[Federal Register Volume 80, Number 218 (Thursday, November 12, 2015)]
[Notices]
[Pages 69957-69958]
[FR Doc No: 2015-28636]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER16-160-000]

New-Indy Ontario 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
New-Indy Ontario 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 24, 2015.

    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 electronic 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: November 4, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-28636 Filed 11-10-15; 8:45 am]
BILLING CODE 6717-01-P


Draft Questionnaire Content for Public Comment

Survey Overview

You will use this document to guide you through the question sequence.
You will not enter your responses in this document, the responses will
be entered in the answer key spreadsheet, which maps the question
numbers in this document to columns in the spreadsheets. After you have
reviewed your responses, you will e-mail all of your completed responses
to   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>by the specified
response deadline. This survey is divided into four parts:

Part I – Facility Level Data

Please answer these questions for the facility listed in the Section 114
letter you received in the mail. If you received more than one Section
114 letter for multiple facilities, you must create a separate survey
response for each facility.

Part II – Data from each relevant Combustion Unit*

II.A Design, Operating, Air Pollution Control Device, and Emission Data
for Small Gas-fired* Boilers or Process Heaters

Please fill out Section II.A for all boilers or process heaters that
qualify as small gas-fired* fired combustion units.

II.B Unit Design, Operation, and Air Pollution Control Data for all
other combustion units

II.C. Fuels/Materials burned in the Combustion Unit

Please fill out Sections II.B-II.C for each combustion unit that does
not qualify under section II.A or PART IV.  Sections II.B-II.C have been
designed to request answers about a particular combustion unit before
moving on to other combustion units at the facility.

II.D. Emission Data

Section II.D will collect available emissions test data, CEM data, and
Permitted and Regulatory emission limits from all combustion units that
were not eligible to complete Section II.A.  All facilities who complete
sections II.B and II.C must complete this section.

Part III – Fuel/Materials Analysis Data

Please fill out Part III for any fuel/material used in a combustion unit
at the facility other than natural gas, propane, liquefied petroleum
gas, and refinery gas.  All facilities using any fuel/material other
than natural gas, propane, liquefied petroleum gas, and refinery gas
must complete this section

Part IV – Data from each Incinerator Unit*

Please fill out Part IV if you have any incinerators* at your facility.
Otherwise you may skip this part.

________________________________________________________________________
_______________________

  SEQ CHAPTER \h \r 1 Part I:  Facility Data

1. Name of facility: ______________________________

2. Complete street address of facility (physical location):

	a. Address _____________

	b. City    _____________

	c. State  _____________

	d. Zip	   _____________

	e. County  _____________

3.  Facility contact

a. Name (First Name, Last Name): _________________________

b. Title: _____________________________

c. Telephone number: (____) ______________________ ext. ___

	d. Fax number: (____) ______________________

e. E-mail: _________________________

4.  If not the same as question #1, provide legal name of the owner of
this facility:  _____________________

5. Is the owner of this facility a private enterprise, not-for-profit,
or a public sector entity? (select one)

	() private enterprise

 	() not-for-profit

() public sector

6.. Is your facility a major source* of HAP? (Y/N)

7.  Size of entity

a. If private company owns facility:

a1.  Please enter the approximate number of employees of the business
enterprise that owns this facility, including where applicable, the
parent company and all subsidiaries, branches, and unrelated
establishments owned by the parent company:

(select from list)

a2  Please enter the number of facility employees: (select from list)

b. If public sector owns facility:

b1. What is the population of the local government entity (city, county,
town, school district, special district) that owns the facility?
________________

8. Is the legal owner a small entity* as defined by the Regulatory
Flexibility Act? (select one)

___ Yes

 ___No

 ___Don’t know

9.  Select facility’s primary NAICS. The primary NAICS code represents
the line of business that generates the most income for the facility:
(select from list of 3-digit NAICS codes)

10  SEQ CHAPTER \h \r 1 . Do any combustion units at your facility fire
any non-fossil or other* fuels/materials? (Y/N) If no skip questions 11
and 12.

11. If the unit were to stop burning non-fossil or other* material in
your combustion unit(s), what would happen to the material? (Please
answer questions 11 and 12 separately for each non-fossil fuel burned)

(a) Select non-fossil fuel from list

(b) Check corresponding alternative disposal method(s).

() Send to a landfill off-site

() Dispose on-site

() Dispose through local trash collection

() Vent to atmosphere

() Send to waste water treatment plant

() Contract for special disposal service

() Sell as a product

() Sell it to another facility as a fuel (off-site incineration)

() Stop purchasing material from 3rd Party

() Don’t know

() No other alternative currently available

() Other: _________________________________________________

12  SEQ CHAPTER \h \r 1 .	If the unit were to stop burning this
non-fossil or other* fuel/material in your combustion unit(s), how would
you compensate for the lost heating value?

(a) Select non-fossil fuel from list

(b) Check corresponding compensation for lost heating value.

() burn a fossil fuel such as coal, oil, or gas in the same units

() buy new equipment capable of burning another fuel

() not applicable, material has no heating value

() purchase steam from another nearby facility

(c)  Would your combustion units likely stop combusting these non-fossil
or other materials if continuing to burn these materials would result in
the unit being subject to 129 instead of 112? (Y/N)

If you fire more than one type of non-fossil or other* fuel/material at
your facility, repeat questions 11 and 12 for each non-fossil or other*
fuel/material.

13. What additional annualized costs would you incur to comply with
Section 129 CISWI rule (40 CFR Part 60 Subpart CCCC) as compared to the
vacated Boiler MACT? (Check appropriate cost range, and provide note on
cost components evaluated).

a.             () $0 to $50,000  (

() $50,001 to $100,000

() $100,001 to $500,000

() $500,001 to $1,000,000

() >$1,000,000

b.               Indicate the cost components evaluated in your cost
estimate above:
__________________________________________________________________

II.A Design, Operation, Air Pollution Control Device, and Emission Data
for Small Gas-Fired* Boilers or Process Heaters

Please provide a brief inventory of each similar group of small natural
gas fired boilers:

Enter the number of natural-gas fired boilers less than or equal to 10
million Btu/hr (mmBtu/hr) design capacity? _____

Please classify any tune-up practices performed on this group of boilers
along with the corresponding frequency (i.e., daily, monthly, quarterly,
semiannually, annually, every two years, every five years or longer).
Tune-up practices include activities that involve checking the unit’s
combustion processes and adjusting as needed:

() using the scheduled tune-up and procedures provided by the boiler
manufacturer

() Inspection and cleaning, as necessary, of fireside and water-side
surfaces.

() Inspecting, cleaning and/or reconditioning of fuel systems.

() Checking all electrical and combustion control systems.

() Testing of exhaust gases (CO, CO2, other) as necessary to calculate
combustion efficiency and make necessary adjustments to the combustion
system. If this option is checked, indicate what level the CO is
adjusted to: _______________

() Inspection and repair of all valves (relief, safety, hydraulic,
pneumatic, etc.).

() Inspection and repair of refractories.

() Cleaning and inspecting fan housing, blades, and inlet screens.

() Cleaning/reconditioning and inspecting the feedwater system.

Please classify any good combustion practices performed on this group of
boilers, along with the corresponding frequency (i.e., daily, monthly,
quarterly, semiannually, annually, every two years, every five years or
longer) of each practice:

() Using up to date operating procedures, training, recordkeeping

() Maintenance knowledge (including training on applicable equipment and
procedures)

() Maintenance practices including maintenance procedures and
recordkeeping

() Fuel/air ratio periodic checks

() Automatic O2/CO trim control systems

() Monitoring furnace residence time and temperature

() Fuel quality and proper fuel handling (including monitoring quality,
periodic sampling and analysis, fuel supplier certification, if used)

() Proper fuel distribution in the combustion zone

() Combustion air distribution based on observations with periodic or
continuous adjustments

() Low NOx burners

If any of these boilers are subject to a CO limit, please provide the
numerical limit with units.

CO numerical limit _________

Fuel associated with numerical limit (select from list)_ _______

Corresponding Averaging Time (i.e., 30-day rolling average, hourly,
other) for CO limit: ______

Corresponding O2 concentration (if applicable) ____

Corresponding CO2 concentration (if applicable)____

CO limit units ______

Please provide a brief inventory of each similar group of small natural
gas fired process heaters:

Enter the number of natural-gas fired process heaters less than or equal
to 10 million Btu/hr (mmBtu/hr) design capacity? _____

Please classify any tune-up practices performed on this group of process
heaters along with the corresponding frequency (i.e., daily, monthly,
quarterly, semiannually, annually, every two years, every five years or
longer). Tune-up practices include activities that involve checking the
unit’s combustion processes and adjusting as needed:

() using the scheduled tune-up and procedures provided by the boiler
manufacturer

() Inspection and cleaning, as necessary, of fireside and water-side
surfaces.

