Notice2026-19660
Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments
Primary source
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Published
September 25, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is hosting a hybrid public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2028 through 2032. The BsUFA authorizes FDA to collect user fees to support the process for the review of biosimilar biological product applications. The current legislative authority for BsUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations, as necessary.
Full Text
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[Federal Register Volume 91, Number 185 (Friday, September 25, 2026)]
[Notices]
[Pages 60962-60967]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19660]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3326]
Reauthorization of the Biosimilar User Fee Act; Public Meeting;
Request for Comments
AGENCY: Food and Drug Administration, HHS.
[[Page 60963]]
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
hosting a hybrid public meeting to discuss proposed recommendations for
the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal
years (FYs) 2028 through 2032. The BsUFA authorizes FDA to collect user
fees to support the process for the review of biosimilar biological
product applications. The current legislative authority for BsUFA
expires in September 2027. At that time, new legislation will be
required for FDA to continue collecting user fees in future fiscal
years. Following discussions with the regulated industry and periodic
consultations with public stakeholders, the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) directs FDA to publish the recommendations
for the reauthorized program in the Federal Register, hold a meeting at
which the public may present its views on such recommendations, and
provide for a period of 30 days for the public to provide written
comments on such recommendations. FDA will then consider such public
views and comments and revise such recommendations, as necessary.
DATES: The public meeting will be held on October 26, 2026, from 9 a.m.
to 12 p.m. Eastern Time, and will take place in person and virtually.
Either electronic or written comments on the proposed recommendations
must be submitted by November 25, 2026.
ADDRESSES: The hybrid public meeting will be held in-person at the FDA
White Oak Campus, 10903 New Hampshire Ave., Building Conference Center,
the White Oak Great Room, Silver Spring, MD 20993-0002 and virtually
using the Microsoft Teams platform. Entrance for the public meeting
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. Participants must be REAL
ID compliant to access Federal facilities. For additional information
regarding REAL ID, refer to <a href="https://www.dhs.gov/real-id/real-id-faqs">https://www.dhs.gov/real-id/real-id-faqs</a>.
For security and parking information, please refer to <a href="https://www.fda.gov/about-fda/visitor-information">https://www.fda.gov/about-fda/visitor-information</a> and <a href="https://www.fda.gov/about-fda/visitor-information/visitor-parking-and-campus-map">https://www.fda.gov/about-fda/visitor-information/visitor-parking-and-campus-map</a>.
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 November 25, 2026. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 25, 2026. 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-3326 for ``Reauthorization of the Biosimilar User Fee Act;
Public Meeting; Request for Comments.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: Thamar Bailey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 4171, Silver Spring, MD 20993-0002, 301-
796-6645, <a href="/cdn-cgi/l/email-protection#90d2c3c5d6d1c2f5f1e5e4f8ffe2f9eaf1e4f9fffed0f6f4f1bef8f8e3bef7ffe6"><span class="__cf_email__" data-cfemail="99dbcaccdfd8cbfcf8ecedf1f6ebf0e3f8edf0f6f7d9fffdf8b7f1f1eab7fef6ef">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Introduction
FDA is announcing a hybrid public meeting to begin the
reauthorization process for BsUFA, the legislation that authorizes FDA
to collect user fees to support the process for the review of
biosimilar biological product applications. The current authorization
of the program (BsUFA III) expires in
[[Page 60964]]
September 2027. Without new legislation, FDA will no longer be able to
collect user fees for future fiscal years to help fund the process for
the review of biosimilar biological product applications. Section
744I(f)(5) of the FD&C Act (21 U.S.C. 379j-53(f)(5)) requires that
after FDA holds negotiations with regulated industry and periodic
consultations with patient and consumer advocacy groups, we do the
following: (1) present the recommendations to the relevant
Congressional committees, (2) publish the recommendations in the
Federal Register, (3) provide a period of 30 days for the public to
provide written comments on the recommendations, (4) hold a meeting at
which the public may present its views, and (5) after consideration of
public views and comments, revise the recommendations as necessary.
This notice, the comment period, and the public meeting described
in this notice help satisfy these requirements. After the public
meeting, we will revise the recommendations as necessary and present
our proposed recommendations to the relevant Congressional committees.
The purpose of the meeting is to hear the public's views on the
proposed recommendations for the reauthorized program (BsUFA IV). The
following information is provided to help potential meeting
participants better understand the history and evolution of the BsUFA
program and the status of the proposed BsUFA IV recommendations.
