[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)]
[Rules and Regulations]
[Pages 48762-48764]
[FR Doc No: 2017-22769]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2017-N-5371]

Medical Devices; Immunology and Microbiology Devices;
Classification of the Device To Detect and Identify Microbial Pathogen
Nucleic Acids in Cerebrospinal Fluid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the device to detect and identify microbial pathogen nucleic acids in
cerebrospinal fluid into class II (special controls). The special
controls that will apply to the device type are identified in this
order and will be part of the codified language for the device to
detect and identify microbial pathogen nucleic acids in cerebrospinal
fluid's classification. We are taking this action because we have
determined that classifying the device into class II (special controls)
will provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices, in part by reducing regulatory burdens.

DATES: This order is effective October 20, 2017. The classification was
applicable on October 8, 2015.

FOR FURTHER INFORMATION CONTACT: Kimberly Sconce, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4524, Silver Spring, MD, 20993-0002, 301-
796-6679<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the device to detect and identify
microbial pathogen nucleic acids in cerebrospinal fluid as class II
(special controls), which we have determined will provide a reasonable
assurance of safety and effectiveness. In addition, we believe this
action will enhance patients' access to beneficial innovation, in part
by reducing regulatory burdens by placing the device into a lower
device class than the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (the FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After

receiving an order from FDA classifying the device into class III under
section 513(f)(1) of the FD&C Act, the person then requests a
classification under section 513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically placed
within class III, the De Novo classification is considered to be the
initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application in order to market a substantially
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial
equivalence''). Instead, sponsors can use the less burdensome 510(k)
process, when necessary, to market their device.

II. De Novo Classification

    On April 9, 2015, BioFire Diagnostics, LLC submitted a request for
De Novo classification of the FilmArray[supreg] Meningitis/Encephalitis
(ME) Panel. FDA reviewed the request in order to classify the device
under the criteria for classification set forth in section 513(a)(1) of
the FD&C Act. We classify devices into class II if general controls by
themselves are insufficient to provide reasonable assurance of safety
and effectiveness, but there is sufficient information to establish
special controls that, in combination with the general controls,
provide reasonable assurance of the safety and effectiveness of the
device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review
of the information submitted in the request, we determined that the
device can be classified into class II with the establishment of
special controls. FDA has determined that these special controls, in
addition to general controls, will provide reasonable assurance of the
safety and effectiveness of the device.
    Therefore, on October 8, 2015, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 866.3970. We have named
the generic type of device, device to detect and identify microbial
pathogen nucleic acids in cerebrospinal fluid, and it is identified as
a qualitative in vitro device intended for the detection and
identification of microbial-associated nucleic acid sequences from
patients suspected of meningitis or encephalitis. A device to detect
and identify microbial pathogen nucleic acids in cerebrospinal fluid is
intended to aid in the diagnosis of meningitis or encephalitis when
used in conjunction with clinical signs and symptoms and other clinical
and laboratory findings.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

 Table 1--Device To Detect and Identify Microbial Pathogen Nucleic Acids
          in Cerebrospinal Fluid Risks and Mitigation Measures
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               Identified risks                   Mitigation measures
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Incorrect identification or lack of            Special Controls (1),
 identification of a pathogenic microorganism   (2), (3), (4), and (5).
 by the device can lead to improper patient
 management.
Failure to correctly interpret test results..  Special Controls (6),
                                                (7), (8), and (9).
Failure to correctly operate the instrument..  Special Control (10).
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    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is subject to premarket
notification requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) 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.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other 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
part 807, subpart E, regarding premarket notification submissions have
been approved under OMB control number 0910-0120, the collections of
information in 21 CFR part 820 have been approved under OMB control
number 0910-0073, and the collections of information in 21 CFR parts
801 and 809, regarding labeling have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

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

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for part 866 continues to read as follows:

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

0
2. Add Sec.  866.3970 to subpart D to read as follows:

Sec.  866.3970  Device to detect and identify microbial pathogen
nucleic acids in cerebrospinal fluid.

    (a) Identification. A device to detect and identify microbial
pathogen nucleic acids in cerebrospinal fluid is a qualitative in vitro
device intended for the detection and identification of microbial-
associated nucleic acid

sequences from patients suspected of meningitis or encephalitis. A
device to detect and identify microbial pathogen nucleic acids in
cerebrospinal fluid is intended to aid in the diagnosis of meningitis
or encephalitis when used in conjunction with clinical signs and
symptoms and other clinical and laboratory findings.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Premarket notification submissions must include detailed device
description documentation, including the device components, ancillary
reagents required but not provided, and a detailed explanation of the
methodology, including primer/probe sequence, design, and rationale for
sequence selection.
    (2) Premarket notification submissions must include detailed
documentation from the following analytical studies: Analytical
sensitivity (limit of detection), inclusivity, reproducibility,
interference, cross reactivity, and specimen stability.
    (3) Premarket notification submissions must include detailed
documentation from a clinical study. The study, performed on a study
population consistent with the intended use population, must compare
the device performance to results obtained from well-accepted
comparator methods.
    (4) Premarket notification submissions must include detailed
documentation for device software, including, but not limited to,
software applications and hardware-based devices that incorporate
software.
    (5) The Intended Use statement in the device labeling must include
a statement that the device is intended to be used in conjunction with
standard of care culture.
    (6) A detailed explanation of the interpretation of results and
acceptance criteria must be included in the device's 21 CFR
809.10(b)(9) compliant labeling.
    (7) The device labeling must include a limitation stating that the
negative results do not preclude the possibility of central nervous
system infection.
    (8) The device labeling must include a limitation stating that
device results are not intended to be used as the sole basis for
diagnosis, treatment, or other patient management decisions.
    (9) The device labeling must include a limitation stating that
positive results do not mean that the organism detected is infectious
or is the causative agent for clinical symptoms.
    (10) As part of the risk management activities performed as part of
your 21 CFR 820.30 design controls, you must document an appropriate
end user device training program that will be offered as part of your
efforts to mitigate the risk of failure to correctly operate the
instrument.

    Dated: October 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-22769 Filed 10-19-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: May 31, 2007 (Volume 72, Number 104)]
[Notices]
[Page 30410-30413]
[DOCID:fr31my07-110]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55804; File No. SR-NYSE-2007-21]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing of Proposed Rule Change and Amendment No. 1 Thereto
Relating to Rule 92 (Limitations on Members' Trading Because of
Customers' Orders)

May 23, 2007.
    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 February 23, 2007, New York Stock Exchange LLC (``NYSE'' or
``Exchange'') 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 substantially prepared by NYSE. On
May 22, 2007, NYSE submitted Amendment No. 1 to the proposed rule
change.\3\ The Commission is publishing this notice to solicit comments
on the proposed rule change, as amended, from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 replaced and superseded the original filing
in its entirety.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    NYSE proposes to amend Rule 92 to permit, among other things,
members or member organizations to trade ahead of a customer order if
the purpose of the proprietary order is to execute, on a riskless
principal basis, another order from a customer and to expand the
consent provisions for trading along under Rule 92(b). The text of the
proposed rule change is available at NYSE, the Commission's Public
Reference Room, and http://www.nyse.com.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it had received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant 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 proposes to amend NYSE Rule 92 in order to permit
member organizations to combine multiple orders into a single order and
to route the order to the Display Book[supreg] for execution on a
riskless principal basis via Exchange execution systems. In addition,
the Exchange proposes to change the notification and consent provision
of Rule 92(b) to permit customers to provide affirmative blanket
consent, subject to certain requirements, rather than the current
requirement that members and member organizations obtain and document
consent for members to trade along with customer orders on an order-by-
order basis. Finally, the Exchange proposes adding an additional
exemption to Rule 92 to permit a member organization in certain
situations to enter Regulation NMS (``Reg. NMS'') intermarket sweep
orders at the Exchange, subject to certain conditions, including that
the firm yield its principal executions to any open customer orders
that are required to be protected by Rule 92. The Exchange proposes
these changes to harmonize Rule 92 with similar rules of the NASD and
to address the changes to the marketplace because of the implementation
of NYSE's Hybrid Market and Reg. NMS.

