[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16212-16214]
[FR Doc No: 2022-06031]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0236]

Prioritizing the Addition of Maximum Daily Exposure Information
and Removing Dosage Form Information From the Inactive Ingredient
Database; Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
announcing the establishment of a docket to solicit comments that will
assist the Agency in determining how best to prioritize the addition of
maximum daily exposure (MDE) information for inactive ingredients that
do not currently include MDE information in the Center for Drug
Evaluation and Research's Inactive Ingredient Database (IID) and
whether to restructure the IID by removing dosage form information.

DATES: Submit either electronic or written comments on the notice by
June 21, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 21, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

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-2022-N-0236 for ``Prioritizing the Addition of Maximum Daily
Exposure Information and Removing Dosage Form Information From the
Inactive Ingredient Database; Establishment of a Public Docket; Request
for Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), 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,<PHONE_NUMBER>.
     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>.

FOR FURTHER INFORMATION CONTACT: Susan Zuk, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 6684, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The IID provides information on inactive ingredients in FDA-
approved drug products.\1\ An inactive ingredient, or excipient, is any
component of a drug product other than an active ingredient (21 CFR
210.3(b)(8) and 314.3(b)). Generally, the IID identifies excipients
that appear in approved drug products for a particular dosage form and
route of administration. This information in the IID has been used by
all segments of industry as an aid in developing new drug products,
including new generic drug products. For example, excipients used in
drug products submitted in an abbreviated new drug application are
required to be safe at the levels proposed and under the conditions
prescribed, recommended, or suggested in the labeling proposed for the
drug (see sections 505(j)(4)(H)(i) and (ii) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(j)(4)(H)(i) and (ii))). The IID
provides evidence that a particular excipient was previously permitted
by FDA in specific levels, routes of administration, and dosage forms
in FDA-approved products. FDA may consult the IID when performing
regulatory filing reviews and technical reviews of applications as part
of an evaluation of whether the proposed levels of excipients in drug
product formulations are acceptable or require additional documentation
to support their use.
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    \1\ For more information on the IID, see the draft guidance for
industry entitled ``Using the Inactive Ingredient Database'' (July
2019). When final, this guidance will represent FDA's current
thinking on this topic. For the most recent version of a guidance,
check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
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    FDA made certain enhancements to the IID in 2020 consistent with
the Generic Drug User Fee Amendments (GDUFA) Reauthorization
Performance Goals and Program Enhancements Fiscal Years 2018-2022
(GDUFA II commitment letter).\2\ One of these enhancements permits
users to perform electronic queries to obtain accurate maximum daily
intake (MDI) and MDE information for each route of administration for
which data are available. MDE is defined as the total amount of the
excipient that would be taken in a day based on the maximum daily dose
of the drug products in which it is used. MDE can also be referred to
as MDI for oral drug products. FDA has steadily increased the number of
excipient records that display MDE with each publication of the IID,\3\
but not all excipients in the IID have MDE information. The inclusion
of such information could enhance the ability of applicants to
reference IID information in support of proposed levels of excipients
in their drug products. In meetings with FDA, stakeholders have asked
about FDA's plan to prioritize the addition of MDE information and have
suggested that FDA focus on specific excipients that the stakeholders
consider to be of high priority.
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    \2\ See the GDUFA II commitment letter, p.17, at https://www.fda.gov/media/101052/download.
    \3\ The IID is updated on a quarterly basis at https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm.
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    Further, some stakeholders have expressed that the numerous records
in the IID for each excipient can be confusing. Each IID record
includes the excipient, its route of administration, and its dosage
form. An excipient search can yield a lengthy list of dosage forms for
each route of administration, which could make finding the most
appropriate IID record to reference challenging. Some stakeholders have
suggested that FDA could remove dosage form information from the IID to
simplify searches. We believe such an approach would be consistent with
the GDUFA II commitment letter, which describes upgrades to the IID to
provide excipient MDE information associated with particular routes of
administration. However, we recognize that some stakeholders may find
the IID's dosage form information helpful for drug product development.
For example, applicants may refer to this information to confirm that
FDA has approved drug products in certain dosage forms that contain an
excipient at a particular level. For these applicants, removal of
dosage form information from the IID could hinder their drug
development program.

II. Other Issues for Consideration

    FDA is considering how best to prioritize the addition of MDE
information and plans to target those excipients deemed to be high
priority by various stakeholders. Under such a plan, individual
excipients could be designated for prioritization from those currently
listed in the IID without MDE information. Alternatively, priority
excipients could be designated based on a category of drug products in
which they are used (e.g., excipients used in oral or topical
products), and then FDA would prioritize adding MDE information for
those excipients included in that category of drug products. FDA
intends to develop a priority list based on feedback to this Federal
Register notice. FDA will consider those excipients that are a high
priority for multiple stakeholders and will also consider stakeholders'
rationale for inclusion of specific excipients in developing the
priority list. FDA is also considering how to post information about
recent updates to the IID based on efforts related to this Federal
Register notice.
    FDA intends also to explore the feasibility of modifying the IID
structure to eliminate dosage form information if feedback to this
Federal Register notice indicates that such action would benefit drug
developers and other stakeholders.
    Interested persons are invited to provide detailed comments on all
aspects described in this notice. To facilitate this input, FDA has
developed the following list of questions. These questions are not
meant to be exhaustive, and FDA is also interested in other pertinent
information

stakeholders would like to share on this topic. In all cases, FDA
encourages stakeholders to provide the specific rationale and basis for
their comments, including available supporting information.
    1. Should FDA focus on adding MDE information for certain
excipients? If so, which excipients should be prioritized for inclusion
of MDE information and why?
    2. Should FDA focus on prioritizing excipients used in certain
categories of drug products (e.g., oral or topical products)? If so,
which categories and which specific excipients used in those categories
should be prioritized and why?
    3. Is dosage form information in the IID helpful to your drug
development program? If so, please explain how dosage form information
in the IID is used in your drug development program.
    4. Is the current structure or format of the IID difficult to
navigate? If so, how can it be improved?

    Dated: March 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-06031 Filed 3-21-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 93 (Wednesday, May 14, 2014)]
[Notices]
[Pages 27628-27630]
[FR Doc No: 2014-10976]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2014-0094]

Collection of Information Under Review by Office of Management
and Budget

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding Information Collection Requests (ICRs),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting approval of an
extension to the following collection of information: 1625-0062,
Approval of Alterations to Marine Portable Tanks; Approval of Non-
Specification Portable Tanks. Review and comments by OIRA ensure we
only impose paperwork burdens commensurate with our performance of
duties.

