[Federal Register Volume 83, Number 180 (Monday, September 17, 2018)]
[Notices]
[Pages 46991-46992]
[FR Doc No: 2018-20144]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Availability of the Final Environmental Assessment (EA)
and Finding of No Significant Impact/Record of Decision (FONSI/ROD) for
the Runway 14/32 Relocation/Extension and Associated Improvements
Project for the Lake Elmo Airport (21D) in Lake Elmo, MN

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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SUMMARY: The FAA is issuing this notice to advise the public that the
FAA has prepared and approved (August 31, 2018) a FONSI/ROD based on
the Final EA for a Runway 14/32 Relocation/Extension and Associated
Improvements Project at the Lake Elmo Airport. The Final EA was
prepared in accordance with the National Environmental Policy Act
(NEPA) of 1969, as amended, FAA Orders 1050.1F, ``Environmental
Impacts: Policies and Procedures'' and 5050.4B, ``NEPA Implementing
Instructions for Airport Actions''.

DATE: This notice is applicable September 17, 2018.

FOR FURTHER INFORMATION CONTACT: Mr. Josh Fitzpatrick, Environmental
Protection Specialist, FAA Dakota-Minnesota Airports District Office
(ADO), 6020 28th Avenue South, Suite 102, Minneapolis, Minnesota 55450.
Telephone number is<PHONE_NUMBER>. Copies of the FONSI/ROD and/or
Final EA are available upon written request by contacting Mr. Josh
Fitzpatrick through the contact information above.

SUPPLEMENTARY INFORMATION: The FAA and the Metropolitan Airports
Commission (MAC) jointly prepared the Final EA/State of Minnesota
Environmental Assessment Worksheet (EAW), pursuant to the requirements
of the NEPA and the Minnesota Environmental Policy Act.
    The Final EA evaluated the 21D Runway 14/32 Relocation/Extension
and Associated Improvements Project. The purpose of the proposed action
is to address failing, end of life infrastructure; enhance safety for
airport users and neighbors; and improve facilities for the family of
aircraft using the airport. The proposed action is needed based on the
following four deficiencies at the existing facility: The existing
runway and taxiway pavement is deteriorating and needs to be replaced;
Runway 14/32 has several incompatible land uses within its runway
protection zones (RPZs), including a railroad and two public roads; the
existing pavement and airfield geometry do not meet the needs of
airport users and aircraft; and the existing instrument approach
procedures do not use the latest available navigational technology.
    The Final EA identified and evaluated reasonable alternatives.
Numerous alternatives were considered, but eventually discarded for not
meeting the purpose and need. For the primary runway, Alternatives B,
B1, and the No Action were examined in detail. For the crosswind
runway, the No Action and one other alternative were examined. For
roadway relocation, Alternatives 1, 2, 4A, 4B, and the No Action were
examined. After careful analysis and consultation with various resource
agencies, the MAC selected Primary Runway Alternative B1, the Crosswind
Runway Alternative, and Roadway Alternative 3 as the proposed action.
Primary Runway Alternative B1, the Crosswind Runway Alternative, and
Roadway Alternative 3 satisfies the purpose and need while minimizing
impacts.
    The Proposed Action includes the following elements: Relocate
Runway 14/32 by shifting 615 feet to the northeast and extend to 3,500
feet, including grading, clearing, and runway lighting; extinguish
existing prescriptive easement for 30th Street North and seek a land
release for non-aeronautical use from the FAA to allow realignment of
30th Street North around the new Runway 32 RPZ to reconnect with the
existing Neal Avenue North intersection; relocate the Airport perimeter
fence to reflect the new Runway 32 RPZ; remove the existing north side
taxiway and compass calibration pad and construct a new crossfield
taxiway to serve the new Runway 14 end, including taxiway lighting;
convert existing Runway 14/32 to a partial parallel taxiway and remove
the portion of the existing parallel taxiway south of the Runway 04
threshold; reconstruct Runway 4/22 and extend to 2,750 feet, including
necessary lighting and taxiway connectors; construct other taxiways and
engine run-up pads as needed to support the relocated Runway 14/32 and
extended Runway 04/22, including connector taxiways and a full-length
parallel taxiway on the north side of the relocated Runway 14/32, and
install taxiway lighting and/or reflectors; relocate the compass
calibration pad adjacent to the new partial parallel taxiway (converted
Runway 14/32); establish non-precision GPS-based instrument approach
procedures to all runway ends not already equipped;

provide Runway 14/32 lighting systems with the relocated runway;
install Medium Intensity Runway Lights (MIRLs) on Runway 04/22,
Precision Approach Path Indicators (PAPIs) on the Runway 04, 14, and 22
ends, and Runway End Identifier Lights (REILs) on each end of Runway
04/22; remove approximately 20 acres of on-Airport trees and individual
off-Airport trees as necessary to clear trees that penetrate FAA
Threshold Siting Surface (TSS)/Part 77 approach and transitional
surfaces; install obstruction lighting on Fixed Based Operator (FBO)
and hangar buildings in the Terminal Instrument Procedures (TERPS)
departure surface areas beyond Runway 04, 14, and 22 ends; construct an
on-Airport access road connecting the north and west building areas;
voluntarily explore creation of Rusty Patched Bumble Bee/pollinator
habitat on airport property southwest of proposed 30th Street North
realignment.
    Based on the analysis in the Final EA, the FAA has determined that
the proposed action will not result in significant impacts to resources
identified in accordance with FAA Orders 1050.1F and 5050.4B.
Therefore, an environmental impact statement will not be prepared.

    Issued in Minneapolis, Minnesota, on August 31, 2018.
Andy Peek,
Manager, Dakota-Minnesota Airports District Office, FAA, Great Lakes
Region.
[FR Doc. 2018-20144 Filed 9-14-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 75, Number 35 (Tuesday, February 23, 2010)]
[Rules and Regulations]
[Pages 7942-7945]
[FR Doc No: 2010-3222]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0615; Directorate Identifier 2009-NM-043-AD;
Amendment 39-16206; AD 2010-04-13]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A310-203, -221, -222
Airplanes; and Model A300 F4-605R and -622R Airplanes

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

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    An A300-600 operator reported two events of IPECO pilot seat
moved in the aft position, one during take-off roll and one during
climb out. The investigation of these events showed that a broken/
missing spring contributed to the seat not being correctly locked.
    An unwanted movement of pilot or co-pilot seat in the aft
direction is considered as potentially dangerous, especially during
the take-off phase when the speed of the aeroplane is greater than
100 knots and until landing gear retraction.
* * * * *
The unsafe condition is potential loss of control of the airplane
during take-off and landing. We are issuing this AD to require actions
to correct the unsafe condition on these products.

DATES: This AD becomes effective March 30, 2010.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of March 30,
2010.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-2125; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on July 16, 2009 (74 FR
34509). That NPRM proposed to correct an unsafe condition for the
specified products. The MCAI states:

    An A300-600 operator reported two events of IPECO pilot seat
moved in the aft position, one during take-off roll and one during
climb out. The investigation of these events showed that a broken/
missing spring contributed to the seat not being correctly locked.
    An unwanted movement of pilot or co-pilot seat in the aft
direction is considered as potentially dangerous, especially during
the take-off phase when the speed of the aeroplane is greater than
100 knots and until landing gear retraction.
    To prevent further incidents of inadvertent flight crew seat aft
movement, this AD requires repetitive inspections of the affected
seat springs and replacement of missing or broken parts. In
addition, this AD requires replacement of the affected seats with
modified P/N 3A218-000X-01-2 seats. Installation of both pilot and
co-pilot seats P/N 3A218-000X-01-2 on an aeroplane constitutes
terminating action for the repetitive inspection requirements of
this AD for that aeroplane.