() Inspecting, cleaning and/or reconditioning of fuel systems.

() Checking all electrical and combustion control systems.

() Testing of exhaust gases (CO, CO2, other) as necessary to calculate
combustion efficiency and make necessary adjustments to the combustion
system. If this option is checked, indicate what level the CO is
adjusted to: _______________

() Inspection and repair of all valves (relief, safety, hydraulic,
pneumatic, etc.).

() Inspection and repair of refractories.

() Cleaning and inspecting fan housing, blades, and inlet screens.

() Cleaning/reconditioning and inspecting the feedwater system.

Please classify any good combustion practices performed on this group of
process heaters, along with the corresponding frequency (i.e., daily,
monthly, quarterly, semiannually, annually, every two years, every five
years or longer) of each practice:

() Using up to date operating procedures, training, recordkeeping

() Maintenance knowledge (including training on applicable equipment and
procedures)

() Maintenance practices including maintenance procedures and
recordkeeping

() Fuel/air ratio periodic checks

() Automatic O2/CO trim control systems

() Monitoring furnace residence time and temperature

() Fuel quality and proper fuel handling (including monitoring quality,
periodic sampling and analysis, fuel supplier certification, if used)

() Proper fuel distribution in the combustion zone

() Combustion air distribution based on observations with periodic or
continuous adjustments

() Low NOx burners

If any of these process heaters are subject to a CO limit, please
provide the numerical limit with units.

CO numerical limit _________

Fuel associated with numerical limit (select from list_ _______

Corresponding Averaging Time (i.e., 30-day rolling average, hourly,
other) for CO limit: ______

Corresponding O2 concentration (if applicable) ____

Corresponding CO2 concentration (if applicable)____

CO limit units ______

2. For each small gas-fired* combustion unit, provide the results of the
most recent stack test data for each of the pollutants listed in the
emission test spreadsheet by completing the spreadsheet linked below.
EPA is not requesting actual test reports at this time; however we
reserve the right to request actual copies in the future.  EPA will also
accept other supporting emission test data to document any earlier   SEQ
CHAPTER \h \r 1 emission tests on the unit with similar controls and
fuels.  You may also submit a spreadsheet of any other information
available relative to trials or tests of emission control methods or R&D
efforts.  The Agency is requesting these data only as they may already
be available; no additional sampling or analyses are required to provide
these data. [INSERT LINK to NATURAL GAS EMISSIONS TEST SPREADSHEET]

Provide the daily averages of continuous emissions monitor (CEM) data
for CO, O2, CO2, if available for the most recent 30 days of operation,
and the highest single data point within the most recent calendar year
of CEM data.  You should exclude data from the averages if they are from
periods of start-up, shutdown, or malfunctions. You can submit this data
by completing the CEM data spreadsheet linked below. [INSERT LINK to
NATURAL GAS CEM TEST SPREADSHEET]

Do you have any non-natural gas fired combustion units at your facility?
Y/N

If no, you are done with the survey. Please review your answers and
submit your response to EPA by the deadline listed in the Section 114
letter.

  SEQ CHAPTER \h \r 1 Part II.B Unit Design, Operation, and Air
Pollution Control Device Data for non-natural gas* boilers and process
heaters

1. General Information

Facility Name: (pass through data from Part I)

Combustion device ID:_____

Year built: _______

Design capacity (heat input) value: _______

Fuel type associated with design capacity (heat input) value (select
from list): _____

Design capacity units (select one): (insert list)

Furnace heat release rate (Btu/ ft3): ________

Is unit subject to NSPS? Yes/No

If you indicated yes to question g, indicate the year of NSPS:

()1971

()1984/1986

()1989

() 1997

() 2006

Primary combustion device use (check all that apply):

() steam generation

() space heat

() process heat

() electricity generation

() waste incineration

() cogeneration

() Other (please explain): _______________________

        j.	Additional combustion device uses (select all that apply):

() steam generation

() space heat

() process heat

() electricity generation

() waste incineration

() cogeneration

() Other (please explain): _______________________

        k.	For boilers only, check all that apply (several may apply to
your unit):

	k.1 Erection Design

 () Package (shop erected)

() Field Erected

() Modular (part shop erected and part field erected)

k.2 Unit Design

 () Water tube

() Fire tube

() Hybrid  (if hybrid is selected, check the appropriate subtype)

	() main combustion zone design is watertube

() main combustion zone design is firetube

k.3 Suspension Firing

 () tangential

 ()  wall-fired

 ()  combination of suspension firing and grate firing (i.e., oil and
bark)

 () other (please explain)

l. For solid-fuel* boilers only, check all that apply (several may apply
to your unit):

( ) Stoker

  () spreader

  () mass feed

  () manual feed

  () other (please specify): _________

() Fluidized Bed

   () circulating

   () bubbling

() Pulverized Coal

() Cyclone

() Other

    () fuel cells

    () suspension burners

    () sloped-grate

    () dutch oven

    () gasifier

    () other not listed (please specify): _________

m.  For process heaters only, check all that apply:

( ) Erection Design

 () Package (shop erected)

() Field Erected

( ) Unit Design

 () Fire tube

() Water tube

()Thermal oil heaters

() Other (please explain): _____________

() Draft Configuration

() natural draft

() forced draft

2.  Operating Parameters

a.  Hours of Operation (hr/yr)

	Typical: _________

b. Duty Cycle: (select one)

() base-loaded

() load following

() stand-by

c. Is the operation seasonal*? Y/N

3.   Air Pollution Control

You will first be asked to list all add-on control devices, in the order
contacted by the exhaust, and then you will be asked to identify good
combustion practices used, followed by combustion controls.  Specify the
control device type using the descriptions provided in the drop-down
menus.

a1.  Control device currently installed (select from list)

a2.  Year control device installed:

a3. Has an upgrade/modification been made to the control device since it
was installed? Y/N

a4. Was an upgrade/modification/installation / replacement of the
control device in a1 made to comply with 40 CFR 63 Subpart DDDDD? Y/N
(skip to a9 if no)

a5. If yes to question a4 above, please provide the month and year that
the upgrade/modification/replacement to the control device was made
(mm/yyyy): ______

a6. If yes to a4, what was the control device prior to complying with 40
CFR 63 Subpart DDDDD? (select from list)

a7. If yes to a4, provide the date when the control device selected in
a6 was installed or last upgraded/modified (whichever date is most
recent)? (year)____

a8. If yes to a4, was the prior control device removed or added to in
order to comply with DDDDD?

    () removed

    () added to

a9. Is the control device used as a common control device for more than
one combustion unit?

() Not common

() Common, list names of units affected by this control in comments
section below: ___________

Below is an example table from the answer key for how one might answer
questions a1-a9 on the control devices installed on a particular
combustion unit. In this case, a fabric filter was replaced an existing
ESP to comply with the vacated DDDDD standard, and a venturi scrubber
was installed in 1992. The fabric filter is a common control device
shared with two engines.

Example

Answer Only if a4 was ‘Yes’

	a1.

	a2.

	a3.

	a4. 	a5.	a6.	a7. 	a8.	a9.

Fabric Filter	2005	N	Y	2005	ESP	1988	Removed	Two reciprocating engines

Venturi Scrubber	1992	N	Y

	Not Common

b. Is oxygen or carbon monoxide used for boiler/process heater
combustion air trim control? (select one)

() oxygen

() carbon monoxide

() neither

Please classify any tune-up practices performed on this combustion unit
along with the corresponding frequency (i.e., daily, monthly, quarterly,
semiannually, annually, every two years, every five years or longer).
Tune-up practices include activities that involve checking the unit’s
combustion processes and adjusting as needed:

() using the scheduled tune-up and procedures provided by the boiler
manufacturer

() Inspection and cleaning, as necessary, of fire-side and water-side
surfaces.

() Inspecting, cleaning and/or reconditioning of fuel systems.

() Checking all electrical and combustion control systems.

() Testing of exhaust gases (CO, CO2, other) as necessary to calculate
combustion efficiency and make necessary adjustments to the combustion
system. Indicate what level the CO is adjusted to: _______________

() Inspection and repair of all valves (relief, safety, hydraulic,
pneumatic, etc.).

() Inspection and repair of refractories.

