Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications, 5761-5763 [2015-02025]
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screened and selected from Individuals
and Households, Businesses,
Organizations, and/or State, Local or
Tribal Government. There is no cost to
respondents other than their time. The
estimated total burden hours for this
data collection activity are 268.
Type of collection
Average
number of
respondents
per activity
Annual
frequency
per response
Average
number of
activities
Average hours
per response
Online surveys, Telephone Surveys, Focus Groups, In person observation/
testing ...........................................................................................................
67
1
5
48/60
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2015–02062 Filed 2–2–15; 8:45 am]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; General Licensing
Provisions; Section 351(k) Biosimilar
Applications
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
rljohnson on DSK3VPTVN1PROD with NOTICES
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
14:46 Feb 02, 2015
Jkt 235001
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
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 April 6, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA 305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUMMARY:
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the Board
of Scientific Counselors, National
Center for Environmental Health/
Agency for Toxic Substances and
Disease Registry, Department of Health
and Human Services, has been renewed
for a 2-year period through May 21,
2016.
For information, contact William
Cibulas, Ph.D., Designated Federal
Officer, Board of Scientific Counselors,
National Center for Environmental
Health/Agency for Toxic Substances
and Disease Registry, Department of
Health and Human Services, 4770
Buford Highway, Mailstop F61,
Chamblee, Georgia 30341, telephone
(770) 488–0662 or fax (770) 488–3385.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
VerDate Sep<11>2014
Food and Drug Administration,
HHS.
Board of Scientific Counselors,
National Center for Environmental
Health/Agency for Toxic Substances
and Disease Registry: Notice of
Charter Renewal
BILLING CODE 4163–18–P
[Docket No. FDA–2012–N–0129]
AGENCY:
Centers for Disease Control and
Prevention
[FR Doc. 2015–02026 Filed 2–2–15; 8:45 am]
Food and Drug Administration
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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:
General Licensing Provisions; Section
351(k) Biosimilar Applications (OMB
Control Number 0910–0719)—Extension
The Patient Protection and Affordable
Care Act (Affordable Care Act) (Pub. L.
111–148) contains a subtitle called the
Biologics Price Competition and
Innovation Act of 2009 (BPCI Act),
which amends the Public Health Service
Act (PHS Act) and establishes an
abbreviated licensure pathway for
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biological products shown to be
biosimilar to, or interchangeable with,
an FDA-licensed biological reference
product (See sections 7001 through
7003 of the Affordable Care Act.)
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
demonstrate interchangeability, an
applicant must provide sufficient
information to demonstrate
biosimilarity and that the biosimilar
biological product can be expected to
produce the same clinical result as the
reference product in any given patient
and, if the biosimilar 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
biosimilar 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 health care provider. (See
section 351(i)(3) of the PHS Act.)
In estimating the information
collection burden for 351(k)
applications, we reviewed the number
of 351(k) applications FDA has received
through fiscal year (FY) 2014, 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). For the
information collection burden for 351(a)
applications, FDA described § 601.2(a)
(21 CFR 601.2(a)) as requiring a
manufacturer of a biological product to
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14:46 Feb 02, 2015
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submit an application on forms
prescribed for such purpose with
accompanying data and information
including certain labeling information
to FDA for approval to market a product
in interstate commerce. FDA also added
in the burden estimate the container and
package labeling requirements provided
under §§ 610.60 through 610.65 (21 CFR
610.60 through 610.65). The estimated
hours per response for § 601.2, and
§§ 610.60 through 610.65, are 860 hours.
In addition, in submitting a 351(a)
application, an applicant completes the
Form FDA 356h ‘‘Application to Market
a New Drug, Biologic, or an Antibiotic
Drug for Human Use.’’ The application
form serves primarily as a checklist for
firms to gather and submit certain
information to FDA. The checklist helps
to ensure that the application is
complete and contains all the necessary
information, so that delays due to lack
of information may be eliminated. The
form provides key information to FDA
for efficient handling and distribution to
the appropriate staff for review. The
estimated burden hours for biological
product submissions using FDA Form
356h are included under the applicable
requirements approved under OMB
control number 0910–0338.
To submit an application seeking
licensure of a proposed biosimilar
product under section 351(k)(2)(A)(i)
and (k)(2)(A)(iii) of the PHS Act, FDA
believes that the estimated burden hours
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 section
351(k)(2)(B) and (k)(4) would also be
860 hours. Until we gain more
experience with biosimilar applications,
FDA believes this estimate is
appropriate for 351(k) applications
because to determine biosimilarity or
interchangeability of a proposed 351(k)
product, the application and the
information submitted is expected to be
comparably complex and technically
demanding as a proposed 351(a)
application. FDA may determine, in its
discretion, an element required under a
351(k) application to be unnecessary to
support licensure of a biosimilar or
interchangeable product. In those cases,
the number of hours per response may
be less than the hours estimated.
A summary of the information
collection requirements in the
submission of a 351(k) application as
described under the BPCI Act follows:
Section 351(k)(2)(A)(i) requires
manufactures of 351(k) products to
submit an application for FDA review
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and licensure before marketing a
biosimilar product. An application
submitted under this section shall
include information demonstrating that:
• The biological product is biosimilar
to a reference product based upon data
derived from analytical studies, animal
studies (including toxicity) and a
clinical study or studies (including
immunogenicity and pharmacokinetics
or pharmacodynamics). The Secretary of
Health and Human Services (the
Secretary) may determine that any of
these elements is unnecessary.
• The biological product and
reference product utilize the same
mechanism or mechanisms of action for
the condition or conditions of use
prescribed, recommended, or suggested
in the proposed labeling, but only to the
extent the mechanism or mechanisms of
action are known for the reference
product.
• The condition or conditions of use
prescribed, recommended, or suggested
in the labeling proposed for the
biological product have been previously
approved for the reference product.
• The route of administration, the
dosage form, and the strength of the
biological product are the same as those
of the reference product.
• The facility in which the biological
product is manufactured, processed,
packed, or held meets standards
designed to assure that the biological
product continues to be safe, pure, and
potent.
Section 351(k)(2)(A)(iii) requires the
application to include publicly available
information regarding the Secretary’s
previous determination that the
reference product is safe, pure, and
potent. The application may include
any additional information in support of
the application, including publicly
available information with respect to the
reference product or another biological
product.
Under section 351(k)(2)(B) and (k)(4),
a manufacturer may include information
demonstrating that the biological
product meets the standards for
interchangeability either in the
application to show biosimilarity or in
a supplement to such an application.
The information submitted to meet the
standard for interchangeability must
show that: (1) The biological product is
biosimilar to the reference product and
can be expected to produce the same
clinical result as the reference product
in any given patient; and (2) for a
biological product that is administered
more than once to an individual, the
risk in terms of safety or diminished
efficacy of alternating or switching
between use of the biological product
and the reference product is not greater
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than the risk of using the reference
product without such alternation or
switch.
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
estimates for the patent provisions
under section 351(l)(6)(C) of the BPCI
Act are included in table 1 of this
document and are based on the
estimated number of 351(k) biosimilar
respondents. Based on similar reporting
requirements, FDA estimates this
notification will take 2 hours. A
summary of the collection of
information requirements under section
351(l)(6)(C) follows:
Not later than 30 days after a
complaint from the reference product
sponsor is served to a 351(k) applicant
in an action for patent infringement
described under 351(l)(6), section
351(l)(6)(C) requires that the 351(k)
applicant provide the Secretary with
notice and a copy of such complaint.
The Secretary shall publish in the
Federal Register notice any complaint
received under section 351(l)(6)(C)(i).
Based on the number of 351(k)
applications FDA received through FY
2014, we estimate that we will receive
approximately five 351(k) applications
annually. The number of respondents
submitting 351(k) applications is based
on the number of sponsors submitting
351(k) applications through FY 2014. In
making these estimates, FDA has taken
into account, among other things, the
expiration dates of patents that relate to
potential reference products, and
general market interest in biological
products that could be candidates for
351(k) applications.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
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 .......................................................
351(l)(6)(C) Patent Infringement Notifications .....................
Total ..............................................................................
