Proposed Information Collection Activity; Generic Clearance for Financial Reports Used for ACF Mandatory Grant Programs (Office of Management and Budget #: 0970-0510), 4306-4307 [2024-01206]
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4306
Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2024–01152 Filed 1–22–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Generic Clearance for
Financial Reports Used for ACF
Mandatory Grant Programs (Office of
Management and Budget #: 0970–0510)
Administration for Children
and Families, U.S. Department of Health
and Human Services.
ACTION: Request for public comments.
AGENCY:
The Administration for
Children and Families (ACF) proposes
to extend approval of the existing
overarching generic clearance for
Financial Reports used for ACF
Mandatory Grant Programs (OMB
#0970–0510) as well as all information
collections currently approved under
the overarching generic. There are no
changes to the proposed types of
information collection or uses of data as
described in the overarching generic,
and there are no changes proposed to
currently approved information
collections for which we are requesting
an extension. Burden estimates for the
next 3 years have been adjusted based
on use to date.
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
infocollection@acf.hhs.gov. Identify all
SUMMARY:
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: ACF programs require
detailed financial information from their
grantees that allows ACF to monitor
various specialized cost categories
within each program, to closely manage
program activities, and to have
sufficient financial information to
enable periodic thorough and detailed
audits.
The information included on the
standard Federal Financial Report Form
(SF–425; OMB #4040–0014) provides
only minimal, bare-bones, non-program
specific financial information
insufficient for these purposes. This
generic clearance allows ACF programs
to efficiently develop and receive
approval for financial reports that are
tailored to specific funding recipients
and the associated needs of the program.
This umbrella generic is a mechanism
that is available to all ACF mandatory
grant programs to use to obtain OMB
approval of financial forms. Currently
only a small number of ACF’s
mandatory grant program financial
forms are covered under this umbrella;
it does not cover all ACF mandatory
grant program financial forms. Program
offices use the information collected
under this generic information
collection to:
• Monitor program operations and
prepare technical assistance and
guidance as needed
• Assess the effect of program changes
and make informed decision
• Assist in the computation of the grant
awards issued to each program’s
grantees
• Assist in the computation of the Child
Support Services program’s annual
incentive payments
• Determine that child support
collections are being properly
distributed (Child Support Services
Program only)
• Ensure funding recipients are meeting
funding requirements established by
Congress
• Produce annual financial and
statistical reports as may be required
Number of
respondents
khammond on DSKJM1Z7X2PROD with NOTICES
Study
ACF–196P, TANF Pandemic Emergency Assistance Fund (PEAF) Financial
Report for States, Territories and Tribes .....................................................
Child Care and Development Fund (CCDF) ACF–696 Financial Report for
States and Territories ...................................................................................
Child Care and Development Fund (CCDF) ACF–696T Financial Report for
Tribal Grantees ............................................................................................
Child Support Services Program Financial Reporting Forms (OCSE–34 and
OCSE–396) ..................................................................................................
Form CB–496: Title IV–E Programs Quarterly Financial Report ....................
VerDate Sep<11>2014
17:41 Jan 22, 2024
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Fmt 4703
Sfmt 4703
by Congress and respond to periodic
detailed inquiries from Congress
ACF may require an information
collection approved under this generic
from funding recipients to obtain or
retain benefits.
Prior to a new form being submitted
for review under this umbrella generic,
ACF will publish a notice in the Federal
Register announcing the agency’s
intention to request an OMB review of
the form and providing a 14-day period
for public comment on that specific
request. ACF will review any comments
received and address them as
appropriate. ACF will provide a copy of
any comments received and will
provide a description of how comments
were considered in the submission form
along with the request package for the
individual collection. ACF will then
follow standard OMB requirements for a
generic information collection and
submit a generic information collection
request for each individual data
collection activity under this generic
clearance. Each request will include the
individual form(s) and instructions, a
summary of any comments received,
and a short overview of the proposed
purpose and use of the data collected.
OMB should review requests within 10
days of submission.
Respondents: ACF-funded mandatory
grant programs.
