[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19114-19115]
[FR Doc No: 2017-08288]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 32602; 812-14664]

Homestead Funds, Inc. and RE Advisers Corporation

April 19, 2017.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice.

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    Notice of an application under section 6(c) of the Investment
Company Act of 1940 (``Act'') for an exemption from section 15(a) of
the Act and rule 18f-2 under the Act. The requested exemption would
permit an investment adviser to hire and replace certain sub-advisers
without shareholder approval.

Applicants: Homestead Funds, Inc. (the ``Corporation''), a Maryland
corporation registered under the Act as an open-end management
investment company with multiple series, and RE Advisers Corporation, a
Virginia corporation registered as an investment adviser under the
Investment Advisers Act of 1940 (the ``Initial Manager,'' and,
collectively with the Corporation, the ``Applicants'').

Filing Dates: The application was filed on June 21, 2016, and amended
on November 1, 2016.

Hearing or Notification of Hearing: An order granting the application
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 May 15, 2017, and should be accompanied by proof of service on
the Applicants, in the form of an affidavit or, for lawyers, a
certificate of service. Pursuant to rule 0-5 under the Act, hearing
requests should state the nature of the writer's interest, any facts
bearing upon the desirability of a hearing on the matter, 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, U.S. Securities and Exchange Commission, 100 F
Street NE., Washington, DC 20549-1090. Applicants, 4301 Wilson
Boulevard, Arlington, VA 22203.

FOR FURTHER INFORMATION CONTACT: Christine Y. Greenlees, Senior
Counsel, at<PHONE_NUMBER>, or Robert Shapiro, Branch Chief, at (202)
551-6821 (Division of Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or an applicant
using the Company name box, at http://www.sec.gov/search/search.htm or
by calling<PHONE_NUMBER>.

Summary of the Application

    1. The Manager (as defined below) will serve as the investment
adviser to the Funds \1\ pursuant to an investment advisory agreement
with the Corporation (the ``Investment Management Agreement'').\2\ The

Manager is responsible for the overall management of the Funds'
business affairs and selecting investments according to each Fund's
respective investment objective, policies, and restrictions, subject to
the oversight and authority of each Fund's board of directors
(``Board''). The Investment Management Agreement permits the Manager,
subject to the approval of the Board, to delegate to one or more sub-
advisers (each, a ``Sub-Adviser'' and collectively, the ``Sub-
Advisers'') the responsibility to provide the day-to-day portfolio
investment management of each Fund, subject to the supervision and
direction of the Manager. The primary responsibility for managing the
Funds will remain vested in the Manager. The Manager will hire,
evaluate, allocate assets to and oversee the Sub-Advisers, including
determining whether a Sub-Adviser should be terminated, at all times
subject to the authority of the Board.
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    \1\ One of the Funds, the Stock Index Fund, currently operates
as a feeder fund managed by a third-party manager and invests
substantially all of its assets in a separate series of an
unaffiliated investment company (the ``Master Fund''). The Stock
Index Fund will not engage any sub-advisers other than through
approving the engagement of one or more of the Master Fund's sub-
advisers in the Stock Index Fund's capacity as a shareholder of the
Master Fund. The Master Fund is not an Applicant and the Stock Index
Fund will not rely on the requested order unless it is managed by
the Manager and complies with all of the conditions in the
application.
    \2\ Applicants request relief with respect to any existing or
future series of the Corporation and any other existing or future
registered open-end management investment company or series thereof
that: (a) is advised by the Initial Manager, or any entity
controlling, controlled by, or under common control with the Initial
Manager or its successors (each, a ``Manager''); (b) uses the
manager of managers structure described in the application; and (c)
complies with the terms and conditions of the application (any such
series, a ``Fund'' and collectively, the ``Funds''). For purposes of
the requested order, ``successor'' is limited to an entity that
results from a reorganization into another jurisdiction or a change
in the type of business organization.
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    2. Applicants request an exemption to permit the Manager, subject
to Board approval, to hire certain Sub-Advisers pursuant to Sub-
Advisory Agreements and materially amend existing Sub-Advisory
Agreements without obtaining the shareholder approval required under
section 15(a) of the Act and rule 18f-2 under the Act.\3\
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    \3\ The requested relief will not extend to any sub-adviser that
is an affiliated person, as defined in section 2(a)(3) of the Act,
of the Corporation, a Fund, or the Manager, other than by reason of
serving as a sub-adviser to one or more of the Funds.
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    3. Applicants agree that any order granting the requested relief
will be subject to the terms and conditions stated in the application.
Such terms and conditions provide for, among other safeguards,
appropriate disclosure to Fund shareholders and notification about sub-
advisory changes and enhanced Board oversight to protect the interests
of the Funds' shareholders.
    4. Section 6(c) of the Act provides that the Commission may exempt
any person, security, or transaction or any class or classes of
persons, securities, or transactions from any provisions of the Act, or
any rule thereunder, if such relief is necessary or appropriate in the
public interest and consistent with the protection of investors and
purposes fairly intended by the policy and provisions of the Act.
Applicants believe that the requested relief meets this standard
because, as further explained in the application, the Investment
Management Agreements will remain subject to shareholder approval,
while the role of the Sub-Advisers is substantially similar to that of
individual portfolio managers, so that requiring shareholder approval
of Sub-Advisory Agreements would impose unnecessary delays and expenses
on the Funds.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-08288 Filed 4-24-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Notices]
[Pages 42700-42701]
[FR Doc No: 2016-15563]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 11480-028]

Haida Energy, Inc.; Notice of Application Accepted For Filing,
Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Amendment of License.
    b. Project No.: 11480-028.
    c. Date Filed: March 3, 2016.
    d. Applicant: Haida Energy, Inc. (HEI).
    e. Name of Project: H[iacute]ilangaay Hydroelectric Project.
    f. Location: On Reynolds Creek, near the town of Hydaburg, Alaska.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Glen D. Martin, Alaska Power & Telephone
Company, P.O. Box 3222, Port Townsend, WA 98368<PHONE_NUMBER> x122,
Email<EMAIL_ADDRESS>    i. FERC Contact: Mr. M. Joseph Fayyad,<PHONE_NUMBER>,

<EMAIL_ADDRESS>and Marybeth Gay,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene and protests,
is 30 days from the issuance date of this notice. The Commission
strongly encourages electronic filing. Please file motions to
intervene, protests, comments, and recommendations, using the
Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-11480-028.
    k. Description of Request: HEI requests amendment of several
provisions in its license for the unconstructed H[iacute]ilangaay
Hydroelectric Project, based on a Fish Habitat Permit issued by Alaska
Department of Fish and Game and several factors it has identified that
adversely affect the project economics. Specifically, based on
consultations with state and federal agencies, HEI proposes a series of
changes to the project description and affected license articles: (1)
Move the penstock alignment further to the north; (2) move the location
of the powerhouse about 80 feet further back from Reynolds Creek; (3)
modify the tailrace length as a result of moving the powerhouse
location; (4) add an access road to the diversion area on the south
side of Rich's Pond; (5) adjust the proposed transmission line pole
locations and widen the transmission line right of way in the Jumbo
Island area to minimize tree-fall hazards to the transmission line; (6)
increase the project's hydraulic capacity from 90 cfs to 100 cfs; (7)
change the starting date for in-water construction window; (8) remove
the ``perched ledge'' design requirement for the tailrace; (9) change
the ramping rates requirement to apply only to flow decreases; (10)
replace the requirement for a shunt pipeline with jet deflectors on the
turbine and eliminate a synchronous bypass valve from the powerhouse
design; and (11) change the fish screen design from a retractable T-
cylinder screen to a conventional bar screen.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number excluding the last three digits
in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
and .214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis and otherwise comply with the requirements of 18 CFR
4.34(b). All comments, motions to intervene, or protests should relate
to project works which are the subject of the license surrender.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application. If an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.

    Dated: June 24, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-15563 Filed 6-29-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 214 (Tuesday, November 5, 2013)]
[Rules and Regulations]
[Pages 66252-66254]
[FR Doc No: 2013-24037]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0488; Directorate Identifier 2008-SW-002-AD;
Amendment 39-17619; AD 2013-20-13]
RIN 2120-AA64

Airworthiness Directives; Bell Helicopter Textron Canada Limited
(Bell) Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Bell Model 206B and 206L helicopters. This AD requires installing a
placard beneath the engine power dual tachometer and revising the
operating limitations section of the rotorcraft flight manual (RFM).
This AD was prompted by several incidents of third stage engine turbine
wheel failures, which were caused by excessive vibrations at certain
engine speeds during steady-state operations. These actions are
intended to alert pilots to avoid certain engine speeds during steady-
state operations, prevent failure of the third stage engine turbine,
engine power loss, and subsequent loss of control of the helicopter.

DATES: This AD is effective December 10, 2013.
    The Director of the Federal Register approved the incorporation by
reference of a certain document listed in this AD as of December 10,
2013.

ADDRESSES: For service information identified in this AD, contact Bell
Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel,
Quebec J7J1R4; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax (450)
433-0272; or at http://www.bellcustomer.com/files/. You may review the
referenced service information at the FAA, Office of the Regional
Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth,
Texas 76137.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the foreign authority's AD,
any incorporated-by-reference service information, the economic
evaluation, any comments received, and other information. The street
address for the Docket Operations Office (phone:<PHONE_NUMBER>) is U.S.
Department of Transportation, Docket Operations Office, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Chinh Vuong, Aviation Safety Engineer,
Safety Management Group, Rotorcraft Directorate, FAA, 2601 Meacham
Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    On June 7, 2013, at 78 FR 34280, the Federal Register published our
notice of proposed rulemaking (NPRM), which proposed to amend 14 CFR
part 39 by adding an AD that would apply to Bell Model 206B
helicopters, serial number (S/N) 004 through 4675, including
helicopters converted from Model 206A and Model 206L helicopters, S/N
45001 through 45153, and 46601 through 46617. The NPRM proposed to
require installing a placard on the instrument panel below the NR/N2
dual tachometer and revising the Operating Limitations section of the
Model 206B RFM and 206L RFM to limit steady-state operation between
speeds of 75% and 88%. The proposed requirements were intended to alert
pilots to avoid certain engine speeds during steady-state operations,
prevent failure of the third stage engine turbine, engine power loss,
and subsequent loss of control of the helicopter.
    The NPRM was prompted by AD No. CF-2007-13R2, dated November 10,
2009, issued by Transport Canada Civil Aviation (TCCA), which is the
aviation authority for Canada. TCCA issued AD No. CF-2007-13R2 to
correct an unsafe condition for certain Model 206B (including those
converted from Model 206A) and 206L helicopters. TCCA advises of
several failures of third stage turbine wheels used in Rolls Royce 250-
C20. According to TCCA, Rolls Royce

has determined that detrimental vibrations can occur within a
particular range of turbine speeds, and may be a contributing factor to
these failures. Bell has revised the RFM and has provided a
corresponding decal to inform pilots to avoid steady-state operations
between 75% and 88% turbine speeds.
    The TCCA AD requires amending the RFMs, advising pilots of the
change, and installing a decal as described in Bell Alert Service
Bulletin (ASB) No. 206-07-115, Revision C, dated February 4, 2009, for
Model 206B helicopters (ASB 206-07-115) and Bell ASB No. 206L-07-146,
Revision B, dated March 3, 2009, for Model 206L helicopters (ASB 206L-
07-146).

Comments

    After our NPRM (78 FR 34280, June 7, 2013) was published, we
received comments from one commenter.

Request

    Rolls-Royce Corporation requested that in addition to requiring the
placard on the instrument panel, we allow operators the option to
temporarily mark the Nr/Np gauge with colored
tape, to provide a more visual aide to the pilot for the speed
avoidance zone.
    We disagree. Marking the glass surface of the gauge can create
parallax issues when viewing the avoidance ranges on the gauge,
resulting in erroneous readings.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Canada and are approved for operation in the United States. Pursuant to
our bilateral agreement with Canada, TCCA, its technical
representative, has notified us of the unsafe condition described in
the TCCA AD. We are issuing this AD because we evaluated all
information provided by TCCA, reviewed the relevant information,
considered the comment received, and determined the unsafe condition
exists and is likely to exist or develop on other helicopters of the
same type design and that air safety and the public interest require
adopting the AD requirements as proposed.

Differences Between This AD and the TCCA AD

    The TCCA AD requires compliance within 10 calendar days, while this
AD requires compliance within 30 days.

Related Service Information

    Bell has issued ASB 206-07-115 and ASB 206L-07-146, which contain
procedures for installing a placard on the instrument panel below the
main rotor RPM (Nr)/power turbine RPM (N2) dual tachometer and for
inserting the RFM changes into the flight manual.

Costs of Compliance

    We estimate that this AD will affect 970 helicopters of U.S.
Registry. Based on an average labor rate of $85 per hour, we estimate
that operators will incur the following costs in order to comply with
this AD. Amending the RFM will require about 0.5 work-hour, for a cost
per helicopter of about $43 and a cost to U.S. operators of $41,710.
Installing the decal will require about 0.2 work-hour and required
parts will cost $20, for a cost per helicopter of $37 and a cost to
U.S. operators of $35,890. Based on these estimates, the total cost of
this AD is $80 per helicopter and $77,600 for the U.S. operator fleet.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on helicopters identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979);
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction; and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2013-20-13 Bell Helicopter Textron Canada Limited (Bell): Amendment
39-17619; Docket No. FAA-2013-0488; Directorate Identifier 2008-SW-
002-AD.

(a) Applicability

    This AD applies to the following helicopters, certificated in
any category:
    (1) Bell Model 206B, serial number (S/N) 004 through 4675,
including helicopters converted from Model 206A; and
    (2) Bell Model 206L, S/N 45001 through 45153, and 46601 through
46617.

(b) Unsafe Condition

    This AD defines the unsafe condition as a third stage turbine
vibration, which could result in turbine failure, engine power loss,
and subsequent loss of control of the helicopter.

