[Federal Register Volume 81, Number 48 (Friday, March 11, 2016)]
[Notices]
[Page 13025]
[FR Doc No: 2016-05531]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Policy Statement No. PS-ANM100-1982-00038]

FAR 25.723 Energy Absorption Tests

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of cancellation of policy statement.

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

SUMMARY: The Federal Aviation Administration (FAA) announces the
cancellation of Policy Statement Number PS-ANM100-1982-00038. The
policy statement is cancelled because it was superseded by an advisory
circular (AC) and is no longer necessary.

DATES: This policy statement is cancelled on March 11, 2016.

FOR FURTHER INFORMATION CONTACT: Ian Won, Federal Aviation
Administration, Transport Airplane Directorate, Transport Standards
Staff, Airframe and Cabin Safety Branch, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    On April 13, 1982, the Manager, Transport Airplane Directorate,
Aircraft Certification Service, issued Policy Statement Number PS-
ANM100-1982-00038, FAR 25.723 Energy Absorption Tests. This policy
statement addressed limits of extrapolation of landing gear drop test
data.
    The FAA issued AC 25.723-1, Shock Absorption Tests, on May 25,
2001, concurrently with Amendment 25-103, which changed the rule, 14
CFR 25.723. The AC addresses the same issue as the older policy
statement but reflects the latest rule and is more specific. The FAA
intended to cancel the policy when they released AC 25.723-1 but
overlooked it.

Cancellation of Policy Statement

    As a result of the issuance of AC 25.723-1 and Amendment 25-103,
Policy Statement Number PS-ANM100-1982-00038 is no longer in effect and
is herewith cancelled.

    Issued in Renton, Washington, on March 1, 2016.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service, ANM-100.
[FR Doc. 2016-05531 Filed 3-10-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: June 17, 2008 (Volume 73, Number 117)]
[Proposed Rules]
[Page 34224-34228]
[DOCID:fr17jn08-12]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0657; Directorate Identifier 2007-NM-296-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A300, A310, and A300-600
Series Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to supersede an existing airworthiness
directive (AD) that applies to certain Airbus Model A300, A310, and
A300-600 series airplanes. The existing AD currently requires
repetitive detailed visual inspections to detect cracks in the pylon
thrust and sideload fitting of the wing, and replacement of any cracked
pylon thrust and sideload fitting with a new fitting. This proposed AD
would

reduce the threshold and repetitive intervals for the detailed
inspection for certain airplanes and would reduce the applicability of
the existing AD. This proposed AD results from issuance of mandatory
continuing airworthiness information by a foreign civil airworthiness
authority. We are proposing this AD to detect and correct cracks in the
pylon thrust and sideload fitting of the wing, which could result in
reduced structural integrity of the airplane.

DATES: We must receive comments on this proposed AD by July 17, 2008.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Airbus, 1
Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-1138; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2008-0657;
Directorate Identifier 2007-NM-296-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On July 24, 1998, we issued AD 98-16-11, amendment 39-10687 (63 FR
40816, July 31, 1998), for certain Airbus Model A300, A310, and A300-
600 series airplanes. That AD requires repetitive detailed visual
inspections to detect cracks in the pylon thrust and sideload fitting
of the wing, and replacement of any cracked pylon thrust and sideload
fitting with a new fitting. That AD resulted from issuance of mandatory
continuing airworthiness information by a foreign civil airworthiness
authority. We issued that AD to detect and correct cracks in the pylon
thrust and sideload fitting of the wing, which could result in reduced
structural integrity of the airplane.

Actions Since Existing AD Was Issued

    Since we issued AD 98-16-11, Airbus has issued the following
service bulletins:

                      Table.--New Service Bulletins
------------------------------------------------------------------------
   Airbus service bulletin--                   For model--
------------------------------------------------------------------------
A300-57-0232, Revision 02,       A300 series airplanes.
 dated February 21, 2000.
A300-57-6079, Revision 04,       A300-600 series airplanes.
 dated February 21, 2000.
A310-57-2075, Revision 03,       A310 series airplanes.
 dated December 1, 2006.
------------------------------------------------------------------------

