P-18-0332-0333 Sanitized Support Documents Index:
 P-18-0332-0333 Sanitized Determination Document (linked)
 P-18-0332 Sanitized CHEM Report (attached)
 P-18-0333 Sanitized CHEM Report (attached)
 P-18-0332 Sanitized ECO Report (attached)
 P-18-0333 Sanitized ECO Report (attached)
 P-18-0332-0333 Sanitized ENG Report (attached)
 P-18-0332 Sanitized EXP Report (attached)
 P-18-0333 Sanitized EXP Report (attached)
 P-18-0332 Sanitized Fate Report (attached)
 P-18-0333 Sanitized Fate Report (attached)
 P-18-0332-0333 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


[Federal Register Volume 79, Number 49 (Thursday, March 13, 2014)]
[Notices]
[Pages 14247-14250]
[FR Doc No: 2014-05388]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-1017; FRL-9905-37]

Product Cancellation Order for Certain Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces EPA's order for the cancellations,
voluntarily requested by the registrants and accepted by the Agency, of
the products listed in Table 1 of Unit II., pursuant to the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). This cancellation
order follows a November 20, 2013 Federal Register Notice of Receipt of
Requests from the registrants listed in Table 2 of Unit II. to
voluntarily cancel these product registrations. In the November 20,
2013 notice, EPA indicated that it would issue an order implementing
the cancellations, unless the Agency received substantive comments
within the 30-day comment period that would merit its further review of
these requests, or unless the registrants withdrew their requests. The
Agency did not receive any comments on the notice. However, the Agency
did receive notice via letter dated December 18, 2013 from the
registrant Nufarm Americas Inc. to withdraw their voluntary
cancellation request for products EPA Reg. Nos. 33688-2 (Nufarm S.A.
Technical Butralin) and EPA Reg. No. 33688-4 (Tamex 3EC). Accordingly,
EPA hereby issues in this notice a cancellation order granting the
requested withdrawals and cancellations. Any distribution, sale, or use
of the products subject to this cancellation order is permitted only in
accordance with the terms of this order, including any existing stocks
provisions. In addition, for pertinent information relating to the
pesticide registrations for ME030004 and ME980001 as published in the
November 20, 2013 notice, see Unit II. of this notice.

DATES: The cancellations are effective March 13, 2014.

FOR FURTHER INFORMATION CONTACT: John W. Pates, Jr., Pesticide Re-
Evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2009-1017, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the

Environmental Protection Agency Docket Center (EPA/DC), EPA West Bldg.,
Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

II. What action is the agency taking?

    This notice announces the cancellation, as requested by
registrants, of products registered under FIFRA section 3. These
registrations are listed in sequence by registration number in Table 1
of this unit.
    The Agency also received notice via letter dated December 18, 2013
from the registrant Nufarm Americas Inc. to withdraw their voluntary
cancellation request for products EPA Reg. No. 33688-2 (Nufarm S.A.
Technical Butralin) and EPA Reg. No. 33688-4 (Tamex 3EC). Thus, these
registrations have been removed from this cancellation order notice. In
addition, pesticide registration numbers ME030004 and ME980001 and its
contents have been removed from the listing in Table 1. EPA
inadvertently listed the pesticide product names Glypro and RH-5992 2F
Experimental Insecticide for pesticide registration numbers ME030004
and ME980001, respectively, in the Federal Register of November 20,
2013 (78 FR 69666) (FRL 9902-40). Therefore, this action excludes
pesticide registration numbers ME030004 and ME980001 from cancellation
at this time. EPA will reissue pesticide product numbers ME030004 and
ME980001 for voluntary cancellation in a future Federal Register
notice.

                     Table 1--Product Cancellations
------------------------------------------------------------------------
    EPA Registration No.          Product name          Chemical name
------------------------------------------------------------------------
000264-00619................  Desmedipham           Desmedipham.
                               Technical.
000264-00620................  Betanex Herbicide...  Desmedipham.
000264-00621................  Betamix Herbicide...  Phenmedipham,
                                                     Desmedipham.
000264-00632................  Betamix Progress....  Phenmedipham,
                                                     Desmedipham,
                                                     Ethofumesate.
000264-00640................  TPTH Technical......  Fentin hydroxide.
000264-00780................  Fenhexamid 50 WDG...  Fenhexamid.
000264-00785................  Fenhexamid Technical  Fenhexamid.
000264-00851................  Betanal Forte.......  Phenmedipham,
                                                     Desmedipham.
000264-00853................  Betanal Compact.....  Desmedipham.
000264-00854................  Betanal Power         Phenmedipham,
                               Herbicide.            Desmedipham,
                                                     Ethofumesate.
000270-00348................  Adams Caniderm Mist.  MGK 264, Piperonyl
                                                     Butoxide,
                                                     Pyrethrins (NO
                                                     INERT USE).
000432-01378................  Imidacloprid 0.72% +  Imidacloprid,
                               Cyfluthrin 0.72%      Cyfluthrin.
                               Concentrate
                               Insecticide.
002724-00467................  Sandoz 9412 Mousse    Piperonyl Butoxide,
                               (Light).              S-Methoprene,
                                                     Pyrethrins (NO
                                                     INERT USE).
004787-00054................  Cheminova             Nicosulfuron.
                               Nicosulfuron
                               Technical.
005481-00211................  PCNB 10% Granules     Pentachloronitrobenz
                               Soil Fungicide.       ene.
005481-00212................  PCNB 2-E Liquid       Pentachloronitrobenz
                               Emulsifiable          ene.
                               Concentrate.
005481-00214................  PCNB Soil & Turf      Pentachloronitrobenz
                               Liquid Drench.        ene.
005481-00215................  PCNB 2LF Liquid       Pentachloronitrobenz
                               Flowable.             ene.
005481-00442................  PCNB Flowable RTU     Pentachloronitrobenz
                               Seed Protectant.      ene.
005481-00443................  PCNB 2 Flowable Turf  Pentachloronitrobenz
                               & Ornamental Soil     ene.
                               Fungicide.
005481-00444................  PCNB 10G Turf &       Pentachloronitrobenz
                               Ornamental Soil       ene.
                               Fungicide.
005481-00445................  PCNB ST Liquid        Pentachloronitrobenz
                               Flowable Seed         ene.
                               Treatment Fungicide.
005481-00450................  PCNB 20% WDG Soil     Pentachloronitrobenz
                               Fungicide.            ene.
005481-00464................  Parflo 6F...........  Pentachloronitrobenz
                                                     ene.
005481-00465................  Par-Flo.............  Pentachloronitrobenz
                                                     ene.
005481-00471................  Win-Flo 6F..........  Pentachloronitrobenz
                                                     ene.
005481-00472................  Parflo 4F...........  Pentachloronitrobenz
                                                     ene.
005481-08982................  Terraclor 2EC.......  Pentachloronitrobenz
                                                     ene.
005481-08984................  Terraclor 10%         Pentachloronitrobenz
                               Granular Soil         ene.
                               Fungicide.
005481-08985................  Greenback Lawn        Pentachloronitrobenz
                               Fungicide.            ene.
005481-08986................  Turfcide              Pentachloronitrobenz
                               Emulsifiable          ene.
                               Fungicide.
005481-08987................  Terraclor Super X     Pentachloronitrobenz
                               Emulsifiable.         ene & Etridiazole.
005481-08991................  Terraclor Flowable    Pentachloronitrobenz
                               Fungicide.            ene.
005481-08993................  Terraclor Super X     Pentachloronitrobenz
                               18.8G.                ene & Etridiazole.
005481-08994................  Turfcide 15G........  Pentachloronitrobenz
                                                     ene.
005481-08995................  Terraclor 15G.......  Pentachloronitrobenz
                                                     ene.
005481-08997................  Terrazan 24%          Pentachloronitrobenz
                               Emulsifiable          ene.
                               Concentrate.
005481-08998................  Turfcide WDG........  Pentachloronitrobenz
                                                     ene.
005481-09033................  Gustafson Terra-Coat  Pentachloronitrobenz
                               L-205N.               ene & Etridiazole.
005481-09035................  Gustafson Terra-Coat  Pentachloronitrobenz
                               LT-2N.                ene.
005481-09039................  Trigran-S Seed        Pentachloronitrobenz
                               Protector.            ene.
005785-00042................  Brom-O-Gas 2%.......  Methyl bromide (NO
                                                     INERT USE) &
                                                     Chloropicrin.
010163-00228................  Mesurol Pro.........  Methiocarb.
010163-00229................  Mesurol 75%           Methiocarb.
                               Concentrate.
010163-00232................  Mesurol 2% Bait For   Methiocarb.
                               Homeowner Use.
010163-00252................  Mesurol 75 WDG......  Methiocarb.
010466-00037................  Ultra-Fresh 15......  Diiodomethyl p-tolyl
                                                     sulfone.
044446-00077................  Hub States A-20       Piperonyl Butoxide,
                               Procide Insecticide.  Pyrethrins (NO
                                                     INERT USE).