(c) Effective Date

    This AD becomes effective December 10, 2013.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 30 days:
    (1) For Model 206B helicopters:
    (i) Revise the Operating Limitations section of the Model 206B
Rotorcraft Flight Manual (RFM) by inserting Section 1, Operating
Limitations, page 1-2A, of Bell BHT-206B-FM-1, revision B-50, dated
December 8, 2008.
    (ii) Remove placard part number (P/N) 230-075-213-121, if
installed.
    (iii) Install placard P/N 230-075-213-125, or equivalent, on the
instrument panel directly below the dual tachometer.
    (2) For Model 206L helicopters:

    (i) Revise the Operating Limitations section of the Model 206L
RFM by inserting Section 1, Operating Limitations, page 1-4B, of
Bell BHT-206L-FM-1, revision 28, dated December 8, 2008.
    (ii) Remove placard P/N 230-075-213-123, if installed.
    (ii) Install placard P/N 230-075-213-127, or equivalent, on the
instrument panel below the dual tachometer.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Chinh Vuong, Aviation Safety
Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 2601
Meacham Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office, before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    (1) Bell Alert Service Bulletin (ASB) No. 206-07-115, Revision
C, dated February 4, 2009, and Bell ASB No. 206L-07-146, Revision B,
dated March 3, 2009, which are not incorporated by reference,
contain additional information about the subject of this AD. For
service information identified in this AD, contact Bell Helicopter
Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec
J7J1R4; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax (450) 433-
0272; or at http://www.bellcustomer.com/files/. You may review a
copy of the service information at the FAA, Office of the Regional
Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth,
Texas 76137.
    (2) The subject of this AD is addressed in Transport Canada
Civil Aviation (TCCA) AD No. CF-2007-13R2, dated December 9, 2009.
You may view the TCCA AD on the internet in the AD Docket at http://www.regulations.gov.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 7250: Turbine
Section.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Page 1-2A of Section 1, Operating Limitations, of Bell
Rotorcraft Flight Manual BHT-206B-FM-1, Revision B-50, dated
December 8, 2008.
    (ii) Page 1-4B of Section 1, Operating Limitations, of Bell
Rotorcraft Flight Manual BHT-206L-FM-1, Revision 28, dated December
8, 2008.
    (3) For Bell service information identified in this AD, contact
Bell Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir,
Mirabel, Quebec J7J1R4; telephone<PHONE_NUMBER> or<PHONE_NUMBER>;
fax<PHONE_NUMBER>; or at http://www.bellcustomer.com/files/.
    (4) You may view this service information at FAA, Office of the
Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663,
Fort Worth, Texas 76137. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Fort Worth, Texas, on September 25, 2013.
Lance T. Gant,
Acting Directorate Manager, Rotorcraft Directorate, Aircraft
Certification Service.
[FR Doc. 2013-24037 Filed 11-4-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: April 14, 2009 (Volume 74, Number 70)]
[Notices]
[Page 17196-17197]
[DOCID:fr14ap09-73]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-P-0250] (formerly Docket No. 2007P-0341)

Determination That ZOMETA (Zoledronic Acid for Injection),
Equivalent to 4 Milligrams Base Per Vial, Lyophilized Powder for
Injection, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that
ZOMETA (zoledronic acid for injection), equivalent to (EQ) 4 milligrams
(mg) base/vial, lyophilized powder for injection, was not withdrawn
from sale for reasons of safety or effectiveness. This determination
will allow FDA to approve abbreviated new drug applications (ANDAs) for
zoledronic acid lyophilized powder for injection, 4-mg base/vial.

FOR FURTHER INFORMATION CONTACT: Nancy Boocker, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6244, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
sponsors must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. Sponsors of ANDAs do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA). The only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is generally known as the ``Orange
Book.'' Under FDA regulations, drugs are withdrawn from the list if the
agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    Under 21 CFR 314.161(a)(1), the agency must determine whether a
listed drug was withdrawn from sale for reasons of safety or
effectiveness before an ANDA that refers to that listed drug may be
approved. FDA may not approve an ANDA that does not refer to a listed
drug.
    ZOMETA (zoledronic acid for injection), EQ 4-mg base/vial,
lyophilized powder for injection, is the subject of approved NDA 21-223
held by Novartis Pharmaceuticals Corp. (Novartis). Zoledronic acid,
lyophilized powder for injection, EQ 4-mg base/vial, is indicated for
treatment of hypercalcemia of malignancy. It also is indicated for the
treatment of patients with multiple myeloma and patients with
documented bone metastases from solid tumors, in conjunction with
standard antineoplastic therapy. Novartis ceased manufacturing ZOMETA
(zoledronic acid for injection), EQ 4 mg-base/vial, lyophilized powder
for injection, in May 2003. On September 13, 2007, Kendle
International, on behalf of Sun Pharmaceutical Industries Ltd.,
submitted a citizen petition (Docket No. 2007P-0341/CP1), under 21 CFR
10.30, requesting that the agency determine whether zoledronic acid
lyophilized powder for injection, EQ 4-mg base/vial, was withdrawn from
sale for reasons of safety or effectiveness.
    The agency has determined that ZOMETA (zoledronic acid for
injection), EQ 4-mg base/vial, lyophilized powder for injection, was
not withdrawn from sale for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
zoledronic acid lyophilized powder for injection, 4-mg base/vial, was
withdrawn from sale as a result of safety or effectiveness concerns.
FDA's independent evaluation of relevant information has uncovered no
information that would indicate this product was withdrawn for reasons
of safety or effectiveness.
    After considering the citizen petition and reviewing agency
records, FDA determines that for the reasons outlined previously,
ZOMETA (zoledronic acid for injection), EQ 4-mg base/vial, lyophilized
powder for injection, was not withdrawn from sale for reasons of safety
or effectiveness. Accordingly, the agency will continue to list ZOMETA
(zoledronic acid for injection), 4-mg base/vial, lyophilized powder for
injection, in the ``Discontinued Drug Product List'' section of the
Orange Book. The ``Discontinued Drug Product List'' delineates, among
other items, drug products that have been discontinued from marketing
for reasons other than safety or effectiveness. ANDAs that refer to
ZOMETA (zoledronic acid for injection), EQ 4-mg base/vial, lyophilized
powder for injection, may be approved by the agency as long as they
meet all relevant legal and regulatory requirements for the approval of
ANDAs. If FDA determines that the labeling of this drug product should
be revised to meet current standards, the agency will advise ANDA
applicants to submit such labeling.

    Dated: March 7, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-8524 Filed 4-13-09; 8:45 am]

BILLING CODE 4160-01-S


TABLE 1. AVERAGE ANNUAL EPA RESOURCE REQUIREMENT ( A) ( B) ( C) a ( D) ( E) b Cost EPA h/ Occurrences/ EPA h/ Plants/ EPA per Activity Occurrence plant/ yr plant/ yr year hr/ yr yr Initial Performance Tests ............................ not applicable......................... Report Review New Plant Notification of construction None expected Notification of anticipated startup ......................... not applicable......................... Notification of actual startup ......................... not applicable......................... Initial Report b ......................... not applicable......................... Notification of performance test ......................... not applicable......................... Existing Plant Quarterly reports 2 4 8 140 1120 53,760 Annual Recertification 1 1 1 240 240 11,521 TOTAL ANNUAL HOURS 1220 Travel Expenses d ( 1 person x 14 plants/ yr x 1 d/ plant x $ 50 per diem) + ($ 250 round trip/ plant x 14 plants/ yr) = $ 4,200/ yr TOTAL ANNUAL COST = $ 69,481/ yr a A X B = C b C X D = E d Assume 10% of new affected facilities will be visited e Assume an hourly wage of $ 22.86 plus 110% overhead expenses which equals $ 48. This amount was multiplied by the hours in each line of Column E to estimate the total annual cost per year.


[Federal Register Volume 79, Number 170 (Wednesday, September 3, 2014)]
[Notices]
[Pages 52406-52407]
[FR Doc No: 2014-20989]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Malfunction or
Defect Report

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval for to renew an information
collection. The information collected allows the FAA to evaluate its
certification standards, maintenance programs, and regulatory
requirements. It is also the basis for issuance of Airworthiness
Directives designed to prevent unsafe conditions and accidents.

DATES: Written comments should be submitted by November 3, 2014.

