[Federal Register Volume 78, Number 113 (Wednesday, June 12, 2013)]
[Notices]
[Pages 35265-35268]
[FR Doc No: 2013-13817]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0014; FRL-9388-6]

Notice of Receipt of Requests To Voluntarily Cancel Certain
Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In accordance with the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA is issuing a notice of receipt of requests
by registrants to voluntarily cancel certain pesticide registrations.
EPA intends to grant these requests at the close of the comment period
for this announcement unless the Agency receives substantive comments
within the comment period that would merit its further review of the
requests, or unless the registrants withdraw its requests. If these
requests are granted, any sale, distribution, or use of products listed
in this notice will be permitted after the registration has been
cancelled only if such sale, distribution, or use is consistent with
the terms as described in the final order.

DATES: Comments must be received on or before December 9, 2013.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0014, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI)

or other information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
    Submit written withdrawal request by mail to: Pesticide Re-
Evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001. ATTN: John W. Pates, Jr.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

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.

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 email. 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?

    This notice announces receipt by the Agency of requests from
registrants to cancel 54 pesticide products registered under FIFRA
section 3 or 24(c). These registrations are listed in sequence by
registration number (or company number and 24(c) number) in Table 1 of
this unit.
    Unless the Agency determines that there are substantive comments
that warrant further review of the requests or the registrants withdraw
their requests, EPA intends to issue an order in the Federal Register
canceling all of the affected registrations.

      Table 1--Registrations With Pending Requests for Cancellation
------------------------------------------------------------------------
    Registration No.           Product name            Chemical name
------------------------------------------------------------------------
000264-00668...........  Liberty ATZ Herbicide..  Atrazine, Glufosinate.
000264-00784...........  Renounce 20WP            Cyfluthrin.
                          Insecticide.
000264-00985...........  GB34 Concentrate         Bacillus pumilus
                          Biological Fungicide.    strain GB34.
000264-00986...........  GB34 Technical           Bacillus pumilus
                          Biological Fungicide.    strain GB34.
000264-01007...........  Decis 0.2 EC...........  Deltamethrin.
000264-01008...........  Decis 0.2 EC Gel.......  Deltamethrin.
000264-01012...........  Decis 1.0 Gel            Deltamethrin.
                          Insecticide.
000264-01117...........  Yield Shield FS 200....  Bacillus pumilus
                                                   strain GB34.
000400-00469...........  Dimilin 25W Mushrooms..  Diflubenzuron.
000400-00470...........  Dimilin 35W for          Diflubenzuron.
                          Pasturegrass
                          Mosquitoes.
000400-00471...........  Micromite 25WS.........  Diflubenzuron.
000400-00511...........  Dimilin 80WGS..........  Diflubenzuron.
000432-00954...........  Finale Super             Glufosinate.
                          Concentrate Weed,
                          Grass and Brush Killer.
000432-00955...........  Finale Ready-To-Use      Glufosinate.
                          Weed and Grass Killer.
000432-00956...........  Finale Concentrate       Glufosinate.
                          Weed, Grass and Brush
                          Killer.
000655-00802...........  Prentox Larva-Lur        Propoxur.
                          Contains Propoxur.
009779-00262...........  MCPA Amine Herbicide...  MCPA, dimethylamine
                                                   salt.
009779-00265...........  MCPA LV Ester..........  MCPA, 2-ethylhexyl
                                                   ester.
053883-00220...........  Oryzalin 2G............  Oryzalin, Benfluralin.
AL-090001..............  Reflex Herbicide.......  Sodium salt of
                                                   fomesafen.
AR-080004..............  Reflex Herbicide.......  Sodium salt of
                                                   fomesafen.
AR-080005..............  Superwham! (Alternate    Propanil.
                          Name Forwham ! EZ).
AR-080006..............  Riceshot...............  Propanil.
AR-080007..............  Ricepro................  Quinclorac, Propanil.
AR-080008..............  Duet...................  Propanil, Bensulfuron-
                                                   methyl.
AR-080009..............  Superwham! (Alternate    Propanil.
                          Name For Wham! EZ).
AR-080013..............  Ricebeaux..............  Propanil, Thiobencarb.
AR-120001..............  Ricebeaux Herbicide....  Thiobencarb, Propanil.

AR-120002..............  Ricebeaux..............  Thiobencarb, Propanil.
AR-120003..............  Ricepro................  Quinclorac, Propanil.
CO-060007..............  Gramoxone Inteon.......  Paraquat dichloride.
FL-090006..............  Knockout...............  Diquat dibromide.
GA-090005..............  Milestone VM...........  Triisopropanolamine
                                                   salt of aminopyralid.
GA-100004..............  Endigo ZC..............  Thiamethoxam lambda-
                                                   Cyhalothrin.
MO-120006..............  V-10142 AG Herbicide...  Imazosulfuron.
ND-020009..............  Bravo 720..............  Chlorothalonil.
OR-010006..............  Cobra Herbicide........  Lactofen.
OR-040015..............  Ethrel Brand Ethephon    Ethephon.
                          Plant Regulator.
OR-040031..............  Rovral 4 Flowable        Iprodione.
                          Fungicide.
OR-050017..............  Simazine 4L............  Simazine.
OR-070002..............  Chateau Herbicide WDG..  Flumioxazin.
OR-070019..............  Acramite-4SC...........  Bifenazate.
OR-070022..............  RTU-Vitavax-Thiram Seed  Thiram, Carboxin.
                          Protectant Fungicide.
OR-070028..............  Define SC Herbicide....  Flufenacet.
OR-070030..............  Define SC Herbicide....  Flufenacet.
OR-080020..............  DuPont Direx 4L          Diuron.
                          Herbicide.
OR-100004..............  Chateau Herbicide WDG..  Flumioxazin.
OR-120009..............  Palisade 2EC...........  Trinexapac-ethyl.
WA-000021..............  Orthene 97 Pellets.....  Acephate.
WA-010038..............  Crossbow...............  2,4-D butoxyethyl
                                                   ester acetic acid
                                                   (3,5,6-trichloro-2-
                                                   pyridinyl) oxy)-,2-
                                                   butoxyethel ester.
WA-020012..............  Echo 720...............  Chlorothalonil.
WA-060017..............  Orthene 97.............  Acephate.
WA-810064..............  Orthene 75 S Soluble     Acephate.
                          Powder.
WA-960024..............  Orthene 75 S Soluble     Acephate.
                          Powder.
------------------------------------------------------------------------

    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 this unit.

         Table 2--Registrants Requesting Voluntary Cancellation
------------------------------------------------------------------------
       EPA Company No.                  Company name and address
------------------------------------------------------------------------
264:
    OR-040015; OR-040022; OR-  Bayer CropScience, LP, 2 T.W. Alexander
     040031; OR-070022; OR-     Dr., P.O. Box 12014, Research Triangle
     070028; OR-070030.         Park, NC 27709.
400:
    OR-070019................  Chemtura Corporation, 199 Benson Rd.,
                                Middlebury, CT 06749.
432..........................  Bayer Environmental Science, A Division
                                of Bayer CropScience, LP, 2 T.W.
                                Alexander Dr., P.O. Box 12014, Research
                                Triangle Park, NC 27709.
655..........................  Prentis, LLC, Agent: Pyxis Regulatory
                                Consulting, Inc., 4110 136th St., NW.,
                                Gig Harbor, WA 98332.
9779:
    OR-080020................  Winfield Solutions, LLC, P.O. Box 64589,
                                St. Paul, MN 55164-058.
53883........................  Control Solutions, Inc., 5903 Genoa Red
                                Bluff, Pasadena, TX 77507-1041.
AL-090001; AR-080004; CO-      Syngenta Crop Protection, LLC, 410 Swing
 060007; FL-090006; GA-         Rd., P.O. Box 18300, Greensboro, NC
 100004; ND-020009; OR-120009.  27419-8300.
AR-080005; AR-080006; AR-      Riceco, LLC, 5100 Poplar Ave., Suite
 080007; AR-080008; AR-         2428, Memphis, TN 38137.
 080009; AR-080013; AR-
 120001; AR-120002; AR-120003.
GA-090005; WA-010038.........  Dow AgroSciences, LLC, 9330 Zionsville
                                Rd., 308/2E, Indianapolis, IN 46268-
                                1054.
MO-120006; OR-100004; OR-      Valent U.S.A. Corporation, 1600 Riviera
 010006; OR-070002.             Ave., Suite 200, Walnut Creek, CA 94596.
OR-050017....................  Loveland Products, P.O. Box 1286,
                                Greeley, CO 80632-1286.
WA-000021; WA-060017; WA-      Amvac Chemical Corporation, 4695
 810064; WA-960024.             MacArthur Ct., Suite 1200, Newport
                                Beach, CA 92660-1706.
WA-020012....................  Sipcam Agro U.S.A., Inc., 2520 Meridian
                                Pkwy., Suite 525, Durham, NC 27713.
------------------------------------------------------------------------

III. 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. FIFRA further provides that, before acting on the request,
EPA must publish a notice of receipt of any such request in the Federal
Register.
    Section 6(f)(1)(B) of FIFRA requires that before acting on a
request for voluntary cancellation, EPA must provide a 30-day public
comment period on the request for voluntary

cancellation or use termination. In addition, FIFRA section 6(f)(1)(C)
requires that EPA provide a 180-day comment period on a request for
voluntary cancellation or termination of any minor agricultural use
before granting the request, unless:
    1. The registrants request a waiver of the comment period, or
    2. The EPA Administrator determines that continued use of the
pesticide would pose an unreasonable adverse effect on the environment.
    The registrants in Table 2 of Unit II., have not requested that EPA
waive the 180-day comment period. Accordingly, EPA will provide a 180-
day comment period on the proposed requests.

IV. Procedures for Withdrawal of Request

    Registrants who choose to withdraw a request for cancellation
should submit such withdrawal in writing to the person listed under FOR
FURTHER INFORMATION CONTACT. If the products have been subject to a
previous cancellation action, the effective date of cancellation and
all other provisions of any earlier cancellation action are
controlling.

V. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
that are currently in the United States and that were packaged,
labeled, and released for shipment prior to the effective date of the
cancellation action. Because the Agency has identified no significant
potential risk concerns associated with these pesticide products, upon
cancellation of the products identified in Table 1 of Unit II., EPA
anticipates allowing registrants to sell and distribute existing stocks
of these products for 1 year after publication of the Cancellation
Order in the Federal Register. Thereafter, registrants will be
prohibited from selling or distributing the pesticides identified in
Table 1 of Unit II., except for export consistent with FIFRA section 17
or for proper disposal. Persons other than registrants will generally
be allowed to sell, distribute, or use existing stocks until such
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: June 4, 2013.
Michael Goodis,
Acting, Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2013-13817 Filed 6-11-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 206 (Friday, October 23, 2020)]
[Notices]
[Pages 67550-67552]
[FR Doc No: 2020-23524]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4212]

Wholesale Distributor Verification Requirement for Saleable
Returned Drug Product and Dispenser Verification Requirements When
Investigating a Suspect or Illegitimate Product--Compliance Policies;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Wholesale
Distributor Verification Requirement for Saleable Returned Drug Product
and Dispenser Verification Requirements When Investigating a Suspect or
Illegitimate Product--Compliance Policies.'' This guidance explains
that FDA intends to extend the delay in enforcement described in the
guidance entitled ``Wholesale Distributor Verification Requirement for
Saleable Returned Drug Product--Compliance Policy,'' published in the
Federal Register on September 24, 2019 (the 2019 Compliance Policy),
which relates to Drug Supply Chain Security Act (DSCSA) provisions
requiring wholesale distributors to verify the product identifier prior
to further distributing returned product beginning on November 27,
2019. In addition, this guidance announces FDA's intended enforcement
policy with respect to DSCSA provisions requiring dispensers to verify
the product identifier for suspect or illegitimate product in the
dispenser's possession or control beginning on November 27, 2020.

