Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic User Fee Payment Request Forms, 22493-22495 [2018-10329]
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Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices
through the night, daily hygiene,
participation in sports or social
activities, intimacy with a spouse or
partner, etc.)
4. How has your chronic pain
changed over time? (Considerations
include severity and frequency of your
chronic pain and the effects of chronic
pain on your daily activities.)
daltland on DSKBBV9HB2PROD with NOTICES
Topic 2: Patients’ Perspectives on
Current Approaches to Treatment of
Chronic Pain
1. What are you currently doing to
help treat your chronic pain? (Examples
may include prescription medicines,
over-the-counter products, and nondrug therapies.)
a. How has your treatment regimen
changed over time, and why? (Examples
may include change in your condition,
change in dose, or treatment side
effects.)
b. What factors do you take into
account when making decisions about
selecting a course of treatment?
2. How well does your current
treatment regimen manage your chronic
pain? (Considerations include severity
and frequency of your chronic pain and
the effects of chronic pain on your daily
activities.)
3. What are the most significant
downsides to your current treatments,
and how do they affect your daily life?
4. What challenges or barriers to
accessing or using medical treatments
for chronic pain have you or do you
encounter?
5. What specific things would you
look for in an ideal treatment for your
chronic pain?
III. Participating in the Public Meeting
Registration: To register for the public
meeting, visit https://chronicpainpfdd.eventbrite.com. Please register by
July 2, 2018. Persons without access to
the internet can call 240–402–6525 to
register. If you are unable to attend the
meeting in person, you can register to
view a live webcast of the meeting. You
will be asked to indicate in your
registration if you plan to attend in
person or via the webcast.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public meeting must
register by July 2, 2018. Early
registration is recommended because
seating is limited; therefore, FDA may
limit the number of participants from
each organization. Registrants will
receive confirmation once they have
been accepted. If time and space permit,
onsite registration on the day of the
public meeting will be provided
beginning at 9 a.m. If you need special
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accommodations because of a disability,
please contact Meghana Chalasani (see
FOR FURTHER INFORMATION CONTACT) no
later than July 2, 2018.
Panelist Selection: Patients or patient
representatives who are interested in
presenting comments as part of the
initial panel discussions will be asked
to indicate in their registration which
topic(s) they wish to address. These
patients or patient representatives also
will be asked to send PatientFocused@
fda.hhs.gov a brief summary of
responses to the topic questions by June
25, 2018. Panelists will be notified of
their selection approximately 7 days
before the public meeting. We will try
to accommodate all patients and patient
stakeholders who wish to speak, either
through the panel discussion or
audience participation; however, the
duration of comments may be limited by
time constraints.
Open Public Comment: There will be
time allotted during the meeting for
open public comment. Signup for this
session will be on a first-come, firstserve basis on the day of the workshop.
Individuals and organizations with
common interests are urged to
consolidate or coordinate and request
time for a joint presentation. No
commercial or promotional material
will be permitted to be presented or
distributed at the public workshop.
Streaming Webcast of the Public
Meeting: This public meeting will also
be webcast. Please register for the
webcast by visiting https://chronicpainpfdd.eventbrite.com.
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the website addresses in this
document, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
Transcripts: Please be advised that as
soon as a transcript of the public
meeting is available, it will be accessible
at https://www.regulations.gov. It may
be viewed at the Dockets Management
Staff (see ADDRESSES). A link to the
transcript will also be available on the
internet at https://www.fda.gov/Drugs/
NewsEvents/ucm603093.htm.
Dated: May 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–10284 Filed 5–14–18; 8:45 am]
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22493
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.
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.
SUMMARY:
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
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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
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‘‘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/201523389.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
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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
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Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices
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
respondents
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
User Fee Payment Refund Request—Form FDA
3913.
User Fee Payment Transfer Request—Form
FDA 3914.
1,657
1
1,657
0.40 (24 minutes) .........
663
871
1
871
0.25 (15 minutes) .........
218
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2017–N–4951; FDA–
2017–N–5569; FDA–2017–N–6145; FDA–
2011–N–0275; FDA–2017–N–7012; and
FDA–2017–N–6175]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
SUMMARY:
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
number
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Title of collection
Medical Devices; Humanitarian Use Devices .........................................................................................................
Medical Devices; Device Tracking ..........................................................................................................................
Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine .......................................................................................................................................................
Certification to Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA
3674) ....................................................................................................................................................................
Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based
In Vitro Diagnostics ..............................................................................................................................................
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E:\FR\FM\15MYN1.SGM
15MYN1
Date approval
expires
0910–0332
0910–0442
3/31/2021
3/31/2021
0910–0566
3/31/2021
0910–0616
3/31/2021
0910–0850
3/31/2021
]]>Agencies
[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).
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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
