[Federal Register Volume 85, Number 16 (Friday, January 24, 2020)]
[Rules and Regulations]
[Pages 4204-4210]
[FR Doc No: 2020-00421]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 529, 556, and 558

[Docket No. FDA-2019-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications; Changes of
Sponsor; Change of Sponsor's Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during July, August, and September 2019. FDA is
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable. The
animal drug regulations are also being amended to make technical
amendments to improve the accuracy of the regulations.

DATES: This rule is effective January 24, 2020, except for amendatory
instruction number 3 to 21 CFR 510.600, number 8 to 21 CFR 520.1807,
number 21 to 21 CFR 529.1115, and number 24 to 21 CFR 556.513, which
are effective February 3, 2020.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during July, August, and September 2019,
as listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents may be seen in the
office of the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday. Persons with access
to the internet may obtain these documents at the CVM FOIA Electronic
Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing
exclusivity and patent information may be accessed in FDA's
publication, Approved Animal Drug Products Online (Green Book) at:
https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

                          Table 1--Original and Supplemental NADAs and ANADAs Approved During July, August, and September 2019
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Approval date       File No.         Sponsor             Product name            Species            Effect of the action          Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 1, 2019.........    200-639  Huvepharma EOOD, 5th   MONOVET (monensin)    Cattle and goats..  Original approval as a generic  FOI Summary.
                                   Floor, 3A Nikolay      Type A Medicated                          copy of NADA 095-735.
                                   Haytov Str., 1113      Article.
                                   Sophia, Bulgaria.
July 2, 2019.........    141-519  Zoetis Inc., 333       PROHEART 12           Dogs..............  Original approval for           FOI Summary.
                                   Portage St.,           (moxidectin) for                          prevention of heartworm
                                   Kalamazoo, MI 49007.   Extended-Release                          disease caused by Dirofilaria
                                                          Injectable                                immitis for 12 months in dogs
                                                          Suspension.                               12 months of age and older;
                                                                                and for treatment of existing
                                                                                larval and adult hookworm
                                                                                (Ancylostoma caninum and
                                                                                Uncinaria stenocephala)
                                                                                infections.
July 5, 2019.........    113-645  Intervet, Inc., 2      ESTRUMATE...........  Cattle............  Supplemental approval for       FOI Summary.
                                   Giralda Farms,        (cloprostenol                              synchronization of estrous
                                   Madison, NJ 07940.     injection).                               cycles to allow for fixed
                                                                                time artificial insemination
                                                                                (FTAI) in lactating dairy
                                                                                cows.
July 26, 2019........    141-255  Syndel USA, 1441 W.    35% PEROX-AID         Finfish...........  Supplemental approval for the   FOI Summary.
                                   Smith Rd., Ferndale,   (hydrogen peroxide)                       control of mortality in
                                   WA 98248.              Concentrated                              freshwater-reared coldwater
                                                          Immersion Solution.                       finfish, fingerling and adult
                                                                                freshwater-reared coolwater
                                                                                finfish, and fingerling and
                                                                                adult freshwater-reared
                                                                                warmwater finfish due to
                                                                                saprolegniasis associated
                                                                                with fungi in the family
                                                                                Saprolegniaceae; for the
                                                                                treatment and control of
                                                                                Gyrodactylus spp. in
                                                                                freshwater-reared salmonids;
                                                                                and for the control of
                                                                                mortality in freshwater-
                                                                                reared warmwater finfish due
                                                                                to external columnaris
                                                                                associated with
                                                                                Flavobacterium columnare.
August 27, 2019......    141-465  Elanco US Inc., 2500   Avilamycin and        Chickens..........  Supplemental approval of a      FOI Summary.
                                   Innovation Way,        monensin Type C                           revised age restriction
                                   Greenfield, IN 46140.  medicated feeds.                          caution statement for broiler
                                                                                feeds.
August 27, 2019......    141-467  Do...................  Avilamycin and        Chickens..........  Supplemental approval of a      FOI Summary.
                                                          narasin Type C                            revised age restriction
                                                          medicated feeds.                          caution statement for broiler
                                                                                feeds.

