ConTegoTM Pro SL

Plant Growth Regulator

SOLUBLE LIQUID

S-Abscisic Acid (10.0%)

FOR USE ON

ORNAMENTAL PLANTS

Active Ingredient

S-Abscisic Acid
..........................................................…………
…...............................   10.0% w/v

Other
Ingredients....................................................………
……...................................    90.0% w/v

Total...................................................................
.....……………..................................   100.0% w/v

Contains a total of  10 g of Abscisic Acid (S-ABA) in 100 ml of product.
 S-Abscisic acid, commonly known as S-ABA, is a naturally occurring
growth regulator found in plants.  Application of S-ABA to ornamental
plants causes stomata to close, reduces water usage, and thus allows
plants to conserve water and withstand environmental stress.

This container will treat 1890 square feet when applied at the maximum
rate.

KEEP OUT OF REACH OF CHILDREN

CAUTION

See next panel for First Aid Information.

EPA Registration No.  73049-UAE

EPA Establishment No.	33762-IA-001

This label must be in the possession of the user at the time of
pesticide application.

Permittee:

Valent BioSciences Corporation

870 Technology Way

Libertyville, IL 60048

1-847-968-4700

Net Contents:  34 fl. oz.   (1000 ml)

FIRST AID

If in eyes	Hold eye open and rinse slowly and gently with water for
15-20 minutes.

Remove contact lenses, if present, after the first 5 minutes, then
continue rinsing eye.

Call a poison control center or doctor for treatment advice.

HOT LINE NUMBER

Have the product container or label with you when calling a poison
control center or doctor, or going for treatment.   You may also call
toll-free 1-800-892-0099 (24 hours) for emergency medical treatment
and/or transport emergency information.  For all other information, call
1-847-968-4700.

PRECAUTIONARY STATEMENTS

HAZARDS TO HUMANS & DOMESTIC ANIMALS

CAUTION: Causes moderate eye irritation.  Avoid contact with eyes or
clothing. Wash thoroughly with soap and water after handling and before
eating, drinking, chewing gum, using tobacco or using the toilet.

Personal Protective Equipment (PPE)

Applicators and other handlers must wear:

Long-sleeved shirt and long pants.

Shoes plus socks.

Follow the manufacturer's instructions for cleaning/maintaining PPE.  If
no such instructions for washables, use detergent and hot water.  Keep
and wash PPE separately from other laundry.

User Safety Recommendations

Users should:

Wash hands before eating, drinking, chewing gum, using tobacco or using
the toilet

Remove clothing/PPE immediately if pesticide gets inside.  Then wash
thoroughly and put on clean clothing.

Remove PPE immediately after handling this product.  As soon as
possible, wash thoroughly and change into clean clothing.

ENVIRONMENTAL HAZARDS

Do not apply directly to water, or to areas where surface water is
present or to intertidal areas below the mean high water mark.  Do not
contaminate water when disposing of equipment wash-water or rinsate.

DIRECTIONS FOR USE

It is a violation of Federal law to use this product in a manner
inconsistent with the terms of the Label.  Do not apply this product in
a way that will contact workers or other persons, either directly or
through drift.  Only protected handlers may be in the area during
application.  For any requirements specific to your State or Tribe,
consult the State or Tribal agency responsible for pesticide regulation.

AGRICULTURAL USE REQUIREMENTS

Use this product only in accordance with its labeling and with the
Worker Protection Standard, 40 CFR Part 170.  This Standard contains
requirements for the protection of agricultural workers on farms,
forests, nurseries, and greenhouses, and handlers of agricultural
pesticides.  It contains requirements for training, decontamination,
notification, and emergency assistance.  It also contains specific
instructions and exceptions pertaining to the statements on this label
about personal protective equipment (PPE), and restricted-entry
interval.  The requirements in this box only apply to uses of this
product that are covered by the Worker Protection Standard.

Do not enter or allow worker entry into treated areas during the
restricted entry interval (REI) of 4 hours.

PPE required for early entry to treated areas that is permitted under
the Worker Protection Standard and that involves contact with anything
that has been treated, such as plants, soil, or water is:

Long-sleeved shirt and long pants (or Coveralls).

Chemical resistant gloves (made of any waterproof material).

Shoes plus socks.

GENERAL DIRECTIONS FOR USE ON ORNAMENTALS

Use only as directed.  Read the label thoroughly and make sure it is
understood before making applications.  ConTegoTM Pro SL reduces
transpiration and delays wilting of ornamental plants caused by
environmental stresses.

Application instructions:

ConTegoTM Pro SL contains the active ingredient S-abscisic acid,
commonly known as S-ABA.  S-ABA is a potent Plant Growth Regulator, a
naturally occurring biochemical found in plants.

Under drought conditions, endogenous S-ABA levels increase in leaves.
S-ABA in turn signals stomata to close and thus reduces water loss and
controls water usage by the plant.  Similarly, exogenous application of
S-ABA causes stomata to close, reduces water usage, and thus allows
plants to conserve water.  S-ABA significantly reduces transpiration and
delays wilting of ornamental plants caused by environmental stress,
resulting in more desirable plants.

Undesired effects can result from any deviations from the label
directions in the rates, timings, water volumes, or the adoption of
untested spray mixes, when applying ConTegoTM Pro SL.

To prepare the treatment solution, add the required amount ConTegoTM Pro
SL to a clean spray tank about half-filled with the water.  Agitate
while bringing the total volume of water to the required level.  Mix
thoroughly with agitation and bypass circulation to completely mix the
ConTegoTM Pro SL, and then add surfactant.  Discard any unused treatment
solution at the end of each day following local, state or federal law.

Best results will be achieved from applications during the cooler parts
of the day, avoiding the hottest period of the day.  To maximize
absorption and optimize product effectiveness, apply ConTegoTM Pro SL
under slow drying conditions, e.g. early in the morning or in the
evening (cool to warm temperatures, medium to high relative humidity,
and no wind).

Do not apply ConTegoTM Pro SL to plants under stress (e.g. heat, water,
disease and insect).  Injured or stressed plants will show a reduced
response to ConTegoTM Pro SL or may show phytotoxicity.

Do not overhead irrigate treated plants for at least 6 hours following
application of ConTegoTM Pro SL.

Compatibility With Other Agricultural Products

Compatibility and performance data for ConTegoTM Pro SL with other
agricultural products is not available.  Do not mix with other
agricultural products except an adjuvant (surfactant) suitable for use
on ornamental plants.

APPLICATIONS, RATES, AND TIMINGS

Ornamental PLANTS (non-food crops)

CROP	OBJECTIVE /

 BENEFIT	APPLICATION INSTRUCTIONS

Ornamental plants such as potted flowers, bedding, perennial, nursery
and foliage plants.

Although extensive testing has been conducted with ConTegoTM Pro SL, not
all varieties of ornamental plants have been evaluated.  It is highly
recommended that a small number of plants be tested for undesirable
effects of ConTegoTM Pro SL before treating a large number of plants.

	For reduction of stress from lack of water and delay of wilting in
production and post- production of ornamental plants.

Contact Valent BioSciences Corporation for more information.

Spray Applications:  Apply up to 2.4 ounces of ConTegoTM Pro SL) per
gallon as a foliar spray to fully hydrated plants at 2-3 quarts of final
use solution /100 square feet.  Ensure adequate coverage of the plant.

Table 1:  ConTegoTM Pro SL - Dilution Table for ORNAMENTALS

PPM  S-ABA  Desired	Fluid Oz.

Per

Gallon	Fluid Oz.

Per

10 Gallons	Milliliters

Per

Gallon	Milliliters

Per

10 Gallons

125	0.15	1.5	4.8	48

250	0.3	3.0	9.5	95

500	0.6	6.0	19.0	190

1000	1.2	12.0	38.0	380

2000	2.4	24.0	76.0	760

FACTORS AFFECTING ORNAMENTAL PLANT RESPONSE TO ConTegoTM Pro SL

S-ABA is a potent Plant Growth Regulator, a naturally occurring
biochemical found in plants.  S-ABA signals stomata to close and thus
reduces water loss and controls water usage by the plant.  S-ABA
significantly reduces transpiration and delays wilting of ornamental
plants caused by environmental stress, resulting in more desirable
plants.

In addition to proper application technique, environmental and cultural
factors will affect a plant’s response to treatment with ConTegoTM Pro
SL.

Different varieties or cultivars within a given plant species may
require a higher or lower rate of ConTegoTM Pro SL to achieve the
desired delay in wilting.

Temperature and humidity can be an important factor in a plant’s
response to ConTegoTM Pro SL. Hot dry weather will result in a shorter
duration of effect from S-ABA applications.

Apply in the morning or evening when conditions are best for slow drying
of applied material, in order to ensure adequate absorption of the
product.

Overhead irrigation within 6 hours after application will reduce product
activity.

Use of Adjuvants: An adjuvant suitable for use on ornamental plants will
likely increase ConTegoTM Pro SL product uptake, efficacy and potential
for negative effects. For optimal response, use ConTego with Capsil at 6
ounces per 100 gallons.

Determining Optimal Rates:  Optimal ConTegoTM Pro SL rates will vary
according to the desired wilt delay, growing conditions & practices,
application technique, and environmental conditions.  Different
varieties or cultivars of the same species may respond differently to
ConTegoTM Pro SL.  Therefore, to determine response levels and or
phyto-toxicity potential, treat a small number of plants (using
application rates specified in Table 1) before applying ConTegoTM Pro SL
to a large number of plants.  With increasing temperature and lower
humidity consider using the higher rates within the range given in Table
1, remembering not to apply to plants that are already under stress.

DO NOT exceed the maximum stated rate from Table 1.

ChemigatioN

Apply this product only through the following systems:

	1) Overhead sprinklers, such as impact, micro-sprinklers, or booms.

Do not apply this product through any other type of irrigation system.
Crop injury, lack of effectiveness, or illegal pesticide residues in the
crop can result from non-uniform distribution of treated water.  If you
have questions about calibration, you should contact State Extension
Service specialists, equipment manufacturers or other experts.  Do not
connect an irrigation system (including greenhouse systems) used for
pesticide application to a public water system unless the pesticide
label prescribed safety devices for public water systems are in place.
A person knowledgeable of the chemigation system and responsible for its
operation or under the supervision of the responsible person, shall shut
the system down and make necessary adjustments should the need arise.

CHEMIGATION SYSTEMS CONNECTED TO PUBLIC WATER SYSTEMS

Public water system means a system for the provision to the public of
piped water for human consumption if such system has at least 15 service
connections or regularly serves an average of at least 25 individuals
daily at least 60 days out of the year.  Chemigation systems connected
to public water systems must contain a functional, reduced pressure
zone, backflow preventer (RPZ) or the functional equivalent in the water
supply line upstream from the point of pesticide introduction.  As an
option to the RPZ, the water from the public water system should be
discharged into a reservoir tank prior to pesticide introduction.  There
shall be a complete physical break (air gap) between the outlet end of
the fill pipe and the top or overflow rim of the reservoir tank of at
least twice the inside diameter of the fill pipe.  The pesticide
injection pipeline must contain a functional, automatic, quick closing
check valve to prevent the flow of fluid back toward the injection pump.

The pesticide injection pipeline must contain a functional, normally
closed, solenoid-operated valve located on the intake side of the
injection pump and connected to the system interlock to prevent fluid
from being withdrawn from the supply tank when the irrigation system is
either automatically or manually shut down.  The system must contain
functional interlocking controls to automatically shut off the pesticide
injection pump when the water pump motor stops, or in cases where there
is no water pump, when the water pressure decreases to the point where
pesticide distribution is adversely affected.  Systems must use a
metering pump, such as a positive displacement injection pump (e.g.
diaphragm pump) effectively designed and constructed of materials that
are compatible with pesticides and capable of being fitted with a system
interlock.

SPRINKLER and SPRAY  -  IRRIGATION

The system must contain a functional check valve, vacuum relief valve,
and low-pressure drain appropriately located on the irrigation pipeline
to prevent water source contamination from backflow.

The pesticide injection pipeline must contain a functional, automatic,
quick closing check valve to prevent the flow of fluid back toward the
injection pump.

The pesticide injection pipeline must also contain a functional,
normally closed, solenoid-operated valve located on the intake side of
the injection pump and connected to the system interlock to prevent
fluid from being withdrawn from the supply tank when the irrigation
system is either automatically or manually shut down.

The system must contain functional interlocking controls to
automatically shut off the pesticide injection pump when the water pump
motor stops.