Riskless Principal Transactions
    NYSE Rule 92 generally prohibits members or member organizations
from trading on a proprietary basis ahead of, or along with, customer
orders that are executable at the same price as the proprietary
order.\4\ The rule contains several exceptions that make it permissible
for a member or member organization to enter a proprietary order while
representing a customer order that could be executed at the same price,
so long as it is not for an account of an individual investor and the
customer has provided express permission (referred to herein as a
``Rule 92(b) proprietary order'').\5\
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    \4\ For the purposes of this rule filing and NYSE Rule 92, the
terms proprietary order and principal order have the same meaning.
    \5\ In general, these are transactions in which the member or
member organization is: (1) Liquidating a position held in a
proprietary facilitation account and the customer's order is for
10,000 shares or more; (2) creating a bona fide hedge; (3) modifying
an existing hedge; or (4) engaging in a bona fide arbitrage or risk
arbitrage transaction.
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    The Exchange's proposed amendment would add a new subsection to
Rule 92 that would permit riskless transactions for the purpose of
facilitating the execution, on a riskless principal basis, of one or
more customer orders. The proposed rule defines a riskless principal
transaction as one in which a member or member organization, after
having received one or more orders to buy (sell) a security, purchases
(sells) the security as principal at the same price to satisfy the
order(s) to buy (sell). Under the rule, the member would be required to
give the customer the same price it received, exclusive of any markup
or markdown, commission or commission equivalent, or other fee.
    The proposed amendment seeks to harmonize the rules of NYSE with
similar rules of the NASD, in particular, the NASD's so-called Manning
Rule, which permits riskless principal orders as an exception to the
rule prohibiting trading ahead of customer market and limit orders on
the NASDAQ market.\6\ The Manning Rule is an interpretation of NASD
customer protection rules, which, like NYSE Rule 92, generally prohibit
firms from executing proprietary orders ahead of customer orders that
could be executed at the same price. The Exchange states that the
Manning exception was adopted to permit NASD broker/dealers to manage
their order flow more efficiently; instead of executing a group of like
customer orders individually, the rule permits market makers to
aggregate like customer orders, execute a single trade as principal in
the market in place of those orders, and then allocate shares back to
the customers within 60 seconds of receiving a report on the riskless
principal trade and at the same price as the riskless principal trade,
exclusive of any markup or markdown, commission or commission
equivalent, or other fee. Currently, NYSE has no equivalent exception
to Rule 92 to permit more efficient riskless principal trading on NYSE.
The proposed amendment adapts the riskless principal requirements of
the Manning Rule described above, and integrates those requirements
into the existing requirements of NYSE Rule 92, as follows.
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    \6\ See NASD Rule 2111 and IM-2110-2.
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    The Exchange proposes adopting the underlying order requirements of
the Manning Rule for riskless principal transactions at the Exchange.
Accordingly, the Exchange proposes that a riskless principal
transaction can be effected on behalf of any customer order, regardless
of whether from an institutional account or an individual investor. The
Exchange believes that adopting the riskless principal transaction
requirements of the Manning Rule will ensure that the marketplace will
run efficiently and will enable member organizations to both comply
with their Reg. NMS requirements and meet best execution requirements
for customers.
    Further requirements for proposed riskless principal transactions
include that the receipt time reference for the underlying order would
have to be before the execution report time reference of the riskless
principal transaction. Within 60 seconds of receiving an execution
report from NYSE on the riskless principal transaction, members or
member organizations would be required to allocate to the accounts
represented in the riskless principal transaction the same price at
which the order was executed on NYSE, exclusive of any markup or
markdown, commission equivalent, or other fee.
    In addition, under the proposed amendment, firms would be permitted
to aggregate only orders whose order types and instructions (including
tick restrictions) permit such aggregation. The Exchange believes that
such aggregating meets the standards set forth in the Commission's July
18, 2005 letter to the Securities Industry Association (``SIA''),\7\ in
which the Commission granted a riskless principal exemption from Rule
10a-1 under the Act to permit a broker-dealer to fill customer orders
without complying with the ``tick'' provisions of the Rule, in certain
situations and subject to certain conditions, as set forth in the
letter.
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    \7\See letter to Ira Hammerman, Senior Vice President and
General Counsel, SIA, from James A. Brigagliano, Assistant Director,
Division of Market Regulation (``Division''), Commission, dated July
18, 2005 (available at http://www.sec.gov/divisions/marketreg/mr-noaction/sia071805.htm
).

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    Firms would need to disclose to customers the method by which the
firm would allocate the shares bought or sold in the riskless principal
transaction (e.g., strict time priority, precedence based on size,
etc.), and would be required to allocate shares in accordance with that
method. Such method must be fair and reasonable, be consistently
applied, and not unfairly discriminate against any particular class of
accounts or types of orders. The Exchange would not require a specific
allocation methodology, but would require that the chosen method be
adequately disclosed to customers and be consistent with rules
governing parity of orders.
    The Exchange would require member organizations to keep certain
books and records in connection with riskless principal transactions.
In particular, when executing riskless principal transactions, firms
would be required to submit order execution reports to the Exchange's
Front End Systemic Capture database linking the execution of the
riskless principal order on the Exchange to the specific underlying
orders. The information that will be provided must be sufficient for
both member firms and the Exchange to reconstruct in a time-sequenced
manner all orders, including allocations to the underlying orders, with
respect to which a member organization is claiming the riskless
principal exception.
    As with the Manning Rule, in allocating riskless principal
transactions, if the riskless principal transaction includes Rule 92(b)
proprietary orders, orders from customers that have consented to trade
along with Rule 92(b) proprietary orders, and orders from customers
that either have not or cannot consent (for example, an individual
investor with an order of less than 10,000 shares) to the member firm
trading along with those orders, the Rule 92(b) proprietary orders and
any customer orders that have consented to trading along with such
proprietary orders must yield to the non-consenting customer orders.
Customer Consent Under Rule 92(b)
    The Exchange further proposes amending the requirements surrounding
the obtaining of customer consent to trade along with customer not-held
orders. Under current Rule 92(b), the Exchange requires that a customer
provide express permission, including an understanding of the relative
price

