Document ID: FDA-2012-N-0194-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Biosimilars User Fee Cover Sheet
Posted Date: 2012-03-13T04:00Z

[Federal Register Volume 77, Number 49 (Tuesday, March 13, 2012)]
[Notices]
[Pages 14809-14810]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6034]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities: Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
and to allow 60 days for public comment in response to the notice. This 
notice solicits comments concerning Form FDA 3792, entitled 
``Biosimilars User Fee Cover Sheet.''

DATES: Submit written or electronic comments on the collection of 
information by May 14, 2012.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, 
Juanmanuel.vilela@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60 day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques when appropriate, and other forms of 
information technology.
    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) 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 fiscal years 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 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.
    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 nine annual responses that include the following: Six INDs or 
BPD meetings, two applications, and one supplement. The estimated hours 
per response are based on FDA's past experience with other submissions, 
and average 30 minutes.

[[Page 14810]]

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

    Dated: March 7, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6034 Filed 3-12-12; 8:45 am]
BILLING CODE 4160-01-P