Federal Register / Vol. 88, No. 172 / Thursday, September 7, 2023 / Notices 61593 

By the direction of the Commission. 

Cynthia G. Pierre, 

Chief Operating Officer. 

[FR Doc. 2023–19349 Filed 9–6–23; 8:45 am] 

BILLING CODE 6570–01–P 

FEDERAL DEPOSIT INSURANCE 

CORPORATION 

Notice of Termination of Receiverships 

The Federal Deposit Insurance 

Corporation (FDIC or Receiver), as 

Receiver for each of the following 

insured depository institutions, was 

charged with the duty of winding up the 

affairs of the former institutions and 

liquidating all related assets. The 

Receiver has fulfilled its obligations and 

made all dividend distributions 

required by law. 

NOTICE OF TERMINATION OF RECEIVERSHIPS

Fund Receivership name City State Termination 

date 

10053 ........................................ American Southern Bank .................................. Kennesaw ................................ GA 09/01/2023 

10120 ........................................ Irwin Union Bank and Trust Company ............. Columbus ................................. IN 09/01/2023 

10195 ........................................ The Park Avenue Bank .................................... New York ................................. NY 09/01/2023 

10205 ........................................ Desert Hills Bank .............................................. Phoenix .................................... AZ 09/01/2023 

10317 ........................................ Earthstar Bank .................................................. Southampton ........................... PA 09/01/2023 

10380 ........................................ Bank of Choice ................................................. Greeley .................................... CO 09/01/2023 

10402 ........................................ Country Bank .................................................... Aledo ........................................ IL 09/01/2023 

10412 ........................................ Community Bank of Rockmart .......................... Rockmart ................................. GA 09/01/2023 

10488 ........................................ First National Bank ........................................... Edinburg .................................. TX 09/01/2023 

The Receiver has further irrevocably 

authorized and appointed FDICCorporate as its attorney-in-fact to 

execute and file any and all documents 

that may be required to be executed by 

the Receiver which FDIC-Corporate, in 

its sole discretion, deems necessary, 

including but not limited to releases, 

discharges, satisfactions, endorsements, 

assignments, and deeds. Effective on the 

termination dates listed above, the 

Receiverships have been terminated, the 

Receiver has been discharged, and the 

Receiverships have ceased to exist as 

legal entities. 

(Authority: 12 U.S.C. 1819) 

Federal Deposit Insurance Corporation. 

Dated at Washington, DC, on September 1, 

2023. 

James P. Sheesley, 

Assistant Executive Secretary. 

[FR Doc. 2023–19298 Filed 9–6–23; 8:45 am] 

BILLING CODE 6714–01–P 

FEDERAL ELECTION COMMISSION 

Sunshine Act Meetings 

TIME AND DATE: Tuesday, September 12, 

2023, at 10:30 a.m. and its continuation 

at the conclusion of the open meeting 

on September 14, 2023. 

PLACE: 1050 First Street NE, 

Washington, DC and virtual (this 

meeting will be a hybrid meeting.) 

STATUS: This meeting will be closed to 

the public. 

MATTERS TO BE CONSIDERED: Compliance 

matters pursuant to 52 U.S.C. 30109. 

Information the premature disclosure 

of which would be likely to have a 

considerable adverse effect on the 

implementation of a proposed 

Commission action. 

Matters concerning participation in 

civil actions or proceedings or 

arbitration. 

CONTACT PERSON FOR MORE INFORMATION: 

Judith Ingram, Press Officer. Telephone: 

(202) 694–1220. 

(Authority: Government in the Sunshine Act, 

5 U.S.C. 552b) 

Vicktoria J. Allen, 

Deputy Secretary of the Commission. 

