[Federal Register Volume 85, Number 159 (Monday, August 17, 2020)]
[Notices]
[Pages 50066-50068]
[FR Doc No: 2020-17905]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2020-0034; Notice 1]

Yamaha Motor Corporation, U.S.A., Receipt of Petition for
Decision of Inconsequential Noncompliance

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

ACTION: Receipt of petition.

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SUMMARY: Yamaha Motor Corporation, U.S.A., (Yamaha) has determined that
certain model year (MY) 2019 Yamaha NIKEN motorcycles do not fully
comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 122,
Motorcycle Brake Systems. Yamaha filed a noncompliance report dated
February 26, 2020. Yamaha subsequently petitioned NHTSA on May 28,
2020, for a decision that the subject noncompliance is inconsequential
as it relates to motor vehicle safety. This notice announces receipt of
Yamaha's petition.

DATES: Send comments on or before September 16, 2020.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited in the title of this notice and
submitted by any of the following methods:
     Mail: Send comments by mail addressed to the U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590.
     Hand Delivery: Deliver comments by hand to the U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590. The Docket Section is open on weekdays from 10 a.m. to 5 p.m.
except for Federal holidays.
     Electronically: Submit comments electronically by logging
onto the Federal Docket Management System (FDMS) website at https://www.regulations.gov. Follow the online instructions for submitting
comments.
     Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that comments you have submitted by mail were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to https://www.regulations.gov, including any personal information
provided.
    All comments and supporting materials received before the close of
business on the closing date indicated above will be filed in the
docket and will be considered. All comments and

supporting materials received after the closing date will also be filed
and will be considered to the fullest extent possible.
    When the petition is granted or denied, notice of the decision will
also be published in the Federal Register pursuant to the authority
indicated at the end of this notice.
    All comments, background documentation, and supporting materials
submitted to the docket may be viewed by anyone at the address and
times given above. The documents may also be viewed on the internet at
https://www.regulations.gov by following the online instructions for
accessing the docket. The docket ID number for this petition is shown
in the heading of this notice.
    DOT's complete Privacy Act Statement is available for review in a
Federal Register notice published on April 11, 2000 (65 FR 19477-78).

SUPPLEMENTARY INFORMATION:
    I. Overview: Yamaha has determined that certain MY 2019 Yamaha
NIKEN motorcycles do not fully comply with the requirements of
paragraph S5.1.7 of FMVSS No. 122, Motorcycle Brake Systems (49 CFR
571.122). Yamaha filed a noncompliance report dated February 26, 2020,
pursuant to 49 CFR part 573, Defect and Noncompliance Responsibility
and Reports. Yamaha subsequently petitioned NHTSA on May 28, 2020, for
an exemption from the notification and remedy requirements of 49 U.S.C.
Chapter 301 on the basis that this noncompliance is inconsequential as
it relates to motor vehicle safety, pursuant to 49 U.S.C. 30118(d) and
30120(h) and 49 CFR part 556, Exemption for Inconsequential Defect or
Noncompliance.
    This notice of receipt of Yamaha's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any Agency decision or
other exercise of judgment concerning the merits of the petition.
    II. Motorcycles Involved: Approximately 278 MY 2019 Yamaha NIKEN
motorcycles manufactured between August 1, 2018, and July 31, 2019, are
potentially involved.
    III. Noncompliance: Yamaha explains that the noncompliance is that
the subject motorcycles do not comply with the requirement for class 3-
5 motorcycle braking systems, as specified in paragraph S5.1.7 in FMVSS
No. 122. Specifically, due to the motorcycles being classified as a
category 3-5 motorcycle rather than a 3-3 motorcycle, the motorcycles
lack the required trike parking brake and integrated rear brake system.
    IV. Rule Requirements: Paragraph S5.1.7 of FMVSS No. 122 includes
the requirements relevant to this petition. Each category 3-5
motorcycle shall be equipped with: (a) A parking brake system; and (b)
a foot actuated service brake system which operates the brakes on all
wheels by way of either (1) a split service brake system; or (2) a
combined brake system (CBS) and a secondary brake system, which may be
the parking brake system.
    V. Background: NHTSA contacted Yamaha on February 16, 2020 and
informed the company that the agency's position is that the subject
motorcycles did not meet the definition of a traditional two-wheeled
motorcycle. While Yamaha maintained that the proximity of the two front
wheels to each other indicated that the Niken was a two wheeled
motorcycle, NHTSA classifies the product as a three wheeled trike, and
as such, the Niken does not possess the required trike parking brake
and integrated rear brake system.
    VI. Summary of Yamaha's Petition: The following views and arguments
presented in this section, VI. Summary of Yamaha's Petition, are the
views and arguments provided by Yamaha. They have not been evaluated by
the Agency and do not reflect the views of the Agency. Yamaha described
the subject noncompliance and stated their belief that the
noncompliance is inconsequential as it relates to motor vehicle safety.
    In support of its petition, Yamaha submitted the following
reasoning:
    1. NHTSA stated that their contract test laboratory was unable to
complete compliance testing because the NIKEN lacked two
``requirements'': (1) Parking brake and (2) foot brake actuating on all
wheels. Yamaha independently conducted the relevant compliance testing
and the test results demonstrate that the NIKEN substantially satisfies
the ``requirements'' detailed below:
    a. Parking Brake: Requirements for a parking brake are presumably
in place to keep a vehicle from unwanted movement while in a parked
condition, such as on a slope. However, traditional two-wheeled and
narrow-twin-front-wheeled motorcycles cannot stand unsupported; they
simply fall over. Should a traditional motorcycle be parked on a slope
(up-hill or down) on the side stand, it is a customary for the rider to
park in-gear, locking the vehicle against movement. Likewise, by
adapting this standard practice, the NIKEN can be parked on a slope
(up-hill or down) on the side-stand just as a rider of a traditional
two wheeled motorcycle would be. In an effort to emulate the test
environment, the brake system was conditioned, and the engine was
disconnected (placed in neutral) in accordance with paragraph S6.8; the
NIKEN was placed on the test surface on the vehicle's main stand.
According to requirements in FMVSS No. 122, the Laden vehicle shall be
held stationary for 5 minutes, both in an up-hill and down-hill
configuration at the required 18% (10.2[deg]) gradient for 5 minutes.
The NIKEN, exceeds this requirement.

