Submission for Office of Management and Budget (OMB) Review; Annual Report on State Maintenance-of-Effort (MOE) Programs-ACF-204 (Annual MOE Report) (Office of Management and Budget, 75051-75052 [2022-26542]
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Federal Register / Vol. 87, No. 234 / Wednesday, December 7, 2022 / Notices
validation reviews or complaint
surveys, the state survey agency
monitors corrections as specified at
§ 488.9.
++ CIHQ’s capacity to report
deficiencies to the surveyed facilities
and respond to the facility’s plan of
correction in a timely manner.
++ CIHQ’s capacity to provide CMS
with electronic data and reports
necessary for effective validation and
assessment of the organization’s survey
process.
++ The adequacy of the CIHQ’s staff
and other resources, and its financial
viability.
++ CIHQ’s capacity to adequately
fund required surveys.
++ CIHQ’s policies with respect to
whether surveys are announced or
unannounced, to assure that surveys are
unannounced.
++ CIHQ’s policies and procedures to
avoid conflicts of interest, including the
appearance of conflicts of interest,
involving individuals who conduct
surveys or participate in accreditation
decisions.
++ CIHQ’s agreement to provide CMS
with a copy of the most current
accreditation survey together with any
other information related to the survey
as we may require (including corrective
action plans).
IV. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
V. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Chiquita Brooks-LaSure, having
reviewed and approved this document,
authorizes Lynette Wilson, who is the
Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Dated: December 2, 2022.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2022–26596 Filed 12–6–22; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB No. 0970–0248]
Submission for Office of Management
and Budget (OMB) Review; Annual
Report on State Maintenance-of-Effort
(MOE) Programs—ACF–204 (Annual
MOE Report) (Office of Management
and Budget
Office of Family Assistance,
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) is
requesting a 3-year extension of the
ACF–204 (Annual MOE Report; OMB
#0970–0248, expiration November 30,
2022). There are no changes requested
to this information collection.
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
SUMMARY:
75051
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
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. You can also obtain
copies of the proposed collection of
information by emailing infocollection@
acf.hhs.gov. Identify all emailed
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: The Annual MOE Report
is used to collect descriptive program
characteristics information on the
programs operated by states and
territories in association with their
Temporary Assistance for Needy
Families (TANF) programs. All state and
territory expenditures claimed toward
states and territories MOE requirements
must be appropriate, i.e., meet all
applicable MOE requirements. The
Annual MOE Report provides the ability
to learn about and to monitor the nature
of state and territory expenditures used
to meet states and territories MOE
requirements, and it is an important
source of information about the different
ways that states and territories are using
their resources to help families attain
and maintain self-sufficiency. In
addition, the report is used to obtain
state and territory program
characteristics for ACFs annual report to
Congress, and the report serves as a
useful resource to use in Congressional
hearings about how TANF programs are
evolving, in assessing state and the
territory MOE expenditures, and in
assessing the need for legislative
changes.
Respondents: The 50 States of the
United States, the District of Columbia,
Guam, Puerto Rico, and the Virgin
Islands.
ADDRESSES:
ddrumheller on DSK6VXHR33PROD with NOTICES
ANNUAL BURDEN ESTIMATES
Instrument
Total number
of respondents
per year
Total number
of annual
responses per
respondent
Average
burden hours
per response
Annual burden
hours
ACF–204; Annual MOE Report .......................................................................
54
1
118
6,372
Estimated Total Annual Burden
Hours: 6,372.
VerDate Sep<11>2014
19:54 Dec 06, 2022
Jkt 259001
Authority: Section 402 of the Social
Security Act (42 U.S.C. 602), as
amended by Public Law 104–193, the
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Personal Responsibility and Work
Opportunity Reconciliation Act of 1996.
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75052
Federal Register / Vol. 87, No. 234 / Wednesday, December 7, 2022 / Notices
Mary B. Jones,
ACF/OPRE Certifying Officer.
For further information about IMJUDO
(tremelimumab), approved October 23,
2022, go to the ‘‘Drugs@FDA’’ website at
https://www.accessdata.fda.gov/scripts/
cder/daf/.