044446-00078................  V-230...............  MGK 264, Piperonyl
                                                     Butoxide,
                                                     Pyrethrins (NO
                                                     INERT USE).
047000-00102................  CT Crack And Crevice  MGK 264, Piperonyl
                                                     Butoxide, Propoxur,
                                                     Pyrethrins (NO
                                                     INERT USE).
047000-00165................  R & M Aqueous         Permethrin,
                               Residual Flea &       Pyrethins (NO INERT
                               Tick 1.      USE).
047000-00166................  R+M Flea And Tick     MGK 264, Piperonyl
                               Dip 1.       Butoxide,
                                                     Pyrethrins (NO
                                                     INERT USE).
053883-00270................  CSI Gamma-            Piperonyl Butoxide,
                               Cyhalothrin           Gamma-Cyhalothrin.
                               Synergized Topical
                               Insecticide Pour-On.
061282-00055................  BioSentry 904.......  Alkyl* dimethyl
                                                     benzyl ammonium
                                                     chloride *(61% C12,
                                                     23% C14, 11% C16,
                                                     2.5% C18 2.5% C10
                                                     and trace of C8),
                                                     Alkyl* dimethyl
                                                     benzyl ammonium
                                                     chloride *(50%C14,
                                                     40%C12, 10%C16), 1-
                                                     Decanaminium, N-
                                                     decyl-N,N-dimethyl-
                                                     , chloride and
                                                     Tributyltin oxide
                                                     (NO INERT USE).
061282-00058................  Tributyl Tin Oxide..  Tributyltin Oxide
                                                     (NO INERT USE).
062719-00299................  Frontrow............  Cloransulam-methyl,
                                                     Flumetsulam.
070506-00086................  Agvalue Desmedipham.  Desmedipham.
070506-00087................  DES.................  Desmedipham.
CA-040025...................  Riverdale Endurance   Prodiamine.
                               Herbicide.
MN-010003...................  Treflan H.F.P.......  Trifluralin.
MN-100004...................  Treflan H.F.P.......  Trifluralin.
WA-010015...................  Betamix Herbicide...  Phenmedipham,
                                                     Desmedipham.
------------------------------------------------------------------------

    Table 2 of this unit includes the names and addresses of record for
all registrants of the products in Table 1 of this unit, in sequence by
EPA company number. This number corresponds to the first part of the
EPA registration numbers of the products listed in Table 1 of this
unit.

