[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Notices]
[Pages 11456-11460]
[FR Doc No: 2011-4649]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0909; FRL-8859-4]

Pesticide Reregistration Performance Measures and Goals

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's progress in meeting its
performance measures and goals for pesticide reregistration during
fiscal years 2009 and 2010. The Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) requires EPA to publish information about EPA's
annual achievements in this area. This notice discusses the integration
of tolerance reassessment with the reregistration process, and
describes the status of various regulatory activities associated with
reregistration and tolerance reassessment. The notice gives the total
numbers of products reregistered and products registered under the
``fast-track'' provisions of FIFRA.

DATES: This notice is not subject to a formal comment period.
Nevertheless, EPA welcomes input from stakeholders and the general
public. Written comments, identified by the docket identification (ID)
number EPA-HQ-OPP-2009-0909, should be received on or before May 2,
2011.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0909, 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-
2009-0909. 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 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
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: Carol P. Stangel, Pesticide Re-
evaluation Division (7509P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. Although this
action may be of particular interest to persons who are interested in
the progress and status of EPA's pesticide reregistration and tolerance
reassessment programs, the Agency has not attempted to describe all the
specific entities that may be affected by this action. If you have any
questions regarding the information in this notice, 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

    EPA must establish and publish in the Federal Register its annual
performance measures and goals for pesticide reregistration, tolerance
reassessment, and expedited registration, under section 4(l) of FIFRA,
7 U.S.C. 136a-1(1). Specifically, such measures and goals are to
include:
     The status of reregistration.
     The number of products reregistered, canceled, or amended.
     The number and type of data requests of Data Call-In (DCI)
notices under FIFRA section 3(c)(2)(B) issued to support product
reregistration by active ingredient.
     Progress in reducing the number of unreviewed, required
reregistration studies.
     The aggregate status of tolerances reassessed.
     The number of applications for registration submitted
under section 4(k)(3) (which provides for expedited processing and
review of certain applications) that were approved or disapproved.
     The future schedule for reregistrations in the current and
succeeding fiscal year.

     The projected year of completion of the reregistrations
under section 4.
    FIFRA authorized EPA to conduct a comprehensive pesticide
reregistration program--a complete review of the human health and
environmental effects of older pesticides originally registered before
November 1, 1984. Pesticides meeting today's scientific and regulatory
standards could be declared ``eligible'' for reregistration. To be
eligible, an older pesticide must have a substantially complete data
base, and must not cause unreasonable adverse effects to human health
or the environment when used according to Agency approved label
directions and precautions.
    In addition, all pesticides with food uses must meet the safety
standard of section 408 or the Federal Food, Drug, and Cosmetic Act
(FFDCA) 21 U.S.C. 346a. Under FFDCA, EPA must make a determination that
pesticide residues remaining in or on food are ``safe''; that is,
``that there is reasonable certainty that no harm will result from
aggregate exposure to the pesticide chemical residue'' from dietary and
other sources. In determining allowable levels of pesticide residues in
food, EPA must, among other requirements, perform a comprehensive
assessment of each pesticide's risks, considering:
     Aggregate exposure (from food, drinking water, and
residential uses).
     Cumulative effects from all pesticides sharing a common
mechanism of toxicity.
     Possible increased susceptibility of infants and children.
     Possible endocrine or estrogenic effects.
    The 1996 FFDCA amendments also required the reassessment of all
existing tolerances (pesticide residue limits in food) and tolerance
exemptions within 10 years, to ensure that they met the safety standard
of the law. EPA was directed to give priority to the review of those
pesticides that appeared to pose the greatest risk to public health.
The Agency completed the last of 9,721 required tolerance reassessment
decisions in September 2007, ensuring that all pesticides used on food
in the United States meet the law's safety standard. EPA's approach to
tolerance reassessment under FFDCA was described fully in the Agency's
document, ``Raw and Processed Food Schedule for Pesticide Tolerance
Reassessment'' (62 FR 42020, August 4, 1997) (FRL-5734-6).
    The Pesticide Registration Improvement Act (PRIA) of 2003 became
effective on March 23, 2004 (Pub. L. 108-199, Div. G, Title V, Sec.
501, 118 Stat. 419). Among other things, PRIA amended FIFRA section
4(g)(2) to require EPA to complete Reregistration Eligibility Decisions
(REDs) for pesticides with food uses/tolerances by August 3, 2006, and
to complete all non-food use REDs by October 3, 2008. The Agency
completed decisions for the last of 613 reregistration pesticide cases
in September 2008, meeting the PRIA deadline. REDs are available on the
Agency's Pesticide Reregistration Status web page, http://www.epa.gov/pesticides/reregistration/status.htm.

III. Program Accountability

    Through this summary of performance measures and goals for
pesticide reregistration, tolerance reassessment, and expedited
registration, EPA describes progress made during each of the past 2
years in each of the program areas included in FIFRA section 4(l).

A. Status of Reregistration

    EPA had no remaining reregistration eligibility decisions to
complete in FY 2009 or FY 2010; the last decisions for 613
reregistration cases were completed in FY 2008.
    During FY 2009 and FY 2010, the Agency focused on completing
product reregistration decisions.

B. Product Reregistration; Numbers of Products Reregistered, Canceled,
and Amended

    At the end of the reregistration process, after EPA has issued a
RED and declared a pesticide reregistration case eligible for
reregistration, individual end-use products that contain pesticide
active ingredients included in the case still must be reregistered.
This concluding part of the reregistration process is called ``product
reregistration.''
    In issuing a completed RED document, EPA sends registrants a Data
Call-In (DCI) notice requesting any product-specific data and specific
revised labeling needed to complete reregistration for each of the
individual pesticide products covered by the RED. Based on the results
of EPA's review of these data and labeling, products found to meet
FIFRA and FFDCA standards may be reregistered.
    A variety of outcomes are possible for pesticide products
completing this final phase of the reregistration process. Ideally, in
response to the DCI, the pesticide producer, or registrant, will submit
the required product-specific data and revised labeling, which EPA will
review and find acceptable. At that point, the Agency may reregister
the pesticide product. If, however, the product contains multiple
active ingredients, the Agency instead would first require the
registrant to amend the product's registration, incorporating the
labeling changes specified in the RED as interim measures. A product
with multiple active ingredients could not be fully reregistered until
the last active ingredient in its formulation was eligible for
reregistration. In other situations, the Agency may temporarily suspend
a product's registration if the registrant has not submitted required
product-specific studies within the time frame specified. The Agency
may cancel a product's registration because the registrant did not pay
the required registration maintenance fee. Alternatively, the
registrant may request a voluntary cancellation of their end-use
product registration.
    1. Product reregistration actions in FY 2008, FY 2009, and FY 2010.
EPA counts each of the post-RED product outcomes described above as a
product reregistration action. A single pesticide product may be the
subject of several product reregistration actions within the same year.
For example, a product's registration initially may be amended, then
the product may be reregistered, or the product may first be suspended
and later it may be voluntarily canceled. As a result of 2009 findings
by EPA's Office of the Inspector General from the annual FIFRA
Financial Statements Audit, EPA's Office of Pesticide Programs has
reviewed product reregistration actions completed in FY 2008. Final
numbers of FY 2008 product reregistration actions as well as FY 2009
and FY 2010 actions are presented in Table 1.

