Notice2021-20432
Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 22, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is hosting a virtual public meeting to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2023 through 2027. 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 2022. 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 consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (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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<title>Federal Register, Volume 86 Issue 181 (Wednesday, September 22, 2021)</title>
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[Federal Register Volume 86, Number 181 (Wednesday, September 22, 2021)]
[Notices]
[Pages 52685-52689]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-20432]
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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.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is hosting a
virtual public meeting to discuss proposed recommendations for the
reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years
(FYs) 2023 through 2027. 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 2022. 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 consultations with public
stakeholders, the Federal Food, Drug, and Cosmetic Act (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 November 2, 2021, from 9 a.m.
to 12 p.m. Eastern Time, and will be held by webcast only. Submit
either electronic or written comments on this public
[[Page 52686]]
meeting by December 2, 2021. See SUPPLEMENTARY INFORMATION for
registration date and information.
ADDRESSES: Registration to attend the meeting and other information can
be found at <a href="https://bsufaiii-finalpublicmeeting.eventbrite.com">https://bsufaiii-finalpublicmeeting.eventbrite.com</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 December 2, 2021. 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 December 2, 2021. 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: Emily Ewing, Center for Drug
Evaluation and Research, Food and Drug Administration, 240-402-0196,
<a href="/cdn-cgi/l/email-protection#70351d191c095e3507191e17301614115e1818035e171f06"><span class="__cf_email__" data-cfemail="b3f6dedadfca9df6c4daddd4f3d5d7d29ddbdbc09dd4dcc5">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Introduction
FDA is announcing a virtual public meeting to discuss proposed
recommendations for the reauthorization of 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 II) expires in September 2022.
Without new legislation, FDA will no longer be able to collect user
fees for future FYs to fund the process for the review of biosimilar
biological product applications. Section 744I(f)(2) of the FD&C Act (21
U.S.C. 379j-53(f)(2)) requires the Agency perform the following actions
after holding negotiations with regulated industry members: (1) Present
recommendations to the relevant Congressional committees; (2) publish
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 30-day comment period, and the public meeting will
satisfy some of these requirements. After the public meeting, we will
revise the recommendations as necessary and present our proposed
recommendations to the Congressional committees.
The purpose of the meeting is to hear the public's views on the
proposed recommendations for the reauthorized program (BsUFA III). 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 III recommendations.
II. What is BsUFA and what does it do?
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 as
the Biosimilar User Fee Act under the Food and Drug Administration
Safety and Innovation Act (FDASIA, Pub. L. 112-144) for a period of 5
years. In 2017, BsUFA was renewed for 5 more years under the FDA
Reauthorization Act of 2017 (FDARA, Pub. L. 115-52).
BsUFA is intended to provide additional revenues so that FDA can
hire staff, improve systems, and continue a well-managed biosimilar
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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. These 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 web
page ``Biosimilar User Fee Amendments'' provides more information about
BsUFA, including the statutory text of FDARA, the BsUFA commitment
letter, ``Biosimilar Authorization Performance Goals and Procedures
Fiscal Years 2013 through 2017'' (BsUFA Commitment Letter), key Federal
Register documents, BsUFA-related guidances, BsUFA user fee rates,
performance reports, and financial reports. The Agency's ``Biosimilar
User Fee Amendments'' web page is 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>.
With the current authorization of BsUFA II under FDARA, FDA
implemented a review program (``the Program'') to promote the
efficiency and effectiveness of the first cycle review process. The
Program allows for additional communication between the FDA review team
and applicants of biosimilar biological products, including mid-cycle
communications and late-cycle meetings, while adding 60 days to the
review clock to provide for this increased interaction and to address
review issues. BsUFA II also includes commitments to advance
development of biosimilar biological products through further
clarification of the regulatory pathway that permits a biosimilar
biological product to be licensed under section 351(k) of the Public
Health Service Act, and to enhance capacity for biosimilar guidance
development, reviewer training, and timely communication. More
information on these commitments can be found in the BsUFA II
Commitment Letter at <a href="https://www.fda.gov/media/100573/download">https://www.fda.gov/media/100573/download</a>.
