[Federal Register Volume 86, Number 143 (Thursday, July 29, 2021)]
[Notices]
[Pages 40822-40823]
[FR Doc No: 2021-16165]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP21-473-000]

Columbia Gas Transmission, LLC; Notice of Request Under Blanket
Authorization and Establishing Intervention and Protest Deadline

    Take notice that on July 16, 2021, Columbia Gas Transmission, LLC
(Columbia), 700 Louisiana Street, Suite 1300, Houston, Texas 77002-
2700, filed in the above referenced docket a prior notice pursuant to
sections 157.205 and 157.213 of the Commission's regulations under the
Natural Gas Act (NGA) and its blanket certificate issued in Docket No.
CP83-76-000 requesting authorization to construct and operate: (1) Two
injection/withdrawal (I/W) wells at its Lucas Storage Field; (2) one I/
W well at its Pavonia Storage Field; and (3) related pipeline and
appurtenances for each well, all located in Ashland and Richland
Counties, Ohio. Columbia states that the new wells are designed to
maintain reliability and overall storage field performance. Columbia
asserts that there will be no change to either storage field's
certificated physical parameters, including total inventory reservoir
pressure, reservoir and buffer boundaries, and certificated capacity.
Columbia estimates the cost of the project to be approximately $15
million, all as more fully set forth in the request which is on file
with the Commission and open to public inspection.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://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), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    Any questions concerning this application should be directed to
David A. Alonzo, Manager, Project Authorizations, Columbia Gas
Transmission, LLC, 700 Louisiana Street, Suite 1300, Houston, Texas
77002-2700, by phone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>
Public Participation

    There are three ways to become involved in the Commission's review
of this project: You can file a protest to the project, you can file a
motion to intervene in the proceeding, and you can file comments on the
project. There is no fee or cost for filing protests, motions to
intervene, or comments. The deadline for filing protests, motions to
intervene, and comments is 5:00 p.m. Eastern Time on September 21,
2021. How to file protests, motions to intervene, and comments is
explained below.

Protests

    Pursuant to section 157.205 of the Commission's regulations under
the NGA,\1\ any person \2\ or the Commission's staff may file a protest
to the request. If no protest is filed within the time allowed or if a
protest is filed and then withdrawn within 30 days after the allowed
time for filing a protest, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request for authorization
will be considered by the Commission.
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    \1\ 18 CFR 157.205.
    \2\ Persons include individuals, organizations, businesses,
municipalities, and other entities. 18 CFR 385.102(d).
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    Protests must comply with the requirements specified in section
157.205(e) of the Commission's regulations,\3\ and must be submitted by
the protest deadline, which is September 21, 2021. A protest may also
serve as a motion to intervene so long as the protestor states it also
seeks to be an intervenor.
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    \3\ 18 CFR 157.205(e).
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Interventions

    Any person has the option to file a motion to intervene in this
proceeding. Only intervenors have the right to request rehearing of
Commission orders issued in this proceeding and to subsequently
challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \4\ and the regulations under the NGA \5\ by the
intervention deadline for the project, which is September 21, 2021. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
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    \4\ 18 CFR 385.214.
    \5\ 18 CFR 157.10.
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    All timely, unopposed motions to intervene are automatically
granted by operation of Rule 214(c)(1). Motions to intervene that are
filed after the intervention deadline are untimely and may be denied.
Any late-filed motion to intervene must show good cause for being late
and must explain why the time limitation should be waived and provide
justification by reference to factors set forth in Rule 214(d) of the
Commission's Rules and Regulations. A person obtaining party status
will be placed on the service list maintained by the Secretary of the
Commission and will receive copies (paper or electronic) of all
documents filed by the applicant and by all other parties.

Comments

    Any person wishing to comment on the project may do so. The
Commission considers all comments received about the project in
determining the appropriate action to be taken. To ensure that your
comments are timely and properly recorded, please submit your comments
on or before September 21, 2021. The filing of a comment alone will not
serve to make the filer a party to the proceeding. To become a party,
you must intervene in the proceeding.

How To File Protests, Interventions, and Comments

    There are two ways to submit protests, motions to intervene, and
comments. In both instances, please reference the Project docket number
CP21-473-000 in your submission. The Commission encourages electronic
filing of submissions.
    (1) You may file your protest, motion to intervene, and comments by
using the Commission's eFiling feature, which is located on the
Commission's website (www.ferc.gov) under the link to Documents and
Filings. New eFiling users must first create an account by clicking on
``eRegister.'' You will be

asked to select the type of filing you are making; first select
General'' and then select ``Protest'', ``Intervention'', or ``Comment
on a Filing.''
    The Commission's eFiling staff are available to assist you at (202)
502-8258 or [email protected]
    (2) You can file a paper copy of your submission. Your submission
must reference the Project docket number CP21-473-000.
    To mail via USPS, use the following address: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426.
    To mail via any other courier, use the following address: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852.
    Protests and motions to intervene must be served on the applicant
either by mail or email (with a link to the document) at:
<EMAIL_ADDRESS>700 Louisiana Street, Suite 1300, Houston,
Texas 77002-2700. Any subsequent submissions by an intervenor must be
served on the applicant and all other parties to the proceeding.
Contact information for parties can be downloaded from the service list
at the eService link on FERC Online.

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be available from the Commission's Office of External Affairs, at
(866) 208-FERC, or on the FERC website at www.ferc.gov using the
``eLibrary'' link as described above. The eLibrary link also provides
access to the texts of all formal documents issued by the Commission,
such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.

    Dated: July 23, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-16165 Filed 7-28-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Rules and Regulations]
[Pages 57796-57800]
[FR Doc No: 2016-20148]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

[Docket No. FDA-2016-N-1896]

New Animal Drugs for Use in Animal Feed; Category Definitions

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, we) is
amending the animal drug regulations by revising the definitions of the
two categories of new animal drugs used in medicated feeds to base
category assignment only on approved uses in major animal species. This
revision will preserve the availability of medicated feeds intended for
therapeutic use in minor animal species and prevent a significant
disincentive for future development of additional minor species
therapies.

DATES: This rule is effective December 1, 2016. Submit either
electronic or written comments by November 7, 2016. See Section IV for
further discussion of the effective date.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-N-1896 for ``Category Definitions For Minor Species.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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.'' 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: David Edwards, Center for Veterinary
Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Direct Final Rule
    B. Summary of the Major Provisions of the Direct Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
III. Provisions of the Regulation
IV. Direct Final Rulemaking
V. Legal Authority
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. References

I. Executive Summary

A. Purpose of the Direct Final Rule

    FDA is issuing this direct final rule to revise the definitions of
the two categories of new animal drugs used in

medicated feeds to base category assignment only on approved uses in
major animal species. This action is being taken to address a potential
consequence of animal drug sponsor cooperation in implementing a
strategy initiated by the FDA Center for Veterinary Medicine (CVM) to
address antimicrobial resistance by taking measures to ensure the
judicious use of antimicrobial drugs in animal agriculture. Under this
program, sponsors of antimicrobial new animal drugs that also have
importance in human medicine were requested to voluntarily withdraw
approval of production (e.g., growth production, feed efficiency)
indications for their drug products that are intended for use in the
feed or water of food-producing animals. Based on the existing drug
category definitions, the voluntary withdrawal of production
indications by these drug sponsors would, in some cases, result in a
change to a medicated feed drug's category, potentially leading to
additional consequences not foreseen at the time the program was
initiated.
    The category in which a new animal drug used in medicated feeds is
placed is based on their likelihood of producing unsafe residues in the
edible products of treated animals. Category I consists of those drugs
that require no withdrawal period at the lowest use level in each
species for which they are approved. Category II consists of those
drugs that require a withdrawal period at the lowest use level for at
least one species for which they are approved, or that are regulated on
a ``no-residue'' basis or with a zero tolerance because of a
carcinogenic concern, regardless of whether a withdrawal period is
required.
    New animal drugs approved for use in medicated feeds are approved
as Type A medicated articles, the most concentrated form of the drug
product for use by feed mills. Category I Type A medicated articles can
be handled by both licensed and unlicensed feed mills, whereas Category
II Type A medicated articles can be handled only by licensed feed
mills.
    Certain Category I Type A medicated articles would be recategorized
to Category II when a production indication is voluntarily withdrawn by
a sponsor as part of the judicious use initiative that is currently
underway, based on the next lowest use level that remains once the
production use is withdrawn having a withdrawal period such that the
drug would then meet the definition for Category II. For Category I
Type A medicated articles that include indications for minor species,
FDA is concerned that if such a Type A medicated article is
recategorized to Category II based on a withdrawal period for an
approved therapeutic use in a minor species, sponsors may opt to
request withdrawal of approval of these minor species indications in
order to ensure the Type A medicated article can remain in Category I.
Sponsors may also decline to pursue development of additional therapies
for minor species if these uses would require a withdrawal period that
would trigger a recategorization to Category II.
    This direct final rule revises the category definitions such that
they will be based only on whether a withdrawal period is required for
a major species.\1\ Under this new definition, a Category I Type A
medicated article will not be recategorized to Category II based on the
existence of a withdrawal period for an approved indication in a minor
species, even if that minor species indication is the next lowest
approved use level that remains after the production indication has
been withdrawn. However, if the next lowest use level (apart from the
minor species indication) is an indication approved for use in a major
species that has a withdrawal period, under the new definition the drug
will move to Category II.
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    \1\ As a practical matter, categorization under the revised
definitions in this direct final rule will be driven by approved
indications for major food-producing species (cattle, poultry,
swine, and turkeys). While the definition for major species includes
horses, dogs, and cats, they are not regulated as food-producing
major species and thus drugs approved for use in these species do
not require an assessment of human food safety that may result in
assignment of a withdrawal period. Minor species are defined as
animals, other than humans, that are not major species. Minor
species include animals such as sheep, goats, ducks, geese, and
aquaculture species such as catfish, salmon, and trout.
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    The purpose of this revision is to preserve the present
availability of medicated feeds intended for therapeutic uses in minor
species and to prevent a significant disincentive for future
development of additional therapies for minor species. We believe this
revision will not compromise public health due to the comparatively
lower exposure by humans to potential drug residues in edible tissues
of food-producing minor species inherent in their less frequent
consumption.

B. Summary of the Major Provisions of the Direct Final Rule

    FDA is amending 21 CFR 558.3 Definitions and general considerations
applicable to this part (Sec.  558.3) to base the definition for each
of the two categories (Category I and Category II) of new animal drugs
used in medicated feeds only on approved uses in major species.
Definitions for ``major species'' and ``minor species'' are also being
added to this section.

C. Legal Authority

    FDA is issuing these regulations based on its authority under the
new animal drug provisions in sections 512 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b) and under section
701(a) of the FD&C Act (21 U.S.C. 371(a)), which gives the Agency
general rulemaking authority to issue regulations for the efficient
enforcement of the FD&C Act.

D. Costs and Benefits

    The revisions made by this direct final rule are intended to
preserve the availability of medicated feeds intended for therapeutic
use in minor animal species. In addition, these revisions will prevent
a significant disincentive for future development of additional
therapies for minor species. No additional costs or benefits will
accrue from this rulemaking.

II. Background

    FDA is issuing this direct final rule to revise the definitions of
the two categories of new animal drugs used in medicated feeds to base
category assignment only on approved uses in major animal species. To
strengthen the Agency's medicated feed program, FDA issued a final rule
in the Federal Register of March 3, 1986 (51 FR 7382), which, among
other things, established two categories of new animal drugs used in
medicated feeds. As discussed in the final rule, the Agency placed
these drugs into categories based on their likelihood of producing
unsafe residues in the edible products of treated animals (51 FR 7382).
Category I consists of those drugs that require no withdrawal period at
the lowest use level in each species for which they are approved.
Category II consists of those drugs that require a withdrawal period at
the lowest use level for at least one species for which they are
approved, or that are regulated on a ``no-residue'' basis or with a
zero tolerance because of a carcinogenic concern, regardless of whether
a withdrawal period is required.
    New animal drugs approved for use in medicated feeds are approved
as Type A medicated articles, the most concentrated form of the drug
product for use by feed mills. Category I Type A medicated articles can
be handled by both licensed and unlicensed feed mills, whereas Category
II Type A medicated articles can be handled only by licensed feed
mills.
    This action is being taken to address a potential consequence of
animal drug