DATES: The announcement of the guidance is published in the Federal
Register on October 23, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-4212 for ``Wholesale Distributor Verification Requirement
for Saleable Returned Drug Product and Dispenser Verification
Requirements When Investigating a Suspect or Illegitimate Product--
Compliance Policies.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available

for public viewing and posted on https://www.regulations.gov. Submit
both copies to the Dockets Management Staff. If you do not wish your
name and contact information to be made publicly available, you can
provide this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Sarah Venti, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Wholesale Distributor Verification Requirement for Saleable
Returned Drug Product and Dispenser Verification Requirements When
Investigating a Suspect or Illegitimate Product--Compliance Policies.''
FDA does not intend to take action against wholesale distributors who
do not, prior to November 27, 2023, verify the product identifier prior
to further distributing returned product as required under the DSCSA
(Title II of Pub. L. 113-54). This represents an additional 3-year
delay from the delay set forth in the 2019 Compliance Policy in
enforcement of the requirement for wholesale distributors to verify the
product identifier prior to further distributing that returned product.
In addition, FDA does not intend to take action against dispensers who
do not verify the statutorily-designated portion of product identifiers
of suspect or illegitimate product before November 27, 2023. This
policy represents a 3-year delay in enforcement of the requirements for
dispensers to verify the product identifier when investigating suspect
or illegitimate product.
    This guidance is being issued consistent with FDA's good guidance
practices regulations (21 CFR 10.115). FDA is implementing this
guidance without prior public comment because the Agency has determined
that prior public participation is not feasible or appropriate (21 CFR
10.115(g)(2)). FDA made this determination because this guidance
document provides information pertaining to statutory requirements that
take effect November 27, 2020, for dispensers to verify the product
identifier, including the standardized numerical identifier, for
product in the dispenser's possession or control under section
582(d)(4)(A)(ii)(II) and (d)(4)(B)(iii) of the FD&C Act (21 U.S.C.
360eee-1(d)(4)(A)(ii)(II) and (d)(4)(B)(iii)). It is important that FDA
provide this information before that date. Although this guidance
document is immediately in effect, it remains subject to comment in
accordance with the Agency's good guidance practices (21 CFR
10.115(g)(3)).
    Beginning November 27, 2019, wholesale distributors were required,
under section 582(c)(4)(D) (21 U.S.C. 360eee-1(c)(4)(D)) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act), to verify the product
identifier, including the standardized numerical identifier, on each
sealed homogeneous case of saleable returned product, or, if such
product is not in a sealed homogeneous case, on each package of
saleable returned product, prior to further distributing such returned
product. In the Federal Register published September 24, 2019 (84 FR
50044), FDA issued a notice announcing the availability of the 2019
Compliance Policy. The 2019 Compliance Policy indicated the Agency's
intent to take no enforcement action against wholesale distributors who
are not in compliance with this requirement under section 582(c)(4)(D)
of the FD&C Act before November 27, 2020.
    Since the announcement of the 2019 Compliance Policy, FDA has
received additional comments and feedback from wholesale distributors,
as well as other trading partners and stakeholders, expressing concern
with industry-wide readiness for implementation of the verification of
saleable returned product requirement for wholesale distributors and
the challenges stakeholders face with developing interoperable,
electronic systems to enable such verification and achieve
interoperability between networks. Specifically, comments received
point out continuing challenges posed by the large volume of saleable
returned product, explaining that wholesale distributors still need
more time to test verification systems using real-time volumes of
saleable returned product with all trading partners involved, as
opposed to using small-scale pilot test projects. Additionally,
wholesale distributors point to significant delays in testing these
verification systems due to the competing priority of responding to the
Coronavirus Disease 2019 (COVID-19) pandemic, namely the reassignment
of logistics and supply chain experts from DSCSA matters to COVID-19
pandemic response. Given all these concerns, FDA recognizes that some
wholesale distributors may need additional time beyond November 27,
2020, before they can begin verifying returned products prior to resale
or other further distribution as required by section 582(c)(4)(D) of
the FD&C Act in an efficient, secure, and timely manner.
    To minimize possible disruptions in the distribution of certain
prescription drugs in the United States, FDA has adopted the compliance
policy described in this guidance. Under this compliance policy, FDA
does not intend to take action before November 27, 2023, against
wholesale distributors who do not verify a product identifier prior to
further distribution of a package or sealed homogenous case of product
as required by section 582(c)(4)(D) of the FD&C Act.
    Additionally, section 582 of the FD&C Act requires certain trading
partners (manufacturers, repackagers, wholesale distributors, and
dispensers) to exchange transaction information, transaction history,
and a transaction statement when engaging in transactions involving
certain prescription drugs. Section 581(27)(E) of the FD&C Act (21
U.S.C. 360eee(27)(E)) requires that the transaction statement include a
statement that the entity transferring ownership in a transaction had
systems and processes in place to comply with verification requirements
under section 582 of the FD&C Act. This guidance also

explains that, prior to November 27, 2023, FDA does not intend to take
action against a wholesale distributor for providing a transaction
statement to a subsequent purchaser of product on the basis that such
wholesale distributor does not yet have systems and processes in place
to comply with the saleable return verification requirements under
section 582(c)(4)(D) of the FD&C Act. The guidance explains the scope
of the compliance policy in further detail.
    By extending the delay in enforcement initially provided in the
2019 Compliance Policy until November 27, 2023, FDA believes that
wholesale distributors will be able to focus resources and efforts on
the requirements for the enhanced drug distribution security system,
provided for in section 582(g) of the FD&C Act and required by November
27, 2023. Instead of developing separate processes or infrastructures
solely for the saleable return verification requirement, wholesale
distributors can incorporate the saleable return verification
requirements into enhanced verification required by 2023. Given this
consideration, FDA has not adopted the approach suggested by some
comments suggesting that the Agency revise the 2019 Compliance Policy
to provide for a phased implementation of the saleable return
verification requirements.
    FDA also received comments requesting that we extend the scope of
the 2019 Compliance Policy beyond wholesale distributors to also cover
manufacturers and repackagers, asking FDA to not take enforcement
action where manufacturers and repackagers are not in compliance with
their verification of saleable returned product obligations under
section 582(b)(4)(C) and (e)(4)(C) of the FD&C Act. At this time, we do
not intend to broaden the scope of the 2019 Compliance Policy in this
way because we believe the policies outlined in this guidance will
provide appropriate flexibility. As all trading partners work towards
enhanced system requirements that go into effect in 2023, wholesale
distributors can continue to work with manufacturers and repackagers
for enhanced verification requirements, including those for saleable
returned product. FDA intends to issue additional guidance about the
enhanced system for drug distribution security at a later date.
    Finally, section 582 of the FD&C Act, as amended by the DSCSA, also
established the requirements that specify how dispensers must
investigate suspect and illegitimate product. As part of the
investigation, section 582(d)(4)(A)(ii)(II) of the FD&C Act requires
dispensers to verify the product identifier, including the standardized
numerical identifier, of at least 3 packages or 10 percent of such
suspect product, whichever is greater, or all packages, if there are
fewer than 3, corresponds with the product identifier for such product
in the dispenser's possession or control, beginning November 27, 2020.
Section 582(d)(4)(B)(iii) of the FD&C Act requires dispensers to verify
product as described in section 582(d)(4)(A)(ii), which includes the
section 582(d)(4)(A)(ii)(II) requirement, in response to a notification
of illegitimate product from FDA or a trading partner.
    In response to comments received from stakeholders, this guidance
also announces that FDA does not intend to take action before November
27, 2023, against dispensers who do not verify the statutorily-
designated portion of product identifiers of suspect product as
required by section 582(d)(4)(A)(ii)(II) of the FD&C Act, and that part
of section 582(d)(4)(B)(iii) of the FD&C Act that requires dispensers
to perform the same verification activities of section
582(d)(4)(A)(ii)(II) when responding to a notification of illegitimate
product from FDA or another trading partner. FDA believes that
dispensers can use the 3-year period to ensure the systems and
processes that are put into place to meet the enhanced system
requirements by November 27, 2023, will also fulfill all dispenser
verification requirements under section 582(d)(4) of the FD&C Act.
    This guidance represents the current thinking of FDA on ``Wholesale
Distributor Verification Requirement for Saleable Returned Drug Product
and Dispenser Verification Requirements When Investigating a Suspect or
Illegitimate Product--Compliance Policies.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this guidance contains no collection
of information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: October 19, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23524 Filed 10-22-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 17 (Friday, January 25, 2013)]
[Notices]
[Pages 5527-5529]
[FR Doc No: 2013-01490]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68696; File No. SR-CBOE-2013-005]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change Relating to the BBO Data Feed for CBOE Listed
Options and a BBO Data Feed for Flexible Exchange Options

January 18, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on January 11, 2013, Chicago Board Options Exchange, Incorporated
(the ``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I, II, and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \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 identify certain additional market data
made available by Market Data Express, LLC (``MDX''), an affiliate of
CBOE, as part of the BBO Data Feed for CBOE listed options (``BBO Data
Feed'') and as a separate data feed. The text of the proposed rule
change is available on the Exchange's Web site (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of
the Secretary, and at the Commission.

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

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed

any comments it received on the proposed rule change. The text of these
statements may be examined at the places specified in Item IV below.
The Exchange has prepared summaries, set forth in sections A, B, and C
below, of the most significant aspects of such statements.

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

1. Purpose
    The purpose of the proposed rule change is to reflect MDX's current
practice of making certain additional market data available as part of
the BBO Data Feed \3\ and as a separate data feed.
---------------------------------------------------------------------------

    \3\ The BBO Data Feed and the fees charged by MDX for the BBO
Data Feed were established in March 2011. See Securities Exchange
Act Release No. 63997 (March 1, 2011), 76 FR 12388 (March 7, 2011).
---------------------------------------------------------------------------

    The BBO Data Feed is a real-time, low latency data feed that
includes CBOE ``BBO data'' and last sale data.\4\ The BBO and last sale
data contained in the BBO Data Feed is identical to the data that CBOE
sends to the Options Price Reporting Authority (``OPRA'') for
redistribution to the public.\5\
---------------------------------------------------------------------------

    \4\ The BBO Data Feed includes the ``best bid and offer,'' or
``BBO'', consisting of all outstanding quotes and standing orders at
the best available price level on each side of the market, with
aggregate size (``BBO data,'' sometimes referred to as ``top of book
data''). Data with respect to executed trades is referred to as
``last sale'' data.
    \5\ The Exchange notes that MDX makes available to ``Customers''
the BBO data and last sale data that is included in the BBO Data
Feed no earlier than the time at which the Exchange sends that data
to OPRA. A ``Customer'' is any entity that receives the BBO Data
Feed directly from MDX's system and then distributes it either
internally or externally to Subscribers. A ``Subscriber'' is a
person (other than an employee of a Customer) that receives the BBO
Data Feed from a Customer for its own internal use.
---------------------------------------------------------------------------

    The BBO Data Feed also includes certain data that is not included
in the data sent to OPRA, namely, totals of customer versus non-
customer contracts at the BBO, All-or-None contingency orders priced
better than or equal to the BBO, and BBO data and last sale data for
complex strategies (e.g., spreads, straddles, buy-writes, etc.). MDX
charges Customers a ``direct connect fee'' of $3,500 per connection per
month and a ``per user fee'' of $25 per month per ``Authorized User''
or ``Device'' for receipt of the BBO Data Feed by Subscribers.\6\
Either a CBOE Trading Permit Holder or a non-CBOE Trading Permit Holder
may be a Customer. All Customers are assessed the same fees.
---------------------------------------------------------------------------

    \6\ An ``Authorized User'' is defined as an individual user (an
individual human being) who is uniquely identified (by user ID and
confidential password or other unambiguous method reasonably
acceptable to MDX) and authorized by a Customer to access the BBO
Data Feed supplied by the Customer. A ``Device'' is defined as any
computer, workstation or other item of equipment, fixed or portable,
that receives, accesses and/or displays data in visual, audible or
other form.
---------------------------------------------------------------------------