As part of the current authorization, FDA established an
independent fee structure and fee amounts to improve program funding
predictability, stability, and administrative efficiency. The new
structure established a BsUFA target revenue based on BsUFA program
costs and updated the overall fee structure and related financial
mechanisms. The agreement also included commitments to enhance
management of user fee resources through the development of a resource
capacity planning capability and third-party evaluation of program
resource management, management of the carryover balance, along with
the publication and annual update of a 5-year financial plan.
The current authorization also includes several commitments to
improve the hiring and retention of critical review staff through
modernization of FDA's hiring system, augmentation of hiring staff
capacity and capabilities, creation of a dedicated function focused on
staffing the program, reporting on hiring metrics, and a comprehensive
and continuous assessment of hiring and retention. A list of the
deliverables developed to meet BsUFA II commitments is available on the
FDA web page <a href="https://www.fda.gov/industry/biosimilar-user-fee-amendments/completed-bsufa-ii-deliverables">https://www.fda.gov/industry/biosimilar-user-fee-amendments/completed-bsufa-ii-deliverables</a>.
III. Proposed BsUFA III Recommendations
In preparing the proposed recommendations to Congress for BsUFA
reauthorization, FDA conducted discussions with regulated industry
members, as required by the law. We began the BsUFA reauthorization
process by publishing a notice in the Federal Register requesting
public input on the reauthorization and announcing a public meeting
that was held on November 19, 2020. The meeting included presentations
by FDA and a series of panels with representatives of different
stakeholder groups, including patient advocates, consumer groups,
regulated industry members, health 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/biosimilar-user-fee-amendments/public-meeting-reauthorization-biosimilar-user-fee-act-bsufa-11192020-11192020">https://www.fda.gov/industry/biosimilar-user-fee-amendments/public-meeting-reauthorization-biosimilar-user-fee-act-bsufa-11192020-11192020</a>.
Following the November 2020 public meeting, FDA conducted
negotiations with regulated industry from March 2021 through June 2021.
As directed by Congress, FDA posted minutes of these meetings on its
web page at <a href="https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027">https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027</a>.
The proposed enhancements for BsUFA III address many of the top
priorities identified by public stakeholders, regulated industry, and
FDA. While some of the proposed enhancements are new, many either build
on successful enhancements or refine elements from the existing
program. The enhancements are proposed in the following areas:
Supplemental applications, meeting management, best practices in
communication between FDA and sponsors, inspections and alternative
tools, interchangeable biosimilar biological product development,
regulatory science, finance, hiring and retention, and information
technology. The full text of the proposed BsUFA III Commitment Letter
can be found on the Agency's web page ``BsUFA III: Fiscal Years 2023--
2027,'' available at <a href="https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027">https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027</a>. Each significant new or
modified enhancement is described briefly below:
A. Original and Resubmitted Supplemental Biosimilar Biological Product
Applications
To expedite the review of supplemental biosimilar biological
product applications, FDA proposes to establish new supplement
categories, timelines, and performance goals. New review timelines
range from 3 to 10 months, depending on the content and category of the
supplement submission. Certain supplements for safety labeling updates
and labeling updates to add or remove an indication that do not contain
efficacy data sets would have shorter review timelines than supplements
in other categories. These enhancements are described in section I.A.2
of the proposed BsUFA III Commitment Letter.
B. Meeting Management Goals
To improve overall meeting management, FDA proposes to modify the
Biosimilar Initial Advisory (BIA) meeting, create a new Type 2a
meeting, and modify the timing of Type 4 meeting background packages.
FDA would not require the submission of preliminary comparative
analytical data for a BIA meeting. The new Type 2a meeting would allow
for quicker discussion on a narrow set of issues (e.g., often one but
no more than two issues) involving no more than three review
disciplines or divisions. Traditional Type 2 meetings under BsUFA II
would be renamed to Type 2b meetings in BsUFA III. Under this proposal,
the Type 4 meeting background package may be submitted up to 14
calendar days after FDA receives the meeting request. There would also
be a new followup opportunity to pose clarifying questions after
meetings or a written-response-
[[Page 52688]]
only communication. These enhancements are described in section I.H of
the proposed BsUFA III Commitment Letter.