------------------------------------------------------------------------
        Standard 18% (10.2[deg])              Up-hill        Down-hill
------------------------------------------------------------------------
NIKEN on Main Stand.....................       12.0[deg]    11.8[deg]\0\
------------------------------------------------------------------------

    It should be noted that approximately 70% of NIKENs currently in
use have main stands, the balance have only side stands. Yamaha genuine
accessory Main Stands could be added to those without quite easily.
    b. Foot brake actuating on all wheels: Likewise, NHTSA testing
staff was unable to complete the testing of braking performance of the
``split or CBS'' system, as the NIKEN utilizes the conventional
separate (independently controlled) front and rear braking system found
on most similar sport-performance type motorcycles. When Yamaha tested
the NIKEN's all-wheel, anti-lock brake system, Yamaha found that the
brake system, in a laden condition, met NHTSA's single actuated brake
control test. The NIKEN, in a laden condition, met the requirements
with the rear brake alone and, likewise, when tested with the front
brake alone, the NIKEN exceeded the standard test requirements and
stopping distances. In the lightly loaded condition, the NIKEN exceeded
the braking target by a mere 30 cm. However, when the user-induced
front brake is combined with the NIKEN's rear brake system, typical of
motorcycle rider brake application, this vehicle exceeds NHTSA
requirements by considerable margin.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Mass (kg)
                                                                         ------------------------------------------------   Target (m)      Result (m)
                                                                               Front           Rear            Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Rear......................................  Lightly loaded..............           170.7           181.9           352.6            33.7            34.0
                                            Laden.......................           171.1           289.8           460.9            33.7            31.0
Front.....................................  Laden.......................           171.1           289.8           460.9            61.4            25.8
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Results show that the NIKEN substantially meets the performance
criteria for brake performance without the Split or CBS braking system,
while providing riders the more active control and better brake feel
they expect from a performance sport machine.
    2. It is the belief of Yamaha that the information described above
satisfies the intent of 49 CFR part 573 and that the operator can
safety operate the vehicle. The NIKEN was designed to perform and react
similarly to a traditional two-wheeled motorcycle primarily for
experienced, enthusiast riders, and provides the safety features and
performance that these riders expect from a motorcycle.
    Yamaha concluded by expressing the belief that the subject
noncompliance is inconsequential as it relates to motor vehicle safety,
and that its petition to be exempted from providing notification of the
noncompliance, as required by 49 U.S.C. 30118, and a remedy for the
noncompliance, as required by 49 U.S.C. 30120, should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject motorcycles that Yamaha no
longer controlled at the time it determined that the noncompliance
existed. However, any decision on this petition does not relieve
vehicle distributors and dealers of the prohibitions on the sale, offer
for sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant motorcycles under their control after
Yamaha notified them that the subject noncompliance existed.

(Authority: 49 U.S.C. 30118, 30120: Delegations of authority at 49
CFR 1.95 and 501.8)

Otto G. Matheke III,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2020-17905 Filed 8-14-20; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 87, Number 170 (Friday, September 2, 2022)]
[Notices]
[Page 54212]
[FR Doc No: 2022-19059]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1858-023]

Beaver City Corporation; Notice of Intent To Prepare an
Environmental Assessment

    On July 30, 2021, Beaver City Corporation (Beaver City) filed an
application for a subsequent minor license for the 625-kilowatt (kW)
Beaver City Canyon Plant No. 2 Hydroelectric Project (Beaver City
Project; FERC No. 1858). The Beaver City Project is located on the
Beaver River, in Beaver County, Utah, about 5 miles east of the city of
Beaver. The project currently occupies 10.2 acres of federal land
administered by the U.S. Forest Service and 2.4 acres of federal land
managed by the U.S. Bureau of Land Management. As proposed, the project
would occupy an additional 0.3 acre of federal land administered by the
U.S. Forest Service. As part of its relicensing proposal, Beaver City
proposes to increase the generating capacity of the Beaver City Project
from 625 to 720 kW.
    In accordance with the Commission's regulations, on June 13, 2022,
Commission staff issued a notice that the project was ready for
environmental analysis (REA Notice). Based on the information in the
record, including comments filed on the REA Notice, staff does not
anticipate that licensing the project would constitute a major federal
action significantly affecting the quality of the human environment.
Therefore, staff intends to prepare an Environmental Assessment (EA) on
the application to relicense the Beaver City Project.
    The EA will be issued and circulated for review by all interested
parties. All comments filed on the EA will be analyzed by staff and
considered in the Commission's final licensing decision.
    The application will be processed according to the following
schedule. Revisions to the schedule may be made as appropriate.

------------------------------------------------------------------------
                Milestone                           Target date
------------------------------------------------------------------------
Commission issues Single EA.............  August 2023.\1\
Comments on Single EA...................  September 2023.
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\1\ The Council on Environmental Quality's (CEQ) regulations under 40
  CFR 1501.10(b)(1) require that EAs be completed within 1 year of the
  federal action agency's decision to prepare an EA. This notice
  establishes the Commission's intent to prepare a Single EA for the
  Beaver City Project. Therefore, in accordance with CEQ's regulations,
  the EA must be issued within 1 year of the issuance date of this
  notice.

    Any questions regarding this notice may be directed to Evan
Williams at<PHONE_NUMBER> or [email protected].

    Dated: August 29, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-19059 Filed 9-1-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 231 (Tuesday, December 2, 2014)]
[Notices]
[Pages 71490-71493]
[FR Doc No: 2014-28316]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73683; File No. SR-NASDAQ-2014-110]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing of a Proposed Rule Change To Adopt NASDAQ Rule 7015(i)
To Offer the New IPO Workstation

November 25, 2014.
    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 November 14, 2014 The NASDAQ Stock Market LLC (``NASDAQ'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') a 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

    NASDAQ proposes to adopt NASDAQ Rule 7015(i) to offer the new IPO
Workstation.
    The text of the proposed rule change is available at http://nasdaq.cchwallstreet.com/, at NASDAQ's principal office, and at the
Commission's Public Reference Room.

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

    In its filing with the Commission, NASDAQ included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of those statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant parts of such
statements.

