[Federal Register Volume 81, Number 237 (Friday, December 9, 2016)]
[Notices]
[Pages 89109-89110]
[FR Doc No: 2016-29589]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-4096]

Final Assessment of the Program for Enhanced Review Transparency
and Communication; Public Meeting and Establishment of Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting and establishment of docket, request
for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
establishment of a docket to obtain comments on the final assessment of
the Program for Enhanced Review Transparency and Communication for New
Molecular Entity (NME) New Drug Applications (NDAs) and Original
Biologics License Applications (BLAs) (the Program). FDA is also
announcing a public meeting where the final assessment will be
discussed and public stakeholders may present their views on the
Program to date. The Program is part of the FDA performance commitments
under the fifth authorization of the Prescription Drug User Fee Act
(PDUFA), which enables FDA to collect user fees for the review of human
drug and biologics applications for fiscal years (FYs) 2013-2017. The
Program is described in detail in section II.B of the document entitled
``PDUFA Reauthorization Performance Goals and Procedures Fiscal Years
2013 through 2017.'' The Program is being evaluated by an independent
contractor with expertise in assessing the quality and efficiency of
pharmaceutical and biopharmaceutical development and regulatory review
programs. As part of FDA's performance commitments, FDA is providing a
period for public comment on the final assessment of the Program.

DATES: The public meeting will be held on March 27, 2017, from 10 a.m.
to 1 p.m. Public comments will be accepted through April 3, 2017. See
the ADDRESSES section for information about submitting comments to the
public docket. See the SUPPLEMENTARY INFORMATION section for
registration date and information.

ADDRESSES: The public meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 2, Conference Room 2047 E, Silver
Spring, MD 20993-0002. Entrance for the public meeting participants
(non-FDA employees) is through Building 1 where routine security check
procedures will be performed. For more information on parking and
security procedures, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    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-2016-N-4096. 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: Graham Thompson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993, 301-796-
5003, FAX:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The timely review of the safety and efficacy of new drugs and
biologics is central to FDA's mission to protect and promote the public
health. Since the implementation of PDUFA I in 1993, FDA has used PDUFA
resources to improve the timeliness and predictability of new drug
review while maintaining FDA's rigorous standards for drug quality,
safety and efficacy. With the availability of these additional fee
resources, FDA was able to agree to certain review performance goals,
including a complete review of NDAs and BLAs and taking regulatory
action within specified timeframes. The managed review processes put in
place to accomplish this, and the process enhancements including
investments in modernized post-market safety and regulatory science
over subsequent reauthorizations of PDUFA, have revolutionized the new
drug review process, helping to bring critical products to market for
patients. The PDUFA program has been reauthorized every 5 years, with
the most recent and fifth authorization occurring in 2012. The PDUFA V
Performance Goals and Procedures for Fiscal Years 2013 through 2017 can
be accessed at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf.
    PDUFA V introduced a new review program for NME NDAs and original
BLAs to enhance review transparency and communication between FDA and
applicants on these complex applications. FDA committed to engaging an
independent contractor to evaluate the Program to understand the
Program's effect on the review of these applications. The interim
assessment was published March 31, 2015, and can be accessed at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM436448.pdf. The PDUFA V performance commitments also call for a
final assessment of the Program to be published by December 31, 2016,
for public comment. The final assessment can be accessed at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm327030.htm.
A public meeting will be held on March 27, 2017, where the final
assessment will be discussed and public stakeholders may present their
views on the Program.

II. PDUFA V NME NDA and Original BLA Review Program

    FDA's performance goals for review of priority and standard new
drug applications, 6 and 10 months respectively, have been in place
since the late 1990s. Since that time, additional requirements in the
review process and scientific advances in product development have made
those goals increasingly challenging to meet, particularly for more
complex applications like NME NDAs and original BLAs. FDA further
recognizes that increasing communication and transparency between the
Agency and applicants during FDA's review has the potential to increase
efficiency in the review process.
    To promote greater transparency and improve communication between
the FDA review team and the applicant, FDA implemented a new review
model for NME NDAs and original BLAs in PDUFA V. The Program provides
opportunities for increased communication between FDA and applicants,
including mid-cycle and late-cycle meetings. To accommodate the
increased interaction during regulatory review and to address the need
for additional time to review these complex applications, FDA's review
clock begins after the 60-day administrative filing review period for
applications reviewed under the Program.
    The goal of the Program is to improve the efficiency and
effectiveness of the first-cycle review process by increasing
communications during application review. This will provide sponsors
with the opportunity to clarify previous submissions and provide
additional data and analyses that are readily available, potentially
avoiding the need for an additional review cycle when concerns can be
promptly resolved without compromising FDA's standards for approval.

III. Meeting Attendance and Participation

    FDA is holding the public meeting on March 27, 2017, from 10 a.m.
to 1 p.m. If you wish to attend this public meeting, visit: https://nmemeeting.eventbrite.com. Please register by March 20, 2017. If you
are unable to attend the public meeting in person, you can register to
view a live Webcast of the public meeting. You will be asked to
indicate in your registration if you plan to attend in person or via
the Webcast. Seating will be limited, so early registration is
recommended. Registration is free and will be on a first-come, first-
served basis. However, FDA may limit the number of participants from
each organization based on space limitations. Registrants will receive
confirmation once they have been accepted. Onsite registration on the
day of the public meeting will not be possible. If you need special
accommodations because of a disability, please contact Graham Thompson
(see FOR FURTHER INFORMATION CONTACT) at least 7 days before the public
meeting.
    FDA will hold an open public comment period to give the public an
opportunity to comment during the public meeting. Registration for open
public comment will occur at the registration desk on the day of the
public meeting on a first-come, first-served basis.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets
Management (see ADDRESSES). A link to the transcript will also be
available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm501389.htm.