August 27, 2019......    141-495  Do...................  Avilamycin and        Chickens..........  Supplemental approval of a      FOI Summary.
                                                          salinomycin Type C                        revised age restriction
                                                          medicated feeds.                          caution statement for broiler
                                                                                feeds.
September 3, 2019....    141-494  Do...................  CREDELIO (lotilaner)  Dogs..............  Supplemental approval for       FOI Summary.
                                                          Chewable Tablet.                          prevention of flea
                                                                                infestations for 1 month in
                                                                                dogs and puppies.
September 20, 2019...    200-642  Huvepharma EOOD, 5th   Monensin and tylosin  Cattle............  Original approval for use of    FOI Summary.
                                   Floor, 3A Nikolay      phosphate Type B                          MONOVET 90 (monensin Type A
                                   Haytov Str., 1113      and Type C                                medicated article) with
                                   Sophia, Bulgaria.      medicated feeds.                          TYLOVET (tylosin phosphate)
                                                                                Type A medicated articles in
                                                                                the manufacture of Type B and
                                                                                Type C medicated feeds as a
                                                                                generic copy of NADA 104-646.
September 20, 2019...    200-643  Do...................  Monensin and tylosin  Cattle............  Original approval for use of    FOI Summary.
                                                          phosphate Type B                          MONOVET 90 (monensin Type A
                                                          and Type C                                medicated article) with TYLAN
                                                          medicated feeds.                          (tylosin phosphate) Type A
                                                                                medicated articles in the
                                                                                manufacture of Type B and
                                                                                Type C medicated feeds as a
                                                                                generic copy of NADA 104-646.
September 20, 2019...    200-644  Do...................  Monensin,             Cattle............  Original approval for use of    FOI Summary.
                                                          ractopamine                               MONOVET 90 (monensin Type A
                                                          hydrochloride, and                        medicated article) with
                                                          tylosin phosphate                         OPTAFLEXX (ractopamine
                                                          Type B and Type C                         hydrochloride Type A
                                                          medicated feeds.                          medicated article) and
                                                                                TYLOVET (tylosin phosphate)
                                                                                Type A medicated article in
                                                                                the manufacture of Type B and
                                                                                Type C medicated feeds as a
                                                                                generic copy of NADA 141-224.
September 20, 2019...    200-645  Do...................  Monensin,             Cattle............  Original approval for use of    FOI Summary.
                                                          ractopamine                               MONOVET 90 (monensin Type A
                                                          hydrochloride, and                        medicated article) with
                                                          tylosin phosphate                         ACTOGAIN (ractopamine
                                                          Type B and Type C                         hydrochloride Type A
                                                          medicated feeds.                          medicated article) and
                                                                                TYLOVET (tylosin phosphate)
                                                                                Type A medicated article in
                                                                                the manufacture of Type B and
                                                                                Type C medicated feeds as a
                                                                                generic copy of NADA 141-224.
September 20, 2019...    200-646  Do...................  Monensin,             Cattle............  Original approval for use of    FOI Summary.
                                                          ractopamine                               MONOVET 90 (monensin Type A
                                                          hydrochloride, and                        medicated article) with
                                                          tylosin phosphate                         OPTAFLEXX (ractopamine
                                                          Type B and Type C                         hydrochloride Type A
                                                          medicated feeds.                          medicated article) and TYLAN
                                                                                (tylosin phosphate) Type A
                                                                                medicated article in the
                                                                                manufacture of Type B and
                                                                                Type C medicated feeds as a
                                                                                generic copy of NADA 141-224.
September 20, 2019...    200-647  Do...................  Monensin,             Cattle............  Original approval for use of    FOI Summary.
                                                          ractopamine                               MONOVET 90 (monensin Type A
                                                          hydrochloride, and                        medicated article) with
                                                          tylosin phosphate                         ACTOGAIN (ractopamine
                                                          Type B and Type C                         hydrochloride Type A
                                                          medicated feeds.                          medicated article) and TYLAN
                                                                                (tylosin phosphate) Type A
                                                                                medicated article in the
                                                                                manufacture of Type B and
                                                                                Type C medicated feeds as a
                                                                                generic copy of NADA 141-224.
September 20, 2019...    200-648  Do...................  Monensin,             Cattle............  Original approval for use of    FOI Summary.
                                                          ractopamine                               MONOVET 90 (monensin Type A
                                                          hydrochloride,                            medicated article) with
                                                          tylosin phosphate,                        OPTAFLEXX (ractopamine
                                                          and melengestrol                          hydrochloride Type A
                                                          acetate Type C                            medicated article), TYLOVET
                                                          medicated feeds.                          (tylosin phosphate) Type A
                                                                                medicated article, and MGA
                                                                                (melengestrol acetate Type A
                                                                                medicated article) in the
                                                                                manufacture of Type C
                                                                                medicated feeds as a generic
                                                                                copy of NADA 141-233.
September 20, 2019...    200-649  Do...................  Monensin,             Cattle............  Original approval for use of    FOI Summary.
                                                          ractopamine                               MONOVET 90 (monensin Type A
                                                          hydrochloride,                            medicated article) with
                                                          tylosin phosphate,                        ACTOGAIN (ractopamine
                                                          and melengestrol                          hydrochloride Type A
                                                          acetate Type C                            medicated article), TYLOVET
                                                          medicated feeds.                          (tylosin phosphate) Type A
                                                                                medicated article, and MGA
                                                                                (melengestrol acetate Type A
                                                                                medicated article) in the
                                                                                manufacture of Type C
                                                                                medicated feeds as a generic
                                                                                copy of NADA 141-233.
September 20, 2019...    200-650  Do...................  Monensin,             Cattle............  Original approval for use of    FOI Summary.
                                                          ractopamine                               MONOVET 90 (monensin Type A
                                                          hydrochloride,                            medicated article) with
                                                          tylosin phosphate,                        OPTAFLEXX (ractopamine
                                                          and melengestrol                          hydrochloride Type A
                                                          acetate Type C                            medicated article), TYLOVET
                                                          medicated feeds.                          (tylosin phosphate) Type A
                                                                                medicated article, and MGA
                                                                                (melengestrol acetate Type A
                                                                                medicated article) in the
                                                                                manufacture of Type C
                                                                                medicated feeds as a generic
                                                                                copy of NADA 141-233.

September 20, 2019...    200-651  Do...................  Monensin,             Cattle............  Original approval for use of    FOI Summary.
                                                          ractopamine                               MONOVET 90 (monensin Type A
                                                          hydrochloride,                            medicated article) with
                                                          tylosin phosphate,                        ACTOGAIN (ractopamine
                                                          and melengestrol                          hydrochloride Type A
                                                          acetate Type C                            medicated article), TYLAN
                                                          medicated feeds.                          (tylosin phosphate) Type A
                                                                                medicated article, and MGA
                                                                                (melengestrol acetate Type A
                                                                                medicated article) in the
                                                                                manufacture of Type C
                                                                                medicated feeds as a generic
                                                                                copy of NADA 141-233.
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II. Changes of Sponsor

    The sponsors of the following approved applications have informed
FDA that they have transferred ownership of, and all rights and
interest in, these applications to another sponsor:

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                                                                                21 CFR
         File No.               Product name        Transferring sponsor        New sponsor           section
----------------------------------------------------------------------------------------------------------------
140-872..................  POSILAC (sometribove    Elanco US Inc., 2500    Union Agener, Inc.,          522.2112
                            zinc) Injectable        Innovation Way,         1788 Lovers Ln.,
                            Suspension.             Greenfield, IN 46140.   Augusta, GA 30901.
141-457..................  ENTYCE (capromorelin)   Aratana Therapeutics,   Elanco US Inc., 2500          520.292
                            Oral Solution.          Inc., 11400 Tomahawk    Innovation Way,
                                                    Creek Pkwy., Leawood,   Greenfield, IN 46140.
                                                    KS 66211.
141-461..................  NOCITA (bupivacaine     Aratana Therapeutics,   Do...................         522.224
                            liposome injectable     Inc., 11400 Tomahawk
                            suspension).            Creek Pkwy., Leawood,
                                                    KS 66211.
200-180..................  Ampicillin Trihydrate   G. C. Hanford Mfg.      HQ Specialty Pharma           522.90b
                            (ampicillin             Co., P.O. Box 1017,     Corp., 120 Rte. 17
                            trihydrate) Powder      Syracuse, NY 13201.     North, Suite 130,
                            for Injection.                                  Paramus, NJ 07652.
200-273..................  VETRO-GEN (gentamicin   Dechra, Ltd., Snaygill  Putney, Inc., One           524.1044c
                            sulfate) Veterinary     Industrial Estate,      Monument Sq., Suite
                            Ophthalmic Ointment.    Keighley Rd.,           400, Portland, ME
                                                    Skipton, North          04101.
                                                    Yorkshire, BD23 2RW,
                                                    United Kingdom.
200-388..................  GB (gentamicin sulfate  American                Do...................       524.1044f
                            and betamethasone       Pharmaceuticals and
                            valerate) Topical       Cosmetics. Inc., 1401
                            Spray.                  Joel East Rd., Fort
                                                    Worth, TX 76140.
200-490..................  Carprofen (carprofen)   Dragon Fire Holding     Do...................         520.490
                            Chewable Tablets.       Co., Inc., 2619
                                                    Skyway Dr., Grand
                                                    Prairie, TX 75052.
----------------------------------------------------------------------------------------------------------------

Following these changes of sponsorship, American Pharmaceuticals and
Cosmetics, Inc.; Aratana Therapeutics, Inc.; and Dragon Fire Holding
Co., Inc. are no longer the sponsor of an approved application.
Accordingly, the regulations in parts 510, 520, 522, and 524 are being
amended to reflect these changes.

III. Change of Sponsor's Address

    Halocarbon Products Corp., 887 Kinderkamack Rd., River Edge, NJ
07661 has informed FDA that it has changed its address to 6525 The
Corners Pkwy., Suite 200, Peachtree Corners, GA 30092. Accordingly, we
are amending Sec.  510.600(c) to reflect this change.