The unsafe condition is potential loss of control of the airplane
during take-off and landing. You may obtain further information by
examining the MCAI in the AD docket.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comments received.

Support for the AD

    The Air Line Pilots Association, International (ALPA), supports the
NPRM.

Request for Extension of Proposed Compliance Time for Modification

    FedEx and UPS request that we extend the compliance time for the
modification specified in paragraph (f)(4) of the NPRM from 6 months to
30 months. The commenters explain that 6 months does not provide enough
time for large operators with many aircraft to receive the parts kits.
UPS explains further that their proposed compliance time will enable
adequate industry support of the modification and at the same time
enable operators to utilize regularly scheduled maintenance
opportunities.
    We disagree with extending the proposed compliance time for the
modification. While we recognize that

the initial lead time for parts kit delivery was excessive, IPECO now
has a large stock of complete parts kits ready to be delivered. No
further issue regarding availability of parts kits is foreseen.
However, if parts kits availability becomes a problem in the future,
under the provisions of paragraph (g)(1) of this AD, we will consider
requests for approval of an extension of the compliance time if data
are submitted to substantiate that the extension would provide an
acceptable level of safety, provided that the operators are performing
the repetitive inspections specified in paragraph (f) of this AD. We
have made no change to the AD in this regard.

Request for Permission To Replace Old Parts With New Parts

    FedEx requests that we revise the NPRM to allow for replacing the
existing locking springs with new springs of the same design as an
interim action to delay installation of the modification. FedEx
explains that all of its broken locking springs were found on seats
that had been in service at least 4 years since there was a record of
the springs being changed. FedEx states that the springs that were
returned appeared to be corroded, which indicates that the failure of
the springs was due to corrosion instead of fatigue.
    We do not agree with the request to revise this AD to allow for
replacing the existing locking springs with new springs of the same
design as an interim action to delay installation of the modification.
While we recognize FedEx's assertion that failure of the springs was
due to corrosion instead of fatigue, Airbus did not identify which
failure mode was actually involved, as fatigue cracks could induce
spring protection alteration and then corrosion. Further, it is
possible that corrosion could actually lead to the weakening of the
spring, where the fatigue effort would deteriorate the spring.
Regardless of the findings by FedEx, parts kits are now available for
the replacement of the locking springs, so there is no need to delay
installation of the modification. However, if operators experience a
delay in receiving kits, they may request approval of an AMOC in
accordance with the procedures in paragraph (g)(1) of this AD. We have
made no change to the AD in this regard.

Request To Use an Alternate Inspection Method

    FedEx requests that the NPRM be revised to allow operators to use
other methods to perform the detailed inspection required in paragraph
(f)(1) of this AD. FedEx explains that removing the seat bottom cushion
and trying to view the springs through lightening holes in the seat
bottom is difficult. FedEx explains further that maintenance personnel
have used a mirror to perform the inspection or inspected the seat
springs by looking up directly from underneath the seat. FedEx
indicates that the springs are exposed on the bottom side of the seats
and can be more easily viewed for defects by using this method.
    We agree that other methods of performing the detailed inspection
required in paragraph (f)(1) of this AD might exist for the reasons
stated in the previous paragraph. But, we do not agree to change this
AD in this regard because insufficient data have been submitted to
substantiate that the alternative inspection method would provide an
acceptable level of safety. However, under the provisions of paragraph
(g)(1) of this AD, we will consider requests for approval of an
alternative inspection method if sufficient data are submitted to
substantiate that the alternative inspection method would provide an
acceptable level of safety.

Request for Clarification

    UPS requests that we change the word ``modified'' in paragraph
(f)(3) of the NPRM to clarify that there is no modification required by
that paragraph. UPS explains that the service information listed in
paragraph (f)(3) of the NPRM requires inspection and replacement, but
not modification.
    We agree to clarify paragraph (f)(3) of this final rule for the
reason stated by UPS. We have changed ``modified'' to ``replaced'' in
paragraph (f)(3) of this AD.

Explanation of Additional Change

    We have specified the issue numbers of each Airbus operations
engineering bulletin throughout this final rule to adhere to
requirements of the Office of the Federal Register's (OFR), for
material incorporated by reference (IBR).

Conclusion

    We reviewed the available data, including the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously. We determined that these
changes will not increase the economic burden on any operator or
increase the scope of the AD.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a Note within the AD.

Explanation of Change to Costs of Compliance

    Since issuance of the NPRM, we have increased the labor rate used
in the Costs of Compliance from $80 per work-hour to $85 per work-hour.
The Costs of Compliance information, below, reflects this increase in
the specified hourly labor rate.

Costs of Compliance

    We estimate that this AD will affect 132 products of U.S. registry.
We also estimate that it will take about 11 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour. Required parts will cost about $1,214 per
product. Where the service information lists required parts costs that
are covered under warranty, we have assumed that there will be no
charge for these parts. As we do not control warranty coverage for
affected parties, some parties may incur costs higher than estimated
here. Based on these figures, we estimate the cost of this AD to the
U.S. operators to be $283,668, or $2,149 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have 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.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2010-04-13 Airbus: Amendment 39-16206. Docket No. FAA-2009-0615;
Directorate Identifier 2009-NM-043-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective March
30, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to the airplanes identified in paragraphs
(c)(1) and (c)(2) of the AD, certificated in any category, having
IPECO part number (P/N) 3A218-000X-01-1 pilot or co-pilot mechanical
seats installed.
    (1) Airbus Model A310-203, A310-221, and A310-222 airplanes, all
serial numbers.
    (2) Airbus Model A300 F4-605R and A300 F4-622R airplanes, all
serial numbers.

Subject

    (d) Air Transport Association (ATA) of America Code 25:
Equipment/Furnishings.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    An A300-600 operator reported two events of IPECO pilot seat
moved in the aft position, one during take-off roll and one during
climb out. The investigation of these events showed that a broken/
missing spring contributed to the seat not being correctly locked.
    An unwanted movement of pilot or co-pilot seat in the aft
direction is considered as potentially dangerous, especially during
the take-off phase when the speed of the aeroplane is greater than
100 knots and until landing gear retraction.
    To prevent further incidents of inadvertent flight crew seat aft
movement, this AD requires repetitive inspections of the affected
seat springs and replacement of missing or broken parts. In
addition, this AD requires replacement of the affected seats with
modified P/N 3A218-000X-01-2 seats. Installation of both pilot and
co-pilot seats P/N 3A218-000X-01-2 on an aeroplane constitutes
terminating action for the repetitive inspection requirements of
this AD for that aeroplane.

The unsafe condition is potential loss of control of the airplane
during take-off and landing.

Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) Within 90 days after the effective date of this AD, and
thereafter at intervals not to exceed 30 days, do a detailed visual
inspection of the two springs of the pilot seat and co-pilot seat
locking device, in accordance with Airbus Mandatory Service Bulletin
A310-25A2199 or A300-25A6210, both dated July 9, 2008, as
applicable.
    (i) If only one spring is missing or found damaged during any
inspection required by paragraph (f)(1) of this AD, within 10 days
after the inspection or before further flight, whichever occurs
later, replace the spring with a serviceable part, in accordance
with Airbus Mandatory Service Bulletin A310-25A2199 or A300-25A6210,
both dated July 9, 2008, as applicable. Before an airplane may be
dispatched with one spring missing or damaged, the instructions
contained in Airbus A310 Operations Engineering Bulletin 160, Issue
2, dated October 2008; or Airbus A300-600 Operations Engineering
Bulletin 121, Issue 1, dated May 2008; as applicable; must be
accomplished by the flightcrew.
    (ii) If two springs are missing or found damaged during any
inspection required by paragraph (f)(1) of this AD, before further
flight, replace the springs in accordance with Airbus Mandatory
Service Bulletin A310-25A2199 or A300-25A6210, both dated July 9,
2008, as applicable.
    (2) Replacing parts in accordance with Airbus Mandatory Service
Bulletin A310-25A2199 or A300-25A6210, both dated July 9, 2008, as
applicable, is not a terminating action for the repetitive
inspections required in paragraph (f)(1) of this AD.
    (3) As of the effective date of this AD, do not install an IPECO
pilot or co-pilot mechanical seat P/N 3A218-000X-01-1 on any
airplane, unless the seat has been inspected and replaced as
applicable, in accordance with Airbus Mandatory Service Bulletin
A310-25A2199 or A300-25A6210, both dated July 9, 2008, as
applicable.
    (4) Within 6 months after the effective date of this AD, modify
the airplane by replacing the pilot and co-pilot mechanical seats P/
N 3A218-000X-01-1 with P/N 3A218-000X-01-2 seats, in accordance with
Airbus Mandatory Service Bulletin A310-25-2202 or A300-25-6214, both
dated February 3, 2009, as applicable.
    (5) Installing both pilot and co-pilot seats P/N 3A218-000X-01-2
in accordance with Airbus Mandatory Service Bulletin A310-25-2202 or
A300-25-6214, both dated February 3, 2009, as applicable, on any
airplane is a terminating action for the repetitive inspections
required by paragraph (f)(1) of this AD for that airplane.
    (6) As of 6 months after the effective date of this AD, do not
install an IPECO pilot or co-pilot mechanical seat P/N 3A218-000X-
01-1 on any airplane.
    (7) Although Airbus Mandatory Service Bulletins A310-25A2199 and
A300-25A6210, both dated July 9, 2008, specify to submit certain
information to the manufacturer, this AD does not include that
requirement.

FAA AD Differences

    Note 1:  This AD differs from the MCAI and/or service
information as follows: Although the MCAI or service information
tells you to submit information to Airbus, paragraph (f)(7) of this
AD specifies that such submittal is not required.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN: Dan
Rodina, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington
98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Before
using any approved AMOC on any airplane to which the AMOC applies,
notify your principal maintenance inspector (PMI) or principal
avionics inspector (PAI), as appropriate, or lacking a principal
inspector,

your local Flight Standards District Office. The AMOC approval
letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency Airworthiness
Directive 2009-0045, dated February 27, 2009, and the service
information listed in Table 1 of this AD, for related information.

                                      Table 1--Related Service Information
----------------------------------------------------------------------------------------------------------------
       Airbus Service Information                   Issue/revision                           Date
----------------------------------------------------------------------------------------------------------------
Airbus A300-600 Operations Engineering    1.................................  May 2008.
 Bulletin 121.
Airbus A310 Operations Engineering        2.................................  October 2008.
 Bulletin 160.
Airbus Mandatory Service Bulletin A300-   Original..........................  February 3, 2009.
 25-6214.
Airbus Mandatory Service Bulletin A300-   Original..........................  July 9, 2008.
 25A6210.
Airbus Mandatory Service Bulletin A310-   Original..........................  February 3, 2009.
 25-2202.
Airbus Mandatory Service Bulletin A310-   Original..........................  July 9, 2008.
 25A2199.
----------------------------------------------------------------------------------------------------------------

Material Incorporated by Reference

    (i) You must use the service information contained in Table 2 of
this AD to do the actions required by this AD, unless the AD
specifies otherwise.

                                   Table 2--Material Incorporated by Reference
----------------------------------------------------------------------------------------------------------------
       Airbus Service Information                   Issue/revision                           Date
----------------------------------------------------------------------------------------------------------------
Airbus A300-600 Operations Engineering    1.................................  May 2008.
 Bulletin 121.
Airbus A310 Operations Engineering        2.................................  October 2008.
 Bulletin 160.
Airbus Mandatory Service Bulletin A300-   Original..........................  February 3, 2009.
 25-6214.
Airbus Mandatory Service Bulletin A300-   Original..........................  July 9, 2008.
 25A6210 excluding Appendix 1, and
 including Appendices 2 and 3.
Airbus Mandatory Service Bulletin A310-   Original..........................  February 3, 2009.
 25-2202.
Airbus Mandatory Service Bulletin A310-   Original..........................  July 9, 2008.
 25A2199 excluding Appendix 1, and
 including Appendices 2 and 3.
----------------------------------------------------------------------------------------------------------------

     (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Airbus SAS-EAW (Airworthiness Office), 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 44 51; e-mail<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on February 11, 2010.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-3222 Filed 2-22-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 220 (Friday, November 13, 2020)]
[Notices]
[Pages 72749-72750]
[FR Doc No: 2020-25062]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Availability, Notice of Public Comment Period, Notice
of Public Meeting, and Request for Comment on the Draft Programmatic
Environmental Assessment for the Shuttle Landing Facility Reentry Site
Operator License

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

ACTION: Notice of availability, notice of public comment period, notice
of public meeting, and request for comment.

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SUMMARY: The FAA is announcing the availability of and requesting
comments on the Draft PEA for the Shuttle Landing Facility (SLF)
Reentry Site Operator License. The FAA has prepared the Draft PEA to
evaluate the potential environmental impacts of the FAA issuing a
Reentry Site Operator License to Space Florida for the operation of a
commercial space reentry site at the SLF located at the Cape Canaveral
Spaceport, which includes the Kennedy Space Center and the Cape
Canaveral Air Force Station. A programmatic document is a type of
general, broad National Environmental Policy Act (NEPA) review from
which subsequent NEPA documents can be tiered, focusing on the issues
specific to the subsequent action. If a commercial space operator
applies to the FAA for a reentry license to conduct reentry operations
at the SLF, a separate

environmental document, tiering off the PEA, would be developed to
support the issuance of a reentry license to the prospective reentry
operator. The tiered environmental document would be a more detailed
analysis based on vehicle specific operations.

DATES: Comments on the Draft PEA must be received on or before December
7, 2020.
    The FAA will hold a virtual public meeting on December 2, 2020 from
5:00 to 7:00 p.m. EST. During this meeting, Space Florida will provide
information on their proposed project, FAA will provide a licensing and
PEA overview and members of the public can provide oral comments at the
meeting. The FAA invites all interested parties to attend the meeting.
Information for the meeting is posted on the FAA Office of Commercial
Space Transportation website at: https://www.faa.gov/space/stakeholder_engagement/shuttle_landing_facility/.

