[Federal Register Volume 82, Number 176 (Wednesday, September 13, 2017)]
[Notices]
[Pages 43064-43066]
[FR Doc No: 2017-19378]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81549; File No. SR-NYSEAMER-2017-08]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing and Immediate Effectiveness of a Proposed Rule Change To Modify
the NYSE American Options Fee Schedule

September 7, 2017.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on August 31, 2017, NYSE American LLC (the ``Exchange'' or
``NYSE American'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by the self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to modify the NYSE American Options Fee
Schedule. The proposed change is available on the Exchange's Web site
at www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of this filing is to amend the Fee Schedule effective
September 1, 2017. Specifically, the Exchange proposes to modify the
surcharge that is applied to certain Complex Orders executed on the
Exchange.
    Currently, the Exchange imposes a $0.05 per contract surcharge for
any Electronic Non-Customer Complex Order that executes against a
Customer Complex Order, regardless of whether the execution occurs in a
Complex Order Auction (the ``Surcharge'').\4\ The Exchange proposes to
modify the Surcharge to $0.10 per contract, which surcharge is
comparable to charges imposed by other options exchanges.\5\ For
clarity, the Exchange also proposes to make clear that the Surcharge is
applied on a ``per contract'' basis.\6\
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    \4\ See Fee Schedule, Section I.A., n. 6, available here,
https://www.nyse.com/publicdocs/nyse/markets/american-options/NYSE_American_Options_Fee_Schedule.pdf. Per the Fee Schedule, a
``Customer'' is an individual or organization that is not a Broker-
Dealer, per Rule 900.2NY(18); and is not a Professional Customer;
and a ``Non-Customer'' is anyone who is not a Customer. See id., Fee
Schedule, Key Terms and Definitions. Thus, Non-Customers include
Specialists, e-Specialists, Directed Order Market Makers, Firms,
Broker Dealers, and Professional Customers. The Exchange notes that
Firm Facilitation trades are not electronic and are therefore not
subject to the Surcharge.
    \5\ See MIAX Options fee schedule, available here, https://www.miaxoptions.com/sites/default/files/fee_schedule-files/MIAX_Options_Fee_Schedule_08072017.pdf (imposing a $0.10 on certain
complex orders). See also The Chicago Board Options Exchange, Inc.
(``CBOE'') fee schedule, available here, http://www.cboe.com/publish/feeschedule/CBOEFeeSchedule.pdf, at n. 35 (same).
    \6\ See proposed Fee Schedule, Section I.A., n. 6. The Exchange
also proposes to correct a typographical error referring to ``a CUBE
Auctions'' by removing the word ``a.'' See id.
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    Additionally, to encourage ATP Holders to transact additional Non-
Customer Complex Orders on the Exchange, the Exchange proposes to offer
a reduced Surcharge for those ATP Holders that meet a certain volume
threshold. Specifically, the Exchange proposes to reduce the per
contract surcharge to $0.07 for any ATP Holder that transacts at least
0.20% of Total Industry Customer equity and ETF option average daily
volume (or TCADV) of Electronic Non-Customer Complex Order Executions
in a month.
    Finally, the Exchange proposes to add ``TCADV'' as a defined term
in the Key

