83 FR 30744 - Assessing User Fees Under the Biosimilar User Fee Amendments of 2017; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 126 (June 29, 2018)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.'' This guidance concerns FDA's implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA II) and certain changes in policies and procedures surrounding its application.

[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30744-30746]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-14049]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6209]


Assessing User Fees Under the Biosimilar User Fee Amendments of 
2017; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Assessing 
User Fees Under the Biosimilar User Fee Amendments of 2017.'' This 
guidance concerns FDA's implementation of the Biosimilar User Fee 
Amendments of 2017 (BsUFA II) and certain changes in policies and 
procedures surrounding its application.

DATES: The announcement of the guidance is published in the Federal 
Register on June 29, 2018.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

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.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-D-6209 for ``Assessing User Fees Under the Biosimilar User Fee 
Amendments of 2017.'' Received comments 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.thefederalregister.org/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

[[Page 30745]]

Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of 
Communication, Outreach, and Development, Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Beena Alex, Division of User Fee 
Management and Budget Formulation, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., Rm. 
2185, Silver Spring, MD 20993, 301-796-7900, 
[email protected]; or Stephen Ripley, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Assessing User Fees Under the Biosimilar User Fee Amendments 
of 2017.'' This guidance concerns the implementation of BsUFA II, 
including an explanation about the new fee structure and types of fees 
for which entities are responsible. BsUFA II extends FDA's authority to 
collect user fees from fiscal year (FY) 2018 to 2022 and introduces a 
number of technical revisions that affect what fees are collected and 
how fees are collected. Fees authorized by this legislation help fund 
the process for the review of biosimilar biological product 
applications and have played an important role in expediting the review 
and approval process.
    BsUFA II authorizes biosimilar biological product development 
program fees (BPD fees), biosimilar biological product application 
fees, and biosimilar biological product program fees. This guidance 
describes when these fees are incurred and the process by which 
applicants can submit payments. The guidance also provides information 
on consequences of failing to pay BsUFA II fees and the processes for 
submitting reconsideration and appeal requests.
    In the Federal Register of November 16, 2017 (82 FR 53505), FDA 
announced the availability of a draft version of this guidance and 
provided interested parties an opportunity to submit comments. We have 
reviewed the comment submitted to the docket. This guidance does not 
include any substantive changes from the draft guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance, when finalized, 
will represent the current thinking of FDA on assessing user fees under 
the biosimilar user fee amendments of 2017. It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations. This guidance is not subject to 
Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, 
description, and respondent description of the information collection 
are given under this section with an estimate of the annual reporting 
burden. Included in the estimate is the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.
    With respect to the collection of information associated with this 
document, 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.
    Title: Assessing User Fees Under the Biosimilar User Fee Amendments 
of 2017: Guidance for Industry.
    Description: This guidance provides information on the assessment 
of biosimilar biological product user fees, describes the types of user 
fees authorized, the process for submitting payments to FDA, and 
consequences for failing to pay BsUFA fees. The guidance also describes 
how FDA determines which products are subject to a fee and the changes 
to certain FDA policies regarding BsUFA fees. The Federal Food, Drug, 
and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Act 
of 2012 and recently renewed in 2017 (BsUFA) under the FDA 
Reauthorization Act of 2017, authorizes FDA to assess and collect user 
fees from companies that produce biosimilar biological products in 
conjunction with the review of biosimilar biological product 
applications. The guidance includes processing and policies for the 
initial and the annual biosimilar biological product development (BPD) 
fees; the BPD discontinuation process requirements and BPD reactivation 
fees; process and policies for biosimilar biological product 
application fees including exceptions to the application fees and 
refund of fees; process and policies for the small business waiver of 
the biosimilar application fee; and implementation of the biosimilar 
biological product program fee.
    The burdens associated with requesting a small business waiver of 
BsUFA fees and the associated burdens for new activities as noted in 
the guidance are listed in table 1.
    FDA estimates the annual burden of these new collections of 
information as follows:

[[Page 30746]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                Number of
                Activity                      Number of       responses per     Total annual     Average burden per  response  (hours)     Total hours
                                             respondents       respondent         responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for discontinuation from BPD                     2                 1                 2  1.....................................                 2
 program.
Request to move products to discontinued                 5                 1                 5  0.5 (30 minutes)......................               2.5
 section of the biosimilar list.
Small business waiver of the BsUFA                       1                 1                 1  16....................................                16
 application fee.
Small business waiver reconsiderations..                 1                 1                 1  24....................................                24
Small business waiver appeals...........                 1                 1                 1  12....................................                12
Annual Fee Determination Survey.........                35                 1                35  1.....................................                35
Annual BsUFA fees correspondence........                35                 1                35  2.....................................                70
                                         ---------------------------------------------------------------------------------------------------------------
    Total...............................  ................  ................  ................  ......................................             161.5
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    This guidance also refers to previously approved collections of 
information found in FDA forms developed to support its user fee 
program. Specifically, the guidance refers to Form FDA 3792; Forms FDA 
3913 and 3914; and Form FDA 3971, which have been approved under OMB 
control numbers 0910-0718, 0910-0719, 0910-0805, and 0910-0693, 
respectively. The guidance also refers to previously approved 
collections of information found in FDA regulations. The collections of 
information in 21 CFR part 312 are currently approved under OMB control 
number 0910-0014; the collections of information regarding new drug 
applications under the FD&C Act are approved under OMB control number 
0910-0001; and biologics license applications under sections 351(a) or 
351(k) of the Public Health Service Act are approved under OMB control 
numbers 0910-0338 and 0910-0719, respectively.
    This final guidance contains information collection provisions 
subject to review by OMB under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3520). Except for the provisions listed in table 1, the 
information collections already have been approved. The applicable 
provisions are shaded in the guidance to identify those for which OMB 
approval has not yet been obtained. When approval of these provisions 
has been received, FDA will provide notice. BsUFA II provides the 
statutory authority to collect user fees from FY 2018 through FY 2022. 
Consistent with the statutory requirements of BsUFA II, FDA is issuing 
this guidance to facilitate understanding and enhancing implementation 
of the policies and processes in the assessment of biosimilar user fees 
in upcoming fiscal years.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: June 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14049 Filed 6-28-18; 8:45 am]
 BILLING CODE 4164-01-P