Notice2021-21421
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic User Fee Payment Request Forms
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 1, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 188 (Friday, October 1, 2021)</title>
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[Federal Register Volume 86, Number 188 (Friday, October 1, 2021)]
[Notices]
[Pages 54453-54454]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-21421]
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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: Submit written comments (including recommendations) on the
collection of information by November 1, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0805. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#055557445671646363456361642b6d6d762b626a73"><span class="__cf_email__" data-cfemail="d181839082a5b0b7b791b7b5b0ffb9b9a2ffb6bea7">[email protected]</span></a>.
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 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 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
[[Page 54454]]
are able to request a user fee payment refund or transfer online at
<a href="https://www.fda.gov/forindustry/userfees/default.htm">https://www.fda.gov/forindustry/userfees/default.htm</a>. This electronic
submission is intended to reduce the burden for customers to submit a
user fee payment refund and transfer request.
In the Federal Register of April 29, 2021 (86 FR 22669), 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
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 474 1 474 0.40 (24 190
Request--Form FDA 3913. minutes).
User Fee Payment Transfer 194 1 194 0.25 (15 49
Request--Form FDA 3914. minutes).
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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: September 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21421 Filed 9-30-21; 8:45 am]
BILLING CODE 4164-01-P
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