[Federal Register Volume 87, Number 39 (Monday, February 28, 2022)]
[Rules and Regulations]
[Pages 10964-10973]
[FR Doc No: 2022-03538]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 500, 510, 516, 520, 522, 524, 529, 556, and 558

[Docket No. FDA-2021-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of a New Animal Drug Application; Change of
Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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

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), abbreviated new animal drug
applications (ANADAs), and a conditionally approved new animal drug
application (cNADA) during July, August, and September 2021. 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 improve the accuracy
of the regulations.

DATES: This rule is effective February 28, 2022. The incorporation by
reference of certain material listed in this rule is approved by the
Director of the Federal Register as February 28, 2022. The
incorporation by reference of other material listed in this rule was
approved by the Director of the Federal Register as of November 25,
2011.

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 protected].

SUPPLEMENTARY INFORMATION:

I. Approvals

    FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during July, August, and September 2021,
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,<PHONE_NUMBER>. Persons
with access to the internet may obtain these documents at the CVM FOIA
Electronic Reading Room: https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. Marketing
exclusivity and patent information may be accessed in FDA's
publication, ``Approved Animal Drug Products Online (Green Book)'' at:
https://www.fda.gov/animal-veterinary/products/approved-animal-drug-products-green-book.
    FDA has verified the website addresses as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.

                          Table 1--Original and Supplemental NADAs and ANADAs Approved During July, August, and September 2021
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Effect of the
       Approval date           File No.           Sponsor            Product name             Species                action          Public  documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 7, 2021..............         200-703  Dechra Veterinary    Carprofen Tablets..  Dogs...................  Original approval   FOI Summary.
                                             Products LLC, 7015                                                 as a generic copy
                                             College Blvd.,                                                     of NADA 141-053.
                                             Suite 525,
                                             Overland Park, KS
                                             66211.
July 15, 2021.............         141-545  VetDC, Inc., 320 E   TANOVEA              Dogs...................  Full approval of    FOI Summary.
                                             Vine Dr., Suite      (rabacfosadine for                            conditionally
                                             218, Fort Collins,   injection) Powder                             approved cNADA
                                             CO 80524.            for Injection.                                141-475 for the
                                                                                treatment of
                                                                                lymphoma.
August 2, 2021............         200-708  Felix                Enrofloxacin         Dogs...................  Original approval   FOI Summary.
                                             Pharmaceuticals      Antibacterial                                 as a generic copy
                                             PVT Ltd., 25-288     Injectable                                    of NADA 140-913.
                                             North Wall Quay,     Solution 2.27%.
                                             Dublin, 1, Ireland.
August 16, 2021...........         200-618  Virbac AH, Inc., PO  ZOLETIL (tiletamine  Dogs and cats..........  Original approval   FOI Summary.
                                             Box 162059, Fort     and zolazepam for                             as a generic copy
                                             Worth, TX 76161.     Injection).                                   of NADA 106-111.
August 18, 2021...........         200-709  Cronus Pharma        Amoxicillin and      Dogs and cats..........  Original approval   FOI Summary.
                                             Specialties India    Clavulanate                                   as a generic copy
                                             Private Ltd., Sy     Potassium for Oral                            of NADA 055-101.
                                             No-99/1, M/s GMR     Suspension.
                                             Hyderabad Aviation
                                             SEZ Ltd.,
                                             Mamidipalli
                                             Village,
                                             Shamshabad Mandal,
                                             Ranga Reddy,
                                             Hyderabad,
                                             Telangana, 501218,
                                             India.
August 19, 2021...........         141-063  Intervet, Inc., 2    NUFLOR-S             Swine..................  Supplemental        FOI Summary.
                                             Giralda Farms,       (florfenicol)                                 approval for the
                                             Madison, NJ 07940.   Injectable                                    treatment of
                                                                  Solution.                                     swine respiratory
                                                                                disease.
--------------------------------------------------------------------------------------------------------------------------------------------------------

II. Withdrawal of Approval

    Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140, has
requested that FDA withdraw approval of NADA 093-329 for use of a
sustained-release bolus containing sulfamethazine in cattle because the
product is no longer manufactured or marketed. As provided in the
regulatory text of this document, the animal drug regulations are
amended to reflect this action. Elsewhere in this issue of the Federal
Register, FDA gave notice that approval of NADA 093-329, and all
supplements and amendments thereto, is withdrawn.

III. Change of Sponsor

    VetDC, Inc., 320 E Vine Dr., Suite 218, Fort Collins, CO 80524, has
informed FDA that it has transferred ownership of, and all rights and
interest in, newly approved NADA 141-545 for TANOVEA (rabacfosadine)
for Injection to Elanco US Inc., 2500 Innovation Way, Greenfield, IN
46140. The codification of this application in new 21 CFR 522.2065 will
reflect this change of sponsorship.

IV. Technical Amendments

    FDA is making the following amendments to improve the accuracy of
the animal drug regulations:
     21 CFR 500.1410 is amended to add uncooked edible tissues
of swine to the standard for residues of n-methyl-2-pyrrolidone.
     21 CFR 510.600 is amended to have sponsor addresses
conform to the current style.
     21 CFR 520.905c is amended to reflect the current label
indications for use of fenbendazole paste in horses.
     21 CFR 520.1044c is amended to reflect a current swine
pathogen name for gentamicin soluble powder.
     21 CFR 520.1660d is amended to revise conditions of use of
oxytetracycline in drinking water of swine to reflect approved
applications.
     21 CFR 520.1780 is amended to revise the indications for
use of pimobendan tablets in dogs.
     21 CFR 520.2130 is amended to remove the 90-milligram
strength for spinosad chewable tablets.
     21 CFR 520.2220a is amended to add human food safety
warnings for use of sulfadimethoxine concentrate solution and soluble
powder.
     21 CFR 520.2260b is amended to reflect the voluntary
withdrawal of approval of an application for sustained-release boluses
containing sulfamethazine and to correct the spelling of a disease
condition.
     21 CFR 520.2604 is amended to revise indications for use
of tablets in dogs containing trimeprazine with prednisolone.
     21 CFR 522.558 is amended to reflect the drug labeler code
for the current sponsor of a dexmedetomidine injectable solution.
     21 CFR 522.840 is amended to reflect the current classes
of cattle approved for use of estradiol ear implants.
     21 CFR 522.842 for testosterone propionate and estradiol
benzoate implants is renamed to list the drug with the higher
concentration first and redesignated to be listed in alphabetical
order.
     21 CFR 522.955 is amended to reflect the current
scientific name of a bovine pathogen and the withdrawal

periods for different formulations of florfenicol injectable solution.
     21 CFR 522.1156 is amended to add subcutaneous
administration to the approved conditions of use of imidocarb
dipropionate solution in dogs.
     21 CFR 522.2477 is amended to reorganize an approved use
of trenbolone acetate and estradiol implants in steers.
     21 CFR 524.770 is amended to reflect current label dosage
information and human food safety warnings.
     21 CFR 529.1030 is redesignated as Sec.  529.1004 in
conformity with an announced FDA numbering system (40 FR 13802, March
27, 1975).
     21 CFR 529.1940 is amended to add limitations to the use
of progesterone intravaginal inserts in cows.
     21 CFR 558.59 is amended to reference apramycin's status
as a veterinary feed directive (VFD) drug and to add current
limitations on VFD refills for apramycin medicated feeds.
     21 CFR 558.205 is amended to reflect a current egg food
safety warning for broiler chickens and growing turkeys fed Type C
medicated feeds containing diclazuril.
     21 CFR 558.254 is amended to remove an erroneous table
title.
     21 CFR 558.261 is amended to correct the upper inclusion
rate for florfenicol in Type C medicated feed for freshwater-reared
salmonids.
     21 CFR 558.311 is being amended to codify free-choice Type
C medicated cattle feeds containing lasalocid.
     21 CFR 558.450 is amended to add conditions of use in
honey bees for a Type C extender patty containing oxytetracycline.
     21 CFR 558.633 is amended to add manufacturing limitations
for use of Type C medicated swine feeds containing tylvalosin.
     21 CFR 558.635 is amended to reflect a current egg food
safety warning for broiler chickens fed Type C medicated feeds
containing virginiamycin and diclazuril.