and size of allocated execution reports, before permitting execution of
one of the specified proprietary orders under that rule that could be
executed at the same price as the customer's order. The Exchange has
interpreted this provision to require that consent to trade along be
obtained and documented on an order-by-order basis.
    As the Exchange has transitioned to the Hybrid Market, with its
greater prevalence of automated executions and rapid pace of order
execution, and with the implementation of Reg. NMS, the Exchange has
concluded that the current order-by-order consent rule and attendant
documentation requirements have become outmoded and can operate to
impede market efficiencies. Moreover, the order-by-order consent
requirement for trading along in Rule 92 is inconsistent with other
similar situations where firms are permitted to obtain a general or
``blanket'' approval to trade along with not-held customer orders,
provided they are accompanied by appropriate disclosures.\8\
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    \8\ See, e.g., Information Memo 05-52 (requiring member firms to
provide periodic affirmative notice regarding their practice in
trading for their proprietary accounts while in possession of
customer VWAP orders); see also Information Memo 05-81 (deeming
customers to consent to their Floor brokers' decision to permit a
specialist to trade on parity with their orders, provided that the
Floor broker has adequately disclosed to the customer as to the
broker's regular practice in this regard).
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    The Exchange accordingly is proposing to modify the consent
requirement of NYSE Rule 92(b) to eliminate the order-by-order consent
and instead provide that customers may give ``blanket'' affirmative
written consent for a member firm to trade along provided that: (i) the
customer has received adequate prior affirmative notice of the fact
that the member or member organization may trade along with its orders,
including a disclosure of the method by which the member organization
will allocate shares to the customer's order and a disclosure relating
to the allocation methodology for riskless principal transactions that
include both a Rule 92(b) proprietary order and an order from a
customer that has not consented to trade along with a Rule 92(b)
proprietary order; (ii) the customer affirmatively consents prior to
such trading by the member or member organization; and (iii) the member
or member organization's trading along is permitted under one of the
exceptions contained in NYSE Rule 92.
    The Exchange believes that this proposed consent requirement would
provide the same level of investor protection as the current consent
requirement because both standards require disclosures and consent
before a member organization can enter a Rule 92(b) proprietary order.
However, by eliminating the order-by-order consent, the Exchange
believes that the proposed consent requirement would reduce the burden
associated with obtaining consent in advance of each transaction, thus
permitting member organizations to trade in the faster environment of
today's marketplace without having to pause before each trade to obtain
consent.
    The Exchange proposes that member organizations can document such
affirmative consent either by (i) a signed writing from the customer
that acknowledges the disclosures, including that a customer can opt-
out on an order-by-order basis, and provides consent; or (ii)
documenting consent that was provided orally, provided that written
disclosures were provided to the customer before obtaining the oral
consent and the member organization provides written notice to the
customer documenting that oral consent. Once a customer has provided
affirmative written consent and so long as firms continue to provide
written disclosures on a periodic basis, member organizations will not
need to renew such affirmative consent.
    The Exchange further proposes expanding the class of investors that
may consent to a Rule 92(b) proprietary order. Under the Manning Rule,
the NASD permits customers that meet the NASD's definition of an
institutional account and individual customers with orders of 10,000
shares or more, unless such orders are less than $100,000 in value, to
consent to trade along with a member's proprietary order. In contrast,
the current Rule 92 bars both individual investors and institutional
investors with orders of less than 10,000 shares from consenting to a
member or member organization from trading along with their orders. To
harmonize this portion of the rules, the Exchange proposes amending the
class of investors that can consent to a member or member organization
trading along with a customer order to include all institutional
investors, regardless of the size of the order, and individual
investors with orders of 10,000 shares or more, unless such orders are
less than $100,000 in value. To ensure consistency, the Exchange
proposes to incorporate, for purposes of Rule 92 only, NASD's
definition of an ``institutional account,'' \9\ and therefore proposes
adding that definition to the supplementary material to Rule 92.
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    \9\ See NASD Rule 3110(c)(4).
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    Customers would retain the ability to ``opt-out'' on a trade-by-
trade basis or to modify the instructions obtained under blanket
consent, since the customer always has the option to submit an order
with an instruction that the member or member organization not trade
along or alter the terms for trading along with the order. The Exchange
would require members and member organizations to periodically disclose
this to customers as well.
    Once a customer provides such ``blanket'' consent, a member or
member organization may trade on a proprietary basis along with a
customer order that is executable at the same price as a proprietary
order that meets the exceptions set forth in Rule 92(b). A member or
member organization may seek to include a Rule 92(b) proprietary order
with a proposed Rule 92(c) riskless principal order. In such case, even
though a single order is transmitted to the Exchange, the order would
include both riskless and risk elements, and therefore would no longer
be a pure riskless principal transaction. For purposes of parity,
Exchange systems will recognize the riskless principal order as an
agency order, regardless of whether the order includes any Rule 92(b)
proprietary orders. However, when allocating the underlying orders,
Rule 92(b) proprietary orders and any customer orders that have
consented to the Rule 92(b) proprietary orders must yield to customer
orders that have not or cannot consent to a Rule 92(b) proprietary
order. This allocation methodology must be disclosed to customers that
consent to trade along with Rule 92(b) proprietary orders. If the
riskless principal transaction represents only agency orders and does
not include any proprietary orders, regular allocation of the
underlying orders would apply.
Exemption for Reg. NMS-Compliant Intermarket Sweep Orders
    The Exchange also proposes amending Rule 92 to add an exemption so
that, when facilitating a customer order that would otherwise require
the firm to either violate Rule 92 or trade through protected
quotations, member organizations can comply with their Reg. NMS
obligation without also violating Rule 92. Under the current rule, if a
member organization is required to route intermarket sweep orders as
principal to execute against the full displayed size of any protected
quotation in a security (``ISO''), for example, when facilitating a
customer order at a price inferior to the national best bid or offer or
other protected quotations and in compliance with

Rules 600(b)(30)(ii) and 611(b)(6) of Reg. NMS,\10\ the ISO could
violate Rule 92 by trading ahead of or along with open customer orders.
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    \10\ 17 CFR 242.600(b)(30)(ii) and 17 CFR 242.611(b)(6).
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    The proposed exemption provides that when routing ISOs, the member
organization must yield its principal executions to any open customer
orders that are required to be protected by Rule 92 and capable of
accepting the fill. As defined in Rule 92(a), customer orders that are
required to be protected are those open customer orders that are known
to the member organization before entry of the ISO. In addition, the
proposed exemption would require that if a firm executes an ISO to
facilitate a customer order at a price inferior to one or more
protected quotations, that customer must consent to not receiving the
better price obtained by the ISO(s) or the firm must yield its
principal execution to that customer.\11\ For purposes of this
amendment, the Exchange further proposes adopting the definitions of
Reg. NMS in connection with the terms ``protected quotation'' and
``intermarket sweep order.'' \12\
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    \11\ Telephone conversation between Clare F. Saperstein,
Principal Rule Counsel, Market Surveillance, NYSE, and Theodore S.
Venuti, Attorney, Division, Commission, on May 23, 2007.
    \12\ See 17 CFR 242.600(b)(7) and (30).
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2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under Section 6(b)(5) \13\ that an Exchange have rules that
are designed to promote just and equitable principles of trade, to
remove impediments to and perfect the mechanism of a free and open
market and national market system, and in general, to protect investors
and the public interest.
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    \13\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
result in 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 neither solicited nor received written comments on
the proposed rule change.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding, or (ii) as to
which NYSE consents, the Commission will:
    (A) By order approve such proposed rule change; or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NYSE-2007-21 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.
    All submissions should refer to File Number SR-NYSE-2007-21. 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. Copies of such
filing also will be available for inspection and copying at the
principal office of NYSE. 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 publicly available. All submissions should refer to File Number
SR-NYSE-2007-21 and should be submitted on or before June 21, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-10404 Filed 5-30-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 77, Number 79 (Tuesday, April 24, 2012)]
[Rules and Regulations]
[Pages 24344-24347]
[FR Doc No: 2012-9393]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-1069; Directorate Identifier 2011-NM-025-AD;
Amendment 39-17025; AD 2012-08-08]
RIN 2120-AA64

Airworthiness Directives; Learjet Inc.

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all
Learjet Inc., Model 45 airplanes. This AD was prompted by changes to
the Airworthiness Limitations Section (ALS) of the maintenance manual,
which adds life-limits, revises life-limits, or adds inspections not
previously identified. This AD requires revising the maintenance
program to include new or more restrictive life-limits and inspections.
We are issuing this AD to limit exposure of flight critical components
to corrosion, cracking, or failure due to life-limits, which if not
corrected, could result in loss of roll control, fatigue cracking, or
loss of structural components.

DATES: This AD is effective May 29, 2012.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of May 29, 2012.

ADDRESSES: For service information identified in this AD, contact
Learjet, Inc., One Learjet Way, Wichita, Kansas 67209-2942; telephone
316-946-2000; fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
Internet http://www.bombardier.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 AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (phone:<PHONE_NUMBER>) is Document Management Facility,
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: William Griffith, Aerospace Engineer,
Airframe Branch, ACE-118W, FAA, Wichita Aircraft Certification Office,
1801 Airport Road, Room 100, Mid-Continent Airport, Wichita, Kansas
67209; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on October 19, 2011 (76
FR 64851). That NPRM proposed to require revising the maintenance
program to include new or more restrictive life-limits and inspections.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comment received on the proposal
and the FAA's response to the comment.

Request To Revisit Interpretation of the Meaning of the Word
``Current''

    Flight Concepts requested we revisit our interpretation of the word
``current'' so that the improper use of the airworthiness directive
system would not be needed. This commenter justified its request by
providing Webster's definition of the word ``current.''
    We infer that the requested change is in reference to an FAA
memorandum regarding the legal interpretation of section 91.409(f)(3)
of the Federal Aviation Regulations (14 CFR 91.409) and is not
specifically applicable to this AD.
    We do not agree that the word ``current'' needs to be defined for
this AD. The utilization of the word ``current'' is not within the
textual body of this AD. This AD requires revising the maintenance
program by incorporating certain tasks, which when performed, address
unsafe conditions. Operators utilizing earlier versions of manual-
specific maintenance programs may not be bound or obligated to follow
newer releases or updates to these maintenance programs. The issue of
the terminology of the word ``current'' and explanation of the
requirement for FAA mandates to newer maintenance actions via the AD
process is addressed in an FAA memorandum dated August 13, 2010, from
the Office of the Chief Counsel. This AD ensures that those specific
tasks covering the unsafe conditions are followed by all operators of
this airplane model. We have not changed the AD in this regard.

Explanation of Additional Changes Made to This AD

    We have redesignated Note 1 of the NPRM (76 FR 64851, October 19,
2011) as paragraph (c)(2) of this AD, paragraph (c) as paragraph (c)(1)
of this AD, and Note 2 of the NPRM as Note 1 to paragraph (g) of this
AD.
    IRN  N3220105 was incorrectly included in table 1 of the
NPRM (76 FR 64851, October 19, 2011). We have removed it from the final
rule.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting the
AD as proposed, except for minor editorial changes. We have determined
that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (76 FR 64851, October 19, 2011) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (76 FR 64851, October 19, 2011).

Costs of Compliance

    We estimate that this AD affects 336 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Change ALS in maintenance manual....  1 work-hour x $85 per                $0              $85          $28,560
                                       hour = $85.
----------------------------------------------------------------------------------------------------------------

 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

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2012-08-08 Learjet Inc.: Amendment 39-17025; Docket No. FAA-2011-
1069; Directorate Identifier 2011-NM-025-AD.

(a) Effective Date

    This AD is effective May 29, 2012.

(b) Affected ADs

    None

(c) Applicability

    (1) This AD applies to all Learjet Inc., Model 45 airplanes,
certificated in any category.
    (2) This AD requires revisions to certain operator maintenance
documents to include new actions (e.g. inspections). Compliance with
these actions is required by 14 CFR 91.403(c). For airplanes that
have been previously modified, altered, or repaired in the areas
addressed by these actions, the operator may not be able to
accomplish the inspections described in the revisions. In this
situation, to comply with 14 CFR 91.403(c), the operator must
request approval for an alternative method of compliance according
to paragraph (i) of this AD. The request should include a
description of changes to the required actions that will ensure the
continued operational safety of the airplane. The FAA has provided
guidance for this determination in FAA Advisory Circular (AC)
25.1529-1A, dated November 20, 2007. http://rgl.faa.gov/Regulatory--
and--Guidance--Library/rgAdvisoryCircular.nsf/list/AC%2025.1529-1A/
$FILE/AC%2025.1529-1A.pdf.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 05, Periodic Inspections.

(e) Unsafe Condition

    This AD was prompted by changes to the Airworthiness Limitations
Section (ALS) of the maintenance manual (MM), which adds life-
limits, revises life-limits, or adds inspections not previously
identified. We are issuing this AD to limit exposure of flight
critical components to corrosion, cracking, or failure due to life-
limits, which if not corrected, could result in loss of roll
control, fatigue cracking, or loss of structural components.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Maintenance Program Revision

    Within 90 days after the effective date of this AD, revise the
maintenance program by incorporating the applicable inspection
reference number (IRN) tasks identified in table 1 of this AD, as
specified in Chapter 04, Airworthiness Limitations, of the
Bombardier Learjet 45 Maintenance Manual MM-104, Revision 53, dated
January 10, 2011; or Bombardier Learjet 40 Maintenance Manual MM-
105, Revision 21, dated January 10, 2011; as applicable. The initial
task compliance time is within 90 days after the effective date of
this AD, or the applicable initial compliance time specified in
table 1 of this AD, whichever is later.
    Note 1 to paragraph (g) of this AD: IRN R2710041 shown
in table 1 of this AD is identified as IRN  N2710041 in
prior revisions of Bombardier Learjet 45 Maintenance Manual MM-104,
and Bombardier Learjet 40 Maintenance Manual MM-105.

                                           Table 1--IRN Task Revision
----------------------------------------------------------------------------------------------------------------
                                                                                Chapter 04 of these
              Model--                  IRN --      Initial compliance time--         documents--
----------------------------------------------------------------------------------------------------------------
Model 40, 45......................  R2710041.............  Within 10 years after the   Bombardier Learjet 45
                                                            date of issuance of the     Maintenance Manual MM-
                                                            original standard           104, Revision 53, dated
                                                            airworthiness certificate   January 10, 2011; or
                                                            or the date of issuance     Bombardier Learjet 40
                                                            of the original export      Maintenance Manual MM-
                                                            certificate of              105, Revision 21, dated
                                                            airworthiness, or within    January 10, 2011; as
                                                            10 years after the most     applicable.
                                                            recent replacement,
                                                            whichever occurs later.
Model 40, 45......................  Q5510091.............  Within 600 flight hours     Bombardier Learjet 45
                                                            after the most recent       Maintenance Manual MM-
                                                            inspection done in          104, Revision 53, dated
                                                            accordance with IRN         January 10, 2011; or
                                                             Q5510091.         Bombardier Learjet 40
                                                                                Maintenance Manual MM-
                                                                                105, Revision 21, dated
                                                                                January 10, 2011; as
                                                                                applicable.
Model 40, 45......................  Q5530011.............  Before the accumulation of  Bombardier Learjet 45
                                                            9,600 total flight hours.   Maintenance Manual MM-
                                                                                104, Revision 53, dated
                                                                                January 10, 2011; or
                                                                                Bombardier Learjet 40
                                                                                Maintenance Manual MM-
                                                                                105, Revision 21, dated
                                                                                January 10, 2011; as
                                                                                applicable.
Model 40, 45......................  P3220007.............  Within 48 months after the  Bombardier Learjet 45
                                                            most recent inspection      Maintenance Manual MM-
                                                            done in accordance with     104, Revision 53, dated
                                                            IRN  P3220007.     January 10, 2011; or
                                                                                Bombardier Learjet 40
                                                                                Maintenance Manual MM-
                                                                                105, Revision 21, dated
                                                                                January 10, 2011; as
                                                                                applicable.

Model 40, 45......................  P3220146.............  Before the accumulation of  Bombardier Learjet 45
                                                            4,800 total landings.       Maintenance Manual MM-
                                                                                104, Revision 53, dated
                                                                                January 10, 2011; or
                                                                                Bombardier Learjet 40
                                                                                Maintenance Manual MM-
                                                                                105, Revision 21, dated
                                                                                January 10, 2011; as
                                                                                applicable.
Model 40, 45......................  N3220012, N3220023,    Before the accumulation of  Bombardier Learjet 45
                                     N3220035, N3220036,    10,000 total landings on    Maintenance Manual MM-
                                     and N3220037.          the component.              104, Revision 53, dated
                                                                                January 10, 2011; or
                                                                                Bombardier Learjet 40
                                                                                Maintenance Manual MM-
                                                                                105, Revision 21, dated
                                                                                January 10, 2011; as
                                                                                applicable.
Model 40, 45......................  N3220103, N3220104,    Before the accumulation of  Bombardier Learjet 45
                                     and N3220106.          17,000 total landings on    Maintenance Manual MM-
                                                            the component.              104, Revision 53, dated
                                                                                January 10, 2011; or
                                                                                Bombardier Learjet 40
                                                                                Maintenance Manual MM-
                                                                                105, Revision 21, dated
                                                                                January 10, 2011; as
                                                                                applicable.
Model 45..........................  N5710147, N5710171,    Before the accumulation of  Bombardier Learjet 45
                                     and N5710173.          6,500 total flight hours.   Maintenance Manual MM-
                                                                                104, Revision 53, dated
                                                                                January 10, 2011.
Model 45..........................  N5710175.............  Before the accumulation of  Bombardier Learjet 45
                                                            6,900 total flight hours.   Maintenance Manual MM-
                                                                                104, Revision 53, dated
                                                                                January 10, 2011.
Model 45..........................  N5710177.............  Before the accumulation of  Bombardier Learjet 45
                                                            7,000 total flight hours.   Maintenance Manual MM-
                                                                                104, Revision 53, dated
                                                                                January 10, 2011.
----------------------------------------------------------------------------------------------------------------

(h) No Alternative Intervals

    After accomplishing the revisions required by paragraph (g) of
this AD, no alternative IRN task or IRN task interval may be used
unless the IRN task or IRN task interval is approved as an AMOC in
accordance with the procedures specified in paragraph (i)(1) of this
AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Wichita 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. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in the Related Information
section of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(j) Related Information

    For more information about this AD, William Griffith, Aerospace
Engineer, Airframe Branch, ACE-118W, FAA, Wichita Aircraft
Certification Office, 1801 Airport Road, Room 100, Mid-Continent
Airport, Wichita, Kansas 67209; phone:<PHONE_NUMBER>; fax: 316-946-
4107; email<EMAIL_ADDRESS>
(k) Material Incorporated by Reference

    (1) You must use the following service information to do the
actions required by this AD, unless the AD specifies otherwise. The
Director of the Federal Register approved the incorporation by
reference (IBR) of the following service information under 5 U.S.C.
552(a) and 1 CFR part 51:
    (i) Chapter 04, Airworthiness Limitations, of the Bombardier
Learjet 45 Maintenance Manual MM-104, Revision 53, dated January 10,
2011. Only the title page and record of revisions pages of this
document specify the revision level of the document.
    (ii) Chapter 04, Airworthiness Limitations, of the Bombardier
Learjet 40 Maintenance Manual MM-105, Revision 21, dated January 10,
2011. Only the title page and record of revisions pages of this
document specify the revision level of the document.
    (2) For service information identified in this AD, contact
Learjet, Inc., One Learjet Way, Wichita, Kansas 67209-2942;
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Internet http://www.bombardier.com.
    (3) 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>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at an NARA facility, call<PHONE_NUMBER>, or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on April 9, 2012.
John Piccola,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-9393 Filed 4-23-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 129 (Thursday, July 7, 2022)]
[Notices]
[Pages 40567-40571]
[FR Doc No: 2022-14396]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95188; File No. SR-NSCC-2022-008]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Notice of Filing and Immediate Effectiveness of a Proposed
Rule Change To Decommission the Insurance Profile Service, Adjust Fees
for Insurance Information Exchange Service and Make Certain Other
Corrections in the Rules

June 30, 2022.
    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 June 23, 2022, National Securities Clearing Corporation (``NSCC'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II and III below, which
Items have been prepared by the clearing agency. NSCC filed the
proposed rule change pursuant to Section 19(b)(3)(A) of the Act \3\ and
subparagraphs (f)(2) \4\ and (f)(4) \5\ of Rule 19b-4 thereunder. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(2).
    \5\ 17 CFR 240.19b-4(f)(4).
---------------------------------------------------------------------------

I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    (a) The proposed rule change of NSCC is annexed [sic] hereto as
Exhibit 5 and consists of modifications to Rule 57 and Addendum A of
NSCC's Rules & Procedures (``Rules'') in order to (i) decommission the
Insurance Profile service, (ii) adjust the fees for the Insurance
Information Exchange service (``IIEX'') to (a) provide for fees for
product data that is being moved from Insurance Profile to IIEX and (b)
adjust certain fees for service providers and (iii) make certain other
corrections to the Rules, as described below.\6\
---------------------------------------------------------------------------

    \6\ Capitalized terms used herein and not otherwise defined
shall have the meaning assigned to such terms in the Rules,
available at http://dtcc.com/~/media/Files/Downloads/legal/rules/
nscc_rules.pdf.
---------------------------------------------------------------------------

II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

    In its filing with the Commission, the clearing agency 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 clearing agency has prepared summaries,
set forth in sections A, B, and C below, of the most significant
aspects of such statements.

