[Federal Register Volume 80, Number 145 (Wednesday, July 29, 2015)]
[Notices]
[Pages 45256-45259]
[FR Doc No: 2015-18537]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75509; File No. SR-MIAX-2015-47]

Self-Regulatory Organizations: Miami International Securities
Exchange LLC; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend Exchange Rule 612 Regarding the Reset on
Quote Functionality Included in the MIAX Aggregate Risk Manager

July 23, 2015.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 13, 2015, Miami International Securities Exchange LLC (``MIAX''
or ``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange is filing a proposal to amend Exchange Rule 612
concerning the Reset on Quote functionality included in the MIAX
Aggregate Risk Manager.
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.miaxoptions.com/filter/wotitle/rule_filing, at
MIAX's principal office, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The Exchange proposes to amend Exchange Rule 612, Aggregate Risk
Manager (``ARM'') to make optional and more specifically define the
current ARM ``Reset on Quote'' functionality, as described below.
    The MIAX System \3\ maintains a counting program (``counting
program'') for Market Makers \4\ in their assigned option classes.
Using the counting program, ARM protects Market Makers by limiting the
number of contracts they execute in an option class on the Exchange
within a specified time period that has been established by the Market
Maker (a ``specified time period''). MIAX Market Makers establish a
percentage of their quotations (the ``Allowable Engagement
Percentage'') and the specified time period for each option class in
which they are appointed.\5\ When an execution against a Market Maker's
Standard quote \6\ or Day eQuote (as defined below) occurs, the System
looks back over the specified time period to determine whether the
execution is of sufficient size to trigger the Aggregate Risk Manager.
The System activates the Aggregate Risk Manager when it has determined
that a Market Maker has traded a number of contracts equal to or above
their Allowable Engagement Percentage during the specified time period.
The Aggregate Risk Manager then automatically cancels and removes the
Market Maker's Standard quotes from the Exchange's disseminated
quotation in all series of that particular option class until the
Market Maker sends a notification to the System of the intent to
reengage quoting and submits a new revised quotation in the affected
class. Any eQuotes \7\ other than Day eQuotes \8\ present in the market
are not cancelled by the Aggregate Risk Manager.
---------------------------------------------------------------------------

    \3\ The term ``System'' means the automated trading system used
by the Exchange for the trading of securities. See Exchange Rule
100.
    \4\ The term ``Market Maker'' refers to a ``Lead Market Maker,''
``Primary Lead Market Maker'' and ``Registered Market Maker''
collectively. A Lead Market Maker is a Member registered with the
Exchange for the purpose of making markets in securities traded on
the Exchange and that is vested with the rights and responsibilities
specified in Chapter VI of these Rules with respect to Lead Market
Makers. A Primary Lead Market Maker is a Lead Market Maker appointed
by the Exchange to act as the Primary Lead Market Maker for the
purpose of making markets in securities traded on the Exchange. A
Registered Market Maker is a Member registered with the Exchange for
the purpose of making markets in securities traded on the Exchange,
who is not a Lead Market Maker. See Exchange Rule 100.
    \5\ The Exchange's Board or designated committee appoints one
Primary Lead Market Maker and other Market Makers to each options
class traded on the Exchange. For a complete description of the
Exchange's appointment process, see Exchange Rule 602.
    \6\ A Standard quote is a quote submitted by a Market Maker that
cancels and replaces the Market Maker's previous Standard quote, if
any. See Exchange Rule 517(a)(1).
    \7\ An eQuote is a quote with a specific time in force that does
not automatically cancel and replace a previous Standard quote or
eQuote. An eQuote can be cancelled by the Market Maker at any time,
or can be replaced by another eQuote that contains specific
instructions to cancel an existing eQuote. See Exchange Rule
517(a)(2).
    \8\ A Day eQuote is a quote submitted by a Market Maker that
does not automatically cancel or replace the Market Maker's previous
Standard quote or eQuote. Day eQuotes will expire at the close of
trading each trading day. See Exchange Rule 517(a)(2)(i).
---------------------------------------------------------------------------

    Currently, Exchange Rule 612(b)(1) states that, when a Market Maker
revises his/her quotation on the buy side or sell side of an individual
option, that side of the individual option will not be included in the
Allowable Engagement Percentage and Net Offset calculations until it
trades again.
    Proposed Rule 612(b)(1)(i) would clarify the existing rule to more
precisely define this functionality. Proposed sub-paragraph (b)(1)(i)
would clarify that when a Market Maker revises his/her quotation on the
buy side or sell side of an individual option, contracts executed on
that side will not be included in the Allowable Engagement Percentage
and Net Offset calculations. For ease of reference, the Exchange
proposes to establish the name ``Reset on Quote'' to describe this
functionality in the new sub-paragraph. The Exchange believes that this
change more precisely and accurately describes the Reset on Quote
functionality and should better serve to inform Members and investors
of what happens to the counting program when a Standard quote replaces
another Standard quote.\9\ The proposed rule will specifically state
that, in such a situation, the counting program is reset to zero (i.e.,
the counting system will be reset and begin anew) on that side upon
receipt of the revised quotation for the affected individual option
until it trades again. The Exchange believes this proposed amendment
more precisely describes the current functionality.
---------------------------------------------------------------------------

    \9\ eQuotes, including Day eQuotes, do not cancel or replace
existing eQuotes. See supra notes 7 and 8.
---------------------------------------------------------------------------

    Additionally, the proposed rule would give Market Makers the
ability to opt out of the Reset on Quote functionality, and to opt back
in at any time following the Market Maker's determination to opt out.
Under the proposed rule, a Market Maker may determine to disengage or
re-engage the Reset on Quote functionality for an option class.\10\ A
Market Maker may disengage Reset on Quote by notifying the Exchange of
its determination to disengage in a manner required by the Exchange and
communicated to Members by Regulatory Circular. If a Market Maker
determines to disengage the Reset on Quote functionality, the counting
program will continue to count the number of contracts executed during
the specified time period despite the submission by the Market Maker of
a new Standard quote on that side of the market. If the Reset on Quote
functionality is disengaged, the System will not reset the counting
program to zero upon receipt of a revised quotation and instead will
continue to add the number of contracts executed against the new quote
to the number of contracts executed against any previous quotes on that
side of the individual option during the specified time period. Absent
notification to the Exchange to disengage Reset on Quote, the ARM
counting system will, by default, continue to function as it does
currently.
---------------------------------------------------------------------------

    \10\ The terms ``class of options'' or ``option class'' mean all
option contracts covering the same underlying security. See Exchange
Rule 100.
---------------------------------------------------------------------------