                                    Table 2--Registrants of Canceled Products
----------------------------------------------------------------------------------------------------------------
                         EPA Company No.                                      Company name and address
----------------------------------------------------------------------------------------------------------------
264 WA-010015....................................................  Bayer CropScience LP, 2 T.W. Alexander Drive,
                                                                    P.O. Box 12014, Research Triangle Park, NC
                                                                    27709.
270..............................................................  Farnam Companies, Inc., 301 West Osborn Road,
                                                                    Phoenix, AZ 85013.
432..............................................................  Bayer Environmental Science, A Division of
                                                                    Bayer CropScience LP, 2 T.W. Alexander
                                                                    Drive, P.O. Box 12014, Research Triangle
                                                                    Park, NC 27709.
2724.............................................................  Wellmark International, 1501 E. Woodfield
                                                                    Road, Suite 200 West, Schaumburg, IL 60173.
4787.............................................................  Cheminova A/ S, Agent: Cheminova Inc., 1600
                                                                    Wilson Blvd. Suite 700, Arlington, VA 22209.
5481.............................................................  Amvac Chemical Corporation, 4695 MacArthur
                                                                    Court, Suite 1250, Newport Beach, CA 92660.
5785.............................................................  Great Lakes Chemical Corporation, (A Chemtura
                                                                    Company), 1801 Highway 52 West, P.O. Box
                                                                    2200, West Lafayette, IN 47906.
10163............................................................  Gowan Company, P.O. Box 5569, Yuma, AZ 85366.
10466............................................................  Thomson Research Associates, Agent: Laird's
                                                                    Regulatory Consultants Inc., Shenstone Est.
                                                                    17804 Braemar Pl., Leesburg, VA 20176-7046.
44446............................................................  Questvapco Corporation, P.O. Box 624,
                                                                    Brenham, TX 77834.
47000............................................................  Chem-Tech, LTD., 4515 Fleur Dr. 303,
                                                                    Des Moines, IA 50321.
53883............................................................  Control Solutions, Inc., 5903 Genoa-Red Bluff
                                                                    Road, Pasadena, TX 77507-1041.
61282............................................................  Hacco, Inc., 110 Hopkins Drive, Randolph, WI
                                                                    53956-1316.
62719, MN-010003, MN-100004......................................  Dow AgroSciences LLC, 9330 Zionsville Rd. 308/
                                                                     2E, Indianapolis, IN 46268-1054.
70506............................................................  United Phosphorus, Inc., 630 Freedom Business
                                                                    Center, Suite 402, King of Prussia, PA
                                                                    19406.
CA-040025........................................................  Nufarm SA, Agent: Nufarm Americas, Inc., 4020
                                                                    Aerial Center Pkwy. Suite 101, Morrisville,
                                                                    NC 27560.
----------------------------------------------------------------------------------------------------------------

III. Summary of Public Comments Received and Agency Response to
Comments

    During the public comment period provided, EPA received no comments
in response to the November 20, 2013 Federal Register notice announcing
the Agency's receipt of the requests for voluntary cancellations of
products listed in Table 1 of Unit II.

 IV. Cancellation Order

    Pursuant to FIFRA section 6(f), EPA hereby approves the requested
cancellations of the registrations identified in Table 1 of Unit II.
Accordingly, the Agency hereby orders that the product registrations
identified in Table 1 of Unit II. are canceled. The effective date of
the cancellations that are the subject of this notice is March 13,
2014. Any distribution, sale, or use of existing stocks of the products
identified in Table 1 of Unit II. in a manner inconsistent with any of
the provisions for disposition of existing stocks set forth in Unit VI.
will be a violation of FIFRA.

V. What is the Agency's authority for taking this action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled or

amended to terminate one or more uses. FIFRA further provides that,
before acting on the request, EPA must publish a notice of receipt of
any such request in the Federal Register. Thereafter, following the
public comment period, the EPA Administrator may approve such a
request. The notice of receipt for this action was published for
comment in the Federal Register issue of November 20, 2013 (78 FR
69666) (FRL-9902-40). The comment period closed on December 20, 2013.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
which are currently in the United States and which were packaged,
labeled, and released for shipment prior to the effective date of the
cancellation action. The existing stocks provisions for the products
subject to this order are as follows.

A. For Products<PHONE_NUMBER>7 and<PHONE_NUMBER>8)

    The registrant may continue to sell and distribute existing stocks
of these products listed in Table 1 of Unit II. until September 9,
2015. Thereafter, the registrant is prohibited from selling or
distributing products listed in Table 1, except for export in
accordance with FIFRA section 17, or proper disposal. Persons other
than the registrants may sell, distribute, or use existing stocks of
products listed in Table 1 of Unit II. until existing stocks are
exhausted, provided that such sale, distribution, or use is consistent
with the terms of the previously approved labeling on, or that
accompanied, the canceled products.

B. For Product<PHONE_NUMBER>1)

    The registrant may continue to sell and distribute existing stocks
of this product listed in Table 1 of Unit II. until November 20, 2018.
Thereafter, the registrant is prohibited from selling or distributing
product listed in Table 1, except for export in accordance with FIFRA
section 17, or proper disposal. Persons other than the registrant may
sell, distribute, or use existing stocks of product listed in Table 1
of Unit II. until existing stocks are exhausted, provided that such
sale, distribution, or use is consistent with the terms of the
previously approved labeling on, or that accompanied, the canceled
product.