IV. Withdrawals of Approval

    Fleming Laboratories, Inc., P.O. Box 34384, Charlotte, NC 28234,
has requested that FDA withdraw approval of NADA 010-005 for use of
WAZINE (dipiperazine sulfate and piperazine hydrochloride) Soluble
Powders because the product is no longer manufactured or marketed.
Following this withdrawal of approval, Fleming Laboratories, Inc., is
no longer the sponsor of an approved application. Accordingly, it will
be removed from the list of sponsors of approved applications in Sec.
510.600(c). In addition, Fleming Laboratories, Inc.'s product was the
only piperazine product approved for use in food-producing animals.
Accordingly, tolerances for piperazine will be removed from part 556.
    Also, Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200,
Peachtree Corners, GA 30092, has requested that FDA withdraw approval
of ANADA 200-200 for use of Halothane USP (halothane) because the
product is no longer manufactured or marketed.
    Lastly, Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL
61103, has requested that FDA withdraw approval of ANADA 200-472 for
use of Fomepizole Injection because the product is no longer
manufactured or marketed.
    Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADA 010-005 and ANADAs 200-200 and 200-472, and all
supplements and amendments thereto, is withdrawn effective February 3,
2020. As provided in the regulatory text of this document, the animal
drug regulations in parts 510, 520, 556, and 529 are amended to reflect
these actions.

V. Technical Amendments

    FDA is revising the regulations at 21 CFR 520.2520d to reflect the
approved conditions of use of trichlorfon, phenothiazine, and
piperazine soluble powder for oral administration to horses as an
anthelmintic. This information was deleted in error during
redesignation (79 FR 28833, May 20, 2014). FDA is also revising the
regulations at 21 CFR 520.2612 to reflect the currently approved dosage
for trimethoprim and sulfadiazine

suspension for oral administration to horses as an antimicrobial.
Lastly, FDA is revising the assay limits for nicarbazin medicated feeds
at 21 CFR 558.4(d) in the ``Category II'' table. These actions are
being taken to improve the accuracy of the regulations.

VI. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C.360b(i)), which
requires Federal Register publication of ``notice[s] . . . effective as
a regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth technical amendments to the regulations to codify
recent actions on approved new animal drug applications and corrections
to improve the accuracy of the regulations, and as such does not impose
any burden on regulated entities.
    Although denominated a rule pursuant to the FD&C Act, this document
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.
Likewise, this is not a rule subject to Executive Order 12866, which
defines a rule as ``an agency statement of general applicability and
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, 524, and 529

    Animal drugs.

21 CFR Part 556

    Animal drugs, Food.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510, 520, 522, 524, 529, 556, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for part 510 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600:
0
a. In the table in paragraph (c)(1):
0
i. Remove the entries for ``American Pharmaceuticals and Cosmetics.
Inc.'', ``Aratana Therapeutics, Inc.'', and ``Dragon Fire Holding Co.,
Inc.'';
0
ii. Revise the entry for ``Halocarbon Products Corp.''; and
0
iii. Add an entry in alphabetical order for ``Union Agener, Inc.'';
0
b. In the table in paragraph (c)(2):
0
i. Revise the entry for ``012164'';
0
ii. Remove the entries for ``065531'', ``076033'', and ``086026''; and
0
iii. Add an entry in numerical order for ``086106''.
0
The revisions and additions read as follows:

Sec.  510.600   Names, addresses, and drug labeler codes of sponsors of
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------

                              * * * * * * *
Halocarbon Products Corp., 6525 The Corners Pkwy., Suite          012164
 200, Peachtree Corners, GA 30092.......................

                              * * * * * * *
Union Agener, Inc., 1788 Lovers Ln., Augusta, GA 30901..          086106

                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
   Drug labeler  code                  Firm name and address
------------------------------------------------------------------------

                              * * * * * * *
012164..................  Halocarbon Products Corp., 6525 The Corners
                           Pkwy., Suite 200, Peachtree Corners, GA 30092

                              * * * * * * *
086106..................  Union Agener, Inc., 1788 Lovers Ln., Augusta,
                           GA 30901

                              * * * * * * *
------------------------------------------------------------------------

Sec.  510.600   [Amended]

0
3. Effective February 3, 2020, Sec.  510.600 is further amended, in the
table in paragraph (c)(1), remove the entry for ``Fleming Laboratories,
Inc.''; and in the table in paragraph (c)(2), remove the entry for
``015565''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
4. The authority citation for part 520 continues to read as follows:

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

Sec.  520.292   [Amended]

0
5. In Sec.  520.292, in paragraph (b), remove ``086026'' and in its
place add ``058198''.

Sec.  520.304   [Amended]

0
6. In Sec.  520.304, in paragraph (b)(1), remove ``062250, and 076033''
and in its place add ``and 062250''.

Sec.  520.1286   [Amended]

0
7. In Sec.  520.1286, in paragraph (c)(2), remove ``for the treatment
of flea infestations'' and in its place add ``for the treatment and
prevention of flea infestations''.

Sec.  520.1807   [Removed]

0
8. Effective February 3, 2020, Sec.  520.1807 is removed.

0
9. In Sec.  520.2520d, revise the section heading and add paragraph (c)
to read as follows:

Sec.  520.2520d   Trichlorfon, phenothiazine, and piperazine.

* * * * *
    (c) Conditions of use in horses--(1) Amount. 18.2 milligrams (mg)
of trichlorfon, 12.5 mg of phenothiazine, and 40 mg of piperazine base
per pound of body weight.
    (2) Indications for use. For removal of bots (Gastrophilus nasalis,
Gastrophilus intestinalis), large strongyles (Strongylus vulgaris),
small strongyles, large roundworms (ascarids, Parascaris equorum), and
pinworms (Oxyuris equi).
    (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
10. In Sec.  520.2612, revise paragraph (c)(2)(i) to read as follows:

Sec.  520.2612   Trimethoprim and sulfadiazine suspension.

* * * * *
    (c) * * *
    (2) * * *
    (i) Amount. Administer orally at a dosage of 24 mg combined active
ingredients per kilogram body weight (10.9 mg/lb) twice daily for 10
days. Administered by volume at 2.7 mL per 45.4 kilograms of body
weight (2.7 mL/100 lb).
* * * * *

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

0
11. The authority citation for part 522 continues to read as follows:

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

Sec.  522.90b   [Amended]

0
12. In Sec.  522.90b, in paragraph (b), remove ``010515'' and in its
place add ``042791''.

Sec.  522.224   [Amended]

0
13. In Sec.  522.224, in paragraph (b), remove ``086026'' and in its
place add ``058198''.

0
14. In Sec.  522.460, add paragraph (b)(3), revise paragraphs
(c)(1)(ii) and (iii), add paragraph (c)(1)(iv), and revise paragraph
(c)(2) to read as follows:

Sec.  522.460   Cloprostenol.

