[Federal Register Volume 76, Number 60 (Tuesday, March 29, 2011)]
[Rules and Regulations]
[Pages 17336-17339]
[FR Doc No: 2011-7313]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 522, 526, and 529

[Docket No. FDA-2011-N-0003]

New Animal Drugs; Amikacin Sulfate, Ampicillin Trihydrate,
Ceftiofur Hydrochloride, Cephapirin Benzathine, Chlortetracycline,
Fenbendazole, Formalin, Furosemide, Glucose/Glycine/Electrolyte,
Pyrantel Pamoate, Sulfadimethoxine, Sulfamethazine, and Tetracycline

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correcting amendments.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect revised human food safety warnings or
updated pathogen nomenclature on dosage form new animal drug product
labeling that have not been codified. The regulations are also being
amended to correct the wording of certain other conditions of use, to
correct minor errors, and to revise some sections to reflect a current
format. These actions are being taken to comply with the Federal Food,
Drug, and Cosmetic Act (FD&C Act) and to improve the accuracy and
readability of the regulations.

DATES: This rule is effective March 29, 2011.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA has found that the animal drug
regulations do not reflect certain human food safety warnings or the
scientific nomenclature of pathogens that have been updated on labeling
of various dosage form new animal drug products. At this time, the
regulations are being amended to reflect approved labeling. The
regulations are also being amended to correct the wording of certain
other conditions of use and to correct minor errors. As the opportunity
has presented itself, some sections have been revised to a current
format. These actions are being taken to comply with the FD&C Act and
to improve the accuracy and readability of the regulations.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Parts 520, 522, 526, and 529

    Animal drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 520,
522, 526, and 529 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
2. In Sec.  520.550, revise the section heading and paragraph (a), the
first sentence in paragraph (c)(1), and paragraph (c)(3) to read as
follows:

Sec.  520.550  Glucose/glycine/electrolyte.

    (a) Specifications. The product is distributed in packets each of
which contains the following ingredients: Sodium chloride 8.82 grams,
potassium phosphate 4.20 grams, citric acid anhydrous 0.5 gram,
potassium citrate 0.12 gram, aminoacetic acid (glycine) 6.36 grams, and
glucose 44.0 grams.
    (c) * * *
    (1) Glucose/glycine/electrolyte is indicated for use in the control
of dehydration associated with diarrhea (scours) in calves.* * *
* * * * *
    (3) The product should not be used in animals with severe
dehydration (down, comatose, or in a state of shock). Such animals need
intravenous therapy. A veterinarian should be consulted in severely
scouring calves. The product is not nutritionally complete if
administered by itself for long periods of time. It should not be
administered beyond the recommended treatment period without the
addition of milk or milk replacer.

0
3. In Sec.  520.905a, revise paragraphs (e)(2)(i), (e)(2)(iii),
(e)(3)(i), and (e)(3)(iii) to read as follows:

Sec.  520.905a  Fenbendazole suspension.

* * * * *
    (e) * * *
    (2) * * *
    (i) Amount. Administer orally 5 mg/kg of body weight (2.3 mg/lb).
Retreatment may be needed after 4 to 6 weeks.
* * * * *
    (iii) Limitations. Cattle must not be slaughtered within 8 days
following last treatment. A withdrawal period has not

been established for this product in preruminating calves. Do not use
in calves to be processed for veal.
    (3) * * *
    (i) Amount. Administer orally 10 mg/kg of body weight (2.3 mg/lb).
Retreatment may be needed after 4 to 6 weeks.
* * * * *
    (iii) Limitations. Cattle must not be slaughtered within 8 days
following last treatment. A withdrawal period has not been established
for this product in preruminating calves. Do not use in calves to be
processed for veal. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
* * * * *

0
4. In Sec.  520.905c, revise paragraph (e)(2)(iii) to read as follows:

Sec.  520.905c  Fenbendazole paste.

* * * * *
    (e) * * *
    (2) * * *
    (iii) Limitations. Cattle must not be slaughtered within 8 days
following last treatment. A withdrawal period has not been established
for this product in preruminating calves. Do not use in calves to be
processed for veal.

0
5. In Sec.  520.1422, revise paragraph (b) to read as follows:

Sec.  520.1422  Metoserpate hydrochloride.

* * * * *
    (b) Sponsor. See No. 053501 in Sec.  510.600(c) of this chapter.
* * * * *
0
6. In Sec.  520.2043, revise paragraph (d)(1)(iii) to read as follows:

Sec.  520.2043  Pyrantel pamoate suspension.

* * * * *
    (d) * * *
    (1) * * *
    (iii) Limitations. Do not use in horses intended for human
consumption. When the drug is for administration by stomach tube, it
shall be labeled: ``Federal law restricts this drug to use by or on the
order of a licensed veterinarian.''
* * * * *

0
7. In Sec.  520.2044, revise paragraph (d)(2) to read as follows:

Sec.  520.2044  Pyrantel pamoate paste.

* * * * *
    (d) * * *
    (2) Limitations. Do not use in horses intended for human
consumption.

0
8. In Sec.  520.2220a, revise paragraph (d)(3)(ii) to read as follows:

Sec.  520.2220a  Sulfadimethoxine oral solution and soluble powder.

* * * * *
    (d) * * *
    (3) * * *
    (ii) Indications for use. For the treatment of shipping fever
complex and bacterial pneumonia associated with Pasteurella spp.
sensitive to sulfadimethoxine; and calf diphtheria and foot rot
associated with Fusobacterium necrophorum (Sphaerophorus necrophorus)
sensitive to sulfadimethoxine.
* * * * *

0
9. In Sec.  520.2220b, revise paragraph (d) to read as follows:

Sec.  520.2220b  Sulfadimethoxine tablets and boluses.

* * * * *
    (d) Conditions of use--(1) Cattle--(i) Amount. Administer 2.5 grams
per 100 pounds body weight for 1 day followed by 1.25 grams per 100
pounds body weight per day; treat for 4 to 5 days.
    (ii) Indications for use. For the treatment of shipping fever
complex and bacterial pneumonia associated with Pasteurella spp.
sensitive to sulfadimethoxine; and calf diphtheria and foot rot
associated with Fusobacterium necrophorum sensitive to
sulfadimethoxine.
    (iii) Limitations. Do not administer within 7 days of slaughter;
milk that has been taken from animals during treatment and 60 hours (5
milkings) after the latest treatment must not be used for food. A
withdrawal period has not been established for this product in
preruminating calves. Do not use in calves to be processed for veal.
    (2) Dogs and cats--(i) Amount. Administer 25 milligrams per pound
of body weight on the first day followed by 12.5 milligrams per pound
of body weight per day until the animal is free of symptoms for 48
hours.
    (ii) Indications for use. Treatment of sulfadimethoxine-susceptible
bacterial infections.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
    (3) Beef cattle and nonlactating dairy cattle--(i) Amount.
Administer one 12.5-gram-sustained-release bolus for the nearest 200
pounds of body weight, i.e., 62.5 milligrams per pound of body weight.
Do not repeat treatment for 7 days.
    (ii) Indications for use. Treatment of shipping fever complex and
bacterial pneumonia associated with organisms such as Pasteurella spp.
sensitive to sulfadimethoxine; calf diphtheria and foot rot associated
with Fusobacterium necrophorum sensitive to sulfadimethoxine.
    (iii) Limitations. Do not use in female dairy cattle 20 months of
age or older. Do not administer within 12 days of slaughter. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.

0
10. In Sec.  520.2260a, revise paragraph (a)(3)(iii) to read as
follows:

Sec.  520.2260a  Sulfamethazine oblet, tablet, and bolus.

    (a) * * *
    (3) * * *
    (iii) Limitations. Administer daily until animal's temperature and
appearance are normal. If symptoms persist after using for 2 or 3 days
consult a veterinarian. Fluid intake must be adequate. Treatment should
continue 24 to 48 hours beyond the remission of disease symptoms, but
not to exceed 5 consecutive days. Follow dosages carefully. Do not
treat cattle within 10 days of slaughter. Do not use in female dairy
cattle 20 months of age or older. Use of sulfamethazine in this class
of cattle may cause milk residues. A withdrawal period has not been
established in preruminating calves. Do not use in calves to be
processed for veal. Do not use in horses intended for human
consumption.
* * * * *

0
11. In Sec.  520.2261a, revise the section heading; the first sentence
in paragraph (c)(2)(iii); and paragraph (c)(3) to read as follows:

Sec.  520.2261a  Sulfamethazine solution.

