[Federal Register Volume 77, Number 235 (Thursday, December 6, 2012)]
[Rules and Regulations]
[Page 72737]
[FR Doc No: 2012-29443]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2012-1021]

Drawbridge Operation Regulations; Atlantic Intracoastal Waterway
(Alternate Route), Dismal Swamp Canal, South Mills, NC

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Commander, Fifth Coast Guard District, has issued a
temporary deviation from the regulations governing the operation of the
Great Dismal Swamp Canal Bridge, at mile 28.0, over the Atlantic
Intracoastal Waterway (Alternate Route), Dismal Swamp Canal, South
Mills, NC. The deviation restricts the operation of the draw span and
is necessary in order to facilitate the structural repair of the
bridge.

DATES: This deviation is effective from 8 a.m. December 10, 2012, until
5 p.m. December 14, 2012.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket USCG-2012-1021 and are available online by going to http://www.regulations.gov, inserting USCG-2012-1021 in the ``Search'' box,
and then clicking ``Search''. This material is also available for
inspection or copying the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal Holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Bill H. Brazier, Bridge Management Specialist, Fifth
Coast Guard District, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on reviewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, (202) 366-
9826.

SUPPLEMENTARY INFORMATION: The North Carolina Department of the
Environment and Natural Resources, Division of Parks and Recreation,
who owns and operates this swing-type bridge, has requested a temporary
deviation from the current operating regulations set out in 33 CFR
117.820, to facilitate the structural repair of the bridge.
    The Great Dismal Swamp Canal Bridge is normally maintained in the
open position to navigation, closing only for pedestrian crossings and
periodic maintenance.
    Under this temporary deviation, the drawbridge will be closed to
navigation from 8 a.m., on December 10, 2012, through 5 p.m., on
December 14, 2012.
    Vessel traffic along this part of the Atlantic Intracoastal
Waterway (Alternate Route) consists of pleasure craft including sail
boats, and fishing boats, with some commercial traffic. The alternate
route for vessels transiting is the Atlantic Intracoastal Waterway,
Albemarle Sound to Sunset Beach. The bridge will be unable to open in
an emergency.
    The Coast Guard has carefully coordinated the restrictions with
recreational waterway users. The Coast Guard will inform all users of
the waterway through our Local and Broadcast Notice to Mariners of the
closure periods for the bridge so that vessels can arrange their
transits to minimize any impacts caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the draw must return to its
original operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: November 21, 2012.
Waverly W. Gregory, Jr.,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2012-29443 Filed 12-5-12; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)]
[Notices]
[Pages 12741-12742]
[FR Doc No: 2016-05389]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-2349]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for OPSUMIT 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 May 9,
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 September 6, 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-2349 ``For Determination of Regulatory Review Period for
Purposes of Patent Extension; OPSUMIT.'' 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 OPSUMIT
(macitentan). OPSUMIT is indicated for the treatment of pulmonary
arterial hypertension to delay disease progression. Subsequent to this
approval, the USPTO received a patent term restoration application for
OPSUMIT (U.S. Patent No. 7,094,781) from Actelion Pharmaceuticals Ltd.,
and the USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated May 11,
2015, FDA advised the USPTO that this human drug product had undergone
a regulatory review period and that the approval of OPSUMIT 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
OPSUMIT is 1,935 days. Of this time, 1,570 days occurred during the
testing phase of the regulatory review period, while 365 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: July 3, 2008. The applicant claims July 2, 2008, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was July 3,
2008, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: October
19, 2012. FDA has verified the applicant's claim that the new drug
application (NDA) for OPSUMIT (NDA 204410) was initially submitted on
October 19, 2012.
    3. The date the application was approved: October 18, 2013. FDA has
verified the applicant's claim that NDA 204410 was approved on October
18, 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 application for patent extension,
this applicant seeks 1,151 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://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05389 Filed 3-9-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 167 (Tuesday, August 28, 2012)]
[Notices]
[Page 52021]
[FR Doc No: 2012-21216]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9722-4]

Proposed CERCLA Administrative Settlement Agreement and Order on
Consent for the Mercury Refining Superfund Site, Towns of Guilderland
and Colonie, Albany County, NY

AGENCY: Environmental Protection Agency.

ACTION: Notice; request for public comment.

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

SUMMARY: In accordance with Section 122(i) of the Comprehensive
Environmental Response, Compensation, and Liability Act of 1980, as
amended (``CERCLA''), notice is hereby given by the U.S. Environmental
Protection Agency (``EPA''), Region 2, of a proposed de minimis
administrative settlement agreement and order on consent pursuant to
Section 122(g)(4) of CERCLA, between EPA and American Axle &
Manufacturing, Inc., Amersham Health, Inc., Bishop & Associates, City
of San Diego, County Board of Arlington, Virginia, Energy Solutions
Services, Inc., Scientific Ecology Group, Inc., Genesys Regional
Medical Center, Ingot Metal Company, Ltd., Purina Mills, LLC, Shred-A-
Can Recyclers, Ltd., Triumvirate Environmental, Inc., and Waste
Management of Michigan, Inc. (hereafter ``Settling Parties'')
pertaining to the Mercury Refining Superfund Site (``Site'') located in
the Towns of Guilderland and Colonie, Albany County, New York. The
settlement requires specified individual payments by each Settling
Party to the EPA Hazardous Substance Superfund Mercury Refining
Superfund Site Special Account, which combined total $79,028.49. Each
Settling Party's individual settlement amount is considered to be that
party's fair share of cleanup costs incurred and anticipated to be
incurred in the future, plus a ``premium'' that accounts for, among
other things, uncertainties associated with the costs of that future
work at the Site. The settlement includes a covenant not to sue
pursuant to Sections 106 and 107 of CERCLA, relating to the Site,
subject to limited reservations, and protection from contribution
actions or claims as provided by Sections 113(f)(2) and 122(g)(5) of
CERCLA. For thirty (30) days following the date of publication of this
notice, EPA will receive written comments relating to the settlement.
EPA will consider all comments received and may modify or withdraw its
consent to the settlement if comments received disclose facts or
considerations that indicate that the proposed settlement is
inappropriate, improper, or inadequate.
    EPA's response to any comments received will be available for
public inspection at EPA Region II, 290 Broadway, New York, New York
10007-1866.

DATES: Comments must be submitted on or before September 27, 2012.

ADDRESSES: The proposed settlement is available for public inspection
at EPA Region 2 offices at 290 Broadway, New York, New York 10007-1866.
Comments should be sent to the individual identified below and should
reference the Mercury Refining Superfund Site, Index No. CERCLA-02-
2011-2012. To request a copy of the proposed settlement agreement,
please contact the individual identified below.

FOR FURTHER INFORMATION CONTACT: Sharon E. Kivowitz, Assistant Regional
Counsel, New York/Caribbean Superfund Branch, Office of Regional
Counsel, U.S. Environmental Protection Agency, 17th Floor, 290
Broadway, New York, New York 10007-1866. Telephone:<PHONE_NUMBER>.
Email<EMAIL_ADDRESS>
    Dated: August 21, 2012.
Walter Mugdan,
Director, Emergency and Remedial Response Division, EPA, Region 2.
[FR Doc. 2012-21216 Filed 8-27-12; 8:45 am]
BILLING CODE 6560-50-P