[FR Doc. 2023–19438 Filed 9–5–23; 4:15 pm] 

BILLING CODE 6715–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10390 and 

CMS–10865] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

the necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions, 

the accuracy of the estimated burden, 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected, and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

November 6, 2023. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number: ll, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, please access the CMS PRA 

website by copying and pasting the 


ddrumheller on DSK120RN23PROD with NOTICES1
61594 Federal Register / Vol. 88, No. 172 / Thursday, September 7, 2023 / Notices 

following web address into your web 

browser: https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10390 Hospice Quality 

Reporting Program 

CMS–10865 Monoclonal Antibodies 

Directed Against Amyloid for the 

Treatment of Alzheimer’s Disease 

Under the PRA (44 U.S.C. 3501– 

3520), federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Hospice Quality 

Reporting Program; Use: On July 1, 

2014, hospices began using a newly 

created data collection instrument, 

titled the ‘‘Hospice Item Set’’ (HIS) 

V1.00.0. The HIS is used for the 

collection of quality measure data 

related to the Hospice Quality Reporting 

Program (HQRP), and the HIS V1.00.0 

specified the collection of data items 

that supported seven Consensus Based 

Entity (CBE) endorsed Quality Measures 

(QMs) for hospice. On April 1, 2017, 

hospices began using an updated HIS 

V2.00.0, which includes the same items 

from the HIS V1.00.0 along with the 

addition of several new items for use in 

new measures, measure refinement, 

patient record matching, and future 

public reporting. Data collected from the 

HIS are used to calculate the seven CBEendorsed QMs and the CBE-endorsed 

Hospice and Palliative Care Composite 

Process Measure—Comprehensive 

Assessment at Admission QM. 

During the FY 2021 rule, the Hospice 

Visits when Death is Imminent measure 

pair was removed and replaced with the 

claims-based Hospice Visits in Last 

Days of Life (HVLDL) measure. The 

reduction in provider burden and costs 

occurred when CMS replaced the HISbased HVWDII quality measure via the 

HIS information collection request that 

OMB approved on February 16, 2021. 

CMS is requesting to extend the 

expiration date. The HIS V3.00.0 

consists of data elements that are 

designed to collect standardized, 

patient-level data for the following 

domains of care: pain, respiratory status, 

medications, patient preferences and 

beliefs and values. The HIS V3.00.0 was 

developed specifically for use by 

hospices and contains data elements 

that we can use to collect patient-level 

data to calculate eight CBE endorsed 

quality measures. Form Number: CMS– 

10390 (OMB control number: 0938– 

1153); Frequency: On Occasion; 

Affected Public: State, local, or Tribal 

governments, private sector (not-forprofit institutions); individuals or 

households; Number of Respondents: 

5,640; Total Annual Responses: 

2,763,850; Total Annual Hours: 

1,323,883. (For policy questions 

regarding this collection contact 

Jermama Keys at (410) 786–7778.) 

2. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Monoclonal 

Antibodies Directed Against Amyloid 

for the Treatment of Alzheimer’s 

Disease; Use: On April 7, 2022, CMS 

finalized the national coverage 

determination (NCD) to cover FDA 

approved monoclonal antibodies 

(mAbs) directed against amyloid for the 

treatment of Alzheimer’s disease (AD) 

under coverage with evidence 

development (CED) in patients who 

have a clinical diagnosis of mild 

cognitive impairment (MCI) due to AD 

or mild AD dementia, both with 

confirmed presence of amyloid beta 

pathology consistent with AD. For antiamyloid mAbs that have accelerated 

approval, the mAb may be covered in a 

randomized controlled trial conducted 

under an investigational new drug (IND) 

application or any NIH sponsored trial. 

For antiamyloid mAbs that have 

traditional FDA approval (as opposed to 

accelerated approval), the NCD specifies 

coverage under CED in CMS approved 

prospective comparative studies, where 

data may be collected in a registry. In 

addition to satisfying the study criteria 

specified in the NCD, CMS approved 

studies for anti-amyloid mAbs that have 

received traditional FDA approval must 

address all of the questions below: 

• Does the antiamyloid mAb 

meaningfully improve health outcomes 

(i.e., slow the decline of cognition and 

function) for patients in broad 

community practice? 

