[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]
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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.
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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\
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No. of
FDA form No. No. of responses per Total annual Average burden Total hours
respondents respondent responses per response
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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).
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Total..................... .............. .............. .............. ................ 764
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\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]
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