[Federal Register: July 27, 2009 (Volume 74, Number 142)]
[Notices]
[Page 37067-37069]
[DOCID:fr27jy09-86]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-60352; File No. SR-NASDAQ-2009-059]

Self-Regulatory Organizations; the NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
Modifying Fees for Members Using the NASDAQ Options Market

July 21, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\, and Rule 19b-4 thereunder,\2\ notice is hereby given
that on July 1, 2009, The NASDAQ Stock Market LLC (``NASDAQ'') 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 NASDAQ. Pursuant to Section 19(b)(3)(A)(ii)
of the Act \3\ and Rule 19b-4(f)(2) thereunder,\4\ a proposed rule
change to modify pricing for NASDAQ members using the NASDAQ Options
Market (``NOM''), Nasdaq's facility for the trading of standardized
equity and index options [sic]. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NASDAQ proposes to modify pricing for NASDAQ members using the
Nasdaq Market Center. This proposed rule change, which is effective
upon filing, will become operative on July 1, 2009. The text of the
proposed rule change is available at http://
nasdaqomx.cchwallstreet.com/, at NASDAQ's principal office, 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, NASDAQ included statements
concerning the purpose of and basis for the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. NASDAQ 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
    Nasdaq is modifying NASDQ Rule 7050, the fee schedule for NOM, in
several ways. First, Nasdaq is making changes that apply to orders with
an account type of ``Customer.'' Specifically, Nasdaq is ending its
pricing program to eliminate the fee for the execution of options
orders with an account type of ``Customer'' that take liquidity \5\ in
certain Penny Pilot options. In April, Nasdaq expanded the application
of that rule to all options that are included in the Options Penny
Pilot Program. Nasdaq continued to monitor the trading of options on
these equities to ensure that the proposal is operating in a fashion
that promotes the interests of investors. Nasdaq has concluded that the
reduction of fees is no longer attracting new order flow to NOM and,
therefore, Nasdaq is establishing a fee of $0.20 per executed contract
for Customer orders in Penny Pilot options.
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    \5\ An order that ``takes'' or ``removes'' liquidity is one that
is entered into NOM and that executes against an order resting on
the NOM book.
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    Second, Nasdaq is also changing the fee structure for ``Customer''
orders in options not included in the Options Penny Pilot Program.
Currently, Nasdaq charges no execution fees for members providing
liquidity through the NASDAQ Options Market with an account type
``Customer.'' Nasdaq also offers a credit of $0.20 per executed
contract to members entering orders in options with an account type
``Customer'' that execute and remove liquidity entered by another
member in options that are not included in the Options Penny Pilot
Program. Nasdaq is proposing to eliminate the payment of this credit
when an order with an account type of Customer executes against another
order with an account type of Customer. Nasdaq determined that the
previous rule resulted in disproportionate payment for Customer orders
relative to order volume growth.
    Third, Nasdaq is modifying NASDAQ Rule 7050 to lower from $0.45 to
$0.20 the fees applicable to orders from Firms that remove liquidity in
non-Penny Pilot stocks. Nasdaq believes that lowering this fee will
attract more order flow to NOM and improve its overall competitiveness.
    Nasdaq believes that the proposed fees are competitive, fair and
reasonable, and non-discriminatory in that they apply equally to all
similarly situated members and customers. As with all fees, Nasdaq may
adjust these proposed fees in response to competitive conditions by
filing a new proposed rule change.
2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\6\ in general, and with Section
6(b)(5) of the Act,\7\ in particular, in that the proposal is designed
to prevent fraudulent and manipulative acts and practices, to promote
just and equitable principles of trade, to foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest.
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    \6\ 15 U.S.C. 78f.
    \7\ 15 U.S.C. 78f(b)(5).
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    NASDAQ also believes that the proposed rule change is consistent
with Section 6(b)(4) of the Act,\8\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility or
system which NASDAQ operates or controls. The proposed change
identifies a class of person subject to transaction execution fees
based on the role of that class in bringing order flow to NASDAQ. With
respect to options markets, the Commission has found comparable pricing
distinctions to be consistent with the Act. For example, in SR-ISE-
2006-26,\9\ the Commission approved a fee schedule under which orders
of professional customers were charged higher fees than orders of non-
professional customers. A Firm rate that is lower than other
participant rates is not uncommon. In fact, ISE charges the same
differential rate that NASDAQ is proposing: $0.20 per contract for
Proprietary Firm executions and $0.45 per contract for non-ISE-Market
Makers.\10\
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    \8\ 15 U.S.C. 78f(b)(4).
    \9\ Securities Exchange Act Release No. 59287 (January 23,
2009), 74 FR 5694 (January 30, 2009) (SR-ISE-2006-26).
    \10\ See http://www.ise.com/assets//documents//optionsExchange//
legal/fee/fee_schedule.
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    NASDAQ also believes it is equitable to rebate customer executions
in non-penny pilot options when the customer removes liquidity, unless
the customer removes liquidity from a resting customer order. In that
case, neither side of the trade is charged a fee or given a rebate. In
other words, customer-to-customer transactions will be free to both
sides of the trade (as is the case on most options markets) and
therefore in NASDAQ's view it is not justifiable to pay an additional
rebate. NASDAQ understands that on exchanges that engage in payment-
for-order-flow and that have less transparent fee schedules, customer
orders that interact with other customer orders do not receive payment
whereas customer orders that interact with a market maker do receive
payment for order flow.
    The impact of the changes upon the net fees paid by a particular
market participant will depend upon a number of variables, including
its monthly volume, the order types it uses, and the prices of its
quotes and orders (i.e., its propensity to add or remove liquidity and
to set the best bid and offer), and the extent to which it acts as an
agent for retail customers. NASDAQ 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. NASDAQ is modifying fees to remain competitive
with those charged by other venues and therefore strongly believes that
its fees are reasonable and equitably allocated to those members that
opt to direct orders to NASDAQ rather than competing venues.

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

    NASDAQ does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

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

    Written comments were neither solicited nor received.