* * * * *
    (b) * * *
    (3) No. 000061 for use of product described in paragraph (a)(2) as
in paragraphs (c)(1)(iv) and (c)(2) of this section.
    (c) * * *
    (1) * * *
    (ii) Administer 500 [micro]g by intramuscular injection for
abortion of unwanted pregnancies from mismatings from 1 week after
mating until 5 months after conception; for unobserved (non-detected)
estrus; for treatment of mummified fetus, luteal cysts, and pyometra or
chronic endometritis in beef cows, lactating dairy cows, and
replacement beef and dairy heifers.
    (iii) Administer 500 [micro]g by intramuscular injection as a
single injection regimen or double injection regimen with a second
injection 11 days after the first, for estrus synchronization in beef
cows, lactating dairy cows, and replacement beef and dairy heifers.
    (iv) For use with gonadorelin acetate to synchronize estrous cycles
to allow for fixed time artificial insemination (FTAI) in lactating
dairy cows: Administer to each cow 86 [micro]g gonadorelin by
intramuscular injection, followed 6 to 8 days later by 500 [micro]g
cloprostenol by intramuscular injection, followed 30 to 72 hours later
by 86 [micro]g gonadorelin by intramuscular injection.
    (2) Limitations. Gonadorelin acetate for use in paragraph
(c)(1)(iv) of this section as provided by No. 000061 in Sec.
510.600(c) of this chapter.

0
15. Revise Sec.  522.1451 to read as follows:

Sec.  522.1451   Moxidectin microspheres for injection.

    (a) Specifications. The drug product consists of two separate
vials. One vial contains 10 percent moxidectin microspheres and the
second vial contains a vehicle for constitution of the moxidectin
microspheres.
    (1) Each milliliter (mL) of constituted suspension contains 3.4
milligrams (mg) moxidectin.
    (2) Each mL of constituted suspension contains 10 mg moxidectin.
    (b) Sponsor. See No. 54771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. (i) Using the suspension
described in paragraph (a)(1) of this section, administer 0.05 mL of
the constituted suspension per kilogram (kg) of body weight (0.023 mL
per pound (lb)) as a single subcutaneous injection to provide 0.17 mg/
kg body weight (0.0773 mg/lb).
    (ii) Using the suspension described in paragraph (a)(2) of this
section, administer 0.05 mL of the constituted suspension/kg of body
weight (0.023 mL/lb) as a single subcutaneous injection to provide 0.5
mg/kg body weight (0.23 mg/lb).
    (2) Indications for use--(i) Suspension described in paragraph
(a)(1) of this section. For prevention of heartworm disease caused by
Dirofilaria immitis in dogs 6 months of age and older; and for
treatment of existing larval and adult hookworm (Ancylostoma caninum
and Uncinaria stenocephala) infections.
    (ii) Suspension described in paragraph (a)(2) of this section. For
prevention of heartworm disease caused by Dirofilaria immitis for 12
months in dogs 12 months of age and older; and for treatment of
existing larval and adult hookworm (Ancylostoma caninum and Uncinaria
stenocephala) infections.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

Sec.  522.2112   [Amended]

0
16. In Sec.  522.2112, in paragraph (b), remove ``058198'' and in its
place add ``086106''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
17. The authority citation for part 524 continues to read as follows:

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

Sec.  524.1044c   [Amended]

0
18. In Sec.  524.1044c, in paragraph (b), remove ``043264'' and in its
place add ``026637''.

Sec.  524.1044f   [Amended]

0
19. In Sec.  524.1044f, in paragraph (b), remove ``058829, and 065531''
and in its place add ``and 058829''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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

Sec.  529.1115   [Amended]

0
21. Effective February 3, 2020, in Sec.  529.1115, in paragraph (b),
remove ``Nos. 012164 and 054771'' and in its place add ``No. 054771''.

0
22. In Sec.  529.1150, revise paragraph (c) to read as follows:

Sec.  529.1150   Hydrogen peroxide.

* * * * *
    (c) Conditions of use--(1) Indications and amount. (i) Freshwater-
reared finfish eggs for the control of mortality in due to
saprolegniasis associated with fungi in the family Saprolegniaceae:
    (A) For all coldwater and coolwater species of freshwater-reared
finfish eggs: 500 to 1,000 mg per liter (/L) of culture water for 15
minutes in a continuous flow system once per day on consecutive or
alternate days until hatch, or
    (B) For all freshwater-reared warmwater finfish eggs: 750 to 1,000
mg/L for 15 minutes in a continuous flow system once per day on
consecutive or alternate days until hatch.
    (ii) Freshwater-reared finfish for the control of mortality due to
saprolegniasis associated with the fungi in the family Saprolegniaceae:
For freshwater-reared coldwater finfish including salmonids (all life
stages), freshwater-reared coolwater finfish fingerlings and adults,
and freshwater-reared warmwater finfish fingerlings and adults: 75 mg/L
for 60 minutes in continuous flow water supply or as a static bath once
per day on alternate days for three treatments.
    (iii) Freshwater-reared salmonids for the control of mortality due
to bacterial gill disease associated with Flavobacterium
branchiophilum: 100 mg/L for 30 minutes, or 50 to 100 mg/L for 60
minutes, in a continuous flow water supply or as a static bath once per
day on alternate days for three treatments.
    (iv) Freshwater-reared salmonids for the treatment and control of
Gyrodactylus spp: 100 mg/L for 30 minutes, or 50 to 100 mg/L for 60
minutes, in a continuous flow water supply or as a static bath once per
day on alternate days for three treatments.
    (v) Freshwater-reared coolwater and warmwater finfish fingerlings
and adults for the control of mortality due to external columnaris
disease associated with Flavobacterium columnare: 50 to 75 mg/L for 60
minutes in continuous flow water supply or as a static bath once per
day on alternate days for three treatments.
    (vi) Freshwater-reared coolwater finfish fry and warmwater finfish
fry for the control of mortality due to external columnaris disease
associated with Flavobacterium columnare: 50 mg/L for 60 minutes in
continuous flow water supply or as a static bath once per day on
alternate days for three treatments.
    (2) Limitations. (i) Initial bioassay on a small number is
recommended before treating the entire group.
    (ii) Eggs: Some strains of rainbow trout eggs are sensitive to
hydrogen peroxide treatment at a time during incubation concurrent with
blastopore formation through closure, about 70 to 140 Daily Temperature
Units, [deg]C. Consider withholding treatment or using an alternate
therapeutant during that sensitive time to reduce egg mortalities due
to drug toxicity.
    (iii) Finfish: Because finfish sensitivity to 35% PEROX-AID[supreg]
increases with increasing water temperature, consider administering
initial treatments at the lower end of the treatment regimen or
reducing water temperature before treatment. Do not use this product to
treat northern pike (Esox lucius) or paddlefish (Polyodon spathula) of
any age. Do not use this product to treat pallid sturgeon fry. Use with
caution on walleye (Sander vitreus) and ornamental finfish.
    (iv) Preharvest withdrawal time: Zero days.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
23. The authority citation for part 556 continues to read as follows:

    Authority:  21 U.S.C. 342, 360b, 371.

Sec.  556.513   [Removed]

0
24. Effective February 3, 2020, Sec.  556.513 is removed.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
25. The authority citation for part 558 continues to read as follows:

    Authority:  21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

0
26. In Sec.  558.4, in paragraph (d), revise the entry for ``Nicarbazin
(powder)'' to read as follows:

Sec.  558.4   Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   Category II
----------------------------------------------------------------------------------------------------------------
                                                 Assay limits                                      Assay limits
                     Drug                        percent \1\         Type B maximum  (100x)        percent \1\
                                                    Type A                                         Type B/C \2\
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Nicarbazin (powder)..........................          96-104   9.08 g/lb (2.00%)..............   85-115/75-125

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
27. In Sec.  558.68, revise paragraphs (e)(1)(ii), (iii), and (v) to
read as follows:

Sec.  558.68   Avilamycin.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
      Avilamycin  in grams/ton             Indications for use                 Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(ii) 13.6 to 40.9...................  Monensin, 90 to 110.........  Feed as the sole ration for 21        058198
                                                                     consecutive days. Feed to
                                                                     chickens that are at risk of
                                                                     developing, but not yet showing
                                                                     clinical signs of, necrotic
                                                                     enteritis associated with
                                                                     Clostridium perfringens in
                                                                     broiler chickens. Avilamycin has
                                                                     not been demonstrated to be
                                                                     effective in broiler chickens
                                                                     showing clinical signs of
                                                                     necrotic enteritis prior to the
                                                                     start of medication. To assure
                                                                     responsible antimicrobial drug
                                                                     use in broiler chickens,
                                                                     treatment administration must
                                                                     begin on or before 18 days of
                                                                     age. Do not feed to chickens
                                                                     over 16 weeks of age. The safety
                                                                     of avilamycin has not been
                                                                     established in chickens intended
                                                                     for breeding purposes. Do not
                                                                     allow horses or other equines
                                                                     access to feed containing
                                                                     avilamycin and monensin.
                                                                     Ingestion of monensin by horses
                                                                     has been fatal. Do not feed to
                                                                     chickens producing eggs for
                                                                     human consumption. Monensin as
                                                                     provided by No. 058198 in Sec.
                                                                     510.600(c) of this chapter.
(iii) 13.6 to 40.9..................  Narasin, 54 to 90...........  Feed as the sole ration for 21        058198
                                                                     consecutive days. Feed to
                                                                     chickens that are at risk of
                                                                     developing, but not yet showing
                                                                     clinical signs of, necrotic
                                                                     enteritis associated with
                                                                     Clostridium perfringens.
                                                                     Avilamycin has not been
                                                                     demonstrated to be effective in
                                                                     broiler chickens showing
                                                                     clinical signs of necrotic
                                                                     enteritis prior to the start of
                                                                     medication. To assure
                                                                     responsible antimicrobial drug
                                                                     use in broiler chickens,
                                                                     treatment administration must
                                                                     begin on or before 18 days of
                                                                     age. The safety of avilamycin
                                                                     has not been established in
                                                                     chickens intended for breeding
                                                                     purposes. Do not allow adult
                                                                     turkeys, horses, or other
                                                                     equines access to narasin
                                                                     formulations. Ingestion of
                                                                     narasin by these species has
                                                                     been fatal. Do not feed to
                                                                     chickens producing eggs for
                                                                     human consumption. Narasin as
                                                                     provided by No. 058198 in Sec.
                                                                     510.600(c) of this chapter.

                                                  * * * * * * *
(v) 13.6 to 40.9....................  Salinomycin sodium, 40 to 60  Feed as the sole ration for 21        058198
                                                                     consecutive days. Feed to
                                                                     chickens that are at risk of
                                                                     developing, but not yet showing
                                                                     clinical signs of, necrotic
                                                                     enteritis associated with
                                                                     Clostridium perfringens.
                                                                     Avilamycin has not been
                                                                     demonstrated to be effective in
                                                                     broiler chickens showing
                                                                     clinical signs of necrotic
                                                                     enteritis prior to the start of
                                                                     medication. To assure
                                                                     responsible antimicrobial drug
                                                                     use in broiler chickens,
                                                                     treatment administration must
                                                                     begin on or before 18 days of
                                                                     age. The safety of avilamycin
                                                                     has not been established in
                                                                     chickens intended for breeding
                                                                     purposes. May be fatal if fed to
                                                                     adult turkeys or to horses. Not
                                                                     approved for use with pellet
                                                                     binders. Do not feed to laying
                                                                     hens producing eggs for human
                                                                     consumption. Salinomycin as
                                                                     provided by No. 016592 in Sec.
                                                                     510.600(c) of this chapter.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
28. In Sec.  558.355, revise paragraphs (b) and (f)(6)(i) to read as
follows:

Sec.  558.355   Monensin.

* * * * *
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for
use as in paragraph (f) of this section.
    (1) No. 058198 for use as in paragraph (f) of this section.
    (2) No. 016592 for use of a Type A medicated article containing
90.7 grams monensin, USP, per pound as in paragraphs (f)(3),
(f)(4)(vi), and (f)(6) of this section.
* * * * *
    (f) * * *
    (6) * * *

------------------------------------------------------------------------
                        Indications for
Monensin in grams/ton         use             Limitations       Sponsor
------------------------------------------------------------------------
(i) 20...............  For the           Feed only to goats       058198
                        prevention of     being fed in
                        coccidiosis       confinement. Do not
                        caused by         feed to lactating
                        Eimeria           goats. See
                        crandallis, E.    paragraph (d)(11)
                        christenseni,     of this section for
                        and E.            provisions for
                        ninakohlyakimov   monensin liquid
                        ae.               Type C goat feeds.

                              * * * * * * *
------------------------------------------------------------------------

* * * * *

Sec.  558.625   [Amended]

0
29. Amend Sec.  558.625:
0
a. By removing ``monensin as provided by No. 058198'' and adding in its
place ``monensin as provided by Nos. 016592 or 058198'' in the
``Limitations'' column, in:
0
1. Paragraph (e)(2)(iv),
0
2. Paragraph (e)(2)(v),
0
3. Paragraph (e)(2)(x),
0
4. Paragraph (e)(2)(xi),
0
5. Paragraph (e)(2)(xii), and
0
6. Paragraph (e)(2)(xiii); and
0
b. By adding ``016592'' in numerical order in the ``Sponsors'' column
in:
0
1. Paragraph (e)(2)(x),
0
2. Paragraph (e)(2)(xi),
0
3. Paragraph (e)(2)(xii), and
0
4. Paragraph (e)(2)(xiii).