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

1. Purpose
    NSCC is proposing to move the processing of certain product data
that is currently being processed through Insurance Profile to IIEX and
decommission Insurance Profile. Following the proposed changes, product
data that is currently being processed through Insurance Profile will
be processed through IIEX. The fees for the use of IIEX for processing
of such product data will be moved to IIEX in Addendum A of the Rules
but will remain the same as the fees currently charged for the
processing of such product data through Insurance Profile.
    NSCC is also proposing to remove fees for service providers using
IIEX for policy data and proposing to add fees for service providers
using IIEX for product data.
    Finally, NSCC is proposing to correct incorrect references to
``IPS'' and ``IPS Data'' in the Rules.
    The proposed changes would not have a substantial impact on I&RS
Members (as defined below). I&RS Members would use IIEX rather than
Insurance Profile to process product data, but the fees for processing
such product data would not change. Following the proposed changes,
service providers would be charged for processing product data using
IIEX but would not be charged for processing policy data through IIEX.
(a) Background
    Insurance and Retirement Processing Services (``I&RS'') provides
for transmission of I&RS Data,\7\ including annuity and life insurance
policy applications and premiums, licensing and appointments, fees and
expenses, commission payments, reporting of client positions and
valuations, asset pricing, financial activity reporting and annuity
customer account transfers. Entities that use I&RS services include

(i) insurance companies that are Insurance Carrier/Retirement Services
Members (``Carriers''); and (ii) Carriers' intermediaries, such as
broker-dealers, banks and insurance agencies, that are Members, Mutual
Fund/Insurance Services Members and Data Services Only Members that
distribute participating Carriers' insurance products (collectively,
``Distributors,'' and, together with ``Carriers,'' collectively
referred to herein as ``I&RS Members''). The aim of I&RS is to automate
and provide seamless end-to-end communication between Carriers,
Distributors and their service providers for the sale, processing and
money settlement of insurance and annuity products nationwide.
---------------------------------------------------------------------------

    \7\ I&RS Data is data and information relating to I&RS Eligible
Products. Section 1.(a) of Rule 57, supra note 6. An ``I&RS Eligible
Product'' means insurance products, retirement or other benefit
plans or programs that are identified by NSCC as eligible for
processing through its I&RS. See Definition of I&RS Eligible
Product, Rule 1 and Section 1.(d) of Rule 3, id.
---------------------------------------------------------------------------

    I&RS Data can be categorized generally into three types of data:
product data, policy data and producer data. Product data is general
public data relating to products that are being issued by Carriers,
such as fees and expenses for specific policies and commission schedule
data \8\ relating to the products. Policy data is data relating to
specific insurance and annuity policies that have been issued to
clients based on those products, such as the names and identifying
information of the parties to the contract (i.e., owner, insured,
beneficiary), policy value, certain features of the policies that were
issued, the names of the licensed agents that are authorized to sell
such policies (i.e., the ``producers'') and the type of policy (e.g.,
annuity, life insurance policy, etc.). Producer data is information
relating to the producers that are authorized to sell the products such
as which producers have been appointed to sell particular products and
where the producers are licensed to sell the products.
---------------------------------------------------------------------------

    \8\ Carriers disclose commissions that are paid to producers for
sales of particular products. The commissions are disclosed in
commission schedules that list the particular products and
commissions that are associated with the products.
---------------------------------------------------------------------------

(b) Insurance Profile/IIEX
    Insurance Profile was launched in 2017 to enable annuities
Distributors to access fee, expense and commission schedule data (``Fee
Data'') from Carriers which is product data.\9\ The service is a data
repository that allows I&RS Members to access and exchange Fee Data.
---------------------------------------------------------------------------

    \9\ See Securities Exchange Act Release No. 80404 (April 7,
2017), 82 FR 17916 (April 13, 2017) (SR-NSCC-2017-003) (``Insurance
Profile Filing''). See also Rule 57, Section 10, supra note 6.
---------------------------------------------------------------------------

    IIEX was launched in 2020 to enable I&RS Members and service
providers to access and exchange I&RS Data.\10\ IIEX is also a data
repository but was built on a different platform than Insurance Profile
and was not limited to processing Fee Data.\11\ In addition, IIEX was
built to be accessible by an Application Programming Interface
(``API'') specifically for use with IIEX and is available to service
providers.\12\ Although the Rules provide that IIEX is available to
transmit, view and retrieve I&RS Data, currently IIEX has been used
only to process I&RS Data that is policy data.
---------------------------------------------------------------------------

    \10\ See Securities Exchange Act Release No. 90092 (October 5,
2020), 85 FR 64182 (October 9, 2020) (SR-NSCC-2020-017) (``IIEX
Filing''). See also Rule 57, Section 11, supra note 6.
    \11\ Id.
    \12\ Id.
---------------------------------------------------------------------------

    NSCC would like to use the IIEX platform to process the Fee Data
that is currently being processed through Insurance Profile because it
is inefficient to continue to have two data repositories. IIEX is a
newer platform that is API-enabled. NSCC believes that consolidating
the data repository services onto one platform will be more efficient
because I&RS Members will only need to sign into one platform rather
than two. Using IIEX alone rather than continuing to use Insurance
Profile would create a better user experience, take advantage of newer
and better technology, such as the API-enabled platform and updated
user interfaces that enhance the user experience by, among other
things, offering a single-entry point into upgraded, standardized data
screens and client flexibility in determining level of authorization to
access. In addition, IIEX has been designed to include an architecture
modernization by developing reusable components to be used across I&RS
applications. Discontinuing Insurance Profile would also eliminate
unnecessary regression and other system testing that is required if
Insurance Profile maintained as a separate platform.
    Once the Fee Data is processed through IIEX, the Insurance Profile
platform would no longer be used to process data. Therefore, NSCC is
proposing to decommission Insurance Profile. NSCC would process all Fee
Data on the IIEX platform beginning on June 30, 2022. NSCC would not
change the fees that it is currently charging I&RS Members to access
and exchange the Fee Data through Insurance Profile once such data is
moved to the IIEX platform. NSCC would provide updates to I&RS Members
on the timing of the proposed changes by Important Notice.
(c) IIEX and Service Providers
    IIEX was developed to allow service providers that were authorized
by I&RS Members to access IIEX through APIs.\13\ Addendum A provides a
fee schedule for service providers that use IIEX and Rule 57 provides
that service providers that gain access to IIEX will be required to
enter into an agreement which will include an agreement to pay the fees
set forth in the Rules.\14\ Since the inception of IIEX, however, no
services providers have agreed to sign up for IIEX and pay the fees.
NSCC would like to encourage service providers to access IIEX because
NSCC believes that when service providers use this IIEX, more I&RS
Members would also use the service as counterparties to those service
providers. Therefore, NSCC is proposing to remove the fees for service
providers to use IIEX for transmitting policy data that is currently
processed through IIEX.
---------------------------------------------------------------------------

