Agency Information Collection Activities: Proposed Collection; Comment Request, 61600-61601 [2022-22077]
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Federal Register / Vol. 87, No. 196 / Wednesday, October 12, 2022 / Notices
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 November 14,
2022.
DATES:
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.
ADDRESSES:
jspears on DSK121TN23PROD with NOTICES
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
VerDate Sep<11>2014
18:37 Oct 11, 2022
Jkt 259001
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: Solicitation
for Applications for Medicare
Prescription Drug Plan 2024 Contracts;
Use: Coverage for the prescription drug
benefit is provided through contracted
prescription drug plans (PDPs) or
through Medicare Advantage (MA)
plans that offer integrated prescription
drug and health care coverage (MA–PD
plans). Cost Plans that are regulated
under Section 1876 of the Social
Security Act, and Employer Group
Waiver Plans (EGWP) may also provide
a Part D benefit. Organizations wishing
to provide services under the
Prescription Drug Benefit Program must
complete an application, negotiate rates,
and receive final approval from CMS.
Existing Part D Sponsors may also
expand their contracted service area by
completing the Service Area Expansion
(SAE) application.
Collection of this information is
mandated in Part D of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) in
Subpart 3. The application requirements
are codified in Subpart K of 42 CFR 423
entitled ‘‘Application Procedures and
Contracts with PDP Sponsors.’’
The information will be collected
under the solicitation of proposals from
PDP, MA–PD, Cost Plan, Program of AllInclusive Care for the Elderly (PACE),
and EGWP applicants. The collected
information will be used by CMS to: (1)
ensure that applicants meet CMS
requirements for offering Part D plans
(including network adequacy,
contracting requirements, and
compliance program requirements, as
described in the application), (2)
support the determination of contract
awards. Form Number: CMS–10137
(OMB Control Number: 0938–0936);
Frequency: Annually; Affected Public:
Private Sector, Business or other forprofit and not-for-profit institutions;
Number of Respondents: 783; Number
of Responses: 425 Total Annual Hours:
1,861. (For policy questions regarding
this collection contact Arianne
Spaccarelli at 410–786–5715.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title: Applications
for Part C Medicare Advantage, 1876
Cost Plans, and Employer Group Waiver
Plans to Provide Part C Benefits; Use:
Collection of this information is
mandated by the Code of Federal
Regulations, MMA, and CMS
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
regulations at 42 CFR 422, subpart K, in
‘‘Application Procedures and Contracts
for Medicare Advantage Organizations.’’
In addition, the Medicare Improvement
for Patients and Providers Act of 2008
(MIPPA) further amended titles XVII
and XIX of the Social Security Act.
This information collection includes
the process for organizations wishing to
provide healthcare services under MA
plans. These organizations must
complete an application annually (if
required), file a bid, and receive final
approval from CMS. The MA
application process has two options for
applicants that include (1) request for
new MA product or (2) request for
expanding the service area of an existing
product. CMS utilizes the application
process as the means to review, assess
and determine if applicants are
compliant with the current
requirements for participation in the
MA program and to make a decision
related to contract award. This
collection process is the only
mechanism for organizations to
complete the required MA application
process. Form Number: CMS–10237
(OMB Control Number: 0938–0935);
Frequency: Annually; Affected Public:
Private Sector, Business or other forprofit and not-for-profit institutions;
Number of Respondents: 500; Number
of Responses: 500 Total Annual Hours:
9,173. (For policy questions regarding
this collection contact Keith Penn-Jones
at 410–786–3104 or Keith.Penn-Jones@
cms.hhs.gov.)
Dated: October 5, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2022–22076 Filed 10–11–22; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10628]
Agency Information Collection
Activities: Proposed Collection;
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
SUMMARY:
E:\FR\FM\12OCN1.SGM
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Federal Register / Vol. 87, No. 196 / Wednesday, October 12, 2022 / Notices
Paperwork Reduction Act of 1995 (the
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
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates 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 must be received by
December 12, 2022.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number: lll, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
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.
jspears on DSK121TN23PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
VerDate Sep<11>2014
18:37 Oct 11, 2022
Jkt 259001
and associated materials (see
ADDRESSES).
CMS–10628—Initial Request for State
Implemented Moratorium Form
Under the 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
requires federal agencies to publish a
60-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.
Information Collection
1. Type of Information Collection
Request: Reinstatement of a previously
approved collection; Title of
Information Collection: Initial Request
for State Implemented Moratorium
Form; Use: Congress has enacted section
1866 (j)(7) of the Social Security Act,
which allows for the imposition of
temporary moratorium. CMS
promulgated 42 CFR 424.570 in order to
comply with that statute, which requires
that prior to implementing state
Medicaid moratoria the state Medicaid
agency must notify the Secretary in
writing, including all of the details of
the moratoria, and obtain the Secretary’s
concurrence with the imposition of the
moratoria.
The Initial Request for State Medicaid
Implemented Moratorium, named the
‘‘Initial Request for State Medicaid
Implemented Moratorium’’ has been
created to collect that data, in a uniform
manner, which the states report to CMS
when they request a moratorium.