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 \11\ and subparagraph (f)(2) of Rule 19b-4
thereunder.\12\ At any time within 60 days of the filing of the
proposed rule change, the Commission may summarily abrogate 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.
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    \11\ 15 U.S.C. 78s(b)(3)(a)(ii).
    \12\ 17 CFR 240.19b-4(f)(2).
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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. In addition, the Commission seeks
comment generally on whether the proposed assessment of transaction
fees is consistent with the Act, in particular whether the proposal
provides for an equitable allocation of reasonable dues, fees, and
other charges among its members and issuers and other persons using its
facilities under Section 6(b)(4) of the Act or whether the proposal
permits unfair discrimination between customers, issuers, brokers, or
dealers under Section 6(b)(5) of the Act. Specifically:
    1. The Exchange has determined that the previous $0.20 rebate for a
Customer account for removing liquidity resulted in disproportionate
payment for Customer orders relative to order volume growth. Do
commenters believe that eliminating the rebate to Customers removing
liquidity in non-Penny Pilot options when that Customer trades against
a Customer order, while retaining the rebate to Customers that trade
against a Firm or Market Maker order is consistent with the Act,
including whether it is an equitable allocation of fees under Section
6(b)(4) and not unfairly discriminatory under Section 6(b)(5)? Why or
why not?
    2. The Commission notes that the fee schedules of some options
exchanges provide for different levels of transaction fees for
different categories of market participants. Generally, if there is a
distinction between transaction fees for market makers and other non-
customers (e.g. broker-dealers, firms), the market maker transaction
fee is less than the non-customer fee. However, the Exchange notes that
one exchange charges away market makers more than non-customer
orders.\13\ The Exchange proposes to charge Market Makers $0.45 per
contract to remove orders in non-Penny Pilot options and to charge
Firms $0.20 per contract to remove such orders. Is this fee
differential consistent with the Act, including whether it is an
equitable allocation of fees under Section 6(b)(4) and not unfairly
discriminatory under Section 6(b)(5)? Why or why not?
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    \13\ See supra note 10 and accompanying text.
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    3. In non-Penny Pilot options, the Exchange proposes to lower the
fees charged to firms that remove liquidity from $0.45 to $0.20. The
Exchange, however, maintains the fee of $0.45 for sending orders via
the Options Intermarket Linkage that execute on NOM. Is creating a
differential in this manner consistent with the Act, including whether
it is an equitable allocation of fees under Section 6(b)(4) and not
unfairly discriminatory under Section 6(b)(5)? Why or why not?
    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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2009-059 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-NASDAQ-2009-059.
This file number should be included on the subject line if e-mail 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 inspection
and copying 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 such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File No. SR-NASDAQ-2009-059 and should be
submitted on or before August 17, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-17819 Filed 7-24-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: August 11, 2010 (Volume 75, Number 154)]
[Proposed Rules]
[Page 48620-48623]
[DOCID:fr11au10-21]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0761; Directorate Identifier 2010-NM-069-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Model 737-100, -200,
-200C, -300, -400, and -500 Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Model 737-100, -200, -200C, -300, -400, and -500 series
airplanes. This proposed AD would require installing two warning level
indicator lights on the P2-2 center instrument panel in the flight
compartment for certain airplanes. For a certain other airplane, this
proposed AD would require activating the cabin altitude warning and
takeoff configuration warning lights. For all airplanes, this proposed
AD also would require revising the airplane flight manual to remove
certain requirements included by previous AD actions, to require new
pressure altitude limitations for certain airplanes, and to advise the
flightcrew of the following changes: revised emergency procedures to
use when a cabin altitude warning or rapid depressurization occurs, and
revised cabin pressurization procedures for normal operations. This
proposed AD results from a design change in the cabin altitude warning
system that would address the identified unsafe condition. We are
proposing this AD to prevent failure of the flightcrew to recognize and
react to a valid cabin altitude warning horn, which could result in
incapacitation of the flightcrew due to hypoxia (lack of oxygen in
body), and consequent loss of control of the airplane.

DATES: We must receive comments on this proposed AD by September 27,
2010.

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 proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone 206-
544-5000, extension 1; fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet https://www.myboeingfleet.com. You may review copies of the
referenced service information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

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: Jeffrey W. Palmer, Aerospace Engineer,
Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft
Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057-
3356; telephone<PHONE_NUMBER>; 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-2010-0761;
Directorate Identifier 2010-NM-069-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

    The Model 737 cabin altitude warning is an intermittent horn that
sounds when cabin altitude exceeds 10,000 feet. The same intermittent
warning horn sound is utilized by the takeoff configuration warning
system (TCWS) to warn of unsafe airplane configuration for takeoff. The
TCWS warning functionality is inhibited by air/ground logic when the
airplane is in flight. However, the Model 737 cabin altitude warning
system design does not currently incorporate a dedicated means of
positively identifying the warning horn as a cabin altitude warning or
a takeoff configuration warning. There are approximately 25 known
instances where flightcrews have misinterpreted a valid cabin altitude
warning as a takeoff configuration warning.
    Failure of the flightcrew to recognize and react to a valid cabin
altitude warning horn could result in incapacitation of the flightcrew
due to hypoxia (lack of oxygen in body), and consequent loss of control
of the airplane. To address this unsafe condition, we issued the
following ADs.
    On November 7, 2003, we issued related AD 2003-03-15 R1, Amendment
39-13366 (68 FR 64802, November 17, 2003), for various The Boeing
Company and McDonnell Douglas Corporation transport category airplanes.
That AD requires revising the airplane flight manual (AFM) to advise
the flightcrew to don oxygen masks as a first and immediate step when
the cabin altitude warning occurs. We issued that AD to prevent
incapacitation of the flightcrew due to lack of oxygen, which could
result in loss of control of the airplane.
    On June 15, 2006, we issued related AD 2006-13-13, Amendment 39-
14666 (71 FR 35781, June 22, 2006). (A correction of that AD was
published in the Federal Register on July 3, 2006 (71 FR 37980).) That
AD applies to all Model 737 airplanes. That AD requires revising the
AFM to advise the flightcrew of improved procedures for pre-flight
setup of the cabin pressurization system, as well as improved
procedures for interpreting and responding to the cabin altitude/
configuration warning horn. That AD resulted from reports that
airplanes had failed to pressurize, and that the flightcrews failed to
react properly to the cabin altitude warning horn. We issued that AD to
prevent failure of the airplane to pressurize and subsequent failure of
the flightcrew to recognize and react to a valid cabin altitude warning
horn, which could result in incapacitation of the flightcrew due to
hypoxia (lack of oxygen in body) and consequent loss of airplane
control.
    On October 24, 2008, we issued related AD 2008-23-07, Amendment 39-
15728 (73 FR 66512, November 10, 2008), for all Model 737 airplanes.
That AD requires revising the AFM to include a new flightcrew briefing
that must be done before the first flight of the day and following any
change in flightcrew members, and to advise the flightcrew of this
additional briefing. That AD resulted from continuing reports that
flightcrews have failed to recognize and react properly to the cabin
altitude warning horn. We issued that AD to prevent failure of the
flightcrew to recognize and react properly to a valid cabin altitude
warning horn, which could result in incapacitation of the flightcrew
due to hypoxia (lack of oxygen in body) and consequent loss of airplane
control.
    The preambles to AD 2006-13-13 and AD 2008-23-07 explain that the
revisions to the AFM required by those ADs are considered to be interim
action. The manufacturer had advised us that it was developing a design
change in the cabin altitude warning system that would address the
identified unsafe condition(s), and that once this design change was
developed, approved, and available, the FAA might consider additional
rulemaking. The manufacturer now has developed such a modification, and
we have determined that further rulemaking is necessary; this proposed
AD follows from that determination. We can better ensure long-term
continued operational safety by modifications or design changes to
remove the source of the problem, rather than by AFM revisions alone.