V. Incorporation by Reference

    FDA is incorporating by reference an analytical method approved by
the Office of the Federal Register in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. To obtain a copy of the analytical method, go to:
https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. You may inspect a copy at the office of the
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, between 9
a.m. and 4 p.m., Monday through Friday.
    This standard adds a method of detection for total for residues of
the carcinogenic excipient n-methyl-2-pyrrolidone in uncooked edible
swine tissues to a section established for a method for residues of n-
methyl-2-pyrrolidone in uncooked edible cattle tissues.

VI. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (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 500

    Animal drugs, Animal feeds, Cancer, Incorporation by reference,
Labeling, Packaging and containers, Polychlorinated biphenyls (PCBs).

21 CFR Part 510

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

21 CFR Part 516

    Administrative practice and procedure, Animal drugs, Confidential
business information, 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
500, 510, 516, 520, 522, 524, 529, 556, and 558 are amended as follows:

PART 500--GENERAL

0
1. The authority citation for part 500 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353,
360b, 371, 379e.

0
2. Revise Sec.  500.1410 to read as follows:

Sec.  500.1410   N-methyl-2-pyrrolidone.

    (a) Standard for residues. No residues of n-methyl-2-pyrrolidone
may be found in the uncooked edible tissues of cattle and swine as
determined by methods in paragraph (b) of this section.
    (b) Incorporation by reference. The standards required in this
section are incorporated by reference into this section with the
approval of the Director of the Federal Register under 5 U.S.C. 552(a)
and 1 CFR part 51. All approved material is available for inspection at
the Food and Drug Administration's Dockets Management Staff (HFA-305),
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>, between
9 a.m. and 4 p.m., Monday through Friday. It may be obtained from the
sources indicated elsewhere in paragraph (b) of this section and at:
https://www.fda.gov/about-fda/center-veterinary-medicine/cvm-foia-electronic-reading-room. It is also available for inspection at the
National Archives and Records Administration (NARA). For information on
the availability of this material at NARA, email
[email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.
    (1) Food and Drug Administration, Center for Veterinary Medicine,
7500 Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>.
    (i) ``Method of Analysis: N-methyl-2-pyrrolidone,'' September 26,
2011; the method of analysis for uncooked edible tissues of cattle.
    (ii) [Reserved]
    (2) Merck Animal Health, 29160 Intervet Lane, Millsboro, DE 19966,
1-800-211-3573.
    (i) ``Determinative and Confirmatory Procedures for the Analysis of
N-Methyl-2-pyrrolidone (NMP) in Swine Liver Tissue using LC-MS/MS,''
July 20, 2017; the method of analysis for uncooked edible tissues of
swine.
    (ii) [Reserved]

    (c) Related conditions of use. See Sec. Sec.  522.814 and 522.955
of this chapter.

PART 510--NEW ANIMAL DRUGS

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

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

Sec.  510.600   [Amended]

0
4. In Sec.  510.600:
0
a. In the table in paragraph (c)(1), revise the entries for ``Anzac
Animal Health, LLC'', ``AquaBounty Technologies, Inc.'', ``Dechra
Veterinary Products LLC'', ``Halocarbon Products Corp.'', ``Kindred
Biosciences, Inc.'', ``Mizner Bioscience LLC'', ``QBiotics Group
Ltd.'', ``Revivicor, Inc.'', and ``Ridley USA, Inc.'', remove ``Suite''
and in its place add ``suite''; and
0
b. In the table in paragraph (c)(2), revise the entries for ``012164'',
``017033'', ``067949'', ``086039'', ``086053'', ``086073'', ``086078'',
``086132'', and ``086134''.
    The revisions read as follows:
    (c) * * *

                  (1) Alphabetical Listing of Sponsors
------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------

                              * * * * * * *
Anivive Lifesciences, Inc., 3250 Airflite Way, Suite              086121
 400, Long Beach, CA 90807..............................
Anzac Animal Health, LLC, 218 Millwell Dr., suite B,              086073
 Maryland Heights, MO 63043.............................
AquaBounty Technologies, Inc., 2 Mill and Main Pl.,               086053
 Suite 395, Maynard, MA 01754...........................

                              * * * * * * *
Dechra Veterinary Products LLC, 7015 College Blvd.,               017033
 Suite 525, Overland Park, KS 66211.....................

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

                              * * * * * * *
Kindred Biosciences, Inc., 1555 Bayshore Hwy., Suite              086078
 200, Burlingame, CA 94010..............................

                              * * * * * * *
Mizner Bioscience LLC, 225 NE Mizner Blvd., Suite 760,            086039
 Boca Raton, FL 33432...................................

                              * * * * * * *
QBiotics Group Ltd., Suite 3A, Level 1, 165 Moggill Rd.,          086132
 Taringa, Queensland 4068, Australia....................

                              * * * * * * *
Revivicor, Inc., a wholly owned subsidiary of United              086134
 Therapeutics Corp., 1700 Kraft Dr., Suite 2400,
 Blacksburg, VA 24060...................................
Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato,           067949
 MN 56001...............................................

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

                    (2) Numerical Listing of Sponsors
------------------------------------------------------------------------
    Drug labeler code                  Firm name and address
------------------------------------------------------------------------

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

                              * * * * * * *
017033..................  Dechra Veterinary Products LLC, 7015 College
                           Blvd., Suite 525, Overland Park, KS 66211.

                              * * * * * * *
067949..................  Ridley USA, Inc., 111 W Cherry St., Suite 500,
                           Mankato, MN 56001.

                              * * * * * * *
086039..................  Mizner Bioscience LLC, 225 NE Mizner Blvd.,
                           Suite 760, Boca Raton, FL 33432.

                              * * * * * * *
086053..................  AquaBounty Technologies, Inc., 2 Mill and Main
                           Pl., Suite 395, Maynard, MA 01754.

                              * * * * * * *
086073..................  Anzac Animal Health, LLC, 218 Millwell Dr.,
                           Suite B, Maryland Heights, MO 63043.
086078..................  Kindred Biosciences, Inc., 1555 Bayshore Hwy.,
                           Suite 200, Burlingame, CA 94010.

                              * * * * * * *
086121..................  Anivive Lifesciences, Inc., 3250 Airflite Way,
                           Suite 400, Long Beach, CA 90807.
086132..................  QBiotics Group Ltd., Suite 3A, Level 1, 165
                           Moggill Rd., Taringa, Queensland 4068,
                           Australia.
086134..................  Revivicor, Inc., a wholly owned subsidiary of
                           United Therapeutics Corp., 1700 Kraft Dr.,
                           Suite 2400, Blacksburg, VA 24060

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

PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

0
5. The authority citation for part 516 continues to read as follows:

    Authority: 21 U.S.C. 360ccc, 360ccc-2, 371.

Sec.  516.2065   [Removed]

0
6. Remove Sec.  516.2065.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
8. Revise Sec.  520.88h to read as follows:

Sec.  520.88h   Amoxicillin trihydrate and clavulanate potassium for
oral suspension.

