80 FR 26268 - Determination of Regulatory Review Period for Purposes of Patent Extension; ISTENT TRABECULAR MICRO-BYPASS STENT

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 88 (May 7, 2015)

Page Range		26268-26269
FR Document		2015-10999

The Food and Drug Administration (FDA) has determined the regulatory review period for the ISTENT TRABECULAR MICRO-BYPASS STENT 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 80 Issue 88 (Thursday, May 7, 2015)

[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26268-26269]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-10999]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-0397]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ISTENT TRABECULAR MICRO-BYPASS STENT

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for the ISTENT TRABECULAR MICRO-BYPASS STENT
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.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Campus, Rm. 3180, Silver Spring, MD 20993, 301-796-7900.

SUPPLEMENTARY INFORMATION: 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 ISTENT TRABECULAR
MICRO-BYPASS STENT. ISTENT TRABECULAR MICRO-BYPASS STENT is indicated
for use in conjunction with cataract surgery for the reduction of
intraocular pressure in adult patients with mild to moderate open-angle
glaucoma currently treated with ocular hypotensive medication.
Subsequent to this approval, the USPTO received a patent term
restoration application for the ISTENT TRABECULAR MICRO-BYPASS STENT
(U.S. Patent No. 6,626,858) from Glaukos Corporation, and the USPTO
requested FDA's assistance in determining this patent's eligibility for
patent term restoration. In a letter dated January 30, 2014, FDA
advised the USPTO that this medical device had undergone a regulatory
review period and that the approval of the ISTENT TRABECULAR MICRO-
BYPASS STENT represented the first permitted commercial marketing or
use of the product. Thereafter, the USPTO requested that FDA determine
the product's regulatory review period.
FDA has determined that the applicable regulatory review period for
the ISTENT TRABECULAR MICRO-BYPASS STENT is 2,820 days. Of this time,
1,535 days occurred during the testing phase of the regulatory review
period, while 1,285 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: October 7, 2004. 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 October 7, 2004.
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): December
19, 2008. FDA has verified the applicant's claim that the premarket
approval application (PMA) for the ISTENT TRABECULAR MICRO-BYPASS STENT
(PMA P080030) was initially submitted December 19, 2008.
3. The date the application was approved: June 25, 2012. FDA has
verified the applicant's claim that PMA P080030 was approved on June
25, 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 5 years of patent term extension.

[[Page 26269]]

Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by July 6, 2015. 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 November 3, 2015. To meet its burden, the petition must 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.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

Dated: May 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10999 Filed 5-6-15; 8:45 am]
BILLING CODE 4164-01-P

