Assessing User Fees Under the Biosimilar User Fee Amendments of 2017; Draft Guidance for Industry; Availability, 53505-53507 [2017-24831]
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Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Notices
Written/Paper Submissions
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2017; Draft Guidance for Industry;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.
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announcing the availability of a draft
guidance for industry entitled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 This draft guidance concerns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written comments on the draft guidance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draft guidance before it begins work on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:
SUMMARY:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
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’’).
VerDate Sep<11>2014
16:52 Nov 15, 2017
Jkt 244001
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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
PO 00000
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53505
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,
CDERCollections@fda.hhs.gov; 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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53506
Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Notices
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
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:
This information collection supports
‘‘Assessing User Fees Under the
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Average
burden per
response
(hours)
Total
annual
responses
Total
hours
Request for discontinuation from BPD program ..................
Request to move products to discontinued section of the
biosimilar list .....................................................................
Small business waiver of the BsUFA application fee ..........
—Reconsiderations .......................................................
—Appeals .....................................................................
Annual Fee Determination Survey .......................................
Annual BsUFA Fees Correspondence ................................
2
1
2
1
2
5
1
1
1
35
35
1
1
1
1
1
1
5
1
1
1
35
35
.5
16
24
12
1
2
2.5
16
24
12
35
70
Total .......................................................................
........................
........................
........................
........................
161.5
asabaliauskas on DSKBBXCHB2PROD with NOTICES
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
VerDate Sep<11>2014
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Jkt 244001
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.
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Fmt 4703
Sfmt 4703
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
E:\FR\FM\16NON1.SGM
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Federal Register / Vol. 82, No. 220 / Thursday, November 16, 2017 / Notices
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
between 9 a.m. and 4 p.m., Monday
through Friday. Publicly available
submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT:
Rachael Vieder Linowes, Office of
Scientific Integrity, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4206, Silver Spring,
MD 20993, 240–402–5931.
SUPPLEMENTARY INFORMATION:
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–1981–N–0245 (Formerly
81N–0080)]
I. Background
Mepergan Fortis Capsules; Final
Decision on Proposal To Refuse
Approval of Supplemental New Drug
Application; Availability of Final
Decision
AGENCY:
Food and Drug Administration;
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing that the Initial Decision of
the Administrative Law Judge (ALJ), to
refuse approval of the supplemental
new drug application (sNDA) for
Mepergan Fortis Capsules (MFC)
(meperidine HCl, promethazine HCl), is
the final decision of the Commissioner
by operation of law. In the Initial
Decision, the ALJ found that MFC had
not been shown to be supported by
substantial evidence consisting of
adequate and well-controlled studies to
be effective for sedation and analgesia in
patients with concurrent moderate pain
and apprehension, such as
postoperative and post-trauma patients
with those symptoms; that the drug did
not satisfy the combination drug policy;
and that it is a ‘‘new drug.’’ The sNDA
applicant filed exceptions to the ALJ’s
Initial Decision. FDA recently requested
that the current owner of the sNDA
application affirm its desire to pursue
the appeal of the ALJ’s Initial Decision;
however, the applicant did not affirm its
desire to pursue the appeal within the
specified timeframe. Accordingly, FDA
now deems those exceptions as
withdrawn. Consequently, the
proceeding is in the same procedural
position as if no exceptions to the ALJ’s
Initial Decision had been filed;
therefore, the ALJ’s Initial Decision has
become the final decision of the
Commissioner by operation of law.
DATES: This final decision is effective
November 16, 2017.
ADDRESSES: For access to the docket, go
to https://www.regulations.gov and
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:52 Nov 15, 2017
Jkt 244001
In 1962, the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) was
amended by the Drug Amendments Act
of 1962, and these amendments
provided that new drugs could no
longer be approved unless both safety
and efficacy had been established for
them. As amended, the FD&C Act also
required FDA to evaluate drugs
approved as safe between 1938 and
1962 to determine whether such drugs
were effective and to withdraw approval
for any new drug application (NDA)
where there was not substantial
evidence of the drug’s effectiveness. The
person contesting the withdrawal of the
approval had the burden of coming
forward with evidence of effectiveness
for the drug. FDA’s review of these pre1962 drugs is known as the Drug
Efficacy Study Implementation (DESI)
program.