    The repetitive detailed inspections and replacement procedures are
essentially identical to those specified in previous issues of the
service bulletins. (AD 98-16-11 refers to Airbus Service Bulletins
A300-57-0232, Revision 01 (for Model A300 series airplanes); A310-57-
2075, Revision 01 (for Model A310 series airplanes); and A300-57-6079,
Revision 02 (for Model A300-600 series airplanes); all dated January
12, 1998; as the appropriate sources of service information for
accomplishing the required actions.) Revision 03 of Airbus Service
Bulletin A310-57-2075 reduces the detailed inspection thresholds and
repeat intervals for certain airplanes. In addition, the effectivity
listing of all three service bulletins has been revised to remove
airplanes that have been scrapped. No more work is necessary for
airplanes on which previous issues of the service bulletins were done.
    Accomplishing the actions specified in the service information is
intended to adequately address the unsafe condition. The European
Aviation Safety Agency (EASA), which is the Technical Agent for the
Member States of the European Community, mandated the service
information and issued EASA airworthiness directive 2007-0243, dated
September 4, 2007, to ensure the continued airworthiness of these
airplanes in the European Union.

FAA's Determination and Requirements of the Proposed AD

    These airplanes are manufactured in France and are type
certificated for operation in the United States under the provisions of
section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and
the applicable bilateral airworthiness agreement. As described in FAA
Order 8100.14A, ``Interim Procedures for Working with the European
Community on Airworthiness Certification and Continued Airworthiness,''
dated August 12, 2005, the EASA has kept the FAA informed of the
situation described above. We have examined the EASA's findings,
evaluated all pertinent information, and determined that AD action is
necessary for airplanes of this type design that are certificated for
operation in the United States.
    This proposed AD would supersede AD 98-16-11 and would continue to
require, at reduced thresholds and repetitive intervals for certain
airplanes, repetitive detailed visual inspections to detect cracks in
the pylon thrust and

sideload fitting of the wing, and would continue to require replacement
of any cracked pylon thrust and sideload fitting with a new fitting.
This proposed AD would also require accomplishing the actions specified
in service information described previously.

Differences Between Proposed Rule and EASA AD

    The proposed AD would differ from the parallel EASA airworthiness
directive in that it would not allow for adjustment in compliance time
based on airplane utilization. In developing an appropriate compliance
time for this proposed AD, the FAA considered not only the
manufacturer's recommendation, but the degree of urgency associated
with addressing the subject unsafe condition, and the average
utilization of the affected fleet. In light of these factors, we find
the compliance times specified in paragraphs (f)(1) and (f)(2) of this
proposed AD to be warranted, in that they represent an appropriate
interval of time allowable for affected airplanes to continue to
operate without compromising safety.

Change to Existing AD

    This proposed AD would retain all requirements of AD 98-16-11.
Since AD 98-16-11 was issued, the AD format has been revised, and
certain paragraphs have been rearranged. As a result, the corresponding
paragraph identifiers have changed in this proposed AD, as listed in
the following table:

                      Revised Paragraph Identifiers
------------------------------------------------------------------------
                                             Corresponding  requirement
        Requirement in AD 98-16-11              in this  proposed AD
------------------------------------------------------------------------
paragraph (a).............................  paragraph (f).
paragraph (b).............................  paragraph (g).
------------------------------------------------------------------------

    In addition, we have revised the applicability of this proposed AD
to refer to the latest revisions of the service information described
previously.
    We also changed all references to a ``detailed visual inspection''
in the existing AD to ``detailed inspection'' in this action.

Costs of Compliance

    This proposed AD would affect about 164 Model A300, A310, and A300-
600 series airplanes of U.S. registry.
    The inspections that are required by AD 98-16-11 and retained in
this proposed AD take about 3 work hours per airplane, at an average
labor rate of $80 per work hour. Based on these figures, the estimated
cost of the currently required actions is $39,360, or $240 per
airplane, per inspection cycle.

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 products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 the proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. 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 a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket. See the
ADDRESSES section for a location to examine the regulatory evaluation.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

    2. The Federal Aviation Administration (FAA) amends Sec.  39.13 by
removing amendment 39-10687 (63 FR 40816, July 31, 1998) and adding the
following new airworthiness directive (AD):

Airbus: Docket No. FAA-2008-0657; Directorate Identifier 2007-NM-
296-AD.

Comments Due Date

    (a) The FAA must receive comments on this AD action by July 17,
2008.

Affected ADs

    (b) This AD supersedes AD 98-16-11.

Applicability

    (c) This AD applies to Airbus airplanes identified in Table 1 of
this AD, certificated in any category.