II. What is BsUFA and what does it do?
The following information is provided to help potential meeting
participants better understand the history and evolution of the BsUFA
program and its status. BsUFA is a law that authorizes FDA to assess
and collect fees from drug companies that submit marketing applications
for certain biosimilar biological products. BsUFA was originally
enacted in 2012 under the Food and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112-144) for a 5-year period. Congress
reauthorized BsUFA (BsUFA II) for an additional 5 years, through FY
2022, under the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-
52). BsUFA was most recently reauthorized in 2022 under Title IV of the
FDA User Fee Reauthorization Act of 2022 (FDAUFRA) (Pub. L. 117-180),
extending the program through FY 2027 (BsUFA III).
BsUFA's intent is to provide additional revenues so that FDA can
hire staff, improve systems, and continue a well-managed biosimilar
biological product review process to make biosimilar biological product
therapies available to patients sooner without compromising review
quality or FDA's high standards for safety, efficacy, and quality. As
part of FDA's agreements with industry during prior BsUFA
authorizations, the Agency agreed to certain performance and procedural
goals and other commitments, which are documented on FDA's website. The
goals apply to the process for the review of biosimilar biological
product applications, including biosimilar biological product
development meetings, review of applications and supplements, and other
review activities. FDA's website provides more information about BsUFA,
including the statutory text of FDAUFRA, the BsUFA III Commitment
Letter, key Federal Register documents, BsUFA-related guidances, BsUFA
user fee rates, performance reports, and financial reports available 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>.
The current authorization of BsUFA (BsUFA III) introduced new
supplement categories, timelines, and performance goals to expedite the
review of supplemental biosimilar biological product applications. It
established new procedures and performance goals for the review of use-
related risk analysis and human factors protocol submissions, aimed at
advancing the development of biosimilar biological product-device
combination products. To improve overall meeting management, BsUFA III
modified two meeting types (Biosimilar Initial Advisory and Type 4),
created a new meeting type (Type 2a), and provided a new follow-up
opportunity after meetings or written-response-only communication. The
agreement introduced a regulatory science pilot program focused on
advancing the development of interchangeable biosimilar biological
products and improving the efficiency of biosimilar biological product
development. It included additional commitments to advance
interchangeable biosimilar biological product development through
publishing foundational guidances and stakeholder engagement. BsUFA III
included commitments to promote best practices in communication between
FDA and sponsors during application reviews, enhance inspection
communication, and provide guidance on alternative tools to assess
manufacturing facilities.
BsUFA III built upon the financial enhancements included in BsUFA
II to ensure optimal use of user fee resources, transparency around the
use of financial resources, and management of the carryover balance.
The agreement committed FDA to leveraging cloud technology to modernize
the Electronic Submissions Gateway and to establish and progress a data
and technology modernization strategy. A comprehensive list of the
deliverables developed to meet BsUFA III commitments is available on
FDA's website at <a href="https://www.fda.gov/industry/biosimilar-user-fee-amendments/completed-bsufa-iii-deliverables">https://www.fda.gov/industry/biosimilar-user-fee-amendments/completed-bsufa-iii-deliverables</a>.
III. Proposed BsUFA IV Recommendations
In preparing the proposed recommendations to Congress for BsUFA
reauthorization, FDA conducted discussions with the regulated industry
and consulted with patient and consumer advocacy groups, as required by
law. We began the BsUFA reauthorization process by publishing a notice
in the Federal Register (90 FR 52967, November 24, 2025) requesting
public input on the reauthorization and announcing a public meeting
that was held on December 3, 2025. The meeting included a presentation
by FDA, remarks from representatives of regulated industry, and public
comments from representatives of a number of different stakeholder
groups, including patient advocates, consumer advocacy groups, health
care professionals, and academic researchers. The materials from the
meeting, including a transcript and webcast recording, can be found at
<a href="https://www.fda.gov/industry/public-meeting-reauthorization-biosimilar-user-fee-act-bsufa-12032025">https://www.fda.gov/industry/public-meeting-reauthorization-biosimilar-user-fee-act-bsufa-12032025</a>.
Following the December 2025 public meeting, FDA conducted
negotiations with the regulated industry and held monthly consultations
with patient and consumer advocacy groups from April 2026 through June
2026. As directed by Congress, FDA posted minutes of these meetings on
its web page, BsUFA IV: Fiscal Years 2028-2032, available at <a href="https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iv-fiscal-years-2028-2032">https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iv-fiscal-years-2028-2032</a>.
