Submission for OMB Review; Mother and Infant Home Visiting Program Evaluation (MIHOPE): Long-Term Follow-Up, Kindergarten data collection (MIHOPE-K) [OMB #0970-0402], 67955-67956 [2021-26102]
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67955
Federal Register / Vol. 86, No. 227 / Tuesday, November 30, 2021 / Notices
1996), as well as the William
Wilberforce Trafficking Victims
Protection Reauthorization Act of 2008
(Pub. L. 110–457), which authorizes
post-release services under certain
conditions to eligible children. All
programs must comply with the Flores
Settlement Agreement, Case No. CV85–
4544–RJK (C.D. Cal. 1996); pertinent
regulations; and ORR policies and
procedures.
Elizabeth Leo,
Senior Grants Policy Specialist, Office of
Grants Policy, Office of Administration.
[FR Doc. 2021–25973 Filed 11–29–21; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review; Mother
and Infant Home Visiting Program
Evaluation (MIHOPE): Long-Term
Follow-Up, Kindergarten data
collection (MIHOPE–K) [OMB #0970–
0402]
Office of Planning, Research,
and Evaluation, Administration for
Children and Families, HHS.
ACTION: Request for public comment.
AGENCY:
The Administration for
Children and Families (ACF), in
partnership with the Health Resources
and Services Administration (HRSA),
both of the U.S. Department of Health
SUMMARY:
and Human Services (HHS), is
proposing to extend data collection
activity as part of the kindergarten
phase of the Mother and Infant Home
Visiting Program Evaluation Long-Term
Follow-Up project (MIHOPE–K). The
purpose of MIHOPE–K is to conduct a
follow-up study that assesses the longterm impact of the Maternal, Infant, and
Early Childhood Home Visiting
(MIECHV) Program when the
participating children are in
kindergarten. This Federal Register
notice is seeking to extend data
collection for the kindergarten followup. The original Federal Register
notices for the MIHOPE–K data
collection were titled under MIHOPELong-Term Follow-Up (MIHOPE–LT).
DATES: Comments due December 30,
2021. 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.
SUPPLEMENTARY INFORMATION:
Description: This request for an
extension is to complete the following
data collection activities for MIHOPE–K:
(1) A survey with the child’s primary
caregiver (who will be the mother if she
is available), (2) direct assessments of
child development, (3) surveys with the
child’s teacher, (4) a direct assessment
of the caregiver, (5) videotaped
interactions between the caregiver and
child, (6) a caregiver website to provide
current contact information, (7) state
child welfare records, and (8) school
records. In addition to collecting these
data, the MIHOPE–K project will
continue to maintain up-to-date consent
forms for the collection of
administrative data. Future information
collection requests and related Federal
Register notices will describe future
data collection efforts for this project.
Data collected during the kindergarten
follow-up study is being used to
estimate the effects of MIECHV-funded
programs on the following seven
domains: (1) Maternal health, (2) child
health, (3) child development and
school performance, (4) child
maltreatment, (5) parenting, (6) crime or
domestic violence, and (7) family
economic self-sufficiency.
Respondents: The respondents in this
extension will include 1,391 families
who have not yet participated in the
kindergarten follow-up study activities.
We have assumed that only 25 percent
of respondents will complete the
caregiver website. We will also obtain
child welfare data from the 11 MIHOPE
states and school records data from state
and local agencies. We have assumed
that we will obtain data from 11 states
and 5 local education agencies.
ANNUAL BURDEN ESTIMATES
No. of
respondents
(total over
request
period)
Instrument
No. of
responses per
respondent
(total over
request
period)
Avg. burden
per response
(in hours)
Total burden
(in hours)
Annual burden
(in hours)
Burden for previously approved, ongoing data collection
lotter on DSK11XQN23PROD with NOTICES1
Survey of caregivers ............................................................
Direct assessments of children ............................................
Survey of the focal children’s teachers ...............................
Direct assessments of caregivers ........................................
Videotaped caregiver-child interactions ...............................
Caregiver website ................................................................
State child welfare records: data file submission ................
School records: data file submission ...................................
