[Federal Register Volume 85, Number 48 (Wednesday, March 11, 2020)]
[Notices]
[Page 14249]
[FR Doc No: 2020-04943]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736.

Extension: Form 5
    SEC File No. 270-323, OMB Control No. 3235-0362.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Under Section 16(a) of the Securities Exchange Act of 1934
(``Exchange Act'') (15 U.S.C. 78a et seq.) every person who is directly
or indirectly the beneficial owner of more than 10 percent of any class
of any equity security (other than an exempted security) which
registered pursuant to Section 12 of the Exchange Act, or who is a
director or an officer of the issuer of such security (collectively
``reporting persons''), must file statements setting forth their
security holdings in the issuer with the Commission. Form 5 (17 CFR
249.105) is an annual statement of beneficial ownership of securities.
Approximately 3,904 reporting persons file Form 5 annually and we
estimate that it takes approximately one hour to prepare the form for a
total of 3,904 annual burden hours.
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Please direct your written comment to David Bottom, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Cynthia
Roscoe, 100 F Street NE, Washington, DC 20549 or send an email to:
<EMAIL_ADDRESS>
    Dated: March 6, 2020.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-04943 Filed 3-10-20; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: April 15, 2009 (Volume 74, Number 71)]
[Notices]
[Page 17487-17489]
[DOCID:fr15ap09-77]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0045; FRL-8409-7]

Notice of Receipt of Several Pesticide Petitions Filed for
Residues of Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the Agency's receipt of several initial
filings of pesticide petitions proposing the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.

DATES: Comments must be received on or before May 15, 2009.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest as shown
in the body of this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).

Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to the docket ID number and the
pesticide petition number of interest as shown in the body of this
document. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: A contact person, with telephone
number and e-mail address, is listed at the end of each pesticide
petition summary. You may also reach each contact person by mail at
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

     1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
     2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. What Action is the Agency Taking?

     EPA is announcing its receipt of several pesticide petitions filed
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, proposing the establishment or modification of
regulations in 40 CFR part 174 or part 180 for residues of pesticide
chemicals in or on various food commodities. EPA has determined that
the pesticide petitions described in this notice contain the data or
information prescribed in FFDCA section 408(d)(2); however, EPA has not
fully evaluated the sufficiency of the submitted data at this time or
whether the data support granting of the pesticide petitions.
Additional data may be needed before EPA can make a final determination
on these pesticide petitions.

     Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
that are the subject of this notice, prepared by the petitioner, is
included in a docket EPA has created for each rulemaking. The docket
for each of the petitions is available on-line at http://
www.regulations.gov.
    As specified in FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)),
EPA is publishing notice of the petition so that the public has an
opportunity to comment on this request for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petition may be obtained
through the petition summary referenced in this unit.

New Tolerance Exemption

    1. PP 9E7525 (EPA-HQ-OPP-2009-0098). The Joint Inerts Task Force,
Cluster Support Team 14, EPA Company Number 84946, c/o CropLife
America, 1156 15th Street, NW., Suite 400, Washington, DC 20005,
proposes to establish an exemption from the requirement of a tolerance
under 40 CFR 180.920 for residues of sodium salts of N-alkyl
(C8-C18)-[beta]-iminodipropionic acid where the
C8-C18 is linear and may be saturated and/or
unsaturated including CAS Reg. Nos. 3655-00-3, 61791-56-8, 14960-06-6,
26256-79-1, 90170-43-7, 91696-17-2, 97862-48-1 when used as inert
ingredients in pesticide formulations. Because this petition is a
request for an exemption from the requirement of a tolerance, no
analytical method is required. Contact: Kerry Leifer,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    2. PP 9E7524 (EPA-HQ-OPP-2009-0099). The Joint Inerts Task Force,
Cluster Support Team 10, EPA Company Number 84915, c/o CropLife
America, 1156 15th Street, NW., Suite 400, Washington, DC 20005,
proposes to establish an exemption from the requirement of a tolerance
under 40 CFR 180.910 and 180.930 for residues of sodium alkyl
naphthalenesulfonates including CAS Reg. Nos. 68909-83-1, 68909-84-2,
68909-82-0, 27213-90-7, 26264-58-4, 27178-87-6, 111163-74-7, 908356-16-
1, 25417-20-3, 25638-17-9, 145578-88-7, 1322-93-6, 1323-19-9, 7403-47-
6, 68442-09-1, 127646-44-0, 908356-18-3 when used as inert ingredients
in pesticide formulations. Because this petition is a request for an
exemption from the requirement of a tolerance, no analytical method is
required. Contact: Kerry Leifer,<PHONE_NUMBER><EMAIL_ADDRESS>    3. PP 9E7531 (EPA-HQ-OPP-2009-0130). The Joint Inerts Task Force,
Cluster Support Team 15, EPA Company Number 84947, c/o CropLife
America, 1156 15th Street, NW., Suite 400, Washington, DC 20005,
proposes to establish an exemption from the requirement of a tolerance
for residues of N, N, N', N'',-tetrakis-(2-
hydroxypropyl)ethylenediamine (CAS No. 102-60-3), under 40 CFR 180.920
when used as an inert ingredient in pesticide formulations with no use
limitations. Because this petition is a request for an exemption from
the requirement of a tolerance, no analytical method is required.
Contact: Kerry Leifer,<PHONE_NUMBER><EMAIL_ADDRESS>     4. PP 9E7533 (EPA-HQ-OPP-2009-0131). The Joint Inerts Task Force,
Cluster Support Team 2, EPA Company Number 84914, c/o CropLife Amercia,
1156 15th Street, NW., Suite 400, Washington, DC 20005, proposes to
establish an exemption from the requirement of a tolerance for residues
of alkyl alcohol alkoxylate phosphate and sulfate derivatives under 40
CFR 180.910; 180.920; and 180.930 when used as inert ingredients in
pesticide formulations including 40 CFR 180.920: [alpha]-alkyl(minimum
C6 linear, branched, saturated and/or unsaturated)-[omega]-
hydroxypolyoxyethylene polymer with or without polyoxypropylene,
mixture of di-; and monohydrogen phosphate esters and the corresponding
ammonium, calcium, magnesium, monoethanolamine, potassium, sodium, and
zinc salts of the phosphate esters; minimum oxyethlyene content is 2
moles; minimum oxypropylene content is 0 moles (CAS Reg. Nos. 9046-01-
9, 39464-66-9, 50643-20-4, 52019-36-0, 68071-35-2, 68458-48-0, 68585-
36-4, 68815-11-2, 68908-64-5, 68511-37-5, 68130-47-2, 42612-52-2,
58318-92-6, 60267-55-2, 68070-99-5, 68186-36-7, 68186-37-8, 68610-65-1,
68071-17-0, 936100-29-7, 936100-30-0, 73038-25-2, 78330-24-2, 154518-
39-5, 317833-96-8, 108818-88-8, 873662-29-4, 61837-79-4, 68311-02-4,
68425-73-0, 37280-82-3, 68649-29-6, 67711-84-6, 68891-13-4); and 40 CFR
180.910 and 180.930: [alpha]-alkyl(C6-C15)-
[omega]-hydroxypoly(oxyethylene)sulfate, and its ammonium, calcium,
magnesium, potassium, sodium, and zinc salts, poly(oxyethylene) content
averages 2-4 moles (CAS Reg. Nos. 9004-82-4, 68585-34-2, 68891-38-3,
9004-84-6, 13150-00-0, 26183-44-8, 68611-55-2, 68511-39-7, 3088-31-1,
9004-82-4, 25446-78-0, 32612-48-9, 50602-06-7, 62755-21-9, 68424-50-0,
73665-22-2). Because this petition is a request for an exemption from
the requirement of a tolerance, no analytical method is required.
Contact Kerry Leifer,<PHONE_NUMBER><EMAIL_ADDRESS>     5. PP 9E7534 (EPA-HQ-OPP-2009-0145). The Joint Inerts Task Force,
Cluster Support Team 1, EPA Company Number 84913, c/o CropLife Amercia,
1156 15th Street, NW., Suite 400, Washington, DC 20005, proposes to
establish an exemption from the requirement of a tolerance for residues
of various [alpha]-alkyl-[omega]-hydroxy(oxypropylene) and/or
poly(oxyethylene) polymers under 40 CFR 180.910, 180.930, 180.940 and
180.960 when used as inert ingredients in pesticide formulations (CAS
Reg. Nos. 9002-92-0, 9004-95-9, 9005-00-9, 26183-52-8, 34398-01-1,
52292-17-8, 66455-14-9, 66455-15-0, 68002-97-1, 68131-39-5, 68131-40-8,
68154-96-1, 68213-23-0, 68439-45-2, 68439-46-3, 68526-94-3, 68439-50-9,
68439-49-6, 68551-12-2, 68951-67-7, 71243-46-4, 97043-91-9, 9043-30-5,
60828-78-6, 61827-42-7, 24938-91-8, 68439-54-3, 69011-36-5, 78330-20-8,
78330-21-9, 106232-83-1, 127036-24-2, 160875-66-1, 9004-98-2, 68920-66-
1, 61804-34-0, 61791-28-4, 71060-57-6, 26468-86-0, 31726-34-8, 52609-
19-5, 61791-20-6, 68155-01-1, 69013-19-0, 69364-63-2, 70879-83-3,
78330-19-5, 97953-22-5, 157627-86-6, 34398-05-5, 72905-87-4, 84133-50-
6, 61702-78-1, 27306-79-2, 169107-21-5, 61791-13-7, 39587-22-9, 85422-
93-1; 68154-98-3, 61725-89-1, 68002-96-0, 68154-97-2, 68439-51-0,
68551-13-3, 68603-25-8, 68937-66-6, 68987-81-5, 69227-21-0, 70750-27-5,
103818-93-5, 166736-08-9, 120313-48-6, 68213-24-1, 68458-88-8, 68551-
14-4, 69013-18-9, 69227-22-1, 72854-13-8, 73049-34-0, 78330-23-1,
37311-02-7, 64366-70-7, 37251-67-5, 9087-53-0, 196823-11-7, 57679-21-7,
111905-54-5). Because this petition is a request for an exemption from
the requirement of a tolerance, no analytical method is required.
Contact Kerry Leifer,<PHONE_NUMBER><EMAIL_ADDRESS>
List of Subjects

