```

[Federal Register Volume 90, Number 21 (Monday, February 3, 2025)]
[Notices]
[Pages 8804-8805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-02153]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Biosimilars User Fee 
Program

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by March 5, 2025.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0718. Also include the FDA docket 
number found in brackets in the heading of this document.

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, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 
its 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 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 [email protected] 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-

[[Page 8805]]

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 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:
     ``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.
     ``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.
     As listed on our Center for Drug Evaluation and Research 
2023 and 2024 Annual Guidance agenda (available at: https://www.fda.gov/media/134778/download), 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) of the FD&C 
Act 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.
    In the Federal Register of September 23, 2024 (89 FR 77531), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this information collection as follows:

                                   Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                   Number of       Total
         FDA form; survey           Number of    responses per     annual      Average burden per    Total hours
                                   respondents    respondent     responses          response
----------------------------------------------------------------------------------------------------------------
Biosimilar User Fee Cover Sheet             30               2           60  0.5 (30 minutes)......           30
 (Form FDA 3792).
Request for discontinuation from             6               1            6  1.....................            6
 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, the majority 
of adjustments correspond with an increase in submissions we are 
receiving.

    Dated: January 28, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-02153 Filed 1-30-25; 11:15 am]
BILLING CODE 4164-01-P
```