DATES: Comments must reach the Coast Guard and OIRA on or before June
13, 2014.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2014-0094] to the Docket Management Facility (DMF) at the
U.S. Department of Transportation (DOT) and/or to OIRA. To avoid
duplicate submissions, please use only one of the following means:
    (1) Online: (a) To Coast Guard docket at http://www.regulations.gov. (b) To

OIRA by email via<EMAIL_ADDRESS>    (2) Mail: (a) DMF (M-30), DOT, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001. (b) To
OIRA, 725 17th Street NW., Washington, DC 20503, attention Desk Officer
for the Coast Guard.
    (3) Hand Delivery: To DMF address above, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The telephone number is
202-366-9329.
    (4) Fax: (a) To DMF,<PHONE_NUMBER>. (b) To OIRA at<PHONE_NUMBER>. To
ensure your comments are received in a timely manner, mark the fax,
attention Desk Officer for the Coast Guard.
    The DMF maintains the public docket for this Notice. Comments and
material received from the public, as well as documents mentioned in
this Notice as being available in the docket, will become part of the
docket and will be available for inspection or copying at room W12-140
on the West Building Ground Floor, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. You may also find the docket on the Internet
at http://www.regulations.gov.
    Copies of the ICRs are available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
Commandant (CG-612), Attn: Paperwork Reduction Act Manager, U.S. Coast
Guard, 2703 Martin Luther King Jr Ave. SE., Stop 7710, Washington, DC
20593-7710.

FOR FURTHER INFORMATION CONTACT: Contact Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER> or fax<PHONE_NUMBER>, for
questions on these documents. Contact Ms. Cheryl Collins, Program
Manager, Docket Operations,<PHONE_NUMBER>, for questions on the docket.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collections. There is
one ICR for each Collection.
    The Coast Guard invites comments on whether these ICRs should be
granted based on the Collections being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collections; (2) the accuracy of the estimated burden of the
Collections; (3) ways to enhance the quality, utility, and clarity of
information subject to the Collections; and (4) ways to minimize the
burden of the Collections on respondents, including the use of
automated collection techniques or other forms of information
technology. These comments will help OIRA determine whether to approve
the ICRs referred to in this Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG 2014-0094], and must be received by June 13,
2014. We will post all comments received, without change, to http://www.regulations.gov. They will include any personal information you
provide. We have an agreement with DOT to use their DMF. Please see the
``Privacy Act'' paragraph below.

Submitting Comments

    If you submit a comment, please include the docket number [USCG-
2014-0094]; indicate the specific section of the document to which each
comment applies, providing a reason for each comment. You may submit
your comments and material online (via http://www.regulations.gov), by
fax, mail, or hand delivery, but please use only one of these means. If
you submit a comment online via www.regulations.gov, it will be
considered received by the Coast Guard when you successfully transmit
the comment. If you fax, hand deliver, or mail your comment, it will be
considered as having been received by the Coast Guard when it is
received at the DMF. We recommend you include your name, mailing
address, an email address, or other contact information in the body of
your document so that we can contact you if we have questions regarding
your submission.
    You may submit comments and material by electronic means, mail,
fax, or delivery to the DMF at the address under ADDRESSES, but please
submit them by only one means. To submit your comment online, go to
http://www.regulations.gov, and type ``USCG-2014-0094'' in the
``Search'' box. If you submit your comments by mail or hand delivery,
submit them in an unbound format, no larger than 8\1/2\ by 11 inches,
suitable for copying and electronic filing. If you submit comments by
mail and would like to know that they reached the Facility, please
enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and will address them accordingly.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this Notice as
being available in the docket, go to http://www.regulations.gov, click
on the ``read comments'' box, which will then become highlighted in
blue. In the ``Search'' box insert ``USCG-2014-0094'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
You may also visit the DMF in Room W12-140 on the ground floor of the
DOT West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.
    OIRA posts its decisions on ICRs online at http://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice
of Action on each ICR will become available via a hyperlink in the OMB
Control Numbers: 1625-0062.

Privacy Act

    Anyone can search the electronic form of comments received in
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act statement
regarding Coast Guard public dockets in the January 17, 2008, issue of
the Federal Register (73 FR 3316).

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard published the 60-day notice (79 FR 16020, March 24, 2014)
required by 44 U.S.C. 3506(c)(2). That Notice elicited no comments.

Information Collection Request

    1. Title: Approval of Alterations to Marine Portable Tanks;
Approval of Non-Specification Portable Tanks.
    OMB Control Number: 1625-0062.
    Type of Request: Extension of a currently approved collection.
    Respondents: Owners of marine portable tanks and owners/designers
of non-specification portable tanks.

    Abstract: The information will be used to evaluate the safety of
proposed alterations to marine portable tanks (MPTs) and non-
specification portable tank designs used to transfer hazardous
materials during offshore operations, e.g., drilling rigs. Respondents
will be those who wish to alter existing MPTs or use non-specification
portable tanks.
    Forms: None.
    Burden Estimate: The estimated burden remains unchanged at 18 hours
a year.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: May 3, 2014.
R.E. Day,
Rear Admiral, U.S. Coast Guard, Assistant Commandant for Command,
Control, Communications, Computers and Information Technology.
[FR Doc. 2014-10976 Filed 5-13-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 87, Number 108 (Monday, June 6, 2022)]
[Notices]
[Pages 34259-34261]
[FR Doc No: 2022-12053]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14655-002]

Cat Creek Energy, LLC; Notice of Intent To File License
Application, Filing of Pre-Application Document (Pad), Commencement of
ILP Pre-Filing Process, Request for Comments on the Pad and Scoping
Document, Identification of Issues and Associated Study Requests, and
Virtual Public Scoping Meetings and Virtual Environmental Site Reviews

    a. Type of Filing: Notice of Intent to File License Application for
an Original License, Commencing Pre-filing Process, and Denial of
Request to Use the Traditional Licensing Process.
    b. Project No.: 14655-002.
    c. Dated Filed: January 3, 2022.
    d. Submitted By: Cat Creek Energy, LLC (CCE).
    e. Name of Project: Cat Creek Energy and Water Storage Project (Cat
Creek Project).
    f. Location: On the south side of U.S. Bureau of Reclamation's
(Reclamation) Anderson Ranch Reservoir on the South Fork Boise River
approximately 25 miles northeast of Mountain Home in Elmore County,
Idaho. The project would be located primarily on private land but would
also include some federal lands owned and/or administered by
Reclamation, the U.S. Forest Service, the Bureau of Land Management,
and Bonneville Power Administration.
    g. Filed Pursuant to: 18 CFR part 5 of the Commission's
regulations.
    h. Applicant Contact: Mr. James Carkulis, Cat Creek Energy, LLC,
398 S 9th Street, Suite 240, Boise, Idaho 83702; phone:<PHONE_NUMBER>.
    i. FERC Contact: Michael Tust,<PHONE_NUMBER>,
[email protected].
    j. CCE filed its Pre-Application Document (PAD) and request to use
the Traditional Licensing Process (TLP) on

