83 FR 22493 - Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic User Fee Payment Request Forms

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 94 (May 15, 2018)

Page Range		22493-22495
FR Document		2018-10329

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.

Federal Register, Volume 83 Issue 94 (Tuesday, May 15, 2018)

[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Notices]
[Pages 22493-22495]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-10329]

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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 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.thefederalregister.org/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,
PRAStaff@fda.hhs.gov.

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\
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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 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).
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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: 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

Document Created: 2018-05-15 00:33:48
Document Modified: 2018-05-15 00:33:48

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by July 16, 2018.
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]
FR Citation		83 FR 22493

83 FR 22493 - Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic User Fee Payment Request Forms

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 94 (May 15, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration