[Federal Register Volume 85, Number 109 (Friday, June 5, 2020)]
[Notices]
[Page 34620]
[FR Doc No: 2020-12220]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL20-49-000]

Shell Energy North America (U.S.), LP; Notice of Petition for
Declaratory Order

    Take notice that on May 29, 2020, pursuant to Rule 207 of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedure, 18 CFR 385.207, Shell Energy North America (U.S.), L.P.
(Petitioner), filed a petition for a declaratory order requesting that
the Commission interpret the PJM Interconnection, L.L.C. Tariff
provisions regarding bilateral transfers of Financial Transmission
Rights and to resolve an ongoing dispute currently pending in Texas
state court, as more fully explained in the petition.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the eFiling link at
http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
eLibrary link. Enter the docket number excluding the last three digits
in the docket number field to access the document. At this time, the
Commission has suspended access to the Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Comment Date: 5:00 p.m. Eastern time on June 29, 2020.

    Dated: June 1, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-12220 Filed 6-4-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 196 (Thursday, October 9, 2014)]
[Rules and Regulations]
[Pages 60953-60954]
[FR Doc No: 2014-24093]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Parts 2 and 38

[Docket No. RM05-5-022; Order No. 676-H]

Standards for Business Practices and Communication Protocols for
Public Utilities; Correction

AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Final rule; correction.

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SUMMARY: This document contains corrections to the final rule in Docket
No. RM05-5-022 that was published in the Federal Register on Wednesday,
September 24, 2014 (79 FR 56939). The final rule amended the
Commission's regulations to incorporate by reference, with certain
enumerated exceptions, the latest version (Version 003) of the
Standards for Business Practices and Communication Protocols for Public
Utilities adopted by the Wholesale Electric Quadrant (WEQ) of the North
American Energy Standards Board (NAESB) as mandatory enforceable
requirements.

DATES: This correction is effective October 24, 2014. Dates for
implementation are provided in the final rule published September 24,
2014 (79 FR 56939).

FOR FURTHER INFORMATION CONTACT:
Tony Dobbins (Technical Issues), Office of Energy Policy and
Innovation, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426,<PHONE_NUMBER>.
Gary D. Cohen (Legal Issues), Office of the General Counsel, Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Need for Correction

    On September 18, 2014, the Commission issued a ``Final Rule, Order
No. 676-H'' in the above-captioned proceeding. Standards for Business
Practices and Communication Protocols for Public Utilities, 148 FERC ]
61,205 (2014).
    This document serves to correct the citations of five of the
incorporated standards listed in PP 18, 89 and in the regulatory text
to incorporate Standards WEQ-000, WEQ-001, WEQ-002, WEQ-003 and WEQ-
013. We also correct a date for waiver requests in P 86.
    Accordingly, we are correcting the citations given in the final
rule in this proceeding (Docket No. RM05-5-022) published on September
24, 2014, 79 FR 56939.

