Submission for Office of Management and Budget Review; Office of Human Services Emergency Preparedness and Response Disaster Human Services Case Management Intake Assessment, Resource Referral, and Case Management Plan, 5909-5910 [2024-01728]
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Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Notices
the MA program for which limited data
are currently available.
III. Collection of Information
Requirements
This is a request for information (RFI)
only. In accordance with the
implementing regulations of the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501 et seq.), specifically 5
CFR 1320.3(h)(4), this general
solicitation is exempt from the PRA.
Facts or opinions submitted in response
to general solicitations of comments
from the public, published in the
Federal Register or other publications,
regardless of the form or format thereof,
provided that no person is required to
supply specific information pertaining
to the commenter, other than that
necessary for self-identification, as a
condition of the agency’s full
consideration, are not generally
considered information collections and
therefore not subject to the PRA.
This RFI is issued solely for
information and planning purposes; it
does not constitute a Request for
Proposal (RFP), applications, proposal
abstracts, or quotations. This RFI does
not commit the U.S. Government to
contract for any supplies or services or
make a grant award. Further, we are not
seeking proposals through this RFI and
will not accept unsolicited proposals.
Responders are advised that the U.S.
Government will not pay for any
information or administrative costs
incurred in response to this RFI; all
costs associated with responding to this
RFI will be solely at the interested
party’s expense. In addition, this RFI
does not commit the Government to any
policy decision and CMS will follow
established methods for proposing
future policy changes, including the MA
Advance Notice and Rate
Announcement process. We note that
not responding to this RFI does not
preclude participation in any future
procurement or rulemaking, if
conducted. It is the responsibility of the
potential responders to monitor this RFI
announcement for additional
information pertaining to this request.
In addition, we note that CMS will not
respond to questions about the policy
issues raised in this RFI.
Chiquita Brooks-LaSure,
Administrator of the Centers for
Medicare & Medicaid Services,
approved this document on January 22,
2024.
Dated: January 25, 2024.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2024–01832 Filed 1–25–24; 4:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for Office of Management
and Budget Review; Office of Human
Services Emergency Preparedness
and Response Disaster Human
Services Case Management Intake
Assessment, Resource Referral, and
Case Management Plan
Office of Human Services
Emergency Preparedness and Response,
Administration for Children and
Families, U.S. Department of Health and
Human Services.
ACTION: Request for public comments.
AGENCY:
The Office of Human Services
Emergency Preparedness and Response
(OHSEPR), Administration for Children
and Families (ACF), U.S. Department of
Health and Human Services (HHS), is
requesting an extension for approval of
the following information collection:
OHSEPR Disaster Human Services Case
Management Intake Assessment,
SUMMARY:
Resource Referral, and Case
Management Plan; OMB No.: 0970–
0619. This information collection was
originally approved for 6 months
through an emergency approval.
Comments due within 30 days of
publication. OMB is required to make a
decision concerning 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. All emailed requests should
be identified by the title of the
information collection.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
Description: OHSEPR is seeking to
continue data collection with all forms
approved under OMB No. 0970–0619,
which OMB recently approved through
an emergency approval for 6 months.
OHSEPR’s Disaster Human Services
Intake Assessment, Resource Referral,
and Case Management Plan collection is
part of a system of tools that OHSEPR
utilizes to support disaster survivors
during response missions. OHSEPR’s
case managers would use this collection
during an intake assessment to identify
a disaster survivor’s unmet needs and to
work with the survivor to develop a case
management plan based on the
survivor’s responses.
Respondents: Disaster survivors.
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
khammond on DSKJM1Z7X2PROD with NOTICES
Data collection
Total number
of responses
per respondent
Average
burden hours
per response
Annual
burden hours
Disaster Human Services Case Management Intake Assessment—Survivor ........................................................................................................
Case Management Plan—Case Manager .................................................
Resource Referral Form—Case Manager .................................................
Case Record Notes—Case Manager ........................................................
Survivor Satisfaction Survey—Survivor .....................................................
9,000
180
180
180
9,000
1
50
50
50
1
1.5
1
1
1
.25
13,500
9,000
9,000
9,000
2,250
Estimated Total Annual Burden Hours: ..............................................
........................
..............................
........................
