[Federal Register Volume 81, Number 178 (Wednesday, September 14, 2016)]
[Notices]
[Pages 63245-63248]
[FR Doc No: 2016-22031]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78790; File No. SR-ISEGemini-2016-08]

Self-Regulatory Organizations; ISE Gemini, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Exchange
Rule 100(a)(37C) (Definitions) To Add Specificity to the Definition of
a Professional

September 8, 2016.
    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 August 31, 2016, ISE Gemini, LLC (``ISE Gemini'' or ``Exchange'')
filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') the proposed rule change as described in Items I, II,
and III, below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend Exchange Rule 100(a)(37C)
(Definitions) to add specificity to the definition of a Professional
with respect to the manner in which the volume threshold will be
calculated by the Exchange.
    The text of the proposed rule change is available on the Exchange's
Web site at www.ise.com, at the principal office of the Exchange, and
at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant 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 the definition of ``Professional''
in Rule 100(a)(37C) to specify the manner in which the Exchange
calculates orders to determine if an order should be treated as
Professional Order.
Background
    Exchange Rule 100(a)(37C) currently states, that the term
Professional Order means an order that is for the account of a person
or entity that is not a Priority Customer. A Priority Customer means a
person or entity that (i) is not a broker or dealer in securities, and
(ii) does not place more than 390 orders in listed options per day on
average during a calendar month for its own beneficial account(s).\3\
In order to properly represent orders entered on the Exchange, members
are required to indicate whether orders are ``Professional Orders.'' To
comply with this requirement, members are required to review their
Priority Customers' activity on at least a quarterly basis to determine
whether orders that are not for the account of a broker-dealer should
be represented as Priority Customer Orders or Professional Orders.\4\
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    \3\ Rule 100(a)(37A).
    \4\ Orders for any customer that had an average of more than 390
orders per day during any month of a calendar quarter must be
represented as Professional Orders for the next calendar quarter.
Members will be required to conduct a quarterly review and make any
appropriate changes to the way in which they are representing orders
within five days after the end of each calendar quarter. While
Members only will be required to review their accounts on a
quarterly basis, if during a quarter the Exchange identifies a
customer for which orders are being represented as Priority Customer
Orders but that has averaged more than 390 orders per day during a
month, the Exchange will notify the Member and the Member will be
required to change the manner in which it is representing the
customer's orders within five days.
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    The Exchange accepts orders routed from other markets that are
marked Professional Orders. The designation of Professional Order does
not result in any different treatment of such orders for purposes of
Exchange rules concerning away market protection. That is, all non-
broker or dealer orders, including those that meet the definition of
Professional Orders, are treated equally for purposes of Exchange away
market protection rules.\5\ The Exchange continues to believe that
identifying Professional Orders based upon the average number of orders
entered in qualified accounts is an appropriately objective approach to
reasonably distinguish such persons and entities from retail investors
or market participants.
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    \5\ See International Securities Exchange, LLC Rules at 1901,
1902 and 1903, which are referenced in the Exchange's rules.
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Proposal
    The Exchange proposes to count each Professional Order, regardless
of the options exchange to which the order was routed in determining
Professional Orders.\6\
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    \6\ All order types count toward the 390 orders on average per
day.
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Cancel and Replace
    A cancel and replace order is a type of order that replaces a prior
order. The Exchange believes that the second order (the replacement
order) should be counted as a new order. With respect to ``single-
strike algorithms,'' which are a series of cancel and replace orders in
an individual strike which track the Best Bid and Offer (``BBO'') or
National Best Bid and Offer (``NBBO''), these orders shall be counted
as new orders.\7\ The Exchange believes that because the Priority
Customer is specifically instructing the executing broker in the
``single-strike algorithm'' scenario to cancel and replace these
orders, that this type of activity is akin to market

making in a Priority Customer account and should be counted, as a new
order.
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    \7\ Cancel messages do not count as an order.
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Parent/Child Orders
    An order that converts into multiple subordinate orders to achieve
an execution strategy shall be counted as one order per side and
series, even if the order is routed away.\8\ An order that cancels and
replaces a resulting subordinate order and results in multiple sides/
series shall be counted as a new order on each side and series. For
purposes of counting Professional Orders, the manner in which the
Priority Customer submitted the order and whether the order was on the
same side and series will determine if the order will count as one
order. If one Priority Customer order on the same side and series is
subsequently broken-up by a broker into multiple orders for purposes of
execution or routed away, this order will count as one order. The
Exchange believes that the proposed amendment will provide more
certainty to market participants in determining the manner in which the
Exchange will compute the number of orders in listed options per day on
average during a calendar month for its own beneficial account(s) to
determine the Professional Order designation.
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    \8\ An order which is placed for the beneficial account(s) of a
person or entity that is not a broker or dealer in securities that
is broken into multiple parts by a broker or dealer or by an
algorithm housed at a broker or dealer or by an algorithm licensed
from a broker or dealer. Strategies include volatility orders, for
example.
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    In order to make clear when orders will count as new orders, the
Exchange offers the following scenarios as examples.
     The Exchange proposes to count multiple orders that were
submitted by the member as separate orders as multiple orders.
     The Exchange proposes to count a single order submitted by
a member, which was automatically executed in multiple parts by the
trading system, as one order, because the member did not intervene to
create multiple orders. Another example is where an order was entered
in the trading system and only partially filled, the order would count
as one order. The subsequent fills, which could be multiple executions,
would not count as additional orders in determining the 390 limit. The
manner in which the order is ultimately executed, as one order or
multiple orders, should not itself determine whether the activity
qualified as a Professional Order; also the member did not intervene in
that circumstance.
     The Exchange proposes to count orders, which result in
multiple orders due to cancel and replacement orders, as new orders.
This is because in this situation the member did intervene to create
the subsequent orders.
     The Exchange proposes to count an order submitted by the
Priority Customer as a single order, on the same side and series, as a
single order despite the fact that a broker broke-up the order into
multiple orders for purposes of execution.
    The Exchange previously issued a notice which described the manner
in which it believed thresholds should be computed for determining if
an order qualifies as a Professional Order.\9\ This rule supersedes the
Exchange's notice.
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    \9\ See International Securities Exchange LLC's Regulatory
Information Circular (2009-179) dated June 23, 2009.
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    The Exchange believes that there has been industry confusion as to
which orders count toward the 390 contract threshold. The Exchange's
proposal is intended to provide clarity and to continue to promote
consistency in the treatment of orders as Professional Orders by filing
a rule change similar to other options exchanges.\10\
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    \10\ NASDAQ BX, Inc, and NASDAQ Options Market LLC have similar
rules in place for computing Professional orders. See BX Rules at
Chapter I, Section 1(49). See NOM Rules at Chapter I, Section 1(48).
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    Below are some examples of the calculation of Professional Orders.
    Example #1:
    A Priority Customer has an order to buy 100 calls at a volatility
level of 35. The order then generates a child order resulting in a 1.00
bid for 100 options which is sent to Exchange A. After the underlying
stock price ticks up 2 cents the child order is then adjusted to
reflect a 35 level volatility which in this case (50 delta) results in
a 1.01 bid sent to Exchange A replacing the current 1.00 bid.
    In determining the number of orders that attribute to the 390 order
count, in this case, because the child order is being canceled and
replaced in the ``same series'' this would only count as one (1) order
for purposes of Professional designation calculation.
    Example #2:
    A Priority Customer has an order to buy 20k Vega at a 35 volatility
level in symbol XYZ. The order then generates 50 child orders across
different strikes. Throughout the day those 50 orders are adjusted as
the stock moves resulting in the replacement of child orders to the
tune of 5 times per order (50 x 5 cancels) resulting in 250 total
orders generated to Exchange A.
    In determining the number of orders that attribute to the 390 order
count, in this case, because the child orders generated are across
multiple series it would be necessary to count all 250 orders
    In addition to the above examples, the Exchange provides the below
chart to demonstrate the manner in which it will count orders.