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

    Dated: April 3, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

[FR Doc. E9-8673 Filed 4-14-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)]
[Notices]
[Pages 54395-54400]
[FR Doc No: 2018-23508]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84470; File No. SR-CBOE-2018-066]

Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Permit
the Exchange To List Options on the Cboe Volatility Index (``VIX
options'') on a Group Basis and Make Conforming Changes Throughout the
Rules, Change the Minimum Increment for VIX Options Listed Under the
Nonstandard Expirations Pilot Program (if the Exchange Lists VIX on a
Group Basis), and Make Nonsubstantive Changes

October 23, 2018.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 12, 2018, Cboe Exchange, Inc. (``Exchange'' or ``Cboe
Options'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Exchange filed the proposal as a ``non-controversial'' proposed rule
change pursuant to Section 19(b)(3)(A)(iii) of the Act \3\ and Rule
19b-4(f)(6) thereunder.\4\ The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Cboe Exchange, Inc. (the ``Exchange'' or ``Cboe Options'') proposes
to amend its rules to permit the Exchange to list options on the Cboe
Volatility Index (``VIX options'') on a group basis and make conforming
changes throughout the Rules, change the minimum increment for VIX
options listed under the Nonstandard Expirations Pilot Program (if the
Exchange lists VIX on a group basis), and make nonsubstantive changes.

(additions are italicized; deletions are [bracketed])
* * * * *

Rules of Cboe Exchange, Inc.

* * * * *

Rule 6.42. Minimum Increments for Bids and Offers

    [The Board of Directors may establish minimum increments for
options traded on the Exchange. When the Board of Directors determines
to change the minimum increments, the Exchange will designate such
change as a stated policy, practice, or interpretation with respect to
the administration of Rule 6.42 within the meaning of subparagraph
(3)(A) of subsection 19(b) of the Exchange Act and will file a rule
change for effectiveness upon filing with the Commission. Until such
time as the Board of Directors makes a change to the minimum
increments, t](a) Simple Orders. The [following] minimum increments
[shall apply to]for bids and offers on simple orders for options traded
on the Exchange are as follows:

------------------------------------------------------------------------
               Class                   Increment    Series Trading Price
------------------------------------------------------------------------
Class Not Participating in Penny             $0.05  Lower than $3.00.
 Pilot Program (including all                 0.10  $3.00 and higher.
 series of VIX options if the
 Exchange does not list VIX on a
 group basis pursuant to Rule
 8.14) and series of VIX Options
 not listed under the Nonstandard
 Expirations Pilot Program (if the
 Exchange lists VIX on a group
 basis pursuant to Rule 8.14)
Class Participating in Penny Pilot            0.01  Lower than $3.00.
 Program.                                     0.05  $3.00 and higher.
QQQs, IWM, and SPY, and Mini-SPX              0.01  All prices
 Index Options (XSP) (as long as
 SPDR options (SPY) participate in
 the Penny Pilot Program)
Series of VIX Options listed under            0.01  All prices.
 the Nonstandard Expirations Pilot
 Program (if the Exchange lists
 VIX on a group basis pursuant to
 Rule 8.14).
Options on the Dow Jones                      0.01  Lower than $3.00.
 Industrial Average (DJX), as long            0.05  $3.00 and higher.
 as Diamonds options (DIA)
 participate in the Penny Pilot
 Program
Mini-Options......................  ..............  Same as permitted
                                                     for standard
                                                     options on the same
                                                     security.
------------------------------------------------------------------------

