ATTACHMENT III:  The unsigned DRAFT HED document entitled, “Revised
Postapplication Exposure and Risk for Episodic Ingestion of the Bonide
Dog & Rabbit Chaser End-Use Product (EPA Reg. No. 4-465)”.  1 p.
[Note:  This document was drafted (08/29/2007) in response to
recommendations specified in the HED Risk Assessment Review Committee
(RARC2) Report dated August 22, 2007.]

Revised Postapplication Exposure and Risk for Episodic Ingestion of the
Bonide Dog & Rabbit Chaser End-Use Product (EPA Reg. No. 4-465)

Because of the way that F&B rabbit and dog chaser is applied in
residential areas, i.e., in inch-wide bands around lawns, ornamentals
and vegetable gardens, there is the potential for young children to pick
up a handful of the applied product and ingest it.  The acute oral LD50
in the rat is >5,050 mg/kg (MRID 43523301).  At this dose none of the
rats in the study died, but treated rats exhibited a number of symptoms
including decreased activity, diarrhea, crust around the eyes and nose,
piloerection, polyuria, ptosis, respiratory gurgle and salivation.  If a
child weighing 10 kg were to ingest 2 teaspoonfuls of the product (about
5-6 grams), the corresponding dose would be approximately 500 mg/kg or
one-tenth of the dose that caused moderate toxicity in rats.  Since, as
discussed elsewhere in this risk assessment, humans appear to be more
sensitive than rats, perhaps by an order of magnitude, and ingestion of
1-2 teaspoons of product by a child is not considered excessive, HED is
concerned about the potential for accidental ingestion of the applied
product.

DRAFT

Page   PAGE  1  of 1


[Federal Register: October 6, 2010 (Volume 75, Number 193)]
[Notices]
[Page 61747-61748]
[DOCID:fr06oc10-83]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13835-000]

Coffin Butte Energy Park, LLC; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

September 21, 2010.
    On August 25, 2010, Coffin Butte Energy Park, LLC filed an
application for a preliminary permit, pursuant to section 4(f) of the
Federal Power Act (FPA), proposing to study the feasibility of the
Coffin Butte Pumped Storage Water Power Project (Coffin Butte Project)
to be located in Wheatland County, Montana. The sole purpose of a
preliminary permit, if issued, is to grant the permit holder priority
to file a license application during the permit term. A preliminary
permit does not authorize the permit holder to perform any land-
disturbing activities or otherwise enter upon lands or waters owned by
others without the owners' express permission.

    The proposed project will consist of the following: (1) A 5,700-
foot-long, 60-foot-high triangular earth and roller compacted concrete
embankment; creating a 50-acre upper reservoir with a storage capacity
of 2,500-acre-foot at an elevation of 6,420 feet National Geodetic
Vertical Datum 1929 (NGVD 29); (2) a 6,300-foot-long, 60-foot-high oval
earth and roller compacted concrete embankment; creating a 50-acre
lower reservoir with a storage capacity of 2,500-acre-foot at an
elevation of 5,200 feet NGVD 29; (3) an 18-foot-diameter, 5,000-foot-
long steel-lined tunnel connecting the two reservoirs; (4) a powerhouse
located on the steel-lined tunnel containing two reversible 125-
megawatt (MW) turbine/generator units, for a total installed capacity
of 250 MW; (5) a temporary earthen/rock diversion with a pump and 2-
foot-diameter pipeline to bring initial fill water to the lower
reservoir from Miller Creek; (6) a 2-foot-diameter well to bring
groundwater to the project to make up evaporation and seepage losses;
(7) an approximately 2-mile-long, 500-kilovolt (kV) transmission line
connecting the powerhouse to an existing 500-kV transmission line in
the area or a 7-mile-long, 230-kV transmission line connecting the
powerhouse to the Two Dot substation; and (8) appurtenant facilities.
The estimated annual generation of the Coffin Butte Project would be
880,000 megawatt-hours.
    Applicant Contact: Carl Borquist, Coffin Butte Energy Park, LLC,
1970 Stadium Drive, Suite 3, Bozeman, MN 59715; phone:<PHONE_NUMBER>.
    FERC Contact: Jennifer Harper<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http:[sol][sol]www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at
http:[sol][sol]www.ferc.gov/docs-filing/ecomment.asp. You must include
your name and contact information at the end of your comments. For
assistance, please contact FERC Online Support. Although the Commission
strongly encourages electronic filing, documents may also be paper-
filed. To paper-file, mail an original and seven copies to: Kimberly D.
Bose, Secretary, Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http:[sol][sol]www.ferc.gov/docs-filing/
elibrary.asp. Enter the docket number (P-13835-000) in the docket
number field to access the document. For assistance, contact FERC
Online Support.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-25101 Filed 10-5-10; 8:45 am]
BILLING CODE 6717-01-P


