Submission for OMB Review; Assessing the Implementation and Cost of High-Quality Early Care and Education: Field Test, OMB 0970-0499, 35301-35302 [2021-14148]
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Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
Comments on the collection(s) of
information must be received by the
OMB desk officer by August 2, 2021.
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.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at: https://
www.cms.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
DATES:
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘collection of
information’’ is defined in 44 U.S.C.
3502(3) and 5 CFR 1320.3(c) and
includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires federal agencies
to publish a 30-day notice in the
Federal Register concerning each
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SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
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proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Evaluation of
the Centers for Medicare & Medicaid
Services (CMS) Network of Quality
Improvement and Innovation
Contractors (NQIIC); Use: The purpose
of this Information Collection Request
(ICR) is to collect data using telephone
surveys to inform the program
evaluation of the CMS NQIIC initiative.
The purpose of NQIIC is to support
quality improvement efforts across
settings and programs for maximum
impact to health care and value to
taxpayers in a manner that aligns with
CMS’ and Department of Health and
Human Services (HHS) priorities. The
NQIIC quality improvement efforts
involve the QIN–QIO Program, which is
one of the largest federal programs
dedicated to improving health quality
for Medicare beneficiaries.
CMS evaluates the quality and
effectiveness of the QIN–QIO Program
as authorized in Part B of Title XI of the
Social Security Act. This ICR is to
conduct data collection using surveys
with administrators or managers of
nursing homes and hospitals.
Subsequent to publishing the 60-day
Federal Register notice on March 9,
2021 (86 FR 13566), CMS conducted
pre-testing with nursing home and
hospital administrators using cognitive
interviews, which provided substantive
input from the targeted respondents to
make sure that questions are clearly
stated and understood as intended. We
have made the required changes to
questions to optimize response validity
before fielding the survey. There was a
slight decrease in burden hours. Form
Number: CMS–10769 (OMB control
number: 0938–NEW); Frequency:
Yearly; Affected Public: State and
Private Sector (Business or other forprofits); Number of Respondents: 1,000;
Total Annual Responses: 1,000; Total
Annual Hours: 290. (For policy
questions regarding this collection,
contact Jeff Mokry at 214–767–4021.)
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Dated: June 29, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–14227 Filed 7–1–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Assessing the Implementation and
Cost of High-Quality Early Care and
Education: Field Test, OMB 0970–0499
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) at the U.S.
Department of Health and Human
Services (HHS) seeks approval to collect
new information to use in testing
measures of the implementation and
costs of high-quality early care and
education as part of the project,
Assessing the Implementation and Cost
of High-Quality Early Care and
Education (ECE–ICHQ). The study
received approval for a field test to
validate and improve the psychometric
properties of these measures in
November 2019. This request is to add
a measure to the approved field test to
help further assess the associations
between measures of implementation,
cost, and quality.
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 using the
search function.
SUPPLEMENTARY INFORMATION:
Description: ACF seeks approval to
collect new information to use in testing
measures of the implementation and
costs of high-quality early care and
education as part of the ECE–ICHQ
SUMMARY:
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35302
Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices
project. The project’s goal is to create a
technically sound and feasible
instrument that will provide consistent,
systematic measures of the
implementation and costs of education
and care in center-based settings that
serve children from birth to age 5. The
resulting measures will inform research,
policy, and practice by improving
understanding of variations in what
centers do to support quality, their
associated costs, and how resources for
ECE may be better aligned with
expectations for quality. The study
received approval for a field test to
validate and improve the psychometric
properties of these measures in
November 2019. For all previously
approved materials for this study, see
https://www.reginfo.gov/public/do/
PRAOMBHistory?ombControlNumber=
0970-0499. This request is to add a
measure to the approved field test to
help further assess the associations
between measures of implementation,
cost, and quality. The field test and this
additional measure will include only
remote data collection.
Respondents: Teachers and aids.