1 There
Number of
responses per
respondent
Number of
respondents
351(k) Applications (42 U.S.C. 262(k))
Total hours
5
1
5
860
4,300
2
5
1
1
2
5
860
2
1,720
10
........................
........................
........................
........................
6,030
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail Stop Code 4875), Telephone (301)
496–2123, or spaethj@od.nih.gov.
[FR Doc. 2015–02025 Filed 2–2–15; 8:45 am]
BILLING CODE 4164–01–P
Dated: January 28, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
[FR Doc. 2015–01976 Filed 2–2–15; 8:45 am]
National Cancer Institute; Notice of
Charter Renewal
rljohnson on DSK3VPTVN1PROD with NOTICES
Average
burden per
response
Total annual
responses
BILLING CODE 4140–01–P
In accordance with Title 41 of the
U.S. Code of Federal Regulations,
Section 102–3.65(a), notice is hereby
given that the Charter for the National
Cancer Institute Council of Research
Advocates (formerly known as the
National Cancer Institute Director’s
Consumer Liaison Group) was renewed
for an additional two-year period on
August 17, 2014.
It is determined that the National
Cancer Institute Council of Research
Advocates is in the public interest in
connection with the performance of
duties imposed on the National
Institutes of Health by law, and that
these duties can best be performed
through the advice and counsel of this
group.
Inquiries may be directed to Jennifer
Spaeth, Director, Office of Federal
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Sep<11>2014
14:46 Feb 02, 2015
Jkt 235001
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
PO 00000
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individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel; Review of Superfund
Hazardous Research and Training Programs.
Date: February 25–27, 2015.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Sheraton Chapel Hill Hotel, One
Europa Drive, Chapel Hill, NC 27514.
Contact Person: Leroy Worth, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, Nat. Institute of Environmental
Health Sciences, P.O. Box 12233, MD EC–30/
Room 3171, Research Triangle Park, NC
27709, (919) 541–0670, worth@niehs.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
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]]>Agencies
[Federal Register Volume 80, Number 22 (Tuesday, February 3, 2015)]
[Notices]
[Pages 5761-5763]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02025]
-----------------------------------------------------------------------
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) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 April 6, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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 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 Patient Protection and Affordable Care Act (Affordable Care
Act) (Pub. L. 111-148) contains a subtitle called the Biologics Price
Competition and Innovation Act of 2009 (BPCI Act), which amends the
Public Health Service Act (PHS Act) and establishes an abbreviated
licensure pathway for
[[Page 5762]]
biological products shown to be biosimilar to, or interchangeable with,
an FDA-licensed biological reference product (See sections 7001 through
7003 of the Affordable Care Act.)
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
demonstrate interchangeability, an applicant must provide sufficient
information to demonstrate biosimilarity and that the biosimilar
biological product can be expected to produce the same clinical result
as the reference product in any given patient and, if the biosimilar
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 biosimilar 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 health
care provider. (See section 351(i)(3) of the PHS Act.)
In estimating the information collection burden for 351(k)
applications, we reviewed the number of 351(k) applications FDA has
received through fiscal year (FY) 2014, 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). For the information
collection burden for 351(a) applications, FDA described Sec. 601.2(a)
(21 CFR 601.2(a)) as requiring a manufacturer of a biological product
to submit an application on forms prescribed for such purpose with
accompanying data and information including certain labeling
information to FDA for approval to market a product in interstate
commerce. FDA also added in the burden estimate the container and
package labeling requirements provided under Sec. Sec. 610.60 through
610.65 (21 CFR 610.60 through 610.65). The estimated hours per response
for Sec. 601.2, and Sec. Sec. 610.60 through 610.65, are 860 hours.
In addition, in submitting a 351(a) application, an applicant
completes the Form FDA 356h ``Application to Market a New Drug,
Biologic, or an Antibiotic Drug for Human Use.'' The application form
serves primarily as a checklist for firms to gather and submit certain
information to FDA. The checklist helps to ensure that the application
is complete and contains all the necessary information, so that delays
due to lack of information may be eliminated. The form provides key
information to FDA for efficient handling and distribution to the
appropriate staff for review. The estimated burden hours for biological
product submissions using FDA Form 356h are included under the
applicable requirements approved under OMB control number 0910-0338.
