[Federal Register Volume 80, Number 106 (Wednesday, June 3, 2015)]
[Notices]
[Pages 31603-31604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-13471]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0194]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Biosimilars User Fee 
Cover Sheet; Form FDA 3792

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: Fax written comments on the collection of information by July 6, 
2015.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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 Cover Sheet; Form FDA 3792

OMB Control Number 0910-0718--Extension

    The Patient Protection and Affordable Care Act (Pub. L. 111-148) 
contains a subtitle called the Biologics Price Competition and 
Innovation Act of 2009 (Title VII Subtitle A) (BPCI Act) that amends 
the Public Health Service Act (42 U.S.C. 262) (PHS Act) and other 
statutes 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, 
added by the BPCI Act, allows a company to submit an application for 
licensure of a biosimilar or interchangeable biological product. The 
BPCI Act also amends section 735 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379g) to include 351(k) applications in the 
definition of ``human drug application'' for the purposes of the 
prescription drug user fee provisions. The BPCI Act directs FDA to 
develop recommendations for a biosimilar biological product user fee 
program for fiscal years 2013 through 2017. FDA's recommendations for a 
biosimilar biological product user fee program were submitted to 
Congress on January 13, 2012.
    FDA's biosimilar biological product user fee program requires FDA 
to assess and collect user fees for certain meetings concerning 
biosimilar biological product development (BPD meetings), 
investigational new drug applications (INDs) intended to support a 
biosimilar biological product application, and biosimilar biological 
product applications and supplements. Form FDA 3792, the Biosimilars 
User Fee Cover Sheet, requests the minimum necessary information to 
determine the amount of the fee required, and to account for and track 
user fees. The form provides a cross-reference of the fees submitted 
for a submission with the actual submission 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, applications, and supplements, and to account 
for and track user fees associated with BPD meetings.
    In the Federal Register of January 27, 2015 (80 FR 4272), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    Respondents to this collection of information are manufacturers of 
biosimilar biological product candidates. Based on the number of Form 
FDA 3792s we have received, we estimate the burden of this collection 
of information as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                     No. of
                          FDA form No.                               No. of       responses per   Total annual     Average burden  per      Total hours
                                                                   respondents     respondent       responses            response
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Biosimilars User Fee Cover Sheet; Form FDA 3792................              20               1              20        0.50 (30 minutes)              10
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 31604]]

    Dated: May 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13471 Filed 6-2-15; 8:45 am]
BILLING CODE 4164-01-P