ADDRESSES: Send comments to the FAA at the following address: Ms. Kathy
DePaepe, Room 126B, Federal Aviation Administration, ASP-110, 6500 S.
MacArthur Blvd., Oklahoma City, OK 73169.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0003.
    Title: Malfunction or Defect Report.
    Form Numbers: FAA Form 8010-4.
    Type of Review: Renewal of an information collection.
    Background: Repair stations certificated under Part 145 and air
taxi operators certificated under Part 135 mandatorily submit
malfunction or defect reports on Federal Aviation Administration (FAA)
Form 8010-4. When defects are reported which are likely to exist on
other products of the same or similar design, the FAA may disseminate
safety information to a particular section of the aviation community.
The FAA also may adopt new regulations or issue Airworthiness

Directives (AD's) to address a specific problem.
    Respondents: Approximately 60,000 operators.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 9 minutes.
    Estimated Total Annual Burden: 9,000 hours.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC, on August 27, 2014.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, ASP-110.
[FR Doc. 2014-20989 Filed 9-2-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 181 (Wednesday, September 18, 2019)]
[Rules and Regulations]
[Pages 49014-49017]
[FR Doc No: 2019-20107]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2019-0634]
RIN 1625-AA08

Special Local Regulation; North Atlantic Ocean, Ocean City, MD

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing special local regulations for
certain waters of the North Atlantic Ocean. This action is necessary to
provide for the safety of life on these navigable waters located at
Ocean City, MD, during a high-speed power boat racing event on
September 29, 2019. This regulation prohibits persons and vessels from
being in the regulated area unless authorized by the Captain of the
Port Maryland-National Capital Region or Coast Guard Patrol Commander.

DATES: This rule is effective from 8:30 a.m. to 5:30 p.m. on September
29, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2019-0634 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Ron Houck, U.S. Coast Guard Sector Maryland-National
Capital Region; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
PATCOM Coast Guard Patrol Commander
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    OPA Racing LLC of Brick Township, NJ, notified the Coast Guard that
it will be conducting the Ocean City Grand Prix between 9:00 a.m. and
5:00 p.m. on September 29, 2019, along a designated, marked racetrack-
type course located in the North Atlantic Ocean, at Ocean City, MD. In
response, on August 23, 2019, the Coast Guard published a notice of

proposed rulemaking (NPRM) titled ``Special Local Regulation; North
Atlantic Ocean, Ocean City, MD'' (84 FR 44263). There we stated why we
issued the NPRM, and invited comments on our proposed regulatory action
related to this power boat racing event. During the comment period that
ended September 9, 2019, we received one comment.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable and contrary to public interest
because it would delay the safety measures necessary to respond to
potential safety hazards associated with this marine event. Immediate
action is needed protect participants, spectators, and other persons
and vessels during the high-speed race event on these navigable waters.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70041. The Captain of the Port Maryland-National Capital Region (COTP)
has determined that potential hazards associated with the power boat
racing event will be a safety concern for anyone intending to operate
in or near the event area. The purpose of this rule is to protect event
participants, spectators, and transiting vessels on specified waters of
the North Atlantic Ocean before, during, and after the scheduled event.

IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received one comment on our NPRM published
August 23, 2019. We thank the commenter for taking time to review the
NPRM and submitting a comment regarding this action.
    The commenter stated that the high-speed power boat racing event
should be cancelled in order to not obstruct normal waterway operations
and waste precious energy.
    With few exceptions, normal waterway operations in the event area
are recreational in nature that will be able to take place safely
outside the regulated area. Waterway users that may be affected by the
regulated area are well informed of this annually occurring offshore
power boat racing event. Methods include Code of Federal Regulations,
internet websites (http://www.oparacing.org/oc.html, https://oceancitymd.gov/oc/event/ocean-city-powerboat-grand-prix/), regional
boating publications (i.e., PropTalk), social media (i.e., Facebook),
and local media outlets (i.e., The Dispatch), which include newspaper,
radio and television. The part of the comment regarding energy is
outside the scope of the rulemaking; the regulated area is established
to provide for waterway safety.
    There are no changes in the regulatory text of this rule from the
proposed rule in the NPRM.
    This rule establishes a special local regulation to be enforced
from 8:30 a.m. to 5:30 p.m. on September 29, 2019. The regulated area
will cover all navigable waters of the North Atlantic Ocean, within an
area bounded by the following coordinates: Commencing at a point near
the shoreline at latitude 38[deg]21'42'' N, longitude 075[deg]04'11''
W, thence east to latitude 38[deg]21'33'' N, longitude 075[deg]03'10''
W, thence southwest to latitude 38[deg]19'25'' N, longitude
075[deg]04'02'' W, thence west to the shoreline at latitude
38[deg]19'35'' N, longitude 075[deg]05'02'' W, at Ocean City, MD. The
duration of the special local regulations and size of the regulated
area are intended to ensure the safety of life on these navigable
waters before, during, and after the power boat racing event, scheduled
from 9:00 a.m. until 5:00 p.m. on September 29, 2019.
    Except for participants and vessels already at berth, a vessel or
person will be required to get permission from the COTP or PATCOM
before entering the regulated area. Vessel operators can request
permission to enter and transit through the regulated area by
contacting the PATCOM on VHF-FM channel 16. Vessel traffic will be able
to safely transit the regulated area once the PATCOM deems it safe to
do so. A person or vessel not registered with the event sponsor as a
participant or assigned as official patrols will be considered a
spectator. Official Patrols are any vessel assigned or approved by the
Commander, Coast Guard Sector Maryland-National Capital Region with a
commissioned, warrant, or petty officer on board and displaying a Coast
Guard ensign.
    If permission is granted by the COTP or PATCOM, a person or vessel
will be allowed to enter the regulated area or pass directly through
the regulated area as instructed. Vessels will be required to operate
at a safe speed that minimizes wake while within the regulated area.
Official patrol vessels will direct spectator vessels while within the
regulated area. Only participant vessels and official patrol vessels
will be allowed to enter the race area.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size, duration
and location of the regulated area. Vessel traffic will be able to
safely transit around this regulated area, which would impact a small
designated area of the North Atlantic Ocean for 9 hours. The Coast
Guard will issue a Broadcast Notice to Mariners via VHF-FM marine
channel 16 about the status of the regulated area. Moreover, the rule
will allow vessels to seek permission to enter the regulated area, and
vessel traffic will be able to safely transit the regulated area once
the PATCOM deems it safe to do so.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rulemaking. The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have a significant economic
impact on a substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement

Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
determined that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves implementation of regulations within 33
CFR part 100 applicable to organized marine events on the navigable
waters of the United States. The temporary regulated area will be in
effect for nine hours. It is categorically excluded from further review
under paragraph L61 in Table 3-1 of U.S. Coast Guard Environmental
Planning Implementing Procedures 5090.1. A Memorandum for the Record
supporting this determination is available in the docket where
indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority:  46 U.S.C. 70041; 33 CFR 1.05-1.

0
2. Add Sec.  [thinsp]100.501T05-0634 to read as follows:

Sec.  100.501T05-0634  Special Local Regulation; North Atlantic Ocean,
Ocean City, MD.