sponsor cooperation in implementing a strategy initiated by CVM to
address antimicrobial resistance by taking measures to ensure the
judicious use of antimicrobials of importance to human medicine (i.e.,
medically important antimicrobials) in animal agriculture.
Specifically, CVM's initiative to ensure the judicious use of medically
important antimicrobial drugs in animal agriculture advocates two
specific changes to the approved conditions of use of medically
important antimicrobials that are administered through the medicated
feed or water of food-producing animals.
    These changes, which are described in Guidance for Industry (GFI)
#213, ``New Animal Drugs and New Animal Drug Combination Products
Administered in or on Medicated Feed or Drinking Water of Food-
Producing Animals: Recommendations for Drug Sponsors for Voluntarily
Aligning Product Use Conditions with GFI #209,'' published December
2013 (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf), are
intended to reduce the development of antimicrobial resistance and
thereby preserve the effectiveness of these important drugs for use in
treating infections in humans. Following publication of GFI #213, all
sponsors of these medically important antimicrobial new animal drug
products approved for use in the feed or water of food-producing
animals notified FDA in writing of their intent to voluntarily make
changes to their affected products as outlined in the guidance.
    Under GFI #213, sponsors of medically important antimicrobial new
animal drugs approved for over-the-counter use in the feed or water of
food-producing animals were asked to change the marketing status of
their products to veterinary prescription (Rx) marketing status in the
case of new animal drugs administered in water, or to veterinary feed
directive (VFD) marketing status for drugs administered in or on animal
feed. New animal drugs with Rx or VFD marketing status can legally only
be used with a veterinarian's oversight. Prescription animal drugs
require a veterinarian's prescription, while use of VFD drugs requires
a VFD; both types of orders must be issued by a licensed veterinarian
in the course of the veterinarian's professional practice.
    In addition, under GFI #213 sponsors of medically important new
animal drugs used in animal feed or water that have production
indications were requested to voluntarily withdraw these indications;
approved therapeutic indications for use of these drugs would remain.
    In some instances, once a sponsor withdraws the production
indication from a drug approved for use in animal feed (which is
generally the lowest use level of the drug), the remaining lowest
therapeutic use level will require a withdrawal period. Based on the
existing definitions of the feed drug categories, this results in a
Category I new animal drug being recategorized as a Category II drug,
the more restrictive of the two possible categories of drugs used in
medicated feed. Category II drugs require that the manufacture of Type
B and Type C medicated feeds from Type A medicated articles be done in
facilities possessing a medicated feed mill license, which number
roughly 900 in the United States. In contrast, there are tens of
thousands of unlicensed feed mills in this country. Such a
recategorization to Category II, thereby limiting the use of the Type A
medicated article to a much smaller subset of feed mills, may disrupt
the existing movement of these medicated feeds through distribution
channels.
    FDA believes that sponsors may request voluntary withdrawal of
those specific therapeutic indications as a way to keep their products
in the less restrictive Category I when the recategorization of a drug
to Category II is triggered by a therapeutic indication for a minor
species. For certain drug products, the only therapeutic indications
requiring a withdrawal period that would remain following the voluntary
withdrawal of approval of production uses are those for minor species.
The loss of therapeutic indications for minor species would adversely
affect the availability of therapeutic medicated feeds necessary for
the health of minor species, which is a matter of significant concern
for the Agency.
    This foreseeable adverse effect on the health of minor species
would directly undermine the intent of Congress in passing the Minor
Use and Minor Species Animal Health Act of 2004 (Pub. L. 108-282) as
well as to our intent in establishing the implementing regulations
under that statute. The Category I drugs likely to be affected have
been safely used in this category for decades, and we have no reason to
believe they would not continue to be safely used in this category
moving forward.
    Under the current category definitions in Sec.  558.3 for feed use
drugs, a drug will be included in Category II if the lowest use level
of the drug in any approved species requires a withdrawal period. This
approach equates the existence of a withdrawal period for a particular
use with the potential risk that edible tissues from animals
administered a medicated feed might contain a residue of concern.
    However, the toxicological analysis of animal drugs used to
calculate a withdrawal period is based on lifetime exposure by humans
to potential drug residues. This assessment of lifetime exposure does
not consider the lower risk to the public health from the use of these
same new animal drugs in food-producing minor species attributable to
the lower human consumption over time of edible tissues from food-
producing minor species (Refs. 1 and 2). For this reason, FDA does not
at this time believe this revision of the category definitions presents
a risk to the public health.
    In a manner similar to its effect on drug indications that are
already approved, CVM believes the existing categorization scheme would
pose a significant disincentive for future development of additional
minor species therapies for existing Category I drugs if those new uses
would require a withdrawal period and thus trigger a change to Category
II for that drug.
    Given the potential for implementation of GFI #213 to result in the
foreseeable consequence of the withdrawal of approval of needed
therapeutic indications for minor species, the definitions of the two
categories of new animal drugs used in medicated feeds in Sec.  558.3
are being revised to base category assignment only on uses in major
species. This revision is expected to preserve the availability of
drugs intended for therapeutic use in minor species and also prevent a
significant disincentive for future development of additional therapies
for minor species without compromising public health.

III. Provisions of the Regulation

    We are amending paragraphs (b)(1)(i) and (ii) of this Agency's
regulations at Sec.  558.3 (Definitions and general considerations
applicable to this part.) to base the definition for each of the two
categories of new animal drugs (Category I and Category II) used in
medicated feeds only on approved uses in major species. Section
558.3(b) is further amended to add definitions for ``major species''
and ``minor species'' that are identical to the definitions of those
terms found in FDA's regulations for new animal drugs for minor use and
minor species (21 CFR 516.3). We are revising the feed drug category
definitions in Sec.  558.3 to preserve the availability of medicated
feeds intended for use in minor species and prevent a

likely disincentive for development of additional therapies for minor
species.

IV. Direct Final Rulemaking

    FDA has determined that the subject of this rulemaking is suitable
for a direct final rule. FDA is amending Sec.  558.3(b)(1) by revising
the definitions of Category I and Category II new animal drugs
administered in or on medicated feed. This rule is intended to make
noncontroversial changes to existing regulations. The Agency does not
anticipate receiving any significant adverse comments on this rule.
    Consistent with FDA's procedures on direct final rulemaking, we are
publishing elsewhere in this issue of the Federal Register a companion
proposed rule. The companion proposed rule and this direct final rule
are substantively identical. The companion proposed rule provides the
procedural framework within which the rule may be finalized in the
event the direct final rule is withdrawn because of any significant
adverse comment. The comment period for this direct final rule runs
concurrently with the comment period of the companion proposed rule.
Any comments received in response to the companion proposed rule will
also be considered as comments regarding this direct final rule.
    FDA is providing a comment period for the direct final rule of 75
days after the date of publication in the Federal Register. If FDA
receives a significant adverse comment, we intend to withdraw this
direct final rule before its effective date by publication of a notice
in the Federal Register within 30 days after the comment period ends. A
significant adverse comment is one that explains why the rule would be
inappropriate, including challenges to the rule's underlying premise or
approach, or would be ineffective or unacceptable without a change. In
determining whether an adverse comment is significant and warrants
withdrawing a direct final rule, the Agency will consider whether the
comment raises an issue serious enough to warrant a substantive
response in a notice-and-comment process in accordance with section 553
of the Administrative Procedure Act (APA) (5 U.S.C. 553).
    Comments that are frivolous, insubstantial, or outside the scope of
this direct final rule will not be considered significant or adverse
under this procedure. For example, a comment recommending a regulation
change in addition to those in the rule would not be considered a
significant adverse comment unless the comment states why the rule
would be ineffective without the additional change. In addition, if a
significant adverse comment applies to an amendment, paragraph, or
section of this rule and that provision can be severed from the
remainder of the rule, FDA may adopt as final those provisions of the
rule that are not the subject of a significant adverse comment.
    If FDA withdraws the direct final rule, all comments received will
be considered under the companion proposed rule in developing a final
rule under the usual notice-and-comment procedures under the APA (5
U.S.C. 552 et seq.). If FDA does not receive a significant adverse
comment in response to the direct final rule, the Agency will publish,
within 30 days after the comment period ends, a document in the Federal
Register confirming the effective date of the final rule. The Agency
intends to make the direct final rule effective December 1, 2016.
    A full description of FDA's policy on direct final rule procedures
may be found in a guidance document announced in the Federal Register
of November 21, 1997 (62 FR 62466). The guidance document may be
accessed at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm.