Relevant Service Information

    We have reviewed Boeing Alert Service Bulletin 737-31A1325, dated
January 11, 2010 (for Model 737-100, -200, -200C, -300, -400, and -500
series airplanes). This service bulletin describes procedures for
installing two warning level indicator lights on the P2-2 center
instrument panel in the flight compartment. This installation includes
changing three wire bundles.
    We have also reviewed Boeing Alert Service Bulletin 737-31A1398,
dated January 7, 2010 (for Model 737-400 series airplane, variable
number PW234). This service bulletin describes procedures for
activating the cabin altitude warning and takeoff configuration warning
lights. The activation includes changing the wiring in the W066 wire
bundle and removing the INOP markers from the cabin altitude warning
and takeoff configuration warning lights.

FAA's Determination and Requirements of This Proposed AD

    We are proposing this AD because we evaluated all relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.
This proposed AD would require accomplishing the actions specified in
the service information described previously. The proposed AD would
also require revising the AFM to remove certain requirements included
by previous AD actions, to require new pressure altitude limitations
for certain airplanes, and to advise the flightcrew of the following
changes: revised emergency procedures to use when a cabin altitude
warning or rapid depressurization occurs, and revised cabin
pressurization procedures for normal operations.

Costs of Compliance

    We estimate that this proposed AD would affect 741 airplanes of
U.S. registry. The following table provides the estimated costs for
U.S. operators to comply with this proposed AD.

                                                                 Table--Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number  of
                                                                          Average  labor                     Cost per          U.S.-
                         Action                             Work hours    rate  per hour       Parts          product       registered      Fleet cost
                                                                                airplanes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Installation of warning indicator lights................              20             $85          $2,738          $4,438             740      $3,284,120
Activation of the cabin altitude warning system/takeoff                1              85               0              85               1              85
 configuration warning lights...........................
AFM revision............................................               1              85               0              85             741          62,985
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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 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 this 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.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, 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 FAA amends Sec.  39.13 by adding the following new AD:

The Boeing Company: Docket No. FAA-2010-0761; Directorate Identifier
2010-NM-069-AD.

Comments Due Date

    (a) We must receive comments by September 27, 2010.

Affected ADs

    (b) This AD affects the ADs identified in paragraphs (b)(1),
(b)(2), and (b)(3) of this AD. This AD does not supersede the
requirements of these ADs.
    (1) AD 2008-23-07, Amendment 39-15728.
    (2) AD 2006-13-13, Amendment 39-14666.
    (3) AD 2003-03-15 R1, Amendment 39-13366.

Applicability

    (c) This AD applies to the airplanes, certificated in any
category, identified in paragraphs (c)(1) and (c)(2) of this AD.
    (1) The Boeing Company Model 737-100, -200, -200C, -300, -400,
and -500 series airplanes identified in Boeing Alert Service
Bulletin 737-31A1325, dated January 11, 2010.
    (2) The Boeing Company Model 737-400 series airplanes identified
in Boeing Alert Service Bulletin 737-31A1398, dated January 7, 2010.

Subject

    (d) Air Transport Association (ATA) of America Code 31:
Instruments.

Unsafe Condition

    (e) This AD results from a design change in the cabin altitude
warning system that would address the identified unsafe condition.
The Federal Aviation Administration is issuing this AD to prevent
failure of the flightcrew to recognize and react properly to a valid
cabin altitude warning horn, which could result in incapacitation of
the flightcrew due to hypoxia (lack of oxygen in body) and
consequent loss of airplane control.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Installation of Warning Indicator Lights

    (g) For airplanes identified in Boeing Alert Service Bulletin
737-31A1325, dated January 11, 2010: Within 36 months after the
effective date of this AD, install two warning level indicator
lights on the P2-2 center instrument panel in the flight
compartment, in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin 737-31A1325, dated January 11, 2010.

Activation of Warning Indicator Lights

    (h) For airplanes identified in Boeing Alert Service Bulletin
737-31A1398, dated January 7, 2010: Within 36 months after the
effective date of this AD, activate the cabin altitude warning and
takeoff configuration warning lights, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin 737-
31A1398, dated January 7, 2010.

Airplane Flight Manual (AFM) Revisions

    (i) Before further flight after doing the installation or
activation of the warning lights required by paragraph (g) or (h) of
this AD, do the actions specified in paragraphs (i)(1), (i)(2), and
(i)(3) of this AD.
    (1) Revise the Limitations Section of the applicable Boeing 737
AFM by doing the actions specified in paragraphs (i)(1)(i) and
(i)(1)(ii) of this AD.
    (i) Delete the ``CABIN ALTITUDE WARNING TAKEOFF BRIEFING'' added
by AD 2008-23-07.
    (ii) Add the following statement. This may be done by inserting
a copy of this AD into the applicable AFM.
    ``For airplanes approved for maximum takeoff and landing
altitudes above 8,400 feet pressure altitude, change the limitation
for Maximum Takeoff and Landing pressure altitude as follows: With
the CABIN ALTITUDE and TAKEOFF CONFIG lights installed and operative
on those airplanes without the High Altitude Landing switch
installed, maximum takeoff and landing altitude is limited to 9,000
feet pressure altitude.''

    (2) Revise the Emergency Procedures Section of the applicable
Boeing 737 AFM by doing the actions specified in paragraphs
(i)(2)(i), (i)(2)(ii), (i)(2)(iii), and (i)(2)(iv) of this AD.
    (i) Delete the procedure ``WARNING HORN--CABIN ALTITUDE OR
CONFIGURATION'' added by AD 2006-13-13.
    (ii) Delete the procedure entitled ``CABIN ALTITUDE WARNING OR
RAPID DEPRESSURIZATION'' added by AD 2006-13-13.
    (iii) If the procedure entitled ``CABIN ALTITUDE (Airplanes with
the CABIN ALTITUDE lights installed)'' is currently contained in the
applicable Boeing 737 AFM, delete the procedure entitled ``CABIN
ALTITUDE (Airplanes with the CABIN ALTITUDE lights installed).''
    (iv) Add the following statement. This may be done by inserting
a copy of this AD into the applicable AFM.

