[Federal Register Volume 82, Number 124 (Thursday, June 29, 2017)]
[Notices]
[Pages 29569-29570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13609]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-3199]


Program for Enhanced Review Transparency and Communication for 
Original 351(k) Biologics License Applications in Biosimilar User Fee 
Act II

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the statement of work for an 
assessment of the Program for Enhanced Review Transparency and 
Communication for original biologics license applications (BLAs) 
(351(k)s) submitted under the Public Health Service Act (hereafter 
referred to as 351(k) applications) (hereafter referred to as the 
Program). The Program is part of the FDA performance commitments under 
the proposed reauthorization of the Biosimilar User Fee Act (BsUFA), 
which, if enacted into law, will allow FDA to collect user fees for the 
review of 351(k) applications for fiscal years (FYs) 2018-2022. As part 
of the FDA performance commitments described in this document, the 
Program will be evaluated by an independent contractor in an interim 
and final assessment.

DATES: FDA is providing a period of 30 days for public comment on the 
statement of work before beginning the assessment. The statement of 
work can be accessed at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM559341.pdf. Public comments will be 
accepted through July 31, 2017. See ADDRESSES section below for 
information about submitting comments to the public docket.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before July 31, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of July 31, 2017. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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.''

[[Page 29570]]

    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-3199 for ``Program for Enhanced Review Transparency and 
Communication for Original 351(k) Biologics License Applications in 
BsUFA II.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Azada Hafiz, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1148, Silver Spring, MD 20993, 240-402-
6073, Fax: 301-847-8443, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The timely review of 351(k) applications is central to FDA's 
mission to protect and promote the public health. The BsUFA was first 
enacted by Congress in 2012 and authorizes FDA to collect user fees for 
351(k) applications. FDA dedicates BsUFA user fees to the efficient 
review of 351(k) applications and to facilitate the development of safe 
and effective biosimilar biological products for the American public. 
FDA dedicates the additional fee resources to hire reviewers and 
support staff and upgrade its information technology systems. With the 
availability of these additional fee resources, FDA was able to agree 
to certain review performance goals, including a complete review of 
351(k) applications and taking regulatory action within specified 
timeframes. The current authorization of the program (BsUFA I) expires 
in September 2017.
    As directed by statute, FDA prepared recommendations for the 
reauthorization of BsUFA for a new 5-year period by conducting 
negotiations with the regulated industry and holding regular 
consultations with public stakeholders including patient advocates, 
consumer advocates, and healthcare professionals. Following these 
discussions, related public meetings, and Agency requests for public 
comment, FDA transmitted proposed recommendations for BsUFA II for 
fiscal years 2018-2022. FDA's BsUFA II recommendations include an FDA 
commitment to implement a new review program for 351(k) applications to 
promote the efficiency and effectiveness of the first-cycle review 
process and minimize the number of review cycles necessary for approval 
of these complex applications. The Program is described in detail in 
section I.B of the document entitled ``Biosimilar Biological Product 
Reauthorization Performance Goals and Procedures Fiscal Years 2018 
Through 2022'' available at https://www.fda.gov/downloads/forindustry/userfees/biosimilaruserfeeactbsufa/ucm521121.pdf.

II. BsUFA II Program for Enhanced Review Transparency and Communication 
for Original 351(k) BLAs

    FDA recognizes that increasing communication between the Agency and 
applicants during FDA's review has the potential to increase efficiency 
in the review process. To enhance review transparency and improve 
communication between the FDA review team and the applicant, FDA has 
proposed for BsUFA II a new review model (the Program), for the review 
of all 351(k) applications. The Program will allow for additional 
communication between FDA review teams and the applicants of biosimilar 
biological products in the form of a Biological Product Development 
Type 4 (pre-351(k) BLA) meetings, mid-cycle communications, and late-
cycle meetings. To accommodate this increased interaction during 
regulatory review and to address the need for additional time to review 
these complex applications, FDA's review clock will begin after the 60-
day administrative filing review period for applications reviewed under 
the Program.
    The goal of the Program is to improve the efficiency and 
effectiveness of the first-cycle review process by increasing 
communications during application review. This will provide sponsors 
with the opportunity to clarify previous submissions and provide 
additional data and analyses that are readily available, potentially 
avoiding the need for an additional review cycle when concerns can be 
promptly resolved without compromising FDA's standards for approval.

    Dated: June 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13609 Filed 6-28-17; 8:45 am]
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