C. Promoting Best Practices in Communication Between FDA and Sponsors
During Application Review
To enhance communication with sponsors during biosimilar biologic
product application review, FDA proposes to update relevant guidances,
our Manual of Policies and Procedures, and our Standard Operating
Procedures and Policies regarding best practices in communication. FDA
would utilize lessons learned from BsUFA II to update the relevant
documents, as appropriate. The details of this enhancement are found in
section II.A of the proposed BsUFA III Commitment Letter.
D. Enhancing Inspection Communication and Alternative Tools
To facilitate the timely development of biosimilar biological
products and their availability to patients, FDA proposes to notify
sponsors of certain pre-license inspections and to issue guidance on
FDA's thinking on the use of alternative tools to assess manufacturing
facilities beyond the COVID-19 pandemic. These enhancements are
described in section II.B of the proposed BsUFA III Commitment Letter.
E. Advancing Development of Biosimilar Biological-Device Combination
Products Regulated by CDER and CBER
Sponsors employ Use-Related Risk Analyses (URRA) studies to
identify the need for risk mitigation strategies and to design a human
factors (HF) validation study. Based on a URRA, a sponsor may propose
that a HF validation study is not needed to support the safe and
effective use of a biosimilar biologic-device combination product. FDA
proposes establishing new procedures for the review of URRAs along with
performance goals. Human factors studies are conducted to evaluate the
user interface of a biosimilar biologic-device combination product to
eliminate or mitigate use-related hazards that may affect the safe and
effective use of the combination product. Over the past decade, more
combination products have been developed to deliver therapeutics via
different routes of administration (e.g., parenteral, inhalation) with
complex engineering designs. HF validation protocols are reviewed
during the investigational new drug application stage with the goal
towards developing a final finished combination product that supports
the marketing application. To achieve this objective, FDA proposes
updating the procedures for HF validation study protocols, along with a
new performance goal. These enhancements are described in section II.C
of the proposed BsUFA III Commitment Letter.
F. Advancing Development of Interchangeable Biosimilar Biological
Products
FDA proposes a focused effort in BsUFA III to further advance the
development of safe and effective interchangeable biosimilar biological
products. This effort would address current needs, prospectively
identify future needs, and incorporate the following components: (1)
Research leveraging the BsUFA III Regulatory Science Pilot Program; (2)
foundational guidance development; and (3) stakeholder engagement
involving a scientific workshop on the development of interchangeable
biosimilar biological products to help identify future needs.
Associated with this workshop, FDA would issue draft and final strategy
documents outlining FDA's actions to facilitate the development of
interchangeable biosimilar biological products. The details of this
enhancement are described in section II.D of the proposed BsUFA III
Commitment Letter.
G. Regulatory Science
To enhance regulatory decision-making and facilitate science-based
recommendations in areas foundational to biosimilar biological product
development, FDA proposes to pilot a regulatory science program broadly
applicable to biosimilar and interchangeable biological product
development, with project goals not specific to a product or product
class. The pilot program would focus on two demonstration projects: (1)
Advancing the development of interchangeable biosimilar biological
products and (2) improving the efficiency of biosimilar biological
product development. As part of these demonstration projects, FDA
proposes to engage stakeholders in a public meeting to review the
progress of the demonstration projects and to solicit input of future
priorities. An interim report would be issued prior to the public
meeting, and a final summary report of outcomes from the pilot program
would be posted on FDA's website. Within 12 months of completing the
demonstration projects, FDA would publish a comprehensive strategy
document outlining actions FDA will take to facilitate the development
of biosimilar and interchangeable biological products. These
enhancements are described in section II.E of the proposed BsUFA III
Commitment Letter.
H. Continued Enhancement of User Fee Resource Management
FDA is committed to ensuring the sustainability of BsUFA program
resources and to enhancing the operational agility of the BsUFA
program. FDA proposes to build on the financial enhancements included
in BsUFA II and continue activities in BsUFA III to ensure optimal use
of user fee resources and the alignment of staff to workload through
the continued maturation and assessment of the Agency's resource
capacity planning capability. This proposal would also include an
independent assessment of the resource capacity planning capability.
FDA proposes to continue activities to promote transparency of the use
of financial resources in support of the BsUFA program through annual
public meetings, publishing a 5-year financial plan along with annual
updates, and additional reporting in the annual BsUFA Financial Report.
