Inflation Adjustment of Civil Monetary Penalties, 10063-10064 [2020-02712]
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Federal Register / Vol. 85, No. 35 / Friday, February 21, 2020 / Rules and Regulations
Accordingly, we conclude that the rule
does not contain policies that have
tribal implications as defined in the E.O.
and, consequently, a tribal summary
impact statement is not required.
XII. References
The following references marked with
an asterisk (*) are on display at the
Dockets Management Staff (see
ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they also are available
electronically at https://
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff. FDA
has verified the website addresses, as of
the date this document publishes in the
Federal Register, but websites are
subject to change over time.
Dated: February 18, 2020.
Stephen M. Hahn,
Commissioner of Food and Drugs.
[FR Doc. 2020–03505 Filed 2–20–20; 8:45 am]
1. Su, M., Y. Ling, J. Yu, et al. ‘‘Small
Proteins: Untapped Area of Potential
Biological Importance,’’ Frontiers in
Genetics, vol. 4, p.286, 2013.
2. Galindo, M. I., J. I. Pueyo, S. Foux, et
al.’’Peptides Encoded by Short ORFs Control
Development and Define a New Eukaryotic
Gene Family’’ PLoS Biology, vol. 5, p. e106,
2007.
3. *FDA, Regulatory Impact Analysis,
‘‘Definition of the Term ‘Biological Product,’’’
available at https://www.fda.gov/AboutFDA/
ReportsManualsForms/Reports/Economic
Analyses/default.htm.
BILLING CODE 4164–01–P
List of Subjects in 21 CFR Part 600
SUMMARY:
Biologics, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 600 is
amended as follows:
PART 600—BIOLOGICAL PRODUCTS:
GENERAL
1. The authority citation for part 600
continues to read as follows:
■
Authority: 21 U.S.C. 321, 351, 352, 353,
355, 356c, 356e, 360, 360i, 371, 374, 379k–
1; 42 U.S.C. 216, 262, 263, 263a, 264.
2. Amend § 600.3 by revising
paragraph (h) introductory text and
adding paragraph (h)(6) to read as
follows:
■
khammond on DSKJM1Z7X2PROD with RULES
derivative, allergenic product, protein,
or analogous product, or arsphenamine
or derivative of arsphenamine (or any
other trivalent organic arsenic
compound), applicable to the
prevention, treatment, or cure of a
disease or condition of human beings.
*
*
*
*
*
(6) A protein is any alpha amino acid
polymer with a specific, defined
sequence that is greater than 40 amino
acids in size. When two or more amino
acid chains in an amino acid polymer
are associated with each other in a
manner that occurs in nature, the size of
the amino acid polymer for purposes of
this paragraph (h)(6) will be based on
the total number of amino acids in those
chains, and will not be limited to the
number of amino acids in a contiguous
sequence.
*
*
*
*
*
§ 600.3
Definitions.
*
*
*
*
*
(h) Biological product means a virus,
therapeutic serum, toxin, antitoxin,
vaccine, blood, blood component or
VerDate Sep<11>2014
17:38 Feb 20, 2020
Jkt 250001
DEPARTMENT OF THE TREASURY
Office of the Secretary of the Treasury
31 CFR Parts 27 and 50
Inflation Adjustment of Civil Monetary
Penalties
Departmental Offices Treasury.
Final rule.
AGENCY:
ACTION:
The Department of the
Treasury (‘‘Department’’ or ‘‘Treasury’’)
publishes this final rule to adjust its
civil monetary penalties (‘‘CMPs’’) for
inflation as mandated by the Federal
Civil Penalties Inflation Adjustment Act
of 1990, as amended by the Federal
Civil Penalties Inflation Adjustment Act
Improvements Act of 2015 (collectively
referred to herein as ‘‘the Act’’). This
rule adjusts CMPs within the
jurisdiction of two components of the
Department to the maximum amount
required by the Act.
DATES: The adjustments to the CMPs set
forth in 31 CFR part 27 and 31 CFR part
50 are effective February 21, 2020.
