Docket Number:  EPA-HQ-OPP-2006-0239

www.regulations.gov

Fomesafen Final Work Plan (FWP)

For Registration Review

August 2007

Approved by:	 ___________________

		Peter Caulkins, Acting Director

		Special Review and Reregistration Division

Date:

Docket Number:  EPA-HQ-OPP-2006-0239

www.regulations.gov

Introduction:

This is the Environmental Protection Agency’s (EPA’s) Final Work
Plan for the registration review of fomesafen.  This work plan includes
the expected registration review timeline.  The work plan also addresses
public comments received concerning the Preliminary Work Plan in the
Summary Document which was posted in the fomesafen registration review
docket, and any other comments concerning initial docket postings.  The
Summary Document provided information on what EPA knows about the
pesticide and what additional risk analyses and data or information the
Agency believes are needed to make a registration review decision.

The Agency is implementing the new registration review program and plans
to review each registered pesticide every 15 years to determine whether
it continues to meet the Federal Insecticide Fungicide and Rodenticide
Act (FIFRA) standard for registration.  Changes in science, public
policy, and pesticide use practices will occur over time.  The
registration review program is intended to make sure that, as the
ability to assess risk evolves and as policies and practices change, all
registered pesticides continue to meet that statutory standard.  The
public phase of registration review begins when the initial docket is
opened for each case.  Information on this program is provided at:
HYPERLINK "http://www.epa.gov/oppsrrd1/registration_review/_"
http://www.epa.gov/oppsrrd1/registration_review/

Comments Received on Preliminary Work Plan:

EPA received comments during the public comment period on the initial
fomesafen docket.  However, these comments, which are addressed in this
document, did not change the data and risk assessment needs or the
timeline detailed in the Preliminary Work Plan.  This document makes
final the work plan for the fomesafen registration review process.  A
listing of the comments and responses are in the “Summary of Comments
and Agency Responses” section of this document.

Risk Assessment and Data Needs:

The Agency does not require any additional ecological effects or
environmental fate data to support the current assessments.  However,
the Agency will conduct an endangered species risk assessment for all
uses.  The Agency does not require any additional human health risk
assessments or related data.

Ecological Risk:

Ecological risk assessments for fomesafen uses were completed January
30, 2006 for use on soybeans, and for new uses of fomesafen on cotton,
snap beans, and dry beans.

Docket Number:  EPA-HQ-OPP-2006-0239

www.regulations.gov

The planned ecological risk assessment will allow the Agency to
determine whether fomesafen use has "no effect" or "may affect"
federally listed threatened or endangered species (listed species) or
their designated critical habitat.  If the assessment indicates that
fomesafen "may affect" a listed species or its designated critical
habitat, the assessment will be refined.  The refined assessment will
allow the Agency to determine whether use of fomesafen is “likely to
adversely affect” the species or critical habitat or "not likely to
adversely affect" the species or critical habitat.  When an assessment
concludes that a pesticide's use "may affect" a listed species or its
designated critical habitat, the Agency will consult with the U.S. Fish
and Wildlife Service and National Marine Fisheries Service (Services),
as appropriate.

Human Health Risk:

The previously completed dietary assessments (2/28/06) that considered
dietary exposure to fomesafen from food and drinking water are adequate
and there is no dietary risk that exceeds the Agency’s level of
concern (LOC).  Thus, no additional data are needed.

The occupational database is completed for the existing uses and the
latest risk assessment (2/28/06) indicates that most of the occupational
scenarios do not result in risk concerns, with the exception of
inhalation risk to mixer/loaders for aerial application.  The Agency is
working with the registrant to address this risk.

Docket Number:  EPA-HQ-OPP-2006-0239

www.regulations.gov

Timeline:

EPA has created the following estimated timeline for the completion of
the fomesafen registration review.

Activities 	Estimated Month/Year

Phase 1: Opening the docket

Open Public Comment Period for Fomesafen Docket  	Mar. 2007

Close Public Comment Period 	June  2007

Phase 2:  Case Development

Develop Final Work Plan (FWP)	Aug. 2007

Open Public Comment Period for Preliminary Risk Assessments 	1st Quarter
2009

Close Public Comment Period	2nd Quarter 2009

Phase 3: Registration Review Decision

Open Public Comment Period for Proposed Reg. Review Decision 	3rd
Quarter 2009

Close Public Comment Period 	4th Quarter 2009

Final Decision and Begin Post-Decision Follow-up	1st Quarter 2010

Total (years)	3.0

Summary of Comments and Agency Responses:

The fomesafen registration review docket was opened for a 90-day comment
period beginning on March 28, 2007.  During that time, comments were
received from the technical registrant, Syngenta Crop Protection, the
FIFRA Endangered Species Task Force (FESTF), and New York State
Department of Environmental Conservation.

Summary of Comments Regarding EPA Proposed Actions

1.	Comment:  Syngenta responded to EPA anticipating conducting an
endangered 	species risk assessment for all fomesafen uses.  Syngenta
indicated that they 	submitted an endangered species assessment for
fomesafen on March 27, 2006 	(MRID No. 46796201).  This submission was
made in support of the addition of 	Cotton, Dry and Snap Beans to the
Reflex Herbicide (EPA Reg.No.100-993) 	label.  The conclusion from this
risk assessment was that even using worst-case 	screening level risk
methodologies there will be no effect to threatened or 	endangered
terrestrial animals, aquatic animals, aquatic plants and monocot plant
species from the use of fomesafen in cotton, dry beans, or snap beans.
In addition 	fomesafen is not likely to adversely affect threatened or
endangered terrestrial 	dicot species or the habitat of listed species.

Docket Number:  EPA-HQ-OPP-2006-0239

www.regulations.gov

	Response:  The Agency thanks Syngenta Crop Protection for its comment,
and 	will consider this information as it conducts the registration
review and makes its 	registration review decision.

2.	Comment: Syngenta responded to EPA’s recommendation for requiring a
		respirator to mitigate inhalation exposure risks.  Syngenta does not
agree with the 	occupational exposure assessment that leads to the
recommendation for requiring 	a respirator to mitigate inhalation
exposure risks.  The registrant feels that the 	toxicity endpoint
selected for the short-term inhalation exposure from the 90-day 	feeding
study is not appropriate because the short-term exposure is defined as 1
to 	30 days exposure duration.  A 90-day study covers a much longer
duration of 	exposure.  Syngenta suggests the use of a developmental
toxicity study in rats for 	selecting the short-term inhalation exposure
assessments.