    \13\ Id.
    \14\ See Section IV.H.2.j of Addendum A of the Rules and Rule
57, Section 11, supra note 6.
---------------------------------------------------------------------------

    Currently, the Fee Data that is accessible through Insurance
Profile is only available to I&RS Members and not to service providers.
NSCC would like to also provide service providers with access to IIEX
to process this Fee Data as well. Product data is more general than
policy data, which is limited to specific clients, and NSCC believes
that service providers would be more likely to pay for the use of IIEX
for such product data. Therefore, NSCC is proposing to require that
service providers that use IIEX for product data pay the current fees
for such service, including for the Fee Data that will be moved from
Insurance Profile to be processed through IIEX.
(d) IIEX Product Data
    NSCC is proposing to identify the different categories for policy
data and product data in the fee schedule in Addendum A of the Rules.
Fees for processing the Fee Data, which is being moved from Insurance
Profile to be processed through IIEX, would be placed under the product
data category and fees for processing the existing policy data that is
currently being processed through IIEX would be placed under the policy
data category.
(e) I&RS and I&RS Data
    In the IIEX Filing, NSCC also amended the Rules to change the name
of I&RS from Insurance and Retirement Processing Services to Insurance
& Retirement Services in order to reflect the conventional use of the
name of the service.\15\ To reflect the name change, NSCC also changed
defined terms relating to the service from ``IPS'' to ``I&RS'' and from
``IPS Data'' to ``I&RS

Data''.\16\ Rule 58 still contains an incorrect use of the defined
terms IPS and IPS Data.\17\ Therefore, NSCC is proposing to correct the
use of the defined terms ``IPS'' and ``IPS Data'' in Rule 58 to
``I&RS'' and ``I&RS Data'', respectively.
---------------------------------------------------------------------------

    \15\ See IIEX Filing, supra note 10.
    \16\ Id.
    \17\ See Section 2.(f) of Rule 58, supra note 6.
---------------------------------------------------------------------------

(f) Proposed Rule Changes
(1) Remove Insurance Profile
    NSCC is proposing to remove Insurance Profile from Section 10 of
Rule 57 and remove references to the fees for Insurance Profile from
Section IV.H.2.i of Addendum A. NSCC would renumber Section 11 of Rule
57 and Section IV.H.2.j of Addendum A to reflect the deletion of
Section 10 of Rule 57 and Section IV.H.2.i of Addendum A.
(2) Adjust Fees for IIEX
    NSCC is proposing to move the fees for processing Fee Data
currently in Insurance Profile to IIEX in proposed Section IV.H.2.i of
Addendum A. NSCC would also add different categories of data in
proposed Section IV.H.2.i of Addendum A with separate fees for policy
data which would include the current IIEX fees, and product data which
would include the fees currently in Insurance Profile with respect to
Fee Data that would be moved to IIEX. With respect to the product data,
NSCC would also add service providers to the list of entities that
would have access in the proposed Section IV.H.2.i of Addendum A.
    To reflect that NSCC would stop charging fees for service providers
to access policy data, as described above, but provide fees for service
providers to access product data, NSCC would change proposed Section 10
of Rule 57 to provide that the agreements with the service providers
will include an agreement to pay the fees set forth in the Rules for
product data for which service providers are required to pay a fee as
set forth in the Rules. NSCC would also remove the fees for policy data
for service providers in new proposed Section IV.H.2.i of Addendum A.
(3) Correct Defined Terms
    NSCC is proposing to correct two references of ``IPS Data'' to
``I&RS Data'' and one reference of ``IPS'' to ``I&RS'' in Section 2.(f)
of Rule 58 to reflect the correct defined terms.
(g) Expected Member/NSCC Impact
    The proposed changes would not have a substantial impact on I&RS
Members. I&RS Members would use IIEX rather than Insurance Profile to
process product data. IIEX would include the IIEX API which is not
currently available for Insurance Profile. The fees for processing such
product data would not change. Following the changes, service providers
would be charged the same fees as I&RS Members for processing product
data using IIEX but would not be charged for processing policy data
through IIEX.
    The changes to use the correct terms ``I&RS'' and ``I&RS Data''
would have no impact on the I&RS Members except to enhance clarity and
transparency of the Rules.
(h) Implementation Timeline
    NSCC would implement the removal of the fees for service providers
for policy data in IIEX and the corrections to the defined terms in
Rule 58 upon filing of the proposed rule changes.
    NSCC would implement the removal of Insurance Profile and movement
of the fees from Insurance Profile to IIEX on June 30, 2022. As
proposed, a legend would be added to Rule 57 and Addendum A stating
there are changes that became effective upon filing with the Commission
but have not yet been implemented. The proposed legend also would
include June 30, 2022, as the date on which such changes would be
implemented and the file number of this proposal, and state that, once
this proposal is implemented, the legend would automatically be removed
from Rule 57 and Addendum A.
2. Statutory Basis
    NSCC believes that the proposal is consistent with the requirements
of the Act and the rules and regulations thereunder applicable to a
registered clearing agency. In particular, NSCC believes that the
proposed rule changes are consistent with Sections 17A(b)(3)(F) and (D)
of the Act \18\ and Rule 17Ad-22(e)(21) promulgated under the Act.\19\
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78q-1(b)(3)(F) and (D).
    \19\ 17 CFR 240.17Ad-22(e)(21).
---------------------------------------------------------------------------

    Section 17A(b)(3)(F) of the Act,\20\ requires, in part, that the
Rules be designed to promote the prompt and accurate clearance and
settlement of securities transactions. The proposed changes to move the
Fee Data from Insurance Profile to IIEX is consistent with this
provision because such changes would enhance the ability of NSCC
Members to access such data by using a more effective and user-friendly
platform and by having access to APIs. In addition, NSCC believes that
consolidating the data repository services onto one platform will be
more efficient because I&RS Members will only need to sign into one
platform rather than two. Also, removing the fees for service providers
to access policy data and providing access to service providers for
product data is expected to incentivize the use of IIEX by service
providers which would have the effect of increasing the use by I&RS
Members that are counterparties to the service providers. Providing a
more efficient and streamlined process with respect to accessing such
Fee Data and incentivizing the use of IIEX by service providers would
promote the prompt and accurate clearance and settlement of securities
transactions by NSCC, consistent with Section 17A(b)(3)(F) of the
Act.\21\
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78q-1(b)(3)(F).
    \21\ Id.
---------------------------------------------------------------------------

    Removing Insurance Profile from the Rules, adding the categories
for policy data and product data and correcting the defined terms
``IPS'' and ``IPS Data'' to ``I&RS'' and ``I&RS Data'', respectively,
are also consistent with 17A(b)(3)(F) of the Act.\22\ Each of the
proposed changes would enhance clarity and transparency for
participants with respect to services offered by NSCC allowing I&RS
Members to have a better understanding of the Rules relating to I&RS.
Having clear and accurate Rules would help I&RS Members to better
understand their rights and obligations regarding NSCC's services. NSCC
believes that when I&RS Members better understand their rights and
obligations regarding NSCC's services, they can act in accordance with
the Rules. NSCC believes that better enabling I&RS Members to comply
with the Rules would promote the prompt and accurate clearance and
settlement of securities transactions by NSCC consistent with Section
17A(b)(3)(F) of the Act.\23\
---------------------------------------------------------------------------