() Cleaning and inspecting fan housing, blades, and inlet screens.

() Cleaning/reconditioning and inspecting the feedwater system.

Please classify any good combustion practices performed on this
combustion unit, along with the corresponding frequency (i.e., daily,
monthly, quarterly, semiannually, annually, every two years, every five
years or longer) of each practice:

() Using up to date operating procedures, training, recordkeeping

() Maintenance knowledge (including training on applicable equipment and
procedures)

() Maintenance practices including maintenance procedures and
recordkeeping

() Fuel/air ratio periodic checks

() Automatic O2/CO trim control systems

() Monitoring furnace residence time and temperature

() Fuel quality and proper fuel handling (including monitoring quality,
periodic sampling and analysis, fuel supplier certification, if used)

() Proper liquid atomization

() Proper fuel distribution in the combustion zone

() Combustion air distribution based on observations with periodic or
continuous adjustments

() fly ash reinjection

() combustion of drier fuel

() better fuel distribution in firebox

() co-firing

() low NOx burners

4. Stack

a. Does combustion unit emit through its own stack? (Y/N) (If no, answer
question b below)

b. List quantity and category of all other combustion units venting to
this common stack: (example: 2 coal fired boilers venting to common
stack)

 _____________________________________

Part II.C Fuels/Materials burned in the Combustion Unit

You will be asked to enter each fuel/material combusted in the
combustion unit in the following order:

Start-up* fuel/material

Individual and co-fired fuels/material combusted during normal operation

Additional fuels/materials combusted on an intermittent basis

Additional Fuels/Materials that are not routinely combusted

Facility Name:  (pass through facility name on each page)      Combustor
ID: (pass through combustor ID on each page)

1. If start-up* fuel is different than normal fuel, please answer
question 1 parts a, b, and c, otherwise proceed to question 2:

a. Select fuel/material from drop-down menu (if other is selected on
drop-down menu provide a space to explain other)

b. Number of start-ups per year ________

c. Typical length of time for start-up (hours) _______

2.  Fuels/Materials Combusted During Normal Operation:

Please complete the table below in the answer key for each fuel stream
combination fired in the combustion unit. A new fuel stream combination
ID should be entered when there is a change in the types of fuels that
make up the fuel stream. A new fuel stream ID should not be entered when
there is a variation in the feed rates of different fuels that make up
the fuel stream. The variation among individual fuel feed rates is
captured by providing the maximum and annual or season average for a
combination of fuel types.  In the example below, this boiler has two
fuel combinations: 2,500 hours per year the boiler fires a combination
of bituminous coal, switchgrass, and #2 fuel oil. The switchgrass is
fired seasonally, and when it is no longer fired, the boiler operates at
a lower rate using bituminous coal and #2 fuel oil.

Fuel Stream Combination ID	Fuel/Material	Is fuel/material fed directly
to combustion unit or fed to a gasifier located upstream (G)	Is this
fuel/material used seasonally (S)* or annually (A)?	Hours used per year
Heat Input

(mmBtu/hr)	Permitted Limit

Question

2a	2b	2c	2d	2e	Max

2f	Annual or Seasonal Average*

2g	Design Capacity

2h	Value

2i	Units

2j

Example:

	1	Bituminous Coal	B	A	2500	100	80	200	100	ton/day

1	#2 Fuel Oil	B	A	2500	30	25	100	25	Gallons per minute

1	Switchgrass 	B	S	2500	100	75	150	175	ton/day

2	Bituminous Coal	B	A	5900	150	100	200	100	ton/day

2	#2 Fuel Oil	B	A	5900	30	25	100	25	Gallons per minute

3.   Fuels/Materials NOT Routinely Combusted

Please complete the table below in the answer key. This table is similar
to question 2 above, however it applies to fuels/materials NOT routinely
fired in the combustion unit. An example response is shown below.

Fuel Stream Combination ID	Fuel/Material	Is fuel/material fed directly
to combustion unit or fed to a gasifier located upstream (G)	Describe
Conditions for Fuel Use	Hours used per year	Heat Input

(mmBtu/hr)	Permitted Limit

3a.	3b.	3c.	3d.	3e.	Max

3f.	Annual or Seasonal Average*

3g.	Design Capacity

3h..	Value

3i.	Units

3j.

Example:

	1	Wood: Pellets	B	Switchgrass unavailable during seasonal operation
200	100	80	150	120	ton/day

4. Do you have an emission test report available for this unit? (EPA is
not requesting actual test reports at this time; however we reserve the
right to request actual copies in the future.)  Y/N

5. If yes to question 5 above, please list where the available test
report occured:

	() dedicated control device, dedicated stack

	() common control device, dedicated stack

() dedicated control device, common stack

() common control device, common stack

6.  Do you have another combustion unit you need to add to this survey?
Y/N  (If Yes, re-start at part II.B, otherwise proceed to part II.D)

Part II.D Emission Data from Combustion Device

Provide the results of the most recent stack test data for each of the
pollutants listed in the emission test spreadsheet by completing and
e-mailing the Excel spreadsheet linked below to   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>.  EPA is not requesting actual test
reports at this time; however we reserve the right to request actual
copies in the future.  EPA will also accept other supporting emission
test data to document any earlier   SEQ CHAPTER \h \r 1 emission tests
on the unit with similar controls and fuels.  You may also submit a
spreadsheet of any other information available relative to trials or
tests of emission control methods or R&D efforts.  The Agency is
requesting these data only as they may already be available; no
additional sampling or analyses are required to provide these data.
[INSERT LINK to EMISSIONS TEST SPREADSHEET]

Provide the daily averages of continuous emissions monitor (CEM) data
for NOx, SO2, CO, O2, CO2, and opacity, if available for the most recent
30 days of operation, and the highest single data point within the most
recent calendar year of CEM data.  You should exclude data from the
averages if they are from periods of start-up, shutdown, or
malfunctions. You can submit this data by completing the CEM data
spreadsheet and e-mailing it to<EMAIL_ADDRESS>[INSERT LINK to CEM TEST
SPREADSHEET]

Provide a summary of permitted or regulatory emission limits, if
applicable to your unit for each pollutant listed in the Permitted and
Regulatory Emission Limit Worksheet. If the unit does not have a limit
for a given unit, you may leave this entry blank. You can submit this
data by completing the permitted and regulatory spreadsheet and
e-mailing it to<EMAIL_ADDRESS>[INSERT LINK to PERMITTED REGULATORY LIMIT
SPREADSHEET]

Part III: Fuel/Material Data

If available, provide the results of the most recent fuel/materials
analysis for all fuels and materials (excluding natural gas) combusted
on-site in combustion units. Use the fuel categories from the list
below, when available. Select the ‘other’ fuel description only if
the fuel burned at this unit is not on the list. If ‘other’ is
selected please provide a brief name for this fuel.  Select the most
descriptive name as possible.  For example, "landfill gas (LFG)" is more
useful than "waste-gas"; "bituminous coal" or "anthracite coal" is more
useful than "coal".

Please e-mail an electronic copy of the fuel analysis to   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>. The fuel analysis should be
formatted according to the linked Excel spreadsheet below. Please
identify the fuel name, facility name, and combustor ID consistently
with how you answered Parts I and II.  You may also provide a summary of
any earlier fuel analyses, as long as these are representative of
fuels/materials still used in the boiler/process heater.

Facility Name:  (pass through facility name on each page)

1. Fuel/Material Description (select from list and be consistent with
selections made in Section II.B. Question 2)

2. Where does fuel/material originate?

() On-site*

() Off-site

() Both (i.e., some bark from on-site combined with some bark generated
off-site)

3. Is fuel/material analysis available? (Y/N)

If you have a fuel/material analysis available, please complete the Fuel
Analysis Excel spreadsheet to   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>for each individual fuel.

4. Do any of your boilers burn another fuel/material? Y/N

If yes, repeat questions 1-3 for each fuel/material combusted in a
process heater or boiler.

Part IV – Data from each Incinerator Unit*

Complete this section for each incinerator* at your facility. If you do
not have any incinerators at your facility, you are done with the
survey. Please review your answers and submit your response to EPA by
the deadline listed in the Section 114 letter.

1. Unit-Data

a.     Combustion device ID: ______

b.    Unit Design Information (check all that apply):

() single batch fed

() starved air

() fixed hearth

() rotary hearth

() intermittent batch fed

() excess air

() rotary kiln

() moving grate

() continuously fed

() single chamber

() multi-chamber/afterburner

() spreader stoker

() other:

c.  Manufacturer:
____________________________________________________________

d.  Model Number:
___________________________________________________________

e.  Installation Date:
_________________________________________________________

f.  Dates/descriptions of major renovations:
_______________________________________

g. Design Capacity (tons waste per day):
__________________________________________

h1. Typical Hours Operated, Per Year:  _________________

h2. Per day:  ___________________

2.  Air Pollution Control Device and Equipment Modifications Information

Repeat this section for each control device or equipment modification
made to the incinerator.

