Federal Register / Vol. 86, No. 171 / Wednesday, September 8, 2021 / Rules and Regulations 50263 

* * * * * 

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 

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 

§ 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 


jbell on DSKJLSW7X2PROD with RULES
50264 Federal Register / Vol. 86, No. 171 / Wednesday, September 8, 2021 / Rules and Regulations 

1https://www.phe.gov/emergency/news/ 

healthactions/section1135/Pages/covid19- 

13March20.aspx. 

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] 

BILLING CODE 4120–01–P 

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 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Final rule. 

SUMMARY: 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 http://

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 http://

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 http://

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 

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 http://

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 


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