               Table 1--Product Reregistration Actions Completed in FY 2008, FY 2009, and FY 2010
                                           [As of September 30, 2010]
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                             Actions                                  FY 2008         FY 2009         FY 2010
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Product reregistration actions..................................             697             603             484
Product amendment actions.......................................             205             292              40
Product cancellation actions....................................             309             869           1,188

Product suspension actions......................................               3               5               6
                                                                 -----------------------------------------------
    Total actions...............................................           1,214           1,769           1,718
----------------------------------------------------------------------------------------------------------------

    2. Status of the product reregistration universe for FY 2008, FY
2009, and FY 2010. EPA also keeps track of the status of the universe
of products subject to reregistration, that is, the overall number of
products reregistered, amended, canceled, and sent for suspension, as
well as the number of products with actions pending, as of the end of
the fiscal year. This overall status information is not
``cumulative''--it is not derived from summing up a series of annual
actions. Adding annual actions would result in a larger overall number
since each individual product is subject to multiple actions--it can be
amended, reregistered, and/or canceled, over time. Instead, the ``big
picture'' status information in Table 2 should be considered a snapshot
in time. As registrants and EPA make marketing and regulatory decisions
in the future, the status of individual products may change, and
numbers in this table are expected to fluctuate.

Table 2--Status of the Universe of Products Subject to Product Reregistration, for FY 2008, FY 2009, and FY 2010
                                           [As of September 30, 2010]
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                             Status                                   FY 2008         FY 2009         FY 2010
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Products reregistered...........................................           3,282           3,885           4,369
Products amended................................................             847           1,139           1,179
Products canceled...............................................           5,355           6,224           7,412
Products sent for suspension....................................               9              14              20
Total products with actions completed...........................           9,493          11,262          12,980
Products with actions pending...................................          12,746          10,860           9,059
                                                                 -----------------------------------------------
    Total products in product reregistration universe...........          22,239          22,122          22,039
----------------------------------------------------------------------------------------------------------------

    At the end of FY 2010, 9,059 products had product reregistration
decisions pending. Some pending products awaited science reviews, label
reviews, or reregistration decisions by EPA. Others were not yet ready
for product reregistration actions, but were associated with more
recently completed REDs. Their product-specific data were not yet due
to be submitted to or reviewed by the Agency.
    The universe of products in product reregistration has increased in
some years and decreased in other years. Generally, an increase
resulted from products associated with the most recently completed
REDs, while a decrease was due to fluctuations in numbers of products
associated with product-specific DCIs (PDCIs).
    During FY 2010, EPA refined the number and status of products in
the product reregistration universe, and the Agency will use the
revised numbers in reporting on the status of the universe starting in
FY 2011. By identifying and including products that were canceled
between the time when REDs were signed and product-specific DCIs were
issued, the Agency has been able to more precisely define the universe
of products that are subject to product reregistration. This will
enable the Agency to more accurately track the status of products
undergoing product reregistration, describe progress in meeting program
goals, and carry out plans to complete remaining product reregistration
decisions during the next few years.
    3. Product reregistration goal in FY 2011. EPA's goal is to
complete 1,500 product reregistration actions during FY 2011.
Additional information is available on EPA's Product Reregistration web
page, http://www.epa.gov/pesticides/reregistration/product-reregistration.htm.

C. Progress in Reducing the Number of Unreviewed, Required
Reregistration Studies

    EPA completed the last REDs in 2008, so all necessary studies to
make reregistration eligibility decisions for all active ingredients
subject to reregistration have been reviewed. Some of the Agency's
records, however, still incorrectly depicted a number of reregistration
studies as ``in review.'' From August 2008 to August 2010, the Agency
conducted an internal examination and clean-up of these records in
order to more precisely categorize reregistration studies still
depicted as ``in review.'' As shown in Table 3, as a result of this
clean-up effort, the Agency succeeded in determining that most
reregistration studies (26,019 or more than 94% of the 27,645 studies
received) have been reviewed or found to be extraneous. Only 5.9%
(1,626) of these studies are still depicted in our data base as ``in
review.'' EPA believes the remaining studies to be duplicative,
unnecessary, or already reviewed, because the Agency has completed REDs
for all pesticides subject to reregistration and no registrant has
objected that the Agency failed to consider a submitted study. At this
time, the Agency does not plan to spend further resources examining
these records.

                    Table 3--Review Status of Studies Submitted for Pesticide Reregistration
                                                [As of July 2010]
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                                                       Studies reviewed
  Pesticide reregistration list, per FIFRA section     (including cited   Studies still ``in     Total studies
                       4(c)(2)                          or extraneous)          review''           received
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List A..............................................        12,960 (95%)            714 (5%)              13,674
List B..............................................         8,789 (93%)            650 (7%)               9,439
List C..............................................         2,800 (97%)             95 (3%)               2,895
List D..............................................         1,470 (90%)           167 (10%)               1,637
                                                     -----------------------------------------------------------
    Total Lists A--D................................      26,019 (94.1%)        1,626 (5.9%)       27,645 (100%)
----------------------------------------------------------------------------------------------------------------

D. Applications for Registration Requiring Expedited Processing;
Numbers Approved and Disapproved

    By law, EPA must expedite its processing of certain types of
applications for pesticide product registration, i.e., applications for
end-use products that would be identical or substantially similar to a
currently registered product (me too products); amendments to current
product registrations that do not require review of scientific data;
and products for public health pesticide uses. During FY 2009 and FY
2010, EPA considered and approved the numbers of applications for
registration requiring expedited processing (also known as ``fast
track'' applications) shown in Table 4.

      Table 4--Fast Track Applications Approved in FY 2009 and 2010
------------------------------------------------------------------------
                                        FY 2009             FY 2010
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Me-too product registrations/                    372                 260
 Fast track.....................
Amendments/Fast track...........               2,653               3,391
                                 ---------------------------------------
    Total applications processed               3,025               3,651
     by fast track means........
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    For those applications not approved, the Agency generally notifies
the registrant of any deficiencies in the application that need to be
corrected or addressed before the application can be approved.
Applications may have been withdrawn after discussions with the Agency,
but none were formally ``denied'' during FY 2009 or FY 2010.
    On a financial accounting basis, EPA devoted 17.8 full-time
equivalents (FTEs) in FY 2009 and 16.6 FTEs in FY 2010 to reviewing and
processing applications for fast track me-too product registrations and
label amendments. The Agency spent approximately $2.4 million in FY
2009 and $2.35 million in FY 2010 in direct costs (i.e., time on task,
not including administrative expenses, computer systems, management
overhead, and other indirect costs) on expedited processing and
reviews.

F. Projected Year of Completion of Reregistrations

    EPA completed the last reregistration eligibility decisions in FY
2008. Product reregistration will not likely be completed before 2014.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: February 24, 2011.
 Stephen A. Owens,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2011-4649 Filed 3-1-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: July 31, 2006 (Volume 71, Number 146)]
[Notices]
[Page 43143]
[DOCID:fr31jy06-58]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER06-1218-000]

PJM Interconnection, LLC; Notice of Extension of Time

July 24, 2006.

