Determination of Regulatory Review Period for Purposes of Patent Extension; SUPERA PERIPHERAL STENT SYSTEM, 8721-8723 [2016-03542]
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Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Notices
OMB No.: 0970–0157.
Description: 42 U.S.C. 612 (Section
412 of the Social Security Act) requires
each Indian Tribe that elects to
administer and operate a TANF program
to submit a TANF Tribal Plan. The
TANF Tribal Plan is a mandatory
statement submitted to the Secretary by
the Indian Tribe, which consists of an
outline of how the Indian Tribes TANF
program will be administered and
operated. It is used by the Secretary to
determine whether the plan is
8721
approvable and to determine that the
Indian Tribe is eligible to receive a
TANF assistance grant. It is also made
available to the public.
Respondents: Indian Tribes applying
to operate a TANF program.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Request for State Data Needed to Determine the Amount of a Tribal Family
Assistance Grant ..........................................................................................
24
1
68
1632
mstockstill on DSK4VPTVN1PROD with NOTICES
Estimated Total Annual Burden
Hours: 1632.
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. 2016–03453 Filed 2–19–16; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–E–0934]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SUPERA PERIPHERAL
STENT SYSTEM
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
SUPERA PERIPHERAL STENT SYSTEM
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 medical
device.
SUMMARY:
Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by April 22, 2016.
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
August 22, 2016. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
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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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2014–E–0934 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; SUPERA
PERIPHERAL STENT SYSTEM’’.
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
E:\FR\FM\22FEN1.SGM
22FEN1
8722
Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Notices
I. Background
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 SUPERA PERIPHERAL
STENT SYSTEM. SUPERA
PERIPHERAL STENT SYSTEM is
indicated to improve luminal diameter
in the treatment of patients with
symptomatic de novo or restenotic
native lesions or occlusions of the
superficial femoral artery and/or
popliteal artery with reference vessel
diameters of 4.0 to 6.5 millimeters (mm)
and lesion lengths up to 140 mm.
Subsequent to this approval, the USPTO
received a patent term restoration
application for SUPERA PERIPHERAL
STENT SYSTEM (U.S. Patent No.
8,419,788) from IDEV Technologies Inc.,
and the USPTO requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated March 19, 2015, FDA
advised the USPTO that this medical
device had undergone a regulatory
review period and that the approval of
SUPERA PERIPHERAL STENT 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.
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
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
SUPERA PERIPHERAL STENT SYSTEM
is 1,894 days. Of this time, 1,396 days
occurred during the testing phase of the
mstockstill on DSK4VPTVN1PROD with NOTICES
https://www.regulations.gov or at the
Division of Dockets Management
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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 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–
0002, 301–796–3600.
SUPPLEMENTARY INFORMATION:
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regulatory review period, while 498
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: January 21, 2009. 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 January 21,
2009.
2. The date an application was
initially submitted with respect to the
device under section 515 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
360e): November 16, 2012. The
applicant claims November 9, 2012, as
the date the premarket approval
application (PMA) for SUPERA
PERIPHERAL STENT SYSTEM (PMA
P120020) was initially submitted.
However, FDA records indicate that
PMA P120020 was submitted on
November 16, 2012.
3. The date the application was
approved: March 28, 2014. FDA has
verified the applicant’s claim that PMA
P120020 was approved on March 28,
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 application for patent extension,
this applicant seeks 158 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 ask for a redetermination
(see DATES). 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. 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
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Petitions that have not been
made publicly available on https://
E:\FR\FM\22FEN1.SGM
22FEN1
Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Notices
www.regulations.gov may be viewed in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: February 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–03542 Filed 2–19–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3655]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Recordkeeping
Requirements for Microbiological
Testing and Corrective Measures for
Bottled Water
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by March 23,
2016.
ADDRESSES: To ensure that comments on
the information collection are received,
SUMMARY:
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0658. Also
include the FDA 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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Recordkeeping Requirements for
Microbiological Testing and Corrective
Measures for Bottled Water—21 CFR
129.35(a)(3)(i), 129.80(g), and
129.80(h)—OMB Control Number 0910–
0658—Extension
The bottled water regulations in parts
129 and 165 (21 CFR parts 129 and 165)
require that if any coliform organisms
are detected in weekly total coliform
testing of finished bottled water,
followup testing must be conducted to
determine whether any of the coliform
organisms are Escherichia coli. The
adulteration provision of the bottled
water standard (§ 165.110(d)) provides
that a finished product that tests
positive for E. coli will be deemed
8723
adulterated under section 402(a)(3) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 342(a)(3)). In addition,
the current good manufacturing practice
(CGMP) regulations for bottled water in
part 129 require that source water from
other than a public water system (PWS)
be tested at least weekly for total
coliform. If any coliform organisms are
detected in the source water, the bottled
water manufacturers are required to
determine whether any of the coliform
organisms are E. coli. Source water
found to contain E. coli is not
considered water of a safe, sanitary
quality and would be unsuitable for
bottled water production. Before a
bottler may use source water from a
source that has tested positive for E.
coli, a bottler must take appropriate
measures to rectify or otherwise
eliminate the cause of the
contamination. A source previously
found to contain E. coli will be
considered negative for E. coli after five
samples collected over a 24-hour period
from the same sampling site are tested
and found to be E. coli negative.