V. Legal Authority

    We are issuing these regulations under the legal authority provided
by section 512 of the FD&C Act relating to new animal drugs and section
701(a) of the FD&C Act. Section 512 gives FDA the authority to approve
new animal drug applications (NADAs). Such approval establishes
conditions of use under which the drug can be used in a safe and
effective manner. Categorization of new animal drugs used in medicated
feeds is one such condition of use. In addition, section 701(a) of the
FD&C Act gives FDA general rulemaking authority to issue regulations
for the efficient enforcement of the FD&C Act.

VI. Economic Analysis of Impacts

    We have examined the impacts of the direct final rule under
Executive Order 12866, Executive Order 13563, the Regulatory
Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform
Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us
to assess all costs and benefits of available regulatory alternatives
and, when regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; distributive impacts;
and equity). We believe that this direct final rule is not a
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this direct final rule would not impose any
compliance costs on the sponsors of animal drug products that are
currently marketed or in development, we certify that this direct final
rule will not have a significant economic impact on a substantial
number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $146
million, using the most current (2015) Implicit Price Deflator for the
Gross Domestic Product. This direct final rule would not result in an
expenditure in any year that meets or exceeds this amount.
    This direct final rule allows certain new animal drugs approved for
use in animal feed that would otherwise be recategorized as Category II
drugs under the current definitions in Sec.  558.3 following withdrawal
of approval of production indications during GFI #213 implementation to
remain in Category I if the change to Category II would have been
triggered by a minor species indication.
    Based on the revised definitions of the two feed drug categories,
there is one drug, sulfamerazine for control of furunculosis in trout
(21 CFR 558.582), that will be recategorized from Category II to
Category I as a result of this direct final rule. No compliance costs
will be incurred due to this recategorization because no changes to the
approved application are required for continued marketing of the drug.

VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VIII. Paperwork Reduction Act of 1995

    This direct final rule contains no collection of information.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.

IX. Federalism

    We have analyzed this direct final rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this direct final rule does not contain policies that have substantial
direct effects on the States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we have concluded that this direct final rule does not contain policies
that have federalism implications as defined in the Executive Order
and, consequently, a federalism summary impact statement is not
required.

X. References

    The following references are on display in the Division of Dockets
Management (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. FDA has
verified the Web site addresses, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.

1. U.S. Department of Agriculture, ``Livestock & Meat Domestic
Data,'' http://www.ers.usda.gov/data-products/livestock-meat-domestic-data (accessed on June 23, 2016).
2. ``Food Fish Production and Sales by Species, by Size Category, by
State and United States: 2005,'' http://www.agcensus.usda.gov/Publications/2002/Aquaculture/aquacen2005_08.pdf (accessed on June
23, 2016).

List of Subjects in 21 CFR Part 558

    Animal drugs, animal feeds.

    Therefore, under the Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
1. The authority citation for part 558 continues to read as follows:

    Authority:  21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

0
2. In Sec.  558.3, revise paragraphs (b)(1)(i) and (ii); and add
paragraphs (b)(13) and (14) to read as follows:

Sec.  558.3  Definitions and general considerations applicable to this
part.

* * * * *
    (b) * * *
    (1) * * *
    (i) Category I--These drugs require no withdrawal period at the
lowest use level in each major species for which they are approved or
are approved for use only in minor species.
    (ii) Category II--These drugs require a withdrawal period at the
lowest use level for at least one major species for which they are
approved, or are regulated on a ``no-residue'' basis or with a zero
tolerance because of carcinogenic concern regardless of whether a
withdrawal period is required in any species.
* * * * *
    (13) ``Major species'' means cattle, horses, swine, chickens,
turkeys, dogs, and cats.
    (14) ``Minor species'' means animals, other than humans, that are
not major species.

    Dated: August 18, 2016.
Jeremy Sharp,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2016-20148 Filed 8-23-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 148 (Friday, July 31, 2020)]
[Proposed Rules]
[Pages 46010-46012]
[FR Doc No: 2020-16282]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 85, No. 148 / Friday, July 31, 2020 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0676; Product Identifier 2020-NM-085-AD]
RIN 2120-AA64

Airworthiness Directives; ATR--GIE Avions de Transport
R[eacute]gional Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all ATR--GIE Avions de Transport R[eacute]gional Model ATR72
airplanes. This proposed AD was prompted by reports of main landing
gear (MLG) hinge pins found cracked or thermally abused. This proposed
AD would require replacing certain MLG hinge pins with serviceable
parts, or replacing an MLG equipped with any affected MLG hinge pin
with an MLG equipped with serviceable MLG hinge pins, as specified in a
European Union Aviation Safety Agency (EASA) AD, which will be
incorporated by reference. The FAA is proposing this AD to address the
unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by September
14, 2020.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For material incorporated by reference (IBR) in this AD, contact
the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49
221 8999 000; email<EMAIL_ADDRESS>internet www.easa.europa.eu.
You may find this IBR material on the EASA website at https://ad.easa.europa.eu. You may view this IBR material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket on the internet at https://www.regulations.gov by searching for
and locating Docket No. FAA-2020-0676.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0676; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, Large Aircraft Section, International Validation Branch, FAA,
2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-
3220; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to participate in this rulemaking by submitting
written comments, data, or views about this proposal. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time. Send your
comments to an address listed under the ADDRESSES section. Include
``Docket No. FAA-2020-0676; Product Identifier 2020-NM-085-AD'' at the
beginning of your comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, as well
as a report summarizing each substantive public contact with FAA
personnel concerning this proposed rulemaking. Before acting on this
proposal, the FAA will consider all comments received by the closing
date for comments. The FAA will consider comments filed after the
comment period has closed if it is possible to do so without incurring
expense or delay. The FAA may change this NPRM because of those
comments.