	Response:  The liver appears to be a target organ in the rat for
fomesafen, since fomesafen has been shown to consistently affect the
liver in subchronic and chronic feeding studies in rats, as well as in
the rat reproduction study. Although it is logical for the registrant to
suggest selecting the toxicity endpoint for short-term inhalation
exposure based on a developmental toxicity study in terms of duration of
exposure, liver effects are not examined in a developmental toxicity
study. Additionally, some pesticides that produce liver toxicity
demonstrate liver effects with repeated dosing for a short duration (2
weeks to 30 days).  Therefore, in the absence of a shorter duration
(e.g., 30-day) feeding study on fomesafen to show otherwise, it is
assumed that fomesafen could cause liver toxicity following short-term
exposure.  Hence, for fomesafen, it is prudent to select the toxicity
endpoint for short-term inhalation exposure based on a 90-day feeding
study.

3.	Comment:  Syngenta responded to EPA’s statement that additional
data has been 	previously required as a condition of registration for
certain new uses for 	fomesafen.  Syngenta 	indicated that the actions
required to satisfy these 	conditional registration requirements are
currently underway and will be 	completed within the required time
frame.

	Response:   The Agency thanks Syngenta Crop Protection for its comment.

Docket Number:  EPA-HQ-OPP-2006-0239

www.regulations.gov

Summary of Comments Regarding Toxicology Endpoints for Fomesafen

4.	Comment:  Syngenta responded to EPA’s use of a 90-day toxicity
study in rats to 	set a short-term toxicity endpoint (inhalation and
incidental oral).  Syngenta 	indicated that this is not appropriate,
because the duration of exposure is 3-fold 	greater than the maximum
definition of “short-term” exposure (1-30 days).  The 	liver effects
seen in this study at 100 ppm (10 mg/kg/day) were observed at the
terminal sacrifice, after 90 days of exposure.  This included an
increased liver 	weight and increased alkaline phosphatase in males at
week 13, plus 	micropathology findings of hepatocyte eosinophilia and
reduce granulation 	(=hepatocyte hyalinization) in males and females at
week 13. The LOAEL 	findings quoted in the tables of Toxicology
Endpoints (EPA, 2006; EPA, 2007) 	inadvertently included increases in
alanine transaminase and aspartate 	transaminase as effects at 10
mg/kg/day, but 	in fact these were only increased at 	the high dose of
100 mg/kg/day (1000 ppm) in this study.  For short-term dermal
toxicity, EPA has selected the rat developmental toxicity NOAEL of 100
mg/kg/day, and this would be an appropriate endpoint for short-term
inhalation 	and oral exposures as well.  In support of this, there is no
evidence for an 	increased concern for exposures via the inhalation
route compared to other routes 	with fomesafen.  In an acute inhalation
study, fomesafen technical had an 	LC50>2.63 mg/L (Carter, 2004) placing
it in EPA Category IV.  Fomesafen 	is not volatile, and typical
agricultural applications of the final herbicide spray 	dilutions do not
produce particles of 	respirable size.  Therefore, the same study 	that
was used for short-term dermal toxicity risk assessment (rat development
	study) is equally applicable to short-term inhalation toxicity risk
assessment.

	Response:  The Agency thanks Syngenta Crop Protection for its comment,
and 	will consider this information as it conducts the registration
review and makes its 	registration review decision.

Summary of Comments Regarding Environmental Exposure Characteristics for
Fomesafen

5.	Comment:  Syngenta noted that they have conducted an anaerobic
aquatic 	metabolism study that will be submitted to EPA to support the
current registration 	review 	(Peters, 2002).  The result of this study
was that fomesafen was found to 	degrade rapidly under anaerobic
conditions.  The degradation of fomesafen 	was studied using three US
water-sediment system and found to degrade with 	total system half-lives
ranging from 3.93 to 7.95 days.  Syngenta believes that

Docket Number:  EPA-HQ-OPP-2006-0239

www.regulations.gov

	the data from this study which indicated an upper 90% confidence limit
of 8.05 	days should be used as the anaerobic aquatic (benthic)
half-life input to 	PRIZM/EXAMS.

	Response:  The Agency thanks Syngenta Crop Protection for its comment,
and 	will consider this information if submitted in a timely fashion as
it conducts the 	registration review and makes its registration review
decision.

6.	Comments:  Syngenta noted that the equilibrium adsorption
coefficient, the 	lowest non-sand Kd value of 0.68 mL/g was used by the
EPA for PRZM/EXAMS 	modeling and Koc =68 mL/g was used for SCI-GROW,
using an assumed organic 	carbon comment of 1%.  Syngenta agrees with
this approach to the SCI-GROW 	input, since there is considerable
scatter in the Kd vs. %OC correlation.  	However, the input to
PRZM/EXAMS that is normally used for this parameter is 	the average
Freundlich Kd or Koc.  In MRID 00259413, the adsorption of 	fomesafen to
each soil is represented as the mean Kd value, rather than the
Freundlich coefficient.

	Response:  The Agency thanks Syngenta Crop Protection for its comment,
and 	will consider this information as it conducts the registration
review and makes its 	registration review decision.

7.	Comment:  Syngenta noted that the fomesafen soil accumulation was
modeled using the 90% confidence limit of the laboratory values for
half-life (428 days) with an assumption that aerobic soil metabolism is
the only degradation process.  Syngenta indicated that this approach
results in exaggerated predictions of fomesafen soil concentrations and
does not believe best estimates the potential for fomesafen residues to
accumulate in the soil.  Field dissipation studies conducted under
actual use conditions and that are cited by the Agency in the Ecological
Risk Assessment for use of Fomesafen on Cotton, Snap and Dry Beans
(Docket ID EPA-HQ-OPP-2006-0239-009) resulted in half-lives ranging from
50 to 150 days in surface soils.  The utilization of these points to
characterize the soil accumulation potential for fomesafen would result
in more appropriate estimates for use in modeling.

	Response:  The Agency thanks Syngenta Crop Protection for its comment,
and 	will consider this information as it conducts the registration
review and makes its 	registration review decision.

Docket Number:  EPA-HQ-OPP-2006-0239

www.regulations.gov

Summary of Comments Regarding the FIFRA Endangered Species Task Force

8.	Comment:  The FIFRA Endangered Species Task Force (FESTF) noted that
EPA 	stated in the Registration Review summary document that fomesafen
does not 	have a complete environmental risk assessment that is in
compliance with 	EPA’s 	Overview Document for Endangered and
Threatened Species Effects 	Determinations.  FESTF requests that EPA
assure that any company that is 	relying upon FESFT data, and are not a
member file a proper offer to pay for data 	compensation.