    (a) Specifications. When constituted, each milliliter (mL) of
suspension contains amoxicillin trihydrate equivalent to 50 milligrams
(mg) amoxicillin and clavulanate potassium equivalent to 12.5 mg
clavulanic acid.
    (b) Sponsors. See Nos. 054771 and 069043 in Sec.  510.600(c) of
this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 6.25 mg/lb (1 mL/10 lb
of body weight) twice a day. Skin and soft tissue infections such as
abscesses, cellulitis, wounds, superficial/juvenile pyoderma, and
periodontal infections should be treated for 5 to 7 days or for 48
hours after all signs have subsided. If no response is seen after 5
days of treatment, therapy should be discontinued and the case
reevaluated. Deep pyoderma may require treatment for 21 days; the
maximum duration of treatment should not exceed 30 days.
    (ii) Indications for use. Treatment of skin and soft tissue
infections such as wounds, abscesses, cellulitis, superficial/juvenile
and deep pyoderma due to susceptible strains of the following
organisms: beta-lactamase-producing Staphylococcus aureus, non-beta-
lactamase-producing Staphylococcus aureus, Staphylococcus spp.,
Streptococcus spp., and Escherichia coli. Treatment of periodontal
infections due to susceptible strains of both aerobic and anaerobic
bacteria.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. 62.5 mg (1 mL) twice daily. Skin and soft
tissue infections such as abscesses and cellulitis/dermatitis should be
treated for 5 to 7 days or 48 hours after all symptoms have subsided,
not to exceed 30 days. If no response is seen after 3 days of
treatment, therapy should be discontinued and the case reevaluated.
Urinary tract infections may require treatment for 10 to 14 days or
longer. The maximum duration of treatment should not exceed 30 days.
    (ii) Indications for use. Treatment of skin and soft tissue
infections, such as wounds, abscesses, and cellulitis/dermatitis due to
susceptible strains of the following organisms: beta-lactamase-
producing Staphylococcus aureus, non-beta-lactamase-producing
Staphylococcus aureus, Staphylococcus spp., Streptococcus spp.,
Escherichia coli, Pasteurella multocida, and Pasteurella spp. Urinary
tract infections (cystitis) due to susceptible strains of E. coli.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

0
9. In Sec.  520.905c, revise paragraphs (e)(1)(i) to read as follows:

Sec.  520.905c  Fenbendazole paste.

* * * * *
    (e) * * *
    (1) * * *
    (i) Indications for use and amounts. (A) For the treatment and
control of large strongyles (Strongylus edentatus, S. equinus, S.
vulgaris), small strongyles, and pinworms (Oxyuris equi). For large
strongyles, small strongyles, and pinworms, the recommended dose is 5
mg/kg (2.3 mg/lb).
    (B) For treatment and control of ascarids (Parascaris equorum). For
ascarids, the recommended dose is 10 mg/kg (4.6 mg/lb).
    (C) For treatment and control of hypobiotic (encysted early third-
stage), late third-stage, and fourth-stage cyathostome larvae, as well
as fourth-stage Strongylus vulgaris larvae, the recommended dose is 10
mg/kg (4.6 mg/lb) daily for 5 consecutive days.
    (D) For the control of arteritis caused by fourth-stage larvae of
Strongylus vulgaris in horses.
    (E) Fenbendazole paste 10 percent may be used concomitantly with
approved forms of trichlorfon for the indications provided in paragraph
(e)(1)(i)(A) of this section and for treating infections of stomach
bots as provided in Sec.  520.2520.
* * * * *

0
10. In Sec.  520.1044c, revise paragraph (d)(2) to read as follows:

Sec.  520.1044c   Gentamicin sulfate powder.

* * * * *
    (d) * * *
    (2) Indications for use. For control and treatment of
colibacillosis in weanling swine caused by strains of Escherichia coli
sensitive to gentamicin, and for control and treatment of swine
dysentery associated with Brachyspira hyodysenteriae.
* * * * *

0
11. In Sec.  520.1660d, revise paragraphs (d)(1)(iii)(A) and (C) to
read as follows:

Sec.  520.1660d   Oxytetracycline powder.

* * * * *
    (d) * * *
    (1) * * *
    (iii) * * *
    (A) Amount. Administer 10 milligrams per pound of body weight daily
in drinking water. Administer up to 14 days; do not use for more than
14 consecutive days those products sponsored by Nos. 054771, 061133,
and 069254. Administer up to 5 days; do not use for more than 5
consecutive days those products sponsored by Nos. 016592 and 061133.
* * * * *
    (C) Limitations. Withdraw zero days prior to slaughter. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
* * * * *

0
12. In Sec.  520.1780, revise paragraph (c)(2) to read as follows:

Sec.  520.1780   Pimobendan.

* * * * *
    (c) * * *
    (2) Indications for use. For the management of the signs of mild,
moderate, or severe congestive heart failure in dogs due to clinical
myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM);
for use with concurrent therapy for congestive heart failure (e.g.,
furosemide, etc.) as appropriate on a case-by-case basis.
* * * * *

0
13. In Sec.  520.2130, revise paragraph (a) to read as follows:

Sec.  520.2130   Spinosad.

    (a) Specifications. Each chewable tablet contains 140, 270, 560,
810, or 1620 milligrams (mg) spinosad.
* * * * *

0
14. In Sec.  520.2220a, revise paragraphs (d)(1)(iii) and (d)(2)(iii)
to read as follows:

Sec.  520.2220a   Sulfadimethoxine oral solution and soluble powder.

* * * * *
    (d) * * *
    (1) * * *
    (iii) Limitations. Withdraw 5 days before slaughter. Do not
administer to chickens over 16 weeks (112 days) of age. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.

    (2) * * *
    (iii) Limitations. Withdraw 5 days before slaughter. Do not
administer to turkeys over 24 weeks (168 days) of age. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
* * * * *

Sec.  520.2260b   [Amended]

0
15. In Sec.  520.2260b, remove and reserve paragraphs (b) and (e); and
in paragraph (f)(2)(ii) remove ``diptheria'' and in its place add
``diphtheria''.

0
16. In Sec.  520.2604, revise paragraph (c)(2) to read as follows:

Sec.  520.2604   Trimeprazine with prednisolone tablets.

* * * * *
    (c) * * *
    (2) Indications for use. For the relief of itching regardless of
cause; and for reduction of inflammation commonly associated with most
skin disorders of dogs such as eczema, caused by internal disorders,
otitis, and dermatitis, allergic, parasitic, pustular, and nonspecific
origins. As adjunctive therapy in various cough conditions including
treatment of ``kennel cough'' or tracheobronchitis, bronchitis
including allergic bronchitis, infections, and coughs of nonspecific
origin.
* * * * *

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

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

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

Sec.  522.558   [Amended]

0
18. In Sec.  522.558, in paragraph (b)(1), remove ``026637'' and in its
place add ``017033''.

0
19. In Sec.  522.812, revise paragraph (b)(1) to read as follows:

Sec.  522.812  Enrofloxacin.

* * * * *
    (b) * * *
    (1) Nos. 016729, 017033, 055529, 058198, and 086101 for use of
product described in paragraph (a)(1) as in paragraph (e)(1) of this
section; and
* * * * *

Sec.  522.840  [Amended]

0
20. In Sec.  522.840, in paragraph (d)(2), in the first sentence,
remove ``confined steers and heifers'' and in its place add ``steers
and heifers fed in confinement for slaughter''.

Sec.  522.842  [Redesignated as Sec.  522.2343]

0
21. Redesignate Sec.  522.842 as Sec.  522.2343.

0
22. In Sec.  522.955:
0
a. Revise paragraph (b)(2);
0
b. Redesignate paragraph (b)(3) as paragraph (b)(4) and add new
paragraph (b)(3);
0
c. In paragraphs (d)(1)(ii)(A)(2) and (d)(1)(ii)(B)(2), remove
``Haemophilus somnus'' and in its place add ``Histophilus somni'';
0
d. Revise paragraph (d)(1)(ii)(C); and
0
e. Add paragraph (d)(2).
    The revisions and additions read as follows:

Sec.  522.955  Florfenicol.

