[Federal Register Volume 77, Number 117 (Monday, June 18, 2012)]
[Notices]
[Pages 36279-36281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-14740]


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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 
18, 2012.

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-New and 
title ``Biosimilars User Fee Cover Sheet; Form FDA 3792''. Also include 
the FDA

[[Page 36280]]

docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
[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-New)

    The March 23, 2010 Affordable Care Act contains a subtitle called 
the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) 
that amends the Public Health Service Act (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 (FD&C 
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 authority conferred by the FD&C Act's 
prescription drug user fee provisions expires in September 2012. The 
BPCI Act directs FDA to develop recommendations for a biosimilar 
biological product user fee program for FYs 2013 through 2017. FDA's 
recommendations for a biosimilar biological product user fee program 
were submitted to Congress on January 13, 2012. If enacted into law, 
FDA's proposed biosimilar biological product user fee program would 
require 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. Proposed 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 would provide a cross-reference of 
the fees submitted for a submission with the actual submission by using 
a unique number tracking system. The information collected would be 
used by FDA's Center for Drug Evaluation and Research (CDER) and Center 
for Biologics Evaluation and Research (CBER) 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 March 13, 2012 (77 FR 14809), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information, Form FDA 3792, the Biosimilar User Fee Cover 
Sheet. FDA received the following comments:
    (Comment 1) Suggests FDA use the term ``Biosimilar Biological 
Product Licensing Application (BBLA)'' or ``Interchangeable Biosimilar 
Biological Product Application (IBLA)'' for a biosimilar application 
instead of Biologics License Application (BLA) to avoid confusion and 
provide greater clarity.
    (Response) FDA notes the Biosimilar User Fee Cover Sheet serves a 
billing and collections purpose, and does not indicate FDA's position 
on reference terms. However, to maintain consistency throughout the 
document and avoid any confusion, FDA refers to a biologics license 
application submitted under section 351(k) of the Public Health Service 
Act as a ``351(k) application''. Under FDA's proposed biosimilar 
biological product user fee program, user fees would be assessed only 
for those 351(k) applications that fall within the scope of the defined 
term ``biosimilar biological product application.'' Accordingly, FDA 
has made changes to the Biosimilar User Fee Cover Sheet to clarify that 
Form 3792 need not be submitted for certain specified types of 351(k) 
applications. Additionally, to address the need for greater clarity, 
FDA has added definitions of several other key terms to the Biosimilar 
User Fee Cover Sheet.
    (Comment 2) Requests FDA to ask for all available product names, 
including the product's code name in addition to trade and proper 
names, because the Biosimilar User Fee Cover Sheet should be consistent 
with Form FDA 1571. Further, requests FDA to amend the ``Product Name'' 
information field to ``Product Name(s).''
    (Response) We agree that the Biosimilar User Fee Cover sheet should 
be consistent with Form 1571, where applicable. Accordingly, FDA 
amended the instructions to request proper name, trade or proprietary 
name, and code name, as applicable, and amended the ``Product Name'' 
information field to ``Product Name(s)''.
    (Comment 3) Requests FDA to remove the question about whether the 
application requires clinical data, other than comparative 
bioavailability studies, for approval because this information does not 
affect the fee amount.
    (Response) FDA notes this question applies only to fees for 
biosimilar biological product applications, and not to fees for 
biosimilar biological products in development. Under FDA's proposed 
biosimilar biological product user fee program, the fee amount for a 
biosimilar biological product application depends on whether clinical 
data with respect to safety or effectiveness are required. 
Specifically:
     A full fee is assessed for a biosimilar biological product 
application for which clinical data (other than comparative 
bioavailability studies) with respect to safety or effectiveness are 
required for approval;
     A half fee is assessed for a biosimilar biological product 
application for which clinical data (other than comparative 
bioavailability studies) with respect to safety or effectiveness are 
not required for approval;
     A half fee is assessed for a supplement for which clinical 
data (other than comparative bioavailability studies) with respect to 
safety or effectiveness are required for approval; and
     No fee is assessed for a supplement for which clinical 
data (other than comparative bioavailability studies) with respect to 
safety or effectiveness are not required for approval.
    Therefore, FDA has retained the question on the Biosimilar User Fee 
Cover Sheet concerning whether clinical data are required because it 
requests information necessary to determine the fee amount for a 
biosimilar biological product application or supplement.
    (Comment 4) Requests FDA to decline to require a patent 
certification as part of a 351(k) application.
    (Response) FDA notes this comment is outside the scope of the 
proposed collection of information, Form FDA 3792, the Biosimilar User 
Fee Cover Sheet.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 36281]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
              Form                   Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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FDA 3792........................               9               1               9             0.5            4.5
                                                                                    (30 minutes)
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\1\ There are no capital costs or operating maintenance costs associated with this collection of information.

    Respondents to this proposed collection of information would be 
manufacturers of biosimilar biological product candidates. Based on 
FDA's database system, there are an estimated 18 manufacturers that 
fall into this category. However, not all manufacturers will have 
submissions in a given year and some may have multiple submissions. FDA 
estimates 9 annual responses that include the following: 6 INDs or BPD 
meetings, 2 applications, and 1 supplement. The estimated hours per 
response are based on FDA's past experience with other submissions, 
which average 30 minutes.

    Dated: June 12, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14740 Filed 6-15-12; 8:45 am]
BILLING CODE 4160-01-P