	Response:  The Agency thanks FESTF for its comment, and will consider
this 	information as it conducts the registration review and makes its
registration 	review decision.

Summary of Comments Regarding the Aquatic Plant Risk Assessment

9.	Comment:  The New York State Department of Environmental Conservation
	(NYDEC) noted that the aquatic risk assessment appeared to be based on
the 	green algae, Selenastrum capricornutum, and did not report any
information for 	the macrophyte (Lemna gibba) study.  NYDEC also
commented that the active 	ingredient fomesafen is used in herbicides,
and therefore the macrophyte study 	is of great importance to
determining ecological risk from use of these products.  	The Department
requests that USEPA add the aquatic macrophyte acute 	toxicity test as
part of the Information Needs Section.

Response:  The Agency thanks the New York State Department of
Environmental Conservation for its comment.  The Agency does have data
on the aquatic vascular plant, Lemna gibba, and this data shows that
Lemna gibba is less sensitive to fomesafen than Selenastrum
capricornutum.  However, the Agency will consider the Lemna gibba data
as it conducts the registration review and makes its registration review
decision.

Next Steps:

The Agency will conduct an endangered species risk assessment for all
uses of fomesafen.


[Federal Register Volume 83, Number 39 (Tuesday, February 27, 2018)]
[Notices]
[Pages 8569-8571]
[FR Doc No: 2018-03943]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2018-0090]

Parts and Accessories Necessary for Safe Operation; Application
for an Exemption From the Automobile Carriers Conference of the
American Trucking Associations

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of application for exemption; request for comments.

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

SUMMARY: The Federal Motor Carrier Safety Administration (FMCSA)
requests public comment on an application for exemption from the
Automobile Carriers Conference (ACC) of the American Trucking
Associations (ATA) requesting that motor carriers operating stinger
steered automobile transporter equipment be relieved from the
requirement to place warning flags on projecting loads of new motor
vehicles. The Federal Motor Carrier Safety Regulations (FMCSRs) require
any commercial motor vehicle (CMV)

transporting a load that extends more than 4 feet beyond the rear of
the vehicle to be marked with a single red or orange fluorescent
warning flag at the extreme rear if the projecting load is 2 feet wide
or less, and two warning flags if the projecting load is wider than 2
feet. The flags must be located to indicate the maximum width of loads
which extend beyond the sides and/or rear of the vehicle. The ACC
believes that the reflex reflectors that are required to be installed
on the new motor vehicles being transported, in conjunction with the
various marking and conspicuity requirements required on the trailer
transporting the new vehicles, provide a level of safety that is
greater than that achieved by the warning flags required by the FMCSRs.

DATES: Comments must be received on or before March 29, 2018.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-2018-0090 using any of the
following methods:
     Website: http://www.regulations.gov. Follow the
instructions for submitting comments on the Federal electronic docket
site.
     Fax: 1-202-493-2251.
     Mail: Docket Management Facility, U.S. Department of
Transportation, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC
20590-0001.
     Hand Delivery: Ground Floor, Room W12-140, DOT Building,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.
e.t., Monday-Friday, except Federal holidays.
    Instructions: All submissions must include the Agency name and
docket number for this notice. For detailed instructions on submitting
comments and additional information on the exemption process, see the
``Public Participation'' heading below. Note that all comments received
will be posted without change to http://www.regulations.gov, including
any personal information provided. Please see the ``Privacy Act''
heading for further information.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or to Room W12-140,
DOT Building, 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays.
    Privacy Act: 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 www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.
    Public participation: The http://www.regulations.gov website is
generally available 24 hours each day, 365 days each year. You may find
electronic submission and retrieval help and guidelines under the
``help'' section of the http://www.regulations.gov website as well as
the DOT's http://docketsinfo.dot.gov website. If you would like
notification that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgment
page that appears after submitting comments online.

FOR FURTHER INFORMATION CONTACT: Mr. Jos[eacute] R. Cestero, Vehicle
and Roadside Operations Division, Office of Carrier, Driver, and
Vehicle Safety, MC-PSV,<PHONE_NUMBER>, Federal Motor Carrier Safety
Administration, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.

SUPPLEMENTARY INFORMATION:

Background

    Section 4007 of the Transportation Equity Act for the 21st Century
(TEA- 21) [Pub. L. 105-178, June 9, 1998, 112 Stat. 401] amended 49
U.S.C. 31315 and 31136(e) to provide authority to grant exemptions from
the Federal Motor Carrier Safety Regulations (FMCSRs). On August 20,
2004, FMCSA published a final rule (69 FR 51589) implementing section
4007. Under this rule, FMCSA must publish a notice of each exemption
request in the Federal Register (49 CFR 381.315(a)). The Agency must
provide the public with an opportunity to inspect the information
relevant to the application, including any safety analyses that have
been conducted. The Agency must also provide an opportunity for public
comment on the request.
    The Agency reviews the safety analyses and the public comments and
determines whether granting the exemption would likely achieve a level
of safety equivalent to or greater than the level that would be
achieved by the current regulation (49 CFR 381.305).
    The decision of the Agency must be published in the Federal
Register (49 CFR 381.315(b)). If the Agency denies the request, it must
state the reason for doing so. If the decision is to grant the
exemption, the notice must specify the person or class of persons
receiving the exemption and the regulatory provision or provisions from
which an exemption is granted. The notice must specify the effective
period of the exemption (up to 5 years) and explain the terms and
conditions of the exemption. The exemption may be renewed (49 CFR
381.315(c) and 49 CFR 381.300(b)).

