[Federal Register Volume 89, Number 82 (Friday, April 26, 2024)]
[Notices]
[Pages 32445-32447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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 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 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-2015-09-18/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.

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: 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

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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 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.
    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]
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