2736 Federal Register / Vol. 87, No. 12 / Wednesday, January 19, 2022 / Proposed Rules 

0660, which can be found at https://

www.regulations.gov. 

The hearing will begin at 1:00 p.m. 

Eastern Time (ET) and end when all 

parties who wish to speak have had an 

opportunity to do so. A five-minute time 

limit will be placed on all oral 

testimony. 

Please note that any updates made to 

any aspect of the hearing will be posted 

online at https://www.epa.gov/ 

regulations-emissions-vehicles-andengines/proposed-rule-control-airpollution-aircraft-engines. While EPA 

expects the hearing to go forward as set 

forth above, please monitor our website 

or contact the person listed in the FOR

FURTHER INFORMATION CONTACT section to 

determine if there are any updates. EPA 

does not intend to publish a document 

in the Federal Register announcing 

updates. 

If you require the services of a 

translator or special accommodations 

such as audio description, please preregister for the hearing and describe 

your needs by February 14, 2022. EPA 

may not be able to arrange 

accommodations without advance 

notice. 

How can I get copies of the proposed 

action and other related information? 

EPA has established a docket for this 

action under Docket ID No. EPA–HQ– 

OAR–2019–0660, which can be found at 

https://www.regulations.gov. EPA has 

also developed a website for this 

proposed rule at https://www.epa.gov/ 

regulations-emissions-vehicles-andengines/proposed-rule-control-airpollution-aircraft-engines. Please refer 

to the notice of proposed rulemaking for 

detailed information on accessing 

information related to the proposal. 

William Charmley, 

Director, Assessment and Standards Division, 

Office of Transportation and Air Quality. 

[FR Doc. 2022–00997 Filed 1–14–22; 4:15 pm] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 493 

[CMS–3355–RCN] 

RIN 0938–AT55 

Clinical Laboratory Improvement 

Amendments of 1988 (CLIA) 

Proficiency Testing Regulations 

Related to Analytes and Acceptable 

Performance; Extension of Timeline for 

Publication of Final Rule 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS); 

Centers for Disease Control and 

Prevention (CDC), HHS. 

ACTION: Extension of timeline for 

publication of final rule. 

SUMMARY: The Social Security Act (the 

Act) specifies that a Medicare final rule 

must be published no later than 3 years 

after the publication date of the 

proposed rule or interim final rule, as 

applicable, except under exceptional 

circumstances. In accordance with the 

Act, this document announces an 

extension of the timeline for publication 

of the final rule and includes a brief 

explanation of the justification for the 

variation. 

DATES: As of January 18, 2022, the 

timeline for publication of the final rule 

to finalize the provisions of the 

proposed rule published on February 4, 

2019 (84 FR 1536), is extended until 

February 4, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Sarah Bennett, CMS, (410) 786–3531 or 

Nancy Anderson, CDC, (404) 498–2741. 

SUPPLEMENTARY INFORMATION: In the 

February 4, 2019, Federal Register (84 

FR 1536), we published a proposed rule 

entitled ‘‘Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) Proficiency Testing Regulations 

Related to Analytes and Acceptable 

Performance’’, which would update 

proficiency testing (PT) regulations 

under the CLIA to address current 

analytes (that is, substances or 

constituents for which the laboratory 

conducts testing) and newer 

technologies. This proposed rule would 

also make additional technical changes 

to PT referral regulations to more 

closely align with the CLIA statute. 

Section 1871(a)(3)(B) of the Social 

Security Act (the Act) requires the 

Secretary to publish a Medicare final 

rule no later than 3 years after the 

publication date of the proposed rule or 

interim final rule, as applicable, except 

under exceptional circumstances. In 

such circumstances, the Secretary may 

vary the final rule publication timeline 

if the Secretary publishes a Federal 

Register notice of the different timeline, 

including a brief explanation of the 

justification for the variation, by no later 

than the previously established 

timeline. To meet the 3-year timeline, 

the final rule would have to be 

published by February 4, 2022. For the 

reasons discussed below, we are unable 

to publish the final rule by February 4, 

2022. In accordance with section 

1871(a)(3)(B) of the Act, this document 

announces an extension of the timeline 

for publication of the final rule by 1 year 

until February 4, 2023. 

Since the COVID–19 public health 

emergency was effective January 27, 

2020, we prioritized our efforts to issue 

appropriate regulatory flexibility 

provisions to increase access to reliable 

and accurate testing relevant to COVID– 

19, while minimizing unnecessary 

regulatory burdens. This redirection 

continues to require considerable focus 

and resources, especially to prioritize 

the publication of notices relevant to 

COVID–19 and to provide guidance to 

laboratories involved in COVID–19 

testing. Therefore, we cannot meet the 

February 4, 2022 deadline. However, we 

intend to publish the final rule by 

February 4, 2023. Extension of the 

timeline to allow for issuing the final 

rule is critical as the release of the final 

rule is anticipated, and we expect 

stakeholders, including the laboratory 

community and others, will react 

positively to the changes to the CLIA 

regulations. The practice of laboratory 

medicine has changed significantly 

since the PT regulations were published 

in 1992. There are several clinically 

important analytes in common use 

today for which PT was not required in 

the 1992 rule. The laboratory 

community is aware of this and other 

gaps that will be addressed by this final 

rule. Stakeholders are actively 

requesting updates to the PT analytes, 

acceptance limits, and microbiology 

model and have frequently inquired 

about the status of the final rule since 

2019. For these reasons and based on 

comments we received in response to 

the proposed rule, it is important to 

extend the timeline to issue this final 

rule to revise and update the CLIA PT 

regulations. 

Karuna Seshasai, 

Executive Secretary to the Department, 

Department of Health and Human Services. 

[FR Doc. 2022–00932 Filed 1–18–22; 8:45 am] 

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