ANNUAL BURDEN ESTIMATES
Number of
respondents
(total over
request period)
Instrument
Center re-engagement call and roster update for teaching staff survey
Teaching staff survey ..............................................................................
Estimated Total Annual Burden
Hours: 600.
Authority: § 658O(a)(5) as amended by the
CCDBG Act of 2014 § 9.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021–14148 Filed 7–1–21; 8:45 am]
BILLING CODE 4184–24–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–0420]
Providing Regulatory Submissions in
Alternate Electronic Format; 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 for industry entitled
‘‘Providing Regulatory Submissions in
Alternate Electronic Format.’’ Under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act), Congress granted FDA the
authority to implement the statutory
electronic submission requirements in
guidance. In response, FDA
implemented binding guidance
requiring that new drug applications
(NDAs), abbreviated new drug
applications (ANDAs), certain drug
master files (DMFs), certain biologics
license applications (BLAs), and certain
investigational new drug applications
(INDs) be submitted to the Agency in
electronic common technical document
format. Recognizing that some
submissions are exempt from this
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SUMMARY:
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Number of
responses per
respondent
(total over
request period)
80
1,120
requirement and that waivers of the
requirement may be granted on a caseby-case basis, the Agency is issuing this
guidance to provide recommendations
on an alternate electronic format for
submissions covered under such
exemptions and waivers. This guidance
replaces the draft guidance of the same
title issued on March 11, 2020.
DATES: The announcement of the
guidance is published in the Federal
Register on July 2, 2021.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances 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
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
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1
1
Avg. burden
per response
(in hours)
Total/annual
burden
(in hours)
.50
.50
40
560
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–
2020–D–0420 for ‘‘Providing Regulatory
Submissions in Alternate Electronic
Format.’’ 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
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Agencies
[Federal Register Volume 86, Number 125 (Friday, July 2, 2021)]
[Notices]
[Pages 35301-35302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14148]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Assessing the Implementation and Cost
of High-Quality Early Care and Education: Field Test, OMB 0970-0499
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) at the U.S.
Department of Health and Human Services (HHS) seeks approval to collect
new information to use in testing measures of the implementation and
costs of high-quality early care and education as part of the project,
Assessing the Implementation and Cost of High-Quality Early Care and
Education (ECE-ICHQ). The study received approval for a field test to
validate and improve the psychometric properties of these measures in
November 2019. This request is to add a measure to the approved field
test to help further assess the associations between measures of
implementation, cost, and quality.
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 using the search function.
SUPPLEMENTARY INFORMATION:
Description: ACF seeks approval to collect new information to use
in testing measures of the implementation and costs of high-quality
early care and education as part of the ECE-ICHQ
[[Page 35302]]
project. The project's goal is to create a technically sound and
feasible instrument that will provide consistent, systematic measures
of the implementation and costs of education and care in center-based
settings that serve children from birth to age 5. The resulting
measures will inform research, policy, and practice by improving
understanding of variations in what centers do to support quality,
their associated costs, and how resources for ECE may be better aligned
with expectations for quality. The study received approval for a field
test to validate and improve the psychometric properties of these
measures in November 2019. For all previously approved materials for
this study, see https://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=0970-0499. This request is to add a
measure to the approved field test to help further assess the
associations between measures of implementation, cost, and quality. The
field test and this additional measure will include only remote data
collection.
Respondents: Teachers and aids.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses per Avg. burden Total/annual
Instrument respondents respondent per response burden (in
(total over (total over (in hours) hours)
request period) request period)
----------------------------------------------------------------------------------------------------------------
Center re-engagement call and roster update 80 1 .50 40
for teaching staff survey..................
Teaching staff survey....................... 1,120 1 .50 560
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 600.
Authority: Sec. 658O(a)(5) as amended by the CCDBG Act of 2014
Sec. 9.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021-14148 Filed 7-1-21; 8:45 am]
BILLING CODE 4184-24-P