C. For all Other Products Identified in Table 1 of Unit II

    The registrants may continue to sell and distribute existing stocks
of products listed in Table 1 of Unit II. until March 13, 2015, which
is 1-year after the publication of the Cancellation Order in the
Federal Register. Thereafter, the registrants are prohibited from
selling or distributing products listed in Table 1, except for export
in accordance with FIFRA section 17, or proper disposal. Persons other
than the registrants may sell, distribute, or use existing stocks of
products listed in Table 1 of Unit II. until existing stocks are
exhausted, provided that such sale, distribution, or use is consistent
with the terms of the previously approved labeling on, or that
accompanied, the canceled products.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: March 5, 2014.
 Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2014-05388 Filed 3-12-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 72 (Monday, April 15, 2019)]
[Notices]
[Pages 15271-15273]
[FR Doc No: 2019-07362]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85578; File No. SR-NASDAQ-2019-027]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Extend the Pilot Related to Rule 4121, Trading Halts Due to
Extraordinary Market Volatility

April 9, 2019.
    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 April 8, 2019, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the Exchange.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to extend the pilot related to Rule 4121,
Trading Halts Due to Extraordinary Market Volatility, to the close of
business on October 18, 2019.
    The text of the proposed rule change is available on the Exchange's
website at http://nasdaq.cchwallstreet.com, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    Rule 4121 provides a methodology for determining when to halt
trading in all stocks due to extraordinary market volatility, i.e.,
market-wide circuit breakers. The market-wide circuit breaker mechanism
under Rule 4121 was approved by the Commission to operate on a pilot
basis, the term of which was to coincide with the pilot period for the
Plan to Address Extraordinary Market Volatility Pursuant to Rule 608 of
Regulation NMS (the ``LULD Plan''),\3\ including any extensions to the
pilot period for the LULD Plan.\4\ The Commission published an
amendment to the LULD

Plan for it to operate on a permanent, rather than pilot, basis.\5\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012) (the ``Limit Up-Limit Down
Release'').
    \4\ See Securities Exchange Act Release Nos. 67090 (May 31,
2012), 77 FR 33531 (June 6, 2012) (SR-NASDAQ-2011-131) (Approval
Order); and 68786 (January 31, 2013), 78 FR 8666 (February 6, 2013)
(SR-NASDAQ-2013-021) (Notice of Filing and Immediate Effectiveness
of Proposed Rule Change to Delay the Operative Date of a Rule Change
to Nasdaq Rule 4121).
    \5\ See Securities Exchange Act Release Nos. 84843 (December 18,
2018), 83 FR 66464 (December 26, 2018) (Amendment No. 18 Proposing
Release).
---------------------------------------------------------------------------