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

1. Purpose
    NASDAQ recently filed a proposed rule change to offer the IPO
Indicator as an enhancement to NASDAQ Workstation subscription at no

additional cost.\3\ The IPO Indicator is designed to assist member
firms in monitoring their orders in the NASDAQ Halt Cross process
leading up to the launch of an initial public offering (``IPO'').
NASDAQ is now proposing to adopt Rule 7015(i) to offer the new IPO
Workstation, which will provide subscribing member firms with stand-
alone access to the IPO Indicator service, at no cost at this time.
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    \3\ See Securities Exchange Act Release No. 73574 (November 12,
2014) (awaiting publication in the Federal Register) (SR-NASDAQ-
2014-100).
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Halt Cross Process
    The NASDAQ Halt Cross is designed to provide for an orderly,
single-priced opening of securities subject to an intraday halt,
including securities that are the subject of an IPO. Prior to the Cross
execution, market participants enter quotes and orders eligible for
participation in the Cross, and NASDAQ disseminates certain information
regarding buying and selling interest entered and the indicative
execution price information, known as the Net Order Imbalance Indicator
or NOII. The NOII is disseminated every five seconds during a
designated period prior to the completion of the Halt Cross, in order
to provide market participants with information regarding the possible
price and volume of the Cross. The information provided in the NOII
message includes the Current Reference Price,\4\ which is the price at
which the Cross would occur if it executed at the time of the NOII's
dissemination, and the number of shares of Eligible Interest,\5\ which
is defined as any quotation or any order that may be entered into the
system and designated with a time-in-force that would allow the order
to be in force at the time of the Halt Cross, that would be paired at
that price.
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    \4\ See Rule 4753(a)(3)(A).
    \5\ See Rule 4753(a)(5).
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    NASDAQ also disseminates a Market Order Imbalance, which is defined
as the number of shares of Eligible Interest entered through market
orders that would not be matched with other order shares at the time of
the dissemination of an NOII, if in fact there are such unexecutable
market order shares. When there is a Market Order Imbalance, NASDAQ
disseminates the imbalance and the buy/sell direction of the imbalance.
For example, if a buy-direction Market Order Imbalance is disseminated,
potential sellers in the Cross would know that buy liquidity is
available at a market price, potentially encouraging them to enter
additional sell orders to allow the Cross to proceed.
    In addition to disseminating information about Market Order
Imbalances, NASDAQ also disseminates information about the size and
buy/sell direction of an Imbalance. An Imbalance is defined as the
number of shares of Eligible Interest with a limit price equal to the
Current Reference Price that may not be matched with other order shares
at a particular price at any given time.\6\ As noted above, Eligible
Interest is defined as any quotation or any order that may be entered
into the system and designated with a time-in-force that would allow
the order to be in force at the time of the Halt Cross. Thus, the
provided information reflects all shares eligible for participation in
the Cross, regardless of time-in-force, and includes non-displayed
shares and reserve size. As such, the Imbalance information indicates
the degree to which available liquidity on one or the other side of the
market would not be executed if the Cross were to occur at that time.
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    \6\ See Rule 4753(a)(1).
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    Generally, a Halt in a security is terminated when NASDAQ
determines to release a security, at which time the Display Only Period
begins, culminating in the Halt Cross whereby the security is released
for regular hours trading at the price that maximizes the number of
shares of trading interest eligible for participation in the Cross to
be executed.\7\ In the case of an IPO, underwriters to an IPO make a
determination to launch an IPO during the Pre-Launch Period \8\ when
they believe the security is ready to trade. When the underwriter
informs NASDAQ that it is ready to launch the IPO, the NASDAQ system
will calculate the Current Reference Price at that time (the ``Expected
Price'') and display it to the underwriter. If the underwriter then
approves proceeding, the NASDAQ system will conduct two validation
checks. Specifically, the NASDAQ system will determine whether all
market orders will be executed in the cross, and whether the Expected
Price and the price calculated by the Cross differ by an amount in
excess of the price band selected by the underwriter.\9\ If either of
the validation checks fail, the security will not be released for
trading and the Pre-Launch Period will continue seamlessly until all
requirements are met. Alternatively, the underwriter may, with the
concurrence of NASDAQ, determine to postpone and reschedule the IPO.
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    \7\ See Rule 4753(b) for a description of the processing of the
Halt Cross.
    \8\ The Pre-Launch Period is the second phase of a two-phase
process that NASDAQ uses for launching IPOs. The Pre-Launch Period
follows a 15-minute Display Only Period and is of no fixed duration.
During both periods, the NOII is disseminated every five seconds.
    \9\ See Rule 4120(c)(8)(B).
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IPO Indicator and IPO Workstation
    The IPO Indicator service will provide member firms with more
information about interest in an IPO security. Specifically, the IPO
Indicator will provide information about the number and price at which
shares of a member firm's orders entered for execution in an IPO Halt
Cross (``IPO shares'') would execute in an IPO if it were to price at
the present time. The IPO Indicator uses the NOII information of an IPO
security together with information about the subscribing member firm's
orders on NASDAQ in the IPO security.\10\ As noted above, NASDAQ has
separately proposed \11\ to offer the IPO Indicator as an enhancement
to the NASDAQ Workstation. Similar to accessing the IPO Indicator from
the NASDAQ Workstation, subscribing member firms will access the IPO
Indicator from the main IPO Workstation screen, which will allow the
subscriber to select an IPO security by ticker and see the Current
Reference Price,\12\ the number of paired shares, and the number of
imbalance shares during the Display Only and Pre-Launch Periods. The
screen will also provide the total number of IPO shares the member firm
has entered for execution in the IPO Halt Cross, the nature of such
shares (buy or sell), and the number of IPO shares that would be
executed in the Halt Cross at that time for each of those categories. A
subscribing member firm will also be able to access further detail on
its IPO shares presented by individual order or order block, which will
include the number of IPO shares in a particular order or order block,
the number and percentage of IPO shares of the order or order block
that would be executed in the Halt Cross if it occurred at any given
time in the process, based on the NOII disseminated every five seconds,
and the price at which the order or order block was submitted. As such,
the IPO Indicator will provide member firms with information consistent
with what NASDAQ currently disseminates during the IPO launch process,
but as it relates to a