    Dated: January 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00421 Filed 1-23-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: February 12, 2010 (Volume 75, Number 29)]
[Proposed Rules]
[Page 6862-6865]
[DOCID:fr12fe10-11]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0039; Directorate Identifier 2009-NM-239-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Model CL-600-1A11 (CL-
600), CL-600-2A12 (CL-601), CL-600-2B16 (CL-601-3A, CL-601-3R, and CL-
604 Variants (Including CL-605 Marketing Variant)) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

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

    Seven cases of on-ground hydraulic accumulator screw cap or end
cap failure have been experienced on CL-600-2B19 (CRJ) aircraft,
resulting in loss of the associated hydraulic system and high-energy
impact damage to adjacent systems and structure. * * *
* * * * *
    A detailed analysis of the systems and structure in the
potential line of trajectory of a failed screw cap/end cap for each
accumulator * * * has been conducted. It has been identified that
the worst case scenario would be failure of one of the brake
accumulator screw caps/end caps, resulting in impact damage causing
loss of both hydraulic systems No. 2 and No. 3, with consequent loss
of both braking and nose wheel steering and the potential for a
runway excursion [resulting in damage to the airplane and hazards to
persons or property on the ground].
* * * * *
The proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by March 29, 2010.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Bombardier, Inc., 400 C[ocirc]te Vertu Road West, Dorval, Qu[eacute]bec
H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet http://www.bombardier.com. You
may review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: Christopher Alfano, Aerospace
Engineer, Airframe and Mechanical Systems Branch, ANE-171, FAA, New
York Aircraft Certification Office, 1600 Stewart Avenue, Suite 410,
Westbury, New York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2010-0039;
Directorate Identifier 2009-NM-239-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We have lengthened the 30-day comment period for proposed ADs that
address MCAI originated by aviation authorities of other countries to
provide adequate time for interested parties to submit comments. The
comment period for these proposed ADs is now typically 45 days, which
is consistent with the comment period for domestic transport ADs.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2009-39, dated October 27, 2009 (referred to after this as ``the
MCAI''), to correct an unsafe condition for the specified products. The
MCAI states:

    Seven cases of on-ground hydraulic accumulator screw cap or end
cap failure have been experienced on CL-600-2B19 (CRJ) aircraft,
resulting in loss of the associated hydraulic system and high-energy
impact damage to adjacent systems and structure. The lowest number
of flight cycles accumulated at the time of failure, to date, has
been 6991 flight cycles.
    Although there have been no failures to date on any CL-600-1A11,
CL-600-2A12 or CL-600-2B16 aircraft, the same accumulators as those
installed on the CL-600-2B19, Part Numbers (P/N) 08-60163-001, 08-
60163-002, 08-60164-001 and 08-60164-002, are installed on some of
the aircraft listed in the Applicability section of this directive.
    Notes:
    1. Earlier accumulators, P/Ns 2770571-102, 2770571-103, 2770571-
104 and 2770571-105, were installed in production on the following
aircraft: CL-600-1A11 [all Serial Numbers (S/Ns)], CL-600-2A12 (all
S/Ns) and CL-600-2B16 (S/Ns 5001 through 5194 and 5301 through 5524
only). These accumulators do not require inspection or replacement.
However, if any of the accumulators with the above P/Ns have been
replaced in-service by P/Ns 08-60163-001, 08-60163-002, 08-60164-001
and 08-60164-002, these latter accumulators require replacement.
    2. The only accumulators ever installed on CL-600-2B16 aircraft,
S/Ns 5525 through 5665 and 5701 and subsequent, are P/Ns 08-60163-
001, 08-60163-002, 08-60164-001 and 08-60164-002; these accumulators
require replacement.
    A detailed analysis of the systems and structure in the
potential line of trajectory of a failed screw cap/end cap for each
accumulator, P/Ns 08-60163-001, 08-60163-002, 08-60164-001 and 08-
60164-002, has been conducted. It has been identified that the worst
case scenario would be failure of one of the brake accumulator screw
caps/end caps, resulting in impact damage causing loss of both
hydraulic systems No. 2 and No. 3, with consequent loss of both
braking and nose wheel steering and the potential for a runway
excursion [resulting in damage to the airplane and hazards to
persons or property on the ground].
    This directive gives instructions to perform identification and
records checks, where applicable, and replace accumulators, P/Ns 08-
60163-001, 08-60163-002, 08-60164-001 and 08-60164-002, within the
time compliance specified.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Bombardier has issued Service Bulletins 600-0742, 601-0597, 604-29-
008, and 605-29-001, all Revision 01, all dated July 6, 2009. The
actions described in this service information are intended to correct
the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

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

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 340 products of U.S. registry. We also estimate that
it would take about 20 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Required parts would cost about $7,717 per product. Where
the service information lists required parts costs that are covered
under warranty, we have assumed that there will be no charge for these
costs. As we do not control warranty coverage for affected parties,
some parties may incur costs higher than estimated here. Based on these
figures, we estimate the cost of the proposed AD on U.S. operators to
be $3,201,780, or $9,417 per product.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

    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]

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

Bombardier, Inc.: Docket No. FAA-2010-0039; Directorate Identifier
2009-NM-239-AD.

Comments Due Date

    (a) We must receive comments by March 29, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to the Bombardier, Inc. airplanes,
certificated in any category, identified in paragraphs (c)(1),
(c)(2), and (c)(3) of this AD.
    (1) Model CL-600-1A11 (CL-600) airplanes, serial numbers 1004
through 1085 inclusive;
    (2) CL-600-2A12 (CL-601) airplanes, serial numbers 3001 through
3066 inclusive; and
    (3) CL-600-2B16 (CL-601-3A, CL-601-3R, and CL-604) airplanes,
serial numbers 5001 through 5194 inclusive, 5301 through 5665
inclusive, and 5701 and subsequent.

    Note 1: Some Model CL-600-2B16 (CL-604) airplanes might be
referred to by the marketing designation CL-605.

Subject

    (d) Air Transport Association (ATA) of America Code 29:
Hydraulic power.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    Seven cases of on-ground hydraulic accumulator screw cap or end
cap failure have been experienced on CL-600-2B19 (CRJ) aircraft,
resulting in loss of the associated hydraulic system and high-energy
impact damage to adjacent systems and structure. The lowest number
of flight cycles accumulated at the time of failure, to date, has
been 6991 flight cycles.
    Although there have been no failures to date on any CL-600-1A11,
CL-600-2A12 or CL-600-2B16 aircraft, the same accumulators as those
installed on the CL-600-2B19, Part Numbers (P/N) 08-60163-001, 08-
60163-002, 08-60164-001 and 08-60164-002, are installed on some of
the aircraft listed in the Applicability section of this directive.
    Notes:
    1. Earlier accumulators, P/Ns 2770571-102, 2770571-103, 2770571-
104 and 2770571-105, were installed in production on the following
aircraft: CL-600-1A11 [all Serial Numbers (S/Ns)], CL-600-2A12 (all
S/Ns) and CL-600-2B16 (S/Ns 5001 through 5194 and 5301 through 5524
only). These accumulators do not require inspection or replacement.
However, if any of the accumulators with the above P/Ns have been
replaced in-service by P/Ns 08-60163-001, 08-60163-002, 08-60164-001
and 08-60164-002, these latter accumulators require replacement.
    2. The only accumulators ever installed on CL-600-2B16 aircraft,
S/Ns 5525 through 5665 and 5701 and subsequent, are P/Ns 08-60163-
001, 08-60163-002, 08-60164-001 and 08-60164-002; these accumulators
require replacement.
    A detailed analysis of the systems and structure in the
potential line of trajectory of a failed screw cap/end cap for each
accumulator, P/Ns 08-60163-001, 08-60163-002, 08-60164-001 and 08-
60164-002, has been conducted. It has been identified that the worst
case scenario would be failure of one of the brake accumulator screw
caps/end caps, resulting in impact damage causing loss of both
hydraulic systems No. 2 and No. 3, with consequent loss of both
braking and nose wheel steering and the potential for a runway
excursion [resulting in damage to the airplane and hazards to
persons or property on the ground].
    This directive gives instructions to perform identification and
records checks, where applicable, and replace accumulators, P/Ns 08-
60163-001, 08-60163-002, 08-60164-001 and 08-60164-002, within the
time compliance specified.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Actions

    (g) Do the following actions as applicable.
    (1) Within 50 flight hours after the effective date of this AD,
inspect to determine the part numbers of the system accumulators
numbers 1, 2, and 3 and brake accumulators numbers 2 and 3 that are
installed on the airplane. A review of airplane maintenance records
is acceptable in lieu of this inspection if the part number of the
accumulator can be conclusively determined from that review. If all
of the installed accumulators have P/N 2770571-102, 2770571-103,
2770571-104, or 2770571-105, no further action is required by this
AD.
    (2) At the applicable time in paragraph (g)(2)(i), (g)(2)(ii),
or (g)(2)(iii) of this AD, replace the accumulator with a new
accumulator with the same part number, in

accordance with the Accomplishment Instructions of the applicable
service bulletin listed in Table 1 of this AD.

