Medicare and Medicaid Programs; Adjustment of Civil Monetary Penalties for Inflation; Continuation of Effectiveness and Extension of Timeline for Publication of the Final Rule, 50263-50264 [2021-19382]
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Federal Register / Vol. 86, No. 171 / Wednesday, September 8, 2021 / Rules and Regulations
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Dated: August 27, 2021.
E.J. Van Camp,
Captain, U.S. Coast Guard, Captain of the
Port Long Island Sound.
[FR Doc. 2021–19148 Filed 9–7–21; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 402, 403, 411, 412, 422,
423, 460, 483, 488, and 493
[CMS–6076–RCN3]
RIN 0991–AC07
Medicare and Medicaid Programs;
Adjustment of Civil Monetary Penalties
for Inflation; Continuation of
Effectiveness and Extension of
Timeline for Publication of the Final
Rule
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Continuation of effectiveness
and extension of timeline for
publication of the final rule.
AGENCY:
This document announces the
continuation of, effectiveness of, and the
extension of the timeline for publication
of a final rule. We are issuing this
document in accordance with the Social
Security Act (the Act), which allows an
interim final rule to remain in effect
after the expiration of the timeline
specified in the Act if the Secretary
publishes a notice of continuation
explaining why we did not comply with
the regular publication timeline.
DATES: Effective September 3, 2021, the
Medicare provisions adopted in the
interim final rule published on
September 6, 2016 (81 FR 61538)
continue in effect and the regular
timeline for publication of the final rule
is extended for an additional year, until
September 6, 2022.
FOR FURTHER INFORMATION CONTACT:
Steve Forry (410) 786–1564 or Jaqueline
Cipa (410) 786–3259.
SUPPLEMENTARY INFORMATION: Section
1871(a) of the Social Security Act (the
Act) sets forth certain procedures for
promulgating regulations necessary to
carry out the administration of the
insurance programs under Title XVIII of
the Act. Section 1871(a)(3)(A) of the Act
requires the Secretary, in consultation
with the Director of the Office of
Management and Budget (OMB), to
establish a regular timeline for the
jbell on DSKJLSW7X2PROD with RULES
SUMMARY:
VerDate Sep<11>2014
16:25 Sep 07, 2021
Jkt 253001
publication of final regulations based on
the previous publication of a proposed
rule or an interim final rule. In
accordance with section 1871(a)(3)(B) of
the Act, such timeline may vary among
different rules, based on the complexity
of the rule, the number and scope of the
comments received, and other relevant
factors. However, the timeline for
publishing the final rule, cannot exceed
3 years from the date of publication of
the proposed or interim final rule,
unless there are exceptional
circumstances. After consultation with
the Director of OMB, the Secretary
published a notice, which appeared in
the December 30, 2004 Federal Register
on (69 FR 78442), establishing a general
3-year timeline for publishing Medicare
final rules after the publication of a
proposed or interim final rule.
Section 1871(a)(3)(C) of the Act states
that upon expiration of the regular
timeline for the publication of a final
regulation after opportunity for public
comment, a Medicare interim final rule
shall not continue in effect unless the
Secretary publishes a notice of
continuation of the regulation that
includes an explanation of why the
regular timeline was not met. Upon
publication of such notice, the regular
timeline for publication of the final
regulation is treated as having been
extended for 1 additional year.
On September 6, 2016 Federal
Register (81 FR 61538), the Department
of Health and Human Services (HHS)
issued a department-wide interim final
rule titled ‘‘Adjustment of Civil
Monetary Penalties for Inflation’’ that
established new regulations at 45 CFR
part 102 to adjust for inflation the
maximum civil monetary penalty
amounts for the various civil monetary
penalty authorities for all agencies
within the Department. HHS took this
action to comply with the Federal Civil
Penalties Inflation Adjustment Act of
1990 (the Inflation Adjustment Act) (28
U.S.C. 2461 note 2(a)), as amended by
the Federal Civil Penalties Inflation
Adjustment Act Improvements Act of
2015 (section 701 of the Bipartisan
Budget Act of 2015, (Pub. L. 114–74),
enacted on November 2, 2015). In
addition, this September 2016 interim
final rule included updates to certain
agency-specific regulations to reflect the
new provisions governing the
adjustment of civil monetary penalties
for inflation in 45 CFR part 102.