42,750
Authority: The Disaster Human
Services Case Management Program is
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17:23 Jan 29, 2024
Jkt 262001
authorized through appropriations
language under the Children and
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Frm 00055
Fmt 4703
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Families Services account. It is operated
by the ACF Office of Human Services
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5910
Federal Register / Vol. 89, No. 20 / Tuesday, January 30, 2024 / Notices
Emergency Preparedness and Response,
which is the lead in HHS for human
service preparation for, response to, and
recovery from, natural disasters.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–01728 Filed 1–29–24; 8:45 am]
BILLING CODE 4184–PC–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–0404]
Considerations for the Development of
Chimeric Antigen Receptor T Cell
Products; 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 entitled ‘‘Considerations for
the Development of Chimeric Antigen
Receptor (CAR) T Cell Products;
Guidance for Industry.’’ The guidance is
intended to assist sponsors, including
industry and academic sponsors,
developing ex vivo-manufactured CAR
T cell products. The guidance provides
CAR T cell specific recommendations
regarding chemistry, manufacturing,
and control (CMC), pharmacology and
toxicology, and design of clinical
studies for oncology indications
(including hematologic malignancies
and solid tumors). The guidance
announced in this notice finalizes the
draft guidance of the same title dated
March 2022.
DATES: The announcement of the
guidance is published in the Federal
Register on January 30, 2024.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
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
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17:23 Jan 29, 2024
Jkt 262001
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–
2021–D–0404 for ‘‘Considerations for
the Development of Chimeric Antigen
Receptor (CAR) T Cell Products;
Guidance for Industry.’’ 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
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
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Frm 00056
Fmt 4703
Sfmt 4703
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 the guidance to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Tami Belouin, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a document entitled ‘‘Considerations for
the Development of Chimeric Antigen
Receptor (CAR) T Cell Products;
Guidance for Industry.’’ The guidance is
intended to assist sponsors, including
industry and academic sponsors,
developing ex vivo-manufactured CAR
T cell products. The guidance provides
CAR T cell specific recommendations
regarding CMC, pharmacology and
toxicology, and design of clinical
studies for oncology indications
(including hematologic malignancies
and solid tumors). Recommendations
E:\FR\FM\30JAN1.SGM
30JAN1
]]>Agencies
[Federal Register Volume 89, Number 20 (Tuesday, January 30, 2024)]
[Notices]
[Pages 5909-5910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01728]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for Office of Management and Budget Review; Office of
Human Services Emergency Preparedness and Response Disaster Human
Services Case Management Intake Assessment, Resource Referral, and Case
Management Plan
AGENCY: Office of Human Services Emergency Preparedness and Response,
Administration for Children and Families, U.S. Department of Health and
Human Services.
ACTION: Request for public comments.
-----------------------------------------------------------------------
SUMMARY: The Office of Human Services Emergency Preparedness and
Response (OHSEPR), Administration for Children and Families (ACF), U.S.
Department of Health and Human Services (HHS), is requesting an
extension for approval of the following information collection: OHSEPR
Disaster Human Services Case Management Intake Assessment, Resource
Referral, and Case Management Plan; OMB No.: 0970-0619. This
information collection was originally approved for 6 months through an
emergency approval.
DATES: Comments due within 30 days of publication. OMB is required to
make a decision concerning 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]. All emailed requests should be
identified by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: OHSEPR is seeking to continue data collection with all
forms approved under OMB No. 0970-0619, which OMB recently approved
through an emergency approval for 6 months. OHSEPR's Disaster Human
Services Intake Assessment, Resource Referral, and Case Management Plan
collection is part of a system of tools that OHSEPR utilizes to support
disaster survivors during response missions. OHSEPR's case managers
would use this collection during an intake assessment to identify a
disaster survivor's unmet needs and to work with the survivor to
develop a case management plan based on the survivor's responses.
Respondents: Disaster survivors.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Total number of Average burden
Data collection Annual number responses per hours per Annual burden
of respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Disaster Human Services Case Management 9,000 1 1.5 13,500
Intake Assessment--Survivor.................
Case Management Plan--Case Manager........... 180 50 1 9,000
Resource Referral Form--Case Manager......... 180 50 1 9,000
Case Record Notes--Case Manager.............. 180 50 1 9,000
Survivor Satisfaction Survey--Survivor....... 9,000 1 .25 2,250
------------------------------------------------------------------
Estimated Total Annual Burden Hours:..... .............. ................. .............. 42,750
----------------------------------------------------------------------------------------------------------------
Authority: The Disaster Human Services Case Management Program is
authorized through appropriations language under the Children and
Families Services account. It is operated by the ACF Office of Human
Services
[[Page 5910]]
Emergency Preparedness and Response, which is the lead in HHS for human
service preparation for, response to, and recovery from, natural
disasters.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024-01728 Filed 1-29-24; 8:45 am]
BILLING CODE 4184-PC-P