    Once a Market Maker has determined to disengage Reset on Quote, it
will not be re-engaged until the Market Maker determines to do so by
notifying the Exchange of such a determination in a manner required by
the Exchange and communicated to Members by Regulatory Circular. This
non-automated notification requires the Exchange to re-engage the Reset
on Quote functionality, as opposed to the method of re-engaging the
standard ARM protections, where the Market Maker re-engages the ARM by
sending a notification to the System of the intent to re-engage quoting
and submits a new revised quotation in the affected class. The purpose
of the non-automated method of re-engaging Reset on Quote is to give
Market Makers the ability to reconsider and re-engage Reset on Quote
during times of peak or unusual market activity, rather than an
automated re-engagement. The Exchange believes that this non-automated
contact will strengthen the efficiency of Reset on Quote by providing
Market Makers with the ability to thoroughly assess current market
conditions in setting risk management levels and controls.
    The System will consider disengagement of Reset on Quote to be a
persistent state; disengagement of the Reset on Quote functionality
will remain in place indefinitely (i.e., for an

entire trading session and across multiple trading sessions) until the
Market Maker notifies the Exchange to re-engage it. A Market Maker may
determine to disengage and re-engage Reset on Quote multiple times
intra-day.
    The purpose of the proposed rule change is to enable individual
Market Makers to tailor their risk management by disengaging or re-
engaging the ARM Reset on Quote functionality for an individual option
class or for multiple classes as market conditions warrant, based on
their own risk tolerance and quoting behavior. The proposed rule change
would provide Market Makers with flexibility to choose to have ARM
count contracts executed during the specified time period that result
from all executions on that side of the market, regardless of the
number, price and/or size of the quotes against which executions occur
during the counting period. This flexibility means that Market Makers
may still elect to have the Reset on Quote functionality engaged, and
thus only count contracts executed against their most recently
submitted quote for purposes of calculating the Allowable Engagement
Percentage. This will provide greater customization of risk controls
based on each individual Market Maker's risk thresholds.
    The Exchange will announce the implementation date of the proposed
rule change by Regulatory Circular to be published no later than 60
days following the operative date of the proposed rule. The
implementation date will be no later than 60 days following the
issuance of the Regulatory Circular.
2. Statutory Basis
    MIAX believes that its proposed rule change is consistent with
Section 6(b) of the Act \11\ in general, and furthers the objectives of
Section 6(b)(5) of the Act \12\ 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 regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in, securities, to remove impediments to and perfect the mechanisms of
a free and open market and a national market system and, in general, to
protect investors and the public interest.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that Members will benefit from the proposed
rule change. Market Makers, who are obligated to submit continuous two-
sided quotations in a certain number of series in their appointed
option classes for a certain percentage of each trading session,\13\
are vulnerable to the risk from unusual market conditions, volatility
in specific option classes, and other market events that may cause them
to receive multiple, extremely rapid automatic executions before they
can adjust their quotations and overall risk exposure in the market.
The Reset on Quote functionality is a valuable tool in assisting Market
Makers in risk management; the ability of a Market Maker to determine
if and when it is engaged or disengaged enables them to further tailor
their risk management based on their expectation of market behavior and
volatility or on actual real-time market conditions.
---------------------------------------------------------------------------

    \13\ For a complete description of MIAX Market Maker quoting
obligations, see Exchange Rule 604.
---------------------------------------------------------------------------

    Without adequate risk management tools in place on the Exchange,
the incentive for Exchange Market Makers to quote aggressively
respecting both price and size could be diminished, and could result in
a concomitant reduction in the depth and liquidity they provide to the
market. Such a result may undermine the quality of the markets that
would otherwise be available to customers and other market
participants. Accordingly, the Exchange proposes to help Market Makers
better manage their risk exposure by giving them the ability to opt out
of the Reset on Quote functionality. This should encourage Market
Makers to provide additional depth and liquidity to the Exchange's
markets, thereby removing impediments to and perfecting the mechanisms
of a free and open market and a national market system and, in general,
protecting investors and the public interest.
    In addition, the proposed rule change promotes just and equitable
principles of trade by providing Exchange Market Makers with the
ability to refine and tailor their participation in risk management
mechanisms on the Exchange to give them confidence that protections are
in place to reduce the risks associated with their Market Making
obligations. Finally, the proposed rule change is designed to protect
investors and the public interest by helping Market Makers prevent
executions resulting from activity that exceeds their risk tolerance
level under these rules as established by the Exchange.
    The amendments to the existing Reset on Quote functionality in the
proposed rule are intended to remove impediments to and perfect the
mechanisms of a free and open market by adding precision and ease of
reference to the Exchange's rules, thus promoting transparency and
clarity for Market Makers seeking to determine their risk management
settings.
    The Exchange notes that the proposed rule change will not relieve
Exchange Market Makers of their continuous quoting obligations under
Exchange Rule 604 and under Reg NMS Rule 602.\14\ All of a Market
Maker's quotes in each option class will be considered firm until such
time as the Allowable Engagement Percentage threshold has been equaled
or crossed and the Market Maker's quotes are removed by the Aggregate
Risk Manager in all series of that option class.\15\
---------------------------------------------------------------------------

    \14\ 17 CFR 242.602.
    \15\ See Exchange Rule 612(c).
---------------------------------------------------------------------------

    With regard to the impact of this proposal on system capacity, the
Exchange notes that it has analyzed its capacity and represents that it
and the Options Price Reporting Authority (``OPRA'') have the necessary
systems capacity to handle any potential additional traffic associated
with the proposed rule change. The Exchange believes that its members
will not have a capacity issue as a result of this proposal.

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.
    On the contrary, the Exchange believes that the proposed rule
change will foster competition by providing Exchange Market Makers with
the ability to enhance and specifically customize their use of the
Exchange's risk management tools to use in submitting quotations with
the best possible price and size in order to compete for executions and
order flow. The Exchange further believes the proposed rule change will
not impose any burden on intra-market competition because its use is
voluntary and is available to all Exchange Market Makers and Market
Maker organizations.
    As to inter-market competition, the Exchange believes that the
proposed rule change should promote competition because it is designed
to protect Exchange Market Makers from unusual market conditions or
events that may cause them to receive multiple, automatic executions
before they can adjust their quotation exposure in the market.
    For all the reasons stated, the Exchange does not believe that the
proposed rule change will impose any

burden on competition not necessary or appropriate in furtherance of
the purposes of the Act, and believes the proposed change will in fact
enhance competition.\16\
---------------------------------------------------------------------------

    \16\ The Commission notes that, in the Form 19b-4, the Exchange
states that the proposed rule change ``is based in part on the rules
of another options exchange,'' Chicago Board Options Exchange, Inc.
Rule 8.18, ``which gives Market Makers the ability to specify a
maximum cumulative percentage, defined as the sum of the percentages
of the original quoted size of each side of each series within a
class that traded, that a Market Maker is willing to trade during a
rolling time period after which their quotations in the affected
class are removed .''
---------------------------------------------------------------------------

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to 19(b)(3)(A) of the Act \17\ and Rule 19b-4(f)(6) \18\
thereunder.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(3)(A).
    \18\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or 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-MIAX-2015-47 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-MIAX-2015-47. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal offices 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-MIAX-2015-47,
and should be submitted on or before August 19, 2015.