(a)  Is your incinerator equipped with an air pollution control device
(e.g. wet scrubber, fabric filter, electrostatic precipitator)?  If yes,
please specify the type and provide any details as specified below for
each control device:

a1. Type:
___________________________________________________________________

a2. Year Installed:
____________________________________________________________

a3. Manufacturer:
_____________________________________________________________

a4. Model No.:
_______________________________________________________________

	a5. Percent of incinerator operating time that control device is
operated:  _________________ %

	a6. Control device air flow capacity (typically in acfm):
______________________________

	a7. Date control device(s) were last modified, repaired, or rebuilt:
______________________

	a8. Annual hours of control device downtime for repairs and
maintenance:  _______________

a9. Is control device shared with other equipment? (Y/N) If yes, please
identify the other equipment that is routed to the same control device:
________________________________________________________________________
___

b1. What were the installed capital costs of the control device? ($,
year)____________________

b2. What are the annual operating costs?($,
year)___________________________________

(c)  If your unit is equipped with a control device, please list the
applicable operating parameters:  c1. Wet scrubber pressure drop (in.
H2O):  ___________

  	c2. Fabric filter air-to-cloth ratio:  __________________

	c3. Other:  _____________________________________

c.  If you have made modifications to the incinerator(s) to reduce
emissions:

c1. When were the modifications
made?_______________________________________

		c2. Briefly describe the type of
modifications?_________________________________

c3. Do you have information on the costs of the modifications? Y/N
_________

 (If you answered “Yes”, please attach copy of cost information)

3. Waste Segregation or Recycling Practices

a.  Does the facility currently employ waste segregation or recycling
practices that reduce the volume of waste being incinerated? Y/N (if no,
skip to question 4)

b.  When were waste segregation practices begun? (month, year)
____________________________

c.  What types of materials are segregated from the waste stream?
(please check all that apply)

() paper/cardboard

() glass

() plastics

() batteries

() fluorescent light bulbs

() other metal containing materials (please list)

____________________________________

() other chlorine containing materials (please list)

__________________________________

() other (please list)

__________________________________

d.  What is done with the materials that are segregated from the waste
stream?
________________________________________________________________________
__

e.  Estimate the current cost of your waste segregation/recycling
program (please indicate whether cost estimate is on an annual basis,
monthly basis, or other).

________________________________________________________________________
__

f.  Do you have any emissions test data that would show the effects of
segregating materials from the waste stream (e.g., test data before and
after waste segregation practices began)?  Y/N

If yes, please attach complete copies of the test reports and any
analyses of the impact of waste segregation on emissions.

4. Emission Test Data

a.   Has emissions testing ever been conducted on this unit(s): Y/N
_______

b.   If so, please provide complete copies of the test reports that
document all emission testing that has been conducted in the last 10
years.  You may provide electronic versions of the test reports in lieu
of attaching paper copies.

5. Do you have another incinerator unit you need to add to this survey?
Y/N  (If Yes, repeat part IV for another unit. Otherwise you are done
with the survey. Please review your answers and submit your response to
EPA by the deadline listed in the Section 114 letter).

Draft Definitions for Questionnaire

Definitions:

1. For purposes of this survey, combustion units are the following
devices:

Boiler means an enclosed device using controlled flame combustion and
having the primary purpose of recovering thermal energy in the form of
steam or hot water. Waste heat boilers are excluded from this
definition.

Process heater means an enclosed device using controlled flame, that is
not a boiler, and the unit’s primary purpose is to transfer heat
indirectly to a process material (liquid, gas, or solid) or to a heat
transfer material for use in a process unit, instead of generating
steam. Process heaters are devices in which the combustion gases do not
directly come into contact with process materials. Process heaters do
not include units used for comfort heat or space heat, food preparation
for on-site consumption, or autoclaves.

Any other combustion unit combusting non-fossil fuel/material whether
covered under another MACT standard or not.

Incinerator refers to a combustion unit with the primary purpose of
destroying matter and/or reducing the volume of the materials and is
neither a boiler or process heater.

2. Small gas-fired boilers or process heaters mean boilers or process
heaters that have a heat input capacity less than 10 mmBtu/hr that: (1)
burn natural gas, propane, liquefied petroleum gas (LPG), or refinery
gas not combined with any other fuels; (2) if a unit burns distillate
liquid fuel only during periods of gas curtailment, gas supply
emergencies, or for periodic testing of liquid fuel and the periodic
testing of liquid fuel does not to exceed a combined total of 48 hours
during any calendar year, this unit is still a gas-fired boiler for the
purpose of this survey.

3. On-site means the fuel/material generated from a process located at
the facility.  Off-site means either a raw material or other material
generated from a process not located at the same facility as the
combustion unit.

4. Major sources are those plant sites with the potential to emit 10
tons per year (tpy) of any one hazardous air pollutant (HAP) or 25 tpy
of a combination of HAPs.  Section 112(b) of the Clean Air Act
Amendments contains the list of HAPs.

5. Small Entity is defined as follows:

(1) for  Private Businesses it is determined for each NAICS of the
owning entity based on number of employees and/or company revenue.
Please see   HYPERLINK
"http://www.sba.gov/idc/groups/public/documents/sba_homepage/serv_sstd_t
ablepdf.pdf"
http://www.sba.gov/idc/groups/public/documents/sba_homepage/serv_sstd_ta
blepdf.pdf  to evaluate the small entity status of your facility;

(2) for local government entities, such as a city, county, town, school
district or special district with a population of less than 50,000; and

(3) for not-for-profits an organization that is independently owned and
operated and is not dominant in its field.

6. Solid fuel fired units are any boilers or process heaters that fire
solid fuel alone or in conjunction with other fuel types

7. Seasonal operation indicates an operating pattern that varies heat
input demand depending on time of year, but follows the same pattern
annually.

8. Seasonal average is the mean value of number (emission rate or
operating parameter) over an entire operating season.  For example, if
bagasse is fired 120 days per year, 24 hours per day, the seasonal
average heat input rate would be the average of all the heat input rates
during the 120 day period.

9. Start-up means the setting in operation of an affected combustion
unit for any purpose. Start-up fuel does not apply to stabilization
fuels. You should include stabilization fuels as part of your response
to questions II.C.2 and II.C.3.

10. Non-fossil or other fuel/material is defined as any material that is
not coal, fuel oil, or natural gas, or derived from coal (i.e., waste
coal, coal refuse (culm, gob, coal tar), oil, or natural gas.  For
illustrative purposes only, EPA has provided a detailed (though not
extensive) list of non-fossil fuels. This definition or list does not
represent or imply any regulatory definition of non-fossil fuel.

Non-Fossil Fuel/Material

Acetone: New and Used Solvent	Glycerol Distillation Byproduct	Red oil
(steam stripper steam condensate, incl terpenes, terpenoids, methanol,
TRS)

Agricultural Residue	Hardboard Dust	Refuse

Agricultural Residue: Corn Fiber	Hardboard Residues	Refuse derived fuel
(RDF)

Agricultural Residue: Corn Gluten Feed	Heavy Recycle	Reinjection char

Agricultural Residue: Corn Mill Dryer Off-gas	High Caustic Fuel
Reprocessed oil

Agricultural Residue: Corn Starch Residue	Hog fuel: Hardwood	Resin Solid

Agricultural Residue: Corn Stover	Hog fuel: Softwood	Restaurant oils &
greases

Agricultural Residue: Cotton And Corn	Hog fuel: Urban	Sander Dust

Agricultural Residue: Cotton Gin Residue	Hydro Pulper Refuse	Sawdust

Agricultural Residue: Cotton Stalks	Industrial Plastics	Sawmill scrap

Agricultural Residue: Cottonseed Hulls	Ink Solvents	Scrap X-Ray Film

Agriculture Residue: Almond Shells	Knots and Knotter Rejects	Screen
rejects

Agriculture Residue: Almond Tree Prunings	Laminate Production Scrap Dust
Sewage gas

Agriculture Residue: Barley dust and chaff	Lamination Finishing Plant
Residue	Sewage Sludge

