Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Program, 77531-77533 [2024-21671]
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Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices
to reflect a resulting increase of 114
hours and 94 responses annually.
Dated: September 16, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–21676 Filed 9–20–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–4146]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Biosimilars User
Fee Program
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 information
collection associated with the Agency’s
Biosimilars User Fee Program.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
November 22, 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
November 22, 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.
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
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
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Jkt 262001
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–
2024–N–4146 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Biosimilars User Fee Program.’’
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
PO 00000
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77531
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:
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. 3501–3521), 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 revision 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
E:\FR\FM\23SEN1.SGM
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77532
Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices
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.
khammond on DSKJM1Z7X2PROD with NOTICES
Biosimilars User Fee Program
OMB Control Number 0910–0718—
Revision
This information collection supports
FDA’s Biosimilars User Fee Program
and implementation of the Biologics
Price Competition and Innovation Act of
2009 (BPCI Act). The BPCI Act creates
an abbreviated approval pathway for
biological products shown to be
biosimilar to or interchangeable with an
FDA-licensed reference biological
product. Section 351(k) of the Public
Health Service Act (PHS Act) (42 U.S.C.
262(k)), added by the BPCI Act, allows
a company to apply for licensure of a
biosimilar or interchangeable biological
product (351(k) application). The BPCI
Act also amended section 735 of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 379g) to include
351(k) applications as a type of
application under ‘‘human drug
application’’ for the purposes of the
prescription drug user fee provisions.
The FD&C Act as amended by the
Biosimilar User Fee Amendments of
2022 (BsUFA III), reauthorizes FDA to
assess and collect fees for biosimilar
biological products from October 2022
through September 2027 to facilitate the
development of safe and effective
biosimilar products for the American
public.
FDA maintains information on our
website at https://www.fda.gov/
industry/fda-user-fee-programs/
biosimilar-user-fee-amendments
regarding FDA’s BsUFA program. Also
available on our website is the
Biosimilars Action Plan (BAP), which
discusses key actions the Agency is
taking to encourage innovation and
competition among biologics and the
development of biosimilars. The BAP
builds on progress in implementing the
approval pathway for biosimilar and
interchangeable products, and provides
interested persons with updates on
related deliverables and activities.
We have revised the information
collection to reflect the currently
agreed-upon performance goals
established and captured in the latest
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reauthorization document entitled,
‘‘Biosimilar Biological Product
Reauthorization Performance Goals and
Procedures Fiscal Years 2023 Through
2027’’ (BsUFA Commitment Letter). The
BsUFA Commitment Letter is available
for download from our website at
https://www.fda.gov/media/152279/
download?attachment. The BsUFA
Commitment Letter outlines current
program goals, including information
technology goals, discusses program
effectiveness considerations, and
discusses user fee resource
management.
The information collection also
includes Form FDA 3792, ‘‘Biosimilars
User Fee Cover Sheet,’’ to be submitted
by each new biological product
development (BPD) entrant (identified
via a new meeting request or
investigational new drug (IND)
submission) or new biologics license
application (BLA) applicant. Form FDA
3792 requests the minimum information
necessary to identify the request, to
determine the amount of the fee to be
assessed, and to account for and track
user fees. Form FDA 3792 is completed
electronically at https://
userfees.fda.gov/OA_HTML/
bsufaCAcdLogin.jsp, and a notification
is emailed to the respondent that
includes information regarding annual
program fees. We are discontinuing use
of the associated annual survey at this
time.
Relatedly, Form FDA 3971 (Small
Business Waiver and Refund Request),
currently approved in OMB control
number 0910–0297, may also be
utilized. As instructed on our BsUFA
web page, respondents should submit
Form FDA 3971 by email to
CDERCollections@fda.hhs.gov at least 4
months prior to the submission of the
application to see if they qualify for a
small business waiver. Finally, user fee
refund and transfer requests, currently
approved in OMB control number 0910–
0805, may be submitted to FDA using
Forms FDA 3913 and FDA 3914,
respectively.
Patent infringement notifications are
also included in the scope of collection
activity. Section 351(l) of the PHS Act
(42 U.S.C. 242(l)) provides for the
exchange of patent information and
resolution of patent disputes between a
351(k) biosimilar applicant and the
holder of the 351(a) BLA reference
product. If a biosimilar applicant is
served with a complaint in an action for
a patent infringement described in
section 351(l)(6) of the PHS Act, the
biosimilar applicant is required to
provide the Secretary of HHS with
notice and a copy of the complaint
within 30 days of service. FDA is
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required to publish notice of a
complaint received under section
351(l)(6)(C) of the PHS Act in the
Federal Register.