* * * * *
    (c) * * *
    (2) * * *
    (iii) Chickens and turkeys. In chickens for control of infectious
coryza (Avibacterium paragallinarum), coccidiosis (Eimeria tenella,
Eimeria necatrix), acute fowl cholera (Pasteurella multocida), and
pullorum disease (Salmonella pullorum). * * *
    (3) Limitations. Add the required dose to that amount of water that
will be consumed in 1 day. Consumption should be carefully checked.
Have only medicated water available during treatment. Withdraw
medication from cattle, chickens, and turkeys 10 days prior to
slaughter for food. Withdraw medication from swine 15 days before
slaughter for food. Do not medicate chickens or turkeys producing eggs
for human consumption. Treatment of all diseases should be instituted
early. Treatment should continue 24 to 48 hours beyond the remission of
disease symptoms, but not to exceed a total of 5 consecutive days in
cattle or swine. Medicated cattle, swine, chickens, and turkeys must
actually consume enough medicated water which provides the recommended
dosages. Do not use in female dairy cattle 20 months of age or

older. Use of sulfamethazine in this class of cattle may cause milk
residues. A withdrawal period has not been established in preruminating
calves. Do not use in calves to be processed for veal.
* * * * *

0
12. In Sec.  520.2261b, revise paragraph (d)(1)(ii) and paragraph
(d)(4)(iii) to read as follows:

Sec.  520.2261b  Sulfamethazine powder.

* * * * *
    (d) * * *
    (1) * * *
    (ii) Indications for use. For control of infectious coryza
(Avibacterium paragallinarum), coccidiosis (Eimeria tenella, E.
necatrix), acute fowl cholera (Pasteurella multocida), and pullorum
disease (Salmonella pullorum).
* * * * *
    (4) * * *
    (iii) Limitations. Add the required dose to that amount of water
that will be consumed in 1 day. Consumption should be carefully
checked. Have only medicated water available during treatment. Withdraw
medication from cattle 10 days prior to slaughter for food. Treatment
of all diseases should be instituted early. Treatment should continue
24 to 48 hours beyond the remission of disease symptoms, but not to
exceed a total of 5 consecutive days. Medicated cattle must actually
consume enough medicated water which provides the recommended dosages.
Do not use in female dairy cattle 20 months of age or older. Use of
sulfamethazine in this class of cattle may cause milk residues. A
withdrawal period has not been established in preruminating calves. Do
not use in calves to be processed for veal.

0
13. In Sec.  520.2345d, revise paragraph (b)(2), the first sentence in
paragraph (d)(1)(iii), and paragraph (d)(2)(iii) to read as follows:

Sec.  520.2345d  Tetracycline powder.

* * * * *
    (b) * * *
    (2) No. 000010: 25, 102.4, and 324 grams per pound as in paragraph
(d) of this section.
* * * * *
    (d) * * *
    (1) * * *
    (iii) Limitations. Administer for 3 to 5 days; do not slaughter
animals for food within 4 days of treatment for No. 000010 and within 5
days of treatment for Nos. 046573, 054925, 057561, 059130, and 061623;
prepare a fresh solution daily; use as the sole source of tetracycline.
* * *
    (2) * * *
    (iii) Limitations. Administer for 3 to 5 days; do not slaughter
animals for food within 7 days of treatment for No. 000010 and within 4
days of treatment for Nos. 046573, 054925, 057561, 059130, and 061623;
prepare a fresh solution daily; use as the sole source of tetracycline.
* * * * *

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
14. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority:  21 U.S.C. 360b.

0
15. Revise Sec.  522.56 to read as follows:

Sec.  522.56  Amikacin.

    (a) Specifications. Each milliliter of solution contains 50
milligrams (mg) of amikacin as amikacin sulfate.
    (b) Sponsors. See Nos. 000856 and 059130 in Sec.  510.600(c) of
this chapter.
    (c) Conditions of use in dogs--(1) Amount. 5 mg/pound (lb) of body
weight twice daily by intramuscular or subcutaneous injection.
    (2) Indications for use. For treatment of genitourinary tract
infections (cystitis) caused by susceptible strains of Escherichia coli
and Proteus spp. and skin and soft tissue infections caused by
susceptible strains of Pseudomonas spp. and E. coli.
    (3) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.

0
16. In Sec.  522.90b, revise the section heading and paragraphs (a),
(b), and (d) to read as follows:

Sec.  522.90b  Ampicillin trihydrate.

    (a) Specifications. Each milliliter of aqueous suspension
constituted from ampicillin trihydrate powder contains 50, 100, or 250
milligrams (mg) ampicillin equivalents.
    (b) Sponsors. See Nos. 000010 and 010515 in Sec.  510.600(c) of
this chapter.
* * * * *
    (d) Conditions of use--(1) Dogs and cats--(i) Amount. 3 mg/pound
(lb) of body weight twice daily by subcutaneous or intramuscular
injection.
    (ii) Indications for use. For treatment of strains of organisms
susceptible to ampicillin and associated with respiratory tract
infections, urinary tract infections, gastrointestinal infections, skin
infections, soft tissue infections, and postsurgical infections.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
    (2) Cattle--(i) Amount. 2 to 5 mg/lb of body weight once daily by
intramuscular injection.
    (ii) Indications for use. For treatment of respiratory tract
infections caused by organisms susceptible to ampicillin, bacterial
pneumonia (shipping fever, calf pneumonia, and bovine pneumonia) caused
by Aerobacter spp., Klebsiella spp., Staphylococcus spp., Streptococcus
spp., Pasteurella multocida, and Escherichia coli.
    (iii) Limitations. Do not treat cattle for more than 7 days. Milk
from treated cows must not be used for food during treatment or for 48
hours (4 milkings) after the last treatment. Cattle must not be
slaughtered for food during treatment or for 144 hours (6 days) after
the last treatment. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.

0
17. In Sec.  522.313b, revise paragraph (a) to read as follows:

Sec.  522.313b  Ceftiofur hydrochloride.

    (a) Specifications. Each milliliter of ceftiofur hydrochloride
suspension contains 50 milligrams (mg) ceftiofur equivalents.
* * * * *

0
18. In Sec.  522.1010, redesignate paragraph (d)(3)(iii) as paragraph
(d)(2)(iii); and add new paragraph (d)(3)(iii) to read as follows:

Sec.  522.1010  Furosemide.

* * * * *
    (d) * * *
    (3) * * *
    (iii) Limitations. Treatment not to exceed 48 hours post-
parturition. Milk taken during treatment and for 48 hours (four
milkings) after the last treatment must not be used for food. Cattle
must not be slaughtered for food within 48 hours following last
treatment.

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

0
19. The authority citation for 21 CFR part 526 continues to read as
follows:

    Authority:  21 U.S.C. 360b.

0
20. In Sec.  526.363, revise paragraph (d)(1) and the first sentence in
paragraph (d)(3) to read as follows:

Sec.  526.363  Cephapirin benzathine.

* * * * *
    (d) * * *
    (1) Amount. Infuse the contents of one syringe into each quarter.
* * * * *
    (3) Limitations. Infuse each quarter following last milking, but no
later than 30 days before calving. * * *

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
21. The authority citation for 21 CFR part 529 continues to read as
follows:

    Authority:  21 U.S.C. 360b.

Sec.  529.50  [Redesignated as Sec.  529.56 and Amended]

0
22. Redesignate Sec.  529.50 as Sec.  529.56 and revise it to read as
follows:

Sec.  529.56  Amikacin.

    (a) Specifications. Each milliliter (mL) of solution contains 250
milligrams of amikacin as amikacin sulfate.
    (b) Sponsors. See Nos. 000856 and 059130 in Sec.  510.600(c) of
this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 2 grams (8
mL) diluted with 200 mL of sterile physiological saline by intrauterine
infusion daily for 3 consecutive days.
    (2) Indications for use. For treating genital tract infections
(endometritis, metritis, and pyometra) in mares caused by susceptible
organisms including Escherichia coli, Pseudomonas spp., and Klebsiella
spp.
    (3) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.