                         Table 1.--Applicability
------------------------------------------------------------------------
                                        As identified in Airbus service
               Model--                             bulletin--
------------------------------------------------------------------------
(1) A300 series airplanes............  A300-57-0232, Revision 02, dated
                                        February 21, 2000.
(2) A310 series airplanes............  A310-57-2075, Revision 03, dated
                                        December 1, 2006.
(3) A300-600 series airplanes........  A300-57-6079, Revision 04, dated
                                        February 21, 2000.
------------------------------------------------------------------------

Unsafe Condition

    (d) This AD results from issuance of mandatory continuing
airworthiness information by a foreign civil airworthiness
authority. We are issuing this AD to detect and correct cracks in
the pylon thrust and sideload fitting of the wing, which could
result in reduced structural integrity of the airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within

the compliance times specified, unless the actions have already been
done.

Requirements of AD 98-16-11:

Repetitive Detailed Inspections at Reduced Thresholds and Repeat
Intervals for Certain Airplanes

    (f) At the applicable time specified in paragraph (f)(1) or
(f)(2) of this AD: Perform a detailed inspection to detect cracks in
the pylon thrust and sideload fitting of the wing, in accordance
with Airbus Service Bulletin A300-57-0232, Revision 01 (for Model
A300 series airplanes); A310-57-2075, Revision 01 (for Model A310
series airplanes); or A300-57-6079, Revision 02 (for Model A300-600
series airplanes); all dated January 12, 1998; as applicable; except
as provided by paragraph (h) of this AD.
    (1) For Model A300 and A300-600 series airplanes: Inspect prior
to the accumulation of 2,800 total flight cycles, or within 18
months after September 4, 1998 (the effective date AD 98-16-11),
whichever occurs later, and thereafter at intervals not to exceed
2,800 flight cycles.
    (2) For Model A310 series airplanes: Inspect at the earlier of
the times specified in paragraph (f)(2)(i) and (f)(2)(ii) of this
AD. Repeat thereafter at the applicable intervals specified in Table
3 of this AD.
    (i) Prior to the accumulation of 2,800 total flight cycles, or
within 18 months after September 4, 1998, whichever occurs later.
    (ii) At the applicable time specified in Table 2 of this AD.

 Table 2.--Reduced Inspection Thresholds for Model A310 Series Airplanes
------------------------------------------------------------------------
                               Compliance time (whichever occurs later)
            Model            -------------------------------------------
                                    Threshold           Grace period
------------------------------------------------------------------------
A310-200 series airplanes...  Before the            Within 800 flight
                               accumulation of       cycles or 1,600
                               1,500 total flight    flight hours after
                               cycles or 3,000       the effective date
                               total flight hours    of this AD,
                               since first flight,   whichever occurs
                               whichever occurs      first.
                               first.
A310-300 series airplanes     Before the            Within 800 flight
 (short range).                accumulation of       cycles or 1,600
                               1,300 total flight    flight hours after
                               cycles or 3,800       the effective date
                               total flight hours    of this AD,
                               since first flight,   whichever occurs
                               whichever occurs      first.
                               first.
A310-300 series airplanes     Before the            Within 800 flight
 (long range).                 accumulation of 800   cycles or 1,600
                               total flight cycles   flight hours after
                               or 4,000 total        the effective date
                               flight hours since    of this AD,
                               first flight,         whichever occurs
                               whichever occurs      first.
                               first.
------------------------------------------------------------------------

   Table 3.--Reduced Repeat Intervals for Model A310 Series Airplanes
------------------------------------------------------------------------
                                  Repeat the detailed    And, thereafter
          For Model--              inspection at the    at intervals not
                                      later of--           to exceed--
------------------------------------------------------------------------
A310-200 series airplanes.....  Within 1,500 flight     1,500 flight
                                 cycles or 3,000         cycles or 3,000
                                 flight hours since      flight hours,
                                 the last detailed       whichever
                                 inspection, whichever   occurs first.
                                 occurs first; or
                                 within 800 flight
                                 cycles or 1,600
                                 flight hours after
                                 the effective date of
                                 this AD, whichever
                                 occurs first.
A310-300 series airplanes       Within 1,300 flight     1,300 flight
 (short range).                  cycles or 3,800         cycles or 3,800
                                 flight hours since      flight hours,
                                 the last detailed       whichever
                                 inspection, whichever   occurs first.
                                 occurs first; or
                                 within 800 flight
                                 cycles or 1,600
                                 flight hours after
                                 the effective date of
                                 this AD, whichever
                                 occurs first.
A310-300 series airplanes       Within 800 flight       800 flight
 (long range).                   cycles or 4,000         cycles or 4,000
                                 flight hours since      flight hours,
                                 the last detailed       whichever
                                 inspection, whichever   occurs first.
                                 occurs first; or
                                 within 800 flight
                                 cycles or 1,600
                                 flight hours after
                                 the effective date of
                                 this AD, whichever
                                 occurs first.
------------------------------------------------------------------------

