UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY

2565 PLYMOUTH ROAD

ANN ARBOR, MICHIGAN 48105-2498

OFFICE OF

AIR AND RADIATION

MEMORANDUM

SUBJECT:	Heavy-Duty Hybrid Onboard Diagnostics

FROM:		Amy Kopin

TO:		The Docket

DATE:		July 15, 2011

	On May 3rd, 2011 we held a conference call with Cummins to discuss
concerns raised by Cummins regarding heavy-duty onboard diagnostic (OBD)
requirements and timing.  Cummins raised concerns during the comment
period for the heavy-duty greenhouse gas notice of proposed rulemaking
that heavy-duty hybrid applications may not be able to meet the 2013
heavy-duty OBD regulations that were published in the 2009 OBD Final
Rulemaking.,  Specifically, their comments include a request for a delay
of the application of HD OBD requirements for hybrid applications until
2020.  Attendees from this meeting are presented in the table below.

 Attendee 	Affiliation

Cleophas Jackson 	EPA – Compliance and Innovative Strategies Division

Anthony Neam 	EPA – Assessment and Standards Division

Amy Kopin 	EPA – Assessment and Standards Division

Mark Stepper	Cummins

Ben Zwissler	Cummins

Morgan Andreae	Cummins

 U.S. EPA, NHTSA, and DOT, “Greenhouse Gas Emission Standards and Fuel
Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles,”
republished December 29, 2010.  Available here:
http://origin.www.gpo.gov/fdsys/pkg/FR-2010-12-29/html/2010-32726.htm

 U.S. EPA, “Control of Air Pollution from New Motor Vehicles and New
Motor Vehicles Engines; Final Rule Regulations Requiring Onboard
Diagnostic Systems on 2010 and Later Heavy-Duty Engines Used in Highway
Applications Over 14,000 Pounds; Revisions to Onboard Diagnostic
Requirements for Diesel Highway Heavy-Duty Vehicles Under 14,000
Pounds,” published February 24, 2009.  Available here:
http://www.epa.gov/otaq/regs/im/obd/regtech/hd-obd-frm-02-24-09-notice-7
4-fr-8310.pdf


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:		August 13, 2009

Subject:	FENARIMOL.  Re-Assessment of Harmonization of Proposed
Tolerance of Fenarimol on Hops with CODEX MRL.

PC Code:  	206600	DP Barcode:	368101

Decision No.:	367682	Registration No.:	10163-273

Petition No.:	6E7074	Regulatory Action:	Section 3

Assessment Type:	None	Registration Case No.:	None

TXR No.:	None	CAS No.:	60168-88-9

MRID No.:	None	40 CFR:	§180.421

  SEQ CHAPTER \h \r 1 From:		  SEQ CHAPTER \h \r 1 Debra Rate, Ph.D.,
Biologist

			Alternative Risk Integration and Assessment (ARIA) Team

			Risk Integration, Minor Use and Emergency Response Branch (RIMUERB)

			Registration Division (RD; 7505P)

Through:		  SEQ CHAPTER \h \r 1 John Redden, Team Leader

				ARIA

				RIMUERB/RD (7505P)

				AND

				Jack Arthur, Acting Branch Chief

			Risk Assessment Branch 5 (RAB5)

			Health Effects Division (HED; 7509P)

To:	Laura Nolen/Barbara Madden/Dan Rosenblatt, RM Team 05

			RIMUERB/RD (7505P)

	  SEQ CHAPTER \h \r 1

Following the risk assessment for fenarimol considering the proposed
new use on hops, dried cone (DP# 330714, B. Hanson, 30/JUL/2009), it was
determined that there was an existing CODEX MRL on the commodity, hops,
dried cone at the level of 5.0 ppm for the chemical fenarimol.
Currently the tolerance recommendation from ARIA is 1.2 ppm.

Since there is an existing CODEX MRL, the question of harmonization has
been re-examined for the use of fenarimol on hops.  Based on use
pattern, residue definition, resulting dietary and aggregate risks and
exposures, ARIA has concluded that no significant increase in harm to
any population or population subgroup would result from the
harmonization of the US EPA tolerance in/on hop, dried cones to 5.0 ppm.

With increased foreign trade, especially with the hops commodity, the
ability to harmonize, when possible is an advantage to both the US and
our foreign partners.  The following arguments will demonstrate the
dietary exposure and risks as well as the aggregate exposure and risks
associated with raising the proposed tolerance on hop, dried cones from
1.2 ppm to 5.0 ppm.

1.  The use patterns of fenarimol on hops for the US and European
community are similar with the following directions for use:

1) application rate of approximately 0.054 lb ai/A, with a maximum of 4
applications; 2) 14-day retreatment interval (RTI); and 3) 10 day
preharvest interval (PHI).

2.  The residue definition for tolerance is also equivalent between the
US EPA and CODEX.

3.  Below, in Table 1, is a summary of the risk and exposure of
fenarimol use with the residue level for hops set at 1.2 ppm and 5.0
ppm.  Notice that the most highly exposed population subgroup is all
infants (<1 year old) at 76% of the chronic population-adjusted dose
(cPAD).  Table 1 also summaries the change in dietary (food + water)
risk and exposure as a result of harmonizing the hops tolerance to 5.0
ppm.

Table 1.  Summary of Chronic Dietary Exposure and Risk for Fenarimol
with 1.2 ppm or 5.0 ppm Residue for Hops, dry cone.

Population Subgroup1	DEEM Chronic Dietary Analysis

	Hops Residue = 1.2 ppm	Hops Residue = 5.0 ppm

	Exposure (mg/kg/day)	% cPAD	Exposure (mg/kg/day)	% cPAD

General U.S. Population	0.001402	23	0.001429	24

All Infants (< 1 year old)	0.004570	76	0.004570	76

Children 1-2 years old	0.002080	35	0.002080	35

Children 3-5 years old	0.001942	32	0.001942	32

Children 6-12 years old	0.001337	22	0.001337	22

Youth 13-19 years old	0.001010	17	0.001020	17

Adults 20-49 years old	0.001315	22	0.001362	23

Adults 50+ years old	0.001374	23	0.001392	23

Females 13-49 years old	0.001300	22	0.001316	22

1 Values for the population with the highest risk for each type of risk
assessment are bolded.

2 NA = Not Applicable; no acute dietary endpoint was identified for
these population subgroups.

4.  Because no appropriate endpoint was available to determine the aRfD
for the general population or any population subgroup, an acute dietary
or aggregate risk assessment was not performed.

≥ 1000 is required since a lowest-observable adverse-effect level
(LOAEL) was used for risk assessment (i.e., a no-observable
adverse-effect level (NOAEL) was not established in the critical study).
 Note: A level of concern (LOC) of a MOE of 300 was previously used but
has since been raised to 1000 (DP#: 331611, C. Swartz, 3/22/2007).

Table 2.  Short-Term Aggregate Risk for Fenarimol

Population	NOAEL	Food + Drinking Water	Dermal	LOC	MOE Aggregate

EXP	EXP

Adults 20-49 years old	35	0.001362	0.0026	1000	8800

Dermal Exposure = TTR (1.53 µg/cm2) x TC (500 cm2/hr) x conversion
factor (1 mg/l,000 µg) x exposure time (4 hrs golfing) x Dermal
Absorption Factor (5/100) / body weight (60 kg adult).  Short-term MOEs
were calculated using DAT 0 residue values.

TTR turf transferable residue

DAT days after treatment

6.  Since intermediate/long-term exposures are not anticipated, an
intermediate-term aggregate risk assessment was not necessary.  Hence, a
rise in the level of residues of hops used in the human health risk
assessment will have no impact.

7.  Since the chronic aggregate risk assessment includes exposure from
food and drinking water only, and the chronic dietary analysis that was
performed included both, no further calculations are necessary.  With
EFED’s suggestions for restricting fenarimol use on turf to
professional stadia and golf course tees, greens, and fairways at the
currently proposed application rates (resulting in an EDWC of 66 ppb)
the chronic dietary and, therefore, chronic aggregate risks are below
ARIA’s and HED’s level of concern.

8.  Because fenarimol is “not likely to be carcinogenic to humans”,
an aggregate cancer risk assessment was not required.