Agriculture Residue: Barley Needles	Lamination Plant Residue	Shredded
cloth

Agriculture Residue: Fruit Pits	Landfill Gas	Silvicultural wood

Agriculture Residue: Nut Shells	Latex Paint Water	Sludge

Agriculture Residue: Oat Hulls	Light weight Asphalt	Solid paraffin

Agriculture Residue: Olive cake	Lignin	Solvents

Agriculture Residue: Olive kernel	Liquefied Chicken Fat	Spent Coffee
Grounds

Agriculture Residue: Orchard Prunings	Log yard Cleanup	Spent Oxide

Agriculture Residue: Pecan hulls	Low carbonate corn fiber (LCCF)
Stripper condensate

Agriculture Residue: Post harvest biomass residues	Lumber Refuse (hogged
pallet boards/other non-treated scrap)	Sulfur Free Organic Byproduct

Agriculture Residue: Rice Hulls	Malt Sprouts	Sunwax- Diatomaceous earth
with sunflower oil wax

Agriculture Residue: Soybean Hulls	Manure	Tall oil, tall oil derivatives

Agriculture Residue: Straw	Manure, bedding and yard residues	Tallow

Agriculture Residue: Straw	Mechanical Pulp Mill Rejects	Tar

Agriculture Residue: Sunflower Hulls	Medium Density Fiber Board Sander
Dust	Tire Chips

Agriculture Residue: Sunflower husks	Medium Density Fiber Board Trim
(some with water based primer)	Tire Derived Fuel (TDF)

Agriculture Residue: Sunflower Pellets	Mill feed	Tires (whole)

Agriculture Residue: Switchgrass	Mill trash	Toluene

Agriculture Residue: Wheat fiber (WF)	Mixed liquid residues	Toluene

Alcohol: Ethanol	Mixed wood residues	Turkey brood woodwaste

Alcohol: Solvent	Neutralene	Turpentine

Animal Fats	Noncondensable Gas (includes stripper offgas)	Used Alcohol

Bagasse	Nonhalogenated Solvent	Used #6 Oil

Bio liquids	Nonhazardous byproduct solvent	Used Gear Oil

Biogas (Excluding Sewage Sludge)	Oil Booms	Used hydraulic oil

Biomass	Oil Residues/excesses/byproducts -- #6, asphalts	Used Lube Oil

Bitumen	Oil Seed (Rape, Canola, Corn, Beans)	Used Motor Oil

Black Liquor	Oil Spill cleanup Residues	Used Oil

Blast Furnace Gas	Oily rags	Used thermal oil

Blond Fiber	Old Corrugate Cardboard (OCC) scraps	Vegetable oil

Boiler ash	Old corrugated container rejects	Virgin Hydraulic Scrap

Cardboard	Oriented strand board trim/dry residuals	Waste Derived Liquid
Fuel

Carpet Scrap	Other biomass	Wastewater Treatment Residuals

Char	Other: Please Explain	Wax and cellophane wrapper and packaging
trimmings

Coal Tar Oil	Paint Rags	Wood

Coal Tar plus soil	Paint residues	Wood: Bark

Coating Residues	Palm oil plantation byproducts (palm kernel exfoliate,
fiber, shell, EFB)	Wood: Briquettes

Coating Sludge	Paper	Wood: char

Coke Oven Gas	Paper broke	Wood: Chips

Composite Water	Paper Byproducts: knots and paper fines	Wood: chips- old

Compressed Paper	Paper cores	Wood: Hardwood chipping and residues

Construction/Demolition Derived Material	Paper- office waste	Wood:
Hardwood pellets (hammer-milled, dried, pelletized - sold as fuel)

Cotton Stalks	Paper wrapper and packaging trimmings	Wood: Hogged Bark

Crankcase Oil	Particle Board sander dust	Wood: Laminated

Deinking residuals	Particle Board trim	Wood: Mixed

Dewatered combustible residues	Paunch Manure	Wood: Pallets

Diaper scraps	Peat	Wood: Pellets

Digester Gas	Petroleum Distillation Solvent	Wood: Pitch

Distiller Grains (DG)	Petroleum Refining Scrap Oil	Wood: Pitch/wood
waste

Distiller Grains Stillage (DGS)	Pine tar	Wood: Plywood trim

Distiller Wet Grains (DWG)	Poultry litter	Wood: Shavings

Dried Distiller Grains with Solubles (DDGs)	Process derived liquid fuel
Wood: Silvicultural

Dry Distiller Grains (DDG)	Process Gas	Wood: unadulterated hardwood

Engineered Wood Plant Scrap	Pulp liquor	Wood: unadulterated softwood

Envirofuel Pellets	Pulp Mill Gas	Wood: waste-clean

Filters	Railroad Ties	Wood: Whole Tree Chips

Foam Residues	Railroad Ties Chipped	Wood: Whole tree chips/harvest
residue

Fuel cubes (paper diaper clippings/refuse)	Reclaimed Ink Solvent	Wood:
chips- fines

Fuel Oil Solids (tank clean out residue)	Recovered Gaseous Butane	Woodex
Pellets

Fume Filter Oil	Rectified methanol	Woodworking residuals (cabinet mfg)

Gluten fee pellets

Yellow grease (used cooking oils- sold as commercial fuel)

The public reporting and recordkeeping burden for this collection of
information is estimated to average 24.2 hours per response.  Send
comments on the Agency's need for this information, the accuracy of the
provided burden estimates, and any suggested methods for minimizing
respondent burden, including through the use of automated collection
techniques to the Director, Collection Strategies Division, U.S.
Environmental Protection Agency (2822T), 1200 Pennsylvania Ave., NW,
Washington, D.C. 20460.  Include the OMB control number in any
correspondence.  Do not send the completed survey to this address.

ICR No. 2286.01

OMB Control No. TBD


[Federal Register: August 13, 2010 (Volume 75, Number 156)]
[Rules and Regulations]
[Page 49411-49412]
[DOCID:fr13au10-14]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 138

[USCG-2008-0007]
RIN 1625-AB25

Consumer Price Index Adjustments of Oil Pollution Act of 1990
Limits of Liability--Vessels and Deepwater Ports

AGENCY: Coast Guard, DHS.

ACTION: Rule; information collection approval.

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

SUMMARY: On July 1, 2009, the Coast Guard amended the Oil Pollution Act
of 1990 limits of liability for vessels and deepwater ports to reflect
significant increases in the Consumer Price Index. The amendment
triggered information collection requirements affecting vessel
operators required to establish evidence of financial responsibility.
This notice announces that the collection of information has been
approved by the Office of Management and Budget (OMB) and may now be
enforced. The OMB Control Number is 1625-0046.

DATES: The collection of information requirement under 33 CFR 138.85
will be enforced from August 13, 2010.

FOR FURTHER INFORMATION CONTACT: If you have questions on this document
contact Mr. Benjamin White, National Pollution Funds Center, Coast
Guard, telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>If you
have questions on viewing the docket (USCG-2005-21780), call Ms. Renee
V. Wright, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On July 1, 2009, the Coast Guard published
an interim rule entitled ``Consumer Price Index Adjustments of Oil
Pollution Act of 1990 Limits of Liability--Vessels and Deepwater
Ports'' (74 FR 31357) (CPI interim rule). This interim rule amended the
Oil Pollution Act of 1990 limits of liability for vessels and deepwater
ports under 33 CFR part 138 subpart B to reflect significant increases
in the Consumer Price Index as required by 33 U.S.C. 2704(d)(4). These
limit of liability amendments triggered information collection
requirements under 33 CFR 138.85. This provision requires operators of
vessels to establish evidence of financial responsibility under OPA 90,
33 U.S.C. 2716, acceptable to the Director, National Pollution Funds
Center, in an amount equal to or greater than the total applicable
amounts determined under 33 CFR 138.80(f). The total applicable amounts
are, in turn, determined by reference to the limits of liability in 33
CFR part 138, subpart B. On January 6, 2010, the Coast Guard published
a final rule adopting the interim rule without change (75 FR 750).
    With the exception of this collection of information, the CPI
interim rule limit of liability amendments became effective on July 31,
2009. As required by the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3520), the preambles to the interim rule and the final rule stated
that the Coast Guard would not enforce the collection of information
requirements occurring under 33 CFR 138.85 until the collection of
information request was approved by OMB, and also stated that the Coast
Guard would publish a notice in the Federal Register announcing that
OMB approved and assigned a control number for the requirement.
    The Coast Guard submitted the information collection request to OMB
for approval in accordance with the Paperwork Reduction Act of 1995. On
June 18, 2010, OMB approved the collection of information and assigned
the collection OMB Control Number 1625-0046 entitled ``Financial
Responsibility for Water Pollution (Vessels).'' The approval for this
collection of information expires on July 31, 2012. A copy of the OMB
notice of action is available in our online docket at http://
www.regulations.gov.