26268 Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices

Estimated Total Annual Burden determination because of the cataract surgery for the reduction of
Hours: 2,352. submission of an application to the intraocular pressure in adult patients
In compliance with the requirements Director of the U.S. Patent and with mild to moderate open-angle
of Section 506(c)(2)(A) of the Paperwork Trademark Office (USPTO), Department glaucoma currently treated with ocular
Reduction Act of 1995, the of Commerce, for the extension of a hypotensive medication. Subsequent to
Administration for Children and patent which claims that medical this approval, the USPTO received a
Families is soliciting public comment device. patent term restoration application for
on the specific aspects of the ADDRESSES: Submit electronic the ISTENT TRABECULAR MICRO-
information collection described above. comments to http:// BYPASS STENT (U.S. Patent No.
Copies of the proposed collection of www.regulations.gov. Submit written 6,626,858) from Glaukos Corporation,
information can be obtained and petitions (two copies are required) and and the USPTO requested FDA’s
comments may be forwarded by writing written comments to the Division of assistance in determining this patent’s
to the Administration for Children and Dockets Management (HFA–305), Food eligibility for patent term restoration. In
Families, Office of Planning, Research and Drug Administration, 5630 Fishers a letter dated January 30, 2014, FDA
and Evaluation, 370 L’Enfant Lane, Rm. 1061, Rockville, MD 20852. advised the USPTO that this medical
Promenade SW., Washington, DC 20447, Submit petitions electronically to device had undergone a regulatory
Attn: ACF Reports Clearance Officer. http://www.regulations.gov at Docket review period and that the approval of
Email address: infocollection@ No. FDA–2013–S–0610. the ISTENT TRABECULAR MICRO-
acf.hhs.gov. All requests should be FOR FURTHER INFORMATION CONTACT: BYPASS STENT represented the first
identified by the title of the information Beverly Friedman, Office of permitted commercial marketing or use
collection. Management, Food and Drug of the product. Thereafter, the USPTO
The Department specifically requests Administration, 10001 New Hampshire requested that FDA determine the
comments on: (a) Whether the proposed Ave., Hillandale Campus, Rm. 3180, product’s regulatory review period.
collection of information is necessary Silver Spring, MD 20993, 301–796– FDA has determined that the
for the proper performance of the 7900. applicable regulatory review period for
functions of the agency, including the ISTENT TRABECULAR MICRO-
SUPPLEMENTARY INFORMATION: The Drug
whether the information shall have BYPASS STENT is 2,820 days. Of this
Price Competition and Patent Term
practical utility; (b) the accuracy of the time, 1,535 days occurred during the
Restoration Act of 1984 (Pub. L. 98–417)
agency’s estimate of the burden of the testing phase of the regulatory review
and the Generic Animal Drug and Patent
proposed collection of information; (c) period, while 1,285 days occurred
Term Restoration Act (Pub. L. 100–670)
the quality, utility, and clarity of the during the approval phase. These
generally provide that a patent may be
information to be collected; and (d) periods of time were derived from the
extended for a period of up to 5 years
ways to minimize the burden of the following dates:
so long as the patented item (human
collection of information on 1. The date an exemption under
drug product, animal drug product,
respondents, including through the use section 520(g) of the Federal Food, Drug,
medical device, food additive, or color
of automated collection techniques or additive) was subject to regulatory and Cosmetic Act (the FD&C Act) (21
other forms of information technology. review by FDA before the item was U.S.C. 360j(g)) involving this device
Consideration will be given to marketed. Under these acts, a product’s became effective: October 7, 2004. FDA
comments and suggestions submitted regulatory review period forms the basis has verified the applicant’s claim that
within 60 days of this publication. for determining the amount of extension the date the investigational device
Robert Sargis, an applicant may receive. exemption (IDE) required under section
A regulatory review period consists of 520(g) of the FD&C Act for human tests
Reports Clearance Officer.
two periods of time: A testing phase and to begin became effective October 7,
[FR Doc. 2015–10987 Filed 5–6–15; 8:45 am]
an approval phase. For medical devices, 2004.
BILLING CODE 4184–01–P
the testing phase begins with a clinical 2. The date an application was
investigation of the device and runs initially submitted with respect to the
until the approval phase begins. The device under section 515 of the FD&C
DEPARTMENT OF HEALTH AND
approval phase starts with the initial Act (21 U.S.C. 360e): December 19,
HUMAN SERVICES
submission of an application to market 2008. FDA has verified the applicant’s
Food and Drug Administration the device and continues until claim that the premarket approval
permission to market the device is application (PMA) for the ISTENT
[Docket No. FDA–2013–E–0397] TRABECULAR MICRO-BYPASS STENT
granted. Although only a portion of a
regulatory review period may count (PMA P080030) was initially submitted
Determination of Regulatory Review December 19, 2008.
Period for Purposes of Patent toward the actual amount of extension
that the Director of USPTO may award 3. The date the application was
Extension; ISTENT TRABECULAR
(half the testing phase must be approved: June 25, 2012. FDA has
MICRO-BYPASS STENT
subtracted as well as any time that may verified the applicant’s claim that PMA
AGENCY: Food and Drug Administration, have occurred before the patent was P080030 was approved on June 25,
HHS. issued), FDA’s determination of the 2012.
ACTION: Notice. length of a regulatory review period for This determination of the regulatory
mstockstill on DSK4VPTVN1PROD with NOTICES

a medical device will include all of the review period establishes the maximum
SUMMARY: The Food and Drug testing phase and approval phase as potential length of a patent extension.
Administration (FDA) has determined specified in 35 U.S.C. 156(g)(3)(B). However, the USPTO applies several
the regulatory review period for the FDA has approved for marketing the statutory limitations in its calculations
ISTENT TRABECULAR MICRO- medical device ISTENT TRABECULAR of the actual period for patent extension.
BYPASS STENT and is publishing this MICRO-BYPASS STENT. ISTENT In its application for patent extension,
notice of that determination as required TRABECULAR MICRO-BYPASS STENT this applicant seeks 5 years of patent
by law. FDA has made the is indicated for use in conjunction with term extension.

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Federal Register / Vol. 80, No. 88 / Thursday, May 7, 2015 / Notices 26269