Corrections to Preamble

    1. On page 56941, third column, and page 56942, first column,
correct WEQ-000, WEQ-001, WEQ-002, and WEQ-003 to read as follows:
     WEQ-000, Abbreviations, Acronyms, and Definition of Terms,
WEQ Version 003, July 31, 2012, as modified by NAESB final actions
ratified on Oct. 4, 2012, Nov. 28, 2012 and Dec. 28, 2012 (with minor
corrections applied Nov. 26, 2013);
     WEQ-001, Open Access Same-Time Information System (OASIS),
OASIS Version 2.0, WEQ Version 003, July 31, 2012, as modified by NAESB
final actions ratified on Dec. 28, 2012 (with minor corrections applied
Nov. 26, 2013) excluding Standards 001-9.5, 001-10.5, 001-14.1.3, 001-
15.1.2 and 001-106.2.5;
     WEQ-002, Open Access Same-Time Information System (OASIS)
Business Practice Standards and Communication Protocols (S&CP), OASIS
Version 2.0, WEQ Version 003, July 31, 2012, as modified by NAESB final
actions ratified on Nov. 28, 2012 and Dec. 28, 2012 (with minor
corrections applied Nov. 26, 2013);
     WEQ-003, Open Access Same-Time Information System (OASIS)
Data Dictionary Business Practice Standards, OASIS Version 2.0, WEQ
Version 003, July 31, 2012, as modified by NAESB final actions ratified
on Dec. 28, 2012 (with minor corrections applied Nov. 26, 2013).
    2. On page 56942, first column, correct WEQ-013 to read as follows:
     WEQ-013, Open Access Same-Time Information System (OASIS)
Implementation Guide, OASIS Version 2.0, WEQ Version 003, July 31,
2012, as modified by NAESB final actions ratified on Dec. 28, 2012
(with minor corrections applied Nov. 26, 2013).
    3. On page 56950, third column, correct ``February 24, 2016'' to
read ``January 24, 2016''.
    4. On page 56951, first column, correct WEQ-000, WEQ-001, WEQ-002,
and WEQ-003 to read as follows:
     WEQ-000, Abbreviations, Acronyms, and Definition of Terms,
WEQ Version 003, July 31, 2012, as modified by NAESB final actions
ratified on Oct. 4, 2012, Nov. 28, 2012 and Dec. 28, 2012 (with minor
corrections applied Nov. 26, 2013);
     WEQ-001, Open Access Same-Time Information System (OASIS),
OASIS Version 2.0, WEQ Version 003, July 31, 2012, as modified by NAESB
final actions ratified on Dec. 28, 2012 (with minor corrections applied
Nov. 26, 2013) excluding Standards 001-9.5, 001-10.5, 001-14.1.3, 001-
15.1.2 and 001-106.2.5;
     WEQ-002, Open Access Same-Time Information System (OASIS)
Business Practice Standards and Communication Protocols (S&CP), OASIS
Version 2.0, WEQ Version 003, July 31, 2012, as modified by NAESB final
actions ratified on Nov. 28, 2012 and Dec. 28, 2012 (with minor
corrections applied Nov. 26, 2013);
     WEQ-003, Open Access Same-Time Information System (OASIS)
Data Dictionary Business Practice Standards, OASIS Version 2.0, WEQ
Version 003, July 31, 2012, as modified by NAESB final actions ratified
on Dec. 28, 2012 (with minor corrections applied Nov. 26, 2013).
    5. On page 56951, second column, correct WEQ-013 to read as
follows:
     WEQ-013, Open Access Same-Time Information System (OASIS)
Implementation Guide, OASIS Version 2.0, WEQ Version 003, July 31,
2012, as modified by NAESB final actions ratified on Dec. 28, 2012
(with minor corrections applied Nov. 26, 2013).

Corrections to Regulatory Text

0
6. On page 56954, third column, and page 56955, first column, correct
Sec.  38.1(b)(1) through (4) and (b)(12), to read as follows:

Sec.  38.1  Incorporation by reference of North American Energy
Standards Board Wholesale Electric Quadrant standards.

* * * * *
    (b) * * *

    (1) WEQ-000, Abbreviations, Acronyms, and Definition of Terms, WEQ
Version 003, July 31, 2012, as modified by NAESB final actions ratified
on Oct. 4, 2012, Nov. 28, 2012 and Dec. 28, 2012 (with minor
corrections applied Nov. 26, 2013);
    (2) WEQ-001, Open Access Same-Time Information System (OASIS),
OASIS Version 2.0, WEQ Version 003, July 31, 2012, as modified by NAESB
final actions ratified on Dec. 28, 2012 (with minor corrections applied
Nov. 26, 2013) excluding Standards 001-9.5, 001-10.5, 001-14.1.3, 001-
15.1.2 and 001-106.2.5;
    (3) WEQ-002, Open Access Same-Time Information System (OASIS)
Business Practice Standards and Communication Protocols (S&CP), OASIS
Version 2.0, WEQ Version 003, July 31, 2012, as modified by NAESB final
actions ratified on Nov. 28, 2012 and Dec. 28, 2012 (with minor
corrections applied Nov. 26, 2013);
    (4) WEQ-003, Open Access Same-Time Information System (OASIS) Data
Dictionary Business Practice Standards, OASIS Version 2.0, WEQ Version
003, July 31, 2012, as modified by NAESB final actions ratified on Dec.
28, 2012 (with minor corrections applied Nov. 26, 2013);
* * * * *
    (12) WEQ-013, Open Access Same-Time Information System (OASIS)
Implementation Guide, OASIS Version 2.0, WEQ Version 003, July 31,
2012, as modified by NAESB final actions ratified on Dec. 28, 2012
(with minor corrections applied Nov. 26, 2013).
* * * * *

