Determination of Regulatory Review Period for Purposes of Patent Extension; Trivascular Ovation Abdominal Stent Graft System, 77638-77640 [2015-31397]
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Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3520) Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
SUPPLEMENTARY INFORMATION:
With respect to the following
collection of information, FDA invites
comments on: (1) Whether the proposed
collection of information is necessary
for the proper performance of FDA’s
functions, including whether the
information will have practical utility;
(2) the accuracy of FDA’ s estimate of
the burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques,
when appropriate, and other forms of
information technology.
Bar Code Label Requirement for
Human Drug and Biological Products
OMB Control Number 0910–0537—
Extension
In the Federal Register of February
26, 2004 (69 FR 9120), we issued a final
rule that required human drug product
and biological product labels to have bar
codes. The rule required bar codes on
most human prescription drug products
and on over-the-counter (OTC) drug
products that are dispensed pursuant to
an order and commonly used in health
care facilities. The rule also required
machine-readable information on blood
and blood components. For human
prescription drug products and OTC
drug products that are dispensed
pursuant to an order and commonly
used in health care facilities, the bar
code must contain the NDC number for
the product. For blood and blood
components, the rule specifies the
minimum contents of the machinereadable information in a format
approved by the Center for Biologics
Evaluation and Research Director as
blood centers have generally agreed
upon the information to be encoded on
the label. The rule is intended to help
reduce the number of medication errors
in hospitals and other health care
settings by allowing health care
professionals to use bar code scanning
equipment to verify that the right drug
(in the right dose and right route of
administration) is being given to the
right patient at the right time.
Most of the information collection
burden resulting from the final rule, as
calculated in table 1 of the final rule (69
FR at 9149), was a one-time burden that
does not occur after the rule’s
compliance date of April 26, 2006. In
addition, some of the information
collection burden estimated in the final
rule is now covered in other OMB
approved information collection
packages for FDA. However, parties may
continue to seek an exemption from the
bar code requirement under certain,
limited circumstances. Section
201.25(d) (21 CFR 201.25(d)) requires
submission of a written request for an
exemption and describes the contents of
such requests. Based on the number of
exemption requests we have received,
we estimate that approximately 2
exemption requests may be submitted
annually, and that each exemption
request will require 24 hours to
complete. This would result in an
annual reporting burden of 48 hours.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
201.25(d) ..............................................................................
2
1
2
24
48
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: December 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–31402 Filed 12–14–15; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2013–E–1694]
BILLING CODE 4164–01–P
asabaliauskas on DSK5VPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Determination of Regulatory Review
Period for Purposes of Patent
Extension; Trivascular Ovation
Abdominal Stent Graft System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) has determined
17:08 Dec 14, 2015
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Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
DATES:
Notice.
SUMMARY:
VerDate Sep<11>2014
the regulatory review period for
TRIVASCULAR OVATION
ABDOMINAL STENT GRAFT 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.
Sfmt 4703
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15DEN1
Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices
or written comments and ask for a
redetermination by February 16, 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
June 13, 2016. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows:
asabaliauskas on DSK5VPTVN1PROD 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): 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–
2013–E–1694 for Determination of
Regulatory Review Period for Purposes
of Patent Extension; TRIVASCULAR
OVATION ABDOMINAL STENT
GRAFT SYSTEM. Received comments
will be placed in the docket and, except
VerDate Sep<11>2014
17:08 Dec 14, 2015
Jkt 238001
77639
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
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,
301–796–3600.
SUPPLEMENTARY INFORMATION:
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, TRIVASCULAR
OVATION ABDOMINAL STENT
GRAFT SYSTEM. TRIVASCULAR
OVATION ABDOMINAL STENT
GRAFT SYSTEM is indicated for the
treatment of patients with abdominal
aortic aneurysms having vascular
morphology suitable for endovascular
repair. Subsequent to this approval, the
USPTO received a patent term
restoration application for
TRIVASCULAR OVATION
ABDOMINAL STENT GRAFT SYSTEM
(U.S. Patent No. 6,395,019) from
TriVascular, Inc., and the USPTO
requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
March 20, 2014, FDA advised the
USPTO that this medical device had
undergone a regulatory review period
and that the approval of TRIVASCULAR
OVATION ABDOMINAL STENT
GRAFT 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.