    MDX currently makes available two additional sets of data as part
of the BBO Data Feed at no additional charge to Customers.
Specifically, the BBO Data Feed also includes (i) BBO data and last
sale data for Flexible Exchange (``FLEX'') options traded on the CBOE
FLEX Hybrid Trading System,\7\ including BBO data and last sale data
for FLEX complex strategies (collectively, ``FLEX BBO data''), and (ii)
expected opening price (``EOP'') and expected opening size (``EOS'')
information that is disseminated prior to the opening of the market and
during trading rotations (collectively, ``EOP/EOS data''). EOP/EOS data
is calculated by the CBOE Hybrid Trading System based on resting orders
in the Book that remain from the prior business day and any orders and
quotes submitted before the opening.\8\ The EOP is the price at which
the greatest number of orders and quotes in the Book are expected to
trade.\9\
---------------------------------------------------------------------------

    \7\ See Chapter 24.B of CBOE Rules.
    \8\ See CBOE Rule 6.2B(a)(ii) (``Hybrid Opening System''). The
Exchange has filed a separate proposed rule change to amend CBOE
Rule 6.2B(a)(ii) to provide that such pre-opening information will
be disseminated to users that have elected to receive such
information and to remove the existing reference to such pre-opening
information being disseminated to market participants (as defined in
CBOE Rules 6.45A and 6.45B). See SR-CBOE-2013-006.
    \9\ Id.
---------------------------------------------------------------------------

    MDX also makes the FLEX BBO data available as a separate data feed
at no charge to any Customer that wishes to subscribe to only that
data. EOP/EOS data is not offered separate from the BBO Data Feed.
1. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the provisions of Section 6 of the Securities Exchange Act of 1934 (the
``Act'') \10\ in general and with Section 6(b)(5) of the Act \11\ in
particular in that it is designed to prevent fraudulent and
manipulative acts and practices, promote just and equitable principles
of trade, to foster cooperation and coordination with persons engaged
in facilitating transactions in securities, to remove impediments to
and perfect the mechanism of a free and open market and a national
market system and, in general, to protect investors and the public
interest, and is not designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(4) and (5). [sic]
---------------------------------------------------------------------------

    In adopting Regulation NMS, the Commission granted self-regulatory
organizations and broker-dealers increased authority and flexibility to
offer new and unique market data to the public. It was believed that
this authority would expand the amount of data available to consumers,
and also spur innovation and competition for the provision of market
data. The Exchange believes that the proposed rule change is in keeping
with those principles by promoting increased transparency through the
dissemination of more useful proprietary data and also by clarifying
its availability to market participants.
    Additionally, the Exchange believes the proposed rule change would
not permit unfair discrimination because the BBO Data Feed, including
FLEX BBO data and EOP/EOS data, and the separate FLEX BBO data feed are
made equally available by MDX to any market participant that wishes to
subscribe to them. The Exchange notes that other exchanges make
information relating to the market opening available to members and
non-members.\12\
---------------------------------------------------------------------------

    \12\ See e.g., Securities Exchange Act Release No. 66967 (May
11, 2012), 77 FR 29440 (May 17, 2012) (SR-PHLX-2012-60); and
Securities Exchange Act Release No. 67720 (August 23, 2012), 77 FR
52769 (August 30, 2012) (SR-NYSEARCA-2012-89). In addition, the
Nasdaq Options Market (``NOM'') disseminates certain pre-opening
order imbalance information every five seconds for a period of time
prior to the open and this information is made available via
subscription. See NOM Chapter VI, Section 8(b)(1) and Chapter XV,
Section 4(e); see also http://www.nasdaqtrader.com/trader.aspx?id=openclose.
---------------------------------------------------------------------------

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. The Exchange believes the
BBO Data Feed, including FLEX BBO data and EOP/EOS data, and the
separate FLEX BBO data feed offered by MDX will help attract new users
and new order flow to the Exchange, thereby improving the Exchange's
ability to compete in the market for options order flow and executions.

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

    The Exchange neither solicited nor received comments on the
proposed rule change.

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

    Because the foregoing proposed rule change does not:
    A. Significantly affect the protection of investors or the public
interest;
    B. Impose any significant burden on competition; and
    C. 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 \13\ and
Rule 19b-4(f)(6) \14\ thereunder.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of this 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.

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-CBOE-2013-005 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2013-005. 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-CBOE-2013-005,
and should be submitted on or before February 15, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-01490 Filed 1-24-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 201 (Monday, October 19, 2015)]
[Rules and Regulations]
[Pages 63090-63091]
[FR Doc No: 2015-26179]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2014-1071; Airspace Docket No. 14-AGL-15]

Revocation of Class D Airspace; Springfield, OH

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: This action removes Class D airspace at Springfield-Beckley
Municipal Airport, Springfield, OH. The closure of the air traffic
control tower has necessitated the need to remove the Class D airspace
area at the airport.

DATES: Effective 0901 UTC, December 10, 2015. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.9Z, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications. For further information, you can
contact the Airspace Policy and ATC Regulations Group, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC, 29591;
telephone:<PHONE_NUMBER>. The order is also available for inspection at
the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Rebecca Shelby, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as removes controlled airspace at Springfield-Beckley Municipal
Airport, Springfield, OH.

History

    On May 29, 2015, the FAA published in the Federal Register a notice
of proposed rulemaking (NPRM) to remove

Class D airspace at Springfield-Beckley Municipal Airport, Springfield,
OH, (80 FR 30632). Interested parties were invited to participate in
this proposed rulemaking effort by submitting written comments on the
proposal to the FAA. No comments were received.
    Class D airspace designations are published in paragraph 5000 of
FAA Order 7400.9Z, dated August 6, 2015, and effective September 15,
2015, which is incorporated by reference in 14 CFR part 71.1. The Class
D airspace designations listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.9Z, airspace Designations and
Reporting Points, dated August 6, 2015, and effective September 15,
2015. FAA Order 7400.9Z is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B,
C, D, and E airspace areas, air traffic service routes, and reporting
points.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by removing Class D airspace at Springfield-Beckley Municipal
Airport, Springfield, OH. The closing of the air traffic control tower
at Springfield-Beckley Municipal Airport has made this action necessary
for the efficient use of airspace within the National Airspace System.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
only affects air traffic procedures and air navigation, it is certified
that this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR part 71.1 of the FAA Order
7400.9Z, Airspace Designations and Reporting Points, dated August 6,
2015, and effective September 15, 2015 is amended as follows:

Paragraph 5000 Class D Airspace Areas Extending Upward From the
Surface of the Earth.