    (a) Locations. All coordinates reference Datum NAD 1983.
    (1) Regulated area. All navigable waters of the North Atlantic
Ocean, within an area bounded by the following coordinates: Commencing
at a point near the shoreline at position latitude 38[deg]21'42'' N,
longitude 075[deg]04'11'' W; thence east to latitude 38[deg]21'33'' N,
longitude 075[deg]03'10'' W; thence southwest to latitude
38[deg]19'25'' N, longitude 075[deg]04'02'' W; thence west to the
shoreline at latitude 38[deg]19'35'' N, longitude 075[deg]05'02'' W, at
Ocean City, MD. The race area, buffer area, and spectator area are
within the regulated area.
    (2) Race area. The race area is a polygon in shape measuring
approximately 3,500 yards in length by 350 yards in width. The area is
bounded by a line commencing at position latitude 38[deg]19'46.85'' N,
longitude 075[deg]04'43.28'' W, thence east to latitude
38[deg]19'44.23'' N, longitude 075[deg]04'29.89'' W, thence north and
parallel to Ocean City, MD shoreline to latitude 38[deg]21'23.24'' N,
longitude 075[deg]03'48.87'' W, thence west to latitude
38[deg]21'25.12'' N, longitude 075[deg]04'02.45'' W; thence south to
the point of origin.
    (3) Buffer zone. The buffer zone is a polygon in shape measuring
approximately 500 yards in all directions surrounding the entire race
area described in paragraph (a) of this section. The area is bounded by
a line commencing at a point near the shoreline at position latitude
38[deg]21'42'' N, longitude 075[deg]04'11'' W; thence east to latitude
38[deg]21'35'' N, longitude 075[deg]03'24'' W; thence southwest to
latitude 38[deg]19'28'' N, longitude 075[deg]04'17'' W; thence west to
the shoreline at latitude 38[deg]19'35'' N, longitude 075[deg]05'02''
W, at Ocean City, MD.
    (4) Spectator area. The designated spectator area is a polygon in
shape measuring approximately 3,500 yards in length by 350 yards in
width. The area is bounded by a line commencing at position latitude
38[deg]19'40'' N, longitude 075[deg]04'12'' W, thence east to latitude
38[deg]19'37'' N, longitude 075[deg]03'59'' W, thence northeast to
latitude 38[deg]21'17'' N, longitude 075[deg]03'17'' W, thence west to
latitude 38[deg]21'20'' N, longitude 075[deg]03'31'' W, thence
southwest to point of origin.
    (b) Definitions. As used in this section:
    Buffer zone is a neutral area that surrounds the perimeter of the
Race Area within the regulated area described by this section. The
purpose of a buffer

zone is to minimize potential collision conflicts with marine event
participants or race boats and spectator vessels or nearby transiting
vessels. This area provides separation between a Race Area and a
specified Spectator Area or other vessels that are operating in the
vicinity of the regulated area established by the special local
regulations.
    Captain of the Port (COTP) Maryland-National Capital Region means
the Commander, U.S. Coast Guard Sector Maryland-National Capital Region
or any Coast Guard commissioned, warrant or petty officer who has been
authorized by the COTP to act on his behalf.
    Coast Guard Patrol Commander (PATCOM) means a commissioned,
warrant, or petty officer of the U.S. Coast Guard who has been
designated by the Commander, Coast Guard Sector Maryland-National
Capital Region.
    Official patrol means any vessel assigned or approved by Commander,
Coast Guard Sector Maryland-National Capital Region with a
commissioned, warrant, or petty officer on board and displaying a Coast
Guard ensign.
    Participant means a person or vessel registered with the event
sponsor as participating in the Ocean City Grand Prix or otherwise
designated by the event sponsor as having a function tied to the event.
    Race area is an area described by a line bound by coordinates
provided in latitude and longitude that outlines the boundary of a race
area within the regulated area defined by this section.
    Spectator means a person or vessel not registered with the event
sponsor as participants or assigned as official patrols.
    (c) Special local regulations. (1) The COTP Maryland-National
Capital Region or PATCOM may forbid and control the movement of all
vessels and persons, including event participants, in the regulated
area. When hailed or signaled by an official patrol, a vessel or person
in the regulated area shall immediately comply with the directions
given by the patrol. Failure to do so may result in the Coast Guard
expelling the person or vessel from the area, issuing a citation for
failure to comply, or both. The COTP Maryland-National Capital Region
or PATCOM may terminate the event, or a participant's operations at any
time the COTP Maryland-National Capital Region or PATCOM believes it
necessary to do so for the protection of life or property.
    (2) Except for participants and vessels already at berth, a person
or vessel within the regulated area at the start of enforcement of this
section must immediately depart the regulated area.
    (3) A spectator must contact the PATCOM to request permission to
either enter or pass through the regulated area. The PATCOM, and
official patrol vessels enforcing this regulated area, can be contacted
on marine band radio VHF-FM channel 16 (156.8 MHz) and channel 22A
(157.1 MHz). If permission is granted, the spectator must pass directly
through the regulated area as instructed by PATCOM. A vessel within the
regulated area must operate at safe speed that minimizes wake.
    (4) Only participant vessels and official patrol vessels are
allowed to enter the race area.
    (5) A person or vessel that desires to transit, moor, or anchor
within the regulated area must obtain authorization from the COTP
Maryland-National Capital Region or PATCOM. A person or vessel seeking
such permission can contact the COTP Maryland-National Capital Region
at telephone number<PHONE_NUMBER> or on Marine Band Radio, VHF-FM
channel 16 (156.8 MHz) or the PATCOM on Marine Band Radio, VHF-FM
channel 16 (156.8 MHz).
    (6) The Coast Guard will publish a notice in the Fifth Coast Guard
District Local Notice to Mariners and issue a marine information
broadcast on VHF-FM marine band radio announcing specific event date
and times.
    (d) Enforcement officials. The Coast Guard may be assisted with
marine event patrol and enforcement of the regulated area by other
Federal, State, and local agencies.
    (e) Enforcement period. This section will be enforced from 8:30
a.m. to 5:30 p.m. on September 29, 2019.

    Dated: September 12, 2019.
Joseph B. Loring,
Captain, U.S. Coast Guard, Captain of the Port Maryland-National
Capital Region.
[FR Doc. 2019-20107 Filed 9-17-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 201 (Friday, October 16, 2020)]
[Notices]
[Pages 65832-65833]
[FR Doc No: 2020-22911]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3179]

Request for Nominations on Public Advisory Panels of the Medical
Devices Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organizations interested in participating in the selection of
nonvoting industry representatives to serve on certain panels of the
Medical Devices Advisory Committee (MDAC or Committee) in the Center
for Devices and Radiological Health (CDRH) notify FDA in writing. FDA
is also requesting nominations for nonvoting industry representatives
to serve on certain device panels of the MDAC in the CDRH. A nominee
may either be self-nominated or nominated by an organization to serve
as a nonvoting industry representative. Nominations will be accepted
for current and upcoming vacancies effective with this notice.

DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to FDA by November
16, 2020 (see sections I and II of this document for further details).
Concurrently, nomination materials for prospective candidates should be
sent to FDA by November 16, 2020.

ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of nonvoting
industry representative nomination should be sent to Margaret Ames (see
FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting
industry representatives should be submitted electronically by
accessing the FDA Advisory Committee Membership Nomination Portal:
https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or
by mail to Advisory Committee Oversight and Management Staff, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993-0002. Information about becoming a member of an
FDA advisory committee can also be obtained by visiting FDA's website
at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Margaret Ames, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5213, Silver Spring, MD 20993,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Agency is requesting nominations for
nonvoting industry representatives to the panels listed in the table in
this document.

I. Medical Devices Advisory Committee

    The Committee reviews and evaluates data on the safety and
effectiveness of marketed and investigational devices and makes
recommendations for their regulation. The panels engage in a number of
activities to fulfill the functions the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) envisions for device advisory panels. With
the exception of the Medical Devices Dispute Resolution Panel, each
panel, according to its specialty area, advises the Commissioner of
Food and Drugs (the Commissioner) regarding recommended classification
or reclassification of devices into one of three regulatory categories;
advises on any possible risks to health associated with the use of
devices; advises on formulation of product development protocols;
reviews premarket approval applications for medical devices; reviews
guidelines and guidance documents; recommends exemption of certain
devices from the application of portions of the FD&C Act; advises on
the necessity to ban a device; and responds to requests from the Agency
to review and make recommendations on specific issues or problems
concerning the safety and effectiveness of devices. With the exception
of the Medical Devices Dispute Resolution Panel, each panel, according
to its specialty area, may also make appropriate recommendations to the
Commissioner on issues relating to the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices. The Committee also provides recommendations to the
Commissioner or designee on complexity categorization of in vitro
diagnostics under the Clinical Laboratory Improvement Amendments of
1988.