FOR FURTHER INFORMATION CONTACT: For
information regarding the Terrorism
Risk Insurance Program’s CMPs, contact
Richard Ifft, Senior Insurance
Regulatory Policy Analyst, Federal
Insurance Office, Room 1410 MT,
Department of the Treasury, 1500
Pennsylvania Avenue NW, Washington,
DC 20220, at (202) 622–2922 (not a tollfree number), or Lindsey Baldwin,
PO 00000
Frm 00029
Fmt 4700
Sfmt 4700
10063
Senior Policy Analyst, Federal
Insurance Office, at (202) 622–3220 (not
a toll free number). Persons who have
difficulty hearing or speaking may
access these numbers via TTY by calling
the toll-free Federal Relay Service at
(800) 877–8339.
For information regarding the
Treasury-wide CMP, contact Richard
Dodson, Senior Counsel, General Law,
Ethics, and Regulation, 202–622–9949.
SUPPLEMENTARY INFORMATION:
I. Background
In order to improve the effectiveness
of CMPs and to maintain their deterrent
effect, the Federal Civil Penalties
Inflation Adjustment Act of 1990, 28
U.S.C. 2461 note (‘‘the Inflation
Adjustment Act’’), as amended by the
Federal Civil Penalties Inflation
Adjustment Act Improvements Act of
2015 (Pub. L. 114–74) (‘‘the 2015 Act’’),
requires Federal agencies to adjust each
CMP provided by law within the
jurisdiction of the agency. The 2015 Act
requires agencies to adjust the level of
CMPs with an initial ‘‘catch-up’’
adjustment through an interim final
rulemaking and to make subsequent
annual adjustments for inflation,
without needing to provide notice and
the opportunity for public comment
required by 5 U.S.C. 553. The
Department’s initial catch-up
adjustment interim final rules were
published on December 7, 2016
(Departmental Offices) (81 FR 88600),
and for 31 CFR part 27, on February 11,
2019 (84 FR 3105). The Department’s
2018 annual adjustment was published
on March 19, 2018 (83 FR 11876), and
the Department’s 2019 annual
adjustment was published on April 17,
2019 (84 FR 15955). The 2015 Act
provides that any increase in a CMP
shall apply to CMPs that are assessed
after the date the increase takes effect,
regardless of whether the underlying
violation predated such increase.1
II. Method of Calculation
The method of calculating CMP
adjustments applied in this final rule is
required by the 2015 Act. Under the
2015 Act and the Office of Management
and Budget guidance required by the
2015 Act, annual inflation adjustments
subsequent to the initial catch-up
adjustment are to be based on the
percent change between the Consumer
Price Index for all Urban Consumers
(‘‘CPI–U’’) for the October preceding the
date of the adjustment and the prior
1 However, the increased CMPs apply only with
respect to underlying violations occurring after the
date of enactment of the 2015 Act, i.e., after
November 2, 2015.
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21FER1
10064
Federal Register / Vol. 85, No. 35 / Friday, February 21, 2020 / Rules and Regulations
year’s October CPI–U. As set forth in
Office of Management and Budget
Memorandum M–20–05 of December
16, 2019, the adjustment multiplier for
2019 is 1.01764. In order to complete
the 2019 annual adjustment, each
current CMP is multiplied by the 2020
adjustment multiplier. Under the 2015
Act, any increase in CMP must be
rounded to the nearest multiple of $1.
of the Code of Federal Regulations are
amended as follows:
ENVIRONMENTAL PROTECTION
AGENCY
PART 27—CIVIL PENALTY
ASSESSMENT FOR MISUSE OF
DEPARTMENT OF THE TREASURY
NAMES, SYMBOLS, ETC.
40 CFR Part 52
1. The authority citation for part 27
continues to read as follows:
■
Procedural Matters
Authority: 31 U.S.C. 321, 333
1. Administrative Procedure Act
2. Regulatory Flexibility Act
Because no notice of proposed
rulemaking is required, the provisions
of the Regulatory Flexibility Act (5
U.S.C. 601 et seq.) do not apply.
3. Executive Order 12866
This rule is not a significant
regulatory action as defined in section
3.f of Executive Order 12866.