Corrective Action

    (g) If any crack is detected during any inspection required by
paragraph (f) of this AD, prior to further flight, replace the pylon
thrust and sideload fitting with a new fitting in accordance with
Airbus Service Bulletin A300-57-0232, Revision 01 (for Model A300
series airplanes); A310-57-2075, Revision 01 (for Model A310 series
airplanes); or A300-57-6079, Revision 02 (for Model A300-600 series
airplanes); all dated January 12, 1998; as applicable; except as
provided by paragraph (h) of this AD.

New Actions Required by This AD:

New Service Information

    (h) For all airplanes: As of the effective date of this AD, use
only the Accomplishment Instructions of the applicable service
bulletin specified in Table 4 of this AD to do the repetitive
detailed inspections required by paragraph (f) of this AD and the
replacement required by paragraph (g) of this AD.

                     Table 4.--New Service Bulletins
------------------------------------------------------------------------
  Airbus service bulletin--                   For model--
------------------------------------------------------------------------
(1) A300-57-0232, Revision     A300 series airplanes.
 02, dated February 21, 2000.
(2) A300-57-6079, Revision     A300-600 series airplanes.
 04, dated February 21, 2000.
(3) A310-57-2075, Revision     A310 series airplanes.
 03, dated December 1, 2006.
------------------------------------------------------------------------

    (i) Actions done before the effective date of this AD in
accordance with Airbus Service Bulletins A300-57-6079, Revision 02,
dated January 12, 1998, or Revision 03, dated October 25, 1999 (for
Model A300-600 series airplanes); A310-57-2075, Revision 01, dated
January 12, 1998, or Revision 02, dated February 21, 2000 (for Model
A310 series airplanes); or A300-57-0232, Revision 01, dated January
12, 1998 (for Model A300 series airplanes); are acceptable for
compliance with the corresponding requirements of this AD.

Alternative Methods of Compliance (AMOCs)

    (j) The Manager, International Branch, ANM-116, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Send information to ATTN: Vladimir
Ulyanov, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.

Related Information

    (k) European Aviation Safety Agency (EASA) airworthiness
directive 2007-0243, dated September 4, 2007, also addresses the
subject of this AD.

    Issued in Renton, Washington, on June 10, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E8-13566 Filed 6-16-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 75 (Wednesday, April 18, 2012)]
[Notices]
[Pages 23295-23298]
[FR Doc No: 2012-9282]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66789; File No. SR-ISE-2012-30]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Increasing Certain Rebates and Taker Fees for
Complex Orders in Options on the SPDR[supreg] S&P500[supreg] ETF Trust

April 12, 2012.
    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 April 10, 2012, the International Securities Exchange, LLC (the
``Exchange'' or the ``ISE'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I and II below, which Items have been prepared by the
Exchange. 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.
---------------------------------------------------------------------------

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

    The ISE proposes to increase certain rebates and taker fees for
complex orders in options on the SPDR[supreg] S&P500[supreg] ETF Trust
(``SPY''). The text of the proposed rule change is available on the
Exchange's Web site (http://www.ise.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 self-regulatory organization
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 self-regulatory organization has prepared summaries, set forth in
sections A, B and C below, of the most significant aspects 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 currently assesses per contract transaction charges
and credits to market participants that add or remove liquidity from
the Exchange (``maker/taker fees'') in a number of options classes (the
``Select Symbols'').\3\ The Exchange's maker/taker fees are applicable
to regular and complex orders executed in the Select Symbols. The
maker/taker fees for complex orders in the Select Symbols also apply to
all symbols that are in the Penny Pilot program.\4\ The Exchange also
currently assesses maker/taker fees for complex orders in symbols that
are in the Penny Pilot program but are not a Select Symbol (``Non-
Select Penny Pilot Symbols'') \5\ and for complex orders in all symbols
that are not in the Penny Pilot Program (``Non-Penny Pilot
Symbols'').\6\ Maker/taker fees (and rebates) for complex orders are
assessed on the following order-type categories: ISE Market Maker,\7\
Market Maker Plus,\8\ Firm Proprietary, Customer (Professional) \9\,
Non-ISE Market Maker\10\, and Priority Customer.\11\ The Exchange is
proposing to increase certain rebate amounts and taker fees for complex
orders in options on only one Select Symbol--SPY--as follows.
---------------------------------------------------------------------------