Superfund Overview Superfund Subcommittee June 18, 2002 Presentation to the NACEPT SUPERFUND SUBCOMMITTEE  June 18 19, 2002 GENERAL OVERVIEW  OERR ( Reed) 2 Outline I. Origins/ Legislative History I. Statutory Provisions I. Regulatory Structure I. Administrative Reforms I. Budget Overview Presentation to the NACEPT SUPERFUND SUBCOMMITTEE  June 18 19, 2002 GENERAL OVERVIEW  OERR ( Reed) Origins/ Legislative History ° Three hazardous waste sites in the late 1970s and early 1980s Love Canal, Valley of the Drums and Times Beach   led to a heightened national awareness of the dangers to public health and the environment posed by such sites.

° Congress responded to this environmental and public health threat by passing the Comprehensive Environmental Response, Compensation and Liability Act ( CERCLA) of 1980.

° CERCLA established a $ 1.6 billion Hazardous Waste Trust Fund to pay for the costs of cleaning up abandoned or uncontrolled hazardous waste sites.

° Two bedrock principles of CERCLA are:

Protection of human health and the environment and

Polluters must pay. Presentation to the NACEPT SUPERFUND SUBCOMMITTEE  June 18 19, 2002 GENERAL OVERVIEW  OERR ( Reed) Statutory Provisions CERCLA ° CERCLA provides comprehensive authority for the government to act.

° EPA can respond to a " release" or " substantial threat" of a release of

a " hazardous substance" into the environment; or

" any pollutant or contaminant which may present an imminent and substantial danger to public health or welfare."

° CERCLA defines " hazardous substances" by referring to other environmental statutes ( for example, " toxic pollutants" under the Clean Water Act).

° While " pollutant or contaminant" are broadly defined and include any substance that " may reasonably be anticipated to cause death, disease, behavior abnormalities,

cancer, genetic mutation, physiological malfunctions or physical deformations"

( excludes petroleum and natural gas).

° EPA responses take one of two forms:

removals ( primarily address environmental emergencies) or Presentation to the NACEPT SUPERFUND SUBCOMMITTEE  June 18 19, 2002 GENERAL OVERVIEW  OERR ( Reed)

remedial actions ( long term, permanent cleanups).

Statutory Provisions SARA ° Congress reauthorized Superfund in 1986 after EPA's early experience in implementing CERCLA led to a realization that the problem of abandoned sites was much greater than originally understood.

° The Superfund Amendments and Reauthorization Act ( SARA) strengthened the Superfund program by:

adding tough civil penalties for polluters;

defining and supporting a role for the public and communities;

setting clear and tough cleanup standards; and

giving the President authority to settle with polluters who are cleaning up their sites.

SARA significantly increased the taxing authority for Superfund from $ 1.6 billion to $ 8.5 billion. Presentation to the NACEPT SUPERFUND SUBCOMMITTEE  June 18 19, 2002 GENERAL OVERVIEW  OERR ( Reed) Regulatory Structure

EPA created three major regulatory mechanisms under Superfund to establish cleanup standards and procedures.

The National Contingency Plan ( NCP) is the primary regulation dictating CERCLA response actions; it tells EPA, the States and private parties what procedures to follow when selecting and conducting emergency removals and longterm cleanup actions.