4. Paperwork Reduction Act
The provisions of the Paperwork
Reduction Act of 1995, Public Law 104–
13, 44 U.S.C. Chapter 35, and its
implementing regulations, 5 CFR part
1320, do not apply to this rule because
there are no new or revised
recordkeeping or reporting
requirements.
List of Subjects
31 CFR Part 27
khammond on DSKJM1Z7X2PROD with RULES
2. Amend § 27.3 by revising paragraph
(c) to read as follows:
■
The Federal Civil Penalties Inflation
Adjustment Act Improvements Act of
2015 (Section 701(b)) requires agencies,
beginning in 2017, to make annual
adjustments for inflation to CMPs,
without needing to provide notice and
the opportunity for public comment and
a delayed effective date required by 5
U.S.C. 553. Additionally, the
methodology used, effective 2017, for
adjusting CMPs for inflation is provided
by statute, with no discretion provided
to agencies regarding the substance of
the adjustments for inflation to CMPs.
The Department is charged only with
performing ministerial computations to
determine the dollar amount of
adjustments for inflation to CMPs.
Accordingly, prior public notice, an
opportunity for public comment, and a
delayed effective date are not required
for this rule.
§ 27.3
Assessment of civil penalties.
*
*
*
*
*
(c) Civil Penalty. An assessing official
may impose a civil penalty on any
person who violates the provisions of
paragraph (a) of this section. The
amount of a civil monetary penalty shall
not exceed $8,116 for each and every
use of any material in violation of
paragraph (a), except that such penalty
shall not exceed $40,576 for each and
every use if such use is in a broadcast
or telecast.
*
*
*
*
*
PART 50—TERRORISM RISK
INSURANCE PROGRAM
3. The authority citation for part 50 is
revised to read as follows:
■
Authority: 5 U.S.C. 301; 31 U.S.C. 321;
Title I, Pub. L. 107–297, 116 Stat. 2322, as
amended by Pub. L. 109–144, 119 Stat. 2660,
Pub. L. 110–160, 121 Stat. 1839, Pub. L. 114–
1, 129 Stat. 3, and Pub. L. 116–94, 133 Stat.
2534 (15 U.S.C. 6701 note); Pub. L. 114–74,
129 Stat. 601, Title VII (28 U.S.C. 2461 note).
4. Amend § 50.83(a) to read as
follows:
■
§ 50.83 Adjustment of civil monetary
penalty amount.
(a) Inflation Adjustment. Any penalty
under the Act and these regulations may
not exceed the greater of $1,419,442
and, in the case of any failure to pay,
charge, collect or remit amounts in
accordance with the Act or these
regulations such amount in dispute.
*
*
*
*
*
David B. Dwyer,
Executive Secretary.
Administrative Practice and
Procedure, Penalties.
[FR Doc. 2020–02712 Filed 2–20–20; 8:45 am]
31 CFR Part 50
BILLING CODE 4810–25–P
Insurance, Terrorism.
Authority and Issuance
For the reasons set forth in the
preamble, part 27 and part 50 of title 31
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[EPA–R05–OAR–2018–0634; FRL–10005–
34–Region 5]
Air Plan Approval; Indiana; Revisions
to NOX SIP Call and CAIR Rules
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is approving under the
Clean Air Act (CAA) a request from the
Indiana Department of Environmental
Management (IDEM) to revise the
Indiana State Implementation Plan (SIP)
to incorporate the following: A new rule
concerning nitrogen oxide (NOX)
emissions for the ozone season from
Electric Generating Units (EGUs) and
large non-EGUs; revisions concerning
NOX emission rate limits for specific
source categories; the repeal of the NOX
Budget Trading Program; and the repeal
of the Clean Air Interstate Rule (CAIR)
NOX ozone season trading program.
This SIP revision will ensure continued
compliance by EGUs and large nonEGUs with the requirements of the NOX
SIP Call.
DATES: This direct final rule is effective
April 21, 2020, unless EPA receives
adverse comments by March 23, 2020. If
adverse comments are received, EPA
will publish a timely withdrawal of the
direct final rule in the Federal Register
informing the public that the rule will
not take effect.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R05–
OAR–2018–0634 at https://
www.regulations.gov or via email to
arra.sarah@epa.gov. For comments
submitted at Regulations.gov, follow the
online instructions for submitting
comments. Once submitted, comments
cannot be edited or removed from
Regulations.gov. For either manner of
submission, EPA may publish any
comment received to its public docket.