January 3, 2022. CCE published public notice of its Notice of Intent to
file a license application, PAD, and request to use the TLP on January
12, 2022; however, the notice did not indicate a deadline for
stakeholders to submit comments to the Commission. At the direction of
Commission staff, CCE again published its notice on January 26, 2022,
which included a deadline of February 25, 2022, for submitting comments
to the Commission. After reviewing comments submitted by stakeholders,
Commission staff denied CCE's request to use the TLP on April 1, 2022.
CCE must use the Integrated Licensing Process to prepare a license
application for the Cat Creek Project.
    k. Cooperating agencies: Federal, state, local, and tribal agencies
with jurisdiction and/or special expertise with respect to
environmental issues that wish to cooperate in the preparation of the
environmental document should follow the instructions for filing such
requests described in item o below. Cooperating agencies should note
the Commission's policy that agencies that cooperate in the preparation
of the environmental document cannot also intervene. See 94 FERC ]
61,076 (2001).
    l. With this notice, we are initiating informal consultation with:
(a) The U.S. Fish and Wildlife Service and/or NOAA Fisheries under
section 7 of the Endangered Species Act and the joint agency
regulations thereunder at 50 CFR part 402; and (b) the Idaho State
Historic Preservation Officer, as required by section 106, National
Historic Preservation Act, and the implementing regulations of the
Advisory Council on Historic Preservation at 36 CFR 800.2.
    m. With this notice, we are designating CCE as the Commission's
non-federal representative for carrying out informal consultation,
pursuant to section 7 of the Endangered Species Act, and section 106 of
the National Historic Preservation Act.
    n. A copy of the PAD is available for review on the Commission's
website (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. At this time, the Commission has
suspended access to the Commission's Public Reference Room, due to the
proclamation declaring a National Emergency concerning the Novel
Coronavirus Disease (COVID-19) pandemic, issued by the President on
March 13, 2020. For assistance, contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY). A copy is also available via the contact in paragraph h.
    You may register online at https://ferconline.ferc.gov/FERCOnline.aspx to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    o. With this notice, we are soliciting comments on the PAD and
Commission staff's Scoping Document 1 (SD1), as well as study requests.
All comments on the PAD and SD1, and study requests should be sent to
the address above in paragraph h. In addition, all comments on the PAD
and SD1, study requests, requests for cooperating agency status, and
all communications to and from Commission staff related to the merits
of the potential application must be filed with the Commission.
    The Commission strongly encourages electronic filing. Please file
documents using the Commission's eFiling system at https://ferconline.ferc.gov/FERCOnline.aspx. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at https://ferconline.ferc.gov/QuickComment.aspx. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online. In lieu of
electronic filing, you may submit a paper copy. Submissions sent via
the U.S. Postal Service must be addressed to: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Room 1A, Washington, DC 20426. Submissions sent via any other carrier
must be addressed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852.
All filings must clearly identify the project name and docket number on
the first page: Cat Creek Energy and Water Storage Project (P-14655-
002).
    All filings with the Commission must bear the appropriate heading:
``Comments on Pre-Application Document,'' ``Study Requests,''
``Comments on Scoping Document 1,'' ``Request for Cooperating Agency
Status,'' or ``Communications to and from Commission Staff.'' Any
individual or entity interested in submitting study requests,
commenting on the PAD or SD1, and any agency requesting cooperating
status must do so by July 30, 2022.
    p. Scoping Process.
    The Commission's scoping process will help determine the required
level of analysis and satisfy the NEPA scoping requirements,
irrespective of whether the Commission prepares an environmental
assessment or Environmental Impact Statement. Due to ongoing concerns
with large gatherings related to COVID-19, we do not intend to hold in-
person public scoping meetings or an in-person environmental site
review. Rather, we will hold virtual public scoping meetings and
virtual environmental site reviews.

Virtual Scoping Meetings

    Commission staff will hold two virtual public scoping meetings via
teleconference. An evening meeting will focus on receiving input from
the public and a daytime meeting will focus on concerns of resource
agencies, Native American tribes, and non-governmental organizations
(NGO). We invite all interested agencies, Native American tribes, NGOs,
and the public to attend one or both of these meetings to assist us in
identifying the scope of environmental issues that should be analyzed
in the NEPA document. The dates and times of the virtual scoping
meetings are listed below.

Evening Meeting for the General Public

Wednesday, June 15, 2022, 7:00 p.m.-9:00 p.m. Mountain Daylight Time
(MDT), Call in number:<PHONE_NUMBER>, Participant passcode: 3472916

    Following entry of the access code, please provide the required
details when prompted.

Daytime Meeting for Resource Agencies, Tribes, and NGOs

Thursday, June 16, 2022, 10:00 a.m.-12:00 p.m. MDT, Call in number:
800-779-8625, Participant passcode: 3472916

    Following entry of the access code, please provide the required
details when prompted.
    Scoping Document 1 (SD1), which outlines the subject areas to be
addressed in the environmental document, was mailed to the individuals
and entities on the Commission's mailing list and CCE's PAD
distribution list. Copies of SD1 may be viewed on the web at http://www.ferc.gov, using the ``eLibrary'' link. Follow the directions for
accessing information in paragraph n. Based on all oral and written
comments, a Scoping Document 2 (SD2) may be issued. SD2 may include a
revised process plan and schedule, as well as a list of issues,
identified through the scoping process.

Virtual Environmental Site Reviews

    CCE and Commission staff will hold two virtual environmental site
reviews of the Cat Creek Project prior to each of the virtual scoping
meetings. The virtual site reviews will be held on Wednesday

June 15, 2022, starting at 6:00 p.m. MDT, and on Thursday June 16,
2022, starting at 9:00 a.m. MDT Please contact CCE at<PHONE_NUMBER>, or
[email protected] by Friday June 10, 2022, if you plan to attend one or
both of the environmental site reviews. Directions for accessing the
virtual site reviews will be provided by CCE staff once attendance is
confirmed.

Meeting Objectives

    At the scoping meetings, Commission staff will: (1) initiate
scoping of the issues; (2) review and discuss existing conditions; (3)
review and discuss existing information and identify preliminary
information and study needs; (4) review and discuss the process plan
and schedule for pre-filing activity that incorporates the time frames
provided for in Part 5 of the Commission's regulations and, to the
extent possible, maximizes coordination of federal, state, and tribal
permitting and certification processes; and (5) discuss the potential
of any federal or state agency or Native American tribe to act as a
cooperating agency for development of an environmental document.
Meeting participants should come prepared to discuss their issues and/
or concerns. Please review CCE's PAD in preparation for the scoping
meetings. Directions on how to obtain a copy of the PAD and SD1 are
included in item n of this document.

Meeting Procedures

    Commission staff will be moderating the scoping meetings. The
meetings will begin promptly at their respective start times listed
above. At the start of the meeting, staff will provide further
instructions regarding the meeting setup, agenda, and how participants
can provide their comments and questions during the meeting. The
scoping meetings will be recorded by a court reporter, and all
statements will become part of the Commission's public record for the
project. Oral comments will initially be limited to 5 minutes in
duration. Interested parties who choose not to speak or who are unable
to attend the scoping meetings may provide written comments and
information to the Commission using the instructions provided in item
o.
    Please note, that if no participants join the meetings within 30
minutes after the start time, staff will end the meeting and conference
call. The meetings will end after participants have presented their
oral comments or at the specified end time (listed above), whichever
occurs first.