The Hazard Ranking System ( HRS) is a numerically based screening system that uses information from initial, limited investigations to assess the hazards a site poses to human health and the environment.

The HRS score is the primary method for determining placement on the National Priorities List ( NPL). It identifies the sites that are national priorities for receiving further investigations and long term cleanup actions. Presentation to the NACEPT SUPERFUND SUBCOMMITTEE  June 18 19, 2002 GENERAL OVERVIEW  OERR ( Reed) Administrative Reforms ° Beginning in the late 1980s, the Agency undertook several evaluations of the Superfund program.

° The result of those evaluations was the initiation of a series of administrative reforms aimed at revitalizing Superfund.

° EPA implemented three rounds of reforms consisting of almost 50 initiatives that improved the effectiveness of cleanups and increased enforcement fairness.

° These reforms included efforts to:

reduce litigation and transaction costs;

make cleanup decisions more cost effective;

encourage the redevelopment of cleaned up sites;

get States, Tribes and communities more involved; and

encourage innovative technologies. Presentation to the NACEPT SUPERFUND SUBCOMMITTEE  June 18 19, 2002 GENERAL OVERVIEW  OERR ( Reed) Budget Overview ° EPA's Superfund budget for 2002 is $ 1.27 billion, excluding post 9/ 11 appropriations

Appropriations have been declining since Superfund's peak in 1991 ($ 1.6 billion)

In 1999, the Superfund appropriation was reduced by $ 100 million ° Approximately half of the Superfund appropriation is used to implement the Response program in the Regions; the remainder is used for:

Enforcement program, including Department of Justice support ( 13%)

Management support functions, e. g, finance, legal, inspector general, rent ( 11%)

Headquarters policy and implementation management ( 9%)

Brownfields and federal facility response programs ( 10%)

Research and development ( 3%)

Other federal agency support of the Superfund program ( 1%) Presentation to the NACEPT SUPERFUND SUBCOMMITTEE  June 18 19, 2002 GENERAL OVERVIEW  OERR ( Reed) Budget Overview ( continued)

Regional Superfund resources are used for a mix of site and non site specific purposes:

Site assessment and National Priorities List additions

Removal and counter terrorism responses and preparedness

Investigations, remedy selection and design, remedial construction

Oversight of responsible party cleanup actions

State and Tribal program development/ support

Community involvement

Laboratory and other technical support

Contract management

Records and data management

Payroll and equipment

Each year, Headquarters allocates resources among the Regions, based partly on historic use patterns, and partly on their site specific planned needs Presentation to the NACEPT SUPERFUND SUBCOMMITTEE  June 18 19, 2002 GENERAL OVERVIEW  OERR ( Reed)

Budget Overview ( continued)

EPA has generally been able to augment its annual resource allocation by recouping previously appropriated resources that were not expended ( deobligations)

due to the changing resource needs of projects over time

Deobligations have been a substantial source of resources in recent years,

but the pool of funds available for deobligation is declining and such funds are becoming more difficult to retreive

The largest discrete block of resources for which Regions use resources is Fund financed construction ( remedial action) to remove, contain, and/ or treat contaminated media

The 2002 budget allocation remedial action is approximately $ 220 million ( excluding payroll and technical support costs)

Although Regions have flexibility in using these remedial action resources, they are commonly directed by Headquarters for use at specific sites,

as identified by the Regions through an annual workplanning process Presentation to the NACEPT SUPERFUND SUBCOMMITTEE  June 18 19, 2002 GENERAL OVERVIEW  OERR ( Reed)

Budget Overview ( continued)

Headquarters' priority for remedial actions is first to continue funding multi year projects to allow them continue at an efficient pace

EPA uses a combination of risk and construction progress criteria to make decisions on what new projects to start with the remaining remedial action budget

Because EPA has a limited budget, large scale construction projects ( often mega sites) must be funded at the expense of other construction projects or other parts of the response program ( e. g., site assessment, investigations, State involvement)