ACC Application for Exemption

    The ACC has applied for an exemption from 49 CFR 393.87, requesting
that motor carriers operating stinger steered automobile transporter
equipment be relieved from the requirement to place warning flags on
projecting loads of new motor vehicles. A copy of the application is
included in the docket referenced at the beginning of this notice.
    Section 393.87 of the FMCSRs requires any commercial motor vehicle
transporting a load which extends beyond the sides by more than 4
inches, or more than 4 feet beyond the rear, to have the extremities of
the load marked with red or orange fluorescent warning flags. Each
warning flag must be at least 18 inches square. There must be a single
flag at the extreme rear if the projecting load is 2 feet wide or less,
and two warning flags are required if the projecting load is wider than
2 feet. The flags must be located to indicate the maximum width of
loads which extend beyond the sides and/or rear of the vehicle.
    In its application, the ACC states ``With the enactment of the FAST
[Fixing America's Surface Transportation] Act in December 2015, stinger
steered automobile transporter equipment are permitted a rear vehicular
overhang allowance of not less than six feet. [49 U.S.C.
31111(b)(1)(G)] Prior to the enactment of the FAST Act, the minimum
rear overhang allowance for all automobile transporters was a minimum
of four feet. [23 CFR Sec. 658.13(e)(ii)].''
    The ACC states:

    The transportation of new motor vehicles poses a dilemma in
adhering to the flag requirements. Affixing flags or anything else
to the surfaces of the vehicles is not allowed by vehicle
manufacturers as it can lead to scratches and other damage to the
vehicle. Auto transporters have attempted to adhere to the intent of
the regulations by affixing flags at the end of the trailers (see
attachments). This in itself can still lead to vehicle damage by
virtue of the flag rubbing on the vehicle surface. However, this
attempt to comply with the regulatory intent does not adhere to the
letter of the regulations and has resulted in carriers receiving
numerous citations for being in violation of the flag requirements.

    The ACC states that motor vehicles are the only commodity to be
transported that must adhere to the requirements of Federal Motor
Vehicle Safety Standard (FMVSS) No. 108,

``Lamps, reflective devices and associated equipment,'' and that FMCSS
No. 108 has required motor vehicles to be equipped with side-facing
reflex reflectors in addition to amber reflectors in the front of the
vehicle and red reflectors in the rear of the vehicle since 1968. The
ACC contends that the reflective devices that are required to be on the
vehicles being transported, along with the required lighting and
conspicuity treatments on the trailer ``more than adequately adhere to
the intent of Sec. 383.87 in notifying the motoring public that a load
extends more than four feet beyond the rear of the trailer.'' In
addition, ACC states that FMVSS No. 108 imposes specific performance
criteria for the required reflectors, whereas there are no such
performance requirements for the flags required by the FMCSRs.
    The ACC states that the automobile transporter vehicle population
is a fraction of the overall CMV population, consisting of
approximately 16,000 units, and that the stinger steered vehicle
population is a subset of that. Further, ACC notes that since the
enactment of the FAST Act, the industry has not experienced an increase
in collisions into the rear end of trucks with the additional 2 feet of
allowable overhang. The ACC states that ``Statistics show that the
accident frequency of collisions into the rear end of auto transporters
is miniscule with a rate of less than 0.05%.''
    The exemption would apply to all motor carriers operating stinger
steered automobile transporter equipment. The ACC believes that the
reflex reflectors that are required to be installed on the new motor
vehicles being transported, in conjunction with the various marking and
conspicuity requirements required on the trailer transporting the new
vehicles, provide a level of safety that is greater than that achieved
by the warning flags required by the FMCSRs.

Request for Comments

    In accordance with 49 U.S.C. 31315 and 31136(e), FMCSA requests
public comment from all interested persons on ACC's application for an
exemption from 49 CFR 393.87. All comments received before the close of
business on the comment closing date indicated at the beginning of this
notice will be considered and will be available for examination in the
docket at the location listed under the ADDRESSES section of this
notice. Comments received after the comment closing date will be filed
in the public docket and will be considered to the extent practicable.
In addition to late comments, FMCSA will continue to file, in the
public docket, relevant information that becomes available after the
comment closing date. Interested persons should continue to examine the
public docket for new material.

    Issued on: February 20, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-03943 Filed 2-26-18; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 83, Number 48 (Monday, March 12, 2018)]
[Notices]
[Pages 10732-10733]
[FR Doc No: 2018-04885]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-0626]

Proprietary Names for New Animal Drugs; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry #240 entitled
``Proprietary Names for New Animal Drugs.'' This draft guidance
provides recommendations to help new animal drug sponsors develop
proprietary names for new animal drugs that do not contribute to
medication errors, negatively impact safe use of the drug, or misbrand
the drug. This draft guidance proposes a framework for evaluating
proposed proprietary names before submitting them for review by the
Center for Veterinary Medicine (CVM or we). It also explains how new
animal drug sponsors can request that CVM evaluate a proposed
proprietary name.

DATES: Submit either electronic or written comments on the draft
guidance by May 11, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2018-D-0626 for ``Proprietary Names for New Animal Drugs.''
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.
     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.gpo.gov/fdsys/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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Tom Modric, Center for Veterinary
Medicine (HFV-216), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
#240 entitled ``Proprietary Names for New Animal Drugs.'' CVM evaluates
proprietary names as a part of the new animal drug approval process.
Selecting a proprietary name is a critical element in the design and
development of drug product labeling because end users may rely, in
part, on the proprietary name to identify which product, among
thousands of available products, is intended for a given animal.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on
``Proprietary Names for New Animal Drugs.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This is not a significant
regulatory action subject to Executive Order 12866.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 514 have been approved under
OMB control numbers 0910-0032 and 0910-0699; 21 CFR part 511 have been
approved under OMB control number 0910-0117.

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or
https://www.regulations.gov.

    Dated: March 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04885 Filed 3-9-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 220 (Thursday, November 16, 2017)]
[Notices]
[Pages 53540-53542]
[FR Doc No: 2017-24783]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82051; File No. SR-BatsBYX-2017-28]

Self-Regulatory Organizations; Cboe BYX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Modify
Its Fees for Physical Ports

November 9, 2017.
    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 November 2, 2017, Cboe BYX Exchange, Inc. (``BYX'' or the
``Exchange'') (formerly known as Bats BYX Exchange, Inc.) filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II, and III below, which Items
have been prepared by the Exchange. The Exchange has designated the
proposed rule change as one establishing or changing a member due, fee,
or other charge imposed by the Exchange under Section 19(b)(3)(A)(ii)
of the Act \3\ and Rule 19b-4(f)(2) thereunder,\4\ which renders the
proposed rule change effective upon filing with the Commission. 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.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

    The Exchange filed a proposal to amend the fee schedule applicable
to Members \5\ and non-Members of the Exchange pursuant to BYX Rules
15.1(a) and (c).
---------------------------------------------------------------------------

    \5\ The term ``Member'' is defined as ``any registered broker or
dealer that has been admitted to membership in the Exchange.'' See
Exchange Rule 1.5(n).
---------------------------------------------------------------------------