[Federal Register Volume 80, Number 127 (Thursday, July 2, 2015)]
[Rules and Regulations]
[Pages 37996-37997]
[FR Doc No: 2015-16399]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2015-0001; Internal Agency Docket No. FEMA-8389]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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

SUMMARY: This rule identifies communities where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP) that are scheduled for suspension on the effective dates
listed within this rule because of noncompliance with the floodplain
management requirements of the program. If the Federal Emergency
Management Agency (FEMA) receives documentation that the community has
adopted the required floodplain management measures prior to the
effective suspension date given in this rule, the suspension will not
occur and a notice of this will be provided by publication in the
Federal Register on a subsequent date. Also, information identifying
the current participation status of a community can be obtained from
FEMA's Community Status Book (CSB). The CSB is available at http://www.fema.gov/fema/csb.shtm.

DATES: The effective date of each community's scheduled suspension is
the third date (``Susp.'') listed in the third column of the following
tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact Bret Gates, Federal Insurance and
Mitigation Administration, Federal Emergency Management Agency, 500 C
Street SW., Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
Federal flood insurance that is not otherwise generally available from
private insurers. In return, communities agree to adopt and administer
local floodplain management measures aimed at protecting lives and new
construction from future flooding. Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale
of NFIP flood insurance unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed in this document no longer meet that
statutory requirement for compliance with program regulations, 44 CFR
part 59. Accordingly, the communities will be suspended on the
effective date in the third column. As of that date, flood insurance
will no longer be available in the community. We recognize that some of
these communities may adopt and submit the required documentation of
legally enforceable floodplain management measures after this rule is
published but prior to the actual suspension date. These communities
will not be suspended and will continue to be eligible for the sale of
NFIP flood insurance. A notice withdrawing the suspension of such
communities will be published in the Federal Register.
    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
The date of the FIRM, if one has been published, is indicated in the
fourth column of the table. No direct Federal financial assistance
(except assistance pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act not in connection with a flood) may be
provided for construction or acquisition of buildings in identified
SFHAs for communities not participating in the NFIP and identified for
more than a year on FEMA's initial FIRM for the community as having
flood-prone areas (section 202(a) of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against
certain types of Federal assistance becomes effective for the
communities listed on the date shown in the last column. The
Administrator finds that notice and public comment procedures under 5
U.S.C. 553(b), are impracticable and unnecessary because communities
listed in this final rule have been adequately notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. This rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Considerations. No environmental impact assessment has been prepared.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended,
Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless
an appropriate public body adopts adequate floodplain management
measures with effective enforcement measures. The communities listed no
longer comply with the statutory requirements, and after the effective
date, flood insurance will no longer be available in the communities
unless remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for Part 64 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.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                 Effective date
                                                 authorization/
                                   Community    cancellation of    Current effective map   Date certain Federal
       State and location             No.        sale of flood             date            assistance no longer
                                                  insurance in                              available in SFHAs
                                                   community
----------------------------------------------------------------------------------------------------------------
           Region III

Virginia:
    Augusta County,                    510013  July 24, 1974,     August 3, 2015........  August 3, 2015.
     Unincorporated Areas.                      Emerg; May 17,
                                                1990, Reg;
                                                August 3, 2015,
                                                Susp.
    Dumfries, Town of, Prince          510120  August 15, 1973,   ......do..............   Do.
     William County.                            Emerg; May 15,
                                                1980, Reg;
                                                August 3, 2015,
                                                Susp.
    New Kent County,                   510306  August 19, 1975,   ......do..............   Do.
     Unincorporated Areas.                      Emerg; December
                                                5, 1990, Reg;
                                                August 3, 2015,
                                                Susp.
    Portsmouth, City of,               515529  May 15, 1970,      ......do..............   Do.
     Independent City.                          Emerg; July 2,
                                                1971, Reg;
                                                August 3, 2015,
                                                Susp.
    Prince William County,             510119  December 15,       ......do..............   Do.
     Unincorporated Areas.                      1972, Emerg;
                                                December 1,
                                                1981, Reg;
                                                August 3, 2015,
                                                Susp.
    Quantico, Town of, Prince          510232  March 19, 1975,    ......do..............   Do.
     William County.                            Emerg; August
                                                15, 1978, Reg;
                                                August 3, 2015,
                                                Susp.
    Suffolk, City of,                  510156  January 22, 1975,  ......do..............   Do.
     Independent City.                          Emerg; November
                                                16, 1990, Reg;
                                                August 3, 2015,
                                                Susp.
    Waynesboro, City of,               515532  June 19, 1970,     ......do..............   Do.
     Independent City.                          Emerg; July 2,
                                                1971, Reg;
                                                August 3, 2015,
                                                Susp.
           Region VII