    [(1) Subject to paragraphs (2) and (3) below, bids and offers shall
be expressed in decimal increments no smaller than $0.10, unless a
different increment is approved by the Exchange for an option contract
of a particular series.
    (2) Subject to paragraph (3) below, bids and offers for all option
series quoted below $3 a contract shall be expressed in decimal
increments no smaller than $0.05
    (3) The decimal increments for bids and offers for all series of
the option classes participating in the Penny Pilot Program are: $0.01
for all option series quoted below $3 (including LEAPS), and $0.05 for
all option series $3 and above (including LEAPS). For QQQQs, IWM, and
SPY, the minimum increment is $0.01 for all option series. The Exchange
may replace any option class participating in the Penny Pilot Program
that has been delisted with the next most actively-traded, multiply-
listed option class, based on national average daily volume in the
preceding six calendar months, that is not yet included in the Pilot
Program. Any replacement class would be added on the second trading day
following July 1, 2018. The Penny Pilot shall expire on December 31,
2018.]
    ([4]b) Complex Orders. Except as provided in Rule 6.53C, the
minimum increment for bids and offers on complex orders, as defined in
Interpretation and Policy .01 below, [may be expressed in any net price
increment (that may not be less than] is $0.01[)] or greater,
[that]which may be determined by the Exchange on a class-by-class basis
and announced to [the] Trading Permit Holders via Regulatory Circular[,
regardless of the minimum increments otherwise appropriate to the
individual legs of the order].

Notwithstanding the foregoing sentence, the minimum increment for bids
and offers on complex orders in options on the S&P 500 Index (SPX) or
on the S&P 100 Index (OEX and XEO), except for box/roll spreads, [shall
be expressed in decimal increments no smaller than]is $0.05 or greater,
or in any increment, [as]which may be determined by the Exchange on a
class-by-class basis and announced to [the] Trading Permit Holders via
Regulatory Circular. In addition:

([a]i) [T]the legs of a complex order may be executed in $0.01
increments; and
([b]ii) complex orders are subject to special priority requirements as
described in Rules 6.45, 6.53C, 24.19 and 24.20.

    . . . Interpretations and Policies:
    .01 For purposes of this rule, ``complex order'' means a spread,
straddle, combination or ratio order as defined in Rule 6.53, a stock-
option order as defined in Rule 1.1(ii), a security future-option order
as defined in Rule 1.1(zz), or any other complex order as defined in
Rule 6.53C.
    .02 For purposes of this rule, ``box/roll spread'' or ``box
spread'' means an aggregation of positions in a long call option and
short put option with the same exercise price (``buy side'') coupled
with a long put option and short call option with the same exercise
price (``sell side'') all of which have the same aggregate current
underlying value, and are structured as either: ([A]a) a ``long box
spread'' in which the sell side exercise price exceeds the buy side
exercise price or ([B]b) a ``short box spread'' in which the buy side
exercise price exceeds the sell side exercise price.
    .03 When the Exchange determines to change the minimum increment
for a class, the Exchange will designate such change as a stated
policy, practice, or interpretation with respect to the administration
of Rule 6.42 within the meaning of subparagraph (3)(A) of subsection
19(b) of the Act and will file a rule change for effectiveness upon
filing with the Commission.
    .04 The Exchange may replace any option class participating in the
Penny Pilot Program that has been delisted with the next most actively
traded, multiply listed option class, based on national average daily
volume in the preceding six calendar months, that is not yet included
in the Pilot Program. Any replacement class would be added on the
second trading day following July 1, 2018. The Penny Pilot will expire
on December 31, 2018.
    [.03 For so long as SPDR options (SPY) and options on Diamonds
(DIA) participate in the Penny Pilot Program, the minimum increments
for Mini-SPX Index Options (XSP) shall be the same as SPY for all
options series (including LEAPS) and for options on the Dow Jones
Industrial Average (DJX) are $0.01 for all option series quoted below
$3 (including LEAPS), and $0.05 for all option series $3 and above
(including LEAPS).
    .04 The minimum price variation for bids and offers for mini-
options shall be determined in accordance with Interpretation and
Policy .22(d) to Rule 5.5.]
* * * * *

Rule 6.53C. Complex Orders on the Hybrid System

    (a)-(d) No change.
    . . . Interpretations and Policies:
    .01 No change.
    .02 If the Exchange determines to list SPX or VIX on a group basis
pursuant to Rule 8.14, a marketable complex order consisting of legs in
different groups of series in the class does not automatically execute
against individual orders residing in the EBook pursuant to Rule
6.53C(c)(ii)(1) or (d)(v)(1) and automatically executes against complex
orders (or COA responses) in accordance with Rules 6.53C(c)(ii)(2) or
(d)(v)(2) through (4). A marketable complex order consisting of legs in
the same group of series in SPX or VIX executes against individual
orders in the EBook in accordance with Rule 6.53C(c)(ii) and (d)(v).
Complex orders consisting of legs in different groups of series that
are marketable against each other may only execute at a net price that
has priority over the individual orders and quotes resting in the
EBook.
    .03-.12 No change.
* * * * *

Rule 8.3. Appointment of Market-Makers

    (a)-(b) No change.
    (c) Market-Maker Appointments. Absent an exemption by the Exchange,
an appointment of a Market-Maker confers the right to quote
electronically and in open outcry in the Market-Maker's appointed
classes during Regular Trading Hours as described below. Subject to
paragraph (e) below, a Market-Maker may change its appointed classes
upon advance notification to the Exchange in a form and manner
prescribed by the Exchange.
    (i) Hybrid Classes. Subject to paragraphs (c)(iv) and (e) below, a
Market-Maker can create a Virtual Trading Crowd (``VTC'') appointment,
which confers the right to quote electronically during Regular Trading
Hours in an appropriate number of Hybrid classes (as defined in Rule
1.1(aaa)) selected from ``tiers'' that have been structured according
to trading volume statistics, except for the AA tier. All classes
within a specific tier will be assigned an ``appointment cost''
depending upon its tier location. The following table sets forth the
tiers and related appointment costs.

------------------------------------------------------------------------
                                                            Appointment
              Tier                Hybrid option classes        cost
------------------------------------------------------------------------
AA.............................  Options on the Cboe             .499 **
                                  Volatility Index (VIX).
                                 Options on the Standard          1.0 **
                                  & Poor's 500 Index
                                  (SPX).

                              * * * * * * *
------------------------------------------------------------------------
** If the Exchange determines to list SPX or VIX on a group basis
  pursuant to Rule 8.14, the SPX or VIX appointment cost, as applicable,
  confers the right to trade in all SPX or VIX groups, respectively.

    (ii)-(v) No change.
    (d)-(e) No change.
* * * * *

Rule 8.13. Preferred Market-Maker Program

    (a)-(d) No change.
    . . . Interpretations and Policies:
    .01-.03 No change.
    .04 If the Exchange determines to list SPX or VIX on a group basis
pursuant to Rule 8.14, obligations of an SPX or VIX Market-Maker, as
applicable, designated as a Preferred Market-Maker, as set forth in
Rule 8.13, apply on a class basis, unless the Exchange determines to
apply obligations on a group basis.

Rule 8.14. Hybrid Trading System Platforms & Market-Maker Participants

    (a)-(b) No change.
    . . . Interpretations and Policies:

    .01 For each Hybrid 3.0 class, the Exchange may determine to
authorize a group of series of the class for trading on the Hybrid
Trading System and, if that authorization is granted, shall determine
the eligible categories of Market-Maker participants for that group of
series. The Exchange will also have the authority to determine whether
to change the trading platform on which the group of series trades. If
the Exchange lists SPX or VIX on the Hybrid Trading System, the
Exchange may determine to list the class on a group basis, with both
groups trading on the Hybrid Trading System. The Exchange will also
have the authority to change the eligible categories of Market-Makers
participants for each group. In addition, the following shall apply:
    (a)-(c) No change.

Rule 8.15. Lead Market-Makers

    (a)-(d) No change.
    . . . Interpretations and Policies:
    .01-.04 No change.
    .05 If the Exchange determines to list SPX or VIX on a group basis
pursuant to Rule 8.14, obligations of an SPX or VIX Market-Maker, as
applicable, designated as a Lead Market-Maker, as set forth in Rule
8.15, apply on a class basis, unless the Exchange determines to apply
obligations on a group basis.
* * * * *

Rule 8.85. DPM Obligations

    (a)-(e) No change.
    . . . Interpretations and Policies:
    .01-.02 No change.
    .03 If the Exchange determines to list SPX or VIX on a group basis
pursuant to Rule 8.14, obligations of a Designated Primary Market-Maker
with an SPX or VIX appointment, as applicable, as set forth in Rule
8.85, apply on a class basis, except if the Exchange determines to
apply obligations on a group basis.
* * * * *
    (b) Not applicable. [sic]
    (c) Not applicable. [sic]
    The text of the proposed rule change is also available on the
Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend its Rules to permit the Exchange to
list options on the Cboe Volatility Index (``VIX options'') on [sic]
group basis and make conforming changes throughout the Rules, change
the minimum increment for VIX options listed under the Nonstandard
Expirations Pilot Program (if the Exchange lists VIX on a group basis),
and make nonsubstantive changes. Rule 8.14, Interpretation and Policy
.01 currently permits the Exchange to authorize a group of series of a
Hybrid 3.0 \5\ class for trading on the Hybrid Trading System. Rule
8.14, Interpretation and Policy .01 also permits the Exchange to list
options on the S&P 500 (``SPX options'') on a group basis, with both
groups trading on the Hybrid Trading System, if the Exchange lists SPX
on the Hybrid Trading System.\6\ If the Exchange authorizes this, it
determines the eligible categories of Market-Maker participants for the
group (Designated Primary Market-Makers (``DPMs''), Lead Market-Makers
(``LMMs''), or Market-Makers). The Exchange may also appoint no DPM or
LMM to a class if the conditions in Rule 8.14(b) are satisfied with
respect to the class. A DPM's or LMM's obligations will apply to a
class, unless the Exchange determines to apply a DPM's or LMM's
obligations on a group basis. Market-Maker appointments apply on a
class basis. The Exchange establishes Hybrid Trading System trading
parameters (e.g., applicable matching algorithm under Rule 6.45,
opening rotation parameters under Rule 6.2B, automatic execution
parameters under Rule 6.13, simple auction liaison parameters under
Rule 6.13A, hybrid agency liaison parameters under Rule 6.14A, complex
order parameters under Rule 6.53C, and automated improvement mechanism
parameters under Rule 6.74A) on a group basis to the extent the Rules
otherwise provide for such parameters to be established on a class
basis.
---------------------------------------------------------------------------

    \5\ ``Hybrid Trading System'' refers to (i) the Exchange's
trading platform that allows Market-Makers to submit electronic
quotes in their appointed classes and (ii) any connectivity to the
foregoing trading platform that is administered by or on behalf of
the Exchange, such as a communications hub. ``Hybrid 3.0 Platform''
is an electronic trading platform on the Hybrid Trading System that
allows one or more quoters to submit electronic quotes which
represent the aggregate Market-Maker quoting interest in a series
for the trading crowd. Classes authorized by the Exchange for
trading on the Hybrid Trading System are referred to as Hybrid
classes. Classes authorized by the Exchange for trading on the
Hybrid 3.0 Platform are referred to as Hybrid 3.0 classes. See Rule
1.1(aaa). Currently, no classes trade on the Hybrid 3.0 Platform.
    \6\ Currently, the Exchange lists SPX options on the Hybrid
Trading System, and lists the class in two groups--one group
consists of SPX options with A.M.-settled standard third-Friday
expirations and the other group consists of SPX options with P.M.-
settled standard third-Friday expirations and nonstandard end-of-
week or end-of-month expirations. The Exchange lists both groups of
SPX options on the Hybrid Trading System.
---------------------------------------------------------------------------

    The proposed rule change amends Rule 8.14, Interpretation and
Policy .01 to permit the Exchange to list a class [sic] VIX options on
a group basis if the Exchange lists VIX options on the Hybrid Trading
System (which it currently does).\7\ The remaining provisions of
Interpretation and Policy .01 would apply. Thus, if the Exchange lists
VIX options in two groups, it may determine on which trading platform
each group trades (both could trade on the Hybrid Trading System, both
could trade on the Hybrid 3.0 Platform, and one could trade on each
platform) and the eligible categories of Market-Maker participants for
each group. If the Exchange determines to appoint a DPM or LMM, the
obligations of the DPM or LMM would apply to the entire VIX class,
unless the Exchange determines to apply the DPM or LMM obligations, as
applicable, on a group basis.\8\ Market-Maker appointments would
continue to apply to the entire VIX class, as further discussed
below.\9\
---------------------------------------------------------------------------

    \7\ If VIX was a Hybrid 3.0 class, the Exchange would be able to
list it on a group basis today pursuant to Rule 8.14, Interpretation
and Policy .01.
    \8\ The proposed rule change makes conforming changes to Rules
8.15 and 8.85. The proposed rule change also makes a similar change
to Rule 8.13 with respect to Preferred Market-Makers.
    \9\ The Exchange does not currently (and does not intend to)
appoint Preferred Market-Makers (``PMMs'') or DPMs to VIX options
pursuant to Rules 8.13 or 8.95, respectively. The Exchange currently
appoints an on-floor LMM to VIX options (which includes VIXW
options), and may determine to apply a DPM or LMM to each group of
VIX options if the Exchange determines to list VIX on a group basis.
---------------------------------------------------------------------------