    \3\ Options classes subject to maker/taker fees are identified
by their ticker symbol on the Exchange's Schedule of Fees.
    \4\ See Exchange Act Release Nos. 65021 (August 3, 2011), 76 FR
48933 (August 9, 2011) (SR-ISE-2011-45); and 65550 (October 13,
2011), 76 FR 64984 (October 19, 2011) (SR-ISE-2011-65).
    \5\ See Exchange Act Release No. 65724 (November 10, 2011), 76
FR 71413 (November 17, 2011) (SR-ISE-2011-72).
    \6\ See Exchange Act Release Nos. 66084 (January 3, 2012), 77 FR
1103 (January 9, 2012) (SR-ISE-2011-84); and 66392 (February 14,
2012), 77 FR 10016 (February 21, 2012) (SR-ISE-2012-06).
    \7\ The term ``Market Makers'' refers to ``Competitive Market
Makers'' and ``Primary Market Makers'' collectively. See ISE Rule
100(a)(25).
    \8\ A Market Maker Plus is an ISE Market Maker who is on the
National Best Bid or National Best Offer 80% of the time for series
trading between $0.03 and $5.00 (for options whose underlying
stock's previous trading day's last sale price was less than or
equal to $100) and between $0.10 and $5.00 (for options whose
underlying stock's previous trading day's last sale price was
greater than $100) in premium in each of the front two expiration
months and 80% of the time for series trading between $0.03 and
$5.00 (for options whose underlying stock's previous trading day's
last sale price was less than or equal to $100) and between $0.10
and $5.00 (for options whose underlying stock's previous trading
day's last sale price was greater than $100) in premium across all
expiration months in order to receive the rebate. The Exchange
determines whether a Market Maker qualifies as a Market Maker Plus
at the end of each month by looking back at each Market Maker's
quoting statistics during that month. If at the end of the month, a
Market Maker meets the Exchange's stated criteria, the Exchange
rebates $0.10 per contract for transactions executed by that Market
Maker during that month. The Exchange provides Market Makers a
report on a daily basis with quoting statistics so that Market
Makers can determine whether or not they are meeting the Exchange's
stated criteria.
    \9\ A Customer (Professional) is a person who is not a broker/
dealer and is not a Priority Customer.
    \10\ A Non-ISE Market Maker, or Far Away Market Maker
(``FARMM''), is a market maker as defined in Section 3(a)(38) of the
Act, registered in the same options class on another options
exchange.
    \11\ A Priority Customer is defined in ISE Rule 100(a)(37A) as a
person or entity that is not a broker/dealer in securities, and does
not place more than 390 orders in listed options per day on average
during a calendar month for its own beneficial account(s).
---------------------------------------------------------------------------