The irrigation line or water pump must include a functional pressure
switch, which will stop the water pump motor when the water pressure
decreases to the point where pesticide distribution is adversely
affected.

Systems must use a metering pump, such as a positive displacement
injection pump (e.g. diaphragm pump) effectively designed and
constructed of materials that are compatible with pesticides and capable
of being fitted with a system interlock.

Fill the supply tank with the desired amount of water. Then add the
amount of ConTegoTM Pro SL required in order to achieve the selected
final use solution rate.  Agitate the mixture of ConTegoTM Pro SL
frequently during the chemigation period to assure a uniform
distribution throughout the system.

Apply ConTegoTM Pro SL continuously for the duration of the water
application but do not exceed maximum rates and volumes stated in Table
1.  For overhead applications apply at a volume of 2 to 3 quarts of
final use solution per 100 sq. ft.

STORAGE AND DISPOSAL

Do not contaminate water, food or feed by storage or disposal.

Pesticide Storage

Keep container tightly closed when not in use. Store product in a cool
and dry place.  Avoid extended storage conditions at temperatures above
25°C (77°F).  Avoid exposure of product to light or sunlight.

Pesticide Disposal

To avoid wastes, use all material in this container by application
according to label directions.  If wastes cannot be avoided, offer
remaining product to a waste disposal facility or pesticide disposal
program (often such programs are run by state or local governments or by
industry).

Container Handling

Nonrefillable container.  Do not reuse or refill this container.  Triple
rinse container (or equivalent) promptly after emptying.  Triple rinse
as follows: Empty the remaining contents into application equipment or a
mix tank and drain for 10 seconds after flow begins to drip.  Fill the
container ¼ full with water and recap.  Shake for 10 seconds.  Pour
rinsate into application equipment or a mix tank or store rinsate for
later use or disposal.  Drain for 10 seconds after the flow begins to
drip.  Repeat this procedure two more times.  Offer for recycling, if
available or puncture and dispose of the container in a sanitary
landfill, or by other procedures approved by state and local
authorities.

Warranty and Disclaimer Statement:

To the fullest extent permitted by law, seller makes no warranty,
express or implied, of merchantability, fitness or otherwise concerning
use of this product other than as indicated on the label.  User assumes
all risks of use, storage or handling not in strict accordance with
accompanying directions.

Valent BioSciences Corp.     ©2009

   Page   PAGE  1  of   NUMPAGES  9 		S-Abscisic acid, (S-ABA)

		  Ornamental – Soluble Liquid – Use Label


[Federal Register Volume 87, Number 174 (Friday, September 9, 2022)]
[Notices]
[Pages 55434-55435]
[FR Doc No: 2022-19506]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2019-E-3162 and FDA-2019-E-3165]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for ORILISSA and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of patents which claim that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by November 8, 2022.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by March 8, 2023. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 8, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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 Nos.
FDA-2019-E-3162 and FDA-2019-E-3165 for Determination of Regulatory
Review Period for Purposes of Patent Extension; ORILISSA. 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,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug

product, medical device, food additive, or color additive) was subject
to regulatory review by FDA before the item was marketed. Under these
acts, a product's regulatory review period forms the basis for
determining the amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, ORILISSA
(elagolix sodium) indicated for the management of moderate to severe
pain associated with endometriosis. Subsequent to this approval, the
USPTO received patent term restoration applications for ORILISSA (U.S.
Patent Nos. 7,056,927 and 7,419,983) from Neurocrine Biosciences, Inc.
and the USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated October 29,
2019, FDA advised the USPTO that this human drug product had undergone
a regulatory review period and that the approval of ORILISSA
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
ORILISSA is 5,452 days. Of this time, 5,117 days occurred during the
testing phase of the regulatory review period, while 335 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
August 21, 2003. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on August
21, 2003.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: August 23,
2017. FDA has verified the applicant's claim that the new drug
application (NDA) for ORILISSA (NDA 210450) was initially submitted on
August 23, 2017.
    3. The date the application was approved: July 23, 2018. FDA has
verified the applicant's claim that NDA 210450 was approved on July 23,
2018.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 5 years of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: August 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19506 Filed 9-8-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Rules and Regulations]
[Pages 21637-21641]
[FR Doc No: 2021-08558]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0311; Project Identifier MCAI-2021-00244-E;
Amendment 39-21517; AD 2021-09-04]
RIN 2120-AA64

Airworthiness Directives; Austro Engine GmbH Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Austro Engine GmbH E4 and E4P model diesel piston engines. This AD was
prompted by reports of an oil pump blockage on E4 model diesel piston
engines. This AD requires replacing a certain oil pump as well as the
oil filter and engine oil. The FAA is issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective May 10, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of May 10,
2021.
    The FAA must receive comments on this AD by June 7, 2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this final rule, contact
Austro Engine GmbH, Rudolf-Diesel-Strasse 11, 2700 Weiner Neustadt,
Austria; phone: +43 2622 23000 2525; website: www.austroengine.at. You
may view this service information at the FAA, Airworthiness Products
Section, Operational Safety Branch, 1200 District Avenue, Burlington,
MA 01803. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0311.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0311; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, the
mandatory continuing airworthiness information (MCAI), any comments
received, and other information. The street address for the Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Wego Wang, Aviation Safety Engineer,
ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone:
(781) 238-7134; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The European Union Aviation Safety Agency (EASA), which is the
Technical Agent for the Member States of the European Community, issued
EASA Emergency AD 2021-0055-E, dated February 25, 2021. EASA Emergency
AD 2021-0055-E was revised by EASA AD 2021-0055R1, dated March 10,
2021. EASA AD 2021-0055R1 was superseded by EASA AD 2021-0094, dated
March 31, 2021 (referred to after this as ``the MCAI''), to address the
unsafe condition on these products. The MCAI states:

    Occurrences were reported of oil pump blockage on E4-A and E4-B
engines. Subsequent investigation determined that the blockage was
caused by oil contamination with casting sand from the production
process of oil pump P/N E4A-50-000-BHY. A blocked oil pump causes
failure of the engine lubrication system. The root cause was found
in the sand casted oil pump housing cleaning process, which was not
properly performed.
    This condition, if not corrected, could lead to engine in-flight
shut-down with consequent forced landing, possibly resulting in
damage to the aeroplane and injury to occupants.
    To address this potential unsafe condition, Austro Engine
published the SB at original issue (later revised to add affected
part s/n) to provide instructions to replace the affected oil pumps,
and EASA issued AD 2021-0055-E to require replacement of affected
parts, and replacement of the oil and filter.