    On July 24, 2006, Long Island Power Authority and its operating
subsidiary, LIPA (collectively ``LIPA'') filed a motion for an
extension of time to file motions to intervene and comments in response
to the Commission's Notice of Filing issued July 11, 2006, in the
above-docketed proceeding. LIPA requests that an extension be granted
to allow LIPA to review the Commission's Final Rule issued July 20,
2006, in Docket No. RM06-8-000 \1\ and to provide substantive comments
in this proceeding based on its review of those new regulations.
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    \1\ Long-Term Firm Transmission Rights in Organized Electricity
Markets, 116 FERC ] 61,077 (2006).
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    Upon consideration, notice is hereby given that an extension of
time to file motions to intervene and comments is granted to and
including August 7, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-12245 Filed 7-28-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 66 (Monday, April 7, 2014)]
[Notices]
[Pages 19154-19158]
[FR Doc No: 2014-07636]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71839; File No. SR-NYSEArca-2014-25]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
of Proposed Rule Change To Make Permanent Its Pilot Program Regarding
Minimum Value Sizes for Opening Transactions in New Series of Flexible
Exchange Options and Establish New Minimum Value Sizes Applicable to
Other FLEX Transactions and FLEX Quotes

April 1, 2014.
    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 March 18, 2014, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') 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 make permanent its pilot program (``Pilot
Program'') regarding minimum value sizes for opening transactions in
flexible exchange options (``FLEX Options'' or ``FLEX''), currently
scheduled to expire on March 31, 2014 and establish new minimum value
sizes applicable to other FLEX transactions and FLEX Quotes. The text
of the proposed rule change is available on the Exchange's Web site at
www.nyse.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to make permanent its Pilot Program regarding
minimum value sizes for FLEX Options,\4\ currently scheduled to expire
on March 31, 2014.\5\ The Exchange believes that the Pilot Program has
been successful and well-received by its membership and the investing
public for the period that it has been in operation as a Pilot
Program.\6\
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    \4\ FLEX Options provide investors with the ability to customize
basic option features including size, expiration date, exercise
style, and certain exercise prices. FLEX Options can be FLEX Index
Options or FLEX Equity Options.
    \5\ See Securities Exchange Act Release No. 69267 (April 2,
2013), 78 FR 20997 (April 8, 2013) (SR-NYSEArca-2013-27).
    \6\ The Pilot Program was initiated on May 12, 2010. See
Securities Exchange Act Release No. 62054 (May 6, 2010), 75 FR 27381
(May 14, 2010) (SR-NYSEArca-2010-34).
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Minimum Value Sizes for FLEX Options
    Prior to the initiation of the Pilot Program, the minimum value
size requirement for every opening FLEX Request for Quotes and every
responsive FLEX Quote [sic] under Rule 5.32(d)(2) was as follows:
     For an opening transaction (other than FLEX Quotes
responsive to a FLEX Request for Quotes) in any FLEX series in which
there is no open interest at the time the Request for Quotes is
submitted, the minimum value size was (i) for FLEX Equity Options, the
lesser of 250 contracts or the number of contracts overlying $1 million
in the underlying securities; and (ii) for FLEX Index Options, $10
million Underlying Equivalent Value in the case of Broad Stock Index
Group FLEX Index Options and $5 million Underlying Equivalent Value in
the case of Stock Index Industry Group FLEX Index Options.
    Pursuant to the terms of the existing Pilot Program,
notwithstanding the above-described rule text, the minimum size for an
opening transaction in a new FLEX Option series is one contract. As
mentioned above, the Pilot Program is currently set to expire on March
31, 2014.
    In addition to the minimum value size applicable to opening FLEX
transactions in new FLEX series, as described above, Rule 5.32(d)(3)-
(4) prescribes minimum value sizes for other FLEX transactions and FLEX
Quotes as follows:
     For a transaction in any currently-opened FLEX series, the
minimum value size is (i) for FLEX Equity Options, the lesser of 100
contracts or the number of contracts overlying $1 million in the
underlying securities in the case of opening transactions, and 25
contracts in the case of closing transactions; and (ii) for FLEX Index
Options, $1 million Underlying Equivalent Value in the case of both
opening and closing transactions; or (iii) for either case, the
remaining underlying size or Underlying Equivalent Value on a closing
transaction, whichever is less.
     The minimum value size for FLEX Quotes responsive to a
Request for Quotes is 25 contracts in the case of FLEX Equity Options
and $1 million Underlying Equivalent Value in the case of FLEX Index
Options or for either case the remaining underlying size or Underlying
Equivalent Value on a closing transaction, whichever is less.
Proposal
    The Exchange is proposing to make the minimum value size Pilot
Program permanent. To accomplish this change, the Exchange is proposing
to eliminate the rule text describing the Pilot Program, which is
contained in Commentary .02 to Rule 5.32, and to eliminate the rule
text describing the minimum value size requirements, which is contained
in Rule 5.32(d)(2).
    In support of approving the Pilot Program on a permanent basis, and
as required by the Pilot Program's approval order, the Exchange is
submitting to the Commission a Pilot Program report (``Report''), which
is a public report detailing the Exchange's experience with the
program.\7\ Specifically, the Exchange is providing the Commission an
annual report, containing data and analysis of underlying equivalent
values, open interest and trading volume, and analysis of the types of
investors that initiated opening FLEX Equity and Index Options
transactions (i.e., institutional, high net worth, or retail) in new
FLEX series.
---------------------------------------------------------------------------

    \7\ A copy of the Report is attached as Exhibit 3.
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    The Exchange believes that there is sufficient investor interest
and demand in the Pilot Program to warrant its permanent approval. The
Exchange believes that, for the period that the Pilot Program has been
in operation, it has provided investors with additional means of
managing their risk exposures and carrying out their investment
objectives. Furthermore, as discussed in more detail below, the
Exchange has not experienced any adverse market effects with respect to
the Pilot Program.
    The Exchange believes that eliminating the minimum value size
requirements for opening transactions in new FLEX series on a permanent
basis is important and necessary to the Exchange's efforts to create a
product and market that provide its membership and investors interested
in FLEX-type options with an improved but comparable alternative to the
over-the-counter (``OTC'') market in customized options, which can take
on contract characteristics similar to FLEX Options but are not subject
to the same restrictions. By making the Pilot Program permanent, market
participants would continue to have greater flexibility in determining
whether to execute their customized options in an exchange environment
or in the OTC market. The Exchange believes that market participants
would benefit from being able to trade these customized options in an
exchange environment in several ways, including, but not limited to,
the following: (i) enhanced efficiency in initiating and closing out
positions; (ii) increased market transparency; and (iii) heightened
contra-party creditworthiness due to the role of The Options Clearing
Corporation (``OCC'') as issuer and guarantor of FLEX Options. The
Exchange also believes that the Pilot Program is wholly consistent with
comments by then Secretary of the Treasury Timothy F. Geithner, to the
U.S. Senate. In particular, Secretary Geithner has stated that:

Market efficiency and price transparency should be improved in
derivatives markets by requiring the clearing of standardized
contracts through regulated [central counterparties] and by moving
the standardized part of these markets onto regulated exchanges and
regulated transparent electronic trade execution systems for OTC
derivatives and by requiring development of a system for timely
reporting of trades and prompt dissemination of prices and other
trade information. Furthermore, regulated financial institutions
should be encouraged to make greater use of regulated exchange-
traded derivatives. Competition between appropriately regulated OTC

derivatives markets and regulated exchanges will make both sets of
markets more efficient and thereby better serve end-users of
derivatives.\8\
---------------------------------------------------------------------------

    \8\ See letter from Secretary Geithner to the Honorable Harry
Reid, United States Senate (May 13, 2009), located at http://www.financialstability.gov/docs/OTCletter.pdf.

