Notice2021-27680
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biosimilars User Fee Program
Primary source
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Published
December 22, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 243 (Wednesday, December 22, 2021)</title>
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[Federal Register Volume 86, Number 243 (Wednesday, December 22, 2021)]
[Notices]
[Pages 72604-72606]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#8fdfddcedcfbeee9e9cfe9ebeea1e7e7fca1e8e0f9"><span class="__cf_email__" data-cfemail="633331223017020505230507024d0b0b104d040c15">[email protected]</span></a>.
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: <a href="https://www.fda.gov/media/134567/download">https://www.fda.gov/media/134567/download</a>. 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: <a href="https://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM521121.pdf">https://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM521121.pdf</a>. 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: <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 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
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