    Dated: May 31, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-12053 Filed 6-3-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 184 (Friday, September 21, 2018)]
[Notices]
[Pages 47923-47924]
[FR Doc No: 2018-20571]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3160]

Joint Meeting of the Psychopharmacologic Drugs Advisory Committee
and the Drug Safety and Risk Management Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Psychopharmacologic Drugs
Advisory Committee and the Drug Safety and Risk Management Advisory
Committee. The general function of the committees is to provide advice
and recommendations to FDA on regulatory issues. The meeting will be
open to the public. FDA is establishing a docket for public comment on
this document.

DATES: The meeting will be held on November 1, 2018, from 8 a.m. to 5
p.m.

ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993. Answers to commonly asked questions
including information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2018-N-3160. The docket will close on October
31, 2018. Submit either electronic or written comments on this public
meeting by October 31, 2018. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before October 31, 2018. The https://www.regulations.gov
electronic filing system will accept comments until midnight Eastern
Time at the end of October 31, 2018. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
    Comments received on or before October 18, 2018, will be provided
to the committees. Comments received after that date will be taken into
consideration by FDA. You may submit comments 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-2018-N-3160 for ``Joint Meeting of the Psychopharmacologic Drugs
Advisory Committee and the Drug Safety and Risk Management Advisory
Committee; Notice of Meeting; Establishment of a Public Docket; Request
for Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), 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.
     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.'' FDA 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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax:<PHONE_NUMBER>, email: [email protected], or FDA
Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in
the Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The committees will discuss the efficacy, safety, and risk-
benefit profile of new drug application (NDA) 210417 for buprenorphine
and samidorphan sublingual tablets, submitted by Alkermes, Inc., for
adjunctive treatment of major depressive disorder.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committees.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before October 18, 2018, will be provided to the
committees. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before October 10, 2018. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by October 11, 2018.
    Persons attending FDA's advisory committee meetings are advised
that FDA is not responsible for providing access to electrical outlets.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require special accommodations due to a
disability, please contact Kalyani Bhatt (see FOR FURTHER INFORMATION
CONTACT) at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: September 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20571 Filed 9-20-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 100 (Tuesday, May 24, 2016)]
[Notices]
[Page 32749]
[FR Doc No: 2016-12212]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR16-16-000]

Rangeland RIO Pipeline, LLC; Notice of Petition for Declaratory
Order

    Take notice that on May 11, 2016, pursuant to Rule 207(a)(2) of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedure, 18 CFR 385.207(a)(2) (2015), Rangeland RIO Pipeline, LLC
(Rangeland), filed a petition for a declaratory order approving
priority and non-priority service, overall rate structure, and terms of
service as more fully set out in the petition, for the 109-mile RIO
Pipeline project, to provide interstate and intrastate crude oil and
condensate gathering and transportation service to serve producers,
marketers, and refiners transport crude oil and condensate from the
Delaware Basin production area to a terminus in Midland, Texas, all as
more fully explained in the petition.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    The Commission encourages electronic submission of 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 5 copies of the protest or intervention to theFederal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on June 1, 2016.

    Dated: May 16, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-12212 Filed 5-23-16; 8:45 am]
BILLING CODE 6717-01-P


1Although some 8 hour ozone nonattainment areas have additional areas beyond the boundary of the former 1 hour nonattainment area and thus would be faced with new requirements for the higher classification. 8/ 1/ 05 8 hr O3 NAAQS implementation rule   phase 2 Voluntary bump up language inserted into RFP section ( in italics)

The requirements for RFP under subparts 1 and 2, as described above, are the minimum required for an area. More reductions may be necessary for attainment within the nonattainment area. Moreover, an upwind area that contributes to nonattainment in a downwind area in the same State may need more reductions in a shorter time in order for the downwind area to reach attainment by its required attainment date. Although we believe most 8 hour nonattainment areas will attain the standard by their statutory attainment date, we recognize that some areas classified under subpart 2 may need additional time beyond the statutory attainment date for their area to attain as expediously as practicable. As discussed in the Phase 1 Rule ( 69 FR at 23959, col. 3), in the event an area cannot practicably attain by the maximum date for its classification, the Clean Air Act provides the opportunity for more time. An area regulated under subpart 2 can receive a later maximum attainment date through a State request to bump up to a higher classification ( e. g. from moderate to serious). The Act requires EPA to grant a State request to reclassify an area to a higher classification; the State plan still must provide for attainment as expeditiously as practicable. Although bump up means that certain additional specified requirements apply, an area may already be meeting most or all of these specified requirements due to controls previously adopted to implement the 1 hour ozone standard. This is because some areas had 1 hour classifications that were higher ( and more restrictive) than the areas' 8 hour classification, 1 and because the Phase 1 final implementation rule for the 8 hour O3 NAAQS contains anti backsliding provisions generally requiring areas to continue implementating measures required for the 1 hour classification. Although there may not be additional mandatory control measures required because the areas may already have such measures in place, an area that needs more time to attain may need additional emission reductions to reach attainment. These reductions may be achieved through implementation of measures that are necessary to demonstrate RFP requirements or additional reductions beyond RFP may be needed. Preliminary analyses indicate that already required control measures ( e. g., motor vehicle and nonroad engine rules, CAIR, etc.) may largely or fully fulfill reasonable further progress requirements for many areas and that they will provide substantial progress toward attainment for most areas.


 Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for GS-omega/kappa-Hxtx-Hv1a

                                Docket ID Number: EPA-HQ-OPP-2012-0389                                               Date: December 20, 2013

Section 408(c)(2)(A)(i) of FFDCA allows the EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if the EPA determines that the exemption is "safe." Section 408(c)(2)(A)(ii) of FFDCA defines "safe" to mean that "there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information." This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, the EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require the EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance exemption, and to "ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue...." Additionally, FFDCA section 408(b)(2)(D) requires that the EPA consider "available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity."

The EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, the EPA determines the toxicity of pesticides. Second, the EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

I. Summary of Petitioned-for Tolerance Exemption

In the Federal Register of July 25, 2012 (77 FR 43562) (FRL-9353-6), the EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 2F8014) by Vestaron Corporation, 4717 Campus Drive, Ste. 1200, Kalamazoo, MI 49008. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of GS-omega/kappa-Hxtx-Hv1a. The notice referenced a summary of the petition prepared by the petitioner, Vestaron Corporation, which is available in Docket ID Number EPA-HQ-OPP-2012-0389 via http://www.regulations.gov.

II. Toxicological Profile

Consistent with section 408(b)(2)(D) of FFDCA, the EPA reviewed the available scientific data and other relevant information on GS-omega/kappa-Hxtx-Hv1a, and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. The EPA also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

A.  Overview of GS-omega/kappa-Hxtx-Hv1a

The active ingredient GS-omega/kappa-Hxtx-Hv1 (Versitude(TM) peptide) acts as an insecticide for use on specified ornamental plants, turf and edible crops against cabbage looper. GS-omega/kappa-Hxtx-Hv1 (Versitude(TM) peptide) functions primarily as a central nervous system inhibitor in insects, and is intended for use in the suppression of cabbage looper.  The end use product, VST-006330 EP, is mixed with water and applied as a foliar spray with ground or aerial pesticide equipment, and it can be used in either the field or greenhouse for the suppression of cabbage looper.