Confidential Business Information

    Confidential Business Information (CBI) is commercial or financial
information that is both customarily and actually treated as private by
its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552),
CBI is exempt from public disclosure. If your comments responsive to
this NPRM contain commercial or financial information that is
customarily treated as private, that you actually treat as private, and
that is relevant or responsive to this NPRM, it is important that you
clearly designate the submitted comments as CBI. Please mark each page
of your submission containing CBI as ``PROPIN.'' The FAA will treat
such marked submissions as confidential under the FOIA, and they will
not be placed in the public docket of this NPRM. Submissions containing
CBI should be sent to the person identified in the FOR FURTHER
INFORMATION CONTACT section. Any commentary that the FAA receives which
is not specifically designated as CBI will be placed in the public
docket for this rulemaking.

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2020-0101, dated May 5, 2020 (``EASA
AD 2020-0101'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for all ATR--GIE Avions de Transport R[eacute]gional Model
ATR72 airplanes.

    This proposed AD was prompted by reports of MLG hinge pins found
cracked or thermally abused. The FAA is proposing this AD to address
MLG hinge pins subjected to a non-detected thermal abuse during
production, which could lead to structural failure and consequent
collapse of the MLG, resulting in damage to the airplane and injury to
the occupants. See the MCAI for additional background information.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2020-0101 describes procedures for replacing certain MLG
hinge pins with serviceable parts or replacing an MLG equipped with any
affected MLG hinge pin with an MLG equipped with serviceable MLG hinge
pins. This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD because the FAA
evaluated all the relevant information and determined the unsafe
condition described previously is likely to exist or develop in other
products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in EASA AD 2020-0101 described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2020-0101
will be incorporated by reference in the FAA final rule. This proposed
AD would, therefore, require compliance with EASA AD 2020-0101 in its
entirety, through that incorporation, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
Using common terms that are the same as the heading of a particular
section in the EASA AD does not mean that operators need comply only
with that section. For example, where the AD requirement refers to
``all required actions and compliance times,'' compliance with this AD
requirement is not limited to the section titled ``Required Action(s)
and Compliance Time(s)'' in the EASA AD. Service information specified
in EASA AD 2020-0101 that is required for compliance with EASA AD 2020-
0101 will be available on the internet at https://www.regulations.gov
by searching for and locating Docket No. FAA-2020-0676 after the FAA
final rule is published.

Costs of Compliance

    The FAA estimates that this proposed AD affects 23 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
4 work-hours x $85 per hour = $340...........................              $*             $340           $7,820
----------------------------------------------------------------------------------------------------------------
* The FAA has received no definitive data that would enable providing parts cost estimates for the replacements
  specified in this proposed AD.

    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected individuals. The FAA does not control warranty
coverage for affected individuals. As a result, the FAA has included
all known costs in the cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

ATR--GIE Avions de Transport R[eacute]gional: Docket No. FAA-2020-
0676; Product Identifier 2020-NM-085-AD.

(a) Comments Due Date

    The FAA must receive comments by September 14, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to ATR--GIE Avions de Transport R[eacute]gional
Model ATR72-101, -102, -201, -202, -211, -212, and -212A airplanes,
certificated in any category, all manufacturer serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 32, Landing
gear.

(e) Reason

    This AD was prompted by reports of main landing gear (MLG) hinge
pins found cracked or thermally abused. The FAA is issuing this AD
to address MLG hinge pins subjected to a non-detected thermal abuse
during production, which could lead to structural failure and
consequent collapse of the MLG, resulting in damage to the airplane
and injury to the occupants.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2020-0101, dated May 5, 2020 (``EASA AD 2020-0101'').

(h) Exceptions to EASA AD 2020-0101

    (1) Where EASA AD 2020-0101 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2020-0101 does not apply
to this AD.

(i) No Reporting or Returning Parts Requirement

    Although the service information referenced in EASA AD 2020-0101
specifies to submit certain information and to return affected parts
to the manufacturer, this AD does not include those requirements.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the Large Aircraft Section, International Validation
Branch, send it to the attention of the person identified in
paragraph (k)(2) of this AD. Information may be emailed to<EMAIL_ADDRESS>Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or ATR--GIE
Avions de Transport R[eacute]gional's EASA Design Organization
Approval (DOA). If approved by the DOA, the approval must include
the DOA-authorized signature.

(k) Related Information

    (1) For information about EASA AD 2020-0101, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email<EMAIL_ADDRESS>internet www.easa.europa.eu. You
may find this EASA AD on the EASA website at https://ad.easa.europa.eu. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2020-0676.
    (2) For more information about this AD, contact Shahram
Daneshmandi, Aerospace Engineer, Large Aircraft Section,
International Validation Branch, FAA, 2200 South 216th St., Des
Moines, WA 98198; telephone and fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
    Issued on July 22, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-16282 Filed 7-30-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: October 6, 2006 (Volume 71, Number 194)]
[Proposed Rules]
[Page 59066-59069]
[DOCID:fr06oc06-16]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2006-0213; FRL-7770-9]
RIN 2070-AB27

Proposed Revocation of Significant New Use Rules on Certain
Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to revoke significant new use rules (SNURs)
promulgated under section 5(a)(2) of the Toxic Substances Control Act
(TSCA) for four chemical substances. The SNUR for the chemical
substance covered by premanufacture notice (PMN) P-98-475 designated
certain activities as significant new uses based on concerns identified
in a corresponding TSCA section 5(e) consent order for that chemical
substance and pursuant to 40 CFR 721.160. For the chemical substances
covered by PMNs P-98-1043, P-99-0467, and P-01-71, EPA issued non-5(e)
SNURs (i.e., SNURS on substances that are not subject to TSCA section
5(e) consent orders) designating certain activities as significant new
uses based on the concern criteria in 40 CFR 721.170(b). EPA has
received and reviewed new information and test data for each of the
chemical substances, and proposes to revoke the SNURs pursuant to 40
CFR 721.185.

DATES: Comments must be received on or before November 6, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2006-0213, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID number EPA-HQ-OPPT-2006-0213. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is<PHONE_NUMBER>. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.