ADDRESSES: Please submit comments or questions regarding the Draft PEA
to Ms. Stacey Zee, SLF PEA, c/o ICF, 9300 Lee Highway, Fairfax, VA
22031 or by email to<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Ms. Stacey Zee, Environmental
Protection Specialist, Federal Aviation Administration, 800
Independence Avenue SW, Suite 325, Washington, DC 20591; email
<EMAIL_ADDRESS>phone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The FAA is the lead agency. The National
Aeronautics and Space Administration, U.S. Space Force, U.S. Fish and
Wildlife Service, and the National Park Service are cooperating
agencies for the Programmatic Environmental Assessment (PEA) due to
their special expertise and jurisdictions.
    The FAA has prepared the Draft PEA in accordance with NEPA (42
U.S.C. 4321 et seq.), the Council on Environmental Quality Regulations
for Implementing the Procedural Provisions of NEPA (40 CFR parts 1500-
1508), and FAA Order 1050.1F, Environmental Impacts: Policies and
Procedures, as part of its licensing process. Concurrent with the NEPA
process and to determine the potential effects of the Proposed Action
on historic and cultural properties, the FAA has initiated Section 106
Consultation with the Florida State Historic Preservation Office and
the following Native American tribes: The Catawba Indian Nation, the
Chitimacha Tribe of Louisiana, the Coushatta Tribe of Louisiana, the
Eastern Band of Cherokee Indians, the Jena Band of Choctaw Indians, the
Miccosukee Tribe of Indians of Florida, the Muscogee (Creek) Nation,
the Poarch Band of Creek Indians, and the Seminole Tribe of Florida.
    The FAA has prepared the Draft PEA to evaluate the potential
environmental impacts of Space Florida's proposal to operate a reentry
location for horizontally landed reentry vehicles at the SLF located at
the Cape Canaveral Spaceport, which includes the Kennedy Space Center
and the Cape Canaveral Air Force Station. The Draft PEA considers the
potential environmental impacts of the Proposed Action and the No
Action Alternative. A programmatic document is a type of general, broad
NEPA review from which subsequent NEPA documents can be tiered,
focusing on the issues specific to the subsequent action (40 CFR
1502.20). If a commercial space operator applies to the FAA for a
reentry license to conduct reentry operations at the SLF, a separate
environmental document, tiering off the PEA, would be developed to
support the issuance of a reentry license to the prospective reentry
operator. The tiered environmental document would be a more detailed
analysis based on vehicle specific operations.
    An electronic version of the Draft PEA is available on the FAA
Office of Commercial Space Transportation website at: https://www.faa.gov/space/environmental/nepa_docs/slf_ea/.
    The FAA encourages all interested agencies, organizations, Native
American tribes, and members of the public to submit comments on the
analysis presented in the Draft PEA by December 7, 2020. Comments
should be as specific as possible and address the analysis of potential
environmental impacts. Reviewers should organize their participation,
so it is meaningful and makes the agency aware of the viewer's
interests and concerns using quotations and other specific references
to the text of the Draft PEA and related documents. Matters that could
have been raised with specificity during the comment period on the
Draft PEA may not be considered if they are raised for the first time
later in the decision process. This comment procedure is intended to
ensure that substantive comments and concerns are made available to the
FAA in a timely manner so that the FAA has an opportunity to address
them.
    Before including your address, phone number, email address, or
other personal identifying information in your comment, be advised that
your entire comment--including your personal identifying information--
may be made publicly available at any time. While you can ask us in
your comment to withhold from the public review your personal
identifying information, we cannot guarantee that we will be able to do
so.

    Issued in Washington, DC.
Daniel Murray,
Manager, Safety Authorization Division.
[FR Doc. 2020-25062 Filed 11-12-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 120 (Friday, June 21, 2019)]
[Notices]
[Page 29270]
[FR Doc No: 2019-13279]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-339, OMB Control No. 3235-0382]

Submission for OMB Review; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Schedule 14D-9F

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget this request for extension of the previously approved
collection of information discussed below.
    Schedule 14D-9F (17 CFR 240.14d-103) under the Securities Exchange
Act of 1934 (15 U.S.C. 78 et seq.) is used by any foreign private
issuer incorporated or organized under the laws of Canada or by any
director or officer of such issuer, where the issuer is the subject of
a cash tender or exchange offer for a class of securities filed on
Schedule 14D-1F. The information required to be filed with the
Commission is intended to permit verification of compliance with the
securities law requirements and assures the public availability of such
information. The information provided is mandatory and all information
is made available to the public upon request. We estimate that Schedule
14D-9F takes approximately 2 hours per response to prepare and is filed
by approximately 6 respondents annually for a total reporting burden of
12 hours (2 hours per response x 6 responses).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    The public may view the background documentation for this
information collection at the following website, www.reginfo.gov.
Comments should be directed to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or by sending an email to:
<EMAIL_ADDRESS>and (ii) Charles Riddle, Acting Director/
Chief Information Officer, Securities and Exchange Commission, c/o
Candace Kenner, 100 F Street NE, Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30
days of this notice.

    Dated: June 18, 2019.
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-13279 Filed 6-20-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 178 (Wednesday, September 14, 2011)]
[Notices]
[Page 56776]
[FR Doc No: 2011-23392]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4020-DR; Docket ID FEMA-2011-0001]

New York; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of New York (FEMA-4020-DR), dated August 31, 2011, and
related determinations.

DATES: Effective Date: September 1, 2011.

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

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of New York is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of August 31, 2011.

    Nassau, Rensselaer, and Westchester Counties for Individual
Assistance.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-23392 Filed 9-13-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 85, Number 212 (Monday, November 2, 2020)]
[Rules and Regulations]
[Pages 69148-69149]
[FR Doc No: 2020-23954]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0730; Airspace Docket No. 20-ASO-20]
RIN 2120-AA66

Amendment of the Class E Airspace; Hartford, KY

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends the Class E airspace extending upward from
700 feet above the surface at Ohio County Airport, Hartford, KY. This
action is the result of an airspace review caused by the
decommissioning of the Central City VHF omnidirectional range (VOR)
navigation aid as part of the VOR Minimum Operational Network (MON)
Program. The geographic coordinates of the airport are also being
updated to coincide with the FAA's aeronautical database.

DATES: Effective 0901 UTC, December 31, 2020. The Director of the
Federal Register approves this incorporation by reference action under
Title 1 Code of Federal Regulations part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11E, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11E at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

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

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends the Class E airspace extending upward from 700 feet above
the surface at Ohio County Airport, Hartford, KY, to support instrument
flight rule operations at this airport.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (85 FR 49610; August 14, 2020) for Docket No. FAA-2020-0730 to

amend the Class E airspace extending upward from 700 feet above the
surface at Ohio County Airport, Hartford, KY. Interested parties were
invited to participate in this rulemaking effort by submitting written
comments on the proposal to the FAA. No comments were received.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11E, dated July 21, 2020, and effective September 15,
2020, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11E, Airspace Designations and
Reporting Points, dated July 21, 2020, and effective September 15,
2020. FAA Order 7400.11E is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11E lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to Title 14 Code of Federal Regulations (14 CFR)
part 71 amends the Class E airspace extending upward from 700 feet
above the surface to within a 6.5-mile radius (increased from a 6.4-
mile radius) of Ohio County Airport, Hartford, KY; and updates the
geographic coordinates of the airport to coincide with the FAA's
aeronautical database.
    This action is the result of an airspace review caused by the
decommissioning of the Central City VOR, which provided navigation
information for the instrument procedures at this airport, as part of
the VOR MON Program.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

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

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

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

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

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

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

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

* * * * *

ASO KY E5 Hartford, KY [Amended]

Ohio County Airport
    (Lat. 37[deg]27'31'' N, long. 86[deg]50'59'' W)

    That airspace extending upward from 700 feet or more above the
surface within a 6.5-mile radius of Ohio County Airport.

    Issued in Fort Worth, Texas, on October 26, 2020.
Martin A. Skinner,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2020-23954 Filed 10-30-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 95 (Monday, May 18, 2015)]
[Notices]
[Pages 28339-28340]
[FR Doc No: 2015-11913]

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

Federal Aviation Administration

[Summary Notice No. PE-2015-28]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of the petition or its final disposition.

DATE: Comments on this petition must identify the petition docket
number and must be received on or before June 8, 2015.

ADDRESSES: You may send comments identified by Docket Number FAA-2015-
0726 using any of the following methods:
     Government-Wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Alphonso Pendergrass<PHONE_NUMBER>.
This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on May 13, 2015.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2015-0726.
    Petitioner: Mr. Michael H. LeMee, MED-Trans Corporation.
    Section of 14 CFR Affected: Sec.  43.3(a).
    Description of Relief Sought: On behalf of MED-Trans Corporation,
Mr. Michael LeMee petitions the FAA for an exemption from 14 CFR
43.3(a) to allow properly trained medical personnel to perform the
insertion and removal of litter systems, isolettes and secondary
stretcher systems in the EC-135 and EC-155 aircraft operated by MED-
Trans Corporation.

[FR Doc. 2015-11913 Filed 5-15-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Pages 56129-56131]
[FR Doc No: 2022-19679]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-95685; File No. SR-ICEEU-2022-014]

Self-Regulatory Organizations; ICE Clear Europe Limited; Order
Approving Proposed Rule Change Relating to the ICE Clear Europe
Outsourcing Policy

September 7, 2022.

I. Introduction

    On July 19, 2022, ICE Clear Europe Limited (``ICE Clear Europe'' or
``ICEEU'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to adopt an Outsourcing Policy. The proposed rule
change was published for comment in the Federal Register on August 4,
2022.\3\ The Commission did not receive comments regarding the proposed
rule change. For the reasons discussed below, the Commission is
approving the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Self-Regulatory Organizations; ICE Clear Europe Limited;
Notice of Filing of Proposed Rule Change Relating to the ICE Clear
Europe Outsourcing Policy, Exchange Act Release No. 95394 (July 29,
2022); 87 FR 47809 (Aug. 4, 2022) (File No. SR-ICEEU-2022-014)
(``Notice'').
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

    The proposed rule change would create an Outsourcing Policy to
describe, in a consolidated document, ICEEU's procedures for management
of its outsourcing arrangements with third-party providers and
affiliates, including how ICEEU's board maintains oversight of these
outsourcing arrangements.\4\
---------------------------------------------------------------------------

    \4\ The description that follows is substantially excerpted from
the Notice. Capitalized terms not otherwise defined herein have the
meanings assigned to them in ICEEU's Outsourcing Policy or Rules, as
applicable.
---------------------------------------------------------------------------

    The Outsourcing Policy, as a rule of the clearing agency, is
designed to complement two of ICE Clear Europe's policies: the Vendor
Management Policy (``VMP'') and the Outsourcing Operating Manual
(``OOM''). The VMP describes certain group-wide policies of ICEEU's
parent, Intercontinental Exchange, Inc., with respect to its
outsourcing arrangements with third parties. The OOM sets out
additional details concerning the steps it follows in order to
introduce, amend and maintain outsourcing arrangements. Together with
the VMP, the proposed Outsourcing Policy would document how the ICEEU
assesses the risks of outsourcing certain functions. The Outsourcing
Policy would not represent a change in the ICEEU's current practices,
but rather more clearly document those practices in an overall policy.
    The Outsourcing Policy would include an introduction section that
describes the differences between outsourcing and purchasing services,
the former described as ICEEU's use of a service provider to perform an
ongoing activity that would usually be performed by ICEEU and which
often involves transferring or sharing related non-public proprietary
information, and the latter being ICEEU's purchases of services, goods
and facilities and which would typically not include any transfer of
non-public proprietary information.
    The Outsourcing Policy would also differentiate ICEEU's outsourcing
practices and purchasing arrangements with third-party providers from
those with its affiliates. The Outsourcing Policy would state that
outsourcing through its affiliates typically have a lower risk profile
for ICEEU because affiliates tend to be regulated entities with the
same or similar systems, risk appetites, standards and processes, among
other commonalities, as ICE Clear Europe. The Outsourcing Policy would
also set out ICEEU's overall objectives when considering outsourcing.
    The Outsourcing Policy would include a discussion of outsourcing to
third parties and to ICEEU's affiliates. As mentioned, outsourcing to
third parties is covered under the VMP, which covers due diligence,
risk assessment, suitability, and performance management, among other
topics. Outsourcing to affiliates of ICEEU would follow the same
process and standards as under the VMP; however, assessments would be
performed by ICEEU's senior management rather than the ICEEU's Vendor
Management Office. ICEEU represented that, in all cases, it would look
to ensure that all service provider-related incidents (such as service
interruptions) are recorded, monitored, and escalated to ICEEU's

senior management in a consistent manner.\5\
---------------------------------------------------------------------------

    \5\ See Notice at 47809.
---------------------------------------------------------------------------