GS-omega/kappa-Hxtx-Hv1a, is a peptide derived from one of the toxicologically active components of Australian funnel spider (Hadronyche versuta) venom.  It is a large molecule made up of a chain of 41 amino acids which will be produced in and isolated from yeast.  Its surface is covered in hydrophilic residues, making it highly soluble in water, but insoluble in ethanol.  The active ingredient GS-omega/kappa-Hxtx-Hv1 acts as an insecticide for use on labeled ornamental plants, turf and edible crops against cabbage looper.  GS-omega/kappa-Hxtx-Hv1 functions primarily as a central nervous system inhibitor in insects, and is intended for use in the suppression of cabbage looper.  Acute toxicity data support the registrants' claim that GS-omega/kappa-Hxtx-Hv1a acts specifically on insects and not on mammals.

B.  Biochemical / Microbial Pesticide Toxicology Data Requirements

All applicable mammalian toxicology data requirements supporting the request for an exemption from the requirement of a tolerance for residues of GS-omega/kappa-Hxtx-Hv1a in or on all food commodities have been fulfilled with data submitted by the petitioner or data waiver requests that have been granted by the EPA.

The toxicity tests (acute oral, dermal, and inhalation toxicity) and irritation tests (acute eye and primary dermal irritation) that address potential routes of exposure to the active ingredient are all classified in Toxicity Category IV (see below or Ref. 1), with the exception of mild skin irritation (Category III), and revealed little to no toxicity attributed to GS-omega/kappa-Hxtx-Hv1a. Finally, the petitioner reported that no hypersensitivity incidents occurred during the research, development, and testing of this active ingredient.

The overall conclusions from all toxicological information submitted by the petitioner are briefly described below, and more in-depth synopses of study results can be found in the associated draft Biopesticides Registration Action Document (BRAD) for GS-omega-kappa-Hxtx-Hv1a, provided as a reference in Section VII of this document (Ref. 1).

1. Acute oral toxicity  -  rat (Harmonized Guideline 870.1100; Master Record Identification Number (MRID No. 487790-07)). An acceptable acute oral toxicity study demonstrated that GS-omega/kappa-Hxtx-Hv1a was not toxic to female rats when dosed at 5,000 milligrams per kilogram (mg/kg) of body weight. The oral median lethal dose (LD50), which is a statistically derived single dose that can be expected to cause death in 50% of test animals, was greater than 5,000 mg/kg for female rats (Toxicity Category IV) (Ref. 2).

2. Acute oral toxicity/pathogenicity (Harmonized Guideline 885.3050; MRID No. 487790-19). Upon consideration of results of other definitive toxicological data submitted by the petitioner, the EPA waived acute oral toxicity/pathogenicity testing for GS-omega/kappa-Hxtx-Hv1a. The acute oral toxicity/pathogenicity study was not required because products containing GS-omega/kappa-Hxtx-Hv1 are purified. The production of this peptide in a yeast does not present a hazard of infectivity or pathogenicity from the yeast itself based on information provided in the product analysis and manufacturing process.  The final product presents no infectivity or pathogenicity hazard since the yeast is inactivated (or killed) during the purification process to yield the final peptide product.   An acute oral toxicity study conducted on female rats (MRID No. 487790-07) demonstrated that GS-omega/kappa-Hxtx-Hv1a was not toxic (LD50 greater than 5,000 mg/kg; Toxicity Category IV). In addition, the yeast used to produce the peptide is not pathogenic, the yeast is removed during the manufacturing process, and samples monitored for microbial contamination have been negative. The EPA believes these data, when taken together, indicate that this peptide would not be toxic, infective, and/or pathogenic through the oral route of exposure and that further testing is not necessary (Ref. 2).

3. Acute inhalation toxicity  -  rat (Harmonized Guideline 870.1300; MRID No. 487790-09). An acceptable acute inhalation toxicity study demonstrated that GS-omega/kappa-Hxtx-Hv1a was not toxic to male and female rats when exposed to 2.05 milligrams per liter (mg/L). The inhalation median lethal concentration (LC50), which is a statistically derived concentration that can be expected to cause death in 50% of test animals, was greater than 2.05 mg/L for female rats, male rats, and both female and male rats combined (Toxicity Category IV) (Ref. 2).

4. Acute pulmonary toxicity/pathogenicity (Harmonized Guideline 885.3150; MRID No. 487790-19). Upon consideration of results of other definitive toxicological data submitted by the petitioner, the EPA waived acute pulmonary toxicity/pathogenicity testing for GS-omega/kappa-Hxtx-Hv1a because products containing GS-omega/kappa-Hxtx-Hv1 are purified  and do not contain yeast. An acute inhalation toxicity study conducted on rats (MRID No. 487790-09) demonstrated that GS-omega/kappa-Hxtx-Hv1a was not toxic (LC50 greater than 2.05 mg/L; Toxicity Category IV). In addition, the yeast used to produce the peptide is not pathogenic, the yeast is removed during the manufacturing process, and samples monitored for microbial contamination have been negative. The EPA believes these data, when taken together, indicate that this peptide would not be toxic, infective, and/or pathogenic through the inhalation route of exposure and that further testing is not necessary (Ref. 2).   5. Acute injection toxicity/pathogenicity (intravenous)  -  rat (Harmonized Guideline 885.3200; MRID No. 487790-19). Upon consideration of results of other definitive toxicological data submitted by the petitioner, the EPA waived acute injection toxicity/pathogenicity testing for GS-omega/kappa-Hxtx-Hv1a because products containing GS-omega/kappa-Hxtx-Hv1 are purified and do not contain yeast. GS-omega/kappa-Hxtx-Hv1a peptide is low in acute toxicity. The acute oral, dermal and inhalation toxicity studies conducted on GS-omega/kappa-Hxtx-Hv1a peptide all reported no deaths at the limit dose. In addition, the yeast used to produce the peptide is not pathogenic, the yeast is removed during the manufacturing process, and samples monitored for microbial contamination have been negative. (Ref. 2).

6. Hypersensitivity incidents (Harmonized Guideline 885.3400; MRID No. 487790-19). The petitioner reported that no hypersensitivity incidents, including immediate-type or delayed-type reactions of humans and domestic animals, occurred during research, development, or testing of GS-omega/kappa-Hxtx-Hv1a (Ref. 2).   7. Acute dermal toxicity  -  rat (Harmonized Guideline 870.1200; MRID No. 487790-08). An acceptable acute dermal toxicity study demonstrated that GS-omega/kappa-Hxtx-Hv1a was not toxic to male and female rats when dosed at 5,000 mg/kg of body weight for 24 hours. The dermal LD50 was greater than 5,000 mg/kg for female and male rats (Toxicity Category IV) (Ref. 2).   8. Primary dermal irritation  - rabbit (Harmonized Guideline 870.2500; MRID No. 487790-11). An acceptable primary dermal irritation study demonstrated that GS-omega/kappa-Hxtx-Hv1a was a moderate irritant to the skin of rabbits (Toxicity Category III) (Ref. 2).