member firm's orders and in greater detail.
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    \10\ The information provided by the IPO Indicator is limited to
the subscribing member firm's orders.
    \11\ Supra note 3.
    \12\ The Exchange notes that, in situations where there is a
Market Order Imbalance, the NOII does not provide a Current
Reference Price, since not all market orders could be executed in
the cross and therefore there is no price at which the IPO cross
could occur.
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    NASDAQ notes that the IPO Indicator will provide member firms with
more information on their orders for participation in an IPO Halt
Cross, which will, in turn, allow them to make better informed
investment decisions. Although, NASDAQ believes the functionality
provided by the IPO Indicator will be useful to all member firms
seeking to participate in the IPO Halt Cross process, underwriters to
an IPO may find the functionality particularly useful as they will have
current and ongoing information on the nature of their order book in
the IPO shares relative to the orders that would be executed at any
given time, thus allowing them to make better informed decisions on the
timing of the IPO's launch. In this regard, the IPO Indicator may help
an underwriter to make a determination to launch an IPO at a time most
likely to avoid an order imbalance,\13\ thus increasing the likelihood
of a fair and orderly launch of the IPO when the underwriter informs
NASDAQ that it is prepared to launch the IPO security.
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    \13\ As defined by Rules 4120(c)(7)(C)(2) and (3).
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    The proposed IPO Workstation will provide member firms with another
means to access IPO Indicator, as an alternative to a full NASDAQ
Workstation subscription. The Exchange notes that not all member firms
subscribe to the NASDAQ Workstation and prospective users of the IPO
Indicator may not desire to pay for a full Workstation subscription for
the sole purpose of accessing the IPO Indicator. Accordingly, the
Exchange is proposing to offer the IPO Indicator functionality through
a stand-alone ``Workstation light'' subscription, the IPO Workstation.
The IPO Indicator functionality is unchanged from the enhancement that
is proposed for a NASDAQ Workstation subscription. Unlike a NASDAQ
Workstation subscription, however, the IPO Workstation subscription
will provide only the IPO Indicator service and the NOII data for IPO
securities.\14\
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    \14\ IPO Workstation subscribers will not have access to various
tools, functionality and data provided with a full NASDAQ
Workstation subscription. For a description of NASDAQ Workstation
functionality, see http://www.nasdaqtrader.com/Trader.aspx?id=Workstation.
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
Section 6(b) of the Act \15\ in general, and furthers the objectives of
Section 6(b)(5) of the Act,\16\ in particular, in that it is designed
to promote just and equitable principles of trade, remove impediments
to and perfect the mechanisms of a free and open market and a national
market system and, in general, to protect investors and the public
interest. The proposal is consistent with these requirements because it
will expand the information made available to market participants about
their orders and the interplay of supply and demand of buy and sell
orders leading up to the completion of an IPO Halt Cross. The
information provided by the proposed IPO Indicator may be particularly
useful to underwriters of IPOs, who ultimately make the decision to
launch an IPO or to postpone it. In this regard, the IPO Indicator will
provide underwriters with a near real time assessment of the number and
price at which their IPO shares will execute at any given time,
consequently allowing them to make better informed decisions with
regard to the timing of an IPO's launch. The proposed change will
thereby perfect the mechanisms of a free and open market by helping
ensure the security price is reasonably stable at the time the
underwriter determines to launch the IPO. Moreover, the proposed change
will protect investors and the public interest by providing additional
transparency regarding the IPO Halt Cross, helping market participants
to understand the degree of supply and demand for the security that is
the subject of the IPO Halt Cross and the nature of the execution of
IPO orders that they would receive at any given time in the IPO launch
process. Offering the IPO Indicator through the IPO Workstation ensures
that all member firms that are interested in subscribing to the IPO
Indicator have a no cost means to access it, in lieu of a paying for a
full NASDAQ Workstation subscription.
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    \15\ 15 U.S.C. 78f (b).
    \16\ 15 U.S.C. 78f(b)(5).
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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 that is not necessary or appropriate
in furtherance of the purposes of the Act. Specifically, the proposed
change serves merely to increase the information provided by NASDAQ
regarding the nature of the execution they would receive in an IPO at
any given time in the process, thereby assisting market participants in
making informed investment decisions regarding their participation in
the IPO Halt Cross. The proposed change also expands access to this
information by offering the service through a no cost alternative to a
full NASDAQ Workstation subscription. The proposed change does not
restrict the ability of market participants to participate in the IPO
Halt Cross in any respect, and therefore does not impose any burden on
competition.

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 45 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 the Exchange consents, the Commission shall: (a) By order approve
or disapprove 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 email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2014-110 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 Number SR-NASDAQ-2014-110. 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 offices of the Exchange. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NASDAQ-2014-110, and should be submitted on or before
December 23, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

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

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-28316 Filed 12-1-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: November 22, 2006 (Volume 71, Number 225)]
[Notices]
[Page 67575-67577]
[DOCID:fr22no06-70]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0628; FRL-8089-9]

Cyproconazole; Notice of Filing of a Pesticide Petition for
Establishment of Regulations for Residues of the Fungicide in or on
Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of the
fungicide cyproconazole in or on soybeans, corn, wheat, and certain
animal commodities.

DATES: Comments must be received on or before December 22, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0628 and pesticide petition number (PP)
6F7072, by one of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
    Mail: Office of Pesticide Programs (OPP) Public Regulatory
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Public Regulatory Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0628. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of

special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP

Public Regulatory Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Drive, Arlington, VA. The hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket telephone number is (703) 305-
5805.

FOR FURTHER INFORMATION CONTACT: Mary Waller, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. What Action is the Agency Taking?

    EPA is printing a summary of a pesticide petition received under
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, proposing the establishment or amendment of regulations in
40 CFR part 180 for residues of pesticide chemicals in or on various
food commodities. EPA has determined that this pesticide petition
contains data or information regarding the elements set forth in FFDCA
section 408(d)(2); however, EPA has not fully evaluated the sufficiency
of the submitted data at this time or whether the data support granting
of the pesticide petition. Additional data may be needed before EPA
rules on this pesticide petition.
    Pursuant to 40 CFR 180.7(f), a summary of the petition included in
this notice, prepared by the petitioner along with a description of the
analytical method available for the detection and measurement of the
pesticide chemical residues is available on EPA's Electronic Docket at
http://www.regulations.gov. To locate this information on the home page

of EPA's Electronic Docket, select ``Quick Search'' and type the OPP
docket ID number. Once the search has located the docket, clicking on
the ``Docket ID'' will bring up a list of all documents in the docket
for the pesticide including the petition summary.