Terms and Definitions section of the Fee Schedule, which would add
clarity and transparency to the Fee Schedule.\7\ As proposed, TCADV
would refer to ``Total Industry Customer equity and ETF option average
daily volume that includes OCC calculated Customer volume of all types,
including Complex Order Transactions and QCC transactions, in equity
and ETF options.'' \8\ This proposed definition is consistent with how
other options exchanges define this term.\9\ Consistent with this
proposed change, the Exchange proposes to utilize this defined term in
Section I.E. regarding the American Customer Engagement (``ACE'')
Program.\10\
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    \7\ See Fee Schedule, Preface, Key Terms and Definitions.
    \8\ See proposed Fee Schedule, Preface, Key Terms and
Definitions.
    \9\ See e.g., NYSE Arca Options Fee Schedule, Endnote 8.
    \10\ See proposed Fee Schedule, Section I.E. The Exchange also
proposes to fix a typographical error and add the word ``for'' to
the end of the first paragraph describing the ACE Program, which
would clearly provide that the ACE Program offers ``two methods for
OFPs to receive credits'' (emphasis added). See id.
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2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\11\ in general, and furthers the
objectives of Sections 6(b)(4) and (5) of the Act,\12\ in particular,
because it provides for the equitable allocation of reasonable dues,
fees, and other charges among its members, issuers and other persons
using its facilities and does not unfairly discriminate between
customers, issuers, brokers or dealers.
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    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(4) and (5).
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    The Exchange believes the proposed increase to the Surcharge is
reasonable, equitable, and not unfairly discriminatory, as it applies
to all similarly situated Non-Customer Complex Orders. Applying the
Surcharge, as modified, to market participant orders except Customer
orders is equitable and not unfairly discriminatory because Customer
order flow enhances liquidity on the Exchange for the benefit of all
market participants. Specifically, Customer liquidity benefits all
market participants by providing more trading opportunities, which
attracts Market Makers. An increase in the activity of Specialists and
Market Makers in turn facilitates tighter spreads, which may cause an
additional corresponding increase in order flow from other market
participants.
    In addition, the proposed surcharge is reasonable, equitable, and
not unfairly discriminatory as it is consistent with fees charged by
other options exchanges.\13\ For example, MIAX imposes a $0.10 ``Per
Contract Surcharge for Removing Liquidity Against A Resting Priority
Customer Complex Order on the Strategy Book'' for all option classes),
which may result in an overall per contract fee of $0.60.\14\
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    \13\ See supra note 5.
    \14\ See MIAX fee schedule, supra note 5 (providing for a
potential total per contract fee of $0.60 for Market Makers, which
includes a ``Complex Per Contract Fee for Penny Classes,'' a per
contract ``Marketing Fee,'' and a $0.10 ``Per Contract Surcharge for
Removing Liquidity Against a Resting Priority Customer Complex Order
on the Strategy Book for Penny and Non-Penny Classes''). The
Exchange believes that MIAX does not subject transactions in a
complex order auction to any fee cap. See also Securities Exchange
Act Release No. 80262 (March 16, 2017), 82 FR 14779 (March 22, 2017)
(SR-NYSEMKT-2017-15) (establishing the Surcharge).
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    Further, the Exchange believes that the proposal to offer a reduced
surcharge to those ATP Holders that achieve certain volume thresholds
is reasonable, equitable and not unfairly discriminatory. The Exchange
believes the proposed reduced rate is reasonably designed to encourage
ATP Holders that transact Non-Customer Complex Orders to direct more of
this order flow to the Exchange to qualify for the reduced rates. The
proposed rates are reasonable and equitable and not unfairly
discriminatory because they apply equally to all ATP Holders that
transact Non-Customer Complex Orders. In addition, the proposed changes
are equitable and not unfairly discriminatory because, while only Non-
Customer Complex Orders qualify for the reduced surcharge, the Exchange
believes any increase in Non-Customer Complex Orders would result in
greater volume and liquidity being attracted to the Exchange, which
benefit all market participants by providing more trading opportunities
and tighter spreads.\15\ To the extent this goal is achieved, the
Exchange would improve its overall competitiveness and strengthen its
market quality for all market participants.
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    \15\ The Exchange notes that it does not impose any fee on
Electronic executions of Customer interest.
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    The proposal to define ``TCADV'' in the Fee Schedule, as well as to
fix the typographical errors in Section I.A.\16\ and I.E.,\17\ is
likewise reasonable, equitable and not unfairly discriminatory because
it would add clarity and transparency to the Fee Schedule to the
benefit of all market participants.
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    \16\ See supra note 6.
    \17\ See supra note 10.
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    For these reasons, the Exchange believes that the proposal is
consistent with the Act.

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

    In accordance with Section 6(b)(8) of the Act,\18\ the Exchange
does not believe that the proposed rule change would impose any burden
on competition that is not necessary or appropriate in furtherance of
the purposes of the Act. The proposed modification to the Surcharge
would not impose an unfair burden on competition as it is consistent
with fees charged by other exchanges.\19\ Further, the proposal to
reduce the surcharge for certain ATP Holders that achieve certain
volume thresholds would likewise not impose an unfair burden on
competition because it is designed to attract Non-Customer Complex
Orders to the Exchange. To the extent that this purpose is achieved,
this proposal would enhance the quality of the Exchange's markets and
increase the volume of Complex Orders traded here. In turn, all the
Exchange's market participants would benefit from the improved market
liquidity. If the proposed changes make the Exchange a more attractive
marketplace for market participants at other exchanges, such market
participants are welcome to become ATP Holders.
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    \18\ 15 U.S.C. 78f(b)(8).
    \19\ See supra note 5.
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    The Exchange notes that it operates in a highly competitive market
in which market participants can readily favor competing venues. In
such an environment, the Exchange must continually review, and consider
adjusting, its fees and credits to remain competitive with other
exchanges. For the reasons described above, the Exchange believes that
the proposed rule change reflects this competitive environment.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \20\ of the Act and