    The text of the proposed rule change is available at the Exchange's
Web site at www.markets.cboe.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    A physical port is utilized by a Member or non-Member to connect to
the Exchange at the data centers where the Exchange's servers are
located. The Exchange currently maintains a presence in two third-party
data centers: (i) The primary data center where the Exchange's business
is primarily conducted on a daily basis, and (ii) a secondary data
center, which is predominantly maintained for business continuity
purposes. The Exchange currently assesses the following physical
connectivity fees for Members and non-Members on a monthly basis:
$2,000 per physical port that connects to the System \6\ via 1 gigabyte
circuit; and $6,000 per physical port that connects to the System via
10 gigabyte circuit. The Exchange proposes to increase the fee per
physical port that connects to the System via a 10 gigabyte circuit
from $6,000 per month to $7,000 per month in order to cover its
increased infrastructure costs associated with establishing physical
ports to connect to the Exchange's Systems and enable it to continue to
maintain and improve its market technology and services.\7\ The
Exchange does not propose to amend the fee for a 1 gigabyte circuit,
which will remain $2,000 per month. The Exchange

proposes to implement this amendment to its fee schedule on January 2,
2018.
---------------------------------------------------------------------------

    \6\ The term ``System'' is defined as ``the electronic
communications and trading facility designated by the Board through
which securities orders of Users are consolidated for ranking,
execution and, when applicable, routing away.'' See Exchange Rule
1.5(aa).
    \7\ The Exchange also proposes two minor technical amendments to
this section of its fee schedule. First is to change the word
``Connection'' to ``Connectivity'' in the section's title. The
second is to change references to ``G'' for gigabyte to ``Gb''.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\8\ in general, and
furthers the objectives of Section 6(b)(4),\9\ in particular, as it is
designed to provide for the equitable allocation of reasonable dues,
fees and other charges among its Members and other persons using its
facilities. The Exchange also notes that it operates in a highly-
competitive market in which market participants can readily direct
order flow to competing venues if they deem fee levels at a particular
venue to be excessive. The proposed rule change reflects a competitive
pricing structure designed to incent market participants to direct
their order flow to the Exchange.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f.
    \9\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rate is equitable and non-
discriminatory in that it applies uniformly to all Members. Members and
non-Members will continue to choose whether they want more than one
physical port and choose the method of connectivity based on their
specific needs. All Members that voluntarily select various service
options will be charged the same amount for the same services. As is
true of all physical connectivity, all Members and non-Members have the
option to select any connectivity option, and there is no
differentiation with regard to the fees charged for the service.
    The Exchange believes that the proposal represents an equitable
allocation of reasonable dues, fees, and other charges as its fees for
physical connectivity are reasonably constrained by competitive
alternatives. If a particular exchange charges excessive fees for
connectivity, affected Members and non-Members may opt to terminate
their connectivity arrangements with that exchange, and adopt a
possible range of alternative strategies, including routing to the
applicable exchange through another participant or market center or
taking that exchange's data indirectly. Accordingly, if the Exchange
charges excessive fees, it would stand to lose not only connectivity
revenues but also revenues associated with the execution of orders
routed to it, and, to the extent applicable, market data revenues. The
Exchange believes that this competitive dynamic imposes powerful
restraints on the ability of any exchange to charge unreasonable fees
for connectivity.
    Furthermore, the proposed rule change is also an equitable
allocation of reasonable dues, fees, and other charges as the Exchange
believes that the increased fees obtained will enable it to cover its
increased infrastructure costs associated with establishing physical
ports to connect to the Exchange's Systems. The additional revenue from
the increased fee will also enable the Exchange to continue to maintain
and improve its market technology and services.
    Lastly, the Exchange believes the fees and credits remain
competitive with those charged by other venues and therefore continue
to be reasonable and equitably allocated to Members. For instance, the
proposed fees for a 10 gigabyte circuit of $7,000 per month is less
than analogous fees charged by the Nasdaq Stock Market LLC (``Nasdaq'')
and NYSE Arca, Inc. (``Arca''), which range from $10,000--$15,000 per
month for 10 gigabyte circuits.\10\
---------------------------------------------------------------------------

    \10\ See Nasdaq Rule 7034(b) and the NYSE Arca fee schedule
available at https://www.nyse.com/publicdocs/nyse/markets/nyse-arca/NYSE_Arca_Marketplace_Fees.pdf (dated October 11, 2017).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. As discussed above, the
Exchange believes that fees for connectivity are constrained by the
robust competition for order flow among exchanges and non-exchange
markets. The Exchange does not believe that the proposed changes
represent a significant departure from previous pricing offered by the
Exchange or pricing offered by the Exchange's competitors.
Additionally, Members may opt to disfavor the Exchange's pricing if
they believe that alternatives offer them better value. Further,
excessive fees for connectivity would serve to impair an exchange's
ability to compete for order flow rather than burdening competition.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from Members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \11\ and paragraph (f) of Rule 19b-4
thereunder.\12\ 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.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-BatsBYX-2017-28 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-BatsBYX-2017-28. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for

inspection and copying at the principal office of the Exchange. All
comments received will be posted without change. Persons submitting
comments are cautioned that we do not redact or edit personal
identifying information from comment submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-BatsBYX-2017-28, and should
be submitted on or before December 7, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-24783 Filed 11-15-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: December 22, 2006 (Volume 71, Number 246)]
[Notices]
[Page 77017-77019]
[DOCID:fr22de06-67]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8260-2; Docket ID No. EPA-HQ-ORD-2006-0950]

Integrated Risk Information System (IRIS); Request for Chemical
Substance Nominations for 2007 Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Request for chemical substance nominations for the IRIS 2007
program.

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

SUMMARY: The Integrated Risk Information System (IRIS) is an
Environmental Protection Agency (EPA) database that contains EPA's
scientific positions on human health effects that may result from
exposure to chemical substances in the environment. EPA is soliciting
public nominations for chemical substances for its 2007 agenda. EPA
invites the public to submit nominations for substances to be
considered for an assessment or reassessment in its IRIS Program in
accordance with the instructions provided at the end of this notice.

DATES: Nominations must be submitted within 30 days of the publication
of this notice. The 30-day period begins December 22, 2006 and ends
January 22, 2007.

ADDRESSES: Nominations may be submitted electronically via
http://www.regulations.gov, by mail, by facsimile, or by hand delivery/

courier. Please follow the detailed instructions provided in the
SUPPLEMENTARY INFORMATION section of this notice.

