Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic User Fee Payment Request Forms, 32445-32447 [2024-08968]
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Federal Register / Vol. 89, No. 82 / Friday, April 26, 2024 / Notices
Clinical Pharmacology, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–1688,
anuradha.ramamoorthy@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES1
I. Background
Clinical pharmacology impacts many
important aspects of drug development
including, but not limited to, dose
selection and optimization, clinical trial
inclusion and exclusion criteria, and
evidence generation for safety and
effectiveness determinations. Clinical
pharmacology derived
recommendations are also critical for
optimizing pharmacotherapy in clinical
practice (e.g., by informing patientspecific treatment strategies).
Within CDER, OCP leverages clinical
pharmacology information on drug
disposition, disease biology,
pharmacology, and determinants of
response variability to support risk/
benefit determinations and therapeutic
individualization recommendations for
patients and practitioners. OCP’s
mission is to advance the development
of innovative new medicines by
applying state-of-the-art scientific
principles and promoting therapeutic
optimization and individualization.
OCP fulfills this mission through its
core functions of regulatory review,
regulatory research, and development
and implementation of scientific
guidances and policies.
To facilitate effective and efficient
drug development, FDA is engaged in
multiple, high-priority policy
initiatives. Consistent with FDA’s
broader initiatives and modernization
efforts, OCP works collaboratively with
stakeholders to develop and implement
contemporary guidance and policy in
the multidisciplinary field of clinical
pharmacology to share the current
regulatory thinking on a topic and
promote effective drug development
programs. FDA is establishing a public
docket to solicit input from interested
parties on specific and actionable
clinical pharmacology-relevant policy
topics that could be prioritized,
developed, and implemented by OCP
staff.
II. Request for Comments
FDA is soliciting specific, actionable
policy suggestions that could be
prioritized, developed, and
implemented in the near-term by OCP
staff to promote effective drug
development programs. We emphasize
that the focus of this request is to seek
input in the multidisciplinary field of
clinical pharmacology. The Agency
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welcomes any relevant information that
interested parties wish to share in a
submission to the docket. We are
particularly interested in seeking input
on:
1. Topics for development of new
clinical pharmacology/translational
medicine guidances to improve clarity
and promote effective drug
development. Please provide a rationale
to support your suggestion and highlight
relevant aspects that could be
considered in guidance development.
2. Topics and concepts where further
clarity on OCP’s existing guidances may
be warranted. Please provide a rationale
to support your suggestions and
actionable recommendations.
3. Topics that promote patient
centricity in drug development and
regulatory assessment. For FDA, patientcentric drug development and providing
patient-centered clinical
recommendations are important
priorities.
III. Electronic Access
Persons with access to the internet
may obtain relevant clinical
pharmacology guidances at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents.
Dated: April 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–08956 Filed 4–25–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–1382]
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, Agency, or we) 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
SUMMARY:
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32445
solicits comments on electronic user fee
payment request forms.
DATES: Either electronic or written
comments on the collection of
information must be submitted by June
25, 2024.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
June 25, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received 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
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–
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26APN1
ddrumheller on DSK120RN23PROD with NOTICES1
32446
Federal Register / Vol. 89, No. 82 / Friday, April 26, 2024 / Notices
2024–N–1382 for ‘‘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, 240–402–7500.
• 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.govinfo.gov/content/pkg/FR-201509-18/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, 240–402–7500.
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, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
agencies must obtain approval from the
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20:31 Apr 25, 2024
Jkt 262001
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
This information collection supports
FDA user fee programs. 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
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estimated hours are based on past FDA
experience with the user fee payment
refund request.
In fiscal year 2023, approximately
1,856 user fee refunds were processed
for cover sheets and invoices including
2 for Animal Drug User Fees, 2 for
Animal Generic Drug User Fees, 3 for
Biosimilar Drug User Fees, 1 for Color
Additive Certification Fees, 1 for
Compounding Quality fees, 32 for
Export Certificate Program Fees, 7 for
Freedom of Information Act requests, 94
for Generic Drug User Fees, 730 for
Medical Device User Fees, 219 for
Medical Device Federal Unified
Registration and Listing fees, 666 for
Mammography inspection fees, 19 for
Over-The-Counter Monograph Drug
User Fees, 77 for Prescription Drug User
Fees, and 3 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 2023, approximately 86
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, 2 for
Compounding Quality fees, 4 for Export
Certificate Program Fees, 20 for Generic
Drug User Fees, 6 for Medical Device
User Fees, 37 for Medical Device
Federal Unified Registration and Listing
fees, 8 for Mammography inspection
fees, 8 for Over-The-Counter Monograph
Drug User Fees, 0 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
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Federal Register / Vol. 89, No. 82 / Friday, April 26, 2024 / Notices
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
32447
are able to request a user fee payment
refund or transfer online at https://
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 2
Number of
respondents
FDA Form No.