For FY 2002, 80% of the resources requested by the Regions for ongoing construction projects was to be used at less than 20% of the total number of ongoing projects needing funding Presentation to the NACEPT SUPERFUND SUBCOMMITTEE  June 18 19, 2002 GENERAL OVERVIEW  OERR ( Reed) Budget Overview ( continued)

Because the resource needs of Fund financed actions that are ongoing and ready to start exceed the current budget for remedial action, EPA must look for ways to stretch resources by:

° Re examining the accuracy of cost estimates ° Spreading construction costs over time ° Improving the coordination of project schedules to continue ongoing work rather than start projects with insufficient funds


[Federal Register Volume 83, Number 246 (Wednesday, December 26, 2018)]
[Notices]
[Pages 66325-66326]
[FR Doc No: 2018-27821]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84846; File No. SR-BX-2014-048]

Self-Regulatory Organizations; Nasdaq BX, Inc.; Order Granting an
Extension to Limited Exemptions From Rule 612(c) of Regulation NMS In
Connection With the Exchange's Retail Price Improvement Program Until
June 30, 2019

December 18, 2018.
    On November 28, 2014, the Securities and Exchange Commission
(``Commission'') issued an order pursuant to its authority under Rule
612(c) of Regulation NMS (``Sub-Penny Rule'') \1\ that granted The
NASDAQ OMX BX, Inc., n/k/a Nasdaq BX, Inc. (``BX'' or ``Exchange''), a
limited exemption from the Sub-Penny Rule in connection with the
operation of the Exchange's Retail Price Improvement Program (the ``RPI
Program'').\2\ The limited exemption was granted concurrently with the
Commission's approval of the Exchange's proposal to adopt its RPI
Program for a one-year pilot term.\3\ On November 20, 2015, the
Commission extended the temporary exemption until December 2016
concurrently with an immediately effective filing that extended the
operation of the RPI Program until December 1, 2016.\4\ On December 1,
2016, the Commission extended the temporary exemption until December 1,
2017 concurrently with an immediately effective filing that extended
the operation of the RPI Program until December 1, 2017.\5\ On December
1, 2017, the Commission extended the temporary exemption until June 30,
2018 concurrently with an immediately effective filing that extended
the operation of the RPI Program until June 30, 2018.\6\ On June 28,
2018, the Commission again extended the temporary exemption until
December 31, 2018 concurrently with an immediately effective filing
that extended the operation of the RPI Program until December 31,
2018.\7\
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    \1\ 17 CFR 242.612(c).
    \2\ See Securities Exchange Act Release No. 73702, 79 FR 72049
(December 4, 2014) (SR-BX-2014-048) (``RPI Approval Order'').
    \3\ See id.
    \4\ See Securities Exchange Act Release No. 76490 (November 20,
2015), 80 FR 74165 (November 27, 2015) (SR-BX-2015-073).
    \5\ See Securities Exchange Act Release No. 79446 (December 1,
2016), 81 FR 88290 (December 7, 2016) (SR-BX-2016-065).
    \6\ See Securities Exchange Act Release No. 82192 (December 1,
2017), 82 FR 57809 (December 7, 2017) (SR-BX-2017-055).
    \7\ See Securities Exchange Act Release No. 83539 (June 28,
2018), 83 FR 31203 (July 3, 2018) (SR-BX-2018-026).
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    The Exchange now seeks to extend the exemption until June 30,
2019.\8\ The Exchange's request was made in conjunction with an
immediately effective filing that extends the operation of the RPI
Program through the same date.\9\ In its request to extend the
exemption, the Exchange notes that given the gradual implementation of
the RPI Program and the preliminary participation and results,
extending the exemption would provide additional opportunities for
greater participation and assessment of the results.\10\ Accordingly,
the Exchange has asked additional time to allow it and the Commission
to analyze data concerning the RPI Program, which the Exchange
committed to provide to the Commission.\11\ For this reason and the
reasons stated in the RPI Approval Order originally granting the
limited exemption, the Commission, pursuant to its authority under Rule
612(c) of Regulation NMS, finds that pursuant to its authority under
Rule 612(c) of Regulation NMS, extending the exemption is appropriate
in the public interest and consistent with the protection of investors.
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    \8\ See Letter from Jeffrey S. Davis, Vice President and Deputy
General Counsel and Secretary, Nasdaq BX, Inc. to Eduardo A. Aleman,
Assistant Secretary, Securities and Exchange Commission, dated
December 11, 2018 (``BX Letter'').
    \9\ See SR-BX-2018-063.
    \10\ See, e.g., BX Letter at 3; RPI Approval Order, supra note
2.
    \11\ See, id.
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    Therefore, it is hereby ordered that, pursuant to Rule 612(c) of
Regulation NMS, the Exchange is granted a limited exemption from Rule
612 of Regulation NMS that allows the Exchange to accept and rank
orders priced equal to or greater than $1.00 per share in increments of
$0.001, in connection with the operation of its RPI Program, until June
30, 2019.
    The limited and temporary exemption extended by this Order is
subject to modification or revocation if at any time the Commission
determines that such action is necessary or appropriate in furtherance
of the purposes of the Securities Exchange Act of 1934. Responsibility
for compliance with any applicable provisions of the Federal securities
laws must rest with the persons relying on the exemptions that are the
subject of this Order.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
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    \12\ 17 CFR 200.30-3(a)(83).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2018-27821 Filed 12-21-18; 8:45 am]
 BILLING CODE 8011-01-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: PV Shah, Branch Chief Inert Assessment Branch (IAB)<PHONE_NUMBER>