``CABIN ALTITUDE WARNING OR RAPID DEPRESSURIZATION (required by
this ad)

    Condition: The CABIN ALTITUDE warning light illuminates or the
intermittent warning horn sounds in flight above 10,000 ft MSL.

RECALL:
    Oxygen Masks and Regulators............  On, 100%
    Crew Communications....................  Establish
REFERENCE:
    Pressurization Mode Selector...........  Manual
    Outflow Valve Switch...................  Close
    Passenger Oxygen (If Required).........  On
    Descent (If Required)..................  Initiate

    (3) Revise the Normal Procedures Section of the applicable
Boeing 737 AFM by doing the actions specified in paragraphs
(i)(3)(i) and (i)(3)(ii) of this AD.
    (i) Delete the ``CABIN ALTITUDE WARNING TAKEOFF BRIEFING''
procedure added by AD 2008-23-07.
    (ii) Add the following statement. This may be done by inserting
a copy of this AD into the applicable AFM.
    ``For normal operations, the pressurization mode selector should
be in AUTO prior to takeoff. (Required by this AD)''

    Note 1:  When statements identical to those specified in
paragraphs (i)(1)(ii), (i)(2)(iv), and (i)(3)(ii) of this AD have
been included in the general revisions of the AFM, the general
revisions may be inserted into the AFM, and the copies of this AD
may be removed from the AFM.

Terminating Action for Affected ADs

    (j) Accomplishment of the requirements of this AD terminates the
specified requirements of the ADs identified in paragraphs (j)(1),
(j)(2), and (j)(3) of this AD, for only the airplanes identified in
paragraphs (c)(1) and (c)(2) of this AD.
    (1) AD 2008-23-07: All requirements of that AD.
    (2) AD 2006-13-13: All requirements of that AD.
    (3) AD 2003-03-15 R1: The requirements specified in paragraph
(a), Table 2, and Figures 2 and 3 of that AD.

Special Flight Permit

    (k) Special flight permits, as described in Section 21.197 and
Section 21.199 of the Federal Aviation Regulations (14 CFR 21.197
and 21.199), are not allowed.

Alternative Methods of Compliance (AMOCs)

    (l)(1) The Manager, Seattle Aircraft Certification Office (ACO),
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: Jeffrey W. Palmer, Aerospace Engineer, Systems and Equipment
Branch, ANM-130S, FAA, Seattle Aircraft Certification Office, 1601
Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6472; fax<PHONE_NUMBER>. Information may be e-mailed to: 9-ANM-
<EMAIL_ADDRESS>    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.

    Issued in Renton, Washington, on July 28, 2010.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-19834 Filed 8-10-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 160 (Monday, August 19, 2019)]
[Notices]
[Pages 42909-42910]
[FR Doc No: 2019-17732]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP19-1064-002.
    Applicants: Stingray Pipeline Company, L.L.C.
    Description: Compliance filing Stingray Second Order No. 587-Y
Compliance Filing to be effective 8/1/2019.
    Filed Date: 8/8/19.
    Accession Number: 20190808-5028.
    Comments Due: 5 p.m. ET 8/20/19.

    Docket Numbers: RP19-1463-000.
    Applicants: Big Sandy Pipeline, LLC, Bobcat Gas Storage, East
Tennessee Natural Gas, LLC, Egan Hub Storage, LLC, Garden Banks Gas
Pipeline, LLC,Maritimes & Northeast Pipeline, L.L.C., Moss Bluff Hub,
LLC, Mississippi Canyon Gas Pipeline, L.L.C., Ozark Gas Transmission,
L.L.C., NEXUS Gas Transmission, LLC, Sabal Trail Transmission, LLC,
Saltville Gas Storage Company L.L.C.,Southeast Supply Header, LLC,
Steckman Ridge, LP, Texas Eastern Transmission, LP, Nautilus Pipeline
Company, L.L.C., Algonquin Gas Transmission, LLC.
    Description: Compliance filing Enbridge (U.S.) Pipelines Request
for Waivers--LINK System Maintenance.
    Filed Date: 8/8/19.
    Accession Number: 20190808-5044.
    Comments Due: 5 p.m. ET 8/20/19.

    Docket Numbers: RP19-1464-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) Rate Filing: Amendment to Neg Rate Agmt
(Entergy 48769) to be effective 6/1/2019.
    Filed Date: 8/8/19.
    Accession Number: 20190808-5076.
    Comments Due: 5 p.m. ET 8/20/19.

    Docket Numbers: RP19-846-002.
    Applicants: Black Hills Shoshone Pipeline, LLC.
    Description: Compliance filing NAESB Compliance Filing--Order No.
587-Y to be effective 4/1/2019.
    Filed Date: 8/8/19.
    Accession Number: 20190808-5130.
    Comments Due: 5 p.m. ET 8/20/19.

    Docket Numbers: RP19-1465-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--NSTAR
releases to BP to be effective 8/9/2019.
    Filed Date: 8/9/19.
    Accession Number: 20190809-5030.
    Comments Due: 5 p.m. ET 8/21/19.

    Docket Numbers: RP19-884-001.
    Applicants: Maritimes & Northeast Pipeline, L.L.C.
    Description: Compliance filing RP19-884-000 Order 587-Y Compliance
Filing to be effective 8/1/2019.
    Filed Date: 8/9/19.
    Accession Number: 20190809-5046.
    Comments Due: 5 p.m. ET 8/21/19.

    Docket Numbers: RP19-904-001.
    Applicants: Freebird Gas Storage, L.L.C.
    Description: Compliance filing Revised FERC Order No. 587-Y
Compliance Filing to be effective 8/1/2019.
    Filed Date: 8/9/19.
    Accession Number: 20190809-5125.
    Comments Due: 5 p.m. ET 8/21/19.

    Docket Numbers: RP19-906-001.
    Applicants: Caledonia Energy Partners, L.L.C.
    Description: Compliance filing Revised FERC Order 587-Y Compliance
Filing to be effective 8/1/2019.
    Filed Date: 8/9/19.
    Accession Number: 20190809-5123.
    Comments Due: 5 p.m. ET 8/21/19.

    Docket Numbers: RP19-907-001.
    Applicants: East Cheyenne Gas Storage, LLC.
    Description: Compliance filing Revised FERC Order No. 587-Y
Compliance Filing to be effective 8/1/2019.
    Filed Date: 8/9/19.
    Accession Number: 20190809-5124.
    Comments Due: 5 p.m. ET 8/21/19.