    The Exchange believes that the elimination of the minimum value
size requirements for opening FLEX transactions in new FLEX series on a
permanent basis would provide FLEX-participating OTP Holders with
greater flexibility in structuring the terms of FLEX Options that best
comports with their and their customers' particular needs. In this
regard, the Exchange notes that the minimum value size requirements for
opening FLEX transactions in new FLEX series were originally put in
place to limit participation in FLEX Options to sophisticated, high net
worth investors rather than retail investors. However, the Exchange
believes that the restriction is no longer necessary and is overly
restrictive. The Exchange has also not experienced any adverse market
effects with respect to the Pilot Program eliminating the minimum value
size requirements for opening FLEX transactions in new FLEX series.
Again, based on the Exchange's experience to date and throughout the
Pilot Program period, the minimum value size requirements are at times
too large to accommodate the needs of OTP Holders and their customers--
who may be institutional, high net worth or retail--that currently
participate in the OTC market. In this regard, the Exchange notes that,
prior to establishing the Pilot Program, it received numerous requests
from broker-dealers representing institutional, high net worth and
retail investors indicating that the minimum value size requirements
for opening transactions in new FLEX series prevented them from
bringing transactions that are already taking place in the OTC market
to an exchange environment. The Exchange believes that eliminating the
minimum value size requirements for opening transactions in new FLEX
series on a permanent basis would further broaden the base of investors
that use FLEX Options to manage their trading and investment risk,
including investors that currently trade in the OTC market for
customized options, where similar size restrictions do not apply. The
Exchange also believes that this may open up FLEX Options to more
retail investors. The Exchange does not believe that this raises any
unique regulatory concerns because existing safeguards--such as certain
position limit, exercise limit, and reporting requirements--continue to
apply.\9\ In addition, the Exchange notes that FLEX Options are subject
to the options disclosure document (``ODD'') requirements of Rule 9b-1
\10\ under the Securities Exchange Act of 1934 (the ``Act'').\11\ No
broker or dealer can accept an order from a customer to purchase or
sell an option contract relating to an options class that is the
subject of a definitive ODD (including FLEX Options), or approve the
customer's account for the trading of such an option, unless the broker
or dealer furnishes or has furnished to the customer a copy of the
definitive ODD. The ODD contains a description, special features, and
special risks of FLEX Options. Lastly, similar to any other options,
FLEX Options are subject to OTP Holder organization supervision and
suitability requirements, such as in Rule 9.2(b) (Account Supervision)
and Rule 9.18(c) (Suitability).
---------------------------------------------------------------------------

    \9\ The Exchange also notes that certain position limit,
aggregation and exercise limit requirements continue to apply to
FLEX Options in accordance with Rule 5.35 (Position Limits) and Rule
5.36. (Exercise Limits). The Commission notes that certain FLEX
Options do not have position or exercise limits.
    \10\ 17 CFR 240.9b-1.
    \11\ 15 U.S.C. 78a et seq.
---------------------------------------------------------------------------

    In proposing the Pilot Program itself and in now proposing to make
it permanent, the Exchange is cognizant of the need for market
participants to have substantial options transaction capacity and
flexibility to hedge their substantial investment portfolios, on the
one hand, and the potential for adverse effects that the minimum value
size restrictions were originally designed to address, on the other.
However, the Exchange has not experienced any adverse market effects
with respect to the Pilot Program. The Exchange is also cognizant of
the OTC market, in which similar restrictions on minimum value size do
not apply. In light of these considerations and Secretary Geithner's
comments on moving the standardized parts of OTC contracts onto
regulated exchanges, the Exchange believes that making the Pilot
Program permanent is appropriate and reasonable and will provide market
participants with additional flexibility in determining whether to
execute their customized options in an exchange environment or in the
OTC market. The Exchange believes that market participants benefit from
being able to trade these customized options in an exchange environment
in several ways, including, but not limited to, enhanced efficiency in
initiating and closing out positions, increased market transparency,
and heightened contra-party creditworthiness due to the role of OCC as
issuer and guarantor of FLEX Options.
    Pursuant to this filing, the Exchange is proposing to adopt the
existing Pilot Program \12\ on a permanent basis. Specifically, the
Exchange proposes to eliminate all references to minimum size
applicable to opening FLEX transactions as presently described in Rule
5.32(d)(2). The proposal to eliminate the minimum value size applicable
to opening transactions in new FLEX series is similar to a rule change
by the CBOE when adopting a similar pilot program on a permanent
basis.\13\
---------------------------------------------------------------------------

    \12\ See supra note 5.
    \13\ See Securities Exchange Act Release Nos. 66934 (May 7,
2012), 77 FR 27822 (May 11, 2012); 67624 (August 8, 2012), 77 FR
48580 (Aug 14, 2012), (SR-CBOE-2012-040).
---------------------------------------------------------------------------

    Present Rules 5.32(d)(3)-(4) govern the minimum value sizes for
FLEX Equity and FLEX Index Options transactions in currently opened
FLEX series and FLEX Quotes in response to a Request for Quotes
(``RFQ''). Subsection (3) establishes minimum value sizes of 100
contracts and 25 contracts respectively, for opening and closing FLEX
Equity transactions in any currently-opened FLEX series and $1 million
Underlying Equivalent Value in the case of FLEX Index transactions or,
in either case the remaining underlying size or Underlying Equivalent
Value on a closing transaction, whichever is less. Subsection (4)
states the minimum value size for FLEX Quotes responsive to an RFQ
shall be 25 contracts in the case of FLEX Equity Options and $1 million
Underlying Equivalent Value in the case of FLEX Index Options or in
either case the remaining underlying size or Underlying Equivalent
Value on a closing transaction, whichever is less. The Exchange now
proposes to adopt a minimum value size of one contract when opening and
closing any Equity or Index FLEX Options transaction in previously
opened FLEX series and for responses to an RFQ. This change, coupled
with the proposed change to the minimum value size for opening
transactions in new FLEX series (described above) will effectively
establish a one contract minimum value size for all FLEX transactions
and FLEX Quotes. A one contract minimum value size for all FLEX
transactions and FLEX Quotes is based on similar rules governing
minimum value size for FLEX Options approved for the CBOE.\14\
---------------------------------------------------------------------------