    Dated: December 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29589 Filed 12-8-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 7, 2009 (Volume 74, Number 128)]
[Notices]
[Page 32142-32143]
[DOCID:fr07jy09-41]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings No. 1

June 22, 2009.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP09-770-000.
    Applicants: Western Gas Interstate Company.
    Description: Western Gas Interstate Company submits Fifth Revised
Sheet 247 to FERC Gas Tariff to be effective 8/1/09.
    Filed Date: 06/18/2009.
    Accession Number: 20090619-0133.
    Comment Date: 5 p.m. Eastern Time on Tuesday, June 30, 2009.

    Docket Numbers: RP09-771-000.
    Applicants: East Tennessee Natural Gas, LLC.
    Description: East Tennessee Natural Gas, LLC submits Fourth Revised
Sheet No 301 et al. to FERC Gas Tariff, Third Revised Volume No. 1, to
be effective 7/1/09.
    Filed Date: 06/19/2009.
    Accession Number: 20090622-0084.
    Comment Date: 5 p.m. Eastern Time on Wednesday, July 01, 2009.

    Docket Numbers: RP09-772-000.
    Applicants: MoGas Pipeline LLC.
    Description: MoGas Pipeline LLC submits First Revised Sheet No. 84
et al. to its FERC Gas Tariff, First Revised Volume No. 1 pursuant to
order 587-T, to be effective 8/1/09.
    Filed Date: 06/19/2009.
    Accession Number: 20090622-0083.
    Comment Date: 5 p.m. Eastern Time on Wednesday, July 01, 2009.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or

call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-15867 Filed 7-6-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 164 (Monday, August 24, 2020)]
[Notices]
[Pages 52111-52112]
[FR Doc No: 2020-18512]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-2669-000]

Neosho Ridge Wind, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Neosho Ridge Wind, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is September 8, 2020.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    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 the Federal
Energy Regulatory Commission at<EMAIL_ADDRESS>or call
toll-free,<PHONE_NUMBER> or TYY,<PHONE_NUMBER>.

    Dated: August 17, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-18512 Filed 8-21-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 247 (Wednesday, December 27, 2017)]
[Notices]
[Pages 61293-61294]
[FR Doc No: 2017-27951]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9972-41-ORD]

Human Studies Review Board; Notification of Public Meetings

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA), Office of the
Science

Advisor announces two separate public meetings of the Human Studies
Review Board (HSRB) to advise the Agency on the ethical and scientific
review of research involving human subjects.

DATES: A virtual public meeting will be held on Tuesday, January 23,
2018 and Wednesday, January 24, 2018, from 1:00 p.m. to approximately
5:30 p.m. Eastern Time on both dates. A separate, subsequent
teleconference meeting is planned for Thursday, March 15, 2018, from
2:00 p.m. to approximately 3:30 p.m. Eastern Time for the HSRB to
finalize its Final Report of the January 23 and 24, 2018 meeting and
review other possible topics.

ADDRESSES: Both of these meetings will be conducted entirely by
telephone and on the internet using Adobe Connect. For detailed access
information visit the HSRB website: http://www2.epa.gov/osa/human-studies-review-board.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes to
receive further information should contact the HSRB Designated Federal
Official (DFO), Thomas O'Farrell on telephone number<PHONE_NUMBER>;
fax number:<PHONE_NUMBER>; email address: [email protected]; or
mailing address: Environmental Protection Agency, Office of the Science
Advisor, Mail Code 8105R, 1200 Pennsylvania Avenue NW, Washington, DC
20460.

SUPPLEMENTARY INFORMATION:
    Meeting access: These meetings will be open to the public. The full
Agenda and meeting materials will be available at the HSRB website:
http://www2.epa.gov/osa/human-studies-review-board. For questions on
document availability, or if you do not have access to the internet,
consult with the DFO, Thomas O'Farrell, listed under FOR FURTHER
INFORMATION CONTACT.
    Special accommodations. For information on access or services for
individuals with disabilities, or to request accommodation of a
disability, please contact the DFO listed under FOR FURTHER INFORMATION
CONTACT at least 10 days prior to the meeting to give EPA as much time
as possible to process your request.

How may I participate in this meeting?

    The HSRB encourages the public's input. You may participate in
these meetings by following the instructions in this section.
    1. Oral comments. To pre-register to make oral comments, please
contact the DFO, Thomas O'Farrell, listed under FOR FURTHER INFORMATION
CONTACT. Requests to present oral comments during either meeting will
be accepted up to Noon Eastern Time on Tuesday, January 16, 2018, for
the January 23 and 24, 2018 meeting and up to Noon Eastern Time on
Tuesday, March 8, 2018 for the March 15, 2018 meeting. To the extent
that time permits, interested persons who have not pre-registered may
be permitted by the HSRB Chair to present oral comments during either
meeting at the designated time on the agenda. Oral comments before the
HSRB are generally limited to five minutes per individual or
organization. If additional time is available, further public comments
may be possible.
    2. Written comments. Submit your written comments prior to the
meetings. For the Board to have the best opportunity to review and
consider your comments as it deliberates, you should submit your
comments by Noon Eastern Time on Tuesday, January 16, 2018, for the
January 23 and 24, 2018 meeting and up to Noon Eastern Time on Tuesday,
March 8, 2018 for the March 15, 2018 meeting. If you submit comments
after these dates, those comments will be provided to the HSRB members,
but you should recognize that the HSRB members may not have adequate
time to consider your comments prior to their discussion. You should
submit your comments to the DFO, Thomas O'Farrell listed under FOR
FURTHER INFORMATION CONTACT. There is no limit on the length of written
comments for consideration by the HSRB.