Do not submit electronically any
information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute. Multimedia
submissions (audio, video, etc.) must be
accompanied by a written comment.
The written comment is considered the
official comment and should include
discussion of all points you wish to
make. EPA will generally not consider
comments or comment contents located
outside of the primary submission (i.e.,
on the web, cloud, or other file sharing
system). For additional submission
SUMMARY:
E:\FR\FM\21FER1.SGM
21FER1
Agencies
- DEPARTMENT OF THE TREASURY
- Office of the Secretary of the Treasury
[Federal Register Volume 85, Number 35 (Friday, February 21, 2020)]
[Rules and Regulations]
[Pages 10063-10064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02712]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF THE TREASURY
Office of the Secretary of the Treasury
31 CFR Parts 27 and 50
Inflation Adjustment of Civil Monetary Penalties
AGENCY: Departmental Offices Treasury.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Department of the Treasury (``Department'' or
``Treasury'') publishes this final rule to adjust its civil monetary
penalties (``CMPs'') for inflation as mandated by the Federal Civil
Penalties Inflation Adjustment Act of 1990, as amended by the Federal
Civil Penalties Inflation Adjustment Act Improvements Act of 2015
(collectively referred to herein as ``the Act''). This rule adjusts
CMPs within the jurisdiction of two components of the Department to the
maximum amount required by the Act.
DATES: The adjustments to the CMPs set forth in 31 CFR part 27 and 31
CFR part 50 are effective February 21, 2020.
FOR FURTHER INFORMATION CONTACT: For information regarding the
Terrorism Risk Insurance Program's CMPs, contact Richard Ifft, Senior
Insurance Regulatory Policy Analyst, Federal Insurance Office, Room
1410 MT, Department of the Treasury, 1500 Pennsylvania Avenue NW,
Washington, DC 20220, at (202) 622-2922 (not a toll-free number), or
Lindsey Baldwin, Senior Policy Analyst, Federal Insurance Office, at
(202) 622-3220 (not a toll free number). Persons who have difficulty
hearing or speaking may access these numbers via TTY by calling the
toll-free Federal Relay Service at (800) 877-8339.
For information regarding the Treasury-wide CMP, contact Richard
Dodson, Senior Counsel, General Law, Ethics, and Regulation, 202-622-
9949.
SUPPLEMENTARY INFORMATION:
I. Background
In order to improve the effectiveness of CMPs and to maintain their
deterrent effect, the Federal Civil Penalties Inflation Adjustment Act
of 1990, 28 U.S.C. 2461 note (``the Inflation Adjustment Act''), as
amended by the Federal Civil Penalties Inflation Adjustment Act
Improvements Act of 2015 (Pub. L. 114-74) (``the 2015 Act''), requires
Federal agencies to adjust each CMP provided by law within the
jurisdiction of the agency. The 2015 Act requires agencies to adjust
the level of CMPs with an initial ``catch-up'' adjustment through an
interim final rulemaking and to make subsequent annual adjustments for
inflation, without needing to provide notice and the opportunity for
public comment required by 5 U.S.C. 553. The Department's initial
catch-up adjustment interim final rules were published on December 7,
2016 (Departmental Offices) (81 FR 88600), and for 31 CFR part 27, on
February 11, 2019 (84 FR 3105). The Department's 2018 annual adjustment
was published on March 19, 2018 (83 FR 11876), and the Department's
2019 annual adjustment was published on April 17, 2019 (84 FR 15955).