* * * * *
    (b) * * *
    (2) No. 000061 for use of product described in paragraph (a)(2) of
this section as in paragraphs (d)(1)(ii) and (d)(2) of this section.
    (3) No. 086050 for use of product described in paragraph (a)(2) of
this section as in paragraph (d)(1)(ii) of this section.
* * * * *
    (d) * * *
    (1) * * *
    (ii) * * *
    (C) Limitations. Animals intended for human consumption must not be
slaughtered within 28 days of the last intramuscular treatment. No.
000061: Animals intended for human consumption must not be slaughtered
within 38 days of subcutaneous treatment. No. 055529: Animals intended
for human consumption must not be slaughtered within 33 days of
subcutaneous treatment. This product is not approved for use in female
dairy cattle 20 months of age or older, including dry dairy cows. Use
in these cattle may cause drug residues in milk and/or in calves born
to these cows. A withdrawal period has not been established in pre-
ruminating calves. Do not use in calves to be processed for veal.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
    (2) Swine--(i) 300 mg/mL florfenicol in the inactive vehicles n-
methyl-2-pyrrolidone, propylene glycol, and polyethylene glycol:
    (A) Amount. 15 mg/kg of body weight as an intramuscular injection.
A second dose should be administered 48 hours later.
    (B) Indications for use. For the treatment of swine respiratory
disease associated with Actinobacillus pleuropneumoniae, Pasteurella
multocida, Salmonella Choleraesuis, Streptococcus suis, Bordetella
bronchiseptica, and Glaesserella (Haemophilus) parasuis in swine except
for nursing piglets and swine of reproductive age intended for
breeding.
    (C) Limitations. Swine intended for human consumption must not be
slaughtered within 11 days of the last intramuscular treatment. Federal
law restricts this drug to use by or on the order of a licensed
veterinarian.
    (ii) [Reserved]

0
23. In Sec.  522.1156, revise paragraph (c)(1) to read as follows:

Sec.  522.1156  Imidocarb solution.

* * * * *
    (c) * * *
    (1) Amount. Administer 6.6 mg per kilogram (3 mg per pound) of body
weight by intramuscular or subcutaneous injection. Repeat the dose
after 2 weeks for a total of two treatments.
* * * * *

0
24. Add Sec.  522.2065 to read as follows:

Sec.  522.2065  Rabacfosadine.

    (a) Specifications. Each vial of powder contains 16.4 milligrams
(mg) rabacfosadine. Each milliliter of constituted solution contains
8.2 mg rabacfosadine.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer rabacfosadine
at 1 mg/kilogram body weight as a 30-minute intravenous infusion, once
every 3 weeks, for up to 5 doses.
    (2) Indications for use. For the treatment of lymphoma in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

0
25. Revise the section heading of newly designated Sec.  522.2343 to
read as follows:

Sec.  522.2343  Testosterone propionate and estradiol benzoate.

0
26. In Sec.  522.2470, revise paragraph (b) introductory text to read
as follows:

Sec.  522.2470  Tiletamine and zolazepam for injection.

* * * * *
    (b) Sponsors. See Nos. 026637, 051311, and 054771 in Sec.
510.600(c) of this chapter.
* * * * *

0
27. In Sec.  522.2477, revise paragraph (b)(2), remove paragraph
(d)(1)(i)(G), and add paragraph (d)(6) to read as follows:

Sec.  522.2477  Trenbolone acetate and estradiol.

* * * * *
    (b) * * *

    (2) No. 000061 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(C),
(d)(1)(i)(D), (d)(1)(ii), (d)(1)(iii), (d)(2)(i)(A), (d)(2)(i)(C),
(d)(2)(i)(D), (d)(2)(ii), (d)(2)(iii), (d)(3)(i)(A), (d)(3)(ii),
(d)(3)(iii), (d)(4), (d)(5), and (d)(6) of this section.
* * * * *
    (d) * * *
    (6) Steers fed in confinement for slaughter--(i) Amount. Each
extended-release implant contains 200 mg trenbolone acetate and 40 mg
estradiol (one implant consisting of 6 coated and 4 uncoated pellets,
each containing 20 mg trenbolone acetate and 4 mg estradiol).
    (ii) Indications for use. For increased rate of weight gain and
improved feed efficiency for up to 200 days after implantation.
    (iii) Limitations. Administer implant subcutaneously in the ear
only. Do not use in lactating dairy cows or in animals intended for
subsequent breeding. Use in these cattle may cause drug residues in
milk and/or in calves born to these cows. A withdrawal period has not
been established for this product in pre-ruminating calves. Do not use
in calves to be processed for veal. Effectiveness and animal safety in
veal calves have not been established. Not approved for repeated
implantation (reimplantation) with this or any other cattle ear implant
during the production phase(s) identified on labeling (steers fed in
confinement for slaughter) unless otherwise indicated on labeling
because safety and effectiveness have not been evaluated.

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

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

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

0
29. In Sec.  524.770, revise paragraphs (e)(1) and (e)(3) to read as
follows:

Sec.  524.770  Doramectin.

* * * * *
    (e) * * *
    (1) Amount. Administer topically 1 mL (5 mg doramectin) per 22 lb
(10 kg) of body weight.
* * * * *
    (3) Limitations. Cattle must not be slaughtered for human
consumption within 45 days of treatment. Not for use in female dairy
cattle 20 months of age or older. A withdrawal period has not been
established for this product in pre-ruminating calves. Do not use in
calves to be processed for veal.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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

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

Sec.  529.1030  [Redesignated as Sec.  529.1004]

0
31. Redesignate Sec.  529.1030 as Sec.  529.1004.

0
32. In Sec.  529.1940, revise paragraph (e)(1)(iii) to read as follows:

Sec.  529.1940  Progesterone intravaginal inserts.

* * * * *
    (e) * * *
    (1) * * *
    (iii) Limitations. Do not use in beef or dairy heifers of
insufficient size or age for breeding or in animals with abnormal,
immature, or infected genital tracts. Do not use in anestrous lactating
dairy cows less than 42 days or greater than 78 days postpartum. Do not
use in lactating dairy cows less than 40 days postpartum. Do not use in
beef cows that are less than 20 days postpartum. Do not use an insert
more than once. To prevent the potential transmission of venereal and
bloodborne diseases, the inserts should be disposed after a single use.
Administration of vaginal inserts for periods greater than 7 days may
result in reduced fertility. Dinoprost injection for use in paragraphs
(e)(1)(ii)(A) and (e)(1)(ii)(B) of this section as in Sec.  522.690 of
this chapter, as provided by No. 054771 in Sec.  510.600(c) of this
chapter.
* * * * *

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

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

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

0
34. In Sec.  556.710, revise paragraph (c) to read as follows:

Sec.  556.710  Testosterone.

* * * * *
    (c) Related conditions of use. See Sec.  522.2343 of this chapter.

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

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

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

0
36. In Sec.  558.59, redesignate paragraph (d) as paragraph (e) and add
new paragraph (d) to read as follows:

Sec.  558.59  Apramycin.

* * * * *
    (d) Special considerations. (1) Federal law restricts medicated
feed containing this veterinary feed directive (VFD) drug to use by or
on the order of a licensed veterinarian. See Sec.  558.6 for additional
requirements.
    (2) The expiration date of VFDs for apramycin medicated feeds must
not exceed 6 months from the date of issuance. VFDs for apramycin shall
not be refilled.
* * * * *

0
37. In Sec.  558.205, revise paragraphs (d)(1) and (2) to read as
follows:

Sec.  558.205  Diclazuril.

* * * * *
    (d) * * *
    (1) Chickens. For chickens it is used as follows:

----------------------------------------------------------------------------------------------------------------
   Diclazuril grams/ton    Combination grams/ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.91.................  .....................  Broiler chickens: For the   Feed continuously as        058198
                                                   prevention of coccidiosis   the sole ration. Do
                                                   caused by Eimeria           not feed to birds
                                                   tenella, E. necatrix, E.    producing eggs for
                                                   acervulina, E. brunetti,    human consumption.
                                                   E. mitis (mivati), and E.
                                                   maxima. Because
                                                   diclazuril is effective
                                                   against E. maxima later
                                                   in its life cycle,
                                                   subclinical intestinal
                                                   lesions may be present
                                                   for a short time after
                                                   infection. Diclazuril was
                                                   shown in studies to
                                                   reduce lesion scores and
                                                   improve performance and
                                                   health of birds
                                                   challenged with E. maxima.

