Determination of Regulatory Review Period for Purposes of Patent Extension; Intercept Blood System for Plasma, 31974-31976 [2017-14454]
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31974
Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices
The notices are available for
immediate inspection at the Federal
Reserve Bank indicated. The notices
also will be available for inspection at
the offices of the Board of Governors.
Interested persons may express their
views in writing to the Reserve Bank
indicated for that notice or to the offices
of the Board of Governors. Comments
must be received not later than July 24,
2017.
A. Federal Reserve Bank of Chicago
(Colette A. Fried, Assistant Vice
President) 230 South LaSalle Street,
Chicago, Illinois 60690–1414:
1. Scott Michael Rasmussen,
Germantown, Wisconsin; as trustee
under a 2017 Voting Agreement, to
acquire voting shares of Waupaca
Bancorporation, Inc., and thereby
indirectly acquire shares of First
National Bank, both of Waupaca,
Wisconsin.
B. Federal Reserve Bank of
Minneapolis (Brendan S. Murrin,
Assistant Vice President) 90 Hennepin
Avenue, Minneapolis, Minnesota
55480–0291:
1. Nancy J. Petersen, Bismarck, North
Dakota; to individually acquire voting
shares of Cornerstone Holding
Company, Inc., Fargo, North Dakota,
and thereby indirectly acquire voting
shares of Cornerstone Bank, Fargo,
North Dakota.
Board of Governors of the Federal Reserve
System, July 6, 2017.
Yao-Chin Chao,
Assistant Secretary of the Board.
[FR Doc. 2017–14506 Filed 7–10–17; 8:45 am]
BILLING CODE 6210–01–P
FEDERAL RESERVE SYSTEM
mstockstill on DSK30JT082PROD with NOTICES
Change in Bank Control Notices;
Acquisitions of Shares of a Bank or
Bank Holding Company
The notificants listed below have
applied under the Change in Bank
Control Act (12 U.S.C. 1817(j)) and
§ 225.41 of the Board’s Regulation Y (12
CFR 225.41) to acquire shares of a bank
or bank holding company. The factors
that are considered in acting on the
notices are set forth in paragraph 7 of
the Act (12 U.S.C. 1817(j)(7)).
The notices are available for
immediate inspection at the Federal
Reserve Bank indicated. The notices
also will be available for inspection at
the offices of the Board of Governors.
Interested persons may express their
views in writing to the Reserve Bank
indicated for that notice or to the offices
of the Board of Governors. Comments
must be received not later than July 26,
2017.
VerDate Sep<11>2014
18:01 Jul 10, 2017
Jkt 241001
percent of the outstanding voting shares
of Bank of Lincoln County, both of
Fayetteville, Tennessee.
A. Federal Reserve Bank of
Minneapolis (Jacquelyn K. Brunmeier,
Assistant Vice President) 90 Hennepin
Avenue, Minneapolis, Minnesota
55480–0291:
1. Nancy J. Petersen, Bismarck, North
Dakota; to individually retain voting
shares of Cornerstone Holding
Company, Inc., Fargo, North Dakota,
and thereby indirectly retain shares of
Cornerstone Bank, Fargo, North Dakota.
Board of Governors of the Federal Reserve
System, July 6, 2017.
Yao-Chin Chao,
Assistant Secretary of the Board.
Board of Governors of the Federal Reserve
System, July 5, 2017.
Yao-Chin Chao,
Assistant Secretary of the Board.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–14435 Filed 7–10–17; 8:45 am]
[FR Doc. 2017–14507 Filed 7–10–17; 8:45 am]
BILLING CODE 6210–01–P
Food and Drug Administration
BILLING CODE 6210–01–P
[Docket Nos. FDA–2015–E–4727 and FDA–
2015–E–4615]
FEDERAL RESERVE SYSTEM
Determination of Regulatory Review
Period for Purposes of Patent
Extension; Intercept Blood System for
Plasma
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications will also be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than August 3, 2017.
A. Federal Reserve Bank of Atlanta
(Chapelle Davis, Assistant Vice
President) 1000 Peachtree Street NE.,
Atlanta, Georgia 30309. Comments can
also be sent electronically to
Applications.Comments@atl.frb.org:
1. BOLC Corp; to become a bank
holding company by acquiring 100
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AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
INTERCEPT BLOOD SYSTEM FOR
PLASMA and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of
applications to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of a patent which claims that
medical device.
DATES: Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by September 11, 2017.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
January 8, 2018. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
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 11,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of September 11, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
SUMMARY:
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Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices
service acceptance receipt is on or
before that date.
mstockstill on DSK30JT082PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way.
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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 Nos. FDA–
2015–E–4727 and FDA–2015–E–4615
for ‘‘Determination of Regulatory
Review Period for Purposes of Patent
Extension; INTERCEPT BLOOD
SYSTEM FOR PLASMA.’’ 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
VerDate Sep<11>2014
18:01 Jul 10, 2017
Jkt 241001
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
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
PO 00000
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31975
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For medical devices,
the testing phase begins with a clinical
investigation of the device and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the device and continues until
permission to market the device is
granted. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of USPTO may award
(half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a medical device will include all of the
testing phase and approval phase as
specified in 35 U.S.C. 156(g)(3)(B).
FDA has approved for marketing the
medical device INTERCEPT BLOOD
SYSTEM FOR PLASMA. INTERCEPT
BLOOD SYSTEM FOR PLASMA is
indicated for inactivation of bacterial
and viral contaminants in Fresh Frozen
Plasma prior to transfusion. Subsequent
to this approval, the USPTO received
patent term restoration applications for
INTERCEPT BLOOD SYSTEM FOR
PLASMA (U.S. Patent Nos. 5,593,823
and 6,951,713) from Cerus Corporation,
and the USPTO requested FDA’s
assistance in determining this patents’
eligibility for patent term restoration. In
a letter dated April 26, 2016, FDA
advised the USPTO that this medical
device had undergone a regulatory
review period and that the approval of
INTERCEPT BLOOD SYSTEM FOR
PLASMA represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
INTERCEPT BLOOD SYSTEM FOR
PLASMA is 6,497 days. Of this time,
6,114 days occurred during the testing
phase of the regulatory review period,
while 383 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 520(g) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 360j(g)) involving this device
became effective: March 5, 1997. The
applicant claims that the investigational
device exemption (IDE) required under
section 520(g) of the FD&C Act for
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Federal Register / Vol. 82, No. 131 / Tuesday, July 11, 2017 / Notices
human tests to begin became effective
on March 10, 1997. However, FDA
records indicate that the IDE was
determined substantially complete for
clinical studies to have begun on March
5, 1997, which represents the IDE
effective date.
2. The date an application was
initially submitted with respect to the
biological device under section 515 of
the FD&C Act (21 U.S.C. 360e):
November 29, 2013. The applicant
claims December 23, 2013, as the date
the premarket approval application
(PMA) for INTERCEPT BLOOD
SYSTEM FOR PLASMA (PMA
BP130076) was initially submitted.
However, FDA records indicate that the
complete PMA BP130076 was submitted
on November 29, 2013.
3. The date the application was
approved: December 16, 2014. FDA has
verified the applicant’s claim that PMA
BP130076 was approved on December
16, 2014.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 1,860 days or 5
years of patent term extension.
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III. Petitions
Food and Drug Administration
[Docket No. FDA–2017–N–1129]
Medical Devices; Exemptions From
Premarket Notification: Class II
Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing a list of class II devices that
the Agency has determined based on
established factors to no longer require
premarket notification to provide
reasonable assurance of safety and
effectiveness, subject to certain
limitations. FDA is publishing this
notice of that determination in
accordance with procedures established
by the 21st Century Cures Act. This
notice represents FDA’s final
determination with respect to the list of
class II devices proposed in a March 14,
2017, Federal Register document. The
exemptions in this notice will decrease
regulatory burdens on the medical
device industry and will eliminate
private costs and expenditures required
to comply with certain Federal
regulations.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in 21 CFR
60.30, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must be
timely (see DATES) and contain sufficient
facts to merit an FDA investigation. (See
H. Rept. 857, part 1, 98th Cong., 2d
sess., pp. 41–42, 1984.) Petitions should
be in the format specified in 21 CFR
10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (see
ADDRESSES).
Dated: July 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–14454 Filed 7–10–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
18:01 Jul 10, 2017
Jkt 241001
Bryce Bennett, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5244, Silver Spring,
MD 20993, email: Gregory.Bennett@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 14,
2017 (82 FR 13609), FDA issued a notice
proposing to exempt a list of class II
devices from the premarket notification
requirements under section 510(k) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360(k)),
subject to certain limitations. This
notice was issued in accordance with
the 21st Century Cures Act (Pub. L. 114–
255), which was signed into law on
December 13, 2016. Section 3054 of that
statute amended section 510(m) of the
FD&C Act. As amended, section
510(m)(1)(A) of the FD&C Act provides
that, within 90 days after enactment of
the 21st Century Cures Act and at least
once every 5 years thereafter, FDA must
publish in the Federal Register a notice
containing a list of each type of class II
device that FDA determines no longer
requires a report under section 510(k) of
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Sfmt 4703
the FD&C Act (generally referred to as
a premarket notification or ‘‘510(k)’’) to
provide reasonable assurance of safety
and effectiveness. Within 210 days of
enactment of the 21st Century Cures
Act, FDA must publish in the Federal
Register a list representing its final
determination regarding the list of
devices proposed in the March 14, 2017,
notice. Section 510(m)(3) of the FD&C
Act provides that upon the date that this
final list is published in the Federal
Register, a 510(k) will no longer be
required for the listed devices and the
applicable classification regulation for
these devices shall be deemed amended
to incorporate such exemption.
Interested persons were given until May
15, 2017, to comment on the proposed
list of class II devices. After reviewing
these comments and considering
whether the proposed list should be
modified, FDA is now identifying its
final determination as to which of those
devices are now exempt from premarket
notification requirements, subject to
certain limitations, as indicated in
tables 1 to 3 of this notice.
In a future action, FDA intends to
amend the codified language for each
listed device’s classification regulation
to reflect this final determination.
Persons with pending 510(k)
submissions for devices that are now
exempt from premarket notification,
subject to the limitations on
exemptions, should withdraw their
submissions.
These exemptions will decrease
regulatory burdens on the medical
device industry and will eliminate
private costs and expenditures required
to comply with Federal regulation.
Specifically, regulated industry will no
longer have to invest time and resources
in premarket notifications, including
preparation of documents and data for
submission to FDA, payment of user
fees associated with 510(k) submissions,
and responding to questions and
requests for additional information from
FDA during 510(k) review.
II. Criteria for Exemption
There are a number of factors FDA
may consider to determine whether a
510(k) is necessary to provide
reasonable assurance of the safety and
effectiveness of a class II device. These
factors are discussed in the January 21,
1998, Federal Register notice (63 FR
3142) and subsequently in the guidance
the Agency issued on February 19, 1998,
entitled ‘‘Procedures for Class II Device
Exemptions from Premarket
Notification, Guidance for Industry and
CDRH Staff’’ (‘‘Class II 510(k)
Exemption Guidance’’) (Ref. 1).
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]]>Agencies
[Federal Register Volume 82, Number 131 (Tuesday, July 11, 2017)]
[Notices]
[Pages 31974-31976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14454]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2015-E-4727 and FDA-2015-E-4615]
Determination of Regulatory Review Period for Purposes of Patent
Extension; Intercept Blood System for Plasma
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for INTERCEPT BLOOD SYSTEM FOR PLASMA and is
publishing this notice of that determination as required by law. FDA
has made the determination because of the submission of applications to
the Director of the U.S. Patent and Trademark Office (USPTO),
Department of Commerce, for the extension of a patent which claims that
medical device.
DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
September 11, 2017. Furthermore, any interested person may petition FDA
for a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period by January 8,
2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for
more information.
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 11, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of September 11, 2017. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
[[Page 31975]]
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 Nos.
FDA-2015-E-4727 and FDA-2015-E-4615 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; INTERCEPT BLOOD SYSTEM
FOR PLASMA.'' 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: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of USPTO may award (half the testing phase
must be subtracted as well as any time that may have occurred before
the patent was issued), FDA's determination of the length of a
regulatory review period for a medical device will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA has approved for marketing the medical device INTERCEPT BLOOD
SYSTEM FOR PLASMA. INTERCEPT BLOOD SYSTEM FOR PLASMA is indicated for
inactivation of bacterial and viral contaminants in Fresh Frozen Plasma
prior to transfusion. Subsequent to this approval, the USPTO received
patent term restoration applications for INTERCEPT BLOOD SYSTEM FOR
PLASMA (U.S. Patent Nos. 5,593,823 and 6,951,713) from Cerus
Corporation, and the USPTO requested FDA's assistance in determining
this patents' eligibility for patent term restoration. In a letter
dated April 26, 2016, FDA advised the USPTO that this medical device
had undergone a regulatory review period and that the approval of
INTERCEPT BLOOD SYSTEM FOR PLASMA represented the first permitted
commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.
II. Determination of Regulatory Review Period
FDA has determined that the applicable regulatory review period for
INTERCEPT BLOOD SYSTEM FOR PLASMA is 6,497 days. Of this time, 6,114
days occurred during the testing phase of the regulatory review period,
while 383 days occurred during the approval phase. These periods of
time were derived from the following dates:
1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: March 5, 1997. The applicant claims that
the investigational device exemption (IDE) required under section
520(g) of the FD&C Act for
[[Page 31976]]
human tests to begin became effective on March 10, 1997. However, FDA
records indicate that the IDE was determined substantially complete for
clinical studies to have begun on March 5, 1997, which represents the
IDE effective date.
2. The date an application was initially submitted with respect to
the biological device under section 515 of the FD&C Act (21 U.S.C.
360e): November 29, 2013. The applicant claims December 23, 2013, as
the date the premarket approval application (PMA) for INTERCEPT BLOOD
SYSTEM FOR PLASMA (PMA BP130076) was initially submitted. However, FDA
records indicate that the complete PMA BP130076 was submitted on
November 29, 2013.
3. The date the application was approved: December 16, 2014. FDA
has verified the applicant's claim that PMA BP130076 was approved on
December 16, 2014.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 1,860 days or 5 years of patent term extension.
III. Petitions
Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in 21 CFR 60.30, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period. To meet its burden,
the petition must be timely (see DATES) and contain sufficient facts to
merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d
sess., pp. 41-42, 1984.) Petitions should be in the format specified in
21 CFR 10.30.
Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (see ADDRESSES).
Dated: July 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14454 Filed 7-10-17; 8:45 am]
BILLING CODE 4164-01-P