In a document published in the
Federal Register of April 20, 1972 (37
FR 7827), after evaluating reports
received from the National Academy of
Sciences/National Research Council,
Drug Efficacy Study Group, and other
available evidence, FDA classified MFC
as ‘‘possibly effective’’ for moderate to
moderately severe pain. This document
also stated that no NDA had been
approved or deemed approved for MFC
and that additional evidence needed to
be submitted to FDA to establish MFC’s
effectiveness. Thereafter, Wyeth, a
division of American Home Products
(Wyeth), submitted a supplement to its
approved NDA 11–730 (Mepergan
Injection) for MFC (NDA 11–730, S–
003). In a document published in the
Federal Register of September 18, 1981
(46 FR 46404), the Director of the
Bureau of Drugs (now the Center for
Drug Evaluation and Research)
proposed to refuse approval of the
sNDA and offered Wyeth the
opportunity for a hearing.
Wyeth submitted its request for a
hearing and, by a document published
PO 00000
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Fmt 4703
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53507
in the Federal Register of December 31,
1984 (49 FR 50788), the Office of the
Commissioner granted the hearing
request. Following the submission of
written testimony and documentary
evidence, an ALJ, Daniel J. Davidson,
conducted a hearing from January 14 to
17, 1986. He issued his Initial Decision
on December 4, 1987. The ALJ found
that: (1) The effectiveness of MFC had
not been proven by substantial evidence
of adequate and well-controlled clinical
trials, (2) the requirements of the
combination drug policy had not been
met, and (3) MFC is a new drug under
21 U.S.C. 321(p). Wyeth timely
appealed the ALJ’s Initial Decision by
filing exceptions with the Commissioner
under 21 CFR 12.125.
On August 23, 2017, FDA sent a letter
to West-Ward Pharmaceuticals
Corporation (West-Ward), successor to
Wyeth, to determine whether WestWard remained interested in pursuing
its appeal of the ALJ’s Initial Decision.
FDA informed the company that if it did
not respond and affirm its desire to
pursue its appeal by September 21,
2017, the Office of the Commissioner
would conclude that West-Ward no
longer wishes to pursue the appeal of
the ALJ’s Initial Decision and will
proceed as if the appeal has been
withdrawn. The Office of the
Commissioner did not receive a
response from West-Ward by the given
date; therefore, the Commissioner now
deems the exceptions withdrawn.
II. Conclusion and Order
Given that the exceptions have been
deemed withdrawn, this proceeding is
now in the same procedural posture as
if no exceptions had ever been filed.
When parties do not file exceptions to
the ALJ’s Initial Decision, and the
Commissioner does not file a notice of
review, the ALJ’s Initial Decision
becomes the final decision of the
Commissioner (see 21 CFR 12.120(e)).
FDA will publish a notice in the Federal
Register when an initial decision
becomes the final decision of the
Commissioner without appeal to or
review by the Commissioner (see 21
CFR 12.120(f)).
Therefore, the ALJ’s Initial Decision is
the final decision of the Commissioner
effective November 16, 2017. Pursuant
to the findings in the ALJ’s Initial
Decision, under section 505(d) of the
FD&C Act (21 U.S.C. 355(d)) and under
the authority delegated by the Secretary
of Health and Human Services, the
Commissioner finds that there is a lack
of substantial evidence that MFC will
have the effect it purports or is
represented to have under the
conditions of use prescribed,
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]]>Agencies
[Federal Register Volume 82, Number 220 (Thursday, November 16, 2017)]
[Notices]
[Pages 53505-53507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24831]
[[Page 53505]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.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.
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,
CDERCollections@fda.hhs.gov; 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
[[Page 53506]]
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\
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per
Activity respondents responses per responses response Total hours
respondent (hours)
----------------------------------------------------------------------------------------------------------------
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
-------------------------------------------------------------------------------
Total................... .............. .............. .............. .............. 161.5
----------------------------------------------------------------------------------------------------------------
\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/
[[Page 53507]]
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
