Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic User Fee Payment Request Forms, 79930-79931 [2024-22443]
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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
PO 00000
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
Federal Register / Vol. 89, No. 190 / Tuesday, October 1, 2024 / Notices
to be re-applied to another cover sheet
or invoice (transfer of funds).
The electronic user fee payment
request forms streamline the refund and
transfer processes, facilitate processing,
and improve the tracking of refund or
transfer requests. The burden for this
collection of information is the same for
all customers (small and large
organizations). The information being
79931
In the Federal Register of April 26,
2024 (89 FR 32445), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
requested or required has been held to
the absolute minimum required for the
intended use of the data. Respondents
are able to request a user fee payment
refund or transfer online at https://
www.fda.gov/forindustry/userfees/
default.htm. This electronic submission
is intended to reduce the burden for
customers to submit a user fee payment
refund and transfer request.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1 2
No. of
respondents
FDA form No.
No. of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
User Fee Payment Refund Request—Form FDA
3913.
User Fee Payment Transfer Request—Form
FDA 3914.
1,856
1
1,856
0.40 (24 minutes) ..........
742
86
1
86
0.25 (15 minutes) ..........
22
Total ..............................................................
........................
........................
........................
.......................................
764
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
2 Numbers
Our estimated burden for the
information collection reflects an
overall increase of 525 hours and a
corresponding increase of 1,274
responses. We attribute this adjustment
to an increase in the number of
submissions we received over the last
few years.
Dated: September 25, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–22443 Filed 9–30–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Announcement of Solicitation of
Written Comments on Proposed
Healthy People 2030 Objectives
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary of
Health, Office of Disease Prevention and
Health Promotion.
ACTION: Notice.
AGENCY:
The U.S. Department of
Health and Human Services (HHS)
solicits written comments from the
public on 12 new objectives proposed to
be added to Healthy People 2030, and
written comments from the public
proposing additional new core,
developmental, or research objectives or
topics to be included in Healthy People
2030. Public comment informed the
development of Healthy People 2030.
HHS will provide opportunities for
public input periodically throughout the
decade to ensure Healthy People 2030
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
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17:42 Sep 30, 2024
Jkt 265001
reflects current public health priorities
and public input. The updated set of
Healthy People 2030 objectives and
topics will be incorporated on https://
health.gov/healthypeople. This updated
set will reflect further review and
deliberation by federal Healthy People
topic area workgroups, the Federal
Interagency Workgroup on Healthy
People 2030, and other federal subject
matter experts.
DATES: Written comments will be
accepted through 11:59 p.m. ET,
October 31, 2024.
ADDRESSES: Written comments should
be submitted by email to
HP2030Comment@hhs.gov.
FOR FURTHER INFORMATION CONTACT: Erik
Orta, Office of Disease Prevention and
Health Promotion, U.S. Department of
Health and Human Services, 1101
Wootton Parkway, Suite 420, Rockville,
MD 20852; Phone: 240–268–0823;
Email: HP2030@hhs.gov.
SUPPLEMENTARY INFORMATION: Since
1980, Healthy People has provided a
comprehensive set of national health
promotion and disease prevention
objectives with 10-year targets aimed at
improving the health of all. Healthy
People 2030 objectives present a picture
of the nation’s health at the beginning
of the decade, establish national goals
and targets to be achieved by the year
2030, and monitor progress over time.
The U.S. Department of Health and
Human Services (HHS) is soliciting the
submission of written comments
regarding 12 new objectives proposed to
be added to the current set of Healthy
People 2030 objectives. The public is
also invited to submit proposals for
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additional new core, developmental, or
research objectives that meet the criteria
outlined below.
Healthy People 2030 is the product of
an extensive collaborative process that
relies on input from a diverse array of
individuals and organizations, both
within and outside the federal
government, with a common interest in
improving the nation’s health. Public
comments were a cornerstone of
Healthy People 2030’s development.
During the first phase of planning for
Healthy People 2030, HHS asked for the
public’s comments on the initiative’s
vision, mission, and overarching goals.
Those comments helped set the
framework for Healthy People 2030. The
public was also invited to submit
comments on proposed Healthy People
2030 objectives, which helped shape the
current set of Healthy People 2030
objectives.
The public now is invited to comment
on 12 new objectives proposed to be
added to Healthy People 2030. These
new objectives were developed by
Healthy People topic area workgroups
led by various agencies within the
Federal Government. They have been
reviewed by the Federal Interagency
Workgroup on Healthy People 2030 and
are presented now for the public’s
review and comment. They are:
1. CKD–NEW–11: Increase the
proportion of people with chronic
kidney disease and diabetes who receive
glucose-lowering medications based on
the most recent guidelines. This
objective is new to Healthy People 2030.
Data source: National Health and
Nutrition Examination Survey
(NHANES).
E:\FR\FM\01OCN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 190 (Tuesday, October 1, 2024)]
[Notices]
[Pages 79930-79931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22443]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of 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,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 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
[[Page 79931]]
to be re-applied to another cover sheet or invoice (transfer of funds).
The electronic user fee payment request forms streamline the refund
and transfer processes, facilitate processing, and improve the tracking
of refund or transfer requests. The burden for this collection of
information is the same for all customers (small and large
organizations). The information being requested or required has been
held to the absolute minimum required for the intended use of the data.
Respondents are able to request a user fee payment refund or transfer
online at https://www.fda.gov/forindustry/userfees/default.htm. This
electronic submission is intended to reduce the burden for customers to
submit a user fee payment refund and transfer request.
In the Federal Register of April 26, 2024 (89 FR 32445), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\ \2\
----------------------------------------------------------------------------------------------------------------
No. of
FDA form No. No. of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
User Fee Payment Refund 1,856 1 1,856 0.40 (24 742
Request--Form FDA 3913. minutes).
User Fee Payment Transfer 86 1 86 0.25 (15 22
Request--Form FDA 3914. minutes).
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 764
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Numbers have been rounded.
Our estimated burden for the information collection reflects an
overall increase of 525 hours and a corresponding increase of 1,274
responses. We attribute this adjustment to an increase in the number of
submissions we received over the last few years.
Dated: September 25, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-22443 Filed 9-30-24; 8:45 am]
BILLING CODE 4164-01-P