0
23. In Sec.  529.1030, revise paragraphs (d)(1)(i) and (d)(1)(iv) to
read as follows:

Sec.  529.1030  Formalin.

* * * * *
    (d) * * *
    (1) * * *
    (i) Select finfish. For control of external protozoa
Ichthyophthirius spp., Chilodonella spp., Ichthyobodo spp., Ambiphrya
spp., Epistylis spp., and Trichodina spp., and monogenetic trematodes
Cleidodiscus spp., Gyrodactylus spp., and Dactylogyrus spp., on salmon,
trout, catfish, largemouth bass, and bluegill.
* * * * *
    (iv) All finfish. For control of external protozoa Ichthyophthirius
spp., Chilodonella spp., Ichthyobodo spp., Ambiphrya spp., Epistylis
spp., and Trichodina spp., and monogenetic trematodes Cleidodiscus
spp., Gyrodactylus spp., and Dactylogyrus spp.
* * * * *

    Dated: March 23, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-7313 Filed 3-28-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 76 (Friday, April 19, 2013)]
[Notices]
[Pages 23617-23620]
[FR Doc No: 2013-09192]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69378; File No. SR-EDGX-2013-13]

Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Footnote 4 of the Exchange's Fee Schedule Regarding Retail Orders

April 15, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 5, 2013, EDGX Exchange, Inc. (the ``Exchange'' or
``EDGX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II, which items have been prepared by the self-regulatory organization.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes [sic] Footnote 4 of the Exchange's fee
schedule regarding Retail Orders. All of the changes described herein
are applicable to EDGX Members. The text of the proposed rule change is
available on the Exchange's Internet Web site at www.directedge.com, at
the Exchange's principal office, and at the Public Reference Room of
the Commission.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    In SR-EDGX-2012-47,\3\ the Exchange introduced new Flags ZA (Retail
Order, adds liquidity) and ZR (Retail Order, removes liquidity) and
appended to each flag Footnote 4 to the Exchange's fee schedule.
Footnote 4 defined a ``Retail Order,'' provided an attestation
requirement for Members \4\ to comply with when sending Retail Orders
to the Exchange, and noted that Members may designate orders as Retail
Orders on an order-by-order basis. In SR-EDGX-2012-48,\5\ the Exchange
subsequently expanded Members' ability to send the Exchange Retail
Orders by designating certain of their FIX ports at the Exchange as
``Retail Order Ports.'' The attestation requirement, as described in
SR-EDGX-2012-47,\6\ will continue to apply to all Members who submit
Retail Orders, whether on an order-by-order basis or via Retail Order
Ports.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 68310 (November 28,
2012), 77 FR 71860 (December 4, 2012) (SR-EDGX-2012-47).
    \4\ As defined in Exchange Rule 1.5(n).
    \5\ See Securities Exchange Act Release No. 68554 (December 31,
2012), 78 FR 966 (January 7, 2013) (SR-EDGX-2012-48).
    \6\ See Securities Exchange Act Release No. 68310 (November 28,
2012), 77 FR 71860 (December 4, 2012) (SR-EDGX-2012-47).
---------------------------------------------------------------------------

Proposed Amendment to Definition of ``Retail Order''
    Footnote 4 on the Exchange's fee schedule currently defines a
Retail Order as: ``(i) an agency order that originates from a natural
person; (ii) is submitted to EDGX by a Member, provided that no change
is made to the terms of the order; and (iii) the order does not
originate from a trading algorithm or any other computerized

methodology.'' \7\ The Exchange believes that its definition of a
``Retail Order'' is unnecessarily restrictive compared to that of other
exchanges in that the Exchange does not include ``riskless principal
orders'' in its definition.\8\ The Exchange believes that its
comparatively narrow definition may create confusion among the
Exchange's Members, preventing Members from submitting Retail Orders
and benefiting from the enhanced rebate and transparency of such
orders. In addition, the Exchange believes that the restrictiveness of
the Exchange's definition may inadvertently put the Exchange at a
competitive disadvantage in relation to other exchanges that provide a
less restrictive definition of a ``Retail Order.''
---------------------------------------------------------------------------