Subsequently, [EASA] AD 2021-0055R1 was issued to refer to the SB at
Revision 2, where certain engines were removed from the
applicability. The SB at Revision 2 also expanded the list of
affected part s/n, but without impact on [EASA] AD compliance, as
all added s/n were still in stock and would not be delivered to
operators anymore. Since that [EASA] AD was issued, it was
determined that affected parts are installed on additional engines,
and Austro Engine published the SB at Revision 3 to correct the list
of affected engine s/n. An additional oil pump replacement option
was introduced with SB Revision 4 (with no further change to the
list of affected engines/parts).
    For the reason described above, this [EASA] AD retains the
requirements of EASA AD 2021-0055R1, which is superseded, and refers
to the SB at Revision 4 (including the additional engine s/n and the
new oil pump replacement option). This [EASA] AD also expands the
Applicability to include all engines where the affected part is
eligible for installation, and prohibits (re)installation of an
affected part on all engines.

    You may obtain further information by examining the MCAI in the AD
docket at https://www.regulations.gov by searching for and locating
Docket No. FAA-2021-0311.

FAA's Determination

    This product has been approved by EASA and is approved for
operation in the United States. Pursuant to our bilateral agreement
with the European Community, EASA has notified the FAA of the unsafe
condition described in the MCAI and service information. The FAA is
issuing this AD because the agency evaluated all the relevant
information provided by EASA and determined the unsafe condition
described previously is likely to exist or develop in other products of
the same type design.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Austro Engine GmbH Mandatory Service Bulletin No.
MSB-E4-030/4, Revision No. 4, dated March 30, 2021 (the MSB). This
service information specifies procedures for replacing the affected oil
pumps installed on E4 and E4P model diesel piston engines. This service
information also specifies procedures for replacing the oil filter and
engine oil installed on these engines. In addition, this service
information identifies the applicable serial numbers (S/Ns) of affected
E4 and E4P model diesel piston engines, the affected oil pumps
requiring replacement, and an additional oil pump replacement option.
This service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

AD Requirements

    This AD requires removing the affected oil pump from service and
replacing it with a part eligible for installation. This AD also
requires replacing the oil filter and engine oil.

Differences Between the AD and the MCAI or Service Information

    The MSB specifies that the removed oil pump must be returned to
Austro Engine GmbH. The MSB specifies that information, including the
engine flight hours (FHs) recorded at the time of the oil pump
replacement, must be sent to Austro Engine GmbH. This AD does not
mandate sending the removed oil pump or information, including the
engine flight hours recorded at the time of oil pump replacement, to
Austro Engine GmbH.
    The MSB also specifies that for all engines with 10 FHs or less, to
replace the affected oil pump, oil filter, and engine oil before the
next flight. Whereas, this AD requires, for Group 1 and Group 2 engines
with 10 FHs or less, replacement of the affected oil pump, oil filter,
and engine oil within 30 days, before accumulating 10 FHs, or during
the next scheduled maintenance, whichever occurs first after the
effective date of this AD.

Interim Action

    The FAA considers this AD an interim action. If final action is
later identified, the FAA might consider further rulemaking.

Justification for Immediate Adoption and Determination of the Effective
Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency, for ``good cause,'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules effective in less than thirty days,
upon a finding of good cause.
    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies foregoing notice and comment prior to adoption of this rule.
The FAA received reports of an oil pump blockage on the E4, configured
as E4-A and E4-B, model diesel piston engines. The manufacturer
subsequently determined that the blockage was caused by oil
contamination with casting sand from the production process of the oil
pump. Austro Engine issued service information providing instructions
for replacement of a certain oil pump, oil filter, and engine oil
installed on E4 and E4P model diesel piston engines.
    A blocked oil pump can result in failure of the engine lubrication
system, resulting in failure of the engine, in-flight shutdown, and
loss of the airplane. The FAA considers a blocked oil pump to be an
urgent safety issue that requires immediate action to avoid loss of the
airplane. Accordingly, notice and opportunity for prior public comment
are impracticable and contrary to the public interest pursuant to 5
U.S.C. 553(b)(3)(B). In addition, the FAA finds that good cause exists
pursuant to 5 U.S.C. 553(d) for making this amendment effective in less
than 30 days, for the same reasons the FAA found good cause to forego
notice and comment.

Comments Invited

    The FAA invites you to send any written data, views, or arguments
about this final rule. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2021-0311 and Project Identifier
MCAI-2021-00244-E'' at the beginning of your comments. The most helpful
comments reference a specific portion of the final rule, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this final rule.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private,

that you actually treat as private, and that is relevant or responsive
to this AD, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this AD. Submissions containing CBI should be sent to Wego
Wang, Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803. Any commentary that the FAA receives which is not
specifically designated as CBI will be placed in the public docket for
this rulemaking.

Regulatory Flexibility Act

    The requirements of the Regulatory Flexibility Act (RFA) do not
apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt
a rule without prior notice and comment. Because FAA has determined
that it has good cause to adopt this rule without prior notice and
comment, RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 55 engines installed on
airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Remove and replace the oil pump, oil    16 work-hours x $85 per           $1,488          $1,360         $74,800
 filter, and engine oil.                 hour = $1,360.
----------------------------------------------------------------------------------------------------------------

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected operators.

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.
    The FAA is 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

    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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    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 airworthiness
directive:

2021-09-04 Austro Engine GmbH: Amendment 39-21517; Docket No. FAA-
2021-0311; Project Identifier MCAI-2021-00244-E.

(a) Effective Date

    This airworthiness directive (AD) is effective May 10, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Austro Engine GmbH E4 and E4P model
diesel piston engines.

(d) Subject

    Joint Aircraft System Component (JASC) Code 8550, Reciprocating
Engine Oil System.

