16190 Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices 

Committee meeting, which is open to 

the public. Interested individuals must 

register to attend as instructed below 

under SUPPLEMENTARY INFORMATION. 

DATES: The Green Building Advisory 

Committee will hold a web-based public 

meeting on Monday, April 18, 2022 

from 11:00 a.m. to 5:00 p.m. Eastern 

Time (ET). 

FOR FURTHER INFORMATION CONTACT: Dr. 

Ken Sandler, Designated Federal 

Officer, Office of Federal HighPerformance Green Buildings, Office of 

Government-wide Policy, General 

Services Administration, 1800 F Street 

NW (Mail-code: MG), Washington, DC 

20405, at ken.sandler@gsa.gov or 202– 

219–1121. Additional information about 

the Committee, including meeting 

materials and agendas, will be available 

on-line at https://www.gsa.gov/gbac. 

SUPPLEMENTARY INFORMATION: 

Procedures for Attendance 

Contact Dr. Ken Sandler at 

ken.sandler@gsa.gov to register to attend 

this public web-based meeting. To 

register, submit your full name, 

organization, email address and phone 

number. Requests to attend the webbased meeting must be received by 5:00 

p.m. ET, on Tuesday, April 12, 2022. 

Meeting call-in information will be 

provided to interested parties who 

register by the deadline. (GSA will be 

unable to provide technical assistance to 

any listener experiencing technical 

difficulties. Testing access to the webbased meeting site before the meetings 

is recommended.) Contact Dr. Sandler to 

register to provide public comment 

during the April 18, 2022 meeting 

public comment period. Attendees 

registered to provide public comment 

will be allowed a maximum of five 

minutes each and will need to provide 

written copies of their comments. 

Requests to provide public comment at 

the Committee meeting must be 

received by 5:00 p.m. ET, on Tuesday, 

April 12, 2022. To request for an 

accommodation, such as closed 

captioning, or to ask about accessibility, 

please contact Mr. Bryan Steverson at 

bryan.steverson@gsa.gov by Monday, 

April 4, 2022 to give GSA as much time 

as possible to process the request. 

Background 

The Administrator of GSA established 

the Committee on June 20, 2011 

(Federal Register/Vol. 76, No. 118) 

pursuant to Section 494 of the Energy 

Independence and Security Act of 2007 

(42 U.S.C. 17123). Under this statute, 

the Committee provides independent 

policy advice and recommendations to 

GSA to advance federal building 

innovations in planning, design, and 

operations to reduce costs, enable 

agency missions, enhance human health 

and performance, and minimize 

environmental impacts. 

April 18, 2022 Meeting Agenda 

• Updates and Introductions 

• Update on Embodied Carbon 

• Environmental Justice and Equity for 

Federal Green Buildings Task Group: 

Proposed Advice Letter 

• Federal Building Decarbonization 

Task Group: Proposed Advice Letter 

and Update 

• Executive Order 14057: Update and 

Discussion 

• New Committee Topics and 

Directions 

• Public Comment 

• Next Steps and Closing Comments 

Kevin Kampschroer, 

Federal Director, Office of Federal HighPerformance Green Buildings, Office of 

Government-wide Policy, General Services 

Administration. 

[FR Doc. 2022–06040 Filed 3–21–22; 8:45 am] 

BILLING CODE 6820–14–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3422–N] 

Announcement of the Re-Approval of 

the American Association for 

Laboratory Accreditation (A2LA) as an 

Accreditation Organization Under the 

Clinical Laboratory Improvement 

Amendments of 1988 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: This notice announces the 

application of the American Association 

for Laboratory Accreditation (A2LA) for 

approval as an accreditation 

organization for clinical laboratories 

under the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) program. We have determined 

that the A2LA meets or exceeds the 

applicable CLIA requirements. In this 

notice, we announce the approval and 

grant the A2LA deeming authority for a 

period of 6 years. 

DATES: The approval announced in this 

notice is effective from March 23, 2022, 

until March 22, 2028. 

FOR FURTHER INFORMATION CONTACT: 

Cindy Flacks, 410–786–6520. 

SUPPLEMENTARY INFORMATION: 

I. Background and Legislative 

Authority 

On October 31, 1988, the Congress 

enacted the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) (Pub. L. 100–578). CLIA 

amended section 353 of the Public 

Health Service Act. We issued a final 

rule implementing the accreditation 

provisions of CLIA on July 31, 1992 (57 

FR 33992). Under those provisions, we 

may grant deeming authority to an 

accreditation organization if its 

requirements for laboratories accredited 

under its program are equal to or more 

stringent than the applicable CLIA 

program requirements in 42 CFR part 

493 (Laboratory Requirements). Subpart 

E of part 493 (Accreditation by a Private, 

Nonprofit Accreditation Organization or 

Exemption Under an Approved State 

Laboratory Program) specifies the 

requirements an accreditation 

organization must meet to be approved 

by CMS as an accreditation organization 

under CLIA. 

