[Federal Register Volume 85, Number 248 (Monday, December 28, 2020)]
[Notices]
[Pages 84345-84347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28602]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Interim 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 public meeting entitled ``Interim Assessment 
of the Program for Enhanced Review Transparency and Communication in 
the Biosimilar User Fee Act (BsUFA)'' and an opportunity for public 
comment. The topics to be discussed are the interim assessment and 
public stakeholder views of the program to date.

DATES: The public meeting will be held on January 27, 2021, from 9:30 
a.m. to 12:30 p.m. Eastern Time and will take place virtually by Adobe 
Connect only. Submit either electronic or written comments on this 
public meeting by March 29, 2021. See the SUPPLEMENTARY INFORMATION 
section for registration date and information.
    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 March 29, 2021. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of March 29, 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.

[[Page 84346]]

     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 ``Interim 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 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

    The 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, the BsUFA was 
renewed for 5 more years under the FDA Reauthorization Act of 2017 
(FDARA) (BsUFA II) (Pub. L. 115-52, Title IV)). The 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. 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). 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 BsUFA applications. In addition to publishing 
an interim assessment on FDA's website, a public meeting will be held 
on January 27, 2021, where the interim assessment will be discussed, 
and public stakeholders may present their views on the Program to date.
    Additional information concerning the 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 
interim 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 to date, including any proposed plans to improve the 
likelihood of the Program's success. A panel of external stakeholders 
will also provide their perspective. To view the interim assessment 
report, please visit here: https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-ii-assessment-program-enhanced-review-transparency-and-communication-biosimilar-user-fee-act.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the 
following website to register: https://www.eventbrite.com/e/public-meeting-on-the-interim-assessment-of-the-bsufa-ii-program-tickets-127577568943. Please provide complete contact information for each 
attendee, including name, affiliation, and email.
    Persons interested in attending this public meeting must register 
by January 26, 2021, at 11:59 p.m. Eastern Time. Registrants will 
receive confirmation once they have been accepted.
    Requests for Oral Presentations: Those who register online by 
January 14, 2021, 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

[[Page 84347]]

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 January 15, 2021, 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 January 20, 2021. No commercial or promotional material 
will be permitted to be presented at the public meeting.
    Streaming Webcast of the Public Meeting: This public meeting will 
be held via Adobe Connect. The link for this public meeting is https://collaboration.fda.gov/bsufa012721.
    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 at 
www.regulations.gov in this docket.

    Dated: December 21, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28602 Filed 12-23-20; 8:45 am]
BILLING CODE 4164-01-P