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

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

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-18537 Filed 7-28-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 184 (Monday, September 25, 2023)]
[Proposed Rules]
[Page 65649]
[FR Doc No: 2023-20522]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 271 and 272

[EPA-R08-RCRA-2023-0034; FRL 10614-01-R8]

Wyoming: Authorization of State Hazardous Waste Management
Program Revisions and Incorporation by Reference

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
grant authorization to the State of Wyoming for the changes to its
hazardous waste program under the Solid Waste Disposal Act, as amended,
commonly referred to as the Resource Conservation and Recovery Act
(RCRA). The EPA has determined that these changes satisfy all
requirements needed to qualify for final authorization and is
authorizing the State's changes through a direct final action, which
can be found in the ``Rules and Regulations'' section of this Federal
Register. In addition, the EPA is proposing to codify in the
regulations entitled, ``Hazardous Waste Rules and Regulations, Chapter
1, General Provisions,'' Wyoming's authorized hazardous waste program.
The EPA will incorporate by reference into the Code of Federal
Regulations (CFR) those provisions of the State regulations that are
authorized and that the EPA will enforce under RCRA.

DATES: Send written comments by October 25, 2023.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R08-
RCRA-2023-0034, at https://www.regulations.gov. Follow the detailed
instructions for submitting comments electronically or by other methods
in the ADDRESSES section of the direct final rule located in the
``Rules and Regulations'' section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Moye Lin at<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In the ``Rules and Regulations'' section of
this Federal Register, the EPA is authorizing changes to the Wyoming
program, in addition to codifying and incorporating by reference the
State's hazardous waste program as a direct final rule. The EPA did not
make a proposal prior to the direct final rule because we believe these
actions are not controversial and do not expect comments that oppose
them. We have explained the reasons for this authorization and
incorporation by reference in the preamble to the direct final rule.
    Unless EPA receives written comments that oppose the authorization
and incorporation by reference during the comment period, the direct
final rule will become effective on the date it establishes, and we
will not take further action on this proposal. If we get comments that
oppose the authorization, we will withdraw the direct final rule and it
will not take immediate effect. We will then respond to public comments
in a later final rule based on this proposal. You may not have another
opportunity for comment. If you want to comment on this action, you
must do so at this time.

    Dated: August 31, 2023.
KC Becker,
Regional Administrator, Region 8.
[FR Doc. 2023-20522 Filed 9-22-23; 8:45 am]
BILLING CODE 6560-50-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

  SEQ CHAPTER \h \r 1 								PC Code 	044309

				DP Barcode	D360266

Date                  August 4, 2009

MEMORANDUM

SUBJECT:	Tier I Estimated Environmental Concentrations of Clothianidin for the Use in the Human Health Risk Assessment, Registration of Two New Products for Seed Treatment Containing Multiple Active Ingredients, Sepresto 75WS and PROCEED™ Optimum, and New Uses for Arena 50WDG, V-10170 2.13SC, V-1017 5FS, CLUTCH 50WDG and Belay 16WSG

FROM:	José L. Meléndez, Chemist

		Environmental Risk Branch V

		Environmental Fate and Effects Division (7507P)

THROUGH:	Mah T. Shamim, Branch Chief

		Environmental Risk Branch V

		Environmental Fate and Effects Division (7507P)

TO:		Kable Davis, Risk Manager Reviewer

		Venus Eagle, Risk Manager #1

		Meredith Laws, Branch Chief

		Insecticide-Rodenticide Branch

		Registration Division (7505P)

AND:		Michael Doherty, Risk Assessor

		Christina Schwartz, Branch Chief

		Registration Action Branch II

		Health Effects Division (7509P)

PROCEED™ Optimum [clothianidin (1.46% a.i.), and prothioconazole, tebuconazole and methalaxil].  In addition, there are new uses on tuberous and corm vegetables, bulb vegetables, leafy green vegetables, brassica (cole) leafy vegetables, fruiting vegetables, cucurbit vegetables, tree nut, fig, pomegranate, cotton, soybean, peach and low growing berry (except strawberry) for Arena 50WDG, V-10170 2.13SC, V-1017 5FS, CLUTCH 50WDG and Belay 16WSG (note, not all uses for all products).

It was found that turf is still the use with the major exposure, with an application rate of 0.4 lb a.i./A, and the highest percent crop area and, therefore, the drinking waters assessment (DWA) results do not change from the previous ones.  The previous DWA still applies. An electronic copy of the previous assessment is included (Attachment A).

The EDWCs for clothianidin were calculated based on a maximum application rate of 0.4 lb a.i./A/season.  The acute drinking water concentration in surface water is 7.29 ppb of clothianidin, based on applications of the chemical to turf.  The cancer/chronic surface drinking water concentration is 1.35 ppb, also based on applications to turf.  The SCI-GROW generated EDWC is 5.88 ppb of clothianidin, which is recommended for use, both for acute and chronic exposures.  Table I provides a summary of the Tier I modeled drinking water concentrations.  Should there be a need for additional refinements, the EFED can perform a Tier II aquatic assessment, for surface waters.  For additional details, refer to Attachment A.

Table 1.  Maximum Tier I Estimated  Drinking Water Concentrations (EDWCs) (as ug/L or ppb) for drinking water  risk assessment based on ground application of clothianidin on turf.

Surface water (acute)	Surface water (chronic)	Ground water (acute and chronic)

FIRST	FIRST	SCI-GROW

7.29	1.35	5.88

Previous assessments

Tier 1 drinking waters assessments were issued on 2/10/03 and 7/6/04, using FIRST and SCI-GROW.  In the latter assessment, the most conservative scenario was found to be turfgrass (maximum single and seasonal application rate 0.4 lb a.i./A).  This is still the use with the highest seasonal application rate.

Table 2.  Summary of Clothianidin Drinking Water Exposure Assessments

Date	Reference	Uses included	Model(s)1

2/10/2003	DP Barcode: 278110	Canola and corn seed treatment	FIRST (SW)

SCI-GROW (GW)

7/6/2004	DP Barcodes: 299401 and 301729	Turfgrass, Tobacco, Apples, Pears, and Ornamentals – turf modeled because of highest seasonal rate.	FIRST (SW)

SCI-GROW (GW)

8/23/2005	DP Barcodes: 313414 and 313415	Foliar uses on potatoes and grapes, sorghum seed treatment	No new modeling needed

This assessment	DP Barcode 360266	This assessment:  Registration of two new products for seed treatment containing multiple active ingredients: Sepresto 75WS and PROCEED™ Optimum.  New uses on tuberous and corm, bulb, leafy green, brassica (cole) leafy, fruiting and cucurbit vegetables, and tree nut, fig, pomegranate, cotton, soybean, peach and low growing berry	No new modeling needed

1 SW =surface water; GW = ground water.

Data Gaps

835.4300 Aerobic Aquatic Metabolism:  The available study (MRID 45422324) was deemed supplemental.  A new study was required in reviews dated 2/20/03 (D228110) and 9/28/05 (D313414+).  The fate of the thiazolyl ring needs to be monitored.

