Proposed Information Collection Activity: Strengthening Child Welfare Systems To Achieve Expected Child and Family Outcomes Cross-Site Evaluation (New Collection), 35884-35885 [2023-11634]
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35884
Federal Register / Vol. 88, No. 105 / Thursday, June 1, 2023 / Notices
purpose of the forms and provide
general guidance on completion.
Respondents: Healthcare providers
(pediatricians, medical specialists, and
dentists), Care Provider Program Staff
Annual Burden Estimates
ESTIMATED OPPORTUNITY TIME FOR RESPONDENTS
Instrument
Medical Assessment Form
Dental Assessment Form ...
Total
number of
respondents
Respondent
Pediatricians, General ........
Medical specialist, General
Dentists ..............................
Total
number of
responses per
respondent
300
750
250
Average
burden
hours per
response
840
22
64
0.22
0.22
0.12
Total
burden
hours
166,320
10,890
5,760
Annual
burden
hours
55,440
3,630
1,920
Estimated Total Annual Burden
Hours: 60,990.
ESTIMATED RECORDKEEPING TIME
Instrument
Medical Assessment Form
completed by a medical
professional.
Medical Assessment form
not completed by a medical professional (information obtained via health
records).
Dental Assessment Form ...
Care Provider Program
Staff.
Estimated Total Annual Burden
Hours: 99,825.
ddrumheller on DSK120RN23PROD with NOTICES1
Authority: 6 U.S.C. 279: Exhibit 1,
part A.2 of the Flores Settlement
Agreement (Jenny Lisette Flores, et al.,
v. Janet Reno, Attorney General of the
United States, et al., Case No. CV 85–
4544–RJK [C.D. Cal. 1996])
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–11626 Filed 5–31–23; 8:45 am]
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19:19 May 31, 2023
Jkt 259001
Total
number of
responses per
respondent
265,815
88,605
500
100
0.17
25,500
8,500
500
32
0.17
8,160
2,720
Children’s Bureau,
Administration for Children and
Families, United States Department of
Health and Human Services.
AGENCY:
Request for public comments.
The Children’s Bureau,
Administration for Children and
Families (ACF), Department of Health
and Human Services, is proposing to
collect data for a new process and
outcome study, Strengthening Child
Welfare Systems to Achieve Expected
Child and Family Outcomes (SCWS).
SUMMARY:
Comments due within 60 days of
publication. 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:
Frm 00060
Annual
burden
hours
0.33
Proposed Information Collection
Activity: Strengthening Child Welfare
Systems To Achieve Expected Child
and Family Outcomes Cross-Site
Evaluation (New Collection)
PO 00000
Total
burden
hours
537
Administration for Children and
Families
ACTION:
Average
burden
hours per
response
500
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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.
VerDate Sep<11>2014
Total
number of
respondents
Respondent
Fmt 4703
Sfmt 4703
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 SCWS study will
collect information to understand (1)
implementation processes and the
impact of grant interventions and (2)
examine whether and the degree to
which grant recipients were able to
address common Child and Family
Services Reviews (CFSR) outcomes.
Proposed data sources for this effort
include one survey and one focus group.
The survey will gather information to
understand the factors that supported or
hindered implementation, as well as
assess collaboration efforts and the
intended impact of grant interventions.
The focus groups will gather
information to understand
implementation of SCWS strategies and
interventions, successes and challenges,
and the perceived effect of the strategies
on short and long-term child welfare
outcomes, with specific attention to
CFSR outcomes related to permanency.
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01JNN1
35885
Federal Register / Vol. 88, No. 105 / Thursday, June 1, 2023 / Notices
Respondents: Respondents will
include grant recipient staff, evaluators,
and community partners.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
SCWS web-based survey ....................................................
SCWS focus group ..............................................................
Estimated Total Annual Burden
Hours: 25.
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: Statutory Authority Title II,
Section 203(b)(4) of the Child Abuse
Prevention and Treatment and Adoption
Reform Act of 1978 (42 U.S.C.
5113(b)(4)).
BILLING CODE 4184–29–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0742]
ddrumheller on DSK120RN23PROD with NOTICES1
Human Cells, Tissues, and Cellular and
Tissue-Based Product Establishments
That Are Improperly Registered in the
Electronic Human Cell and Tissue
Establishment Registration System
Due to Lack of Annual Registration
Update; Action Dates
Food and Drug Administration,
HHS.
Notice of intent.
The Food and Drug
Administration (FDA) is announcing its
intention to begin inactivating the
registration of establishments that
SUMMARY:
VerDate Sep<11>2014
19:19 May 31, 2023
Jkt 259001
manufacture human cells, tissues, or
cellular or tissue-based products (HCT/
Ps) that have not updated their
registration during the annual update
period, in accordance with FDA
regulations, in the electronic human cell
and tissue establishment registration
system (eHCTERS). FDA regulations
require establishments that manufacture
certain HCT/Ps to update their
establishment registration annually.
These regulations also require
establishments to amend their
registration within 30 calendar days of
certain changes.
This notice is applicable August
30, 2023.
DATES:
FOR FURTHER INFORMATION CONTACT:
Andrew C. Harvan, 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.
HCT/Ps are defined in § 1271.3(d) (21
CFR 1271.3(d)) as articles containing or
consisting of human cells or tissues that
are intended for implantation,
transplantation, infusion, or transfer
into a human recipient. FDA has a
tiered, risk-based approach to the
regulation of HCT/Ps. If all of the
criteria in 21 CFR 1271.10(a) are met,
and none of the exceptions in § 1271.15
(21 CFR 1271.15) apply, then the HCT/
P is regulated solely under section 361
of the PHS Act (42 U.S.C. 264) and the
regulations in part 1271 (21 CFR part
1271) (361 HCT/P), and FDA’s
premarket review and approval are not
required.
Establishments that manufacture 361
HCT/Ps are required to register and list
their HCT/Ps with FDA’s Center for
Biologics Evaluation and Research
(CBER) using the electronic registration
and listing system (§§ 1271.1(b),
1271.21, and 1271.22 (21 CFR 1271.1(b),
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
Average
burden
hours per
response
1
1
I. Background
[FR Doc. 2023–11634 Filed 5–31–23; 8:45 am]
ACTION:
60
30
SUPPLEMENTARY INFORMATION:
Mary B. Jones,
ACF/OPRE Certifying Officer.
AGENCY:
Total
number of
responses per
respondent
0.5
1.5
Total
burden
hours
Annual
burden
hours
30
45
10
15
1271.21, and 1271.22)).1 2 Under
§ 1271.3(b), establishment ‘‘means a
place of business under one
management, at one general physical
location, that engages in the
manufacture of [HCT/Ps].’’ This
includes ‘‘any individual, partnership,
corporation, association, or other legal
entity engaged in the manufacture of
[HCT/Ps] . . . [and includes] [f]acilities
that engage in contract manufacturing
services . . . .’’ Under § 1271.3(e),
‘‘manufacture means, but is not limited
to, any or all steps in the recovery,
processing, storage, labeling, packaging,
or distribution of any human cell or
tissue, and the screening or testing of
the cell or tissue donor.’’
Pursuant to § 1271.21, establishments
that manufacture 361 HCT/Ps must
register with FDA and submit a list of
every HCT/P that they manufacture
within 5 days after beginning
operations. Establishments are required
to update their registration annually
each December. Establishments are also
required to update their HCT/P list
when changes occur. Such new
information must be submitted at the
time of change, or each June or
December, whichever month occurs
first. An establishment may accomplish
its required annual registration update
in conjunction with updating its HCT/
P list.
In addition, under 21 CFR 1271.26, if
the ownership or location of the
1 An establishment that meets any of the
exceptions in § 1271.15 is not required to register
or comply with other requirements in part 1271.
2 Manufacturers of HCT/Ps that are regulated as
drugs, devices, and/or biological products under
section 351 of the PHS Act (42 U.S.C. 262) and/or
the Federal Food, Drug, and Cosmetic Act and
applicable regulations, must register and list their
products in accordance with part 207 or part 807
(21 CFR part 207 or part 807), as applicable
(§ 1271.1(b)(2)). FDA does not require
establishments that manufacture HCT/Ps regulated
as drugs, devices, and/or biological products that
are only for use in research under an investigational
new drug application (IND) (21 CFR part 312) or an
investigational device exemption (IDE) (21 CFR part
812) to register and list those HCT/Ps in accordance
with part 207 or part 807 if they do not engage in
other activities that would require them to register
(21 CFR 207.13(e), 807.65(f), and 812.1).
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]]>Agencies
[Federal Register Volume 88, Number 105 (Thursday, June 1, 2023)]
[Notices]
[Pages 35884-35885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11634]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity: Strengthening Child
Welfare Systems To Achieve Expected Child and Family Outcomes Cross-
Site Evaluation (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), Department of Health and Human Services, is proposing
to collect data for a new process and outcome study, Strengthening
Child Welfare Systems to Achieve Expected Child and Family Outcomes
(SCWS).
DATES: Comments due within 60 days of publication. 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 SCWS study will collect information to understand
(1) implementation processes and the impact of grant interventions and
(2) examine whether and the degree to which grant recipients were able
to address common Child and Family Services Reviews (CFSR) outcomes.
Proposed data sources for this effort include one survey and one focus
group. The survey will gather information to understand the factors
that supported or hindered implementation, as well as assess
collaboration efforts and the intended impact of grant interventions.
The focus groups will gather information to understand implementation
of SCWS strategies and interventions, successes and challenges, and the
perceived effect of the strategies on short and long-term child welfare
outcomes, with specific attention to CFSR outcomes related to
permanency.
[[Page 35885]]
Respondents: Respondents will include grant recipient staff,
evaluators, and community partners.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Total number Average burden
Instrument Total number of responses hours per Total burden Annual burden
of respondents per respondent response hours hours
----------------------------------------------------------------------------------------------------------------
SCWS web-based survey........... 60 1 0.5 30 10
SCWS focus group................ 30 1 1.5 45 15
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 25.
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: Statutory Authority Title II, Section 203(b)(4) of the
Child Abuse Prevention and Treatment and Adoption Reform Act of 1978
(42 U.S.C. 5113(b)(4)).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023-11634 Filed 5-31-23; 8:45 am]
BILLING CODE 4184-29-P
