82 FR 53505 - Assessing User Fees Under the Biosimilar User Fee Amendments of 2017; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 220 (November 16, 2017)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.'' This draft guidance concerns FDA's implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA II) and certain intended changes in policies and procedures surrounding its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

[Federal Register Volume 82, Number 220 (Thursday, November 16, 2017)]
[Notices]
[Pages 53505-53507]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24831]



[[Page 53505]]

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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2017; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Assessing 
User Fees Under the Biosimilar User Fee Amendments of 2017.'' This 
draft guidance concerns FDA's implementation of the Biosimilar User Fee 
Amendments of 2017 (BsUFA II) and certain intended changes in policies 
and procedures surrounding its application.

DATES: Submit either electronic or written comments on the draft 
guidance by January 16, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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 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 draft 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, 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 draft 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 to 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 draft guidance for industry 
entitled ``Assessing User Fees Under the Biosimilar User Fee Amendments 
of 2017.'' This draft 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 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

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program fees (BPD fees), biosimilar biological product application 
fees, and biosimilar biological product program fees. This draft 
guidance describes when these fees are incurred and the process by 
which applicants can submit payments. The draft guidance also provides 
information on consequences of failing to pay BsUFA II fees and the 
processes for submitting reconsideration and appeal requests.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on assessing user 
fees under BsUFA II. 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

    Under the Paperwork Reduction Act of 1995 (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 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 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.

Assessing User Fees Under the Biosimilar User Fee Amendments of 2017: 
Draft Guidance for Industry

OMB Control Number 0910--NEW

    This information collection supports ``Assessing User Fees Under 
the Biosimilar User Fee Amendments of 2017: Draft Guidance for 
Industry.'' The Federal Food, Drug, and Cosmetic Act as amended by the 
Biosimilar User Fee Act of 2012 and recently renewed in 2017 (BsUFA II) 
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 draft guidance includes processing and 
policies for the initial and the annual 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 draft guidance are listed in table 1.
    FDA estimates the annual burden of these new collections of 
information as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                                                      Average
                                     Number of       Number of     Total  annual    burden per
            Activity                respondents    responses per     responses       response      Total  hours
                                                    respondent                        (hours)
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Request for discontinuation from               2               1               2               1               2
 BPD program....................
Request to move products to                    5               1               5              .5             2.5
 discontinued section of the
 biosimilar list................
Small business waiver of the                   1               1               1              16              16
 BsUFA application fee..........
    --Reconsiderations..........               1               1               1              24              24
    --Appeals...................               1               1               1              12              12
Annual Fee Determination Survey.              35               1              35               1              35
Annual BsUFA Fees Correspondence              35               1              35               2              70
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        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 draft guidance also refers to previously approved collections 
of information found in FDA forms developed to support its user fee 
program. Specifically, the draft guidance refers to Form FDA 3792, Form 
FDA 3913, and Form FDA 3971, which have been approved under OMB control 
numbers 0910-0718, 0910-0805, and 0910-0693, respectively. The draft 
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 and 
biologics license applications are approved under OMB control numbers 
0910-0001 and 0910-0338, respectively.

III. Electronic Access

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

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default.htm, or https://www.regulations.gov.

    Dated: November 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24831 Filed 11-15-17; 8:45 am]
 BILLING CODE 4164-01-P