    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2006-0213. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the
regulations.gov index. Although listed in the index, some information
is not publicly available, e.g., CBI or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available electronically at
http://www.regulations.gov, or, if only available in hard copy, at the

OPPT Docket, EPA Docket Center (EPA/DC). The EPA/DC suffered structural
damage due to flooding in June 2006. Although the EPA/DC is continuing
operations, there will be temporary changes to the EPA/DC during the
clean-up. The EPA/DC Public Reading Room, which was temporarily closed
due to flooding, has been relocated in the EPA Headquarters Library,
Infoterra Room (Room Number 3334) in the EPA West Bldg., located at
1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number of the EPA/DC Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPPT
Docket is<PHONE_NUMBER>. EPA visitors are required to show
photographic identification and sign the EPA visitor log. Visitors to
the EPA/DC Public Reading Room will be provided with an EPA/DC badge
that must be visible at all times while in the EPA Building and
returned to the guard upon departure. In addition, security personnel
will escort visitors to and from the new EPA/DC Public Reading Room
location. Up-to-date information about the EPA/DC is on the EPA web
site at http://www.epa.gov/epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
    For technical information contact: James Alwood, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture,
import, process, or use the chemical substances contained in this
proposed revocation. Potentially affected entities may include, but are
not limited to:
     Chemical manufacturers (NAICS code 325), e.g., persons
manufacturing, importing, processing, or using chemicals for commercial
purposes.
     Petroleum and coal product industries (NAICS code 324),
e.g., persons manufacturing, importing, processing, or using chemicals
for commercial purposes.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in 40 CFR 721.5. If you
have any questions regarding the applicability of this action to a
particular entity, consult the technical person listed under FOR
FURTHER INFORMATION CONTACT.

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed 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 the estimate.
    vi. Provide specific examples to illustrate your concerns and
suggested 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. Background

A. What Action is the Agency Taking?

    In the documents that published in the Federal Register of January
5, 2000 (65 FR 373, 374) (FRL-6055-2), December 26, 2000 (65 FR 81400)
(FRL-6592-8), and December 17, 2003 (68 FR

70179) (FRL-7307-3), EPA issued separate SNURs for four separate
chemical substances. The SNUR for the chemical substance covered by PMN
P-98-475 designated certain activities as significant new uses based on
concerns identified in a corresponding TSCA section 5(e) consent order
for that chemical substance and pursuant to 40 CFR 721.160. For the
other three chemical substances covered by PMNs P-98-1043, P-99-0467,
and P-01-71, EPA issued non-5(e) SNURs designating certain activities
as significant new uses based on the concern criteria identified in 40
CFR 721.170(b). EPA has received and reviewed new information and test
data for each of these four chemical substances, and, based on that
information and test data, EPA now proposes to revoke the SNURs
pursuant to 40 CFR 721.185. In this unit, EPA provides a brief
description for each chemical substance, including its PMN number,
chemical name (generic name if the specific name is claimed as CBI),
CAS number (if assigned and not claimed as CBI), basis for the
revocation of the TSCA section 5(e) consent order, if any, for the
substance, the basis for revoking the SNUR under 40 CFR 721.185, and
the CFR citation of the SNUR.
PMN Number P-98-475
Chemical name: Benzenesulfonic acid, 2,2'-[(1E)-1,2-ethenediyl] bis[5-
[[4-(methylamino)-6-[[4-[(methylamino)carbonyl-phenyl]amino]-1,3,5-
triazin-2-yl]amino]-,disodium salt.
CAS number: 180850-95-7.
Federal Register publication date and reference: January 5, 2000 (65 FR
373).
Docket number: OPPTS-50635.
Basis for revocation of SNUR: EPA issued a TSCA section 5(e) consent
order between EPA and the PMN submitter for this substance based on a
potential unreasonable risk of developmental and reproductive toxicity
of the PMN substance, based on test data for the chemical category for
stilbene, derivatives of 4,4-bis(triazin-2-ylamino)-. EPA also
promulgated a SNUR for this chemical substance pursuant to 40 CFR
721.160. Subsequently, an industry consortium conducted a range-finding
and definitive 2-generation study in rats (gavage) and range-finding
and definitive developmental toxicity studies in rats and rabbits
(gavage) for C.I. Fluorescent Brightener 220 (CAS No. 16470-24-9).
Based on the results of that testing, EPA has concluded that available
information does not support continued identification of stilbenes as a
new chemical category presenting concerns for possible developmental
and reproductive toxicity. Thus, EPA concludes that a rational basis no
longer exists for finding that activities involving the chemical
substance may present an unreasonable risk of injury to human health as
required by section 5(e)(1)(A) of TSCA. Therefore, EPA has revoked the
consent order for P-98-475 and, pursuant to 40 CFR 721.185(a)(5),
proposes that the SNUR for this chemical substance be revoked.
CFR citation: 40 CFR 721.9785.

PMN Number P-98-1043
Chemical name: Substituted amino alkyl triazinyl benzenesulfonic acid
derivative (generic).
CAS number: CBI.
Federal Register publication date and reference: January 5, 2000 (65 FR
374).
Docket number: OPPTS-50635.
Basis for revocation of SNUR: EPA issued a SNUR for this substance
based on the concern criteria at Sec.  721.170(b)(3)(ii). The PMN
submitter petitioned EPA to revoke the SNUR based on the results of
test data developed by an industry consortium which consisted of a
range-finding and definitive 2-generation study in rats (gavage) and
range-finding and definitive developmental toxicity studies in rats and
rabbits (gavage) for C.I. Fluorescent Brightener 220 (CAS No. 16470-24-
9). EPA has concluded that available information does not support
continued identification of stilbenes as a new chemical category
presenting concerns for possible developmental and reproductive
toxicity and that, based on available information, the substance no
longer meets the concern criteria at Sec.  721.170(b)(3)(ii).
Therefore, EPA proposes that the SNUR for this chemical substance be
revoked pursuant to 40 CFR 721.185(a)(4).
CFR citation: 40 CFR 721.9810.

PMN Number P-99-0467
Chemical name: Acrylated (long-chainalkyl) glycidal ether (generic).
CAS number: CBI.
Federal Register publication date and reference: December 26, 2000 (65
FR 81400).
Docket number: OPPTS-50638.
Basis for revocation of SNUR: EPA issued a SNUR for this substance
based on the concern criteria at Sec.  721.170(b)(4)(ii). Subsequently,
the PMN submitter petitioned EPA to revoke the SNUR based on the
results of acute aquatic toxicity test data for fish, daphnia, and
algae, as well as the results of biodegradation testing. The toxicity
testing demonstrated concerns for potential chronic environmental
toxicity at concentrations as low as 2 parts per billion (ppb).
However, biodegradation testing demonstrated that the substance is
readily biodegradable, mitigating concerns for chronic toxicity.
Therefore, EPA no longer finds that releases to water resulting in
stream concentrations greater than 2 ppb may cause significant adverse
environmental effects. Therefore, based on available information, the
substance no longer meets the concern criteria at Sec.
721.170(b)(4)(ii) and EPA proposes that the SNUR for this chemical
substance be revoked pursuant to 40 CFR 721.185(a)(4).
CFR citation: 40 CFR 721.3850.

