[Federal Register Volume 80, Number 88 (Thursday, May 7, 2015)]
[Notices]
[Pages 26273-26274]
[FR Doc No: 2015-10998]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-E-0296]

Determination of Regulatory Review Period for Purposes of Patent
Extension; COFLEX INTERLAMINAR TECHNOLOGY

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 COFLEX INTERLAMINAR TECHNOLOGY 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. Patents and Trademarks 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, Center for Drug Evaluation and Research, Food and Drug
Administration, 10001 New Hampshire Ave., Hillandale Bldg., Rm. 3180,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

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 COFLEX
INTERLAMINAR TECHNOLOGY. COFLEX INTERLAMINAR TECHNOLOGY is indicated
for use in one- or two-level lumbar stenosis from L1-L5 in skeletally
mature patients with at least moderate impairment in function, who
experience relief in flexion from their symptoms of leg/buttocks/groin
pain, with or without back pain, and who have undergone at least 6
months of non-operative treatment. Subsequent to this approval, USPTO
received a patent term restoration application for COFLEX INTERLAMINAR
TECHNOLOGY (U.S. Patent No. 5,645,599) from Paradigm Spine, LLC, and
the USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated December 24,
2013, FDA advised the USPTO that this medical device had undergone a
regulatory review period and that the approval of COFLEX INTERLAMINAR
TECHNOLOGY represented the first permitted commercial marketing or use
of the product. Thereafter, the USPTO requested that the FDA determine
the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
COFLEX INTERLAMINAR TECHNOLOGY is 2,382 days. Of this time, 1,787 days
occurred during the testing phase of the regulatory review period,
while 595 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: April 12, 2006. 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
March 10, 2006. However, FDA records indicate that the IDE was
determined substantially complete for clinical studies to have begun on
April 12, 2006, 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): March 3,
2011. The applicant claims March 4, 2011, as the date the premarket
approval application (PMA) for COFLEX INTERLAMINAR TECHNOLOGY (PMA
P110008) was initially submitted. However, FDA records indicate that
PMA P110008 was submitted on March 3, 2011.
    3. The date the application was approved: October 17, 2012. FDA has
verified the applicant's claim that PMA P110008 was approved on October
17, 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 1,503 days of patent term extension.
    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. 2015-10998 Filed 5-6-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 103 (Wednesday, May 31, 2017)]
[Proposed Rules]
[Pages 24913-24914]
[FR Doc No: 2017-10923]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2017-0064; FRL-9962-76-Region 3]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Revisions to Allegheny County Health Department Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) proposes to approve
the state implementation plan (SIP) revision submitted by the
Commonwealth of Pennsylvania for the purpose of updating the SIP to
include administrative and definition amendments made to Allegheny
County Health Department's (ACHD) Rules and Regulations Article XXI,
Air Pollution Control. The amendments update the name of the Bureau of
Environmental Quality to the Bureau of Environmental Health and revise
the definition of ``County Executive'' to agree with the definition
contained in the Allegheny County Home Rule Charter. In the Final Rules
section of this Federal Register, EPA is approving the Commonwealth's
SIP submittal as a direct final rule without prior proposal because the
Agency views this as a noncontroversial submittal and anticipates no
adverse comments. A detailed rationale for the approval is set forth in
the direct final rule. If no adverse comments are received in response
to this action, no further activity is contemplated. If EPA receives
adverse comments, the direct final rule will be withdrawn and all
public comments received will be addressed in a subsequent final rule
based on this proposed rule. EPA will not institute a second comment
period. Any parties interested in commenting on this action should do
so at this time.

DATES: Comments must be received in writing by June 30, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2017-0064 at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov, follow
the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, the EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be confidential business information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the For Further Information Contact section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Sara Calcinore,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For further information, please see the
information provided in the direct final action, with the same title,
Revisions to Allegheny County Health Department Rules, that is located
in the ``Rules and Regulations'' section of this Federal Register
publication. Please note that if EPA receives adverse comment on an
amendment, paragraph, or section of this rule and if that provision may
be severed from the remainder of the rule, EPA may adopt as final those
provisions of the rule that are not the subject of an adverse comment.

    Dated: May 4, 2017.
Cecil Rodrigues,
Acting Regional Administrator, Region III.
[FR Doc. 2017-10923 Filed 5-30-17; 8:45 am]
 BILLING CODE 6560-50-P