Document ID: FDA-2015-N-3155-0001
Agency: fda
Document Type: Notice
Title: Interim Results of Study of Workload Volume and Full Costs Associated
With Review of Biosimilar Biological Product Applications
Posted Date: 2015-09-24T04:00Z

[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)]
[Notices]
[Page 57621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24227]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3155]

Interim Results of Study of Workload Volume and Full Costs 
Associated With Review of Biosimilar Biological Product Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the interim results of a study of 
the workload volume and full costs associated with the process for the 
review of biosimilar biological product applications (interim report). 
This study was conducted by an independent consulting firm, and it 
fulfills FDA's statutory requirement under the first authorization of 
the Biosimilar User Fee Act of 2012 (BsUFA), which enables FDA to 
collect user fees for the review of biosimilar biological applications 
for fiscal years 2013 to 2017. This notice solicits comments on the 
interim report.

DATES: The interim report will be released on September 24, 2015, and 
will be available at http://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM459686.pdf. Submit either electronic or 
written comments on the interim report by October 26, 2015.

ADDRESSES: Submit electronic comments on the interim report 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.

FOR FURTHER INFORMATION CONTACT: Mark Ascione, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1150, Silver Spring, MD 20993-0002, 301-
796-7652, FAX: 301-847-8443.

SUPPLEMENTARY INFORMATION: 

I. Background

    The Patient Protection and Affordable Care Act of 2010 (Pub. L. 
111-148) amended the Public Health Service Act to create an abbreviated 
licensure pathway for biological products that are demonstrated to be 
``biosimilar'' to or ``interchangeable'' with an FDA-licensed 
biological product. The Federal Food, Drug, and Cosmetic Act (the FD&C 
Act), as amended by BsUFA (Title IV of the Food and Drug Administration 
Safety and Innovation Act, Pub. L. 112-144), authorizes FDA to assess 
and collect fees for biosimilar biological products from October 2012 
through September 2017. FDA uses these fees to expedite the review 
process for biosimilar biological products. Biosimilar biological 
products represent an important public health benefit, with the 
potential to offer life-saving or life-altering benefits at reduced 
cost to the patient. BsUFA facilitates the development of safe and 
effective biosimilar products for the American public.
    As part of BsUFA, FDA is required to contract with an independent 
accounting or consulting firm to study the workload volume and full 
costs associated with the process for the review of biosimilar 
biological product applications. This notice solicits comments on the 
interim report, and the final report is due no later than September 30, 
2016. The interim report is described in section 744I(d) of the FD&C 
Act (21 U.S.C. 379j-53(d)) (http://uscode.house.gov/view.xhtml?req=granuleid:U.S.C.-prelim-title21-section379j-53#=0&edition=prelim), as amended by the Food and Drug 
Administration Safety and Innovation Act enacted in 2012.

II. Comments

    FDA is issuing this notice to request public comment on the interim 
report. Interested persons may submit either electronic comments to 
http://www.regulations.gov or written comments to the Division of 
Dockets Management (see ADDRESSES). It is only necessary to send one 
set of comments. Identify comments with the docket number found in 
brackets in the heading of this document. Received comments may be seen 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    The interim report can be accessed at http://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM459686.pdf.

    Dated: September 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24227 Filed 9-23-15; 8:45 am]
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