Currently, CMS is collecting this data on
an ad-hoc basis, however this process
needs to be standardized so that
moratoria decisions are being made
based on the same criteria each time.
The form may be used by states and
territories who wish to impose a
Medicaid or Children’s Health
Insurance Program moratorium. CMS
will use this information as a
standardized method to collect and
track state-imposed moratoria requests.
Form number: CMS–10628 (OMB
control number: 0938–1328); Frequency:
Occasionally; Affected Public: State,
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
61601
Local, or Tribal Governments; Number
of Respondents: 5; Number of
Responses: 5; Total Burden Hours: 25.
(For questions regarding this collection
contact Alisha Jacobs at 410–786–0671).
Dated: October 5, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2022–22077 Filed 10–11–22; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration.
[Docket No. FDA–2022–N–2354]
Generic Drug User Fee Rates for Fiscal
Year 2023
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Federal Food, Drug, and
Cosmetic Act (FD&C Act or statute), as
amended by the Generic Drug User Fee
Amendments of 2022 (GDUFA III),
authorizes the Food and Drug
Administration (FDA, Agency, or we) to
assess and collect fees for abbreviated
new drug applications (ANDAs); drug
master files (DMFs); generic drug active
pharmaceutical ingredient (API)
facilities, finished dosage form (FDF)
facilities, and contract manufacturing
organization (CMO) facilities; and
generic drug applicant program user
fees. In this document, FDA is
announcing fiscal year (FY) 2023 rates
for GDUFA III fees. These fees are
effective on October 1, 2022, and will
remain in effect through September 30,
2023.
FOR FURTHER INFORMATION CONTACT:
Robert Marcarelli, Office of Financial
Management, Food and Drug
Administration, 4041 Powder Mill Rd.,
Rm. 61075, Beltsville, MD 20705–4304,
and the User Fees Support Staff at OOOFBAP-OFM-UFSS-Government@
fda.hhs.gov, 301–796–7223.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Sections 744A and 744B of the FD&C
Act (21 U.S.C. 379j–41 and 379j–42), as
amended by GDUFA III, authorize FDA
to assess and collect fees associated
with human generic drug products. Fees
are assessed on: (1) certain types of
applications for human generic drug
products; (2) certain facilities where
APIs and FDFs are produced; (3) certain
E:\FR\FM\12OCN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 196 (Wednesday, October 12, 2022)]
[Notices]
[Pages 61600-61601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22077]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10628]
Agency Information Collection Activities: Proposed Collection;
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
[[Page 61601]]
Paperwork Reduction Act of 1995 (the 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
60 days for public comment on the proposed action. Interested persons
are invited to send comments regarding our burden estimates 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 must be received by December 12, 2022.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number. To be assured consideration, comments and
recommendations must be submitted in any one of the following ways:
1. Electronically. You may send your comments electronically to
https://www.regulations.gov. Follow the instructions for ``Comment or
Submission'' or ``More Search Options'' to find the information
collection document(s) that are accepting comments.
2. By regular mail. You may mail written comments to the following
address: CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development, Attention: Document Identifier/OMB
Control Number: ___, Room C4-26-05, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850.
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 N. Parham at (410) 786-4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the use and burden associated
with the following information collections. More detailed information
can be found in each collection's supporting statement and associated
materials (see ADDRESSES).
CMS-10628--Initial Request for State Implemented Moratorium Form
Under the 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 requires federal agencies
to publish a 60-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.
Information Collection
1. Type of Information Collection Request: Reinstatement of a
previously approved collection; Title of Information Collection:
Initial Request for State Implemented Moratorium Form; Use: Congress
has enacted section 1866 (j)(7) of the Social Security Act, which
allows for the imposition of temporary moratorium. CMS promulgated 42
CFR 424.570 in order to comply with that statute, which requires that
prior to implementing state Medicaid moratoria the state Medicaid
agency must notify the Secretary in writing, including all of the
details of the moratoria, and obtain the Secretary's concurrence with
the imposition of the moratoria.
The Initial Request for State Medicaid Implemented Moratorium,
named the ``Initial Request for State Medicaid Implemented Moratorium''
has been created to collect that data, in a uniform manner, which the
states report to CMS when they request a moratorium. Currently, CMS is
collecting this data on an ad-hoc basis, however this process needs to
be standardized so that moratoria decisions are being made based on the
same criteria each time. The form may be used by states and territories
who wish to impose a Medicaid or Children's Health Insurance Program
moratorium. CMS will use this information as a standardized method to
collect and track state-imposed moratoria requests.
Form number: CMS-10628 (OMB control number: 0938-1328); Frequency:
Occasionally; Affected Public: State, Local, or Tribal Governments;
Number of Respondents: 5; Number of Responses: 5; Total Burden Hours:
25. (For questions regarding this collection contact Alisha Jacobs at
410-786-0671).
Dated: October 5, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2022-22077 Filed 10-11-22; 8:45 am]
BILLING CODE 4120-01-P