------------------------------------------------------------------------
            Panels                              Function
------------------------------------------------------------------------
Anesthesiology and             Reviews and evaluates data concerning the
 Respiratory Therapy Devices    safety and effectiveness of marketed and
 Panel.                         investigational devices for use in
                                anesthesiology and respiratory therapy
                                and makes appropriate recommendations to
                                the Commissioner.
Dental Products Panel (one     Reviews and evaluates data concerning the
 representative--to represent   safety and effectiveness of marketed and
 the dental drug industry).     investigational products for use in
                                dentistry, endodontics or bone
                                physiology relative to the oral and
                                maxillofacial area and makes appropriate
                                recommendations to the Commissioner.

Medical Devices Dispute        Provides advice to the Center Director on
 Resolution Panel.              complex or contested scientific issues
                                between FDA and medical device sponsors,
                                applicants, or manufacturers relating to
                                specific products, marketing
                                applications, regulatory decisions and
                                actions by FDA, and Agency guidance and
                                policies.
Microbiology Devices Panel...  Reviews and evaluates data concerning the
                                safety and effectiveness of marketed and
                                investigational in vitro diagnostic
                                devices for use in clinical laboratory
                                medicine including microbiology,
                                virology, and infectious disease and
                                makes recommendations to the
                                Commissioner.
Molecular and Clinical         Reviews and evaluates data concerning the
 Genetics Panel.                safety and effectiveness of marketed and
                                investigational in vitro devices for use
                                in clinical laboratory medicine
                                including clinical and molecular
                                genetics and makes appropriate
                                recommendations to the Commissioner.
Neurological Devices Panel...  Reviews and evaluates data concerning the
                                safety and effectiveness of marketed and
                                investigational devices for use in the
                                neurological system and makes
                                appropriate recommendations to the
                                Commissioner.
Radiological Devices Panel...  Reviews and evaluates data concerning the
                                safety and effectiveness of marketed and
                                investigational diagnostic or
                                therapeutic radiological and nuclear
                                medicine devices and makes appropriate
                                recommendations to the Commissioner.
------------------------------------------------------------------------

II. Qualifications

    Persons nominated for the device panels should be full-time
employees of firms that manufacture products that would come before the
panel, or consulting firms that represent manufacturers, or have
similar appropriate ties to industry.

III. Selection Procedure

    Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a complete list of all such organizations; and a list of all nominees
along with their current r[eacute]sum[eacute]s. The letter will also
state that it is the responsibility of the interested organizations to
confer with one another and to select a candidate, within 60 days after
the receipt of the FDA letter, to serve as the nonvoting member to
represent industry interests for a particular device panel. The
interested organizations are not bound by the list of nominees in
selecting a candidate. However, if no individual is selected within 60
days, the Commissioner will select the nonvoting member to represent
industry interests.

IV. Application Procedure

    Individuals may self-nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Nomination must include a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee including
current business address and telephone number, email address if
available, and a signed copy of the Acknowledgement and Consent form
available at the FDA Advisory Committee Membership Nomination Portal
(see ADDRESSES) within 30 days of publication of this document (see
DATES). Nominations must also specify the advisory panel for which the
nominee is recommended. Nominations must also acknowledge that the
nominee is aware of the nomination unless self-nominated. FDA will
forward all nominations to the organizations expressing interest in
participating in the selection process for the particular device panels
listed in the table. (Persons who nominate themselves as nonvoting
industry representatives will not participate in the selection
process).
    FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore encourages nominations of
appropriately qualified candidates from these groups.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: October 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22911 Filed 10-15-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 137 (Monday, July 18, 2016)]
[Notices]
[Pages 46725-46728]
[FR Doc No: 2016-16849]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78305; File No. SR-BatsBZX-2016-36]

Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change Related to
Fees for Use of Bats BZX Exchange, Inc.

July 12, 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 July 1, 2016, Bats BZX Exchange, Inc. (the ``Exchange'' or
``BZX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the Exchange. The
Exchange has designated the proposed rule change as one establishing or
changing a member due, fee, or other charge imposed by the Exchange
under section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposed rule change effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange filed a proposal to amend the fee schedule applicable
to Members \5\ and non-members of the Exchange pursuant to BZX Rules
15.1(a) and (c).
---------------------------------------------------------------------------

    \5\ The term ``Member'' is defined as ``any registered broker or
dealer that has been admitted to membership in the Exchange.'' See
Exchange Rule 1.5(n).
---------------------------------------------------------------------------

    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
    The Exchange proposes to amend its fee schedule for its equity
options platform (``BZX Options'') to: (i) Reduce the rate for fee code
PA, which is appended to Professional \6\ orders in Penny Pilot
Securities; \7\ (ii) add a new tier under footnote 9, Professional
Penny Pilot Add Volume Tiers; (iii) to modify the criteria for the
Customer Penny Pilot Add Tier 5 under footnote 1; and (iv) to modify
the criteria for the Non-Customer Penny Pilot Take Volume Tier 1 under
footnote 3. Additionally, the Exchange proposes to rename and ease the
qualifications for the: (i) Firm, Broker Dealer, and Joint Back Office
Penny Pilot Add Volume Step-Up Tier under footnote 2; (ii) Firm, Broker
Dealer, and Joint Back Office Non-Penny Pilot Add Volume Step-Up Tier
under footnote 8; and (iii) the Away Market Penny Pilot Add Volume
Step-Up Tier under footnote 10. The Exchange also proposes to ease the
criteria for the NBBO Setter Tier 3 under footnote 4.
---------------------------------------------------------------------------

    \6\ The term ``Professional'' applies to any transaction
identified by a Member as such pursuant to Exchange Rule 16.1.
    \7\ The term ``Penny Pilot Security'' applies to those issues
that are quoted pursuant to Exchange Rule 21.5, Interpretation and
Policy .01.
---------------------------------------------------------------------------

Fee Code PA
    The Exchange proposes to reduce the rebate for fee code PA, under
which a Member is currently receiving a rebate of $0.40 per contract
for its Professional orders in Penny Pilot Securities. The Exchange
proposes to reduce the rebate for fee code PA from $0.40 per contract
to $0.25 per contract. The Exchange also proposes to update the
Standard Rate table to reflect the new rebate.
New Professional Penny Pilot Add Volume Tier
    The Exchange currently offers one tier under footnote 9,
Professional Penny Pilot Add Volume Tier. Under that tier (to be
renamed Tier 2), a Member receives a rebate of $0.43 per contract for
its orders that yield fee code PA where it has a combined ADAV \8\ in
Customer \9\ and Professional orders equal to or greater than 0.20% of
average TCV.\10\ The Exchange now proposes to add a new tier under
footnote 9 to be named Tier 1, under which a Member would receive a
rebate of $0.40 per contract for its orders that yield fee code PA
where it has an ADV \11\ equal to or greater than 0.25% of average TCV.
The current tier under footnote 9 would be renamed Tier 2.
---------------------------------------------------------------------------