    \7\ See EDGX Fee Schedule, http://www.directedge.com/Membership/FeeSchedule/EDGXFeeSchedule.aspx.
    \8\ The Exchange notes that other market centers include
``riskless principal orders'' as part of their definitions of
``Retail Orders.'' See, e.g., Securities Exchange Act Release No.
68937 (February 15, 2013), 78 FR 12397 (February 22, 2013) (SR-
NASDAQ-2012-129); Securities Exchange Act Release No. 69103 (March
11, 2013), 78 FR 16547 (March 15, 2013) (SR-NYSE-2013-20);
Securities Exchange Release No. 69104 (March 11, 2013), 78 FR 16556
(March 15, 2013) (SR-NYSEMKT-2013-22).
---------------------------------------------------------------------------

    Accordingly, the Exchange proposes to amend the definition of a
``Retail Order'' in Footnote 4 to add riskless principal orders to the
types of orders that may qualify as Retail Orders.\9\ The Exchange
proposes to amend Footnote 4 to state ``[w]here a Retail Order is
defined as (i) an agency order or riskless principal order that
satisfies the criteria of FINRA Rule 5320.03 that originates from a
natural person; (ii) is submitted to EDGX by a Member, provided that no
change is made to the terms of the order; and (iii) the order does not
originate from a trading algorithm or any other computerized
methodology.'' (emphasis added).\10\
---------------------------------------------------------------------------

    \9\ The Exchange notes that in order to qualify as a ``Retail
Order,'' a ``riskless principal'' order must satisfy the criteria
set forth in FINRA Rule 5320.03.
    \10\ The Exchange notes that it will amend its attestation form
for Members designating Retail Orders to conform with these new
requirements.
---------------------------------------------------------------------------

    The Exchange believes that, for purposes of determining whether an
order should qualify as a Retail Order, there is no difference between
a riskless principal order that meets the requirements of FINRA Rule
5320.03 and an agency order. A riskless principal transaction is a
transaction in which a Member, after having received an order to buy
(sell) a security, purchases (sells) the security as principal and,
contemporaneously, satisfies the original order by selling (buying) as
principal at the same price. Generally, a riskless principal
transaction involves two orders, the execution of one being dependent
upon the receipt or execution of the other; thus, there is no ``risk''
in the interdependent transactions when completed. Unlike a riskless
principal transaction, an agency order is entered directly in the
System \11\ by a Member on behalf of a customer. Ultimately, however,
the results of a riskless principal transaction and an agency order are
the same: the customer receives an execution while the involved Member
acts as an intermediary to effect the transaction.\12\
---------------------------------------------------------------------------

    \11\ As defined in Exchange Rule 1.5(cc).
    \12\ A principal transaction differs from both a riskless
principal transaction and an agency order in that it is an order for
the principal account of the entering Member.
---------------------------------------------------------------------------