• Do benefits, and harms such as 

brain hemorrhage and edema, associated 

with use of the antiamyloid mAb, 

depend on characteristics of patients, 

treating clinicians, and settings? 

• How do the benefits and harms 

change over time? 

In order to remove the data collection 

requirement under this coverage with 

evidence development (CED) NCD or 

make any other changes to the existing 

policy, we must formally reopen and 

reconsider the policy. CMS supported 

development of a registry, the 

‘‘Monoclonal Antibodies Directed 

Against Amyloid for the Treatment of 

Alzheimer’s Disease CED Study 

Registry’’ (mAb Registry), to facilitate 

coverage under the NCD. Additionally, 

CMS is working with multiple 

organizations preparing to open their 

own registries. Once more registries are 

available, they will also be listed at 

https://www.cms.gov/medicare/ 

coverage-evidence-development/ 

monoclonalantibodies-directed-againstamyloid-treatment-alzheimers-diseasead, and clinicians will be able to choose 

which registry to participate in. 

The data collected and analyzed in 

the CMS-supported mAb Registry and 

potential CMS-approved registries will 

be used by to determine if monoclonal 

antibodies directed against amyloid for 

the treatment of Alzheimer’s Disease 

(AD) is reasonable and necessary (e.g., 

improves health outcomes) for Medicare 

beneficiaries under Section 

1862(a)(1)(A) of the Act. CMS is 

collecting information to learn more 

about which individuals benefit the 

most from this drug. CMS refers to this 

as coverage with evidence development 

or CED. The information being collected 

via registry will be analyzed to assist 

clinicians and patients make informed 

treatment decisions. Furthermore, data 

from the mAb Registry will assist the 

pharmaceutical industry and the Food 

and Drug Administration (FDA) in 

surveillance of the quality, safety and 

efficacy of these types of drugs. Form 

Number: CMS–10865 (OMB control 

number: 0938–NEW); Frequency: 

Annually; Affected Public: Business or 

other for-profits and Not-for-profit 

institutions; Number of Respondents: 

40,000; Number of Responses: 40,000; 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 172 / Thursday, September 7, 2023 / Notices 61595 

Total Annual Hours: 3,320. (For policy 

questions regarding this collection, 

contact Lori Ashby at 410–786–6322.) 

Dated: August 31, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–19211 Filed 9–6–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3437–FN] 

Medicare and Medicaid Programs: 

Application From the Accreditation 

Commission for Health Care, Inc. for 

Continued Approval of its Ambulatory 

Surgical Center (ASC) Accreditation 

Program 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces our 

decision to approve the Accreditation 

Commission for Health Care, Inc for 

continued recognition as a national 

accrediting organization for Ambulatory 

Surgical Centers that wish to participate 

in the Medicare or Medicaid programs. 

DATES: The decision announced in this 

notice is applicable on September 22, 

2023 through September 22, 2027. 

FOR FURTHER INFORMATION CONTACT: Joy 

Webb, (410) 786–1667; Erin Imhoff, 

(410) 786–2337. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Ambulatory Surgical Centers (ASCs) 

are distinct entities that operate 

exclusively for the purpose of 

furnishing outpatient surgical services 

to patients. Under the Medicare 

program, eligible beneficiaries may 

receive covered services from an ASC, 

provided that certain requirements are 

met. Section 1832(a)(2)(F)(i) of the 

Social Security Act (the Act) establishes 

distinct criteria for facilities seeking 

designation as an ASC. 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. The regulations at 42 CFR part 

416 specify the conditions that an ASC 

must meet to participate in the Medicare 

program, the scope of covered services, 

and the conditions for Medicare 

payment for ASCs. 

Generally, to enter into an agreement, 

an ASC must first be certified by a state 

survey agency (SA) as complying with 

the conditions or requirements set forth 

in part 416 of our Medicare regulations. 