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.
1,856
1
1,856
0.40 (24 minutes) ...........
742
86
1
86
0.25 (15 minutes) ..........
22
Total ................................................................
........................
..........................
........................
........................................
764
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
2 Numbers
Our estimated burden for the
information collection reflects an
overall increase of 525 hours and a
corresponding increase of 1,274
responses. We attribute this adjustment
to an increase in the number of
submissions we received over the last
few years.
Dated: April 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–08968 Filed 4–25–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–1057]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Pregnancy
Exposure Registry Enrollment Project:
A Survey of Healthcare Providers To
Advance Pregnancy Safety Data
Collection and Improve Health
Communications
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 and
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
20:31 Apr 25, 2024
Jkt 262001
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on a proposed study
entitled ‘‘Pregnancy Exposure Registry
Enrollment Project: A Survey of
Healthcare Providers To Advance
Pregnancy Safety Data Collection and
Improve Health Communications.’’
DATES: Either electronic or written
comments on the collection of
information must be submitted by June
25, 2024.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
June 25, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received 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
PO 00000
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Fmt 4703
Sfmt 4703
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–
2024–N–1057 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Pregnancy Exposure Registry
Enrollment Project: A Survey of
Healthcare Providers To Advance
Pregnancy Safety Data Collection and
Improve Health Communications.’’
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
E:\FR\FM\26APN1.SGM
26APN1
]]>Agencies
[Federal Register Volume 89, Number 82 (Friday, April 26, 2024)]
[Notices]
[Pages 32445-32447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08968]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-1382]
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, Agency, or we) 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: Either electronic or written comments on the collection of
information must be submitted by June 25, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 25, 2024. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received 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 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-
[[Page 32446]]
2024-N-1382 for ``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, 240-402-7500.
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.govinfo.gov/content/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, 240-402-7500.
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,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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
This information collection supports FDA user fee programs. 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 2023, approximately 1,856 user fee refunds were
processed for cover sheets and invoices including 2 for Animal Drug
User Fees, 2 for Animal Generic Drug User Fees, 3 for Biosimilar Drug
User Fees, 1 for Color Additive Certification Fees, 1 for Compounding
Quality fees, 32 for Export Certificate Program Fees, 7 for Freedom of
Information Act requests, 94 for Generic Drug User Fees, 730 for
Medical Device User Fees, 219 for Medical Device Federal Unified
Registration and Listing fees, 666 for Mammography inspection fees, 19
for Over-The-Counter Monograph Drug User Fees, 77 for Prescription Drug
User Fees, and 3 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 2023, approximately 86 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, 2 for Compounding Quality fees, 4 for Export
Certificate Program Fees, 20 for Generic Drug User Fees, 6 for Medical
Device User Fees, 37 for Medical Device Federal Unified Registration
and Listing fees, 8 for Mammography inspection fees, 8 for Over-The-
Counter Monograph Drug User Fees, 0 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
[[Page 32447]]
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 are able to request a user fee payment refund or transfer
online at https://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 2
----------------------------------------------------------------------------------------------------------------
Number of
FDA Form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
User Fee Payment Refund 1,856 1 1,856 0.40 (24 minutes) 742
Request--Form FDA 3913.
User Fee Payment Transfer 86 1 86 0.25 (15 minutes) 22
Request--Form FDA 3914.
--------------------------------------------------------------------------------
Total...................... .............. ............... .............. ................. 764
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Numbers have been rounded.
Our estimated burden for the information collection reflects an
overall increase of 525 hours and a corresponding increase of 1,274
responses. We attribute this adjustment to an increase in the number of
submissions we received over the last few years.
Dated: April 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-08968 Filed 4-25-24; 8:45 am]
BILLING CODE 4164-01-P
