Submission for Office of Management and Budget Review; Administration of Psychotropic Medication to Unaccompanied Children (New Collection), 90295-90296 [2024-26690]
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90295
Federal Register / Vol. 89, No. 221 / Friday, November 15, 2024 / Notices
completing the error rate reports,
including their estimated burden hours
for each report. All CCDF Lead Agencies
required to submit the error rate reports
were invited to participate, and 56
percent (29 out of 52 Lead Agencies)
responded. Lead Agency respondents
represented a geographically diverse
group of states with a range in size as
defined by the numbers of children and
families served by CCDF. There were
expected variations in responses which
may reflect differences in states’
administrative structures and
complexity, staff capacity, reporting
technology, interpretation of the survey
questions, and other factors. However,
even considering the range of responses
and any outliers, OCC determined that
the burden hours estimates should be
lowered to reflect the survey results. In
addition, to more accurately account for
the work described by survey
respondents, OCC further broke out the
estimated burden hours for the RRW
into the following two parts: (1) the
estimated hours needed for states to
customize the standard RRW template
to reflect their state’s rules, policies, and
procedures; and (2) the estimated hours
needed for states to use the customized
RRW to conduct each of the 276 case
reviews.
• Root Causes of Error: OCC proposes
to standardize the root causes of error in
Item 19 of the ACF–404 State Improper
Payment Report by creating a dropdown list of error cause choices.
Currently, Lead Agencies enter free text
to describe the causes of errors in their
Federal error rate reviews. While this
approach allows flexibility at the
individual reporting level, inconsistent
terminology and descriptions across
states and reporting cycles makes it
difficult to analyze, report, and track
national and state-level error trends over
time. Further, the current approach can
add additional burden to states during
the report review and approval process
because clarifications about error cause
descriptions are often requested by
Federal reviewers. We request comment
on whether standardizing error causes
in Item 19 would benefit Lead Agencies
in their data analysis, ease of report
preparation, and tracking of error trends
over time. We also request comments on
whether the proposed list of
standardized error causes would meet
Lead Agency reporting needs, and if not,
what additional or different error causes
should be included.
Respondents: CCDF grantees from
states, the District of Columbia, and
Puerto Rico.
Annual Burden Estimates: Burden
estimates are shown based on the total
burden over a 3-year period divided by
three to show average annual burden
estimates.
Total
number of
respondents
Total
number of
responses per
respondent
Sampling Decisions, Assurances, and Fieldwork Preparation Plan .......
ACF–403 Record Review Worksheet: template ......................................
ACF–403 Record Review Worksheet: case record reviews ...................
ACF–404 State Improper Payments Report ............................................
ACF–405 State Improper Payments Report Corrective Action Plan ......
52
52
52
52
6
1
1
276
1
a2
35
63
3.0
66
24
1,820
3,276
43,056
3,432
288
607
1,092
14,352
1,144
96
Estimated Total Annual Burden Hours: ............................................
....................
........................
........................
................
17,291
Instrument
Average
burden hours
per response
Total
burden
hours
Annual
burden
hours
a The
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total number of responses per respondent over 3 years ranges from 1–3, depending on how long it takes respondents to reduce the Improper Payment Rate to below the threshold. Respondents submit a Corrective Action Plan that covers a 1-year period; at the end of each year,
if respondents have not reduced the Improper Payment Rate to below the threshold, they submit a new Corrective Action Plan for the following
year. An average of two responses per respondent over a 3 year period is used to calculate annual burden estimates.
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: 45 CFR part 98 subpart K.
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–26684 Filed 11–14–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for Office of Management
and Budget Review; Administration of
Psychotropic Medication to
Unaccompanied Children (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 two forms that will allow the
Unaccompanied Children (UC) Bureau
to obtain informed consent from
authorized consenters and informed
SUMMARY:
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Sfmt 4703
assent or agreement from
unaccompanied children for the
administration of psychotropic
medication.