(ii) 0.91................  Bacitracin             Broiler chickens: For the   Feed continuously as        058198
                            methylenedisalicylat   prevention of coccidiosis   the sole ration. Do
                            e, 4 to 50.            caused by Eimeria           not feed to birds
                                                   tenella, E. necatrix, E.    producing eggs for
                                                   acervulina, E. brunetti,    human consumption.
                                                   E. mitis (mivati), and E.   Bacitracin
                                                   maxima, and for increased   methylenedisalicylat
                                                   rate of weight gain and     e provided by No.
                                                   improved feed efficiency.   054771 in Sec.
                                                   Because diclazuril is       510.600(c) of this
                                                   effective against E.        chapter.
                                                   maxima later in its life
                                                   cycle, subclinical
                                                   intestinal lesions may be
                                                   present for a short time
                                                   after infection.
                                                   Diclazuril was shown in
                                                   studies to reduce lesion
                                                   scores and improve
                                                   performance and health of
                                                   birds challenged with E.
                                                   maxima.
(iii) 0.91...............  Bambermycins, 1 to 2.  Broiler chickens: For the   Feed continuously as        058198
                                                   prevention of coccidiosis   the sole ration. Do
                                                   caused by Eimeria           not feed to birds
                                                   tenella, E. necatrix, E.    producing eggs for
                                                   acervulina, E. brunetti,    human consumption.
                                                   E. mitis (mivati), and E.   Bambermycins
                                                   maxima, and for increased   provided by No.
                                                   rate of weight gain and     016592 in Sec.
                                                   improved feed efficiency.   510.600(c) of this
                                                   Because diclazuril is       chapter.
                                                   effective against E.
                                                   maxima later in its life
                                                   cycle, subclinical
                                                   intestinal lesions may be
                                                   present for a short time
                                                   after infection.
                                                   Diclazuril was shown in
                                                   studies to reduce lesion
                                                   scores and improve
                                                   performance and health of
                                                   birds challenged with E.
                                                   maxima.
----------------------------------------------------------------------------------------------------------------

    (2) Turkeys. For turkeys it is used as follows:

----------------------------------------------------------------------------------------------------------------
   Diclazuril grams/ton    Combination grams/ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 0.91.................  .....................  Growing turkeys: For the    Feed continuously as        058198
                                                   prevention of coccidiosis   the sole ration. Do
                                                   caused by Eimeria           not feed to breeding
                                                   adenoeides, E.              turkeys. Do not feed
                                                   gallopavonis, and E.        to birds producing
                                                   meleagrimitis.              eggs for human
                                                                               consumption.
(ii) 0.91................  Bacitracin             Growing turkeys: For the    Feed continuously as        058198
                            methylenedisalicylat   prevention of coccidiosis   the sole ration. Do
                            e, 4 to 50.            caused by Eimeria           not feed to breeding
                                                   adenoeides, E.              turkeys. Do not feed
                                                   gallopavonis, and E.        to birds producing
                                                   meleagrimitis, and for      eggs for human
                                                   increased rate of weight    consumption.
                                                   gain and improved feed      Bacitracin
                                                   efficiency.                 methylenedisalicylat
                                                                               e as provided by No.
                                                                               054771 in Sec.
                                                                               510.600(c) of this
                                                                               chapter.
(iii) 0.91...............  Bambermycins 1 to 2..  Growing turkeys: For the    Feed continuously as        058198
                                                   prevention of coccidiosis   the sole ration. Do
                                                   caused by Eimeria           not feed to breeding
                                                   adenoeides, E.              turkeys. Do not feed
                                                   gallopavonis, and E.        to birds producing
                                                   meleagrimitis, and for      eggs for human
                                                   improved feed efficiency.   consumption.
                                                                               Bambermycins as
                                                                               provided by No.
                                                                               016592 in Sec.
                                                                               510.600(c) of this
                                                                               chapter.
(iv) 0.91................  Bambermycins 2.......  Growing turkeys: For the    Feed continuously as        058198
                                                   prevention of coccidiosis   the sole ration. Do
                                                   caused by Eimeria           not feed to breeding
                                                   adenoeides, E.              turkeys. Do not feed
                                                   gallopavonis, and E.        to birds producing
                                                   meleagrimitis, and for      eggs for human
                                                   increased rate of weight    consumption.
                                                   gain and improved feed      Bambermycins as
                                                   efficiency.                 provided by No.
                                                                               016592 in Sec.
                                                                               510.600(c) of this
                                                                               chapter.
----------------------------------------------------------------------------------------------------------------

Sec.  558.254   [Amended]

0
38. In Sec.  558.254, in paragraph (e) introductory text, remove
``Table 2--Size Proxies for SRCs in 2016''.

0
39. In Sec.  558.261, revise paragraph (e)(2)(ii) to read as follows:

Sec.  558.261  Florfenicol.

* * * * *
    (e) * * *
    (2) * * *

----------------------------------------------------------------------------------------------------------------
  Florfenicol in grams/ton of feed          Indications for use                       Limitations
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(ii) 182 to 1,816...................  Freshwater-reared salmonids:     Feed as a sole ration for 10 consecutive
                                       For the control of mortality     days to deliver 10 to 15 mg florfenicol
                                       due to coldwater disease         per kg of fish. Feed containing
                                       associated with Flavobacterium   florfenicol shall not be fed for more
                                       psychrophilum and furunculosis   than 10 days. Following administration,
                                       associated with Aeromonas        fish should be reevaluated by a licensed
                                       salmonicida.                     veterinarian before initiating a further
                                                                        course of therapy. The effects of
                                                                        florfenicol on reproductive performance
                                                                        have not been determined. Feeds
                                                                        containing florfenicol must be withdrawn
                                                                        15 days prior to slaughter.

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

* * * * *

0
39. In Sec.  558.311, add paragraph (e)(3)(ix) to read as follows:

Sec.  558.311  Lasalocid.

* * * * *
    (e) * * *
    (3) * * *

----------------------------------------------------------------------------------------------------------------
           Lasalocid amount               Indications for use                Limitations               Sponsor
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(ix) 60 to 300 mg of lasalocid per     Growing beef steers and   Feed continuously as a Type C free-      054771
 head per day.                          heifers on pasture        choice medicated feed at a rate
                                        (stocker, feeder, and     of 60 to 300 mg of lasalocid per
                                        slaughter) and            head per day. Daily intakes of
                                        replacement beef and      lasalocid in excess of 200 mg/
                                        dairy heifers on          head/day have not been shown to
                                        pasture: For increased    be more effective than 200 mg/
                                        rate of weight gain.      head/day.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
40. In Sec.  558.450, revise paragraph (e)(5)(ii), redesignate
paragraphs (e)(5)(iii) through (vii) as paragraphs (e)(5)(iv) through
(viii), and add new paragraph (e)(5)(iii) to read as follows:

Sec.  558.450  Oxytetracycline.

* * * * *
    (e) * * *
    (5) * * *

----------------------------------------------------------------------------------------------------------------
          Oxytetracycline amount               Indications for use              Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(ii) 200 mg/colony as a dust (200 mg/oz)   Honey bees: For control of   Apply every 4 to 5 days for       066104
 or syrup (200 mg/5 lb).                    American foulbrood caused    a total of three                 069254
                                            by Paenibacillus larvae      applications. Remove at
                                            and European foulbrood       least 6 weeks prior to
                                            caused by Melissococcus      main honey flow.
                                            plutonius susceptible to
                                            oxytetracycline.
(iii) 800 mg/colony as an extender patty   Honey bees: For control of   Use as a single                   066104
 (800 mg/patty).                            American foulbrood caused    application. Remove at           069254
                                            by Paenibacillus larvae      least 6 weeks prior to
                                            and European foulbrood       main honey flow.
                                            caused by Melissococcus
                                            plutonius susceptible to
                                            oxytetracycline.

