[Federal Register Volume 89, Number 184 (Monday, September 23, 2024)]
[Notices]
[Pages 77531-77533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21671]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-4146]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Biosimilars User Fee Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on information collection associated with the 
Agency's Biosimilars User Fee Program.

DATES: Either electronic or written comments on the collection of 
information must be submitted by November 22, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 22, 2024. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <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-2024-N-4146 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Biosimilars User Fee Program.'' 
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.
    <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 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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
<a href="/cdn-cgi/l/email-protection#eabab8abb99e8b8c8caa8c8e8bc4828299c48d859c"><span class="__cf_email__" data-cfemail="0e5e5c4f5d7a6f68684e686a6f2066667d20696178">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed revision of an existing collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical

[[Page 77532]]

utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Biosimilars User Fee Program

OMB Control Number 0910-0718--Revision

    This information collection supports FDA's Biosimilars User Fee 
Program and implementation of the Biologics Price Competition and 
Innovation Act of 2009 (BPCI Act). The BPCI Act creates an abbreviated 
approval pathway for biological products shown to be biosimilar to or 
interchangeable with an FDA-licensed reference biological product. 
Section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 
262(k)), added by the BPCI Act, allows a company to apply for licensure 
of a biosimilar or interchangeable biological product (351(k) 
application). The BPCI Act also amended section 735 of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379g) to include 
351(k) applications as a type of application under ``human drug 
application'' for the purposes of the prescription drug user fee 
provisions. The FD&C Act as amended by the Biosimilar User Fee 
Amendments of 2022 (BsUFA III), reauthorizes FDA to assess and collect 
fees for biosimilar biological products from October 2022 through 
September 2027 to facilitate the development of safe and effective 
biosimilar products for the American public.
    FDA maintains information on our website at https://www.fda.gov/industry/fda-user-fee-programs/biosimilar-user-fee-amendments regarding 
FDA's BsUFA program. Also available on our website is the Biosimilars 
Action Plan (BAP), which discusses key actions the Agency is taking to 
encourage innovation and competition among biologics and the 
development of biosimilars. The BAP builds on progress in implementing 
the approval pathway for biosimilar and interchangeable products, and 
provides interested persons with updates on related deliverables and 
activities.
    We have revised the information collection to reflect the currently 
agreed-upon performance goals established and captured in the latest 
reauthorization document entitled, ``Biosimilar Biological Product 
Reauthorization Performance Goals and Procedures Fiscal Years 2023 
Through 2027'' (BsUFA Commitment Letter). The BsUFA Commitment Letter 
is available for download from our website at https://www.fda.gov/media/152279/download?attachment. The BsUFA Commitment Letter outlines 
current program goals, including information technology goals, 
discusses program effectiveness considerations, and discusses user fee 
resource management.
    The information collection also includes Form FDA 3792, 
``Biosimilars User Fee Cover Sheet,'' to be submitted by each new 
biological product development (BPD) entrant (identified via a new 
meeting request or investigational new drug (IND) submission) or new 
biologics license application (BLA) applicant. Form FDA 3792 requests 
the minimum information necessary to identify the request, to determine 
the amount of the fee to be assessed, and to account for and track user 
fees. Form FDA 3792 is completed electronically at https://userfees.fda.gov/OA_HTML/bsufaCAcdLogin.jsp, and a notification is 
emailed to the respondent that includes information regarding annual 
program fees. We are discontinuing use of the associated annual survey 
at this time.
    Relatedly, Form FDA 3971 (Small Business Waiver and Refund 
Request), currently approved in OMB control number 0910-0297, may also 
be utilized. As instructed on our BsUFA web page, respondents should 
submit Form FDA 3971 by email to <a href="/cdn-cgi/l/email-protection#88cbcccddacbe7e4e4edebfce1e7e6fbc8eeece9a6e0e0fba6efe7fe"><span class="__cf_email__" data-cfemail="c08384859283afacaca5a3b4a9afaeb380a6a4a1eea8a8b3eea7afb6">[email protected]</span></a> at least 4 
months prior to the submission of the application to see if they 
qualify for a small business waiver. Finally, user fee refund and 
transfer requests, currently approved in OMB control number 0910-0805, 
may be submitted to FDA using Forms FDA 3913 and FDA 3914, 
respectively.
    Patent infringement notifications are also included in the scope of 
collection activity. Section 351(l) of the PHS Act (42 U.S.C. 242(l)) 
provides for the exchange of patent information and resolution of 
patent disputes between a 351(k) biosimilar applicant and the holder of 
the 351(a) BLA reference product. If a biosimilar applicant is served 
with a complaint in an action for a patent infringement described in 
section 351(l)(6) of the PHS Act, the biosimilar applicant is required 
to provide the Secretary of HHS with notice and a copy of the complaint 
within 30 days of service. FDA is required to publish notice of a 
complaint received under section 351(l)(6)(C) of the PHS Act in the 
Federal Register.
    Relevant information regarding applicable statutory requirements is 
discussed in topical guidance documents, issued consistent with our 
BsUFA Commitment Letter and Agency Good Guidance Practice regulations 
in 21 CFR 10.115, which provide for public comment at any time. The 
following draft and final guidance documents include instructional and 
procedural information on communicating with FDA regarding the BsUFA 
program:
    <bullet> ``Assessing User Fees Under the Biosimilar User Fee 
Amendments of 2022'' (July 2023), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-user-fees-under-biosimilar-user-fee-amendments-2022. The guidance document 
instructs respondents on requesting discontinuation from the BPD 
program, as well as requesting to move products to the discontinued 
section of the biosimilar list. The guidance document also provides 
information on the consequences of failing to pay BsUFA III fees as 
well as processes for submitting reconsideration and appeal requests.
    <bullet> ``Formal Meetings Between the FDA and Sponsors or 
Applicants of BsUFA Products'' (August 2023), available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-sponsors-or-applicants-bsufa-products-guidance-industry. The guidance document explains standardized 
procedures for requesting, preparing, scheduling, conducting, and 
documenting formal meetings with FDA, and discusses good meeting 
management practices.
    <bullet> As listed on our CDER 2023 and 2024 Annual Guidance 
agenda, we are planning to issue a draft guidance for industry entitled 
``Pediatric Study Plans for Biosimilar Products,'' to help implement 
provisions of the Pediatric Research Equity Act, codified in section 
505B of the FD&C Act (21 U.S.C. 355c). For more information regarding 
FDA guidance documents, including ways to participate, please visit 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.
    Description of Respondents: Sponsors and applicants who have or 
intend to submit an application for a biosimilar product for licensure 
under section 351(k) of the PHS Act or who intend to submit an initial 
pediatric study plan (iPSP) as described in section 505B(e)