Background

    The HSRB is a Federal advisory committee operating in accordance
with the Federal Advisory Committee Act 5 U.S.C. App. 2 9. The HSRB
provides advice, information, and recommendations on issues related to
scientific and ethical aspects of third-party human subjects research
that are submitted to the Office of Pesticide Programs (OPP) to be used
for regulatory purposes.
    Topic for discussion. On January 23 and 24, 2018, EPA's Human
Studies Review Board will consider two topics: (1) A completed study
and monograph report titled ``Agricultural Handler Exposure during Open
Pour Loading of Granules'' by the Agricultural Handlers Exposure Task
Force, and (2) a study protocol titled ``Laboratory Evaluation of Bite
Protection From Repellent-Impregnated Fabrics'' by Pinebelt Industries.
    The Agenda and meeting materials for this topic will be available
in advance of the meeting at http://www2.epa.gov/osa/human-studies-review-board.
    On March 15, 2018, the HSRB will review and finalize their draft
Final Report from the January 23 and 24, 2018 meeting, in addition to
other topics that may come before the Board. The HSRB may also discuss
planning for future HSRB meetings. The agenda and the draft report will
be available prior to the meeting at http://www2.epa.gov/osa/human-studies-review-board.
    Meeting minutes and final reports. Minutes of these meetings,
summarizing the matters discussed and recommendations made by the HSRB,
will be released within 90 calendar days of the meeting. These minutes
will be available at http://www2.epa.gov/osa/human-studies-review-board. In addition, information regarding the HSRB's Final Report, will
be found at http://www2.epa.gov/osa/human-studies-review-board or from
Thomas O'Farrell listed under FOR FURTHER INFORMATION CONTACT.

    Dated: December 14, 2017.
Jennifer Orme-Zavaleta,
EPA Science Advisor.
[FR Doc. 2017-27951 Filed 12-26-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 104 (Tuesday, May 31, 2011)]
[Notices]
[Page 31349]
[FR Doc No: 2011-13388]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2010-E-0328, FDA-2010-E-0324, and FDA-2010-E-0325]

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

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 ACTEMRA and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of applications to the Director of Patents
and Trademarks, Department of Commerce, for the extension of patents
which claim that human biological product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 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. 6222, 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 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 Patents and
Trademarks 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 approved for marketing the human biologic product ACTEMRA
(tocilizumab). ACTEMRA is indicated for treatment of rheumatoid
arthritis. Subsequent to this approval, the Patent and Trademark Office
received patent term restoration applications for ACTEMRA (U.S. Patent
Nos. 5,670,373 and 5,795,965), filed by Chugai Seiyaku Kabushiki
Kaisha, and for U.S. Patent No. 5,888,510, filed by Chugai Seiyaku
Kabushiki Kaisha and Tadamitsu Kishimoto for ACTEMRA. The Patent and
Trademark Office requested FDA's assistance in determining these
patents' eligibilities for patent term restoration. In a letter dated
September 30, 2010, FDA advised the Patent and Trademark Office that
this human biological product had undergone a regulatory review period
and that the approval of ACTEMRA represented the first permitted
commercial marketing or use of the product. Thereafter, the Patent and
Trademark Office requested that FDA determine the product's regulatory
review period.
    FDA has determined that the applicable regulatory review period for
ACTEMRA is 1,893 days. Of this time, 1,111 days occurred during the
testing phase of the regulatory review period, while 782 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: November 4,
2004. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on November
4, 2004.
    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): November 19, 2007. FDA has verified the
applicant's claim that the biologics license application (BLA) for
ACTEMRA (BLA 125276/0) was initially submitted on November 19, 2007.
    3. The date the application was approved: January 8, 2010. FDA has
verified the applicant's claim that BLA 125276/0 was approved on
January 8, 2010.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 1,338 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 August 1, 2011. 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, 2011. 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 petitions.
It is only necessary to send one set of comments. It is no longer
necessary to send three copies of mailed comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with the docket number found in brackets in
the heading of this document.
    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: April 15, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2011-13388 Filed 5-27-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 195 (Tuesday, October 8, 2019)]
[Notices]
[Pages 53717-53718]
[FR Doc No: 2019-21969]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD19-15-000]

Notice Inviting Post-Technical Conference Comments: Managing
Transmission Line Ratings

    On September 10 and September 11, 2019, Federal Energy Regulatory
Commission (Commission) staff convened a technical conference to
discuss what transmission line ratings and related practices might
constitute best practices, and what, if any, Commission action in these
areas might be appropriate.
    All interested persons are invited to file initial and reply post-
technical workshop comments on any or all of the questions listed in
the attachment to this Notice. Commenters may also respond to the
questions outlined in the September 4, 2019 supplemental notice of
technical conference.\1\ Commenters need not answer all of the
questions. Commenters should organize responses consistent with the
structure of the attached questions. Commenters are also invited to
reference material previously filed in this docket, including technical
workshop transcripts, but are encouraged to avoid repetition or
replication of previous material. Initial comments must be submitted on
or before 30 days from the date of this notice. Reply comments must be
submitted on or before 15 days after the deadline to submit initial
comments.
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    \1\ Available at https://www.ferc.gov/CalendarFiles/20190904173327-AD19-15-000supplTC.pdf.
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    For more information about this Notice, please contact:

Dillon Kolkmann (Technical Information), Office of Energy Policy and
Information, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426,<PHONE_NUMBER><EMAIL_ADDRESS>Kevin Ryan (Legal Information), Office of the General Counsel, Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426,<PHONE_NUMBER><EMAIL_ADDRESS>
    Dated: October 2, 2019.
Kimberly D. Bose,
Secretary.

Post-Technical Conference Questions for Comment

    Commenters may respond to the questions outlined in the September
4, 2019 supplemental notice of technical conference.\2\ In addition,
based on discussions during the Managing Transmission Line Ratings
technical conference, Staff developed the following questions to better
understand whether Commission action might be appropriate. To guide
discussion, ambient-adjusted ratings (AAR) are defined as ratings that
are adjusted daily, hourly, or more frequently and account for ambient
air temperatures. Dynamic line ratings (DLRs) are defined as line
ratings that are adjusted hourly or more frequently and account for
local weather conditions (e.g., ambient temperature, wind,
precipitation, solar irradiation) and/or account for conductor
parameters (conductor temperature, tension, sag, clearance), typically
as measured by local sensors.
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    \2\ Available at https://www.ferc.gov/CalendarFiles/20190904173327-AD19-15-000supplTC.pdf.
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1. Discussion of a Possible Requirement for Transmission Owners To
Implement AARs

    a. Should transmission owners be required to implement AARs? If so,
to which lines would the requirement apply? What criteria (e.g.,
congestion, facility age) and process would be used to determine to
which lines the requirement would apply? What would be the benefits or
drawbacks to such a requirement?
    b. If AARs are required, should they be required for modeling in
both the day-ahead and real-time markets?
    c. What type of forecasting (e.g., how frequently, how granularly,
and of what variables) is needed to incorporate AARs and DLRs into both
real-time and day-ahead markets? If forecasts submitted in day-ahead
markets differ from the real-time rating, how should

the difference be treated by the transmission system operator? Who is
liable if forecasted ratings are wrong?
    d. Aside from ambient air temperature, are there other ambient
conditions that can be forecasted or calculated without need for local
sensors that should be considered in AARs? Should maximum possible
solar irradiance intensity (conservatively calculated or forecast
assuming no cloud cover) be included in calculation of any required
AARs? Are there any instances where wind can be conservatively forecast
without local sensors, such that wind should be considered in AARs for
such lines?

2. Reducing Barriers to DLRs

    a. Can RTOs/ISOs currently accept and use a DLR data stream from a
transmission owner in both real-time and day-ahead markets? Can
transmission owners outside of RTO/ISOs currently automatically
implement a DLR data stream in operations? Are there limits on what
type and amount of data can be received and incorporated into dispatch?
Would a transmission owner's or RTO/ISO's implementation of AARs be
sufficient to also implement DLRs? If not, what additional changes
would be necessary and how feasible are such changes?
    b. Would a requirement for transmission owners or other entities
(e.g., RTOs/ISOs) to study the cost effectiveness of DLRs on their most
congested lines be appropriate? If so, what metrics for congestion
(e.g., congestion cost, hours of congestion) would be appropriate for
determining the most congested lines?

3. AARs/DLRs in Available Transmission Capacity (ATC) Calculations

    a. In the non-RTO/ISO regions, a transmission owner's use of AARs
could affect ATC for transmission customers. ATC could also be affected
at RTO/ISO seams. Given the importance of ATC calculations, should
AARs/DLRs be incorporated into the determination of ATC? Specifically:
    i. At what times in advance of transmission reservation and/or
scheduling deadlines should ATC made possible through AARs/DLRs be made
available to point-to-point and network customers?
    ii. Should AARs/DLRs affect when network customers (and the
transmission provider's own resources) are subjected to redispatch,
load shedding, and/or curtailments under sections 30.5 and 33 of the
pro forma open access transmission tariff (OATT)?
    iii. Would any revisions be needed to section 30.5, section 33, or
Attachment C of the pro forma OATT to accommodate a requirement to
implement AARs or voluntary implementation of DLRs? Are there any other
sections of the pro forma OATT that would be relevant to or affected by
AAR/DLR implementation?

4. Discussion of Transparency of Transmission Line Rating Methodologies

    Currently, some transmission line rating methodology information is
made available through certain transmission expansion processes or
voluntarily on certain transmission owners' websites. Transmission line
rating methodologies are also sometimes provided in annual FERC Form
715 part 4 filings. Lastly, some RTO/ISOs post actual facility ratings
on their open access same-time information system (OASIS) pages.
However, there appear to be concerns about the inaccessibility of
transmission line rating methodologies and resulting ratings.
    a. Should transmission owners' transmission line rating methodology
be made more transparent? If so, how and how much additional
transparency? Should underlying assumptions be made available? Should
transmission line ratings be made more transparent? If so, how? For
both transmission line rating methodologies and resulting ratings, who
should have access to such information?
    b. Should transmission owners or other entities (e.g., NERC
regional entities or RTOs/ISOs) be required to develop a database to
document each transmission facility's most limiting element? Should
limiting elements consider first and second contingency operating
conditions? Please describe the burden associated with reporting and
maintaining such a database. Who should have access to such a database
and what levels of confidentiality protections would need to exist for
such a limiting elements database?
    c. If a transmission system operator contacts a transmission owner
to request an ad hoc increase in transmission line ratings above static
or seasonal ratings, should information about the request be publicly
posted? If so, where, when, and how often should such information be
posted?

5. Review and Audit Procedures for Transmission Line Rating Practices

    a. Are the current review and audit procedures for transmission
line ratings sufficient to ensure that such transmission line ratings
are consistent with the methodology set forth by the transmission owner
under FAC-008?
    b. What entities currently review or audit transmission line rating
methodologies, assumptions, and values? What standards or criteria do
these entities use in their reviews?
    c. What changes, if any, should be made to the review and audit
procedures for transmission line ratings?
    d. What, if any, changes to information and document retention with
respect to transmission line ratings might be needed?
    e. Where should any non-reliability criteria (e.g., economic) for
transmission line ratings be established (e.g., regulations, tariff,
policy statement)? What should these criteria be, and how would the
Commission ensure that such criteria for transmission line ratings are
consistent with reliability criteria?
    f. In implementing DLR, is there any data verification necessary
from devices that measure DLR by the transmission system operators or
transmission owners? If so, what data and why?

6. NERC Reliability Standards

    a. Are there security concerns associated with implementing AARs
and DLRs with respect to communicating line ratings and field
measurements?

[FR Doc. 2019-21969 Filed 10-7-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 79 (Friday, April 24, 2015)]
[Proposed Rules]
[Pages 22964-22965]
[FR Doc No: 2015-09624]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 192

[EPA-HQ-OAR-2012-0788; FRL-9926-76-OAR]
RIN 2060-AP43

Health and Environmental Protection Standards for Uranium and
Thorium Mill Tailings; Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The U.S. Environmental Protection Agency is announcing an
extension of the public comment period for the Notice of Proposed
Rulemaking (NPRM) requesting public comment and information on
revisions to the EPA's ``Health and Environmental Protection Standards
for Uranium and Thorium Mill Tailings.'' The EPA published the NPRM on
January 26, 2015 in the Federal Register (80 FR 4156), which included a
request for comments on or before April 27, 2015. The purpose of this
action is to extend this comment period an additional 30 days.

DATES: Written comments must be received on or before May 27, 2015.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2012-0788, by one of the following methods:
     http://www.regulations.gov: Follow the online instructions
for submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: U.S. Postal Service, send comments to: Air and
Radiation Docket, EPA Docket Center, Docket ID No. EPA-HQ-OAR-2012-
0788, 1200 Pennsylvania Ave. NW., Washington, DC 20460. Please include
a total of two copies.
    Hand Delivery: In person or by courier, deliver comments to: EPA
Docket Center, Docket ID No. EPA-HQ-OAR-2012-0788, EPA West, Room 3334,
1301 Constitution Avenue NW., Washington, DC 20004. Such deliveries are
only accepted during the Docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information. Please include a total of two copies.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2012-0788. The Agency's policy is that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to EPA without
going through http://www.regulations.gov, your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about the EPA's
public docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
for which disclosure is restricted by statute. Certain other material,
such as copyrighted material, will be publicly available only in hard
copy. Publicly available docket materials are available either
electronically in http://www.regulations.gov or in hard copy at the EPA
Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the Docket Center is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Ingrid Rosencrantz, EPA Office of
Radiation and Indoor Air; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

A. What should I consider as I prepare my comments for the EPA?

    1. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number, subject heading,
Federal Register date and page number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow it to be
reproduced.
     Illustrate your concerns with specific examples and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

B. How can I get copies of this document, the proposed rule, and other
related information?

    The EPA has established a docket for this action under Docket ID
No. EPA-HQ-OAR-2012-0788. The EPA has also developed a Web site for the
NPRM at: http://www.epa.gov/radiation/tenorm/40CFR192.html. Please
refer to the original Federal Register document on the NPRM for
detailed information on accessing information related to the document.
    In response to requests for an extension, we are extending the
public comment period for this NPRM through May 27, 2015. This
extension will provide the public additional time to provide comment on
updating this standard.

    Dated: April 17, 2015.
Janet G. McCabe,
Acting Assistant Administrator, Office of Air and Radiation.
[FR Doc. 2015-09624 Filed 4-23-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 184 (Friday, September 21, 2012)]
[Notices]
[Pages 58560-58562]
[FR Doc No: 2012-23349]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2012-0003; Internal Agency Docket No. FEMA-B-1270]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report, once effective, will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings.

DATES: Comments are to be submitted on or before December 20, 2012.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location and the respective Community Map Repository address listed in
the tables below. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at www.msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1270, to
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance
and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and also are used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at
www.fema.gov/pdf/media/factsheets/2010/srp_fs.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location and
the respective Community Map Repository address listed in the tables.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
www.msc.fema.gov for comparison.

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                                             Community map repository
               Community                             address
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             Tipton County, Indiana, and Incorporated Areas
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Maps Available for Inspection Online at: http://www.in.gov/dnr/water/6497.htm
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City of Tipton.........................  Tipton County Courthouse, 101
                                          East Jefferson Street, Tipton,
                                          IN 46072.
Town of Sharpsville....................  Town Hall, 124 South Main
                                          Street, Sharpsville, IN 46068.
Town of Windfall.......................  Town Hall, 210 South
                                          Independence Street, Windfall,
                                          IN 46076.
Unincorporated Areas of Tipton County..  Tipton County Courthouse, 101
                                          East Jefferson Street, Tipton,
                                          IN 46072.
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              White County, Indiana, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.in.gov/dnr/water/6648.htm
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City of Monticello.....................  White County Government Center,
                                          110 North Main Street,
                                          Monticello, IN 47960.
Town of Brookston......................  White County Government Center,
                                          110 North Main Street,
                                          Monticello, IN 47960.
Town of Monon..........................  White County Government Center,
                                          110 North Main Street,
                                          Monticello, IN 47960.
Unincorporated Areas of White County...  White County Government Center,
                                          110 North Main Street,
                                          Monticello, IN 47960.
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              Miami County, Kansas, and Incorporated Areas
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Maps Available for Inspection Online at: www.ksda.gov/structures/?cid=1985
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City of Fontana........................  City Hall, 204 East North
                                          Street, Fontana, KS 66026.
City of Louisburg......................  City Hall, 5 South Peoria
                                          Street, Suite 105, Louisburg,
                                          KS 66053.
City of Osawatomie.....................  City Hall, 439 Main Street,
                                          Osawatomie, KS 66064.
City of Paola..........................  City Hall, 19 East Peoria
                                          Street, Paola, KS 66071.
Unincorporated Areas of Miami County...  Miami County Administration
                                          Building, 201 South Pearl
                                          Street, Suite 201, Paola, KS
                                          66071.
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            Hancock County, Kentucky, and Incorporated Areas
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Maps Available for Inspection Online at: http://www.bakeraecom.com/index.php/kentucky/hancock/
------------------------------------------------------------------------
City of Hawesville.....................  City Hall, 395 Main Street,
                                          Hawesville, KY 42348.
City of Lewisport......................  City Hall, 405 Second Street,
                                          Lewisport, KY 42351.

Unincorporated Areas of Hancock County.  Hancock County Administration
                                          Building, 225 Main Cross
                                          Street, Hawesville, KY 42348.
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               Wayne County, Michigan (All Jurisdictions)
------------------------------------------------------------------------
Maps Available for Inspection Online at: http://www.starr-team.com/starr/RegionalWorkspaces/RegionV/RomulusPMR/SitePages/Home.aspx
------------------------------------------------------------------------
City of Dearborn Heights...............  6045 Fenton Street, Dearborn
                                          Heights, MI 48127.
City of Romulus........................  11111 Wayne Road, Romulus, MI
                                          48174.
City of Taylor.........................  25605 Northline Road, Taylor,
                                          MI 48180.
City of Westland.......................  36601 Ford Road, Westland, MI
                                          48185.
Township of Huron......................  22950 Huron River Drive, New
                                          Boston, MI 48164.
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              Delaware County, Ohio, and Incorporated Areas
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Maps Available for Inspection Online at: http://www.starr-team.com/starr/RegionalWorkspaces/RegionV/DelawareCoOH/SitePages/Home.aspx
------------------------------------------------------------------------
City of Delaware.......................  City Hall, Planning and Zoning
                                          Department, 1 South Sandusky
                                          Street, 2nd Floor, Delaware,
                                          OH 43015.
Unincorporated Areas of Delaware County  Code Compliance Building, 50
                                          Channing Street, South Wing,
                                          Delaware, OH 43015.
------------------------------------------------------------------------
           Mason County, West Virginia, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: www.rampp-team.com/wv.htm
------------------------------------------------------------------------
City of Point Pleasant.................  City Hall, 400 Viand Street,
                                          Point Pleasant, WV 25550.
Town of Hartford.......................  Town Hall, 133 2nd Street,
                                          Hartford, WV 25247.
Town of Henderson......................  Town Hall, 1 Railroad Street,
                                          Henderson, WV 25106.
Town of Leon...........................  Town Hall, 136 Main Street,
                                          Leon, WV 25123.
Town of Mason..........................  Office of the Mayor, 656 2nd
                                          Street, Mason, WV 25260.
Town of New Haven......................  City Hall, 218 5th Street, New
                                          Haven, WV 25265.
Unincorporated Areas of Mason County...  Mason County Courthouse, 200
                                          6th Street, Point Pleasant, WV
                                          25550.
------------------------------------------------------------------------
           Wood County, West Virginia, and Incorporated Areas
------------------------------------------------------------------------
Maps Available for Inspection Online at: www.rampp-team.com/wv.htm
------------------------------------------------------------------------
City of Parkersburg....................  City Hall, 1 Government Square,
                                          Parkersburg, WV 26101.
City of Vienna.........................  City Hall, 609 29th Street,
                                          Vienna, WV 26105.
City of Williamstown...................  City Hall, 100 West 5th Street,
                                          Williamstown, WV 26187.
Town of North Hills....................  North Hills Municipal Court,
                                          176 North Hills Drive,
                                          Parkersburg, WV 26101.
Unincorporated Areas of Wood County....  Wood County Courthouse, 1 Court
                                          Square, Parkersburg, WV 26101.
------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: September 3, 2012.
Sandra K. Knight,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2012-23349 Filed 9-20-12; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Notices]
[Pages 43306-43308]
[FR Doc No: 2016-15717]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78180; File No. SR-BatsBYX-2016-15]

Self-Regulatory Organizations; Bats BYX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to Rule
11.24, Retail Price Improvement Program, To Extend the Pilot Period

June 28, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on June 23, 2016, Bats BYX Exchange, Inc. (the ``Exchange'' or
``BYX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the Exchange. The Exchange
has designated this proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6)(iii) thereunder,\4\ which renders it effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6)(iii).
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange filed a proposal to extend the pilot period for the
Exchange's Retail Price Improvement (``RPI'') Program (the
``Program''), which is currently set to expire on July 31, 2016, for 12
months, to expire on July 31, 2017.
    The text of the proposed rule change is available at the Exchange's
Web site at www.batstrading.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant parts of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    In November 2012, the Commission approved the RPI Program on a
pilot basis.\5\ The Program is designed to attract retail order flow to
the Exchange, and allows such order flow to receive potential price
improvement. The Program is currently limited to trades occurring at
prices equal to or greater than $1.00 per share. Under the Program, all
Exchange Users \6\ are permitted to provide potential price improvement
for Retail Orders \7\ in the form of non-displayed interest that is
better than the national best bid that is a Protected Quotation
(``Protected NBB'') or the national best offer that is a Protected
Quotation (``Protected NBO'', and together with the Protected NBB, the
``Protected NBBO'').\8\
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    \5\ See Securities Exchange Act Release No. 68303 (November 27,
2012), 77 FR 71652 (December 3, 2012) (``RPI Approval Order'') (SR-
BYX-2012-019).
    \6\ A ``User'' is defined in BYX Rule 1.5(cc) as any member or
sponsored participant of the Exchange who is authorized to obtain
access to the System.
    \7\ A ``Retail Order'' is defined in Rule 11.24(a)(2) as an
agency order that originates from a natural person and is submitted
to the Exchange by a RMO, provided that no change is made to the
terms of the order with respect to price or side of market and the
order does not originate from a trading algorithm or any
computerized methodology. See Rule 11.24(a)(2).
    \8\ The term Protected Quotation is defined in BYX Rule 1.5(t)
and has the same meaning as is set forth in Regulation NMS Rule
600(b)(58). The terms Protected NBB and Protected NBO are defined in
BYX Rule 1.5(s). The Protected NBB is the best-priced protected bid
and the Protected NBO is the best-priced protected offer. Generally,
the Protected NBB and Protected NBO and the national best bid
(``NBB'') and national best offer (``NBO'', together with the NBB,
the ``NBBO'') will be the same. However, a market center is not
required to route to the NBB or NBO if that market center is subject
to an exception under Regulation NMS Rule 611(b)(1) or if such NBB
or NBO is otherwise not available for an automatic execution. In
such case, the Protected NBB or Protected NBO would be the best-
priced protected bid or offer to which a market center must route
interest pursuant to Regulation NMS Rule 611.

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    The Program was approved by the Commission on a pilot basis running
one-year from the date of implementation.\9\ The Commission approved
the Program on November 27, 2012.\10\ The Exchange implemented the
Program on January 11, 2013, and has extended the pilot period three
times.\11\ The pilot period for the Program is scheduled to end on July
31, 2016.
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    \9\ See RPI Approval Order, supra note 5 at 71652.
    \10\ Id.
    \11\ See Securities Exchange Act Release Nos. 71249 (January 7,
2014), 79 FR 2229 (January 13, 2014) (SR-BYX-2014-001) (Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change to
Extend the Pilot Period for the Retail Price Improvement Program);
74111 (January 22, 2015), 80 FR 4598 (January 28, 2015) (SR-BYX-
2015-05) (Notice of Filing and Immediate Effectiveness of a Proposed
Rule Change to Extend the Pilot Period for BATS Y-Exchange, Inc.'s
Retail Price Improvement (``RPI'') Program for 12 Months, To Expire
on January 31, 2016); 76965 (January 22, 2016), 81 FR 4682 (January
27, 2016) (SR-BYX-2016-01) (Notice of Filing and Immediate
Effectiveness of a Proposed Rule Change to Rule 11.24, Retail Price
Improvement Program, To Extend the Pilot Period).
---------------------------------------------------------------------------

Proposal To Extend the Operation of the Program
    The Exchange established the RPI Program in an attempt to attract
retail order flow to the Exchange by potentially providing price
improvement to such order flow. The Exchange believes that the Program
promotes competition for retail order flow by allowing Exchange members
to submit Retail Price Improvement Orders (``RPI Orders'') \12\ to
interact with Retail Orders. Such competition has the ability to
promote efficiency by facilitating the price discovery process and
generating additional investor interest in trading securities, thereby
promoting capital formation. The Exchange believes that extending the
pilot is appropriate because it will allow the Exchange and the
Commission additional time to gather and analyze data regarding the
Program that the Exchange has committed to provide.\13\ As such, the
Exchange believes that it is appropriate to extend the current
operation of the Program.\14\ Through this filing, the Exchange seeks
to extend the current pilot period of the Program until July 31, 2017.
---------------------------------------------------------------------------