II. Notice of Approval of A2LA as an 

Accreditation Organization 

In this notice, we approve the 

American Association for Laboratory 

Accreditation (A2LA) as an organization 

that may accredit laboratories for 

purposes of establishing their 

compliance with CLIA requirements in 

all specialties and subspecialties. We 

have examined the initial A2LA 

application and all subsequent 

submissions to determine its 

accreditation program’s equivalency 

with the requirements for approval of an 

accreditation organization under 

subpart E of part 493. We have 

determined that the A2LA meets or 

exceeds the applicable CLIA 

requirements. We have also determined 

that the A2LA will ensure that its 

accredited laboratories will meet or 

exceed the applicable requirements in 

subparts H, I, J, K, M, Q, and the 

applicable sections of subpart R of part 

493. Therefore, we grant the A2LA 

approval as an accreditation 

organization under subpart E of part 

493, for the period stated in the DATES

section of this notice for all specialties 

and subspecialties under CLIA. As a 

result of this determination, any 

laboratory that is accredited by the 

A2LA during the time period stated in 

the DATES section of this notice will be 

deemed to meet the CLIA requirements 

for the listed specialties and 

subspecialties, and therefore, will 

generally not be subject to routine 

inspections by a State survey agency to 

determine its compliance with CLIA 

requirements. The accredited laboratory, 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices 16191 

however, is subject to validation and 

complaint investigation surveys 

performed by CMS, or its agent(s). 

III. Evaluation of the A2LA Request for 

Approval as an Accreditation 

Organization Under CLIA 

The following describes the process 

used to determine that the A2LA 

accreditation program meets the 

necessary requirements to be approved 

by CMS and that, as such, we may 

approve the A2LA as an accreditation 

program with deeming authority under 

the CLIA program. The A2LA formally 

applied to CMS for approval as an 

accreditation organization under CLIA 

for all specialties and subspecialties. 

In reviewing these materials, we 

reached the following determinations 

for each applicable part of the CLIA 

regulations: 

A. Subpart E—Accreditation by a 

Private, Nonprofit Accreditation 

Organization or Exemption Under an 

Approved State Laboratory Program 

The A2LA submitted its mechanism 

for monitoring compliance with all 

requirements equivalent to conditionlevel requirements, a list of all its 

current laboratories and the expiration 

date of their accreditation, and a 

detailed comparison of the individual 

accreditation requirements with the 

comparable condition-level 

requirements. We have determined that 

the A2LA policies and procedures for 

oversight of laboratories performing all 

laboratory testing covered by CLIA are 

equivalent to those required by our 

CLIA regulations in the matters of 

inspection, monitoring proficiency 

testing (PT) performance, investigating 

complaints, and making PT information 

available. The A2LA submitted 

documentation regarding its 

requirements for monitoring and 

inspecting laboratories and describing 

its own standards regarding 

accreditation organization data 

management, inspection processes, 

procedures for removal or withdrawal of 

accreditation, notification requirements, 

and accreditation organization 

resources. We have determined that the 

requirements of the accreditation 

program submitted for approval are 

equal to or more stringent than the 

requirements of the CLIA regulations. 

B. Subpart H—Participation in 

Proficiency Testing for Laboratories 

Performing Nonwaived Testing 

We have determined that the A2LA’s 

requirements are equal to or more 

stringent than the CLIA requirements at 

§§ 493.801 through 493.865. Consistent 

with the CLIA requirements, all of the 

A2LA’s accredited laboratories are 

required to participate in an HHSapproved PT program for tests listed in 

subpart I. The CLIA requirement at 

§ 493.801(b)(6) requires PT activities for 

the primary methods for nonwaived 

testing, whereas the A2LA requires its 

accredited laboratories to conduct PT 

activities for both primary and 

secondary test systems for waived and 

non-waived testing. 

C. Subpart J—Facility Administration 

for Nonwaived Testing 

The A2LA’s requirements are equal to 

or more stringent than the CLIA 

requirements at §§ 493.1100 through 

493.1105. 

D. Subpart K—Quality System for 

Nonwaived Testing 

We have determined that the quality 

control requirements of the A2LA are 

equal to or more stringent than the CLIA 

requirements at §§ 493.1200 through 

493.1299. 

E. Subpart M—Personnel for Nonwaived 

Testing 

We have determined that the A2LA’s 

requirements are equal to or more 

stringent than the CLIA requirements at 

§§ 493.1403 through 493.1495 for 

laboratories that perform moderate and 

high complexity testing. 