    The Outsourcing Policy would provide that ICEEU would consider, in
its assessment of service providers, the lower risk associated in
outsourcing functions to third parties that are also regulated or
authorized. ICEEU would also consider in its assessment of a service
provider how the service provider's presence in a different
jurisdiction impacts the risks associated with outsourcing functions to
that service providers.
    The Outsourcing Policy would also state that ICEEU would look to
manage any potential or actual conflicts of interest resulting from its
outsourcing arrangements, particularly in respect of outsourcing
arrangements it has with its affiliates.
    Additionally, ICE Clear Europe proposes to include in the
Outsourcing Policy that it looks to reserve independent audit rights to
check compliance with legal and regulatory requirements and policies in
its outsourcing agreements with third-party and affiliate service
providers, as required.
    ICE Clear Europe also proposes to include in the Outsourcing Policy
information about its cloud-based outsourcing arrangements. Outsourcing
to the cloud is generally covered under the existing VMP. Relevant ICE
Clear Europe and ICE Group policies, such as the Corporate Information
Security Policy, would also be considered when engaging in cloud
outsourcing arrangements. Adding a new or significantly changing an
existing cloud outsource arrangement would be covered under the OOM.
    The Outsourcing Policy would include a section describing ICEEU's
considerations when deciding whether to outsource a function considered
``critical or important.'' A function is considered by ICEEU to be
``critical or important'' where a defect or failure in its performance
would materially impair the ICEEU's continuing compliance with the
conditions and obligations or its authorizations or other obligations,
financial performance, or the soundness or continuity of its services
and activities.
    The Outsourcing Policy would include an acknowledgment by ICEEU
that outsourcing ``critical or important'' functions could impact
ICEEU's risk profile, ability to oversee the service provider and
manage risks, business continuity measures, and performance of its
business activities. Under the proposed Outsourcing Policy, ICEEU would
ensure that such matters would be considered in the decision-making
processes with respect to outsourcing. Additionally, ``critical or
important'' functions would impact how an outsourcing arrangement is
assessed, documented and managed by ICEEU (including by having an exit
plan, if practical). Also, if a function to be outsourced is or would
be a dependency to the delivery of one or more of ICEEU's important
business services under its operational resilience framework, such
function would be mapped accordingly with appropriate consideration
given to potential vulnerabilities, resiliency, and impact to the
relevant impact tolerances.
    The Outsourcing Policy would also include a discussion of
additional considerations of particular importance to ICEEU, in light
of its position as a systemically important financial market
infrastructure and in alignment with its regulatory oversight. The
proposed Outsourcing Policy would highlight the following additional
items that ICEEU would consider with respect to its outsourcing
arrangements: (i) business continuity arrangements, (ii) incident
management responsiveness and reporting, (iii) independent assurances,
and (iv) redundancies, notice periods and exit strategies. Regarding
business continuity arrangements, the proposed rule change would state
that, during the onboarding process and through periodic reviews and
testing, ICEEU would assess the service provider's business continuity
plans to ensure that they are fit for the relevant purposes. The
proposal would state that incident management and responsiveness and
timely reporting are important factors in ICEEU's outsourcing
arrangements, given the services that ICEEU operates. Accordingly, the
proposal would require that outsourcing providers have appropriate
mechanisms for timely response and incident management. Regarding
independent assurances, the proposal would state that where possible
and practicable, ICEEU would look to collect independent assurances of
the outsourcing providers' services, which may include but are not
limited to SOC2 audits, Regulation SCI audits, and enterprise
technology risk assessments. Finally, the proposed Outsourcing Policy
would state that where possible and practicable, the ICEEU would look
to mitigate the risk of disruption to its services from outsourcing
providers ceasing to provide their services to ICEEU, through
redundancies (the use of multiple providers), sufficient notice
periods, or exit strategies.
    The proposed Outsourcing Policy would also include a section
describing ICEEU's Board oversight of outsourcing arrangements. The
Board oversees ICEEU's outsourcing arrangements through risk appetite
metrics that include service and incident reporting, operational risk
reporting that covers incidents observed in the relevant period, their
resolution and other performance metrics, and an Annual Outsourcing
Assessment Report.
    The proposed Outsourcing Policy would state that the COO or its
delegate would prepare the Annual Outsourcing Assessment Report, which
would be reviewed by the Board each year directly or via its
committees. The Annual Outsourcing Assessment Report would cover the
following topics: (i) the activities and services that are outsourced,
(ii) the identities of the outsource providers, (iii) the performance
of the outsourcing providers and their adherence to agreed service
levels, (iv) where relevant, the security measures of the outsourcing
providers, (v) risk reviews of the outsourcing providers, particularly
those providing critical or important cloud outsourcing arrangements,
(vi) exit strategies and contingency arrangements associated with
outsourcing critical or important functions, and (vii) results and
conclusions of additional assurance mechanisms (for example, SOC2
audits) where applicable.
    Finally, the proposed Outsourcing Policy would describe governance
and exception handling. The document owner would be responsible for
ensuring that it remains up to date and reviewed in accordance with
ICEEU's governance processes. Exceptions to the Outsourcing Policy
would also be approved in accordance with such governance processes.
Any deviations from the Outsourcing Policy would have to be
appropriately escalated and reported in a timely manner by the document
owner, and the document owner would also be responsible for reporting
any material breaches or deviations to the President of ICE Clear
Europe and the Risk Oversight Department in order to determine the
appropriate governance escalation and notification requirements.

III. Discussion and Commission Findings

    Section 19(b)(2)(C) of the Act directs the Commission to approve a
proposed rule change of a self-regulatory organization if it finds that
such proposed rule change is consistent with the requirements of the
Act and the rules and regulations thereunder

applicable to such organization.\6\ For the reasons discussed below,
the Commission finds that the proposed rule change is consistent with
Section 17A(b)(3)(F) of the Act,\7\ and Rules 17Ad-22(e)(2)(v) and
(e)(3)(i) thereunder.\8\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2)(C).
    \7\ 15 U.S.C. 78q-1(b)(3)(F).
    \8\ 17 CFR 240.17Ad-22(e)(2)(v) and (e)(3)(i).
---------------------------------------------------------------------------

A. Consistency With Section 17A(b)(3)(F) of the Act

    Section 17A(b)(3)(F) of the Act requires, among other things, that
the rules of ICE Clear Europe be designed to promote the prompt and
accurate clearance and settlement of securities transactions and, to
the extent applicable, derivative agreements, contracts, and
transactions.\9\ As noted above, the proposed rule change would create
a consolidated policy-level document for managing outsourcing of
services with both third-party providers and affiliates of ICEEU.
Specifically, the proposed rule change would lay out in detail certain
key considerations of ICEEU in outsourcing, including assessing service
providers' operational capabilities, dependencies, resilience,
financial, reputational, legal, and regulatory standing. The proposed
rule change would also include an acknowledgment by ICEEU that
outsourcing critical or important functions could impact its risk
profile, ability to oversee the service provider and manage risks,
business continuity measures, and performance of its business
activities, and would be considered in outsourcing decisions. The
proposed Outsourcing Policy would also include that ICEEU looks to
manage any potential or actual conflicts of interest resulting from its
outsourcing arrangements. The Commission believes that these
overarching considerations, combined with a description of ICEEU's
Board oversight of outsourcing arrangements, would enhance ICEEU's
ability to manage risks associated with outsourcing as they arise as
well as its ability to regularly assess outsourcing providers. The
Commission believes that this in turn should strengthen ICEEU's ability
to carry out its operations, thereby promoting the prompt and accurate
clearance and settlement of securities transactions.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    For these reasons, the Commission believes that the proposed rule
change is consistent with Section 17A(b)(3)(F) of the Act.\10\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

B. Consistency With Rule 17Ad-22(e)(2)(v) Under the Act

    Rule 17Ad-22(e)(2)(v) requires, in relevant part, that ICEEU
establish, implement, maintain, and enforce written policies and
procedures reasonably designed, as applicable, to provide for
governance arrangements that specify clear and direct lines of
responsibility.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 240.17 Ad-22(e)(2)(v).
---------------------------------------------------------------------------

