81 FR 8721 - Determination of Regulatory Review Period for Purposes of Patent Extension; SUPERA PERIPHERAL STENT SYSTEM

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 34 (February 22, 2016)

Page Range		8721-8723
FR Document		2016-03542

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.

Federal Register, Volume 81 Issue 34 (Monday, February 22, 2016)

[Federal Register Volume 81, Number 34 (Monday, February 22, 2016)]
[Notices]
[Pages 8721-8723]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-03542]

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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.

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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: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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]]

http://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 http://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: http://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 http://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 http://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 http://

[[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

Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Notices 8723

www.regulations.gov may be viewed in OMB recommends that written adulterated under section 402(a)(3) of
the Division of Dockets Management comments be faxed to the Office of the Federal Food, Drug, and Cosmetic
between 9 a.m. and 4 p.m., Monday Information and Regulatory Affairs, Act (21 U.S.C. 342(a)(3)). In addition,
through Friday. OMB, Attn: FDA Desk Officer, FAX: the current good manufacturing practice
Dated: February 16, 2016. 202–395–7285, or emailed to oira_ (CGMP) regulations for bottled water in
submission@omb.eop.gov. All part 129 require that source water from
Leslie Kux,
comments should be identified with the other than a public water system (PWS)
Associate Commissioner for Policy.
OMB control number 0910–0658. Also be tested at least weekly for total
[FR Doc. 2016–03542 Filed 2–19–16; 8:45 am] include the FDA docket number found coliform. If any coliform organisms are
BILLING CODE 4164–01–P in brackets in the heading of this detected in the source water, the bottled
document. water manufacturers are required to
FOR FURTHER INFORMATION CONTACT: FDA determine whether any of the coliform
DEPARTMENT OF HEALTH AND
PRA Staff, Office of Operations, Food organisms are E. coli. Source water
HUMAN SERVICES
and Drug Administration, 8455 found to contain E. coli is not
Food and Drug Administration Colesville Rd., COLE–14526, Silver considered water of a safe, sanitary
Spring, MD 20993–0002, PRAStaff@ quality and would be unsuitable for
[Docket No. FDA–2015–N–3655] bottled water production. Before a
fda.hhs.gov.
bottler may use source water from a
Agency Information Collection SUPPLEMENTARY INFORMATION: In
source that has tested positive for E.
Activities; Submission for Office of compliance with 44 U.S.C. 3507, FDA
coli, a bottler must take appropriate
Management and Budget Review; has submitted the following proposed
measures to rectify or otherwise
Comment Request; Recordkeeping collection of information to OMB for
eliminate the cause of the
Requirements for Microbiological review and clearance.
contamination. A source previously
Testing and Corrective Measures for Recordkeeping Requirements for found to contain E. coli will be
Bottled Water Microbiological Testing and Corrective considered negative for E. coli after five
AGENCY: Food and Drug Administration, Measures for Bottled Water—21 CFR samples collected over a 24-hour period
HHS. 129.35(a)(3)(i), 129.80(g), and from the same sampling site are tested
ACTION: Notice. 129.80(h)—OMB Control Number 0910– and found to be E. coli negative.
0658—Extension Description of Respondents: The
SUMMARY: The Food and Drug The bottled water regulations in parts respondents to this information
Administration (FDA) is announcing 129 and 165 (21 CFR parts 129 and 165) collection are domestic and foreign
that a proposed collection of require that if any coliform organisms bottled water manufacturers that sell
information has been submitted to the are detected in weekly total coliform bottled water in the United States.
Office of Management and Budget testing of finished bottled water, In the Federal Register of October 19,
(OMB) for review and clearance under followup testing must be conducted to 2015 (80 FR 63228) FDA published a 60-
the Paperwork Reduction Act of 1995. determine whether any of the coliform day notice requesting public comment
DATES: Fax written comments on the organisms are Escherichia coli. The on the proposed collection of
collection of information by March 23, adulteration provision of the bottled information. No comments were
2016. water standard (§ 165.110(d)) provides received.
ADDRESSES: To ensure that comments on that a finished product that tests We estimate the burden of this
the information collection are received, positive for E. coli will be deemed collection of information as follows:

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual Total
21 CFR Section; Activity records per burden per
recordkeepers records hours
recordkeeper recordkeeping

§ 129.35(a)(3)(i), § 129.80(h); Bottlers subject to source water 319 6 1,914 0.08 (5 minutes) 153
and finished product testing.
§ 129.80(g), § 129.80(h); Bottlers testing finished product only .... 95 3 285 0.08 (5 minutes) 23
§ 129.35(a)(3)(i), § 129.80(h); Bottlers conducting secondary test- 3 5 15 0.08 (5 minutes) 1
ing of source water.
§ 129.35(a)(3)(i), § 129.80(h); Bottlers rectifying contamination .... 3 3 9 0.25 (15 min- 2
utes)

Total Annual Burden ............................................................... 179
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The current CGMP regulations already recordkeeping based on followup testing coli when total coliform positives occur.
reflect the time and associated that is required if any coliform We expect that 319 bottlers that use
mstockstill on DSK4VPTVN1PROD with NOTICES

recordkeeping costs for those bottlers organisms detected in the source water sources other than PWSs may find a
that are required to conduct test positive for E.coli are negligible. We total coliform positive sample about
microbiological testing of their source estimate that the labor burden of three times per year in source testing
water, as well as total coliform testing keeping records of each test is about 5 and about three times in finished
of their finished bottled water products. minutes per test. We also require product testing, for a total of 153 hours
We therefore conclude that any followup testing of source water and of recordkeeping. In addition to the 319
additional burden and costs in finished bottled water products for E. bottlers, about 95 bottlers that use PWSs

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Document Created: 2016-02-19 23:56:57
Document Modified: 2016-02-19 23:56:57

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
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.
FR Citation		81 FR 8721

81 FR 8721 - Determination of Regulatory Review Period for Purposes of Patent Extension; SUPERA PERIPHERAL STENT SYSTEM

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 34 (February 22, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration