UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES, AND

TOXIC SUBSTANCES

PC Code: 005209

DP BARCODE: D361926

MEMORANDUM					July 24, 2009

SUBJECT:	Tier I Drinking Water Exposure Assessment for the Section 3 New
Use of Triisopropanolamine Salt of Aminopyralid on Field Corn and Field
Corn Grown for Ensilage.

TO:			Douglas Dotson, Chemist

Health Effects Division (7509P)

Kathryn Montague, Product Manager

Registration Division (7505P)

FROM:		Reuben Baris, Environmental Scientist

Environmental Fate and Effects Division (7507P)

Office of Pesticide Programs

REVIEWED BY:	Marietta Echeverria, Senior Environmental Scientist

Environmental Fate and Effects Division (7507P)

Office of Pesticide Programs

THRU:		Elizabeth Behl, Branch Chief

Environmental Fate and Effects Division (7507P)

Office of Pesticide Programs

This memo summarizes the Tier I estimated drinking water concentrations
(EDWC) for Triisopropanolamine Salt of Aminopyralid (TIPA Salt) in
surface water and in ground water in support of the Section 3 New Use on
field corn and field corn grown for ensilage.  Aminopyralid is a
pyridine carboxylic acid herbicide to be used for annual and perennial
broadleaf weed control for field corn and field corn grown for ensilage.
 Based on available data, aminopyralid is moderately persistent to
persistent and highly mobile.  The EDWCs for both surface and ground
water recommended for use in HED’s human health risk assessment are
summarized in Table 1 and are based on the registered use on rangeland
grasses and wheat.  The EDWCs resulting from the proposed application
rate are lower than the EDWCs for surface and ground water in the
previous drinking water assessment for aminopyralid (D301682).  Since
the proposed application rates for field corn and field corn grown for
ensilage are lower than other registered uses, it is expected that the
EDWCs resulting from the proposed application rates for field corn and
field corn grown for ensilage will be lower, all other variables being
equal.

EFED used the screening model FIRST (FQPA Index Reservoir Screening
Tool, version 1.1, 01/01/07) to calculate the surface water EDWCs.  The
FIRST-calculated acute value represents a 1-in-10 year peak value and
the chronic value represents the 1-in-10 year annual mean.  Estimated
ground water EDWCs were calculated using the screening model SCI-GROW
(Screening Concentrations in Ground Water, version 2.3, 07/29/03).  The
SCI-GROW-calculated value should be used to represent both acute and
chronic exposure.

Table 1.  Tier I EDWCs for drinking water risk assessment based on
aminopyralid use on rangeland grasses (application rate of 0.11 lbs
a.e./A/yr) (D301682)

Surface water drinking water sources	acute: 10.024 ppb

chronic: 1.937  ppb

Groundwater drinking water sources	0.630 ppb

The concentrations presented in Tables 2 and 3 are the result of an
implied maximum application rate (0.57 fluid oz/acre) on the proposed
supplemental label for use on field corn and field corn grown for
ensilage.  The label indicates, in the section titled “Maximum
Application Rate”, “Use Precautions and Restrictions” section:

“An application rate of Milestone in excess of 0.57 fluid oz per acre
can [cause] [injury] to corn and reduce yield.”

While our assessment, EFED assumes this represents the maximum
application rate, in fact there is no maximum rate on the label.
Revising the label to stipulate a maximum rate would eliminate this
uncertainty (e.g. “do not exceed 0.57 fluid oz per acre for a single
application.”).  Although there is little difference in the peak and
chronic EDWCs resulting from 3 applications at the lower rate vs. a
single application at the maximum annual rate, the revised language will
avoid misinterpretation and potential injury to the crop.

	This assessment uses data from registrant-submitted fate studies for
aminopyralid.  Both the aminopyralid TIPA salt and aminopyralid acid
will dissociate in the environment to yield the free anion (PC code:
005100).  The dissociation process is governed by an equilibrium
constant which is so low (pKa of 2.56) that greater than 99.9% of the
compound will be in the anion form at environmental pH ranges,
regardless of the original molecular species (US EPA, 2005).
Aminopyralid is expected to be moderately persistent to persistent and
highly mobile in the environment.  Since it is stable to hydrolysis and
aerobic and anaerobic aquatic metabolism, and moderately degraded by
aerobic metabolism in some soils, transport of aminopyralid to surface
water and ground water is likely.

The 2005 Aminopyralid: Tier I Estimated Drinking Water Concentrations
(EDWC) for Use in the Human Health Risk Assessment was conducted for the
parent compound.  The only degradates of aminopyralid were observed in
the aqueous photolysis study (MRID 46235727), identified as oxamic acid
(CAS#471-47-6) and malonamic acid (CAS# 2345-56-4), plus unidentified
degradates 2-3-carbons long, with O, N, and other substituents.  No
environmental degradates other than CO2 and bound residues were observed
in the remaining fate studies (D301682).  Based on the available
information, HED does not believe that it is appropriate to include
residues of either oxamic acid or malonamic acid in dietary risk
assessments; therefore, these compounds should not be included in
estimates of residues of concern in drinking water (D301689). Both
chemicals are small amino acid analogs.  Following uptake, HED indicated
they are expected to be readily metabolized and/or rapidly excreted
without any significant biological effects.

A summary of the model input parameter values used in FIRST is presented
in Table 2. A summary of the model input parameter values used in
SCI-GROW is presented in Table 3.   Input parameters were selected in
accordance with EFED’s “Guidance for Selecting Input Parameters in
Modeling the Environmental Fate and Transport of Pesticides,” Version
II (February 28, 2002).

For FIRST surface water modeling, the soil sorption coefficient (Kd) was
used instead of the organic carbon partition coefficient (KOC) because
correlation of Kd with organic carbon was low (R2 = 0.3656) for the
eight soils tested, suggesting that the adsorption of aminopyralid is
not closely related to organic carbon content (MRID 46235732).
Therefore, Kd, the sorption coefficient uncorrected for organic carbon,
was assumed to better represent sorption in soil.  The aerobic soil
metabolism half-life was calculated by nonlinear two-parameter
exponential decay analysis, and then that value was multiplied by 3 to
account for the uncertainty associated with using a single value.  The
proposed label allows for ground spray applications and tank mixes; a
broadcast ground spray was modeled as the method of application in order
to be protective of all application scenarios.  The aerobic aquatic
metabolism half-lives were calculated using first-order linear
regression on log-transformed data, then the 90th percentile of the
upper confidence bound on the mean of the three half-lives was
calculated.  The aqueous photolysis study was continuously illuminated
and the aqueous photolysis half-life input value was adjusted to reflect
photolysis in summer sunlight at 40o N latitude.  There was no
degradation observed in the dark controls and no dark-control correction
necessary.

The FIRST output file is located in Appendix 1.  The SCI-GROW output
file is located in Appendix 2.

Table 2.  FIRST (v1.1.0) input parameter values and results for TIPA
Salt of aminopyralid applied to field corn and field corn grown for
ensilage.

Parameter

Value

Source

Application Rate (lb a.e./A)1	0.57 fl oz/A

(0.0089 lbs a.e./A)

Annual maximum:  1.7 fl oz/A/yr

(0.0266 lbs a.e./A/yr)	Proposed label.

Number of Applications	3	Proposed label.

Interval between Applications (days)	5	Assumed. Not specified on
proposed label.

Soil Sorption Coefficient (Kd; mL/g)	0.03	Represents the lowest non-sand
value among eight values ranging from 0.03 to 0.72 mL/g;

MRID: 46235732.

Aerobic Soil Metabolism Half-life (days)	116.1	Determined by multiplying
the calculated half-life (38.7) by 3 to account for the uncertainty
associated with using a single value; MRID: 46235729.

Wetted in?	No	Proposed label.

Depth of Incorporation (inches)	0	Proposed label.

Method of Application	ground spray	Proposed label.

Percent Cropped Area	0.46	PRZM input guidance (US EPA, 2002)

Solubility in Water @ 20 OC, unbuffered (mg/L or ppm)	2480	MRID:
46235701.

Aerobic Aquatic Metabolism Half-life (days)	1074	 Represents the 90th
percentile of the upper confidence bound on the mean of three half-life
values (772.9).  MRID: 46235731.

Hydrolysis Half-life @ pH 7 (days)	stable	MRID: 46235726.

Aquatic Photolysis Half-life  @ pH 5 (days)	0.6	MRID: 46235727.

FIRST Results (EDWCs for surface water drinking water sources)

3 applications per year at 0.57 fl oz/A (0.0089 lbs a.e./A)	Acute
Concentration: 1.25 µg/L

Chronic Concentration: 0.24 µg/L

	Maximum annual application rate 1.7 fl oz/A/yr  (0.0266 lbs a.e./A/yr)
Acute Concentration: 1.28 µg/L

Chronic Concentration: 0.25 µg/L

	1 Application rates are given in lbs acid equivalents (a.e.)/A. The
acid equivalent for aminopyralid is 21.1% - 2lb/gal. Therefore the
conversion from fl oz/A to lbs a.e./A is completed using the following
formula:

X fl oz/A * 1 gal/128 fl oz * 2 lb a.i/gal = X lbs a.e./A

Table 3.  SCI-GROW (v2.3) input parameter values and results for
aminopyralid applied to field corn and field corn grown for ensilage.

Parameter

Value

Source and/or Comments

Maximum Application Rate

(lb a.e./A)1	1.7 fl oz/A/yr

(0.0266 lb a.e./A)	Proposed label.

Number of Applications per Year	1	Represents the most conservative
label-allowed  scenario in which the total maximum rate per year is
applied in one application.

Aerobic Soil Metabolism Half-life (days)	38.7	Represents one value for
the aerobic soil metabolism of the parent compound;

MRID: 46235729.

Organic Carbon Partition Coefficient (Koc; mL/g)2	1.05	Represents the
lowest value of eight values ranging from 1.05 to 24.30 mL/g for the
parent compound; MRID: 46235732.

Results (EDWC for groundwater drinking water sources)	Concentration:
0.15 µg/L

	1 See footnote 1 in Table 2.

2 Koc was used for ground water modeling as per US EPA, 2002 Guidance
for Selecting Input Parameters in Modeling the Environmental Fate and
Transport of Pesticides.

References:

DP 301682. US EPA. 2005. Aminopyralid: Tier I Estimated Drinking Water
Concentrations (EDWC) for Use in the Human Health Risk Assessment. US
EPA, Office of Pesticide Programs, Environmental fate and Effects
Division, 1200 Pennsylvania Ave., NW Washington, DC.

DP 301689. US EPA. 2005. Aminopyralid: Aggregate Human Health Risk
Assessment for the Proposed Uses on Wheat, Grasses, Non-cropland Areas,
and Natural Areas. US EPA, Office of Pesticide Programs, Environmental
fate and Effects Division, 1200 Pennsylvania Ave., NW Washington, DC.

US EPA. 2005. Environmental Fate and Ecological Risk Assessment for the
Registration of Aminopyralid (PC Codes: 005100, 005209). US EPA, Office
of Pesticide Programs, Environmental fate and Effects Division, 1200
Pennsylvania Ave., NW Washington, DC.

Appendix 1.  FIRST Modeling Output file

Recommended Application Rate

   RUN No.   1 FOR aminopyralid     ON   fieldcorn     * INPUT VALUES *

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

   RATE (#/AC)   No.APPS &   SOIL  SOLUBIL   APPL TYPE  %CROPPED INCORP

    ONE(MULT)    INTERVAL     Kd   (PPM )    (%DRIFT)     AREA    (IN)

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

   .009(   .026)   3   5        .0 2480.0   GROUND( 6.4)  46.0      .0

   FIELD AND RESERVOIR HALFLIFE VALUES (DAYS)

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

   METABOLIC  DAYS UNTIL  HYDROLYSIS   PHOTOLYSIS   METABOLIC  COMBINED

    (FIELD)  RAIN/RUNOFF  (RESERVOIR)  (RES.-EFF)   (RESER.)   (RESER.)

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

    116.10        2          N/A       .60-   74.40   ******     69.58

   UNTREATED WATER CONC (MICROGRAMS/LITER (PPB)) Ver 1.1.0  JAN 1, 2007

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

        PEAK DAY  (ACUTE)      ANNUAL AVERAGE (CHRONIC)

          CONCENTRATION             CONCENTRATION

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

              1.246                       .241

Annual Maximum Application Rate

   RUN No.   2 FOR aminopyralid     ON   fieldcorn_    * INPUT VALUES *

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

   RATE (#/AC)   No.APPS &   SOIL  SOLUBIL   APPL TYPE  %CROPPED INCORP

    ONE(MULT)    INTERVAL     Kd   (PPM )    (%DRIFT)     AREA    (IN)

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

   .027(   .027)   1   1        .0 2480.0   GROUND( 6.4)  46.0      .0

   FIELD AND RESERVOIR HALFLIFE VALUES (DAYS)

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

   METABOLIC  DAYS UNTIL  HYDROLYSIS   PHOTOLYSIS   METABOLIC  COMBINED

    (FIELD)  RAIN/RUNOFF  (RESERVOIR)  (RES.-EFF)   (RESER.)   (RESER.)

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

    116.10        2          N/A       .60-   74.40   ******     69.58

   UNTREATED WATER CONC (MICROGRAMS/LITER (PPB)) Ver 1.1.0  JAN 1, 2007

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

        PEAK DAY  (ACUTE)      ANNUAL AVERAGE (CHRONIC)

          CONCENTRATION             CONCENTRATION

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

.247

Appendix 2.  SCIGROW Modeling Output File

                           SCIGROW

                          VERSION 2.3

            ENVIRONMENTAL FATE AND EFFECTS DIVISION

                 OFFICE OF PESTICIDE PROGRAMS

             U.S. ENVIRONMENTAL PROTECTION AGENCY

                        SCREENING MODEL

                FOR AQUATIC PESTICIDE EXPOSURE

 SciGrow version 2.3

 chemical:aminopyralid

 time is  6/10/2009  15:10:45

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

  Application      Number of       Total Use    Koc      Soil Aerobic

  rate (lb/acre)  applications   (lb/acre/yr)  (ml/g)   metabolism
(days)

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

      0.027           1.0           0.027      1.05E+00       38.7

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

 groundwater screening cond (ppb) =   1.55E-01

 ***********************************************************************
*


[Federal Register Volume 80, Number 74 (Friday, April 17, 2015)]
[Notices]
[Pages 21247-21248]
[FR Doc No: 2015-08845]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0152]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for RAVICTI 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.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Campus Rm. 3180, Silver Spring, MD 20993,<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 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 RAVICTI
(glycerol phenylbutyrate). RAVICTI is indicated for use as a nitrogen-
binding agent for chronic management of adult and pediatric patients 2
years of age or older with urea cycle disorders that cannot be managed
by dietary protein restriction

and/or amino acid supplementation alone. Subsequent to this approval,
the USPTO received a patent term restoration application for RAVICTI
(U.S. Patent No. 5,968,979) from Hyperion Therapeutics, Inc., and the
USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated May 2, 2014,
FDA advised the USPTO that this human drug product had undergone a
regulatory review period and that the approval of RAVICTI represented
the first permitted commercial marketing or use of the product.
Thereafter, the USPTO requested that FDA determine the product's
regulatory review period.
    FDA has determined that the applicable regulatory review period for
RAVICTI is 2,126 days. Of this time, 1,719 days occurred during the
testing phase of the regulatory review period, while 407 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: April 10, 2007. The applicant claims April 8, 2006, as the
date the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was April 10,
2007, when the IND was removed from clinical hold.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: December
23, 2011. FDA has verified the applicant's claim that the new drug
application (NDA) for RAVICTI (NDA 203284) was submitted on December
23, 2011.
    3. The date the application was approved: February 1, 2013. FDA has
verified the applicant's claim that NDA 203284 was approved on February
1, 2013.
    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 1,450 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 June 16, 2015. 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 October 14, 2015. 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 or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. 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: April 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-08845 Filed 4-16-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: January 30, 2008 (Volume 73, Number 20)]
[Notices]
[Page 5548]
[DOCID:fr30ja08-63]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP07-208-000]

Rockies Express Pipeline LLC; Notice of Technical Conference

January 22, 2008.
    On January 28, 2008, staff of the Office of Energy Projects (OEP)
will hold a technical conference concerning issues raised by the U.S.
Fish and Wildlife Service for the REX East Project. In particular,
construction impacts dealing with the biological assessment and the
Migratory Bird Treaty Conservation Agreement will be discussed.
    The technical conference will be held on Monday, January 28, 2008,
at 1:30 p.m. (EST) in Room 3M-2B at the Commission Headquarters in
Washington, DC.
    Information concerning any changes to the above may be obtained
from the Commission's Office of External Affairs at<PHONE_NUMBER> or
toll free at 1-866-208-FERC (208-3372).

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-1595 Filed 1-29-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 8 (Tuesday, January 13, 2015)]
[Notices]
[Pages 1631-1632]
[FR Doc No: 2015-00311]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP15-41-000; PF14-13-000]

 Equitrans, L.P.; Notice of Application

    Take notice that on December 30, 2014, Equitrans, L.P. (Equitrans),
filed an application pursuant to section 7(c) of the Natural Gas Act
(NGA) and Part 157 of the Commission's Regulations, for a certificate
of public convenience and necessity to own, construct, and operate
certain pipeline and compression facilities located in West Virginia
and Ohio (Ohio Valley Connector Project). Equitrans also requests
authority to own, operate, and maintain the proposed facilities under
its Part 284, Subpart G blanket transportation certificate pursuant to
the terms and conditions of Equitrans' FERC Gas Tariff. The filing may
also be viewed on the web at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC at<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or
TYY,<PHONE_NUMBER>.
    Any questions regarding this application should be directed to Paul
W. Diehl, Senior Counsel, Midstream, EQT Corporation, 625 Liberty
Avenue, Suite 1700, Pittsburgh, PA 15222. Telephone<PHONE_NUMBER>, fax
(412) 553-7781, and email<EMAIL_ADDRESS>    Equitrans proposes to construct 50 miles of pipeline and 36,000
horsepower compression facilities located in West Virginia and Ohio.
The project will provide up to 850,000 dekatherms per day of additional
firm transportation service to mid-continent and Gulf Coast markets.
The Project will provide tie-ins with Rockies Express Pipeline, LLC,
Texas Eastern Transmission, LP (TETCO), and existing Equitrans Mainline
and Sunrise Transmission System facilities. The estimated cost of these
facilities will be $416.00 million and Equitrans proposes to create a
separate rate zone for the Project. Equitrans proposes an in-service
date of June 2016.
    On June 20, 2014, the Commission staff granted Equitrans' request
to use the National Environmental Policy Act (NEPA) Pre-Filing Process
and assigned Docket No. PF14-13-000 to staff activities involving the
proposed facilities. Now, as of the filing of this application on
December 30, 2014, the NEPA Pre-Filing Process for this project has
ended. From this time forward, this proceeding will be conducted in
Docket No. CP15-41-000, as noted in the caption of this Notice.
    Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding, or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule will serve to
notify

federal and state agencies of the timing for the completion of all
necessary reviews, and the subsequent need to complete all federal
authorizations within 90 days of the date of issuance of the Commission
staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 5 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    Motions to intervene, protests and comments may be filed
electronically via the internet in lieu of paper; see, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.
    Comment Date: January 28, 2015.

    Dated: January 7, 2015.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-00311 Filed 1-12-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)]
[Notices]
[Pages 10946-10949]
[FR Doc No: 2016-04507]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-77239; File No. SR-NASDAQ-2016-027]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Nasdaq Rule 7018

February 25, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 \2\ thereunder, notice is hereby given
that, on February 22, 2016, The NASDAQ Stock Market LLC (``Nasdaq'' 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.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq is proposing changes to amend Nasdaq Rule 7018(a), governing
fees and credits assessed for execution and routing of securities.
    The text of the proposed rule change is available at
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 those statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant parts of such
statements.

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

1. Purpose
    The Exchange proposes to amend Nasdaq Rule 7018(a), governing fees
and credits assessed for execution and routing of securities listed on
Nasdaq,\3\ listed on the New York Stock Exchange (``NYSE'') \4\ and
listed on exchanges other than Nasdaq and NYSE \5\ (collectively, the
``Tapes'').
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    \3\ Nasdaq Rule 7018(a)(1).
    \4\ Nasdaq Rule 7018(a)(2).
    \5\ Nasdaq Rule 7018(a)(3).
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    Specifically, the purpose of the proposed rule change is to
indicate that Nasdaq will not charge a fee for the use of its recently
approved routing option, the Retail Order Process (``RTFY''),\6\
regardless of where the execution occurs.\7\ The RTFY order routing
option

is designed to enhance execution quality and benefit retail investors
by providing price improvement opportunities to retail order flow.
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    \6\ See Securities Exchange Act Release No. 76335 (Nov. 3,
2015), 80 FR 69256 (Nov. 9, 2015) (SR-NASDAQ-2015-112).
    \7\ The Exchange proposed RTFY because retail order firms often
send non-marketable order flow (i.e., orders that are not executable
against the best prices available in the market place based on their
limit price) to post and display on exchanges. Some of the orders
that have been deemed to be non-marketable by the entering firm
become marketable by the time the exchange receives them and
ultimately remove liquidity from the exchange order book.
---------------------------------------------------------------------------

    Members entering RTFY orders, regardless of where the orders
execute will not incur a fee if they use this optional routing
strategy. Currently, unless the member is eligible for a lower charge
to enter orders that execute in the Nasdaq Market Center (``remove
liquidity fee'' or ``remove rate''),\8\ all routing strategies that
execute on Nasdaq are charged $0.0030 per share executed. Therefore,
the proposed $0.0000 per share executed for orders electing to use RTFY
is a reduction from the standard remove rate of $0.0030 per share
executed that orders with routing instructions currently face.
---------------------------------------------------------------------------

    \8\ See Nasdaq Rule 7014(d).
---------------------------------------------------------------------------

    The Exchange does not expect an order using RTFY to execute on the
Exchange, but Nasdaq will cover this atypical scenario by specifically
stating that no fee will be assessed if the order ultimately executes
on the Exchange. Currently, if an order removes liquidity from the
Exchange, unless specifically exempted in a Nasdaq rule, the standard
remove rate applies. In sum, this proposed rule change reduces the
remove rate from $0.0030 to $0.0000 per share executed for orders
electing to use RTFY and establishes routing fees for RFTY as $0.0000
per share executed.
    Members using TFTY, in contrast to RTFY, which is a comparable
routing strategy, incurs [sic] fees for routing. Members using TFTY are
assessed a charge of $0.0030 per share executed for orders that execute
at NASDAQ OMX PSX and are assessed a charge of $0.0007 per share
executed for orders that execute on venues other than BX or NASDAQ OMX
PSX. Orders using TFTY on the Exchange also incur remove liquidity
fees. In the case of RTFY, the Exchange intends to provide the RFTY
routing option at no charge as an incentive for members to use this new
routing strategy. No member that uses this new routing strategy to seek
price improvement opportunities for the retail orders that it routes
will incur a routing fee. A member that elects not to use this new
routing strategy will be assessed the routing fee applicable to the
strategy it selected and will be charged the remove rate the member
otherwise qualifies for on Nasdaq.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\9\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\10\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using its facilities which
the Exchange operates or controls, and is not designed to permit unfair
discrimination between customers, issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Commission and the courts have repeatedly expressed their
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. In Regulation
NMS, while adopting a series of steps to improve the current market
model, the Commission highlighted the importance of market forces in
determining prices and SRO revenues and, also, recognized that current
regulation of the market system ``has been remarkably successful in
promoting market competition in its broader forms that are most
important to investors and listed companies.'' \11\ Likewise, in
NetCoalition v. Securities and Exchange Commission \12\
(``NetCoalition'') the D.C. Circuit upheld the Commission's use of a
market-based approach in evaluating the fairness of market data fees
against a challenge claiming that Congress mandated a cost-based
approach.\13\ As the court emphasized, the Commission ``intended in
Regulation NMS that `market forces, rather than regulatory
requirements' play a role in determining the market data . . . to be
made available to investors and at what cost.'' \14\
---------------------------------------------------------------------------

    \11\ Securities Exchange Act Release No. 34-51808 (June 9, 2005)
(``Regulation NMS Adopting Release'').
    \12\ NetCoalition v. SEC. 615 F.3d 525 (D.C. Cir. 2010).
    \13\ Id. at 534-535.
    \14\ Id. at 537.
---------------------------------------------------------------------------

    Further, ``[n]o one disputes that competition for order flow is
`fierce.' . . . As the SEC explained, `[i]n the U.S. national market
system, buyers and sellers of securities, and the broker-dealers that
act as their order-routing agents, have a wide range of choices of
where to route orders for execution'; [and] `no exchange can afford to
take its market share percentages for granted' because `no exchange
possesses a monopoly, regulatory or otherwise, in the execution of
order flow from broker dealers' . . . .'' \15\
---------------------------------------------------------------------------

    \15\ Id. at 539 (quoting ArcaBook Order, 73 FR at 74782-74783).
---------------------------------------------------------------------------

    Nasdaq believes that the proposed rule change to Nasdaq Rule
7018(a)(1), (2) and (3) is reasonable because it is an incentive for
members to select RTFY and a price reduction versus other order types,
routing strategies and services offered by the Exchange and other away
venues. Additionally, the new fees of $0.0000 per share executed will
apply equally to all members entering RTFY orders that execute in the
Nasdaq Market Center, as well as in a venue other than the Nasdaq
Market Center. A member that elects not to use this new routing
strategy will be assessed charges the member otherwise qualifies for,
often $0.0030 per share executed when executing on Nasdaq and ranging
from a rebate to a fee when routing to venues other than Nasdaq.
    The new fees are being proposed in connection with the recently
approved RTFY order routing option under Nasdaq Rule 4758(a)(1)(A)(v)
for Designated Retail Orders (``DROs'').\16\ If a DRO electing the RTFY
routing option is not marketable, it will rest on the Exchange book and
other Nasdaq members will have the opportunity to interact with the
order at its limit price.\17\ The RTFY order routing option is designed
to enhance execution quality and benefit retail investors by providing
price improvement opportunities to retail order flows. The Exchange
believes that this new Exchange functionality will enhance coordination
and cooperation with market participants and produce a more efficient
market because the Exchange believes more retail investor orders will
be sent to the Exchange to add liquidity or to obtain price
improvement. Increasing retail activity on the Exchange, in turn,
benefits all participants through more robust price discover
opportunities on Nasdaq.
---------------------------------------------------------------------------

    \16\ Supra note 6.
    \17\ Supra note 7.
---------------------------------------------------------------------------

    The lower cost ($0.0000 per share executed) of this routing
strategy as compared with other existing routing strategies is
reasonable because of the lower costs that Nasdaq is charged by the
venues to which the RTFY orders are routed. For the majority of orders
routed, Nasdaq believes it will not be charged a fee for the orders
that become marketable and route to other market centers using this
routing strategy.
    Equally important, the $0.0000 per share executed is a fee
reduction versus an assessed a charge of $0.0030 per share executed for
a member who elects not to use this new routing strategy, as well as a
fee reduction versus other choices currently available on Nasdaq. The
Exchange believes that the lower

cost of this routing strategy is reasonable since it is designed to act
as an incentive to encourage members to try this new routing strategy.
Members have a wide range of options of where to send their orders and
the proposed pricing is influenced by these factors. While Nasdaq
believes that this new functionality is novel and desired by market
participants, Nasdaq equally believes that the proposed rate of $0.0000
per share executed is the appropriate incentive to encourage market
participants to use this innovative order routing strategy in lieu of
other choices in the market place. The practice of exchanges offering
lower rates for new services or those geared toward investors or
customers is not novel. For example, there are a variety of programs
that exist today that offer incentives and execution opportunities for
retail orders, as long as they use specific programs or functionality.
    One such program is the retail price improvement (``RPI'') programs
that exist on the New York Stock Exchange LLC, NYSE ARCA, Inc., BATS Y-
Exchange, Inc., and NASDAQ OMX BX, Inc. (``BX''). For example, on BX a
retail order in the RPI program receives higher rebates than an
otherwise situated order because of its use of the program's specific
order types. Similar to how members currently take advantage of other
price reductions, discounts or rebates via volume discounts and tiers,
members may elect to use the RTFY routing strategy to receive a reduced
fee, just as members may use RPI programs and various order types to
receive enhanced rebates or reduced fees. Further, Chicago Board
Options Exchange, Incorporated (``CBOE'') and NASDAQ PHLX LLC
(``Phlx'') all offer inventive programs designed to attract customer
orders.\18\ While not identical to the CBOE and Phlx programs, the
proposed rate is an incentive designed to attract member's that act as
agent for retail orders to choose RTFY over all other alternatives in
the market place in the same manner as the CBOE and Phlx supplemental
rebates encourage members that rout customer order flow to choose their
respective exchanges for execution. The Exchange believes that offering
lower fees, even if for a new routing strategy, is consistent with the
Exchange Act.
---------------------------------------------------------------------------

    \18\ See CBOE Fee Schedule, Volume Incentive Program; see also
Section B of the Phlx Pricing Schedule, Customer Rebate Program.
---------------------------------------------------------------------------

    The Exchange also believes that the proposed rule change is an
equitable allocation and is not unfairly discriminatory because the new
fees will be applied uniformly across all members that are willing to
use Nasdaq's routing services and opt to use the RTFY routing
strategy.\19\ All members sending DROs may elect to use the RTFY
routing strategy when sending orders. Moreover, assessing different
rates when a member elects to use a routing strategy but executes on
the venue where the order was originally entered in not novel. BX
provided a higher rebate to remove liquidity for members if they
elected to use specific routing strategies (the ``BX filing'').\20\ In
the BX filing, a member using the BDRK or BCST routing strategy was
able to receive a $0.0014 rebate for removing liquidity in the BX
Equities System rather than the standard $0.0004 rebate for removing
liquidity on the BX Equities System. Thus, the same order (apart from
the routing strategy used) was eligible for a different rebate when
removing liquidity on BX solely because of its routing strategy. This
is similar to the proposed $0.0000 fee for RTFY orders that execute on
the Nasdaq Market Center in that the member receives a different rate
for an otherwise similar order, but by using a specific routing
strategy.
---------------------------------------------------------------------------

    \19\ See Securities Exchange Act Release No. 66763 (April 6,
2012), 77 FR 22008 (April 12, 2012) (SR-EDGA-2012-13) (an example of
another exchange using a proposed rate of $0.0000 per share executed
that is an equitable allocation of reasonable dues, fees, and other
charges).
    \20\ See Securities Exchange Act Release No. 69053 (March 7,
2013), 78 FR 15999 (March 13, 2013) (SR-BX-2013-019).
---------------------------------------------------------------------------

    Additionally, the proposed rule change also is not unfairly
discriminatory because all members sending DROs to Nasdaq for execution
are eligible to use RTFY. Each member may elect to use the RTFY routing
strategy as they see fit.

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

    The proposed rule change will not result in a burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act, as amended.\21\ In terms of inter-market competition, the
Exchange notes that it operates in a highly competitive market in which
market participants can readily favor competing venues if they deem fee
levels at a particular venue to be excessive, or credit opportunities
available at other venues to be more favorable. In such an environment,
the Exchange must continually adjust its fees and credits to remain
competitive with other exchanges and with alternative trading systems
that have been exempted from compliance with the statutory standards
applicable to exchanges.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

    Because competitors are free to modify their own fees and credits
in response, and because market participants may readily adjust their
order routing practices, the Exchange believes that the degree to which
fee changes in this market may impose any burden on competition is
extremely limited.
    In this instance, the proposed new fees applicable across the Tapes
apply to member firms entering RTFY orders that execute in the Nasdaq
Market Center, as well as in a venue other than the Nasdaq Market
Center (although the proposed new fees are $0.0000 per share executed)
do not impose a burden on competition because the Exchange's execution
services are voluntary and subject to extensive competition both from
other exchanges and from off-exchange venues. The Exchange believes
that the competition among exchanges and other venues will help to
drive price improvement and overall execution quality higher for end
retail investors.
    In sum, if the change proposed herein is unattractive to market
participants, it is likely that the Exchange will lose market share as
a result. Accordingly, the Exchange does not believe that the proposed
change will impair the ability of members or competing order execution
venues to maintain their competitive standing in the financial markets.

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

    The foregoing change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\22\ 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.
---------------------------------------------------------------------------

    \22\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

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-NASDAQ-2016-027 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-NASDAQ-2016-027. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2016-027 and should
be submitted on or before March 23, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-04507 Filed 3-1-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Notices]
[Page 22473]
[FR Doc No: 2023-07787]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4689-DR; Docket ID FEMA-2023-0001]

South Dakota; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of South Dakota (FEMA-4689-DR), dated February 27, 2023,
and related determinations.

DATES: This amendment was issued March 21, 2023.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of South Dakota is hereby amended to include the
following areas among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of February 27, 2023.

    Ziebach County for Public Assistance.
    Jackson and Oglala Lakota Counties for snow assistance under the
Public Assistance program for any continuous 48-hour period during
or proximate to the incident period (already designated for Public
Assistance).
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-07787 Filed 4-12-23; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 85, Number 109 (Friday, June 5, 2020)]
[Notices]
[Page 34711]
[FR Doc No: 2020-12208]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2020-0563]

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Aircraft Noise
Certification Documents for International Operations

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The collection aids to make the aircraft noise
certification information easily accessible to the flight crew and
presentable upon request to the appropriate foreign officials for
international airline operation of U.S. carriers. The information to be
collected upholds the U.S. obligations under the Convention on
International Civil Aviation and for which FAA policy comply with
International Civil Aviation Organization (ICAO) Standards and
Recommended Practices to the maximum extent practicable. Thus the FAA
has adopted ICAO's Standards and Recommended Practices as US
regulations as a means of compliance with Annex 16 and requires noise
documentation be carried on board aircraft that leave the United
States.

DATES: Written comments should be submitted by August 4, 2020.

ADDRESSES: Please send written comments:
    By Electronic Docket: www.regulations.gov (Enter docket number into
search field).
    By mail: Sandy Liu, 800 Independence Ave. SW, Washington, DC 20591,
Attn: AEE-100.
    By fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Sandy R. Liu by email at:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-0737.
    Title: Aircraft Noise Certification Documents for International
Operations.
    Form Numbers: None. Reference: ICAO Annex 16, Vol.1--Aircraft
Noise, Eighth edition (July 2017) Attachment G for format.
    Type of Review: Renewal of an information collection.
    Background: On March 2, 2010, the FAA published the final rule
Notice No. 91-312, Aircraft Noise Certification Documents for
International Operations (75 FR 9327). It requires operators that fly
outside the United States, using aircraft subject to ICAO, Annex 16,
Volume 1, to carry aircraft noise certification information on board
the aircraft. This collection is needed to ensure consistent
international compliance with the ICAO, Annex 16, Volume 1, Amendment 8
that requires certain noise information be carried on board the
aircraft. This information must be easily accessible to the flight crew
and presentable upon request to the appropriate foreign National
Aviation Authority (NAA) officials. The collection is mandatory based
on U.S. regulations and international standards.
    Respondents: Operators of U.S. registered civil aircraft flying
outside the United States.
    Frequency: 70 airplanes.
    Estimated Average Burden per Response: 25 minutes (0.42 hours).
    Estimated Total Annual Burden: $25 per airplane x 70 airplanes
affected = $1,750.