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

* * * * *

0
41. In Sec.  558.633, revise paragraph (d)(3) to read as follows:

Sec.  558.633  Tylvalosin.

* * * * *
    (d) * * *
    (3) An expiration date of 1 week is required for tylvalosin Type C
medicated swine feeds in pelleted or crumbled form. Pelleted Type C
medicated feeds must bear an expiration date of 30 days after the date
of manufacture. Crumbled Type C medicated feeds must bear an expiration
date of 7 days after the date of manufacture.
* * * * *

0
42. In Sec.  558.635, revise paragraph (e)(1)(iv) to read as follows:

Sec.  558.635  Virginiamycin.

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

----------------------------------------------------------------------------------------------------------------
Virginiamycin in grams/   Combination in grams/
          ton                      ton                Indications for use           Limitations        Sponsor
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(iv) 20................  Diclazuril, 0.91......  Broiler chickens: For          Feed continuously         058198
                                                  prevention of necrotic         as the sole
                                                  enteritis caused by            ration. Do not
                                                  Clostridium perfringens        feed to birds
                                                  susceptible to                 producing eggs for
                                                  virginiamycin; and for the     human consumption.
                                                  prevention of coccidiosis      Diclazuril as
                                                  caused by Eimeria tenella,     provided by No.
                                                  E. necatrix, E. acervulina,    058198 in Sec.
                                                  E. brunetti, E. mitis          510.600(c) of this
                                                  (mivati), and E. maxima.       chapter.
                                                  Because diclazuril is
                                                  effective against E. maxima
                                                  later in its life cycle,
                                                  subclinical intestinal
                                                  lesions may be present for a
                                                  short time after infection.
                                                  Diclazuril was shown in
                                                  studies to reduce lesions
                                                  scores and improve
                                                  performance and health of
                                                  birds challenged with E.
                                                  maxima.

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

* * * * *

    Dated: February 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03538 Filed 2-25-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 114 (Tuesday, June 14, 2011)]
[Proposed Rules]
[Pages 34627-34629]
[FR Doc No: 2011-14715]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0458; Airspace Docket No. 11-AAL-6]
RIN 2120-AA66

Proposed Modification of Offshore Airspace Areas: Norton Sound
Low, Control 1234L and Control 1487L; Alaska

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: This action proposes to modify the Norton Sound Low, Control
1234L, and Control 1487L Offshore Airspace Areas in Alaska. The
airspace floors would be lowered to provide controlled airspace beyond
12 miles from the coast of the United States given that there is a
requirement to provide Instrument Flight Rules (IFR) en route Air
Traffic Control (ATC) services and within which the United States is
applying domestic ATC procedures.

DATES: Comments must be received on or before July 29, 2011.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, 1200 New Jersey Avenue, SE.,
West Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
telephone:<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2011-
0458 and Airspace Docket No. 11-AAL-6 at the beginning of your
comments. You may also submit comments through the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Ken McElroy, Airspace, Regulations and
ATC Procedures Group, Office of Airspace Services, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (FAA Docket No. FAA-
2011-0458 and Airspace Docket No. 11-AAL-6) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2011-0458 and Airspace Docket No. 11-AAL-6.'' The
postcard will be date/time stamped and returned to the commenter. All
communications received on or before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. An
informal docket may also be examined during normal business hours at
the office of the Alaskan Service Center, Operations Support Group,
Federal Aviation Administration, 222 West 7th Avenue, Box 14,
Anchorage, AK 99513.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed

Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 to modify the Norton Sound Low, Control
1234L, and Control 1487L Offshore Airspace Areas in Alaska. The Norton
Sound Low Offshore Airspace Area would be modified by lowering the
offshore airspace floor to 1,200 feet mean sea level (MSL) within a 73-
mile radius of Port Clarence CGS Airport, excluding that airspace west
of a line extending from lat. 64[deg]48'20'' N., long. 169[deg]31'27''
W., to lat. 65[deg]00'00'' N., long. 168[deg]58'23'' W., to lat.
66[deg]05'44'' N., long. 168[deg]58'23'' W.; and within 73 miles of the
Savoonga Airport excluding that airspace west of a line from lat.
68[deg]00'00'' N., long. 168[deg]58'23'' W., to lat. 65[deg]00'00'' N.,
long. 168[deg]58'23'' W., to lat. 62[deg]35'00'' N., long.
175[deg]00'00'' W.; and within 73 miles of Platinum Airport excluding
that airspace west of a line from lat. 59[deg]59'57'' N., long.
168[deg]00'08'' W., to lat. 57[deg]45'57'' N., long. 161[deg]46'08'' W.
    The Offshore Airspace Area Control 1234L would be modified by
lowering the offshore airspace floor to 1,200 feet above the surface
within a 10-mile radius of the Casco Cove CGS Airport. Additionally,
Control 1234L would be further modified by lowering the offshore
airspace floor to 700 feet above the surface within an 8-mile radius of
St. Paul Island Airport, St. Paul Island, AK.
    Control 1487L would be modified by lowering the offshore airspace
floor to 1,200 feet above the surface within 75 miles of the Yakutat
VOR/DME.
    Offshore airspace areas are published in paragraph 2003 of FAA
Order 7400.9U dated August 18, 2010 and effective September 15, 2010,
which is incorporated by reference in 14 CFR 71.1. The offshore
airspace areas listed in this document will be published subsequently
in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation: (1) Is not a ``significant
regulatory action'' under Executive Order 12866; (2) is not a
``significant rule'' under Department of Transportation (DOT)
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart I, section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it modifies offshore airspace areas in Alaska.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, Environmental Impacts: Policies and Procedures,
paragraph 311a. This airspace action is not expected to cause any
potentially significant environmental impacts, and no extraordinary
circumstances exist that warrant preparation of an environmental
assessment.

ICAO Considerations

    As part of this proposal relates to navigable airspace outside the
United States, this notice is submitted in accordance with the
International Civil Aviation Organization (ICAO) International
Standards and Recommended Practices.
    The application of International Standards and Recommended
Practices by the FAA, Office of Airspace Services, Airspace,
Regulations and ATC Procedures Group, in areas outside the United
States domestic airspace, is governed by the Convention on
International Civil Aviation. Specifically, the FAA is governed by
Article 12 and Annex 11, which pertain to the establishment of
necessary air navigational facilities and services to promote the safe,
orderly, and expeditious flow of civil air traffic. The purpose of
Article 12 and Annex 11 is to ensure that civil aircraft operations on
international air routes are performed under uniform conditions.
    The International Standards and Recommended Practices in Annex 11
apply to airspace under the jurisdiction of a contracting state,
derived from ICAO. Annex 11 provisions apply when air traffic services
are provided and a contracting state accepts the responsibility of
providing air traffic services over high seas or in airspace of
undetermined sovereignty. A contracting state accepting this
responsibility may apply the International Standards and Recommended
Practices that are consistent with standards and practices utilized in
its domestic jurisdiction.
    In accordance with Article 3 of the Convention, state-owned
aircraft are exempt from the Standards and Recommended Practices of
Annex 11. The United States is a contracting state to the Convention.
Article 3(d) of the Convention provides that participating state
aircraft will be operated in international airspace with due regard for
the safety of civil aircraft. Since this action involves, in part, the
designation of navigable airspace outside the United States, the
Administrator is consulting with the Secretary of State and the
Secretary of Defense in accordance with the provisions of Executive
Order 10854.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

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

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

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

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of FAA Order
7400.9U, Airspace Designations and Reporting Points, dated August 18,
2010, and effective September 15, 2010, is amended as follows:

Paragraph 6007--Offshore Airspace Areas

* * * * *

Norton Sound Low, AK [Amended]

