61596 Federal Register / Vol. 88, No. 172 / Thursday, September 7, 2023 / Notices 

++ Confirm ACHC’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. 

++ Obtain ACHC’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. Analysis of and Responses to Public 

Comments on the Proposed Notice 

In accordance with section 

1865(a)(3)(A) of the Act, the April 3, 

2023, proposed notice also solicited 

public comments regarding whether 

ACHC’s requirements met or exceeded 

the Medicare CfCs for ASCs. We 

received two (2) timely pieces of 

correspondence. 

Comment: Two commenters 

expressed support for ACHC and their 

ASC accreditation program and 

encouraged CMS to approve them for 

continued recognition as a national AO 

for ASCs. 

Response: We appreciate the support 

from commenters and agree that ACHC 

should be approved for continued 

recognition as a national AO for ASCs 

that wish to participate in the Medicare 

or Medicaid programs. 

V. Provisions of the Final Notice 

A. Differences Between ACHC’s 

Standards and Requirements for 

Accreditation and Medicare Conditions 

and Survey Requirements 

We compared ACHC’s ASC 

accreditation requirements and survey 

process with the Medicare CfCs of part 

416, and the survey and certification 

process requirements of parts 488 and 

489. Our review and evaluation of 

ACHC’s ASC accreditation application, 

which were conducted as described in 

section III of this notice, yielded the 

following areas where, as of the date of 

this notice, ACHC has completed 

revising its standards and certification 

processes in order to— 

• Meet the standard’s requirements of 

all the following regulations: 

++ Section 416.44(a), to address that 

an ASC ‘‘must provide a functional and 

sanitary environment for the provision 

of surgical services.’’ 

++ Section 416.44(b)(2), to address the 

requirements regarding Life Safety Code 

(LSC) waivers. 

++ Section 416.45(a), to address the 

regulatory language for granting 

privileges in accordance with 

recommendations from qualified 

medical personnel. 

++ Section 416.54(d)(2), to clarify the 

cycle of testing for the ASC’s emergency 

preparedness plans. 

In addition to the standards review, 

CMS also reviewed ACHC’s comparable 

survey processes, which were 

conducted as described in section III of 

this notice, and yielded the following 

areas where, as of the date of this notice, 

ACHC has completed revising its survey 

processes to demonstrate that it uses 

survey processes that are comparable to 

state survey agency processes by: 

++ Revising the compliant policies 

and processes to align with the State 

Operations Manual, Chapter 5 guidance. 

In particular, ACHC’s Administrative 

Review Offsite Investigation process to 

align with the triage process to track and 

trend for potential focus areas during 

the next onsite survey or complete an 

onsite complaint investigation. 

++ Revising ACHC’s ASC 

Accreditation Process policies to 

include the applicable sections of the 

Health Care Facilities Code (HCFC) 

National Fire Protection Agency (NFPA 

99) in accordance with section 

416.44(c). 

++ Ensuring that all ASC LSC 

surveyors have received comparable, 

adequate training or have sufficient 

experience to make them qualified to 

survey health care facilities to both the 

2012 LSC and 2012 NFPA 99 

requirements. 

++ Ensuring that each deficiency 

citation of the Medicare ASC CfCs is 

documented in such a way that is 

comparable to the state survey agencies 

conducting federal Medicare ASC 

surveys. 

++ Ensuring that all findings of noncompliance, that crosswalk to a 

comparable Medicare CfC, is identified 

in the final survey report. 

++ Providing guidance and 

instruction to surveyors on determining 

the appropriate level of citation for LSC 

deficiencies. 

B. Term of Approval 

Based on our review and observations 

described in section III and section V of 

this notice, we approve ACHC as a 

national accreditation organization for 

ASCs that request participation in the 

Medicare program. The decision 

announced in this notice is effective 

September 22, 2023, through September 

22, 2027 (4 years). In accordance with 

§ 488.5(e)(2)(i) the term of the approval 

will not exceed 6 years. 

While ACHC has taken actions based 

on the findings annotated in section 

V.A, of this notice, (Differences Between 

ACHC’s Standards and Requirements for 

Accreditation and Medicare Conditions 

and Survey Requirements) as authorized 

under § 488.8, we will continue ongoing 

review of ACHC’s ASC survey processes 

to ensure full implementation and 

sustained compliance. In keeping with 

CMS’s initiative to increase AO 

oversight broadly and ensure that our 

requested revisions by ACHC are fully 

implemented, CMS expects more 

frequent review of ACHC’s activities in 

the future. 

VI. 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.). 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Evell J. Barco Holland, who 

is the Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Evell J. Barco Holland, 

Federal Register Liaison, Center for Medicare 

& Medicaid Services. 