Annual Burden Estimates
Find currently approved information
collections here: https://
www.reginfo.gov/public/do/PRAICList?
ref_nbr=202308-0970-008. The request
to OMB will include an extension
request for approved information
collections that are planned to continue
beyond spring 2024. The current list of
ongoing collections follows, but more
collections may be approved prior to
submission of the extension request to
OMB. We will update the list in the
subsequent Federal Register notice, if
needed.
Burden Estimates—Ongoing Requests
Number of
responses per
respondent
Average
burden hours
per response
Burden hours
137
1
6
822
56
4
5
1,120
221
1
7
1,547
168
67
4
4
14
25
9,408
6,700
E:\FR\FM\23JAN1.SGM
23JAN1
4307
Federal Register / Vol. 89, No. 15 / Tuesday, January 23, 2024 / Notices
Number of
respondents
Study
Number of
responses per
respondent
Average
burden hours
per response
Burden hours
Refugee Cash and Medical Assistance Federal Financial Report (ORR–2)
Supplemental Data Collection ......................................................................
Refugee Support Services Federal Financial Report (SF–425) Supplemental
Data Collection .............................................................................................
66
1
1.67
110
53
4
4
848
Totals ........................................................................................................
768
Avg: 2.7
Avg: 8.9
20,555
Burden Estimates—New Requests
Based on use of this generic, we have
revised burden estimates for the next 3
years.
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Burden hours
Mandatory Grant Financial Reports .................................................................
1,200
3
9
32,400
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.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–01206 Filed 1–22–24; 8:45 am]
BILLING CODE 4184–88–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1262]
Notice of Approval of Product Under
Voucher: Rare Pediatric Disease
Priority Review Voucher
khammond on DSKJM1Z7X2PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of approval of a product
redeeming a priority review voucher.
The Federal Food, Drug, and Cosmetic
Act (FD&C Act) authorizes FDA to
SUMMARY:
VerDate Sep<11>2014
17:41 Jan 22, 2024
Jkt 262001
award priority review vouchers to
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA is required to
publish notice of the issuance of priority
review vouchers as well as the approval
of products redeeming a priority review
voucher. FDA has determined that the
supplemental application (Supplement35) for COSENTYX (secukinumab),
approved June 16, 2020, meets the
criteria for redeeming a priority review
voucher.
FOR FURTHER INFORMATION CONTACT:
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1394, email: Cathryn.Lee@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the approval of a product
redeeming a rare pediatric disease
priority review voucher. Under section
529 of the FD&C Act (21 U.S.C. 360ff),
FDA will report the issuance of rare
pediatric disease priority review
vouchers and the approval of products
for which a voucher was redeemed.
FDA has determined that the
supplemental application (Supplement35) for COSENTYX (secukinumab)
meets the redemption criteria.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about COSENTYX
(secukinumab), go to the ‘‘Drugs@FDA’’
website at https://www.accessdata.fda.
gov/scripts/cder/daf/.
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Dated: January 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01164 Filed 1–22–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–5430]
Characterization of Metallic Coatings
and/or Calcium Phosphate Coatings on
Orthopedic Devices; 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 ‘‘Characterization of
Metallic Coatings and/or Calcium
Phosphate Coatings on Orthopedic
Devices.’’ This draft guidance document
provides recommendations for
premarket submissions for orthopedic
devices that contain metallic coatings
and/or calcium phosphate coatings on
the surface. 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 25, 2024 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:
E:\FR\FM\23JAN1.SGM
23JAN1
Agencies
[Federal Register Volume 89, Number 15 (Tuesday, January 23, 2024)]
[Notices]
[Pages 4306-4307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01206]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Generic Clearance for
Financial Reports Used for ACF Mandatory Grant Programs (Office of
Management and Budget #: 0970-0510)
AGENCY: Administration for Children and Families, U.S. Department of
Health and Human Services.
ACTION: Request for public comments.
-----------------------------------------------------------------------
SUMMARY: The Administration for Children and Families (ACF) proposes to
extend approval of the existing overarching generic clearance for
Financial Reports used for ACF Mandatory Grant Programs (OMB #0970-
0510) as well as all information collections currently approved under
the overarching generic. There are no changes to the proposed types of
information collection or uses of data as described in the overarching
generic, and there are no changes proposed to currently approved
information collections for which we are requesting an extension.
