[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34352-34353]
[FR Doc No: 2016-12708]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-E-3441 and FDA-2015-E-3439]

Determination of Regulatory Review Period for Purposes of Patent
Extension; OLYSIO

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 OLYSIO 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 August
1, 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 November 28, 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-2015-E-3441 or FDA-2015-E-3439 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; OLYSIO.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at 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,<PHONE_NUMBER>.

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 human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, 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 human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product OLYSIO
(simeprevir). OLYSIO is indicated for

treatment of chronic hepatitis C infection as a component of a
combination antiviral treatment regimen. Subsequent to this approval,
the USPTO received patent term restoration applications for OLYSIO
(U.S. Patent Nos. 7,671,032 and 8,349,869) from Medivir AB and Janssen
R&D Ireland, and the USPTO requested FDA's assistance in determining
the patents' eligibility for patent term restoration. In a letter dated
October 15, 2015, FDA advised the USPTO that this human drug product
had undergone a regulatory review period and that the approval of
OLYSIO 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
OLYSIO is 2,006 days. Of this time, 1,766 days occurred during the
testing phase of the regulatory review period, while 240 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: May 28, 2008. FDA has verified the Medivir AB and Janssen
R&D Ireland claim that May 28, 2008, is the date the investigational
new drug application (IND) became effective.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: March 28,
2013. FDA has verified the applicant's claim that the new drug
application (NDA) for OLYSIO (NDA 205123) was initially submitted on
March 28, 2013.
    3. The date the application was approved: November 22, 2013. FDA
has verified the applicant's claim that NDA 205123 was approved on
November 22, 2013.
    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 applications for patent extension
and amendments, the applicants seek 801 or 280 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.

    Dated: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12708 Filed 5-27-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 29 (Wednesday, February 12, 2020)]
[Notices]
[Pages 7989-7990]
[FR Doc No: 2020-02805]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP19-484-000; Docket No. CP19-488-000]

Kinder Morgan Louisiana Pipeline LLC; Columbia Gulf Transmission,
LLC; Notice of Availability of the Environmental Assessment for the
Proposed Acadiana Project and the Louisiana Xpress Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared an environmental assessment (EA) for the
Acadiana Project and Louisiana Xpress Project, proposed by Kinder
Morgan Louisiana Pipeline LLC (KMLP) and Columbia Gulf Transmission,
LLC (Columbia Gulf) respectively in the above-referenced dockets.
    KMLP requests authorization to construct and operate three new
natural gas-fired compressor units (31,900 horsepower [hp] each) at its
existing Compressor Station 760 in Acadia Parish, Louisiana, make
modifications to meter piping and new control valves at its existing
meter station in Evangeline Parish, Louisiana, as well as install
auxiliary facilities at both locations. The Acadiana Project would
increase the north-south natural gas delivery capacity on KMLP's
pipeline system by approximately 894 million cubic feet per day.

    Columbia Gulf requests authorization to construct and operate three
new greenfield compressor stations (totaling 46,940 hp each) and modify
one existing compressor station in East Carroll, Catahoula, Evangeline,
and Rapides Parishes, Louisiana. The Louisiana Xpress Project would
provide an additional 850 million cubic feet of open access firm
transportation capacity from a primary receipt point at Columbia Gulf's
Mainline Pool to a primary delivery point at an interconnection with
KMLP in Evangeline Parish, Louisiana.
    The EA assesses the potential environmental effects of the
construction and operation of the projects in accordance with the
requirements of the National Environmental Policy Act (NEPA). The FERC
staff concludes that approval of the proposed projects, with
appropriate mitigating measures, would not constitute a major federal
action significantly affecting the quality of the human environment.
    The Commission mailed a copy of the Notice of Availability to
federal, state, and local government representatives and agencies;
elected officials; environmental and public interest groups; Native
American tribes; potentially affected landowners and other interested
individuals and groups; and newspapers and libraries in both project
areas. The EA is only available in electronic format. It may be viewed
and downloaded from the FERC's website (www.ferc.gov), on the
Environmental Documents page (https://www.ferc.gov/industries/gas/enviro/eis.asp). In addition, the EA may be accessed by using the
eLibrary link on the FERC's website. Click on the eLibrary link
(https://www.ferc.gov/docs-filing/elibrary.asp), click on General
Search, and enter the docket number in the ``Docket Number'' field,
excluding the last three digits (i.e. CP19-484 or CP19-488. Be sure you
have selected an appropriate date range. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>or toll free at (866)
208-3676, or for TTY, contact<PHONE_NUMBER>.
    Any person wishing to comment on the EA may do so. Your comments
should focus on the EA's disclosure and discussion of potential
environmental effects, reasonable alternatives, and measures to avoid
or lessen environmental impacts. The more specific your comments, the
more useful they will be. To ensure that the Commission has the
opportunity to consider your comments prior to making its decision on
this project, it is important that we receive your comments in
Washington, DC on or before 5:00 p.m. Eastern Time on March 9, 2020.
    For your convenience, there are three methods you can use to file
your comments to the Commission. The Commission encourages electronic
filing of comments and has staff available to assist you at (866) 208-
3676 or<EMAIL_ADDRESS>Please carefully follow these
instructions so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature on the Commission's website (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for submitting brief,
text-only comments on a project;
    (2) You can also file your comments electronically using the
eFiling feature on the Commission's website (www.ferc.gov) under the
link to Documents and Filings. With eFiling, you can provide comments
in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on ``eRegister.'' You must select the type of filing you are making. If
you are filing a comment on a particular project, please select
``Comment on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the following address. Be sure to reference the project docket number
(CP19-484-000 or CP19-488-000) with your submission: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Room 1A, Washington, DC 20426.
    Any person seeking to become a party to the proceeding must file a
motion to intervene pursuant to Rule 214 of the Commission's Rules of
Practice and Procedures (18 CFR 385.214). Motions to intervene are more
fully described at http://www.ferc.gov/resources/guides/how-to/intervene.asp. Only intervenors have the right to seek rehearing or
judicial review of the Commission's decision. The Commission may grant
affected landowners and others with environmental concerns intervenor
status upon showing good cause by stating that they have a clear and
direct interest in this proceeding which no other party can adequately
represent. Simply filing environmental comments will not give you
intervenor status, but you do not need intervenor status to have your
comments considered.
    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website (www.ferc.gov) using the eLibrary link. The eLibrary link
also provides access to the texts of all formal documents issued by the
Commission, such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: February 6, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-02805 Filed 2-11-20; 8:45 am]
 BILLING CODE 6717-01-P