[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Notices]
[Pages 22493-22495]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10329]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 July 16, 2018.

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 July 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of July 16, 2018. 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

[[Page 22494]]

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-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.
     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.gpo.gov/fdsys/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.

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, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 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

[[Page 22495]]

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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
        21 CFR section             Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
User Fee Payment Refund                  1,657               1           1,657  0.40 (24                     663
 Request--Form FDA 3913.                                                         minutes).
User Fee Payment Transfer                  871               1             871  0.25 (15                     218
 Request--Form FDA 3914.                                                         minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................             881
----------------------------------------------------------------------------------------------------------------
\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: May 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10329 Filed 5-14-18; 8:45 am]
 BILLING CODE 4164-01-P


