Submission for OMB Review; Judicial, Court, and Attorney Measures of Performance: Feedback and Implementation (New Collection), 61596-61598 [2023-19228]
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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
ddrumheller on DSK120RN23PROD with NOTICES1
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.
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++ 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
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Frm 00098
Fmt 4703
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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)
Children’s Bureau,
Administration for Children and
Families, United States Department of
Health and Human Services.
ACTION: Request for public comments.
AGENCY:
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.
SUMMARY:
E:\FR\FM\07SEN1.SGM
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61597
Federal Register / Vol. 88, No. 172 / Thursday, September 7, 2023 / Notices
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.
DATES:
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
ADDRESSES:
(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
Annual
number of
respondents
ddrumheller on DSK120RN23PROD with NOTICES1
Instrument
JCAMP Feedback Survey ...............................................................................
Parent Experience Survey ...............................................................................
Parent Court Experience Question Bank ........................................................
Parent Focus Group Guide .............................................................................
Youth Post-Hearing Survey Short ...................................................................
Youth Experience Survey ................................................................................
Youth Court Experience Question Bank .........................................................
Youth Focus Group Guide ...............................................................................
Caregiver Survey .............................................................................................
Stakeholder Survey .........................................................................................
Stakeholder Focus Group Guide .....................................................................
Annual
number of
responses per
respondent
100
250
250
80
250
250
250
80
250
1,500
400
1
1
1
1
1
1
1
1
1
1
1
1 https://www.reginfo.gov/public/do/
PRAViewICR?ref_nbr=202203-0970-010.
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Average
burden hours
per response
0.25
0.17
0.17
1
0.08
0.17
0.17
1
0.08
0.17
1
Annual
burden hours
25
42.5
42.5
80
20
42.5
42.5
80
20
255
400
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
Dated: September 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[Docket No. FDA–2023–N–2607]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
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
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
[FR Doc. 2023–19287 Filed 9–6–23; 8:45 am]
Food and Drug Administration,
HHS.
ACTION:
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/.
VerDate Sep<11>2014
19:19 Sep 06, 2023
Jkt 259001
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.
Notice; establishment of a
public docket; request for comments.
ACTION:
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
SUMMARY:
PO 00000
Frm 00100
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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
E:\FR\FM\07SEN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 172 (Thursday, September 7, 2023)]
[Notices]
[Pages 61596-61598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19228]
-----------------------------------------------------------------------
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.
[[Page 61597]]
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 [email protected]. 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:
---------------------------------------------------------------------------
\1\ https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202203-0970-010.
---------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Annual number Average burden
Instrument Annual number of responses hours per Annual burden
of respondents per respondent response 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
----------------------------------------------------------------------------------------------------------------
[[Page 61598]]
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
