Agency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Program, 30746-30748 [2018-14057]
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30746
Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
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.
Small business waiver reconsiderations ..
Small business waiver appeals ...............
Annual Fee Determination Survey ...........
Annual BsUFA fees correspondence ......
Total ..................................................
sradovich on DSK3GMQ082PROD with NOTICES
1 There
Number of
responses per
respondent
Number of
respondents
Activity
Average burden per
response
(hours)
Total annual
responses
Total hours
2
1
2
1 ................................
2
5
1
5
0.5 (30 minutes) ........
2.5
1
1
1
16 ..............................
16
1
1
35
35
1
1
1
1
1
1
35
35
24 ..............................
12 ..............................
1 ................................
2 ................................
24
12
35
70
............................
............................
............................
....................................
161.5
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.
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III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1967]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Biosimilars User
Fee Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on information
collection supporting the Agency’s
Biosimilars User Fee Program.
SUMMARY:
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
Submit either electronic or
written comments on the collection of
information by August 28, 2018.
DATES:
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 August 28,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of August 28, 2018.
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.
ADDRESSES:
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
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Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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–
2018–N–1967 for ‘‘Biosimilars User Fee
Program.’’ 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/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
VerDate Sep<11>2014
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Jkt 244001
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:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under 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 for members of the
public when submitting reports, keeping
records, or providing 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, including each proposed
extension of an existing 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 following
collection of information, 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.
Biosimilars User Fee Program
OMB Control Number 0910–0718—
Extension
This information collection supports
FDA’s Biosimilars User Fee Program.
The Biologics Price Competition and
Innovation Act of 2009 (BPCI Act),
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30747
amended the Public Health Service Act
(PHS Act) by adding section 351(k) (42
U.S.C. 262(k)) to create an abbreviated
approval pathway for biological
products shown to be biosimilar to or
interchangeable with an FDA-licensed
reference biological product. This
allows a company to apply for licensure
of a biosimilar or interchangeable
biological product (351(k) application).
The BPCI Act also amended section 735
of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 379g) to include 351(k)
applications as a type of application
under ‘‘human drug application’’ for the
purposes of the prescription drug user
fee provisions.
The Biosimilar User Fee Act of 2012
(BsUFA) authorized FDA to assess and
collect user fees for certain activities in
connection with biosimilar biological
product development (BPD). BsUFA
was reauthorized for an additional 5
years in August 2017 (BsUFA II). FDA’s
biosimilar biological product user fee
program requires FDA to assess and
collect user fees for certain meetings
concerning biosimilar BPD (BPD
meetings), investigational new drug
applications (INDs) intended to support
a biosimilar biological product
application, and biosimilar biologic
license applications (BLAs).
Form FDA 3792, entitled ‘‘Biosimilars
User Fee Cover Sheet’’, is submitted by
each new BPD entrant (identified via a
new meeting request or IND submission)
and new BLAs. Form FDA 3792 requests
the minimum necessary information to
identify the request and determine the
amount of the fee to be assessed, and to
account for and track user fees. The
form provides a cross-reference of the
fees submitted for an activity with the
actual submission or activity by using a
unique number tracking system. The
information collected is used by FDA’s
Center for Drug Evaluation and Research
and Center for Biologics Evaluation and
Research to initiate the administrative
screening of biosimilar biological
product INDs, and BLAs, and to account
for and track user fees associated with
BPD meetings.
In addition to the Biosimilars User
Fee Cover Sheet, the information
collection includes an annual survey of
all BsUFA II participants designed to
provide information to FDA of
anticipated BsUFA II activity in the
upcoming fiscal year. This information
helps FDA set appropriate annual
BsUFA II fees.
FDA has also developed the draft
guidance entitled, ‘‘Assessing User Fees
Under the Biosimilar User Fee
Amendments of 2017’’ to assist industry
in understanding when fees are incurred
and the process by which applicants can
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Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices
submit payments. The draft guidance
also explains how respondents can
request discontinuation from the BPD
program as well as how respondents can
request to move products to the
discontinued section of the biosimilar
list. Finally, the draft guidance provides
information on the consequences of
failing to pay BsUFA II fees, as well as
processes for submitting reconsideration
and appeal requests. The draft guidance
is available on our website at https://
www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/
UCM584984.pdf.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Information collection title
Number of
responses per
respondent
Total annual
responses
Average burden per
response
(hours)
Total hours
Biosimilar User Fee Cover Sheet; Form FDA 3792
Annual Survey ..........................................................