    Docket Numbers: RP19-926-001.
    Applicants: Rendezvous Pipeline Company, LLC.
    Description: Compliance filing Revised NAESB Compliance Filing--
Order No. 587-Y to be effective 8/1/2019.
    Filed Date: 8/9/19.
    Accession Number: 20190809-5108.
    Comments Due: 5 p.m. ET 8/21/19.

    Docket Numbers: RP19-929-001.
    Applicants: TransColorado Gas Transmission Company LLC.

    Description: Compliance filing NAESB 3.1 Compliance Filing to be
effective 8/1/2019.
    Filed Date: 8/9/19.
    Accession Number: 20190809-5077.
    Comments Due: 5 p.m. ET 8/21/19.

    Docket Numbers: RP19-930-001.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Compliance filing NAESB 3.1 Compliance Filing to be
effective 8/1/2019.
    Filed Date: 8/9/19.
    Accession Number: 20190809-5083.
    Comments Due: 5 p.m. ET 8/21/19.

    Docket Numbers: RP19-940-001.
    Applicants: Golden Triangle Storage, Inc.
    Description: Compliance filing GTS Compliance Filing Pursuant to
Order in Docket No. RP19-940-000 to be effective 8/1/2019.
    Filed Date: 8/9/19.
    Accession Number: 20190809-5120.
    Comments Due: 5 p.m. ET 8/21/19.

    Docket Numbers: RP19-997-001.
    Applicants: MoGas Pipeline LLC.
    Description: Compliance filing MoGas Revised NAESB Compliance
Filing to be effective 8/1/2019.
    Filed Date: 8/9/19.
    Accession Number: 20190809-5038.
    Comments Due: 5 p.m. ET 8/21/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 12, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-17732 Filed 8-16-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 152 (Monday, August 8, 2011)]
[Proposed Rules]
[Pages 48058-48062]
[FR Doc No: 2011-19959]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2011-N-0505]

Effective Date of Requirement for Premarket Approval for
Cardiovascular Permanent Pacemaker Electrode

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA) is proposing to require
the filing of a premarket approval application (PMA) or a notice of
completion of a product development protocol (PDP) for the following
class III preamendments device: Cardiovascular permanent pacemaker
electrode. The Agency is also summarizing its proposed findings
regarding the degree of risk of illness or injury designed to be
eliminated or reduced by requiring this device to meet the statute's
approval requirements and the benefits to the public from the use of
the device. In addition, FDA is announcing the opportunity for
interested persons to request that the Agency change the classification
of the cardiovascular permanent pacemaker electrode based on new
information. This action implements certain statutory requirements.

DATES: Submit either electronic or written comments by November 7,
2011. Submit requests for a change in classification by August 23,
2011. FDA intends that, if a final rule based on this proposed rule is
issued, anyone who wishes to continue to market the device will need to
submit a PMA within 90 days of the effective date of the final rule.
Please see section XI of this document for the proposed effective date
of any final rule that may publish based on this proposal.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0505, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2011-N-0505 for this rulemaking. All comments
received may be posted without change to http://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT: Elias Mallis, Food and Drug
Administration, Center for Devices and Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1538, Silver Spring, MD 20993-0002, 301-
796-6216.

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L.
94-295), the Safe Medical Devices Act of 1990 (the SMDA) (Pub. L. 101-
629), and the Food and Drug Administration Modernization Act of 1997
(FDAMA) (Pub. L. 105-115), the Medical Device User Fee and
Modernization Act of 2002 (Pub. L. 107-250), the Medical Devices
Technical Corrections Act (Pub. L. 108-214), and the Food and Drug
Administration Amendments Act of 2007 (Pub. L. 110-85), establish a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established
three categories (classes) of devices, reflecting the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
    Under section 513 of the FD&C Act, devices that were in commercial
distribution before the enactment of the 1976 amendments, May 28, 1976
(generally referred to as preamendments devices), are classified after
FDA has: (1) Received a recommendation from a device classification
panel (an FDA advisory committee); (2) published the panel's
recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices), are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless and until the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and 21 CFR part 807.
    A preamendments device that has been classified into class III may
be marketed by means of premarket notification procedures (510(k)
process) without submission of a PMA until FDA issues a final
regulation under section 515(b) of the FD&C Act (21 U.S.C. 360e(b))
requiring premarket approval. Section 515(b)(1) of the FD&C Act (21
U.S.C. 360e(b)(1)) establishes the requirement that a preamendments
device that FDA has classified into class III is subject to premarket
approval. A preamendments class III device may be commercially
distributed without an approved PMA or a notice of completion of a PDP
until 90 days after FDA issues a final rule requiring premarket
approval for the device, or 30 months after final classification of the
device under section 513 of the FD&C Act, whichever is later. Also, a
preamendments device subject to the rulemaking procedure under section
515(b) of the FD&C Act is not required to have an approved
investigational

