Document ID: FDA-2018-N-1967-0002
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: 2018-11-05T05:00Z

[Federal Register Volume 83, Number 214 (Monday, November 5, 2018)]
[Notices]
[Pages 55370-55371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24130]

=======================================================================
-----------------------------------------------------------------------

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.

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

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: Fax written comments on the collection of information by 
December 5, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written

[[Page 55371]]

comments be faxed to the Office of Information and Regulatory Affairs, 
OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to 
[email protected]. All comments should be identified with the 
OMB control number 0910-0718. Also include the FDA docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[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--Extension

    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 by adding section 
351(k) (42 U.S.C. 262(k)) to create an abbreviated approval pathway for 
biological products shown to be biosimilar to or interchangeable with 
an FDA-licensed reference biological product. This 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) authorized 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). FDA's biosimilar 
biological product user fee program requires FDA to assess and collect 
user fees for certain meetings concerning biosimilar BPD (BPD 
meetings), investigational new drug applications (INDs) intended to 
support a biosimilar biological product application, and biosimilar 
biologic license applications (BLAs).
    Form FDA 3792, entitled ``Biosimilars User Fee Cover Sheet'', is 
submitted by each new BPD entrant (identified via a new meeting request 
or IND submission) and new BLAs. Form FDA 3792 requests the minimum 
necessary information to identify the request and 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 the Biosimilars User Fee Cover Sheet, 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.
    FDA has also 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 our website at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM584984.pdf.
    In the Federal Register of June 29, 2018 (83 FR 30746), 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 \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
  Information collection title       Number of     responses per   Total annual    per  response    Total hours
                                    respondents     respondent       responses        (hours)
----------------------------------------------------------------------------------------------------------------
Biosimilar User Fee Cover Sheet;              35               1              35           * 0.5            17.5
 Form FDA 3792..................
Annual Survey...................              35               1              35               1              35
Request for discontinuation from               2               1               2               1               2
 BPD program....................
Request to move products to                    5               1               5           * 0.5             2.5
 discontinued section of the
 biosimilar list................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............              57
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
* 30 minutes.

    We have increased our estimate by an additional 15 respondents 
since last OMB approval of the information collection. This estimated 
increase is based on our expectation that participation in the BPD 
program will continue to grow, consistent with our experience since 
establishment of the information collection in 2012.

    Dated: October 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24130 Filed 11-2-18; 8:45 am]
 BILLING CODE 4164-01-P