------------------------------------------------------------------------
                                            Singular         Multiple
------------------------------------------------------------------------
                         Single Strike Activity
------------------------------------------------------------------------
Priority Customer Order posted to 1                  x   ...............
 SRO order Book.......................
Priority Customer Order posted to                    x   ...............
 Multiple SRO order Books
 simultaneously.......................
Cancel/Replace Activity...............               x   ...............
Cancel/Replace Activity tracking BBO    ...............               x
 or NBBO..............................
------------------------------------------------------------------------
Singular--counts as a single order towards the 390 count.
Multiple--each order applies towards the 390 count.

    The Exchange proposes to implement this rule on October 3, 2016 to
provide market participants with advance notice for their quarterly
calculations. The Exchange will issue a Market Information Circular in
advance to inform market participants of such date.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \11\ in general, and furthers the objectives of Section
6(b)(5) of the Act \12\

in particular, in that it is designed to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system, and, in general
to protect investors and the public interest, by promoting the
consistent application of its rules by further defining the manner in
which the Exchange will compute the number of orders in listed options
per day on average during a calendar month for its own beneficial
account(s) for purposes of determining the Professional Order
designation. Furthermore, the Exchange believes that specifying the
manner in which the 390 threshold will be calculated within its Rules
will provide members with certainty and provide them with insight as
they conduct their own quarterly reviews for purposes of designating
orders.
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that counting all orders toward the number of
orders, regardless of the options exchange to which the order was
routed, will promote the consistent application of its rules by making
clear that all order types shall be counted as well as all orders for
the purpose of determining whether the definition of Professional Order
has been met.
Cancel and Replace
    With respect to determining the Professional Order designation, a
cancel and replace order which replaces a prior order shall be counted
as a second order. An order that is filled partially or in its entirety
or is a replacement order that is automatically canceled or reduced by
the number of contracts that were executed will not count as second
order because it was not replaced. The Exchange believes that counting
the replacement order as a second order is consistent with Exchange
Rules because the replacement order is viewed as a new order with its
own unique identifier.
    The Exchange believes that counting cancel and replace orders with
``single-strike algorithms,'' which are a series of cancel and replace
orders in an individual strike which track the BBO or NBBO, as new
orders is consistent with the Act because the Priority Customer is
specifically instructing the executing broker in the ``single-strike
algorithm'' scenario to cancel and replace these orders. Tracking the
BBO or NBBO \13\ is akin to market making on the Exchange in a Priority
Customer account and should be counted as new orders. The Exchange
believes that the Priority Customers order designation should be
reserved for a Priority Customer.
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    \13\ Tracking the BBO or NBBO shall mean any parent order that
consumes any self-regulatory organization order book data feed, or
the OPRA feed, to generate automated child orders, and move with, or
follow the Bid or Offer of the series in question.
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Parent/Child Orders
    The Exchange's adoption of the Professional Order was to treat
orders in listed options per day on average during a calendar month in
his or her own beneficial account differently from Priority Customer
Orders for purposes of priority within the order book and pricing.\14\
For this reason, the Exchange is adopting rules concerning the
computation of orders which convert into multiple subordinate orders
for the purpose of determining the Professional Order designation. The
Exchange's proposal to count multiple subordinate orders that achieve
an execution strategy as one order per side and series and count an
order that cancels and replaces a resulting subordinate order and
results in multiple sides/series as a new order is consistent with the
Act, because the Exchange is distinguishing where the member is
actively entering orders that result in multiple orders and canceling
and replacing orders that result in multiple orders versus where the
member had no control of the resulting executions. Allowing orders on
the same side of the market to be counted as a single order is
consistent with the original intent of the Professional Order
designation. The same side of market distinction protects Priority
Customers. This practice is typically the type of transaction Priority
Customers execute versus a Professional trader. Multiple related orders
resulting from a large order filled in part, or an order which is
cancelled and replaced several times are considered part of a related
order. The Exchange does not desire to count large orders filled in
part as multiple orders because the member did not intervene in the
outcome of the execution. An order that results in several separate and
unrelated orders would be counted as multiple orders because the member
intervened in this circumstance.
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    \14\ See Exchange Rule 713 and the Exchange's Fee Schedule.
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    The Exchange believes that the proposed amendment will provide more
certainty to market participants in determining the computation of the
number of orders in listed options per day on average during a calendar
month for its own beneficial account(s) to determine the Professional
Order designation. The Exchange believes that there is confusion as to
which orders count toward the 390 contract threshold. The Exchange
proposes to provide clarity to its Rules with specific guidance as to
the computation of Professional Orders, which it believes will promote
consistency in the treatment of orders as Professional orders. The
Exchange believes that this proposed guidance will promote consistency
and permit the proper calculation of options orders to prevent members
with high volume from receiving benefits reserved for Priority Customer
Orders. The Professional Order designation focuses specifically on the
number of orders generated.
    Priority is one of the marketplace advantages provided to Priority
Customer orders on the Exchange. Priority Customer orders are given
execution priority over non-Customer orders and quotations of market
makers at the same price. Another marketplace advantage afforded to
Priority Customer Orders on the Exchange is that members are generally
not assessed transaction fees for the execution of Priority Customer
Orders. The purpose of these marketplace advantages is to attract
retail order flow to the Exchange by leveling the playing field for
retail investors over market Professionals.\15\ The Exchange believes
that permitting certain types of orders to be counted as a single order
and other types of orders to be counted as multiple orders is
consistent with the original intent of the Professional Order
designation which was to continue to provide Priority Customer accounts
with marketplace advantages and distinguish those accounts non-
Professional retail investors from the Professionals accounts some non-
broker-dealer individuals and entities have access to information and
technology that enables them to Professionally trade listed options in
the same manner as a broker or dealer in securities.\16\
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    \15\ Market Professionals have access to sophisticated trading
systems that contain functionality not available to retail
customers, including things such as continuously updated pricing
models based upon real-time streaming data, access to multiple
markets simultaneously and order and risk management tools.
    \16\ For example, some broker-dealers provided their
Professional customers with multi-screened trading stations equipped
with trading technology that allows the trader to monitor and place
orders on all six options exchanges simultaneously. These trading
stations also provide compliance filters, order managements tools,
the ability to place orders in the underlying securities, and market
data feeds.
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    Finally, the proposed guidance is being issued to stem confusion as
to the manner in which options exchanges compute the Professional Order
volume.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act because the Exchange will
uniformly apply the rules to calculate volume on all members in
determining Professional Orders. The designation of Professional Orders
would not result in any different treatment of such orders for purposes
of the Exchange's Rules concerning order protection or routing to away
exchanges. The guidance is being issued to stem confusion as to the
manner in which options exchanges compute the Professional Order
volume.
Counting All Orders
    The Exchange believes that counting all orders entered by a
Professional toward the number of orders, regardless of the options
exchange to which the order was routed, does not create an undue burden
on intra-market competition because this proposed rule change will be
consistently applied to all members in determining Professional Orders.
Cancel and Replace
    The Exchange believes that its application of cancel and replace
orders does not create an undue burden on intra-market competition
because this application is consistent with Exchange Rules, where the
replacement order is viewed as a new order. This treatment is
consistent with the manner in which this order type is applied today
within the order Book.
Parent/Child Orders
    The Exchange's treatment of subordinate orders does not create an
undue burden on intra-market competition because allowing orders on the
same side of the market to be counted as a single order is consistent
with the original intent of the Professional Order designation which is
to count distinct orders and focus on the number of orders generated.
    The Exchange does not believe that the proposed rule change will
impose an undue burden on inter-market competition because other
exchanges have adopted similar guidance.\17\ The Exchange believes that
disparate rules regarding Professional Order designation, and a lack of
uniform application of such rules, does not promote the best regulation
and may, in fact, encourage regulatory arbitrage. The Exchange believes
that it is therefore prudent and necessary to conform its rules to that
of other options exchanges for purposes of calculating the threshold
volume of orders to be designated as a Professional Order. This is
particularly true where the Exchange's third-party routing broker-
dealers are members of several exchanges that have rules requiring
Professional Order designations.
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    \17\ NASDAQ BX, Inc, and NASDAQ Options Market LLC have similar
rules in place for computing Professional orders. See BX Rules at
Chapter I, Section 1(49). See NOM Rules at Chapter I, Section 1(48).
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \18\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\19\
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    \18\ 15 U.S.C. 78s(b)(3)(a)(iii).
    \19\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
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    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: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File No. SR-ISEGemini-2016-08 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File No. SR-ISEGemini-2016-08. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File No. SR-ISEGemini-2016-08, and should
be submitted on or before October 5, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
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    \20\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2016-22031 Filed 9-13-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: October 15, 2009 (Volume 74, Number 198)]
[Notices]
[Page 52969]
[DOCID:fr15oc09-62]

