[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Pages 54453-54454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21421]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1837]


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 November 1, 2021.

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

    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 2020, approximately 474 user fee refunds 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, 0 for Export Certificate Program fees, 0 for Freedom of 
Information Act requests, 31 for Generic Drug User Fees, 200 for 
Medical Device User Fees, 240 for Medical Device Federal Unified 
Registration and Listing fees, 0 for Mammography inspection fees, 1 for 
Prescription Drug User Fees, and 0 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 2020, approximately 194 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, 34 for Generic Drug User Fees, 78 for Medical Device 
User Fees, 80 for Medical Device Federal Unified Registration and 
Listing fees, 0 for Mammography inspection fees, 1 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 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

[[Page 54454]]

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 29, 2021 (86 FR 22669), 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
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                                                   Number of
        21 CFR section             Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
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User Fee Payment Refund                    474               1             474  0.40 (24                     190
 Request--Form FDA 3913.                                                         minutes).
User Fee Payment Transfer                  194               1             194  0.25 (15                      49
 Request--Form FDA 3914.                                                         minutes).
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    Total.....................  ..............  ..............  ..............  ................             239
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The current burden estimate shows a decrease of approximately 642 
hours for this information collection over that reported previously. 
The change reflects increased experience by the respondents to 
correctly submit fee payments and increased sophistication in use of 
the forms to request payments made in error. The use of the forms for 
the user fee programs (e.g., Prescription Drug User Fees, Generic Drug 
User Fees, Animal Drug User Fees, Animal Generic Drug User Fees, 
Biosimilar Drug User Fees) are optional.
    In addition, new information technology applications have more 
accurately calculated the number of registrants of drug facilities/food 
facilities/medical device facilities/medicated feed facilities, and we 
have therefore revised the number of respondents to the information 
collection.

    Dated: September 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21421 Filed 9-30-21; 8:45 am]
BILLING CODE 4164-01-P