    Issued in Washington, DC, on June 2, 2020.
Sandy Lium,
Engineer, Noise Division, Office of Environment and Energy, Noise
Division (AEE-100).
[FR Doc. 2020-12208 Filed 6-4-20; 8:45 am]
 BILLING CODE 4910-13-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on August 1, 2006

   NOTICE OF ACTION TAKEN -- DOCKET OST-98-3652

________________________________________________________________________
_________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of POLAR AIR CARGO, INC. (POLAR) filed 6/8/06 for:

XX Renewal of exemption for two years under 49 U.S.C. 40109 to provide
the following service:

Scheduled foreign air transportation of property and mail between points
in the United States and Jeddah, Saudi Arabia, via Prestwick, Scotland,
and Amsterdam, the Netherlands, and beyond Saudi Arabia to Johannesburg,
South Africa; Harare, Zimbabwe; and Nairobi, Kenya.

Applicant rep: Kevin P. Montgomery<PHONE_NUMBER>   DOT Analyst:  Thuy
H. Cooper<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted (subject to conditions, see below)

The above action was effective when taken: August 1, 2006, through
August 1, 2008.

Action taken by:   Paul L. Gretch, Director

		    Office of International Aviation

XX  The authority granted is consistent with the aviation agreements
between the United States and Saudi Arabia, between the United States
and the United Kingdom, between the United States and the Netherlands,
between the United States and South Africa, and with the overall state
of aviation relations between the United States and Zimbabwe and between
the United States and Kenya.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:

	XX  Holder’s certificates of public convenience and necessity

	XX  Standard exemption conditions (attached)

________________________________________________________________________
______

On the basis of data officially noticeable under Rule 24(g) of the
Department's regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that

(1) our action was consistent with Department policy; (2) grant of the
exemption authority was consistent with the public interest; and (3)
grant of the authority would not constitute a major regulatory action
under the Energy Policy and Conservation Act of 1975.  To the extent not
granted, we denied all requests in the referenced Docket.  We may amend,
modify, or revoke the authority granted in this Notice at any time
without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

05/2004

 PAGE

 PAGE   2


[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61030-61032]
[FR Doc No: 2022-21832]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0514 and FDA-2005-D-0027]

Postmarket Surveillance Under Section 522 of the Federal Food,
Drug, and Cosmetic Act; Guidance for Industry and Food and Drug
Administration Staff; and Procedures for Handling Post-Approval Studies
Imposed by Premarket Approval Application Order; Guidance for Industry
and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of the final guidance documents entitled
``Postmarket Surveillance Under Section 522 of the Federal Food, Drug,
and Cosmetic Act'' and ``Procedures for Handling Post-Approval Studies
Imposed by PMA [Premarket Approval Application] Order.'' These guidance
documents are intended to facilitate and set expectations for timely
initiation and completion of certain studies fulfilling postmarket
surveillance requirements and of Post-Approval Studies (PAS),
respectively. Additionally, these guidance documents are intended to
increase transparency to stakeholders on FDA's approach to the issuance
and tracking of postmarket surveillance orders and of PAS requirements.
The final guidance ``Postmarket Surveillance Under Section 522 of the
Federal Food, Drug, and Cosmetic Act'' is intended to update and
replace the guidance issued in May 2016; the final guidance
``Procedures for Handling Post-Approval Studies Imposed by PMA Order''
is intended to update and replace the guidance issued in June 2009.

DATES: The announcement of the guidance is published in the Federal
Register on October 7, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

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-2011-D-0514 for ``Postmarket Surveillance Under Section 522 of the
Federal Food, Drug, and Cosmetic Act'' or Docket No. FDA-2005-D-0027
for ``Procedures for Handling Post-Approval Studies Imposed by PMA
Order.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 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>.
    You may submit comments on any guidance at any time (see Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))).
    Electronic copies of the guidance documents are available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Postmarket Surveillance Under Section 522 of the Federal Food, Drug,
and Cosmetic Act'' or ``Procedures for Handling Post-Approval Studies
Imposed by PMA Order'' to the Office of Policy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.

FOR FURTHER INFORMATION CONTACT: Megha Reddy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The guidance ``Postmarket Surveillance Under Section 522 of the
Federal Food, Drug, and Cosmetic Act'' is intended to assist
manufacturers of devices subject to section 522 orders, by providing:
     an overview of section 522 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360l),
     information on how to fulfill section 522 obligations, and
     recommendations on the format, content, and review of
postmarket surveillance plan and report submissions.
    The guidance ``Procedures for Handling Post-Approval Studies
Imposed by PMA Order'' is intended to assist stakeholders with
understanding PAS requirements imposed as a condition of PMA approval
by providing:
     procedural information,
     recommendations concerning the format, content, and review
of PAS-related submissions,
     recommendations to help facilitate FDA's review of a PAS
protocol in a timely manner,
     recommendations for study timelines including enrollment
milestones and study completion,
     revised definitions to PAS status categories that we
believe better reflect progress of the PAS, and
     revised FDA review time goals for PAS-related submissions.
    The primary changes for the guidance ``Postmarket Surveillance
Under Section 522 of the Federal Food, Drug, and Cosmetic Act'' from
the 2016 version of this guidance document include: (1) clarification
on when postmarket surveillance is considered commenced, (2)
recommendations for achieving an approved postmarket surveillance plan
in a timely manner, (3) recommendations for postmarket surveillance
completion timelines, (4) updated surveillance status categories to
better reflect progress, (5) revised FDA's review times for postmarket
surveillance related submissions, and (6) updated FDA points of contact
and organizational structure.
    A notice of availability of the draft guidance ``Postmarket
Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic
Act'' appeared in the Federal Register of May 27, 2021 (86 FR 28602).
FDA considered comments received and revised this guidance as
appropriate in response to the comments, including (1) by providing
additional clarification on information to be included in postmarket
surveillance plans, enrollment reports, interim reports, and final
reports; (2) additional clarification on how changes to an approved
postmarket surveillance plan should be made by the companies and
reviewed by the FDA; and (3) additional clarification on information to
be posted on FDA's 522 web page.
    A notice of availability of the draft guidance ``Procedures for
Handling Post-Approval Studies Imposed by PMA Order'' appeared in the
Federal Register of May 27, 2021 (86 FR 28630). FDA considered comments
received and revised this guidance as appropriate in response to the
comments, including: (1) by providing additional clarification on
information to be included in PAS protocols, enrollment reports,
interim PAS reports, and final PAS reports; (2) additional
clarification on how changes to an approved PAS protocol should be made
by the sponsors and reviewed by the FDA; (3) additional clarification
on using alternative study designs such as Real-World Data; and (4) one
revised definition of PAS status.
    These guidance documents are being issued consistent with FDA's
good guidance practices regulation (Sec.  10.115). These guidance
documents represent the current thinking of FDA on ``Postmarket
Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic
Act,'' and ``Procedures for Handling Post-Approval Studies Imposed by
PMA Order,'' respectively. They do not establish any rights for any
person and are not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidances may do so
by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. These guidance documents are
also available at https://www.regulations.gov or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of either ``Postmarket Surveillance Under
Section 522 of the Federal Food, Drug, and Cosmetic Act (document
number 19042)'' or ``Procedures for Handling Post-Approval Studies
Imposed by PMA Order (document number 1043)'' may send an email request
to [email protected] to receive an electronic copy of the
document. Please use the document number and complete title to identify
the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While these guidance documents contain no new collection of
information, they do refer to previously approved FDA collections of
information. Therefore, clearance by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.
3501-3521) is not required for these guidance documents. The previously
approved collections of information are subject to review by OMB under
the PRA. The collections of information in the following FDA
regulations, guidance, and forms have been approved by OMB as listed in
the following table:

------------------------------------------------------------------------
 21 CFR Part; Guidance; or FDA                              OMB Control
              Form                        Topic                 No.
------------------------------------------------------------------------
822............................  Postmarket Surveillance       0910-0449
                                  of Medical Devices.
807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
814, subpart H.................  Humanitarian Use              0910-0332
                                  Device; Humanitarian
                                  Device Exemption.
860, subpart D.................  De Novo classification        0910-0844
                                  process.
``Requests for Feedback and      Q-submissions;                0910-0756
 Meetings for Medical Device      Presubmissions.
 Submissions: The Q-Submission
 Program''.
------------------------------------------------------------------------

    Dated: October 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21832 Filed 10-6-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: January 21, 2010 (Volume 75, Number 13)]
[Notices]
[Page 3513-3515]
[DOCID:fr21ja10-99]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61347; File No. SR-NASDAQ-2010-003]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of a Proposed Rule Change by the NASDAQ Stock Market LLC
To Amend the $1 Strike Program To Allow the Listing of $1 LEAPS

January 13, 2010.
    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 11, 2010, The NASDAQ Stock Market LLC (``Nasdaq'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I and II 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 Substance
of the Proposed Rule Change

    Nasdaq is filing with the Securities and Exchange Commission
(``SEC'' or ``Commission'') a proposal for the NASDAQ Options Market
(``NOM'' or ``Exchange'') to amend its Chapter IV Supplementary
Material .02 to Section 6 (Series of Options Contracts Open for
Trading) to expand the Exchange's $1 Strike Price Program (``Program''
or ``$1 Strike Program'') \3\ to allow listing long-term option series
(``LEAPS'') \4\ in $1 strike price intervals up to $5 in up to 200
option classes in individual stocks.
---------------------------------------------------------------------------

    \3\ The $1 Strike Price Program was initially approved as a
pilot on March 12, 2008. See Securities Exchange Act Release No.
57478 (March 12, 2008), 73 FR 14521 (March 18, 2008) (SR-NASDAQ-
2007-004 and SR-NASDAQ-2007-080) (order approving). The program was
subsequently made permanent and expanded. See Securities Exchange
Act Release Nos. 58093 (July 3, 2008), 73 FR 39756 (July 10,
2008)(SR-NASDAQ-2008-057) (notice of filing and immediate
effectiveness); and 59588 (March 17, 2009), 74 FR 12410 (March 24,
2009)(SR-NASDAQ-2009-025) (notice of filing and immediate
effectiveness).
    \4\ Long-Term Equity Anticipation Securities (LEAPS) are long
term options that expire from twelve to thirty-nine months from the
time they are listed. Chapter IV Section 8. Long-term index options
are considered separately in Chapter XIV Section 11. For purposes of
the Program, long-term options (LEAPS) are considered to be option
series having greater than nine months until expiration. Chapter IV
Supplementary Material .02 to Section 6.
---------------------------------------------------------------------------

    The Exchange requests that the Commission waive the 30-day
operative delay period contained in Exchange Act Rule 19b-
4(f)(6)(iii).\5\
---------------------------------------------------------------------------

    \5\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The text of the proposed rule change is available from Nasdaq's Web
site at http://nasdaq.cchwallstreet.com/Filings/, 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
    This proposed rule change is based on a filing previously submitted
by Chicago Board Options Exchange, Incorporated (``CBOE'') that was
recently approved by the Commission.\6\
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    \6\ See Securities Exchange Act Release No. 60978 (November 10,
2009), 74 FR 59296 (November 17, 2009) (SR-CBOE-2009-068) (order
approving proposed rule change to allow listing LEAPS in $1 Strike
Program).
---------------------------------------------------------------------------

    The purpose of the proposal is to expand the $1 Strike Program in a
limited fashion to allow NASDAQ to list new series in $1 strike price
intervals up to $5 in LEAPS in up to 200 option classes on individual
stocks.
    Currently, under the $1 Strike Program, the Exchange may not list
option series having greater than nine months until expiration (LEAPS)
at $1 strike price intervals for any class selected for the Program.
The Exchange also is restricted from listing any series that would
result in strike prices being $0.50 apart, unless the series are part
of the $.50 Strike Program.\7\
---------------------------------------------------------------------------

    \7\ Regarding the $0.50 Strike Program, see Chapter IV
Supplementary Material .05 to Section 6 and Securities Exchange Act
Release No. 60952 (November 6, 2009), 74 FR 59277 (November 17,
2009) (SR-NASDAQ-2009-099) (notice of filing and order approving).
The $0.50 Strike Program establishes strike price intervals of $0.50
for options on stocks trading at or below $3.00.
---------------------------------------------------------------------------

    NASDAQ believes that its proposal to allow limited listing of
option series having greater than nine months until expiration (LEAPS)
in the Program is appropriate and will allow investors to

establish option positions that are better tailored to meet their
investment objectives, vis-[agrave]-vis credit risk, using deep out-of-
the-money, long-term put options. These types of options are viewed as
a viable, liquid alternative to over the counter-traded (``OTC'')
credit default swaps (``CDS''), because such options do not possess the
negative characteristics associated with CDS, namely, lack of
transparency, insufficient collateral requirements, and inefficient
trade processing.
    The Exchange notes that its proposal is limited in scope, as $1
strikes in LEAPS may only be listed up to $5 and in only up to 200
option classes. As is currently the case in the $1 Strike Program, the
Exchange would not list series with $1.00 intervals within $0.50 of an
existing $2.50 strike price in the same series.\8\ As a result, the
Exchange does not believe that this proposal will cause a significant
increase in quote traffic.
---------------------------------------------------------------------------

    \8\ However, strike prices of $2 and $3 are permitted within
$0.50 of a $2.50 strike price for classes also selected for the
$0.50 Strike Program. See proposed Chapter IV Supplementary Material
.02(c) to Section 6, which is similar in this respect to the current
Chapter IV Supplementary Material .02(b) to Section 6.
---------------------------------------------------------------------------

