85290 Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Notices 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Office of Strategic Business 

Initiatives, Office of the Chief Operating 

Officer, Centers for Disease Control and 

Prevention. 

[FR Doc. 2023–26843 Filed 12–6–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice of Closed Meeting 

Pursuant to 5 U.S.C. 1009(d), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended, and the Determination of 

the Director, Office of Strategic Business 

Initiatives, Office of the Chief Operating 

Officer, CDC, pursuant to Public Law 

92–463. The grant applications and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material, and 

personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Disease, 

Disability, and Injury Prevention and 

Control Special Emphasis Panel (SEP)— 

RFA–OH–23–003, Panel B, 

Occupational Safety and Health 

Education and Research Centers (ERC). 

Dates: February 28–29, 2024. 

Times: 11 a.m.–5 p.m., EST. 

Place: Video-Assisted Meeting. 

Agenda: To review and evaluate grant 

applications. 

For Further Information Contact: 

Michael Goldcamp, Ph.D., Scientific 

Review Officer, Office of Extramural 

Programs, National Institute for 

Occupational Safety and Health, Centers 

for Disease Control and Prevention, 

1095 Willowdale Road, Morgantown, 

West Virginia 26505. Telephone: (304) 

285–5951; Email: MGoldcamp@cdc.gov. 

The Director, Office of Strategic 

Business Initiatives, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Office of Strategic Business 

Initiatives, Office of the Chief Operating 

Officer, Centers for Disease Control and 

Prevention. 

[FR Doc. 2023–26843 Filed 12–6–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3451–PN] 

Medicare and Medicaid Programs; 

Application From the Joint 

Commission (TJC) for Initial Approval 

of Its Rural Health Clinic (RHC) 

Accreditation 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 Joint Commission 

(TJC) for initial 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 8, 2024. 

ADDRESSES: In commenting, refer to file 

code CMS–3451–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–3451–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 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3451–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: 

Caecilia Blondiaux (410) 786–2190. 

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 in a rural health clinic (RHC) 

provided certain requirements are met 

by the RHC. Section 1861(aa)(1) and (2) 

and 1905(l)(1) of the Social Security Act 

(the Act), establishes distinct criteria for 

facilities 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 

are at 42 CFR part 488, subpart A. The 

regulations at 42 CFR part 491, subpart 

A specify the conditions that a RHC 

must meet to participate in the Medicare 

program, the scope of covered services, 

and the conditions for Medicare 

payment for RHCs are set forth at 42 

CFR 405, subpart X. 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 234 / Thursday, December 7, 2023 / Notices 85291 

part 491 of CMS 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 an 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 

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 

CMS approval of their 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 accrediting organizations are set forth 

at § 488.5. 

The Joint Commission (TJC) is 

requesting initial approval by CMS for 

its RHC program. 

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 accrediting 

organization’s requirements consider, 

among other factors, the applying 

accrediting organization’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 TJC’s request 

for initial approval for its RHC 

accreditation program. This notice also 

solicits public comment on whether 

TJC’s requirements meet or exceed the 

Medicare conditions of participation 

(CoPs) for RHCs. 

III. Evaluation of Deeming Authority 

Request 

TJC 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 27, 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 TJC will be conducted 

in accordance with, but not necessarily 

limited to, the following factors: 

• The equivalency of TJC’s standards 

for RHCs as compared with CMS’ RHC 

CoPs. 

• TJC’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 TJC’s 

processes to those of State agencies, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited RHCs. 

++ TJC’s processes and procedures for 

monitoring RHCs found out of 

compliance with TJC’s program 

requirements. These monitoring 

procedures are used only when TJC 

identifies noncompliance. If 

noncompliance is identified through 

validation reviews or complaint 

surveys, the State survey agency 

monitors corrections as specified at 

§ 488.9(c). 

++ TJC’s capacity to report 

deficiencies to the surveyed RHCs and 

respond to the RHC’s plan of correction 

in a timely manner. 

++ TJC’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 TJC’s staff and 

other resources, and its financial 

viability. 

++ TJC’s capacity to adequately fund 

required surveys. 

++ TJC’s policies with respect to 

whether surveys are announced or 

unannounced, to assure that surveys are 

unannounced. 

++ TJC’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. 

++ TJC’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. 2023–26805 Filed 12–6–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–E–2136] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Truseltiq 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 


ddrumheller on DSK120RN23PROD with NOTICES1