Sasol Chemicals (USA) LLC Petition Number: IN-10990  EPA has received a pesticide petition (IN-10990) from Spring Trading Company on behalf of Sasol Chemicals (USA) LLC], 12120 Wickchester Ln., Houston, Texas 77079 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.

       To amend the exemption from the requirement of a tolerance for Poly(oxy-1,2-ethanediyl), α-isooctyl-ω-hydroxy where the alkyl chain contains a minimum of six carbons, minimum number average molecular weight (in amu) 1,100.; (AAA's) in or on the raw agricultural commodity growing crops at under 40 CFR 180.910, 930, 940 or 960.

 This petition proposes the addition of the following CAS. No.: 61723-78-2	Alcohols, ethoxylated  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

 Residue Chemistry

Residue chemistry data are not necessary since the request is for an exemption from the requirement of a tolerance.

 Analytical method. An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

 Magnitude of residues. Sasol Chemicals is petitioning the agency to amend an existing exemption from the requirement of a tolerance. Therefore, information regarding the nature and magnitude of chemical residues resulting from the use of this inert ingredient is not required.

    Toxicological Profile

 Acute toxicity. The AAAs are not acutely toxic by the oral and dermal routes of exposure under normal use conditions. Concentrated materials are generally moderate to severe eye and skin irritants and may be skin sensitizers. There is no evidence of mutagenicity in the Ames assay (bacterial strains).

 Genotoxicty. The AAA's showed no evidence of mutagenicity, or chromosome aberration.

 Reproductive	and	developmental	toxicity.	No	reproductive	or developmental/offspring toxicity was observed. It is generally accepted that increased ethoxylation decreases lipophilicity resulting in decreased absorption and decreased toxicity. The lower molecular weight AAAs would be expected to be absorbed and distributed more readily than higher molecular weight AAAs and therefore to potentially be more toxic. The representative ethoxylated compounds tested have the lowest weight percent ethoxylation and lowest molecular weight of the series and are potentially the most bioavailable of the series. Although metabolism data are not available, the major metabolic pathway for AAA surfactants is expected to include the hydrolysis of ether linkage to the corresponding alkyl alcohol and polyalkoxylate (POE or POE/POP) group which subsequently undergoes oxidative degradation and/or excretion.

 Subchronic toxicity. Following subchronic exposure to rats and dogs, decreases in body weight and food consumption were observed, but  no specific target organ toxicity or neurotoxicity was seen. No effects were detected in a functional observational battery (FOB) or motor activity assessment. In a 90 - day dermal toxicity study with AAA surfactant, no systemic toxicity was observed at doses up to 125 mg/kg/day (the highest dose tested).