    Moreover, as the Commission is aware, the Exchange has adopted
various quote mitigation strategies in an effort to lessen the growth
rate of quotations. When it expanded the $1 Strike Price Program
several months ago the Exchange included a delisting policy that would
be applicable with regard to this proposed expansion; the Exchange has
likewise established a number of other delisting policies.\9\ The
Exchange and other options exchanges amended the Options Listing
Procedures Plan (``OLPP'') in 2008 to impose a minimum volume threshold
of 1,000 contracts national average daily volume (``ADV'') per
underlying class to qualify for an additional year of LEAP series.\10\
Most recently, the Exchange, along with the other options exchanges,
amended the OLPP to adopt objective, exercise price range limitations
applicable to equity option classes, options on Exchange Traded Funds
(``ETFs'') and options on trust issued receipts (``TIRs'')(the ``range
limitation strategy'').\11\ The Exchange has filed a rule change
proposal to codify the range limitation strategy in its own rules.\12\
The Exchange believes that these price range limitations, in
conjunction with the delisting policies in place at the Exchange,\13\
will have a meaningful quote mitigation impact.
---------------------------------------------------------------------------

    \9\ For the $1 Strike Program delisting policy, see Securities
Exchange Act Release No. 59588 (March 17, 2009), 74 FR 12410 (March
24, 2009) (SR-NASDAQ-2009-025) (notice of filing and immediate
effectiveness). The $1 Strike Program delisting policy includes a
provision stating that the Exchange may grant member requests and
add strikes and/or maintain strikes in series of options classes
traded pursuant to the Program that are eligible for delisting. For
other delisting policies proposed and implemented by the Exchange,
see Securities Exchange Act Release No. 60248 (July 6, 2009), 74 FR
33504 (July 13, 2009) (SR-NASDAQ-2009-063) (notice of filing and
immediate effectiveness regarding Quarterly Options Series program);
and Chapter IV Section 4(l) (low ADV delisting policy) and
Securities Exchange Act Release No. 59923 (May 14, 2009), 74 FR
23902 (May 21, 2009) (SR-NASDAQ-2009-046) (notice of filing and
immediate effectiveness regarding, among other things, delisting
securities underlying low ADV options).
    \10\ See Securities Exchange Act Release No. 58630 (September
24, 2008), 73 FR 57166 (October 1, 2008) (File No. 4-443) (order
approving Amendment No. 2 to OLPP).
    \11\ See Securities Exchange Act Release No. 60531 (August 19,
2009), 74 FR 43173 (August 26, 2009) (File No 4-443) (order
approving Amendment No. 3 to OLPP). NASDAQ's proposal to list $1
strikes in LEAPs to $5 would not be subject to the exercise price
range limitations contained in new paragraph (3)(g)(ii) of the OLPP.
    \12\ See Securities Exchange Act Release No. 61203 (December 18,
2009), 74 FR 68653 (December 28, 2009) (SR-NSDAQ-2009-108).
    \13\ See, for example, Securities Exchange Act Release No. 60248
(July 6, 2009), 74 FR 33504 (July 13, 2009) (SR-NASDAQ-2009-063)
(notice of filing and immediate effectiveness regarding Quarterly
Options Series program); and Chapter IV Section 4(l) (low ADV
delisting policy) and Securities Exchange Act Release No. 59923 (May
14, 2009), 74 FR 23902 (May 21, 2009) (SR-NASDAQ-2009-046) (notice
of filing and immediate effectiveness regarding, among other things,
delisting securities underlying low ADV options).
---------------------------------------------------------------------------

    The margin requirements set forth in Chapter XIII Sections 1
through 5 and the position and exercise requirements set forth in
Chapter III Sections 7 and 9, respectively, will continue to apply to
these new series, and no changes are being proposed to those
requirements by this rule change.
    With regard to the impact on system capacity, the Exchange has
analyzed its capacity and represents that it and the Options Price
Reporting Authority (``OPRA'') have the necessary systems capacity to
handle the additional traffic that may be associated with the listing
and trading of LEAPS in the $1 Strike Program as proposed by this
filing.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \14\ in general, and furthers the objectives of Section
6(b)(5) of the Act \15\ in particular, in that it is designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to foster cooperation and
coordination with persons engaged in facilitating transactions in
securities, and to remove impediments to and perfect the mechanisms of
a free and open market and a national market system. The Exchange
believes that the ability to list and trade LEAPS at $1 strike price
intervals will benefit investors by giving them more flexibility to
more closely tailor their investment and hedging decisions.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78f(b).
    \15\ 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.

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; or (iii)
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate, if consistent with the
protection of investors and the public interest, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \16\ and Rule 19b-
4(f)(6) thereunder.\17\
---------------------------------------------------------------------------

    \16\ 15 U.S.C. 78s(b)(3)(A).
    \17\ 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, along
with a brief description and text of 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.
---------------------------------------------------------------------------

    The Exchange has requested that the Commission waive the 30-day
operative delay. The Commission hereby grants that request.\18\ The
Commission believes that waiver of the operative delay is consistent
with the protection of investors and the public interest because it
recently approved a proposal from CBOE which is nearly identical to the
current proposal and on which no comments were received.\19\ Therefore,
the proposal is operative upon filing.
---------------------------------------------------------------------------

    \18\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \19\ See Securities Exchange Act Release No. 60978 (November 10,
2009), 74 FR 59296 (November 17, 2009) (approving SR-CBOE-2009-68).

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

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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.

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 No. SR-NASDAQ-2010-003 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 No. SR-NASDAQ-2010-003. 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 NASDAQ. 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 No. SR-NASDAQ-2010-003 and should be
submitted on or before February 11, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-1018 Filed 1-20-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 67 (Tuesday, April 7, 2020)]
[Notices]
[Page 19471]
[FR Doc No: 2020-07251]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP20-745-000]

Alliance for Open Markets, BP Canada Energy Marketing Corp.,
Oasis Petroleum Marketing LLC and Tenaska Marketing Ventures v.
Northern Border Pipeline Company; Notice of Complaint

    Take notice that on March 31, 2020, pursuant to Rule 206 of the
Rules of Practice and Procedures of the Federal Energy Regulatory
Commission (Commission), 18 CFR 385.206 (2019), BP Canada Energy
Marketing Corp., Oasis Petroleum Marketing LLC, and Tenaska Marketing
Ventures (Complainants) filed a complaint against Northern Border
Pipeline Company (NBPL or Respondent), alleging that that Respondent
awarded capacity in a pre-arranged transaction in a manner violating
sections 4 and 5 of the Natural Gas Act, 18 CFR 284.13(d)(1) (2019),
Commission policy, and the provisions of NBPL's Tariff., as more fully
explained in the complaint.
    The Complainant certifies that copies of the complaint were served
on the contacts for the Respondent as listed on the Commission's list
of Corporate Officials.
    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. All interventions,
or protests must be filed on or before the comment date.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern Time on April 20, 2020.

    Dated: April 1, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-07251 Filed 4-6-20; 8:45 am]
BILLING CODE 6717-01-P