[Federal Register Volume 83, Number 123 (Tuesday, June 26, 2018)]
[Notices]
[Pages 29792-29793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-13688]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6209]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for 
Industry: Assessing User Fees Under the Biosimilar User Fee Amendments 
of 2017

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.

[[Page 29793]]


DATES: Fax written comments on the collection of information by July 
26, 2018.

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

Guidance for Industry: Assessing User Fees Under the Biosimilar User 
Fee Amendments of 2017

OMB Control Number 0910-0718--Revision

    This information collection supports the above captioned Agency 
guidance and implementation of the Biosimilar User Fee Amendments of 
2017 (BsUFA II). Under BsUFA II, FDA's authority is extended to collect 
user fees from fiscal years 2018-2022 and includes a number of 
technical revisions that affect what fees and how fees are collected. 
Fees authorized by this legislation help fund the review process for 
biosimilar biological product applications and play an important role 
in expediting the review and approval process.
    We have developed the guidance document entitled ``Assessing User 
Fees Under the Biosimilar User Fee Amendments of 2017'' to assist 
industry in understanding when these fees are incurred and the process 
by which applicants can submit payments. The guidance also provides 
information on the consequences of failing to pay BsUFA II fees, as 
well as processes for submitting reconsideration and appeal requests. 
The guidance document is available on our website at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM584984.pdf.
    In the Federal Register of November 16, 2017 (82 FR 53505), we 
published a notice announcing availability of the subject guidance 
document, including a 60-day notice requesting public comment on the 
information collection. One comment was received in response to the 
notice from a trade organization indicating that interested persons 
``have reviewed the draft guidance and appreciate(s) FDA applying the 
user fee provisions consistent with the BsUFA II negotiations and 
Commitment Letter.'' In addition, and upon our own review, we believe 
it is appropriate to include the guidance document under the existing 
information collection ``Biosimilar User Fee Cover Sheet'' currently 
approved under OMB control number 0910-0718 rather than to establish a 
new collection. FDA is preparing to renew OMB control number 0910-0718 
and will include the guidance document accordingly.
    We estimate the burden of the information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                    Average burden
            Activity                 Number of     responses per   Total annual    per response     Total hours
                                    respondents     respondent       responses        (hours)
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Request for discontinuation from               2               1               2               1               2
 biological product development
 program........................
Request to move products to                    5               1               5           * 0.5             2.5
 discontinued section of the
 biosimilar list................
Small business waiver of the                   1               1               1              16              16
 BsUFA application fee..........
Small business waiver                          1               1               1              24              24
 reconsiderations...............
Small business waiver appeals...               1               1               1              12              12
Annual Fee Determination Survey.              35               1              35               1              35
Annual BsUFA Fees Correspondence              35               1              35               2              70
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    Total.......................  ..............  ..............  ..............  ..............           161.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
* 30 minutes.

    Our estimate is based on the number of Biosimilars User Fee 
submissions we have received since establishing the program.

    Dated: June 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-13688 Filed 6-25-18; 8:45 am]
 BILLING CODE 4164-01-P