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DEPARTMENT OF HEALTH AND HUMAN SERIVCES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Advancing Clinical Development of Molecular and Other Diagnostic
Tests for Respiratory Tract Infections; Notice of Public Workshop

AGENCY:  Food and Drug Administration.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing a public
workshop, co-sponsored with the Infectious Diseases Society of America
(IDSA), regarding scientific issues in the development of molecular and
other tests for the diagnosis of respiratory infections, entitled
``Advancing Clinical Development of Molecular and Other Diagnostic
Tests for Respiratory Tract Infections.'' The purpose of the public
workshop is to provide an opportunity to share information and
perspectives with health care providers, academia, and industry on
various aspects of diagnostic test development for respiratory
infections. Topics for discussion will include the role of emerging
diagnostic tests in promoting appropriate use of antibiotics by
physicians, the use of novel diagnostic tests in the study of new drugs
for respiratory infections, and the possible contribution of biomarkers
in the approach to treatment of respiratory infections.
    Date and Time: The public workshop will be held on November 12,
2009, from 8 a.m. to 6 p.m. and on November 13, 2009, from 8 a.m. to
4:30 p.m.
    Location: The public workshop will be held at the Hilton Washington
DC North/Gaithersburg, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD
20877. Seating is limited and available only on a first-come, first-
served basis.
    Contact Person: Christine Kellerman, Center for Devices and
Radiological Health, Food and Drug Administration, Office of In Vitro
Diagnostic Devices, 10903 New Hampshire Ave., Building 66, rm. 5677,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    Registration: To register electronically, e-mail registration
information (including: Name, title, firm name, address, telephone, and
fax numbers) to<EMAIL_ADDRESS>by November 8, 2009. Persons
without access to the Internet can call<PHONE_NUMBER> to register.
Registration is free for the public workshop. Interested parties are
encouraged to register early because space is limited. Seating will be
available on a first-come, first-served basis. Persons needing a sign
language interpreter or other special accommodations should notify
Christine Kellerman (see Contact Person) at least 7 days in advance.
Additional information is also available at http://www.fda.gov/
MedicalDevices/NewsEvents/WorkshopsConferences/ucm181140.htm.

SUPPLEMENTARY INFORMATION:

I. Background

    New diagnostic technologies offer opportunities to guide the
appropriate clinical use of anti-infective agents, facilitate the study
of new anti-infective agents, and aid in tracking the spread of
infectious diseases. To explore issues regarding the development and
adoption of emerging diagnostic tests, FDA is announcing a public
workshop, co-sponsored with IDSA to address scientific issues in the
development of in vitro diagnostic tests for respiratory infections.

II. Topics for Discussion at the Public Workshop

    Topics to be discussed at the workshop include:
     Principles of clinical trial design and their application
to studies of new diagnostics, or studies where new diagnostics and new
drugs are investigated simultaneously;
     Test characteristics for emerging tests that would promote
clinical adoption and improve antibiotic stewardship;
     Principles for including specific viral or bacterial
pathogens in multiplex diagnostic test panels;
     Discussion of approaches to developing a new molecular
method when there is no ``gold standard'' reference method; and
     The use of biomarkers in respiratory infections.
    The input from this public workshop will help in developing topics
for further discussion. The agency encourages individuals, patient
advocates, industry, consumer groups, health care professionals,
researchers, and other interested persons to attend this public
workshop.
    Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 20 working days after the public workshop at a cost of 10
cents per page. A link to the transcripts will also be available on the
Internet at http://www.fda.gov/MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm approximately 45 days after the
workshop.

    Dated: October 7, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-24828 Filed 10-14-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 88, Number 146 (Tuesday, August 1, 2023)]
[Rules and Regulations]
[Pages 50011-50014]
[FR Doc No: 2023-16192]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-0015; Project Identifier AD-2022-01281-T;
Amendment 39-22496; AD 2023-13-11]
RIN 2120-AA64

Airworthiness Directives; AVOX Systems Inc. (Formerly Scott
Aviation) Oxygen Cylinder and Valve Assemblies; and Oxygen Valve
Assemblies

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2022-04-
09, which applied to certain AVOX Systems Inc. (formerly Scott
Aviation) oxygen cylinder and valve assemblies; and oxygen valve
assemblies; installed on but not limited to various transport
airplanes. AD 2022-04-09 required an inspection of the oxygen valve
assemblies, and oxygen cylinder and valve assemblies, to determine the
serial number; for certain assemblies and parts, a detailed inspection
of the gap between the bottom of the packing retainer and top of the
valve body on the assemblies; and replacement of assemblies having
unacceptable gaps. This AD was prompted by a determination that
additional assemblies and parts are affected by the unsafe condition.
This AD requires an inspection of the oxygen valve assemblies, and
oxygen cylinder and valve assemblies, to determine the serial number of
the valve, cylinder, and entire assembly; for certain assemblies and
parts, a detailed inspection for correct spacing of the gap between the
bottom of the packing retainer and top of the valve body on the
assemblies and replacement of assemblies having unacceptable gaps. This
AD also limits the installation of affected parts under certain
conditions and reporting inspection results and returning certain
assemblies to the manufacturer. The FAA is issuing this AD to address
the unsafe condition on these products.