New Tolerances

    PP 6F7072. Syngenta Crop Protection, Inc.; P.O. Box 18300;
Greensboro, NC 27419-8300, proposes to establish tolerances for
residues of the fungicide cyproconazole in or on food commodities
soybean, seed at 0.05 parts per million (ppm); soybean, forage at 1.0
ppm; soybean, hay at 2.5 ppm; corn, field, grain at 0.02 ppm; corn,
field, forage at 0.6 ppm; corn, field, stover at 1.5 ppm; wheat, grain
at 0.05 ppm; wheat, forage at 1.0 ppm; wheat, hay at 1.5 ppm; wheat,
straw at 1.0 ppm; aspirated grain fraction at 0.6 ppm; cattle, fat at
0.01 ppm; cattle, liver at 0.3 ppm; cattle, meat at 0.01 ppm; cattle,
meat byproducts (except liver) at 0.01 ppm; milk at 0.01 ppm; goat, fat
at 0.01 ppm; goat, liver at 0.3 ppm; goat, meat at 0.01 ppm; goat, meat
byproducts (except liver) at 0.01 ppm; hog, fat at 0.01 ppm; hog, liver
at 0.3 ppm; hog, meat at 0.01 ppm; hog, meat byproducts (except liver)
at 0.01 ppm; horse, liver at 0.3 ppm; horse, meat at 0.01; horse, meat
byproducts at 0.01, sheep, fat at 0.01 ppm; sheep, kidney at 0.3;
sheep, meat at 0.01 ppm; sheep, meat byproducts (except liver) at 0.01.
    The analytical methods AM-0822-0994-3 and AM-0842-0790-0 are used
to measure and evaluate the chemical residue(s). Residues are
quantified by gas chromatography equipped with a nitrogen-phosphorus
detector. The limit of quantitation (LOQ) is 0.01 ppm for cyproconazole
parent.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: November 9, 2006.
Donald L. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E6-19578 Filed 11-21-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Proposed Rules]
[Pages 54531-54532]
[FR Doc No: 2016-19510]

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

Coast Guard

33 CFR Part 110

[Docket No. USCG-2015-1118]
RIN 1625-AA01

Anchorage Grounds; Lower Chesapeake Bay, Cape Charles, VA

AGENCY: Coast Guard, DHS.

ACTION: Notice of public meeting and reopening of comment period.

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

SUMMARY: The Coast Guard announces an August 17, 2016 public meeting to
receive comments on an advance notice of proposed rulemaking (ANPRM)
for anchorage grounds that was published in the Federal Register on
April 19, 2016. As stated in the ANPRM, the Coast Guard is considering
amending the regulations for Hampton Roads, VA, and adjacent waters
anchorages by establishing a new anchorage, near Cape Charles, VA, on
the Lower Chesapeake Bay. We are reopening the comment period on the
ANPRM so that comments may be received both at the public meeting and
up to 2 weeks after the public meeting.

DATES: A public meeting will be held on Wednesday, August 17, 2016,
from 6 p.m. to 7:30 p.m., to provide an opportunity for oral comments.
Written comments and related material may also be submitted to Coast
Guard personnel specified at that meeting. All comments and related
material submitted after the meeting must be received by the Coast
Guard on or before August 31, 2016.

ADDRESSES: The public meeting will be held at Cape Charles Civic
Center, 500 Tazewell Avenue, Cape Charles, VA 23310.
    You may submit written comments identified by docket number USCG-
2015-1118 using the Federal eRulemaking Portal at http://www.regulations.gov. Comments and related material must be received by
the Coast Guard on or before August 31, 2016. If you submit a comment,
please include the docket number for this rulemaking, indicate the
specific section of this document to which each comment applies, and
provide a reason for each suggestion or recommendation.
    If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION
CONTACT section of this document for alternate instructions. We accept
anonymous comments. All comments received will be posted without change
to http://www.regulations.gov and will include any personal information
you have provided. For more about privacy and the docket, you may
review a Privacy Act notice regarding the Federal Docket Management
System in the March 24, 2005, issue of the Federal Register (70 FR
15086).

FOR FURTHER INFORMATION CONTACT: If you have questions concerning the
meeting or the advance proposed rule, please call or email LCDR Barbara
Wilk, Sector Hampton Roads Waterways Management Officer, Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background and Purpose

    We published an advance notice of proposed rulemaking (ANPRM) in
the Federal Register on April 19, 2016 (81 FR 22939), entitled
``Anchorage Grounds; Lower Chesapeake Bay, Cape Charles, VA.'' In it we
stated our intention to hold public meetings, and to publish a notice
announcing the location and date (81 FR 22940). This document is the
notice of that meeting.
    In the ANPRM, we stated that the Coast Guard is considering
amending the regulations for Hampton Roads, VA and adjacent waters
anchorages by establishing a new anchorage, near Cape Charles, VA on
the Lower Chesapeake Bay.
    You may view the ANPRM in our online docket, in addition to
supporting documents prepared by the Coast Guard (Illustration
Contemplated Anchorage R), and comments submitted thus far by going to
http://www.regulations.gov. Once there, insert ``USCG-2015-1118'' in
the ``Keyword'' box and click ``Search.''
    We encourage you to participate in this rulemaking by submitting
comments either orally at the meeting or in writing. If you bring
written comments to the meeting, you may submit them to Coast Guard
personnel specified at the meeting to receive written comments. These
comments will be submitted to our online public docket. All comments
received will be posted without change to http://www.regulations.gov
and will include any personal information you have provided.
    Comments submitted after the meeting must reach the Coast Guard on
or before August 31, 2016. We encourage you to submit comments through
the Federal eRulemaking Portal at http://www.regulations.gov. If your
material cannot be submitted using http://www.regulations.gov, contact
the person in the FOR FURTHER INFORMATION CONTACT section of this
document for alternate instructions.
    Anyone can search the electronic form of 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 a Privacy Act notice
regarding our public dockets in the March 24, 2005, issue of the
Federal Register (70 FR 15086).

Agenda of Public Meeting

    The agenda includes the following:
    (1) Introduction of speakers.
    (2) Overview of meeting format.
    (3) Background on proposed commercial anchorage.
    (4) Comments from interested persons.

Comments may be delivered in written form at the public meeting and
made part of the docket or delivered in oral presentations not to
exceed 10 minutes.

