Submission for Office of Management and Budget (OMB) Review; Generic Clearance for the Comprehensive Child Welfare Information System (CCWIS) Technical Assistance and Review Process (OMB #: 0970-0568), 34250-34251 [2024-09226]
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34250
Federal Register / Vol. 89, No. 84 / Tuesday, April 30, 2024 / Notices
development of public reports that will
be published by the Departments on
prescription drug reimbursements for
plans and coverage, prescription drug
pricing trends, and the role of
prescription drug costs in contributing
to premium increases or decreases
under the plans or coverage. The 2021
interim final rules, ‘‘Prescription Drug
and Health Care Spending’’ (2021
interim final rules), issued by the
Departments and the Office of Personnel
Management (OPM) implement the
provisions of section 9825 of the Code,
section 725 of ERISA, and section
2799A–10 of the PHS Act, as enacted by
section 204 of Title II of Division BB of
the CAA. OPM joined the Departments
in issuing the 2021 interim final rules,
requiring Federal Employees Health
Benefits (FEHB) carriers to report
information about prescription drug and
health care spending, premiums, and
plan enrollment in the same manner as
a group health plan or health insurance
issuer offering group or individual
health insurance coverage.
The 2023 Prescription Drug Data
Collection (RxDC) Reporting
Instructions reflect changes for the 2023
reference year and beyond. As a result
of removing first-year implementation
costs and burdens that were incurred
prior to 2024, it is estimated that there
will be a decrease in total three-year
average annual burden from 1,684,080
to 668,952. Form Number: CMS–10788
(OMB Control Number: 0938–1407);
Frequency: Annually; Affected Public:
Private Sector; Number of Respondents:
356; Number of Responses: 356; Total
Annual Hours: 668,952. (For policy
questions regarding this collection
contact Christina Whitefield at 202–
536–8676.)
if OMB receives it within 30 days of
publication.
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
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: The CCWIS Technical
Assistance and Review information
collection includes two components.
• The CCWIS Assessment Review
(CAR) Process.
• TA tools for title IV–E agencies to
self-assess their conformity to CCWIS
project and design requirements at 45
CFR 1355.52–3.
The CCWIS requirements at 45 CFR
1355.55 require the review, assessment,
and inspection of the planning, design,
development, installation, operation,
and maintenance of each CCWIS project
on a continuing basis. The Advance
Planning Document (APD) regulations at
45 CFR 95.621 require periodic reviews
of state and local agency methods and
practices to ensure information systems,
including CCWIS, are utilized for
purposes consistent with proper and
efficient administration.
This request is for an extension with
no changes to the umbrella generic and
all currently approved information
collections, which can be found here:
https://www.reginfo.gov/public/do/
PRAICList?ref_nbr=202311-0970-010.
Respondents: Title IV–E agencies
under the Social Security Act.
[FR Doc. 2024–09314 Filed 4–29–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for Office of Management
and Budget (OMB) Review; Generic
Clearance for the Comprehensive
Child Welfare Information System
(CCWIS) Technical Assistance and
Review Process (OMB #: 0970–0568)
Children’s Bureau,
Administration for Children and
Families, U.S. Department of Health and
Human Services.
ACTION: Request for public comments.
AGENCY:
The Children’s Bureau (CB),
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS) is
requesting a 3-year extension of the
Generic Clearance for the
Comprehensive Child Welfare
Information System (CCWIS) Technical
Assistance (TA) and Review Process,
(OMB #0970–0568, expiration 4/30/
2024) and all approved information
collections under this generic. There are
no changes requested to the terms of the
umbrella generic or to the currently
approved information collections.
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
SUMMARY:
ADDRESSES:
Annual Burden Estimates
ANNUAL BURDEN—CURRENTLY APPROVED INFORMATION COLLECTIONS
Total
number of
respondents
lotter on DSK11XQN23PROD with NOTICES1
Instrument
CCWIS Self-Assessment—Administration ...........................................
CCWIS Self-Assessment—Adoption ...................................................
CCWIS Self-Assessment—Case Management ...................................
