Notice2024-21671
Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Program
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Published
September 23, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 184 (Monday, September 23, 2024)</title>
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[Federal Register Volume 89, Number 184 (Monday, September 23, 2024)]
[Notices]
[Pages 77531-77533]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-21671]
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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.
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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 <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 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: <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-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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <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: 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 <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> 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 <a href="https://www.fda.gov/media/152279/download?attachment">https://www.fda.gov/media/152279/download?attachment</a>. 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 <a href="https://userfees.fda.gov/OA_HTML/bsufaCAcdLogin.jsp">https://userfees.fda.gov/OA_HTML/bsufaCAcdLogin.jsp</a>, 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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-user-fees-under-biosimilar-user-fee-amendments-2022">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-user-fees-under-biosimilar-user-fee-amendments-2022</a>. 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: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-sponsors-or-applicants-bsufa-products-guidance-industry">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-sponsors-or-applicants-bsufa-products-guidance-industry</a>. 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
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>.
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
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Number of
FDA form; survey Number of responses per Total annual Average burden per Total hours
respondents respondent responses response
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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.
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Total.................... ........... .............. 419 ......................... 26,055
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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
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