Missouri:
    Avondale, City of, Clay            290087  September 29,      ......do..............   Do.
     County.                                    1972, Emerg;
                                                October 26,
                                                1976, Reg;
                                                August 3, 2015,
                                                Susp.
    Clay County, Unincorporated        290086  September 6,       ......do..............   Do.
     Areas.                                     1974, Emerg;
                                                March 18, 1980,
                                                Reg; August 3,
                                                2015, Susp.
    Claycomo, Village of, Clay         290089  September 6,       ......do..............   Do.
     County.                                    1974, Emerg;
                                                August 1, 1977,
                                                Reg; August 3,
                                                2015, Susp.
    Excelsior Springs, City of,        290090  November 12,       ......do..............   Do.
     Clay and Ray Counties.                     1971, Emerg;
                                                March 15, 1977,
                                                Reg; August 3,
                                                2015, Susp.
    Gladstone, City of, Clay           290091  February 9, 1973,  ......do..............   Do.
     County.                                    Emerg; January
                                                5, 1978, Reg;
                                                August 3, 2015,
                                                Susp.
    Glenaire, City of, Clay            290092  September 12,      ......do..............   Do.
     County.                                    1975, Emerg;
                                                September 15,
                                                1977, Reg;
                                                August 3, 2015,
                                                Susp.
    Holt, City of, Clay and            290093  April 17, 1980,    ......do..............   Do.
     Clinton County.                            Emerg; April 17,
                                                1980, Reg;
                                                August 3, 2015,
                                                Susp.
    Lawson, City of, Clay              290705  October 19, 1989,  ......do..............   Do.
     County.                                    Emerg; December
                                                5, 1996, Reg;
                                                August 3, 2015,
                                                Susp.
    Liberty, City of, Clay             290096  May 29, 1973,      ......do..............   Do.
     County.                                    Emerg; March 15,
                                                1978, Reg;
                                                August 3, 2015,
                                                Susp.
    Missouri City, City of,            290097  January 13, 1976,  ......do..............   Do.
     Clay County.                               Emerg; August
                                                15, 1979, Reg;
                                                August 3, 2015,
                                                Susp.
    North Kansas City, City of,        290099  October 29, 1971,  ......do..............   Do.
     Clay County.                               Emerg; March 5,
                                                1976, Reg;
                                                August 3, 2015,
                                                Susp.
    Pleasant Valley, City of,          290100  September 9,       ......do..............   Do.
     Clay County.                               1974, Emerg;
                                                July 18, 1977,
                                                Reg; August 3,
                                                2015, Susp.
    Prathersville, Village of,         290101  June 6, 1978,      ......do..............   Do.
     Clay County.                               Emerg; November
                                                15, 1978, Reg;
                                                August 3, 2015,
                                                Susp.
    Randolph, Village of, Clay         290102  March 17, 1976,    ......do..............   Do.
     County.                                    Emerg; July 18,
                                                1977, Reg;
                                                August 3, 2015,
                                                Susp.
    Smithville, City of, Clay          295271  June 5, 1970,      ......do..............   Do.
     County.                                    Emerg; May 21,
                                                1971, Reg;
                                                August 3, 2015,
                                                Susp.
----------------------------------------------------------------------------------------------------------------
......do = Ditto.
Code for reading third column: Emerg. --Emergency; Reg. --Regular; Susp. --Suspension.

