Federal Register / Vol. 88, No. 244 / Thursday, December 21, 2023 / Notices 88393 

concert, to retain voting shares of Lakin 

Bancshares, Inc., and thereby indirectly 

retain voting shares of the KCB Bank, 

both of Lakin, Kansas. 

Board of Governors of the Federal Reserve 

System. 

Erin M. Cayce, 

Assistant Secretary of the Board. 

[FR Doc. 2023–28035 Filed 12–20–23; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9889–N] 

Charter Renewal for Advisory 

Committee on Ground Ambulance and 

Patient Billing (GAPB)—November 16, 

2023 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The No Surprises Act, 

enacted as part of the Consolidated 

Appropriations Act, 2021, requires the 

Secretary of Health and Human Services 

(HHS), the Secretary of Labor, and the 

Secretary of the Treasury (the 

Secretaries) to establish and convene an 

advisory committee for the purpose of 

reviewing options to improve the 

disclosure of charges and fees for 

ground ambulance services, better 

inform consumers of insurance options 

for such services, and protect consumers 

from balance billing (the ‘‘GAPB 

Advisory Committee’’ or the 

‘‘Committee’’). The Secretaries 

established the GAPB Advisory 

Committee on November 16, 2021 with 

a standard 2-year expiration period 

ending November 16, 2023. In 

accordance with the Federal Advisory 

Committee Act (FACA), HHS is hereby 

giving notice that the charter for the 

Advisory Committee on Ground 

Ambulance and Patient Billing (GAPB) 

was renewed effective November 16, 

2023. 

DATES: The charter for the Advisory 

Committee on GAPB was renewed is 

November 16, 2023. 

ADDRESSES: Inquiries about the 

Committee can be mailed to Center for 

Consumer Information & Insurance 

Oversight, Centers for Medicare & 

Medicaid Services, 7500 Security 

Boulevard, Mail Stop WB–22–75, 

Baltimore, MD 21244–8016. 

FOR FURTHER INFORMATION CONTACT: 

Shaheen Halim, CMS, by phone (410) 

786–0641 or via email at 

gapbadvisorycommittee@cms.hhs.gov. 

Press inquiries may be submitted by 

phone at (202) 690–6145 or via email at 

press@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

117(a) of the No Surprises Act, enacted 

as part of the Consolidated 

Appropriations Act, 2021, div. BB, tit. I, 

Public Law 116–260 (Dec. 27, 2020), 

requires the Secretaries of Labor, HHS, 

and the Treasury to establish and 

convene an advisory committee for the 

purpose of reviewing options to 

improve the disclosure of charges and 

fees for ground ambulance services, 

better inform consumers of insurance 

options for such services, and protect 

consumers from balance billing. The 

GAPB Advisory Committee is governed 

by the provisions of the Federal 

Advisory Committee Act (FACA), Public 

Law 92–463 (Oct. 6, 1972), as amended, 

5 U.S.C. App. 2. 

The GAPB Advisory Committee first 

convened in 2023. It will make 

recommendations with respect to the 

disclosure of charges and fees for 

ground ambulance services and 

insurance coverage, consumer 

protection and enforcement authorities 

of the Departments of Labor, Health and 

Human Services, and the Treasury (the 

Departments) and relevant States, and 

the prevention of balance billing to 

consumers. The recommendations shall 

address options, best practices, and 

identified standards to prevent 

instances of balance billing; steps that 

can be taken by State legislatures, State 

insurance regulators, State attorneys 

general, and other State officials as 

appropriate, consistent with current 

legal authorities regarding consumer 

protection; and legislative options for 

Congress to prevent balance billing. The 

purpose of renewing the GAPB 

Advisory Committee is to provide the 

Committee with more time to review 

relevant information, review options 

and best practices, and consider the 

recommendations that it has been 

charged with making. A copy of the 

charter and other information regarding 

the GAPB Advisory Committee’s 

activity can be found at: https://

www.cms.gov/medicare/regulationsguidance/advisory-committees/ 

advisory-committee-ground-ambulanceand-patient-billing-gapb. The 

Administrator of CMS, Chiquita BrooksLaSure, having reviewed and approved 

this document, authorizes Vanessa 

Garcia, who is the Federal Register 

Liaison, to electronically sign this 

document for purposes of publication in 

the Federal Register. 

