Document ID: FDA-2018-N-1967-0005
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review;
Comment Request; Biosimilars User Fee Program
Posted Date: 2021-12-22T05:00Z

[Federal Register Volume 86, Number 243 (Wednesday, December 22, 2021)]
[Notices]
[Pages 72604-72606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27680]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1967]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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 January 21, 2022.

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 0910-0719. 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. The Biologics Price Competition and Innovation Act of 2009 
(BPCI Act) amended the Public Health Service Act (PHS Act) to create 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 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 (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 Biosimilar User Fee Act of 2012 (BsUFA) authorizes FDA to 
assess and collect user fees for certain activities in connection with 
biosimilar biological

[[Page 72605]]

product development (BPD). BsUFA was reauthorized for an additional 5 
years in August 2017 (BsUFA II). We developed the guidance entitled 
``Assessing User Fees Under the Biosimilar User Fee Amendments of 
2017'' to assist industry in understanding when fees are incurred and 
the process by which applicants can submit payments. The guidance also 
explains how respondents can request discontinuation from the BPD 
program as well as how respondents can request to move products to the 
discontinued section of the biosimilar list. Finally, the guidance 
provides information on the consequences of failing to pay BsUFA II 
fees as well as processes for submitting reconsideration and appeal 
requests. The guidance is available on the FDA website at: https://www.fda.gov/media/134567/download. The guidance was issued consistent 
with our good guidance practice regulations in Sec.  10.115 (21 CFR 
10.115), which provide for public comment at any time.
    We also developed Form FDA 3792, the Biosimilars User Fee Cover 
Sheet, which is submitted by each new BPD entrant (identified via a new 
meeting request or investigational new drug (IND) submission) and for 
new biologics license applications (BLAs). Form FDA 3792 requests the 
minimum necessary information to identify the request, to determine the 
amount of the fee to be assessed, and to account for and track user 
fees. The form provides a cross-reference of the fees submitted for an 
activity with the actual submission or activity by using a unique 
number tracking system. The information collected is used by FDA's 
Center for Drug Evaluation and Research and Center for Biologics 
Evaluation and Research to initiate the administrative screening of 
biosimilar biological product INDs and BLAs and to account for and 
track user fees associated with BPD meetings.
    In addition to Form FDA 3792, the information collection includes 
an annual survey of all BsUFA II participants designed to provide 
information to FDA of anticipated BsUFA II activity in the upcoming 
fiscal year. This information helps FDA set appropriate annual BsUFA II 
fees.
    For efficiency of Agency operations, we are consolidating related 
information collection currently approved in OMB control number 0910-
0719. Specifically we are including our current commitment goals as set 
forth in the document ``BsUFA Reauthorization Performance Goals and 
Procedures Fiscal Years 2018 Through 2022,'' which represents the 
product of FDA discussions with regulated industry and public 
stakeholders, as mandated by Congress. The document, referred to as the 
``BsUFA II letter,'' is available on our website at: https://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM521121.pdf. The performance and procedural goals specified in the 
BsUFA II letter apply to aspects of the biosimilar biological product 
review program that are important for facilitating timely access to 
safe and effective biosimilar medicines for patients. Among those 
considerations is providing feedback to requests from regulated 
industry. Each year, FDA review staff participate in many meetings with 
requesters who seek advice relating to the development and review of a 
biosimilar or interchangeable product. Because these meetings often 
represent critical points in the regulatory and development process, it 
is important that there are clear procedures for the timely and 
effective conduct of such meeting. Accordingly, we issued draft 
guidance, ``Formal Meetings Between the FDA and Sponsors or Applicants 
of BsUFA Products,'' available on our website 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 was issued consistent with Section I, Part 6 of 
the BsUFA II letter (see p. 25), and with our good guidance practice 
regulations in Sec.  10.115, which provide for public comment at any 
time. The guidance provides procedural instruction helpful to 
respondents and helps us reach what we believe is a more accurate 
burden estimate for the information collection.
    Also available from our website is our 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 and resource material.
    In the Federal Register of September 17, 2021 (86 FR 51900), 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 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 response           Total hours
                                                 respondents     respondent       responses
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Biosimilar User Fee Cover Sheet (Form FDA                  60               1              60  0.5 (30 minutes).........................              30
 3792).
Annual Survey................................              60               1              60  1........................................              60
Request for discontinuation from BPD program.              10               1              10  1........................................              10
Request to move products to discontinued                    5               1               5  0.5 (30 minutes).........................             2.5
 section of the Biosimilar List.
Biosimilar product applications                             4            2.25               9  860......................................           7,740
 (351(k)(2)(A)).
Interchangeable product applications                        2               1               2  860......................................           1,720
 (351(k)(2)(B)).
Patent infringement notifications............               4            2.25               9  2........................................              18
Formal Meetings Guidance for Industry                      69            2.30             159  21.42....................................           3,405
 Recommendations.
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    Total....................................  ..............  ..............             314  .........................................        12,985.5
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    In anticipation of increased participation in the BPD program, we 
have adjusted our estimate to reflect an increase in the number of 
respondents since last OMB review. We have also made adjustments to 
reflect information collection consolidated from OMB control number 
0910-0719. We invite comment on our estimates and assumptions.

[[Page 72606]]

    Dated: December 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27680 Filed 12-21-21; 8:45 am]
BILLING CODE 4164-01-P