    Dated: June 22, 2015.
Roy E. Wright,
Deputy Associate Administrator, Federal Insurance and Mitigation
Administration, Department of Homeland Security, Federal Emergency
Management Agency.
[FR Doc. 2015-16399 Filed 7-1-15; 8:45 pm]
BILLING CODE 9110-12-P


[Federal Register Volume 78, Number 21 (Thursday, January 31, 2013)]
[Notices]
[Page 6826]
[FR Doc No: 2013-02085]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-E-0037]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

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

FOR FURTHER INFORMATION CONTACT:  Beverly Friedman, Office of
Regulatory Policy, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6284, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product XALKORI
(crizotinib). XALKORI is a kinase inhibitor indicated for the treatment
of patients with locally advanced or metastatic non-small cell lung
cancer that is anaplastic lymphoma kinase-positive as detected by an
FDA-approved test. Subsequent to this approval, the Patent and
Trademark Office received a patent term restoration application for
XALKORI (U.S. Patent No. 7,230,098) from Pfizer Inc., and the Patent
and Trademark Office requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
July 9, 2012, FDA advised the Patent and Trademark Office that this
human drug product had undergone a regulatory review period and that
the approval of XALKORI represented the first permitted commercial
marketing or use of the product. Thereafter, the Patent and Trademark
Office requested that FDA determine the product's regulatory review
period.
    FDA has determined that the applicable regulatory review period for
XALKORI is 2,054 days. Of this time, 1,904 days occurred during the
testing phase of the regulatory review period, while 150 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: January 12, 2006. The applicant claims January 21, 2006, as
the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was January 12, 2006, 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(b) of the FD&C Act: March 30,
2011. FDA has verified the applicant's claim that the new drug
application (NDA) for XALKORI (NDA 202-570) was submitted on March 30,
2011.
    3. The date the application was approved: August 26, 2011. FDA has
verified the applicant's claim that NDA 202-570 was approved on August
26, 2011.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 178 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by April 1, 2013. 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 July 30, 2013. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with the docket number found in brackets in
the heading of this document. Comments and petitions that have not been
made publicly available on http://www.regulations.gov may be viewed in
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

    Dated: January 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02085 Filed 1-30-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 106 (Friday, June 2, 2023)]
[Notices]
[Pages 36350-36351]
[FR Doc No: 2023-11715]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97605; File No. SR-ISE-2023-10]

Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Delay the
Implementation of Certain Trading Functionality

May 26, 2023.
    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 May 17, 2023, Nasdaq ISE, LLC (``ISE'' or ``Exchange'') filed with
the Securities and Exchange Commission (``SEC'' or ``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 proposes to delay the implementation of certain
trading functionality rule changes.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/ise/rules, 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 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
    In connection with a technology migration to an enhanced Nasdaq,
Inc. (``Nasdaq'') functionality, the Exchange filed various rule
changes to adopt certain trading functionality currently utilized at
Nasdaq affiliate exchanges. At this time, the Exchange proposes to
delay the implementation of the various rule changes. Each impacted
rule change and the new implementation date is described below.
Impacted Rule Filings
    The Exchange filed the following rule changes in connection with
its technology migration:
    [ssquf] SR-ISE-2022-11 which impacts routing; \3\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 94897 (May 12,
2022), 87 FR 30294 (May 18, 2022) (SR-ISE-2022-11) (Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Routing
Functionality in Connection With a Technology Migration).
---------------------------------------------------------------------------

    [ssquf] SR-ISE-2022-25 which amended ATR and Repricing Rules; \4\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 96362 (November 18,
2022), 87 FR 72539 (November 25, 2022) (SR-ISE-2022-25) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
ATR and Re-Pricing Rules in Connection With a Technology Migration
to Enhanced Nasdaq Functionality).
---------------------------------------------------------------------------

    [ssquf] SR-ISE-2022-28 which amended Complex Order Rules; \5\ and
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 96518 (December 16,
2022), 87 FR 78740 (December 22, 2022) (SR-ISE-2022-28) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Certain ISE Complex Order Functionalities in Connection With a
Technology Migration).
---------------------------------------------------------------------------

    [ssquf] SR-ISE-2023-06 a rule change amending multiple
functionalities.\6\
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 96818 (February 6,
2023), 88 FR 8950 (February 10, 2023) (SR-ISE-2023-06) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Its Rules in Connection With a Technology Migration to Enhanced
Nasdaq, Inc. (``Nasdaq'') Functionality).
---------------------------------------------------------------------------

