Agency Information Collection Activities: Submission for OMB Review; Comment Request, 9883 [2023-03149]
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Federal Register / Vol. 88, No. 31 / Wednesday, February 15, 2023 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Centers for Medicare & Medicaid
Services
SUPPLEMENTARY INFORMATION:
William Parham at (410) 786–4669.
[Document Identifiers CMS–10141]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
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.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by March 17, 2023.
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, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
ddrumheller on DSK120RN23PROD with NOTICES
DATES:
VerDate Sep<11>2014
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Jkt 259001
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
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: Revision of a currently
approved collection; Title of
Information Collection: Medicare
Prescription Drug Benefit Program; Use:
Plan sponsor and State information is
used by CMS to approve contract
applications, monitor compliance with
contract requirements, make proper
payment to plans, and ensure that
correct information is disclosed to
potential and current enrollees. Form
Number: CMS–10141 (OMB control
number: 0938–0964); Frequency:
Annually; Affected Public: Private
Sector, State, Local, or Tribal
Governments; Number of Respondents:
4,631,393; Total Annual Responses:
95,802,400; Total Annual Hours:
25,506,943. (For policy questions
regarding this collection contact Shelly
Winston at 410–786–3694.)
Dated: February 9, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–03149 Filed 2–14–23; 8:45 am]
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9883
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–D–0169]
Compounding Certain Ibuprofen Oral
Suspension Products Under Section
503B of the Federal Food, Drug, and
Cosmetic Act; Guidance for Industry;
Availability
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice of availability.
AGENCY:
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a final
guidance for industry entitled
‘‘Compounding Certain Ibuprofen Oral
Suspension Products Under Section
503B of the Federal Food, Drug, and
Cosmetic Act.’’ This guidance describes
FDA’s regulatory and enforcement
priorities regarding compounding
certain ibuprofen oral suspension
products by outsourcing facilities to
provide to hospitals and health systems
for administration within the hospital or
health-system and State-licensed
pharmacies (including those within
hospitals and health systems), and
applicable Federal facilities, to dispense
to patients for use at home after
receiving a valid, patient-specific
prescription. This final guidance revises
and replaces the guidance of the same
name issued on January 25, 2023.
Revisions were made to describe the
Agency’s regulatory and enforcement
priorities regarding the compounding of
certain ibuprofen oral suspension
products by outsourcing facilities to
provide to State-licensed pharmacies
(including those within hospitals and
health systems), and applicable Federal
facilities, to dispense to patients for use
at home after receiving a valid, patientspecific prescription.
DATES: The announcement of the
guidance is published in the Federal
Register on February 15, 2023.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances 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.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
E:\FR\FM\15FEN1.SGM
15FEN1
]]>Agencies
[Federal Register Volume 88, Number 31 (Wednesday, February 15, 2023)]
[Notices]
[Page 9883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03149]
[[Page 9883]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers CMS-10141]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is
announcing an opportunity for the public to comment on CMS' intention
to collect 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.
DATES: Comments on the collection(s) of information must be received by
the OMB desk officer by March 17, 2023.
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, please access
the CMS PRA website by copying and pasting the following web address
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.
FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION: 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 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: Revision of a currently
approved collection; Title of Information Collection: Medicare
Prescription Drug Benefit Program; Use: Plan sponsor and State
information is used by CMS to approve contract applications, monitor
compliance with contract requirements, make proper payment to plans,
and ensure that correct information is disclosed to potential and
current enrollees. Form Number: CMS-10141 (OMB control number: 0938-
0964); Frequency: Annually; Affected Public: Private Sector, State,
Local, or Tribal Governments; Number of Respondents: 4,631,393; Total
Annual Responses: 95,802,400; Total Annual Hours: 25,506,943. (For
policy questions regarding this collection contact Shelly Winston at
410-786-3694.)
Dated: February 9, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2023-03149 Filed 2-14-23; 8:45 am]
BILLING CODE 4120-01-P
