Agency Information Collection Activities: Proposed Collection; Comment Request, 12686 [2023-04068]
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12686
Federal Register / Vol. 88, No. 39 / Tuesday, February 28, 2023 / Notices
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES Centers for
Medicare & Medicaid Services
[Document Identifier: CMS–10716]
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
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
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
May 1, 2023.
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
ddrumheller on DSK120RN23PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:37 Feb 27, 2023
Jkt 259001
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–10716 Applicable Integrated
Plan Coverage Decision Letter
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: Revision of a currently
approved collection; Title of
Information Collection: Applicable
Integrated Plan Coverage Decision
Letter; Use: Sections 1859(f)(8) of the
Act require development of unified
grievance and appeals processes for
D–SNPs, to the extent feasible. We
finalized the implementation of this
regulation for integrated organization
determinations at § 422.631, effective
January 1, 2021. This rule requires
applicable integrated plans to send an
enrollee a written notice of any adverse
decision on an integrated organization
determination using a notice that is
written in plain language and contains
the information detailed at
§ 422.631(d)(1)(iii).
Applicable integrated plans as
defined at § 422.561 are required to
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
issue form CMS–10716 when a request
for either a medical service or payment
is denied in whole or in part after
considering both the Medicare or
Medicaid benefit. Applicable integrated
plans issue this form to enrollees when
the plan reduces, stops, suspends, or
denies, in whole or in part, a request for
a service or item (including a Part B
drug) or a request for payment of a
service or item (including a Part B drug)
that the enrollee has already received.
The form provides the enrollee with
information regarding their right to an
appeal of the applicable integrated
plan’s decision and the enrollee will use
the instructions to navigate the appeal
process. Form Number: CMS–10716
(OMB control number: 0938–1386);
Frequency: Occasionally; Affected
Public: Private sector (Business or other
for-profits); Number of Respondents:
112; Total Annual Responses: 24,716;
Total Annual Hours: 4,120. (For policy
questions regarding this collection
contact Kristi Sugarman Coats at 415–
744–3629.)
Dated: February 23, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2023–04068 Filed 2–27–23; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0333]
Richard M. Fleming; Denial of Hearing
on Application for Termination of
Debarment
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
denying Dr. Richard M. Fleming’s (Dr.
Fleming’s) request for a hearing and
denying his application for termination
of debarment under the Federal Food,
Drug, and Cosmetic Act (FD&C Act). Dr.
Fleming has failed to file information
and analyses sufficient to create a basis
for a hearing concerning this action.
DATES: This order is applicable February
28, 2023.
ADDRESSES: You may be submit
comments at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
E:\FR\FM\28FEN1.SGM
28FEN1
Agencies
- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services
[Federal Register Volume 88, Number 39 (Tuesday, February 28, 2023)]
[Notices]
[Page 12686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04068]
[[Page 12686]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid
Services
[Document Identifier: CMS-10716]
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 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 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 May 1, 2023.
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-10716 Applicable Integrated Plan Coverage Decision Letter
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: Revision of a currently
approved collection; Title of Information Collection: Applicable
Integrated Plan Coverage Decision Letter; Use: Sections 1859(f)(8) of
the Act require development of unified grievance and appeals processes
for D-SNPs, to the extent feasible. We finalized the implementation of
this regulation for integrated organization determinations at Sec.
422.631, effective January 1, 2021. This rule requires applicable
integrated plans to send an enrollee a written notice of any adverse
decision on an integrated organization determination using a notice
that is written in plain language and contains the information detailed
at Sec. 422.631(d)(1)(iii).
Applicable integrated plans as defined at Sec. 422.561 are
required to issue form CMS-10716 when a request for either a medical
service or payment is denied in whole or in part after considering both
the Medicare or Medicaid benefit. Applicable integrated plans issue
this form to enrollees when the plan reduces, stops, suspends, or
denies, in whole or in part, a request for a service or item (including
a Part B drug) or a request for payment of a service or item (including
a Part B drug) that the enrollee has already received. The form
provides the enrollee with information regarding their right to an
appeal of the applicable integrated plan's decision and the enrollee
will use the instructions to navigate the appeal process. Form Number:
CMS-10716 (OMB control number: 0938-1386); Frequency: Occasionally;
Affected Public: Private sector (Business or other for-profits); Number
of Respondents: 112; Total Annual Responses: 24,716; Total Annual
Hours: 4,120. (For policy questions regarding this collection contact
Kristi Sugarman Coats at 415-744-3629.)
Dated: February 23, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2023-04068 Filed 2-27-23; 8:45 am]
BILLING CODE 4120-01-P