CCWIS Self-Assessment—Foster Care and Service Provider Management ............................................................................................
CCWIS Self-Assessment—Intake ........................................................
CCWIS Self-Assessment—Investigation .............................................
CCWIS Self-Assessment: Child Welfare Contributing Agency
(CWCA) ............................................................................................
CCWIS Self-Assessment: Data Exchanges ........................................
CCWIS Self-Assessment: Data Quality ...............................................
VerDate Sep<11>2014
17:27 Apr 29, 2024
Jkt 262001
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Total number
of responses
per
respondent
(3 years)
Average
burden
hours per
response
Total
burden
hours
Annual
burden
hours
55
55
55
1
1
1
10
10
10
550
550
550
183
183
183
55
55
55
1
1
1
10
10
10
550
550
550
183
183
183
55
55
55
1
1
1
10
10
10
550
550
550
183
183
183
E:\FR\FM\30APN1.SGM
30APN1
34251
Federal Register / Vol. 89, No. 84 / Tuesday, April 30, 2024 / Notices
ANNUAL BURDEN—CURRENTLY APPROVED INFORMATION COLLECTIONS—Continued
Total
number of
respondents
Instrument
CCWIS Self-Assessment: Design Requirements ................................
CCWIS Self-Assessment: Financial ....................................................
CCWIS Self-Assessment: ....................................................................
Reporting ..............................................................................................
CCWIS Self-Assessment: Security ......................................................
CCWIS Self-Assessment: Title IV–E Foster Care Maintenance Eligibility ..................................................................................................
CCWIS Self-Assessment: User Experience ........................................
Total number
of responses
per
respondent
(3 years)
Average
burden
hours per
response
Total
burden
hours
Annual
burden
hours
55
55
1
1
24
10
1320
550
440
183
55
55
1
1
10
10
550
550
183
183
55
55
1
1
10
10
550
550
183
183
9020
3,002
Total Annual Burden for Currently Approved Generics
ANNUAL BURDEN—POTENTIAL ADDITIONAL INFORMATION COLLECTION REQUESTS
Instrument
Total
number of
respondents
Total number
of responses
per
respondent
(3 years)
Average
burden
hours per
response
Total
burden
hours
Annual
burden
hours
Future Tools to be developed ..............................................................
55
1
10
550
183
Authority: 5 U.S.C. 301; 42 U.S.C.
470, 620 et seq., 622(b), 629b(a), 652(b),
654A, 670 et seq., 671(a), 1302, and
1396a(a).
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–09226 Filed 4–29–24; 8:45 am]
BILLING CODE 4184–25–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–D–1243]
Safety Testing of Human Allogeneic
Cells Expanded for Use in Cell-Based
Medical Products; 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
document entitled ‘‘Safety Testing of
Human Allogeneic Cells Expanded for
Use in Cell-Based Medical Products;
Draft Guidance for Industry.’’
Allogeneic cells of human origin may be
expanded in culture to manufacture
medical products consisting of live
cells, inactivated cells, cell lysates, or
other cell-based materials such as cellderived particles. The draft guidance
document provides sponsors of
allogeneic cell-based medical products
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:27 Apr 29, 2024
Jkt 262001
recommendations for determining the
appropriate cell safety testing to support
an investigational new drug application
(IND) or a biologics license application
(BLA). Cell safety testing should be
based on a risk analysis that considers
the expansion potential of the cells, the
reagents that are used to expand the
cells in culture, and the number of
individuals the cell-based medical
product is capable of treating.
DATES: Submit either electronic or
written comments on the draft guidance
by July 29, 2024 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
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
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–
2024–D–1243 for ‘‘Safety Testing of
Human Allogeneic Cells Expanded for
Use in Cell-Based Medical Products;
Draft 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.
E:\FR\FM\30APN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 84 (Tuesday, April 30, 2024)]
[Notices]
[Pages 34250-34251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09226]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for Office of Management and Budget (OMB) Review;
Generic Clearance for the Comprehensive Child Welfare Information
System (CCWIS) Technical Assistance and Review Process (OMB #: 0970-
0568)
AGENCY: Children's Bureau, Administration for Children and Families,
U.S. Department of Health and Human Services.