DATES: Comments due December 16,
2024. The Office of Management and
Budget (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
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90296
Federal Register / Vol. 89, No. 221 / Friday, November 15, 2024 / Notices
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: The ORR UC Bureau is
proposing two new forms: Psychotropic
Medication Informed Consent (Form
MMH–1) and Psychotropic Medication
Assent Notice (Form MMH–2). The
proposed information collection is
necessary to allow the ORR UC Bureau
to comply with a court order and
improve processes for the
administration of psychotropic
medication. 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
psychotropic medication claim, ORR is
required, whenever possible, to obtain
informed consent for the administration
of psychotropic medication and provide
certain information to the authorized
consenter. Additionally, ORR is
required to provide a written notice and
obtain informed assent or agreement
from children aged 14 or older before
administering psychotropic medication.
The psychotropic medication settlement
agreement must be fully implemented
by August 3, 2026, but data collection
must be implemented by February 3,
2025, to ensure compliance with the
Agreement.
Respondents: Care provider grantees
and contractors.
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
Form
Psychotropic Medication Informed Consent (Form MMH–1) ..............................
Psychotropic Medication Assent Notice (Form MMH–2) .....................................
Estimated Total Annual Burden
Hours: 1,125.
Authority: 6 U.S.C. 279; 8 U.S.C.
1232; 45 CFR part 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) Psychotropic Medication
Settlement Agreement.
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–26690 Filed 11–14–24; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–D–4624]
Nonclinical Safety Assessment of
Oligonucleotide-Based Therapeutics;
Draft 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 draft
guidance for industry entitled
‘‘Nonclinical Safety Assessment of
Oligonucleotide-Based Therapeutics.’’
FDA is publishing this draft guidance
which, when finalized, will provide
recommendations on approaches for the
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SUMMARY:
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300
nonclinical safety evaluation of
oligonucleotide-based therapeutics
(ONTs) to support clinical development
and marketing of these products. ONTs
present unique challenges and
opportunities in the nonclinical
evaluation of safety that differ in many
regards from those appropriate for small
molecule drugs or therapeutic proteins.
DATES: Submit either electronic or
written comments on the draft guidance
by January 14, 2025 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time 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
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Number of
responses per
respondent
2
1
Average
burden
hours per
response
1.50
0.75
Total annual
burden hours
900
225
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–
2024–D–4624 for ‘‘Nonclinical Safety
Assessment of Oligonucleotide-Based
Therapeutics.’’ 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.
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]]>Agencies
[Federal Register Volume 89, Number 221 (Friday, November 15, 2024)]
[Notices]
[Pages 90295-90296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26690]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for Office of Management and Budget Review;
Administration of Psychotropic Medication to Unaccompanied Children
(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 two forms that will allow the Unaccompanied
Children (UC) Bureau to obtain informed consent from authorized
consenters and informed assent or agreement from unaccompanied children
for the administration of psychotropic medication.
DATES: Comments due December 16, 2024. The Office of Management and
Budget (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
[[Page 90296]]
requests by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: The ORR UC Bureau is proposing two new forms:
Psychotropic Medication Informed Consent (Form MMH-1) and Psychotropic
Medication Assent Notice (Form MMH-2). The proposed information
collection is necessary to allow the ORR UC Bureau to comply with a
court order and improve processes for the administration of
psychotropic medication. 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 psychotropic medication claim, ORR is
required, whenever possible, to obtain informed consent for the
administration of psychotropic medication and provide certain
information to the authorized consenter. Additionally, ORR is required
to provide a written notice and obtain informed assent or agreement
from children aged 14 or older before administering psychotropic
medication. The psychotropic medication settlement agreement must be
fully implemented by August 3, 2026, but data collection must be
implemented by February 3, 2025, to ensure compliance with the
Agreement.
Respondents: Care provider grantees and contractors.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Average
Annual Number of burden Total annual
Form number of responses per hours per burden hours
respondents respondent response
----------------------------------------------------------------------------------------------------------------
Psychotropic Medication Informed Consent (Form MMH- 300 2 1.50 900
1).................................................
Psychotropic Medication Assent Notice (Form MMH-2).. 300 1 0.75 225
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 1,125.
Authority: 6 U.S.C. 279; 8 U.S.C. 1232; 45 CFR part 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) Psychotropic
Medication Settlement Agreement.
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024-26690 Filed 11-14-24; 8:45 am]
BILLING CODE 4184-45-P