[FR Doc. 2022–26542 Filed 12–6–22; 8:45 am]
BILLING CODE 4184–82–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Food and Drug Administration
[FR Doc. 2022–26565 Filed 12–6–22; 8:45 am]
BILLING CODE 4164–01–P
[Docket No. FDA–2018–N–1262]
Notice of Approval of Product Under
Voucher: Rare Pediatric Disease
Priority Review Voucher
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration,
HHS.
ACTION:
[Docket No. FDA–2022–D–2301]
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), as amended by the
Food and Drug Administration Safety
and Innovation Act (FDASIA),
authorizes FDA to 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 IMJUDO
(tremelimumab), approved October 23,
2022, 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.
SUMMARY:
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),
which was added by FDASIA, 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 IMJUDO
(tremelimumab), approved October 23,
2022, 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/RarePediatricDisease
PriorityVoucherProgram/default.htm.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK6VXHR33PROD with NOTICES
Food and Drug Administration
VerDate Sep<11>2014
19:54 Dec 06, 2022
Jkt 259001
Small Volume Parenteral Drug
Products and Pharmacy Bulk
Packages for Parenteral Nutrition:
Aluminum Content and Labeling
Recommendations; 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 ‘‘Small
Volume Parenteral Drug Products and
Pharmacy Bulk Packages for Parenteral
Nutrition: Aluminum Content and
Labeling Recommendations.’’ This draft
guidance is intended to clarify the key
factors in determining the appropriate
aluminum content in a small volume
parenteral (SVP) drug product and/or a
pharmacy bulk package (PBP) intended
as a component of parenteral nutrition
(PN) and provide FDA’s
recommendations regarding the
concentration of aluminum in SVP drug
products and PBPs for PN. Additionally,
this guidance is intended to assist
applicants in determining the
appropriate content and placement of
information on aluminum in SVP and
PBP human prescription drug product
labeling.
DATES: Submit either electronic or
written comments on the draft guidance
by February 6, 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:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
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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–
2022–D–2301 for ‘‘Small Volume
Parenteral Drug Products and Pharmacy
Bulk Packages for Parenteral Nutrition:
Aluminum Content and Labeling
Recommendations.’’ 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
E:\FR\FM\07DEN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 234 (Wednesday, December 7, 2022)]
[Notices]
[Pages 75051-75052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26542]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
[OMB No. 0970-0248]
Submission for Office of Management and Budget (OMB) Review;
Annual Report on State Maintenance-of-Effort (MOE) Programs--ACF-204
(Annual MOE Report) (Office of Management and Budget
AGENCY: Office of Family Assistance, 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) is
requesting a 3-year extension of the ACF-204 (Annual MOE Report; OMB
#0970-0248, expiration November 30, 2022). There are no changes
requested to this information collection.
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. You can
also obtain copies of the proposed collection of information by
emailing [email protected]. Identify all emailed requests by
the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: The Annual MOE Report is used to collect descriptive
program characteristics information on the programs operated by states
and territories in association with their Temporary Assistance for
Needy Families (TANF) programs. All state and territory expenditures
claimed toward states and territories MOE requirements must be
appropriate, i.e., meet all applicable MOE requirements. The Annual MOE
Report provides the ability to learn about and to monitor the nature of
state and territory expenditures used to meet states and territories
MOE requirements, and it is an important source of information about
the different ways that states and territories are using their
resources to help families attain and maintain self-sufficiency. In
addition, the report is used to obtain state and territory program
characteristics for ACFs annual report to Congress, and the report
serves as a useful resource to use in Congressional hearings about how
TANF programs are evolving, in assessing state and the territory MOE
expenditures, and in assessing the need for legislative changes.
Respondents: The 50 States of the United States, the District of
Columbia, Guam, Puerto Rico, and the Virgin Islands.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Total number of
Total number of annual Average burden Annual burden
Instrument respondents per responses per hours per hours
year respondent response
----------------------------------------------------------------------------------------------------------------
ACF-204; Annual MOE Report.................. 54 1 118 6,372
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 6,372.
Authority: Section 402 of the Social Security Act (42 U.S.C. 602),
as amended by Public Law 104-193, the Personal Responsibility and Work
Opportunity Reconciliation Act of 1996.
[[Page 75052]]
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022-26542 Filed 12-6-22; 8:45 am]
BILLING CODE 4184-82-P
