[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, 
<a href="/cdn-cgi/l/email-protection#df8f8d9e8cabbeb9b99fb9bbbef1b7b7acf1b8b0a9"><span class="__cf_email__" data-cfemail="1f4f4d5e4c6b7e79795f797b7e3177776c31787069">[email protected]</span></a>.

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).
                               ---------------------------------------------------------------------------------
    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]
BILLING CODE 4164-01-P


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