[[Page 77533]]

for those products intended to be licensed under section 351(k) of the 
PHS Act and being developed as a proposed biosimilar to a reference 
product.
    FDA estimate the burden of this collection of information as 
follows:

                                   Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                               Number of
       FDA form; survey         Number of    responses per  Total annual      Average burden per     Total hours
                               respondents    respondent      responses            response
----------------------------------------------------------------------------------------------------------------
Biosimilar User Fee Cover               30               2            60  0.5 (30 minutes).........           30
 Sheet (Form FDA 3792).
Request for discontinuation              6               1             6  1........................            6
 from BPD program or to move
 products to discontinued
 section of Biosimilar List.
Biosimilar product &                    16           ~1.94            31  ~610.90..................       18,938
 interchangeable product
 applications (351(k));
 patent infringement
 notifications (351(l)).
Formal meeting requests as             135            2.30           311  21.42....................        6,661
 recommended in FDA guidance.
Submission of Pediatric                 11               1            11  ~38.18...................          420
 Assessment; iPSP template
 information, including
 deferrals of pediatric
 assessments for proposed
 biosimilar products; iPSP
 amendments as recommended in
 FDA guidance.
                              ----------------------------------------------------------------------------------
    Total....................  ...........  ..............           419  .........................       26,055
----------------------------------------------------------------------------------------------------------------

    Our estimated burden for the information collection reflects an 
overall increase of 13,069 hours and 105 responses annually. Although 
part of the increase may be attributed to the inclusion of burden 
associated with the submission of pediatric study plans, we regard the 
majority of adjustments as nominal fluctuations consistent with the 
number of applications and submissions we are receiving.

    Dated: September 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21671 Filed 9-20-24; 8:45 am]
BILLING CODE 4164-01-P


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>