    As noted above, the proposed Outsourcing Policy would explain the
Board's role in overseeing outsourcing arrangements, including through
utilization of risk metrics, operational risk reporting, and the review
of the annual outsourcing assessment report (prepared by the COO).
Further, the proposed rule change would state that the document owner
is responsible for updating the proposed Outsourcing Policy, that any
exceptions to the document would be escalated and reported by the
document holder, and that the document owner would report any material
breaches or deviations to the President of ICEEU and will notify the
Risk Oversight Department in order to determine the appropriate
governance escalation and notification requirements. The Commission
believes that documenting the roles and responsibilities for managing
the proposed Outsourcing Policy in this way provides for governance
arrangements that specify clear and direct lines of responsibility.
    For these reasons, the Commission believes that the proposed rule
change is consistent with Rule 17Ad-22(e)(2)(v).\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 240.17 Ad-22(e)(2)(v).
---------------------------------------------------------------------------

C. Consistency With Rule 17Ad-22(e)(3)(i) Under the Act

    Rule 17Ad-22(e)(3)(i) requires that ICEEU establish, implement,
maintain, and enforce written policies and procedures reasonably
designed to, as applicable, maintain a sound risk management framework
for comprehensively managing legal, credit, liquidity, operational,
general business, investment, custody, and other risks that arise in or
are borne by ICEEU, which includes risk management policies,
procedures, and systems designed to identify, measure, monitor, and
manage the range of risks that arise in or are borne by ICEEU, that are
subject to review on a specified periodic basis and approved by ICEEU's
board of directors annually.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 240.17 Ad-22(e)(3)(i).
---------------------------------------------------------------------------

    Because the proposed Outsourcing Policy described above sets forth
considerations and approaches to measuring, monitoring, and identifying
the risks related to outsourcing arrangements and lays out governance
of this process on an annual basis, the Commission believes that it
strengthens ICEEU's management of a range of risks borne by it which is
also subject to periodic and annual Board review. For example, the
Commission believes that the proposed procedures related to identifying
critical functions (defining a function as ``critical or important''),
the regular assessment of service providers (assessment of service
provider's business continuity plans and timely response to incidents),
and mitigation of risk (through redundancies, notice periods and exit
strategies) from service providers, all support and strengthen ICEEU's
ability to identify, monitor, and measure the risks related to
outsourcing arrangements.
    For these reasons, the Commission believes that the proposed rule
change is consistent with Rule 17Ad-22(e)(3)(i).\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 240.17Ad-22(e)(3)(i).
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposed rule change is consistent with the requirements of the Act,
and in particular, with the requirements of Section 17A(b)(3)(F) of the
Act,\15\ and Rules 17Ad-22(e)(2)(v) and 17Ad-22(e)(3)(i).\16\
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78q-1(b)(3)(F).
    \16\ 17 CFR 240.17Ad-22(e)(2)(i) and (v) and 17 CFR 240.17Ad-
22(e)(3)(i).
---------------------------------------------------------------------------

    It is therefore ordered pursuant to Section 19(b)(2) of the Act
\17\ that the proposed rule change (SR-ICEEU-2022-014), be, and hereby
is, approved.\18\
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(2).
    \18\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-19679 Filed 9-12-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 237 (Wednesday, December 9, 2020)]
[Notices]
[Pages 79177-79178]
[FR Doc No: 2020-27033]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP20-1111-002.
    Applicants: Transcontinental Gas Pipe Line Company.
    Description: Compliance filing GT&C Section 49--Bid Evaluation--
Compliance Filing to be effective 1/2/2021.
    Filed Date: 12/2/20.
    Accession Number: 20201202-5097.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-241-001.
    Applicants: Southern Star Central Gas Pipeline, Inc.
    Description: Compliance filing Annual Cash-Out Activity Report
2020--Correction to be effective N/A.
    Filed Date: 12/2/20.
    Accession Number: 20201202-5129.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-287-000.
    Applicants: Southern Natural Gas Company, L.L.C.
    Description: Compliance filing Abandon Tenneco X-Rate Schedules
Compliance Filing to be effective 2/1/2021.
    Filed Date: 12/2/20.
    Accession Number: 20201202-5013.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-288-000.
    Applicants: Rover Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Summary of Negotiated Rate
Capacity Release Agreements on 12-2-20 to be effective 12/1/2020.
    Filed Date: 12/2/20.
    Accession Number: 20201202-5044.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-289-000.
    Applicants: Northwest Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Non Conforming Service
Agreements--XTO, Citadel, Cascade to be effective 1/2/2021.
    Filed Date: 12/2/20.
    Accession Number: 20201202-5073.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-290-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate--Yankee Gas
510802 eff 12-3-2020 to be effective 12/3/2020.
    Filed Date: 12/2/20.
    Accession Number: 20201202-5100.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-291-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 120220 Negotiated Rates--
Castleton Commodities Merchant Trading R-4010-28 to be effective 12/3/
2020.
    Filed Date: 12/2/20.
    Accession Number: 20201202-5111.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-292-000.
    Applicants: Iroquois Gas Transmission System, L.P.
    Description: Sec.  4(d) Rate Filing: 120220 Negotiated Rates--
Castleton Commodities Merchant Trading R-4010-27 to be effective 12/3/
2020.
    Filed Date: 12/2/20.
    Accession Number: 20201202-5113.
    Comments Due: 5 p.m. ET 12/14/20.

    Docket Numbers: RP21-293-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: REX 2020-12-02 Negotiated Rate
Agreements to be effective 12/2/2020.
    Filed Date: 12/2/20.
    Accession Number: 20201202-5176.
    Comments Due: 5 p.m. ET 12/14/20.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 3, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-27033 Filed 12-8-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Notices]
[Page 68873]
[FR Doc No: 2012-27868]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68199; File No. SR-NASDAQ-2012-059]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Designation of Longer Period for Commission Action on
Proceedings to Determine Whether to Approve or Disapprove Proposed Rule
Change To Establish ``Benchmark Orders'' Under NASDAQ Rule 4751(f)

 November 9, 2012.
    On May 1, 2012, The NASDAQ Stock Market LLC (``NASDAQ'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to establish various ``Benchmark Orders'' under
NASDAQ Rule 4751(f). The proposed rule change was published for comment
in the Federal Register on May 17, 2012.\3\ On June 26, 2012, the
Commission extended to August 15, 2012, the time period in which to
approve the proposed rule change, disapprove the proposed rule change,
or institute proceedings to determine whether to disapprove the
proposed rule change.\4\ On August 14, 2012, the Commission instituted
proceedings to determine whether to approve or disapprove the proposed
rule change.\5\ In response to the Order Instituting Proceedings, the
Commission received two comment letters on the proposed rule change.\6\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 66972 (May 11,
2012), 77 FR 29435 (May 17, 2012) (``Notice'').
    \4\ See Securities Exchange Act Release No. 67258 (June 26,
2012), 77 FR 39314 (July 2, 2012).
    \5\ See Securities Exchange Act Release No. 67655 (August 14,
2012), 77 FR 50191 (August 20, 2012) (``Order Instituting
Proceedings.'').
    \6\ See Letters to the Commission from James J. Angel, dated
August 16, 2012; and Theodore R. Lazo, Managing Director and
Associate General Counsel, SIFMA, dated October 5, 2012.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \7\ provides that, after initiating
proceedings, the Commission shall issue an order approving or
disapproving the proposed rule change not later than 180 days after the
date of publication of notice of the filing. The Commission may,
however, extend the period for issuing an order approving or
disapproving the proposed rule change by up to 60 days if the
Commission determines that a longer period is appropriate and publishes
the reasons for such determination. In this case, the proposed rule
change was published for notice and comment in the Federal Register on
May 17, 2012; November 13, 2012, is 180 days from that date, and
January 12, 2013, is 240 days from that date.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to issue an order approving or disapproving the proposed
rule change so that it has sufficient time to consider the proposal and
the issues that commenters have raised concerning the proposal.
    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\8\ designates January 12, 2013, as the date by which the
Commission shall either approve or disapprove the proposed rule change
(File No. SR-NASDAQ-2012-059).
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
Kevin M. O'Neill,
Deputy Secretary.
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