Anyone with knowledge that any of and FDA’s plans for their topic. It does not create or confer any
the dates as published are incorrect may implementation. rights for or on any person and does not
submit to the Division of Dockets DATES: Although you may comment on operate to bind FDA or the public. An
Management (see ADDRESSES) either any guidance at any time, to ensure that alternative approach may be used if
electronic or written comments and ask the Agency considers your comments on such approach satisfies the
for a redetermination by July 6, 2015. this draft guidance before it completes requirements of the applicable statutes
Furthermore, any interested person may a final version of the guidance, submit and regulations.
petition FDA for a determination electronic or written comments on the II. Paperwork Reduction Act of 1995
regarding whether the applicant for draft guidance by July 6, 2015.
extension acted with due diligence This guidance does not refer to any
ADDRESSES: Submit written requests for information collection provisions found
during the regulatory review period by single copies of the guidance to the
November 3, 2015. To meet its burden, in FDA regulations. Collections of
Outreach and Information Center (HFS– information are subject to review by the
the petition must contain sufficient facts 009), Center for Food Safety and
to merit an FDA investigation. (See H. Office of Management and Budget
Applied Nutrition (HFS–317), Food and (OMB) under the Paperwork Reduction
Rept. 857, part 1, 98th Cong., 2d sess., Drug Administration, 5100 Paint Branch
pp. 41–42, 1984.) Petitions should be in Act of 1995 (44 U.S.C. 3501–3520). We
Pkwy., College Park, MD 20740. Send conclude that the Draft Guidance for
the format specified in 21 CFR 10.30. two self-addressed adhesive labels to
Interested persons may submit to the Industry: Questions and Answers
assist that office in processing your Regarding Mandatory Food Recalls is
Division of Dockets Management (see request. See the SUPPLEMENTARY
ADDRESSES) electronic or written not subject to Paperwork Reduction Act
INFORMATION section for electronic of 1995.
comments and written or electronic access to the guidance.
petitions. It is only necessary to send Submit electronic comments on the III. Comments
one set of comments. Identify comments guidance to http://www.regulations.gov. Interested persons may submit either
with the docket number found in Submit written comments to the written comments regarding the
brackets in the heading of this Division of Dockets Management (HFA– guidance to the Division of Dockets
document. If you submit a written 305), Food and Drug Administration, Management (see ADDRESSES) or
petition, two copies are required. A 5630 Fishers Lane, Rm. 1061, Rockville, electronic comments regarding the
petition submitted electronically must MD 20852. guidance to http://www.regulations.gov.
be submitted to http:// FOR FURTHER INFORMATION CONTACT: It is only necessary to send one set of
www.regulations.gov, Docket No. FDA– Cecilia M. Wolyniak, Food and Drug comments. Identify comments with the
2013–S–0610. Comments and petitions Administration, WO32 Rm. 4352 HFC– docket number found in brackets in the
that have not been made publicly 210, 10903 New Hampshire Ave., Silver heading of this document. Received
available on http://www.regulations.gov Spring, MD 20993–0002, 301–796–8209. comments may be seen in the Division
may be viewed in the Division of
SUPPLEMENTARY INFORMATION: of Dockets Management between 9 a.m.
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
and 4 p.m., Monday through Friday. I. Background will be posted to the docket at http://
Dated: May 1, 2015. FDA’s mandatory food recall www.regulations.gov.
Leslie Kux, authority went into effect when FSMA
was enacted on January 4, 2011. Section IV. Electronic Access
Associate Commissioner for Policy.
[FR Doc. 2015–10999 Filed 5–6–15; 8:45 am] 423 of the Federal Food, Drug and Persons with access to the Internet
Cosmetic Act (FD&C Act), as added by may obtain the guidance at either
BILLING CODE 4164–01–P
section 206 of FSMA, gives FDA the http://www.fda.gov/FoodGuidances or
authority to order a responsible party to http://www.regulations.gov. Use the
DEPARTMENT OF HEALTH AND recall an article of food where FDA FDA Web site listed in the previous
HUMAN SERVICES determines that there is a reasonable sentence to find the most current
probability that the article of food (other version of the guidance.
Food and Drug Administration than infant formula) is adulterated Dated: May 1, 2015.
under section 402 of the FD&C Act [21 Leslie Kux,
[Docket No. FDA–2015–D–0138]
U.S.C. 342] or misbranded under section Associate Commissioner for Policy.
Questions and Answers Regarding 403(w) of the FD&C Act [21 U.S.C. [FR Doc. 2015–11009 Filed 5–6–15; 8:45 am]
Mandatory Food Recalls; Draft 343(w)] and that the use of or exposure
BILLING CODE 4164–01–P
Guidance for Industry to such article will cause serious
adverse health consequences or death to
AGENCY: Food and Drug Administration, humans or animals (SAHCODHA). DEPARTMENT OF HEALTH AND
HHS. FDA is announcing the availability of HUMAN SERVICES
ACTION: Notice of availability. a draft guidance for industry entitled
‘‘Questions and Answers Regarding Food and Drug Administration
SUMMARY: The Food and Drug Mandatory Food Recalls; Draft Guidance
Administration (FDA or we) is for Industry.’’ The draft guidance [Docket No. FDA–2014–N–2029]
announcing the availability of a draft provides answers to common questions Agency Information Collection
mstockstill on DSK4VPTVN1PROD with NOTICES

guidance for industry on the that might arise about the mandatory Activities; Submission for Office of
implementation of the mandatory food recall provisions and FDA’s plans for Management and Budget Review;
recall provisions of the FDA Food Safety their implementation. Comment Request; Administrative
Modernization Act (FSMA). The This guidance is being issued
Practices and Procedures; Formal
guidance is in the form of Questions and consistent with our good guidance
Evidentiary Public Hearing
Answers and provides answers to practices regulation (21 CFR 10.115).
common questions that might arise The draft guidance, when finalized, will AGENCY: Food and Drug Administration,
about the mandatory recall provisions represent our current thinking on this HHS.

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Document Created: 2015-12-16 07:50:01
Document Modified: 2015-12-16 07:50:01

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.
Contact		Beverly Friedman, Office of Management, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Campus, Rm. 3180, Silver Spring, MD 20993, 301-796-7900.
FR Citation		80 FR 26268

80 FR 26268 - Determination of Regulatory Review Period for Purposes of Patent Extension; ISTENT TRABECULAR MICRO-BYPASS STENT

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 88 (May 7, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration