules and Regulations
b. In paragraph (e), remove ‘‘$18,936’’
and add in its place ‘‘$19,322’’.
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:
DEPARTMENT OF HOMELAND
SECURITY
Authority: 22 U.S.C. 2651a; 22 U.S.C. 6701
et seq.; Pub. L. 114–74, 129 Stat. 584.
Coast Guard
§ 103.6
33 CFR Parts 100, 117, 147, and 165
■
[Amended]
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
[USCG–2017–1008]
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).
■
2016 Quarterly Listings; Safety Zones,
Security Zones, Special Local
Regulations, Drawbridge Operation
Regulations and Regulated Navigation
Areas
PART 127—VIOLATIONS AND
PENALTIES
Coast Guard, DHS.
Notification of expired
temporary rules issued.
AGENCY:
ACTION:
5. The authority citation for part 127
continues to read as follows:
■
§ 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.
jstallworth on DSKBBY8HB2PROD with RULES
■
■
VerDate Sep<11>2014
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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
https://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
SUMMARY:
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.
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237
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.
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]]>Agencies
[Federal Register Volume 83, Number 2 (Wednesday, January 3, 2018)]
[Rules and Regulations]
[Pages 234-237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-28395]
=======================================================================
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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.
-----------------------------------------------------------------------
[[Page 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, [email protected]. 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/wp-content/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
[[Page 236]]
------------------------------------------------------------------------
Citation in 22 CFR Old penalty 2018 penalty
------------------------------------------------------------------------
Sec. 35.3................. $10,957 up to $11,181 up to
$328,734. $335,443.
Sec. 103.6 Prohibited Acts $36,849............. $37,601.
Sec. 103.6 Recordkeeping $7,370.............. $7,520.
Violations.
Sec. 127.10(a)(1)(i)...... $1,111,908.......... $1,134,602.
Sec. 127.10(a)(1)(ii)..... $808,458............ $824,959.
Sec. 127.10(a)(1)(iii).... $962,295............ $981,935.
Sec. 138.400 First $18,936............. $19,322.
Offenders.
Sec. 138.400.............. $19,246 up to $19,639 up to
$192,459. $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
0
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.
Sec. 35.3 [Amended]
0
2. In Sec. 35.3:
0
a. Remove ``$10,957'' and add in its place ``$11,181'', wherever it
occurs.
0
b. In paragraph (f), remove ``$328,734'' and add in its place
``$335,443''.
[[Page 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
0
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.
Sec. 103.6 [Amended]
0
4. Amend Sec. 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
0
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.
Sec. 127.10 [Amended]
0
6. Section 127.10 is amended as follows:
0
a. In paragraph (a)(1)(i), remove ``$1,111,908'' and add in its place
``$1,134,602'';
0
b. In paragraph (a)(1)(ii), remove ``$808,458'' and add in its place
``$824,959''; and
0
c. In paragraph (a)(1)(iii), remove ``$962,295'' and add in its place
``$981,935.''
PART 138--RESTRICTIONS ON LOBBYING
0
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.
Sec. 138.400 [Amended]
0
8. In Sec. 138.400:
0
a. Remove ``$19,246'' and ``$192,459'' and add in their place
``$19,639'' and ``$196,387'', respectively, wherever they occur.
0
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