(e) Unsafe Condition

    This AD was prompted by reports of an oil pump blockage on the
E4 model diesel piston engines. The FAA is issuing this AD to
prevent failure of the engine lubrication system. The unsafe
condition, if not addressed, could result in failure of the engine,
in-flight shutdown, and loss of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    Within the compliance time specified in Table 1 to paragraph (g)
of this AD:
    (1) Remove the oil pump, part number (P/N) E4A-50-000-BHY, from
service and replace with a part eligible for installation using the
Accomplishment/Instructions, paragraph 2.2.1 or paragraph 2.2.2, of
Austro Engine GmbH Mandatory Service Bulletin No. MSB-E4-030/4,
Revision 4, dated March 30, 2021 (the MSB), as applicable.
    (2) Replace the oil filter and engine oil using the
Accomplishment/Instructions, paragraph 2.2.1 or paragraph 2.2.2, of
the MSB, as applicable.

[GRAPHIC] [TIFF OMITTED] TR23AP21.000

(h) No Reporting Requirements

    The reporting requirements in the Accomplishment/Instructions,
paragraph 2.2., of the MSB, are not required by this AD.

(i) Installation Prohibition

    After the effective date of this AD, do not install onto any
engine an oil pump having a P/N and serial number (S/N) listed in
paragraph 1.2., Engines Affected, of the MSB.

(j) Definitions

    For the purpose of this AD:
    (1) Group 1 engines are E4 model diesel piston engines in
configuration ``-A'' that are installed on single-engine airplanes.
    (2) Group 2 engines are E4 model diesel piston engines in
configuration ``-B'' or ``-C'' and E4P model diesel piston engines
that are installed on twin-engine airplanes.
    (3) A part eligible for installation is an oil pump with a P/N
and S/N that is not listed in paragraph 1.2., Engines Affected, of
the MSB.

(k) Credit for Previous Actions

    You may take credit for replacing the oil pump, oil filter, and
engine oil required by paragraph (g) of this AD if you performed
these replacements before the effective date of this AD using the
Accomplishment/Instructions, paragraph 2.2., of Austro Engine GmbH
MSB No. MSB-E4-030, Original Issue, dated February 18, 2021;
Revision 1, dated February 23, 2021; Revision 2, dated March 3,
2021; or Revision 3, dated March 18, 2021.

(l) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
certification office, send it to the attention of the person
identified in Related Information. Information may be emailed to:
<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(m) Related Information

    (1) For more information about this AD, contact Wego Wang,
Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) Refer to European Union Aviation Safety Agency (EASA) AD
2021-0094, dated March 31, 2021, for more information. You may
examine the EASA AD in the AD docket at https://www.regulations.gov
by searching for and locating it in Docket No. FAA-2021-0311.

(n) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Austro Engine GmbH Mandatory Service Bulletin No. MSB-E4-
030/4, Revision 4, dated March 30, 2021.
    (ii) [Reserved]
    (3) For service information identified in this AD, you may
contact Austro Engine GmbH, Rudolf-Diesel-Strasse 11, 2700 Weiner
Neustadt, Austria; phone: +43 2622 23000 2525; website:
www.austroengine.at.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 1200
District Avenue, Burlington, MA 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this 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, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on April 14, 2021.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021-08558 Filed 4-21-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 218 (Tuesday, November 14, 2017)]
[Rules and Regulations]
[Page 52667]
[FR Doc No: 2017-24635]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52, 62, and 70

[EPA-R07-OAR-2017-0470; FRL-9970-85-Region 7]

State of Iowa; Approval and Promulgation of the State
Implementation Plan, the Operating Permits Program, and the 111(d)
Plan; Withdrawal

AGENCY: Environmental Protection Agency (EPA).

ACTION: Withdrawal of direct final rule.

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

SUMMARY: Due to adverse comments, the Environmental Protection Agency
(EPA) is withdrawing the direct final rule for ``State of Iowa;
Approval and Promulgation of the State Implementation Plan, the 111(d)
Plan, and the Operating Permits Program,'' published in the Federal
Register on September 15, 2017. Iowa's SIP revision included
administrative changes, corrections to technical errors, revisions to
titles and explanations of the scope of rules. The revision also
rescinded outdated or no longer required rules for general conformity
and emissions inventory relating to the Clean Air Interstate Rule
(CAIR) which has been rescinded by EPA. Finally, the revision updated
state rules by incorporating by reference more recent Code of Federal
Regulation dates to ensure consistency between the state and Federally-
approved rules.

DATES: The direct final rule published at 82 FR 43303, September 15,
2017, is withdrawn effective November 14, 2017.

FOR FURTHER INFORMATION CONTACT: Heather Hamilton Environmental
Protection Agency, Air Planning and Development Branch, 11201 Renner
Boulevard, Lenexa, Kansas 66219 at<PHONE_NUMBER>, or by email at
[email protected].

SUPPLEMENTARY INFORMATION: Due to adverse comments, EPA is withdrawing
the direct final rule to approve revisions to the Iowa State
Implementation Plan (SIP), the 111(d) plan, and the Operating Permits
Program. In the direct final rule published on September 15, 2017, (82
FR 43303), we stated that if we received adverse comment by October 16,
2017, the rule would be withdrawn and not take effect. EPA received
adverse comments. EPA will address the comments in a subsequent final
action based upon the proposed action also published on September 15,
2017 (82 FR 43315). EPA will not institute a second comment period on
this action.

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Sulfur
oxides, Volatile organic compounds.

40 CFR Part 62

    Environmental protection, Air pollution control, Administrative
practice and procedure, Reporting and recordkeeping requirements.

40 CFR Part 70

    Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Operating permits,
Reporting and recordkeeping requirements.

    Dated: November 3, 2017.
James B. Gulliford,
Regional Administrator, Region 7.

    Accordingly, the direct final rule published at 82 FR 43303,
September 15, 2017, is withdrawn effective November 14, 2017.

[FR Doc. 2017-24635 Filed 11-13-17; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: July 31, 2008 (Volume 73, Number 148)]
[Notices]
[Page 44791-44793]
[DOCID:fr31jy08-88]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58226; File No. SR-FINRA-2008-037]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of
Proposed Rule Change Relating to Amendments to NASD Rule 11890 (Clearly
Erroneous Transactions)

July 25, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 8, 2008, Financial Industry Regulatory Authority, Inc.
(``FINRA'') (f/k/a National Association of Securities Dealers, Inc.
(``NASD'')) filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by FINRA. FINRA designated the
proposed rule change as ``non-controversial'' under Section
19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(6) thereunder,\4\
which renders the proposal effective upon filing with the Commission.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 5 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    FINRA is proposing to amend NASD Rule 11890 (Clearly Erroneous
Transactions) to: (1) Extend the time limit that FINRA has to take
action on a transaction under the rule; and (2) clarify the
circumstances under which FINRA initiates a review of a transaction.
The text of the proposed rule change is available at FINRA, the
Commission's Public Reference Room, and http://www.finra.org.

