Agency Information Collection Activities: Proposed Collection; Comment Request, 5239-5240 [2024-01582]
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5239
Federal Register / Vol. 89, No. 18 / Friday, January 26, 2024 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Form name
Primary care providers ......................
Men ages 55–69 ...............................
Men ages 55–69 ...............................
Men ages 55–69 ...............................
Men ages 55–69 ...............................
Men ages 55–69 ...............................
Men ages 55–69 ...............................
Clinic coordinators ............................
Provider survey ................................
Patient eligibility screener ................
Pre-exposure survey ........................
Post-exposure survey ......................
Post-clinic survey .............................
Usability survey ................................
User experience interview ................
Clinic coordinator interview ..............
40
900
900
900
300
30
900
4
1
1
1
1
1
1
1
1
10/60
8/60
20/60
20/60
18/60
20/60
20/60
30/60
7
120
300
300
90
10
300
2
Total ...........................................
...........................................................
........................
........................
........................
1,129
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. 2024–01550 Filed 1–25–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10887]
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.
SUMMARY:
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Number of
respondents
Type of respondents
VerDate Sep<11>2014
18:02 Jan 25, 2024
Jkt 262001
Comments must be received by
March 26, 2024.
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.
DATES:
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–10887 The Medicare
Advantage and Prescription Drug
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
Programs: Part C and Part D Medicare
Advantage Prescription Drug (MARx)
System Updates for the Medicare
Prescription Payment Plan Program
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: New collection (Request for a
new OMB control number); Title of
Information Collection: The Medicare
Advantage and Prescription Drug
Programs: Part C and Part D Medicare
Advantage Prescription Drug (MARx)
System Updates for the Medicare
Prescription Payment Plan Program;
Use: The IRA amended the Act by
adding section 1860D–2(b)(2)(E) which,
beginning January 1, 2025, establishes
the Medicare Prescription Payment Plan
program (hereinafter referred to as the
‘‘program’’). Under this program, MA
Organizations offering Part D coverage
and Part D sponsors (collectively ‘‘Part
D plans’’ or ‘‘Plans’’) are required to
offer enrollees the option to pay their
Part D cost sharing in monthly amounts
spread out over the plan year based on
the formulae described in section
1860D–2(b)(2)(E)(iv) of the Act.
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5240
Federal Register / Vol. 89, No. 18 / Friday, January 26, 2024 / Notices
To effectively monitor the program,
Part D plans will be required to report
data elements related to the program at
the beneficiary, contract, and Plan
Benefit Package (PBP)1 levels beginning
in Contract Year (CY) 2025. In this
information collection package, CMS
addresses the proposal to require Part D
plans to submit beneficiary-level data
elements into the MARx system via a
program-specific transaction (separate
from the enrollment file). In accordance
with the Plan Communication User
Guide (PCUG), plans may submit
multiple transaction files during any
CMS business day, Monday through
Friday. Plan transactions are processed
as received; there is no minimum or
maximum limit to the number of files
that Plans may submit in a day. In
general, transaction and processing
occur throughout the Current Calendar
Month (CCM). For CY 2025, CMS will
not require independent data validation
for this new MARx reporting
requirement. Form Number: CMS–
10887 (OMB control number: 0938New); Frequency: Monthly; Affected
Public: Private, Federal Government,
Business or other for profits, Not-forprofits institutions; Number of
Respondents: 856; Total Annual
Responses: 3,200,856; Total Annual
Hours: 59,958. (For policy questions
regarding this collection contact
Michael Brown at (872) 287–1370 or
michael.brown3@cms.hhs.gov.)
Dated: January 23, 2024.
William N. Parham, III
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–01582 Filed 1–25–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3768]
Best Practices for Food and Drug
Administration Staff in the
Postmarketing Safety Surveillance of
Human Drug and Biological Products;
Final Document; Availability
AGENCY:
Food and Drug Administration,
HHS.
lotter on DSK11XQN23PROD with NOTICES1
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
document entitled ‘‘Best Practices for
FDA Staff in the Postmarketing Safety
Surveillance of Human Drug and
Biological Products.’’ The 21st Century
SUMMARY:
VerDate Sep<11>2014
18:02 Jan 25, 2024
Jkt 262001
Cures Act (Cures Act), enacted on
December 13, 2016, requires that FDA
make publicly available on its internet
website best practices for certain
postmarketing drug safety surveillance
activities. This final document sets forth
risk-based principles for FDA’s conduct
of ongoing postmarketing safety
surveillance for human drug products
and human biological products, in part,
to address the Cures Act requirements.
This document finalizes the draft
document entitled ‘‘Best Practices in
Drug and Biological Product Postmarket
Safety Surveillance for FDA Staff’’ that
was issued on November 7, 2019.
DATES: The announcement of the final
document is published in the Federal
Register on January 26, 2024.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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
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
PO 00000
Frm 00041
Fmt 4703
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information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–N–3768 for ‘‘Best Practices for
FDA Staff in the Postmarketing Safety
Surveillance of Human Drug and
Biological Products.’’ 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
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this document to the Division
of Drug Information, Center for Drug
E:\FR\FM\26JAN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 18 (Friday, January 26, 2024)]
[Notices]
[Pages 5239-5240]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01582]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10887]
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 March 26, 2024.
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-10887 The Medicare Advantage and Prescription Drug Programs:
Part C and Part D Medicare Advantage Prescription Drug (MARx) System
Updates for the Medicare Prescription Payment Plan Program
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: New collection (Request
for a new OMB control number); Title of Information Collection: The
Medicare Advantage and Prescription Drug Programs: Part C and Part D
Medicare Advantage Prescription Drug (MARx) System Updates for the
Medicare Prescription Payment Plan Program; Use: The IRA amended the
Act by adding section 1860D-2(b)(2)(E) which, beginning January 1,
2025, establishes the Medicare Prescription Payment Plan program
(hereinafter referred to as the ``program''). Under this program, MA
Organizations offering Part D coverage and Part D sponsors
(collectively ``Part D plans'' or ``Plans'') are required to offer
enrollees the option to pay their Part D cost sharing in monthly
amounts spread out over the plan year based on the formulae described
in section 1860D-2(b)(2)(E)(iv) of the Act.
[[Page 5240]]
To effectively monitor the program, Part D plans will be required
to report data elements related to the program at the beneficiary,
contract, and Plan Benefit Package (PBP)1 levels beginning in Contract
Year (CY) 2025. In this information collection package, CMS addresses
the proposal to require Part D plans to submit beneficiary-level data
elements into the MARx system via a program-specific transaction
(separate from the enrollment file). In accordance with the Plan
Communication User Guide (PCUG), plans may submit multiple transaction
files during any CMS business day, Monday through Friday. Plan
transactions are processed as received; there is no minimum or maximum
limit to the number of files that Plans may submit in a day. In
general, transaction and processing occur throughout the Current
Calendar Month (CCM). For CY 2025, CMS will not require independent
data validation for this new MARx reporting requirement. Form Number:
CMS-10887 (OMB control number: 0938-New); Frequency: Monthly; Affected
Public: Private, Federal Government, Business or other for profits,
Not-for-profits institutions; Number of Respondents: 856; Total Annual
Responses: 3,200,856; Total Annual Hours: 59,958. (For policy questions
regarding this collection contact Michael Brown at (872) 287-1370 or
[email protected].)
Dated: January 23, 2024.
William N. Parham, III
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-01582 Filed 1-25-24; 8:45 am]
BILLING CODE 4120-01-P