    That airspace extending upward from 14,500 feet MSL within an
area bounded by a line beginning at lat. 56[deg]42'59'' N., long.
160[deg]00'00'' W., then north by a line 12 miles from and parallel
to the U.S. coastline to the intersection with 164[deg]00'00'' W.
longitude

near the outlet to Kotzebue Sound, then north to the intersection
with a point 12 miles from the U.S. coastline, then north by a line
12 miles from and parallel to the shoreline to lat. 68[deg]00'00''
N., long. 168[deg]58'23'' W., to lat. 65[deg]00'00'' N., long.
168[deg]58'23'' W., to lat. 62[deg]35'00'' N., long. 175[deg]00'00''
W., to lat. 59[deg]59'57'' N., long. 168[deg]00'08'' W., to lat.
57[deg]45'57'' N., long. 161[deg]46'08'' W., to lat. 58[deg]06'57''
N., long. 160[deg]00'00'' W., to the point of beginning; and that
airspace extending upward from 1,200 feet MSL north of the Alaska
Peninsula and east of 160[deg] W. longitude within 73 miles of Port
Heiden NDB/DME, AK, and north of the Alaska Peninsula and east of
160[deg] W. longitude within an 81.2-mile radius of Perryville
Airport, AK, and north of the Alaska Peninsula and east of 160[deg]
W. longitude within a 72.8-mile radius of Chignik Airport, AK, and
within a 35-mile radius of lat. 60[deg]21'17'' N., long.
165[deg]04'01'' W., and within a 73-mile radius of Chevak Airport,
AK, and within a 73-mile radius of Clarks Point Airport, AK, and
within a 73-mile radius of Elim Airport, AK, and within a 45-mile
radius of Hooper Bay Airport, AK, and within a 73-mile radius of
King Salmon Airport, AK, and that airspace within a 73-mile radius
of Platinum Airport, AK, excluding that portion of the airspace
extending west of a line from lat. 59[deg]59'57'' N., long.
168[deg]00'08'' W., to lat 57[deg]45'57'' N., long. 161[deg]46'08''
W., and within a 73-mile radius of Kivalina Airport, AK, and within
a 74-mile radius of Kotzebue VOR/DME, AK, and within a 73-mile
radius of Kwethluk Airport, AK, and within a 74-mile radius of
Manokotak Airport, AK, and within a 73-mile radius of Napakiak
Airport, AK, and within a 77.4-mile radius of Nome VORTAC, AK, and
within a 73-mile radius of Savoonga Airport, AK, excluding that
airspace west of a line from lat. 68[deg]00'00'' N., long.
168[deg]58'23'' W.; to lat. 65[deg]00'00'' N., long. 168[deg]58'23''
W., to lat. 62[deg]35'00'' N., long. 175[deg]00'00'' W., and within
a 71NM radius of New Stuyahok Airport, AK, and within a 73-mile
radius of Noatak Airport, AK, and within a 72.5-mile radius of Red
Dog Airport, AK, and within a 73-mile radius of Scammon Bay Airport,
AK, and within a 73-mile radius of Shaktoolik Airport, AK, and
within a 74-mile radius of Selawik Airport, AK, and within a 73-mile
radius of St. Michael Airport, AK, and within a 73-mile radius of
Toksook Bay Airport, AK, and within a 73-mile radius of Port
Clarence CGS Airport, AK excluding that airspace west of a line
extending from lat. 64[deg]48'20'' N., long. 169[deg]31'27'' W., to
lat. 65[deg]00'00'' N., long. 168[deg]58'23'' W., to 66[deg]05'44''
N., to long. 168[deg]58'23'' W., and within a 30-mile radius of lat.
66[deg]09'58'' N., long. 166[deg]30'03'' W., and within a 30-mile
radius of lat. 66[deg]19'55'' N., long. 165[deg]40'32'' W.; and that
airspace extending upward from 700 feet MSL within 8-miles west and
4-miles east of the 339[deg] bearing from Port Heiden NDB/DME, AK,
extending from Port Heiden NDB/DME, AK, to 20-miles north of Port
Heiden NDB/DME, AK, and within a 25-mile radius of Nome Airport, AK.
* * * * *

Control 1234L, AK [Amended]

    That airspace extending upward from 2,000 feet above the surface
within an area bounded by a line beginning at lat. 58[deg]06'57''
N., long. 160[deg]00'00'' W., then south along 160[deg]00'00'' W.
longitude until it intersects the Anchorage Air Route Traffic
Control Center (ARTCC) boundary; then southwest, northwest, north,
and northeast along Anchorage ARTCC boundary to lat. 62[deg]35'00''
N., long. 175[deg]00'00'' W., to lat. 59[deg]59'57'' N., long.
168[deg]00'08'' W., to lat. 57[deg]45'57'' N., long. 161[deg]46'08''
W., to the point of beginning; and that airspace extending upward
from 1,200 feet above the surface within a 10-mile radius of Casco
Cove CGS Airport, AK, and within a 26.2-mile radius of Eareckson Air
Station, AK, within an 11-mile radius of Adak Airport, AK, and
within 16 miles of Adak Airport, AK, extending clockwise from the
033[deg] bearing to the 081[deg] bearing from Mount Moffett NDB, AK,
and within a 10-mile radius of Atka Airport, AK, and within a 10.6-
mile radius from Cold Bay Airport, AK, and within 9 miles east and
4.3 miles west of the 321[deg] bearing from Cold Bay Airport, AK,
extending from the 10.6-mile radius to 20 miles northwest of Cold
Bay Airport, AK, and 4 miles each side of the 070[deg] bearing from
Cold Bay Airport, AK, extending from the 10.6-mile radius to 13.6
miles northeast of Cold Bay Airport, AK, and within a 26.2-mile
radius of Eareckson Air Station, AK, and west of 160[deg] W.
longitude within an 81.2-mile radius of Perryville Airport, AK, and
within a 73-mile radius of the Nikolski Airport, AK, within a 74-
mile radius of Manokotak Airport, AK, and within a 73-mile radius of
the Clarks Point Airport, AK, and west of 160[deg] W. longitude
within a 73-mile radius of Port Heiden NDB/DME, AK, and within a 10-
mile radius of St. George Airport, AK, and within a 73-mile radius
of St. Paul Island Airport, AK, and within a 20-mile radius of
Unalaska Airport, AK, extending clockwise from the 305[deg] bearing
from Dutch Harbor NDB, AK, to the 075[deg] bearing from Dutch Harbor
NDB, AK, and west of 160[deg] W. longitude within a 25-mile radius
of Borland NDB/DME, AK, and west of 160[deg] W. longitude within a
72.8-mile radius of Chignik Airport, AK; and that airspace extending
upward from 700 feet above the surface within a 6.9-mile radius of
Eareckson Air Station, AK, and within a 7-mile radius of Adak
Airport, AK, and within 5.2 miles northwest and 4.2 miles southeast
of the 061[deg] bearing from Mount Moffett NDB, AK, extending from
the 7-mile radius of Adak Airport, AK, to 11.5 miles northeast of
Adak Airport, AK, and within a 6.5-mile radius of King Cove Airport,
and extending 1.2 miles either side of the 103[deg] bearing from
King Cove Airport from the 6.5-mile radius out to 8.8 miles, and
within a 6.4-mile radius of Atka Airport, AK, and within a 6.3-mile
radius of Nelson Lagoon Airport, AK, and within a 6.3-mile radius of
the Nikolski Airport, AK, and within a 6.4-mile radius of Sand Point
Airport, AK, and within 3 miles each side of the 172[deg] bearing
from Borland NDB/DME, AK, extending from the 6.4-mile radius of Sand
Point Airport, AK, to 13.9 miles south of Sand Point Airport, AK,
and within 5 miles either side of the 318[deg] bearing from Borland
NDB/DME, AK, extending from the 6.4-mile radius of Sand Point
Airport, AK, to 17 miles northwest of Sand Point Airport, AK, and
within 5 miles either side of the 324[deg] bearing from Borland NDB/
DME, AK, extending from the 6.4-mile radius of Sand Point Airport,
AK, to 17 miles northwest of Sand Point Airport, AK, and within a
6.6-mile radius of St. George Airport, AK, and within an 8-mile
radius of St. Paul Island Airport, AK, and within a 6.4-mile radius
of Unalaska Airport, AK, and within 2.9 miles each side of the
360[deg] bearing from the Dutch Harbor NDB, AK, extending from the
6.4-mile radius of Unalaska Airport, AK, to 9.5 miles north of
Unalaska Airport, AK; and that airspace extending upward from the
surface within a 4.6-mile radius of Cold Bay Airport, AK, and within
1.7 miles each side of the 150[deg] bearing from Cold Bay Airport,
AK, extending from the 4.6-mile radius to 7.7 miles southeast of
Cold Bay Airport, AK, and within 3 miles west and 4 miles east of
the 335[deg] bearing from Cold Bay Airport, AK, extending from the
4.6-mile radius to 12.2 miles northwest of Cold Bay Airport, AK.
* * * * *