DATES: This AD is effective September 5, 2023.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of September 5,
2023.

ADDRESSES:
    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-0015; or in person at Docket Operations between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD
docket contains this final rule, any comments received, and other
information. The address for Docket Operations is U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For service information identified in this final rule,
contact AVOX Systems Inc., 225 Erie Street, Lancaster, NY 14086;
telephone<PHONE_NUMBER>; website safranaerosystems.com.
     You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available at
regulations.gov under Docket No. FAA-2023-0015.

FOR FURTHER INFORMATION CONTACT: Elizabeth Dowling, Aviation Safety
Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2022-04-09, Amendment 39-21951 (87 FR
10958, February 28, 2022) (AD 2022-04-09). AD 2022-04-09 applied to
certain AVOX Systems Inc. (formerly Scott Aviation) oxygen cylinder and
valve assemblies, and oxygen valve assemblies, installed on but not
limited to various transport airplanes. AD 2022-04-09 was prompted by
reports of cylinder and valve assemblies having oxygen leakage from the
valve assembly vent hole, caused by the absence of a guide that
maintains appropriate spacing between certain parts. The NPRM published
in the Federal Register on January 27, 2023 (88 FR 5278). The NPRM was
prompted by a determination that additional assemblies and parts are
affected by the unsafe condition. In the NPRM, the FAA proposed to
continue to require an inspection of the oxygen valve assemblies, and
oxygen cylinder and valve assemblies, to determine the serial number of
the valve, cylinder, and entire assembly. For assemblies and parts with
certain serial numbers, the FAA also proposed to continue to require a
detailed inspection for correct spacing of the gap between the bottom
of the packing retainer and top of the valve body on the assemblies,
and replacement of assemblies having unacceptable gaps. The NPRM also
proposed to limit the installation of affected parts under certain
conditions and reporting inspection results and returning certain
assemblies to the manufacturer. The FAA is issuing this AD to address
oxygen leakage from the cylinder and valve assemblies, which could
result in decreased or insufficient oxygen supply during a
depressurization event; and heating or flow friction, which could cause
an ignition event in the valve assembly.

Discussion of Final Airworthiness Directive

Comments

    The FAA received comments from four commenters, including Atlas
Air, Aviation Partners Boeing, FlyPersia Airlines, and SIA Engineering.
The following presents the comments received on the NPRM and the FAA's
response to each comment.

Effect of Winglets on Accomplishment of the Proposed Actions

    Aviation Partners Boeing stated that the installation of winglets
per Supplemental Type Certificate (STC) ST00830SE, STC ST01219SE, STC
ST01518SE, and STC ST01920SE does not affect the accomplishment of the
manufacturer's service instructions.
    The FAA agrees with the commenter that STC ST00830SE, STC
ST01219SE, STC ST01518SE, and STC ST01920SE do not affect the
accomplishment of the manufacturer's service instructions. Therefore,
the installation of STC ST00830SE, STC ST01219SE, STC ST01518SE, and
STC ST01920SE do not affect the ability to accomplish the actions
required by this AD. The FAA has not changed this AD in this regard.

Request To Change the Applicability for Certain Airplanes

    FlyPersia Airlines requested that paragraph (c)(12) of the proposed
AD be changed to ``The Boeing Company Airplanes.'' The commenter
asserted that some of the affected oxygen cylinder and valve assemblies
may be installed on other Boeing airplanes.
    The FAA does not agree with the change requested. The applicability
of this AD includes the airplane models that are known to be affected.
However, as stated in paragraph (c) of this AD, the affected oxygen
cylinder and valve assemblies might be installed on, but are not
limited to, the aircraft identified in paragraphs (c)(1) through (12)
of this AD, certificated in any category. This AD has not been changed
in regard to this request.

Request for Clarification on Compliance of a Specific Airplane

    SIA Engineering requested clarification on whether Boeing Model
737-8 airplane, Manufacturer Serial Number (MSN) 44257, is in
compliance with the proposed AD. The commenter declared that the
airplane was delivered in May of 2022 and was in compliance with AD
2022-04-09. The commenter also pointed out that the proposed AD
provided credit for the service information that was required by AD
2022-04-09 and asked if credit may be taken for airplanes that have
complied with AD 2022-04-09 and reported the results as required by
that AD.
    The FAA agrees to clarify. An airplane without a part identified in
paragraph (c) of this AD is not affected by this AD. However, an
airplane delivered without an affected part, but on which the part was
later replaced with an affected part (one identified in paragraph (c)
of this AD) is affected by this AD and must comply with this AD; this
includes complying with the revised parts installation prohibition
specified in paragraph (k) of this AD.

Request To Correct Typographical Error

    Atlas Air and SIA Engineering noted a typographical error in the
regulatory text of the proposed AD. The commenters pointed out that the
paragraph designation of the Parts Installation Limitation paragraph
should have been designated as paragraph (k) of the proposed AD.
    The FAA agrees and has redesignated that paragraph, and subsequent
paragraphs, accordingly.

Conclusion

    The FAA reviewed the relevant data, considered any comments
received, and determined that air safety requires adopting this AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these products. Except for minor editorial changes, and
any other changes described previously, this AD is adopted as proposed
in the NPRM. None of the changes will increase the economic burden on
any operator.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed the following service information, which describes
procedures for an inspection to determine the serial numbers of the
oxygen cylinder and valve assemblies, and the oxygen valve assemblies,
a detailed inspection for correct spacing of the gap between the bottom
of the packing retainer and top of the valve body on the assemblies,
parts marking, inspection report, and return of parts to the
manufacturer. These documents are distinct since they apply to
different assembly part numbers.
     AVOX Systems Inc. Alert Service Bulletin 10015804-35-01,
Revision 03, dated June 7, 2021.
     AVOX Systems Inc. Alert Service Bulletin 10015804-35-02,
Revision 03, dated March 11, 2022.
     AVOX Systems Inc. Alert Service Bulletin 10015804-35-03,
Revision 03, dated June 18, 2021.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 3,034 oxygen cylinder and
valve assemblies, and oxygen valve assemblies, installed on various
transport category airplanes of U.S. registry. The FAA estimates the
following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
               Action                         Labor cost            Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Serial number inspection...........  1 work-hour x $85 per hour             None             $85        $257,890
                                      = $85.
Reporting..........................  1 work-hour x $85 per hour               $0              85         257,890
                                      = $85.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary follow-on
actions that would be required based on the results of the inspection.
The FAA has no way of determining the number of aircraft that might
need these actions:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                   Action                                 Labor cost                Parts cost        product
----------------------------------------------------------------------------------------------------------------
Detailed inspection........................  1 work-hour x $85 per hour = $85...              $0             $85
Replacement................................  1 work-hour x $85 per hour = $85...             * 0              85
----------------------------------------------------------------------------------------------------------------
* The FAA has received no definitive data on the parts cost for the on-condition replacements.