                                           Table 1--Service Bulletins
----------------------------------------------------------------------------------------------------------------
                                                 Bombardier
               Airplane model--                    Service     Revision--                 Dated--
                                                 Bulletin--
----------------------------------------------------------------------------------------------------------------
CL-600-1A11 (CL-600).........................        600-0742          01  July 6, 2009.
CL-600-2A12 (CL-601).........................        601-0597          01  July 6, 2009.
CL-600-2B16 (CL-601-3A, CL-601-3R variant)...
CL-600-2B16 (CL-604 variant).................      604-29-008          01  July 6, 2009.
CL-600-2B16 (CL-605).........................      605-29-001          01  July 6, 2009.
----------------------------------------------------------------------------------------------------------------

    (i) For each accumulator (P/Ns 08-60163-001, 08-60163-002, 08-
60164-001, and 08-60164-002) that has accumulated more than 3,650
total flight cycles as of the effective date of this AD, replace the
accumulator within 100 flight cycles after the effective date of
this AD.
    (ii) For each accumulator (P/Ns 08-60163-001, 08-60163-002, 08-
60164-001, and 08-60164-002) that has accumulated 3,650 total flight
cycles or fewer as of the effective date of this AD, replace the
accumulator before the accumulation of 3,750 total flight cycles on
the accumulator.
    (iii) For each accumulator (P/Ns 08-60163-001, 08-60163-002, 08-
60164-001, and 08-60164-002) for which it is not possible to
determine the number of flight cycles accumulated, replace the
accumulator within 100 flight cycles after the effective date of
this AD.
    (3) Thereafter, before the accumulation of 3,750 total flight
cycles on any accumulator having P/N 08-60163-001, 08-60163-002, 08-
60164-001, or 08-60164-002, replace the accumulator with a new
accumulator having the same part number, in accordance with the
Accomplishment Instructions of the applicable service bulletin
listed in Table 1 of this AD.
    (4) Replacement of an accumulator with a new accumulator having
the same part number is also acceptable for compliance with the
requirements of paragraph (g)(2) of this AD, if done before the
effective date of this AD in accordance with the applicable service
bulletin listed in Table 2 of this AD:

                   Table 2--Previous Service Bulletins
------------------------------------------------------------------------
                                Bombardier
      Airplane model--            Service               Dated--
                                Bulletin--
------------------------------------------------------------------------
CL-600-1A11 (CL-600)........        600-0742  November 10, 2008.
CL-600-2A12 (CL-601)........        601-0597  November 10, 2008.
CL-600-2B16 (CL-601-3A, CL-
 601-3R variant).
CL-600-2B16 (CL-604 variant)      604-29-008  November 10, 2008.
CL-600-2B16 (CL-605)........      605-29-001  November 10, 2008.
------------------------------------------------------------------------

FAA AD Differences

    Note 2: This AD differs from the MCAI and/or service information
as follows:
    (1) The MCAI specifies that certain airplanes do not need to be
inspected for the part number; however, this AD requires that
inspections be done on all airplanes to determine the part number.
    (2) The MCAI specifies to record the number of flight cycles
accumulated on each affected part. This AD does not require that
operators record the number of flight cycles.

Other FAA AD Provisions

    (h) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Send information to ATTN: Program
Manager, Continuing Operational Safety, FAA, New York ACO, 1600
Stewart Avenue, Suite 410, Westbury, New York, 11590; telephone 516-
228-7300; fax<PHONE_NUMBER>. Before using any approved AMOC on any
airplane to which the AMOC applies, notify your principal
maintenance inspector (PMI) or principal avionics inspector (PAI),
as appropriate, or lacking a principal inspector, your local Flight
Standards District Office. The AMOC approval letter must
specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (i) Refer to MCAI Canadian Airworthiness Directive CF-2009-39,
dated October 27, 2009, and the service bulletins listed in Table 1
of this AD, for related information.

    Issued in Renton, Washington, on February 5, 2010.
Stephen P. Boyd,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-2993 Filed 2-11-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 16 (Thursday, January 24, 2013)]
[Notices]
[Page 5175]
[FR Doc No: 2013-01367]

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

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: EC13-61-000.
    Applicants: Puget Sound Energy, Inc.
    Description: Application for Authorization for Disposition of
Jurisdictional Facilities and Request For Expedited Action of Puget
Sound Energy, Inc.
    Filed Date: 1/11/13.
    Accession Number: 20130111-5192.
    Comments Due: 5 p.m. ET 2/1/13.

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

    Docket Numbers: ER10-2839-002.
    Applicants: Midland Cogeneration Venture Limited Partnership.
    Description: Notice of Change in Status, Updated Market Power
Analysis, and Motion for Leave to File One Day Out of Time of Midland
Cogeneration Venture Limited Partnership.
    Filed Date: 1/11/13.
    Accession Number: 20130111-5193.
    Comments Due: 5 p.m. ET 2/1/13.

    Docket Numbers: ER10-2912-003.
    Applicants: Alliance for Cooperative Energy Services Marketing LLC.
    Description: Notice of Non-Material Change in Status of Alliance
for Cooperative Energy Services Power Marketing LLC.
    Filed Date: 1/11/13.
    Accession Number: 20130111-5185.
    Comments Due: 5 p.m. ET 2/1/13.

    Docket Numbers: ER13-685-001.
    Applicants: Public Service Company of New Mexico.
    Description: Supplemental Filing associated with Revised Sheets in
PNM's Coordination Tariff to be effective 8/31/2010.
    Filed Date: 1/14/13.
    Accession Number: 20130114-5000.
    Comments Due: 5 p.m. ET 2/1/13.

    Docket Numbers: ER13-752-000.
    Applicants: Energy Storage Holdings, LLC.
    Description: Energy Storage Holdings, LLC to be effective 1/12/
2013.
    Filed Date: 1/11/13.
    Accession Number: 20130111-5163.
    Comments Due: 5 p.m. ET 2/1/13.

    Docket Numbers: ER13-753-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Amendment to PWRPA IA Appendix B and Filing of Mocho 3
WDT Service Agreement to be effective 1/15/2013.
    Filed Date: 1/14/13.
    Accession Number: 20130114-5001.
    Comments Due: 5 p.m. ET 2/4/13.

