Proposed Information Collection Activity; Services for Unaccompanied Children With Disabilities (New Collection), 60428-60429 [2024-16347]
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Federal Register / Vol. 89, No. 143 / Thursday, July 25, 2024 / Notices
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participation for Long-Term Care (LTC)
facilities that must be met in order to
participate in the Medicare and
Medicaid Programs. LTC facilities
include skilled nursing facilities (SNFs)
as defined in section 1819(a) of the
Social Security Act in the Medicare
program and nursing facilities (NFs) as
defined in 1919(a) of the Act in the
Medicaid program. SNFs and NFs
provide skilled nursing care and related
services for residents who require
medical or nursing care, or
rehabilitation services for the
rehabilitation of injured, disabled, or
sick persons. In addition, NFs provide
health-related care and services to
individuals who because of their mental
or physical condition require care and
services (above the level of room and
board) which can be made available to
them only through institutional
facilities, and is not primarily for the
care and treatment of mental diseases.
SNFs and NFs must care for their
residents in such a manner and in such
an environment as will promote
maintenance or enhancement of the
quality of life of each resident and must
provide to residents services to attain or
maintain the highest practicable
physical, mental, and psychosocial
well-being of each resident, in
accordance with a written plan of care,
which describes the medical, nursing,
and psychosocial needs of the resident
and how such needs will be met and is
updated periodically.
The primary users of this information
will be State agency surveyors, CMS,
and the LTC facilities for the purposes
of ensuring compliance with Medicare
and Medicaid requirements as well as
ensuring the quality of care provided to
LTC facility residents. The ICs specified
in the regulations may be used as a basis
for determining whether a LTC is
meeting the requirements to participate
in the Medicare program. In addition,
the information collected for purposes
of ensuring compliance may be used to
inform the data provided on CMS’
Nursing Home Compare website and as
such used by the public in considering
nursing home selections for services.
We are revising this information
collection request to include new
requirements proposed at 42 CFR 483.35
and 483.71. The proposed requirements
were discussed in detail in the proposed
rule that published September 6, 2023
(88 FR 61352). The discussion related to
proposed requirements and the
associated information collection
burden begins on page 61391.
Subsequent to publishing the 60-day
Federal Register (89 FR 26892), the final
rule (89 FR 40876) finalized the new
requirements. Based upon our analysis
of the public comments received on the
proposed rule, we revised our burden
estimates by adding a burden estimate
for LTC facilities to solicit and consider
any input received by residents,
resident representatives, and family
members. Form Number: CMS–10573
(OMB control number: 0938–1363);
Frequency: Occasionally; Affected
Public: Private Sector: Business or other
for-profit and not-for-profit institutions;
Number of Respondents: 15,600; Total
Annual Responses: 18,687,318 Total
Annual Hours: 30,206,846. (For policy
questions regarding this collection
contact Diane Corning at 410–786–
8486.)
William N. Parham, III
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–16398 Filed 7–24–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Services for Unaccompanied
Children With Disabilities (New
Collection)
Office of Refugee Resettlement,
Administration for Children and
Families, U.S. Department of Health and
Human Services.
ACTION: Request for public comments.
AGENCY:
The Office of Refugee
Resettlement (ORR), Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services is inviting public comment on
the proposed collection. The request
consists of one form that will allow the
Unaccompanied Children (UC) Bureau
SUMMARY:
to provide services to unaccompanied
children identified as having a
disability.
Comments due September 23,
2024. In compliance with the
requirements of the Paperwork
Reduction Act of 1995, ACF is soliciting
public comment on the specific aspects
of the information collection described
above.
DATES:
You can obtain copies of the
proposed collection of information and
submit comments by emailing
infocollection@acf.hhs.gov. Identify all
requests by the title of the information
collection.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
Description: The ORR UC Bureau is
proposing a new form, the
Individualized Section 504 Service Plan
(Form S–25). The proposed information
collection is necessary to allow the ORR
UC Bureau to comply with a court order
and improve service delivery for
unaccompanied children identified as
having a disability. On June 29, 2018,
Plaintiffs filed their federal class action
lawsuit in the Central District of
California, western division, captioned
Lucas R. et al v. Becerra et al (Case No.
2:18–CV–05741 DMG PLA), asserting
claims under the Flores consent decree,
the Trafficking Victims Protection
Reauthorization Act, the Due Process
clause, and the First Amendment.
Plaintiffs allege violation of
unaccompanied children rights in
decisions regarding family reunification,
placement in restrictive facilities,
services for children with disabilities,
administration of psychotropic
medication, and access to legal
assistance. On May 3, 2024, the Court
granted final approval for the settlement
agreements of the Plaintiffs’ claims for
disabilities, psychotropic medication,
and legal assistance. As part of the
settlement agreement for the disabilities
claim, ORR is required to develop and
implement individualized Section 504
service plans for any child identified as
having a disability. The disabilities
settlement agreement must be fully
implemented by May 3, 2025.