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some or all of the costs of
this AD may be covered under warranty, thereby reducing the cost impact
on affected operators.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to a penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a currently valid OMB Control Number. The OMB
Control Number for this information collection is 2120-0056. Public

reporting for this collection of information is estimated to take
approximately 1 hour per response, including the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Send comments regarding this burden estimate
or any other aspect of this collection of information, including
suggestions for reducing this burden to: Information Collection
Clearance Officer, Federal Aviation Administration, 10101 Hillwood
Parkway, Fort Worth, TX 76177-1524.

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.
    The FAA is 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) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

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:
0
a. Removing Airworthiness Directive (AD) 2022-04-09, Amendment 39-21951
(87 FR 10958, February 28, 2022); and
0
b. Adding the following new AD:

2023-13-11 AVOX Systems Inc. (formerly Scott Aviation): Amendment
39-22496; Docket No. FAA-2023-0015; Project Identifier AD-2022-
01281-T.

(a) Effective Date

    This airworthiness directive (AD) is effective September 5,
2023.

(b) Affected ADs

    This AD replaces AD 2022-04-09, Amendment 39-21951 (87 FR 10958,
February 28, 2022) (AD 2022-04-09).

(c) Applicability

    This AD applies to AVOX Systems Inc. (formerly Scott Aviation)
oxygen cylinder and valve assemblies having part number (P/N)
89794077, 89794015, 891511-14, 806835-01, 807982-01, 808433-01, or
891311-14; and oxygen valve assemblies (body and gage assemblies)
having P/N 807206-01. These assemblies might be installed on, but
not limited to, the aircraft identified in paragraphs (c)(1) through
(12) of this AD, certificated in any category.
    (1) Airbus SAS Model A300 B2-1A, B2-1C, B2K-3C, B2-203, B4-2C,
B4-103, and B4-203 airplanes.
    (2) Airbus SAS Model A300 B4-601, B4-603, B4-620, B4-622, B4-
605R, B4-622R, F4-605R, F4-622R, and C4-605R Variant F airplanes.
    (3) Airbus SAS Model A310-203, -204, -221, -222, -304, -322, -
324, and -325 airplanes.
    (4) Airbus SAS Model A318-111, -112, -121, and -122 airplanes.
    (5) Airbus SAS Model A319-111, -112, -113, -114, -115, -131, -
132, -133, and -151N airplanes.
    (6) Airbus SAS Model A320-211, -212, -214, -216, -231, -232, -
233, -251N, -252N, -253N, -271N, -272N, and -273N airplanes.
    (7) Airbus SAS Model A321-111, -112, -131, -211, -212, -213, -
231, -232, -251N, -252N, -253N, -271N, -272N, -251NX, -252NX, -
253NX, -271NX, and -272NX airplanes.
    (8) Airbus SAS Model A330-201, -202, -203, -223, -243, -301, -
302, -303, -321, -322, -323, -341, -342, -343, and -941 airplanes.
    (9) Airbus Model A340-211, -212, -213, -311, -312, -313, -541,
and -642 airplanes.
    (10) ATR--GIE Avions de Transport R[eacute]gional Model ATR42-
200, -300, -320, and -500 airplanes.
    (11) ATR--GIE Avions de Transport R[eacute]gional Model ATR72-
101, -102, -201, -202, -211, -212, and -212A airplanes.
    (12) The Boeing Company Model 747-8 series airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 35, Oxygen.

(e) Unsafe Condition

    This AD was prompted by reports of cylinder and valve assemblies
having oxygen leakage from the valve assembly vent hole, caused by
the absence of a guide that maintains appropriate spacing between
certain parts. The FAA is issuing this AD to address oxygen leakage
from cylinder and valve assemblies. The unsafe condition, if not
addressed, could result in decreased or insufficient oxygen supply
during a depressurization event; and heating or flow friction, which
could cause an ignition event in the valve assembly.

(f) Compliance

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

(g) Definition of Detailed Inspection

    For the purposes of this AD, a detailed inspection is an
intensive examination of a specific item, installation, or assembly
to detect damage, failure, or irregularity. Available lighting is
normally supplemented with a direct source of good lighting at an
intensity deemed appropriate. Inspection aids such as mirror,
magnifying lenses, etc., may be necessary. Surface cleaning and
elaborate procedures may be required.

(h) Identification of Affected Cylinder and Valve Assemblies

    Within 60 days after the effective date of this AD, inspect the
oxygen valve assemblies, and oxygen cylinder and valve assemblies,
to determine if the serial numbers of the valve, cylinder, and
entire assembly, are listed in Appendix 1 or Appendix 2, ``Affected
Shipments,'' of the applicable service information identified in
paragraphs (h)(1) through (3) of this AD. A review of airplane
maintenance records is acceptable in lieu of this inspection if the
serial numbers can be conclusively determined from that review.
    (1) AVOX Systems Inc. Alert Service Bulletin 10015804-35-01,
Revision 03, dated June 7, 2021.
    (2) AVOX Systems Inc. Alert Service Bulletin 10015804-35-02,
Revision 03, dated March 11, 2022.
    (3) AVOX Systems Inc. Alert Service Bulletin 10015804-35-03,
Revision 03, dated June 18, 2021.

(i) Inspection of the Gap, Parts Marking Actions, and Replacement, With
No Changes

    If, during any inspection or records review required by
paragraph (h) of this AD, any oxygen valve assembly, valve or
cylinder of an oxygen cylinder and valve assembly, or oxygen
cylinder and valve assembly having an affected serial number is
found: Before further flight, do a detailed inspection for correct
spacing of the gap between the bottom of the packing retainer and
top of the valve body, in accordance with paragraph 3.C. of the
Accomplishment Instructions of the applicable service information
identified in paragraphs (h)(1) through (3) of this AD.
    (1) If the gap is found to be acceptable, as defined in the
applicable service information identified in paragraphs (h)(1)
through (3) of this AD, before further flight, do the parts marking
actions in accordance with paragraph 3.D.(1) of the Accomplishment
Instructions of the applicable service information identified in
paragraphs (h)(1) through (3) of this AD.
    (2) If the gap is found to be unacceptable, as defined in the
applicable service information identified in paragraphs (h)(1)
through (3) of this AD, before further flight, remove the affected
assembly, in accordance with paragraphs 3.D.(2) or 3.D.(3), as
applicable, of the Accomplishment Instructions of the applicable
service information identified in paragraphs (h)(1) through (3) of
this AD; and replace with a serviceable assembly.

