Agency Information Collection Activities: Proposed Collection; Comment Request, 79929-79930 [2024-22536]
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79929
Federal Register / Vol. 89, No. 190 / Tuesday, October 1, 2024 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form name
Individuals in households .......
Day1 Dietary Instrument; MEC Dietary Recruitment Scheduling Instrument; Dietary Front-End Instrument; Dietary Incentives and Scheduling Instrument; MEC Dietary Reminder Call-in Instrument; & Flexible Consumer Behavior
Survey (FCBS) Instrument.
Day2 Dietary Instrument ........................................................
Developmental Projects & Special Studies ............................
Individuals in households .......
Individuals in households .......
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. 2024–22473 Filed 9–30–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–10593]
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
December 2, 2024.
SUMMARY:
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Number of
respondents
Type of respondents
VerDate Sep<11>2014
17:42 Sep 30, 2024
Jkt 265001
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: ll, 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.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
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–10539 Medicare and Medicaid
Programs: Home Health Facilities
(HHAs) and Supporting Regulations
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.
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Frm 00045
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(in hours)
5,882
1
1
5,882
3,500
1
1
36/60
3
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 Collections
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare and
Medicaid Programs: Home Health
Facilities (HHAs) and Supporting
Regulations; Use: Home health services
are covered for the elderly and disabled
under the Hospital Insurance (Part A)
and Supplemental Medical Insurance
(Part B) benefits of the Medicare
program and are described in section
1861(m) of the Social Security Act (the
Act) (42 U.S.C. 1395x). These services
must be furnished by, or under
arrangement with, an HHA that
participates in the Medicare program,
and be provided on a visiting basis in
the beneficiary’s home. They may
include the following:
• Part-time or intermittent skilled
nursing care furnished by or under the
supervision of a registered nurse.
• Physical therapy, speech-language
pathology, or occupational therapy.
• Medical social services under the
direction of a physician.
• Part-time or intermittent home
health aide services.
• Medical supplies (other than drugs
and biologicals) and durable medical
equipment.
• Services of interns and residents if
the HHA is owned by or affiliated with
E:\FR\FM\01OCN1.SGM
01OCN1
79930
Federal Register / Vol. 89, No. 190 / Tuesday, October 1, 2024 / Notices
a hospital that has an approved medical
education program.
• Services at hospitals, Skilled
Nursing Facilities (SNFs), or
rehabilitation centers when they involve
equipment too cumbersome to bring to
the home.
Under the authority of sections
1861(o), 1871 and 1891 of the Act, the
Secretary has established in regulations
the requirements that an HHA must
meet to participate in the Medicare
program. These requirements are set
forth in 42 CFR part 484 as Conditions
of Participation for Home Health
Agencies. The CoPs apply to an HHA as
an entity as well as the services
furnished to each individual under the
care of the HHA, unless a condition is
specifically limited to Medicare
beneficiaries. Under section 1891(b) of
the Act, the Secretary is responsible for
assuring that the CoPs, and their
enforcement, are adequate to protect the
health and safety of individuals under
the care of an HHA and to promote the
effective and efficient use of Medicare
funds. To implement this requirement,
State survey agencies generally conduct
surveys of HHAs to determine whether
they are complying with the CoPs. Form
Number: CMS–10539 (OMB Control
Number: 0938–1299); Frequency:
Annually; Affected Public: Private
Sector (Business or other for-profit, and
not-for-profit institutions); Number of
Respondents: 20,765; Number of
Responses: 12,300,588 Total Annual
Hours: 870,000. (For policy questions
regarding this collection contact Claudia
Molinar at claudia.molinar@
cms.hhs.gov.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–22536 Filed 9–30–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
khammond on DSKJM1Z7X2PROD with NOTICES
[Docket No. FDA–2024–N–1382]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Electronic User
Fee Payment Request Forms
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
SUMMARY:
VerDate Sep<11>2014
17:42 Sep 30, 2024
Jkt 265001
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by October 31,
2024.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0805. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Electronic User Fee Payment Request
Forms—Form FDA 3913 and Form FDA
3914
OMB Control Number 0910–0805—
Extension
This information collection supports
FDA user fee programs. Form FDA 3913,
User Fee Payment Refund Request, is
designed to provide the minimum
necessary information for FDA to review
and process a user fee payment refund.
The information collected includes the
organization, contact, and payment
information. The information is used to
determine the reason for the refund, the
refund amount, and who to contact if
there are any questions regarding the
refund request. A submission of the
User Fee Payment Refund Request form
does not guarantee that a refund will be
issued. FDA estimates an average of 0.40
hours per response, including the time
to review instructions, search existing
data sources, gather and maintain the
data needed, and complete and review
the collection of information. The
estimated hours are based on past FDA
experience with the user fee payment
refund request.