    As it does today, when determining whether to list a class on a
group basis, the Exchange intends to generally select series with
common expirations or classifications (e.g., end-of-week series or end-
of-month series, short-term option series, long-term option series, or
series that expire on a particular expiration date) and trade them
under individual listing symbols. For example, the Exchange currently
lists SPX

options with A.M.-settled standard third-Friday expirations under
symbol ``SPX'' and lists options on the S&P 500 Index with P.M-settled
standard third-Friday expirations and nonstandard expirations with all
other expirations under symbol ``SPXW.'' The Exchange would provide
sufficient notice to Trading Permit Holders if it determines to list
VIX on a group basis.
    If the Exchange determines to list VIX on a group basis, the
Exchange would establish trading parameters (e.g. applicable matching
algorithm under Rule 6.45, opening rotation parameters under Rule 6.2,
automatic execution parameters under Rule 6.13, simple auction liaison
parameters under Rule 6.13A, hybrid agency liaison parameters under
Rule 6.14A, complex order parameters under Rule 6.53C, and automated
improvement mechanism parameters under Rule 6.74A) on a group basis, as
it does today for SPX and SPXW. Pursuant to the proposed rule change,
the Exchange could apply a different allocation algorithm to each group
of VIX options.
    The Exchange believes for VIX, groups of series may exhibit
different trading characteristics, including appeal to different
categories of market participants. For example, the Exchange believes
VIXW options may be more appealing to retail customers given their
short expiration, and would be in more demand with a smaller trading
increment (see discussion below). The Exchange generally establishes
market models for classes based on these characteristics that most fit
the product, which the Exchange believes benefits investors. This is
true for VIX options with standard third-Friday expirations and VIX
options with nonstandard expirations, which is why the Exchange
believes it is appropriate to permit the Exchange to list VIX options
in groups.
    The Exchange proposes to amend Rule 6.53C, Interpretation and
Policy .02 to state if the Exchange determines to list VIX options on a
group basis pursuant to Rule 8.14, if a marketable complex order
consists of legs in different groups of series in the class, it will
not automatically execute against individual orders residing in the
EBook pursuant to Rule 6.53C(c)(ii)(1) or (d)(v)(1). This is consistent
with current functionality today applicable to SPX and SPXW pursuant to
Rule 6.53C, Interpretation and Policy .10. The proposed rule change
extends this functionality to VIX, if the Exchange lists it on a group
basis.
    As discussed above, if the Exchange lists VIX on a group basis, the
Exchange may apply different trading parameters (including different
allocation algorithms) to each group. Due to system limitations that in
the Exchange's experience were prohibitively expensive to modify,
complex orders consisting of different groups of series will not
automatically execute against individual orders residing in the EBook,
even if they trade on the same platform. Pursuant to Rule 6.53C,
complex orders may only consist of legs from the same class. While VIX
and VIXW series would be part of the same class even if the Exchange
lists VIX on a group basis, and thus permissible for electronic
handling under the Rules, the System would treat VIX and VIXW series as
different classes (since they would potentially have different
settings) and would be unable to process complex orders with components
in different classes. The System has settings for each class.
Currently, trading is not possible ``across'' classes given these
different settings. Each class also has separate market data inputs, as
the System must read different market data for each class in connection
with potential executions in the class. If the System receives a
complex order with one VIX leg and one VIXW leg, it would need to trade
the VIX leg against the appropriate leg in the VIX ``class.'' After
that leg execution, it would then need to trade the VIXW leg against
the appropriate leg in the VIXW ``class.'' Given the time these
executions would take across classes, it would not result in the near
simultaneous execution of legs that is sought by the entry of complex
orders. Additionally, after the first leg execution, because the
complex order has not fully executed, the System would not be able to
execute any other orders within the series of the first leg, which may
prevent execution opportunities of those other orders.
    For example, suppose the Exchange lists VIX on a group basis, as
VIX and VIXW (similar to SPX and SPXW). The Exchange may determine
pursuant to Rule 6.45(a) the allocation algorithm applicable to VIX/
VIXW orders.\10\ VIX/VIXW orders may execute against other VIX/VIXW
orders in the COB upon entry or against orders and COA responses
following a COA in accordance with the allocation and priority rules
set forth in 6.53C(c)(ii)(2) and (d)(v)(2) through (4),
respectively.\11\ The proposed rule change states marketable VIX/VIXW
orders will be eligible to automatically execute against other VIX/VIXW
orders resting in the COB provided the execution is at a net price that
has priority over the individual orders and quotes residing in the
EBook (which is consistent with the manner in which the Exchange
currently handles these complex orders are handled [sic], as provided
in Rule 6.53C, Interpretation and Policy .10(b)). A VIX/VIXW order that
is marketable against individual orders resting in the EBook but not
marketable against any complex orders resting in the COB or COA
responses will enter the COB or instead be routed to a PAR workstation
during Regular Trading Hours and rejected back to the Trading Permit
Holder during Extended Trading Hours if not eligible for COB entry due
to the terms of the order (for example, if the order is for an origin
code the Exchange does not permit to rest in the COB). This is how SPX/
SPXW orders are handled today.\12\
---------------------------------------------------------------------------

    \10\ Rule 6.45(a)(i) permits the Exchange to determine which
base electronic allocation algorithm will apply to a class, and Rule
6.53C(ii)(2) permits the Exchange to determine which electronic
allocation algorithm will apply to executions of complex orders on
the COB. Pursuant to the proposed rule change, as discussed above,
the Exchange may establish trading parameters on a group basis when
the Rules otherwise provide for parameters to be established on a
class basis.
    \11\ Rule 6.53C(c)(ii)(2) states the allocation of a complex
order within the COB will be pursuant to the rules of trading
priority otherwise applicable to incoming electronic orders in the
individual component legs or another electronic matching algorithm
from Rule 6.45, as determined by the Exchange on a class-by-class
basis. Therefore, pursuant to that provision and the proposed rule
change, the Exchange will determine for VIX/VIXW complex orders
which electronic matching algorithm will apply to those orders when
executing against other orders in the COB. Rules 6.53(d)(v)(2)
through (4) specify the matching algorithm applicable to complex
orders that execute following a COA, and those provisions will apply
to VIX/VIXW complex orders pursuant to the proposed rule change.
    \12\ See Rule 6.12(a)(1), which states orders initially routed
for electronic processing that are not eligible for automatic
execution or book entry will route to PAR or back to the Trading
Permit Holder, Rule 6.53C(d)(vi), which states a COA-eligible order
that cannot be filled in whole or in a permissible ratio will route
to the COB or back to PAR, as applicable, and Rule 6.1A(b), which
states if in accordance with the Rules, an order would route to PAR,
the order entry firm's booth, or otherwise for manual handling, the
System will return the order to the Trading Permit Holder during
Extended Trading Hours.
---------------------------------------------------------------------------