Description of Respondents: The
respondents to this information
collection are domestic and foreign
bottled water manufacturers that sell
bottled water in the United States.
In the Federal Register of October 19,
2015 (80 FR 63228) FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section; Activity
§ 129.35(a)(3)(i), § 129.80(h); Bottlers subject to source water
and finished product testing.
§ 129.80(g), § 129.80(h); Bottlers testing finished product only ....
§ 129.35(a)(3)(i), § 129.80(h); Bottlers conducting secondary testing of source water.
§ 129.35(a)(3)(i), § 129.80(h); Bottlers rectifying contamination ....
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
319
6
1,914
0.08 (5 minutes)
153
95
3
3
5
285
15
0.08 (5 minutes)
0.08 (5 minutes)
23
1
3
3
9
Total Annual Burden ...............................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
1 There
Total
hours
0.25 (15 minutes)
2
179
are no capital costs or operating and maintenance costs associated with this collection of information.
The current CGMP regulations already
reflect the time and associated
recordkeeping costs for those bottlers
that are required to conduct
microbiological testing of their source
water, as well as total coliform testing
of their finished bottled water products.
We therefore conclude that any
additional burden and costs in
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19:03 Feb 19, 2016
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recordkeeping based on followup testing
that is required if any coliform
organisms detected in the source water
test positive for E.coli are negligible. We
estimate that the labor burden of
keeping records of each test is about 5
minutes per test. We also require
followup testing of source water and
finished bottled water products for E.
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
coli when total coliform positives occur.
We expect that 319 bottlers that use
sources other than PWSs may find a
total coliform positive sample about
three times per year in source testing
and about three times in finished
product testing, for a total of 153 hours
of recordkeeping. In addition to the 319
bottlers, about 95 bottlers that use PWSs
E:\FR\FM\22FEN1.SGM
22FEN1
]]>Agencies
[Federal Register Volume 81, Number 34 (Monday, February 22, 2016)]
[Notices]
[Pages 8721-8723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03542]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-E-0934]
Determination of Regulatory Review Period for Purposes of Patent
Extension; SUPERA PERIPHERAL STENT SYSTEM
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for SUPERA PERIPHERAL STENT SYSTEM 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
medical device.
DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
22, 2016. 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 August 22, 2016.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2014-E-0934 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; SUPERA PERIPHERAL STENT SYSTEM''.
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at
[[Page 8722]]
https://www.regulations.gov or at the Division of Dockets Management
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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 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 20993-0002, 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 SUPERA PERIPHERAL
STENT SYSTEM. SUPERA PERIPHERAL STENT SYSTEM is indicated to improve
luminal diameter in the treatment of patients with symptomatic de novo
or restenotic native lesions or occlusions of the superficial femoral
artery and/or popliteal artery with reference vessel diameters of 4.0
to 6.5 millimeters (mm) and lesion lengths up to 140 mm. Subsequent to
this approval, the USPTO received a patent term restoration application
for SUPERA PERIPHERAL STENT SYSTEM (U.S. Patent No. 8,419,788) from
IDEV Technologies Inc., and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated March 19, 2015, FDA advised the USPTO that this medical
device had undergone a regulatory review period and that the approval
of SUPERA PERIPHERAL STENT 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
SUPERA PERIPHERAL STENT SYSTEM is 1,894 days. Of this time, 1,396 days
occurred during the testing phase of the regulatory review period,
while 498 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: January 21, 2009. 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 January 21, 2009.
2. The date an application was initially submitted with respect to
the device under section 515 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e): November 16, 2012. The applicant claims November
9, 2012, as the date the premarket approval application (PMA) for
SUPERA PERIPHERAL STENT SYSTEM (PMA P120020) was initially submitted.
However, FDA records indicate that PMA P120020 was submitted on
November 16, 2012.
3. The date the application was approved: March 28, 2014. FDA has
verified the applicant's claim that PMA P120020 was approved on March
28, 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 application for patent extension,
this applicant seeks 158 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 ask for
a redetermination (see DATES). 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.
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 Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Petitions that have not been made publicly available on https://
[[Page 8723]]
www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: February 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03542 Filed 2-19-16; 8:45 am]
BILLING CODE 4164-01-P