835.7100 Small-Scale Prospective Groundwater Monitoring (old guideline number 166-1):  A study was also required in the reviews dated 2/20/03 and 9/28/05.

Use Characterization

™ Optimum (a proposed new product containing clothianidin and prothioconazole, tebuconazole and methalaxil).  The use information was obtained from the proposed labels for Arena 50WDG (EPA Reg. No. 59639-152), V-10170 2.13 SC (EPA Reg. No. 59639-150), V-1017 5FS (EPA Reg. No. 59639-151), CLUTCH 50 WDG (EPA Reg. No. 59369-152), Belay 16WSG (EPA Reg. No. 59639-153) and Sepresto 75WS (EPA Reg. No. 264-XXX) and PROCEED™ Optimum (EPA Reg. No. 264-XXX).

From Table 3 it is noted that of all the uses, turf could involve the highest exposure, with use rate for a single application at 0.4 lb a.i./A, applied in granules.  This rate was assessed, using FIRST and SCI-GROW, in memorandum dated 7/06/04 from L. Liu to D. Kenny and C. Swartz (Attachment A).  Therefore, a new assessment is not required.

Table 3.  Summary use information for clothianidin, including current uses (not shaded) and proposed uses (shaded gray) [from proposed labels for Arena 50WDG (EPA Reg. No. 59639-152), V-10170 2.13 SC (EPA Reg. No. 59639-150), V-1017 5FS (EPA Reg. No. 59639-151), CLUTCH 50 WDG (EPA Reg. No. 59369-152), Belay 16WSG (EPA Reg. No. 59639-153), Sepresto 75WS3 (EPA Reg. No. 264-XXX) and PROCEED™ Optimum4 (EPA Reg. No. 264-XXX)].  The modeled use (turf) appears bolded.

PURPOSE/ SOURCE	USE	oz a.i./         100 lb seed	oz a.i./ 1000 seed	MAX. IND. APP. RATE (lb. a.i./A)	SEASONAL APP. RATE (lb. a.i./A)	Comments

Sepresto 75WS4	Root & Tuber veg.(CG 1)	NA	0.01575	0.245	0.375	Seed Treatment

Arena 50WDG, V-10170 2.13SC	Tuberous and corm veg (CSG 1C)	NA	NA	0.05

In furrow 0.2	0.2

	Sepresto 75WS	Potato Seed pieces	0.20	NA	0.25*	NS	Seed Treatment

Arena 50WDG, V-10170 2.13SC, Belay 16WSG	Potato	NA	NA	0.05

In furrow 0.2	0.2

	V-10170 2.13SC	Potato Seed pieces	0.14	NA	0.175*	NS

	V-1017 5FS	Potato Seed pieces	0.12	NA	0.15*	NS	Seed Treatment – *based on seeding rate of 2000 lb/A (from this label)

Sepresto 75WS	Bulb veg. (CG 3)	NA	0.0071	0.196	0.375	Seed Treatment

Sepresto 75WS	Leafy Greens veg.        (CG 4 or 4A)	NA	0.028	0.0757 0.375	Seed Treatment

Arena 50WDG, V-10170 2.13SC

NA	NA	0.067

Soil-0.2	0.2

	Sepresto 75WS	Brassica (Cole) Leafy veg (CG 5)	NA	0.0416	0.118	0.375 Seed Treatment

Arena 50WDG, V-10170 2.13 SC

NA	NA	Foliar-0.067

Soil-0.2	0.2

	Sepresto 75WS	Fruiting veg. (CG 8)	NA	0.0174	0.0019	0.375	Seed Treatment

Arena 50WDG, V-10170 2.13SC

NA	NA	0.067

Soil-0.2	0.2

	Sepresto 75WS,	Cucurbit veg. (CG 9)	NA	0.034	0.04610	0.375	Seed Treatment

Arena 50WDG, V-10170 2.13SC

NA	NA	0.067

PROCEED™ OPTIMUM5	Barley, wheat & triticale	0.11	NA	0.00901	NA	Seed Treatment

V-10170 5FS	Sorghum	3.1	NA	NS

Seed Treatment

V-10170 5FS	Canola, Rapeseed	4.89	NA	NS

Seed Treatment

V-10170 5FS	Corn (field, pop, seed & sweet corn)	NA	NA	NS

Seed Treatment: 5.64 oz product/ 80,000 seed; 1.25 mg a.i./ kernel

Arena 50WDG, V-10170 2.13SC	Figs	NA	NA	0.0938	0.2

	Arena 50WDG, V-10170 2.13SC	Pomegranates	NA	NA	0.0938	0.2

	Arena 50WDG, V-10170 2.13SC	Cotton	NA	NA	0.067	0.2	Foliar applic.

V-1017 5FS	Soybeans	0.612	NA	0.0211	NS	Seed treatment

Arena 50WDG, V-10170 2.13SC

NA	NA	0.067	0.2

	Arena 50WDG	Peach	NA	NA	0.1	0.2

	Arena 50WDG, V-10170 2.13SC	Cranberry and low growing berry, except strawberry (CSG 13-07H)	NA	NA	0.066

Soil: 0.2	0.2

	Arena 50WDG, V-10170 2.13SC, Clutch 50WDG	Grapes	NA	NA	0.1

soil 0.2	0.2

	Arena 50WDG, V-10170 2.13SC, Clutch 50WDG	Pome Fruits (various)	NA	NA 0.2	0.2

	Arena 50WDG, V-10170 2.13SC, Belay 16WSG	Tobacco	NA	NA	0.0625

soil 0.2	0.2

	Arena 50WDG, V-10170 2.13SC	Turfgrass	NA	NA	0.4	0.4	Highest individual & seasonal appln. rate.

Arena 50WDG	Residential apple & pear trees	NA	NA	0.188	0.2	Apply by ground in 200 gal solution/ A

Arena 50WDG,+ V-10170 2.13SC	Non-bearing fruits & nut trees (in landscapes not for commercial prod.)	NA	NA	0.2	0.2	+Apply in 200 gal soln/ A

Arena 50WDG	Containerized Ornamental Plants in Production Greenhouse and Field Nurseries	NA	NA	NS	0.4	2 oz prod/100 gal water, drench application

Arena 50WDG	Ornamentals in Production Greenhouse and Field Nurseries	NA NA	NS	0.4	1.26 oz prod/100 gal water, foliar application

V-10170 2.13SC	Ornamentals	NA	NA	NS	0.4	2.4 oz prod/100 gal water, foliar application

V-10170 2.13SC	Ornamentals grown in flat benches or beds	NA	NA	0.21	0.4 *2.4 oz product/7500 sq ft

Arena 50WDG	In-Ground Plants in Production Greenhouse and Field Nurseries	NA	NA	NS	0.4	Shrubs-2.4 g per ft of hght; Multi-Trunk Trees 4.8 g/cumulat. inch of trunk diameter at breast hght (soil drench or soil injection)

Arena 50WDG	Ornamentals in Commercial and Residential Outdoor Landscapes and Interior Plantscapes	NA	NA	NS	0.4	Foliar (1.26 oz prod/ 100 gal water)

Soil drench or soil injection - Shrubs-2.4 g per ft of hght; Multi-Trunk Trees 4.8 g/cumulat. inch of trunk diameter at breast hght

0.4	0.4	Soil applic. for plants grown in beds

CG = Crop Group; CSG = Crop Sub-Group; NA = Not Available; N/A = Not Applicable; NS = Not Specified; No aerial applications are allowed.

D

¬

®

ø

®

¼

¾

h

h

h

h

>

^

€

萮Z萯Z摧䒾¦ᄀ

*

+

/

A

M

N

T

U

Z

[

\

]

w

x

€

ä

í

  h

  h

h

  h

h

h

~欀앤

×ù8/

×ù8/

㮛⚛

㮛⚛

㮛⚛

  hEu

  hà

(. PROCEED™ OPTIMUM is a combination product, containing clothianidin (1.46% a.i.), and prothioconazole, tebuconazole and methalaxil.

5. Carrots, representative crop, source for approximate seeding rate:   HYPERLINK "http://pmep.cce.cornell.edu/piap/carrot96/agpractices.html"  http://pmep.cce.cornell.edu/piap/carrot96/agpractices.html  - and   HYPERLINK "http://aggie-horticulture.tamu.edu/extension/vegetable/cropguides/carro t.html"  http://aggie-horticulture.tamu.edu/extension/vegetable/cropguides/carrot .html  (23000 seeds/oz and 2-2.5 lb seeds/A => 920,000 seeds/A; app rate for carrots 0.0042 oz/1000 seeds  => 0.24 lb a.i./A)

6. Onions, representative crop, source for approximate seeding rate:   HYPERLINK "http://www.ag.ndsu.edu/pubs/alt-ag/onions.htm"  http://www.ag.ndsu.edu/pubs/alt-ag/onions.htm    (8000 seeds/oz and 2-4 lb/A => 512000 seeds/A; app. rate for onions 0.006 oz a.i/1000 seeds. => 0.19 lb a.i./A)

7. Lettuce, representative crop, source of approximate seeding rate:   HYPERLINK "http://www.ipmcenters.org/cropprofiles/CP_form.cfm"  http://www.ipmcenters.org/cropprofiles/CP_form.cfm     (ultimately, 43000 plants/A => 0.075 lb a.i./A)

8.  Same source as above (7).  In CA about 44,000 plants cabbage /A => 0.11 lb a.i./A

9.  Same source as above (7):  In FL, maximum plant density of tomatoes is around 4,840/A; for tomatoes, the max. application rate is 0.00348 oz a.i./1000 seed => 0.001 lb a.i./A (note, transplants are not considered)

10.  Same source as above (7), in FL, cucumbers maximum plant population is 21,780/A => 0.046 lb a.i./A

11.    HYPERLINK "http://www.ces.purdue.edu/extmedia/AY/AY-217-W.pdf"  http://www.ces.purdue.edu/extmedia/AY/AY-217-W.pdf   Max seeding rate 210,025 seeds/A;   HYPERLINK "http://www.ipm.iastate.edu/ipm/icm/1998/10-12-1998/lowersoycost.html"  http://www.ipm.iastate.edu/ipm/icm/1998/10-12-1998/lowersoycost.html    2000-4000 seeds/lb

 Environmental chemistry methods used to generate data associated with this study must include results of a successful confirmatory method trial (validation) by an independent laboratory. Agency approval of a protocol is necessary prior to initiation of the study.

  PAGE   1

  PAGE

  PAGE   7


R-22 Precharged Products Rule

Julius Banks

to:

jarmas

05/28/2009 05:23 PM

Cc:

Cindy Newberg, Jeremy Arling

Mr. Armas,

We are currently drafting a final version of the rule that proposed a ban

on the import/export of a/c components that are pre-charged with R-22, as

of January 1, 2010. EPA staff understands the time sensitivity of this

important action.   We anticipate a final version of the rule to be

published by late summer.  EPA will post a copy of the rule on-line

(www.epa.gov/ozone/strathome.html) as soon as the final version can be

made public.   Feel free to call me if you have specific questions.

Regards,

Julius Banks

Team Lead, Refrigerant Recovery and Recycling Prog.

Stratospheric Protection Division

tel:<PHONE_NUMBER>

fax:<PHONE_NUMBER>

www.epa.gov/ozone/title6/608/608fact.html

- Forwarded by Cindy Newberg/DC/USEPA/US on 05/27/2009 03:00 PM -----

From:	"Jose Armas"<EMAIL_ADDRESS> To:	Cindy Newberg/DC/USEPA/US@EPA

Date:	05/27/2009 02:52 PM

Subject:

Dear Cindy:

As we approach the middle of this year, we prepare our purchases of

imported

pre-charged R22 bearing equipment for the last quarter and will like to

know

the final rule on this issue.

As mentioned above, the product will be purchased for sales in the last

quarter of 2009; therefore, the new rule regarding pre-charged appliances

will not have an impact.  However; imports are sometimes delayed and we

might have product coming in after January 1 2010.

Your comments are greatly appreciated.

Jose A. Armas

Refricenter International

PH-305 477 8880

FX-305 715 7137


[Federal Register Volume 75, Number 234 (Tuesday, December 7, 2010)]
[Proposed Rules]
[Pages 75945-75949]
[FR Doc No: 2010-30613]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket ID FEMA-2010-0003; Internal Agency Docket No. FEMA-B-1168]

Proposed Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Proposed rule.

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

SUMMARY: Comments are requested on the proposed Base (1% annual-chance)
Flood Elevations (BFEs) and proposed BFE modifications for the
communities listed in the table below. The purpose of this notice is to
seek general information and comment regarding the proposed regulatory
flood elevations for the reach described by the downstream and upstream
locations in the table below. The BFEs and modified BFEs are a part of
the floodplain management measures that the community is required
either to adopt or to show evidence of having in effect in order to
qualify or remain qualified for participation in the National Flood
Insurance Program (NFIP). In addition, these elevations, once
finalized, will be used by insurance agents and others to calculate
appropriate flood insurance premium rates for new buildings and the
contents in those buildings.

DATES: Comments are to be submitted on or before March 7, 2011.