    In the Select Symbols, the Exchange currently provides a base
rebate of $0.32 per contract, per leg, for Priority Customer complex
orders when these orders trade with non-Priority Customer complex
orders in the complex orderbook. Additionally, Members can earn a
higher rebate amount by achieving certain average daily volume (ADV)
thresholds on a month-to-month basis. In order to enhance the
Exchange's competitive position and to incentivize Members to increase
the amount of Priority Customer complex orders for options on SPY that
they send to the Exchange, the Exchange is proposing to increase the
base amount of the rebate for options on SPY to $0.33 per contract.
Additionally, the Exchange is proposing to increase the amount of that
rebate even further, on a month-by-month and Member-by-Member basis, if
such Member achieves a certain ADV of Priority Customer complex order
contracts executed during the calendar month, as follows: If the Member
achieves an ADV of 75,000 Priority Customer complex order contracts,
the rebate amount for such SPY option contracts shall be $0.34
(currently $0.33) per contract per leg; if the Member achieves an ADV
of 125,000 Priority Customer complex order contracts, the rebate amount
for such SPY option contracts shall be $0.35 (currently $0.34) per
contract per leg. The highest SPY rebate amount achieved by the Member
for the current calendar month shall apply retroactively to all
Priority Customer complex order SPY contracts that trade with non-
Priority Customer complex orders in the complex orderbook executed by
the Member during such calendar month.
    Further, the Exchange currently provides a rebate of $0.06 per
contract, per leg, for Priority Customer complex orders when these
orders trade against quotes or orders in the regular orderbook. In
order to enhance the Exchange's competitive position and to incentivize
Members to increase the amount of Priority Customer complex orders for
options on SPY that they send to the Exchange, the Exchange is
proposing to increase the rebate to $0.07 per contract, per leg, for
Priority Customer complex orders for options on SPY, regardless of
size, when these orders trade against quotes or orders in the regular
orderbook.
    Finally, for complex orders in the Select Symbols (including SPY),
the Exchange currently charges a ``taker'' fee of: (i) $0.34 Per
contract for ISE Market Maker, Market Maker Plus, Firm Proprietary and
Customer (Professional) orders; and (ii) $0.38 per contract for Non-ISE
Market Maker orders. Priority Customer orders are not charged a
``taker'' fee for complex orders in the Select Symbols. The Exchange
now proposes to increase the ``taker'' fee for complex orders in SPY to
(i) $0.35 per contract for ISE Market Maker, Market Maker Plus, Firm
Proprietary and Customer (Professional) orders; and (ii) $0.39 for Non-
ISE Market Maker orders. The Exchange is not proposing to change the
``maker'' fees in SPY.
    Additionally, ISE Market Makers who remove liquidity in SPY from
the complex order book by trading with Priority Customer orders that
are preferenced to them are currently charged $0.32 per contract. The
Exchange now proposes to increase to $0.33 per contract the amount
charged to ISE Market Makers who remove liquidity in SPY from the
complex order book by trading with Priority Customer orders that are
preferenced to them.
    Since the rate changes to the Schedule of Fees pursuant to this
proposal will be effective upon filing, for the transactions occurring
in April 2012 prior to the effective date of this filing members will
be assessed the rates in effect immediately prior to those proposed by
this filing. For transactions occurring in April 2012 on and after the
effective date of this filing, members will be assessed the rates
proposed by this filing.
2. Statutory Basis
    The Exchange believes that its proposal to amend its Schedule of
Fees is consistent with Section 6(b) of the Act \12\ in general, and
furthers the objectives of Section 6(b)(4) of the Act \13\ in
particular, in that it is an equitable allocation of reasonable dues,
fees and

other charges among Exchange members and other persons using its
facilities. The impact of the proposal upon the net fees paid by a
particular market participant will depend on a number of variables,
most important of which will be its propensity to interact with and
respond to certain types of orders.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that it is reasonable and equitable to
provide rebates for Priority Customer complex orders when these orders
trade with Non-Priority Customer complex orders in the complex order
book because paying a rebate would continue to attract additional order
flow to the Exchange and create liquidity in the symbols that are
subject to the rebate, which the Exchange believes ultimately will
benefit all market participants who trade on ISE. The Exchange already
provides these types of rebates, and is now merely proposing to
increase the rebate amount with respect to the SPY product only. The
Exchange believes that the proposed rebates are competitive with
rebates provided by other exchanges and are therefore reasonable and
equitably allocated to those members that direct orders to the Exchange
rather than to a competing exchange.
    The Exchange also believes that it is reasonable and equitable to
provide rebates for Priority Customer complex orders when these orders
trade against quotes or orders in the regular orderbook because paying
a rebate, in those instances, would also attract additional order flow
to the Exchange.
    The Exchange believes that its proposal to increase to $0.35 per
contract (from $0.34 per contract) the ``taker'' fee for ISE Market
Maker, Market Maker Plus, Firm Proprietary and Customer (Professional)
orders, and to increase to $0.39 per contract (from $0.38 per contract)
for Non-ISE Market Maker orders, in SPY is reasonable because the fee
is within the range of fees assessed by other exchanges employing
similar pricing schemes and in some cases, is lower than the fees
assessed by other exchanges. In addition, the Exchange believes that
charging Non-ISE Market Maker orders a higher rate than the fee charged
to ISE Market Maker, Market Maker Plus, Firm Proprietary and Customer
(Professional) orders is appropriate and not unfairly discriminatory
because Non-ISE Market Makers are not subject to many of the non-
transaction based fees that these other categories of membership are
subject to, e.g., membership fees, access fees, API/Session fees,
market data fees, etc. Therefore, it is appropriate and not unfairly
discriminatory to assess a higher transaction fee on Non-ISE Market
Makers because the Exchange incurs costs associated with these types of
orders that are not recovered by non-transaction based fees paid by
members.
    The complex order pricing employed by the Exchange has proven to be
an effective pricing mechanism and attractive to Exchange participants
and their customers. The Exchange believes that increasing its complex
order rebates will attract additional complex order business.
    The Exchange further believes that the Exchange's complex order
rebates and its maker/taker fees are not unfairly discriminatory
because those structures are consistent with fee structures that exist
today at other options exchanges. Additionally, the Exchange believes
that the proposed fees and rebates are fair, equitable and not unfairly
discriminatory because the proposed fees and rebates are consistent
with price differentiation that exists today at other option exchanges.
The Exchange operates in a highly competitive market in which market
participants can readily direct order flow to another exchange if they
deem fee levels at a particular exchange to be excessive. With this
proposed rebate change, the Exchange believes it remains an attractive
venue for market participants to trade complex orders.