    Dated: August 3, 2010.
Craig A. Bennett,
Director, National Pollution Funds Center, U.S. Coast Guard.
[FR Doc. 2010-19753 Filed 8-12-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 199 (Tuesday, October 17, 2017)]
[Notices]
[Pages 48301-48302]
[FR Doc No: 2017-22392]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81855; File No. SR-NASDAQ-2017-103]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change to
Postpone Implementation of a New Attribute for Designated Retail Orders

October 11, 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 September 29, 2017, The NASDAQ Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the Exchange.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to postpone implementation of a new attribute
for designated retail orders
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaq.cchwallstreet.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 aspects of such
statements.

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

1. Purpose
    On July 7, 2017, the Commission approved the Exchange's new
Extended Life Priority Order Attribute (``ELO'').\3\ ELO will allow
certain Displayed Orders \4\ that are committed to a one-second or
longer resting period to receive higher priority than other Displayed
Orders of the same price on the Nasdaq Book. Currently, Nasdaq's System
\5\ places a time-stamp on each Order entered by a member, which
determines the time ranking of the Order for purposes of processing the
Order.\6\ The System presents resting Orders on the Nasdaq Book for
execution against incoming Orders in accordance with a price/display/
time algorithm.\7\ Price means that better priced Orders will be
presented for execution first. The Exchange proposed ELO to promote
Displayed Orders with longer time horizons, thereby enhancing the
market so that it works for a wider array of market participants.
Implementation of ELO requires the Exchange to make an exception to the
general priority rules \8\ so that Displayed Orders with an Extended
Life Priority Attribute are allowed to earn queue priority on the
Nasdaq Book at any given price level ahead of all other Displayed
Orders without the Extended Life Priority Attribute.\9\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 81097 (July 7,
2017), 82 FR 32386 (July 13, 2017) (SR-NASDAQ-2016-161) (approving
the proposal as modified by Amendment No. 1).
    \4\ Only Designated Retail Orders, as defined by Rule 7018, are
available for ELO.
    \5\ As defined by Rule 4701(a).
    \6\ See Rule 4756(a)(2).
    \7\ See Rule 4757. To implement ELO's exception to the price/
display/time algorithm the Exchange proposed amending Rule 4757. See
supra note 3.
    \8\ Id.
    \9\ The Exchange proposed to designate orders with the ELO
attribute with a new, unique identifier or they may alternatively be
entered through an order port that has been set to designate, by
default, all orders with the new identifier. Orders marked with the
new identifier--whether on an order-by-order basis or via a
designated port--would be disseminated via Nasdaq's TotalView ITCH
data feed.
---------------------------------------------------------------------------

    In proposing ELO, the Exchange anticipated a progressive rollout of
the ELO functionality, beginning with a small set of symbols and
gradually expanding further. The Exchange also committed to publish the
symbols eligible for ELO on its Web site. The Exchange noted that it
intended to implement the initial set of symbols for ELO in the third
quarter of 2017, with the exact implementation date being reliant on
several factors, such as the results of extensive testing and industry
events and initiatives.
    The Exchange has encountered unforeseen issues in developing ELO,
which have delayed its implementation. These issues concern the
complexity of programming the System to account for ELO priority over
other Orders on the Nasdaq Book. The issues will require additional
thoughtful and methodical development efforts to ensure that risks are
adequately addressed, and the System will accurately account for the
new ELO priority. As a consequence, the Exchange is proposing to
implement ELO in the second half of 2018. As it originally committed to
do, the Exchange will notify market participants via an Equity Trader
Alert once a specific date for the initial rollout is determined.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\10\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\11\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest, because it will allow the Exchange to adequately address
complex unforeseen issues that introduce risk to the development and
functioning of ELO. The Exchange believes that, to address these issues
in a thorough and thoughtful manner, additional time is needed for it
to solve these issues before it can implement ELO. As a consequence,
the proposed delay will serve to protect investors by decreasing the
likelihood of potential disruption to the market caused by the
implementation of ELO.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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. Delaying the implementation of
ELO will allow the Exchange to adequately analyze issues, as well as to
further develop and test Nasdaq systems to ensure that ELO functions as
proposed. Ensuring that the Exchange has adequate time to do so does
not place a burden on competition whatsoever, since ELO has not been
implemented and market participants have not yet begun to program their
systems to accept ELO. Thus market participants will not be affected by
the delay in its implementation.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6) thereunder.\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \13\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \14\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay so that
the Exchange may immediately extend the ELO implementation date. The
Exchange stated that it will not be able to implement ELO by the end of
the third quarter of 2017. According to the Exchange, it has
encountered unforeseen issues in developing ELO, and these issues will
require additional thoughtful and methodical development efforts to
ensure that risks are adequately addressed and the System will
accurately account for the new ELO priority. The Exchange also stated
that waiving the operative delay will allow it to implement the
proposed implementation delay and provide notice to market participants
thereof.\15\ The Commission believes that waiving the 30-day operative
delay is consistent with the protection of investors and the public
interest. Therefore, the Commission hereby waives the operative delay
and designates the proposed rule change operative upon filing.\16\
---------------------------------------------------------------------------

    \13\ 17 CFR 240.19b-4(f)(6).
    \14\ 17 CFR 240.19b-4(f)(6)(iii).
    \15\ The Exchange stated that, as it originally committed to do,
it will notify market participants via an Equity Trader Alert once a
specific date for the initial rollout is determined and will publish
the symbols that are eligible for ELO on its Web site.
    \16\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2017-103 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-NASDAQ-2017-103. 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; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2017-103, and should
be submitted on or before November 7, 2017.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

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

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-22392 Filed 10-16-17; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 60 (Monday, March 30, 2015)]
[Notices]
[Pages 16723-16724]
[FR Doc No: 2015-07292]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket No. DOT-OST-2012-0087]

Advisory Committee for Aviation Consumer Protection

AGENCY: Office of the Secretary (OST), Department of Transportation
(DOT).

ACTION: Notice of seventh meeting of advisory committee.

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SUMMARY: This notice announces the seventh meeting of the Advisory
Committee for Aviation Consumer Protection.

DATES: The seventh meeting of the advisory committee is scheduled for
April 14, 2015, from 9:00 a.m. to 4:00 p.m., Eastern Time.

ADDRESSES: The meeting will be held in the Media Center (located on the
lobby level of the West Building) at the U.S. Department of
Transportation (DOT) headquarters, 1200 New Jersey Avenue SE.,
Washington, DC. Attendance is open to the public up to the room's

capacity of 100 attendees. Since space is limited and access to the DOT
headquarters building is controlled for security purposes, any member
of the general public who plans to attend this meeting must notify the
registration contact identified below no later than April 7, 2015.

FOR FURTHER INFORMATION CONTACT: To register to attend the meeting,
please contact Amy Przybyla, Research Analyst, CENTRA Technology, Inc.,
<EMAIL_ADDRESS>703-894-6962. For other information
please contact Kathleen Blank Riether, Senior Attorney, Office of
Aviation Enforcement and Proceedings<EMAIL_ADDRESS>
U.S. Department of Transportation, 1200 New Jersey Ave. SE.,
Washington, DC 20590;<PHONE_NUMBER> (phone),<PHONE_NUMBER> (fax).