[FR Doc. 2023–19323 Filed 9–6–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; Judicial, 

Court, and Attorney Measures of 

Performance: Feedback and 

Implementation (New Collection) 

AGENCY: Children’s Bureau, 

Administration for Children and 

Families, United States Department of 

Health and Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Children’s Bureau, 

Administration for Children and 

Families (ACF), U.S. Department of 

Health and Human Services (HHS), is 

proposing to collect data for a new 

descriptive study, Judicial, Court, and 

Attorney Measures of Performance 

(JCAMP): Feedback and 

Implementation. This expands on 

earlier work around technical 

assistance, as approved under Office of 

Management and Budget (OMB) #: 

0970–0593. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 172 / Thursday, September 7, 2023 / Notices 61597 

1https://www.reginfo.gov/public/do/ 

PRAViewICR?ref_nbr=202203-0970-010. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. You can also obtain 

copies of the proposed collection of 

information by emailing infocollection@

acf.hhs.gov. Identify all emailed 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: This study will expand 

on a collection from field testing sites 

that informed the development of a 

suite of measures and tools, which 

became the JCAMP (OMB #0970– 

0593 1). The information collection 

proposed here will further those efforts 

now that the suite of documents has 

been released. Specifically, this effort 

will (1) collect information from JCAMP 

implementation teams to understand 

their experiences with JCAMP 

implementation support, and (2) collect 

information from parents and children 

with child welfare cases, foster/kinship 

caregivers, judges, case workers, parent 

attorneys, children’s attorneys, and 

child welfare agency attorneys to gather 

information for JCAMP measures 

selected for use by jurisdictions 

(jurisdictions will collect only the data 

elements relevant to them). This will be 

accomplished using eleven instruments: 

JCAMP Feedback Survey: Members of 

JCAMP implementation teams will 

answer questions about their 

experiences with JCAMP written 

materials, technical assistance, and the 

eJCAMP online platform. 

Parent Experience Survey: A brief 

survey that collects data post-hearing 

about parent experiences in court 

including, strategies used by judges to 

engage families, satisfaction with their 

legal representation, and collects 

demographic information. 

Parent Court Experience Question 

Bank: This question bank includes 

options for items to include on a survey 

of parents with child welfare cases. 

Sites will select items that align with 

their chosen JCAMP measures. It is 

expected that surveys created from this 

bank will include up to 30 questions. 

Parent Focus Group Guide: This focus 

group guide includes questions for 

parents with child welfare cases about 

their experiences with the child welfare 

court process. 

Youth Post-Hearing Short Survey: 

This brief survey asks youth about their 

experiences immediately following 

hearings and collects demographic 

information (for example to allow 

assessment of equity aspects of judicial 

and legal practice and differences 

among age groups). 

Youth Experience Survey: This survey 

collects information from youth with 

child welfare cases about their 

experiences with the child welfare court 

process and collects demographic 

information (for example to allow 

assessment of equity aspects of judicial 

and legal practice and differences 

among age groups). 

Youth Court Experience Question 

Bank: This question bank includes 

options for items to include on a survey 

of youth with child welfare cases. Sites 

will select items that align with their 

chosen JCAMP measures. It is expected 

that surveys created from this bank will 

include up to 30 questions. 

Youth Focus Group Guide: This focus 

group guide includes questions for 

youth with child welfare cases about 

their experiences with the child welfare 

court process. 

Caregiver Survey: This survey collects 

information from adults caring for 

children with child welfare cases about 

their experiences with the child welfare 

court process and demographic 

information. 

Stakeholder Survey: This survey 

collects data regarding judges’ and 

attorneys’ experiences in court 

including, persons present at hearings, 

judicial engagement strategies used with 

parents, children, and caregivers, the 

practices of parent, child, and agency 

attorneys during hearings, typical 

timelines to permanency, and case 

processing activities. 

Stakeholder Focus Group Guide: This 

focus group guide asks judges, parent 

attorneys, children’s attorneys, and 

child welfare agency attorneys their 

perceptions of the child welfare court 

system, including how families are 

engaged, how families receive due 

process, the quality of legal 

representation, safety decision-making, 

and permanency decision-making. 

Respondents: Respondents consist of 

Court Improvement Program 

administrators and staff, parents, youth, 

adults caregivers, judges, case workers, 

parent attorneys, children’s attorneys, 

and agency attorneys. 