Control 1487L, Alaska [Amended]

    That airspace extending upward from 8,000 feet MSL within 149.5
miles of the Anchorage VOR/DME clockwise from the 090[deg] radial to
the 185[deg] radial of the Anchorage VOR/DME, AK; and that airspace
extending upward from 5,500 feet MSL within the area bounded by a
line beginning at lat. 58[deg]19'58'' N., long. 148[deg]55'07'' W.,
to lat. 59[deg]08'35'' N., long. 147[deg]16'04'' W., thence
counterclockwise via the 149.5-mile radius of the Anchorage VOR/DME,
AK, to the intersection with a point 12 miles from and parallel to
the U.S. coastline, thence southeast 12 miles from and parallel to
the U.S. coastline to a point 12 miles offshore on the Vancouver FIR
boundary, to lat. 54[deg]32'57'' N., long. 133[deg]11'29'' W., to
lat. 54[deg]00'00'' N., long. 136[deg]00'00'' W., to lat.
52[deg]43'00'' N., long. 135[deg]00'00'' W., to lat 56[deg]45'42''
N., long. 151[deg]45'00'' W., to the point of beginning; and that
airspace extending upward from 1,200 feet MSL within an 85-mile
radius of the Biorka Island VORTAC, AK, and within a 43-mile radius
of the Middleton Island VOR/DME, AK, and within a 30-mile radius of
the Glacier River NDB, AK, and within a 149.5-mile radius of the
Anchorage VOR/DME, AK, and within the 73-mile radius of Homer
Airport, AK, and within a 75-mile radius of the Yakutat VOR/DME, AK,
and that airspace extending upward from 700 feet MSL within 14 miles
of the Biorka Island VORTAC, AK, and within 4 miles west and 8 miles
east of the Biorka Island VORTAC 209[deg] radial extending to 16
miles southwest of the Biorka Island VORTAC, AK.
* * * * *

    Issued in Washington, DC, on June 6, 2011.
Gary A. Norek,
Acting Manager, Airspace, Regulations and ATC Procedures Group.
[FR Doc. 2011-14715 Filed 6-13-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 225 (Wednesday, November 21, 2012)]
[Notices]
[Pages 69901-69903]
[FR Doc No: 2012-28259]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68239; File No. SR-NYSEARCA-2012-125]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Amending NYSE Arca
Equities Rule 7.31(x) To Clarify That When There Is an Early Scheduled
Close, the 3:45 p.m. ET Time Specified in the Rule Is Adjusted to 15
Minutes Before the Early Scheduled Close

November 15, 2012
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on November 6, 2012, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend NYSE Arca Equities Rule 7.31(x) to
clarify that when there is an early scheduled close, the 3:45 p.m. ET
time specified in the rule is adjusted to 15 minutes before the early
scheduled close. The text of the proposed rule change is available on
the Exchange's Web site at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those 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 parts of such statements.

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

1. Purpose
    The Exchange proposes to amend NYSE Arca Equities Rule 7.31(x) to
clarify that when there is an early scheduled close, the 3:45 p.m. ET
time specified in the rule is adjusted to 15 minutes before the early
scheduled close.
    NYSE Arca Equities Rule 7.31(x) defines the Exchange's Primary Only
Order (``PO Order''), which is a market or limit order to be routed to
the primary market. The rule currently provides that PO Orders routed
to the New York Stock Exchange LLC (``NYSE'') or NYSE MKT LLC (``NYSE
MKT'') that are designated as Market on Close (``MOC'') or Limit on
Close (``LOC'') may not be electronically cancelled or reduced in size
after 3:45 p.m. ET and that any electronic submissions after 3:45 p.m.
ET will be automatically rejected.
    The 3:45 p.m. ET time specified in NYSE Arca Equities Rule 7.31(x)
is based on NYSE Rule 123C and NYSE MKT Rule 123C--Equities
requirements governing the entry and cancellation of MOC and LOC Orders
after 3:45 p.m. ET. In the case of an early scheduled close, NYSE and
NYSE MKT use a time based on 15 minutes before the early scheduled
close instead of the 3:45 p.m. time specified in the rule.\4\
---------------------------------------------------------------------------

    \4\ The Exchange notes that the NYSE and NYSE MKT have filed
rule proposals to amend their respective rules to clarify that when
the scheduled close of trading is before 4:00 p.m., the times
specified in NYSE Rule 123C and NYSE MKT Rule 123C--Equities shall
be adjusted based on the early closing time, and specifically, that
references to 3:45 p.m. shall mean 15 minutes before the early
scheduled close. See SR-NYSE-2012-62 and SR-NYSEMKT-2012-63.
---------------------------------------------------------------------------

    The Exchange proposes to clarify NYSE Arca Equities Rule 7.31(x) to
similarly provide that in the case of an early scheduled close, the
3:45 p.m. ET time would instead be 15 minutes before the early
scheduled close. In addition, because the rules of NYSE MKT regarding
the designation ``DNS'' are the same as the rules of the NYSE, the
Exchange proposes to further clarify the rule to add references to NYSE
MKT in addition to the existing references to NYSE when discussing
routing PO Orders to the NYSE.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \5\ of the
Securities Exchange Act of 1934 (the ``Act''), in general, and furthers
the objectives of Section 6(b)(5),\6\ 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 mechanism 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. In
particular, the Exchange believes that the proposed rule change to
clarify that the 3:45 p.m. ET time specified in NYSE Arca Equities Rule
7.31(x) is adjusted in the case of an early scheduled close removes
impediments to and perfects the mechanism of a free and open market and
national market system because it provides transparency in Exchange
rules of how times are adjusted in NYSE Arca Equities Rule 7.31(x) in
the case of an early scheduled close.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

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

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \7\ and Rule 19b-4(f)(6) thereunder.\8\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
---------------------------------------------------------------------------

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

    A proposed rule change filed under Rule 19b-4(f)(6) \9\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b4(f)(6)(iii),\10\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. NYSE Arca believes that
because the proposed rule change proposes to clarify NYSE Arca Equities
Rule 7.31(x), the public will benefit from immediate implementation of
the rule due to the additional transparency to the rule. NYSE Arca also
believes that adding clarity to its rules before the next early
scheduled close, November 23, 2012, could reduce any potential
confusion regarding how NYSE Arca treats the routing of PO Orders
designated as MOC or LOC orders on that day. The Commission believes
that adding clarity to NYSE Arca's rules before the next early
scheduled close on November 23, 2012 could reduce potential confusion.
Therefore, the Commission believes that waiver of the operative delay
is consistent with investor protection and the public interest. As a
result, the Commission is hereby waiving the 30-day operative
delay.\11\
---------------------------------------------------------------------------

    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ 17 CFR 240.19b-4(f)(6)(iii).
    \11\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File

Number SR-NYSEARCA-2012-125 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-NYSE-2012-125. 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 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 offices 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-NYSE-2012-125, and should be submitted on or before
December 12, 2012.
---------------------------------------------------------------------------

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

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-28259 Filed 11-20-12; 8:45 am]
BILLING CODE 8011-01-P