Notice2022-03926
Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act; Public Meeting; Request for Comments
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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
February 24, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 37 (Thursday, February 24, 2022)</title>
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[Federal Register Volume 87, Number 37 (Thursday, February 24, 2022)]
[Notices]
[Pages 10371-10373]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.eventbrite.com/e/public-meeting-on-the-final-assessment-of-the-bsufa-ii-program-tickets-229459628927">https://www.eventbrite.com/e/public-meeting-on-the-final-assessment-of-the-bsufa-ii-program-tickets-229459628927</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 May 23, 2022. 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 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:
<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-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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9
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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: 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, <a href="/cdn-cgi/l/email-protection#a8e3c1c5cacddac4d186dcc9d1c4c7dae8ceccc986c0c0db86cfc7de"><span class="__cf_email__" data-cfemail="a5eeccc8c7c0d7c9dc8bd1c4dcc9cad7e5c3c1c48bcdcdd68bc2cad3">[email protected]</span></a>.
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 <a href="https://www.fda.gov/media/144130/download">https://www.fda.gov/media/144130/download</a>. 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 <a href="https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-ii-assessment-program-enhanced-review-transparency-and-communication-biosimilar-user-fee-act">https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-ii-assessment-program-enhanced-review-transparency-and-communication-biosimilar-user-fee-act</a>. 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 <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>.
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 <a href="https://www.eventbrite.com/e/public-meeting-on-the-final-assessment-of-the-bsufa-ii-program-tickets-229459628927">https://www.eventbrite.com/e/public-meeting-on-the-final-assessment-of-the-bsufa-ii-program-tickets-229459628927</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 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: <a href="https://fda.zoomgov.com/j/1617691719?pwd=dy9yRTVqdEw1dVEzTUNqelFEa3Vpdz09">https://fda.zoomgov.com/j/1617691719?pwd=dy9yRTVqdEw1dVEzTUNqelFEa3Vpdz09</a>. 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 <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 meeting recording will also be available
on the internet at <a href="https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-final-assessment-program-enhanced-review-transparency-and-communication-biosimilar">https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-final-assessment-program-enhanced-review-transparency-and-communication-biosimilar</a>.
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
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