Determination of Regulatory Review Period for Purposes of Patent Extension; Senza Spinal Cord Stimulation System, 56250-56252 [2017-25684]
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Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices
different types of premarket
submissions for devices intended for
use in pediatric populations.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on pediatric
information for x-ray imaging device
510(k)s. It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
ethrower on DSK3G9T082PROD with NOTICES
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. This
guidance document is also available at
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Pediatric Information for X-ray
Imaging Device Premarket
Notifications’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 1771 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations and guidance
documents. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 807, subpart E have been
approved under OMB control number
0910–0120; the collections of
information in 21 CFR part 801 have
been approved under OMB control
number 0910–0485; and the collections
of information in 21 CFR parts 1002,
1010, 1020, 1030, 1040, and 1050 have
been approved under OMB control
number 0910–0025. The collections of
information in the guidance document
‘‘Requests for Feedback on Medical
Device Submissions: The PreSubmission Program and Meetings with
Food and Drug Administration Staff’’
have been approved under OMB control
number 0910–0756. In addition, FDA
concludes that the Indications for Use
VerDate Sep<11>2014
19:51 Nov 27, 2017
Jkt 244001
warning label does not constitute a
‘‘collection of information’’ under the
PRA. Rather, the labeling statements are
‘‘public disclosure(s) of information
originally supplied by the Federal
government to the recipient for the
purpose of disclosure to the public.’’ (5
CFR 1320.3(c)(2).)
Dated: November 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–25632 Filed 11–27–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2016–E–1195 and FDA–
2016–E–1534]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; Senza Spinal Cord
Stimulation System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for Senza Spinal Cord Stimulation
System 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 January 29, 2018.
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
May 29, 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 January 29,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of January 29, 2018.
Comments received by mail/hand
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
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 Nos. FDA–
2016–E–1195 and FDA–2016–E–1534
for Determination of Regulatory Review
Period for Purposes of Patent Extension;
SENZA SPINAL CORD STIMULATION
SYSTEM. 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.
E:\FR\FM\28NON1.SGM
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Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices
• 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 § 10.20 (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:
ethrower on DSK3G9T082PROD with NOTICES
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
VerDate Sep<11>2014
19:51 Nov 27, 2017
Jkt 244001
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 Senza Spinal Cord
Stimulation System. Senza Spinal Cord
Stimulation System is indicated as an
aid in the management of chronic
intractable pain of the trunk and/or
limbs, including unilateral or bilateral
pain associated with the following:
Failed back surgery syndrome,
intractable low back pain, and leg pain.
Subsequent to this approval, the USPTO
received patent term restoration
applications for Senza Spinal Cord
Stimulation System (U.S. Patent Nos.
8,712,533 and 8,768,472) from Nevro
Corporation, and the USPTO requested
FDA’s assistance in determining the
patents’ eligibility for patent term
restoration. In a letter dated July 12,
2016, FDA advised the USPTO that this
medical device had undergone a
regulatory review period and that the
approval of SENZA Spinal Cord
Stimulation System 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
Senza Spinal Cord Stimulation System
is 1,136 days. Of this time, 820 days
occurred during the testing phase of the
regulatory review period, while 316
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,
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Sfmt 4703
56251
and Cosmetic Act (the FD&C Act) (21
U.S.C. 360j(g)) involving this device
became effective: March 30, 2012. FDA
has verified the applicant’s claim that
the date the investigational device
exemption (IDE) required under section
520(g) of the FD&C Act for human tests
to begin became effective was March 30,
2012.
2. The date an application was
initially submitted with respect to the
device under section 515 of the FD&C
Act (21 U.S.C. 360e): June 27, 2014. FDA
has verified the applicant’s claim that
the premarket approval application
(PMA) for SENZA SPINAL CORD
STIMULATION SYSTEM (PMA
P130022) was initially submitted June
27, 2014.
3. The date the application was
approved: May 8, 2015. FDA has
verified the applicant’s claim that PMA
P130022 was approved on May 8, 2015.
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 312 days 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 § 60.30 (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
comply with all the requirements of
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (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 (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
E:\FR\FM\28NON1.SGM
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56252
Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Notices
Dated: November 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–25684 Filed 11–27–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–E–1237]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SAVAYSA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for SAVAYSA and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
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 January 29, 2018.
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
May 29, 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 January 29,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of January 29, 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.
ethrower on DSK3G9T082PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
VerDate Sep<11>2014
19:51 Nov 27, 2017
Jkt 244001
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–
2016–E–1237 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; SAVAYSA.’’
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
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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 § 10.20 (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
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 human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
E:\FR\FM\28NON1.SGM
28NON1
]]>Agencies
[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)]
[Notices]
[Pages 56250-56252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25684]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2016-E-1195 and FDA-2016-E-1534]
Determination of Regulatory Review Period for Purposes of Patent
Extension; Senza Spinal Cord Stimulation System
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for Senza Spinal Cord
Stimulation System 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 January
29, 2018. 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 May 29, 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 January 29, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of January 29, 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 Nos.
FDA-2016-E-1195 and FDA-2016-E-1534 for Determination of Regulatory
Review Period for Purposes of Patent Extension; SENZA SPINAL CORD
STIMULATION SYSTEM. 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.
[[Page 56251]]
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 Sec. 10.20 (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 Senza Spinal Cord
Stimulation System. Senza Spinal Cord Stimulation System is indicated
as an aid in the management of chronic intractable pain of the trunk
and/or limbs, including unilateral or bilateral pain associated with
the following: Failed back surgery syndrome, intractable low back pain,
and leg pain. Subsequent to this approval, the USPTO received patent
term restoration applications for Senza Spinal Cord Stimulation System
(U.S. Patent Nos. 8,712,533 and 8,768,472) from Nevro Corporation, and
the USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated July 12,
2016, FDA advised the USPTO that this medical device had undergone a
regulatory review period and that the approval of SENZA Spinal Cord
Stimulation System 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
Senza Spinal Cord Stimulation System is 1,136 days. Of this time, 820
days occurred during the testing phase of the regulatory review period,
while 316 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 30, 2012. FDA has verified the
applicant's claim that the date the investigational device exemption
(IDE) required under section 520(g) of the FD&C Act for human tests to
begin became effective was March 30, 2012.
2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): June 27,
2014. FDA has verified the applicant's claim that the premarket
approval application (PMA) for SENZA SPINAL CORD STIMULATION SYSTEM
(PMA P130022) was initially submitted June 27, 2014.
3. The date the application was approved: May 8, 2015. FDA has
verified the applicant's claim that PMA P130022 was approved on May 8,
2015.
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 312 days 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 Sec. 60.30 (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 comply with all the requirements
of Sec. 60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec. 10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (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 (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
[[Page 56252]]
Dated: November 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-25684 Filed 11-27-17; 8:45 am]
BILLING CODE 4164-01-P