F. Subpart Q—Inspection 

We have determined that the A2LA’s 

inspection requirements are equal to or 

more stringent than the CLIA 

requirements at §§ 493.1771 through 

493.1780. The A2LA will continue to 

conduct biennial onsite inspections. 

The A2LA requires annual review of all 

accredited laboratories. Laboratories are 

required to submit any updates on 

information about its organization, 

facilities, key personnel, and results of 

any proficiency testing. Laboratories 

may be required to undergo an onsite 

surveillance visit if they do not submit 

their annual review documentation to 

the A2LA by the established 30-day 

deadline, if significant changes to the 

facility or organization have occurred, 

or if proficiency testing results have 

been consistently poor. The CLIA 

regulations do not have these 

requirements. 

G. Subpart R—Enforcement Procedures 

We have determined that A2LA meets 

the requirements of subpart R to the 

extent that it applies to accreditation 

organizations. The A2LA policy sets 

forth the actions the organization takes 

when laboratories it accredits do not 

comply with its requirements and 

standards for accreditation. When 

appropriate, the A2LA will deny, 

suspend, or revoke accreditation in a 

laboratory accredited by A2LA and 

report that action to us within 30 days. 

A2LA also provides an appeals process 

for laboratories that have had 

accreditation denied, suspended, or 

revoked. 

We have determined that the A2LA’s 

laboratory enforcement and appeal 

policies are equal to or more stringent 

than the requirements of part 493, 

subpart R, as they apply to accreditation 

organizations. 

IV. Federal Validation Inspections and 

Continuing Oversight 

The Federal validation inspections of 

laboratories accredited by the A2LA 

may be conducted on a representative 

sample basis or in response to 

substantial allegations of 

noncompliance (that is, complaint 

inspections). The outcome of those 

validation inspections, performed by 

CMS or our agents, or the State survey 

agencies, will be our principal means 

for verifying that the laboratories 

accredited by the A2LA remain in 

compliance with CLIA requirements. 

This Federal monitoring is an ongoing 

process. 

V. Removal of Approval as an 

Accrediting Organization 

Our regulations provide that we may 

rescind the approval of an accreditation 

organization, such as that of the A2LA, 

for cause, before the end of the effective 

date of approval. If we determine that 

the A2LA has failed to adopt, maintain, 

and enforce requirements that are equal 

to, or more stringent than, the CLIA 

requirements, or that systemic problems 

exist in its monitoring, inspection or 

enforcement processes, we may impose 

a probationary period, not to exceed 1 

year, in which the A2LA would be 

allowed to address any identified issues. 

Should the A2LA be unable to address 

the identified issues within that 

timeframe, we may, in accordance with 

the applicable regulations, revoke the 

A2LA’s deeming authority under CLIA. 

Should circumstances result in our 

withdrawal of the A2LA’s approval, we 

will publish a notice in the Federal 

Register explaining the basis for 

removing its approval. 

VI. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting record keeping or third 

party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget (OMB) under the authority of the 


lotter on DSK11XQN23PROD with NOTICES1
16192 Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices 

1We note that the Citizen’s Advisory Panel on 

Medicare Education is also referred to as the 

Advisory Panel on Medicare Education (65 FR 

4617). The name was updated in the Second 

Amended Charter approved on July 24, 2000. 

2Health Insurance Marketplace® and 

Marketplace® are service marks of the U.S. 

Department of Health and Human Services. 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). The requirements associated 

with the accreditation process for 

clinical laboratories under the CLIA 

program, and the implementing 

regulations in 42 CFR part 493, subpart 

E, are currently approved under OMB 

control number 0938–0686. 

VII. Executive Order 12866 Statement 

In accordance with the provisions of 

Executive Order 12866, this notice was 

not reviewed by the Office of 

Management and Budget. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Lynette Wilson, who is the 

Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Dated: March 17, 2022. 

Lynette Wilson, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2022–06023 Filed 3–21–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–7066–N] 

Announcement of the Advisory Panel 

on Outreach and Education (APOE) 

April 7, 2022 Virtual Meeting 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Health and 

Human Services (HHS). 

ACTION: Notice. 

SUMMARY: This notice announces the 

next meeting of the APOE (the Panel) in 

accordance with the Federal Advisory 

Committee Act. The Panel advises and 

makes recommendations to the 

Secretary of the U.S. Department of 

Health and Human Services (HHS) (the 

Secretary) and the Administrator of the 

Centers for Medicare & Medicaid 

Services (CMS) on opportunities to 

enhance the effectiveness of consumer 

education strategies concerning the 

Health Insurance Marketplace®, 

Medicare, Medicaid, and the Children’s 

Health Insurance Program (CHIP). This 

meeting is open to the public. 