Estimated Total Annual Burden
Hours: 2,983
VerDate Sep<11>2014
18:17 Nov 29, 2021
Jkt 256001
1,391
1,391
1,391
1,391
2,782
348
11
16
1
1
1
1
1
1
2
2
Authority: Social Security Act Title V
511 [42 U.S.C. 711]. As extended by the
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
0.99
1.33
0.5
0.17
0.25
0.17
15
22.5
1,377
1,850
696
236
696
59
330
720
689
925
348
118
348
30
165
360
Bipartisan Budget Act of 2018 (Pub. L.
115–123) through FY22.
E:\FR\FM\30NON1.SGM
30NON1
67956
Federal Register / Vol. 86, No. 227 / Tuesday, November 30, 2021 / Notices
Linda Hitt,
ACF Certifying Officer.
[FR Doc. 2021–26102 Filed 11–26–21; 4:15 pm]
BILLING CODE 4184–74–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[CFDA Number: 93.676]
Announcement of Intent To Issue
Replacement Award To Provide
Residential Services (Shelter)
Office of Refugee Resettlement
(ORR), Administration for Children and
Families (ACF), Department of Health
and Human Services (HHS).
ACTION: Notice of issuance of
Replacement Award to Lutheran Social
Services of the South Upbring (LSS
Upbring).
AGENCY:
ACF, ORR announces the
intent to award a Replacement Award to
LSS Upbring in the amount of up to
$20,929,074 in Brownsville, Texas. On
September 17, 2021, Comprehensive
Health Services, LLC (CHS)
relinquished a federally funded
discretionary grant. Per HHS policy,
ORR has identified current recipient
LSS Upbring to transfer the current
permanent capacity to provide shelter
for apprehensions of Unaccompanied
Children (UC) at the Southwest Border.
The continuation of permanent capacity
is a prudent step to ensure that ORR is
able to meet its responsibility, by law,
to provide shelter and appropriate
services for UC referred to its care by the
Department of Homeland Security. The
purpose of this award is to ensure the
continuation of residential services for
the capacity of 76 shelter beds for UC.
DATES: The proposed period of
performance is December 1, 2021–
September 30, 2022.
FOR FURTHER INFORMATION CONTACT:
Stephen Antkowiak, Office of Refugee
Resettlement, Division of
Unaccompanied Children Operations,
330 Street SW, Washington, DC 20447.
Phone: 202–260–6165. Email:
stephen.antkowiak@acf.hhs.gov.
SUPPLEMENTARY INFORMATION: ORR
announces the intent to award a
Replacement Award to LSS Upbring in
the amount of up to $20,929,074. This
award will prevent the disruption in
residential services currently available
at the CHS Loma Alta location and
prevent children unnecessarily pending
placement from Border Patrol.
ORR has specific requirements for the
provision of services. Award recipients
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:17 Nov 29, 2021
Jkt 256001
must have the infrastructure, licensing if
applicable, experience, and appropriate
level of trained staff to meet those
requirements.
Statutory Authority: This program is
authorized by—
(A) Section 462 of the Homeland
Security Act of 2002, which in March
2003, transferred responsibility for the
care and custody of UC from the
Commissioner of the former
Immigration and Naturalization Service
to the Director of ORR within HHS.
(B) The Flores Settlement Agreement,
Case No. CV85–4544–RJK (C.D. Cal.
1996), as well as the William
Wilberforce Trafficking Victims
Protection Reauthorization Act of 2008
(Pub. L. 110–457), which authorizes
post release services under certain
conditions to eligible children. All
programs must comply with the Flores
Settlement Agreement, Case No. CV85–
4544–RJK (C.D. Cal. 1996); pertinent
regulations; and ORR policies and
procedures.
Elizabeth Leo,
Senior Grants Policy Specialist, Office of
Grants Policy, Office of Administration.
[FR Doc. 2021–25970 Filed 11–29–21; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–1146]
Real-World Data: Assessing Registries
To Support Regulatory DecisionMaking for Drug and Biological
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
guidance for industry entitled ‘‘RealWorld Data: Assessing Registries to
Support Regulatory Decision-Making for
Drug and Biological Products.’’ FDA is
issuing this guidance as part of its RealWorld Evidence (RWE) Program and to
satisfy, in part, the mandate under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) to issue guidance about the
use of RWE in regulatory decisionmaking. This guidance provides
sponsors and other stakeholders with
considerations when either proposing to
design a registry or using an existing
registry to support regulatory decisionmaking about a drug’s effectiveness or
safety.