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

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

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

1. Purpose
    NASD Rule 11890 provides that, in the event of a disruption or
malfunction in the use or operation of any quotation, communication, or
trade reporting system owned or operated by FINRA, or under
extraordinary market conditions, officers of FINRA can review an over-
the-counter (``OTC'') transaction arising out of or reported through
any such quotation, communication, or trade reporting system, and may
declare the transaction null and void or modify the terms if any such
officer determines that the transaction is clearly erroneous or such
action is necessary for the maintenance of a fair and orderly market or
the protection of investors and the public interest. Rule 11890
requires a FINRA officer acting pursuant to the rule to cancel or
adjust an erroneous transaction to do so ``within thirty (30) minutes
of detection of the transaction,'' except in the case of extraordinary
circumstances, in which case the FINRA officer has until 3 p.m.,
Eastern Time (ET), on the next trading day after the date of the
transaction at issue.

    FINRA is proposing to amend Rule 11890 to replace the language that
FINRA must, except in extraordinary circumstances, take action under
the subsection within thirty (30) minutes of detection of an erroneous
transaction, with language that FINRA shall act as soon as possible
after becoming aware of the transaction, but in all cases by 3 p.m.,
Eastern Time (ET) on the next trading day after the date of the
transaction at issue. Although FINRA believes that determinations under
the rule should always be made in a timely manner, FINRA has found that
most transactions reviewed under Rule 11890 involve coordination
between multiple market centers and the time required to gather and
evaluate the information necessary to make an informed determination is
often in excess of 30 minutes. Accordingly, FINRA does not believe that
the rule's strict 30-minute time limit is in the best interests of the
marketplace or investors.\5\
---------------------------------------------------------------------------

    \5\ The Commission recently approved amendments to the clearly
erroneous rule of The NASDAQ Stock Market LLC (``Nasdaq'') (Nasdaq
Rule 11890). As part of those amendments, Nasdaq deleted the
requirement that a Nasdaq officer must make a determination
regarding whether a transaction was ``clearly erroneous'' under the
rule within 30 minutes of detection. See Securities Exchange Act
Release No. 57826 (May 15, 2008), 73 FR 29802 (May 22, 2008)
(``Release 34-57826'') (SR-NASDAQ-2007-001).
---------------------------------------------------------------------------

    Also as a practical matter, because FINRA, as the regulator of the
OTC market, does not operate a listed market, it generally does not
``detect'' erroneous transactions, particularly those involving listed
securities executed OTC. Rather, in most cases, other market centers
notify FINRA staff of the potential for such transactions, and FINRA
staff coordinates its review with such market center(s). Similarly, for
potentially erroneous transactions involving only OTC trades, the
information typically comes from other sources, such as market
participants, and FINRA does not ``detect'' potentially erroneous
transactions. Accordingly, FINRA proposes to amend Rule 11890 to more
accurately reflect the operation of the rule by deleting the
``detection'' language from the text of the rule.
    Lastly, FINRA is proposing certain technical, non-substantive
changes to the text of Rule 11890. Given that many clearly erroneous
transactions are caused by trader errors and not disruptions or
malfunctions of FINRA systems, the proposed rule change amends the rule
text to reflect the manner in which FINRA applies it to a clearly
erroneous authority. Additionally, FINRA is proposing to amend the text
of Rule 11890(a) to replace the word ``approved'' with the word
``authorized'' to reflect that, technically, not all FINRA system rules
are ``approved'' by the Commission, but, for example, a system's rules
may take effect upon filing with the Commission (e.g., for immediate
effectiveness pursuant to Section 19(b)(3)(A) of the Act).
    As noted above, FINRA has filed the proposed rule change for
immediate effectiveness. FINRA proposes to make the rule change
operative on the date of filing.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\6\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. FINRA believes that the proposed rule change better
reflects the application of Rule 11890 and provides additional time to
resolve clearly erroneous transactions.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

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

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

    Written comments were neither solicited nor received.

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

    Because the proposed rule change does not: (i) Significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days after the date of filing, or such shorter time as the Commission
may designate if consistent with the protection of investors and the
public interest, the proposed rule change has become effective pursuant
to Section 19(b)(3)(A) of the Act \7\ and subparagraph (f)(6) of Rule
19b-4 thereunder.\8\ As required under Rule 19b-4(f)(6)(iii),\9\ FINRA
provided the Commission with written notice of its intent to file the
proposed rule change, along with a brief description and text of the
proposed rule change, prior to the filing of the proposed rule change.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6).
    \9\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally may
not become operative prior to the 30th day after the date of
filing.\10\ However, Rule 19b-4(f)(6)(iii) \11\ permits the Commission
to designate a shorter time if such action is consistent with the
protection of investors and the public interest. FINRA requested that
the Commission waive the 30-day operative delay and make the proposed
rule change effective and operative upon filing because the proposed
rule change clarifies the current application of Rule 11890 and better
reflects the time necessary to address potentially clearly erroneous
transactions. The Commission believes that waiving the 30-day operative
delay is consistent with the protection of investors and the public
interest. In particular, the Commission does not believe that the rule
change presents any novel issues and notes that it recently approved
revisions to Nasdaq's clearly erroneous transactions rule that, among
other things, revised the time frame for a Nasdaq officer to make a
determination regarding whether a transaction is ``clearly erroneous''
under the Nasdaq rule.\12\ Accordingly, the Commission designates the
proposed rule change operative upon filing with the Commission.\13\
---------------------------------------------------------------------------

    \10\ See id.
    \11\ Id.
    \12\ See Release 34-57826, supra note 5.
    \13\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate the rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or

     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2008-037 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2008-037. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of FINRA. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-FINRA-2008-037 and should be
submitted on or before August 21, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
Florence E. Harmon,
Acting Secretary.
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

[FR Doc. E8-17501 Filed 7-30-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 83, Number 177 (Wednesday, September 12, 2018)]
[Rules and Regulations]
[Pages 46104-46107]
[FR Doc No: 2018-19855]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 110

[Docket No. FDA-2011-N-0920]

Current Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Human Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; partial withdrawal.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
removing instruction 13 from the Current Good Manufacturing Practice,
Hazard Analysis, and Risk-Based Preventive Controls for Human Food
(Preventive Controls for Human Food) regulation. Instruction 13 directs
the Federal Register to remove and reserve as of September 17, 2018,
the Current Good Manufacturing Practice in Manufacturing, Packing, or
Holding Human Food (Human Food CGMP) regulation. Removal of instruction
13 is necessary because the compliance dates for certain facilities
subject to the modernized current good manufacturing practice
requirements in the Preventive Controls for Human Food regulation have
been extended. Retaining the Human Food CGMP regulation will maintain
the status quo while these facilities prepare for compliance with the
new CGMP requirements and will avoid an unintended gap in public health
protection.