* * * * *

AGL OH D Springfield, OH [Removed]

    Issued in Fort Worth, TX, on October 7, 2015.
Robert W. Beck,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2015-26179 Filed 10-16-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 103 (Friday, May 27, 2011)]
[Notices]
[Pages 30936-30937]
[FR Doc No: 2011-13151]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP11-476-000 ]

 Transwestern Pipeline Company, LLC; Notice of Request Under
Blanket Authorization

    Take notice that on May 9, 2011, Transwestern Pipeline Company, LLC
(Transwestern), 711 Louisiana Street, Suite 900, Houston, TX 77002-
2716, filed in Docket No. CP11-476-000, an application pursuant to
sections 157.203, 157.205 and 157.216 of the Commission's Regulations
under the Natural Gas Act (NGA) as amended, to abandon the 20-inch
Gomez Lateral, and associated ancillary facilities located in Pecos,
Reeves, and Ward Counties, Texas, under Transwestern's blanket
certificate issued in Docket No. CP67-220-000, all as more fully set
forth in the application which is on file with the Commission and open
to public inspection. The filing may also be viewed on the web at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to Kelly
Allen, Manager Certificates and Reporting, Transwestern Pipeline
Company, LLC, 711 Louisiana Street, Suite 900, Houston, TX 77002-2716,
via telephone at<PHONE_NUMBER>, fax<PHONE_NUMBER> or e-mail:
<EMAIL_ADDRESS>or Shemeika Landry, Senior Counsel,
Transwestern Pipeline Company, LLC, 711 Louisiana Street, Suite 900,
Houston, TX 77002-2716, via telephone at<PHONE_NUMBER>, fax (281) 714-
2181 or email<EMAIL_ADDRESS>    Specifically, Transwestern proposes to abandon in place or offer by
sale, approximately 33.4 miles of 20-inch diameter pipeline which
begins at the discharge of the Gomez Processing Plant near the city of
Ft. Stockton in Pecos County, Texas and traverses in a northeasterly
direction to an interconnect with Transwestern's 24-inch West Texas
Lateral near the town of Peyote in Ward County, Texas. As a result of
the sale of the previously attached Gomez Gathering System,
Transwestern asserts that the Gomez Lateral has been rendered
underutilized

and an unnecessary part of its pipeline system.
    Any person or the Commission's staff may, within 60 days after
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and pursuant to Section 157.205 of
the regulations under the NGA (18 CFR 157.205), a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for filing a protest. If a protest is filed and
not withdrawn within 30 days after the allowed time for filing a
protest, the instant request shall be treated as an application for
authorization pursuant to Section 7 of the NGA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenter's will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenter's will not be required to serve copies of filed
documents on all other parties. However, the non-party commentary, will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 7 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.

    Dated: May 20, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-13151 Filed 5-26-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 118 (Thursday, June 18, 2020)]
[Notices]
[Pages 36918-36921]
[FR Doc No: 2020-13118]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89058; File No. SR-CBOE-2020-051]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Filing of a Proposed Rule Change To Amend Its Automated Price
Improvement Auction Rules in Connection With Agency Order Size
Requirements

June 12, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 11, 2020, Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe
Options'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the 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

    Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe Options'') proposes
to amend its automated price improvement auction rules in connection
with Agency Order size requirements. The text of the proposed rule
change is provided in Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend Rule 5.37(a)(3) and Rule 5.38(a)(8)
to allow the Exchange to determine maximum size requirements for Agency
Orders in SPX submitted though the Automated Price Improvement
Mechanism (``AIM'' or ``AIM Auction'') and the Complex Automated Price
Improvement Mechanism (``C-AIM'' or ``C-AIM Auction'').
    Currently, Rules 5.37(a)(3) and 5.38(a)(3), which govern the size
requirements for AIM and C-AIM Agency and Initiating Orders, provide
that there is no minimum size for orders submitted into AIM and C-AIM
Auctions, respectively, and that the Initiating Order must be for the
same size as the Agency Order. As such, an Agency Order of any size \3\
may currently be submitted in an AIM or C-AIM Auction.
---------------------------------------------------------------------------

    \3\ The proposed rule change indicates the maximum size may be
up to 100 contracts.
---------------------------------------------------------------------------

    The Exchange now proposes to amend Rule 5.37(a)(3) to provide that
the Exchange may determine a maximum size requirement for Agency Orders
in SPX, and by amending Rule 5.38(a)(3) to provide that the Exchange
may determine a maximum size requirement for the smallest leg of an
Agency Order in SPX.\4\ The Exchange believes that the proposed
flexibility to allow the Exchange to determine to limit the size of SPX
Agency Orders submitted in an AIM or C-AIM Auction will allow the
Exchange to appropriately address the specific trading characteristics,
market model, and investor basis of SPX. The Exchange notes that the
maximum size requirement for Agency Orders in SPX would apply to all
Agency Orders in the entire SPX class (including SPX Weeklys
(``SPXW'')).
---------------------------------------------------------------------------

    \4\ Application of the maximum size to the smallest leg of
complex orders is consistent with the application of a size
requirement for the Exchange's Complex Solicitation Auction
Mechanism, which is a similar price improvement auction mechanism on
the Exchange. See Rule 5.40(a)(3).
---------------------------------------------------------------------------