SUMMARY:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Submit either electronic or
written comments on the draft guidance
by February 28, 2022 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:
DATES:
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–
2021–D–1146 for ‘‘Real-World Data:
Assessing Registries to Support
Regulatory Decision-Making for Drug
and Biological Products.’’ 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\30NON1.SGM
30NON1
]]>Agencies
[Federal Register Volume 86, Number 227 (Tuesday, November 30, 2021)]
[Notices]
[Pages 67955-67956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26102]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Mother and Infant Home Visiting
Program Evaluation (MIHOPE): Long-Term Follow-Up, Kindergarten data
collection (MIHOPE-K) [OMB #0970-0402]
AGENCY: Office of Planning, Research, and Evaluation, Administration
for Children and Families, HHS.
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Administration for Children and Families (ACF), in
partnership with the Health Resources and Services Administration
(HRSA), both of the U.S. Department of Health and Human Services (HHS),
is proposing to extend data collection activity as part of the
kindergarten phase of the Mother and Infant Home Visiting Program
Evaluation Long-Term Follow-Up project (MIHOPE-K). The purpose of
MIHOPE-K is to conduct a follow-up study that assesses the long-term
impact of the Maternal, Infant, and Early Childhood Home Visiting
(MIECHV) Program when the participating children are in kindergarten.
This Federal Register notice is seeking to extend data collection for
the kindergarten follow-up. The original Federal Register notices for
the MIHOPE-K data collection were titled under MIHOPE-Long-Term Follow-
Up (MIHOPE-LT).
DATES: Comments due December 30, 2021. 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.
SUPPLEMENTARY INFORMATION:
Description: This request for an extension is to complete the following
data collection activities for MIHOPE-K: (1) A survey with the child's
primary caregiver (who will be the mother if she is available), (2)
direct assessments of child development, (3) surveys with the child's
teacher, (4) a direct assessment of the caregiver, (5) videotaped
interactions between the caregiver and child, (6) a caregiver website
to provide current contact information, (7) state child welfare
records, and (8) school records. In addition to collecting these data,
the MIHOPE-K project will continue to maintain up-to-date consent forms
for the collection of administrative data. Future information
collection requests and related Federal Register notices will describe
future data collection efforts for this project.
Data collected during the kindergarten follow-up study is being
used to estimate the effects of MIECHV-funded programs on the following
seven domains: (1) Maternal health, (2) child health, (3) child
development and school performance, (4) child maltreatment, (5)
parenting, (6) crime or domestic violence, and (7) family economic
self-sufficiency.
Respondents: The respondents in this extension will include 1,391
families who have not yet participated in the kindergarten follow-up
study activities. We have assumed that only 25 percent of respondents
will complete the caregiver website. We will also obtain child welfare
data from the 11 MIHOPE states and school records data from state and
local agencies. We have assumed that we will obtain data from 11 states
and 5 local education agencies.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
No. of
No. of responses per
respondents respondent Avg. burden Total burden Annual burden
Instrument (total over (total over per response (in hours) (in hours)
request request (in hours)
period) period)
----------------------------------------------------------------------------------------------------------------
Burden for previously approved, ongoing data collection
----------------------------------------------------------------------------------------------------------------
Survey of caregivers............ 1,391 1 0.99 1,377 689
Direct assessments of children.. 1,391 1 1.33 1,850 925
Survey of the focal children's 1,391 1 0.5 696 348
teachers.......................
Direct assessments of caregivers 1,391 1 0.17 236 118
Videotaped caregiver-child 2,782 1 0.25 696 348
interactions...................
Caregiver website............... 348 1 0.17 59 30
State child welfare records: 11 2 15 330 165
data file submission...........
School records: data file 16 2 22.5 720 360
submission.....................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 2,983
Authority: Social Security Act Title V 511 [42 U.S.C. 711]. As
extended by the Bipartisan Budget Act of 2018 (Pub. L. 115-123) through
FY22.
[[Page 67956]]
Linda Hitt,
ACF Certifying Officer.
[FR Doc. 2021-26102 Filed 11-26-21; 4:15 pm]
BILLING CODE 4184-74-P