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

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 unsolicited 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)(ii) of the Act.\14\ At any time within 60 days of the
filing of such 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. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

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-ISE-2012-30 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2012-30. 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
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2012-30 and should be
submitted on or before May 9, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-9282 Filed 4-17-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96010-96011]
[FR Doc No: 2016-31511]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0234]

Clinical Pharmacology Data To Support a Demonstration of
Biosimilarity to a Reference Product; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Clinical
Pharmacology Data to Support a Demonstration of Biosimilarity to a
Reference Product.'' This guidance is to assist the pharmaceutical
industry and other investigators engaged in biosimilar product
development in determining the clinical pharmacology data necessary for
evaluation of a proposed biosimilar product. This guidance finalizes
the draft guidance with the same name issued in May 2014. This guidance
is one in a series of guidances that FDA is developing to implement the
Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-D-0234 for ``Clinical Pharmacology Data To Support a
Demonstration of Biosimilarity to a Reference Product; Guidance for
Industry; Availability.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301-
796-2500; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Clinical Pharmacology Data to Support a Demonstration of
Biosimilarity to a Reference Product.'' This guidance is intended to
assist the pharmaceutical industry and other investigators engaged in
biosimilar product development with the design and use of clinical
pharmacology data necessary for evaluation of a proposed biosimilar
product. This guidance provides recommendations on how clinical
pharmacology studies that assess the presence or absence of clinically
meaningful differences between the proposed biosimilar product and the
U.S.-licensed reference product should be conducted and analyzed to
address questions arising during biosimilar product development.

    Clinical pharmacology studies are part of a stepwise approach for
developing the data and information needed to support a demonstration
of biosimilarity. These studies can reduce the residual uncertainty in
assessing the biosimilarity between a proposed biosimilar product and
reference product and inform the design of subsequent clinical trials
to assess clinically meaningful differences. This guidance is intended
to assist sponsors in designing such studies in support of applications
submitted under section 351(k) of the Public Health Service Act (42
U.S.C. 262(k)), as added by the BPCI Act.\1\ In particular, this
guidance discusses certain critical considerations for using clinical
pharmacology testing to support biosimilarity, approaches for
developing the appropriate clinical pharmacology database to support a
demonstration of biosimilarity, and the utility of modeling and
simulation for designing and analyzing clinical trials. Scientific
principles described in the guidance may also be informative for the
development of certain biological products under section 505(b)(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(2)).
---------------------------------------------------------------------------

    \1\ The BPCI Act was enacted as part of the Patient Protection
and Affordable Care Act (Pub. L. 111-148) on March 23, 2010.
---------------------------------------------------------------------------

    On May 14, 2014, FDA issued a notice announcing the availability of
a draft guidance with the same name as the current guidance to solicit
comments from the public (79 FR 27622). After carefully reviewing
received comments and in light of increased regulatory experience and
the evolution of the science in biosimilar product development and
evaluation, FDA has finalized that guidance with certain changes. These
changes are for clarity, however, and are not substantive.
    This guidance is one in a series that FDA is developing to
implement the BPCI Act and is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the current thinking of FDA on conducting clinical pharmacology studies
in support of proposed biosimilar products. It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    The guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collection of information submitted under section 351(k)
applications for biosimilars is approved under OMB control number 0910-
0719. The collection of information submitted under 21 CFR part 312 is
approved under OMB control number 0910-0014.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: December 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31511 Filed 12-28-16; 8:45 am]
 BILLING CODE 4164-01-P