[Federal Register Volume 83, Number 194 (Friday, October 5, 2018)]
[Notices]
[Pages 50382-50383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21682]


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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: Fax written comments on the collection of information by 
November 5, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0805. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[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

[[Page 50383]]

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 user fee payment 
refund requests.
    In fiscal year 2017, approximately 1,657 user fee refunds were 
processed for cover sheets and invoices including 12 for Animal Drug 
User Fee Act, 2 for Animal Generic Drug User Fee Act, 13 for Biosimilar 
Drug User Fee Act, 68 for Export Certificate Program, 14 for Freedom of 
Information Act requests, 227 for Generic Drug User Fee Amendments, 
1,021 for Medical Device User Fee Amendments, 227 for mammography 
inspection fees, 67 for Prescription Drug User Fee Act, and 6 for 
tobacco product fees.
    Form FDA 3914, User Fee Payment Transfer Request, is designed to 
provide the minimum information necessary 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 user fee 
payment transfer requests.
    In fiscal year 2017, approximately 871 user fee payment transfers 
were processed for cover sheets and invoices including 8 for Animal 
Drug User Fee Act, 1 for Animal Generic Drug User Fee Act, 1 for 
Biosimilar Drug User Fee Act, 163 for Generic Drug User Fee Amendments, 
692 for Medical Device User Fee Amendments, and 6 for Prescription Drug 
User Fee Act.
    Respondents for the electronic request forms include domestic and 
foreign firms (including pharmaceutical, medical device, 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 reapplied to another cover sheet or invoice (transfer of funds).
    The electronic user fee payment request forms will streamline the 
refund and transfer processes, facilitate processing, and improve the 
tracking of 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. Customers will be 
able to request a user fee payment refund and transfer online at 
https://www.fda.gov/forindustry/userfees/default.htm. This electronic 
submission is intended to reduce the burden for customers to submit 
user fee payment refund and transfer requests.
    In the Federal Register of May 15, 2018 (83 FR 22493), 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       Total
           FDA Form             Number of    responses per     annual        Average burden per      Total hours
                               respondents    respondent     responses            response
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User Fee Payment Refund              1,657               1        1,657  0.40 (24 minutes).........          663
 Request--Form FDA 3913.
User Fee Payment Transfer              871               1          871  0.25 (15 minutes).........          218
 Request--Form FDA 3914.
    Total....................  ...........  ..............  ...........  ..........................          881
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We have adjusted our burden estimate, which has resulted in a 
decrease to the currently approved burden. 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: October 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21682 Filed 10-4-18; 8:45 am]
 BILLING CODE 4164-01-P