One of the purposes of the Inflation
Adjustment Act (see section 2(b)(1)) was
to create a mechanism to allow for
regular inflationary adjustments to
federal civil monetary penalties. The
2015 amendments removed an inflation
update exclusion that previously
PO 00000
Frm 00051
Fmt 4700
Sfmt 4700
50263
applied to the Social Security Act as
well as to the Occupational Safety and
Health Act. The 2015 amendments also
‘‘reset’’ the inflation calculations by
excluding prior inflationary adjustments
under the Inflation Adjustment Act and
requiring agencies to identify, for each
penalty, the year and corresponding
amount(s) for which the maximum
penalty level or range of minimum and
maximum penalties was established
(that is, originally enacted by Congress)
or last adjusted other than pursuant to
the Inflation Adjustment Act. In
accordance with section 4 of the
Inflation Adjustment Act, agencies were
required to: (1) Adjust the level of civil
monetary penalties with an initial
‘‘catch-up’’ adjustment through an
interim final rulemaking (IFR) to take
effect by August 1, 2016; and (2) make
subsequent annual adjustments for
inflation.
In the September 2016 interim final
rule, HHS adopted new regulations at 45
CFR part 102 to govern adjustment of
civil monetary penalties for inflation.
The regulation at 45 CFR 102.1 provides
that part 102 applies to each statutory
provision under the laws administered
by HHS concerning civil monetary
penalties, and that the regulations in
part 102 supersede existing HHS
regulations setting forth civil monetary
penalty amounts. The civil money
penalties and the adjusted penalty
amounts administered by all HHS
agencies are listed in tabular form in 45
CFR 102.3. In addition to codifying the
adjusted penalty amounts identified in
§ 102.3, the HHS-wide interim final rule
included several technical conforming
updates to certain agency-specific
regulations, including various CMS
regulations, to identify their updated
information, and incorporate a crossreference to the location of HHS-wide
regulations.
Because the conforming changes to
the Medicare provisions were part of a
larger, omnibus departmental interim
final rule, we inadvertently missed
setting a target date for publication of
the final rule to make permanent the
conforming changes to the Medicare
regulations in accordance with section
1871(a)(3)(A) of the Act and the
procedures outlined in the December
2004 notice. Therefore, in the January 2,
2020 Federal Register (85 FR 7), we
published a document continuing the
effectiveness of the interim final rule for
an additional year, until September 6,
2020.
On January 31, 2020, pursuant to
section 319 of the Public Health Service
Act (PHSA), the Secretary determined
that a Public Health Emergency (PHE)
exists for the United States to aid the
E:\FR\FM\08SER1.SGM
08SER1
50264
Federal Register / Vol. 86, No. 171 / Wednesday, September 8, 2021 / Rules and Regulations
nation’s healthcare community in
responding to COVID–19. On March 11,
2020, the World Health Organization
(WHO) publicly declared COVID–19 a
pandemic. On March 13, 2020, the
President declared the COVID–19
pandemic a national emergency. This
declaration, along with the Secretary’s
January 31, 2020 declaration of a PHE,
conferred on the Secretary certain
waiver authorities under section 1135 of
the Act. On March 13, 2020, the
Secretary authorized waivers under
section 1135 of the Act, effective March
1, 2020.1 Effective July 20, 2021, the
Secretary renewed the January 31, 2020
determination that was previously
renewed on April 21, 2020, July 23,
2020, October 2, 2020, January 7, 2021,
April 15, 2021, and July 19, 2021, that
a PHE exists and has existed since
January 27, 2020. The unprecedented
nature of this national emergency has
placed enormous responsibilities upon
CMS to respond appropriately, and
resources have had to be re-allocated
throughout the agency in order to be
responsive.
Due to the PHE and in accordance
with section 1871(a)(3)(C) of the Act, on
September 8, 2020 (85 FR 55385), we
published a second document
continuing the effectiveness of effect
and the regular timeline for publication
of the final rule for an additional year,
until September 6, 2021.
Because of CMS’s continued efforts to
address resource challenges resulting
from the PHE and consistent with
section 1871(a)(3)(C) of the Act, we are
publishing a third notice of
continuation extending the effectiveness
of the technical conforming changes to
the Medicare regulations that were
implemented through interim final rule
and to allow time to publish a final rule.