    The aforementioned rule changes (collectively ``Impacted Rule
Changes'') indicated that the technology migration for ISE would
commence by Q4 2023 or prior to December 2023.
New Implementation
    At this time, the Exchange proposes to delay the implementation of
the Impacted Rule Changes, which all relate to ISE's upcoming
technology migration, to a date prior to December 20, 2024. The
Exchange will announce the initial migration date and symbol rollout
schedule to Members in an Options Trader Alert.
    The Exchange proposes to delay the migration to allow the Nasdaq
GEMX, LLC (``GEMX'') migration \7\ to complete

and thereafter allow the Exchange and its Members additional time to
prepare and test the new ISE functionality.
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    \7\ GEMX's migration will commence on November 6, 2023. See
http://www.nasdaqtrader.com/MicroNews.aspx?id=OTA2023-4. See also
Securities Exchange Act Release No. 97126 (March 13, 2023), 88 FR
16485 (March 17, 2023) (SR-GEMX-2023-04) (Notice of Filing and
Immediate Effectiveness of Proposed Rule Change To Delay the
Implementation of Certain Trading Functionality).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with section
6(b) of the Act,\8\ in general, and furthers the objectives of section
6(b)(5) of the Act,\9\ in particular, in that it is designed to promote
just and equitable principles of trade and to protect investors and the
public interest for the reasons discussed below. The Exchange proposes
to delay the implementation of the Impacted Rule Changes, which all
relate to ISE's upcoming technology migration, to allow the GEMX
migration to complete \10\ and thereafter allow the Exchange and its
Members additional time to prepare and test the new functionality. The
Exchange believes that the delay is consistent with the Act because the
additional time will allow the Exchange to ensure a successful ISE
migration while protecting investors and the public interest by
allowing the Exchange and Members more time to prepare and test.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
    \10\ See note 7.
---------------------------------------------------------------------------

    The Exchange notes that the substance of the impacted rules is not
changing, only the implementation timeline is changing with 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 not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange's proposal to
delay the implementation of the Impacted Rule Changes does not impose
an undue burden on competition. The proposed delay will allow the GEMX
migration to complete \11\ and thereafter allow the Exchange and its
Members additional time to prepare and test the new functionality.
---------------------------------------------------------------------------

    \11\ See note 7.
---------------------------------------------------------------------------

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

    No written comments were either solicited or 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 from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to section 19(b)(3)(A)(iii) of the Act \12\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\13\
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    \12\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \13\ 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 protected]. Please include
File Number SR-ISE-2023-10 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-ISE-2023-10. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of the Exchange. Do not include
personal identifiable information in submissions; you should submit
only information that you wish to make available publicly. We may
redact in part or withhold entirely from publication submitted material
that is obscene or subject to copyright protection. All submissions
should refer to File Number SR-ISE-2023-10 and should be submitted on
or before June 23, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Lynn Taylor,
Assistant Secretary.
[FR Doc. 2023-11715 Filed 6-1-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: July 25, 2007 (Volume 72, Number 142)]
[Notices]
[Page 40908-40910]
[DOCID:fr25jy07-101]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56102; File No. SR-Amex-2007-64]

Self-Regulatory Organizations; American Stock Exchange LLC;
Notice of Filing and Order Granting Accelerated Approval of Proposed
Rule Change Relating to an Extension of the Linkage Fee Pilot Program

July 19, 2007.
    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 June 27, 2007, the American Stock Exchange LLC (``Amex'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been substantially prepared by the Exchange.
This order provides notice of the proposed rule change and approves the
proposed rule change on an accelerated basis.
---------------------------------------------------------------------------

    \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 proposes to extend for one year, until July 31, 2008,
the current pilot program regarding transaction fees for trades
executed through the intermarket options linkage (the ``Linkage'') on
the Exchange. The text of the proposed rule change is available at the
Exchange, the Commission's Public Reference Room, and http://www.amex.com
.