Relevant information regarding
applicable statutory requirements is
discussed in topical guidance
documents, issued consistent with our
BsUFA Commitment Letter and Agency
Good Guidance Practice regulations in
21 CFR 10.115, which provide for
public comment at any time. The
following draft and final guidance
documents include instructional and
procedural information on
communicating with FDA regarding the
BsUFA program:
• ‘‘Assessing User Fees Under the
Biosimilar User Fee Amendments of
2022’’ (July 2023), available at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
assessing-user-fees-under-biosimilaruser-fee-amendments-2022. The
guidance document instructs
respondents on requesting
discontinuation from the BPD program,
as well as requesting to move products
to the discontinued section of the
biosimilar list. The guidance document
also provides information on the
consequences of failing to pay BsUFA III
fees as well as processes for submitting
reconsideration and appeal requests.
• ‘‘Formal Meetings Between the FDA
and Sponsors or Applicants of BsUFA
Products’’ (August 2023), available at:
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/formal-meetings-betweenfda-and-sponsors-or-applicants-bsufaproducts-guidance-industry. The
guidance document explains
standardized procedures for requesting,
preparing, scheduling, conducting, and
documenting formal meetings with
FDA, and discusses good meeting
management practices.
• As listed on our CDER 2023 and
2024 Annual Guidance agenda, we are
planning to issue a draft guidance for
industry entitled ‘‘Pediatric Study Plans
for Biosimilar Products,’’ to help
implement provisions of the Pediatric
Research Equity Act, codified in section
505B of the FD&C Act (21 U.S.C. 355c).
For more information regarding FDA
guidance documents, including ways to
participate, please visit https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs.
Description of Respondents: Sponsors
and applicants who have or intend to
submit an application for a biosimilar
product for licensure under section
351(k) of the PHS Act or who intend to
submit an initial pediatric study plan
(iPSP) as described in section 505B(e)
E:\FR\FM\23SEN1.SGM
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Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices
for those products intended to be
licensed under section 351(k) of the
PHS Act and being developed as a
proposed biosimilar to a reference
product.
77533
FDA estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
FDA form; survey
Number of
responses per
respondent
30
6
2
1
Total annual
responses
Average burden per
response
Total hours
60
6
0.5 (30 minutes) .....
1 .............................
30
6
Biosimilar User Fee Cover Sheet (Form FDA 3792) ............
Request for discontinuation from BPD program or to move
products to discontinued section of Biosimilar List.
Biosimilar product & interchangeable product applications
(351(k)); patent infringement notifications (351(l)).
Formal meeting requests as recommended in FDA guidance.
Submission of Pediatric Assessment; iPSP template information, including deferrals of pediatric assessments for
proposed biosimilar products; iPSP amendments as recommended in FDA guidance.
16
∼1.94
31
∼610.90 ..................
18,938
135
2.30
311
21.42 ......................
6,661
11
1
11
∼38.18 ....................
420
Total ................................................................................
....................
........................
419
................................
26,055
Our estimated burden for the
information collection reflects an
overall increase of 13,069 hours and 105
responses annually. Although part of
the increase may be attributed to the
inclusion of burden associated with the
submission of pediatric study plans, we
regard the majority of adjustments as
nominal fluctuations consistent with the
number of applications and submissions
we are receiving.
Dated: September 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–21671 Filed 9–20–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
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Number of
respondents
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Biobehavioral and
Behavioral Processes Integrated Review
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16:57 Sep 20, 2024
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Group; Adult Lifespan Psychopathology
Study Section.
Date: October 17–18, 2024.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Benjamin G. Shapero,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3182,
MSC 7848, Bethesda, MD 20892, (301) 402–
4786, shaperobg@mail.nih.gov.
Name of Committee: Oncology 1—Basic
Translational Integrated Review Group; Gene
Regulation in Cancer Study Section.
Date: October 21–22, 2024.
Time: 9:30 a.m. to 7:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Manzoor A. Zarger, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6208,
MSC 7804, Bethesda, MD 20892, (301) 435–
2477, zargerma@csr.nih.gov.
Name of Committee: Biobehavioral and
Behavioral Processes Integrated Review
Group; Biobehavioral Regulation, Learning
and Ethology Study Section.
Date: October 21–22, 2024.