PMN Number P-01-71
Chemical name: Phenol, 2,2'-[6-(2,4-dibutoxyphenyl)-1,3,5-triazine-2,4-
diyl]bis[5-butoxy-.
CAS number: 208343-47-9.
Federal Register publication date and reference: December 17, 2003 (68
FR 70179).
Docket number: OPPT-2002-0078.
Basis for revocation of SNUR: EPA issued a SNUR for this substance
based on the concern criteria at Sec.  721.170(b)(4)(ii). Subsequently,
the PMN submitter petitioned EPA to revoke the SNUR based on the
results of chronic fish and daphnia testing. The toxicity testing
demonstrated that there were no effects at saturation (i.e., the
maximum concentration at which the PMN substance can be dissolved in
water). A concentration of concern was not established. The substance
was determined to pose low concern for environmental toxicity, and has
a low ``persistence, bioaccumulation, and toxicity'' (PBT) rating of
P2B1T1 (on a scale of 1 to 3, with 3 being the highest). Therefore, EPA
no longer finds that releases to water may result in exposures which
may cause significant adverse environmental effects. Therefore, based
on available information, the substance no longer meets the concern
criteria at Sec.  721.170(b)(4)(ii) and EPA proposes that the SNUR for
this chemical substance be revoked pursuant to 40 CFR 721.185(a)(4).
CFR citation: 40 CFR 721.5718.

B. What is the Agency's Authority for Taking this Action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including those listed in section 5(a)(2) of TSCA.
Once EPA determines that a use of a chemical substance is a

significant new use, section 5(a)(1)(B) of TSCA requires persons to
submit a notice to EPA at least 90 days before they manufacture,
import, or process the substance for that use. The mechanism for
reporting under this requirement is established under 40 CFR part 721.
    During a review of PMN P-98-475, EPA concluded that regulation was
warranted and issued a TSCA section 5(e) consent order for the chemical
substance and promulgated a corresponding SNUR under 40 CFR 721.160.
Upon conclusion of the reviews of PMNs P-98-1043, P-99-0467, and P-01-
71, based on the concern criteria in 40 CFR 721.170(b)(3)(ii) or
(b)(4)(ii) as discussed in Unit II.A., EPA determined that there was a
concern about the substances' health or environmental effects and
promulgated non-5(e) SNURs for these chemical substances.
    Under 40 CFR 721.185, EPA may at any time revoke a SNUR for a
chemical substance which has been added to subpart E of 40 CFR part 721
if EPA makes one of the determinations set forth in Sec.  721.185(a)(1)
through (a)(6). Revocation may occur at EPA's initiative or in response
to a written request. Under Sec.  721.185(b)(3), if EPA concludes that
a SNUR should be revoked, the Agency will propose the changes in the
Federal Register, briefly describe the grounds for the action and
provide interested parties an opportunity to comment.
    EPA has determined that the criteria set forth in Sec.  721.185(a)
have been satisfied for each of the four chemical substances, and
therefore EPA is proposing to revoke the SNUR provisions for these
chemical substances. When this revocation becomes final, EPA will no
longer require notice of intent to manufacture, import, or process
these substances for any significant new uses. In addition, export
notification requirements under section 12(b) of TSCA triggered by
these SNURs will no longer be required.

III. Statutory and Executive Order Reviews

    This proposed rule revokes or eliminates an existing regulatory
requirement and does not contain any new or amended requirements. As
such, the Agency has determined that this SNUR revocation will not have
any adverse impacts, economic or otherwise.
    The Office of Management and Budget (OMB) has exempted these types
of regulatory actions from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This
proposed rule does not contain any information collections subject to
approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et
seq.). Since this proposed rule eliminates a reporting requirement, the
Agency certifies pursuant to section 605(b) of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), that this SNUR revocation
will not have a significant economic impact on a substantial number of
small entities.
    For the same reasons, this action does not require any action under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). This proposed rule has neither Federalism implications, because
it will not have substantial direct effects on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999), nor tribal implications, because it
will not have substantial direct effects on one or more Indian tribes,
on the relationship between the Federal Government and Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes, as specified in Executive Order
13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000).
    This action is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), because this is not an economically
significant regulatory action as defined under Executive Order 12866,
and it does not address environmental health or safety risks
disproportionately affecting children. It is not subject to Executive
Order 13211, entitled Actions Concerning Regulations That Significantly
Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001),
because this action is not expected to affect energy supply,
distribution, or use. Because this action does not involve any
technical standards, section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note), does not apply to this action. This action does
not involve special considerations of environmental justice related
issues as required by Executive Order 12898, entitled Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: September 26, 2006.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.
    Therefore, it is proposed that 40 CFR part 721 be amended as
follows:

PART 721--[AMENDED]

    1. The authority citation for part 721 would continue to read as
follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

Sec. Sec.  721.3850, 721.5718, 721.9785, and 721.9810  [Removed]

    2. Remove Sec. Sec.  721.3850, 721.5718, 721.9785, and 721.9810.

[FR Doc. E6-16574 Filed 10-5-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Notices]
[Pages 65833-65835]
[FR Doc No: 2015-27218]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76208; File No. SR-NYSEMKT-2015-78]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Modifying the NYSE Amex
Options Fee Schedule Related to the Amex Customer Engagement Program

October 21, 2015.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on October 15, 2015, NYSE MKT LLC (the ``Exchange'' or
``NYSE MKT'') 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 self-regulatory
organization. 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\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to modify the NYSE Amex Options Fee Schedule
(``Fee Schedule'') related to the Amex Customer Engagement (``ACE'')
Program. The Exchange proposes to implement the fee change effective
October 15, 2015. The text of the proposed rule change is available on
the Exchange's Web site at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of this filing is to increase the credits available to
participants that achieve Tier 2 of the ACE Program as described below.
    Section I.E. of the Fee Schedule describes the ACE Program,\4\
which features five tiers expressed as a percentage of total industry
Customer equity and ETF option average daily volume (``ADV'').\5\ Order
Flow Providers (``OFPs'') receive per contract credits solely for
Electronic Customer volume that the OFP, as agent, submits to the
Exchange.\6\ The ACE Program offers the following two methods for OFPs
to receive credits:
---------------------------------------------------------------------------