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 III 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
    Amex proposes to extend for one year, until July 31, 2008, the
current pilot program establishing Exchange fees for Principal Orders
(``P Orders'') and Principal Acting As Agent Orders (``P/A Orders'')
submitted through the Linkage. The fees in connection with the pilot
program are scheduled to expire on July 31 2007.\3\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 54161 (July 17,
2006), 71 FR 42141 (July 25, 2006) (SR-Amex-2006-62).
---------------------------------------------------------------------------

    The current fees applicable to P Orders and P/A Orders executed on
the Exchange are as follows: (i) $0.10 per contract side options
transaction fee for equity options, exchange traded fund share
(``ETF'') options, QQQQ options and trust issued receipt options; (ii)
$0.21 per contract side options transaction fee for index options
(including MNX and NDX options); (iii) $0.05 per contract side options
comparison fee; (iv) $0.05 per contract side options floor brokerage
fee; and (v) an options licensing fee for certain ETF and index option
products ranging from $0.15 per contract side to $0.05 per contract
side depending on the particular ETF or index option.\4\ These are the
same fees charged to specialists and registered option traders
(``ROTs'') for transactions executed on the Exchange.\5\ The Exchange
does not charge for the execution of Satisfaction Orders sent through
the Linkage.
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    \4\ See the Options Licensing Fee section of the Amex Options
FeeSchedule available at http://www.amex.com.

    \5\ As set forth in the Amex Options Fee Schedule, P/A Orders
and POrders are not subject to the options marketing fee and the
options cancellation fee even though specialists and ROTs may be
subject to these fees for trades executed on the Exchange. E-mail
from Jeffrey P. Burns, Vice President & Associate General Counsel,
Amex to David Liu, Assistant Director, Division of Market
Regulation, Commission dated July 18, 2007.
---------------------------------------------------------------------------

    As was the case in the original pilot program and subsequent
extensions, the Exchange believes that the existing fees currently
charged to Exchange specialists and ROTs should also apply to
executions resulting from Linkage Orders.
    Based on the experience to date, the Exchange believes that an
extension of the pilot program for one year until July 31, 2008 is
appropriate.
2. Statutory Basis
    The proposed fee change is consistent with Section 6(b)(4) of the
Act \6\ regarding an equitable allocation of reasonable dues, fees, and
other charges among its members and other persons using Exchange
facilities.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    The proposed rule change will impose no burden on competition that
is not necessary or appropriate in furtherance of the purposes of the
Act.

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. 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-Amex-2007-64 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-Amex-2007-64. 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 inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, 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 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-Amex-2007-64 and should be
submitted on or before August 15, 2007.

IV. Commission's Findings and Order Granting Accelerated Approval of
the Proposed Rule Change

    After careful consideration, the Commission finds that the proposed
rule change is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to a national securities
exchange,\7\ and, in particular, the requirements of Section 6(b) of
the Act \8\ and the rules and regulations thereunder. The Commission
finds that the proposed rule change is consistent with Section 6(b)(4)
of the Act,\9\ which requires that the rules of the Exchange provide
for the equitable allocation of reasonable dues, fees, and other
charges among its members and other persons using its facilities. The
Commission believes that the extension of the Linkage fee pilot until
July 31, 2008 will give the Exchange and the Commission further
opportunity to evaluate whether such fees are appropriate.
---------------------------------------------------------------------------

    \7\ In approving this rule change, the Commission notes that it
hasconsidered the proposal's impact on efficiency, competition, and
capital formation. See 15 U.S.C. 78c(f).
    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Commission also finds good cause for approving the proposed
rule change prior to the 30th day after the date of publication of the
notice of filing thereof in the Federal Register. The Commission
believes that granting accelerated approval of the proposed rule change
will preserve the Exchange's existing pilot program for Linkage fees
without interruption as the Exchange and the Commission continue
considering the appropriateness of Linkage fees. Therefore, the
Commission

finds good cause, consistent with Section 19(b)(2) of the Exchange
Act,\10\ to approve the proposed rule change on an accelerated basis.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\11\ that the proposed rule change (SR-Amex-2007-64), be and it
hereby is, approved on an accelerated basis.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-14358 Filed 7-24-07; 8:45 am]

BILLING CODE 8010-01-P