9. Primary dermal sensitization  -  guinea pig (Harmonized Guideline 870.2600; MRID No. 487790-12). An acceptable primary dermal sensitization study demonstrated GS-omega/kappa-Hxtx-Hv1a to be a non-sensitizing agent (Toxicity Category IV) (Ref. 2).

10. Acute eye irritation  -  rabbit (Harmonized Guideline 870.2400; MRID No. 487790-10). An acceptable eye irritation study demonstrated that GS-omega/kappa-Hxtx-Hv1a was minimally irritating to the eyes of rabbits.  No corneal opacity or iritis was observed in any treated eye during this study.  However, one hour after test substance instillation, two treated eyes exhibited `positive' conjunctivitis.  All animals were free of ocular irritation by 48 hours (Toxicity Category IV) (Ref. 2).

III.  Aggregate Exposure

In examining aggregate exposure, FFDCA section 408 directs the EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

Food Exposure: Exposure to residues of GS-omega/kappa-Hxtx-Hv1a, a 41 amino acid peptide derived from one of the toxicologically active components of Australian funnel spider (Hadronyche versuta) venom and isolated from yeast (Ref. 3), in consumed food is possible.  GS-omega/kappa-Hxtx-Hv1a may be applied foliarly to edible plants, turf and ornamentals. Since GS-omega/kappa-Hxtx-Hv1a is applied as a foliar insecticide to crops, it is possible that edible food commodities may retain residues of GS-omega/kappa-Hxtx-Hv1a. Further, treated crops could be diverted for food or feed purposes; therefore, exposure to GS-omega/kappa-Hxtx-Hv1a in this situation is also plausible. Regardless of the scenario, should GS-omega/kappa-Hxtx-Hv1a be present on food, supporting toxicological data and product analysis data indicate that no toxicity, pathogenicity, and/or infectivity is likely to occur with any food exposure resulting from the use of GS-omega/kappa-Hxtx-Hv1a as a pesticide when applied in accordance with label directions and good agricultural practices (see additional discussion in Section II of this document).

Drinking Water Exposure: Like consumed food, exposure to residues of GS-omega/kappa-Hxtx-Hv1a, a 41 amino acid peptide, in consumed drinking water is anticipated to be possible but negligible. However, GS-omega/kappa-Hxtx-Hv1a interacts specifically with the insect nervous system and does not interact with vertebrate systems.  The submitted and reviewed acute oral data suggest GS-omega/kappa-Hxtx-Hv1a is not toxic via the oral route (> 5,000 mg/kg).  Submitted literature studies on surrogate peptide compounds indicate lack of bioavailability by mammals via the oral route (MRID 48779019).  Based on the low toxicity profile of the compound and low bioavailability, exposure to this compound from treated food or residues in water is not of concern.

Other Non-occupational Exposure: Based on the lack of acute toxicity and pathogenicity, residential exposure to GS-omega/kappa-Hxtx-Hv1a is not expected to pose undue risk provided the product is applied or used in accordance with label directions.  In addition, potential handler exposure is reduced through the requirement of personal protection equipment (PPE) on the label, including long-sleeved shirt and long pants, waterproof gloves and shoes plus socks.

IV.  Cumulative Effects from Substances with a Common Mechanism of Toxicity

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the EPA consider "available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity."

The EPA has not found GS-omega/kappa-Hxtx-Hv1a to share a common mechanism of toxicity with any other substances, and GS-omega/kappa-Hxtx-Hv1a does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, the EPA has assumed that GS-omega/kappa-Hxtx-Hv1a does not have a common mechanism of toxicity with other substances. Following from this, therefore, the EPA concludes that there are no cumulative effects associated with GS-omega/kappa-Hxtx-Hv1a that need to be considered. For information regarding the EPA's efforts to determine chemicals that have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the EPA's website at http://www.epa.gov/pesticides/cumulative.

V.  Determination of Safety for the United States Population, Infants and Children

FFDCA section 408(b)(2)(C) provides that, in considering the establishment of a tolerance or tolerance exemption for a pesticide chemical residue, the EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) provides that the EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure, unless the EPA determines that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor. In applying this provision, the EPA either retains the default value of 10X, or uses a different additional or no safety factor when reliable data are available to support a different additional or no safety factor.

Based on the acute toxicity and product analysis data discussed in Section II of this document, the EPA concludes that there are no threshold effects of concern to infants, children, or adults when GS-omega/kappa-Hxtx-Hv1a is applied or used in accordance with label directions and good agricultural practices.. As a result, the EPA concludes that no additional margin of exposure (safety) is necessary.

Moreover, based on the same data and the EPA analysis as presented directly above, the Agency concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to the residues of GS-omega/kappa-Hxtx-Hv1a in or on all food commodities when applied or used in accordance with label directions and good agricultural practices.  Such exposure includes all anticipated dietary exposures and all other exposures for which there is reliable information. The EPA has arrived at this conclusion because, considered collectively, the data and information available on GS-omega/kappa-Hxtx-Hv1a do not demonstrate toxic, pathogenic, and/or infective potential to mammals, including infants and children.

VI.  Conclusions

The EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of GS-omega/kappa-Hxtx-Hv1a. Therefore, an exemption from the requirement of a tolerance is established for residues of GS-omega/kappa-Hxtx-Hv1a in or on all food commodities when applied or used in accordance with label directions and good agricultural practices.

VII.  References

1.  Draft Biopesticides Registration Action Document (BRAD) for GS-omega/kappa-Hxtx-Hv1a

2. U.S. EPA.  2013a  "GS-omega/kappa-Hxtx-Hv1a:  Qualitative Human Health Assessment." Memorandum from E . Reaves, Ph.D. and P. Shah, Ph.D. dated December 6, 2013.

3.  U.S. EPA.  2013b. "Product characterization of Versitude(TM) peptide consisting of 30% GS-omega/kappa-Hxtx-Hv1a." Memorandum from J. Gagliardi, Ph.D. to S. Cerrelli dated September 11, 2013.