Request for discontinuation from BPD program ......
Request to move products to discontinued section
of the biosimilar list.
35
35
2
5
1
1
1
1
35
35
2
5
0.5 (30 minutes) ........
1 ................................
1 ................................
0.5 (30 minutes) ........
17.5
35
2
2.5
Total ..................................................................
........................
........................
........................
....................................
57
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We have increased our estimate by an
additional 15 respondents since last
OMB approval of the information
collection. This estimated increase is
based on our expectation that
participation in the BPD program will
continue to grow, consistent with our
experience since establishment of the
information collection in 2012.
Dated: June 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–14057 Filed 6–28–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1903]
Modernizing Pharmaceutical Quality
Systems; Studying Quality Metrics and
Quality Culture; Quality Metrics
Feedback Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we)
Center for Drug Evaluation and Research
(CDER) is announcing two new efforts to
gather feedback on the use of quality
metrics to modernize pharmaceutical
quality systems and advance innovation
based on stakeholder feedback. These
efforts include Type C formal meeting
requests and pre-abbreviated new drug
application (pre-ANDA) meeting
requests, and a pilot study to gain
feedback from those establishments for
which Type C formal meetings or preANDA meetings do not apply (e.g.,
active pharmaceutical ingredients (API)
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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establishments, contract manufacturing
organizations, over-the-counter (OTC)
monograph products establishments, or
marketed unapproved finished drug
products establishments). Participation
in either of these efforts is voluntary and
the programs are intended to foster the
joint efforts of FDA and stakeholders to
further develop an FDA Quality Metrics
Program. The FDA Quality Metrics
Program aims to evaluate a new
approach for regulatory oversight of
pharmaceutical products through the
collection of certain quality information
developed and maintained in the course
of manufacturing drugs under current
good manufacturing practices. FDA
intends to use quality metrics data to
further develop the Agency’s risk-based
inspection scheduling (e.g., decreased
surveillance inspection frequency for
certain establishments) to improve the
efficiency and effectiveness of
establishment inspections, improve
FDA’s evaluation of drug manufacturing
and control operations, and identify
situations in which there may be a risk
for drug supply disruption.
DATES: Submit a written request to
participate in the program by July 29,
2019. See sections II and III.B of this
notice for information to include in
such requests. FDA will start accepting
requests beginning July 30, 2018.
FOR FURTHER INFORMATION CONTACT: Tara
Gooen Bizjak, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2109,
Silver Spring, MD 20993, 301–796–
3257, Tara.Gooen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
More than a decade ago, FDA
launched an initiative to encourage the
PO 00000
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implementation of a modern, risk-based
pharmaceutical quality assessment
system. As part of this initiative, and in
recognition of the increasing complexity
of pharmaceutical manufacturing, FDA
developed a 21st century vision for
manufacturing and quality with input
from academia and industry. The
desired state was described as follows:
‘‘A maximally efficient, agile, flexible
pharmaceutical manufacturing sector
that reliably produces high-quality drug
products without extensive regulatory
oversight.’’ 1
There has been significant progress
toward this vision in the intervening
years, as evidenced by programs and
guidance from FDA around major
initiatives such as pharmaceutical
development and quality by design,
quality risk management and
pharmaceutical quality systems, process
validation, and process analytical
technology, among other initiatives.
These programs and guidances are
intended to promote effective use of the
most current pharmaceutical science
and engineering principles and
knowledge throughout the life cycle of
a product.
While much progress has been made,
we have not fully realized our 21st
century vision for manufacturing and
quality. Rather than focusing on use of
science- and risk-based principles as
described in current good
manufacturing practices, many
establishments continue to focus on
minimum requirements (e.g., check-box
approach). Recalls and drug shortages,
which are often indications of serious
product quality defects caused by drug
1 See ‘‘FDA Pharmaceutical Quality Oversight:
One Quality Voice’’ at https://www.fda.gov/
downloads/AboutFDA/CentersOffices/Officeof
MedicalProductsandTobacco/CDER/
UCM442666.pdf.