FOR FURTHER INFORMATION CONTACT: For information on the IRIS Program,
contact Abdel Kadry, Ph.D., Program Director, National Center for
Environmental Assessment (mail code 8601D), Office of Research and
Development, U.S. Environmental Protection Agency, Washington, DC
20460, or call<PHONE_NUMBER>, or send electronic mail inquiries to:
<EMAIL_ADDRESS>For general questions about access to IRIS or the

content of IRIS, please call the IRIS Hotline at<PHONE_NUMBER> or send
electronic mail inquiries to<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    IRIS is an EPA database containing EPA consensus scientific
positions on potential adverse human health effects that might result
from exposure to chemical substances found in the environment. IRIS
currently provides information on health effects associated with more
than 500 chemical substances. The database includes chemical-specific
summaries of qualitative and quantitative health information in support
of the first two steps of the risk assessment process, i.e., hazard
identification and dose-response evaluation. Combined with specific
situational exposure assessment information, the information in IRIS
may be used as a source in evaluating potential public health risks
from environmental contaminants.
    EPA's overall process for developing IRIS assessments consists of:
(1) An annual Federal Register announcement of EPA's IRIS agenda and
call for scientific information from the public on selected chemical
substances; (2) a search of the current literature; (3) development of
draft health assessments and IRIS summaries; (4) peer review within EPA
and the Federal Government; (5) external peer review; (6) management
approval; (7) preparation of final IRIS summaries and supporting
documents; and (8) entry of summaries and supporting documents into the
IRIS database.

A. The IRIS Annual Agenda

    Each year, EPA develops a list of priority chemical substances and
an annual agenda for the IRIS Program. EPA uses the following general
criteria to set these priorities: (1) EPA statutory, regulatory, or
program-specific implementation needs; (2) potential public health
impact; (3) availability of new scientific information or methodology
that might significantly change the current IRIS information; (4)
interest to other levels of government or the public; and (5)
availability of other scientific assessment documents such that only a
modest additional effort would be needed to complete the review and
documentation for IRIS. The decision to assess any given substance
depends on available EPA resources. Timing of EPA's risk assessment
guidance, guidelines, and science policy decisions may also play a role
in deciding when the Agency has the appropriate methods to assess a
chemical substance.
    EPA continues to build and update the IRIS database by addressing
the foremost user needs, as expressed by EPA, other federal agencies,
and the public. EPA also works toward updating all assessments in the
database where new scientific information is available to do so.
    EPA is currently conducting the following 80 assessments. Unless
otherwise noted, EPA expects to assess noncancer and cancer endpoints
for each substance. For all endpoints assessed, EPA intends to develop
both qualitative and quantitative assessments if adequate data are
available to support those assessments.

------------------------------------------------------------------------
              Substance name                           CAS no.
------------------------------------------------------------------------
Acetaldehyde..............................  75-07-0
Acrolein (acute exposure duration)........  107-02-8
Acrylamide................................  79-06-1
Acrylonitrile.............................  107-13-1
Aldicarb and aldicarb sulfoxide...........  116-06-3/1646-87-3
Aldicarb sulfone..........................  1646-88-4
Arsenic, inorganic........................  7440-38-2
Asbestos (noncancer and cancer effects)...  1332-21-4

Benzene (less-than-lifetime exposure        71-43-2
 durations).
Benzo(a)pyrene............................  50-32-8
Beryllium (cancer effects)................  7440-41-7
Bromobenzene..............................  108-86-1
Butyl benzyl phthalate....................  85-68-7
Cadmium...................................  7440-43-9
Carbon tetrachloride......................  56-23-5
Cerium and compounds......................  1306-38-3
Chloroethane..............................  75-00-3
Chloroform (inhalation route).............  67-66-3
Chloroprene...............................  126-99-8
Cobalt....................................  7440-48-4
Copper....................................  7440-50-8
Dibutyl phthalate.........................  84-74-2
1,2-Dichlorobenzene.......................  95-50-1
1,3-Dichlorobenzene.......................  541-73-1
1,4-Dichlorobenzene.......................  106-46-7
cis-1,2-Dichloroethylene..................  156-59-2
trans-1,2-Dichloroethylene................  156-60-5
Di(2-ethylhexyl)adipate...................  103-23-1
Di(2-ethylhexyl) phthalate................  117-81-7
1,4-Dioxane...............................  123-91-1
Ethanol...................................  64-17-5
Ethyl tertiary-butyl ether (ETBE).........  637-92-3
Ethylbenzene..............................  100-41-4
Ethylene dichloride.......................  107-06-2
Ethylene glycol monobutyl ether (cancer     111-76-2
 effects).
Ethylene oxide (acute exposure duration)..  75-21-8
Ethylene oxide (cancer effects)...........  75-21-8
Formaldehyde..............................  50-00-0
Hexachlorobutadiene.......................  87-68-3
Hexachloro- cyclopentadiene (acute          77-47-4
 exposure duration).
Hexachloroethane..........................  67-72-1
Hexahydro-1,3,5-trinitro-triazine (RDX)...  121-82-4
2-Hexanone................................  591-78-6
Hydrogen cyanide..........................  74-90-8
Hydrogen sulfide (acute exposure duration)  7783-06-4
Isopropanol...............................  67-63-0
Kepone....................................  143-50-0
Methanol..................................  67-56-1
Methyl tertiary-butyl ether (MTBE)........  1634-04-4
Methylene chloride (dichloromethane)......  75-09-2
Mirex.....................................  2385-85-5
Naphthalene...............................  91-20-3
Nickel (soluble salts)....................  [N.A.-various]
Nitrobenzene..............................  98-95-3
PAH mixtures..............................  [N.A.-various]
Pentachlorophenol.........................  87-86-5
Perfluorooctanoic acid--ammonium salt.....  3825-26-1
Perfluorooctane sulfonate--potassium salt.  2795-39-3
Phosgene (acute exposure duration)........  75-44-5
Platinum..................................  7440-06-4
Polybrominated diphenyl ethers (PBDEs)
  -tetraBDE...............................  5436-43-1
  -pentaBDE...............................  60348-60-9
  -hexaBDE................................  68631-49-2
  -decaBDE................................  1163-19-5
Polychlorinated biphenyls (PCBs)..........  1336-36-3
Propionaldehyde...........................  123-38-6
Refractory ceramic fibers.................  [N.A.]
Styrene...................................  100-42-5
2,3,7,8-TCDD (dioxin).....................  1746-01-6
1,1,2,2-Tetrachloroethane.................  79-34-5
Tetrachloroethylene (perchloroethylene)...  127-18-4
Tetrahydrofuran...........................  109-99-9
Thallium..................................  7440-28-0
Trichloroacetic acid......................  76-03-9
1,1,1-Trichloroethane.....................  71-55-6
Trichloroethylene.........................  79-01-6
1,2,3-Trichloropropane....................  96-18-4
2,2,4-Trimethylpentane....................  540-84-1
Uranium compounds.........................  7440-61-1
Vinyl acetate.............................  108-05-4
------------------------------------------------------------------------

B. Submission of Nominations for New Assessments for the 2007 IRIS
Program

    Today's notice invites voluntary public nominations for chemical
substances not already listed in this notice. Nominations are most
useful if they identify the nominator; including full name, title,
affiliation, mailing address, e-mail address, and telephone number.