[FR Doc. 2012-27868 Filed 11-15-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 154 (Friday, August 9, 2019)]
[Notices]
[Pages 39340-39341]
[FR Doc No: 2019-17053]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3019]

Transit Times to Slaughter Facilities, Milking Frequency, and
Interpretation of Zero-Day Withdrawal Periods and Zero-Day Milk Discard
Times Assigned to New Animal Drugs; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
soliciting comments on transit times to slaughter, milking frequency,
and how end users interpret zero-day withdrawal period or zero-day milk
discard time statements found on new animal drug labeling.

DATES: Submit either electronic or written comments by October 8, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 8, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 8, 2019. Comments
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 that date.

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-2019-N-3019 for ``Transit Times to Slaughter Facilities, Milking
Frequency, and Interpretation of Zero-Day Withdrawal Periods and Zero-
Day Milk Discard Times Assigned to New Animal Drugs.'' 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: Charli M. Long-Medrano, Center for
Veterinary Medicine (HFV-150), Food and Drug Administration, 7500
Standish Place, Rm. E340, Rockville, MD 20855,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    New animal drugs are assigned withdrawal periods and milk discard
times when approved for use in food-producing animals. The withdrawal
period or milk discard time is the interval between the time of the
last administration of a new animal drug and the time when the animal
can be slaughtered safely for human food or the milk can be consumed
safely by humans, respectively.\1\ Zero-day withdrawal periods and
zero-day milk discard times are assigned to new animal drugs when the
labeling indications and directions (i.e., the approved conditions of
use) allow entry of edible tissues, including milk, into the human food
supply without regard to the elapsed time following the last drug
administration.\2\ In most instances, we assign a zero-day withdrawal
period or zero-day milk discard time to new animal drugs when data or
information demonstrate that edible tissues or milk can be consumed
safely at timepoints known as practical zero withdrawal or practical
zero-milk discard time, respectively. Practical zero withdrawal \3\ and
practical zero-milk discard time are

the shortest time intervals, including transit time to a slaughter
facility, between administration of the last dose of the drug and
slaughter or collection of milk for human consumption, respectively.
---------------------------------------------------------------------------

    \1\ Guidance for Industry #3, ``General Principles for
Evaluating the Human Food Safety of New Animal Drugs Used in Food-
Producing Animals'' (https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052180.pdf).
    \2\ Guidance for Industry #207 (VICH GL48), ``Studies to
Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in
Food-producing Animals: Marker Residue Depletion Studies to
Establish Product Withdrawal Periods'' (https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM207941.pdf).
    \3\ Ibid.
---------------------------------------------------------------------------

    Since the 1980s, the Agency has assumed that poultry spent at least
6 hours in transit to a slaughter facility, cattle and pigs spent at
least 12 hours in transit to a slaughter facility, and dairy cows were
milked at 12-hour intervals. These assumptions led the Agency to define
practical zero withdrawal as 6 hours for poultry and 12 hours for
cattle and pigs and practical zero-milk discard time as 12 hours for
lactating dairy cows. Accordingly, we currently assign a zero-day
withdrawal period or zero-day milk discard time to new animal drugs if
data from scientific studies or other available information confirm
that residue concentrations in edible tissues or milk from treated
animals are safe for human consumption after 6 hours withdrawn from
drug for poultry or after 12 hours withdrawn from drug for cattle,
pigs, sheep, goats, and lactating dairy animals (i.e., practical zero
withdrawal and practical zero-milk discard time). A zero-day withdrawal
period or zero-day milk discard time is often communicated to the end
user by a labeling statement (e.g., ``zero-day withdrawal period,''
``zero-day milk discard time,'' or ``no withdrawal period or milk
discard time is required'').
    The concept of practical zero withdrawal does not apply to drugs
administered to laying hens (eggs only), food-producing aquatic
animals, or honey bees. In these situations, we apply an ``absolute
zero withdrawal approach,'' meaning that collection time or transit
time is not considered and drug residues in eggs from treated hens,
edible tissues from treated food-producing aquatic animals, and honey
from treated honey bees must be below the assigned tolerance at all
times during and after administration of a drug that has been assigned
a zero-day withdrawal. Samples intended to support a zero-day
withdrawal in these species are collected while animals are on the drug
or immediately following the final drug administration.

II. Issues for Consideration

    We recognize that the animal agriculture industry has undergone
significant changes since the 1980s, when the current assumptions about
transit time to slaughter and milking frequency were formulated. An
accurate understanding of current industry practices and the end user's
interpretation of labeling statements is necessary to approve labeling
that ensures the safe and effective use of new animal drugs, which is
central to our mission to protect and promote public health. Therefore,
we are requesting comments on current industry practices regarding
transit times to slaughter for food-producing animals, milking
frequency, and how end users interpret a zero-day withdrawal period or
zero-day milk discard time. We welcome comments on these topics for all
food-producing animals except laying hens, honey bees, and food-
producing aquatic animals because, as noted earlier, the concept of
practical zero withdrawal does not apply to these classes of food-
producing animals.
    We invite comments on any or all the questions from individuals
with direct knowledge of current industry practices. Please include the
sector within the industry from where this information is derived
(e.g., a veterinarian, cooperative, individual producer, hauler, trade
organization, packers and processors, etc.), as well as the source of
the information (e.g., survey, farm practices, published information,
etc.) We specifically request comment on the following:
    1. What is the minimum amount of time that food-producing animals
spend in transit to a slaughter facility in the United States (i.e.,
minimum transit time)? Please include the animal species and animal
class(es) for each time provided.
    2. What is the minimum amount of time that food-producing animals
spend at slaughter facilities in the United States prior to being
slaughtered for human consumption (i.e., minimum holding time)? Please
include the animal species and animal class(es) for each time provided.
    3. What milking frequencies do United States commercial dairy
operations commonly use (e.g., two times per day, three times per day,
greater than three times per day)? To what extent is each milking
frequency used nationally, regionally, or within a particular sector
(e.g., 25 percent of dairies nationally, 30 percent of dairies in the
Midwest, 50 percent of dairies serviced by a veterinary practice,
etc.)?
    4. How do end users of new animal drugs interpret labeling that has
a ``zero-day withdrawal period'' or ``zero-day milk discard time,'' or
that states ``no withdrawal period or milk discard time is required''?
    We will consider the submitted comments to evaluate if our current
approach to assigning zero-day withdrawal periods and zero-day milk
discard times to new animal drugs is appropriate.

    Dated: August 5, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17053 Filed 8-8-19; 8:45 am]
 BILLING CODE 4164-01-P