Therefore, the Medicare provisions
adopted in interim final regulation
continue in effect and the regular
timeline for publication of the final rule
is extended for an additional year, until
September 6, 2022.
Karuna Seshasai,
Executive Secretary to the Department,
Department of Health and Human Services.
[FR Doc. 2021–19382 Filed 9–3–21; 11:15 am]
jbell on DSKJLSW7X2PROD with RULES
BILLING CODE 4120–01–P
1 https://www.phe.gov/emergency/news/
healthactions/section1135/Pages/covid1913March20.aspx.
VerDate Sep<11>2014
16:25 Sep 07, 2021
Jkt 253001
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 17
[Docket No. FWS–R4–ES–2018–0069;
FF09E21000 FXES11110900000 212]
RIN 1018–BD36
Endangered and Threatened Wildlife
and Plants; Endangered Species
Status for Slenderclaw Crayfish and
Designation of Critical Habitat
Fish and Wildlife Service,
Interior.
ACTION: Final rule.
AGENCY:
We, the U.S. Fish and
Wildlife Service (Service), determine
endangered species status under the
Endangered Species Act of 1973, as
amended (Act), for the slenderclaw
crayfish (Cambarus cracens), a cryptic
freshwater crustacean that is endemic to
streams on Sand Mountain within the
Tennessee River Basin in DeKalb and
Marshall Counties, Alabama. This rule
adds this species to the Federal List of
Endangered and Threatened Wildlife. In
addition, we designate approximately
78 river miles (126 river kilometers) in
DeKalb and Marshall Counties,
Alabama, as critical habitat for the
species under the Act.
DATES: This rule is effective October 8,
2021.
ADDRESSES: This final rule is available
on the internet at https://
www.regulations.gov under Docket No.
FWS–R4–ES–2018–0069 and at https://
www.fws.gov/southeast/. Comments and
materials we received, as well as
supporting documentation we used in
preparing this rule, are available for
public inspection at https://
www.regulations.gov under Docket No.
FWS–R4–ES–2018–0069. Comments,
materials, and documentation that we
considered in this rulemaking will be
available by appointment, during
normal business hours at: U.S. Fish and
Wildlife Service, Alabama Ecological
Services Field Office (see FOR FURTHER
INFORMATION CONTACT).
The coordinates or plot points or both
from which the maps are generated are
included in the administrative record
for this critical habitat designation and
are available at https://
www.regulations.gov under Docket No.
FWS–R4–ES–2018–0069, at https://
www.fws.gov/southeast/, and at the
Alabama Ecological Services Field
Office (see FOR FURTHER INFORMATION
CONTACT). Any additional tools or
supporting information that we
developed for this critical habitat
SUMMARY:
PO 00000
Frm 00052
Fmt 4700
Sfmt 4700
designation will also be available at the
Service website and Field Office set out
above, and may also be included in the
preamble and/or at https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
William Pearson, Field Supervisor, U.S.
Fish and Wildlife Service, Alabama
Ecological Services Field Office, 1208–
B Main Street, Daphne, AL 36526;
telephone 251–441–5870. Persons who
use a telecommunications device for the
deaf (TDD) may call the Federal Relay
Service at 800–877–8339.
SUPPLEMENTARY INFORMATION:
Executive Summary
Why we need to publish a rule. Under
the Act, a species may warrant
protection through listing if it is
endangered or threatened throughout all
or a significant portion of its range. In
addition, to the maximum extent
prudent and determinable, we must
designate critical habitat for any species
that we determine to be an endangered
or threatened species under the Act.
Listing a species as an endangered or
threatened species and designation of
critical habitat can only be completed
by issuing a rule.
What this rule does. This rule will list
the slenderclaw crayfish (Cambarus
cracens) as an endangered species and
will finalize the designation of critical
habitat for the species under the Act.
Accordingly, this rule revises part 17 of
title 50 of the Code of Federal
Regulations at 50 CFR 17.11 and 17.95.
The basis for our action. Under the
Act, we may determine that a species is
an endangered or threatened species
based on any of five factors: (A) The
present or threatened destruction,
modification, or curtailment of its
habitat or range; (B) overutilization for
commercial, recreational, scientific, or
educational purposes; (C) disease or
predation; (D) the inadequacy of
existing regulatory mechanisms; or (E)
other natural or manmade factors
affecting its continued existence. We
have determined that the slenderclaw
crayfish is threatened by competition
from a nonnative species (Factors A and
E) and habitat degradation resulting
from poor water quality (Factor A).