(j) Reporting and Return of Parts

    (1) Report the results of the inspection required by paragraph
(i) of this AD within the applicable time specified in paragraph
(j)(1)(i) or (ii) of this AD. Report the results in accordance with
paragraph 3.D.(1)(a) of the Accomplishment Instructions of the
applicable service information identified in paragraphs (h)(1)
through (3) of this AD.
    (i) If the inspection was done on or after the effective date of
this AD: Submit the report within 30 days after the inspection.
    (ii) If the inspection was done before the effective date of
this AD: Submit the report within 30 days after the effective date
of this AD.
    (2) If, during the inspection required by paragraph (i) of this
AD, any gap is found to be unacceptable, within the applicable time
specified in paragraph (j)(2)(i) or (ii) of this AD, return the
assembly to the manufacturer in accordance with paragraph 3.D.(2) or
3.D.(3), as applicable, of the Accomplishment Instructions of the
applicable service information identified in paragraphs (h)(1)
through (3) of this AD, except you are not required to contact AVOX
Systems Inc. for shipping instructions.
    (i) If the inspection was done on or after the effective date of
this AD: Return the assembly within 30 days after the inspection.
    (ii) If the inspection was done before the effective date of
this AD: Return the assembly within 30 days after the effective date
of this AD.

(k) Parts Installation Limitation

    As of the effective date of this AD, no AVOX Systems Inc. oxygen
valve assembly, or valve or cylinder that is part of an oxygen
cylinder and valve assembly, or oxygen cylinder and valve assembly
having an affected serial number identified in Appendix 1,
``Affected Shipments,'' or Appendix 2, ``Affected Shipments,'' of
any AVOX Systems Inc. service information identified in paragraphs
(h)(1) through (3) of this AD may be installed on any airplane
unless the requirements of paragraph (i) of this AD have been
accomplished on that affected assembly.

(l) Credit for Previous Actions

    (1) This paragraph provides credit for the actions specified in
paragraphs (h) or (i) of this AD, if those actions were performed
before the effective date of this AD using the service information
specified in paragraphs (l)(1)(i) through (iii) of this AD. This
service information is not incorporated by reference in this AD.
    (i) AVOX Systems Inc. Service Bulletin 10015804-35-01, dated
March 6, 2019; and AVOX Systems Inc. Alert Service Bulletin
10015804-35-01, Revision 01, dated July 9, 2019.
    (ii) AVOX Systems Inc. Alert Service Bulletin 10015804-35-02,
Revision 1, dated September 4, 2019.
    (iii) AVOX Systems Inc. Service Bulletin 10015804-35-03, dated
April 11, 2019; and AVOX Systems Inc. Alert Service Bulletin
10015804-35-03, Revision 01, dated May 21, 2019.
    (2) This paragraph provides credit for the actions specified in
paragraphs (h) or (i) of this AD, if those actions were performed
before the effective date of this AD using the service information
specified in paragraphs (l)(2)(i) through (iii) of this AD, which
was incorporated by reference in AD 2022-04-09.
    (i) AVOX Systems Inc. Alert Service Bulletin 10015804-35-01,
Revision 02, dated October 16, 2019.
    (ii) AVOX Systems Inc. Alert Service Bulletin 10015804-35-02,
Revision 2, dated October 31, 2019.
    (iii) AVOX Systems Inc. Alert Service Bulletin 10015804-35-03,
Revision 02, dated October 15, 2019.

(m) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, East Certification Branch, 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 responsible Flight
Standards Office, as appropriate. If sending information directly to
the manager of the East Certification Branch, send it to ATTN:
Program Manager, Continuing Operational Safety, at the address
identified in paragraph (n) of this AD or email to: [email protected]. If mailing information, also submit information by
email.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards Office.

(n) Related Information

    For more information about this AD, contact Elizabeth Dowling,
Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; email [email protected].

(o) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) AVOX Systems Inc. Alert Service Bulletin 10015804-35-01,
Revision 03, dated June 7, 2021.
    (ii) AVOX Systems Inc. Alert Service Bulletin 10015804-35-02,
Revision 03, dated March 11, 2022.
    (iii) AVOX Systems Inc. Alert Service Bulletin 10015804-35-03,
Revision 03, dated June 18, 2021.
    (3) For service information identified in this AD, contact AVOX
Systems Inc., 225 Erie Street, Lancaster, NY 14086; telephone 716-
683-5100; website safranaerosystems.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on July 7, 2023.
Michael Linegang,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-16192 Filed 7-31-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 18 (Tuesday, January 28, 2020)]
[Notices]
[Pages 5004-5005]
[FR Doc No: 2020-01454]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2019-0025; OMB No. 1660-0017]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; Public Assistance Program

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice and request for comments.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. The submission will describe the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use.

DATES: Comments must be submitted on or before February 27, 2020.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the Desk
Officer for the Department of Homeland Security, Federal Emergency
Management Agency, and sent via electronic mail to
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Information Management Division, 500 C Street SW, Washington, DC 20472,
email address<EMAIL_ADDRESS>or
Rachel Hildebrand, Process Improvement Section Chief, Public Assistance
Program Delivery Branch,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This proposed information collection
previously published in the Federal Register on November 14, 2019 at 84
FR 61922 with a 60 day public comment period. FEMA received one
comment. The comment concerned the requirement for schools or
educational facilities to provide proof of accreditation or
certification requested on FEMA Form 009-0-49, Request for Public
Assistance. While the specific citations in 44 CFR 206.221(a) are now
out of date, the Elementary and Secondary Education Act of 1965
continues to have definitions for elementary school (20 U.S.C.
7801(19)) and secondary school (20 U.S.C. 7801(45)) that define such
schools as providing elementary and secondary education ``as determined
under state law.'' Government regulation of private schools is limited.
In general, the U.S. Department of Education does not have authority to
regulate private elementary and secondary schools or home schools. If
any regulation is made, it is usually implemented at the State level
and the extent of such regulation varies. For example, some States do
not require accreditation, and FEMA cannot require formal accreditation
where a State does not. However, FEMA may require that an applicant
private nonprofit school demonstrate that it meets the required
criteria for an educational institution and facility under the Public
Assistance Program. This includes the requirement for a private
nonprofit school to demonstrate that it meets the regulatory
requirements of education ``as determined under state law.'' Likewise,
the Higher Education Act of 1965 continues to have a definition of
institution of higher education (20 U.S.C. 1001(a)) which has five
criteria that are aligned with the criteria in Table 5 on page 132 of
the Public Assistance Program and Policy Guide. FEMA continues to rely
on the definitions in these two acts, and we do not believe that
Congress, when they reorganized these acts, intended to eliminate
FEMA's longstanding eligibility criteria.
    The salary used to calculate the Estimated Total Annual Cost to the
Federal Government has been updated to reflect the 2020 Salary Table.
    The purpose of this notice is to notify the public that FEMA will
submit the information collection abstracted below to the Office of
Management and Budget for review and clearance.

