Submission for OMB Review; Follow-Up Study of Coaching Practices in Early Care and Education Settings (OMB #0970-0515), 22058-22059 [2021-08614]
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22058
Federal Register / Vol. 86, No. 78 / Monday, April 26, 2021 / Notices
minimal to the states to provide the
additional requested information.
Lastly, the request includes a survey
for the sub-grantees (or CSBG-eligible
entities). The survey focuses on the
customer service that the CSBG sub-
grantees receive from the CSBG
grantees. The survey is optional, and
this will be the fifth time that the CSBG
sub-grantees that chose to submit will
complete it. There are no revisions
proposed to the survey.
Respondents: State governments,
including the District of Columbia and
the Commonwealth of Puerto Rico, and
U.S. territories, and local level subgrantees.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
CSBG State Plan Application for States .............................
CSBG Eligible Entity Master List .........................................
CSBG ACSI Survey of Eligible Entities ...............................
Estimated Total Annual Burden
Hours: 1,848 hours for CSBG grantees;
111 for CSBG sub-grantees.
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: Sec. 676, Pub. L. 105–285, 112
Stat. 2735 (42 U.S.C. 9908).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021–08604 Filed 4–23–21; 8:45 am]
BILLING CODE 4184–27–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Office of Planning, Research,
and Evaluation, Administration for
Children and Families, HHS.
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This is a primary data
collection request for the Follow-up
Study of Coaching Practices in Early
Care and Education Settings (Follow-up
SCOPE), a follow-up to the previously
approved Study of Coaching Practices in
Early Care and Education Settings
(SCOPE) survey (OMB #0970–0515).
The study aims to examine, using
surveys and qualitative interviews, the
practice and processes of coaching and
professional development in supporting
early care and education (ECE) settings
in their provision of care for preschool
children and their families as COVID–19
has progressed. The study will focus on
both centers and family child care (FCC)
homes that serve low-income children,
with a primary target of settings that
serve children supported by Child Care
and Development Fund subsidies or a
Head Start grant.
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.
SUMMARY:
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.
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Average
burden hours
per response
3
3
1
Request for public comment.
ADDRESSES:
Submission for OMB Review; FollowUp Study of Coaching Practices in
Early Care and Education Settings
(OMB #0970–0515)
AGENCY:
ACTION:
Total
number of
responses per
respondent
31
2
.33
Total burden
hours
Annual
burden hours
5,208
336
332
1,736
112
111
SUPPLEMENTARY INFORMATION:
Description: Follow-up SCOPE will
examine the practice of coaching and
professional development more broadly
provided in support of centers and FCC
homes. The study will collect
information on the following: How
coaching and professional development
are supporting centers and FCC homes;
the perceived value and role of
coaching, professional development,
and quality improvement; the features
of coaching and how they are delivered;
and the role(s) of coaches and how they
have been supported. The study will
also examine the degree to which
coaching has been sustained and/or
changed compared to before COVID–19.
In particular, there will be a focus on
understanding the use of remote versus
in-person strategies for coaching and
professional development. This study
aims to explore the implementation of
coaching and professional development
in ECE settings as COVID–19 has
progressed. The study will not allow for
statistical generalization to different
sites or service populations.
Survey and interview questions will
focus on the current status of these
activities at the time of the data
collection, changes compared to before
COVID–19 began, and what has been
challenging or worked well. The study
will use surveys and interviews with
center directors, FCC providers, and
coaches. The sample frame will be
comprised of respondents to the 2019
survey.
Respondents: ECE center directors,
coaches, and FCC providers who
responded to 2019 SCOPE surveys.
E:\FR\FM\26APN1.SGM
26APN1
22059
Federal Register / Vol. 86, No. 78 / Monday, April 26, 2021 / Notices
ANNUAL BURDEN ESTIMATES
[Data collection will be completed within a one-year period]
Number of
respondents
(total over
request
period)
Instrument
Coach Survey (Instrument 1) ...........................................................................
Center Director Survey (Instrument 2) ............................................................
FCC Provider Survey (Instrument 3) ...............................................................
Coach Interview (Instrument 4) .......................................................................
Center Director Interview (Instrument 5) .........................................................
FCC Provider Interview (Instrument 6): FCC providers ..................................
Estimated Total Annual Burden
Hours: 104.
Authority: 42 U.S.C. 9858(a)(5), 42 U.S.C.
