Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices 67301 

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 

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–1561/1561A Health Insurance 

Benefit Agreement 

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: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: Health 

Insurance Benefit Agreement; Use: The 

CMS–1561 form applies to specific 

types of health care providers and 

opioid treatment programs and the 

CMS–1561A form applies to rural health 

clinics (RHCs). The CMS–1561 and 

CMS–1561A forms are health insurance 

benefits agreements that are essential for 

the Centers for Medicare and Medicaid 

Services (CMS) to ensure that applicants 

to the Medicare program have made a 

binding commitment to comply with all 

applicable Federal requirements. The 

CMS–1561/1561A forms are essential in 

that they allow CMS to ensure that 

applicants are in compliance with the 

requirements. Applicants will be 

required to sign the completed form and 

provide operational information to CMS 

to assure that they continue to meet the 

requirements after approval. The 

collection is made only once, when the 

provider or RHC submits their 

application for participation in 

Medicare by signing the completed 

CMS–1561 or CMS–1561A form (as 

applicable). Form Number: CMS–1561/ 

1561A (OMB control number: 0938– 

0832); Frequency: Once only; Affected 

Public: Private sector—(Business or 

other for-profits and Not-for-profit 

institutions); Number of Respondents: 

2,050; Total Annual Responses: 2,050; 

Total Annual Hours: 2,050. (For policy 

questions regarding this collection 

contact Caroline Gallaher at 410–786– 

8705). 

Dated: September 25, 2023 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–21334 Filed 9–28–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3383–N2] 

Clinical Laboratory Improvement 

Amendments of 1988 Exemption of 

Laboratories Licensed by the State of 

Washington; Exemption Period 

Extension 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Notice; exemption period 

extension. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) announce the 

extension of the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) exemption period for the State of 

Washington. The exemption period is 

extended for 6 months, that is until 

April 2, 2024. 

DATES: The exemption granted by this 

notice is effective from October 2, 2023 

to April 2, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Mary Hasan, (410) 786–6480. 

SUPPLEMENTARY INFORMATION: In the 

‘‘Medicare, Medicaid, and CLIA 

Programs; Clinical Laboratory 

Improvement Amendments of 1988 

Exemption of Laboratories Licensed by 

the State of Washington’’ notice that 

appeared in the September 30, 2019 

Federal Register (84 FR 51591), we 

announced that laboratories located in 

and licensed by the State of Washington 

that possess a valid license under the 

Medical Test Site law, Chapter 70.42 of 

the Revised Code of Washington, are 

exempt from the requirements of the 

Clinical Laboratory Improvement 

Amendments of 1988 (CLIA) for a 

period of 4 years. This period expires on 

October 2, 2023. Pending re-approval of 

Washington State’s CLIA exemption 

period, we are extending Washington 

State’s current CLIA exemption period 

for 6 months, that is until April 2, 2024. 

The Administrator of CMS, Chiquita 

Brooks-LaSure, having reviewed and 

approved this document, authorizes 

Chyana Woodard, who is the Federal 

Register Liaison, to electronically sign 

this document for purposes of 

publication in the Federal Register. 

Chyana Woodard, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2023–21460 Filed 9–28–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–3900] 

Graft-Versus-Host Diseases: 

Developing Drugs, Biological 

Products, and Certain Devices for 

Prevention or Treatment; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 


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