subparagraph (f)(2) of Rule 19b-4 \21\ thereunder, because it
establishes a due, fee, or other charge imposed by the Exchange.
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    \20\ 15 U.S.C. 78s(b)(3)(A).
    \21\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \22\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \22\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEAMER-2017-08 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-NYSEAMER-2017-08. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of 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; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEAMER-2017-08, and should
be submitted on or before October 4, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
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    \23\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-19378 Filed 9-12-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: October 1, 2008 (Volume 73, Number 191)]
[Proposed Rules]
[Page 57040-57046]
[DOCID:fr01oc08-23]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0647; FRL-8382-4]

Chlorantraniliprole; Proposed Time-Limited Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes to establish time-limited tolerances
for residues of chlorantraniliprole in or on cowpeas, forage and hay;
field peas, vines and hay; forage, fodder and straw of cereal grains,
crop group 16; grass forage, fodder and hay, crop group 17; leaves of
root and tuber vegetables, crop group 2, leeks, nongrass animal feeds
(forage, fodder, straw and hay), crop group 18; okra; onions, green;
onions, Welsh; peanuts, hay; shallots; soybeans, forage and hay;
strawberries and sugarcane, sugar under the Federal Food, Drug, and
Cosmetic Act (FFDCA). The tolerances expire on April 25, 2010.

DATES: Comments must be received on or before December 1, 2008.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2008-0647, 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 docket ID number EPA-HQ-OPP-
2008-0647. 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: Kable Bo Davis, Registration Division
(7505P), Office of Pesticide Programs, 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 ID number and other identifying
information (subject heading, Federal Register date and page number).
     ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background and Statutory Findings

    EPA on its own initiative, under section 408(e) of FFDCA, 21 U.S.C.
346a(e), is proposing to establish a tolerances for residues of the
insecticide chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-
[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide, in or on cowpeas, forage and hay at 0.20 parts per million
(ppm); field peas, vines and hay at 0.20 ppm; forage, fodder and straw
of cereal grains, crop group 16 at 0.20 ppm, grass forage, fodder and
hay, crop group 17 at 0.20 ppm; leaves of root and tuber vegetables,
crop group 2 at 0.20 ppm; leeks at 0.20 ppm; nongrass animal feeds
(forage, fodder, straw and hay), crop group 18 at 0.20 ppm; okra at
0.70 ppm; onions, green at 0.20 ppm; onions,

Welsh at 0.20 ppm; peanuts, hay at 0.20 ppm; shallots at 0.20 ppm;
soybeans, forage and hay at 0.20 ppm; strawberries at 1.2 ppm; and
sugarcane, sugar at 0.20 ppm.
    Recently, EPA established tolerances for chlorantraniliprole on
apple, wet pomace; brassica, head and stem, subgroup 5A; brassica,
leafy greens, subgroup 5B; cotton, gin byproduct; cotton, hulls; cotton
undelinted seed; fruit, pome, group 11; fruit, stone, group 12; grape;
grape, raisen; potato; vegetable, cucurbit, group 9; vegetable,
fruiting, group 8; vegetable, leafy, except brassica, group 4; milk;
meat; meat byproduct and fat. At that time EPA determined rotational
crop tolerances were required, and that the petitioner needed to
conduct extensive field rotational crop trials. The Agency concluded
that until the requested data are submitted, a restriction should be
imposed on labels prohibiting the rotation to any crop not on the
label. In response, the registrant submitted proposals for the
establishment of tolerances for inadvertent residues for a number of
crops pending submission of the requested data. After considering the
registrant's submission, EPA is now proposing time-limited tolerances
to address rotated crops.
    EPA has decided to propose time-limited rotational crop tolerances
for chlorantraniliprole. Rotational crop trials (2003, 2004, 2005) were
conducted in Canada and the United States on leafy vegetables (Swiss
chard, lettuce, spinach), root vegetables (radish, beet, turnip),
cereal grains (wheat, oat) and soybean. Based on the data on
chlorantraniliprole, the Agency believes that the residue data would
not underestimate residues on rotated crops. Thus the Agency believes
that the 0.20 ppm tolerances on rotational crops are appropriate and
protective. EPA also determined that adding these proposed tolerances
would not change its prior safety finding for chlorantraniliprole.
EPA's updated risk assessment can be found at http://
www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0647.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that `` there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
. ''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of
chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-
[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide, in or on cowpeas, forage and hay at 0.20 ppm; field peas,
vines and hay at 0.20 ppm; forage, fodder and straw of cereal grains,
crop group 16 at 0.20 ppm, grass forage, fodder and hay, crop group 17
at 0.20 ppm; leaves of root and tuber vegetables, crop group 2 at 0.20
ppm; leeks at 0.20 ppm; nongrass animal feeds (forage, fodder, straw
and hay), crop group 18 at 0.20 ppm; okra at 0.70 ppm; onions, green at
0.20 ppm; onions, Welsh at 0.20 ppm; peanuts, hay at 0.20 ppm; shallots
at 0.20 ppm; soybeans, forage and hay at 0.20 ppm; strawberries at 1.20
ppm; and sugarcane, sugar at 0.20 ppm. EPA's assessment of exposures
and risks associated with establishing the tolerance follows:

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Chlorantraniliprole has no significant acute toxicity via the oral,
dermal, and inhalation routes of exposure. This substance is not an eye
or skin irritant and does not cause skin sensitization. In short-term
studies, the most consistent effects are those associated with non
adverse pharmacological response to the xenobiotic, induction of liver
enzymes and subsequent increase in liver weights. Chlorantraniliprole
is not genotoxic, neurotoxic, immunotoxic, carcinogenic, or
teratogenic. Furthermore, it is not uniquely toxic to the conceptus as
there were no maternal or fetal effects in studies conducted in rats
and rabbits. Based on the results of a 28-day dermal study in rats, as
well as the dermal LD50 study, chlorantraniliprole has
relatively low dermal toxicity.
    Overall, chlorantraniliprole exhibits minimal mammalian toxicity
after long-term exposure. The only consistent observation in the
mammalian toxicology studies is an increased degree of
microvesiculation of the adrenal cortex after dermal or dietary
administration of chlorantraniliprole. Based on the lack of adverse
effect on the function of the adrenal gland, this observation was
considered treatment related, but not ``adverse.''In addition to the
adrenal effects, liver effects (e.g., increased liver weight and
induction of cytochrome P450 enzymes) were reported in the 90-day oral
subchronic studies across species and only at the highest dose tested
(HDT) >1,000 milligram/kilogram/day (mg/kg/day). While in the
subchronic studies, these effects were considered adaptive, the liver
effects were more pronounced in the 18-month chronic mouse study at the
HDT. Increased eosinophilic foci (preneoplastic foci) were noted in
male mice at 935 mg/kg/day and liver hypertrophy and weight increase
were evident at the next lower dose (158 mg/kg/day), but progression to
tumors was not apparent for these effects. Therefore, the eosinophilic
foci appear to be an adverse effect only seen in the HDT and was graded
minimal in severity.
    Specific information on the studies received and the nature of the
toxic effects caused by chlorantraniliprole as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://
www.regulations.gov. The referenced document is available in the docket
established by this action, which is described under ADDRESSES, and is
identified as EPA-HQ-OPP-2007-0275 in that docket.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable

risk, the toxicological level of concern (LOC) is derived from the
highest dose at which no adverse effects are observed (the NOAEL) in
the toxicology study identified as appropriate for use in risk
assessment. However, if a NOAEL cannot be determined, the lowest dose
at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the LOC to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
risks by comparing aggregate exposure to the pesticide to the acute
population adjusted dose (aPAD) and chronic population adjusted dose
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all
applicable UFs. Short-term, intermediate-term, and long-term risks are
evaluated by comparing aggregate exposure to the LOC to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://
www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for chlorantraniliprole
used for human risk assessment can be found at http://
www.regulations.gov in document Chlorantraniliprole (DPX-E2Y45): Human
Health Risk Assessment for Proposed Uses on pome fruit, stone fruit,
leafy vegetables, brassica leafy vegetables, cucurbit vegetables,
fruiting vegetables, cotton, grapes, potatoes, rice, turf and
ornamentals pages 22-24 in docket ID number EPA-HQ-OPP-2007-0275.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to chlorantraniliprole, EPA considered exposure under the
petitioned-for tolerances as well as all existing chlorantraniliprole
tolerances in (40 CFR 180.628). EPA assessed dietary exposures from
chlorantraniliprole in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for chlorantraniliprole;
therefore, a quantitative acute dietary exposure assessment is
unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the United States
Department of Agriculture (USDA) 1994-1996 and 1998 CSFII. As to
residue levels in food, EPA assumed all foods for which there are
tolerances were treated and contain tolerance-level residues.
    The inclusion of additional livestock feeds such as forage, fodder
and straw from cowpea, field pea, soybean, cereal grains, nongrass
animal feeds or peanut does not increase the livestock dietary burdens
and thus the meat and milk tolerances. While the addition of
strawberries, sugarcane, leek, onions, shallot, and okra that are
considered human food results in a miniscule increase in exposure, a
DEEM analysis that incorporates all the new commodities does not change
the risk outcome which remains at 1% of the cPAD for the most highly
exposed population, children ages 1-2. In addition, the dietary
exposure from leeks, onions and shallots is negligible.
    iii. Cancer. Because chlorantraniliprole has been classified as a
``not likely human carcinogen'', a quantitative exposure assessment
relative to cancer risk is not necessary.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for chlorantraniliprole in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the environmental
fate characteristics of chlorantraniliprole. Further information
regarding EPA drinking water models used in pesticide exposure
assessment can be found at http://www.epa.gov/oppefed1/models/water/
index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated environmental concentrations (EECs) of
chlorantraniliprole for acute exposures are estimated to be 26.862
parts per billion (ppb) for surface water and 1.06 ppb for ground
water. The EECs for chronic exposures are estimated to be 3.650 ppb for
surface water and 1.06 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. Because no acute hazard,
attributable to a single dose, was identified; acute dietary risk was
not assessed. For chronic dietary risk assessment, the water
concentration value 3.650 ppb was used to access the contribution to
drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Chlorantraniliprole is registered for use on the following
residential non-dietary sites: Turfgrass and ornamental plants.
Although residential exposure could occur, due to the lack of toxicity
identified for short-term and intermediate-term durations via the
relevant routes of exposure, no risk is expected from these exposures.
    Additional information on residential exposure assumptions can be
found at www.regulations.gov (Docket ID EPA-HQ-OPP-2007-0275, pages 36
through 37).
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to chlorantraniliprole and
any other substances and chlorantraniliprole does not appear to produce
a toxic metabolite produced by other substances. For the purposes of
this tolerance action, therefore, EPA has not assumed that
chlorantraniliprole has a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances

found to have a common mechanism on EPA's website at  http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (10X) tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA safety factor. In applying
this provision, EPA either retains the default value of 10X when
reliable data do not support the choice of a different factor, or, if
reliable data are available, EPA uses a different additional FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There were no effects on
fetal growth or postnatal development up to the limit dose of 1,000 mg/
kg/day in rats or rabbits in the developmental or 2-generation
reproduction studies. Additionally, there were no treatment related
effects on the numbers of litters, fetuses (live or dead), resorptions,
sex ratio, or post-implantation loss and no effects on fetal body
weights, skeletal ossification, and external, visceral, or skeletal
malformations or variations.
    3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
    i. The toxicology database for chlorantraniliprole is complete for
the purposes of this risk assessment and the characterization of
potential prenatal and postnatal risks to infants and children.
    ii. No susceptibility was identified in the toxicological database,
and there are no residual uncertainties re: prenatal and/or postnatal
exposure.
    iii. There are no treatment-related neurotoxic findings in the
acute and subchronic oral neurotoxicity studies in rats.
    iv. The exposure assessment is protective: The dietary food
exposure assessment utilizes tolerance level residues and 100 percent
crop treated (PCT) information for all commodities. The submitted field
rotational crop studies do not match those recommended in the
guidelines. However, data from confined rotational crop studies and
field rotational crop studies show that uptake of chlorantraniliprole
is below the quantification level in roots and grains, and range of
0.01 to 0.15 ppm in tops of root vegetables and forage, fodder and
straw of cereal grains and soybean. The 0.20 ppm tolerances based on
the collective data should be conservative. Also, the tolerances on
rotational crops strawberry and okra are conservative since the
strawberry tolerance is based on residues in grape from direct
application of chlorantraniliprole and the okra tolerance is based on
residues resulting from direct treatment on tomato and pepper. An
exposure assessment using conservative residue values is expected to be
protective.
    The drinking water assessment utilizes values generated by models
and associated modeling parameters which are designed to provide
conservative, health protective, high-end estimates of water
concentrations. By using these screening-level exposure assessments,
the chronic dietary (food and drinking water) risk is not
underestimated.
    v. Although residential exposure is expected over the short- and
possibly intermediate-term (via the dermal and/or incidental oral
route), there is no hazard expected via these routes/durations, and
therefore no risk for these scenarios.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-term, intermediate-term,
and long-term risks are evaluated by comparing aggregate exposure to
the LOC to ensure that the MOE called for by the product of all
applicable UFs is not exceeded.
    1. Acute risk. No acute risk is expected because no acute hazard,
attributable to a single dose, was identified.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
chlorantraniliprole from food and water will utilize <1% of the cPAD
for the population group children 1-2 years (the highest exposed
subpopulation). Based the use pattern, chronic residential exposure to
residues of chlorantraniliprole is not expected.
    3. Short-term/intermediate risk. Short-term aggregate and
intermediate-term exposure takes into account residential exposure plus
chronic exposure to food and water (considered to be a background
exposure level).
    There is potential for short-term and intermediate-term post-
application dermal (adults and children) and incidental oral (children
only) exposure to chlorantraniliprole. However, due to the lack of
toxicity via dermal route, as well as the lack of toxicity over the
acute, short-term and intermediate-term via the oral route - no risk is
expected from these exposures. Inhalation exposure is not expected due
to the low vapor pressure of chlorantraniliprole (so applied/deposited
residues are not expected to volatilize into the air).
    4. Aggregate cancer risk for U.S. population. Chlorantraniliprole
has been classified as a ``not likely human carcinogen.'' It is not
expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to chlorantraniliprole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology liquid chromatography/mass
spectrometry (LC/MS) is available to enforce the tolerance expression.
The methods may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. International Residue Limits

    There are no international residue limits that affect the Agency's
recommendations at this time. There are no CODEX or Mexican maximum
residue limits (MRLs) for chlorantraniliprole that exists at this time.

C. Conditions

    Tolerances may be made permanent following submission of rotational
crop residue data suitable for establishing tolerances.

V. Conclusion

    Time-limited tolerances are proposed for residues of
chlorantraniliprole, 3-bromo-N-[4-chloro-2-methyl-6-
[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide, in or on cowpea, forage and hay at 0.20 ppm; field pea,
vines and hay at 0.20 ppm; forage, fodder and straw of cereal grains,
crop group 16 at 0.20 ppm, grass forage, fodder and hay,

crop group 17 at 0.20 ppm; leaves of root and tuber vegetables, crop
group 2 at 0.20 ppm; leek at 0.20 ppm; nongrass animal feeds (forage,
fodder, straw and hay), crop group 18 at 0.20 ppm; okra at 0.70 ppm;
onion, green at 0.20 ppm; onion, Welsh at 0.20 ppm; peanut, hay at 0.20
ppm; shallot at 0.20 ppm; soybean, forage and hay at 0.20 ppm;
strawberries at 1.20 ppm; and sugarcane, sugar at 0.20 ppm.

VI. Statutory and Executive Order Reviews

    This proposed rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this proposed rule has
been exempted from review under Executive Order 12866 due to its lack
of significance, this proposed rule is not subject to Executive Order
13211, entitled Actions Concerning Regulations That Significantly
Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001).
This proposed rule does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
et seq., or impose any enforceable duty or contain any unfunded mandate
as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). Nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or OMB review or any
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). The Agency hereby certifies, under the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), that this proposed action
will not have significant negative economic impact on a substantial
number of small entities. A tolerance is one of the regulatory
requirements needed for use of a pesticide and thus establishing a
tolerance is expected to have no adverse economic impact. In addition,
the Agency has determined that this action will not have a substantial
direct effect on States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This proposed rule directly regulates growers, food
processors, food handlers, and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this proposed rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000). Executive Order 3175, requires EPA to develop
an accountable process to ensure ``meaningful and timely input by
tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This proposed rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: September 19, 2008.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, it is proposed that 40 CFR chapter I be amended as
follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as
follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.
    2. Section 180.628 is amended by revising paragraph (d) to read as
follows:

Sec.  180.628  Chlorantraniliprole; tolerances for residues.