    \8\ As set forth in the Exchange's fee schedule, ``ADAV'' means
average daily volume calculated as the number of contracts added per
day.
    \9\ As set forth in the Exchange's fee schedule, the term
``Customer'' applies to any transaction identified by a Member for
clearing in the Customer range at the Options Clearing Corporation
(``OCC''), excluding any transaction for a Broker Dealer or a
``Professional'' as defined in Exchange Rule 16.1.
    \10\ As set forth in the Exchange's fee schedule, ``TCV'' means
total consolidated volume calculated as the volume reported by all
exchanges to the consolidated transaction reporting plan for the
month for which the fees apply.
    \11\ As set forth in the Exchange's fee schedule, ``ADV'' means
average daily volume calculated as the number of contracts added or
removed, combined, per day.
---------------------------------------------------------------------------

Customer Add Volume Tier 5
    Customer orders that add liquidity on the Exchange in Penny Pilot
Securities yield fee code PY and receive a standard rebate of $0.25 per
contract. In addition, footnote 1 of the fee schedule currently sets
forth eight different types of Customer Penny Pilot Add Tiers, each
providing an enhanced rebate ranging from $0.40 to $0.53 per contract
to a Member's Customer orders that yield fee code PY upon satisfying
monthly volume criteria required by the respective tier.
    The Exchange proposes to amend Customer Add Volume Tier 5 to amend
the qualification criteria for the tier. In order to qualify for
Customer Add Volume Tier 5 and receive a rebate of $0.53 per contract,
the Exchange currently requires a Member to: (1) Have an ADAV in
Customer orders equal to or greater than 0.80% of average TCV; and (2)
have an ADAV in Market Maker \12\ orders equal to or greater than

0.30% of average TCV. The Exchange proposes to reduce the first prong
of the qualifying criteria to require a Member to have an ADAV in
Customer orders equal to or greater than 0.60% of average TCV. In
addition, the Exchange proposes to add a third prong to the qualifying
criteria to require that the Member have an ADV equal to or greater
than 0.30% of average TCV on the Exchange's equity platform (``BZX
Equities''). The Exchange notes that no changes are required to the
Standard Rates table of the fee schedule in connection with the changes
to footnote 1.
---------------------------------------------------------------------------

    \12\ As set forth in the Exchange's fee schedule, the term
``Market Maker'' applies to any transaction identified by a Member
for clearing in the Market Maker range at the OCC, where such Member
is registered with the Exchange as a Market Maker as defined in Rule
16.1(a)(37).
---------------------------------------------------------------------------

Non-Customer Add Volume Tier 1
    Non-Customer \13\ orders that remove liquidity from the Exchange in
Penny Pilot Securities yield fee code PP and are charged a standard fee
of $0.50 per contract. In addition, footnote 3 of the fee schedule
currently sets forth four [sic] different types of Non-Customer Penny
Pilot Take Volume Tiers, each providing a reduced fee ranging from
$0.44 to $0.47 per contract to a Member's Non-Customer orders that
yield fee code PP upon satisfying monthly volume criteria required by
the respective tier.
---------------------------------------------------------------------------

    \13\ As set forth in the Exchange's fee schedule, the term
``Non-Customer'' applies to any transaction that is not a Customer
order.
---------------------------------------------------------------------------

    The Exchange proposes to amend the Non-Customer Take Volume Tier 1
to amend the qualification criteria for the tier. In order to qualify
for current Non-Customer Take Volume Tier 1, the Exchange currently
requires a Member to: (1) Have an ADAV in Customer orders equal to or
greater than 0.80% of average TCV; and (2) have an ADAV in Market Maker
orders equal to or greater than 0.30% of average TCV. The Exchange
proposes to reduce the first prong of the qualifying criteria to
require a Member have an ADAV in Customer orders equal to or greater
than 0.60% of average TCV. In addition, the Exchange proposes to add a
third prong to the qualifying criteria to require that the Member have
an ADV equal to or greater than 0.30% of average TCV on BZX Equities.
The Exchange notes that no changes are required to the Standard Rates
table of the fee schedule in connection with the changes to footnote 3.
Step-Up Tier Amendments
    The Exchange proposes to rename and ease the qualifications for
the: (i) Firm, Broker Dealer, and Joint Back Office Penny Pilot Add
Volume Step-Up Tier under footnote 2; (ii) Firm, Broker Dealer, and
Joint Back Office Non-Penny Pilot Add Volume Step-Up Tier under
footnote 8; and (iii) the Away Market Penny Pilot Add Volume Step-Up
Tier under footnote 10. The Exchange also proposes to ease the criteria
for the NBBO Setter Tier 3 under footnote 4. Each of the above tiers
include the same criteria under which a Member must have an: (i)
Options Step-Up Add TCV \14\ in Non-Customer orders from March 2015
baseline equal to or greater than 0.15%; and (ii) ADAV in Away Market
Maker/Firm/Broker-Dealer/Joint Back Office orders equal to or greater
than 0.30% of average TCV. Upon satisfying the tier's criteria, the
Member would receive an enhanced rebate of $0.43 per contract, $0.67
per contract, $0.43 per contract, and $0.04 per contract under the
Firm, Broker Dealer, and Joint Back Office Penny Pilot Add Volume Step-
Up Tier, Firm, Broker Dealer, and Joint Back Office Non-Penny Pilot Add
Volume Step-Up Tier, the Away Market Penny Pilot Add Volume Step-Up
Tier, and the NBBO Setter Tier 3, respectively.
---------------------------------------------------------------------------

    \14\ As set forth in the Exchange's fee schedule, ``Options
Step-Up TCV'' means ``ADAV as a percentage of TCV in the relevant
baseline month subtracted from current ADAV as a percentage of
TCV.''
---------------------------------------------------------------------------

    The Exchange now proposes to ease the first prong of each of the
above tier's criteria by replacing the requirement that the Member have
an Options Step-Up Add TCV in Non-Customer orders from March 2015
baseline equal to or greater than 0.15% with a new requirement that the
Member have an ADV equal to or greater than 0.40% of average TCV. The
Exchange does not propose to amend the second prong of each of the
above tiers as Members would continue to be required to have an ADAV in
Away Market Maker/Firm/Broker-Dealer/Joint Back Office orders equal to
or greater than 0.30% of average TCV.
    In light of removing the monthly baseline step-up requirement, the
Exchange proposes to rename the Firm, Broker Dealer, and Joint Back
Office Penny Pilot Add Volume Step-Up Tier, the Firm, Broker Dealer,
and Joint Back Office Non-Penny Pilot Add Volume Step-Up Tier, and the
Away Market Penny Pilot Add Volume Step-Up Tier as follows:
     The Firm, Broker Dealer, and Joint Back Office Penny Pilot
Add Volume Step-Up Tier would be renamed as the ``the Firm, Broker
Dealer, and Joint Back Office Penny Pilot Add Volume Tier 2'';
     the Firm, Broker Dealer, and Joint Back Office Non-Penny
Pilot Add Volume Step-Up Tier would be renamed as the ``the Firm,
Broker Dealer, and Joint Back Office Non-Penny Pilot Add Volume Tier
3''; and
     the Away Market Penny Pilot Add Volume Step-Up Tier would
be renamed as the ``the Away Market Penny Pilot Add Volume Tier 3''.