[Federal Register Volume 84, Number 34 (Wednesday, February 20, 2019)]
[Notices]
[Pages 5126-5129]
[FR Doc No: 2019-02741]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85123; File No. SR-CboeBZX-2019-006]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Amend
the BZX Fee Schedule as It Relates to Pricing for the Use of Certain
Routing Strategies

February 13, 2019.
    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 February 1, 2019, Cboe BZX Exchange, Inc. (the ``Exchange'' or
``BZX'') 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

    Cboe BZX Exchange, Inc. (``BZX'' or the ``Exchange'') is filing
with the Securities and Exchange Commission (the ``Commission'') a
proposed rule change to amend the fee schedule applicable to the BZX
equities trading platform (``BZX Equities'') as it relates to pricing
for the use of certain routing strategies. The text of the proposed
rule change is attached [sic] as Exhibit 5.
    The text of the proposed rule change is also available on the
Exchange's website (http://markets.cboe.com/us/equities/regulation/rule_filings/bzx/), 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 purpose of the proposed rule change is to amend the BZX
Equities fee schedule to change the pricing applicable to orders routed
using the SLIM routing strategy in connection with planned changes to
the System routing table.\3\ SLIM is a routing strategy offered by the
Exchange that is used to target certain low cost protected market
centers by routing to those venues after accessing available liquidity
on the BZX Book, and prior to routing to other trading centers included
in the System routing table. The Exchange periodically changes the low
cost venues targeted by the SLIM routing strategy to ensure that the
venues prioritized for routing can be accessed at a low cost.
Currently, four exchanges are included in the System routing table as
low cost protected market centers: Cboe BYX Exchange, Inc. (``BYX''),
Cboe EDGA Exchange, Inc. (``EDGA''), Nasdaq BX, Inc. (``BX''), and New
York Stock Exchange LLC (``NYSE''). Pursuant to Rule 11.13(b)(3), the
Exchange has determined to modify System routing table such that NYSE
would no longer be listed as a low cost protected market center where
orders are first routed after seeking available liquidity on the BZX
Book. In addition, the Exchange has decided to add NYSE American LLC
(``NYSE American'') and NYSE National, Inc. (``NYSE National'') as low
cost protected market centers. These changes to the System routing
table are scheduled to be introduced on February 1, 2019.
---------------------------------------------------------------------------

    \3\ The term ``System routing table'' refers to the proprietary
process for determining the specific trading venues to which the
System routes orders and the order in which it routes them. See Rule
11.13(b)(3). The Exchange reserves the right to maintain a different
System routing table for different routing options and to modify the
System routing table at any time without notice. Id.
---------------------------------------------------------------------------

    Currently, orders routed using the SLIM routing strategy are
charged a fee of $0.00260 per share, except when routed to BYX or
NYSE.\4\ Orders routed to BYX using the SLIM routing strategy are
provided a rebate of $0.00150 per share,\5\ and orders routed to NYSE
using this routing strategy are charged a fee of $0.00280 per share.\6\
The Exchange proposes a number of changes to these fees in connection
with the changes to the routing table for SLIM.
---------------------------------------------------------------------------

    \4\ See Cboe BZX U.S. Equities Exchange Fee Schedule, fee code
``SX.''
    \5\ See Cboe BZX U.S. Equities Exchange Fee Schedule, fee code
``BY.''
    \6\ See Cboe BZX U.S. Equities Exchange Fee Schedule, fee code
``D.''
---------------------------------------------------------------------------

    First, in recognition of the fact that EDGA and BX can be accessed
at a low cost today, the Exchange proposes to provide a rebate to
orders routed to these exchanges using the SLIM routing strategy. As
proposed, the rebate would be $0.00240 per share for orders routed to
EDGA, and $0.00100 for orders routed to BX. The rebates are consistent
with rebates currently offered for orders routed to EDGA and BX using
the TRIM or TRIM2 routing strategies, which yield fee codes ``BJ'' and
``TV,'' respectively. To effect the proposed change, the Exchange would
therefore add SLIM to the list of routing strategies that yield fee
code BJ and TV when routed to EDGA or BX. In addition, the fee schedule
currently provides that the rebates offered pursuant to fee codes BJ
and TV are applicable to eligible orders in all securities. EDGA and
BX, however, do not provide rebates to orders that remove liquidity in
securities priced below $1.00.\7\ As such, the Exchange proposes to
amend the pricing for orders routed to these exchanges pursuant to fee
codes BJ and TV, such that no charge or rebate would be provided in
securities priced below $1.00.
---------------------------------------------------------------------------

    \7\ Orders that remove liquidity on EDGA for Tapes A, B, and C
are neither charged a fee nor provided a rebate in securities priced
below $1.00. See Cboe EDGA U.S. Equities Exchange Fee Schedule, fee
codes ``BB,'' ``N,'' ``W.'' Orders that remove liquidity on Nasdaq
BX in such securities are charged a fee equal to 0.10% of the total
transaction cost. See Nasdaq BX Rulebook, Equity 7, Section 118(b).
---------------------------------------------------------------------------

    Second, the Exchange proposes to add two new fee codes, MX and NX,
that relate to orders routed to NYSE American and NYSE National,
respectively, using the SLIM routing strategy. Orders routed using the
SLIM routing strategy would be charged a fee of $0.00020 per share if
executed on NYSE American. If executed on NYSE National, those orders
would be provided a rebate of $0.00200 per share in securities priced
at or above $1.00, and no charge or rebate would be applied for
securities priced below $1.00. The proposed fees and rebates chosen for
routing to these venues generally reflect the current transaction fees
and rebates available for accessing liquidity on those markets.\8\
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    \8\ NYSE American currently charges a fee for removing liquidity
that is $0.00020 per share in securities priced at or above $1.00,
and 0.25% of the total dollar value of the transaction in securities
priced below $1.00. See NYSE American Equities Price List, I.
Transaction Fees.
    NYSE National currently provides a rebate of $0.00200 per share
in securities priced at or above $1.00 for members that achieve
their taking tier. See NYSE National Schedule of Fees and Rebates,
I. Transaction Fees, B. Tiered Rates. Orders that remove liquidity
in securities below $1.00 are executed without charge or rebate. See
NYSE National, Schedule of Fees and Rebates, I. Transaction Fees, A.
General Rates.
---------------------------------------------------------------------------

    Third, since the Exchange would now charge a low fee or pay a
rebate for routing to all low cost protected market centers using the
SLIM routing strategy, the Exchange proposes to increase the default
fee charged to orders routed using the SLIM routing strategy to
$0.00290 per share. This routing fee, designated under fee code SX,
would apply to all orders routed using the SLIM routing strategy,
except when routed to BX, BYX, EDGA, NYSE American, or NYSE National.
Since NYSE would no longer be included as a low cost protected market
center, the Exchange proposes to eliminate special pricing for orders
routed to NYSE using the SLIM routing strategy under fee code D. Such
orders would now pay the default routing fee for orders routed using
this routing strategy, as described above.
    Finally, the Exchange proposes to charge no fee and provide no
rebate in securities priced below $1.00 for liquidity providing orders
routed to The Nasdaq Stock Market LLC (``Nasdaq'') using the ROOC
routing strategy. Currently, these orders would be eligible for a
$0.00150 rebate pursuant to fee code ``RN.'' \9\ The Exchange is
proposing to provide free executions instead as Nasdaq charges a fee
instead of providing a rebate for securities priced below $1.00.\10\
---------------------------------------------------------------------------