Burden estimates for the next 3 years have been adjusted based on use
to date.
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: ACF programs require detailed
financial information from their grantees that allows ACF to monitor
various specialized cost categories within each program, to closely
manage program activities, and to have sufficient financial information
to enable periodic thorough and detailed audits.
The information included on the standard Federal Financial Report
Form (SF-425; OMB #4040-0014) provides only minimal, bare-bones, non-
program specific financial information insufficient for these purposes.
This generic clearance allows ACF programs to efficiently develop and
receive approval for financial reports that are tailored to specific
funding recipients and the associated needs of the program. This
umbrella generic is a mechanism that is available to all ACF mandatory
grant programs to use to obtain OMB approval of financial forms.
Currently only a small number of ACF's mandatory grant program
financial forms are covered under this umbrella; it does not cover all
ACF mandatory grant program financial forms. Program offices use the
information collected under this generic information collection to:
Monitor program operations and prepare technical assistance
and guidance as needed
Assess the effect of program changes and make informed
decision
Assist in the computation of the grant awards issued to each
program's grantees
Assist in the computation of the Child Support Services
program's annual incentive payments
Determine that child support collections are being properly
distributed (Child Support Services Program only)
Ensure funding recipients are meeting funding requirements
established by Congress
Produce annual financial and statistical reports as may be
required by Congress and respond to periodic detailed inquiries from
Congress
ACF may require an information collection approved under this
generic from funding recipients to obtain or retain benefits.
Prior to a new form being submitted for review under this umbrella
generic, ACF will publish a notice in the Federal Register announcing
the agency's intention to request an OMB review of the form and
providing a 14-day period for public comment on that specific request.
ACF will review any comments received and address them as appropriate.
ACF will provide a copy of any comments received and will provide a
description of how comments were considered in the submission form
along with the request package for the individual collection. ACF will
then follow standard OMB requirements for a generic information
collection and submit a generic information collection request for each
individual data collection activity under this generic clearance. Each
request will include the individual form(s) and instructions, a summary
of any comments received, and a short overview of the proposed purpose
and use of the data collected. OMB should review requests within 10
days of submission.
Respondents: ACF-funded mandatory grant programs.
Annual Burden Estimates
Find currently approved information collections here: https://www.reginfo.gov/public/do/PRAICList?ref_nbr=202308-0970-008. The
request to OMB will include an extension request for approved
information collections that are planned to continue beyond spring
2024. The current list of ongoing collections follows, but more
collections may be approved prior to submission of the extension
request to OMB. We will update the list in the subsequent Federal
Register notice, if needed.
Burden Estimates--Ongoing Requests
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Study Number of responses per hours per Burden hours
respondents respondent response
----------------------------------------------------------------------------------------------------------------
ACF-196P, TANF Pandemic Emergency Assistance 137 1 6 822
Fund (PEAF) Financial Report for States,
Territories and Tribes.........................
Child Care and Development Fund (CCDF) ACF-696 56 4 5 1,120
Financial Report for States and Territories....
Child Care and Development Fund (CCDF) ACF-696T 221 1 7 1,547
Financial Report for Tribal Grantees...........
Child Support Services Program Financial 168 4 14 9,408
Reporting Forms (OCSE-34 and OCSE-396).........
Form CB-496: Title IV-E Programs Quarterly 67 4 25 6,700
Financial Report...............................
[[Page 4307]]
Refugee Cash and Medical Assistance Federal 66 1 1.67 110
Financial Report (ORR-2) Supplemental Data
Collection.....................................
Refugee Support Services Federal Financial 53 4 4 848
Report (SF-425) Supplemental Data Collection...
---------------------------------------------------------------
Totals...................................... 768 Avg: 2.7 Avg: 8.9 20,555
----------------------------------------------------------------------------------------------------------------
Burden Estimates--New Requests
Based on use of this generic, we have revised burden estimates for
the next 3 years.
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Burden hours
respondents respondent response
----------------------------------------------------------------------------------------------------------------
Mandatory Grant Financial Reports........... 1,200 3 9 32,400
----------------------------------------------------------------------------------------------------------------
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.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024-01206 Filed 1-22-24; 8:45 am]
BILLING CODE 4184-88-P