DATES: Effective September 12, 2018, FDA withdraws amendatory
instruction 13 on page 56144 of the final rule published at 80 FR 55908
at 56144 on September 17, 2015. Submit either electronic or written
comments by October 12, 2018.

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 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 12, 2018. 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-2011-N-0920 for ``Current Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive Controls for Human Food.'' 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: Jenny Scott, Center for Food Safety
and Applied Nutrition (HFS-300), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background and Discussion
II. Legal Authority
III. Analysis of Environmental Impact
IV. Paperwork Reduction Act of 1995

I. Background and Discussion

    In the Federal Register of September 17, 2015, FDA published the
final rule, ``Current Good Manufacturing Practice, Hazard Analysis, and
Risk-Based Preventive Controls for Human Food'' (80 FR 55908; the
``rule establishing part 117''). Among other things, in the final rule
establishing part 117 (21 CFR part 117), we modernized and placed in
part 117, subpart B the longstanding current good manufacturing
practice requirements (CGMPs) codified in part 110 (21 CFR part 110).
We staggered the compliance dates for part 117 based on business size.
We also instructed the Federal Register to remove and reserve part 110
effective September 17, 2018, the latest of the staggered compliance
dates, which we treated as a conforming amendment (see instruction
number 13 at 80 FR 55908 at 56144).
    Subsequently, in a final rule published in the Federal Register of
August 24, 2016 (81 FR 57784; the ``compliance date final rule''),
among other things, we extended by up to 16 months the part 117
compliance dates for certain facilities, to address concerns about the
practicality of compliance, consider changes to the regulatory text,
and better align compliance dates across various rules. The compliance
date final rule extended the part 117 compliance dates for the
following establishments, as set out in table 1:

  Table 1--Facilities That Received Extended Part 117 Compliance Dates
------------------------------------------------------------------------
                                                        Compliance date
                                    Compliance date    with extension as
                                  announced in final     announced in
                                   rule establishing    compliance date
                                       part 117           final rule
------------------------------------------------------------------------
Facility solely engaged in
 packing and/or holding
 activities on produce RACs,
 that is:
     a very small         September 17, 2018  January 27, 2020.
     business.
     a small business...  September 18, 2017  January 28, 2019.
     not a small or very  September 19, 2016  January 26, 2018.
     small business.
Facility that would qualify as a
 secondary activities farm
 except for ownership of the
 facility, that is:
     a very small         September 17, 2018  January 27, 2020.
     business.
     a small business...  September 18, 2017  January 28, 2019.
     not a small or very  September 19, 2016  January 26, 2018.
     small business.
Facilities that would qualify as
 a farm if it did not color
 RACs, that is:
    a very small business.......  September 17, 2018  January 27, 2020.
    a small business............  September 18, 2017  January 28, 2019.
    not a small or very small     September 19, 2016  January 26, 2018.
     business.
------------------------------------------------------------------------

    A small business is a business (including any subsidiaries and
affiliates) employing fewer than 500 full-time equivalent employees. A
very small business is a business (including any subsidiaries and
affiliates) averaging less than $1 million, adjusted for inflation, per
year, during the 3-year period preceding the applicable calendar year
in sales of human food plus the market value of human food
manufactured, processed, packed or held without sale (e.g., held for a
fee). (See Sec.  117.3.)
    After issuing the compliance date final rule, FDA announced that as
a matter of enforcement policy it did not intend to enforce certain
part 117 requirements for certain facilities, including some of the
facilities in table 1 whose compliance dates had been extended by the
compliance date final rule. See the January 2018 guidance entitled
``Policy Regarding Certain Entities Subject to the Current Good
Manufacturing Practice and Preventive Controls, Produce Safety, and/or
Foreign Supplier Verification Programs'' (https://www.fda.gov/downloads/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm590661.pdf). The present
rulemaking does not change the policies contained in this guidance.
    As mentioned above, in the final rule establishing part 117 we
instructed the Federal Register to remove and reserve part 110,
effective September 17, 2018, which at the time was the latest of the
staggered compliance dates. The goal was to have firms subject to the
Human Food CGMP regulation until the Preventive Controls for Human Food
regulation took its place, leaving no gap in public health protection.
However, in the compliance date final rule we extended the compliance
dates for part 117 by up to 16 months but failed to