ADDRESSES: The corresponding preliminary Flood Insurance Rate Map
(FIRM) for the proposed BFEs for each community is available for
inspection at the community's map repository. The respective addresses
are listed in the table below.
    You may submit comments, identified by Docket No. FEMA-B-1168, to
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance
and Mitigation Administration, Federal Emergency Management Agency, 500
C Street, SW., Washington, DC 20472,<PHONE_NUMBER>, or (e-mail)
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>, or (e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) proposes to make determinations of BFEs and modified BFEs for
each community listed below, in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR
67.4(a).
    These proposed BFEs and modified BFEs, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. These proposed elevations
are used to meet the floodplain management requirements of the NFIP and
also are used to calculate the appropriate flood insurance premium
rates for new buildings built after these elevations are made final,
and for the contents in those buildings.
    Comments on any aspect of the Flood Insurance Study and FIRM, other
than the proposed BFEs, will be considered. A letter acknowledging
receipt of any comments will not be sent.

    National Environmental Policy Act. This proposed rule is
categorically excluded from the requirements of 44 CFR part 10,
Environmental Consideration. An environmental impact assessment has not
been prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Executive Order 12866, Regulatory Planning and Review. This
proposed rule is not a significant regulatory action under the criteria
of section 3(f) of Executive Order 12866, as amended.
    Executive Order 13132, Federalism. This proposed rule involves no
policies that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This proposed rule
meets the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 67

    Administrative practice and procedure, Flood insurance, Reporting
and recordkeeping requirements.

    Accordingly, 44 CFR part 67 is proposed to be amended as follows:

PART 67--[AMENDED]

    1. The authority citation for part 67 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.

Sec.  67.4  [Amended]

    2. The tables published under the authority of Sec.  67.4 are
proposed to be amended as follows:

----------------------------------------------------------------------------------------------------------------
                                                                    * Elevation in feet
                                                                  (NGVD)  + Elevation in
                                                                  feet  (NAVD)
                                       Location of referenced       Depth in feet above
         Flooding source(s)                  elevation**          ground  [and] Elevation   Communities affected
                                                                     in meters  (MSL)
                                                                --------------------------
                                                                  Effective     Modified
----------------------------------------------------------------------------------------------------------------
                                Skagit County, Washington, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Left Bank Overflow Main Stem Skagit  Approximately 1,400 feet     2          +23  City of Mount Vernon,
 River.                               north of the intersection                             Unincorporated Areas
                                      of Hickox Road and I-5.                               of Skagit County.
                                     Approximately 300 feet       2          +24
                                      west of the intersection
                                      of Anderson Road and Old
                                      Highway 99.
Left Bank Overflow Main Stem Skagit  Approximately 0.43 mile             +19          +24  City of Mount Vernon,
 River.                               east of the intersection                              Unincorporated Areas
                                      of Dike Road and Britt                                of Skagit County.
                                      Road.
                                     Approximately 1,500 feet            +19          +27
                                      west of the intersection
                                      of Riverview Lane and
                                      Dike Road.
Left Bank Overflow Main Stem Skagit  Just northwest of the        3          +26  City of Mount Vernon,
 River.                               intersection of Britt                                 Unincorporated Areas
                                      Road and Dike Road.                                   of Skagit County.
                                     Approximately 250 feet       3          +28
                                      north of Dike Road and
                                      approximately 1,000 feet
                                      west of Riverview Lane.
Left Bank Overflow Main Stem Skagit  Approximately 900 feet       1          +25  City of Mount Vernon,
 River.                               north of Blackburn Road                               Unincorporated Areas
                                      between 2nd Street and                                of Skagit County.
                                      3rd Street.
                                     At the intersection of       1          +39
                                      Freeway Drive and Cameron
                                      Way.
Left Bank Overflow Main Stem Skagit  Just north of Stewart Road   3          +41  City of Mount Vernon.
 River.                               between Riverside Drive
                                      and the Burlington
                                      Northern Railroad.
                                     Just northwest of the        3          +42
                                      intersection of Hoag Road
                                      and the Burlington
                                      Northern Railroad.
Left Bank Overflow Main Stem Skagit  Approximately 1.4 miles             +34          +40  City of Mount Vernon,
 River.                               west of the intersection                              Unincorporated Areas
                                      of I-5 and State Route                                of Skagit County.
                                      538, at levee.
                                     At the intersection of the          +34          +40
                                      Burlington Northern
                                      Railroad and State Route
                                      538.
Left Bank Overflow Main Stem Skagit  Just north of the                  None          +24  City of Mount Vernon,
 River.                               intersection of Hickox                                Unincorporated Areas
                                      Road and Dike Road.                                   of Skagit County.
                                     Approximately 640 feet             None          +27
                                      west of the intersection
                                      of Riverview Lane and
                                      Dike Road.
Left Bank Overflow Main Stem Skagit  At the intersection of I-5         None          +24  City of Mount Vernon.
 River.                               and Anderson Road.
                                     At the intersection of I-5         None          +28
                                      and Section Street.
Left Bank Overflow Main Stem Skagit  Just north of Fir Island     3          +20  City of Mount Vernon,
 River/South Fork Skagit River.       Road, at the intersection                             Unincorporated Areas
                                      with the Burlington                                   of Skagit County.
                                      Northern Railroad.
                                     Approximately 500 feet       3          +23
                                      south of Hickox Road
                                      between the levee and the
                                      Burlington Northern
                                      Railroad.
Left Bank Overflow Main Stem Skagit  Approximately 0.75 mile             +13          +16  Unincorporated Areas
 River/South Fork Skagit River.       south of the intersection                             of Skagit County.
                                      of Milltown Road and
                                      Pioneer Highway.
                                     At the intersection of              +13          +20
                                      State Route 534 and I-5.