    The proposed rule change amends Rule 8.3(c)(i) to state if the
Exchange determines to list VIX on a group basis pursuant to Rule 8.14,
the appointment cost for VIX confers the right to trade in all groups
of the class. This is consistent with how appointment costs currently
work for VIX, and is consistent with how the appointment cost for SPX
works (which the Exchange has determined to list on a group basis). A
VIX Market-Maker's obligations pursuant to Rule 8.7 will continue to
apply to VIX on a class basis (i.e., series within all VIX groups),
even if the

Exchange lists VIX on a group basis. This is consistent with how VIX
Market-Makers' obligations apply to VIX today, as VIX Market-Makers'
obligations apply to all VIX series. The Exchange proposes no change to
the appointment cost, and thus Market-Makers with VIX appointments will
not need to purchase any additional trading permits to quote VIX if the
Exchange determines to list VIX on a group basis.
    The Exchange also proposes to amend Rule 6.42 to permit series of
VIX options listed under the Nonstandard Expiration pilot program
(``VIXW'') to have a minimum increment of $0.01 for all strike prices
if the Exchange determines to list VIX on a group basis. Currently, all
VIX options have a minimum increment of $0.05 for series trading below
$3 and $0.10 for series trading above $3.\13\ The Exchange believes
market demand (particularly by retail investors, who generally prefer
lower trading increments) supports a lower trading increment for these
series. Permitting a different minimum increment for VIXW and VIX is
consistent with the Exchange's current authority (as discussed above)
to determine all trading parameters and market model elements other
than minimum increment on a group basis to address different trading
characteristics and market demand between groups of series. Permitting
VIXW series to trade at a different minimum increment than VIX series
will permit the Exchange to similarly address the different trading
characteristics and market demand for these two groups of series.
---------------------------------------------------------------------------

    \13\ As set forth in proposed Rule 6.42, if the Exchange does
not list VIX on a group basis, these same increments would apply to
the entire class.
---------------------------------------------------------------------------

    Additionally, penny pricing is available in weekly options on
competitor products such as the iPath S&P 500 VIX Short-Term Futures
exchange-traded note (``VXX''). As a result, the Exchange believes
penny pricing for VIXW options is necessary for competitive reasons to
allow the Exchange to price these weekly options at the same level of
granularity as permitted for competitor weekly products.\14\ The
Exchange expects this more granular pricing to lead to narrowing of the
bid-ask spread for these options and increase the possible number of
price points available to investors for these series. The Exchange also
notes that penny increments are appropriate for Nonstandard Expiration
series, because they have shorter durations than standard options, and
finer increments permit more precise pricing in line with the
theoretical value of these shorter-term options. The proposed rule
change also makes nonsubstantive changes to Rule 6.42, including moving
certain provisions from the main body of the Rule to interpretations
and policies .03 and .04, making language more plain English,
conforming paragraph numbering and lettering to other rules, and
displaying the increments in a more user-friendly table.
---------------------------------------------------------------------------

    \14\ The Exchange notes that other options that trade on the
Exchange are currently permitted to trade in penny increments
because competitive products are able to trade in penny increments.
See Rule 6.42, Interpretation and Policy .03 (the minimum for XSP
options is $0.01 because that is the minimum increment for SPY
options, and the minimum increment for DJX options is $0.01 for
series below $3 and $0.05 for series $3 and above because that is
the minimum increment for DIA options).
---------------------------------------------------------------------------

    With regard to the impact of this proposed rule change on system
capacity, the Exchange has analyzed its capacity and represents that it
and the Options Price Reporting Authority have the necessary systems
capacity to handle any potential additional traffic associated with
this proposal. The Exchange does not believe any potential increased
traffic will become unmanageable since this proposed rule change with
respect to minimum trading increments is limited to a single class of
options. The proposed rule change does not impact the number of
expirations for VIX options the Exchange may list pursuant to Rule
24.9.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\15\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \16\ requirements that the rules of an exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and facilitating
transactions in securities, to remove impediments to and perfect the
mechanism of a free and open market and a national market system, and,
in general, to protect investors and the public interest. Additionally,
the Exchange believes the proposed rule change is consistent with the
Section 6(b)(5) \17\ requirement that the rules of an exchange not be
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(5).
    \17\ Id.
---------------------------------------------------------------------------

    In particular, the Exchange believes the proposed rule change to
permit the Exchange to list VIX options on a group basis will benefit
investors and promote just and equitable principles of trade, as it
provides the Exchange with flexibility to establish a more appropriate
market model for a group of VIX options series that may exhibit
different trading characteristics than other series in the class, even
if both groups trade on the same platform. Currently, the Exchange may
list VIX on a group basis if the groups of a class trade on different
trading platforms (e.g., if VIX was a Hybrid 3.0 class); the proposed
rule change merely permits the Exchange to similarly list VIX on a
group basis on the same trading platform.
    Similarly, the proposed rule change to provide [sic] that VIX/VIXW
complex orders will not execute against individual orders in the EBook,
which is consistent with the treatment of SPX/SPXW orders. These orders
will continue to be eligible for electronic processing, including
electronic execution, in the same manner as complex orders consisting
of VIX series only or VIXW series only, except they will not
automatically execute against individual orders in the EBook for the
legs due to system limitations described above and would instead rest
in the COB (if eligible) or route to PAR or the Trading Permit Holder
during Regular Trading Hours, or be rejected back to the Trading Permit
Holder during Extended Trading Hours.
    Additionally, the proposed rule change will similarly benefit
investors. Retail customers generally prefer options with shorter
expirations, and the proposed rule change will permit series of VIX
with short expirations to be listed in a smaller increment consistent
with that demand from retail investors. Permitting a different minimum
increment for VIXW and VIX is consistent with the Exchange's current
authority (as discussed above) to determine all trading parameters and
market model elements other than minimum increment on a group basis to
address different trading characteristics and market demand between
groups of series. Permitting VIXW series to trade at a different
minimum increment than VIX series will permit the Exchange to similarly
address the different trading characteristics and market demand for
these two groups of series.
    Penny increments for VIXW series may lead to more granular pricing
and narrowing of the bid-ask spread for these options and increase the
possible

number of price points available for investors for these series.
Additionally, as discussed above, penny pricing is available in weekly
options on competitive products. The Exchange believes penny pricing
for VIXW options is necessary for competitive reasons, which will and
promote just and equitable principles of trade, to allow the Exchange
to price these weekly options at the same level of granularity as
permitted for competitor weekly products.\18\ The Exchange also notes
that penny increments are appropriate for Nonstandard Expiration
series, because they have shorter durations than standard options, and
finer increments permit more precise pricing in line with the
theoretical value of these shorter-term options.
---------------------------------------------------------------------------