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

    Adopting the same minimum value size for all FLEX transactions and
FLEX Quotes would afford market

participants, both those trading in new a FLEX series, and those
trading in an existing FLEX series, equal opportunity to tailor FLEX
transactions and FLEX Quotes to meet their own investment objectives
without being encumbered by a minimum value size. The Exchange does not
believe that the difference between effecting a FLEX transaction in an
existing series and effecting a FLEX transaction in a new series is
material to the extent that there should be different minimum value
sizes for the two types of transactions. In addition, the Exchange
believes it would be consistent to apply the same minimum value size to
closing transactions so that investors may elect to close just a
portion of their FLEX position, without being subject to a minimum
value size that may be greater than the equivalent value size necessary
to meet their investment objectives. Lastly, the Exchange believes that
it would be consistent to apply the same minimum value size to FLEX
Quotes so that market participants may respond to an RFQ with the
precise number of contracts or underlying equivalent value needed to
trade with a submitting OTP Holder who has requested the RFQ.
    As previously stated, the Exchange is submitting to the Commission
a Report detailing the Exchange's experience with the Pilot Program.
The Report is attached as Exhibit 3 to this filing. The Exchange notes
that the Report includes data specific to the trade activity under
present Rule 5.32(d)(2) and does not include data for transactions
pursuant to subsections (3)-(4) dealing with opening transactions of
less than 100 contracts in previously opened FLEX series, and closing
transactions and responses to RFQs of less than 25 contracts, which the
Exchange is also proposing to amend at this time. Based on the
Exchange's internal review, the Exchange believes that these types of
FLEX transactions, had they been part of the Exchange's Pilot Program,
would be de minimis and does not believe that the absence of trade data
specific to opening transactions of less than 100 contracts in
previously opened FLEX series, or closing transactions and FLEX Quotes
of less than 25 contracts would be material to the extent that the
findings in the Report would fail to provide evidence supporting the
elimination of specific contract and value sizes for all FLEX
transactions.
    For the foregoing reasons, the Exchange believes that the proposed
changes to the minimum value size for FLEX transactions and FLEX Quotes
are reasonable and appropriate, promote just and equitable principles
of trade, and facilitate transactions in securities while continuing to
foster the public interest and investor protection, and therefore
should be adopted on a permanent basis.
    The Exchange will continue to monitor the usage of FLEX Options and
review whether changes need to be made to its Rules or the ODD to
address any changes in retail FLEX Option participation or any other
issues that may occur as a result of the elimination of the minimum
value sizes on a permanent basis.
    In conjunction with the above proposed changes, the Exchange is
proposing certain non-substantive changes to reorganize the rule text.
In particular, text from Rule 5.32(d)(1) pertaining to the maximum 15-
year term for a FLEX Option would be relocated and renumbered as Rule
5.32(b)(6). As proposed, Rule 5.32(b)(6) would state that the maximum
term for both equity and index FLEX Options shall be 15 years. In
addition, the Exchange proposes to relocate the relevant text
pertaining to the minimum value size for FLEX Options from Commentary
.02 and renumber it as Rule 5.32(b)(7). As proposed, Rule 5.32(b)(7)
would state that the minimum value size for all FLEX Options
transaction shall be 1 contract. These changes are proposed simply to
reorganize the rule text in light of the other changes being proposed.
As noted above, the changes are not substantive.
 2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act, in general, and furthers the objectives of Section 6(b)(5), in
particular, in that it is 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 facilitating transactions in securities, and to
remove impediments to and perfect the mechanism of a free and open
market and a national market system.
    Specifically, the Exchange believes that the permanent approval of
the Pilot Program, which eliminates minimum value size requirements for
opening FLEX transactions in new FLEX series, would provide greater
opportunities for investors to manage risk through the use of FLEX
Options. Further, the Exchange notes that it has not experienced any
adverse effects from the operation of the Pilot Program. The Exchange
also believes that making the Pilot Program permanent does not raise
any unique regulatory concerns.
    The Exchange also believes that eliminating the minimum value size
requirements for all FLEX transactions and FLEX Quotes, thus affording
all market participants with an equal opportunity to tailor FLEX
transactions and FLEX quotes to meet their own investment objectives
without being encumbered by a minimum contract size, will help to
remove impediments to and perfect the mechanism of a free and open
market and a national market system. In addition, affording market
participants on NYSE Amex Options [sic] the same investment tools
available to their counterparts on the CBOE will foster cooperation and
coordination with persons engaged in facilitating transactions in
securities and will help to remove impediments to a free and open
market and a national market system. The Exchange believes that
adopting rules similar to those approved for and in use at the CBOE
does not raise any unique regulatory concerns.
    Lastly, the Exchange also believes that the proposed rule change,
which provides all market participants, including public investors,
with additional opportunities to trade customized options in an
exchange environment and subject to exchange-based rules, is
appropriate in the public interest and for the protection of investors.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. Specifically, the proposal
is structured to offer the same enhancement to all market participants,
regardless of account type, and will not impose a competitive burden on
any participant. The Exchange believes that adopting similar FLEX rules
to those of the CBOE will allow NYSE Arca to more efficiently compete
for FLEX Options orders. In addition, the Exchange believes that
adopting the Pilot Program on a permanent basis will enable the
Exchange to compete with the OTC market, in which similar restrictions
on minimum value size do not apply.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2014-25 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-NYSEArca-2014-25. 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-NYSEArca-2014-25 and should
be submitted on or before April 28, 2014.

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

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

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-07636 Filed 4-4-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 177 (Wednesday, September 12, 2012)]
[Notices]
[Pages 56202-56207]
[FR Doc No: 2012-22197]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-1017; FRL-9359-1]

Product Cancellation Order for Certain Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces EPA's order for the cancellations,
voluntarily requested by the registrants and accepted by the Agency, of
the products listed in Table 1 and 2 of Unit II., pursuant to the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This
cancellation order follows a June 13, 2012 Federal Register Notice of
Receipt of Requests from the registrants listed in Table 3 of Unit II.
to voluntarily cancel these product registrations. In the June 13, 2012
notice, EPA indicated that it would issue an order implementing the
cancellations, unless the Agency received substantive comments within
the 30 day comment period that would merit its further review of these
requests, or unless the registrants withdrew their requests. The Agency
received notice from one registrant, Aceto Agricultural Chemicals Corp,
to withdraw their cancellation request for registration no. 002749-
00119, a tributyltin oxide product. EPA did not receive any other
comments on the notice. Accordingly, EPA hereby issues in this notice a
cancellation order granting the requested cancellations, with the
exception of registration no.<PHONE_NUMBER>9. Any distribution, sale, or
use of the products subject to this cancellation order is permitted
only in accordance with the terms of this order, including any existing
stocks provisions.

DATES: The cancellations are effective September 12, 2012.

FOR FURTHER INFORMATION CONTACT: Katie Weyrauch, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2009-1017, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave., NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

II. What Action is the Agency Taking?

    This notice announces the cancellation, as requested by
registrants, of 121 products registered under FIFRA section 3. These
registrations are listed in sequence by registration number in Tables 1
and 2 of this unit.

