[Federal Register Volume 86, Number 178 (Friday, September 17, 2021)]
[Notices]
[Pages 51900-51902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20060]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

AGENCY: Food and Drug Administration, Health and Human Services (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: Submit either electronic or written comments on the collection 
of information by November 16, 2021.

ADDRESSES: 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 November 16, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 16, 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.
     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-2018-N-1967 for ``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.
     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, 
[email protected].

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 extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice

[[Page 51901]]

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 
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. 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 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.
    We estimate the burden of this collection of information as 
follows:

[[Page 51902]]



                                   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 (hours)
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Biosimilar User Fee Cover                 60               1              60  0.5 (30 minutes)..              30
 Sheet (Form FDA 3792).
Annual Survey...............              60               1              60  1.................              60
Request for discontinuation               10               1              10  1.................              10
 from BPD program.
Request to move products to                5               1               5  0.5 (30 minutes)..             2.5
 discontinued section of the
 Biosimilar List.
Biosimilar product                         4            2.25               9  860...............           7,740
 applications (351(k)(2)(A)).
Interchangeable product                    2               1               2  860...............           1,720
 applications (351(k)(2)(B).
Patent infringement                        4            2.25               9  2.................              18
 notifications.
Formal Meetings GFI                       69            2.30             159  21.42.............           3,405
 Recommendations.
                             -----------------------------------------------------------------------------------
    Total...................  ..............  ..............             314  ..................        12,985.5
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    In anticipation of increased participation in the BPD program, we 
have increased 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.

    Dated: September 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-20060 Filed 9-16-21; 8:45 am]
BILLING CODE 4164-01-P