 Chronic toxicity. There is no evidence that the AAA surfactants are carcinogenic. The Agency used a qualitative structure activity relationship (SAR) database, DEREK Version 11, to determine if there were structural alerts. No structural alerts were identified. In addition, there was little concern about any of the postulated metabolites having greater toxicity than the parent compounds.

Specific information on the studies received and the nature of the adverse effects caused by AAA, as well as, the no-observed-adverse-effect-level (NOAEL) and the lowest-observed adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Alkyl Alcohol Alkoxylates (AAA  -  JITF CST 1 Inert Ingredient). Human Health Risk Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pesticide Formulations at pp 13 - 20 and pp 61 - 75 in docket ID number EPA -  HQ - OPP - 2009 - 0145.

 Endocrine disruption. FQPA requires EPA to develop a screening program to determine whether certain substances, including all pesticide chemicals (both inert and active ingredients), ``may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect. . .'' EPA has been working with interested stakeholders to develop a screening and testing program as well as a priority setting scheme. As the Agency proceeds with implementation of this program, further testing of products containing AAA's for endocrine effects may be required.

    Aggregate Exposure

 Dietary exposure. [In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

The AAAs are used as inert ingredients in pesticide products that are currently registered for uses that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to the AAAs. EPA has concluded that the combined intermediate-term aggregated food, water, and residential exposures result in aggregate MOEs of 230 for both adult males and females, respectively. Adult residential exposure includes high-end post application dermal exposure from contact with treated pets. EPA has concluded that the

combined intermediate-term aggregated food, water, and residential exposures result in an aggregate MOE of 110 for children. Children's residential exposure includes total combined pet exposure. As the level of concern is for MOEs that are lower than 100, these MOEs are not of concern.

The Agency has used various screening-level models to estimate some of the existing levels of exposure and those that could occur as a result of establishing this tolerance exemption.

    Cumulative Effects

We have not found a common mechanism of toxicity finding as Poly(oxy-1,2- ethanediyl), α-isooctyl-ω-hydroxy does not appear to produce a toxic metabolite produced by other substances. For the purposes of this requested tolerance action Poly(oxy-1,2- ethanediyl), α-isooctyl-ω-hydroxy does not have a common mechanism of toxicity with other substances.

    Safety Determination

 U.S. population. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to residues of the AAAs.

 Infants and children. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to residues of the lower weight AAAs.

    International Tolerances

Sasol Chemicals is not aware of any country requiring a tolerance for the AAAs nor have any CODEX Maximum Residue Levels been established for any food crops at this time.


MemoTo:	Docket EPA-HQ-OAR-2021-0208
From:	Michael Shelby, U.S. EPA-OTAQ-TCD
CC:	Michael Olechiw, U.S. EPA-OTAQ-ASD
Date:	June 22[nd], 2021
Re:	Docket of Reference Materials (That are not Copyrighted) for VMT Rebound (Chapter 3.1 in DRIA NPRM LDV)
	Hello Michael

      Here are the Reference materials that do not have copyright restrictions used for the VMT Rebound section of Chapter 3.1 of the DRIA of the NPRM for the LDV rule.

      The following Reference materials are for the docket (see attachments in accompanying file).
 The 2020 EPA Automotive Trends Report. Greenhouse gas emissions, fuel economy and technology since 1975. Executive Summary. U.S. EPA 420-5-21-001. January 2021.
 Gillingham, K. 2011. The Consumer Response to Gasoline Prices: Empirical Evidence and Policy Implications, Stanford University Ph.D. Dissertation. Accessed at: https://stacks.stanford.edu/file/druid:wz808zn3318/Gillingham_Dissertation-augmented.pdf
 Leung, W. 2015, Three Essays in Energy Economics, University of California San Diego PhD Dissertation, Accessed at: https://escholarship.org/content/qt3h51364m/qt3h51364m.pdf
 Wenzel, T. and Fujita, K. 2018. Elasticity of Vehicle Miles of Travel to Changes in the Price of Gasoline and the Cost of Driving in Texas, Lawrence Berkeley National Laboratory Report LBNL-2001138. Accessed at: https://eln.lbl.gov/publications/elasticity-vehiclemiles-travel.
 U.S. Department of Transportation, National Highway Traffic Safety Administration, U.S. Environmental Protection Agency, Preliminary Regulatory Impact Analysis, The Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule for Model Year 2021 - 2026 Passenger Cars and Light Trucks, 2018. July. Updated August 2018; October 2018.