    The Exchange believes that the requirement that the entry of such
riskless principal orders satisfy FINRA Rule 5320.03 provides
sufficient protection against Members submitting orders for their own
account to the Exchange. A Member entering a riskless principal
transaction will have to, contemporaneously with the execution of the
customer's order, submit a report identifying the trade as riskless
principal to FINRA. Additionally, the Member will need to have written
policies and procedures to ensure that riskless principal transactions
comply with applicable FINRA rules. The policies and procedures, at a
minimum, must require that the customer order be received prior to the
offsetting principal transaction, and that the offsetting principal
transaction is at the same price as the customer order exclusive of any
markup or markdown, commission equivalent, or other fee, and is
allocated to a riskless principal or customer account in a consistent
manner and within 60 seconds of execution. Additionally, the Member
must have supervisory systems in place that produce records that enable
the Member and FINRA to reconstruct accurately, readily, and in a time-
sequenced manner all Retail Orders that are entered on a riskless
principal basis.
    The Exchange believes that the Member must also ensure that non-
Retail Orders from customers are not included with the Retail Orders as
part of a riskless principal transaction. The above requirements ensure
that despite the procedural differences between the execution of a
riskless principal transaction and an agency order, the only difference
will be the procedure in which the transactions are effected and not
the result.
    The Exchange further believes that clarifying that riskless
principal orders that meet the requirements of FINRA Rule 5320.03 are
able to be submitted as Retail Orders on the same basis as agency
orders will enable Members, and in turn, their retail customers, to
benefit from the enhanced rebate (Flag ZA) and transparency offered by
the Exchange.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Securities Exchange Act of 1934 (the
``Act''),\13\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\14\ in particular, in that it is designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, and to remove impediments to and
perfect the mechanism of a free and open market and a national market
system.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f.
    \14\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change promotes just
and equitable principles of trade because it will ensure that riskless
principal orders that meet the requirements of FINRA Rule 5320.03 will
have the same opportunity to be submitted as Retail Orders as agency
orders. As discussed above, there is no functional distinction for
purposes of Retail Orders between an order entered by a Member on an
agency basis and one entered on a riskless principal basis. The
Exchange believes that the proposed change would tend to reduce any
potential discrimination between similarly situated customers or
brokers by ensuring that the ability of retail customers to benefit
from the use of Retail Orders does not depend on a distinction in
capacity that is not meaningful for purposes of submitting Retail
Orders. As a result of the change, a retail customer would be able to
benefit from the rebate (Flag ZA) for utilizing Retail Orders without
regards to whether the Member enters the order on a riskless principal
or agency basis.
    The Exchange believes that the proposed rule change will remove
impediments to and perfect the mechanism of a free and open market and
a national market system because it will clarify that riskless
principal orders that meet the requirements of FINRA Rule 5320.03 are
eligible to be submitted as Retail Orders on the same basis as agency
orders. By allowing all orders that are functionally equivalent to
agency orders to be submitted as Retail Orders, the proposed change
would potentially stimulate further competition for retail order flow.

    The Exchange believes that the proposed change would protect
investors and the public interest by expanding the access of Members to
the rebate for Flag ZA and the transparency offered by the Exchange as
well as the access of the public to an exchange sponsored alternative
to broker-operated internalization venues. In this regard, the Exchange
believes that maintaining or increasing the proportion of Retail Orders
in exchange-listed securities that are executed on a registered
national securities exchange (rather than relying on certain available
off-exchange execution methods) would contribute to investors'
confidence in the fairness of their transactions and would benefit all
investors by deepening the Exchange's liquidity pool, supporting the
quality of price discovery, promoting market transparency and improving
investor protection.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.
    The Exchange believes that the proposed amendment to allow Members
to submit Retail Orders on a riskless principal basis will not burden
intramarket competition because the ability to submit Retail Orders on
a riskless principal basis would be open to all Members that wish to
send Retail Orders to the Exchange.
    The Exchange believes that the proposed amendment, by increasing
the eligible orders that qualify as Retail Orders, would reduce burdens
on competition around retail executions such that Members would receive
better rebates than they currently do on the Exchange and potentially
through bilateral internalization arrangements. The Exchange believes
that the transparency and competitiveness of designating Retail Orders
on an exchange market would result in better rebates for Members, and
ultimately benefit retail investors by expanding the capabilities of
Exchanges to encompass practices currently allowed on non-Exchange
venues.

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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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

    Because the foregoing proposed rule change: (1) Does not
significantly affect the protection of investors or the public
interest; (2) does not impose any significant burden on competition;
and (3) by its terms does not become operative for 30 days after the
date of this 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 \15\ and Rule 19b-4(f)(6)
thereunder.\16\
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to provide 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,
at least five business days prior to the date of filing of the
proposed rule change, or such shorter time as designated by the
Commission. The Commission has waived this requirement in this case.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days after the date of filing. However,
Rule 19b-4(f)(6)(iii) permits the Commission to designate a shorter
time if such action is consistent with the protection of investors and
the public interest. The Exchange has asked the Commission to waive the
30-day operative delay so that the proposal may become operative
immediately upon filing. The Commission believes that waiving the 30-
day operative delay is consistent with the protection of investors and
the public interest because such waiver would allow the Exchange to add
riskless principal orders to the types of orders that may qualify as
Retail Orders for purposes of the Exchange's fee schedule.\17\ The
Commission also notes that several other market centers have recently
added riskless principal orders to its definition of retail orders.\18\
Accordingly, the Commission hereby grants the Exchange's request and
designates the proposal operative upon filing.
---------------------------------------------------------------------------