device exemption (IDE) (see 21 CFR part 812) contemporaneous with its
interstate distribution until the date identified by FDA in the final
rule requiring the submission of a PMA for the device. At that time, an
IDE is required only if a PMA has not been submitted or a PDP
completed.
    Section 515(b)(2)(A) of the FD&C Act provides that a proceeding to
issue a final rule to require premarket approval shall be initiated by
publication of a notice of proposed rulemaking containing: (1) The
regulation; (2) proposed findings with respect to the degree of risk of
illness or injury designed to be eliminated or reduced by requiring the
device to have an approved PMA or a declared completed PDP and the
benefit to the public from the use of the device; (3) an opportunity
for the submission of comments on the proposed rule and the proposed
findings; and (4) an opportunity to request a change in the
classification of the device based on new information relevant to the
classification of the device.
    Section 515(b)(2)(B) of the FD&C Act provides that if FDA receives
a request for a change in the classification of the device within 15
days of the publication of the notice, FDA shall, within 60 days of the
publication of the notice, consult with the appropriate FDA advisory
committee and publish a notice denying the request for change in
reclassification or announcing its intent to initiate a proceeding to
reclassify the device under section 513(e) of the FD&C Act. Section
515(b)(3) of the FD&C Act provides that FDA shall, after the close of
the comment period on the proposed rule and consideration of any
comments received, issue a final rule to require premarket approval or
publish a document terminating the proceeding together with the reasons
for such termination. If FDA terminates the proceeding, FDA is required
to initiate reclassification of the device under section 513(e) of the
FD&C Act, unless the reason for termination is that the device is a
banned device under section 516 of the FD&C Act (21 U.S.C. 360f).
    If a proposed rule to require premarket approval for a
preamendments device is finalized, section 501(f)(2)(B) of the FD&C Act
(21 U.S.C. 351(f)(2)(B)) requires that a PMA or notice of completion of
a PDP for any such device be filed within 90 days of the date of
issuance of the final rule or 30 months after the final classification
of the device under section 513 of the FD&C Act, whichever is later. If
a PMA or notice of completion of a PDP is not filed by the later of the
two dates, commercial distribution of the device is required to cease
since the device would be deemed adulterated under section 501(f) of
the FD&C Act.
    The device may, however, be distributed for investigational use if
the manufacturer, importer, or other sponsor of the device complies
with the IDE regulations. If a PMA or notice of completion of a PDP is
not filed by the later of the two dates, and the device does not comply
with IDE regulations, the device is deemed to be adulterated within the
meaning of section 501(f)(1)(A) of the FD&C Act, and subject to seizure
and condemnation under section 304 of the FD&C Act (21 U.S.C. 334) if
its distribution continues. Shipment of devices in interstate commerce
will be subject to injunction under section 302 of the FD&C Act (21
U.S.C. 332), and the individuals responsible for such shipment will be
subject to prosecution under section 303 of the FD&C Act (21 U.S.C.
333). In the past, FDA has requested that manufacturers take action to
prevent the further use of devices for which no PMA or PDP has been
filed and may determine that such a request is appropriate for the
class III device that is the subject of this regulation.
    The FD&C Act does not permit an extension of the 90-day period
after issuance of a final rule within which an application or a notice
is required to be filed. The House Report on the 1976 amendments states
that: ``[t]he thirty month grace period afforded after classification
of a device into class III * * * is sufficient time for manufacturers
and importers to develop the data and conduct the investigations
necessary to support an application for premarket approval (H. Rept.
94-853, 94th Cong., 2d sess. 42 (1976)).''
    The SMDA added section 515(i) to the FD&C Act requiring FDA to
review the classification of preamendments class III devices for which
no final rule requiring the submission of PMAs has been issued, and to
determine whether or not each device should be reclassified into class
I or class II or remain in class III. For devices remaining in class
III, the SMDA directed FDA to develop a schedule for issuing
regulations to require premarket approval. The SMDA does not, however,
prevent FDA from proceeding immediately to rulemaking under section
515(b) of the FD&C Act on specific devices, in the interest of public
health, independent of the procedures of section 515(i). Proceeding
directly to rulemaking under section 515(b) of the FD&C Act is
consistent with Congress' objective in enacting section 515(i), i.e.,
that preamendments class III devices for which PMAs have not been
previously required either be reclassified to class I or class II or be
subject to the requirements of premarket approval. Moreover, in this
proposal, interested persons are being offered the opportunity to
request reclassification of the device.

II. Dates New Requirements Apply

    In accordance with section 515(b) of the FD&C Act, FDA is proposing
to require that a PMA or a notice of completion of a PDP be filed with
the Agency for class III devices within 90 days after issuance of any
final rule based on this proposal. An applicant whose device was
legally in commercial distribution before May 28, 1976, or whose device
has been found to be substantially equivalent to such a device, will be
permitted to continue marketing such class III devices during FDA's
review of the PMA or notice of completion of the PDP. FDA intends to
review any PMA for the device within 180 days, and any notice of
completion of a PDP for the device within 90 days of the date of
filing. FDA cautions that under section 515(d)(1)(B)(i) of the FD&C
Act, the Agency may not enter into an agreement to extend the review
period for a PMA beyond 180 days unless the Agency finds that ``the
continued availability of the device is necessary for the public
health.''
    FDA intends that under Sec.  812.2(d), the preamble to any final
rule based on this proposal will state that, as of the date on which
the filing of a PMA or a notice of completion of a PDP is required to
be filed, the exemptions from the requirements of the IDE regulations
for preamendments class III devices in Sec.  812.2(c)(1) and (c)(2)
will cease to apply to any device that is: (1) Not legally on the
market on or before that date, or (2) legally on the market on or
before that date but for which a PMA or notice of completion of a PDP
is not filed by that date, or for which PMA approval has been denied or
withdrawn.
    If a PMA or notice of completion of a PDP for a class III device is
not filed with FDA within 90 days after the date of issuance of any
final rule requiring premarket approval for the device, commercial
distribution of the device must cease. The device may be distributed
for investigational use only if the requirements of the IDE regulations
are met. The requirements for significant risk devices include
submitting an IDE application to FDA for its review and approval. An
approved IDE is required to be in effect before an investigation of the
device may be initiated or continued under Sec.  812.30. FDA,
therefore, cautions that IDE applications should be submitted to FDA at
least 30 days before the end of

the 90-day period after the issuance of the final rule to avoid
interrupting investigations.

III. Proposed Findings With Respect to Risks and Benefits

    As required by section 515(b) of the FD&C Act, FDA is publishing
its proposed findings regarding: (1) The degree of risk of illness or
injury designed to be eliminated or reduced by requiring that this
device have an approved PMA or a declared completed PDP, and (2) the
benefits to the public from the use of the device.
    These findings are based on the reports and recommendations of the
advisory committee (panel) for the classification of this device along
with information submitted in response to the 515(i) order (74 FR
16214, April 9, 2009) and any additional information that FDA has
encountered. Additional information regarding the risks as well as
classification associated with this device type can be found in the
following proposed and final rules and notices published in the Federal
Register on these dates: (45 FR 7907 at 7971, February 5, 1980; 52 FR
17736, May 11, 1987; and 60 FR 41986, August 14, 1995).

IV. Device Subject to This Proposal

    Cardiovascular Permanent or Temporary Pacemaker Electrode;
Permanent Pacemaker Electrode (21 CFR 870.3680(b)).

A. Identification

    A permanent pacemaker electrode is a device consisting of flexible
insulated electrical conductors with one end connected to an
implantable pacemaker pulse generator and the other end applied to the
heart. The device is used to transmit a pacing electrical stimulus from
the pulse generator to the heart and/or to transmit the electrical
signal of the heart to the pulse generator.

B. Summary of Data

    The Cardiovascular Devices Classification Panel recommended that
this device be classified into class III as permanent pacemaker
electrodes are permanent implants providing life-supporting or life-
sustaining therapy. Over time, the devices that have been designed and
developed have evolved and are widely variable from model to model as
well as from manufacturer to manufacturer. These designs are generally
more complex and of smaller sizes which may increase risk of failure
and introduce new failure modes. Accordingly, this has limited the
ability to develop comprehensive performance standards which would
apply to all aspects of pacemaker lead design, testing, and use.
Adequate performance standards have not yet been developed. The
potential safety and effectiveness risks, unsuitability of general and
special controls, long-term use as permanent implants of life-
sustaining therapy, and documented field failures warrant
classification of this device as class III.