    \9\ See Cboe BZX U.S. Equities Exchange Fee Schedule, fee code
``RN.''
    \10\ Nasdaq's standard fee is equal to 0.3% of the total
transaction cost for orders in securities priced at less than $1.00.
See Nasdaq Rulebook, Equity 7, Section 118(b).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6 of the Act,\11\ in general, and furthers the
requirements of Section 6(b)(4),\12\ in particular, as it is designed
to provide for the equitable allocation of reasonable dues, fees and
other charges among its members and other persons using its facilities.
The Exchange believes the proposed routing fee changes are appropriate
as they reflect changes to the System routing table used to determine
the order in which venues are accessed using the SLIM routing strategy.
SLIM specifically targets certain equities exchanges that provide cheap
executions or rebates to liquidity removing orders, and routes to those
venues after trading with the BZX Book, and prior to accessing
liquidity

that may be available on other venues on the System routing table. The
Exchange believes that the proposed changes reflect the intent of
members when they submit routable order flow to the Exchange using the
SLIM routing strategy.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f.
    \12\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that it is reasonable and equitable to begin
rebating orders routed to EDGA and BX using the SLIM routing strategy.
Although the Exchange does not offer special pricing when routing to
those markets using the SLIM routing strategy today, the Exchange does
offer such incentives when routing to those markets using certain other
routing strategies, including TRIM or TRIM2. As is the case for orders
routed to EDGA and BX using those routing strategies, the proposed
rebates applicable to the SLIM routing strategy are designed to reflect
incentives offered to liquidity taking orders on these two venues,
which operating using taker/maker pricing models that offer rebates to
remove liquidity.
    The Exchange also believes that it is reasonable and equitable to
provide free executions, rather than rebates, for orders routed to EDGA
and BX using the TRIM, TRIM2, or SLIM routing strategies in securities
priced below $1.00. Although EDGA and BX both generally provide rebates
to orders that remove liquidity, as described above, those rebates are
limited to securities priced at or above $1.00.\13\ For orders that
remove liquidity in securities priced below $1.00, EDGA charges no fee
and provides no rebate, while BX instead charges a fee.\14\ With the
proposed changes to the routing fees, the Exchange would recoup some,
but not all, of the cost associated with routing orders in lower priced
securities to these markets on behalf of members that use the TRIM,
TRIM2, or SLIM routing strategies.
---------------------------------------------------------------------------

    \13\ See supra note 7.
    \14\ Id.
---------------------------------------------------------------------------

    Similarly, the Exchange believes that it is reasonable and
equitable to provide special pricing for orders routed to NYSE American
and NYSE National using the SLIM routing strategy. As mentioned
previously, the Exchange is adding these two exchanges to its list of
low cost protected market centers, and wishes to provide the benefit of
the rebate or lower fee provided by those markets to BZX members using
the SLIM routing strategy. The Exchange believes that these changes may
increase interest in the Exchange's SLIM routing strategy, in
particular, by passing on better pricing to BZX members that choose to
enter such orders on the Exchange, thereby encouraging additional order
flow to be entered to the BZX Book.
    The rebates provided to orders routed to NYSE National using the
SLIM routing strategy would be limited to order price at or above $1.00
in light of the fact that NYSE National does not provide rebates to
liquidity removing orders in securities priced below $1.00. For
securities priced below $1.00, the Exchange would charge no fee and
provide no rebate, which is equivalent to pricing on NYSE National.\15\
Without limiting the proposed rebate for NYSE National to securities
priced at or above $1.00, the Exchange would pay a significant rebate
that would not be recouped via a rebate provided by the execution
venue. The Exchange believes that is reasonable and equitable to limit
routing rebates to circumstances where the Exchange would actually earn
a rebate from the away venue in order to properly recoup the costs of
accessing liquidity on such markets.
---------------------------------------------------------------------------

    \15\ See supra note 8.
---------------------------------------------------------------------------

    Given the proposed changes to the fees charged or rebates provided
when routing low cost protected market centers, the Exchange also
believes that it is reasonable and equitable to increase the fee
charged when routing to other equities markets. Specifically, the
Exchange charges a default routing fee for orders routed using the SLIM
routing strategy that is, in effect, a blended fee designed to
compensate the Exchange for routing to one of the venues not otherwise
subject to special pricing. Since the Exchange is introducing special
pricing for orders routed to low cost protected market centers, the
venues subject to this pricing, would, on average, charge a higher
execution fee for liquidity removing orders. Indeed, a number of the
trading centers that are accessible using the SLIM routing strategy,
including, for example, The Nasdaq Stock Market LLC (``Nasdaq'') and
Cboe EDGX Exchange, Inc. (``EDGX''), charge a taker fee of $0.00300 per
share.\16\ The Exchange believes that the proposed increased routing
fee for these orders reflects an appropriate blended rate for accessing
liquidity on those markets, and would appropriately compensate the
Exchange for the costs associated with routing to such venues.
Furthermore, the Exchange believes that the changes to the System
routing table would reduce the chance that an order is routed to a high
cost venue since routing to low cost protected market centers is
prioritized.
---------------------------------------------------------------------------

    \16\ See Nasdaq, Equity Rules, Pricing Schedule; EDGX U.S.
Equities Exchange Fee Schedule, Fee Codes and Associated Fees.
---------------------------------------------------------------------------

    In addition, the Exchange believes that it is reasonable and
equitable to provide free executions, rather than rebates, for
liquidity providing orders routed to Nasdaq using the ROOC routing
strategy in securities priced below $1.00. While Nasdaq typically
provides a rebate to orders that add liquidity in securities priced at
or above $1.00, it instead charges a fee for orders in securities
priced below $1.00. Similar to other proposed changes described in this
proposed rule change for securities priced below $1.00, this proposed
change would ensure that rebates for routed orders are limited to
securities that are rebate eligible on the execution venue.
    Finally, the Exchange believes that the proposed changes are
equitable and not unfairly discriminatory as the proposed fees and
rebates would apply equally to all members that use the Exchange to
route orders using the associated routing strategy. The proposed fees
are designed to reflect the fees charged and rebates offered by certain
away trading centers that are accessed by Exchange routing strategies,
and are being made in conjunction with changes to the System routing
table designed to provide members with low cost executions for their
routable order flow. Furthermore, if members do not favor the proposed
pricing, they can send their routable orders directly to away markets
instead of using routing functionality provided by the Exchange.
Routing through the Exchange is voluntary, and the Exchange operates in
a competitive environment where market participants can readily direct
order flow to competing venues or providers of routing services if they
deem fee levels to be excessive.

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

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended. The
proposed routing fee changes are designed to reflect changes being made
to the System routing table used to determine where to send certain
routable orders, and generally provide better pricing to members for
orders routed to low cost protected market centers using the Exchange's
routing strategies. The Exchange operates in a highly competitive
market in which market participants can readily direct their order flow
to competing venues. In such an environment, the Exchange must
continually review, and consider

adjusting, its fees and rebates to remain competitive with other
exchanges. For the reasons described above, the Exchange believes that
the proposed fee changes reflect this competitive environment.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \17\ and paragraph (f) of Rule 19b-4\18\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(3)(A).
    \18\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CboeBZX-2019-006 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-CboeBZX-2019-006. 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-CboeBZX-2019-006 and should be submitted
on or before March 13, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-02741 Filed 2-19-19; 8:45 am]
BILLING CODE 8011-01-P