    \17\ For purposes only of waiving the 30-day operative delay,
the Commission has also considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \18\ See Securities Exchange Act Release No. 68937 (February 15,
2013), 78 FR 12397 (February 22, 2013) (SR-NASDAQ-2012-129);
Securities Exchange Act Release No. 69103 (March 11, 2013), 78 FR
16547 (March 15, 2013) (SR-NYSE-2013-20); Securities Exchange
Release No. 69104 (March 11, 2013), 78 FR 16556 (March 15, 2013)
(SR-NYSEMKT-2013-22).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-EDGX-2013-13 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.
All submissions should refer to File Number SR-EDGX-2013-13. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-EDGX-

2013-13 and should be submitted on or before May 10, 2013.

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

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

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-09192 Filed 4-18-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 58 (Monday, March 26, 2012)]
[Notices]
[Page 17470]
[FR Doc No: 2012-7139]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC12-81-000
    Applicants: Kansas City Power & Light Company
    Description: Application of Kansas City Power & Light Company for
Authorization under section 203 of the Federal Power Act and Request
for Expedited Action.
    Filed Date: 3/16/12
    Accession Number: 20120316-5013
    Comments Due: 5 p.m. ET 4/6/12

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER11-2604-003
    Applicants: Commonwealth Chesapeake Company LLC
    Description: Tariff Amendment--March 15, 2012 to be effective 5/14/
2012.
    Filed Date: 3/15/12
    Accession Number: 20120315-5120
    Comments Due: 5 p.m. ET 4/5/12

    Docket Numbers: ER11-4100-003
    Applicants: California Independent System Operator Corporation
    Description: 2012-03-15 CAISO ER11-4100 Errata to Order 745
Compliance filing to be effective 12/15/2011.
    Filed Date: 3/15/12
    Accession Number: 20120315-5147
    Comments Due: 5 p.m. ET 4/5/12

    Docket Numbers: ER12-126-003
    Applicants: Trademark Merchant Energy, LLC
    Description: Compliance Filing--Market-Based Rate Tariff Amendment
to be effective 5/14/2012.
    Filed Date: 3/15/12
    Accession Number: 20120315-5096
    Comments Due: 5 p.m. ET 4/5/12

    Docket Numbers: ER12-126-004; ER10-3079-002
    Applicants: Tyr Energy, LLC, Trademark Merchant Energy, LLC
    Description: Trademark Merchant Energy, LLC and Tyr Energy, LLC's
Compliance Filing and Updated Market Power Analyses for the Northeast
and Southeast region Southeast regions.
    Filed Date: 3/15/12
    Accession Number: 20120315-5173
    Comments Due: 5 p.m. ET 4/5/12

    Docket Numbers: ER12-1271-000
    Applicants: PJM Interconnection, L.L.C.
    Description: Queue Position O09; Original Service Agreement No.
3267 to be effective 2/14/2012.
    Filed Date: 3/15/12
    Accession Number: 20120315-5122
    Comments Due: 5 p.m. ET 4/5/12

    Docket Numbers: ER12-1272-000
    Applicants: Orange and Rockland Utilities, Inc.
    Description: O&R Undergrounding Filing to be effective 4/1/2012.
    Filed Date: 3/15/12
    Accession Number: 20120315-5145
    Comments Due: 5 p.m. ET 4/5/12

    Docket Numbers: ER12-1273-000
    Applicants: PJM Interconnection, L.L.C.
    Description: Queue Position W4-102; Original Service Agreement Nos.
3268 & 3269 to be effective 2/14/2012.
    Filed Date: 3/15/12
    Accession Number: 20120315-5146
    Comments Due: 5 p.m. ET 4/5/12

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or 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
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: March 16, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-7139 Filed 3-23-12; 8:45 am]
BILLING CODE 6717-01-P