Office of Management and Budget (OMB) Expedited Review and Public Comment: Revisions to Recordkeeping To Mitigate the Spread of COVID-19 in Head Start (OMB #: 0970-0583), 2101-2102 [2023-00429]
Download as PDF
<![CDATA[
2101
Federal Register / Vol. 88, No. 8 / Thursday, January 12, 2023 / Notices
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: On an annual basis,
Tribal Lead Agencies for the Child Care
and Development Fund (CCDF) are
required to submit aggregate
information on services provided via the
CCDF Tribal Annual Report, also known
as the ACF–700 report and offers the
Office of Child Care (OCC) a glimpse
into how CCDF program dollars are
being spent. The ACF–700 report
captures administrative data about the
number of families and children served.
The report also contains specific
questions that gather programmatic
information about Tribal quality
activities, coordination of activities with
other early childhood programs, use of
funds, technical assistance needs, use of
the Data Tracker software, and progress
toward identified goals. The data
derived from this report allows OCC to
generate and analyze aggregate
information, thereby giving OCC a more
comprehensive understanding of Tribal
program activities more easily. The data
are essential for demonstrating the
accomplishments of Tribal child care
programs.
Respondents: Tribal Grantees
receiving CCDF funding. Tribes that
operate child care under Public Law
102–477 Indian Employment, Training,
and Related Services Plan are exempt
from the ACF–700.
ANNUAL BURDEN ESTIMATES
Total number
of responses
per respondent
Instrument
Total number
of respondents
ACF–700 ......................
ACF–700 ......................
141 (Tribes with small allocations) ...................
78 (Tribes with medium/large allocations) ........
Estimated Total Annual Burden
Hours: 4,780.
Authority: 42 U.S.C. 9857.
John M. Sweet, Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–00421 Filed 1–11–23; 8:45 am]
BILLING CODE 4184–43–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Office of Management and Budget
(OMB) Expedited Review and Public
Comment: Revisions to Recordkeeping
To Mitigate the Spread of COVID–19 in
Head Start (OMB #: 0970–0583)
Office of Head Start;
Administration for Children and
Families; Department of Health and
Human Services.
ACTION: Request for public comments.
AGENCY:
The Office of Head Start,
Administration for Children and
Families (ACF), U.S. Department of
SUMMARY:
Average
burden hours
per response
3
3
Health and Human Services, is
requesting expedited review from OMB
and inviting public comments on
revisions to the recordkeeping
requirements under Recordkeeping to
Mitigate the Spread of COVID–19 in
Head Start (OMB #: 0970–0583). A Final
Rule requires grant recipients to update
their program policies and procedures
to include an evidence-based COVID–19
mitigation policy developed in
consultation with their Health Services
Advisory Committee.
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
in this notice.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
submitted by emailing infocollection@
acf.hhs.gov. Identify all requests by the
title of the information collection:
Recordkeeping to Mitigate the Spread of
COVID–19 in Head Start (OMB #: 0970–
0583).
Total burden
hours
19
26
Annual
burden hours
7,866
6,474
2,622
2,158
SUPPLEMENTARY INFORMATION:
Description: The requirement that
grant recipients establish a COVID–19
mitigation policy in their program
policies and procedures will go into
effect 60 days following the publication
of the Final Rule. The use of normal
clearance procedures will not allow for
this recordkeeping requirement to be
approved prior to the effective date of
the final rule. Therefore, ACF is
requesting that OMB grant a 180-day
approval for this request under
procedures for expedited processing. A
request for review under normal
procedures will be submitted within
180 days of the approval for this
request. Only the burden related to the
new recordkeeping requirement is
displayed below. See OMB number
0970–0583 for additional information
about existing recordkeeping
requirements. This request under
normal procedures will include an
extension for all record keeping
requirements under this OMB number.
Respondents: Head Start Grant
recipients.
khammond on DSKJM1Z7X2PROD with NOTICES
ANNUAL BURDEN ESTIMATES
Instrument
Total
number of
respondents
Responses
per
respondent
Average
burden hours
per response
Annual
burden hours
Grant Recipient Updating Program Policies and Procedures .........................
1,604
1
8
12,832
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
VerDate Sep<11>2014
17:36 Jan 11, 2023
Jkt 259001
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
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
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
E:\FR\FM\12JAN1.SGM
12JAN1
2102
Federal Register / Vol. 88, No. 8 / Thursday, January 12, 2023 / Notices
within 60 days of this publication.
Comments will be considered and any
necessary updates to materials made
prior to, and responses provided in, the
submission to OMB that will follow this
public comment period.