II. How to Submit Nominations to the Docket at http://www.regulations.gov

    Submit your nominations, identified by Docket ID No. EPA-HQ-ORD
2006-0950 by one of the following methods:
     http://www.regulations.gov: Follow the on-line

instructions for submitting comments.
     E-Mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460. The phone number is (202)
566-1752.
     Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, EPA West Building, Room 3334, 1301
Constitution Ave., NW., Washington, DC. The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Eastern Standard Time
(EST), Monday through Friday, excluding Federal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER>. Such deliveries
are only accepted during the docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    Consult EPA's EPA Web site at http://www.epa.gov/epahome/[fxsp0
]dockets.htm for current information on docket operations,

locations and telephone numbers.
    If you provide nominations by mail or hand delivery, please submit
one unbound original with pages numbered consecutively, and three
copies of the nominations. For attachments, provide an index, number
pages consecutively with the nominations, and submit an unbound
original and three copies.
    Instructions: Direct your nominations to Docket ID No. EPA-HQ-ORD-
2006-0950. Please ensure that your comments are submitted within the
specified nomination period. Nominations received after the closing
date will be marked ``late,'' and may only be considered if time
permits. It is EPA's policy to include all comments it receives in the
public docket without change and to make the comments available online
at http://www.regulations.gov, including any personal information

provided, unless a comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov

or e-mail. The http://www.regulations.gov Web site is an ``anonymous access''

system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
http://www.regulations.gov, your e-mail address will be automatically captured

and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket, visit
the EPA

Docket Center homepage at http://www.epa.gov/[fxsp0]epahome/

dockets.htm.
    Docket: Documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other materials,
such as copyrighted material, are publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the OEI Docket in the EPA

Headquarters Docket Center.

    Dated: December 14, 2006.
George Alapas,
Deputy Director, National Center for Environmental Assessment.
 [FR Doc. E6-21970 Filed 12-21-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 153 (Thursday, August 10, 2017)]
[Notices]
[Page 37461]
[FR Doc No: 2017-16844]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2017-0648]

Certificate of Alternative Compliance for Viking Yacht Company's
92C Enclosed Bridge Yacht, HIN: VKY92111I617

AGENCY: Coast Guard, DHS.

ACTION: Notice.

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SUMMARY: The Coast Guard announces that the District Five Prevention
Division (Dp) has issued a Certificate of Alternate Compliance (COAC)
from the International Regulations for Preventing Collisions at Sea,
1972 (72 COLREGS), for Viking Yacht Company's 92C Enclosed Bridge
yacht, HIN: VKY92111I617, as required by statue. Due to the
construction and placement of the pilothouse aft of amidships, the
vessel cannot fully comply with the masthead light provisions of the 72
COLREGS without interfering with the vessel's design and construction,
as there are no structures forward of amidships on which a masthead
light could be affixed. This notice promotes the Coast Guard's maritime
safety and stewardship missions.

ADDRESSES: Documents mentioned in the preamble are part of docket USCG-
2017-0648. To view documents mentioned in this preamble as being
available in the docket, go to the Federal eRulemaking Portal at http://www.regulations.gov, type the docket number in the ``SEARCH'' box, and
click ``SEARCH.'' Click on ``Open Docket Folder'' on the line
associated with this notice.

FOR FURTHER INFORMATION CONTACT: For further information or questions
about this notice, call or email: CDR Scott W. Muller, District Five,
Chief, Inspections and Investigations, U.S. Coast Guard; telephone:
757-398-6389, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The United States is signatory to the
International Maritime Organization's International Regulations for
Preventing Collisions at Sea, 1972 (72 COLREGS), as amended. The
special construction or purpose of some vessels makes them unable to
comply with the light, shape, and sound signal provisions of the 72
COLREGS. Under statutory law \1\ and Coast Guard regulation, \2\ a
vessel may instead meet alternative requirements and the vessel's
owner, builder, operator, or agent may apply for a COAC. For vessels of
special construction, the cognizant Coast Guard District Office
determines whether the vessel for which the COAC is sought complies as
closely as possible with the 72 COLREGS and decides whether to issue
the COAC. Once issued, a COAC remains valid until information supplied
in the COAC application or the COAC terms become inapplicable to the
vessel. Under the governing statute \3\ and regulation,\4\ the Coast
Guard must publish notice of this action.
---------------------------------------------------------------------------

    \1\ 33 U.S.C. 1605(c).
    \2\ 33 CFR 81.3.
    \3\ 33 U.S.C. 1605(c).
    \4\ 33 CFR 81.18.
---------------------------------------------------------------------------

    The Commandant, U.S. Coast Guard, hereby finds and certifies that
Viking Yacht Company's 92C Enclosed Bridge yacht, HIN: VKY92111I617, is
a vessel of special construction or purpose and that, with respect to
the position of the masthead light, it is not possible to comply fully
with the requirements of the provisions enumerated in the 72 COLREGS
without interfering with the design and construction of the vessel. The
Prevention Division, Fifth Coast Guard District, further finds and
certifies that the proposed placement of the masthead light is in the
closest possible compliance with the applicable provisions of the 72
COLREGS and that full compliance with the 72 COLREGS would not
significantly enhance the safety of the vessel's operation.
    This notice is issued under authority of 33 U.S.C. 1605(c) and 33
CFR 81.