    \18\ The Exchange notes that other options that trade on the
Exchange are currently permitted to trade in penny increments
because competitive products are able to trade in penny increments.
See Rule 6.42, Interpretation and Policy .03 (the minimum for XSP
options is $0.01 because that is the minimum increment for SPY
options, and the minimum increment for DJX options is $0.01 for
series below $3 and $0.05 for series $3 and above because that is
the minimum increment for DIA options).
---------------------------------------------------------------------------

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

    Cboe Options 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 proposed rule change has
no impact on intramarket competition, as it will apply to all market
participants that trade VIX if the Exchange determines to list VIX on a
group basis. If VIX was a Hybrid 3.0 class, the Exchange could
determine to list VIX on a group basis under current rules; the
proposed rule change merely permits the Exchange to similarly list VIX
on a group basis on the same trading platform. The proposed rule change
has no impact on intermarket competition, as the proposed rule change
relates to products exclusively listed on the Exchange. Additionally,
the proposed rule change to permit VIXW options to be listed in penny
increments may relieve any burden on, or otherwise promote,
competition, as it will allow the Exchange to price these options at
the same level of granularity as permitted for competitor weekly
products. The Exchange notes that other options that trade on the
Exchange are currently permitted to trade in penny increments because
competitive products are able to trade in penny increments.\19\
---------------------------------------------------------------------------

    \19\ See Rule 6.42, Interpretation and Policy .03 (the minimum
for XSP options is $0.01 because that is the minimum increment for
SPY options, and the minimum increment for DJX options is $0.01 for
series below $3 and $0.05 for series $3 and above because that is
the minimum increment for DIA options).
---------------------------------------------------------------------------

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

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

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

    Because the foregoing proposed rule change does not:
    A. Significantly affect the protection of investors or the public
interest;
    B. impose any significant burden on competition; and
    C. become operative for 30 days from the date on which it was
filed, or such shorter time as the Commission may designate, it has
become effective pursuant to Section 19(b)(3)(A) of the Act \20\ and
Rule 19b-4(f)(6) \21\ thereunder. At any time within 60 days of the
filing of the proposed rule change, the Commission summarily may
temporarily suspend such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission will institute proceedings to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78s(b)(3)(A).
    \21\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-CBOE-2018-066 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2018-066. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CBOE-2018-066, and should be submitted
on or before November 19, 2018.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\22\
---------------------------------------------------------------------------

    \22\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-23508 Filed 10-26-18; 8:45 am]
BILLING CODE P


[Federal Register: April 26, 2006 (Volume 71, Number 80)]
[Notices]
[Page 24692-24693]
[DOCID:fr26ap06-78]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0190; FRL-8062-5

Notice of Filing of a Pesticide Petition for Establishment of a
Regulation for Residues of Metaldehyde in or on Various Food
Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of a regulation for residues of
the molluscicide metaldehyde in or on various food commodities.

DATES: Comments must be received on or before May 26, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0190 and pesticide petition number (PP)
5F6995, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502C), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPP Regulatory Public Docket, Environmental
Protection Agency, Rm. 119, Crystal Mall 2, 1801 S. Bell St.,
Arlington, VA. Deliveries are only accepted during the Docket's normal
hours of operation (8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays). Special arrangements should be made for
deliveries of boxed information. The Docket telephone number is (703)
305-5805.
     Important Note: OPP will be moving to a new location the
first week of May 2006. As a result, from Friday, April 28 to Friday,
May 5, 2006, the OPP Regulatory Public Docket will NOT be accepting any
deliveries at the Crystal Mall 2 address and this facility
will be closed to the public. Beginning on May 8, 2006, the OPP
Regulatory Public Docket will reopen at 8:30 a.m. and deliveries will
be accepted in Rm. S-4400, One Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA 22202. The mail code for the mailing
address will change to (7502P), but will otherwise remain the same. The
Docket telephone number and hours of operation will remain the same
after the move.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0190. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

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

if only available in hard copy, at the OPP Regulatory Public Docket at
the location identified under ``Delivery'' and ``Important Note.'' The
hours of operation for this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
telephone number is<PHONE_NUMBER>.

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

I. General Information

A. Does this Action Apply to Me?

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

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

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

II. What Action is the Agency Taking?

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

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

New Tolerance

    (PP) 5F6995. Lonza, Inc., 90 Boroline Road, Annandale, NJ 07401,
proposes to establish a tolerance for residues of the molluscicide
metaldehyde in or on food commodities broccoli, cabbage, mustard
(greens) (representing the Brassica (Cole) Crop Group) at 2.5 parts per
million (ppm); lemon, grapefruit, and oranges (representing the Citrus
Crop Group) at 0.26 ppm; tomato at 0.24 ppm; lettuce at 1.73 ppm;
strawberries at 6.25 ppm; and the processed food commodities citrus,
oil and dry pulp at 0.26 ppm; and tomato, paste and puree at 0.24 ppm.
The analytical method for the determination of the residues of
metaldehyde in various food crops was validated with respect to
specificity and non-analyte interference, precision (repeatability),
accuracy, sensitivity, linearity, of standards, stability of standard
solutions and precision (replicate injections) under EN-CAS Analytical
Laboratories Study No. 99-0055 (MRID 46010501). The method of detection
(GS/MSD) ensured the specificity of the method.

List of Subjects

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

    Dated: April 17, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E6-6293 Filed 4-25-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 77, Number 138 (Wednesday, July 18, 2012)]
[Notices]
[Pages 42305-42306]
[FR Doc No: 2012-17486]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OEI-2012-0547, FRL-9520-4]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Regulations.gov Information Collection

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this
document announces that EPA is planning to submit a request to the
Office of Management and Budget (OMB) to renew the following existing
Information Collection Request (ICR): Regulations.gov Information
Collection, OMB Control Number 2025-0008, EPA ICR Number 2357.04.
Before submitting this ICR to OMB for review and approval, EPA is
soliciting comments on specific aspects of the proposed information
collection as described below.

DATES: Comments must be submitted on or before September 17, 2012.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OEI-
2012-0547, to (1) EPA online using www.regulations.gov (our preferred
method), by email to<EMAIL_ADDRESS>by mail to: EPA Docket
Center, Environmental Protection Agency, mail code 28221T, 1200
Pennsylvania Ave. NW., Washington, DC 20460, or by hand delivery: EPA
Docket Center, EPA West Bldg, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC 20460. Such deliveries are only accepted during the
Docket's normal hours of operation.