Authority: 88 FR 993.
John M. Sweet Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–00429 Filed 1–11–23; 8:45 am]
BILLING CODE 4184–40–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–3116]
Photobiomodulation Devices—
Premarket Notification Submissions;
Draft Guidance for Industry and Food
and Drug Administration Staff;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Photobiomodulation
(PBM) Devices—Premarket Notification
[510(k)] Submissions.’’ This draft
guidance provides recommendations on
premarket submissions for
photobiomodulation devices, which are
used in applications such as aesthetics,
dermatology, and other general
indications. This draft guidance is not
final nor is it for implementation at this
time.
DATES: Submit either electronic or
written comments on the draft guidance
by March 13, 2023 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:
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
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
VerDate Sep<11>2014
17:36 Jan 11, 2023
Jkt 259001
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–
2022–D–3116 for ‘‘Photobiomodulation
(PBM) Devices—Premarket Notification
[510(k)] Submissions.’’ 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
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled
‘‘Photobiomodulation (PBM) Devices—
Premarket Notification [510(k)]
Submissions.’’ to the Office of Policy,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5431, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request.
FOR FURTHER INFORMATION CONTACT:
Jessica Mavadia-Shukla, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4643,
Silver Spring, MD 20993–0002, 301–
348–1596.
SUPPLEMENTARY INFORMATION:
I. Background
PBM devices, also known as low level
light therapy devices, are intended for
use in applications such as aesthetics,
dermatology, and other general
indications. A PBM device is designed
to deliver a non-heating dose of light
energy into the body to provide clinical
benefit to the patient. This draft
guidance document provides FDA’s
recommendations on non-clinical
testing, clinical studies, and labeling to
support premarket submissions for PBM
devices. The recommendations reflect
current review practices and are
intended to promote consistency and
facilitate efficient review of these
submissions.
E:\FR\FM\12JAN1.SGM
12JAN1
]]>Agencies
[Federal Register Volume 88, Number 8 (Thursday, January 12, 2023)]
[Notices]
[Pages 2101-2102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00429]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Office of Management and Budget (OMB) Expedited Review and Public
Comment: Revisions to Recordkeeping To Mitigate the Spread of COVID-19
in Head Start (OMB #: 0970-0583)
AGENCY: Office of Head Start; Administration for Children and Families;
Department of Health and Human Services.
ACTION: Request for public comments.
-----------------------------------------------------------------------
SUMMARY: The Office of Head Start, Administration for Children and
Families (ACF), U.S. Department of Health and Human Services, is
requesting expedited review from OMB and inviting public comments on
revisions to the recordkeeping requirements under Recordkeeping to
Mitigate the Spread of COVID-19 in Head Start (OMB #: 0970-0583). A
Final Rule requires grant recipients to update their program policies
and procedures to include an evidence-based COVID-19 mitigation policy
developed in consultation with their Health Services Advisory
Committee.
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 in this notice.
ADDRESSES: Copies of the proposed collection of information can be
obtained and comments may be submitted by emailing
[email protected]. Identify all requests by the title of the
information collection: Recordkeeping to Mitigate the Spread of COVID-
19 in Head Start (OMB #: 0970-0583).
SUPPLEMENTARY INFORMATION:
Description: The requirement that grant recipients establish a
COVID-19 mitigation policy in their program policies and procedures
will go into effect 60 days following the publication of the Final
Rule. The use of normal clearance procedures will not allow for this
recordkeeping requirement to be approved prior to the effective date of
the final rule. Therefore, ACF is requesting that OMB grant a 180-day
approval for this request under procedures for expedited processing. A
request for review under normal procedures will be submitted within 180
days of the approval for this request. Only the burden related to the
new recordkeeping requirement is displayed below. See OMB number 0970-
0583 for additional information about existing recordkeeping
requirements. This request under normal procedures will include an
extension for all record keeping requirements under this OMB number.
Respondents: Head Start Grant recipients.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Average burden
Instrument Total number Responses per hours per Annual burden
of respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Grant Recipient Updating Program Policies 1,604 1 8 12,832
and Procedures.............................
----------------------------------------------------------------------------------------------------------------
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
[[Page 2102]]
within 60 days of this publication. Comments will be considered and any
necessary updates to materials made prior to, and responses provided
in, the submission to OMB that will follow this public comment period.
Authority: 88 FR 993.
John M. Sweet Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2023-00429 Filed 1-11-23; 8:45 am]
BILLING CODE 4184-40-P