Information on Service for Individuals With Disabilities

    For information on facilities or services for individuals with
disabilities or to request special assistance at the public meeting,
contact LCDR Barbara Wilk at the telephone number or email address
indicated under the FOR FURTHER INFORMATION CONTACT section of this
notice.

Public Meeting

    The Coast Guard will hold a public meeting regarding its
``Anchorage Grounds; Lower Chesapeake Bay, Cape Charles, VA'' advance
notice of proposed rulemaking on Wednesday, August 17, 2016, from 6
p.m. to 7:30 p.m., at Cape Charles Civic Center, 500 Tazewell Avenue,
Cape Charles, VA 23310. A written summary of the meeting and comments
will be placed in the docket.

    Dated: August 3, 2016.
R.J. Wester,
Captain, U.S. Coast Guard, Captain of the Port Hampton Roads.
[FR Doc. 2016-19510 Filed 8-15-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 119 (Thursday, June 22, 2023)]
[Notices]
[Page 40801]
[FR Doc No: 2023-13258]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2582-089]

Rochester Gas and Electric Corporation; Notice of Effectiveness
of Withdrawal of Application for Amendment of License

    On June 17, 2022, Rochester Gas and Electric Corporation (licensee)
filed an application for non-capacity amendment of the license for the
14.8-megawatt Station No. 2 Hydroelectric Project No. 2582. On May 26,
2023, the licensee filed a notice of withdrawal of the amendment
application. The project is located on the Genesee River in the City of
Rochester, Monroe County, New York.
    No motion in opposition to the notice of withdrawal has been filed,
and the Commission has taken no action to disallow the withdrawal.
Pursuant to Rule 216(b) of the Commission's Rules of Practice and
Procedure,\1\ the withdrawal of the application became effective on
June 12, 2023,\2\ and this proceeding is hereby terminated.
---------------------------------------------------------------------------

    \1\ 18 CFR 385.216(b) (2022).
    \2\ The Commission's Rules of Practice and Procedure provide
that if a deadline falls on a Saturday, Sunday, holiday, or other
day when the Commission is closed for business, the deadline does
not end until the close of business on the next business day. 18 CFR
385.2007(a)(2) (2022). Because the 15-day deadline fell on a
Saturday (i.e., June 10, 2023), the deadline was extended until the
close of business on Monday, June 12, 2023.

    Dated: June 15, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-13258 Filed 6-21-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)]
[Rules and Regulations]
[Pages 54006-54007]
[FR Doc No: 2018-23409]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 868

[Docket No. FDA-2018-N-3729]

Medical Devices; Anesthesiology Devices; Classification of the
High Flow Humidified Oxygen Delivery Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the high flow humidified oxygen delivery device into class II (special
controls). The special controls that apply to the device type are
identified in this order and will be part of the codified language for
the high flow humidified oxygen delivery device'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 26, 2018. The classification was
applicable on April 10, 2018.

FOR FURTHER INFORMATION CONTACT: Derya Coursey, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2563, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the high flow humidified oxygen
delivery device 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 (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 (see 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 (Pub. L. 105-115) established the first procedure for De
Novo classification. Section 607 of the Food and Drug Administration
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo
application process by adding a second procedure. 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 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 January 3, 2017, Vapotherm, Inc. submitted a request for De Novo
classification of the Precision Flow[supreg] HVNI. 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 the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on April 10, 2018, FDA issued an order to the requester
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 868.5454. We have named
the generic type of device high flow humidified oxygen delivery device,
and it is identified as a prescription device that delivers high flow
oxygen with humidification for patients who are suffering from
respiratory distress and/or hypoxemia.
    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--High Flow Humidified Oxygen Delivery Device Risks and
                           Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction................  Biocompatibility evaluation,
                                          Non-clinical performance
                                          testing, and Labeling.
Interference with other devices........  Electromagnetic compatibility
                                          testing, Radiofrequency
                                          identification testing, and
                                          Labeling.
Infection..............................  Cleaning validation and
                                          Labeling.
Device software failure leading to       Software verification,
 delayed initiation of therapy.           validation, and hazard
                                          analysis; and Labeling.
Device failure/malfunction leading to    Non-clinical performance
 ineffective treatment.                   testing and Labeling.
Electrical shock injury from device      Electrical safety, thermal
 failure.                                 safety, and mechanical safety
                                          testing.
Use error/improper device use leading    Labeling.
 to hypoxia or worsening hypercarbia.
------------------------------------------------------------------------

    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. 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.
    At the time of classification, high flow humidified oxygen delivery
devices are for prescription use only. Prescription devices are exempt
from the requirement for adequate directions for use for the layperson
under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21
CFR 801.5, as long as the conditions of 21 CFR 801.109 are met
(referring to 21 U.S.C. 352(f)(1)).

III. Analysis of Environmental Impact

    We have 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 and guidance. 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 the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 820, regarding quality system regulation,
have been approved under OMB control number 0910-0073; the collections
of information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 868

    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
868 is amended as follows:

PART 868--ANESTHESIOLOGY DEVICES

0
1. The authority citation for part 868 continues to read as follows:

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

0
2. Add Sec.  868.5454 to subpart F to read as follows:

Sec.  868.5454  High flow humidified oxygen delivery device.

    (a) Identification. A high flow humidified oxygen delivery device
is a prescription device that delivers high flow oxygen with
humidification for patients who are suffering from respiratory distress
and/or hypoxemia.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions for use,
including the following:
    (i) Alarm testing must be performed;
    (ii) Continuous use thermal stability testing must be performed;
    (iii) Humidity output testing must be performed; and
    (iv) Blender performance testing must evaluate fraction of inspired
oxygen (FiO2) blending accuracy.
    (3) Performance data must validate cleaning instructions for any
reusable components of the device.
    (4) Electrical safety, thermal safety, mechanical safety,
electromagnetic compatibility, and radiofrequency identification
testing must be performed.
    (5) Software verification, validation, and hazard analysis must be
performed.
    (6) Labeling must include:
    (i) A description of available FiO2 ranges for different
flowrates and inlet gas pressures;
    (ii) Instructions for applicable flowrates for all intended
populations;
    (iii) A warning that patients on high flow oxygen are acute and
require appropriate monitoring, to include pulse oximetry;
    (iv) A warning regarding the risk of condensation at low set
temperatures and certain flows; and
    (v) A description of all alarms and their functions.

