[Federal Register Volume 82, Number 65 (Thursday, April 6, 2017)]
[Notices]
[Page 16821]
[FR Doc No: 2017-06836]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 9222-032]

Erie Boulevard Hydropower, L.P.; Notice of Intent To File License
Application, Filing of Pre-Application Document, Approving Use of the
Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 9222-032.
    c. Date Filed: January 31, 2017.
    d. Submitted By: Erie Boulevard Hydropower, L.P.
    e. Name of Project: Yaleville Hydroelectric Project.
    f. Location: On Raquette River, in St. Lawrence County, New York.
No federal lands are occupied by the project works or located within
the project boundary.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Steven Murphy, Brookfield
Renewable, 33 West 1st Street South, Fulton, NY;<PHONE_NUMBER>;
<EMAIL_ADDRESS>    i. FERC Contact: Dustin Wilson at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. Erie Boulevard Hydropower filed its request to use the
Traditional Licensing Process on January 31, 2017. Erie Boulevard
Hydropower provided public notice of its request on January 27, 2017.
In a letter dated March 30, 2017, the Director of the Division of
Hydropower Licensing approved Erie Boulevard Hydropower's request to
use the Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service under section 7 of the Endangered
Species Act and the joint agency regulations thereunder at 50 CFR, part
402. We are also initiating consultation with the New York State
Historic Preservation Officer, as required by section 106, National
Historic Preservation Act, and the implementing regulations of the
Advisory Council on Historic Preservation at 36 CFR 800.2.
    l. With this notice, we are designating Erie Boulevard Hydropower
as the Commission's non-federal representative for carrying out
informal consultation pursuant to section 7 of the Endangered Species
Act and consultation pursuant to section 106 of the National Historic
Preservation Act.
    m. Erie Boulevard Hydropower filed a Pre-Application Document (PAD;
including a proposed process plan and schedule) with the Commission,
pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(http://www.ferc.gov), using the ``eLibrary'' link. Enter the docket
number, excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). A copy is also available for inspection and reproduction at
the address in paragraph h.
    o. The licensee states its unequivocal intent to submit an
application for a new license for Project No. 9222-032. Pursuant to 18
CFR 16.8, 16.9, and 16.10 each application for a new license and any
competing license applications must be filed with the Commission at
least 24 months prior to the expiration of the existing license. All
applications for license for this project must be filed by January 31,
2020.
    p. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: March 30, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-06836 Filed 4-5-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 231 (Monday, December 2, 2013)]
[Rules and Regulations]
[Page 72011]
[FR Doc No: 2013-28758]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-0002; Airspace Docket No. 12-ASO-46]

Establishment of Class E Airspace; Umatilla, FL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule: correction.

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SUMMARY: This action corrects the geographic coordinates in the
airspace description of a final rule, published in the Federal Register
on August 23, 2013, establishing controlled airspace at Umatilla
Municipal Airport, Umatilla, FL.

DATES: Effective 0901 UTC, December 12, 2013. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On August 23, 2013, the FAA published a final rule in the Federal
Register establishing Class E airspace at Umatilla Municipal Airport,
Umatilla, FL (78 FR 52425). After publication, the FAA found that the
geographic coordinates of the airport were incorrect. The longitude
coordinate is corrected from ``long. 82[deg]39'07'' W.'' to ``long.
81[deg]39'07'' W.''

Correction to Final Rule

    Accordingly, pursuant to the authority delegated to me, amendatory
instruction 2 and the geographic coordinates listed in the airspace
designation of the Class E airspace for Umatilla Municipal Airport,
Umatilla, FL, as published in the Federal Register of August 23, 2013,
(78 FR 52425), FR Doc. 2013-20512, are corrected as follows:

PART 71 [AMENDED]

0
1. On page 52425, column 3, revise amendatory instruction 2 to read:
The incorporation by reference in 14 CFR 71.1 of the Federal Aviation
Administration Order 7400.9X, Airspace Designations and Reporting
Points, dated August 7, 2013, and effective September 15, 2013, is
amended as follows:

ASO FL E5 Umatilla, FL [Corrected]

0
2. On page 52425, column 3, line 59, remove, ``lat. 28[deg]55'27'' N.,
long. 82[deg]39'07'' W'', and insert ``lat. 28[deg]55'27'' N., long.
81[deg]39'07'' W''.

    Issued in College Park, Georgia, on November 20, 2013.
Kip B. Johns,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2013-28758 Filed 11-29-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 242 (Tuesday, December 19, 2023)]
[Notices]
[Page 87787]
[FR Doc No: 2023-27853]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-5431]

Hospira, Inc., et al.; Withdrawal of Approval of Eight
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
withdrawing approval of eight abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.

DATES: Approval is withdrawn as of January 18, 2024.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [email protected].

SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec.  314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived the opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
     Application No.               Drug                  Applicant
------------------------------------------------------------------------
ANDA 063081.............  Tobramycin Sulfate,     Hospira, Inc., 275
                           Injectable,             North Field Dr.,
                           Equivalent to (EQ)      Building H1-3S, Lake
                           1.2 milligrams (mg)     Forest, IL 60045.
                           base/milliliters
                           (mL), EQ 1.6 mg base/
                           mL, EQ 80 mg base/100
                           mL.
ANDA 063112.............  Tobramycin Sulfate,     Do.
                           Injection, EQ 10 mg
                           base/mL.
ANDA 078907.............  Fentanyl Citrate,       SpecGx LLC, 385
                           Troche/Lozenges, EQ     Marshall Ave.,
                           0.2 mg base, EQ 0.4     Webster Groves, MO
                           mg base, EQ 0.6 mg      63119.
                           base, EQ 0.8 mg base,
                           EQ 1.2 mg base, EQ
                           1.6 mg base.
ANDA 080629.............  Promethazine            Watson Laboratories,
                           Hydrochloride (HCl),    Inc. (an indirect,
                           Injectable, 50 mg/mL.   wholly owned
                                                   subsidiary of Teva
                                                   Pharmaceuticals USA,
                                                   Inc.), 400 Interpace
                                                   Parkway, Building A,
                                                   Parsippany, NJ 07054.
ANDA 091170.............  Zoledronic Acid,        Breckenridge
                           Injectable, EQ 4 mg     Pharmaceutical, Inc.,
                           base/5 mL.              15 Massirio Dr.,
                                                   Suite 201, Berlin, CT
                                                   06037.
ANDA 201846.............  Azelastine HCl,         Apotex Corp, U.S.
                           Metered Spray, 0.2055   Agent for Apotex
                           mg/spray.               Inc., 2400 North
                                                   Commerce Parkway,
                                                   Suite 400, Weston, FL
                                                   33326.
ANDA 207698.............  Nevirapine Extended-    Aurobindo Pharma USA,
                           Release Tablets, 400    Inc., U.S. Agent for
                           mg.                     Aurobindo Pharma
                                                   Limited, 279
                                                   Princeton-Hightstown
                                                   Rd., East Windsor, NJ
                                                   08520.
ANDA 208616.............  Nevirapine Extended-    Do.
                           Release Tablets, 100
                           mg.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
January 18, 2024. Approval of each entire application is withdrawn,
including any strengths and dosage forms inadvertently missing from the
table. Introduction or delivery for introduction into interstate
commerce of products listed in the table without an approved new drug
application or ANDA violates sections 505(a) and 301(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Drug
products that are listed in the table that are in inventory on January
18, 2024 may continue to be dispensed until the inventories have been
depleted or the drug products have reached their expiration dates or
otherwise become violative, whichever occurs first.

    Dated: December 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27853 Filed 12-18-23; 8:45 am]
BILLING CODE 4164-01-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on May 11, 2004

   NOTICE OF ACTION TAKEN -- DOCKET OST-98-4031

________________________________________________________________________
______

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of Atlas Air, Inc. filed 3/26/04 to:

XX  Renew for two years an exemption under 49 U.S.C. 40109 to provide
the following service:

Scheduled foreign air transportation of property and mail between points
in the United States and Prestwick/Glasgow, Scotland.  Atlas also
requests that the exemption include the right to integrate this
authority with its other existing certificate and exemption authorities.

Applicant rep:  Russell E. Pommer<PHONE_NUMBER>    DOT Analyst:  Linda
Senese<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted (subject to conditions, see below)

The above action was effective when taken:  May 11, 2004, through  May
11, 2006.

Action taken by:   Paul L. Gretch, Director

		    Office of International Aviation

XX  The authority granted is consistent with the aviation agreement
between the United States and the United Kingdom.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:  XX Holder’s
certificates of public convenience and necessity

	   	         XX  Standard exemption conditions (attached)

Conditions:  The route integration authority granted is subject to the
condition that any service provided under this exemption shall be
consistent with all applicable agreements between the United States and
the foreign countries involved.  Furthermore, (a) nothing in the award
of the route integration authority requested should be construed as
conferring upon Atlas rights (including fifth-freedom intermediate
and/or beyond rights) to serve markets where U.S. carrier entry is
limited unless Atlas notifies the Department of its intent to serve such
a market and

(See Reverse Side)

2

unless and until the Department has completed any necessary carrier
selection procedures to determine which carrier(s) should be authorized
to exercise such rights; and (b) should there be a request by any
carrier to use the limited-entry route rights that are included in
Atlas’ authority by virtue of the route integration exemption granted
here, but that are not then being used by Atlas, the holding of such
authority by route integration will not be considered as providing any
preference for Atlas in a competitive carrier selection proceeding to
determine which carrier(s) should be entitled to use the authority at
issue.

________________________________________________________________________
______

On the basis of data officially noticeable under Rule 24(g) of the
Department's regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that

(1) our action was consistent with Department policy; (2) grant of the
exemption authority was consistent with the public interest; and (3)
grant of the authority would not constitute a major regulatory action
under the Energy Policy and Conservation Act of 1975.  To the extent not
granted, we denied all requests in the referenced Docket.  We may amend,
modify, or revoke the authority granted in this Notice at any time
without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

										05/2004


[Federal Register Volume 83, Number 236 (Monday, December 10, 2018)]
[Notices]
[Pages 63500-63501]
[FR Doc No: 2018-26690]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2015-0765; FRL-9987-57-ORD]

Board of Scientific Counselors (BOSC) Chemical Safety for
Sustainability Subcommittee Meeting--January 2019

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meeting.

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SUMMARY: Pursuant to the Federal Advisory Committee Act, the U.S.
Environmental Protection Agency, Office of Research and Development
(ORD), gives notice of a meeting of the Board of Scientific Counselors
(BOSC) Chemical Safety for Sustainability Subcommittee.

DATES: The meeting will be held on Monday, January 14, 2019, from 8:00
a.m. to 5:00 p.m., Tuesday, January 15, 2019, from 8:00 a.m. until 5:00
p.m. and Wednesday, January 16, 2019, from 8:00 a.m. until 2:00 p.m.
All times noted are Eastern Time and approximate. The meeting may
adjourn early if all business is finished. Attendees should register by
January 7, 2019 at https://epa-bosc-css-subcommittee-meeting.eventbrite.com. Requests for making oral presentations at the
meeting will be accepted up to one business day before the meeting.

ADDRESSES: The meeting will be held at the EPA's Research Triangle Park
Main Campus Facility, 109 T.W. Alexander Drive, Research Triangle Park,
North Carolina 27711. Submit your comments to Docket ID No. EPA-HQ-ORD-
2015-0765 by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email: Send comments by electronic mail (email) to:
<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-ORD-2015-0765.
     Fax: Fax comments to:<PHONE_NUMBER>, Attention Docket ID
No. EPA-HQ-ORD-2015-0765.
     Mail: Send comments by mail to: Board of Scientific
Counselors (BOSC) Chemical Safety for Sustainability Subcommittee
Docket, Mail Code: 2822T, 1301 Constitution Ave. NW, Washington, DC,
20004, Attention Docket ID No. EPA-HQ-ORD-2015-0765.
     Hand Delivery or Courier: Deliver comments to: EPA Docket
Center (EPA/DC), Room 3334, William Jefferson Clinton West Building,
1301 Constitution Ave. NW, Washington, DC, Attention Docket ID No. EPA-
HQ-ORD-2015-0765. Note: this is not a mailing address. Deliveries are
only accepted during the docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    Instructions: The EPA's policy is that all comments received will
be included in the public docket without change and may be made
available online at 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 www.regulations.gov
or email. The www.regulations.gov website is an ``anonymous access''
system, which means the 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 the EPA without going through
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, the 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 the EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, the 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/dockets/.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose 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 www.regulations.gov or in hard copy at the Board of Scientific
Counselors (BOSC) Chemical Safety for Sustainability Subcommittee
Docket, EPA/DC, William Jefferson Clinton West Building, 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
(202) 566-1744, and the telephone number for the ORD Docket is (202)
566-1752.

FOR FURTHER INFORMATION CONTACT: The Designated Federal Officer via
mail at: Tom Tracy, Mail Code 8104R, Office of Science Policy, Office
of Research and Development, U.S. Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460; via phone/voice mail at:
(202) 564-6518;

via fax at:<PHONE_NUMBER>; or via email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    General Information: The meeting is open to the public. Any member
of the public interested in receiving a draft agenda, attending the
meeting, or making a presentation at the meeting may contact Tom Tracy,
the Designated Federal Officer, via any of the contact methods listed
in the FOR FURTHER INFORMATION CONTACT section above. Individuals
making an oral presentation will be limited to a total of three
minutes. For security purposes, all attendees must provide their names
to the Designated Federal Officer by registering online at https://epa-bosc-css-subcommittee-meeting.eventbrite.com by January 7, 2019, and
must go through a metal detector, sign in with the security desk, and
show REAL ID Act-compliant government-issued photo identification to
enter the building. Attendees are encouraged to arrive at least 15
minutes prior to the start of the meeting to allow sufficient time for
security screening. Proposed agenda items for the meeting include but
are not limited to the following: Overview of materials provided to the
subcommittee, update on ORD's Chemical Safety for Sustainability and
Human Health Risk Assessment Research Programs, draft Strategic
Research Action Plans, review of charge questions, and subcommittee
discussion.
    Information on Services for Individuals with Disabilities: For
information on access or services for individuals with disabilities,
please contact Tom Tracy at<PHONE_NUMBER> or<EMAIL_ADDRESS>To
request accommodation of a disability, please contact Tom Tracy,
preferably at least ten days prior to the meeting, to give the EPA as
much time as possible to process your request.

    Dated: November 29, 2018.
Fred S. Hauchman,
Director, Office of Science Policy.
[FR Doc. 2018-26690 Filed 12-7-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: May 24, 2006 (Volume 71, Number 100)]
[Notices]
[Page 29991-29995]
[DOCID:fr24my06-136]

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SECURITIES AND EXCHANGE COMMISSION

Release No. IC-27323; 812-12354]

ProShares Trust, et al.; Notice of Application

May 18, 2006.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice of an application for an order under section 6(c) of the
Investment Company Act of 1940 (the ``Act'') for an exemption from
sections 2(a)(32), 5(a)(1), 22(d) and 24(d) of the Act and rule 22c-1
under the Act, and under sections 6(c) and 17(b) of the Act for an
exemption from sections 17(a)(1) and (a)(2) of the Act.

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    Applicants: ProShares Trust (``Trust''), ProShare Advisors LLC
(``ProShare Advisors''), and SEI Investments Distribution Company
(``Distributor'').
    Summary of Application: Applicants request an order that would
permit: (a) Series of an open-end management investment company to
issue shares of limited redeemability; (b) secondary market
transactions in the shares of the

series to occur at negotiated prices on the American Stock Exchange LLC
(``Amex''), or another national securities exchange as defined in
section 2(a)(26) of the Act, or on The NASDAQ Stock Market LLC (each,
an ``Exchange''); (c) dealers to sell shares of the series of the Trust
to purchasers in the secondary market unaccompanied by a prospectus,
when prospectus delivery is not required by the Securities Act of 1933
(the ``Securities Act''); and (d) affiliated persons of a series to
deposit securities into, and receive securities from, the series in
connection with the purchase and redemption of aggregations of the
series' shares.
    Filing Dates: The application was filed on December 5, 2000, and
amended on January 7, 2005, June 22, 2005, July 6, 2005, and March 29,
2006.
    Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by writing to the Commission's
Secretary and serving applicants with a copy of the request, personally
or by mail. Hearing requests should be received by the Commission by
5:30 p.m. on June 12, 2006, and should be accompanied by proof of
service on applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Hearing requests should state the nature of the
writer's interest, the reason for the request, and the issues
contested. Persons who wish to be notified of a hearing may request
notification by writing to the Commission's Secretary.

ADDRESSES: Secretary, Securities and Exchange Commission, 100 F Street,
NE., Washington, DC 20549-1090. Applicants: ProShares Trust and
ProShare Advisors, 7501 Wisconsin Avenue, Suite 1000, Bethesda, MD
20814; SEI Investments Distribution Company, One Freedom Valley Drive,
Oaks, PA 19456.

FOR FURTHER INFORMATION CONTACT: John Yoder, Senior Counsel, at (202)
551-6878, Julia Kim Gilmer, Branch Chief, at<PHONE_NUMBER>, or Michael
W. Mundt, Senior Special Counsel, at<PHONE_NUMBER> (Division of
Investment Management, Office of Investment Company Regulation).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained for a fee at the
Commission's Public Reference Desk, 100 F Street, NE., Washington, DC
20549-0102 (tel.<PHONE_NUMBER>).

Applicants' Representations

    1. The Trust is an open-end management investment company
registered under the Act and organized as a Delaware statutory trust.
The Trust intends to offer multiple series (each series, a ``Fund'')
with different types of investment objectives as further described
below. ProShare Advisors is registered as an investment adviser under
the Investment Advisers Act of 1940 (``Advisers Act''). Each Fund will
be advised by ProShare Advisors or an entity controlled by or under
common control with ProShare Advisors (each, an ``Adviser''). The
Adviser may enter into subadvisory agreements with additional
investment advisers to act as subadviser to the Trust and any of its
series. Any subadviser to the Trust or a Fund will be registered under
the Advisers Act. The Distributor is registered as a broker-dealer
under the Securities Exchange Act of 1934 (``Exchange Act'') and will
act as the distributor and principal underwriter for each Fund's shares
(``ETS'').
    2. The Funds will seek daily investment results, before fees and
expenses, that: (a) Correspond to the return of various equity
securities indices (``Conventional Funds''); (b) provide 125%, 150% or
200% of the return of equity securities indices (``Leveraged Funds'');
or (c) move in the opposite direction of the performance of equity
securities indices in multiples of 100%, 125%, 150% or 200% (``Inverse
Funds''). Of the twelve initial Funds, four will be Leveraged Funds and
eight will be Inverse Funds.\1\
---------------------------------------------------------------------------

    \1\ The Leveraged Funds will seek to return 200% of the return
of the S&P 500 Index, the Nasdaq100 Index, the Dow Jones Industrial
Average and the S&P MidCap400 Index. The Inverse Funds will seek to
return the inverse, or 200% of the inverse, of the same indices. The
Trust may offer additional Funds based on these indices and the
following indices (collectively, the ``Underlying Indices''):
Russell 2000 Index, S&P Small Cap 600 Index, Nasdaq Composite Index,
S&P 500 BARRA Value Index, S&P 500 BARRA Growth Index, S&P MidCap400
BARRA Value Index, S&P MidCap 400/BARRA Growth Index, S&P SmallCap
600/Barra Value Index, S&P SmallCap 600/BARRA Growth Index, Dow
Jones U.S. Airlines Index, Dow Jones U.S. Banks Index, Dow Jones
U.S. Basic Materials Sector Index, Dow Jones U.S. Biotechnology
Index, Dow Jones U.S. Composite Internet Index, Dow Jones U.S.
Consumer Services Index, Dow Jones U.S. Consumer Goods Index, Dow
Jones U.S. Oil & Gas Index, Dow Jones U.S. Financials Index, Dow
Jones U.S. Health Care Index, Dow Jones U.S. Industrials Index, Dow
Jones U.S. Leisure Goods Index, Dow Jones U.S. Oil Equipment,
Services & Distribution Index, Dow Jones U.S. Pharmaceuticals Index,
Dow Jones U.S. Precious Metals Index, Dow Jones U.S. Real Estate
Index, Dow Jones U.S. Semiconductors Index, Dow Jones U.S.
Technology Index, Dow Jones U.S. Telecommunications Index, Dow Jones
U.S. Utilities Index, Dow Jones U.S. Mobile Communications Index. No
index provider is or will be an affiliated person, as defined in
section 2(a)(3) of the Act, or an affiliated person of an affiliated
person, of the Trust, a promoter, the Adviser, any sub-adviser to
any Fund, or the Distributor.
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    3. In addition to equity securities, the Funds may invest in short-
term debt instruments that meet the definition of ``Eligible Security''
in rule 2a-7 under the Act (``Money Market Instruments''), and in
futures contracts, options, equity caps, collars and floors, swap
agreements, forward contracts, and reverse repurchase agreements
(collectively, ``Financial Instruments'') in order to meet their
investment objectives. A Conventional Fund will invest 95% or more of
its total assets in the equity securities contained in the relevant
Underlying Index and may invest up to 5% of its total assets in
Financial Instruments and Money Market Instruments. Leveraged Funds
will invest 85% or more of their total assets in equity securities
contained in the relevant Underlying Index and up to 15% of their total
assets in Financial Instruments and Money Market Instruments. The
Inverse Funds will only invest in Financial Instruments and Money
Market Instruments; they will not invest in equity securities.
    4. The Adviser will seek to achieve the investment objectives of
the Funds by using a mathematical model that takes into account a
variety of specified criteria, the most important of which are: (a) The
net assets in each Fund's portfolio at the end of each trading day; (b)
the amount of required exposure to the Underlying Index; and (c) the
positions in equity securities, Financial Instruments and Money Market
Instruments at the beginning of each trading day. On each day that a
Fund is open for business (``Business Day'') the full portfolio
holdings of each Fund will be disclosed on the Web site of the Trust
and/or the relevant Exchange. The portfolio holdings information
disclosed each Business Day will form the basis for that Fund's net
asset value (``NAV'') calculation as of 4 p.m. that day and will
reflect portfolio trades made on the immediately preceding Business
Day. Intra-day values of each Underlying Index will be disseminated
every 15 seconds throughout the trading day.
    5. Applicants expect that each Conventional Fund will have an
annual tracking error of less than 5% (excluding the impact of expenses
and interest, if any) to the performance of its Underlying Index. For
the Leveraged Fund and Inverse Funds, applicants expect a daily
tracking error of less than 5% (excluding the impact of expenses and
interest, if any) to the specified multiple or inverse multiple,

respectively, of the performance of the relevant Underlying Index.
    6. Each Fund will issue ETS in aggregations of 25,000 to 50,000 ETS
(each, a ``Creation Unit''). Applicants expect the price of a Creation
Unit to be a minimum of $1 million. Creation Units may be purchased
only by or through the Distributor or a party that has entered into a
participant agreement with the Distributor (an ``Authorized
Participant''). An Authorized Participant must be either (a) a broker-
dealer or other participant in the continuous net settlement system of
the National Securities Clearing Corporation, a clearing agency that is
registered with the Commission, or (b) a participant in the Depository
Trust Company (``DTC'') system.
    7. Creation Units of Conventional and Leveraged Funds generally
will be purchased and redeemed in exchange for an ``in-kind'' transfer
of securities and cash (``In-Kind Payment''). Inverse Funds will
generally be purchased and redeemed entirely for cash because of the
limited transferability of Financial Instruments.\2\ An investor making
an In-Kind Payment will be required to transfer to the Trust a
``Deposit Basket'' consisting of: (a) A basket of equity securities
consisting of some or all of the securities in the relevant Underlying
Index or equivalent equity securities selected by the Adviser to
correspond to the performance of the Underlying Index (the ``Deposit
List''); and (b) a cash amount equal to the differential, if any,
between the market value of the equity securities in the Deposit Basket
and the NAV per Creation Unit (``Balancing Amount'').\3\ An investor
purchasing a Creation Unit from a Fund will be charged a fee
(``Transaction Fee'') to prevent the dilution of the interests of the
remaining shareholders resulting from the Fund incurring costs in
connection with the purchase of the Creation Units.\4\ The maximum
Transaction Fee and any variations or waivers of the Transaction Fee
will be disclosed in the prospectus for ETS (``Prospectus'') and the
method of determining the Transaction Fees will be disclosed in the
Prospectus and/or statement of additional information (``SAI'').
    8. All orders to purchase Creation Units must be placed on a
Business Day with the Distributor. The Distributor also will be
responsible for delivering the Prospectus to those persons purchasing
Creation Units and for maintaining records of the orders and
acknowledgements of acceptance for orders.
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    \2\ The Trust may also accept and deliver all-cash payments for
the purchase and redemption of Creation Units of any Fund in certain
limited circumstances.
    \3\ On each Business Day, prior to the opening of trading on the
New York Stock Exchange, the Trust's index receipt agent will make
available the list of the names and the required number of shares of
each equity security included in the current Deposit Basket and the
Balancing Amount for each Fund. Such Deposit Basket will apply to
all purchases of Creation Units until a new Deposit Basket for a
Fund is announced. The Amex will disseminate every 15 seconds during
regular Amex trading hours, through the facilities of the
Consolidated Tape Association, an amount representing on a per share
basis the sum of the current value of the securities on the Deposit
List, and the estimated amount of cash and Money Market Instruments
held in the portfolio of a Conventional or Leveraged Fund. If such
funds hold Financial Instruments, the amount would also include, on
a per share basis, the marked-to-market gains or losses of the
Financial Instruments held by the Fund. For Inverse Funds, the Amex
will disseminate an amount representing, on a per share basis, the
estimated amount of cash and Money Market Instruments, and the
marked-to-market gains or losses of the Fund's Financial
Instruments.
    \4\ A purchaser permitted to substitute cash for certain
securities on the Deposit List may be assessed a higher transaction
Fee to cover the cost of purchasing such securities, including
operational processing and brokerage costs, and part or all of the
spread between the expected bid and offer side of the market
relating to such securities.
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    9. Persons purchasing Creation Units from a Fund may hold the ETS
or sell some or all of them in the secondary market. Shares of the
Funds will be listed on an Exchange and trade in the secondary market
in the same manner as other exchange-traded funds. It is expected that
one or more Exchange members will act as a specialist or market maker
and maintain a market on the listing Exchange for ETS.\5\ The price of
ETS traded on an Exchange will be based on a current bid/offer market.
The initial trading price for each ETS of each Fund will fall in the
range of $50 to $250. Transactions involving the sale of ETS in the
secondary market will be subject to customary brokerage commissions and
charges.
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    \5\ The listing requirements established by The NASDAQ Stock
Market LLC require that at least two market makers be registered in
ETS in order for the ETS to maintain a listing. Registered market
makers must make a continuous two-sided market in a listing or face
regulatory sanctions.
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    10. Applicants expect that purchasers of Creation Units will
include institutional and retail investors, arbitrageurs, traders,
financial advisors, portfolio managers and other market
participants.\6\ An Exchange specialist or market maker, in providing
for a fair and orderly secondary market for ETS, also may purchase or
redeem Creation Units for use in its market-making activities.
Applicants expect that the market price of ETS will be disciplined by
arbitrage opportunities created by the ability to purchase or redeem
Creation Units at their NAV, which should ensure that the market price
of ETS at or close to 4 p.m. stays close to the NAV on that Business
Day.
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    \6\ ETS will be registered in book-entry form only. DTC or its
nominee will be the record or registered owner of all outstanding
ETS. DTC or its participants will maintain records reflecting the
beneficial owners of ETS.
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    11. ETS will not be individually redeemable. ETS will only be
redeemable in Creation Units through the Distributor, which will act as
the Trust's agent for redemption. To redeem, an investor must
accumulate enough ETS to constitute a Creation Unit. An investor
redeeming a Creation Unit of a Conventional or Leveraged Fund generally
will receive an ``in-kind'' payment comprised of equity securities
published by the Trust's index receipt agent (the ``Redemption List'')
plus a Balancing Amount equal to the difference between the market
value of the equity securities on the Redemption List and the NAV of
the ETS being redeemed. Redemptions of Creation Units for Inverse Funds
will occur entirely in cash. A redeeming investor will pay a
Transaction Fee to offset the transactional expenses associated with
redeeming Creation Units.
    12. Applicants state that neither the Trust nor any Fund will be
advertised, marketed or otherwise held out as a ``mutual fund.'' The
term ``mutual fund'' will not be used in the Prospectus except to
compare and contrast the Trust or a Fund with conventional mutual
funds. In all marketing materials where the features or methods of
obtaining, buying, or selling Creation Units are described or where
there is reference to redeemability, applicants will include a
prominent statement to the effect that individual ETS are not
redeemable except in Creation Units. The same approach will be followed
in connection with reports and other communications to shareholders, as
well as any other investor education materials issued or circulated in
connection with ETS. The Trust will provide copies of its annual and
semi-annual shareholder reports to DTC participants for distribution to
beneficial holders of ETS.

Applicants' Legal Analysis

    1. Applicants request an order under section 6(c) of the Act
granting an exemption from sections 2(a)(32), 5(a)(1), 22(d) and 24(d)
of the Act and rule 22c-1 under the Act, and under sections 6(c) and
17(b) of the Act granting an exemption from sections 17(a)(1) and
17(a)(2) of the Act.
    2. Section 6(c) of the Act provides that the Commission may exempt
any person, security or transaction, or any

class of persons, securities or transactions, from any provision of the
Act, if and to the extent that such exemption is necessary or
appropriate in the public interest and consistent with the protection
of investors and the purposes fairly intended by the policy and
provisions of the Act.

Sections 5(a)(1) and 2(a)(32) of the Act

    3. Section 5(a)(1) of the Act defines an ``open-end company'' as a
management investment company that is offering for sale or has
outstanding any redeemable security of which it is the issuer. Section
2(a)(32) of the Act defines a redeemable security as any security,
other than short-term paper, under the terms of which the holder, upon
its presentation to the issuer, is entitled to receive approximately
his proportionate share of the issuer's current net assets, or the cash
equivalent. Because ETS will not be individually redeemable, applicants
request an order that would permit the Trust to register as an open-end
management investment company and issue ETS of Funds that are
redeemable in Creation Units only. Applicants state that investors may
always redeem ETS in Creation Units from the Trust. Applicants further
state that because the market price of ETS will be disciplined by
arbitrage opportunities, investors should be able to sell ETS in the
secondary market at or close to 4 p.m. on a Business Day at prices that
do not vary substantially from the NAV on that Business Day.

Section 22(d) of the Act and Rule 22c-1 Under the Act

    4. Section 22(d) of the Act, among other things, prohibits a dealer
from selling a redeemable security, which is currently being offered to
the public by or through a principal underwriter, except at a current
public offering price described in the prospectus. Rule 22c-1 under the
Act generally requires that a dealer selling, redeeming, or
repurchasing a redeemable security do so only at a price based on its
NAV. Applicants state that secondary market trading in ETS will take
place at negotiated prices, not at a current offering price described
in the Prospectus as required by section 22(d) of the Act, and not at a
price based on NAV as required by rule 22c-1 under the Act. Applicants
request an exemption under section 6(c) from these provisions.
    5. Applicants assert that the concerns sought to be addressed by
section 22(d) of the Act and rule 22c-1 under the Act with respect to
pricing are equally satisfied by the proposed method of pricing ETS.
Applicants maintain that while there is little legislative history
regarding section 22(d), its provisions, as well as those of rule 22c-
1, appear to have been intended to (a) prevent dilution caused by
certain riskless-trading schemes by principal underwriters and contract
dealers, (b) prevent unjust discrimination or preferential treatment
among buyers, and (c) ensure an orderly distribution of shares by
eliminating price competition from dealers offering shares at less than
the published sales price and repurchasing shares at more than the
published redemption price.
    6. Applicants believe that none of these purposes will be thwarted
by permitting ETS to trade in the secondary market at negotiated
prices. Applicants state that (a) secondary market trading in ETS does
not involve the Trust's assets and cannot result in dilution of an
investment in ETS, and (b) to the extent different prices exist during
a given trading day, or from day to day, such variances occur as a
result of third-party market forces, such as supply and demand, not as
a result of unjust or discriminatory manipulation. Therefore,
applicants assert that secondary market transactions in ETS will not
lead to discrimination or preferential treatment among purchasers.
Finally, applicants contend that the proposed distribution system will
be orderly because competitive forces in the marketplace will ensure
that the difference between the market price of ETS and their NAV
remains narrow.

Section 24(d) of the Act

    7. Section 24(d) of the Act provides, in relevant part, that the
prospectus delivery exemption provided to dealer transactions by
section 4(3) of the Securities Act does not apply to any transaction in
a redeemable security issued by an open-end investment company.
Applicants request an exemption from section 24(d) to permit dealers
selling ETS to rely on the prospectus delivery exemption provided by
section 4(3) of the Securities Act.\7\
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    \7\Applicants do not seek relief from the prospectus delivery
requirement for non-secondary market transactions, such as
transactions in which an investor purchases ETS in Creations Units
from the Issuer or an underwriter. Applicants state that persons
purchasing Creation Units will be cautioned in the Prospectus that
some activities on their part may, depending on the circumstances,
result in their being deemed statutory underwriters and subject them
to the prospectus delivery and liability provisions on the
Securities Act. The Prospectus will state that whether a person is
an underwriter depends upon all the facts and circumstances
pertaining to that person's activities. For example, a broker-dealer
firm and/or its client may be deemed a statutory underwriter if it
takes Creation Units after placing an order with the Distributor,
breaks them down into the constituent ETS, and sells ETS directly to
its customers, or if it chooses to couple the purchase of a supply
of new ETS with an active selling effort involving solicitation of
secondary market demand for ETS. The Prospectus also will state that
dealers who are not ``underwriters'' but are participating in a
distribution (as contrasted to ordinary secondary market trading
transactions), and thus dealing with ETS that are part of an
``unsold allotment'' within the meaning of section 4(3)(C) of the
Securities Act, would be unable to take advantage of the prospectus
delivery exemption provided by section 4(3) of the Securities Act.
---------------------------------------------------------------------------

    8. Applicants state that secondary market investors will regard ETS
in a manner similar to other securities, including closed-end fund
shares that are listed, bought and sold on an Exchange. Applicants note
that shares of closed-end fund investment companies are sold in the
secondary market unaccompanied by a prospectus.
    9. Applicants contend that ETS, as a listed security, merit a
reduction in the compliance costs and regulatory burdens resulting from
the imposition of prospectus delivery obligations in the secondary
market. Because ETS will be exchange-listed, prospective investors will
have access to several types of market information about ETS.
Applicants state that information regarding market price and volume
will be continually available on a real-time basis throughout the day
from the relevant Exchange, automated quotation systems, published or
other public sources or on-line information services. Applicants expect
that the previous day's closing price and volume information for ETS
also will be published daily in the financial section of newspapers. In
addition, the Trust expects to maintain a We bsite that includes
quantitative information updated on a daily basis, including, for each
Fund, daily trading volume, the NAV and the reported closing price. The
Web site will also include, for each Fund, a calculation of the premium
or discount of the reported closing price against NAV, and data in
chart format displaying the frequency distribution of discounts and
premiums of the reported closing price against the NAV, within
appropriate ranges, for each of the four previous calendar quarters.
    10. Investors also will receive a product description (``Product
Description'') describing the Trust, the Funds and the ETS. Applicants
state that, while not intended as a substitute for a Prospectus, the
Product Description will contain information about ETS that is tailored
to meet the needs of investors purchasing ETS in the secondary market.

Sections 17(a)(1) and (2) of the Act

    11. Section 17(a) of the Act generally prohibits an affiliated
person of a registered investment company, or an affiliated person of
such a person, from selling any security to or purchasing any security
from the company. Section 2(a)(3) of the Act defines ``affiliated
person'' to include any person directly or indirectly owning,
controlling, or holding with power to vote 5% or more of the
outstanding voting securities of the other person and any person
directly or indirectly controlling, controlled by, or under common
control with, the other person. Section 2(a)(9) of the Act provides
that a control relationship will be presumed where one person owns 25%
or more of another person's voting securities. Applicants state that
one or more holders of Creation Units could own more than 5% of a Fund,
or in excess of 25% of that Fund, and could be deemed affiliated with
the Trust or such Fund under section 2(a)(3)(A) or 2(a)(3)(C) of the
Act. Also, an Exchange specialist or market maker for ETS of any Fund
might accumulate, from time to time, more than 5% or in excess of 25%
of that Fund's ETS. Applicants request an exemption from section 17(a)
of the Act under sections 6(c) and 17(b) of the Act, to permit persons
that are affiliated persons of the Funds solely by virtue of a 5% or
25% ownership interest (or affiliated persons of such affiliated
persons that are not otherwise affiliated with the Fund) to purchase
and redeem Creation Units through ``in-kind'' transactions.
    12. Section 17(b) of the Act authorizes the Commission to exempt a
proposed transaction from section 17(a) of the Act if evidence
establishes that the terms of the transaction, including the
consideration to be paid or received, are reasonable and fair and do
not involve overreaching on the part of any person concerned, and the
proposed transaction is consistent with the policies of the registered
investment company and the general provisions of the Act. Applicants
contend that no useful purpose would be served by prohibiting the
affiliated persons of a Fund described above from purchasing or
redeeming Creation Units through ``in-kind'' transactions. The deposit
and redemption procedures for ``in-kind'' purchases and redemptions of
Creations Units will be effected in exactly the same manner for all
purchases and redemptions. The securities contained in the ``in-kind''
transactions will be valued in the same manner and according to the
same standards as the securities held by the relevant Fund. Therefore,
applicants state that ``in-kind'' purchases and redemptions will afford
no opportunity for the affiliated persons described above to effect a
transaction detrimental to the other holders of its ETS. Applicants
also believe that ``in-kind'' purchases and redemptions will not result
in abusive self-dealing or overreaching by affiliated persons of the
Funds.

Applicants' Conditions

    Applicants agree that any order granting the requested relief will
be subject to the following conditions:
    1. Applicants will not register a series of the Trust not
identified herein, by means of filing a post-effective amendment to the
Trust's registration statement or by any other means, unless applicants
have requested and received with respect to such series, either (a)
exemptive relief from the Commission, or (b) a no-action letter from
the Division of Investment Management of the Commission.
    2. The Prospectus and the Product Description will clearly disclose
that, for purposes of the Act, ETS are issued by the Funds and that the
acquisition of ETS by investment companies is subject to the
restrictions of section 12(d)(1) of the Act, except as permitted by an
exemptive order that permits registered investment companies to invest
in a Fund beyond the limits in section 12(d)(1), subject to certain
terms and conditions, including that the registered investment company
enter into an agreement with the Fund regarding the terms of the
investment.
    3. As long as the Trust operates in reliance on the requested
order, the ETS will be listed on an Exchange.
    4. Neither the Trust nor any Fund will be advertised or marketed as
an open-end fund or a mutual fund. The Prospectus will prominently
disclose that ETS are not individually redeemable shares and will
disclose that the owners of the ETS may acquire those ETS from the
Trust and tender those ETS for redemption to the Trust in Creation
Units only. Any advertising material that describes the purchase or
sale of Creation Units or refers to redeemability will prominently
disclose that ETS are not individually redeemable and that owners of
ETS may acquire those ETS from the Trust and tender those ETS for
redemption to the Trust in Creation Units only.
    5. Before a Fund may rely on the order, the Commission will have
approved, pursuant to rule 19b-4 under the Exchange Act, an Exchange
rule or an amendment thereto, requiring Exchange members and member
organizations effecting transactions in ETS to deliver a Product
Description to purchasers of ETS.
    6. The Web site for the Trust, which will be publicly accessible at
no charge, will contain the following information, on a per ETS basis,
for each Fund: (a) The prior Business Day's NAV and the reported
closing price, and a calculation of the premium or discount of such
price against such NAV; and (b) data in chart format displaying the
frequency distribution of discounts and premiums of the daily closing
price against the NAV, within appropriate ranges, for each of the four
previous calendar quarters (or the life of the Fund, if shorter). In
addition, the Product Description for each Fund will state that the
Trust's Web site has information about the premiums and discounts at
which the ETS have traded.
    7. The Prospectus and annual report for each Fund will also
include: (a) The information listed in condition 6(b), (i) in the case
of the Prospectus, for the most recently completed year (and the most
recently completed quarter or quarters, as applicable), and (ii) in the
case of the annual report, for the immediately preceding five years (or
the life of the Fund, if shorter); and (b) the following data,
calculated on a per ETS basis for one, five and ten year periods (or
life of the Fund, if shorter), (i) the cumulative total return and the
average annual total return based on NAV and closing price, and (ii)
the cumulative total return of the relevant Underlying Index.

    By the Commission.
J. Lynn Taylor,
Assistant Secretary.
 [FR Doc. E6-7913 Filed 5-23-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)]
[Notices]
[Pages 2794-2796]
[FR Doc No: 2018-00903]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0055]

Gastrointestinal Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Gastrointestinal Drugs
Advisory Committee. The general function of the committee is to provide
advice and recommendations to FDA on regulatory issues. The meeting
will be open to the public. FDA is establishing

a docket for public comment on this document.

DATES: The meeting will be held on March 8, 2018, from 8 a.m. to 5 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2018-N-0055. The docket will close on March 7,
2018. Submit either electronic or written comments on this public
meeting by March 7, 2018. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before March 7, 2018. The https://www.regulations.gov electronic
filing system will accept comments until midnight Eastern Time at the
end of March 7, 2018. Comments received by mail/hand delivery/courier
(for written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.
    Comments received on or before February 22, 2018, will be provided
to the committee. Comments received after that date will be taken into
consideration by FDA.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2018-N-0055 for ``Gastrointestinal Drugs Advisory Committee; Notice
of Meeting; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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.'' FDA 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 https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information 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 the 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jay R. Fajiculay, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax:<PHONE_NUMBER>, email: [email protected], or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The committee will discuss supplemental new drug
application (sNDA) 203214 supplement 18, XELJANZ (tofacitinib) tablets,
submitted by Pfizer Inc., proposed for the treatment of adult patients
with moderately to severely active ulcerative colitis who have
demonstrated an inadequate response, loss of response, or intolerance
to corticosteroids, azathioprine, 6-mercaptopurine, or tumor necrosis
factor inhibitor therapy.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
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    Dated: January 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00903 Filed 1-18-18; 8:45 am]
 BILLING CODE 4164-01-P


                       Technical Support Document (TSD)
                                     for
                              EPA's Rulemaking
                                   For the
                       Arizona State Implementation Plan
                              Bullhead City Area
                 2[nd] Period Limited Maintenance Plan (LMP)

                                 December 2021

This document presents calculations and data required to support the review of the Bullhead City PM10 Limited Maintenance Plan (LMP). Specifically, we discuss the LMP eligibility criteria related to average design value concentration and motor vehicle growth analysis.
1. Average Design Value Concentration
The memo "Limited Maintenance Plan Option for Moderate PM10 Nonattainment Areas" outlines the requirements for an area to qualify for the LMP option:
      "To qualify for the limited maintenance plan option, an area should meet the following applicability criteria. The area should be attaining the NAAQS and the average PM10 design value for the area, based upon the most recent 5 years of air quality data at all monitors in the area, should be at or below 40 [ug]/m[3] for the annual and 98 [ug]/m[3] for the 24-hr PM10 NAAQS with no violations at any monitor in the nonattainment area. If an area cannot meet this test it may still be able to qualify for the LMP option if the average design values of the site are less than their respective site-specific CDV.
      We believe it is appropriate to offer this second method of qualifying for the LMP because, based on the air quality data we have studied, we believe there are some monitoring sites with average design values above 40 [ug]/m[3] or 98 [ug]/m[3], depending on the NAAQS in question, that have experienced little variability in the data over the years. When the CDV calculation was performed for these sites we discovered that their average design values are less than their CDVs, indicating that the areas have a very low probability (1 in 10) of exceeding the NAAQS in the future. We believe it is appropriate to provide these areas the opportunity to qualify for the LMP in this circumstance since the 40 [ug]/m[3] or 98 [ug]/m[3] criteria are based on a national analysis and don't take into account each local situation."
To calculate the average design value concentration, the LMP Option memo references a separate EPA guidance document, the PM10 SIP Development Guideline, which outlines multiple methods to perform this calculation, including a "table look-up" approach based on monitored PM10 concentrations. This approach selects the annual design value concentration from among the highest measured concentrations based on the total number of 24-hour PM10 concentrations available over three years. For example, if a PM10 -  monitor samples every day and provides 1,095 24-hour concentration measurements over the three years, then the annual design value concentration calculated by this approach is the fourth-highest concentration measured during the three-year period. A PM10 monitor that samples once every six days, in contrast, would have only approximately 183 24-hour concentration measurements available over three years, and the annual design value concentration would be the highest concentration measured during the three-year period. To calculate the average design value concentration based on five years of air quality data, three adjacent annual design value concentrations are calculated, and these annual design value concentrations are averaged together.
The methodology to calculate a "site-specific CDV" is found in Attachment A to the LMP Option memo. The equation set forth is:
                             CDV = NAAQS/(1+tc*CV)
Where:
      CDV = Critical Design Value in ug/m[3];
      NAAQS = 150 ug/m[3] for the 24-hour PM10 NAAQS;
      tc = critical t-value corresponding to a 10 percent probability of exceeding the NAAQS; and
      CV = coefficient of variation of the annual design values.

Eligibility for the LMP option is then determined by comparing the average design value concentration to the CDV calculated for the same period. The CDV can be calculated using five years of data or across a longer period of time.
There is one PM10 monitor located in the Bullhead City PM10 -  maintenance area. This monitor is operated by the Arizona Department of Environmental Quality (ADEQ) and has been operating at its current location since November of 1997. Originally, ADEQ operated a Federal Reference Monitor (FRM) for PM10 at the site, that operated on a sampling schedule of once every six days. On July 1, 2012, this monitor was replaced by a continuous Federal Equivalent Method (FEM) instrument and provides data on a daily sampling schedule. The FEM monitor has continued to operate at the site since 2012. Because the sampling frequency of the monitor changed in 2012, the rank of the value used to calculate annual design values via the lookup method described above has changed over time.
In evaluating the Bullhead City PM10 -  LMP for eligibility for the LMP option, we evaluated data from 2006-2010, which were the years analyzed in the Second 10-Year LMP. We also evaluated the most recently available data from the site. In addition, we  provided evaluations of the data for the time period of 2013-2020 (using all data years with daily monitoring) but did not rely on these data years for qualification for the LMP.
Table 1 below provides the total valid days, table look-up rank, and resulting design concentration for design value years 2004 (data years 2002-2004) through 2020 (data years 2018-2020).

Table 1: Design Value Years with Design Concentration Determination for the Bullhead City area
                              Design Value Years
                               Total Valid Days
                                  Lookup Rank
                        Design Concentration (ug/m[3])
                                   2002-2004
                                      167
                                       1
                                      55
                                   2003-2005
                                      175
                                       1
                                      48
                                   2004-2006
                                      178
                                       1
                                      72
                                   2005-2007
                                      176
                                       1
                                      72
                                   2006-2008
                                      179
                                       1
                                      72
                                   2007-2009
                                      177
                                       1
                                      98
                                   2008-2010
                                      179
                                       1
                                      98
                                   2009-2011
                                      181
                                       1
                                      132
                                   2010-2012
                                      333
                                       1
                                      185
                                   2011-2013
                                      628
                                       2
                                      185
                                   2012-2014
                                      932
                                       3
                                      108
                                   2013-2015
                                     1085
                                       4
                                      84
                                   2014-2016
                                     1081
                                       4
                                      90
                                   2015-2017
                                     1066
                                       4
                                      91
                                   2016-2018
                                     1064
                                       4
                                      110
                                   2017-2019
                                     1076
                                       4
                                      192
                                   2018-2020
                                     1081
                                       4
                                      102

As stated above, we evaluated the LMP qualification primarily based on the years provided in the original submission. As shown in Table 2 below, the five years evaluated in the original submission were 2006 - 2010. Based on these years, we calculated the average design value concentration to be 89 μg/m[3]. The average design value concentration was below 98 μg/m[3] and therefore qualifies for this criterion of the LMP. For the motor vehicle calculation described later in this document, the site-specific CDV was calculated to be 114 μg/m[3] as shown in Table 3 below.

Table 2: 2006  -  2010 Average Design Value Concentration Calculation (Most recent five years upon plan submission)
                              Design Value Years
                        Design Concentration (ug/m[3])
                 Average Design Value Concentration (ug/m[3])
                                   2006-2008
                                      72
                                      89
                                   2007-2009
                                      98

                                   2008-2010
                                      98

Table 3: 2006  -  2010 CDV Calculation
                                     Mean
                                     89.3
                                       n
                                       3
                                      df
                                       2
                                      tc
                                     1.886
                              Standard Deviation
                                    15.011
                                      CV
                                    0.16803
                                      CDV
                                      114

We also evaluated the most recent five years (2016-2020). As shown in Table 4, the average design value concentration for Bullhead City was 101 μg/m[3], above the 98 μg/m[3] threshold. Because the average design value concentration was not below 98 μg/m[3], the site-specific CDV was calculated for this site. The values and results for the CDV calculation were given below in Table 5. As indicated in Table 5, we calculated the CDV for 2016- 2020 to be 128 μg/m[3]. Because the average design value concentration for that period, 101 μg/m[3], is below the CDV, 128 μg/m[3], the monitor also passes the second test for LMP qualification in the five most recent years.

Table 4: 2016  -  2020 Average Design Value Concentration Calculation (Most recent five years)
                              Design Value Years
                        Design Concentration (ug/m[3])
                 Average Design Value Concentration (ug/m[3])
                                   2016-2018
                                      110
                                      101
                                   2017-2019
                                      92

                                   2018-2020
                                      102

Table 5: 2016  -  2020 CDV Calculation
                                     Mean
                                     101.3
                                       n
                                       3
                                      df
                                       2
                                      tc
                                     1.886
                              Standard Deviation
                                     9.018
                                      CV
                                   0.088998
                                      CDV
                                      128

Tables 6 and 7 provide the average design value concentration and site-specific CDVs for the 2013  -  2020 time period. As stated above, this time period was reviewed because it encompassed using all data years with continuous monitoring.

As indicated in Tables 6 and 7, we calculate the 2013  -  2020 average design value concentration to be 95 μg/m[3] and the 2013  -  2020 site-specific CDV to be 131 μg/m[3]. Because the average design value concentration was below the CDV as well as the criteria of 98 μg/m[3] provided in the LMP Option memo, the area also passes the LMP qualification using all data with a daily sampling schedule from 2013  -  2020.

Table 6: 2013  -  2020 Average Design Value Concentration Calculation (All complete data years with daily sampling schedule)
                              Design Value Years
                        Design Concentration (ug/m[3])
                 Average Design Value Concentration (ug/m[3])
                                   2013-2015
                                      84
                                      95
                                   2014-2016
                                      90

                                   2015-2017
                                      91

                                   2016-2018
                                      110

                                   2017-2019
                                      92

                                   2018-2020
                                      102

Table 7: 2013  -  2020 CDV Calculation
                                     Mean
                                     94.83
                                       n
                                       6
                                      df
                                       5
                                      tc
                                     1.476
                              Standard Deviation
                                    9.43222
                                      CV
                                    0.09946
                                      CDV
                                      131

In its annual reports following submission of the Second 10-Year LMP, ADEQ identified eight monitored high PM10 values occurring between 2011 and 2018 that could have affected Bullhead City's CDV calculations. However, these events did not result in violations and therefore did not trigger the contingency measures in the Second 10-Year Plan. ADEQ indicated that these values were single-day episodes and attributed them to high wind events. EPA has not evaluated these possible events, so the high values are included in our average design value concentration calculations.
Table 8: High PM10 Values 2011-2018
Date
Measured 24-hr Conc.
                           Cause Identified by ADEQ
August 19, 2011
132 μg/m3
Thunderstorm-driven, wind-blown dust event
August 15, 2012
185 μg/m3
Thunderstorm-driven, windblown dust event
April 15, 2013
208 μg/m3
Regional Wind Event
May 10, 2014
108 μg/m3
Regional Wind Event
January 31, 2016
119 μg/m3
Regional Wind Event
March 30, 2017
125 μg/m3
Regional Wind Event
February 11, 2018
118 μg/m3
Regional Wind Event
July 9, 2018
102 μg/m3
Regional Thunderstorm Wind Event

In summary, the Bullhead City area met the average design value concentration criterion for LMP eligibility for the years presented in the Second 10-Year LMP (2006-2010), for the most recent years (2016-2020), and for all intervening years with continuous monitoring (2013-2020).

2. Motor Vehicle Growth Analysis
 ADEQ's motor vehicle growth analysis demonstration for the Second 10-Year LMP years of 2006-2010 yielded 99.6 ug/m[3], which is less than the 101 ug/m[3] site-specific CDV threshold that ADEQ calculated. However, ADEQ calculated the motor vehicle design value concentration based only on the on-road mobile portion of the 2008 attainment year inventory, yielding a value of 5 ug/m[3]. According to table 3.6 of the Second 10-Year LMP, total motor vehicle emissions made up 8.4% of the emissions inventory for 2008.
Using ADEQ's calculated design value concentration of 98 ug/m[3] with the 8.4% figure yields a motor vehicle design value concentration of 8.23 ug/m[3] and a motor vehicle regional analysis value of 100.62 ug/m[3]. Using EPA's calculated design value concentration for 2006-2010 of 89 ug/m3 yields a motor vehicle design value of 7.5 ug/m[3] and a motor vehicle regional analysis value of 91.4 ug/m[3]. Both 100.62 ug/m[3] and 91.4 ug/m[3] are lower than ADEQ's calculated site-specific CDV threshold of 101 ug/m[3] and below EPA's calculated site-specific CDV threshold of 114 ug/m[3] for the years 2006-2010.
In 2013, ADEQ provided EPA with updated exhaust, brake wear and tire wear emissions for the Second 10-Year LMP based on the development of EPA's Motor Vehicle Emission Simulator (MOVES) model. ADEQ found that using MOVES added 17.9 tons per year in total on-road PM10 emissions to the total emissions in Table 3.6 of its submittal. This would have yielded a motor vehicle design value concentration of 8.47 ug/m3 using ADEQ's maximum design value calculation of 98 ug/m[3]. Adding 0.24 ug/m3 to ADEQ's motor vehicle regional analysis value would not have raised it beyond ADEQ's calculated site-specific CDV. The updated motor vehicle emissions would also not have significantly impacted EPA's calculated motor vehicle regional analysis value, which was more than 20 ug/m3 below EPA's site-specific CDV calculation.
ADEQ's motor vehicle regional analysis calculation in the Second 10-Year LMP was a forward-looking projection of vehicle growth over the next 10 years. Given that Bullhead City's population grew less than 5% between the 2010 and 2020 Census, we find that the Second 10-Year LMP's motor vehicle growth analysis demonstration is sufficient and consistent with the area's continued attainment of the PM10 NAAQS.
Because the purpose of the LMP threshold is to indicate the probability that an area will exceed the NAAQS in the future, and because Bullhead City has stayed in attainment, the Second 10-Year LMP fulfilled the purpose intended by EPA's guidance.


[Federal Register: January 23, 2009 (Volume 74, Number 14)]
[Notices]
[Page 4179]
[DOCID:fr23ja09-45]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER09-513-000]

Cyprus Energy Futures, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

January 14, 2009.
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Kimberly D. Bose,
Secretary.
 [FR Doc. E9-1353 Filed 1-22-09; 8:45 am]

BILLING CODE 6717-01-P