Left Bank Overflow North Fork        Just east of the levee,      1          +16  Unincorporated Areas
 Skagit River.                        approximately 350 feet                                of Skagit County.
                                      northeast of the
                                      intersection of Moore
                                      Road and Polson Road.
                                     Just east of the levee,      1          +18
                                      approximately 450 feet
                                      north of Moore Road.
Main Stem Skagit River.............  At the confluence with the          +27          +30  City of Burlington,
                                      North Fork Skagit River                               City of Mount
                                      and South Fork Skagit                                 Vernon, City of
                                      River.                                                Sedro-Woolley, Town
                                                                                of La Conner,
                                                                                Unincorporated Areas
                                                                                of Skagit County.
                                     Just downstream of the              +49          +52
                                      Burlington Northern
                                      Railroad.
North Fork Skagit River............  At the confluence with              +14          +16  Unincorporated Areas
                                      Skagit Bay.                                           of Skagit County.
                                     At the confluence with the          +27          +30
                                      Main Stem Skagit River
                                      and South Fork Skagit
                                      River.
Overflow from the Main Stem Skagit   At the confluence with              +12          +14  Unincorporated Areas
 River between the North Fork         Skagit Bay.                                           of Skagit County.
 Skagit River and the South Fork
 Skagit River.
                                     At the intersection of              +13          +18
                                      Moore Road and Dry Slough
                                      Road.
Overflow from the Main Stem Skagit   Approximately 200 feet       3          +18  Unincorporated Areas
 River between the North Fork         north of Moore Road                                   of Skagit County.
 Skagit River and the South Fork      between the North Fork
 Skagit River Padilla Bay.            Skagit River and Dry
                                      Slough Road.
                                     Approximately 880 feet       3          +21
                                      southwest of the
                                      confluence with North
                                      Fork Skagit River and the
                                      South Fork Skagit River.
                                     Approximately 1,000 feet           None          +13  Swinomish Indian
                                      northwest of the                                      Tribal Community.
                                      intersection of Highway
                                      20 and Padilla Heights
                                      Road.
                                     Approximately 100 feet             None          +13
                                      north of the crossing at
                                      State Route 20 and the
                                      Swinomish Channel.
Right Bank Overflow Main Stem        Approximately 0.36 mile      3          +21  City of Mount Vernon,
 Skagit River.                        west of the intersection                              Unincorporated Areas
                                      of Penn Road and Calhoun                              of Skagit County.
                                      Road.
                                     Approximately 400 feet       3          +30
                                      south of the levee
                                      between Moores Garden
                                      Road and Baker Street.
Right Bank Overflow Main Stem        Approximately 300 feet       3          +24  Unincorporated Areas
 Skagit River.                        north of the intersection                             of Skagit County.
                                      of Dunbar Avenue and Avon
                                      Allen Road.
                                     Aproximately 500 feet east   3          +31
                                      of Avon Allen Road
                                      between Bennett Road and
                                      State Route 536.
Right Bank Overflow Main Stem        Approximately 400 feet       3          +25  Unincorporated Areas
 Skagit River.                        northeast of the                                      of Skagit County.
                                      intersection of Bennett
                                      Road and State Route 536.
                                     Approximately 500 feet       3          +34
                                      southeast of the
                                      intersection of Bennett
                                      Road and Silver Lane.
Right Bank Overflow Main Stem        Approximately 400 feet       3          +32  Unincorporated Areas
 Skagit River.                        west of the intersection                              of Skagit County.
                                      of Pulver Road and
                                      McCorquedale Road.
                                     Approximately 400 feet       3          +34
                                      east of Pulver Road
                                      between Whitemarsh Road
                                      and McCorquedale Road.
Right Bank Overflow Main Stem        At Kamb Road approximately   3          +19  Unincorporated Areas
 Skagit River/North Fork Skagit       0.47 mile south of                                    of Skagit County.
 River Right Bank Overflow North      Calhoun Road.
 Fork Skagit River.
                                     Approximately 0.38 mile      3          +20
                                      southeast of the
                                      intersection of Calhoun
                                      Road and Kamb Road.
                                     Just south of Kamb Road      3          +19  Unincorporated Areas
                                      approximately 0.66 mile                               of Skagit County.
                                      east of Beaver Marsh Road.
                                     Approximately 1,600 feet     3          +19
                                      east of the intersection
                                      of Beaver Marsh Road and
                                      Marsh Road.

Right Bank Overflow South Fork       Between Moore Road and       1          +17  Unincorporated Areas
 Skagit River Samish Bay.             Polson Road Approximately   1          +18   of Skagit County.
                                      870 feet south of Moore
                                      Road, at levee.
                                     At the intersection of              +12          +13  Unincorporated Areas
                                      Chuckanut Drive and South                             of Skagit County.
                                      Blanchard Drive.
Samish Bay/Padilla Bay Simlik Bay..  At the intersection of              +12          +13  Unincorporated Areas
                                      Bayview-Edison Road and                               of Skagit County.
                                      Samish Island Road.
                                     Approximately 0.32 mile            None          +12  Swinomish Indian
                                      southwest of the                                      Tribal Community.
                                      intersection of Snee-Oosh
                                      Road and Snee-Oosh Lane.
                                     Approximately 100 feet             None          +12
                                      southwest of the
                                      intersection of
                                      Reservation Road and
                                      Simlik Bay Road.
Skagit Bay.........................  Approximately 0.36 mile             +15          +14  Unincorporated Areas
                                      northwest of the                                      of Skagit County.
                                      intersection of Pioneer
                                      Highway and Milltown Road.
                                     At the confluence of                +17          +14
                                      Ishois Slough and Tom
                                      Moore Slough.
Skagit Bay.........................  Approximately 200 feet             None          +12  Swinomish Indian
                                      northwest of the                                      Tribal Community.
                                      intersection of Sherman
                                      Avenue and Chilberg
                                      Avenue.
                                     Approximately 0.32 mile            None          +12
                                      southwest of the
                                      intersection of Snee-Oosh
                                      Road and Snee-Oosh Lane.
Skagit Bay.........................  Approximately 400 feet             None          +14  Swinomish Indian
                                      northwest of Pull and Be                              Tribal Community.
                                      Damned Point Road.
                                     Approximately 200 feet             None          +14
                                      southwest of the
                                      intersection of Sherman
                                      Avenue and Chilberg
                                      Avenue.
Skagit Bay/Swinomish Channel.......  Approximately 600 feet             None          +12  Swinomish Indian
                                      southwest of the                                      Tribal Community.
                                      intersection of North
                                      Pearle Jensen Way and
                                      East Pearle Jensen Way.
                                     Approximately 400 feet             None          +12
                                      west of Pull and Be
                                      Damned Point Road.
Skagit River.......................  Just upstream of the                +49          +52  City of Sedro-
                                      Burlington Northern                                   Woolley, Town of
                                      Railroad.                                             Concrete, Town of
                                                                                Hamilton, Town of
                                                                                Lyman,
                                                                                Unincorporated Areas
                                                                                of Skagit County.
                                     Approximately 1.0 mile             +197         +198
                                      upstream of the
                                      confluence with the Baker
                                      River.
Skagit River Delta Overbank          Just upstream of Pulver             +27          +32  City of Burlington,
 Flowpath 1.                          Road.                                                 Unincorporated Areas
                                                                                of Skagit County.
                                     Approximately 1,170 feet            +45          +46
                                      southeast of the
                                      intersection of Lafayette
                                      Road and Peter Anderson
                                      Road.
Skagit River Delta Overbank          At the confluence with              +12          +13  Unincorporated Areas
 Flowpath 2 Skagit River Delta        Samish Bay.                                           of Skagit County.
 Overbank Flowpath 3.
                                     Just downstream of Pulver           +27          +32
                                      Road.
                                     At the confluence with the          +12          +15  Town of La Conner,
                                      Swinomish Channel.                                    Unincorporated Areas
                                                                                of Skagit County.
                                     Just downstream of Pulver           +27          +32
                                      Road.
South Fork Skagit River............  At the confluence with              +17          +14  Unincorporated Areas
                                      Ishois Slough and Tim                                 of Skagit County.
                                      Moore Slough.
                                     At the confluence with the          +27          +30
                                      Main Stem Skagit River
                                      and the North Fork Skagit
                                      River.
Swinomish Channel..................  Just north of Highway 20..         None          +11  Swinomish Indian
                                                                                Tribal Community.
                                     Approximately 600 feet             None          +11
                                      northwest of the
                                      intersection of North
                                      Pearle Jensen Way and
                                      East Pearle Jensen Way.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[and] Mean Sea Level, rounded to the nearest 0.1 meter.
** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation
 Administration, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.
                                                    ADDRESSES

City of Burlington
Maps are available for inspection at 900 East Fairhaven Avenue, Burlington, WA 98233.