SUPPLEMENTARY INFORMATION: On May 24, 2012, the Secretary, as mandated
by Section 411 of the FAA Modernization and Reform Act of 2012 (Pub. L.
112-95, 126 Stat. 11 (2012)), established the Advisory Committee on
Aviation Consumer Protection. The committee's charter, drafted in
accordance with the Federal Advisory Committee Act, as amended, 5
U.S.C. App. 2, sets forth policies for the operation of the advisory
committee and is available on the Department's Web site at http://www.facadatabase.gov/committee/charters.aspx?cid=2448&aid=47.
    The seventh meeting of the committee is scheduled for Tuesday,
April 14, 2015, from 9:00 a.m. to 4:00 p.m. Eastern Time in the Media
Center at the DOT headquarters, 1200 New Jersey Avenue SE., Washington,
DC 20590. At the meeting, the issues that will be discussed are space
allocated per passenger on the aircraft and airlines' frequent flyer
programs.
    As announced in the notices of prior meetings of the committee, the
meeting will be open to the public, and, time permitting, comments by
members of the public are invited. Attendance will necessarily be
limited by the size of the meeting room (maximum 100 attendees). Since
space is limited and access to the DOT headquarters building is
controlled for security purposes, we ask that any member of the general
public who plans to attend the seventh meeting notify the registration
contact noted above no later than April 7, 2015. Additionally, DOT will
stream the event live on the Internet at www.dot.gov/airconsumer/ACACP.
    Members of the public may present written comments at any time. The
docket number referenced above (DOT-OST-2012-0087, available at https://www.regulations.gov) has been established for committee documents
including any written comments that may be filed. At the discretion of
the Chairperson and time permitting, after completion of the planned
agenda, individual members of the public may provide oral comments. Any
oral comments presented must be limited to the objectives of the
committee and will be limited to five (5) minutes per person.
Individual members of the public who wish to present oral comments must
notify the Department of Transportation contact noted above via email
that they wish to attend and present oral comments no later than April
7, 2015.
    Persons with a disability who plan to attend the meeting and
require special accommodations, such as an interpreter for the hearing
impaired, should notify the registration contact noted above no later
than April 7, 2015.
    Notice of this meeting is being provided in accordance with the
Federal Advisory Committee Act and the General Services Administration
regulations covering management of Federal advisory committees.

(41 CFR part 102-3.)

    Issued in Washington, DC, on the 25th of March, 2015.
Blane A. Workie,
Assistant General Counsel for Aviation Enforcement & Proceedings, U.S.
Department of Transportation.
[FR Doc. 2015-07292 Filed 3-27-15; 8:45 am]
 BILLING CODE 4910-9X-P


[Federal Register Volume 80, Number 199 (Thursday, October 15, 2015)]
[Rules and Regulations]
[Pages 61983-61985]
[FR Doc No: 2015-26193]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2015-0809]
RIN 1625-AA00

Safety Zone, Atlantic Intracoastal Waterway; Oak Island, NC

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on the
navigable waters of the Atlantic Intracoastal Waterway near Oak Island,
North Carolina. This action is necessary to provide the safety of
mariners on navigable waters due to the transfer of power cables across
the Atlantic Intracoastal Waterway. Entry into or movement within the
safety zone during the enforcement period is prohibited without
approval of the Captain of the Port.

DATES: This rule is effective without actual notice from October 15,
2015 until October 20, 2015. For the purposes of enforcement, actual
notice will be used from October 12, 2015 until October 15, 2015.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2015-0809]. To view documents mentioned in this preamble as being
available in the docket, go to 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 rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LT Derek J. Burrill, Waterways Management Division Chief,
Sector North Carolina, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Cheryl Collins, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because final project details were not
submitted to the Coast Guard until September 4, 2015. As such, it's
impractical to provide a full comment period due to lack of time.
Delaying the effective date for comment would be contrary to the public
interest, since immediate action is needed to ensure protection of
persons and vessels transiting the area.
    For similar reasons, under 5 U.S.C. 553(d)(3), the Coast Guard
finds that good cause exists for making this rule effective less than
30 days after publication in the Federal Register. Due to the need for
immediate action, the restriction of vessel traffic is necessary to
protect life, property and the environment. Therefore, a 30-day notice
is impracticable. The Coast Guard will provide advance notifications to
users via marine information broadcasts and local notice to mariners.

B. Basis and Purpose

    The legal basis for this rule is 33 U.S.C. 1231; 46 U.S.C. Chapter
701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6,
160.5; Public Law 107-295, 116 Stat. 2064; and DHS Delegation No.
0170.1. Under these authorities the Coast Guard may establish a safety
zone in defined water areas that are determined to have hazardous
conditions and in which vessel traffic can be regulated in the interest
of safety.
    On October 12, 13, 19, and 20, 2015 Coastal Power will be
installing power cables that will run across the Atlantic Intracoastal
Waterway at latitude 33[deg]55'11'' N, longitude 078[deg]03'24'' W in
Oak Island, North Carolina. To facilitate the safety of mariners and
the public, the U.S Coast Guard will require temporary closures of the
channel on October 12, 13, 19, 20, 2015.

C. Discussion of the Final Rule

    The Coast Guard is establishing a temporary safety zone on the
navigable waters of the Atlantic Intracoastal Waterway within a 100
yard radius of latitude 33[deg]55'11'' N, longitude 078[deg]03'24'' W
in Oak Island, North Carolina. This safety zone will be established in
the interest of public safety due to the transfer of power cables
across the Atlantic Intracoastal Waterway. The regulated area for this
safety zone includes all the water of the Atlantic Intracoastal
Waterway within a 100 yard radius of latitude 33[deg]55'11'' N,
longitude 078[deg]03'24'' W, a position located north of the Oak Island
Fixed Bridge in Oak Island, North Carolina. This rule will be enforced
on October 12, 13, 19, 20, 2015 during the times of 09:00 a.m. to 12:00
p.m. and 01:00 p.m. to 04:00 p.m. Vessels authorized by the Captain of
the Port or his/her Representative to enter or remain in the safety
zone during the above listed time frame must have a height clearance of
30 feet and greater and are required to notify on scene Coastal Power
and Electric work boats at a minimum of 40 minutes prior to transiting
the area on VHF marine radio channels 13 or 16 or via phone at 910-512-
1645.
    Except for vessels authorized by the Captain of the Port or his/her
Representative, no person or vessel may enter or remain in the safety
zone during the time frame listed. The Captain of the Port will give
notice of the enforcement of the safety zone by all appropriate means
to provide the widest dissemination of notice among the affected
segments of the public. This will include publication in the Local
Notice to Mariners and Marine Information Broadcasts.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under

section 6(a)(3) of Executive Order 12866 or under section 1 of
Executive Order 13563. The Office of Management and Budget has not
reviewed it under those Orders. The primary impact of these regulations
will be on limiting all vessels wishing to transit the affected
waterways during enforcement of the safety zone on the Atlantic
Intracoastal Waterway within a 100 yard radius of latitude
33[deg]55'11'' N., longitude 078[deg]03'24'' W. in Oak Island, North
Carolina on October 12, 13, 19, and 20, 2015. Although these
regulations prevent traffic from transiting a portion of the Atlantic
Intracoastal Waterway during this incident, that restriction is limited
in duration, affects only a limited area, and will be well publicized
to allow mariners to make alternative plans for transiting the affected
area.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    This rule will affect the following entities, some of which might
be small entities: The owners or operators of vessels intending to
transit or anchor in waters of the Atlantic Intracoastal Waterway
within a 100 yard radius of latitude 33[deg]55'11'' N., longitude
078[deg]03'24'' W. position during the outlined timeframe.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons: (i) The
safety zone will only be in place for a limited duration, and (ii)
before the enforcement period, maritime advisories will be issued
allowing mariners to adjust their plans accordingly.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves the establishment of a safety zone to
protect life, property and the environment. This rule is categorically
excluded from further review under paragraph 34(g) of Figure 2-1 of the
Commandant Instruction. We seek any comments or information that may
lead to the

discovery of a significant environmental impact from this rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T05-809 to read as follows:

Sec.  165.T05-809  Safety Zone, Atlantic Intracoastal Waterway; Oak
Island, North Carolina.

    (a) Definitions. For the purposes of this section, Captain of the
Port means the Commander, Sector North Carolina. Representative means
any Coast Guard commissioned, warrant or petty officer who has been
authorized to act on the behalf of the Captain of the Port.
    (b) Location. The following area is a safety zone: Specified waters
of the Captain of the Port Sector North Carolina zone, as defined in 33
CFR 3.25-10, all waters of the Atlantic Intracoastal Waterway within a
100 yard radius of latitude 33[deg]55'11'' N., longitude
078[deg]03'24'' W. in Oak Island, North Carolina.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry into this zone is prohibited unless authorized by
the Captain of the Port, North Carolina or his designated
representatives.
    (2) The operator of any vessel in the immediate vicinity of this
safety zone shall:
    (i) If on scene proceed as directed by any commissioned, warrant or
petty officer on shore or on board a vessel that is displaying a U.S.
Coast Guard Ensign.
    (ii) [Reserved]
    (3) The Captain of the Port, North Carolina can be reached through
the Sector North Carolina Command Duty Officer at Sector North Carolina
in Wilmington, North Carolina at telephone number<PHONE_NUMBER>.
    (4) The Coast Guard Representatives enforcing the safety zone can
be contacted on VHF-FM marine band radio channel 13 (165.65 Mhz) and
channel 16 (156.8 Mhz).
    (d) Enforcement period. This section will be enforced on October
12, 13, 19, and 20, 2015, between 9:00 a.m. to 12:00 p.m. and 1:00 p.m.
to 4:00 p.m.

