Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications, 31152-31154 [2018-14265]
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31152
Federal Register / Vol. 83, No. 128 / Tuesday, July 3, 2018 / Notices
respondent for the MAQI demonstration
to be 15 hours, to match the hours listed
in the equivalent QPP forms. Full detail
of how these estimates were derived can
be found in the forthcoming Calendar
Year 2019 Proposed QPP rule.
If Demonstration participants
submitted information, but did not meet
these conditions of the Demonstration,
their participation in the Demonstration
would not be terminated, but they
would not receive the waivers from
MIPS reporting requirements and
payment adjustments. Therefore, unless
they become QPs or are excluded from
MIPS for other reasons, the participating
clinicians would be subject to MIPS and
would face the MIPS payment
adjustments for the applicable year. We
are requesting approval of 2 information
collections associated with the MAQI
Demonstration: (a) A Qualifying
Payment Arrangement Submission Form
and (b) a Threshold Data Submission
Form. Form Number: CMS–10673 (OMB
control number: 0938–NEW);
Frequency: Annually; Affected Public:
Private sector—Business or other forprofit and Not-for-profit institutions;
Number of Respondents: 100,000; Total
Annual Responses: 100,000; Total
Annual Hours: 1,500,000. (For policy
questions regarding this collection
contact John Amoh at john.amoh@
cms.hhs.gov.)
Dated: June 28, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–14336 Filed 6–29–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA 2012–N–0129]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; General Licensing
Provisions; Section 351(k) Biosimilar
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or 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
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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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 the information
collection in an application for a
proposed biosimilar product and an
application for a supplement for a
proposed interchangeable product.
DATES: Submit either electronic or
written comments on the collection of
information by September 4, 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 September 4,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of September 4, 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
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.
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
• 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 2012–
N–0129 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; General
Licensing Provisions; Section 351(k)
Biosimilar Applications.’’ 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
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
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31153
Federal Register / Vol. 83, No. 128 / Tuesday, July 3, 2018 / Notices
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
General Licensing Provisions; Section
351(k) Biosimilar Applications
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
OMB Control Number 0910–0719—
Extension
FOR FURTHER INFORMATION CONTACT:
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 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,
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.
SUPPLEMENTARY INFORMATION:
The Biologics Price Competition and
Innovation Act of 2009 (BPCI Act)
amended the Public Health Service Act
(PHS Act) and other statutes to create an
abbreviated licensure pathway for
biological products shown to be
biosimilar to, or interchangeable with,
an FDA-licensed reference product.
Section 351(k) of the PHS Act (42 U.S.C.
262(k)), added by the BPCI Act, sets
forth the requirements for an
application for a proposed biosimilar
product and an application or a
supplement for a proposed
interchangeable product. Section 351(k)
defines biosimilarity to mean that the
biological product is highly similar to
the reference product notwithstanding
minor differences in clinically inactive
components and that ‘‘there are no
clinically meaningful differences
between the biological product and the
reference product in terms of the safety,
purity, and potency of the product (see
section 351(i)(2) of the PHS Act). A
351(k) application must contain, among
other things, information demonstrating
that the biological product is biosimilar
to a reference product based upon data
derived from analytical studies, animal
studies, and clinical studies, unless
FDA determines, in its discretion, that
certain studies are unnecessary in a
351(k) application (see section 351(k)(2)
of the PHS Act). To meet the standard
for interchangeability, an applicant
must provide sufficient information to
demonstrate biosimilarity and also to
demonstrate that the biological product
can be expected to produce the same
clinical result as the reference product
in any given patient and, if the
biological product is administered more
than once to an individual, the risk in
terms of safety or diminished efficacy of
alternating or switching between the use
of the biological product and the
reference product is not greater than the
risk of using the reference product
without such alternation or switch (see
section 351(k)(4) of the PHS Act).
Interchangeable products may be
substituted for the reference product
without the intervention of the
prescribing healthcare provider (see
section 351(i)(3) of the PHS Act) In
estimating the information collection
burden for 351(k) biosimilar product
applications and interchangeable
product applications or supplements,
we reviewed the number of 351(k)
applications FDA has received in fiscal
years 2015, 2016, and 2017, considered
responses to a survey of biosimilar
sponsors and applicants regarding
projected future 351(k) submission
volumes, as well as the collection of
information regarding the general
licensing provisions for biologics
license applications under section
351(a) of the PHS Act submitted to OMB
(approved under OMB control number
0910–0338).
To submit an application seeking
licensure of a proposed biosimilar
product under sections 351(k)(2)(A)(i)
and (iii) of the PHS Act, the estimated
burden hours (FDA believes) would be
approximately the same as noted under
OMB control number 0910–0338 for a
351(a) application—860 hours. The
burden estimates for seeking licensure
of a proposed biosimilar product that
meets the standards for
interchangeability under sections
351(k)(2)(B) and (k)(4) would also be
860 hours per application. FDA believes
these estimates are appropriate for
351(k) applications because the
paperwork burden for a 351(k)
application is expected to be
comparable to the paperwork burden for
a 351(a) application.
In addition to the collection of
information regarding the submission of
a 351(k) application for a proposed
biosimilar or interchangeable biological
product, section 351(l) of the BPCI Act
establishes procedures for identifying
and resolving patent disputes involving
applications submitted under section
351(k) of the PHS Act. The burden
estimate for the patent notification
provisions under section 351(l)(6)(C) of
the BPCI Act are included in table 1 and
are based on the estimated number of
351(k) applicants. Based on similar
reporting requirements, FDA estimates
this notification will take 2 hours.
FDA estimates the burden of this
collection of information as follows:
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
351(k) Applications
(42 U.S.C. 262(k))
351(k)(2)(A)(i) and 351(k)(2)(A)(iii) Biosimilar Product Applications ...........................................................................
351(k)(2)(B) and (k)(4) Interchangeable Product Applications or Supplements .......................................................
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Number of
responses per
respondent
Number of
respondents
PO 00000
Frm 00037
Average
burden per
response
Total annual
responses
Total hours
4
9
860
7,740
2
Fmt 4703
2.25
1
2
860
1,720
Sfmt 4703
E:\FR\FM\03JYN1.SGM
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Federal Register / Vol. 83, No. 128 / Tuesday, July 3, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
351(k) Applications
(42 U.S.C. 262(k))
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total hours
351(l)(6)(C) Patent Infringement Notifications .....................
4
2.25
9
2
18
Total ..............................................................................
........................
........................
........................
........................
9,478
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, the estimated burden for
the information collection reflects an
overall increase in total hours and
responses. We attribute this adjustment
to an increase in the number of
submissions received over the last few
years and additional interest in the
biosimilars program.
Dated: June 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–14265 Filed 7–2–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2490]
Antimicrobial Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Antimicrobial Drugs
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to FDA on
regulatory issues. The meeting will be
open to the public. FDA is establishing
a docket for public comment on this
document.
DATES: The meeting will be held on
August 7, 2018, from 8:30 a.m. to 4 p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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17:07 Jul 02, 2018
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FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2018–N–1073.
The docket will close on August 6,
2018. Submit either electronic or
written comments on this public
meeting by August 6, 2018. Please note
that late, untimely filed comments will
not be considered. Electronic comments
must be submitted on or before August
6, 2018. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of
August 6, 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.
Comments received on or before July
24, 2018, will be provided to the
committee. Comments received after
that date will be taken into
consideration by FDA.
You may submit comments 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
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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–2490 for ‘‘Antimicrobial Drugs
Advisory Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ Received
comments, those filed in a timely
manner (see the ADDRESSES section),
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.’’ FDA
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 be made publicly
available, you can provide this
information on the cover sheet and not
E:\FR\FM\03JYN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 128 (Tuesday, July 3, 2018)]
[Notices]
[Pages 31152-31154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14265]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA 2012-N-0129]
Agency Information Collection Activities; Proposed Collection;
Comment Request; General Licensing Provisions; Section 351(k)
Biosimilar Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or 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 the information collection in an
application for a proposed biosimilar product and an application for a
supplement for a proposed interchangeable product.
DATES: Submit either electronic or written comments on the collection
of information by September 4, 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 September 4, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of September 4, 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 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 2012-N-0129 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; General Licensing Provisions;
Section 351(k) Biosimilar Applications.'' 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
[[Page 31153]]
Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[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 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, 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.
General Licensing Provisions; Section 351(k) Biosimilar Applications
OMB Control Number 0910-0719--Extension
The Biologics Price Competition and Innovation Act of 2009 (BPCI
Act) amended the Public Health Service Act (PHS Act) and other statutes
to create an abbreviated licensure pathway for biological products
shown to be biosimilar to, or interchangeable with, an FDA-licensed
reference product. Section 351(k) of the PHS Act (42 U.S.C. 262(k)),
added by the BPCI Act, sets forth the requirements for an application
for a proposed biosimilar product and an application or a supplement
for a proposed interchangeable product. Section 351(k) defines
biosimilarity to mean that the biological product is highly similar to
the reference product notwithstanding minor differences in clinically
inactive components and that ``there are no clinically meaningful
differences between the biological product and the reference product in
terms of the safety, purity, and potency of the product (see section
351(i)(2) of the PHS Act). A 351(k) application must contain, among
other things, information demonstrating that the biological product is
biosimilar to a reference product based upon data derived from
analytical studies, animal studies, and clinical studies, unless FDA
determines, in its discretion, that certain studies are unnecessary in
a 351(k) application (see section 351(k)(2) of the PHS Act). To meet
the standard for interchangeability, an applicant must provide
sufficient information to demonstrate biosimilarity and also to
demonstrate that the biological product can be expected to produce the
same clinical result as the reference product in any given patient and,
if the biological product is administered more than once to an
individual, the risk in terms of safety or diminished efficacy of
alternating or switching between the use of the biological product and
the reference product is not greater than the risk of using the
reference product without such alternation or switch (see section
351(k)(4) of the PHS Act).
Interchangeable products may be substituted for the reference
product without the intervention of the prescribing healthcare provider
(see section 351(i)(3) of the PHS Act) In estimating the information
collection burden for 351(k) biosimilar product applications and
interchangeable product applications or supplements, we reviewed the
number of 351(k) applications FDA has received in fiscal years 2015,
2016, and 2017, considered responses to a survey of biosimilar sponsors
and applicants regarding projected future 351(k) submission volumes, as
well as the collection of information regarding the general licensing
provisions for biologics license applications under section 351(a) of
the PHS Act submitted to OMB (approved under OMB control number 0910-
0338).
To submit an application seeking licensure of a proposed biosimilar
product under sections 351(k)(2)(A)(i) and (iii) of the PHS Act, the
estimated burden hours (FDA believes) would be approximately the same
as noted under OMB control number 0910-0338 for a 351(a) application--
860 hours. The burden estimates for seeking licensure of a proposed
biosimilar product that meets the standards for interchangeability
under sections 351(k)(2)(B) and (k)(4) would also be 860 hours per
application. FDA believes these estimates are appropriate for 351(k)
applications because the paperwork burden for a 351(k) application is
expected to be comparable to the paperwork burden for a 351(a)
application.
In addition to the collection of information regarding the
submission of a 351(k) application for a proposed biosimilar or
interchangeable biological product, section 351(l) of the BPCI Act
establishes procedures for identifying and resolving patent disputes
involving applications submitted under section 351(k) of the PHS Act.
The burden estimate for the patent notification provisions under
section 351(l)(6)(C) of the BPCI Act are included in table 1 and are
based on the estimated number of 351(k) applicants. Based on similar
reporting requirements, FDA estimates this notification will take 2
hours.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
351(k) Applications (42 U.S.C. Number of responses per Total annual Average burden Total hours
262(k)) respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
351(k)(2)(A)(i) and 4 2.25 9 860 7,740
351(k)(2)(A)(iii) Biosimilar
Product Applications...........
351(k)(2)(B) and (k)(4) 2 1 2 860 1,720
Interchangeable Product
Applications or Supplements....
[[Page 31154]]
351(l)(6)(C) Patent Infringement 4 2.25 9 2 18
Notifications..................
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Total....................... .............. .............. .............. .............. 9,478
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, the estimated burden for the information
collection reflects an overall increase in total hours and responses.
We attribute this adjustment to an increase in the number of
submissions received over the last few years and additional interest in
the biosimilars program.
Dated: June 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14265 Filed 7-2-18; 8:45 am]
BILLING CODE 4164-01-P
