
[Federal Register Volume 80, Number 123 (Friday, June 26, 2015)]
[Notices]
[Pages 36822-36824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15711]


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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) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed 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 August 25, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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

[[Page 36823]]

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 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-NEW)

    The Government Paperwork Elimination Act (GPEA), Public Law 105-
277, title XVII, was signed into law on October 21, 1998. GPEA requires 
Federal Agencies to allow individuals or entities that deal with the 
Agencies the option to submit information or transact business with the 
Agency electronically, when practicable, and to maintain records 
electronically, when practicable. Its goal is to encourage agencies to 
incorporate technologically improved respondent reporting as this 
process typically lowers the burden on the respondent. GPEA allows FDA 
to collect information relating to a user fee payment refund request 
and transfer request.
    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 2014, approximately 1,741 user fee refunds were 
processed for cover sheets and invoices including 27 for Animal Drug 
User Fee Act, 5 for Animal Generic Drug User Fee Act, 3 for Biosimilar 
Drug User Fee Act, 1 for a Center for Tobacco Products Civil Money 
Penalties, 216 for Export Certificate Program, 79 for Freedom of 
Information Act requests, 523 for Generic Drug User Fee Amendments, 539 
for Medical Device User Fee Amendments, 266 for Mammography inspection 
fee, 81 for Prescription Drug User Fee Act, and 1 for a Tobacco product 
fee.
    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 request.
    In fiscal year 2014, approximately 1,291 user fee payment transfers 
were processed for cover sheets and invoices including 21 for Animal 
Drug User Fee Act, 2 for Animal Generic Drug User Fee Act, 544 for 
Generic Drug User Fee Amendments, 627 for Medical Device User Fee 
Amendments, and 97 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 re-applied 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 http://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    Total hours
                                                                       respondents     respondent       responses          response
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User Fee Payment Refund Request--Form FDA 3913.....................           1,700               1           1,700    0.40 (24 minutes)             680
User Fee Payment Transfer Request--Form FDA 3914...................           1,700               1           1,700    0.25 (15 minutes)             425
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    Total..........................................................  ..............  ..............  ..............  ...................           1,105
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 36824]]

    Dated: June 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15711 Filed 6-25-15; 8:45 am]
 BILLING CODE 4164-01-P