Under section 4(a)(3) of the Act, if we
determine that any species is an
endangered or threatened species we
must, to the maximum extent prudent
and determinable, designate critical
habitat. Under section 4(b)(2) of the Act,
the Secretary shall designate critical
habitat on the basis of the best available
scientific data after taking into
consideration the economic impact,
national security impact, and any other
E:\FR\FM\08SER1.SGM
08SER1
]]>Agencies
[Federal Register Volume 86, Number 171 (Wednesday, September 8, 2021)]
[Rules and Regulations]
[Pages 50263-50264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19382]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 402, 403, 411, 412, 422, 423, 460, 483, 488, and 493
[CMS-6076-RCN3]
RIN 0991-AC07
Medicare and Medicaid Programs; Adjustment of Civil Monetary
Penalties for Inflation; Continuation of Effectiveness and Extension of
Timeline for Publication of the Final Rule
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Continuation of effectiveness and extension of timeline for
publication of the final rule.
-----------------------------------------------------------------------
SUMMARY: This document announces the continuation of, effectiveness of,
and the extension of the timeline for publication of a final rule. We
are issuing this document in accordance with the Social Security Act
(the Act), which allows an interim final rule to remain in effect after
the expiration of the timeline specified in the Act if the Secretary
publishes a notice of continuation explaining why we did not comply
with the regular publication timeline.
DATES: Effective September 3, 2021, the Medicare provisions adopted in
the interim final rule published on September 6, 2016 (81 FR 61538)
continue in effect and the regular timeline for publication of the
final rule is extended for an additional year, until September 6, 2022.
FOR FURTHER INFORMATION CONTACT: Steve Forry (410) 786-1564 or
Jaqueline Cipa (410) 786-3259.
SUPPLEMENTARY INFORMATION: Section 1871(a) of the Social Security Act
(the Act) sets forth certain procedures for promulgating regulations
necessary to carry out the administration of the insurance programs
under Title XVIII of the Act. Section 1871(a)(3)(A) of the Act requires
the Secretary, in consultation with the Director of the Office of
Management and Budget (OMB), to establish a regular timeline for the
publication of final regulations based on the previous publication of a
proposed rule or an interim final rule. In accordance with section
1871(a)(3)(B) of the Act, such timeline may vary among different rules,
based on the complexity of the rule, the number and scope of the
comments received, and other relevant factors. However, the timeline
for publishing the final rule, cannot exceed 3 years from the date of
publication of the proposed or interim final rule, unless there are
exceptional circumstances. After consultation with the Director of OMB,
the Secretary published a notice, which appeared in the December 30,
2004 Federal Register on (69 FR 78442), establishing a general 3-year
timeline for publishing Medicare final rules after the publication of a
proposed or interim final rule.
Section 1871(a)(3)(C) of the Act states that upon expiration of the
regular timeline for the publication of a final regulation after
opportunity for public comment, a Medicare interim final rule shall not
continue in effect unless the Secretary publishes a notice of
continuation of the regulation that includes an explanation of why the
regular timeline was not met. Upon publication of such notice, the
regular timeline for publication of the final regulation is treated as
having been extended for 1 additional year.
On September 6, 2016 Federal Register (81 FR 61538), the Department
of Health and Human Services (HHS) issued a department-wide interim
final rule titled ``Adjustment of Civil Monetary Penalties for
Inflation'' that established new regulations at 45 CFR part 102 to
adjust for inflation the maximum civil monetary penalty amounts for the
various civil monetary penalty authorities for all agencies within the
Department. HHS took this action to comply with the Federal Civil
Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment
Act) (28 U.S.C. 2461 note 2(a)), as amended by the Federal Civil
Penalties Inflation Adjustment Act Improvements Act of 2015 (section
701 of the Bipartisan Budget Act of 2015, (Pub. L. 114-74), enacted on
November 2, 2015). In addition, this September 2016 interim final rule
included updates to certain agency-specific regulations to reflect the
new provisions governing the adjustment of civil monetary penalties for
inflation in 45 CFR part 102.