revise the previous instruction to remove part 110. Without the current
action, the small and very small facilities described in table 1 will
not be subject to any CGMPs until, respectively, January 28, 2019, and
January 27, 2020. However, FDA's intent always has been that part 110
would remain unchanged and in effect until all establishments have
reached the date when they must be in compliance with part 117.
Therefore, we are amending the rule establishing part 117 to remove the
instruction to the Federal Register to remove and reserve part 110. We
intend to remove part 110 in a separate action after all establishments
have reached their compliance dates for the part 117 CGMPs.
    When FDA conducts rulemaking, it normally does so using notice-and-
comment procedures established under the Administrative Procedure Act
(APA) and FDA regulations. These procedures allow the public an
opportunity to participate in Agency rulemaking by submitting written
comments on proposed rules. FDA considers these comments as it
finalizes rules. (5 U.S.C. 553(b) and (c); Sec.  10.40 (21 CFR 10.40.))
The APA, however, does not require an agency to use notice-and-comment
procedures in all rulemaking. For example, the APA provides that
Agencies shall not use notice-and-comment procedures, and shall proceed
with a final rule, when the Agency for good cause finds that notice and
public procedure thereon are impracticable, unnecessary, or contrary to
public interest, and incorporates the finding and a brief statement of
reasons therefor in the rules issued. (5 U.S.C. 553(b)(B).) Likewise,
FDA's regulations provide that the requirements of notice and public
procedure do not apply when the Commissioner of Food and Drugs
determines for good cause that they are impracticable, unnecessary, or
contrary to the public interest, in which case, the notice issuing the
regulation will state the reasons for the determination, and provide an
opportunity for comment to determine whether the regulation should
subsequently be modified or revoked. (Sec.  10.40(e)(1).) Pursuant to
this regulation, FDA requests comments on the timing for the removal of
part 110.
    In this instance, for several reasons, FDA finds good cause for
issuing this final rule without notice and comment.
    Notice and comment are unnecessary because this final rule is a
minor and technical repair of an obvious oversight in the compliance
date final rule, maintains the CGMP regulatory status quo for industry,
affirms FDA's plan for transitioning from part 110 to part 117 as
outlined in the rule establishing part 117, and is not expected to
generate public concern. FDA is addressing the gap in CGMP regulatory
coverage from September 17, 2018, to January 27, 2020, by issuing a
narrowly tailored amendment to remove instruction 13 from the rule to
establish part 117. The result of this amendment will be that the part
110 CGMPs will continue in effect for establishments that have not
reached their part 117 compliance date. This action will serve to
correct an obvious oversight made in the compliance date final rule.
FDA does not anticipate public concern with this action. The Agency
previously sought public comment on its proposal to remove part 110 in
coordination with the compliance dates for part 117 and received no
comments that disagreed. The present continuation and planned eventual
removal of part 110 is a repeat of what was previously proposed without
public objection. Furthermore, it is clear from the rule establishing
part 117 that we intended for facilities to remain subject to part 110
until their part 117 compliance date (80 FR 55908 at 56127). Thus, we
do not believe there was ever any reasonable expectation on the part of
the establishments listed in table 1 that they would not be
continuously subject to CGMPs. For these various reasons, we have
determined that notice and comment is unnecessary.
    FDA finds further good cause for issuing this final rule without
notice and comment because notice and comment are contrary to the
public interest and impracticable. There could be negative public
health implications if there were a temporal gap in CGMP coverage; for
example, there have been outbreaks associated with the types of
facilities still subject to part 110 (e.g., listeria in cantaloupe).
Many of the establishments listed in table 1 are not required to comply
with the replacement CGMPs in part 117 until January 2019 or January
2020, depending on business size. This means that these establishments
would have no applicable CGMP requirements for 4 to 16 months. CGMP
requirements have existed for all human food manufacturers since at
least 1970 (see 34 FR 6977) and serve as a significant basis for FDA's
determination of what constitutes an insanitary food production
environment that may result in food that is injurious to public health
under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 342(a)(4)), among other authorities. It would be contrary to the
public interest to allow the temporal gap in CGMP coverage.
    To summarize, a gap in CGMP coverage would leave FDA without a
primary tool to execute its function of ensuring that food
manufacturing establishments follow basic food safety practices,
potentially endangering the public health, in order to provide the
public an opportunity to comment on a non-controversial technical
matter. For these reasons, we are issuing this amendment to the final
rule establishing part 117 without prior notice and comment. (5 U.S.C.
553(b)(3)(B)).
    In addition, we find good cause for this amendment to the rule
establishing part 117 to become effective on the date of publication.
The APA allows an effective date less than 30 days after publication as
provided by the Agency for good cause found and published within the
rule (5 U.S.C. 553(d)(3)). As provided at 80 FR 55908, September 17,
2015, the amendment removing part 110 was to take effect on September
17, 2018. In order to continue part 110 for an interim period, this
final rule needs to be effective on or before September 16, 2018, and
therefore it is not possible for this rule to take effect 30 days after
publication in the Federal Register. As previously described, in order
to prevent a gap in CGMP coverage for certain establishments, an
immediate effective date is necessary to remove, before September 17,
2018, the instruction to remove and reserve part 110. Further, because
the facilities' responsibility to comply with CGMP requirements remains
unchanged, this rule places no burden on affected parties for which
they would need a reasonable time to prepare. Therefore, the
Commissioner finds good cause under 5 U.S.C. 553(d)(3) and Sec.
10.40(c)(4)(ii) for this amendment to become effective on the date of
publication.

II. Legal Authority

    We are issuing this final rule removing instruction number 13 of
the rule to establish part 117 under the same authority for which the
rule containing instruction number 13 was originally issued. That
analysis may be found in section II, ``Legal Authority,'' of the rule
to establish part 117 (80 FR 55908 at 55917 to 55920).

III. Analysis of Environmental Impact

    FDA has determined that the removal of instruction 13 will not
change the status quo and, therefore, is not a major Federal action
significantly affecting the quality of the human environment within the
meaning of section 102(2)(C) of the National Environmental Policy

Act (42 U.S.C. 4321 et seq.). Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

List of Subjects in 21 CFR Part 110

    Food packaging, Foods.

0
Therefore, in FR Rule Doc. No. 2015-21920, published September 17,
2015, at 80 FR 55908-56168, amendatory instruction 13 in the third
column on page 56144 is withdrawn.

    Dated: September 7, 2018.
Scott Gottlieb,
Commissioner of Food and Drugs.
[FR Doc. 2018-19855 Filed 9-11-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 240 (Tuesday, December 15, 2015)]
[Notices]
[Page 77688]
[FR Doc No: 2015-31597]

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

SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

 In The Matter of Oxford City Football Club, Inc.; Order of
Suspension of Trading

December 11, 2015.
    Oxford City Football Club, Inc., (``Oxford City'') is a Florida
corporation with principal place of business listed as Deerfield Beach,
Florida. Its stock is quoted on the OTCBB and OTC Link using the ticker
symbol ``OXFC.'' It appears to the Securities and Exchange Commission
that there is a lack of current and accurate information concerning the
securities of Oxford City because of questions regarding the accuracy
of assertions by Oxford City and its CEO Thomas A. Guerriero, and by
others, in press releases and other statements to investors concerning,
among other things: (1) The company's assets; (2) projections for the
company's income; (3) the nature of the company's management; and (4)
other general corporate plans and information.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed company.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed company is suspended for the period from 9:30 a.m. EST, on
December 11, 2015, through 11:59 p.m. EST on December 24, 2015.

    By the Commission.
Brent J. Fields,
Secretary.
[FR Doc. 2015-31597 Filed 12-11-15; 11:15 am]
 BILLING CODE 8011-01-P