* * * * *
    (d) Indirect or inadvertent resisues. Time-limited tolerances are
established for indirect or inadvertent residues of the insecticide
chlorantraniliprole (3-bromo-N-[4-chloro-2-methyl-6-
[(methylamino)carbonyl]phenyl]-1-(3-chloro-2-pyridinyl)-1H-pyrazole-5-
carboxamide) in or on the following commodities. The tolerances will
expire and are revoked on the dates specified in the following table.

----------------------------------------------------------------------------------------------------------------
                     Commodity                          Parts per million         Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
Animal feed, nongrass, group 18....................                     0.20                             4/25/10
Cowpea, forage.....................................                     0.20                             4/25/10
Cowpea, hay........................................                     0.20                             4/25/10
Field pea, hay.....................................                     0.20                             4/25/10
Field pea, vine....................................                     0.20                             4/25/10
Grain, cereal, forage, fodder and straw, group 16..                     0.20                             4/25/10
Grass, forage, fodder and hay, group 17............                     0.20                             4/25/10
Leek...............................................                     0.20                             4/25/10
Okra...............................................                     0.70                             4/25/10
Onion, green.......................................                     0.20                             4/25/10

Onion, Welsh.......................................                     0.20                             4/25/10
Peanut, hay........................................                     0.20                             4/25/10
Shallot............................................                     0.20                             4/25/10
Soybean, forage....................................                     0.20                             4/25/10
Soybean, hay.......................................                     0.20                             4/25/10
Strawberry.........................................                     1.20                             4/25/10
Sugarcane..........................................                     0.20                             4/25/10
Vegetable, leaves of root and tuber, group 2.......                     0.20                             4/25/10
----------------------------------------------------------------------------------------------------------------

[FR Doc. E8-22946 Filed 9-30-08; 8:45 am]

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[Federal Register Volume 75, Number 237 (Friday, December 10, 2010)]
[Notices]
[Pages 76991-76992]
[FR Doc No: 2010-31064]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2010-E-0039 and FDA-2010-E-0040]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for MULTAQ 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 Patents
and Trademarks, Department of Commerce, for the extension of patents
which claim that human drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: 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 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 drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks 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 drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product MULTAQ
(dronedarone hydrochloride). MULTAQ is indicated to reduce the risk of
cardiovascular hospitalization in patients with paroxysmal or
persistent atrial fibrillation (AF) or atrial flutter (AFL), with a
recent episode of AF/AFL and associated cardiovascular risk factors who
are in sinus rhythm or who will be cardioverted. Subsequent to this
approval, the Patent and Trademark Office received patent term
restoration applications for MULTAQ (U.S. Patent Nos. 5,223,510 and
7,323,493) from Sanofi-Aventis, and the Patent and Trademark Office
requested FDA's assistance in determining the patents' eligibility for
patent term restoration. In a letter dated March 3, 2010, FDA advised
the Patent and Trademark Office that this human drug product had
undergone a regulatory review period and that the approval of MULTAQ
represented the first permitted commercial marketing or use of the
product. Thereafter, the Patent and Trademark Office requested that FDA
determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
MULTAQ is 5,076 days. Of this time, 3,593 days occurred during the
testing phase of the regulatory review period, while 1,483 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 (the FFD&C act) (21 U.S.C. 355(i)) became
effective: August 10, 1995. FDA has verified the applicant's claim that
the date the investigational new drug application became effective was
on August 10, 1995.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FFD&C act: June 10,
2005. FDA has verified the applicant's claim that the first new drug
application (NDA) for MULTAQ (NDA 21-913) was submitted on June 10,
2005.

    3. The date the application was approved: July 1, 2009. FDA has
verified the applicant's claim that NDA 21-425 for MULTAQ was approved
on July 1, 2009.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
applications for patent extension, this applicant seeks 519 days and 5
years, respectively, of patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by February 8, 2011. 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 June 8, 2011. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (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.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. It is no longer
necessary to send three copies of mailed comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with the docket number found in brackets in
the heading of this document.
    Comments and petitions that have not been made publicly available
on regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-31064 Filed 12-9-10; 8:45 am]
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