These enhancements are described in section III of the proposed BsUFA
III Commitment Letter.
I. Information Technology
FDA proposes to establish and progress a data and technology
modernization strategy that provides FDA's strategic direction for
current and future state data-driven regulatory initiatives.
Additionally, FDA would advance the use of cloud-based technology to
modernize the Electronic Submission Gateway to support greater data
submission bandwidth and storage in the BsUFA program. These
enhancements are described in section V of the proposed BsUFA III
Commitment Letter.
J. Enhancements to Fee Mechanisms for Increased Predictability,
Stability, and Efficiency
The proposed BsUFA III agreement continues to build on the resource
capacity planning capability established in BsUFA II and continues
financial transparency initiatives. In addition, to manage financial
risks in the program, BsUFA III proposes to enhance the operating
reserve adjustment mechanism to provide for a defined minimum and
maximum required amount of operating reserves. The proposed minimum
amount is equivalent to 10 weeks of operating reserves and the maximum
amount is equivalent to 21 weeks of available operating reserves to be
maintained each year. The annual maximum
[[Page 52689]]
amount of available operating reserves would be phased in over the
first 3 years of BsUFA III (33 weeks in fiscal year 2023, 27 weeks in
fiscal year 2024, and 21 weeks in fiscal year 2025). BsUFA III also
proposes to add a strategic hiring and retention adjustment to ensure
FDA has the funding necessary to provide for the costs of retaining and
hiring highly qualified scientific and technical staff for the process
for the review of biosimilar biological product applications under
BsUFA. This strategic hiring and retention adjustment would add
$150,000 to the base revenue amount each fiscal year during BsUFA III.
K. Impact of BsUFA III Enhancements on User Fee Revenue
To implement the proposed enhancements for BsUFA III, funding for a
cumulative total of 15 FTE staff is proposed to be phased in over the
course of BsUFA III. The new funding would be phased in as follows:
<bullet> $4,428,886 for fiscal year 2023
<bullet> $320,569 for fiscal year 2024
IV. Public Meeting Information
A. Purpose and Scope of the Meeting
The virtual public meeting will include a presentation by FDA and
an industry panel. For members of the public who would like to make
verbal comments on the proposed enhancements, there will be a public
comment period at the end of the meeting (see instructions below). We
will also provide an opportunity for individuals to submit written
comments to the docket before and after the meeting.
B. Participating in the Public Meeting
Registration: Registration is optional and not required to attend
this virtual public meeting. However, registering will allow FDA to
provide you with email updates if any meeting details change. If you
wish to register, you can do so at <a href="https://bsufaiii-finalpublicmeeting.eventbrite.com">https://bsufaiii-finalpublicmeeting.eventbrite.com</a>.
Opportunity for Verbal Public Comment: Those who register online
will receive a confirmation email that includes a link to a request
form to make a verbal public comment at the meeting. If you wish to
speak during the public comment session, follow the instructions in the
notification and identify which topic(s) you wish to address. 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 comments and request time jointly. All
requests to make a public comment during the meeting must be received
by October 19, 2021, 11:59 p.m. Eastern Time. Depending on the number
of requests, we will determine the amount of time allotted to each
commenter, the approximate time each comment is to begin, and will
select and notify participants by October 26, 2021. No commercial or
promotional material will be permitted to be presented at the public
meeting.
Streaming Webcast of the Public Meeting: The Zoom Webinar ID for
this public meeting is 161 047 8285. The webcast link for this public
meeting can be found here: <a href="https://fda.zoomgov.com/j/1610478285?pwd=MG1lN2hrYzBVTGhsd1F2eVhwZG1DQT09">https://fda.zoomgov.com/j/1610478285?pwd=MG1lN2hrYzBVTGhsd1F2eVhwZG1DQT09</a>. The link above should
allow you to enter the webinar directly. If Zoom asks for a passcode,
please use the case-sensitive passcode below.
Case-Sensitive Passcode for Zoom Webinar: S9d&fx
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). Transcripts of the meeting will be available on the
FDA web page <a href="https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027">https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027</a> approximately 30 days after
the meeting.
Dated: September 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-20432 Filed 9-21-21; 8:45 am]
BILLING CODE 4164-01-P
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