    In particular, SPX has a different and more complicated market
model,

involves taking on greater risk, has a significantly higher notional
value (e.g., they are ten times the notional size of SPY options),
tends to trade in much larger size, and tends to execute increasingly
more complex strategies (e.g., SPX Combo orders) than in other options
classes. The Exchange understands these factors may limit retail
customer participation in SPX to simpler strategies and smaller-sized
orders. These factors also have contributed to the Exchange's
historical determination to not activate AIM in SPX when the floor is
open so to encourage liquidity on the trading floor to accommodate
these large and complex trades. Therefore, the Exchange believes the
application of an Agency Order size ceiling may provide more price
improvement opportunities in SPX geared towards retail customers. The
Exchange believes this may incentivize increased retail customer
auction participation in SPX and provide retail customers with
execution and price improvement opportunities in SPX while
incentivizing continued liquidity on the trading floor for larger and
more complex orders.
    The Exchange has observed that increased smaller size order flow
tends to attract Market-Maker responses, as such orders are generally
easier to hedge than larger orders, which may encourage Market-Makers
to compete to provide price improvement in an electronic competitive
auction process. This, in turn, may contribute to a deeper, more liquid
auction process with additional price improvement opportunities for
market participants, and particularly retail customers. The Exchange
notes, too, that the Exchange's trading floor may be better suited for
crosses in SPX with more complex orders, complicated strategies and
larger size. Such orders are more generally executed on the trading
floor, where Trading Permit Holders (``TPHs'') may negotiate and fine-
tune the terms of a trade. In addition to this, the trading crowd in
open outcry may provide markets that are more tailored to the
complexity and size of orders typically submitted in SPX. Greater
execution and price improvement opportunities for SPX orders may result
from the markets given by the trading crowd that better define the
nuanced complexity and size of such orders than if the same orders were
submitted via AIM or C-AIM--which, instead, may provide greater price
improvement opportunities for simpler and smaller orders. Permitting
the Exchange to determine a maximum size for SPX orders submitted to
AIM and C-AIM will enable the Exchange to activate AIM and C-AIM in SPX
to provide additional price improvement opportunities for smaller
orders and maintain liquidity on the trading floor for larger complex
orders, thus creating a liquid hybrid environment for orders in this
class.
    In a sample of SPX orders submitted into simple AIM during a week
of trading in April 2020,\5\ the Exchange observed that orders
containing quantities from one to ten contracts submitted through AIM
received an average price improvement of approximately $0.34 over their
limit prices, orders containing quantities from 11 to 50 contracts
received an average price improvement of approximately $0.22, and
orders for 51 to 100 contracts received an average price improvement of
$0.08; whereas, orders containing quantities of between 100 and 250
contracts received an average of $0.08 and orders containing quantities
of between 251 and 500 received an average of $0.15. That is
approximately 325% larger average price improvement that orders for one
to ten contracts received than orders for 100 to 250 contracts and
approximately 127% larger average price improvement than orders for 251
to 500 contracts. The Exchange also observed this trend generally in
the sample of SPX orders submitted to C-AIM, as well, where greater
price improvement generally occurred for smaller sized orders as
compared to larger sized orders. For C-AIM, the Exchange observed that
orders for one to ten contracts received an average price improvement
of $0.14, for 11 to 50 contracts received an average of $1.69, and for
51 to 100 contracts received an average of $2.36; whereas orders for
100 to 250 contracts received an average price improvement of $1.15 and
orders for 251 to 500 contracts received an average of $0.24. As this
data demonstrates, price improvement on smaller orders in SPX, a class
which generally exhibits more complicated trading characteristics and
complex market factors, is generally more beneficial than price
improvement on larger orders submitted through AIM and C-AIM.\6\ As a
result, if the Exchange is able to implement a maximum size requirement
for SPX as proposed, it may determine to activate AIM when the trading
floor is open. The Exchange believes this could incentive the
submission of smaller size SPX orders to the Exchange. As a result, the
Exchange believes the proposed rule change will provide retail
customers with additional price improvement opportunities for retail
customers overall when the trading floor is open while preserving
liquidity available in the market, particularly on the trading floor,
for larger and more complicated orders.
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    \5\ The sample was taken for average price improvement over the
limit price of Agency Orders submitted into AIM and C-AIM from April
6 through April 9.
    \6\ The proposed rule change to designate a maximum ``maximum
size'' of 100 is based on this data, which demonstrates that orders
with size up to 100 contracts generally receive the most beneficial
price improvement (and are generally considered to be ``retail''
sized orders).
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    Finally, pursuant to current Rule 5.37.02 and Rule 5.38.02, it is
deemed conduct inconsistent with just and equitable principles of trade
and a violation of Exchange Rule 8.1 to engage in a pattern of conduct
where the Initiating Member breaks up an Agency Order into separate
orders for the purpose of gaining a higher allocation percentage than
the Initiating TPH would have otherwise received in accordance with the
allocation procedures contained in the AIM and C-AIM Rules,
respectively. In light of the proposed rule change, the Exchange also
proposes to amend Rules 5.37.02 and 5.38.02 to make it clear that
Initiating TPHs also may not break up an Agency Order into separate
orders for the purpose of circumventing a maximum quantity requirement
as determined by the Exchange pursuant to subparagraph(s) (a)(3). The
Exchange notes that its surveillance program will monitor for such
violations in the same manner in which it currently monitors for
allocation-related break up violations.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\7\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \8\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest.

Additionally, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \9\ requirement that the rules of
an exchange not be designed to permit unfair discrimination between
customers, issuers, brokers, or dealers.
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    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
    \9\ Id.
---------------------------------------------------------------------------

    In particular, the Exchange believes the proposed rule change to
allow the Exchange to determine a maximum size for AIM and C-AIM Agency
Orders in SPX will provide the Exchange with the flexibility to
activate AIM and C-AIM Auctions for SPX in a manner the Exchange
believes will appropriately address the different trading
characteristics, market model, investor basis and conditions presented
in SPX as compared to different option classes. The Exchange has
considered these factors in its determination to not activate AIM and
C-AIM in SPX when operating in a normal hybrid trading environment.
With the proposed rule change, the Exchange would consider activating
AIM and C-AIM in SPX when the trading floor is open to provide
additional execution and price improvement opportunities to retail
customers. The Exchange believes this may encourage an increase
smaller-sized SPX orders and meaningful and competitive responses to
the auctions, as applicable, which ultimately benefits investors and
retail customers in particular.
    The Exchange acknowledges that price improvement auctions have
provided the market with benefits, such as providing an efficient
manner of access to liquidity for customers. However, the options
industry overall has observed that quoted liquidity on the book has
decreased, quotes have widened, and options market makers have reduced
their participation in the market, which has impacted market
quality.\10\ Thus, the Exchange believes that the flexibility to impose
a maximum order size for these auctions would permit the Exchange to
provide retail customers in SPX with access to these auctions while
continuing to create incentives for SPX Market-Makers to continue to
provide liquidity in the in the trading crowd for larger and more
complex orders. As such, the Exchange believes the proposed rule change
may encourage a general increase in retail order flow and execution
opportunities in AIM and C-AIM Auctions in SPX, thus enhancing the
quality of the auctions, while maintaining market quality and liquidity
for larger and more complicated orders, which removes impediments to
and perfects the mechanism of a free and open market and a national
market system, and benefits the entire market and all investors.
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    \10\ See Letter to Brett Redfearn, Director, Division of Trading
& Markets, from Cboe Global Markets, Inc. the Listed Options Trading
Committee of the Securities Industry and Financial Markets
Association (``SIFMA''), and the Listed Options Committee of the
Security Traders Association (``STA''), dated June 4, 2018,
available at http://cdn.batstrading.com/resources/comment_letters/Cboe-Joint-Letter-with-SIFMA-and-The-STA-on-Options-Market-Structure.pdf.
---------------------------------------------------------------------------

