[Federal Register Volume 87, Number 37 (Thursday, February 24, 2022)]
[Notices]
[Pages 10371-10373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03926]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2252]


Final Assessment of the Program for Enhanced Review Transparency 
and Communication in 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, the Agency, or we) is 
announcing the following virtual public meeting entitled ``Final 
Assessment of the Program for Enhanced Review Transparency and 
Communication in the Biosimilar User Fee Act (BsUFA)'' (the Program) 
and an opportunity for public comment. The topics to be discussed are 
the final assessment and public stakeholder views of the Program.

DATES: The public meeting will be held on March 22, 2022, from 9:30 
a.m. to 12:30 p.m. Eastern Time and will be held by webcast only. 
Submit either electronic or written comments on this public meeting by 
May 23, 2022. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: Registration to attend the meeting and other information can 
be found at https://www.eventbrite.com/e/public-meeting-on-the-final-assessment-of-the-bsufa-ii-program-tickets-229459628927.
    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 May 23, 2022. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of May 23, 2022. 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-2020-N-2252 for ``Final Assessment of the Program for Enhanced 
Review Transparency and Communication in the Biosimilar User Fee Act 
(BsUFA); 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

[[Page 10372]]

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: Kimberly Taylor, Food and Drug 
Administration, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1152, Silver 
Spring, MD 20993, 240-402-5193, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    BsUFA was originally enacted in 2012 as the Biosimilar User Fee Act 
under the Food and Drug Administration Safety and Innovation Act (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) (BsUFA II) 
(Pub. L. 115-52, Title IV)). BsUFA was intended 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. 
BsUFA II was authorized to continue the collection of user fees by FDA 
to facilitate and expedite the process for the review of biosimilar 
biological products in the United States.
    Under BsUFA II, FDA committed to apply a new review model to 
original biosimilar biologics license application (BLA) reviews. That 
review model is identified in section II.B. of the BsUFA II Commitment 
Letter as the Program for Enhanced Review Transparency and 
Communication for Original 351(k) BLAs. The Program provides 
opportunities for increased communication between FDA and applicants, 
including mid-cycle and late-cycle meetings. To accommodate the 
increased interaction during regulatory review, FDA's review clock 
begins after the 60-day administrative filing review period for 
applications reviewed under the Program. The goal of the Program is to 
promote the efficiency and effectiveness of the first-cycle review 
process and minimize the number of review cycles necessary for 
approval, ensuring that patients have timely access to safe, effective, 
and high-quality biosimilar and interchangeable biological products.
    An independent evaluator is assessing the Program to understand its 
effect on the review of original 351(k) BLAs. An interim assessment was 
published December 3, 2020, and can be accessed at https://www.fda.gov/media/144130/download. The BsUFA II performance commitments also call 
for a final assessment of the Program to be published by June 30, 2022, 
for public comment. The final assessment can be accessed at https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-ii-assessment-program-enhanced-review-transparency-and-communication-biosimilar-user-fee-act. A public meeting will be held on March 22, 
2022, where the final assessment will be discussed, and public 
stakeholders may present their views on the Program.
    Additional information concerning BsUFA--including the text of the 
law, the ``Biosimilar Biological Product Reauthorization Performance 
Goals and Procedures Fiscal Years 2018 through 2022'' (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--may be 
found at https://www.fda.gov/industry/fda-user-fee-programs/biosimilar-user-fee-amendments.

II. Topics for Discussion at the Public Meeting

    FDA and an independent contractor will discuss the findings of the 
final assessment, including anonymized and aggregated feedback from 
biosimilar BLA applicants and FDA review teams resulting from 
independent contractor interviews. FDA will discuss any issues 
identified, including any proposed plans to improve the likelihood of 
the Program's success. A panel of external stakeholders will also 
provide their perspectives.

III. 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://www.eventbrite.com/e/public-meeting-on-the-final-assessment-of-the-bsufa-ii-program-tickets-229459628927.
    Opportunity for Verbal Public Comment: Those who register online 
will receive a confirmation email that includes a link to a request 
form to make 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 March 10, 2022, 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 March 18, 2022. 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 161 769 1719. The webcast link for this public 
meeting can be found here: https://fda.zoomgov.com/j/1617691719?pwd=dy9yRTVqdEw1dVEzTUNqelFEa3Vpdz09. This link

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should allow you to enter the webinar directly. If Zoom asks for a 
passcode, please use the passcode f7DLM=, which is case-sensitive.
    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 meeting recording will also be available 
on the internet at https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-final-assessment-program-enhanced-review-transparency-and-communication-biosimilar.

    Dated: February 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03926 Filed 2-23-22; 8:45 am]
BILLING CODE 4164-01-P