C. Risks to Health

     Material risks. The material properties of
pacemaker leads, including mechanical, electrical, biostability,
biocompatibility, corrosion and other characteristics can affect acute
and chronic performance.
     Design risks. Lead designs may introduce
features or geometries that depart from traditional designs,
geometries, or sizes and which may result in degradation of performance
and safety of use.
     Manufacturing risks. Manufacturing variation,
the introduction of more complex and smaller designs, or quality system
failures may introduce device defects that may not be identified with
bench testing or acute in vivo studies.
     Clinical-use risks. Thromboembolism,
perforation, tissue reaction (exit block), dislodgement, infection, air
embolism, muscle/nerve stimulation, stenosis, and erosion/extrusion may
occur as a result of the clinical use and/or device malfunction.

V. PMA Requirements

    A PMA for this device must include the information required by
section 515(c)(1) of the FD&C Act. Such a PMA should also include a
detailed discussion of the risks identified previously, as well as a
discussion of the effectiveness of the device for which premarket
approval is sought. In addition, a PMA must include all data and
information on: (1) Any risks known, or that should be reasonably
known, to the applicant that have not been identified in this document;
(2) the effectiveness of the device that is the subject of the
application; and (3) full reports of all preclinical and clinical
information from investigations on the safety and effectiveness of the
device for which premarket approval is sought.
    A PMA must include valid scientific evidence to demonstrate
reasonable assurance of the safety and effectiveness of the device for
its intended use (see Sec.  860.7(c)(2) (21 CFR 860.7(c)(2)). Valid
scientific evidence is ``evidence from well-controlled investigations,
partially controlled studies, studies and objective trials without
matched controls, well-documented case histories conducted by qualified
experts, and reports of significant human experience with a marketed
device, from which it can fairly and responsibly be concluded by
qualified experts that there is reasonable assurance of the safety and
effectiveness of a device under its conditions of use. * * * Isolated
case reports, random experience, reports lacking sufficient details to
permit scientific evaluation, and unsubstantiated opinions are not
regarded as valid scientific evidence to show safety or
effectiveness.'' (Sec.  860.7(c)(2)).

VI. PDP Requirements

    A PDP for this device may be submitted instead of a PMA, and must
follow the procedures outlined in section 515(f) of the FD&C Act. A PDP
must provide: (1) A description of the device; (2) preclinical trial
information (if any); (3) clinical trial information (if any); (4) a
description of the manufacturing and processing of the device; (5) the
labeling of the device; and (6) all other relevant information about
the device. In addition, the PDP must include progress reports and
records of the trials conducted under the protocol on the safety and
effectiveness of the device for which the completed PDP is sought.

VII. Opportunity To Request a Change in Classification

    Before requiring the filing of a PMA or notice of completion of a
PDP for a device, FDA is required by section 515(b)(2)(A)(i) through
(b)(2)(A)(iv) of the FD&C Act and 21 CFR 860.132 to provide an
opportunity for interested persons to request a change in the
classification of the device based on new information relevant to the
classification. Any proceeding to reclassify the device will be under
the authority of section 513(e) of the FD&C Act.
    A request for a change in the classification of this device is to
be in the form of a reclassification petition containing the
information required by Sec.  860.123 (21 CFR 860.123), including new
information relevant to the classification of the device.
    The Agency advises that to ensure timely filing of any such
petition, any request should be submitted to the Division of Dockets
Management (see ADDRESSES) and not to the address provided in Sec.
860.123(b)(1). If a timely request for a change in the classification
of this device is submitted, the Agency will, within 60 days after
receipt of the petition, and after consultation with the appropriate
FDA resources, publish an order in the Federal Register that either
denies the request or gives notice of its intent to initiate a change
in the

classification of the device in accordance with section 513(e) of the
FD&C Act and Sec.  860.139 (21 CFR 860.130) of the regulations.

VIII. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IX. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this proposed rule is not a
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because none of the manufacturers of affected
products are small businesses, the Agency proposes to certify that the
final rule would not have a significant economic impact on a
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $136 million, using the most current (2010) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any one-year expenditure that would meet or
exceed this amount.

A. Costs of the Proposed Rule

    Under the proposed rule, FDA would require producers in the
cardiovascular permanent pacemaker electrode industry to obtain PMA or
establish a PDP before marketing new products. Similarly, producers of
cardiovascular permanent pacemaker electrodes that are already on the
market would need to submit PMA applications or establish PDPs in order
to continue commercial distribution of these products. Based on an
analysis of registration and listing data, manufacturer Web sites, and
responses to previous Federal Register requests for comment; FDA
estimates that 5 to 10 manufacturers are marketing approximately 18 to
23 devices that would be affected by this proposed rule. We therefore
estimate that the proposed rule would generate between 18 and 23 PMA or
PDP submissions. FDA has estimated an upper bound on the cost of PMA at
approximately $1,000,000 (see, for example, 73 FR 7501, February 8,
2008), and we assume that the cost of a PDP is roughly equal to that of
a PMA; this yields a rule-induced upfront cost of between $18 and $23
million. We lack data with which to estimate how the burden of this
cost would be distributed among device manufacturers, patients and
insurance providers.
    For a new product (i.e., a cardiovascular permanent pacemaker
electrode not currently on the market), the rule-induced cost would be
the difference between the cost of preparing and submitting a premarket
approval application and the cost of preparing and submitting a 510(k)
application. However, FDA has not received any submissions for new
devices of the type subject to the proposed rule since August 2004. We
expect the recent pattern of zero submissions to continue; therefore,
the proposed rule would not generate submission costs on an ongoing
basis.
    Some producers of devices that are subject to the proposed rule
could be dissuaded from seeking approval by the cost of submitting a
PMA application or by a low expectation that FDA would grant approval
for their products. In these cases, producers would experience a rule-
induced cost equal to the foregone expected profit on the withdrawn or
withheld cardiovascular permanent pacemaker electrodes, which is
necessarily less than the cost of PMA submission (otherwise, the
producers in question would not be dissuaded from seeking PMA).
Additionally, there would be a welfare loss experienced by consumers
who would, in the absence of the proposed rule, use the cardiovascular
permanent pacemaker electrodes that would be withdrawn or withheld from
the market as a result of the call for PMA or PDP. Due to the lack of
sufficient market data, we cannot quantify these consumers' welfare
loss. FDA requests comment on this issue and on all methods and results
of our cost estimation.
    In addition to the cost to industry of preparing and submitting
PMAs or PDPs, the proposed rule would impose incremental review costs
on FDA. Geiger (2005) (Ref. 1) estimated that, for devices reviewed by
FDA's Center for Devices and Radiological Health in 2003 and 2004,
review costs averaged $563,000 per PMA. Updated for inflation (using
U.S. Department of Commerce, 2011) (Ref. 2) to 2010 dollars, this
average review cost becomes $653,000 per PMA. Thus, the proposed rule's
review-related costs are expected to be between $11.8 million (18 x
$653,000) and $15.0 million (23 x $653,000). A portion of this total
would be paid by industry in the form of user fees, with the remainder
coming from general revenues. FDA's Data universal numbering system
database reveals that the manufacturers affected by this proposed rule
have annual revenues over $100 million, so they would not be eligible
for small business user fees. The standard user fee is currently set at
$236,298 for a premarket application (PMA or PDP) (75 FR 45632 at
45643), so user fees would likely cover $4.3 million (= 18*$236,298) to
$5.4 million (= 23*$236,298) of FDA review costs, with the remaining
$7.5 to $9.6 million coming from general revenues.