                     Table 1--Product Cancellations
------------------------------------------------------------------------
     Registration No.          Product name           Chemical name
------------------------------------------------------------------------
000056-00068.............  Eaton's Answer II..  Piperonyl butoxide,
                                                 Pyrethrins, Silicon
                                                 Dioxide.
000279-03106.............  Command 50 WP        Clomazone.
                            Herbicide.
000402-00123.............  No. 2306 Di-Cide...  Poly(oxy-1,2-
                                                 ethanediyl(dimethylimin
                                                 o)-1,2-
                                                 ethanediyl(dimethylimin
                                                 o)-1,2-ethanediyl
                                                 dichloride).
000577-00545.............  Clear Cuprinol       Zinc naphthenate.
                            Brand Wood
                            Preservative No.
                            20.
000707-00286.............  Durotex 5000.......  Octhilinone, 5-Chloro-2-
                                                 methyl-3(2H)-
                                                 isothiazolone, 2-Methyl-
                                                 3(2H)-isothiazolone.
000748-06010.............  Liquid Chlorine....  Chlorine.
000748-06011.............  Liquid Chlorine MU.  Chlorine.
001706-00159.............  Nalco 2594.........  Poly(oxy-1,2-
                                                 ethanediyl(dimethylimin
                                                 o)-1,2-
                                                 ethanediyl(dimethylimin
                                                 o)-1,2-ethanediyl
                                                 dichloride).
002724-00457.............  Zoecon 9204 Fogger.  Permethrin, 2,4-
                                                 Dodecadienoic acid,
                                                 3,7,11-trimethyl-,
                                                 ethyl ester, (S-(E,E))-
                                                 .
002724-00780.............  Permethrin Plus      MGK 264, Permethrin,
                            Inverted Carpet      Pyriproxyfen.
                            Spray.
005481-00434.............  Tre-Hold for Citrus  Ethyl 1-
                                                 naphthaleneacetate.
010088-00086.............  Flying Insect        d-trans-Chrysanthemum
                            Killer.              monocarboxylic ester of
                                                 dl-2-allyl-4-hydroxy-3-
                                                 methyl-2-cyclopenten-1-
                                                 one, MGK 264, Piperonyl
                                                 butoxide.
010807-00191.............  Misty Fire Ant       Tetramethrin,
                            Injector Spray II.   Esfenvalerate.
032802-00028.............  Seed Safe--Turf      Siduron.
                            Care (3.71%
                            Siduron + 10-15-10
                            Lawn Food).
035571-00001.............  Chem Pro Algae       Poly(oxy-1,2-
                            Control Ed Liquid.   ethanediyl(dimethylimin
                                                 o)-1,2-
                                                 ethanediyl(dimethylimin
                                                 o)-1,2-ethanediyl
                                                 dichloride).
047000-00085.............  Chem-Tech Dy-Sect    d-trans-Chrysanthemum
                            Spray.               monocarboxylic ester of
                                                 dl-2-allyl-4-hydroxy-3-
                                                 methyl-2-cyclopenten-1-
                                                 one, Permethrin.
047000-00088.............  CT-250.............  Piperonyl butoxide,
                                                 Pyrethrins, Permethrin.
055137-00001.............  Bio/Tec 112........  Poly(oxy-1,2-
                                                 ethanediyl(dimethylimin
                                                 o)-1,2-
                                                 ethanediyl(dimethylimin
                                                 o)-1,2-ethanediyl
                                                 dichloride).
060061-00009.............  Wolman Wood          Zinc naphthenate,
                            Preservative with    Diiodomethyl p-tolyl
                            Water Repellent      sulfone.
                            Clear.
060061-00016.............  No. 00 Ready to Use  Copper naphthenate.
                            Copper Treat.
061842-00012.............  Polyquat...........  Poly(oxy-1,2-
                                                 ethanediyl(dimethylimin
                                                 o)-1,2-
                                                 ethanediyl(dimethylimin
                                                 o)-1,2-ethanediyl
                                                 dichloride).
062719-00263.............  Lawn Fertilizer      Clopyralid
                            Plus Confront Weed  Triclopyr, triethylamine
                            Control.             salt.

066806-00001.............  MB-507.............  Poly(oxy-1,2-
                                                 ethanediyl(dimethylimin
                                                 o)-1,2-
                                                 ethanediyl(dimethylimin
                                                 o)-1,2-ethanediyl
                                                 dichloride).
067360-00003.............  Intercide TJP......  Tributyltin oxide.
075613-00001.............  Stormoellen A/S--    Copper sulfate
                            Stalosan F.          pentahydrate.
081880-00020.............  MON 12036 Herbicide  Halosulfuron-methyl.
AR020001.................  Goal 2XL Herbicide.  Oxyfluorfen.
AR940005.................  Lorsban 4E-HF......  Chlorpyrifos.
AR960009.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
AZ020002.................  Kerb 50W Herbicide   Propyzamide.
                            in WSP.
AZ020010.................  Kerb 50W Herbicide   Propyzamide.
                            in WSP.
AZ050005.................  Kerb 50W Herbicide   Propyzamide.
                            in WSP.
CA000014.................  Visor 2E Herbicide.  Thiazopyr.
CA010017.................  Visor 2E Herbicide.  Thiazopyr.
CA020010.................  Success............  Spinosad.
CA020016.................  GF120 Fruit Fly      Spinosad.
                            Bait.
CA040020.................  Kerb...............  Propyzamide.
CA040021.................  Visor*2E...........  Thiazopyr.
CA790002.................  Kerb 50W Selective   Propyzamide.
                            Herbicide.
CA950008.................  Goal 1.6E Herbicide  Oxyfluorfen.
CA950014.................  Lorsban4E..........  Chlorpyrifos.
CA960019.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
CA960020.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
CA960021.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
CA960022.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
CA960023.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
CA960026.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
CA960028.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
CA970026.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
CA990007.................  Visor 2E Herbicide.  Thiazopyr.
CA990008.................  Visor 2E Herbicide.  Thiazopyr.
CT020003.................  Goal 2XL Herbicide.  Oxyfluorfen.
DE930004.................  Lorsban 4EHF.......  Chlorpyrifos.
FL990010.................  Visor 2E Herbicide.  Thiazopyr.
GA980001.................  Tracer.............  Spinosad.
HI020001.................  Goal 2XL Herbicide.  Oxyfluorfen.
IA080001.................  GF2017.............  Nitrapyrin.
ID910016.................  Kerb 50W Herbicide   Propyzamide.
                            in WSP.
KY040001.................  Strongarm..........  Diclosulam.
LA020001.................  Goal 2XL Herbicide.  Oxyfluorfen.
LA020007.................  Goal 2XL...........  Oxyfluorfen.
LA060011.................  Intrepid 2F........  Methoxyfenozide.
LA960012.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
MI940001.................  Lorsban 4EHF.......  Chlorpyrifos.
MI970002.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
MN960006.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
MO040004.................  Lorsban4E..........  Chlorpyrifos.
MS000010.................  Goal 2XL Herbicide.  Oxyfluorfen.
MS010012.................  Glyphomax..........  Glyphosateisopropylammon
                                                 ium.
MS020003.................  Goal 2XL Herbicide.  Oxyfluorfen.
MS050001.................  Glyphomax XRT......  Glyphosateisopropylammon
                                                 ium.
MS050002.................  Glypro.............  Glyphosateisopropylammon
                                                 ium.
MS960015.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
MT960003.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
NC020003.................  Goal 2XL Herbicide.  Oxyfluorfen.
NC960005.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
NC960006.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
NC970004.................  Tracer.............  Spinosad.
NC990007.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
ND010005.................  NAF545.............  Glyphosateisopropylammon
                                                 ium.
ND020006.................  Goal 2XL Herbicide.  Oxyfluorfen.
ND020007.................  Goal 2XL Herbicide.  Oxyfluorfen.
ND050008.................  Durango............  Glyphosate-
                                                 isopropylammonium.
ND960005.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
ND980001.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
NJ010001.................  Spintor 2SC........  Spinosad.
NV940002.................  Lorsban 4E-HF......  Chlorpyrifos.
NV990007.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
NY060002.................  Garlon 3A..........  Triclopyr, triethylamine
                                                 salt.
NY080008.................  Radiant SC.........  Spinetoram (minor
                                                 component (4-methyl))
                                                Spinetoram (major
                                                 component (4,5-
                                                 dihydro)).
NY080009.................  Delegate WG........  Spinetoram (minor
                                                 component (4-methyl))
                                                Spinetoram (major
                                                 component (4,5-
                                                 dihydro)).