    \4\ See NYSE Amex Options Fee Schedule, available here, https://www.theice.com/publicdocs/nyse/markets/amex-options/NYSE_Amex_Options_Fee_Schedule.pdf.
    \5\ In calculating ADV, the Exchange utilizes monthly reports
published by the OCC for equity options and ETF options that show
cleared volume by account type. See OCC Monthly Statistics Reports,
available here, http://www.theocc.com/webapps/monthly-volume-reports
(including for equity options and ETF options volume, subtotaled by
exchange, along with OCC total industry volume). The Exchange
calculates the total OCC volume for equity and ETF options that
clear in the Customer account type and divide this total by the
number of trading days for that month (i.e., any day the Exchange is
open for business). For example, in a month having 21 trading days
where there were 252,000,000 equity option and ETF option contracts
that cleared in the Customer account type, the calculated ADV would
be 12,000,000 (252,000,000/21 = 12,000,000).
    \6\ Electronic Customer volume is volume executed electronically
through the Exchange System, on behalf of an individual or
organization that is not a Broker-Dealer and who does not meet the
definition of a Professional Customer.
---------------------------------------------------------------------------

    1. By calculating, on a monthly basis, the average daily Customer
contract volume an OFP executes Electronically on the Exchange as a
percentage of total average daily industry Customer equity and ETF
options volume; \7\ or
---------------------------------------------------------------------------

    \7\ See supra n. 5
---------------------------------------------------------------------------

    2. By calculating, on a monthly basis, the average daily contract
volume an OFP executes Electronically in all participant types (i.e.,
Customer, Firm, Broker-Dealer, NYSE Amex Options Market Maker, Non-NYSE
Amex Options Market Maker, and Professional Customer) on the Exchange,
as a percentage of total average daily industry Customer equity and ETF
option volume,\8\ with the further requirement that a specified
percentage of the minimum volume required to qualify for the Tier must
be Customer volume.
---------------------------------------------------------------------------

    \8\ Id.
---------------------------------------------------------------------------

    Upon reaching a higher tier, an OFP would receive for all eligible
Customer

volume the per contract credit associated with the highest tier
achieved, retroactive to the first contract traded each month,
regardless of which of the two calculation methods the OFP qualifies
under.\9\
---------------------------------------------------------------------------

    \9\ In the event that an OFP is eligible for credits under both
calculation methods, the OFP would benefit from whichever criterion
results in the highest per contract credit for all the OFP's
eligible ADV. In calculating an OFP's Electronic volume, certain
volumes are excluded (e.g., QCC trades). See Fee Schedule (Section
I.E.), supra n. 4.
---------------------------------------------------------------------------

    The Exchange proposes to modify the ACE Program by increasing the
credits available for Tier 2 as illustrated in the table below, with
proposed additions appearing italicized and proposed deletions
appearing in brackets:
* * * * *

----------------------------------------------------------------------------------------------------------------
                         ACE program--standard options                Credits payable on customer volume only
              --------------------------------------------------------------------------------------------------
                                               Total electronic
                                              ADV (of which 20%
                                              or greater of the
               Customer electronic            minimum qualifying                      1 Year          3 Year
     Tier         ADV as a % of                volume for each       Customer        enhanced        enhanced
                industry customer      OR        tier must be         volume         customer        customer
                  equity and ETF             customer) as a % of      credits         volume          volume
                   Options ADV                industry customer                       credits         credits
                                                equity and ETF
                                                 options ADV
----------------------------------------------------------------------------------------------------------------
1............  0.00% to 0.60%.....  .......  N/A................           $0.00           $0.00           $0.00
2............  >0.60% to 0.80%....  .......  N/A................         ($0.13)       [($0.13)]       [($0.13)]
                                                                                ($0.15)         ($0.16)
3............  >0.80% to 1.25%....  .......  1.50% to 2.50% of           ($0.14)         ($0.16)         ($0.18)
                                              which 20% or
                                              greater of 1.50%
                                              must be Customer.
4............  >1.25 to 1.75%.....  .......  >2.50% to 3.50% of          ($0.17)         ($0.19)         ($0.21)
                                              which 20% or
                                              greater of 2.50%
                                              must be Customer.
5............  >1.75%.............  .......  >3.50% of which 20%         ($0.19)         ($0.21)         ($0.23)
                                              or greater of 3.5%
                                              must be Customer.
----------------------------------------------------------------------------------------------------------------

    The proposed amendments to the ACE Program are designed to enhance
the rebates, which the Exchange believes would attract more volume and
liquidity to the Exchange to the benefit of Exchange participants
through increased opportunities to trade as well as enhancing price
discovery.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\10\ in general, and furthers the
objectives of Sections 6(b)(4) and (5) of the Act,\11\ in particular,
because it provides for the equitable allocation of reasonable dues,
fees, and other charges among its members, issuers and other persons
using its facilities and does not unfairly discriminate between
customers, issuers, brokers or dealers.
---------------------------------------------------------------------------

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

    The Exchange believes that the proposed changes to the ACE Program
are reasonable, equitable and not unfairly discriminatory because the
credits offered are based on the amount of business transacted on the
Exchange. In addition, the Exchange believes that the proposed
amendments to the ACE Program are reasonable, equitable and not
unfairly discriminatory because they would enhance the incentives to
OFPs to transact Customer orders on the Exchange, which would benefit
all market participants by providing more trading opportunities and
tighter spreads, even to those market participants that do not
participate in the ACE Program. Additionally, the Exchange believes the
proposed changes to the ACE Program are consistent with the Act because
they may attract greater volume and liquidity to the Exchange, which
would benefit all market participants by providing tighter quoting and
better prices, all of which perfects the mechanism for a free and open
market and national market system.
    For these reasons, the Exchange believes that the proposal is
consistent with the Act.

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

    In accordance with Section 6(b)(8) of the Act,\12\ 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 proposed amendments
to the ACE Program are pro-competitive as the proposed increased
rebates may encourage OFPs to direct Customer order flow to the
Exchange and any resulting increase in volume and liquidity to the
Exchange would benefit all of Exchange participants through increased
opportunities to trade as well as enhancing price discovery.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

    The Exchange notes that it operates in a highly competitive market
in which market participants can readily favor competing venues. In
such an environment, the Exchange must continually review, and consider
adjusting, its fees and credits to remain competitive with other
exchanges. For the reasons described above, the Exchange believes that
the proposed rule change reflects 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 solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \13\ of the Act and subparagraph (f)(2) of Rule
19b-4 \14\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \15\ of the Act to determine whether the proposed
rule

change should be approved or disapproved.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

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-NYSEMKT-2015-78 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-NYSEMKT-2015-78. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEMKT-2015-78, and should
be submitted on or before November 17, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-27218 Filed 10-26-15; 8:45 am]
BILLING CODE 8011-01-P