    Dated: October 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23409 Filed 10-25-18; 8:45 am]
 BILLING CODE 4164-01-P


Between EPA and APAA 2000 omplex 501 3rd Street /

; Director Office of Atmospheric Programs ( OAP) ratospheric Protection Division ( SPD) hief, Program Implementation Branch ( PIB)

TOPIC Update on proposed rule Protection of Stratospheric Ozone; Substitute Refrigerants ( 63 FR 32044) June 1 I, 1998 AL ss MC ss JB PS AL JB APAA requested meeting in order to receive an update on the substitutes rule and to meet new personnel anticipate rule becoming effective Fall 2000 will a sales restriction on HFC 134a be included in the rulemaking?

At this date there is more work to be done. The Agency has not decided on a sales restriction.

SPD will provide APAA with a request for documents supporting their position against a sales restriction. ,

Budget restrictions and personnel changes have slowed the rule making process. OAP is not as contractor dependent as other offices of EPA.

Retrofit rates have greatly decreased since 1998.

How will a decrease in retroffiting affect the rulemaking?

AL & MC The RIA is based upon cross contamination due to DlYers attempts at If retrofits are decreasing then the need for a sales restriction JB The first vehicles with OEM MVACs should be nearing the end of their life spans, shouldn't this have an impact on EPAs decision to restrict sales of a substitute refrig e rant? o not believe that those rea the ends of their lifespans.

L No response.

SS Yes they will.

MC APAA has surveys stating that DlYers are environmentally consc DH Does APAA have empirical including the current beha ' ir position on a sales restriction, ulation?

SS How will a DlYer perfo recovery refrigerant without I . recyclingkecovery eq uipm AL There is no evidence ians use the required recycling equip men t .

DH EPA Office of Mobile states otherwise. There have not been industrial and commercial I many enforcement actions a Also violation tips ten sectors, not MVAC shops icians with recycling equipment.

MC Are these inspections blind PS Yes they are blind inspections MC This regulation has no teeth. The Agency should not go after individual users for venting .

AL We prefer mandatory labeling, education at the point of sale, and unique fittings.

DH How is education at the pont of sale more effective, than a structured course followed by testing and eventual certification?

EPA has no data to support that technician certification equates to compliance. It is an argument that APAA has presented earlier. AL


[Federal Register Volume 84, Number 175 (Tuesday, September 10, 2019)]
[Rules and Regulations]
[Pages 47427-47429]
[FR Doc No: 2019-19495]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0760]
RIN 1625-AA00

Safety Zone; Missouri River, Mile Marker 117 to 116.5, Chamois,
MO

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone for
all navigable waters of the Missouri River in a work zone located from
Mile Marker (MM) 116.5 through MM 117. The safety zone is needed to
protect persons, vessels, and the marine environment from potential
hazards created by the installation of electrical lines across the
river. Entry of persons or vessels into this zone is prohibited unless
specifically authorized by the Captain of the Port Sector Upper
Mississippi River (COTP) or a designated representative.

DATES: This rule is effective from October 7, 2019, through October 9,
2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2019-0760 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Commander Christian Barger, Waterways
Management Division, Sector Upper Mississippi River, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Sector Upper Mississippi River
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b) (B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. We must
establish this safety zone by October 7, 2019, and we lack sufficient
time to provide a reasonable comment period and then consider those
comments before issuing the rule. The NPRM process would delay
establishment of the safety zone until after the date of the electrical
line work and compromise public safety.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to public interest because immediate action
is necessary to respond to the potential safety hazards associated with
electrical line installation over the Missouri River.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Sector Upper
Mississippi River (COTP) has determined that potential hazards
associated with electrical line installation over the Missouri River
will be a safety concern for anyone in the work zone from Mile Marker
(MM) 116.5 through MM 117. This rule is needed to protect persons,
vessels, and the marine environment on the navigable waters within the
safety zone while electrical lines are pulled across the river.

IV. Discussion of the Rule

    This rule establishes a temporary safety zone for a three day
period from October 7, 2019 through October 9, 2019 or until the
electrical line work is completed, whichever occurs first. The safety
zone will be enforced at the work zone on the Missouri River between MM
116.5 and MM 117.
    Transit into and through this safety zone is prohibited during
periods of enforcement unless given permission by the Captain of the
Port or a designated representative. This zone will be enforced for up
to ten hours each day from 7 a.m. through 5 p.m. The COTP or a
designated representative will inform the public through Broadcast
Notices to Mariners (BNMs) at least 12 hours in advance of each
enforcement period, and a safety vessel will coordinate all vessel
traffic during the enforcement periods. In addition, the COTP or a
designated representative will release regular BNMs while the zone is
in effect and will also announce

the suspension of the zone via VHF-FM marine channel 16.
    The duration of this temporary safety zone is intended to protect
persons, vessels, and the marine environment on these navigable waters
while the electrical lines are being pulled across the river. No vessel
or person will be permitted to enter the safety zone without obtaining
permission from the COTP or a designated representative. A designated
representative is a commissioned, warrant, or petty officer of the U.S.
Coast Guard assigned to units under the operational control of USCG
Sector Upper Mississippi River. To seek entry into the safety zone,
contact the COTP or the COTP's designated representative by telephone
at<PHONE_NUMBER> or on VHF-FM channel 16. Persons and vessels permitted
to enter this safety zone must transit at their slowest safe speed and
comply with all lawful directions issued by the COTP or the designated
representative.
    The COTP or a designated representative will inform the public of
the enforcement dates and times for this safety zone, as well as any
emergent safety concerns that may delay the suspension of the zone each
day, through BNMs, Local Notices to Mariners (LNMs), and/or Marine
Safety Information Bulletins (MSIBs) as appropriate.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, and duration of the safety zone. This safety zone impacts a
one-half mile stretch of the Missouri River for up to ten hours on
three consecutive days. Additionally this rule allows vessels to seek
permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
temporary safety zone may be small entities, for the reasons stated in
section V.A above, this rule will not have a significant economic
impact on any vessel owner or operator because the rule will allow
persons and vessels to seek permission to enter the zone and
coordinated entry may be arranged on a case by case basis.
Additionally, coordination with several waterways users has taken place
to mitigate as much impact as possible
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
determined that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a safety zone lasting up to ten hours
each day over three consecutive days that will prohibit entry through
an electrical wire work zone on the Missouri River. It is categorically
excluded from further

review under paragraph L60 (a) in Table 3-1 of U.S. Coast Guard
Environmental Planning Implementing Procedures. A Record of
Environmental Consideration supporting this determination is available
in the docket where indicated under ADDRESSES.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation, Reporting and recordkeeping
requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T08-0760 to read as follows:

Sec.  165.T08-0760  Safety Zone; Missouri River, mile marker 117 to
116.5, Chamois, MO.