    Docket Numbers: ER13-754-000.
    Applicants: Pacific Gas and Electric Company.
    Description: 2nd Amendment to Extend the PG&E-NCPA Interconnection
Agreement to be effective 3/31/2013.
    Filed Date: 1/14/13.
    Accession Number: 20130114-5002.
    Comments Due: 5 p.m. ET 2/4/13.

    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 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: January 14, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-01367 Filed 1-23-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 91 (Friday, May 10, 2013)]
[Notices]
[Pages 27462-27464]
[FR Doc No: 2013-11141]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69518; File No. SR-MIAX-2013-18]

Self-Regulatory Organizations; Miami International Securities
Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change Relating to Priority Customer Size

May 6, 2013.
    Pursuant to the provisions of 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 April 24, 2013, Miami International Securities
Exchange LLC (``MIAX'' or ``Exchange'') filed with the Securities and
Exchange Commission (``Commission'') a proposed rule change as
described in Items I, II, and III below, which Items have been prepared
by the Exchange. The Commission is publishing this notice to solicit

comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange is filing a proposal to amend Exchange Rule 506,
Collection and Dissemination of Quotations, by adopting new Exchange
Rule 506(c)(ii) to state that the Exchange will make available to
subscribers of its MIAX Top of Market (``ToM'') data feed the quantity
of Priority Customer (defined below) contracts included in the MIAX
Best Bids and Offers (``MBBOs'') disseminated by the Exchange.
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.miaxoptions.com/filter/wotitle/rule_filing, at
MIAX's principal office, and at the Commission's Public Reference Room.

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

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

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

1. Purpose
    The purpose of the proposed rule change is to make available to
subscribers of its ToM market data product \3\ the quantity of Priority
Customer (defined below) contracts included in the MBBO disseminated by
the Exchange in order to provide additional transparency to ToM
subscribers regarding the disseminated MBBO. The Exchange does not
intend to charge additional fees for the inclusion of Priority Customer
size in the aggregate size component of ToM at this time.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 69007 (February 28,
2013), 78 FR 14617 (March 6, 2013) (SR-MIAX-2013-05).
---------------------------------------------------------------------------

    Currently, the ToM is a direct data feed that includes: the
Exchange's best bid and offer, with aggregate size and last sale
information on the MIAX system; opening imbalance condition
information; opening and intra-day routing information; Expanded Quote
Range information; Post-Halt Notification; and Liquidity Refresh
condition information.\4\ The ToM data feed includes data that is
identical to the data sent to the processor for the Options Price
Reporting Authority (``OPRA''). The ToM and OPRA data leave the MIAX
system at the same time, as required under Section 5.2(c)(iii)(B) of
the Limited Liability Company Agreement of the Options Price Reporting
Authority LLC (the ``OPRA Plan''), which prohibits the dissemination of
proprietary information on any more timely basis than the same
information is furnished to the OPRA System for inclusion in OPRA's
consolidated dissemination of options information.
---------------------------------------------------------------------------

    \4\ See id.
---------------------------------------------------------------------------

    The Exchange now proposes to make available additional information
in the ToM data feed that specifies the quantity of Priority Customer
\5\ contracts that are included in the aggregate size of the MBBO.
Information regarding the quantity of Priority Customer interest
included in the size of the MBBO may provide market participants
transparency as to how orders would be allocated when the Priority
Customer Overlay \6\ is in effect. When the Priority Customer Overlay
is in effect, Priority Customer Orders on the Exchange generally have
priority over Professional Interest and all Market Maker interest at
the same price. The Exchange believes that the additional information
regarding the quantity of Priority Customers contracts may provide
certain ToM subscribers an additional tool to use when making routing,
quotation, price and size decisions regarding where they should send
orders and quotes, and the nature of such orders and quotes (i.e.,
price and size).
---------------------------------------------------------------------------

    \5\ The term ``Priority Customer'' means a person or entity that
(i) is not a broker or dealer in securities, and (ii) does not place
more than 390 orders in listed options per day on average during a
calendar month for its own beneficial accounts(s). See Exchange Rule
100.
    \6\ The Exchange generally uses a pro-rata allocation model, and
deploys certain ``Priority Overlays'' on a class-by-class basis. One
such Priority Overlay is the Priority Customer Overlay. When the
Priority Customer Overlay is in effect, the highest bid and lowest
offer have priority except that Priority Customer Orders have
priority over Professional Interest and all Market Maker interest at
the same price. If there are two or more Priority Customer Orders
for the same options series at the same price, priority is afforded
to such Priority Customer Orders in the sequence in which they are
received by the System. See Exchange Rule 514(d)(1).
---------------------------------------------------------------------------

    As stated above, the Exchange is not proposing at this time to
assess additional fees for the inclusion of Priority Customer size as a
component of the information included in the ToM market data product.
The Exchange notes that it would file a 19b-4 Rule Filing prior to
assessing additional fees for the Priority Customer size component of
the information included in the ToM market data product.
    Because of the technology changes associated with this rule
proposal, the Exchange will announce the implementation date of the
proposal in an Exchange Circular to be published no later than 30 days
after the publication of the notice in the Federal Register. The
implementation date will be no later than 30 days following publication
of the Exchange Circular announcing publication of the notice in the
Federal Register.
2. Statutory Basis
    MIAX believes that its proposed rule change is consistent with
Section 6(b) \7\ of the Act in general, and furthers the objectives of
Section 6(b)(5) \8\ of the Act in particular, in that it is designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to foster cooperation and
coordination with persons engaged in facilitating transactions in
securities, to remove impediments to and perfect the mechanisms of a
free and open market and a national market system and, in general, to
protect investors and the public interest, and it is not designed to
permit unfair discrimination among customers, brokers, or dealers.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The addition of Priority Customer size as a component of the
information included in the ToM product is designed to promote just and
equitable principles of trade by providing ToM subscribers with market
data that should enable them to make informed decisions on trading in
MIAX options by using the ToM data to assess current market conditions
that directly affect such decisions. The proposal removes impediments
to, and is designed to further perfect, the mechanisms of a free and
open market and a national market system by making the MIAX market more
transparent and accessible to market participants making routing
decisions concerning their options orders, and concerning the nature of
their quotes.
    The ToM market data product is also designed to protect investors
and the public interest by providing market data to subscribers that
offers market participants additional information in

order to make decisions concerning their orders and/or quotes.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.
    MIAX operates within a highly competitive market in which market
participants can readily send order flow to other competing venues if,
among other things, they deem allocation rules at a particular venue to
be unreasonable or disproportionate. The proposed rule change is
intended to offer market participants additional information and
transparency in the marketplace, and therefore enhances competition
among exchanges by further enabling market participants to make
informed order routing and quoting decisions.

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 foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days after the date of the filing, or such
shorter time as the Commission may designate, it has become effective
pursuant to 19(b)(3)(A) of the Act \9\ and Rule 19b-4(f)(6) \10\
thereunder.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file 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 Exchange has satisfied this requirement.
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-MIAX-2013-18 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-MIAX-2013-18. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-MIAX-2013-18 and should be
submitted on or before May 31, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-11141 Filed 5-9-13; 8:45 am]
BILLING CODE 8011-01-P