[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4272-4273]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01404]


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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, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection in 
Form FDA 3792, ``Biosimilars User Fee Cover Sheet''.

DATES: Submit either electronic or written comments on the collection 
of information by March 30, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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, including 
each proposed extension of an existing collection of information,

[[Page 4273]]

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 these topics: (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.

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


    Dated: January 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-01404 Filed 1-26-15; 8:45 am]
BILLING CODE 4164-01-P