ACTION: Request for public comments.
-----------------------------------------------------------------------
SUMMARY: The Children's Bureau (CB), Administration for Children and
Families (ACF), U.S. Department of Health and Human Services (HHS) is
requesting a 3-year extension of the Generic Clearance for the
Comprehensive Child Welfare Information System (CCWIS) Technical
Assistance (TA) and Review Process, (OMB #0970-0568, expiration 4/30/
2024) and all approved information collections under this generic.
There are no changes requested to the terms of the umbrella generic or
to the currently approved information collections.
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: The CCWIS Technical Assistance and Review information
collection includes two components.
The CCWIS Assessment Review (CAR) Process.
TA tools for title IV-E agencies to self-assess their
conformity to CCWIS project and design requirements at 45 CFR 1355.52-
3.
The CCWIS requirements at 45 CFR 1355.55 require the review,
assessment, and inspection of the planning, design, development,
installation, operation, and maintenance of each CCWIS project on a
continuing basis. The Advance Planning Document (APD) regulations at 45
CFR 95.621 require periodic reviews of state and local agency methods
and practices to ensure information systems, including CCWIS, are
utilized for purposes consistent with proper and efficient
administration.
This request is for an extension with no changes to the umbrella
generic and all currently approved information collections, which can
be found here: https://www.reginfo.gov/public/do/PRAICList?ref_nbr=202311-0970-010.
Respondents: Title IV-E agencies under the Social Security Act.
Annual Burden Estimates
Annual Burden--Currently Approved Information Collections
----------------------------------------------------------------------------------------------------------------
Total number
Total number of responses Average burden Total Annual
Instrument of respondents per respondent hours per burden burden
(3 years) response hours hours
----------------------------------------------------------------------------------------------------------------
CCWIS Self-Assessment--Administration..... 55 1 10 550 183
CCWIS Self-Assessment--Adoption........... 55 1 10 550 183
CCWIS Self-Assessment--Case Management.... 55 1 10 550 183
CCWIS Self-Assessment--Foster Care and 55 1 10 550 183
Service Provider Management..............
CCWIS Self-Assessment--Intake............. 55 1 10 550 183
CCWIS Self-Assessment--Investigation...... 55 1 10 550 183
CCWIS Self-Assessment: Child Welfare 55 1 10 550 183
Contributing Agency (CWCA)...............
CCWIS Self-Assessment: Data Exchanges..... 55 1 10 550 183
CCWIS Self-Assessment: Data Quality....... 55 1 10 550 183
[[Page 34251]]
CCWIS Self-Assessment: Design Requirements 55 1 24 1320 440
CCWIS Self-Assessment: Financial.......... 55 1 10 550 183
CCWIS Self-Assessment:.................... 55 1 10 550 183
Reporting.................................
CCWIS Self-Assessment: Security........... 55 1 10 550 183
CCWIS Self-Assessment: Title IV-E Foster 55 1 10 550 183
Care Maintenance Eligibility.............
CCWIS Self-Assessment: User Experience.... 55 1 10 550 183
----------------------------------------------------------------------------------------------------------------
Total Annual Burden for Currently Approved Generics 9020 3,002
----------------------------------------------------------------------------------------------------------------
Annual Burden--Potential Additional Information Collection Requests
----------------------------------------------------------------------------------------------------------------
Total number of
Total number of responses per Average burden Total Annual
Instrument respondents respondent (3 hours per burden burden
years) response hours hours
----------------------------------------------------------------------------------------------------------------
Future Tools to be developed......... 55 1 10 550 183
----------------------------------------------------------------------------------------------------------------
Authority: 5 U.S.C. 301; 42 U.S.C. 470, 620 et seq., 622(b),
629b(a), 652(b), 654A, 670 et seq., 671(a), 1302, and 1396a(a).
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024-09226 Filed 4-29-24; 8:45 am]
BILLING CODE 4184-25-P