    \12\ A ``Retail Price Improvement Order'' is defined in Rule
11.24(a)(3) as an order that consists of non-displayed interest on
the Exchange that is priced better than the Protected NBB or
Protected NBO by at least $0.001 and that is identified as such. See
Rule 11.24(a)(3).
    \13\ See RPI Approval Order, supra note 5 at 71655.
    \14\ Concurrently with this filing, the Exchange has submitted a
request for an extension of the exemption under Regulation NMS Rule
612 previously granted by the Commission that permits it to accept
and rank the RPI orders in sub-penny increments. See Letter from
Anders Franzon, SVP, Associate General Counsel, Bats BYX Exchange,
Inc. to Brent J. Fields, Secretary, Securities and Exchange
Commission dated June 23, 2016.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6(b) of the Act.\15\ In particular,
the Exchange believes the proposed change furthers the objectives of
Section 6(b)(5) of the Act,\16\ in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, and to
remove impediments to and perfect the mechanism of a free and open
market and a national market system. The Exchange believes that
extending the pilot period for the RPI Program is consistent with these
principles because the Program is reasonably designed to attract retail
order flow to the exchange environment, while helping to ensure that
retail investors benefit from the better price that liquidity providers
are willing to give their orders. Additionally, as previously stated,
the competition promoted by the Program may facilitate the price
discovery process and potentially generate additional investor interest
in trading securities. The extension of the pilot period will allow the
Commission and the Exchange to continue to monitor the Program for its
potential effects on public price discovery, and on the broader market
structure.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change
extends an established pilot program for 12 months, thus allowing the
RPI Program to enhance competition for retail order flow and contribute
to the public price discovery process.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received from Members, Participants, or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from Members or other interested parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A) of the Act \17\ and Rule 19b-4(f)(6) \18\ thereunder.
Because the foregoing proposed rule change does not: (i) Significantly
affect the protection of investors or the public interest; (ii) impose
any significant burden on competition; and (iii) become operative for
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, it has become effective pursuant to
Section 19(b)(3)(A) of the Act \19\ and subparagraph (f)(6) of Rule
19b-4 thereunder.\20\
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(3)(A).
    \18\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
    \19\ 15 U.S.C. 78s(b)(3)(A).
    \20\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act.\21\ If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule change should be approved or disapproved.\22\
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78s(b)(3)(C).
    \22\ Id.
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-BatsBYX-2016-15 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-BatsBYX-2016-15. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-BatsBYX-2016-15, and should
be submitted on or before July 22, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-15717 Filed 6-30-16; 8:45 am]
 BILLING CODE 8011-01-P


Comment Info: =================

General Comment:Letter and supporting documents concern pages 1 through 213 of 457 concerning an ICR regarding hazardous air pollutants for American Premier, Inc. operations.


[Federal Register Volume 76, Number 216 (Tuesday, November 8, 2011)]
[Notices]
[Page 69260]
[FR Doc No: 2011-28873]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

November 2, 2011.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP12-117-000.
    Applicants: ETC Tiger Pipeline, LLC.
    Description: Tiger Semi-Annual Fuel Filing 002 to be effective 12/
1/2011.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5011.
    Comment Date: 5 p.m. ET on 11/14/2011.

    Docket Numbers: RP12-118-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: ConEd 2011-11-01 Release to Infinite Energy to be
effective 11/1/2011.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5079.
    Comment Date: 5 p.m. ET on 11/14/2011.

    Docket Numbers: RP12-119-000.
    Applicants: Equitrans, L.P.
    Description: ITS Form of Service Agreement Revision to be effective
12/1/2011.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5109.
    Comment Date: 5 p.m. ET on 11/14/2011.

    Docket Numbers: RP12-120-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: ONEOK 34951 to BP Energy 39030 Capacity Release
Negotiated Rate Agreement to be effective 11/1/2011.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5129.
    Comment Date: 5 p.m. ET on 11/14/2011.

    Docket Numbers: RP12-124-000.
    Applicants: Equitrans, L.P.
    Description: Equitrans, L.P. Operational Purchases and Sales Report
for the twelve month period ended August 31, 2011.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5167.
    Comment Date: 5 p.m. ET on 11/14/2011.

    Docket Numbers: RP12-125-000.
    Applicants: ANR Pipeline Company.
    Description: Negotiated Rate Agreements 11-1-11 to be effective 11/
1/2011.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5190.
    Comment Date: 5 p.m. ET on 11/14/2011.

    Docket Numbers: RP12-126-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: 11/01/11 Negotiated Rates--BG Energy Merchants, LLC
(HUB) to be effective 11/1/2011.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5192.
    Comment Date: 5 p.m. ET on 11/14/2011.

    Docket Numbers: RP12-127-000.
    Applicants: Viking Gas Transmission Company.
    Description: PAL Modification to be effective 12/1/2011.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5216.
    Comment Date: 5 p.m. ET on 11/14/2011.

    Docket Numbers: RP12-128-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Nonconforming Agreements--Update RP10-46 and RP10-179
to be effective 12/2/2011 under RP12-128 Filing Type: 570.
    Filed Date: 11/02/2011.
    Accession Number: 20111102-5052.
    Comment Date: 5 p.m. ET on 11/14/2011.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP05-164-018.
    Applicants: Equitrans, L.P.
    Description: Equitrans, L.P. Annual Report on Fuel and Lost and
Unaccounted for gas volumes for the period September 2010 through
August 2011.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5226.
    Comment Date: 5 p.m. ET on 11/14/2011.

    Docket Numbers: RP12-111-001.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Amendment to ConEd 2011-11-01 Releases 3 to
be effective 11/1/2011.
    Filed Date: 11/01/2011.
    Accession Number: 20111101-5107.
    Comment Date: 5 p.m. ET on 11/14/2011.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5 p.m. Eastern time on the specified comment
date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service can be found at:
http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated: November 2, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-28873 Filed 11-7-11; 8:45 am]
BILLING CODE 6717-01-P