    The Exchange proposes to amend Rule 4121 to untie the pilot's
effectiveness from that of the LULD Plan and to extend the pilot's
effectiveness to the close of business on October 18, 2019. The
Exchange does not propose any additional changes to Rule 4121.
    Market-wide circuit breakers under Rule 4121 provide an important,
automatic mechanism that is invoked to promote stability and investor
confidence during a period of significant stress when securities
markets experience extreme broad-based declines. All U.S. equity
exchanges have rules relating to market-wide circuit breakers, which
are designed to slow the effects of extreme price movement through
coordinated trading halts across securities markets when severe price
declines reach levels that may exhaust market liquidity. Market-wide
circuit breakers provide for trading halts in all equities and options
markets during a severe market decline as measured by a single-day
decline in the S&P 500 Index.
    Pursuant to Rule 4121, a market-wide trading halt will be triggered
if the S&P 500 Index declines in price by specified percentages from
the prior day's closing price of that index. Currently, the triggers
are set at three circuit breaker thresholds: 7% (Level 1), 13% (Level
2) and 20% (Level 3). A market decline that triggers a Level 1 or Level
2 circuit breaker after 9:30 a.m. ET and before 3:25 p.m. ET would halt
market-wide trading for 15 minutes, while a similar market decline at
or after 3:25 p.m. ET would not halt market-wide trading. A market
decline that triggers a Level 3 circuit breaker, at any time during the
trading day, would halt market-wide trading for the remainder of the
trading day.
    The Exchange intends to file a separate proposed rule change to
operate Rule 4121 on a permanent, rather than pilot, basis. Extending
the effectiveness of Rule 4121 to the close of business on October 18,
2019 should provide the Commission adequate time to consider whether to
approve the Exchange's separate proposal to operate the market-wide
circuit breaker mechanism under Rule 4121 on a permanent basis.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\6\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\7\ in particular, in that it is designed to promote
just and equitable principles of trade, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general to protect investors and the public interest.
The Exchange also believes that the proposed rule change promotes just
and equitable principles of trade in that it promotes transparency and
uniformity across markets concerning when and how to halt trading in
all stocks as a result of extraordinary market volatility. Extending
the market-wide circuit breaker pilot under Rule 4121 an additional six
months would ensure the continued, uninterrupted operation of a
consistent mechanism to halt trading across the U.S. markets while the
Commission considers whether to approve the pilot on a permanent basis.
The proposed rule change would thus promote fair and orderly markets
and the protection of investors and the public interest. Based on the
foregoing, the Exchange believes the benefits to market participants
from the market-wide circuit breaker mechanism under Rule 4121 should
continue on a pilot basis while the Commission considers whether to
permanently approve Rule 4121.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change
implicates any competitive issues because the proposal would ensure the
continued, uninterrupted operation of a consistent mechanism to halt
trading across the U.S. markets while the Commission considers whether
to permanently approve the market-wide circuit breaker mechanism under
Rule 4121. Further, the Exchange understands that FINRA and other
national securities exchanges will file proposals to extend their rules
regarding the market-wide circuit breaker pilot so that the market-wide
circuit breaker mechanism may continue uninterrupted while the
Commission considers whether to approve its operation on a permanent
basis.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \8\ and Rule 19b-
4(f)(6) thereunder.\9\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \10\ normally
does not become operative for 30 days after the date of filing.
However, pursuant to Rule 19b-4(f)(6)(iii),\11\ the Commission may
designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative upon filing. Extending the pilot for an additional
six months will allow the uninterrupted operation of the existing pilot
to halt trading across the U.S. markets while the Commission considers
whether to approve the pilot on a permanent basis. The extension simply
maintains the status quo. Therefore, the Commission believes that
waiving the 30-day operative delay is consistent with the protection of
investors and the public interest. The Commission hereby designates the
proposed rule change to be operative upon filing.\12\
---------------------------------------------------------------------------

    \10\ Id.
    \11\ 17 CFR 240.19b-4(f)(g)(iii).
    \12\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act.

Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-NASDAQ-2019-027 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2019-027. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NASDAQ-2019-027, and should be submitted
on or before May 6, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-07362 Filed 4-12-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 70 (Thursday, April 11, 2013)]
[Notices]
[Pages 21612-21613]
[FR Doc No: 2013-08442]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0916]

Medical Device Classification Product Codes; Guidance for
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Medical Device Classification
Product Codes.'' This document describes how device product codes are
used in a variety of FDA program areas to regulate and track medical
devices regulated by the Center for Devices and Radiological Health
(CDRH) and the Center for Biologics Evaluation and Research (CBER).