Thereafter, the ASC is subject to regular 

surveys by a SA to determine whether 

it continues to meet these requirements. 

Section 1865(a)(1) of the Act provides 

that, if a provider entity demonstrates 

through accreditation by a Centers for 

Medicare & Medicaid Services (CMS) 

approved national accrediting 

organization (AO) that all applicable 

Medicare conditions are met or 

exceeded, we may deem that 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 the Department 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 may be deemed to meet the 

Medicare conditions. The AO applying 

for approval of its accreditation program 

under 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 AOs are set forth at 

§ 488.5. The regulations at 

§ 488.5(e)(2)(i) require AOs to reapply 

for continued approval of its 

accreditation program every 6 years or 

sooner as determined by CMS. 

Accreditation Commission for Health 

Care’s (ACHC’s) current term of 

approval for its ASC accreditation 

program expires September 22, 2023. 

II. Application Approval Process 

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

provides a statutory timetable to ensure 

that our review of applications for CMSapproval of an accreditation program is 

conducted in a timely manner. The Act 

provides us 210 days after the date of 

receipt of a complete application, with 

any documentation necessary to make 

the determination, to complete our 

survey activities and application 

process. Within 60 days after receiving 

a complete application, we must 

publish a notice in the Federal Register 

that identifies the national accrediting 

body making the request, describes the 

request, and provides no less than a 30- 

day public comment period. At the end 

of the 210-day period, we must publish 

a notice in the Federal Register 

approving or denying the application. 

III. Provisions of the Proposed Notice 

On April 3, 2023, we published a 

proposed notice in the Federal Register 

(88 FR 19645), announcing ACHC’s 

request for continued approval of its 

Medicare ASC accreditation program. In 

the April 3, 2023, proposed notice, we 

detailed our evaluation criteria. Under 

section 1865(a)(2) of the Act and in our 

regulations at § 488.5, we conducted a 

review of ACHC’s Medicare ASC 

accreditation application in accordance 

with the criteria specified by our 

regulations, which include, but are not 

limited to the following: 

• An administrative review of 

ACHC’s: (1) corporate policies; (2) 

financial and human resources available 

to accomplish the proposed surveys; (3) 

procedures for training, monitoring, and 

evaluation of its ASC surveyors; (4) 

ability to investigate and respond 

appropriately to complaints against 

accredited ASCs; and (5) survey review 

and decision-making process for 

accreditation. 

• The comparison of ACHC’s 

Medicare ASC accreditation program 

standards to our current Medicare ASC 

conditions for coverage (CfCs). 

• A documentation review of ACHC’s 

survey process to do the following: 

++ Determine the composition of the 

survey team, surveyor qualifications, 

and ACHC’s ability to provide 

continuing surveyor training. 

++ Compare ACHC’s processes to 

those we require of state survey 

agencies, including periodic resurvey 

and the ability to investigate and 

respond appropriately to complaints 

against ACHC accredited ASCs. 

++ Evaluate ACHC’s procedures for 

monitoring accredited ASCs it has 

found to be out of compliance with 

ACHC’s program requirements. (This 

pertains only to monitoring procedures 

when ACHC identifies non-compliance. 

If noncompliance is identified by a SA 

through a validation survey, the SA 

monitors corrections as specified at 

§ 488.9(c)). 

++ Assess ACHC’s ability to report 

deficiencies to the surveyed ASCs and 

respond to the ASC’s plans of correction 

in a timely manner. 

++ Establish ACHC’s ability to 

provide CMS with electronic data and 

reports necessary for effective validation 

and assessment of the organization’s 

survey process. 

++ Determine the adequacy of ACHC’s 

staff and other resources. 

++ Confirm ACHC’s ability to provide 

adequate funding for performing 

required surveys. 

++ Confirm ACHC’s policies with 

respect to surveys being unannounced. 


ddrumheller on DSK120RN23PROD with NOTICES1