Notice2024-08968
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic User Fee Payment Request Forms
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 26, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on electronic user fee payment request forms.
Full Text
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<title>Federal Register, Volume 89 Issue 82 (Friday, April 26, 2024)</title>
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[Federal Register Volume 89, Number 82 (Friday, April 26, 2024)]
[Notices]
[Pages 32445-32447]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-08968]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-1382]
Agency Information Collection Activities; Proposed Collection;
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, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. 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 of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on electronic user fee payment
request forms.
DATES: Either electronic or written comments on the collection of
information must be submitted by June 25, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 25, 2024. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-
[[Page 32446]]
2024-N-1382 for ``Electronic User Fee Payment Request Forms.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
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,
<a href="/cdn-cgi/l/email-protection#4e1e1c0f1d3a2f28280e282a2f6026263d60292138"><span class="__cf_email__" data-cfemail="c595978496b1a4a3a385a3a1a4ebadadb6eba2aab3">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``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 (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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
[[Page 32447]]
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 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 <a href="https://www.fda.gov/forindustry/userfees/default.htm">https://www.fda.gov/forindustry/userfees/default.htm</a>. This
electronic submission is intended to reduce the burden for customers to
submit a user fee payment refund and transfer request.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1 2
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Number of
FDA Form No. Number 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 minutes) 742
Request--Form FDA 3913.
User Fee Payment Transfer 86 1 86 0.25 (15 minutes) 22
Request--Form FDA 3914.
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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: April 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-08968 Filed 4-25-24; 8:45 am]
BILLING CODE 4164-01-P
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