The Exchange does not propose to amend the name of the NBBO Setter Tier
3.
Implementation Date
    The Exchange proposes to implement these amendments to its fee
schedule July 1, 2016.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of section 6 of the Act,\15\ in general, and
furthers the objectives of section 6(b)(4),\16\ in particular, as it is
designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its Members and other persons using its
facilities. The Exchange also notes that it operates in a highly-
competitive market in which market participants can readily direct
order flow to competing venues if they deem fee levels at a particular
venue to be excessive. The proposed rule change reflects a competitive
pricing structure designed to incentivize market participants to direct
their order flow to the Exchange. The Exchange believes that the
proposed tier is equitable and non-discriminatory in that it would
apply uniformly to all Members. The Exchange believes the rates remain
competitive with those charged by other venues and, therefore, are
reasonable and equitably allocated to Members.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78f.
    \16\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that its proposal to change the standard fee
charged for Professional orders under fee code PA is reasonable, fair
and equitable and non-discriminatory, because the change will apply
equally to all participants, and because, while the change marks a
decrease in the rebate for Professional orders in Penny Pilot
Securities, such proposed rebate remains consistent with pricing
previously offered by the Exchange as well as competitors of the
Exchange and does not represent a significant departure from the
Exchange's general pricing structure and will allow the Exchange to
earn additional revenue that can be used to offset the addition of new
pricing incentives, such as the new Professional Penny Pilot Add Volume
Tier introduced as part of this proposal.
    The Exchange believes that the proposed modifications to the tiered

pricing structure are reasonable, fair and equitable, and non-
discriminatory. The Exchange operates in a highly competitive market in
which market participants may readily send order flow to many competing
venues if they deem fees at the Exchange to be excessive. The proposed
fee structure remains intended to attract order flow to the Exchange by
offering market participants a competitive pricing structure. The
Exchange believes it is reasonable to offer and incrementally modify
incentives intended to help to contribute to the growth of the
Exchange.
    Volume-based rebates such as that proposed herein have been widely
adopted by exchanges, including the Exchange, and are equitable because
they are open to all Members on an equal basis and provide additional
benefits or discounts that are reasonably related to: (i) The value to
an exchange's market quality; (ii) associated higher levels of market
activity, such as higher levels of liquidity provisions and/or growth
patterns; and (iii) introduction of higher volumes of orders into the
price and volume discovery processes.
    The proposed addition of an additional Professional Penny Pilot Add
Volume Tier is broadly intended to incentivize participants to increase
their participation on the Exchange, which will increase the liquidity
and market quality on the Exchange. Thus, the Exchange believes that
the proposed tier is reasonable, fair and equitable, and non-
discriminatory, for the reasons set forth above with respect to volume-
based pricing generally and because such changes will incentivize
participants to further contribute to market quality. The Exchange also
believes the rebate of $0.40 per contract is reasonable as compared to
the existing tier under footnote 9. Currently, to receive a rebate of
$0.43 per contract for orders that yield fee code PA, the Member must
have a combined ADAV in Customer and Professional orders equal to or
greater than 0.20% of average TCV. Under the proposed tier, the Member
would receive a rebate of $0.40 per contract for its orders that yield
fee code PA where it has an ADV equal to or greater than 0.25% of
average TCV. The Exchange, therefore, believes that the lower rebate is
equitable and reasonable as it correlates to the proposed tier's
pricing structure and the criteria necessary to achieve the existing
tier under footnote 9.
    The proposed modifications to the criteria required to qualify for
current Customer Add Volume Tier 5 and Non-Customer Penny Pilot Take
Volume Tier 1 are intended to incentivize additional Members to send
Customer orders and/or Market Maker orders to the Exchange in an effort
to qualify for the enhanced rebate or lower fee made available by the
tiers. The Exchange believes that the proposal to require that the
Member have an ADV equal to or greater than 0.30% of average TCV on BZX
Equities under both tiers is a reasonable, fair and equitable, and not
unfairly discriminatory allocation of fees and rebates because it will
provide Members with an additional incentive to reach certain
thresholds on both BZX Options and BZX Equities. The increased
liquidity from this proposal also benefits all investors by deepening
the BZX Options and BZX Equities liquidity pools, offering additional
flexibility for all investors to enjoy cost savings, supporting the
quality of price discovery, promoting market transparency and improving
investor protection. Such pricing programs thereby reward a Member's
growth pattern on the Exchange and such increased volume increases
potential revenue to the Exchange, and will allow the Exchange to
continue to provide and potentially expand the incentive programs
operated by the Exchange. To the extent a Member participates on BZX
Options and not BZX Equities, the Exchange believes that the proposal
is still reasonable, equitably allocated and non-discriminatory with
respect to such Member based on the overall benefit to the Exchange
resulting from the success of BZX Options. As noted above, such success
allows the Exchange to continue to provide and potentially expand its
existing incentive programs to the benefit of all participants on the
Exchange, whether they participate on BZX Options or not. The proposed
pricing program is also fair and equitable in that membership in BZX
Options is available to all market participants which would provide
them with access to the benefits on BZX Options provided by the
proposed changes, as described above, even where a member of BZX
Options is not necessarily eligible for the proposed increased rebates
on the Exchange. Further, the proposed changes will result in Members
receiving either the same or an increased rebate than they would
currently receive.
    The proposed amendments to the Firm, Broker Dealer, and Joint Back
Office Penny Pilot Add Volume Step-Up Tier, Firm, Broker Dealer, and
Joint Back Office Non-Penny Pilot Add Volume Step-Up Tier, Away Market
Penny Pilot Add Volume Step-Up Tier and, the NBBO Setter Tier 3 are
also are intended to incentivize additional Members to send orders to
the Exchange in an effort to qualify for the enhanced rebate made
available by the tiers. The Exchange notes that requiring improvement
over a March 2015 baseline has become outdated and has prevented
Members from seeking to achieve each tier's criteria. Therefore, the
Exchange believes it is equitable and reasonable to replace the current
March 2015 baseline with a requirement that Members have an ADV equal
to or greater than 0.40% of average TCV. The Exchange believes the
proposed change to each tier's criteria is consistent with the Act. The
Exchange also believes renaming the Firm, Broker Dealer, and Joint Back
Office Penny Pilot Add Volume Step-Up Tier, the Firm, Broker Dealer,
and Joint Back Office Non-Penny Pilot Add Volume Step-Up Tier, and the
Away Market Penny Pilot Add Volume Step-Up Tier is also reasonable
because each tier would no longer require a step-up in volume based on
a March 2015 baseline.

(B) Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange believes the proposed amendment to its fee schedule
would not impose any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The Exchange
does not believe that the proposed change represents a significant
departure from previous pricing offered by the Exchange or pricing
offered by the Exchange's competitors. Additionally, Members may opt to
disfavor the Exchange's pricing if they believe that alternatives offer
them better value. Accordingly, the Exchange does not believe that the
proposed change will impair the ability of Members or competing venues
to maintain their competitive standing in the financial markets. The
Exchange does not believe that the proposed change to the Exchange's
tiered pricing structure burdens competition, but instead, enhances
competition as it is intended to increase the competitiveness of the
Exchange. The Exchange also believes the proposal enhances competition
by seeking to draw additional volume to both BZX Equities and BZX
Options. Therefore, the Exchange believes that the amendment to the
tiers' thresholds contributes to, rather than burdens competition, as
such change is intended to incentivize participants to increase their
participation on the Exchange.

(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 foregoing rule change has become effective pursuant to section
19(b)(3)(A) of the Act \17\ and paragraph (f) of Rule 19b-4
thereunder.\18\ 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
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(3)(A).
    \18\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

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-BatsBZX-2016-36 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-BatsBZX-2016-36. 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 will also 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-BatsBZX-2016-36 and should
be submitted on or before August 8, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-16849 Filed 7-15-16; 8:45 am]
 BILLING CODE 8011-01-P