Time: 9:30 a.m. to 7:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Sara Louise Hargrave,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institute of
Health, 6701 Rockledge Drive, Room 3170,
PO 00000
Frm 00063
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Bethesda, MD 20892, (301) 443–7193,
hargravesl@mail.nih.gov.
Name of Committee: Oncology 1—Basic
Translational Integrated Review Group; Basic
Cancer Immunobiology Study Section.
Date: October 22–23, 2024.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington/Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Meeting Format: In Person.
Contact Person: Sarita Kandula Sastry,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20782, 301–402–4788, sarita.sastry@nih.gov.
Name of Committee: Applied Therapeutics
for Cancer Integrated Review Group;
Mechanisms of Cancer Therapeutics C Study
Section.
Date: October 22–23, 2024.
Time: 8:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Darcy Hotel, 1515 Rhode Island
Ave, NW, Washington, DC 20005.
Meeting Format: In Person.
Contact Person: Gloria Huei-Ting Su,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, 301–496–0465, gloria.su@nih.gov.
Name of Committee: Musculoskeletal, Oral
and Skin Sciences Integrated Review Group;
Skeletal Muscle and Exercise Physiology
Study Section.
Date: October 22–23, 2024.
Time: 8:00 a.m. to 10:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW,
Washington, DC 20015.
Meeting Format: In Person.
Contact Person: Carmen Bertoni, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 805B,
E:\FR\FM\23SEN1.SGM
23SEN1
]]>Agencies
[Federal Register Volume 89, Number 184 (Monday, September 23, 2024)]
[Notices]
[Pages 77531-77533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21671]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4146]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Biosimilars User Fee Program
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 information collection associated with the
Agency's Biosimilars User Fee Program.
DATES: Either electronic or written comments on the collection of
information must be submitted by November 22, 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 November 22, 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-2024-N-4146 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Biosimilars User Fee Program.''
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: 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. 3501-3521), 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 revision 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
[[Page 77532]]
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.
Biosimilars User Fee Program
OMB Control Number 0910-0718--Revision
This information collection supports FDA's Biosimilars User Fee
Program and implementation of the Biologics Price Competition and
Innovation Act of 2009 (BPCI Act). The BPCI Act creates an abbreviated
approval pathway for biological products shown to be biosimilar to or
interchangeable with an FDA-licensed reference biological product.
Section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C.
262(k)), added by the BPCI Act, allows a company to apply for licensure
of a biosimilar or interchangeable biological product (351(k)
application). The BPCI Act also amended section 735 of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379g) to include
351(k) applications as a type of application under ``human drug
application'' for the purposes of the prescription drug user fee
provisions. The FD&C Act as amended by the Biosimilar User Fee
Amendments of 2022 (BsUFA III), reauthorizes FDA to assess and collect
fees for biosimilar biological products from October 2022 through
September 2027 to facilitate the development of safe and effective
biosimilar products for the American public.
FDA maintains information on our website at https://www.fda.gov/industry/fda-user-fee-programs/biosimilar-user-fee-amendments regarding
FDA's BsUFA program. Also available on our website is the Biosimilars
Action Plan (BAP), which discusses key actions the Agency is taking to
encourage innovation and competition among biologics and the
development of biosimilars. The BAP builds on progress in implementing
the approval pathway for biosimilar and interchangeable products, and
provides interested persons with updates on related deliverables and
activities.
We have revised the information collection to reflect the currently
agreed-upon performance goals established and captured in the latest
reauthorization document entitled, ``Biosimilar Biological Product
Reauthorization Performance Goals and Procedures Fiscal Years 2023
Through 2027'' (BsUFA Commitment Letter). The BsUFA Commitment Letter
is available for download from our website at https://www.fda.gov/media/152279/download?attachment. The BsUFA Commitment Letter outlines
current program goals, including information technology goals,
discusses program effectiveness considerations, and discusses user fee
resource management.
The information collection also includes Form FDA 3792,
``Biosimilars User Fee Cover Sheet,'' to be submitted by each new
biological product development (BPD) entrant (identified via a new
meeting request or investigational new drug (IND) submission) or new
biologics license application (BLA) applicant. Form FDA 3792 requests
the minimum information necessary to identify the request, to determine
the amount of the fee to be assessed, and to account for and track user
fees. Form FDA 3792 is completed electronically at https://userfees.fda.gov/OA_HTML/bsufaCAcdLogin.jsp, and a notification is
emailed to the respondent that includes information regarding annual
program fees. We are discontinuing use of the associated annual survey
at this time.
