[Federal Register Volume 81, Number 50 (Tuesday, March 15, 2016)]
[Notices]
[Pages 13804-13805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05720]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0781]


Final 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 final results of a study of 
the workload volume and full costs associated with the process for the 
review of biosimilar biological product applications (final 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 
final report.

DATES: The report will be released on or before March 17, 2016. Submit 
either electronic or written comments on the final report by April 14, 
2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked, and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-0781 for ``Final Results of the Study of Workload Volume and 
Full Costs Associated With Review of Biosimilar Biological Product 
Applications.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper

[[Page 13805]]

submission. You should submit two copies total. One copy will include 
the information you claim to be confidential with a heading or cover 
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' 
The Agency will review this copy, including the claimed confidential 
information, in its consideration of comments. The second copy, which 
will have the claimed confidential information redacted/blacked out, 
will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets 
Management. If you do not wish your name and contact information to be 
made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 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. 112-114), 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 
final report. The final 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 (http://www.gpo.gov/fdsys/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf). (FDA 
has verified the Web site addresses, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.)

II. Electronic Access

    The final report can be accessed at http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/ucm459682.htm.

    Dated: March 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05720 Filed 3-14-16; 8:45 am]
 BILLING CODE 4164-01-P