    Dated: September 23, 2015.
S.R. Murtagh,
Captain, U.S. Coast Guard, Captain of the Port North Carolina.
[FR Doc. 2015-26193 Filed 10-14-15; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)]
[Notices]
[Pages 6196-6198]
[FR Doc No: 2018-02903]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0188]

Proposal To Refuse To Approve a New Drug Application for
Oxycodone Hydrochloride Immediate-Release Oral Capsules, 5 Milligrams,
15 Milligrams, and 30 Milligrams; Opportunity for a Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Director of the Center for Drug Evaluation and Research
(Center Director) of the Food and Drug Administration (FDA or Agency)
is proposing to refuse to approve a new drug application (NDA)
submitted by Pharmaceutical Manufacturing Research Services, Inc.
(PMRS) for oxycodone hydrochloride (HCl) immediate-release (IR) oral
capsules, 5 milligrams (mg), 15 mg, and 30 mg in its present form. This
notice summarizes the grounds for the Center Director's proposal and
offers PMRS an opportunity to request a hearing on the matter.

DATES: Submit either electronic or written requests for a hearing by
March 15, 2018; submit data, information, and analyses in support of
the hearing and any other comments by April 16, 2018.

ADDRESSES: You may submit hearing requests, documents in support of the
hearing, and any other comments as follows. Please note that late,
untimely filed requests and documents will not be considered.
Electronic requests for a hearing must be submitted on or before March
15, 2018; electronic documents in support of the hearing and any other
comments must be submitted on or before April 16, 2018. The https://www.regulations.gov electronic filing system will accept hearing
requests until midnight Eastern Time at the end of March 15, 2018, and
will accept documents in support of the hearing and any other comments
until midnight Eastern Time at the end of April 16, 2018. Documents
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before these dates.

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-N-0188, for ``Proposal to Refuse to Approve a New Drug
Application for Oxycodone Hydrochloride Immediate-Release Oral
Capsules, 5 Milligrams, 15 Milligrams, and 30 Milligrams; Opportunity
for a Hearing.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     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.

FOR FURTHER INFORMATION CONTACT: Patrick Raulerson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6260, Silver Spring, MD, 20993, 301-796-
3522, [email protected].

SUPPLEMENTARY INFORMATION:

I. Proposal To Refuse To Approve NDA 209155

    PMRS submitted NDA 209155 for oxycodone HCl IR oral capsules in 5
mg, 15 mg, and 30 mg strengths (oxycodone HCl IR capsules) under
section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 355(b)(2)), proposing to rely in part on the Agency's
previous finding of safety and effectiveness for ROXICODONE (oxycodone
HCl) IR Tablets (NDA 021011). PMRS proposed that its oxycodone HCl IR
capsules be indicated for the management of acute pain severe enough to
require an opioid analgesic and for which alternative treatments are
inadequate. PMRS also attempted to show that the product had certain
abuse-deterrent properties and sought FDA approval of labeling
describing those properties.
    On November 16, 2017, the Division of Anesthesia, Analgesia, and
Addiction Products of FDA's Center for Drug Evaluation and Research
(CDER) issued a complete response letter to PMRS under Sec.  314.110(a)
(21 CFR 314.110(a)) stating that NDA 209155 could not be approved in
its present form, describing the specific deficiencies, and, where
possible, recommending ways PMRS might remedy these deficiencies. The
deficiencies include the following:
    1. The application in its present form is not approvable with the
proposed labeling describing abuse-deterrent properties, for multiple
reasons. In particular, (1) the oxycodone in the formulation can be
readily extracted in commonly available solvents into a solution
suitable for injection; (2) there were insufficient data showing the
presence of excipients (including dye) in the formulation can be
expected to deter abuse by injection; (3) the data submitted were
insufficient to show the product was meaningfully resistant to
manipulation for misuse or abuse; and (4) there were not data
submitted, including data from pharmacokinetic and human abuse
liability studies, fully characterizing the product's abuse potential
by all relevant routes of abuse. Also, the data submitted were not
sufficient to rule out the possibility that the proposed formulation
could result in a greater proportion of abuse by injection of PMRS's
product compared to a conventional IR oxycodone formulation. Abuse by
injection carries greater risk of overdose and transmission of
infectious disease than abuse by other routes.
    2. The safety and purity of the excipients intended (but not shown)
to confer abuse deterrent properties were not adequately characterized,
either by the intended oral route of use or by expected routes of
abuse, including injection.
    3. An overall evaluation of elemental impurities in the final
formulation and a risk assessment for each heavy metal (taking into
consideration the maximum daily dose) were not provided.
    4. The application did not fully comply with the patent
certification requirements applicable to applications submitted under
section 505(b)(2) of the FD&C Act.
    5. The complete response letter describes additional deficiencies,
which generally relate to chemistry, manufacturing, and controls and
current good manufacturing practice requirements, that CDER determined
preclude approval of the application in its present form. The complete
response letter also noted that satisfactory resolution of
objectionable inspection observations was required before the
application could be approved. Due to applicable limitations on public
disclosure of information contained in unapproved NDAs, including trade
secret information, these specific deficiencies are not described in
this notice.
    The complete response letter stated that PMRS is required to
resubmit the application, fully addressing all deficiencies listed in
the letter, or take other actions available under Sec.  314.110 (i.e.,
withdraw the application or request an opportunity for a hearing).
Applicable regulations, including Sec.  10.75 (21 CFR 10.75), also
provide a mechanism for applicants to obtain formal review of one or
more decisions reflected in a complete response letter (see FDA's
guidance for industry ``Formal Dispute Resolution: Sponsor Appeals
Above the Division Level'' (November 2017) available at: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm343101.pdf).
    In response to the complete response letter, on November 17, 2017,
PMRS submitted a request for an opportunity for a hearing under Sec.
314.110(b)(3) on whether there are grounds under section 505(d) of the
FD&C Act for denying approval of NDA 209155.

II. Notice of Opportunity for a Hearing

    For the reasons stated previously and others described in the
complete response letter, notice is given to PMRS and to all other
interested persons that the Center Director proposes to issue an order
refusing to approve NDA 209155 on the grounds that the application
fails to meet the criteria for approval under section 505(d) of the
FD&C Act, including that: (1) PMRS has not provided sufficient data to
show that the product would be safe (505(d)(1)); (2) PMRS has not shown
that the methods used in, and the facilities and controls used for the
manufacture, processing, or packing of the product are adequate to
preserve its identity, strength, quality, and purity (505(d)(3)); and
(3) the labeling PMRS proposed for the product is false or misleading
(505(d)(7)).
    PMRS may request a hearing before the Commissioner of Food and
Drugs (the Commissioner) on the Center Director's proposal to refuse to
approve NDA 209155. If PMRS decides to seek a hearing, it must file:
(1) A written notice of participation and request for a hearing (see
the DATES section), and (2) the studies, data, information, and
analyses relied upon to justify a hearing (see the DATES section), as
specified in Sec.  [thinsp]314.200.
    As stated in Sec.  314.200(g), a request for a hearing may not rest
upon mere allegations or denials, but must present specific facts
showing that there is a genuine and substantial issue of fact that
requires a hearing to resolve. We note in this regard that because CDER
proposes to refuse to approve NDA 209155 for multiple reasons, any
hearing request from PMRS must address all of those reasons, including
reasons described in the complete response letter but not described in
this notice due to applicable limitations on public disclosure of
information contained in unapproved NDAs, including trade secret
information. Failure to request a hearing within the time provided and
in the manner required by Sec.  314.200 constitutes a waiver of the
opportunity to request a hearing. If a hearing request is not properly
submitted, FDA will issue a notice refusing to approve NDA 209155.

    The Commissioner will grant a hearing if there exists a genuine and
substantial issue of fact or if the Commissioner concludes that a
hearing would otherwise be of public interest (Sec.  314.200(g)(6)). If
a hearing is granted, it will be conducted according to the procedures
provided in 21 CFR parts 10 through 16 (21 CFR 314.201).
    Paper submissions under this notice of opportunity for a hearing
must be filed in two copies. Except for data and information prohibited
from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905,
submissions may be seen in the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, and on the internet at https://www.regulations.gov. This notice is issued under section 505(c)(1)(B)
of the FD&C Act, Sec. Sec.  314.110(b)(3) and 314.200.

    Dated: February 8, 2018.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2018-02903 Filed 2-12-18; 8:45 am]
 BILLING CODE 4164-01-P