Dated: December 18, 2023. 

Vanessa Garcia, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2023–28128 Filed 12–20–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3455–PN] 

Medicare and Medicaid Programs; 

Application From The Compliance 

Team (TCT) for Continued Approval of 

its Rural Health Clinics Program 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Notice with request for 

comment. 

SUMMARY: This proposed notice 

acknowledges the receipt of an 

application from the Compliance Team 

(TCT) for continued recognition as a 

national accrediting organization (AO) 

for Rural Health Clinics (RHCs) that 

wish to participate in the Medicare or 

Medicaid programs. The statute requires 

that within 60 days of receipt of an 

organization’s complete application, the 

Centers for Medicare & Medicaid 

Services (CMS) publish a notice that 

identifies the national accrediting body 

making the request, describes the nature 

of the request, and provides at least a 

30-day public comment period. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, by 

January 22, 2024. 

ADDRESSES: In commenting, refer to file 

code CMS–3455–PN. 

Comments, including mass comment 

submissions, must be submitted in one 

of the following three ways (please 

choose only one of the ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3455–PN, P.O. Box 8013, 

Baltimore, MD 21244–8013. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 


khammond on DSKJM1Z7X2PROD with NOTICES
88394 Federal Register / Vol. 88, No. 244 / Thursday, December 21, 2023 / Notices 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3455–PN, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Joy Webb (410) 786–1667. 

Shonte Carter (410) 786–3532. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following 

website as soon as possible after they 

have been received: http://

www.regulations.gov. Follow the search 

instructions on that website to view 

public comments. We will not post on 

Regulations.gov public comments that 

make threats to individuals or 

institutions or suggest that the 

individual will take actions to harm the 

individual. We continue to encourage 

individuals not to submit duplicative 

comments. We will post acceptable 

comments from multiple unique 

commenters even if the content is 

identical or nearly identical to other 

comments. 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services from a Medicare-participating 

Rural Health Clinic (RHC), provided 

certain requirements are met. Sections 

1861(aa)(1) and (2) and 1905(l)(1) of the 

Social Security Act (the Act) establish 

distinct criteria for an entity seeking 

designation as an RHC. Regulations 

concerning provider agreements are at 

42 CFR part 489, and those pertaining 

to activities relating to the survey and 

certification of facilities and other 

entities are at 42 CFR part 488. The 

regulations at 42 CFR part 491 specify 

the conditions that a RHC must meet to 

participate in the Medicare program. 

Generally, to enter into an agreement, 

a RHC must first be certified by a State 

survey agency as complying with the 

conditions or requirements set forth in 

part 491 of our regulations. Thereafter, 

the RHC is subject to regular surveys by 

a State survey agency to determine 

whether it continues to meet these 

requirements. 

However, there is an alternative to 

surveys by State agencies. Section 

1865(a)(1) of the Act provides that if a 

provider entity demonstrates through 

accreditation by a Center for Medicare & 

Medicaid Services (CMS) approved 

national accrediting organization (AO) 

that all applicable Medicare conditions 

are met or exceeded, we will deem those 

provider entities as having met the 

requirements. Accreditation by an AO is 

voluntary and is not required for 

Medicare participation. 

If an AO is recognized by the 

Secretary of Health and Human Services 

(the Secretary) as having standards for 

accreditation that meet or exceed 

Medicare requirements, any provider 

entity accredited by the national 

accrediting body’s approved program 

would be deemed to meet the Medicare 

conditions. A national AO applying for 

approval of its accreditation program 

under 42 CFR part 488, subpart A must 

provide CMS with reasonable assurance 

that the AO requires the accredited 

provider entities to meet requirements 

that are at least as stringent as the 

Medicare conditions. Our regulations 

concerning the approval of AO are set 

forth at § 488.4 and 488.5. The 

regulations at § 488.5(e)(2)(i) require 

AOs to reapply for continued approval 

of their accreditation program every 6 

years or sooner as determined by CMS. 

The Compliance Team’s (TCT’s) term 

of approval for their RHC accreditation 

program expires July 17, 2024. 

II. Approval of Deeming Organization 

Section 1865(a)(2) of the Act and our 

regulations at § 488.5 require that our 

findings concerning review and 

approval of a national AO’s 

requirements consider, among other 

factors, the applying AO’s requirements 

for accreditation; survey procedures; 

resources for conducting required 

surveys; capacity to furnish information 

for use in enforcement activities; 

monitoring procedures for provider 

entities found not in compliance with 

the conditions or requirements; and 

ability to provide us with the necessary 

data for validation. 

