[Federal Register Volume 85, Number 211 (Friday, October 30, 2020)]
[Notices]
[Pages 68886-68888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24028]


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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 on the reauthorization of the Biosimilar User 
Fee Act (BsUFA) for fiscal years (FYs) 2023 through 2027. BsUFA 
authorizes FDA to collect user fees to support the process for the 
review of biosimilar biological products. 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. FDA begins the BsUFA reauthorization process by 
publishing a notice in the Federal Register requesting public input and 
holding a public meeting where the public may present its views on the 
reauthorization. FDA invites public comment as the Agency begins the 
process to reauthorize the program for FYs 2023 through 2027. These 
comments will be published and available on FDA's website.

DATES: The public meeting will be held on November 19, 2020, from 9 
a.m. to 12:30 p.m., and will be held by webcast only. Registration to 
attend the meeting and other information can be found at https://bsufaiii-publicmeeting.eventbrite.com. Submit either electronic or 
written comments on this public meeting by December 19, 2020. See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: 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 19, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 19, 2020. 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, 240-
402-7500.
     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.
     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

[[Page 68887]]

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.gpo.gov/fdsys/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. Transcripts of the meeting 
will be available on the FDA website at: https://www.fda.gov/industry/biosimilar-user-fee-amendments/public-meeting-reauthorization-biosimilar-user-fee-act-bsufa-11192020-11192020 approximately 30 days 
after the meeting.

FOR FURTHER INFORMATION CONTACT: Emily Ewing, Center for Drug 
Evaluation and Research, 240-402-0196, Emily.Ewing@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a virtual public meeting to begin the process for 
the reauthorization of the Biosimilar User Fee Act (BsUFA). The 
authority to collect user fees under BsUFA expires in September 2022. 
Without new legislation, FDA would no longer be able to collect user 
fees for future fiscal years to fund the biosimilar biological product 
review process. Before FDA begins negotiations with the regulated 
industry on BsUFA reauthorization, the Agency is holding the public 
meeting announced in this notice, at which stakeholders, including all 
members of the public, may present their views on reauthorization, 
including any suggestions for changes to the performance goals referred 
to in the ``Biosimilar Biological Product Reauthorization Performance 
Goals and Procedures Fiscal Years 2018 through 2022'' (the BsUFA II 
Commitment Letter). In addition, FDA will provide a period of 30 days 
after the public meeting for the public to submit written comments. The 
purpose of this public meeting is to hear stakeholder views on BsUFA as 
we consider elements to propose, update, or discontinue in the next 
BsUFA. In addition to any other relevant information the public would 
like to share, the FDA is interested in responses to the following 
three general questions:
     What is your assessment of the overall performance of the 
BsUFA program to date?
     What current elements should be retained, changed, or 
discontinued to further strengthen and improve the program?
     What new elements should FDA consider adding to the 
program to enhance the efficiency and effectiveness of the biosimilar 
biologic review process?

II. What is BsUFA? What does it do?

    FDA provides the following information to help potential meeting 
participants better understand the history and evolution of BsUFA and 
its status. BsUFA is a law that authorizes FDA to assess and collect 
fees from drug companies that submit marketing applications for 
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 five more years under the FDA 
Reauthorization Act of 2017 (FDARA, Pub. L. 115-52). 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. 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 the FDA Reauthorization Act of 2017 (FDARA, Pub. L. 115-52), 
the BsUFA II Commitment Letter, ``Biosimilar Authorization Performance 
Goals and Procedures Fiscal Years 2013 through 2017'' (the BsUFA 
Commitment Letter), key Federal Register documents, BsUFA-related 
guidances, BsUFA user fee rates, performance reports, and financial 
reports: 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 and 
minimize the number of review cycles necessary for approval. The 
Program allowed for additional communication between the FDA review 
team and applicants of biosimilar biological products, including pre-
submission meetings, 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 to accommodate this additional 
interaction. BsUFA II also includes commitments to advance development 
of biosimilar biological products through further clarification of the 
351(k) regulatory pathway, and to enhance capacity for biosimilar 
regulations and 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.
    BsUFA II established an independent fee structure and fee amounts 
to ensure stable and predictable user fee funding, improve the 
predictability of FDA funding and sponsor invoices, improve efficiency 
by simplifying the administration of user fees, and enhance flexibility 
of financial mechanisms to improve management of BsUFA program funding. 
The structure also established a BsUFA target revenue based on BsUFA 
program costs and updated the overall fee structure. 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 five-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 at https://www.fda.gov/industry/biosimilar-user-fee-amendments/completed-bsufa-ii-deliverables.

[[Page 68888]]

III. Public Meeting Information

A. Purpose and Scope of the Meeting

    The meeting format will include presentations by FDA and a series 
of panels representing different stakeholder groups. We will also 
provide an opportunity for other stakeholders to provide public comment 
at the meeting. FDA policy issues outside of the BsUFA program are 
beyond the scope of these reauthorization discussions. Accordingly, the 
comments should focus on process enhancements and funding issues, and 
not on policy issues.

B. Participating in the Public Meeting

    Registration: Persons interested in attending this virtual public 
meeting should register online by 11:59 p.m. Eastern Time on November 
5, 2020, at https://bsufaiii-publicmeeting.eventbrite.com. Please 
provide complete contact information for each attendee, including name, 
title, affiliation, email, and telephone.
    Opportunity for Public Comment: Those who register online by 
November 5, 2020, will receive a notification about an opportunity to 
participate in the public comment session of 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 November 5, 2020, 11:59 p.m. Eastern Time. 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 
November 12, 2020. No commercial or promotional material will be 
permitted to be presented at the public meeting.
    Streaming Webcast of the Public Meeting: The webcast for this 
public meeting is available at https://collaboration.fda.gov/bsufanov2020/.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document, as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.
    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). A link to the transcript will also be available on the 
internet at https://www.fda.gov/industry/biosimilar-user-fee-amendments/public-meeting-reauthorization-biosimilar-user-fee-act-bsufa-11192020-11192020.

    Dated: October 26, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-24028 Filed 10-29-20; 8:45 am]
BILLING CODE 4164-01-P


