[Federal Register Volume 86, Number 181 (Wednesday, September 22, 2021)]
[Notices]
[Pages 52685-52689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://bsufaiii-finalpublicmeeting.eventbrite.com.
    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 https://www.regulations.gov 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:
     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-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 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: Emily Ewing, Center for Drug 
Evaluation and Research, Food and Drug Administration, 240-402-0196, 
Emily.Ewing@fda.hhs.gov.

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 https://www.fda.gov/industry/fda-user-fee-programs/biosimilar-user-fee-amendments.
    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 https://www.fda.gov/media/100573/download.
    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 https://www.fda.gov/industry/biosimilar-user-fee-amendments/completed-bsufa-ii-deliverables.

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 https://www.fda.gov/industry/biosimilar-user-fee-amendments/public-meeting-reauthorization-biosimilar-user-fee-act-bsufa-11192020-11192020.
    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 https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027.
    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 https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027. 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-

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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

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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:

 $4,428,886 for fiscal year 2023
 $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 https://bsufaiii-finalpublicmeeting.eventbrite.com.
    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: https://fda.zoomgov.com/j/1610478285?pwd=MG1lN2hrYzBVTGhsd1F2eVhwZG1DQT09. 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 https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). Transcripts of the meeting will be available on the 
FDA web page https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027 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