ANNUAL BURDEN ESTIMATES

Instrument 

Annual 

number of 

respondents 

Annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual 

burden hours 

JCAMP Feedback Survey ............................................................................... 100 1 0.25 25 

Parent Experience Survey ............................................................................... 250 1 0.17 42.5 

Parent Court Experience Question Bank ........................................................ 250 1 0.17 42.5 

Parent Focus Group Guide ............................................................................. 80 1 1 80 

Youth Post-Hearing Survey Short ................................................................... 250 1 0.08 20 

Youth Experience Survey ................................................................................ 250 1 0.17 42.5 

Youth Court Experience Question Bank ......................................................... 250 1 0.17 42.5 

Youth Focus Group Guide ............................................................................... 80 1 1 80 

Caregiver Survey ............................................................................................. 250 1 0.08 20 

Stakeholder Survey ......................................................................................... 1,500 1 0.17 255 

Stakeholder Focus Group Guide ..................................................................... 400 1 1 400 


ddrumheller on DSK120RN23PROD with NOTICES1
61598 Federal Register / Vol. 88, No. 172 / Thursday, September 7, 2023 / Notices 

Estimated Total Annual Burden 

Hours: 1,050. 

Authority: Sec. 5106, Public Law 111– 

320, the Child Abuse Prevention and 

Treatment Act Reauthorization Act of 

2010, and titles IV–B and IV–E of the 

Social Security Act. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–19228 Filed 9–6–23; 8:45 am] 

BILLING CODE 4184–29–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2607] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a rare pediatric disease 

product application. The Federal Food, 

Drug, and Cosmetic Act (FD&C Act) 

authorizes FDA to award priority review 

vouchers to sponsors of approved rare 

pediatric disease product applications 

that meet certain criteria. FDA is 

required to publish notice of the award 

of the priority review voucher. FDA has 

determined that VEOPOZ (pozelimabbbfg), manufactured by Regeneron 

Pharmaceuticals, Inc., meets the criteria 

for a priority review voucher. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn Lee, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–1394, email: Cathryn.Lee@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the issuance of a priority 

review voucher to the sponsor of an 

approved rare pediatric disease product 

application. Under section 529 of the 

FD&C Act (21 U.S.C. 360ff), FDA will 

award priority review vouchers to 

sponsors of approved rare pediatric 

disease product applications that meet 

certain criteria. FDA has determined 

that VEOPOZ (pozelimab-bbfg), 

approved on August 18, 2023, and 

manufactured by Regeneron 

Pharmaceuticals, Inc., meets the criteria 

for a priority review voucher. VEOPOZ 

(pozelimab-bbfg) injection is indicated 

for the treatment of adult and pediatric 

patients 1 year of age and older with 

CD55-deficient protein-losing 

enteropathy (PLE), also known as 

CHAPLE disease. 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to https://www.fda.gov/ForIndustry/ 

DevelopingProducts

forRareDiseasesConditions/ 

RarePediatricDiseasePriority

VoucherProgram/default.htm. For 

further information about VEOPOZ 

(pozelimab-bbfg), go to the ‘‘Drugs@

FDA’’ website at https://

www.accessdata.fda.gov/scripts/cder/ 

daf/. 

Dated: September 1, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19287 Filed 9–6–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–1190] 

Cellular, Tissue, and Gene Therapies 

Advisory Committee; Notice of 

Meeting; Establishment of a Public 

Docket; Request for Comments— 

Sickle Cell Disease 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Cellular, Tissue, and 

Gene Therapies Advisory Committee 

(the Committee). The general function of 

the Committee is to provide advice and 

recommendations to FDA on regulatory 

issues. On October 31, 2023, the 

Committee will discuss and make 

recommendations on biologics license 

application (BLA) 125787 from Vertex 

Pharmaceuticals, Inc. for exagamglogene 

autotemcel (exa-cel). The applicant has 

requested an indication for the 

treatment of sickle cell disease in 

patients 12 years and older with 

recurrent vaso-occlusive crises. The 

meeting will be open to the public. FDA 

is establishing a docket for public 

comment on this document. 

DATES: The meeting will be held on 

October 31, 2023, from 9 a.m. to 5 p.m. 

Eastern Time. 

ADDRESSES: All meeting participants 

will be heard, viewed, captioned, and 

recorded for this advisory committee 

meeting via an online teleconferencing 

and/or video conferencing platform. 

Answers to commonly asked questions 

about FDA advisory committee meetings 

may be accessed at: https://

www.fda.gov/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. 

The online web conference meeting 

will be available at the following link on 

the day of the meeting at https://

youtube.com/live/M90IjjxOdQg. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2023–N–1190. 

The docket will close on October 30, 

2023. Please note that late, untimely 

filed comments will not be considered. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of October 30, 2023. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are received on or before that 

date. 

Comments received on or before 

October 24, 2023, will be provided to 

the Committee. Comments received after 

that date and on October 30, 2023, will 

be taken into consideration by FDA. In 

the event that the meeting is cancelled, 

FDA will continue to evaluate any 

relevant applications or information, 

and consider any comments submitted 

to the docket, as appropriate. 

You may submit comments 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 


ddrumheller on DSK120RN23PROD with NOTICES1