    \22\ Id.
    \23\ Id.
---------------------------------------------------------------------------

    Section 17A(b)(3)(D) of the Act \24\ requires that the Rules
provide for the equitable allocation of reasonable dues, fees, and
other charges among its participants. NSCC believes that the proposed
rule change to remove the fees for service providers to access policy
data and to provide access to service providers to product data, and to
add fees for such access, are consistent with this provision of the
Act. NSCC believes the removal of fees for policy data would
incentivize use of I&RS by services providers for policy data, which is
not currently being utilized by service providers, and encourage use by
I&RS Members. NSCC also believes that service providers are more likely
access product data and to pay for such

product data, which is more general than policy data and could be used
by service providers across multiple I&RS Member counterparties.
---------------------------------------------------------------------------

    \24\ 15 U.S.C. 78q-1(b)(3)(D).
---------------------------------------------------------------------------

    NSCC believes the proposed changes to the fees are equitable
because they would apply uniformly to all service providers that
utilize the services and would not impact the fees being paid by I&RS
Members. NSCC believes the proposed changes are reasonable because the
fees that would be charged to service providers for product data would
be the same fees that are being charged to I&RS Members that access
such product data through I&RS, which are designed to align with the
cost of delivering the feature.\25\ NSCC believes that removing fees
for access to policy data is reasonable because it would incentivize
the use of I&RS by service providers for such policy data which would
be beneficial to the I&RS Members that are counterparties of such
service providers. Therefore, by establishing fees that align with the
cost of delivery of this feature and allocating those fees equitably
among the subscribing users, including service providers, the proposed
rule change would provide for the equitable allocation of reasonable
dues, fees and other charges among its participants consistent with the
requirements of Section 17A(b)(3)(D) of the Act.\26\
---------------------------------------------------------------------------

    \25\ See Insurance Profile Filing, supra note 9.
    \26\ 15 U.S.C. 78q-1(b)(3)(D).
---------------------------------------------------------------------------

    In addition, the proposed rule change is designed to comply with
Rule 17Ad-22(e)(21) promulgated under the Act.\27\ Rule 17Ad-22(e)(21)
under the Act requires NSCC to, inter alia, establish, implement,
maintain and enforce written policies and procedures reasonably
designed to be efficient and effective in meeting the requirements of
its participants and the markets it serves. The proposed rule change
would enhance the ability of I&RS Members to access Fee Data by
removing the Insurance Profile platform and providing a more efficient
and streamlined platform with access to an API specifically for IIEX.
In addition, removing the fees for service providers to access policy
data and providing access to service providers for product data would
incentivize the use of IIEX by service providers which NSCC believes
will have the effect of increasing the use by I&RS Members that are
counterparties to the service providers. Therefore, by establishing a
more efficient and effective process for I&RS Members and their service
providers to process I&RS Data, NSCC believes that the proposed changes
are consistent with the requirements of Rule 17Ad-22(e)(21),
promulgated under the Act.\28\
---------------------------------------------------------------------------

    \27\ 17 CFR 240.17Ad-22(e)(21).
    \28\ Id.
---------------------------------------------------------------------------

(B) Clearing Agency's Statement on Burden on Competition

    NSCC does not believe that the proposed rule changes would have an
impact on competition. The proposed changes would merely facilitate
I&RS Members access to Fee Data through the IIEX platform rather than
the Insurance Profile platform. The fees for I&RS Members to access
such information would not change. NSCC also does not believe that the
removal of fees for service providers for policy information would
burden competition because service providers are not currently using
the service or paying fees. NSCC believes that removing the fees for
service providers to access policy data and providing that service
providers may have access to product data by paying the same fees as
I&RS Members may promote competition by incentivizing service providers
to use IIEX which NSCC believes would result in more I&RS Members using
IIEX.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants, or Others

    NSCC has not received or solicited any written comments relating to
this proposal. If any written comments are received by NSCC, they will
be publicly filed as an Exhibit 2 to this filing, as required by Form
19b-4 and the General Instructions thereto.
    Persons submitting comments are cautioned that, according to
Section IV (Solicitation of Comments) of the Exhibit 1A in the General
Instructions to Form 19b-4, the Commission does not edit personal
identifying information from comment submissions. Commenters should
submit only information that they wish to make available publicly,
including their name, email address, and any other identifying
information.
    All prospective commenters should follow the Commission's
instructions on how to submit comments, available at https://www.sec.gov/regulatory-actions/how-to-submit-comments. General
questions regarding the rule filing process or logistical questions
regarding this filing should be directed to the Main Office of the
Commission's Division of Trading and Markets at
[email protected] or<PHONE_NUMBER>.
    NSCC reserves the right not to respond to any comments 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) \29\ of the Act and paragraph (f) \30\ of Rule 19b-4
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \29\ 15 U.S.C. 78s(b)(3)(A).
    \30\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment formv(http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NSCC-2022-008 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NSCC-2022-008. 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 website (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 website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the

filing also will be available for inspection and copying at the
principal office of NSCC and on DTCC's website (https://dtcc.com/legal/sec-rule-filings.aspx). 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-NSCC-2022-008 and should be submitted on or before July 28, 2022.
---------------------------------------------------------------------------

    \31\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\31\
Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2022-14396 Filed 7-6-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 75, Number 78 (Friday, April 23, 2010)]
[Notices]
[Pages 21387-21388]
[FR Doc No: 2010-9476]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2010-19]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATES: Comments on this petition must identify the petition docket
number involved and must be received on or before May 13, 2010.

ADDRESSES: You may send comments identified by Docket Number FAA-2002-
13734 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Laverne Brunache<PHONE_NUMBER> or
Tyneka Thomas<PHONE_NUMBER>, Office of Rulemaking, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on April 20, 2010.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2002-13734.
    Petitioner: Republic Airline Inc. d/b/a Midwest Airlines.
    Section of 14 CFR Affected: 14 CFR 93.123.
    Description of Relief Sought:
    To permit Republic Airline Inc. d/b/a Midwest Airlines the use of
slot number 1497 at Ronald Reagan Washington National Airport (DCA) to
augment its service from DCA to Milwaukee, Wisconsin.
    On July 10, 2009, the FAA renewed Midwest's exemption until
September 30, 2010. That grant of exemption stated the FAA would
publish any future extension petitions for public comment.

[FR Doc. 2010-9476 Filed 4-22-10; 8:45 am]
BILLING CODE 4910-13-P


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

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. As a 20 year smoker with asthma and C.O.P.D, e-cigarettes were my only success in quitting smoking cigarettes. I have been a long time sufferer of chronic bronchitis. I always have had it at least 4-5 times a year. I have now been using e-cigarettes for just over two years and not once have I had bronchitis during this time. I am off my daily asthma medication and now only use a rescue inhaler, and that use is minimal. I can breathe better, am not sick due to respiratory issues and just feel so much better overall. I have lowered my nicotine intake since I first started and am on my way to zero nicotine. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.