To submit an application seeking licensure of a proposed biosimilar
product under section 351(k)(2)(A)(i) and (k)(2)(A)(iii) of the PHS
Act, FDA believes that the estimated burden hours 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 section 351(k)(2)(B) and (k)(4) would also be
860 hours. Until we gain more experience with biosimilar applications,
FDA believes this estimate is appropriate for 351(k) applications
because to determine biosimilarity or interchangeability of a proposed
351(k) product, the application and the information submitted is
expected to be comparably complex and technically demanding as a
proposed 351(a) application. FDA may determine, in its discretion, an
element required under a 351(k) application to be unnecessary to
support licensure of a biosimilar or interchangeable product. In those
cases, the number of hours per response may be less than the hours
estimated.
A summary of the information collection requirements in the
submission of a 351(k) application as described under the BPCI Act
follows:
Section 351(k)(2)(A)(i) requires manufactures of 351(k) products to
submit an application for FDA review and licensure before marketing a
biosimilar product. An application submitted under this section shall
include information demonstrating that:
The biological product is biosimilar to a reference
product based upon data derived from analytical studies, animal studies
(including toxicity) and a clinical study or studies (including
immunogenicity and pharmacokinetics or pharmacodynamics). The Secretary
of Health and Human Services (the Secretary) may determine that any of
these elements is unnecessary.
The biological product and reference product utilize the
same mechanism or mechanisms of action for the condition or conditions
of use prescribed, recommended, or suggested in the proposed labeling,
but only to the extent the mechanism or mechanisms of action are known
for the reference product.
The condition or conditions of use prescribed,
recommended, or suggested in the labeling proposed for the biological
product have been previously approved for the reference product.
The route of administration, the dosage form, and the
strength of the biological product are the same as those of the
reference product.
The facility in which the biological product is
manufactured, processed, packed, or held meets standards designed to
assure that the biological product continues to be safe, pure, and
potent.
Section 351(k)(2)(A)(iii) requires the application to include
publicly available information regarding the Secretary's previous
determination that the reference product is safe, pure, and potent. The
application may include any additional information in support of the
application, including publicly available information with respect to
the reference product or another biological product.
Under section 351(k)(2)(B) and (k)(4), a manufacturer may include
information demonstrating that the biological product meets the
standards for interchangeability either in the application to show
biosimilarity or in a supplement to such an application. The
information submitted to meet the standard for interchangeability must
show that: (1) The biological product is biosimilar to the reference
product and can be expected to produce the same clinical result as the
reference product in any given patient; and (2) for a biological
product that is administered more than once to an individual, the risk
in terms of safety or diminished efficacy of alternating or switching
between use of the biological product and the reference product is not
greater
[[Page 5763]]
than the risk of using the reference product without such alternation
or switch.
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 estimates for the patent provisions under section
351(l)(6)(C) of the BPCI Act are included in table 1 of this document
and are based on the estimated number of 351(k) biosimilar respondents.
Based on similar reporting requirements, FDA estimates this
notification will take 2 hours. A summary of the collection of
information requirements under section 351(l)(6)(C) follows:
Not later than 30 days after a complaint from the reference product
sponsor is served to a 351(k) applicant in an action for patent
infringement described under 351(l)(6), section 351(l)(6)(C) requires
that the 351(k) applicant provide the Secretary with notice and a copy
of such complaint. The Secretary shall publish in the Federal Register
notice any complaint received under section 351(l)(6)(C)(i).
Based on the number of 351(k) applications FDA received through FY
2014, we estimate that we will receive approximately five 351(k)
applications annually. The number of respondents submitting 351(k)
applications is based on the number of sponsors submitting 351(k)
applications through FY 2014. In making these estimates, FDA has taken
into account, among other things, the expiration dates of patents that
relate to potential reference products, and general market interest in
biological products that could be candidates for 351(k) applications.
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 5 1 5 860 4,300
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....
351(l)(6)(C) Patent Infringement 5 1 5 2 10
Notifications..................
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Total....................... .............. .............. .............. .............. 6,030
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: January 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02025 Filed 2-2-15; 8:45 am]
BILLING CODE 4164-01-P