The proposed enhancements for BsUFA IV address many of the
priorities identified by public stakeholders, the regulated industry,
and FDA. The proposed enhancements modify aspects of the program to
match advances in science and changes in the industry, establish new
processes to increase efficiency and enhance communication, advance a
lifecycle approach to addressing manufacturing issues, and enhance
regulatory and financial
[[Page 60965]]
transparency. Across the commitment letter, FDA proposes to remove one-
time commitments completed under BsUFA III and streamline the text
where possible. The full text of the proposed BsUFA IV Commitment
Letter can be found on the Agency's web page, BsUFA IV: Fiscal Years
2028-2032, available at <a href="https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iv-fiscal-years-2028-2032">https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iv-fiscal-years-2028-2032</a>. Each significant new or
modified enhancement is described briefly below.
A. Original and Resubmitted Supplemental Biosimilar Biological Product
Applications
To streamline and simplify review, FDA proposes to modify the
supplement categories and timelines. FDA proposes to replace the BsUFA
III supplement categories with two categories that correspond with
either 4- or 6-month review timelines. FDA also proposes to issue
guidance and/or a manual of policies and procedures on (1) post-
approval submissions to 351(k) applications that seek to make labeling
changes to conform to changes in reference product labeling and (2)
submissions for unbranded 351(k) application labeling. These
enhancements are described in section I.A.2 of the proposed BsUFA IV
Commitment Letter.
B. Provisional Determinations
To facilitate Agency action on biosimilar biological applications
upon the expiration of applicable exclusivity periods, FDA proposes to
establish a structured process and review timeline for approval
requests submitted for applications in a provisional determination
status, which refers to applications that otherwise meet applicable
licensure standards but cannot be approved due to an unexpired period
of exclusivity. FDA also proposes to issue guidance or a manual of
policies and procedures on the provisional determination process. These
enhancements are described in section I.A.6. of the proposed BsUFA IV
Commitment Letter.
C. Imminent Action
To promote efficient review, FDA proposes to enable the Agency to
work 60 days past an application goal date to address discrete, late-
arising, resolvable issues to help avoid otherwise unnecessary
provisional determinations and complete response actions. This
enhancement is described in section I.A.7. of the proposed BsUFA IV
Commitment Letter.
D. New Target Action Date
To enhance communication with applicants, FDA proposes to establish
a process under which the Agency would notify the applicant of an
anticipated missed biologics license application (BLA) or supplement
goal date, establish a new internal target action date, and identify
the issue(s) responsible for the delay. If the new target action date
is not met, the Agency would contact the applicant and provide an
update on the issue causing delay and the estimated timeline for
action, when possible. These enhancements are described in section
I.A.8. of the proposed BsUFA IV Commitment Letter.
E. Initial Pediatric Study Plan
To enhance the efficiency of initial pediatric study plan (iPSP)
submissions, FDA proposes to publish a biosimilar-specific iPSP
template and make it available for public comment. FDA proposes to
finalize the template following consideration of public comments. FDA
also proposes to issue guidance addressing pediatric study plans for
biosimilar products and how biosimilar applicants can meet applicable
Pediatric Research Equity Act (PREA) requirements. These enhancements
are described in section I.C. of the proposed BsUFA IV Commitment
Letter.
F. Multi-Dose Pharmacokinetic and/or Pharmacodynamic Study and
Comparative Efficacy Study Protocol Review
To help ensure applicants receive feedback on critical questions
prior to study initiation, FDA proposes to implement a process for
prioritizing review of multi-dose pharmacokinetic and/or
pharmacodynamic study or comparative efficacy study (CES) protocols.
FDA proposes to update relevant manuals of policies and procedures and
standard operating policies and procedures describing processes and
timelines for protocol review to account for this enhancement. This
enhancement is described in section I.H. of the proposed BsUFA IV
Commitment Letter.
G. Meeting Management
To improve overall meeting management, FDA proposes three
enhancements: (1) eliminating the biosimilar initial advisory (BIA)
meeting; (2) providing sponsors with the option to request a written
response only (WRO) for all BsUFA meeting types; and (3) allowing
applicants to use the follow-up opportunity to seek clarification of
FDA's advice following a meeting, a WRO, or a correspondence that
responds to a sponsor's meeting question. Additionally, FDA proposes
revising the biosimilar biological product development (BPD) Type 2b
meeting description. This update replaces the BIA meeting with the Type
2b meeting as a sponsor's initial interaction with FDA to discuss a
proposed development program. These enhancements are described in
section I.I. of the proposed BsUFA IV Commitment Letter.
H. Combination Products
To support the development of biosimilar biological-device
combination products, FDA proposes to establish human factors (HF)
protocol review goals and issue guidance on alternative approaches to
comparative use HF studies. FDA also proposes expanding the BPD Type 2b
meeting description to allow sponsors to request a review of use-
related risk analysis, comparative analysis, or HF study protocols.
These enhancements are described in section I.J. of the proposed BsUFA
IV Commitment Letter.
I. Advancing Chemistry, Manufacturing, and Controls Facility
Assessment: A Risk-Based Lifecycle Approach
To support the timely development and availability of biosimilar
products, FDA proposes to introduce a risk-based lifecycle approach to
identifying and addressing manufacturing facility deficiencies. This
proposed BsUFA IV chemistry, manufacturing, and controls (CMC) facility
lifecycle program is designed to facilitate a proactive approach to
addressing manufacturing facility deficiencies through new and enhanced
engagement mechanisms between FDA and the regulated industry that may
happen before, during, and after an application review cycle. The
program introduces a new option for a single CMC facility pre-
submission meeting to discuss manufacturing facilities for a proposed
application to facilitate readiness before a facility evaluation and
inspection. The program also introduces a new post-pre-license
inspection (PLI) meeting, when needed, to discuss inspection findings
that may impact application approval and corrective actions that may
address identified approvability issues. In addition, the program
introduces a CMC facility post-action meeting for applications that
receive a complete response due in part to manufacturing facility
deficiencies. This meeting provides an opportunity to discuss and
understand the deficiencies that should be corrected before the
application can be approved. FDA proposes to issue guidance describing
the implementation
[[Page 60966]]
of the facility lifecycle program, as well as conduct a third-party
assessment and associated public workshop to assess the program's
effectiveness and its impact on facility-issue driven complete
responses. These enhancements are described in section I.K. of the
proposed BsUFA IV Commitment Letter.
J. BsUFA Regulatory Science Pilot Program
Given the goals for the BsUFA regulatory science pilot program were
met, FDA proposes sunsetting the program at the end of BsUFA III. If
the Agency conducts regulatory science research using BsUFA operating
funds during BsUFA IV, FDA proposes the Agency would notify industry
and make the research results publicly available, as appropriate. These
enhancements are described in section I.L. of the proposed BsUFA IV
Commitment Letter.
K. BLA Revocation and Reissuance
To facilitate the transfer of 351(k) BLA(s) between applicants, FDA
proposes establishing a 180-day timeline for revoking and reissuing
licenses following the receipt of a complete transfer request. The
proposed 180-day timeline does not apply in instances when (1)
transfers include BLAs regulated by both the Center for Drug Evaluation
and Research and the Center for Biologics Evaluation and Research or
(2) the BLA has outstanding facility issues. This enhancement is
described in section I.M. of the proposed BsUFA IV Commitment Letter.
L. Assessment of BsUFA Review Program for Pre-Investigational New Drug
Applications, Investigational New Drug Applications, and BLAs
To understand and enhance the efficiency of the biosimilar
development and regulatory review program, FDA proposes a third-party
assessment of review processes, outcomes, and communications between
FDA and sponsors during first cycle review. This assessment will help
FDA and regulated industry understand challenges and best practices and
provide recommendations to help FDA and sponsors (1) limit first cycle
complete responses (for applications that are ultimately approvable)
and missed goal dates; (2) increase the effectiveness and efficiency of
key review processes, communications, and materials; and (3) assess the
use of imminent action, new target action dates, and review clock
extensions. This enhancement is described in section I.N. of the
proposed BsUFA IV Commitment Letter.
M. Continued Enhancement of User Fee Resource Management
FDA will build on the financial enhancements included in prior
authorization cycles to ensure optimal use of user fee resources and
the alignment of staff to workload through the continued operation of
the Agency's resource capacity planning capability. FDA will also
continue activities to promote transparency of the use of financial
resources in support of the BsUFA program through publication of a 5-
year financial plan (along with annual updates). FDA proposes to update
the topics included in the financial plan, as well as in the annual
Financial Report submitted to Congress. FDA proposes to offer annual
technical staff meetings with regulated industry to support the
transparency and understanding of BsUFA program finances, and to
publish minutes from these meetings on its public website. These
enhancements are described in section II of the proposed BsUFA IV
Commitment Letter.
N. Enhancements to Fee Mechanisms
While the proposed statutory framework for setting the annual
revenue amount is generally consistent with the current authorization,
some updates are proposed for BsUFA IV. The updates include the
discontinuation of the Strategic Hiring and Retention Adjustment,
limits on the use of the Capacity Planning Adjustment, and a reduction
in the maximum operating reserve.
BsUFA IV proposes a personnel compensation and benefits (PC&B) set-
aside. This PC&B set-aside would ensure that FDA will reserve the
funding needed to restaff the BsUFA program at a level consistent with
fiscal year 2025, with appropriate adjustments for terminated staff and
those intended to be transferred to Shared Services. The PC&B set-aside
would ensure that the funds that are set aside will only be used for
purposes relating to the hiring and retaining of staff for the review
of biosimilar biological product applications. Until FDA's BsUFA-fee-
funded PC&B spend exceeds the amount established as the PC&B target
amount, the Capacity Planning Adjustment would be unavailable. FDA
proposes to redirect existing resources to fund enhancements for BsUFA
and restaff the BsUFA program in targeted areas.
The BsUFA IV agreement proposes fee structure changes. BsUFA IV
would eliminate the initial, annual, and reactivation BPD fees. For
sponsors that intend to submit more than one BLA that contains
substantially the same information about the drug substance, BsUFA IV
would also introduce a tiered application fee to incentivize such
sponsors to submit the BLAs at the same time. This simultaneous filing
structure allows the Agency to realize efficiencies in review workload.
The proposed tiered application fee structure establishes: (1) a full
application fee without the current statutory fee differentiation based
on clinical data; (2) no fee for BLAs containing substantially the same
information about the drug substance (or drug substances in the case of
either a fixed-combination product or a combination product) as another
BLA submitted by the same sponsor on the same day; and (3) a half
application fee for BLAs containing substantially the same information
about the drug substance (or drug substances in the case of either a
fixed-combination product or a combination product) as another BLA
submitted by the same sponsor on a prior day. BsUFA IV also proposes to
update the eligibility for the small business waiver to only companies
based in the United States (i.e., applicants created or organized under
the laws of any State).
IV. Public Meeting Information
A. Purpose and Scope of the Meeting
The meeting will include presentations by FDA and panels with FDA
and regulated industry representatives to present and discuss the
agreed-upon proposed enhancements. The meeting will also provide an
opportunity for other interested parties, including scientific and
academic experts, healthcare professionals, representatives of patient
and consumer advocacy groups, and the general public, to verbally
comment on the proposed enhancements. A draft agenda and other
background information for the public meeting will be posted at:
<a href="https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iv-fiscal-years-2028-2032">https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iv-fiscal-years-2028-2032</a>.
B. Participating in the Public Meeting
Registration: Information about how to register for the public
meeting is available on FDA's web page for this public meeting: <a href="https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iv-fiscal-years-2028-2032">https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iv-fiscal-years-2028-2032</a>. Registration is free for both in-person and virtual
attendance. In-person attendance is based on space availability, with
priority given to early registrants. Early registration is recommended
because seating is limited; therefore, FDA may limit the number of
participants from each
[[Page 60967]]
organization. Registrants will receive confirmation when they have been
accepted. If you need special accommodations due to a disability,
please email <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="46043513000714232733322e29342f3c27322f292806202227682e2e3568212930">[email protected]</a> no later than October 16,
2026, 11:59 p.m. Eastern Time.
Opportunity for Public Comment: During online registration, you may
indicate if you wish to make a public comment. We will do our best to
accommodate requests to make public comments. Individuals and
organizations with common interests are urged to consolidate or
coordinate their public comments and request time jointly. Following
the close of registration, we will determine the amount of time
allotted to each commenter and the approximate time each comment is to
begin, and will notify participants by October 19, 2026. All requests
to make a public comment during the meeting must be received via
registration by October 16, 2026, 11:59 p.m. Eastern Time. Onsite
registration for public comments on the day of the public meeting will
not be provided. No commercial or promotional material will be
permitted to be presented or distributed at the public meeting.
Streaming Webcast of the Public Meeting: When available, the
virtual link to the hybrid public meeting will be posted on FDA's
public web page at <a href="https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iv-fiscal-years-2028-2032">https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iv-fiscal-years-2028-2032</a>. FDA will also distribute
the link via email to registered attendees.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on
FDA's public web page at <a href="https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iv-fiscal-years-2028-2032">https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iv-fiscal-years-2028-2032</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-19660 Filed 9-24-26; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on September 25, 2026.
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