Section 1865(a)(3)(A) of the Act 

further requires that we publish, within 

60 days of receipt of an organization’s 

complete application, a notice 

identifying the national accrediting 

body making the request, describing the 

nature of the request, and providing at 

least a 30-day public comment period. 

We have 210 days from the receipt of a 

complete application to publish notice 

of approval or denial of the application. 

The purpose of this proposed notice 

is to inform the public of TCT’s request 

for continued approval for its RHC 

accreditation program. This notice also 

solicits public comment on whether 

TCT’s requirements meet or exceed the 

Medicare conditions for certification 

(CfCs) for RHCs. 

III. Evaluation of Deeming Authority 

Request 

TCT submitted all the necessary 

materials to enable us to make a 

determination concerning its request for 

continued approval of its RHC 

accreditation program. This application 

was determined to be complete on 

October 25, 2023. Under section 

1865(a)(2) of the Act and our regulations 

at § 488.5 (Application and reapplication procedures for national 

accrediting organizations), our review 

and evaluation of TCT will be 

conducted in accordance with, but not 

necessarily limited to, the following 

factors: 

• The equivalency of TCT’s standards 

for RHCs as compared with CMS’ RHC 

CfCs. 

• TCT’s survey process to determine 

the following: 

++ The composition of the survey 

team, surveyor qualifications, and the 

ability of the organization to provide 

continuing surveyor training. 

++ The comparability of TCT’s 

processes to those of State agencies, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited RHCs. 

++ TCT’s processes and procedures 

for monitoring RHCs found out of 

compliance with TCT’s program 

requirements. These monitoring 

procedures are used only when TCT 

identifies noncompliance. If 

noncompliance is identified through 

validation reviews or complaint 

surveys, the State survey agency 

monitors corrections as specified at 

§ 488.9(c). 

++ TCT’s capacity to report 

deficiencies to the surveyed RHCs and 

respond to the RHC’s plan of correction 

in a timely manner. 

++ TCT’s capacity to provide us with 

electronic data and reports necessary for 

effective validation and assessment of 

the organization’s survey process. 

++ The adequacy of TCT’s staff and 

other resources, and its financial 

viability. 

++ TCT’s capacity to adequately fund 

required surveys. 

++ TCT’s policies with respect to 

whether surveys are announced or 

unannounced, to assure that surveys are 

unannounced. 

++ TCT’s policies and procedures to 

avoid conflicts of interest, including the 

appearance of conflicts of interest, 

involving individuals who conduct 

surveys or participate in accreditation 

decisions. 


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Federal Register / Vol. 88, No. 244 / Thursday, December 21, 2023 / Notices 88395 

++ TCT’s agreement to provide us 

with a copy of the most current 

accreditation survey together with any 

other information related to the survey 

as we may require (including corrective 

action plans). 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

V. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the ‘‘DATES’’ section 

of this preamble, and when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Trenesha Fultz-Mimms, who 

is the Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Trenesha Fultz-Mimms, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2023–28111 Filed 12–20–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–2565] 

510(k) Third Party Review Program and 

Third Party Emergency Use 

Authorization (EUA) Review; Draft 

Guidance for Industry, Food and Drug 

Administration Staff, and Third Party 

Review Organizations; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the draft 

guidance entitled ‘‘510(k) Third Party 

Review Program and Third Party 

Emergency Use Authorization (EUA) 

Review.’’ This draft guidance provides 

FDA’s current thinking regarding the 

510(k) Third Party (3P510k) Review 

Program and review of Emergency Use 

Authorizations (EUA) requests by a 

third party review organizations 

(3PEUA review). The 3P510k Review 

Program and 3PEUA review create an 

alternative process for manufacturers to 

seek review of 510(k) submissions and 

EUA requests to assist FDA in reviewing 

in a timely manner. This draft guidance 

is not final nor is it for implementation 

at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by February 20, 2024 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2016–D–2565 for ‘‘510(k) Third Party 

Review Program and Third Party 

Emergency Use Authorization (EUA) 

Review.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 


khammond on DSKJM1Z7X2PROD with NOTICES