    (a) Location. The following area is a safety zone: One work zone on
the Missouri River from Mile Marker (MM) 116.5 through MM 117. Transit
into and through this safety zone is prohibited during periods of
enforcement unless given permission by the Captain of the Port or a
designated representative.
    (b) Effective period. This section is effective from October 7,
2019, through October 9, 2019.
    (c) Enforcement periods. This section will be enforced each day
that electrical line work is to be performed for up to ten hours per
day from October 7, 2019, through October 9, 2019, from approximately 7
a.m. through 5 p.m. each day.
    (d) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry of vessels or persons into this zone is prohibited
unless specifically authorized by the Captain of the Port Sector Upper
Mississippi River (COTP) or designated representative. A designated
representative is a commissioned, warrant, or petty officer of the U.S.
Coast Guard assigned to units under the operational control of USCG
Sector Upper Mississippi River.
    (2) Vessels requiring entry into this safety zone must request
permission from the COTP or a designated representative. To seek entry
into the safety zone, contact the COTP or the COTP's representative by
telephone at<PHONE_NUMBER> or on VHF-FM channel 16.
    (3) Persons and vessels permitted to enter this safety zone must
transit at their slowest safe speed and comply with all lawful
directions issued by the COTP or the designated representative.
    (e) Information broadcasts. The COTP or a designated representative
will inform the public of the enforcement dates and times for this
safety zone, as well as any emergent safety concerns that may delay the
enforcement of the zone each day, through Broadcast Notice to Mariners,
Local Notices to Mariners, and/or Marine Safety Information Bulletins
as appropriate.

    Dated: September 3, 2019.
S.A. Stoermer,
Captain, U.S. Coast Guard, Captain of the Port Sector Upper Mississippi
River.
[FR Doc. 2019-19495 Filed 9-9-19; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 51 (Wednesday, March 16, 2016)]
[Notices]
[Pages 14219-14220]
[FR Doc No: 2016-05687]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Hazardous Materials: Notice of Application for Special Permits

AGENCY: Office of Hazardous Materials Safety, Pipeline and Hazardous
Materials Safety Administration, (PHMSA), DOT.

ACTION: List of applications for special permits.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR part 107,
subpart B), notice is hereby given that the Office of Hazardous
Materials Safety has received the application described herein. Each
mode of transportation for which a particular special permit is
requested is indicated by a number in the ``Nature of Application''
portion of the table below as follows: 1--Motor vehicle, 2--Rail
freight, 3--Cargo vessel, 4--Cargo aircraft only, 5--Passenger-carrying
aircraft.

DATES: Comments must be received on or before April 15, 2016.
    Address Comments To: Record Center, Pipeline and Hazardous
Materials Safety Administration, U.S. Department of Transportation,
Washington, DC 20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Ryan Paquet, Director, Office of
Hazardous Materials Approvals and Permits Division, Pipeline and
Hazardous Materials Safety Administration, U.S. Department of
Transportation, East Building, PHH-30, 1200 New Jersey Avenue
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.
    Copies of the applications are available for inspection in the
Records Center, East Building, PHH-30, 1200 New Jersey Avenue
Southeast, Washington, DC or at http://regulations.gov.
    This notice of receipt of applications for special permit is
published in accordance with Part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR I.53(b)).

    Issued in Washington, DC, on January 28, 2016.
Don Burger,
Chief, General Approvals and Permits.

----------------------------------------------------------------------------------------------------------------
                                                                                Nature
                                                                                of the
      Application No.              Docket No.               Applicant          Regulation(s) affected    special
                                                                                permits
                                                                                thereof
----------------------------------------------------------------------------------------------------------------
                                              Special Permits Data
----------------------------------------------------------------------------------------------------------------
20065-N....................  ......................  BOOST OXYGEN, LLC.....  176.1, 177.800, 172.500,      To
                                                                              173.302a(a)(1), 172.200,   authori
                                                                              172.400.                   ze the
                                                                                transpo
                                                                                rtation
                                                                                in
                                                                                commerc
                                                                                e of
                                                                                certain
                                                                                DOT
                                                                                Specifi
                                                                                cation
                                                                                2Q
                                                                                contain
                                                                                ers
                                                                                with
                                                                                Divisio
                                                                                n 2.2
                                                                                materia
                                                                                ls.
20084-N....................  ......................  CIMARRON COMPOSITES,    173.302a..................    To
                                                      LLC.                                               authori
                                                                                ze the
                                                                                manufac
                                                                                ture,
                                                                                mark,
                                                                                sale
                                                                                and use
                                                                                of non-
                                                                                DOT
                                                                                specifi
                                                                                cation
                                                                                cylinde
                                                                                rs for
                                                                                the
                                                                                transpo
                                                                                rtation
                                                                                in
                                                                                commerc
                                                                                e of
                                                                                certain
                                                                                Divisio
                                                                                ns 2.1
                                                                                and 2.2
                                                                                compres
                                                                                sed
                                                                                gases.
20088-N....................  ......................  DSM NUTRITIONAL         107.601(a), 177.804(a),       To
                                                      PRODUCTS, INC.          172.500(a), 172.504(e),    authori
                                                                              172.400.                   ze the
                                                                                transpo
                                                                                rtation
                                                                                in
                                                                                commerc
                                                                                e of
                                                                                certain
                                                                                Divisio
                                                                                n 4.2,
                                                                                Packing
                                                                                Group
                                                                                III
                                                                                self-
                                                                                heating
                                                                                solid
                                                                                materia
                                                                                ls as
                                                                                excepte
                                                                                d from
                                                                                registr
                                                                                ation,
                                                                                marking
                                                                                ,
                                                                                labelin
                                                                                g,
                                                                                placard
                                                                                ing,
                                                                                and
                                                                                certain
                                                                                carrier
                                                                                require
                                                                                ments.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2016-05687 Filed 3-15-16; 8:45 am]
 BILLING CODE 4909-60-M