OR940027.................  Lorsban 4E-HF......  Chlorpyrifos.
OR960037.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
OR970008.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
PA010003.................  Spintor 2SC........  Spinosad.
SC000001.................  Telone II..........  Telone.
SC970005.................  Tracer.............  Spinosad.
SD010002.................  Goal 2XL Herbicide.  Oxyfluorfen.
SD960006.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
TN060005.................  Telone II..........  Telone.
TN990002.................  Tracer.............  Spinosad.
TX000002.................  Visor 2E Herbicide.  Thiazopyr.
TX040023.................  Lock-On............  Chlorpyrifos.
VA020002.................  Spintor 2SC........  Spinosad.
WA000010.................  Lorsban-4E.........  Chlorpyrifos.
WA970024.................  Goal (R) 2XL         Oxyfluorfen.
                            Herbicide.
WI030005.................  Lorsban-4E.........  Chlorpyrifos.
WV010001.................  Spintor 2SC........  Spinosad
------------------------------------------------------------------------

    Table 2 contains a list of registrations for which companies paying
at one of the maintenance fee caps requested cancellation in the FY
2012 maintenance fee billing cycle. Because maintaining these
registrations as active would require no additional fee, the Agency is
treating these requests as voluntary cancellations under 6(f)(1).

  Table 2--Cancellations of Products Due to Non-Payment of Maintenance
                                  Fees
------------------------------------------------------------------------
     Registration No.          Product name           Chemical name
------------------------------------------------------------------------
002724-00621.............  Speer Py-Perm        Permethrin; Pyrethrins;
                            Aqueous Insect       Piperonyl butoxide.
                            Killer 4.
010324-00100.............  Maquat MC1416-255T.  Alkyl* dimethyl benzyl
                                                 ammonium chloride;
                                                 Tributyltin oxide.
010324-00101.............  Microbiocide T-40..  Alkyl* dimethyl benzyl
                                                 ammonium chloride;
                                                 Tributyltin oxide.
083504-00003.............  Polyquat MUP.......  Poly(oxyethylene(dimethy
                                                 limino)ethylene(dimethy
                                                 limino)ethylene
                                                 dichloride).
ID970015.................  Comite Agricultural  Propargite.
                            Miticide.
OR080004.................  Comite Agricultural  Propargite.
                            Miticide.
OR080005.................  Comite Agricultural  Propargite.
                            Miticide.
OR080006.................  Dimilin 2L.........  Diflubenzuron.
OR080007.................  Comite Agricultural  Propargite.
                            Miticide.
OR080008.................  Dimilin 2L.........  Diflubenzuron.
OR080009.................  Comite Agricultural  Propargite.
                            Miticide.
OR080011.................  Comite Agricultural  Propargite.
                            Miticide.
OR080012.................  Comite.............  Propargite.
------------------------------------------------------------------------

    Table 3 of this unit includes the names and addresses of record for
all registrants of the products in Tables 1 and 2 of this unit, in
sequence by EPA company number. This number corresponds to the first
part of the EPA registration numbers of the products listed in Tables 1
and 2 of this unit.

               Table 3--Registrants of Cancelled Products
------------------------------------------------------------------------
           EPA Company number                Company name and address
------------------------------------------------------------------------
56.....................................  Eaton JT & Company Inc., 1393
                                          E. Highland Rd., Twinsburg, OH
                                          44087.
279....................................  FMC Corp., Agricultural
                                          Products Group, ATTN: Michael
                                          C. Zucker, 1735 Market St.,
                                          RM. 1978, Philadelphia, PA
                                          19103.
402....................................  Hill Manufacturing Co., Inc.,
                                          1500 Jonesboro Rd. SE,
                                          Atlanta, GA 30315.
577....................................  The Sherwin-Williams Co., 101
                                          Prospect Ave., Cleveland, OH
                                          44115.
707....................................  Rohm & Haas Co., 100
                                          Independence Mall West,
                                          Philadelphia, PA 19106.
748....................................  PPG Industries, Inc., 4325
                                          Rosanna Drive, Allison Park,
                                          PA 15101.
1706...................................  Nalco Company, 1601 West Diehl
                                          Road, Naperville, IL 60563.
2724...................................  Wellmark International--D/B/A
                                          Central Life Sciences, 1501 E.
                                          Woodfield Rd., Suite 200 W.,
                                          Schaumburg, IL 60173.
5481...................................  Amvac Chemical Corporation,
                                          4695 MacArthur Court, Suite
                                          1200, Newport Beach, CA 92660-
                                          1706.
10088..................................  Athea Laboratories Inc., P.O.
                                          Box 240014, Milwaukee, WI
                                          53224.
10324..................................  Mason Chemical Co, 721 W
                                          Algonquin Rd, Arlington
                                          Heights, IL 60005.
10807..................................  Amrep, Inc., 990 Industrial
                                          Park Drive, Marietta, GA
                                          30062.