    Dated: October 3, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-24093 Filed 10-8-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 34 (Friday, February 18, 2022)]
[Notices]
[Pages 9344-9345]
[FR Doc No: 2022-03583]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP22-46-000]

Northern Natural Gas Company; Notice of Request Under Blanket
Authorization and Establishing Intervention and Protest Deadline

    Take notice that on Northern Natural Gas Company (Northern), 1111
South 103rd Street, Omaha, Nebraska 68124, filed in the above
referenced docket a prior notice pursuant to sections 157.205 and
157.210 of the Commission's regulations under the Natural Gas Act (NGA)
and its blanket certificate issued in Docket No. CP82-401-000
requesting authorization to install and operate the approximately 1.88-
mile, 16-inch-diameter MNM80511 C-line and appurtenances in Martin
County, Minnesota (West Leg 2022 Expansion Project). Northern has
executed eight service agreements for a total of 10,065 dekatherms per
day of incremental winter firm service. Northern estimates the cost of
the project to be $5,887,342, all as more fully set forth in the
request which is on file with the Commission and open to public
inspection.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    Any questions concerning this application should be directed to
Michael T. Loeffler, Senior Director, Certificates and External Affairs
for Northern, 1111 South 103rd Street, Omaha, Nebraska 68124, by
telephone at<PHONE_NUMBER> or by email at [email protected].

Public Participation

    There are three ways to become involved in the Commission's review
of this project: You can file a protest to the project, you can file a
motion to intervene in the proceeding, and you can file comments on the
project. There is no fee or cost for filing protests, motions to
intervene, or comments. The deadline for filing protests, motions to
intervene, and comments is 5:00 p.m. Eastern Time on April 15, 2022.
How to file protests, motions to intervene, and comments is explained
below.

Protests

    Pursuant to section 157.205 of the Commission's regulations under
the NGA,\1\ any person \2\ or the Commission's staff may file a protest
to the request. If no protest is filed within the time allowed or if a
protest is filed and then withdrawn within 30 days after the allowed
time for filing a protest, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request for authorization
will be considered by the Commission.
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    \1\ 18 CFR 157.205.
    \2\ Persons include individuals, organizations, businesses,
municipalities, and other entities. 18 CFR 385.102(d).
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    Protests must comply with the requirements specified in section
157.205(e) of the Commission's regulations,\3\ and must be submitted by
the protest deadline, which is April 15, 2022. A protest may also serve
as a motion to intervene so long as the

protestor states it also seeks to be an intervenor.
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    \3\ 18 CFR 157.205(e).
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Interventions

    Any person has the option to file a motion to intervene in this
proceeding. Only intervenors have the right to request rehearing of
Commission orders issued in this proceeding and to subsequently
challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \4\ and the regulations under the NGA \5\ by the
intervention deadline for the project, which is April 15, 2022. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
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    \4\ 18 CFR 385.214.
    \5\ 18 CFR 157.10.
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    All timely, unopposed motions to intervene are automatically
granted by operation of Rule 214(c)(1). Motions to intervene that are
filed after the intervention deadline are untimely and may be denied.
Any late-filed motion to intervene must show good cause for being late
and must explain why the time limitation should be waived and provide
justification by reference to factors set forth in Rule 214(d) of the
Commission's Rules and Regulations. A person obtaining party status
will be placed on the service list maintained by the Secretary of the
Commission and will receive copies (paper or electronic) of all
documents filed by the applicant and by all other parties.

Comments

    Any person wishing to comment on the project may do so. The
Commission considers all comments received about the project in
determining the appropriate action to be taken. To ensure that your
comments are timely and properly recorded, please submit your comments
on or before April 15, 2022. The filing of a comment alone will not
serve to make the filer a party to the proceeding. To become a party,
you must intervene in the proceeding.