City of Mount Vernon
Maps are available for inspection at 910 Cleveland Avenue, Mount Vernon, WA 98273.

City of Sedro-Woolley
Maps are available for inspection at 720 Murdock Street, Sedro-Woolley, WA 98284.

Swinomish Indian Tribal Community
Maps are available for inspection at 11404 Moorway Way, La Conner, WA 98257.

Town of Concrete
Maps are available for inspection at 45672 Main Street, Concrete, WA 98237.

Town of Hamilton
Maps are available for inspection at 584 Maple Street, Hamilton, WA 98255.

Town of La Conner
Maps are available for inspection at 204 Douglas Street, La Conner, WA 98257.

Town of Lyman
Maps are available for inspection at 8224 South Main Street, Lyman, WA 98263.

                                      Unincorporated Areas of Skagit County
Maps are available for inspection at 1800 Continental Place, Mount Vernon, WA 98273.
----------------------------------------------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: November 23, 2010.
Sandra K. Knight,
Deputy Federal Insurance and Mitigation Administrator, Mitigation,
Department of Homeland Security, Federal Emergency Management Agency.
[FR Doc. 2010-30613 Filed 12-6-10; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 79, Number 155 (Tuesday, August 12, 2014)]
[Notices]
[Page 47162]
[FR Doc No: 2014-19100]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Federal Register Citation of Previous Announcement: [to be
published]

STATUS: Closed Meeting.

PLACE: 100 F Street NE., Washington, DC.

Date and Time of Previously Announced Meeting: Thursday, August 14,
2014.

Change in the Meeting: Cancellation of Meeting.
    The Closed Meeting scheduled for Thursday, August 14, 2014 at 2:00
p.m. has been cancelled.
    For further information please contact the Office of the Secretary
at<PHONE_NUMBER>.

    Dated: August 7, 2014.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-19100 Filed 8-8-14; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 16 (Tuesday, January 25, 2011)]
[Notices]
[Pages 4406-4407]
[FR Doc No: 2011-1433]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-63728; File No. SR-NASDAQ-2011-009]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Regarding a Clerical Change to Nasdaq Rules

January 14, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on January 6, 2011, The NASDAQ Stock Market LLC (``Nasdaq'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II, and III below, which Items
have been prepared by Nasdaq. The Commission is publishing this notice
to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    Nasdaq proposes to make clerical corrections to correct cross
references within Rule 5705 of to [sic] the Nasdaq rulebook. Nasdaq
proposes to implement the proposed rule change immediately.
    The text of the proposed rule change is available on Nasdaq's Web
site http://nasdaq.cchwallstreet.com, at Nasdaq's principal office, 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, Nasdaq included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. Nasdaq has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    Nasdaq proposes to make a clerical correction to the Nasdaq
rulebook. Specifically, Nasdaq proposes that in Nasdaq Rule 5705 that
all references to Rule 5205 be changed to Rule 5705. Nasdaq is making
this change due to an inadvertent clerical error in the original filing
adopting this rule.\3\ Nasdaq is making no other changes to Nasdaq Rule
5705.
---------------------------------------------------------------------------

    \3\ Securities Exchange Act Release No. 59663 (March 31, 2009),
74 FR 15552 (April 6, 2009) (SR-NASDAQ-2009-018).
---------------------------------------------------------------------------

2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\4\ in general, and with Section
6(b)(5) of the Act,\5\ in particular, in that the proposal 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 regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest. The proposed rule change
makes a minor clerical change to an existing Nasdaq rule.
---------------------------------------------------------------------------

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

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

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

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

    Written comments were neither solicited nor received.

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

    Pursuant to Section 19(b)(3)(A) of the Act\6\ and Rule 19b-4(f)(3)
thereunder,\7\ Nasdaq has designated this proposal as one that is
concerned solely with the administration of the self-regulatory
organization. Accordingly, Nasdaq believes that its proposal should
become immediately effective.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 240.19b-4(f)(3).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or 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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2011-009 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2011-009. This
file number should be included on the subject line if e-mail 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 website
viewing and printing in the Commission's Public Reference Room on
official business days between the hours of 10 a.m. and 3 p.m. Copies
of such filing also will be available for inspection and copying at the
principal offices 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-NASDAQ-2011-009, and should be submitted on or before
February 15, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
Elizabeth M. Murphy,
Secretary.
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

[FR Doc. 2011-1433 Filed 1-24-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 55 (Wednesday, March 21, 2012)]
[Notices]
[Page 16544]
[FR Doc No: 2012-6791]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EL12-48-000]

City of New Martinsville, WV; Notice of Petition for Enforcement

    Take notice that on March 15, 2012, pursuant to section
210(h)(2)(B) of the Public Utility Regulatory Policies Act of 1978
(PURPA), the City of New Martinsville, West Virginia filed a petition
requesting the Federal Energy Regulatory Commission (Commission)
initiate an enforcement action against the Public Service Commission of
West Virginia (PSC) and granting such other relief as the Commission
may deem proper in order to remedy the PSC's violations of PURPA.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on March 29, 2012.

    Dated: March 15, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-6791 Filed 3-20-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 228 (Wednesday, November 29, 2023)]
[Notices]
[Pages 83415-83417]
[FR Doc No: 2023-26251]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-E-2091]

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

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 Kerendia and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application 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
SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic
or written comments and ask for a redetermination by January 29, 2024.
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 May 28, 2024. 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 January 29, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically,

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-E-2091 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; KERENDIA.'' 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, 240-
402-7500.
     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, Kerendia
(finerenone) indicated to reduce the risk of sustained eGFR decline,
end stage kidney disease, cardiovascular death, non-fatal myocardial
infarction, and hospitalization for heart failure in adult patients
with chronic kidney disease associated with type 2 diabetes. Subsequent
to this approval, the USPTO received a patent term restoration
application for Kerendia (U.S. Patent No. 8,436,180) from Bayer
Intellectual Property GmbH and the USPTO requested FDA's assistance in
determining the patent's eligibility for patent term restoration. In a
letter dated September 13, 2022, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of Kerendia 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
Kerendia is 2,950 days. Of this time, 2,707 days occurred during the
testing phase of the regulatory review period, while 243 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:
June 13, 2013. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on June 13,
2013.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: November 9,
2020. FDA has verified the applicant's claim that the new drug
application (NDA) for Kerendia (NDA 215341) was initially submitted on
November 9, 2020.

    3. The date the application was approved: July 9, 2021. FDA has
verified the applicant's claim that NDA 215341 was approved on July 9,
2021.
    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 application for patent extension,
this applicant seeks 1,597 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: November 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26251 Filed 11-28-23; 8:45 am]
BILLING CODE 4164-01-P