Collection of Information

    Title: Public Assistance Program.
    Type of information collection: Revision of a currently approved
collection.
    OMB Number: 1660-0017.
    Form Titles and Numbers: FEMA Form 009-0-49 Request for Public
Assistance; FEMA Form 009-0-91 Project Worksheet (PW); FEMA Form 009-0-
91A Project Worksheet (PW)--Damage Description and Scope of Work
Continuation Sheet; FEMA Form 009-0-91B Project Worksheet (PW)--Cost
Estimate Continuation Sheet; FEMA Form 009-0-91C Project Worksheet
(PW)--Maps and Sketches Sheet; FEMA Form 009-0-91D Project Worksheet
(PW)--Photo Sheet; FEMA Form 009-0-120 Special Considerations
Questions; FEMA Form 009-0-121 PNP Facility Questionnaire; FEMA Form
009-0-123 Force Account Labor Summary Record; FEMA Form 009-0-124
Materials Summary Record; FEMA Form 009-0-125 Rented Equipment Summary
Record; FEMA Form 009-0-126 Contract Work Summary Record; FEMA Form
009-0-127 Force Account Equipment Summary Record; FEMA Form 009-0-128
Applicant's Benefits Calculation Worksheet; FEMA Form 009-0-111,
Quarterly Progress Reports; FEMA Form 009-0-141, FAC-TRAX System.
    Abstract: The information collected is utilized by FEMA to make
determinations for Public Assistance grants based on the information
supplied by the respondents.
    Affected Public: State, Local or Tribal government.
    Estimated Number of Respondents: 1,012.
    Estimated Number of Responses: 398,068.
    Estimated Total Annual Burden Hours: 466,025.
    Estimated Total Annual Respondent Cost: $29,601,921.
    Estimated Respondents' Operation and Maintenance Costs: N/A.
    Estimated Respondents' Capital and Start-Up Costs: N/A.
    Estimated Total Annual Cost to the Federal Government: $1,920,626.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a)

evaluate whether the proposed data collection is necessary for the
proper performance of the agency, including whether the information
shall have practical utility; (b) evaluate the accuracy of the agency's
estimate of the burden of the proposed collection of information,
including the validity of the methodology and assumptions used; (c)
enhance the quality, utility, and clarity of the information to be
collected; and (d) minimize the burden of the collection of information
on those who are to respond, including through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g., permitting
electronic submission of responses.

Maile Arthur,
Deputy Director, Information Management Division, Office of the Chief
Administrative Officer, Mission Support, Federal Emergency Management
Agency, Department of Homeland Security.
[FR Doc. 2020-01454 Filed 1-27-20; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 82, Number 173 (Friday, September 8, 2017)]
[Notices]
[Pages 42575-42576]
[FR Doc No: 2017-19012]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2017-0047]

Reports, Forms, and Recordkeeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Request for extension of a currently approved collection of
information.

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SUMMARY: This notice solicits public comments on continuation of the
requirements for the collection of information on safety standards.
Before a Federal agency can collect certain information from the
public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatement of previously approved collections.
    This document describes a collection of labeling information on
four Federal motor vehicle safety standards, for which NHTSA intends to
seek OMB approval. The labeling requirements include brake fluid
warning, glazing labeling, and safety belt labeling.

DATES: Comments must be received on or before November 7, 2017.

ADDRESSES: You may submit comments (identified by the DOT Docket ID
Number above) by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility; M-30, U.S. Department of
Transportation, West Building Ground Floor, Rm. W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590 between 9
a.m. and 5 p.m. Eastern Time, Monday through Friday, except Federal
holidays.
     Fax:<PHONE_NUMBER>.
    Regardless of how you submit your comments, you should mention the
docket number of this document. You may call the Docket at (202) 366-
9324. Please identify the proposed collection of information for which
a comment is provided, by referencing its OMB clearance Number. It is
requested, but not required, that two copies of the comment be
provided.
    Note that all comments received will be posted without change to
http://www.regulations.gov, including any personal information
provided. Anyone is able to search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of 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: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or the street
address listed above. Follow the online instructions for accessing the
dockets.

FOR FURTHER INFORMATION CONTACT: Complete copies of each request for
collection of information may be obtained at no charge from Ms. Lori
Summers, U.S. Department of Transportation, NHTSA, Room W43-320, 1200
New Jersey Avenue SE., Washington, DC 20590. Mrs. Summers' telephone
number is<PHONE_NUMBER> and fax number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before a proposed collection of information is submitted to OMB for
approval, Federal agencies must first publish a document in the Federal
Register providing a 60-day comment period and otherwise consult with
members of the public and affected agencies concerning each proposed
collection of information. The OMB has promulgated regulations
describing what must be included in such a document. Under OMB's
regulation (at 5 CFR 1320.8(d)), an agency must ask for public comment
on the following:
    (i) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (ii) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;

    (iii) How to enhance the quality, utility, and clarity of the
information to be collected;
    (iv) How to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g. permitting electronic
submission of responses.
    In compliance with these requirements, NHTSA asks for public
comments on the following proposed collection of information:
    Title: Consolidated Labeling Requirements for Motor Vehicles
(except the VIN).
    OMB Control Number: 2127-0512.
    Requested Expiration Date of Approval: Three years from the
approval date.
    Type of Request: Extension of a currently approved collection.
    Affected Public: Businesses.
    Summary of the Collection of Information: 49 U.S.C. 30111
authorizes the issuance of Federal motor vehicle safety standards
(FMVSS). The agency, in prescribing a FMVSS, considers available
relevant motor vehicle safety data, and consults with other agencies,
as it deems appropriate. Further, the statute mandates that in issuing
any FMVSS, the agency considers whether the standard is ``reasonable,
practicable and appropriate for the particular type of motor vehicle or
item of motor vehicle equipment for which it is prescribed,'' and
whether such a standard will contribute to carrying out the purpose of
the Act.
    The Secretary is authorized to invoke such rules, as deemed
necessary to carry out these requirements. Using this authority, the
agency issued the following FMVSS, specifying labeling requirements to
aid the agency in achieving many of its safety goals:
    FMVSS No. 105, ``Hydraulic and electric brake systems,''
    FMVSS No. 135, ``Light vehicle brake systems,''
    FMVSS No. 205, ``Glazing materials,'' and
    FMVSS No. 209, ``Seat belt assemblies.''
    This notice requests comments on the labeling requirements of these
FMVSS.
    FMVSS No. 105, ``Hydraulic and electric brake systems,'' and FMVSS
No. 135, ``Light vehicle brake systems,'' require that each vehicle
shall have a brake fluid warning statement in letters at least one-
eighth of an inch high on the master cylinder reservoirs. The lettering
shall be permanently affixed, engraved or embossed; located so as to be
visible by direct view; and of a color that contrasts with its
background, if it not engraved or embossed.
    FMVSS No. 205, ``Glazing materials,'' provides labeling
requirements for glazing and motor vehicle manufacturers. In accordance
with the standard, NHTSA requires each new motor vehicle glazing
manufacturer to request and be assigned a unique mark or number. This
number is then used by the manufacturer as their unique company
identification on their self-certification label on each piece of motor
vehicle glazing. As part of that certification label, the company must
identify with the simple two or three-digit number assigned by the
agency and the model of the glazing. In addition to these requirements,
which apply to all glazing, certain specialty glazing items, such as
standee windows in buses, roof openings, and interior partitions made
of plastic require that the manufacturer affix a removable label to
each item. The label specifies cleaning instructions, which will
minimize the loss of transparency. Other information may be provided by
the manufacturer but is not required.
    FMVSS No. 209, ``Seat belt assemblies,'' requires safety belts to
be labeled with the year of manufacture, the model, and the name or
trademark of the manufacturer (S4.1(j)). Additionally, replacement
safety belts that are for use only in specifically stated motor
vehicles must have labels or accompanying instruction sheets to specify
the applicable vehicle models and seating positions (S4.1(k)). Seat
belt assemblies installed as original equipment in new motor vehicles
need not be required to be labeled with position/model information.
    Description of the Likely Respondents (Including Estimated Number
and Proposed Frequency of Response to the Collection of Information):
NHTSA anticipates that approximately 25 new prime glazing manufacturers
per year will contact the agency and request a manufacturer
identification number. These new glazing manufacturers must submit one
letter, one time, identifying their company. In turn, the agency
responds by assigning them a unique manufacturer number. For other
collections in this notice, no response is necessary from
manufacturers. These labels are only required to be placed on each
master cylinder reservoir, glazing, and each safety belt intended for
retail sale in the United Sates. Therefore, the number of respondents
is not applicable.
    Estimate of the Total Annual Reporting and Recordkeeping Burden
Resulting From the Collection of Information: NHTSA estimates that all
manufacturers will need a total of 7,874 hours to comply with these
requirements.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology.