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]]>Agencies
[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30746-30748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14057]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1967]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Biosimilars User Fee Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
supporting the Agency's Biosimilars User Fee Program.
DATES: Submit either electronic or written comments on the collection
of information by August 28, 2018.
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 August 28, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of August 28, 2018. 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
[[Page 30747]]
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-2018-N-1967 for ``Biosimilars User Fee Program.'' 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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under 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 for members of
the public when submitting reports, keeping records, or providing
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, including each proposed extension of an existing
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 following collection of information, 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.
Biosimilars User Fee Program
OMB Control Number 0910-0718--Extension
This information collection supports FDA's Biosimilars User Fee
Program. The Biologics Price Competition and Innovation Act of 2009
(BPCI Act), amended the Public Health Service Act (PHS Act) by adding
section 351(k) (42 U.S.C. 262(k)) to create an abbreviated approval
pathway for biological products shown to be biosimilar to or
interchangeable with an FDA-licensed reference biological product. This
allows a company to apply for licensure of a biosimilar or
interchangeable biological product (351(k) application). The BPCI Act
also amended section 735 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379g) to include 351(k) applications as a type of
application under ``human drug application'' for the purposes of the
prescription drug user fee provisions.
The Biosimilar User Fee Act of 2012 (BsUFA) authorized FDA to
assess and collect user fees for certain activities in connection with
biosimilar biological product development (BPD). BsUFA was reauthorized
for an additional 5 years in August 2017 (BsUFA II). FDA's biosimilar
biological product user fee program requires FDA to assess and collect
user fees for certain meetings concerning biosimilar BPD (BPD
meetings), investigational new drug applications (INDs) intended to
support a biosimilar biological product application, and biosimilar
biologic license applications (BLAs).
Form FDA 3792, entitled ``Biosimilars User Fee Cover Sheet'', is
submitted by each new BPD entrant (identified via a new meeting request
or IND submission) and new BLAs. Form FDA 3792 requests the minimum
necessary information to identify the request and determine the amount
of the fee to be assessed, and to account for and track user fees. The
form provides a cross-reference of the fees submitted for an activity
with the actual submission or activity by using a unique number
tracking system. The information collected is used by FDA's Center for
Drug Evaluation and Research and Center for Biologics Evaluation and
Research to initiate the administrative screening of biosimilar
biological product INDs, and BLAs, and to account for and track user
fees associated with BPD meetings.
In addition to the Biosimilars User Fee Cover Sheet, the
information collection includes an annual survey of all BsUFA II
participants designed to provide information to FDA of anticipated
BsUFA II activity in the upcoming fiscal year. This information helps
FDA set appropriate annual BsUFA II fees.
FDA has also developed the draft guidance entitled, ``Assessing
User Fees Under the Biosimilar User Fee Amendments of 2017'' to assist
industry in understanding when fees are incurred and the process by
which applicants can
[[Page 30748]]
submit payments. The draft guidance also explains how respondents can
request discontinuation from the BPD program as well as how respondents
can request to move products to the discontinued section of the
biosimilar list. Finally, the draft guidance provides information on
the consequences of failing to pay BsUFA II fees, as well as processes
for submitting reconsideration and appeal requests. The draft guidance
is available on our website at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM584984.pdf.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden[thinsp]\1\
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Number of
Information collection title Number of responses per Total annual Average burden per response (hours) Total hours
respondents respondent responses
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Biosimilar User Fee Cover Sheet; Form FDA 35 1 35 0.5 (30 minutes).......................... 17.5
3792.
Annual Survey............................... 35 1 35 1......................................... 35
Request for discontinuation from BPD program 2 1 2 1......................................... 2
Request to move products to discontinued 5 1 5 0.5 (30 minutes).......................... 2.5
section of the biosimilar list.
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Total................................... .............. .............. .............. .......................................... 57
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We have increased our estimate by an additional 15 respondents
since last OMB approval of the information collection. This estimated
increase is based on our expectation that participation in the BPD
program will continue to grow, consistent with our experience since
establishment of the information collection in 2012.
Dated: June 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14057 Filed 6-28-18; 8:45 am]
BILLING CODE 4164-01-P