In fiscal year 2023, approximately
1,856 user fee refunds were processed
for cover sheets and invoices including
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Frm 00046
Fmt 4703
Sfmt 4703
2 for Animal Drug User Fees, 2 for
Animal Generic Drug User Fees, 3 for
Biosimilar Drug User Fees, 1 for Color
Additive Certification Fees, 1 for
Compounding Quality fees, 32 for
Export Certificate Program Fees, 7 for
Freedom of Information Act requests, 94
for Generic Drug User Fees, 730 for
Medical Device User Fees, 219 for
Medical Device Federal Unified
Registration and Listing fees, 666 for
Mammography inspection fees, 19 for
Over-The-Counter Monograph Drug
User Fees, 77 for Prescription Drug User
Fees, and 3 for Tobacco product fees.
Form FDA 3914, User Fee Payment
Transfer Request, is designed to provide
the minimum necessary information for
FDA to review and process a user fee
payment transfer request. The
information collected includes payment
and organization information. The
information is used to determine the
reason for the transfer, how the transfer
should be performed, and who to
contact if there are any questions
regarding the transfer request. A
submission of the User Fee Payment
Transfer Request form does not
guarantee that a transfer will be
performed. FDA estimates an average of
0.25 hours per response, including the
time to review instructions, search
existing data sources, gather and
maintain the data needed, and complete
and review the collection of
information. FDA estimated hours are
based on past FDA experience with the
user fee payment transfer requests.
In fiscal year 2023, approximately 86
user fee payment transfers were
processed for cover sheets and invoices
including 0 for Animal Drug User Fees,
0 for Animal Generic Drug User Fees, 1
for Biosimilar Drug User Fees, 2 for
Compounding Quality fees, 4 for Export
Certificate Program Fees, 20 for Generic
Drug User Fees, 6 for Medical Device
User Fees, 37 for Medical Device
Federal Unified Registration and Listing
fees, 8 for Mammography inspection
fees, 8 for Over-The-Counter Monograph
Drug User Fees, 0 for Prescription Drug
User Fees, and 0 for Tobacco product
fees.
Respondents for the electronic request
forms include domestic and foreign
firms (including pharmaceutical,
biological, medical device firms, etc.).
Specifically, refund request forms target
respondents who submitted a duplicate
payment or overpayment for a user fee
cover sheet or invoice. Respondents
may also include firms that withdrew an
application or submission. Transfer
request forms target respondents who
submitted payment for a user fee cover
sheet or invoice and need that payment
E:\FR\FM\01OCN1.SGM
01OCN1
Agencies
[Federal Register Volume 89, Number 190 (Tuesday, October 1, 2024)]
[Notices]
[Pages 79929-79930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22536]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-10593]
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 December 2, 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-10539 Medicare and Medicaid Programs: Home Health Facilities (HHAs)
and Supporting Regulations
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 Collections
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicare and
Medicaid Programs: Home Health Facilities (HHAs) and Supporting
Regulations; Use: Home health services are covered for the elderly and
disabled under the Hospital Insurance (Part A) and Supplemental Medical
Insurance (Part B) benefits of the Medicare program and are described
in section 1861(m) of the Social Security Act (the Act) (42 U.S.C.
1395x). These services must be furnished by, or under arrangement with,
an HHA that participates in the Medicare program, and be provided on a
visiting basis in the beneficiary's home. They may include the
following:
Part-time or intermittent skilled nursing care furnished
by or under the supervision of a registered nurse.
Physical therapy, speech-language pathology, or
occupational therapy.
Medical social services under the direction of a
physician.
Part-time or intermittent home health aide services.
Medical supplies (other than drugs and biologicals) and
durable medical equipment.
Services of interns and residents if the HHA is owned by
or affiliated with
[[Page 79930]]
a hospital that has an approved medical education program.
Services at hospitals, Skilled Nursing Facilities (SNFs),
or rehabilitation centers when they involve equipment too cumbersome to
bring to the home.
Under the authority of sections 1861(o), 1871 and 1891 of the Act,
the Secretary has established in regulations the requirements that an
HHA must meet to participate in the Medicare program. These
requirements are set forth in 42 CFR part 484 as Conditions of
Participation for Home Health Agencies. The CoPs apply to an HHA as an
entity as well as the services furnished to each individual under the
care of the HHA, unless a condition is specifically limited to Medicare
beneficiaries. Under section 1891(b) of the Act, the Secretary is
responsible for assuring that the CoPs, and their enforcement, are
adequate to protect the health and safety of individuals under the care
of an HHA and to promote the effective and efficient use of Medicare
funds. To implement this requirement, State survey agencies generally
conduct surveys of HHAs to determine whether they are complying with
the CoPs. Form Number: CMS-10539 (OMB Control Number: 0938-1299);
Frequency: Annually; Affected Public: Private Sector (Business or other
for-profit, and not-for-profit institutions); Number of Respondents:
20,765; Number of Responses: 12,300,588 Total Annual Hours: 870,000.
(For policy questions regarding this collection contact Claudia Molinar
at [email protected].)
William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts,
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2024-22536 Filed 9-30-24; 8:45 am]
BILLING CODE 4120-01-P