    In addition to this, the Exchange does not believe that the
proposed rule change would significantly impact TPHs that submit larger
and more complicated orders in SPX because the trading floor is
generally better suited and more appropriate for such orders, where
TPHs tend to execute much larger and more complex orders given the
flexibility to negotiate and fine-tune the terms of an order.\11\ As
discussed above, the Exchange believes not permitting these larger
orders to execute in AIM and C-AIM auctions will create incentives for
Market-Makers to continue to provide on the trading floor to execute
against those orders. Additionally, given that the Exchange does not
generally activate AIM and C-AIM in SPX, the proposed rule change will
have no impact on larger orders, which TPHs are unable to submit into
AIM and C-AIM Auctions when the trading floor is open. In addition, the
Exchange believes that the proposed rule change to amend Rules 5.37.02
and 5.38.02 would protect investors by prohibiting TPHs to break up
Agency Orders to circumvent maximum size requirements.
---------------------------------------------------------------------------

    \11\ This is demonstrated by the significant decrease in complex
order execution while the Exchange has operated in an all-electronic
environment.
---------------------------------------------------------------------------

    The Exchange does not believe that the purpose of the proposed rule
change to accommodate retail customers is new or unique, as the
Exchange and other options exchanges currently have rules, such as
certain reduced fees and market structure benefits, in place that
provide preferential treatment to or are geared toward benefitting
retail customers particularly. Moreover, the Exchange believes that the
proposed rule change is consistent with longstanding precedent, thus
indicating that it is consistent with the Act, to provide reasonable
incentives to retail investors that rely on the public markets for
their investment needs. Indeed, the Commission has long stressed the
need to ensure that the markets are structured in a way that meets the
needs of ordinary investors.\12\ The Exchange believes that the
proposed rule change would assist the Exchange in achieving the
Commission's stated goal of improving the retail investor experience in
the public markets while protecting overall market quality.
---------------------------------------------------------------------------

    \12\ See e.g. U.S. Securities and Exchange Commission, Strategic
Plan, Fiscal Years 2018-2022, available at https://www.sec.gov/files/SEC_Strategic_Plan_FY18-FY22_FINAL_0.pdf, wherein the
Commission's strategic plan for fiscal years 2018-2022 touts ``focus
on the long-term interests of our Main Street investors'' as the
Commission's number one strategic goal.
---------------------------------------------------------------------------

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. The Exchange does not
believe the proposed rule change will impose any burden on intramarket
competition that is not necessary or appropriate in furtherance of the
purposes of the Act, because it will apply to all Agency Orders in SPX
where the Exchange imposes a maximum size submitted into the AIM and C-
AIM auctions by all market participants. The Exchange believes having
the ability to designate a maximum size for SPX orders only is
appropriate given the trading characteristics, market model, investor
base, and large notional value of SPX options compared to other
options. The Exchange believes all market participants in SPX may
benefit from any additional liquidity and price improvement in the AIM
and C-AIM Auctions that may result from the proposed rule change.
Moreover, the Exchange believes that determination of a maximum
quantity in SPX would not significantly affect TPHs that submit larger
and more complicated orders as open outcry auctions are generally
better suited to facilitating liquidity for larger order size and/or
more complex order strategies. The Exchange notes it generally does not
activate AIM and C-AIM in SPX options, so the proposed rule change
would have no impact on larger-sized SPX orders that currently are not
permitted to be submitted into AIM and C-AIM auctions when the Exchange
is operating in a normal hybrid trading environment. The Exchange
believes not permitting larger orders into these auctions will
encourage Market-Makers to continue to provide liquidity in the trading
crowd while providing retail customers with price improvement
opportunities, which may increase competition for these orders. As
stated above, the Exchange believes the proposed rule change is
consistent with the Commission's goal and industry practice to provide
reasonable incentives to retail investors that rely on

the public markets for their investment needs. The Exchange also notes
the proposed rule change has no impact on the allocation or priority of
orders and responses at the conclusion of AIM and C-AIM auctions.
Additionally, any Agency Order for less than 50 contracts must continue
to have an auction price that improves the then-current NBBO.
    The Exchange does not believe the proposed rule change will impose
any burden on intermarket competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as the proposed
rule change relates to an Exchange-specific auction mechanism in a
class of options only listed for trading on the Exchange. The Exchange
also notes that other options exchanges offer similar price improvement
auctions \13\ that are available to market participants, and other
options exchanges may, in their discretion, adopt similar flexibility
in connection with their auctions.
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    \13\ See e.g., BOX Options' Price Improvement Period (``PIP'')
available at https://boxoptions.com/about/price-improvement; and
Complex Order Price Improvement Period (``COPIP'') available at
https://boxoptions.com/about/complex-order-description/; and MIAX
Options' Price Improvement Mechanism (``PRIME'') and Complex Price
Improvement Mechanism (``cPRIME'') available at https://www.miaxoptions.com/sites/default/files/knowledge-center/2017-07/MIAX_PRIME_07212017.pdf.
---------------------------------------------------------------------------

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

    The Exchange neither solicited nor received 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 up to 90 days (i) as the
Commission may designate 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 will:
    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-CBOE-2020-051 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-CBOE-2020-051. 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-CBOE-2020-051, and should be submitted
on or before July 9, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

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

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-13118 Filed 6-17-20; 8:45 am]
BILLING CODE 8011-01-P