[Federal Register Volume 86, Number 81 (Thursday, April 29, 2021)]
[Notices]
[Pages 22669-22671]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08947]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 or Agency) 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: Submit either electronic or written comments on the collection 
of information by June 28, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before June 28, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 28, 2021. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is 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

[[Page 22670]]

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-2015-N-1837 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; 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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

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

    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

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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 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\
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                                                                   Number of
                21 CFR Section                     Number of     responses per   Total annual          Average burden per response          Total hours
                                                  respondents     respondent       responses
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User Fee Payment Refund Request-Form FDA 3913.             474               1             474  0.40 (24 minutes).......................             190
User Fee Payment Transfer Request-Form FDA                 194               1             194  0.25 (15 minutes).......................              49
 3914.
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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: April 23, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08947 Filed 4-28-21; 8:45 am]
BILLING CODE 4164-01-P