    Dated: July 31, 2017.
Jerry R. Barnes,
Captain, Chief, Prevention Division, U. S. Coast Guard.
[FR Doc. 2017-16844 Filed 8-9-17; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 236 (Thursday, December 8, 2011)]
[Notices]
[Page 76713]
[FR Doc No: 2011-31505]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER11-4580-000]

 California Independent System Operator Corporation; Notice of
Technical Conference

    By order dated November 25, 2011, in Docket No. ER11-4580-000, the
Federal Energy Regulatory Commission (Commission) directed staff to
convene a technical conference regarding California Independent System
Operator Corporation's (CAISO) proposal to eliminate convergence
bidding at intertie scheduling points. Take notice that such conference
will be held on February 2, 2012 at the Commission's headquarters at
888 First Street NE., Washington, DC 20426, beginning at 9 a.m.
(Eastern Time) in Hearing Room 1. The technical conference will be led
by Commission staff.
    The purpose of the technical conference is to discuss the issues
raised by CAISO's proposal to eliminate convergence bidding at intertie
scheduling points. A subsequent notice detailing the topics to be
discussed and agenda will be issued in advance of the conference.
    Parties will have an opportunity to listen to the conference by
telephone. Further call-in information will be provided in a subsequent
notice.
    FERC conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an email to<EMAIL_ADDRESS>or call toll free 1 (866) 208-
3372 (voice) or<PHONE_NUMBER> (TTY); or send a fax to<PHONE_NUMBER>
with the required accommodations.
    For more information on this conference, please contact Moon Athwal
at<EMAIL_ADDRESS>or<PHONE_NUMBER>, or Colleen Farrell at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.

    Dated: December 2, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-31505 Filed 12-7-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 204 (Tuesday, October 22, 2013)]
[Notices]
[Page 62616]
[FR Doc No: 2013-24565]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER14-41-000]

RE Rosamond One LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
RE Rosamond One LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR Part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is November 5, 2013.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 16, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-24565 Filed 10-21-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 184 (Thursday, September 22, 2011)]
[Notices]
[Pages 58856-58857]
[FR Doc No: 2011-24191]

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

Office of the Secretary

Application of Jet-A, LLC for Certificate Authority

AGENCY: Department of Transportation.

ACTION: Notice of Order to Show Cause (Order 2011-9-8). Docket DOT-OST-
2010-0120.

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

SUMMARY: The Department of Transportation is directing all interested
persons to show cause why it should issue an order finding Jet-A, LLC
fit, willing, and able to operate interstate charter air transportation
of persons, property and mail, using one large aircraft.

DATES: Persons wishing to file objections should do so no later than
September 28, 2011.

ADDRESSES: Objections and answers to objections should be filed in
Docket DOT-OST-2010-0120 and addressed to U.S. Department of
Transportation, Docket Operations, (M-30, Room W12-140), 1200 New
Jersey Avenue, SE., West Building Ground Floor, Washington, DC 20590,
and should be served upon the parties listed in Attachment A to the
order.

FOR FURTHER INFORMATION CONTACT: Catherine J. O'Toole, Air Carrier
Fitness Division (X-56, Room W86-489), U.S.

Department of Transportation, 1200 New Jersey Avenue, SE., Washington,
DC 20590,<PHONE_NUMBER>.

    Dated: September 14, 2011.
Robert Letteney,
Deputy Assistant Secretary for Aviation and International Affairs.
[FR Doc. 2011-24191 Filed 9-21-11; 8:45 am]
BILLING CODE P


[Federal Register Volume 85, Number 20 (Thursday, January 30, 2020)]
[Proposed Rules]
[Pages 5346-5347]
[FR Doc No: 2020-01586]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2019-0787; Airspace Docket No. 19-ASW-11]
RIN 2120-AA66

Proposed Amendment of Class E Airspace; Sweetwater, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E airspace areas extending
upward from 700 feet or more above the surface of the earth at Avenger
Field Airport, Sweetwater, TX. The FAA is proposing this action as the
result of an airspace review caused by the decommissioning of the
Sweetwater non-directional radio beacon (NDB). The geographic
coordinates for the airport and the name of the airport would be
updated to coincide with the FAA's aeronautical database. Airspace
redesign is necessary for the safety and management of instrument
flight rules (IFR) operations at these airports.

DATES: Comments must be received on or before March 16, 2020.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590, telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2019-0787; Airspace Docket No. 19-ASW-11, at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    FAA Order 7400.11D, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11D at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Rebecca Shelby, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend Class E airspace at Avenger Field Airport, in support
of standard instrument approach procedures for IFR operations at the
airport.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views,

or arguments, as they may desire. Comments that provide the factual
basis supporting the views and suggestions presented are particularly
helpful in developing reasoned regulatory decisions on the proposal.
Comments are specifically invited on the overall regulatory,
aeronautical, economic, environmental, and energy-related aspects of
the proposal. Communications should identify both docket numbers and be
submitted in triplicate to the address listed above. Commenters wishing
the FAA to acknowledge receipt of their comments on this notice must
submit with those comments a self-addressed, stamped postcard on which
the following statement is made: ``Comments to Docket No. FAA-2019-
0787; Airspace Docket No. 19-ASW-11.'' The postcard will be date/time
stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace-amendments/">https://www.faa.gov/air_traffic/publications/airspace-amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11D, Airspace
Designations and Reporting Points, dated August 8, 2019, and effective
September 15, 2019. FAA Order 7400.11D is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11D lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by amending Class E airspace extending
upward from 700 feet above the surface within a 6.6-mile radius of the
Avenger Field Airport, Sweetwater, TX, and within 2 miles each side of
the 174[deg] bearing from the airport extending from the 6.6-mile
radius to 12.1 miles southeast of the airport, and by removing the
Sweetwater NDB and associated extension from the airspace legal
description; and removing the city associated with the airport from the
airspace legal description to comply with FAA Order 7400.2L, Procedures
for Handling Airspace Matters and updating the geographic coordinates
of the airport to coincide with the FAA's aeronautical database. This
action would enhance safety and the management of IFR operations at the
airport.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11D, dated August 8, 2019, and effective September 15,
2019, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

     Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11D,
Airspace Designations and Reporting Points, dated August 8, 2019, and
effective September 15, 2019, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward from 700
Feet or More Above the Surface of the Earth.

* * * * *

ASW TX E5 Sweetwater, TX [Amended]

Avenger Field Airport, TX
    (Lat. 32[deg]28'03'' N, long 100[deg]27'00'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of the Avenger Field Airport, and within 2
miles each side of the 174[deg] bearing from the airport extending
from the 6.6-mile radius to 12.1 miles southeast of the airport.

    Issued in Fort Worth, Texas, on January 23, 2020.
Steve Szukala,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2020-01586 Filed 1-29-20; 8:45 am]
BILLING CODE 4910-13-P