Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant, 18858 [2016-07364]
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18858
Federal Register / Vol. 81, No. 63 / Friday, April 1, 2016 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
LIHEAP Leveraging Report .............................................................................
70
1
38
2,660
Estimated Total Annual Burden
Hours: 2,660.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW.,
Washington DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2016–07359 Filed 3–31–16; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Food and Drug Administration
[Docket No. FDA–2015–N–2489]
Receipt of Notice That a Patent
Infringement Complaint Was Filed
Against a Biosimilar Applicant
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
17:25 Mar 31, 2016
Jkt 238001
The Food and Drug
Administration (FDA) is publishing
notice that an applicant for a proposed
biosimilar product notified FDA that a
patent infringement action was filed in
connection with the applicant’s
biologics license application (BLA).
Under the Public Health Service Act
(PHS Act), an applicant for a proposed
biosimilar product or interchangeable
product must notify FDA within 30 days
after the applicant was served with a
complaint in a patent infringement
action described under the PHS Act.
FDA is required to publish notice of the
complaint in the Federal Register.
SUMMARY:
FDA has received notice of the
following complaint under section
351(l)(6)(C) of the PHS Act:
Amgen, Inc., v. Apotex, Inc., 15–cv–
61631 (consolidated with 15–cv–62081,
S.D. Fla., filed October 2, 2015).
FDA has only a ministerial role in
publishing notice of a complaint
received under section 351(l)(6)(C) of
the PHS Act, and does not perform a
substantive review of the complaint.
Dated: March 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–07364 Filed 3–31–16; 8:45 am]
BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT:
Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6208, Silver Spring,
MD 20993–0002, 240–402–0979,
daniel.orr@fda.hhs.gov.
The
Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) was
enacted as part of the Patient Protection
and Affordable Care Act (Pub. L. 111–
148) on March 23, 2010. The BPCI Act
amended the PHS Act and created an
abbreviated licensure pathway for
biological products shown to be
biosimilar to, or interchangeable with,
an FDA-licensed biological reference
product. Section 351(k) of the PHS Act
(42 U.S.C. 262(k)), added by the BPCI
Act, describes the requirements for a
BLA for a proposed biosimilar product
or a proposed interchangeable product
(351(k) BLA). Section 351(l) of the PHS
Act, also added by the BPCI Act,
describes certain procedures for
exchanging patent information and
resolving patent disputes between a
351(k) BLA applicant and the holder of
the BLA reference product. If a 351(k)
applicant is served with a complaint for
a patent infringement described in
section 351(l)(6) of the PHS Act, the
applicant is required, under section
351(l)(6)(C) of the PHS Act, to provide
the FDA with notice and a copy of the
complaint within 30 days of service.
FDA is required to publish notice of a
complaint received under section
351(l)(6)(C) of the PHS Act in the
Federal Register.
SUPPLEMENTARY INFORMATION:
PO 00000
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Fmt 4703
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0031]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Clinical Laboratory
Improvement Amendments Act of 1988
Waiver Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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
collections of information associated
with Clinical Laboratory Improvement
Amendments of 1988 (CLIA) waiver
applications.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by May 31, 2016.
DATES:
ADDRESSES:
You may submit comments
as follows:
E:\FR\FM\01APN1.SGM
01APN1
]]>Agencies
[Federal Register Volume 81, Number 63 (Friday, April 1, 2016)]
[Notices]
[Page 18858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07364]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-2489]
Receipt of Notice That a Patent Infringement Complaint Was Filed
Against a Biosimilar Applicant
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing notice
that an applicant for a proposed biosimilar product notified FDA that a
patent infringement action was filed in connection with the applicant's
biologics license application (BLA). Under the Public Health Service
Act (PHS Act), an applicant for a proposed biosimilar product or
interchangeable product must notify FDA within 30 days after the
applicant was served with a complaint in a patent infringement action
described under the PHS Act. FDA is required to publish notice of the
complaint in the Federal Register.
FOR FURTHER INFORMATION CONTACT: Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 240-402-0979,
daniel.orr@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) was enacted as part of the Patient
Protection and Affordable Care Act (Pub. L. 111-148) on March 23, 2010.
The BPCI Act amended the PHS Act and created an abbreviated licensure
pathway for biological products shown to be biosimilar to, or
interchangeable with, an FDA-licensed biological reference product.
Section 351(k) of the PHS Act (42 U.S.C. 262(k)), added by the BPCI
Act, describes the requirements for a BLA for a proposed biosimilar
product or a proposed interchangeable product (351(k) BLA). Section
351(l) of the PHS Act, also added by the BPCI Act, describes certain
procedures for exchanging patent information and resolving patent
disputes between a 351(k) BLA applicant and the holder of the BLA
reference product. If a 351(k) applicant is served with a complaint for
a patent infringement described in section 351(l)(6) of the PHS Act,
the applicant is required, under section 351(l)(6)(C) of the PHS Act,
to provide the FDA with notice and a copy of the complaint within 30
days of service. FDA is required to publish notice of a complaint
received under section 351(l)(6)(C) of the PHS Act in the Federal
Register.
FDA has received notice of the following complaint under section
351(l)(6)(C) of the PHS Act:
Amgen, Inc., v. Apotex, Inc., 15-cv-61631 (consolidated with 15-cv-
62081, S.D. Fla., filed October 2, 2015).
FDA has only a ministerial role in publishing notice of a complaint
received under section 351(l)(6)(C) of the PHS Act, and does not
perform a substantive review of the complaint.
Dated: March 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07364 Filed 3-31-16; 8:45 am]
BILLING CODE 4164-01-P