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Medical Device Classification Product Codes'' to
the Division of Small Manufacturers, International, and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver
Spring, MD 20993-0002 or the Office of Communication, Outreach and
Development (HFM-40), 1401 Rockville Pike, suite 200N, Rockville, MD
20852. Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to CDRH at<PHONE_NUMBER>.
See the SUPPLEMENTARY INFORMATION section for information on electronic
access to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Diane Garcia, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1644, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17),
Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Since the May 28, 1976, Medical Device Amendments were passed, the
Classification Regulation Panels (parts 862 through 892 (21 CFR parts
862 through 892)) have been the basis for CDRH's Classification Product
Code structure and organization. These 16 Panels have largely been the
driving force for CDRH's internal organizational structure as well.
These Panels were established with the 1976 Medical Device Amendments,
and rulemaking is required in order to add to or modify the Panels.
However, rulemaking has resulted in very few additions or modifications
to the Panels and subgroups since 1976.
    In order to respond to the evolution of device technology,
classification product codes were created to assist in accurate
identification and tracking of current medical devices and to allow for
tracking and easy reference of predicate device types. Classification
product codes are a method of classifying medical devices. CDRH and a
subset of CBER-regulated medical device product codes consist of a
three-letter combination that associates a device's type with a product
classification designated for the application. Classification product
codes and information associated with these devices, such as names and
attributes, are assigned by CDRH to support their regulation.
    The purpose of this guidance document is to educate regulated
industry and FDA Staff on how, when, and why to use classification
product codes for medical devices regulated by CDRH and CBER. This
document describes how classification product codes are used in a
variety of FDA program areas to regulate and track medical devices.
This document is limited to medical devices as defined in section
201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))
and does not discuss classification products codes used to regulate
nonmedical electronic radiation-emitting products.
    The scope of the guidance document includes devices described in
the existing classification under parts 862 through 892. It also
describes how classification product codes are used for CBER regulated
devices, which currently do not fall within this existing
classification. This guidance may be applicable to future devices. It
also covers unclassified devices and devices not yet classified.
    In the Federal Register of January 3, 2012 (77 FR 125), FDA
announced the availability of the draft guidance document. Interested
persons were invited to comment by May 2, 2012. Five comments were
received with multiple recommendations pertaining to the administrative
processes and policies regarding medical device classification product
codes. In response to these comments, FDA revised the guidance document
to clarify the processes and policies as appropriate.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on medical device classification product
codes. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. An alternative approach may
be used if such approach satisfies the requirements of the applicable
statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov or from CBER
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive
``Medical Device Classification Product Codes,'' you may either send an
email request to<EMAIL_ADDRESS>to receive an electronic copy of
the document or send a fax request to<PHONE_NUMBER> to receive a hard
copy. Please use the document number 1774 to identify the guidance you
are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 803, subpart A through E,
have been approved under OMB control number 0910-0437; the collections
of information in 21 CFR part 807, subpart E, have been approved under
OMB control number 0910-0120; and the

collections of information under 21 CFR part 814 have been approved
under OMB control number 0910-0231.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: April 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08442 Filed 4-10-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 166 (Friday, August 26, 2011)]
[Notices]
[Pages 53447-53448]
[FR Doc No: 2011-21784]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13987-000]

Northland Power Mississippi River LLC; Notice of Preliminary
Permit Application Accepted for Filing and Soliciting Comments, Motions
To Intervene, and Competing Applications

    On January 3, 2011, Northland Power Mississippi River LLC filed an
application, pursuant to section 4(f) of the Federal Power Act,
proposing to study the feasibility of hydropower on the Mississippi
River, near the town of North Vacherie, in St. James Parish, Louisiana.
The sole purpose of a preliminary permit, if issued, is to grant the
permit holder priority to file a license application during the permit
term. A preliminary permit does not authorize the permit holder to
perform any land-disturbing activities or otherwise enter upon lands or
waters owned by others without the owners' express permission.
    The proposed NPI 019 hydrokinetic project would consist of the
following: (1) Up to 200 TREK generating units installed in a matrix on
the bottom of the river; (2) the total capacity of the installation
would be up to 50,000 kilowatts; (3) shielded underwater cables would
convey each matrix power

to a substation; and (4) a transmission line would interconnect with
the power grid. The proposed project would have an average annual
generation of 438 gigawatt-hours (GWh), which would be sold to a local
utility.
    Applicant Contact: Tim Richardson, 30 St. Clair Avenue West 17th
Floor, Toronto, Ontario, Canada; phone<PHONE_NUMBER>.
    FERC Contact: Michael Spencer,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>call toll-free at (866) 208-
3676; or, for TTY, contact<PHONE_NUMBER>. Although the Commission
strongly encourages electronic filing, documents may also be paper-
filed. To paper-file, mail an original and seven copies to: Kimberly D.
Bose, Secretary, Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13987-000) in the docket number field to
access the document. For assistance, contact FERC Online Support.

    Dated: August 18, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-21784 Filed 8-25-11; 8:45 am]
BILLING CODE 6717-01-P