B. Benefits of the Proposed Rule

    The proposed requirement for premarket approval applications or
product development protocols for cardiovascular permanent pacemaker
electrodes would produce social benefits equal to the value of the
information generated by the safety and effectiveness tests that
producers would be required to conduct as part of the PMA or PDP
process. Provided first to FDA, this information would eventually
assist physicians, patients and insurance providers in making more
informed decisions about these devices. FDA expects there to be
approximately 18 to 23 PMA or PDP submissions as a result of the
proposed rule, but we are unable to quantify the value of information
associated with each submission. We request comment on this issue.

X. Paperwork Reduction Act of 1995

    This proposed rule refers to previously approved collections of
information found in FDA regulations. These collections of information
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 collections of information in 21 CFR part
812 have been approved under OMB control number 0910-0078; the
collections of information in 21 CFR part 807, subpart E have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 814, subpart B have been approved under OMB
control number 0910-0231; and the collections of information under 21
CFR part 801 have been approved under OMB control number 0910-0485.

XI. Proposed Effective Date

    FDA is proposing that any final rule based on this proposal become
effective on the date of its publication in the Federal Register or at
a later date if stated in the final rule.

XII. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

XIII. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site address, but FDA is not responsible for
any subsequent changes to the Web site after this document publishes in
the Federal Register.)

1. Geiger, Dale R, ``FY 2003 and 2004 Unit Costs for the Process of
Medical Device Review,'' September 2005, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/umc109216.
2. U.S. Department of Commerce, Bureau of Economic Analysis,
National Income and Product Accounts Table 1.1.9, http://www.bea.gov/national/nipaweb/SelectTable.asp, accessed March 25,
2011.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 870 be amended as follows:

PART 870--CARDIOVASCULAR DEVICES

    1. The authority citation for 21 CFR part 870 continues to read as
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    2. Section 870.3680 is amended by revising paragraph (c) to read as
follows:

Sec.  870.3680  Cardiovascular permanent or temporary pacemaker
electrode.

* * * * *
    (c) Date PMA or notice of completion of PDP is required. A PMA or
notice of completion of a PDP is required to be filed with the Food and
Drug Administration on or before [A DATE WILL BE ADDED 90 DAYS AFTER
DATE OF PUBLICATION OF A FUTURE FINAL RULE IN THE FEDERAL REGISTER],
for any permanent pacemaker electrode that was in commercial
distribution before May 28, 1976, or that has, on or before [A DATE
WILL BE ADDED 90 DAYS AFTER DATE OF PUBLICATION OF A FUTURE FINAL RULE
IN THE FEDERAL REGISTER], been found to be substantially equivalent to
any permanent pacemaker electrode that was in commercial distribution
before May 28, 1976. Any other permanent pacemaker electrode shall have
an approved PMA or declared completed PDP in effect before being placed
in commercial distribution.

    Dated: August 2, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-19959 Filed 8-5-11; 8:45 am]
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[Federal Register: August 19, 2010 (Volume 75, Number 160)]
[Rules and Regulations]
[Page 51176-51177]
[DOCID:fr19au10-7]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0182; Airspace Docket No. 10-ASW-4]

Establishment of Class E Airspace; Pauls Valley, OK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace for Pauls Valley, OK to
accommodate Area Navigation (RNAV) Standard Instrument Approach
Procedures (SIAPs) at Pauls Valley Municipal Airport. The FAA is taking
this action to enhance the safety and management of Instrument Flight
Rule (IFR) operations at the airport.

DATES: Effective Date: 0901 UTC, November 18, 2010. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone (817) 321-
7716.

SUPPLEMENTARY INFORMATION:

History

    On May 17, 2010, the FAA published in the Federal Register a notice
of proposed rulemaking to amend Class E airspace for Pauls Valley, OK,
creating additional controlled airspace at Pauls Valley Municipal
Airport (75 FR 27494) Docket No. FAA-2010-0182. Interested parties were
invited to participate in this rulemaking effort by submitting written
comments on the proposal to the FAA. No comments were received. Class E
airspace designations are published in paragraph 6005 of FAA Order
7400.9T signed August 27, 2009, and effective September 15, 2009, which
is incorporated by reference in 14 CFR 71.1. The Class E airspace
designations listed in this document will be published subsequently in
the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by adding additional Class E airspace extending upward from 700
feet above the surface to accommodate SIAPs at Pauls Valley Municipal
Airport, Pauls Valley, OK. Adjustments to the geographic coordinates
also will be made in accordance with the FAA's National Aeronautical
Navigation Services. This action is necessary for the safety and
management of IFR operations at the airport.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (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); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart I, section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends controlled airspace at Pauls Valley Municipal Airport,
Pauls Valley, OK.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9T, Airspace Designations and
Reporting Points, signed August 27, 2009, and effective September 15,
2009 is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface.

* * * * *

ASW OK E5 Pauls Valley, OK [Amended]

Pauls Valley Municipal Airport, OK
    (Lat. 34[deg]42'34'' N., long. 97[deg]13'24'' W.)
Pauls Valley NDB
    (Lat. 34[deg]42'55'' N., long. 97[deg]13'44'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of Pauls Valley Municipal Airport and
within 2.6 miles each side of the 169[deg] bearing from the Pauls
Valley NDB extending from the 6.6-mile radius to 7.6 miles south of
the airport, and within 4 miles each side of the 000[deg] bearing
from the airport extending from the 6.6-mile radius to 11.5 miles
north of the airport.

    Issued in Fort Worth, Texas, on August 6, 2010.
Anthony D. Roetzel,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2010-20397 Filed 8-18-10; 8:45 am]
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