 The Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule for Model Years 2021-2026 Passenger Cars and Light Trucks". 83 Fed. Reg. 42,986 Aug. 24, 2018.

 Assessment of Technologies for Improving Light-Duty Vehicle Fuel Economy−2025-2035, Committee on Assessment of Technologies for Improving Fuel Economy of Light-Duty Vehicles−Phase 3, Board on Energy and Environmental Systems Division on Engineering and Physical Sciences. A Consensus Study Report of the National Academies of Sciences, Engineering and Medicine.
 U.S. Energy Information Administration (EIA), U.S. Department of Energy (DOE), Annual Energy Outlook, 2021, https://www.eia.gov/outlooks/aeo/pdf/00%20AEO2021%20Chart%20Library.pdf, see slide entitled, Gross Domestic Product and population assumptions.


[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Page 22528]
[FR Doc No: 2015-09302]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0131]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for COMETRIQ 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 COMETRIQ
(cabozanitinib (S)-maleate). COMETRIQ is indicated for the treatment of
patients with progressive, metastatic medullary thyroid cancer.
Subsequent to this approval, the USPTO received a patent term
restoration application for COMETRIQ (U.S. Patent No. 7,579,473) from
Exelixis, Incorporated, and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated March 27, 2014, FDA advised the USPTO that this human drug
product had undergone a regulatory review period and that the approval
of COMETRIQ 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
COMETRIQ is 2,698 days. Of this time, 2,513 days occurred during the
testing phase of the regulatory review period, while 185 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: July 13, 2005. FDA has verified the applicant's claim that
the date the investigational new drug application became effective was
on July 13, 2005.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: May 29,
2012. FDA has verified the applicant's claim that the new drug
application (NDA) for COMETRIQ (NDA 203756) was submitted on May 29,
2012.
    3. The date the application was approved: November 29, 2012. FDA
has verified the applicant's claim that NDA 203756 was approved on
November 29, 2012.
    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 688 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 22, 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 19, 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 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09302 Filed 4-21-15; 8:45 am]
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[Federal Register Volume 88, Number 133 (Thursday, July 13, 2023)]
[Notices]
[Page 44848]
[FR Doc No: 2023-14884]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No.: FAA-2022-1814; Summary Notice No. 2023-15]

Petition for Exemption; Summary of Petition Received; Bewired USA
LLC dba SkyEagle Aviation Academy

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion nor omission of information in the
summary is intended to affect the legal status of the petition or its
final disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before August 2, 2023.

ADDRESSES: Send comments identified by docket number FAA-2022-1814
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Sean O'Tormey at<PHONE_NUMBER>, Office
of Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC.
Angela O. Anderson,
Director, Regulatory Support Division, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2022-1814.
    Petitioner: Bewired USA LLC dba SkyEagle Aviation Academy.
    Section(s) of 14 CFR Affected: Sec.  141.33(a)(4)(ii).
    Description of Relief Sought: Petitioner seeks relief from Sec.
141.33(a)(4)(ii) in order to allow Mr. Alexey Belkin to substitute his
flight and training experience gained under International Civil
Aviation Organization (ICAO) and European Union Aviation Safety
Aviation (EASA) regulations to satisfy the Sec.  141.33(a)(4)(ii)
requirement of 2 years of experience as a pilot in command in
operations conducted under Sec.  91.1053(a)(2)(i) or Sec.
135.243(a)(1) of this chapter, or as a pilot in command or second in
command in any operation conducted under part 121.

[FR Doc. 2023-14884 Filed 7-12-23; 8:45 am]
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