Respondents: Care provider grantees
and contractors
Annual Burden Estimates:
Form
Annual
number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total annual
burden hours
Individual Section 504 Service Plan (Form S–25) ..........................................
300
7
3
6,300
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Federal Register / Vol. 89, No. 143 / Thursday, July 25, 2024 / Notices
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 6 U.S.C. 279; 8 U.S.C.
1232; 45 CFR 410; Flores v. Reno
Settlement Agreement, No. CV85–4544–
RJK (C.D. Cal. 1996); Lucas R. et al v.
Becerra et al (Case No. 2:18–CV–05741
DMG PLA) Disabilities Settlement
Agreement
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–16347 Filed 7–24–24; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–2059]
Providing Over-the-Counter
Monograph Submissions in Electronic
Format; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Providing Over-the-Counter
Monograph Submissions in Electronic
Format.’’ This guidance is intended to
assist submitters by describing the
electronic over-the-counter (OTC)
monograph submissions requirement in
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) and providing
recommendations and other information
on how to send such OTC monograph
submissions to FDA in electronic
format. This guidance finalizes the draft
guidance of the same title issued on
September 28, 2022.
DATES: The announcement of the
guidance is published in the Federal
Register on July 25, 2024.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
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
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2022–D–2059 for ‘‘Providing Over-theCounter Monograph Submissions in
Electronic Format.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
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60429
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Trang Tran, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
240–402–7945, Trang.Tran@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 89, Number 143 (Thursday, July 25, 2024)]
[Notices]
[Pages 60428-60429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16347]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Services for
Unaccompanied Children With Disabilities (New Collection)
AGENCY: Office of Refugee Resettlement, Administration for Children and
Families, U.S. Department of Health and Human Services.
ACTION: Request for public comments.
-----------------------------------------------------------------------
SUMMARY: The Office of Refugee Resettlement (ORR), Administration for
Children and Families (ACF), U.S. Department of Health and Human
Services is inviting public comment on the proposed collection. The
request consists of one form that will allow the Unaccompanied Children
(UC) Bureau to provide services to unaccompanied children identified as
having a disability.
DATES: Comments due September 23, 2024. In compliance with the
requirements of the Paperwork Reduction Act of 1995, ACF is soliciting
public comment on the specific aspects of the information collection
described above.
ADDRESSES: You can obtain copies of the proposed collection of
information and submit comments by emailing [email protected].
Identify all requests by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: The ORR UC Bureau is proposing a new form, the
Individualized Section 504 Service Plan (Form S-25). The proposed
information collection is necessary to allow the ORR UC Bureau to
comply with a court order and improve service delivery for
unaccompanied children identified as having a disability. On June 29,
2018, Plaintiffs filed their federal class action lawsuit in the
Central District of California, western division, captioned Lucas R. et
al v. Becerra et al (Case No. 2:18-CV-05741 DMG PLA), asserting claims
under the Flores consent decree, the Trafficking Victims Protection
Reauthorization Act, the Due Process clause, and the First Amendment.
Plaintiffs allege violation of unaccompanied children rights in
decisions regarding family reunification, placement in restrictive
facilities, services for children with disabilities, administration of
psychotropic medication, and access to legal assistance. On May 3,
2024, the Court granted final approval for the settlement agreements of
the Plaintiffs' claims for disabilities, psychotropic medication, and
legal assistance. As part of the settlement agreement for the
disabilities claim, ORR is required to develop and implement
individualized Section 504 service plans for any child identified as
having a disability. The disabilities settlement agreement must be
fully implemented by May 3, 2025.
Respondents: Care provider grantees and contractors
Annual Burden Estimates:
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form Annual number responses per hours per Total annual
of respondents respondent response burden hours
----------------------------------------------------------------------------------------------------------------
Individual Section 504 Service Plan (Form S- 300 7 3 6,300
25)........................................
----------------------------------------------------------------------------------------------------------------
[[Page 60429]]
Comments: The Department specifically requests comments on (a)
whether the proposed collection of information is necessary for the
proper performance of the functions of the agency, including whether
the information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden of the collection
of information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Authority: 6 U.S.C. 279; 8 U.S.C. 1232; 45 CFR 410; Flores v. Reno
Settlement Agreement, No. CV85-4544-RJK (C.D. Cal. 1996); Lucas R. et
al v. Becerra et al (Case No. 2:18-CV-05741 DMG PLA) Disabilities
Settlement Agreement
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024-16347 Filed 7-24-24; 8:45 am]
BILLING CODE 4184-45-P