9835, and 42 U.S.C. 9844.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021–08614 Filed 4–23–21; 8:45 am]
BILLING CODE 4184–22–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–P–2304]
Determination That Sodium Chloride
14.6% Solution for Injection, 50
Milliequivalent/20 Milliliters, in Plastic
Containers, Was Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that Sodium Chloride
14.6% solution for injection, 50
milliequivalent (mEq)/20 milliliters
(mL), in plastic containers, was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for sodium
chloride 14.6% solution for injection, 50
mEq/20 mL, in plastic containers, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Ayako Sato, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6206, Silver Spring,
MD 20993–0002, 240–402–4191,
Ayako.Sato@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
SUMMARY:
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24
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Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
Sodium chloride 14.6% solution for
injection, 50 mEq/20 mL, in plastic
containers, is the subject of NDA 18897,
held by Hospira Inc., and initially
approved on July 20, 1984. Sodium
chloride 14.6% solution for injection is
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Sfmt 4703
Number of
responses per
respondent
(total over
request
period)
1
1
1
1
1
1
Avg. burden
per response
(in hours)
.33
.33
.33
.75
.75
.75
Total/annual
burden
(in hours)
33
22
13
9
18
9
indicated for use as an electrolyte
replenisher in parenteral fluid therapy.
In a communication dated September
6, 2019, Hospira Inc. notified FDA that
sodium chloride 14.6% solution for
injection, 50 mEq/20 mL, in plastic
containers, was being discontinued, and
FDA moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Fresenius Kabi USA, LLC submitted a
citizen petition dated December 16,
2020 (Docket No. FDA–2020–P–2304),
under 21 CFR 10.30, requesting that the
Agency determine whether sodium
chloride 14.6% solution for injection, 50
mEq/20 mL, in plastic containers, was
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that sodium chloride 14.6%
solution for injection, 50 mEq/20 mL, in
plastic containers, was not withdrawn
for reasons of safety or effectiveness.
The petitioner has identified no data or
other information suggesting that
sodium chloride 14.6% solution for
injection, 50 mEq/20 mL, in plastic
containers, was withdrawn for reasons
of safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of sodium
chloride 14.6% solution for injection, 50
mEq/20 mL, in plastic containers, from
sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have reviewed the available
evidence and determined that this drug
product was not withdrawn from sale
for reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list sodium chloride 14.6%
solution for injection, 50 mEq/20 mL, in
plastic containers, in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
E:\FR\FM\26APN1.SGM
26APN1
]]>Agencies
[Federal Register Volume 86, Number 78 (Monday, April 26, 2021)]
[Notices]
[Pages 22058-22059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08614]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Follow-Up Study of Coaching Practices
in Early Care and Education Settings (OMB #0970-0515)
AGENCY: Office of Planning, Research, and Evaluation, Administration
for Children and Families, HHS.
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: This is a primary data collection request for the Follow-up
Study of Coaching Practices in Early Care and Education Settings
(Follow-up SCOPE), a follow-up to the previously approved Study of
Coaching Practices in Early Care and Education Settings (SCOPE) survey
(OMB #0970-0515). The study aims to examine, using surveys and
qualitative interviews, the practice and processes of coaching and
professional development in supporting early care and education (ECE)
settings in their provision of care for preschool children and their
families as COVID-19 has progressed. The study will focus on both
centers and family child care (FCC) homes that serve low-income
children, with a primary target of settings that serve children
supported by Child Care and Development Fund subsidies or a Head Start
grant.
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.
SUPPLEMENTARY INFORMATION:
Description: Follow-up SCOPE will examine the practice of coaching
and professional development more broadly provided in support of
centers and FCC homes. The study will collect information on the
following: How coaching and professional development are supporting
centers and FCC homes; the perceived value and role of coaching,
professional development, and quality improvement; the features of
coaching and how they are delivered; and the role(s) of coaches and how
they have been supported. The study will also examine the degree to
which coaching has been sustained and/or changed compared to before
COVID-19. In particular, there will be a focus on understanding the use
of remote versus in-person strategies for coaching and professional
development. This study aims to explore the implementation of coaching
and professional development in ECE settings as COVID-19 has
progressed. The study will not allow for statistical generalization to
different sites or service populations.
Survey and interview questions will focus on the current status of
these activities at the time of the data collection, changes compared
to before COVID-19 began, and what has been challenging or worked well.
The study will use surveys and interviews with center directors, FCC
providers, and coaches. The sample frame will be comprised of
respondents to the 2019 survey.
Respondents: ECE center directors, coaches, and FCC providers who
responded to 2019 SCOPE surveys.
[[Page 22059]]
Annual Burden Estimates
[Data collection will be completed within a one-year period]
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses per
respondents respondent Avg. burden Total/annual
Instrument (total over (total over per response burden (in
request request (in hours) hours)
period) period)
----------------------------------------------------------------------------------------------------------------
Coach Survey (Instrument 1)..................... 100 1 .33 33
Center Director Survey (Instrument 2)........... 66 1 .33 22
FCC Provider Survey (Instrument 3).............. 38 1 .33 13
Coach Interview (Instrument 4).................. 12 1 .75 9
Center Director Interview (Instrument 5)........ 24 1 .75 18
FCC Provider Interview (Instrument 6): FCC 12 1 .75 9
providers......................................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 104.
Authority: 42 U.S.C. 9858(a)(5), 42 U.S.C. 9835, and 42 U.S.C.
9844.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021-08614 Filed 4-23-21; 8:45 am]
BILLING CODE 4184-22-P