One of the purposes of the Inflation Adjustment Act (see section
2(b)(1)) was to create a mechanism to allow for regular inflationary
adjustments to federal civil monetary penalties. The 2015 amendments
removed an inflation update exclusion that previously applied to the
Social Security Act as well as to the Occupational Safety and Health
Act. The 2015 amendments also ``reset'' the inflation calculations by
excluding prior inflationary adjustments under the Inflation Adjustment
Act and requiring agencies to identify, for each penalty, the year and
corresponding amount(s) for which the maximum penalty level or range of
minimum and maximum penalties was established (that is, originally
enacted by Congress) or last adjusted other than pursuant to the
Inflation Adjustment Act. In accordance with section 4 of the Inflation
Adjustment Act, agencies were required to: (1) Adjust the level of
civil monetary penalties with an initial ``catch-up'' adjustment
through an interim final rulemaking (IFR) to take effect by August 1,
2016; and (2) make subsequent annual adjustments for inflation.
In the September 2016 interim final rule, HHS adopted new
regulations at 45 CFR part 102 to govern adjustment of civil monetary
penalties for inflation. The regulation at 45 CFR 102.1 provides that
part 102 applies to each statutory provision under the laws
administered by HHS concerning civil monetary penalties, and that the
regulations in part 102 supersede existing HHS regulations setting
forth civil monetary penalty amounts. The civil money penalties and the
adjusted penalty amounts administered by all HHS agencies are listed in
tabular form in 45 CFR 102.3. In addition to codifying the adjusted
penalty amounts identified in Sec. 102.3, the HHS-wide interim final
rule included several technical conforming updates to certain agency-
specific regulations, including various CMS regulations, to identify
their updated information, and incorporate a cross-reference to the
location of HHS-wide regulations.
Because the conforming changes to the Medicare provisions were part
of a larger, omnibus departmental interim final rule, we inadvertently
missed setting a target date for publication of the final rule to make
permanent the conforming changes to the Medicare regulations in
accordance with section 1871(a)(3)(A) of the Act and the procedures
outlined in the December 2004 notice. Therefore, in the January 2, 2020
Federal Register (85 FR 7), we published a document continuing the
effectiveness of the interim final rule for an additional year, until
September 6, 2020.
On January 31, 2020, pursuant to section 319 of the Public Health
Service Act (PHSA), the Secretary determined that a Public Health
Emergency (PHE) exists for the United States to aid the
[[Page 50264]]
nation's healthcare community in responding to COVID-19. On March 11,
2020, the World Health Organization (WHO) publicly declared COVID-19 a
pandemic. On March 13, 2020, the President declared the COVID-19
pandemic a national emergency. This declaration, along with the
Secretary's January 31, 2020 declaration of a PHE, conferred on the
Secretary certain waiver authorities under section 1135 of the Act. On
March 13, 2020, the Secretary authorized waivers under section 1135 of
the Act, effective March 1, 2020.\1\ Effective July 20, 2021, the
Secretary renewed the January 31, 2020 determination that was
previously renewed on April 21, 2020, July 23, 2020, October 2, 2020,
January 7, 2021, April 15, 2021, and July 19, 2021, that a PHE exists
and has existed since January 27, 2020. The unprecedented nature of
this national emergency has placed enormous responsibilities upon CMS
to respond appropriately, and resources have had to be re-allocated
throughout the agency in order to be responsive.
---------------------------------------------------------------------------
\1\ https://www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx.
---------------------------------------------------------------------------
Due to the PHE and in accordance with section 1871(a)(3)(C) of the
Act, on September 8, 2020 (85 FR 55385), we published a second document
continuing the effectiveness of effect and the regular timeline for
publication of the final rule for an additional year, until September
6, 2021.
Because of CMS's continued efforts to address resource challenges
resulting from the PHE and consistent with section 1871(a)(3)(C) of the
Act, we are publishing a third notice of continuation extending the
effectiveness of the technical conforming changes to the Medicare
regulations that were implemented through interim final rule and to
allow time to publish a final rule. Therefore, the Medicare provisions
adopted in interim final regulation continue in effect and the regular
timeline for publication of the final rule is extended for an
additional year, until September 6, 2022.
Karuna Seshasai,
Executive Secretary to the Department, Department of Health and Human
Services.
[FR Doc. 2021-19382 Filed 9-3-21; 11:15 am]
BILLING CODE 4120-01-P
