Federal Register / Vol. 87, No. 99 / Monday, May 23, 2022 / Notices 31241 

research portfolios, and (5) review of 

program proposals. 

Matters to be Considered: The closed 

meeting will focus on the Secondary 

Peer Review of extramural research 

grant applications received in response 

to two (2) Notice of Funding 

Opportunities (NOFOs): (1) RFA–CE– 

22–002—‘‘Grants to Support New 

Investigators in Conducting Research 

Related to Preventing Interpersonal 

Violence Impacting Children and 

Youth’’; (2) RFA–CE–22–004— 

‘‘Research Grants to Prevent FirearmRelated Violence and Injuries (R01)’’; as 

well as PA–21–259—PHS 2021–2 

Omnibus Solicitation of the NIH, CDC 

and FDA for Small Business Innovation 

Research (SBIR) Grant Applications 

(Parent SBIR [R43/R44] Clinical Trial 

Not Allowed) and PA–21–260—PHS 

2021–2 Omnibus Solicitation of the NIH 

and CDC for SBIR Grant Applications 

(Parent SBIR [R43/R44] Clinical Trial 

Required). Agenda items are subject to 

change as priorities dictate. 

The Director, Strategic Business 

Initiatives Unit, 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, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2022–10944 Filed 5–20–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3428–PN] 

Medicare and Medicaid Programs: 

Application From the National Dialysis 

Accreditation Commission (NDAC) for 

Continued Approval of Its End Stage 

Renal Disease (ESRD) Facility 

Accreditation Program 

AGENCY: Centers for Medicare and 

Medicaid Services, HHS. 

ACTION: Notice with request for 

comment. 

SUMMARY: This notice acknowledges the 

receipt of an application from the 

National Dialysis Accreditation 

Commission for continued recognition 

as a national accrediting organization 

for End Stage Renal Disease facilities 

that wish to participate in the Medicare 

or Medicaid programs. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on June 22, 2022. 

ADDRESSES: In commenting, refer to file 

code CMS–3428–PN. Because of staff 

and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

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–3428–PN, P.O. Box 8010, 

Baltimore, MD 21244–8010. 

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–3428–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. 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services from an end-stage renal disease 

(ESRD) facility provided certain 

requirements are met. Section 1881(b) of 

the Social Security Act (the Act) 

establishes distinct criteria for facilities 

seeking designation as a Medicarecertified ESRD facility. 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 

494 subparts A through D specify the 

conditions that an ESRD must meet in 

order to participate in the Medicare 

program, the scope of covered services, 

and the conditions for Medicare 

payment for ESRD facilities. 

Generally, to enter into an agreement, 

an ESRD facility must first be certified 

by a State survey agency as complying 

with the conditions or requirements set 

forth in part 494 subparts A through D 

of our Medicare regulations. Thereafter, 

the ESRD facility is subject to regular 

surveys by a State survey agency 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 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 the Department 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 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 § 488.4 and 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. 

The National Dialysis Accreditation 

Commission’s (NDAC’s) current term of 

approval for their ESRD facility 

accreditation program expires January 4, 

2023. 

II. Approval of Deeming Organizations 

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

regulations at § 488.5 require that our 

findings concerning review and 

approval of an AO’s requirements 

consider, among other factors, the 


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31242 Federal Register / Vol. 87, No. 99 / Monday, May 23, 2022 / Notices 

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 CMS 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 notice is to inform 

the public of NDAC’s request for 

continued CMS-approval of its ESRD 

facility accreditation program. This 

notice also solicits public comment on 

whether NDAC’s requirements meet or 

exceed the Medicare conditions for 

coverage (CfCs) for ESRDs. 

III. Evaluation of Deeming Authority 

Request 

NDAC submitted all the necessary 

materials to enable us to make a 

determination concerning its request for 

continued CMS-approval of its ESRD 

facility accreditation program. This 

application was determined to be 

complete on March 14, 2022. Under 

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

regulations at § 488.5 (Application and 

re-application procedures for national 

accrediting organizations), our review 

and evaluation of NDAC will be 

conducted in accordance with, but not 

necessarily limited to, the following 

factors: 

• The equivalency of NDAC’s 

standards for ESRD facilities as 

compared with CMS’ ESRD facility 

CfCs. 

• NDAC’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 NDAC’s 

processes to those of state agencies, 

including survey frequency, and the 

ability to investigate and respond 

appropriately to complaints against 

accredited facilities. 

++ NDAC’s processes and procedures 

for monitoring an ESRD facility out of 

compliance with NDAC’s program 

requirements. These monitoring 

procedures are used only when NDAC’s 

identifies noncompliance. If 

noncompliance is identified through 

validation reviews or complaint 

surveys, the state agency (SA) monitors 

corrections as specified at § 488.9. 

++ NDAC’s capacity to report 

deficiencies to the surveyed facilities 

and respond to the facility’s plan of 

correction in a timely manner. 

++ NDAC’s capacity to provide CMS 

with electronic data and reports 

necessary for effective validation and 

assessment of the organization’s survey 

process. 

++ The adequacy of NDAC’s staff and 

other resources, and its financial 

viability. 

++ NDAC’s capacity to adequately 

fund required surveys. 

++ NDAC’s policies with respect to 

whether surveys are announced or 

unannounced, to assure that surveys are 

unannounced. 

++ NDAC’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. 

++ NDAC’s agreement to provide 

CMS 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. Chapter 35). 

V. Response to Public 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 Lynette Wilson, who is the 

Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Dated: May 18, 2022. 

Lynette Wilson, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2022–10999 Filed 5–20–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10398 #7] 

Medicaid and Children’s Health 

Insurance Program (CHIP) Generic 

Information Collection Activities: 

Proposed Collection; Comment 

Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: On May 28, 2010, the Office 

of Management and Budget (OMB) 

issued Paperwork Reduction Act (PRA) 

guidance related to the ‘‘generic’’ 

clearance process. Generally, this is an 

expedited process by which agencies 

may obtain OMB’s approval of 

collection of information requests that 

are ‘‘usually voluntary, low-burden, and 

uncontroversial collections,’’ do not 

raise any substantive or policy issues, 

and do not require policy or 

methodological review. The process 

requires the submission of an 

overarching plan that defines the scope 

of the individual collections that would 

fall under its umbrella. On October 23, 

2011, OMB approved our initial request 

to use the generic clearance process 

under control number 0938–1148 

(CMS–10398). It was last approved on 

April 26, 2021, via the standard PRA 

process which included the publication 

of 60- and 30-day Federal Register 

notices. The scope of the April 2021 

umbrella accounts for Medicaid and 

CHIP State plan amendments, waivers, 

demonstrations, and reporting. This 

Federal Register notice seeks public 

comment on one or more of our 

collection of information requests that 

we believe are generic and fall within 

the scope of the umbrella. Interested 

persons are invited to submit 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 


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