    Authority:  44 U.S.C. 3506(c); delegation of authority at 49 CFR
1.50.

Raymond R. Posten,
Associate Administrator for Rulemaking.
[FR Doc. 2017-19012 Filed 9-7-17; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register Volume 84, Number 248 (Friday, December 27, 2019)]
[Notices]
[Pages 71430-71431]
[FR Doc No: 2019-27835]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2434]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Formal Meetings
Between the Food and Drug Administration and Sponsors and Applicants of
Prescription Drug User Fee Act Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January
27, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0429.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Formal Meetings Between FDA and Sponsors and Applicants of Prescription
Drug User Fee Act Products

OMB Control Number 0910-0429--Reinstatement

    This information collection supports implementation of the
Prescription Drug User Fee Amendments (PDUFA) of the FDA
Reauthorization Act of 2017 (FDARA). Consistent with Agency regulations
and provisions found in our ``Reauthorization Performance Goals And
Procedures: Fiscal Years 2018 Through 2022,'' we have established
procedural guidance pertaining to formal meetings between FDA and
sponsors or applicants of certain drug or biological drug products
regulated by the Center for Drug Evaluation (CDER) and Research and the
Center for Biologics Evaluation and Research (CBER). Because these
meetings often represent critical points in the regulatory process, we
intend these recommendations to facilitate the timely and effective
scheduling of such meetings, as well as ensure their efficiency and
appropriate documentation.
    While FDA regulations in 21 CFR 10.65, 312.47, 314.50, and 314.102
describe general considerations and set forth certain information
collection elements pertaining to meetings with FDA, the guidance
document entitled, ``Formal Meetings Between the FDA and Sponsors or
Applicants of PDUFA Products,'' discusses specific topics for sponsors
of PDUFA products such as types of meetings, meeting formats, meetings
requests, FDA response, and meeting packages. The guidance
recommendations do not apply to abbreviated new drug applications,
applications for biosimilar biological products, or submissions for
medical devices. Issued consistent with our Good Guidance Practice
regulations in 21 CFR 10.115, we originally developed the guidance in
1999 and it has since undergone various revisions to reflect
reauthorization of relevant user fee legislation. The guidance explains
our recommendations with regard to PDUFA meetings and that the
following elements be included in a meeting request to FDA:
     Information identifying and describing the product;
     the type of meeting being requested; a brief statement of
the purpose of the meeting;
     a list of objectives and expected outcomes from the
meeting;
     a preliminary proposed agenda; a draft list of questions
to be raised at the meeting;
     a list of individuals who will represent the sponsor or
applicant at the meeting;
     a list of Agency staff requested to be in attendance;
     the approximate date that the information package will be
sent to the Agency;
     and suggested dates and times for the meeting.
    We use the information to determine the purpose of the meeting and
to

arrange for scheduling and participation as appropriate.
    Similarly, the guidance explains and discusses the preparation of
an ``information package'' and recommends that it include the following
information:
     Identifying information about the underlying product;
     a brief statement of the purpose of the meeting; a list of
objectives and expected outcomes of the meeting;
     a proposed agenda for the meeting;
     a list of specific questions to be addressed at the
meeting;
     a summary of clinical data that will be discussed (as
appropriate);
     a summary of preclinical data that will be discussed (as
appropriate); and
     chemistry, manufacturing, and controls information that
may be discussed (as appropriate).
    The information package enables us to prepare for the meeting and
allows appropriate time for reviewing relevant product data. Although
FDA reviews similar information in the meeting request, the information
package should provide updated data reflecting the most current and
accurate information available to the sponsor or applicant.
    In the Federal Register of July 11, 2018 (83 FR 32130) we published
a 60-day notice under the Paperwork Reduction Act of 1995 (PRA)
requesting public comment on the proposed collection of information
associated with meeting requests under PDUFA. No comments were received
in response to the PRA notice. Separately, in the Federal Register
(December 29, 2017; 82 FR 61763), we published a notice of availability
announcing a 2017 revised draft version of the subject guidance,
ultimately intending it to replace the current 2009 version. In the
December 2017 notice of availability, the 2009 version was
inadvertently withdrawn and the associated information collection
discontinued. Accordingly, we are requesting reinstatement of the
information collection. Although the associated guidance is currently
being revised to reflect 2018-2022 PDUFA reauthorization goals and is
being issued consistent with our Good Guidance Practice Regulation at
21 CFR 10.115, no changes have been made to the information collection
elements recommended, nor have we modified the burden estimate we
ascribe to the related activities.
    We therefore estimate the burden of the information collection as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
    Guidance recommendations         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Meeting Requests:
    CDER........................           1,319            2.31           3,058              10          30,580
    CBER........................             301            1.21             363              10           3,630
                                 -------------------------------------------------------------------------------
        Subtotal................  ..............  ..............  ..............  ..............          34,210
                                 -------------------------------------------------------------------------------
Information Packages:
    CDER........................           1,149            2.19           2,522              18          45,396
    CBER........................             187            1.12             210              18           3,780
                                 -------------------------------------------------------------------------------
        Subtotal................  ..............  ..............  ..............  ..............          49,176
                                 -------------------------------------------------------------------------------
            Total...............  ..............  ..............  ..............  ..............          83,386
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimate reflects an overall increase since the previous OMB
approval. We attribute this adjustment to an increase in the number of
PDUFA-related meeting requests and information packages we have
received over the last few years.
    Based on Agency data, we estimate 1,319 sponsors and applicants
(respondents) request 3,058 formal meetings with CDER annually, and 301
respondents request 363 formal meetings with CBER annually regarding
the development and review of a PDUFA product. The hours per response,
which is the estimated number of hours that a respondent spends
preparing the information to be submitted with a meeting request in
accordance with the guidance, is estimated to be 10 hours. We expect it
takes this amount of time to gather and copy brief statements about the
product as well as a description of the purpose and details of the
meeting.
    Also consistent with Agency data, we estimate 1,149 respondents
submitted 2,522 information packages to CDER annually, and 187
respondents submitted 210 information packages to CBER annually, prior
to a formal meeting regarding the development and review of a PDUFA
product. We estimate 18 hours is needed to prepare the information
package in accordance with the guidance.

    Dated: December 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-27835 Filed 12-26-19; 8:45 am]
 BILLING CODE 4164-01-P