DATES: Meeting Date: Thursday, April 7, 

2022 from 12:00 p.m. to 5:00 p.m. 

eastern daylight time (e.d.t). 

Deadline for Meeting Registration, 

Presentations, Special 

Accommodations, and Comments: 

Thursday, March 31, 2022 5:00 p.m. 

(e.d.t). 

ADDRESSES: Meeting Location: Virtual. 

All those who RSVP will receive the 

link to attend. 

Presentations and Written Comments: 

Presentations and written comments 

should be submitted to: Lisa Carr, 

Designated Federal Official (DFO), 

Office of Communications, Centers for 

Medicare & Medicaid Services, 200 

Independence Avenue SW, Mailstop 

325G HHH, Washington, DC 20201, 

202–690–5742, or via email at APOE@

cms.hhs.gov. 

Registration: Persons wishing to 

attend this meeting must register at the 

website https://www.eventbrite.com/e/ 

apoe-april-7-2022-virtual-meetingtickets-261248299697 or by contacting 

the DFO listed in the FOR FURTHER

INFORMATION CONTACT section of this 

notice, by the date listed in the DATES

section of this notice. Individuals 

requiring sign language interpretation or 

other special accommodations should 

contact the DFO at the address listed in 

the ADDRESSES section of this notice by 

the date listed in the DATES section of 

this notice. 

FOR FURTHER INFORMATION CONTACT: Lisa 

Carr, Designated Federal Official, Office 

of Communications, 200 Independence 

Avenue SW, Mailstop 325G HHH, 

Washington, DC 20201, 202–690–5742, 

or via email at APOE@cms.hhs.gov. 

Additional information about the 

APOE is available at: https://

www.cms.gov/Regulations-andGuidance/Guidance/FACA/APOE Press 

inquiries are handled through the CMS 

Press Office at (202) 690–6145. 

SUPPLEMENTARY INFORMATION: 

I. Background and Charter Renewal 

Information 

A. Background 

The Advisory Panel for Outreach and 

Education (APOE) (the Panel) is 

governed by the provisions of the 

Federal Advisory Committee Act 

(FACA) (Pub. L. 92–463), as amended (5 

U.S.C. Appendix 2), which sets forth 

standards for the formation and use of 

federal advisory committees. The Panel 

is authorized by section 1114(f) of the 

Social Security Act (the Act) (42 U.S.C. 

1314(f)) and section 222 of the Public 

Health Service Act (42 U.S.C. 217a). 

The Secretary of the U.S. Department 

of Health and Human Services (HHS) 

(the Secretary) signed the charter 

establishing the Citizen’s Advisory 

Panel on Medicare Education 1 (the 

predecessor to the APOE) on January 21, 

1999 (64 FR 7899) to advise and make 

recommendations to the Secretary and 

the Administrator of the Centers for 

Medicare & Medicaid Services (CMS) on 

the effective implementation of national 

Medicare education programs, including 

with respect to the Medicare+Choice 

(M+C) program added by the Balanced 

Budget Act of 1997 (Pub. L. 105–33). 

The Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA) (Pub. L. 108–173) 

expanded the existing health plan 

options and benefits available under the 

M+C program and renamed it the 

Medicare Advantage (MA) program. 

CMS has had substantial responsibilities 

to provide information to Medicare 

beneficiaries about the range of health 

plan options available and better tools 

to evaluate these options. The 

successful MA program implementation 

required CMS to consider the views and 

policy input from a variety of private 

sector constituents and to develop a 

broad range of public-private 

partnerships. 

In addition, Title I of the MMA 

authorized the Secretary and the 

Administrator of CMS (by delegation) to 

establish the Medicare prescription drug 

benefit. The drug benefit allows 

beneficiaries to obtain qualified 

prescription drug coverage. In order to 

effectively administer the MA program 

and the Medicare prescription drug 

benefit, we have substantial 

responsibilities to provide information 

to Medicare beneficiaries about the 

range of health plan options and 

benefits available, and to develop better 

tools to evaluate these plans and 

benefits. 

The Patient Protection and Affordable 

Care Act (Pub. L. 111–148) and Health 

Care and Education Reconciliation Act 

of 2010 (Pub. L. 111–152) (collectively 

referred to as the Affordable Care Act) 

expanded the availability of other 

options for health care coverage and 

enacted a number of changes to 

Medicare as well as to Medicaid and 

CHIP. Qualified individuals and 

qualified employers are now able to 

purchase private health insurance 

coverage through a competitive 

marketplace, called an Affordable 

Insurance Exchange (also called Health 

Insurance Marketplace®, or 

Marketplace® 2). In order to effectively 

implement and administer these 

changes, we must provide information 


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