Notice2025-02153
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biosimilars User Fee Program
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Published
February 3, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 90 Issue 21 (Monday, February 3, 2025)</title>
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[Federal Register Volume 90, Number 21 (Monday, February 3, 2025)]
[Notices]
[Pages 8804-8805]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-02153]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4146]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Biosimilars User Fee
Program
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by March 5, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0718. Also include the FDA docket
number found in brackets in the heading of this document.
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,
<a href="/cdn-cgi/l/email-protection#6c3c3e2d3f180d0a0a2c0a080d4204041f420b031a"><span class="__cf_email__" data-cfemail="aefefceffddacfc8c8eec8cacf80c6c6dd80c9c1d8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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 <a href="https://www.fda.gov/industry/fda-user-fee-programs/biosimilar-user-fee-amendments">https://www.fda.gov/industry/fda-user-fee-programs/biosimilar-user-fee-amendments</a> regarding
its 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 <a href="https://www.fda.gov/media/152279/download?attachment">https://www.fda.gov/media/152279/download?attachment</a>. 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 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 <a href="https://userfees.fda.gov/OA_HTML/bsufaCAcdLogin.jsp">https://userfees.fda.gov/OA_HTML/bsufaCAcdLogin.jsp</a>, 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 <a href="/cdn-cgi/l/email-protection#84c7c0c1d6c7ebe8e8e1e7f0edebeaf7c4e2e0e5aaececf7aae3ebf2"><span class="__cf_email__" data-cfemail="7132353423321e1d1d141205181e1f02311715105f1919025f161e07">[email protected]</span></a> 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-
[[Page 8805]]
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 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:
<bullet> ``Assessing User Fees Under the Biosimilar User Fee
Amendments of 2022'' (July 2023), available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-user-fees-under-biosimilar-user-fee-amendments-2022">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-user-fees-under-biosimilar-user-fee-amendments-2022</a>. 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.
<bullet> ``Formal Meetings Between the FDA and Sponsors or
Applicants of BsUFA Products'' (August 2023), available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-sponsors-or-applicants-bsufa-products-guidance-industry">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-sponsors-or-applicants-bsufa-products-guidance-industry</a>. The guidance document explains standardized
procedures for requesting, preparing, scheduling, conducting, and
documenting formal meetings with FDA, and discusses good meeting
management practices.
<bullet> As listed on our Center for Drug Evaluation and Research
2023 and 2024 Annual Guidance agenda (available at: <a href="https://www.fda.gov/media/134778/download">https://www.fda.gov/media/134778/download</a>), 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 <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>.
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) of the FD&C
Act 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.
In the Federal Register of September 23, 2024 (89 FR 77531), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this information collection as follows:
Table 1--Estimated Annual Reporting Burden
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Number of Total
FDA form; survey Number of responses per annual Average burden per Total hours
respondents respondent responses response
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Biosimilar User Fee Cover Sheet 30 2 60 0.5 (30 minutes)...... 30
(Form FDA 3792).
Request for discontinuation from 6 1 6 1..................... 6
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.
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Total........................ ........... .............. 419 ...................... 26,055
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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, the majority
of adjustments correspond with an increase in submissions we are
receiving.
Dated: January 28, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-02153 Filed 1-30-25; 11:15 am]
BILLING CODE 4164-01-P
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