How To File Protests, Interventions, and Comments

    There are two ways to submit protests, motions to intervene, and
comments. In both instances, please reference the Project docket number
CP22-46-000 in your submission. The Commission encourages electronic
filing of submissions.
    (1) You may file your protest, motion to intervene, and comments by
using the Commission's eFiling feature, which is located on the
Commission's website (www.ferc.gov) under the link to Documents and
Filings. New eFiling users must first create an account by clicking on
``eRegister.'' You will be asked to select the type of filing you are
making; first select General'' and then select ``Protest'',
``Intervention'', or ``Comment on a Filing.''
    The Commission's eFiling staff are available to assist you at (202)
502-8258 or [email protected]
    (2) You can file a paper copy of your submission. Your submission
must reference the Project docket number CP22-46-000.
    To mail via USPS, use the following address: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426.
    To mail via any other courier, use the following address: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852.
    Protests and motions to intervene must be served on the applicant
either by mail or email (with a link to the document) at:
[email protected], 1111 South 103rd Street, Omaha, Nebraska
68124. Any subsequent submissions by an intervenor must be served on
the applicant and all other parties to the proceeding. Contact
information for parties can be downloaded from the service list at the
eService link on FERC Online.

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be available from the Commission's Office of External Affairs, at
(866) 208-FERC, or on the FERC website at www.ferc.gov using the
``eLibrary'' link as described above. 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. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.

    Dated: February 14, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-03583 Filed 2-17-22; 8:45 am]
BILLING CODE 6717-01-P


March 31, 2004 Margaret Hoffman Executive Director Texas Commission on Environmental Quality P. O. Box 13087   MC 109 Austin, Texas 78711 3087 Mayor Richard Greene Regional Administrator U. S. EPA Region 6 1445 Ross Avenue Suite 1200 Dallas, Texas 75202 Re: Clean Air Action Plan for Northeast Texas ( 1332.05; 1.2)

Dear Ms. Hoffman and Mayor Greene:

On behalf of Northeast Texas Air Care ( NETAC) I am pleased to submit to you the Clean Air Action Plan for Northeast Texas as required by our Early Action Compact. The preliminary Clean Air Action Plan was submitted to you on January 31, 2004. This final Clean Air Action Plan reflects modifications based upon written comments received from both the TCEQ and EPA and from meetings of the NETAC Technical Advisory Committee on March 19 and March 26 and the NETAC Policy Committee on March 26, 2004. The final Clean Air Action Plan has been approved by both the NETAC Technical Advisory committee and the NETAC Policy Committee.

NETAC appreciates the ongoing cooperation provided by each of your agencies and looks forward to working with you in incorporating the Clean Air Action Plan into the state implementation plan for our area.

Please let me know if we can provide any additional information or assistance.

Sincerely,

Jim Mathews 2 Cc: Judge Bill Stoudt Mayor Joey Seeber Gerry Wolfe James Red Michael Morton Samuel May Mark Sweeney


[Federal Register Volume 80, Number 248 (Monday, December 28, 2015)]
[Notices]
[Pages 80774-80775]
[FR Doc No: 2015-32475]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-E-1692 and FDA-2013-E-1691]

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

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 KADCYLA 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 biological product.

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
February 26, 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 June 27,
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 Nos.
FDA-2013-E-1692 and FDA-2013-E-1691 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; KADCYLA''.
    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 biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological 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
biological 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 biologic product KADCYLA
(ado-trastuzumab emtansine). KADCYLA is indicated as a single agent,
for the treatment of patients with HER2-positive metastatic breast
cancer who previously received trastuzumab and a taxane, separately or
in combination. Subsequent to this approval, the USPTO received patent
term restoration applications for KADCYLA (U.S. Patent Nos. 7,097,840
and 8,337,856) from Genentech, Inc., and the USPTO requested FDA's
assistance in determining these patents' eligibility for patent term
restoration. In a letter dated May 23, 2014, FDA advised the USPTO that
this human biological product had undergone a regulatory review period
and that the approval of KADCYLA 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
KADCYLA is 2,594 days. Of this time, 2,414 days occurred during the
testing phase of the regulatory review period, while 180 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 (21 U.S.C. 355(i)) became effective: January 18,
2006. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on January
18, 2006.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): August 27, 2012. The applicant claims
August 24, 2012, as the date the biologics license application (BLA)
for KADCYLA (BLA 125427) was initially submitted. However, FDA records
indicate that BLA 125427 was submitted on August 27, 2012.
    3. The date the application was approved: February 22, 2013. FDA
has verified the applicant's claim that BLA 125427 was approved on
February 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,
this applicant seeks 1,277 or 60 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: December 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32475 Filed 12-24-15; 8:45 am]
 BILLING CODE 4164-01-P