I. Background
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
TRIVASCULAR OVATION
ABDOMINAL STENT GRAFT SYSTEM
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)
PO 00000
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15DEN1
77640
Federal Register / Vol. 80, No. 240 / Tuesday, December 15, 2015 / Notices
asabaliauskas on DSK5VPTVN1PROD with NOTICES
is 3,607 days. Of this time, 3,429 days
occurred during the testing phase of the
regulatory review period, while 178
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: November 22, 2002.
The applicant claims that the
investigational device exemption (IDE)
required under section 520(g) of the
FD&C Act for human tests to begin
became effective on October 24, 2002.
However, FDA records indicate that the
IDE was determined substantially
complete for clinical studies to have
begun on November 22, 2002, which
represents the IDE effective date.
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): April 11, 2012.
FDA has verified the applicant’s claim
that the premarket approval application
(PMA) for TRIVASCULAR OVATION
ABDOMINAL STENT GRAFT SYSTEM
(PMA P120006) was initially submitted
April 11, 2012.
3. The date the application was
approved: October 5, 2012. FDA has
verified the applicant’s claim that PMA
P120006 was approved on October 5,
2012.
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 1,802 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,
VerDate Sep<11>2014
17:08 Dec 14, 2015
Jkt 238001
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Petitions that have not been
made publicly available on https://
www.regulations.gov may be viewed in
the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: December 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–31397 Filed 12–14–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–E–0182]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; VIZAMYL
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
VIZAMYL 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 February 16, 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
June 13, 2016. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
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
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
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–0182 for Determination of
Regulatory Review Period for Purposes
of Patent Extension; VIZAMYL.
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
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
E:\FR\FM\15DEN1.SGM
15DEN1
]]>Agencies
[Federal Register Volume 80, Number 240 (Tuesday, December 15, 2015)]
[Notices]
[Pages 77638-77640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31397]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-E-1694]
Determination of Regulatory Review Period for Purposes of Patent
Extension; Trivascular Ovation Abdominal Stent Graft System
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for TRIVASCULAR OVATION ABDOMINAL STENT GRAFT
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
[[Page 77639]]
or written comments and ask for a redetermination by February 16, 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 June 13, 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-2013-E-1694 for Determination of Regulatory Review Period for
Purposes of Patent Extension; TRIVASCULAR OVATION ABDOMINAL STENT GRAFT
SYSTEM. Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
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, 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, TRIVASCULAR
OVATION ABDOMINAL STENT GRAFT SYSTEM. TRIVASCULAR OVATION ABDOMINAL
STENT GRAFT SYSTEM is indicated for the treatment of patients with
abdominal aortic aneurysms having vascular morphology suitable for
endovascular repair. Subsequent to this approval, the USPTO received a
patent term restoration application for TRIVASCULAR OVATION ABDOMINAL
STENT GRAFT SYSTEM (U.S. Patent No. 6,395,019) from TriVascular, Inc.,
and the USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated March 20,
2014, FDA advised the USPTO that this medical device had undergone a
regulatory review period and that the approval of TRIVASCULAR OVATION
ABDOMINAL STENT GRAFT 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
TRIVASCULAR OVATION ABDOMINAL STENT GRAFT SYSTEM
[[Page 77640]]
is 3,607 days. Of this time, 3,429 days occurred during the testing
phase of the regulatory review period, while 178 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: November 22, 2002. The applicant claims
that the investigational device exemption (IDE) required under section
520(g) of the FD&C Act for human tests to begin became effective on
October 24, 2002. However, FDA records indicate that the IDE was
determined substantially complete for clinical studies to have begun on
November 22, 2002, which represents the IDE effective date.
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): April
11, 2012. FDA has verified the applicant's claim that the premarket
approval application (PMA) for TRIVASCULAR OVATION ABDOMINAL STENT
GRAFT SYSTEM (PMA P120006) was initially submitted April 11, 2012.
3. The date the application was approved: October 5, 2012. FDA has
verified the applicant's claim that PMA P120006 was approved on October
5, 2012.
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 1,802 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://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: December 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-31397 Filed 12-14-15; 8:45 am]
BILLING CODE 4164-01-P