32802..................................  Gro Tec, Inc., D/B/A Howard
                                          Johnson's Enterprises Inc.,
                                          Agent: RegWest Company, LLC,
                                          8203 West 20th St., Suite A,
                                          Greeley, CO 80634-4696.
35571..................................  Chem Pro Lab, Inc., 941 W. 190
                                          St., Gardena, CA 90248.
47000..................................  Chem-Tech, LTD, 4515 Fleur Dr.
                                          303, Des Moines, IA
                                          50321.
55137..................................  Southwest Engineers, 39478 HWY
                                          190 E, Slidell, LA 70461.
60061..................................  Kop-Coat, Inc., 436 Seventh
                                          Avenue, Pittsburgh, PA 15219.
61842..................................  Tessenderlo Kerley, Inc.,
                                          Agent: Pyxis Regulatory
                                          Consulting, Inc., 4110 136th
                                          Street N.W., Gig Harbor, WA
                                          98332.
66806..................................  Tandem Technologies
                                          International, P.O. Box 1125,
                                          Carrollton, GA 30112.
67360..................................  Ackros Chemicals, Inc., Agent:
                                          Technology Sciences Group
                                          Inc., 1150 18th St. N.W.,
                                          Suite 1000, Washington DC
                                          20036.
75613..................................  Stormollen A/S, Agent: Vitfoss
                                          USA, D/B/A Kongskilde
                                          Industries, Inc., 19500 N.
                                          1425 East Road, Hudson, IL
                                          61748.
81880..................................  Canyon Group LLC, c/o Gowan
                                          Company, 370 S. Main Street,
                                          Yuma, AZ 85364.
83504..................................  Kerley Trading Inc., P.O. Box
                                          15627, Phoenix, AZ 85060.
62719; NY060002; CA020016; NY080009;     Dow AgroSciences LLC, 9330
 MS050001; ND050008; IA080001;            Zionsville RD 308/2E,
 AR940005; CA950014; DE930004;            Indianapolis, IN 46268-1054
 MI940001; MO040004; NV940002;
 OR940027; WA000010; WI030005;
 AZ020002; AZ020010; AZ050005;
 CA040020; CA790002; ID910016;
 CA000014; CA010017; CA040021;
 CA990007; CA990008; FL990010;
 TX000002; CA950008; MS010012;
 MS050002; ND010005; KY040001;
 SC000001; TN060005; NJ010001;
 PA010003; VA020002; WV010001;
 NY080008; CA020010; GA980001;
 NC970004; SC970005; TN990002;
 TX040023; AR960009; CA960019;
 CA960020; CA960021; CA960022;
 CA960023; CA960026; CA960028;
 CA970026; CT020003; LA020007;
 LA960012; MI970002; MN960006;
 MS000010; MS960015; MT960003;
 NC020003; NC960005; NC960006;
 NC990007; ND960005; ND980001;
 NV990007; OR960037; OR970008;
 SD010002; SD960006; WA970024;
 AR020001; HI020001; LA020001;
 MS020003; ND020006; ND020007; LA060011.
ID970015; OR080004; OR080005; OR080006;  Chemtura Corp., 199 Benson Rd.,
 OR080007; OR080008; OR080009;            Middlebury, CT 6749.
 OR080011; OR080012.
------------------------------------------------------------------------

III. Summary of Public Comments Received and Agency Response to
Comments

    During the public comment period provided, EPA received a request
from one registrant to rescind their request for voluntary
cancellation. Aceto Agricultural Chemicals Corp. rescinded their
request for voluntary cancellation of registration number<PHONE_NUMBER>9,
containing tributyltin oxide. EPA received no other comments in
response to the June 13, 2012 Federal Register notice announcing the
Agency's receipt of the requests for voluntary cancellations of
products listed in Table 1 of Unit II.

 IV. Cancellation Order

    Pursuant to FIFRA section 6(f), EPA hereby approves the requested
cancellations of the registrations identified in Tables 1 and 2 of Unit
II. Accordingly, the Agency hereby orders that the product
registrations identified in Tables 1 and 2 of Unit II. are cancelled.
The effective date of the cancellations that are the subject of this
notice is September 12, 2012. Any distribution, sale, or use of
existing stocks of the products identified in Table 1 and 2 of Unit II.
in a manner inconsistent with any of the provisions for disposition of
existing stocks set forth in Unit VI. will be a violation of FIFRA.

V. What is the agency's authority for taking this action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be cancelled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish a notice
of receipt of any such request in the Federal Register. Thereafter,
following the public comment period, the EPA Administrator may approve
such a request. The notice of receipt for this action was published for
comment in the Federal Register issue of June 13, 2012 (77 FR 35379)
(FRL-9351-7). The comment period closed on July 13, 2012.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
which are currently in the United States and which were packaged,
labeled, and released for shipment prior to the effective date of the
cancellation action. The existing stocks provisions for the products
subject to this order are as follows:

A. Registrations Listed in Table 1 of Unit II

    The registrants may continue to sell and distribute existing stocks
of products listed in Table 1 of Unit II. until September 12, 2013,
which is 1 year after the publication of the Cancellation Order in the
Federal Register. Thereafter, the registrants are prohibited from
selling or distributing products listed in Table 1, except for export
in accordance with FIFRA section 17, or proper disposal. Persons other
than the registrants may sell, distribute, or use existing stocks of
products listed in Table 1 of Unit II. until existing stocks are
exhausted,

provided that such sale, distribution, or use is consistent with the
terms of the previously approved labeling on, or that accompanied, the
cancelled products.

B. Registrations Listed in Table 2 of Unit II

    Registrants are allowed to sell and distribute existing stocks of
these products until January 13, 2013, 1 year after the date on which
the maintenance fee was due. Thereafter, registrants will be prohibited
from selling or distributing the pesticides identified in Table 2 of
Unit II., except for export consistent with FIFRA section 17 or for
proper disposal. Persons other than registrants are allowed to sell,
distribute, or use existing stocks until such stocks are exhausted,
provided that such sale, distribution, or use is consistent with the
terms of the previously approved labeling on, or that accompanied, the
cancelled products.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: August 30, 2012.
 Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2012-22197 Filed 9-11-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 126 (Friday, July 1, 2022)]
[Notices]
[Pages 39531-39533]
[FR Doc No: 2022-14134]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2021-E-0452; FDA-2021-E-0453]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for IMCIVREE 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 drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by August
30, 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 December 28, 2022.
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 August 30, 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-2021-E-0452; FDA-2021-E-0453 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; IMCIVREE.'' 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 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 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
drug 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 drug product, IMCIVREE
(setmelanotide acetate) indicated for chronic weight management in
adult and pediatric patients 6 years of age and older with obesity due
to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin
type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by
genetic testing demonstrating variants in POMC, PCSKI, or LEPR genes
that are interpreted as pathogenic, likely pathogenic, or of uncertain
significance. Subsequent to this approval, the USPTO received patent
term restoration applications for IMCIVREE (U.S. Patent Nos. 8,039,435;
9,458,195) from RHYTHM PHARMACEUTICALS, INC. and the USPTO requested
FDA's assistance in determining the patents' eligibility for patent
term restoration. In a letter dated June 8, 2021, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of IMCIVREE 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
IMCIVREE is 3,304 days. Of this time, 3,060 days occurred during the
testing phase of the regulatory review period, while 244 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 (FD&C Act) (21 U.S.C. 355(i)) became effective:
November 11, 2011. The applicant claims November 12, 2011, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was November
11, 2011, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: March 27,
2020. FDA has verified the applicant's claim that the new drug
application (NDA) for IMCIVREE (NDA 213793) was initially submitted on
March 27, 2020.
    3. The date the application was approved: November 25, 2020. FDA
has verified the applicant's claim that NDA 213793 was approved on
November 25, 2020.
    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 879 days or 1,774 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: June 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14134 Filed 6-30-22; 8:45 am]
BILLING CODE 4164-01-P