The 2015 Act provides that any increase in a CMP shall apply to CMPs
that are assessed after the date the increase takes effect, regardless
of whether the underlying violation predated such increase.\1\
---------------------------------------------------------------------------
\1\ However, the increased CMPs apply only with respect to
underlying violations occurring after the date of enactment of the
2015 Act, i.e., after November 2, 2015.
---------------------------------------------------------------------------
II. Method of Calculation
The method of calculating CMP adjustments applied in this final
rule is required by the 2015 Act. Under the 2015 Act and the Office of
Management and Budget guidance required by the 2015 Act, annual
inflation adjustments subsequent to the initial catch-up adjustment are
to be based on the percent change between the Consumer Price Index for
all Urban Consumers (``CPI-U'') for the October preceding the date of
the adjustment and the prior
[[Page 10064]]
year's October CPI-U. As set forth in Office of Management and Budget
Memorandum M-20-05 of December 16, 2019, the adjustment multiplier for
2019 is 1.01764. In order to complete the 2019 annual adjustment, each
current CMP is multiplied by the 2020 adjustment multiplier. Under the
2015 Act, any increase in CMP must be rounded to the nearest multiple
of $1.
Procedural Matters
1. Administrative Procedure Act
The Federal Civil Penalties Inflation Adjustment Act Improvements
Act of 2015 (Section 701(b)) requires agencies, beginning in 2017, to
make annual adjustments for inflation to CMPs, without needing to
provide notice and the opportunity for public comment and a delayed
effective date required by 5 U.S.C. 553. Additionally, the methodology
used, effective 2017, for adjusting CMPs for inflation is provided by
statute, with no discretion provided to agencies regarding the
substance of the adjustments for inflation to CMPs. The Department is
charged only with performing ministerial computations to determine the
dollar amount of adjustments for inflation to CMPs. Accordingly, prior
public notice, an opportunity for public comment, and a delayed
effective date are not required for this rule.
2. Regulatory Flexibility Act
Because no notice of proposed rulemaking is required, the
provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) do
not apply.
3. Executive Order 12866
This rule is not a significant regulatory action as defined in
section 3.f of Executive Order 12866.
4. Paperwork Reduction Act
The provisions of the Paperwork Reduction Act of 1995, Public Law
104-13, 44 U.S.C. Chapter 35, and its implementing regulations, 5 CFR
part 1320, do not apply to this rule because there are no new or
revised recordkeeping or reporting requirements.
List of Subjects
31 CFR Part 27
Administrative Practice and Procedure, Penalties.
31 CFR Part 50
Insurance, Terrorism.
Authority and Issuance
For the reasons set forth in the preamble, part 27 and part 50 of
title 31 of the Code of Federal Regulations are amended as follows:
PART 27--CIVIL PENALTY ASSESSMENT FOR MISUSE OF DEPARTMENT OF THE
TREASURY NAMES, SYMBOLS, ETC.
0
1. The authority citation for part 27 continues to read as follows:
Authority: 31 U.S.C. 321, 333
0
2. Amend Sec. 27.3 by revising paragraph (c) to read as follows:
Sec. 27.3 Assessment of civil penalties.
* * * * *
(c) Civil Penalty. An assessing official may impose a civil penalty
on any person who violates the provisions of paragraph (a) of this
section. The amount of a civil monetary penalty shall not exceed $8,116
for each and every use of any material in violation of paragraph (a),
except that such penalty shall not exceed $40,576 for each and every
use if such use is in a broadcast or telecast.
* * * * *
PART 50--TERRORISM RISK INSURANCE PROGRAM
0
3. The authority citation for part 50 is revised to read as follows:
Authority: 5 U.S.C. 301; 31 U.S.C. 321; Title I, Pub. L. 107-
297, 116 Stat. 2322, as amended by Pub. L. 109-144, 119 Stat. 2660,
Pub. L. 110-160, 121 Stat. 1839, Pub. L. 114-1, 129 Stat. 3, and
Pub. L. 116-94, 133 Stat. 2534 (15 U.S.C. 6701 note); Pub. L. 114-
74, 129 Stat. 601, Title VII (28 U.S.C. 2461 note).
0
4. Amend Sec. 50.83(a) to read as follows:
Sec. 50.83 Adjustment of civil monetary penalty amount.
(a) Inflation Adjustment. Any penalty under the Act and these
regulations may not exceed the greater of $1,419,442 and, in the case
of any failure to pay, charge, collect or remit amounts in accordance
with the Act or these regulations such amount in dispute.
* * * * *
David B. Dwyer,
Executive Secretary.
[FR Doc. 2020-02712 Filed 2-20-20; 8:45 am]
BILLING CODE 4810-25-P