Relatedly, Form FDA 3971 (Small Business Waiver and Refund
Request), currently approved in OMB control number 0910-0297, may also
be utilized. As instructed on our BsUFA web page, respondents should
submit Form FDA 3971 by email to [email protected] at least 4
months prior to the submission of the application to see if they
qualify for a small business waiver. Finally, user fee refund and
transfer requests, currently approved in OMB control number 0910-0805,
may be submitted to FDA using Forms FDA 3913 and FDA 3914,
respectively.
Patent infringement notifications are also included in the scope of
collection activity. Section 351(l) of the PHS Act (42 U.S.C. 242(l))
provides for the exchange of patent information and resolution of
patent disputes between a 351(k) biosimilar applicant and the holder of
the 351(a) BLA reference product. If a biosimilar applicant is served
with a complaint in an action for a patent infringement described in
section 351(l)(6) of the PHS Act, the biosimilar applicant is required
to provide the Secretary of HHS with notice and a copy of the complaint
within 30 days of service. FDA is required to publish notice of a
complaint received under section 351(l)(6)(C) of the PHS Act in the
Federal Register.
Relevant information regarding applicable statutory requirements is
discussed in topical guidance documents, issued consistent with our
BsUFA Commitment Letter and Agency Good Guidance Practice regulations
in 21 CFR 10.115, which provide for public comment at any time. The
following draft and final guidance documents include instructional and
procedural information on communicating with FDA regarding the BsUFA
program:
``Assessing User Fees Under the Biosimilar User Fee
Amendments of 2022'' (July 2023), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-user-fees-under-biosimilar-user-fee-amendments-2022. The guidance document
instructs respondents on requesting discontinuation from the BPD
program, as well as requesting to move products to the discontinued
section of the biosimilar list. The guidance document also provides
information on the consequences of failing to pay BsUFA III fees as
well as processes for submitting reconsideration and appeal requests.
``Formal Meetings Between the FDA and Sponsors or
Applicants of BsUFA Products'' (August 2023), available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-sponsors-or-applicants-bsufa-products-guidance-industry. The guidance document explains standardized
procedures for requesting, preparing, scheduling, conducting, and
documenting formal meetings with FDA, and discusses good meeting
management practices.
As listed on our CDER 2023 and 2024 Annual Guidance
agenda, we are planning to issue a draft guidance for industry entitled
``Pediatric Study Plans for Biosimilar Products,'' to help implement
provisions of the Pediatric Research Equity Act, codified in section
505B of the FD&C Act (21 U.S.C. 355c). For more information regarding
FDA guidance documents, including ways to participate, please visit
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.
Description of Respondents: Sponsors and applicants who have or
intend to submit an application for a biosimilar product for licensure
under section 351(k) of the PHS Act or who intend to submit an initial
pediatric study plan (iPSP) as described in section 505B(e)
[[Page 77533]]
for those products intended to be licensed under section 351(k) of the
PHS Act and being developed as a proposed biosimilar to a reference
product.
FDA estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Number of
FDA form; survey Number of responses per Total annual Average burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Biosimilar User Fee Cover 30 2 60 0.5 (30 minutes)......... 30
Sheet (Form FDA 3792).
Request for discontinuation 6 1 6 1........................ 6
from BPD program or to move
products to discontinued
section of Biosimilar List.
Biosimilar product & 16 ~1.94 31 ~610.90.................. 18,938
interchangeable product
applications (351(k));
patent infringement
notifications (351(l)).
Formal meeting requests as 135 2.30 311 21.42.................... 6,661
recommended in FDA guidance.
Submission of Pediatric 11 1 11 ~38.18................... 420
Assessment; iPSP template
information, including
deferrals of pediatric
assessments for proposed
biosimilar products; iPSP
amendments as recommended in
FDA guidance.
----------------------------------------------------------------------------------
Total.................... ........... .............. 419 ......................... 26,055
----------------------------------------------------------------------------------------------------------------
Our estimated burden for the information collection reflects an
overall increase of 13,069 hours and 105 responses annually. Although
part of the increase may be attributed to the inclusion of burden
associated with the submission of pediatric study plans, we regard the
majority of adjustments as nominal fluctuations consistent with the
number of applications and submissions we are receiving.
Dated: September 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21671 Filed 9-20-24; 8:45 am]
BILLING CODE 4164-01-P