FOR FURTHER INFORMATION CONTACT: Shanita Brackett, OEI/OIC/CStD at the
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., (2822T),
Washington, DC 20460; telephone number<PHONE_NUMBER>; fax number (202)
566-1008: email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

What information is EPA particularly interested in?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to: (i) Evaluate whether
the proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) Evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) Enhance the quality, utility, and clarity of the
information to be collected; and (iv) Minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. In
particular, EPA is requesting comments from very small businesses
(those that employ less than 25) on examples of specific additional
efforts that EPA could make to reduce the paperwork burden for very
small businesses affected by this collection.

What should I consider when I prepare my comments for EPA?

    You may find the following suggestions helpful for preparing your
comments. 1. Explain your views as clearly as possible and provide
specific examples. 2. Describe any assumptions that you used. 3.
Provide copies of any technical information and/or data you used that
support your views. 4. If you estimate potential burden or costs,
explain how you arrived at the estimate that you provide. 5. Offer
alternative ways to improve the collection activity. 6. Make sure to
submit your comments by the deadline identified under DATES. 7. To
ensure proper receipt by EPA, be sure to identify the ICR title on the
first page of your response. You may also provide the Federal Register
citation.

What Information Collection Activity or ICR does this apply to?

    Title: Regulations.gov Information Collection. OMB Control Number:
2025-0008.
    Abstract: In response to the Presidential memorandum, the
eRulemaking Program launched the Regulations.gov `feedback exchange'
Web site in May 2009. This interactive Web site showcases new
technologies being considered for the Regulations.gov `feedback
exchange' and Regulations.gov, as well as other agency-specific
initiatives and rulemaking activities. The `feedback exchange' serves
as a learning laboratory for open government, enabling the public to
provide input on the Regulations.gov interface, build a community of
practice on the Federal regulatory development process, and ensure that
the eRulemaking Program can efficiently manage federal resources by
testing new tools before they are launched. New technologies considered
for the Regulations.gov `feedback exchange' and Regulations.gov
include: User Profiles; Comment Threads and Wikis; Ratings, Polls, and
Tagging; an interactive Educational Tool; and Information Export and
Sharing capabilities, such as application programming interfaces (or
APIs). These technologies have been deployed iteratively, with some
components deployed upon the site's original release in May 2009, and
others deployed during updates throughout the last three years. Other
components are still being considered and will be released during
subsequent upgrades to the Regulations.gov `feedback exchange' and
Regulations.gov. User profiles enable the public to register on the
site and pre-load submitter information for later use as well as save
their own

personalized searches, RSS feeds, and email alerts without the use of
persistent cookies. Comment Threads allow the public to enter into
virtual conversations with one another about a topic. Wikis enable the
public to collaboratively develop and modify narrative descriptions
about a topic. Ratings and Polls allow the public to indicate a
preference for a topic or issue via the selection of stars or thumbs
up/thumbs down icons which graphically provide an at-a-glance
indication of public sentiment and can simplify navigation. Tagging
provides the public with the ability to tag or label information they
or someone else has posted to the site to ease navigation and to
promote the formation of common interest categories. The Educational
Tool informs the public about the Federal rulemaking process through
interactive text and images. The Data Export capability and APIs enable
the public to download and review the contents of a rulemaking docket
as well as mix and match such information with other information in new
and innovative ways. The Regulations.gov ``feedback exchange'' relies
on feedback from Government, Industry, Academia and Citizenry to
improve Regulations.gov as time goes on.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 35
hours per year. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
    Affected Entities: Anyone that chooses to visit Regulations.gov.
    Estimated Total Number of Potential Respondents: 1,000.
    Estimated Total Number of Potential Responses: 7,000.
    Frequency of Response: Occasionally.
    Estimated Total Annual Burden Hours: 35 hours.
    Estimated Total Annual Capital and Operations and Maintenance
Costs: $30,000.

What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. At that time, EPA will
issue another Federal Register notice pursuant to 5 CFR
1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB. If you have any
questions about this ICR or the approval process, please contact the
person listed under FOR FURTHER INFORMATION CONTACT.

John Moses,
Director, Collection Strategies Division.
[FR Doc. 2012-17486 Filed 7-17-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 130 (Friday, July 8, 2022)]
[Notices]
[Pages 40847-40849]
[FR Doc No: 2022-14548]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-E-1909; FDA-2020-E-1906; FDA-2020-E-1901; FDA-
2020-E-1899]

Determination of Regulatory Review Period for Purposes of Patent
Extension; PADCEV

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for PADCEV and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by September 6, 2022.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by January 4, 2023. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing

system will accept comments until 11:59 p.m. Eastern Time at the end of
September 6, 2022. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2020-E-1909; FDA-2020-E-1906; FDA-2020-E-1901; FDA-2020-E-1899, for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; PADCEV.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO may award (for example, half the testing phase must
be subtracted as well as any time that may have occurred before the
patent was issued), FDA's determination of the length of a regulatory
review period for a human biological product will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human biologic product PADCEV
(enfortumab vedotin-ejfv). PADCEV is indicated for the treatment of
adult patients with locally advanced or metastatic urothelial cancer
who have previously received a programmed death receptor-1 or
programmed death-ligand inhibitor, and a platinum-containing
chemotherapy in the neoadjuvant/adjuvant, locally advanced or
metastatic setting. This indication is approved under accelerated
approval based on tumor response rate. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in confirmatory trials. Subsequent to this approval,
the USPTO received patent term restoration applications for PADCEV
(U.S. Patent Nos. 9,078,931; 9,314,538; 9,962,454; RE48,389 (previously
U.S. Patent No. 8,637,642)) from AGENSYS, Inc. and SEATTLE GENETICS,
Inc., and the USPTO requested FDA's assistance in determining the
patents' eligibility for patent term restoration. In a letter dated
December 14, 2020, FDA advised the USPTO that this human biological
product had undergone a regulatory review period and that the approval
of PADCEV represented the first permitted

commercial marketing or use of the product. Thereafter, the USPTO
requested that FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
PADCEV is 2,546 days. Of this time, 2,389 days occurred during the
testing phase of the regulatory review period, while 157 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: December
30, 2012. The applicants' claim January 4, 2013, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was December 30, 2012,
which was the first date after receipt of the IND that the
investigational studies were allowed to proceed.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): July 15, 2019. FDA has verified the
applicants' claims that the biologics license application (BLA) for
PADCEV (BLA 761137) was initially submitted on July 15, 2019.
    3. The date the application was approved: December 18, 2019. FDA
has verified the applicants' claims that BLA 761137 was approved on
December 18, 2019.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 374 days, 748 days, or 811 days of patent term
extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: July 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14548 Filed 7-7-22; 8:45 am]
BILLING CODE 4164-01-P