[Federal Register Volume 83, Number 242 (Tuesday, December 18, 2018)]
[Rules and Regulations]
[Pages 64738-64744]
[FR Doc No: 2018-27238]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

[Docket No. FDA-2018-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications;
Changes of Sponsorship; Change of a Sponsor's Name and Address

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) and abbreviated new animal drug
applications (ANADAs) during April, May, and June 2018. FDA is
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable. The
animal drug regulations are also being amended to make technical
amendments to improve the accuracy and readability of the regulations.

DATES: This rule is effective December 18, 2018.

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

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during April, May, and June 2018, as
listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents may be seen in the
office of the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday. Persons with access
to the internet may obtain these documents at the CVM FOIA Electronic
Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing
exclusivity and patent information may be accessed in FDA's
publication, Approved Animal Drug Products Online (Green Book) at:
https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

                              Table 1--Original and Supplemental NADAs and ANADAs Approved During April, May, and June 2018
--------------------------------------------------------------------------------------------------------------------------------------------------------
      Approval date       File  No.         Sponsor            Product name           Species          Effect of the action        Public  documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
May 4, 2018.............    141-481  Kindred Biosciences,  MIRATAZ (mirtazapine  Cats.............  Original approval for the  FOI Summary.
                                      Inc., 1555 Bayshore   transdermal                              management of weight
                                      Hwy., Suite 200,      ointment).                               loss in cats.
                                      Burlingame, CA
                                      94010.
May 15, 2018............    141-501  Boehringer Ingelheim  SEMINTRA              Cats.............  Original approval for the  FOI Summary.
                                      Vetmedica, Inc.,      (telmisartan oral                        control of systemic
                                      2621 North Belt       solution).                               hypertension in cats.
                                      Hwy., St. Joseph,
                                      MO 64506-2002.
May 25, 2018............    141-063  Intervet, Inc., 2     NUFLOR                Cattle...........  Supplemental approval to   FOI Summary.
                                      Giralda Farms,        (florfenicol),                           provide human food
                                      Madison, NJ 07940.    Injectable Solution.                     safety information for
                                                                                the use of the inactive
                                                                                ingredient n[dash]methyl-
                                                                                2-pyrrolidone (NMP).
May 31, 2018............    141-495  Elanco US Inc., 2500  INTEPRITY             Chickens.........  Original approval for the  FOI Summary.
                                      Innovation Way,       (avilamycin) and                         prevention of mortality
                                      Greenfield, IN        BIO-COX                                  caused by necrotic
                                      46140.                (salinomycin                             enteritis and for the
                                                            sodium) Type C                           prevention of
                                                            medicated feeds.                         coccidiosis in broiler
                                                                                chickens.
June 6, 2018............    141-342  Jurox Pty. Ltd., 85   ALFAXAN               Dogs and cats....  Supplemental approval      FOI Summary.
                                      Gardiner Rd.,         (alfaxalone),                            providing for addition
                                      Rutherford, NSW       Injectable Solution.                     of preservatives and use
                                      2320, Australia.                                               of a multidose vial.
June 14, 2018...........    098-379  Merial, Inc., 3239    CYSTORELIN            Cattle...........  Supplemental approval for  FOI Summary, EA/FONSI.\1\
                                      Satellite Blvd.,      (gonadorelin),                           use with cloprostenol
                                      Bldg. 500, Duluth,    Injectable Solution.                     sodium to synchronize
                                      GA 30096-4640.                                                 estrous cycles to allow
                                                                                for fixed-time
                                                                                artificial insemination
                                                                                (FTAI) in lactating
                                                                                dairy cows and beef cows.
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\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
  no significant impact (FONSI).

II. Technical Amendments

    With the approval of NADA 141-481, Kindred Biosciences, Inc. is now
the sponsor of an approved application. Accordingly, we are amending
Sec.  510.600(c) to add the name, address, and drug labeler code of
this sponsor.
    Piramal Healthcare Ltd., Piramal Tower, Ganpatrao Kadam Marg, Lower
Parel, Mumbai-400 013, India, has informed FDA that it has changed its
name and address to Piramal Enterprises Ltd., Ananta, Agastya Corporate
Park, Opp Fire Brigade, Kamani Junction, LBS Mag Kurla (West), Mumbai,
400070, India. We are amending Sec.  510.600(c) to reflect this change.
    We are also making technical amendments to update the scientific
name of a pathogenic bacterium and to accurately list the
concentrations of active ingredients in an otic dosage form new animal
drug. We are also making a technical amendment to correct the sponsor
of epsiprantel tablets. These actions are being taken to improve the
accuracy of the regulations.
    In addition, we are reformatting the regulations to create a
tabular display of

the approved uses of narasin and a separate section for uses of a
fixed-ratio, combination drug Type A medicated article containing
narasin and nicarbazin. These actions are being taken to improve the
readability, consistency, and accuracy of the regulations.

III. 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 510

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

21 CFR Parts 520, 522, and 524

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

21 CFR Part 558

    Animal drugs, Animal feeds.

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

PART 510--NEW ANIMAL DRUGS

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

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

0
2. In Sec.  510.600, in the table in paragraph (c)(1), alphabetically
add an entry for ``Kindred Biosciences, Inc.'' and remove the entry for
``Piramal Healthcare Ltd.'' and add an entry for ``Piramal Enterprises
Ltd.'' in its place; and in the table in paragraph (c)(2), revise the
entry for ``065085'' and numerically add an entry for ``086078'' to
read as follows:

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

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

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

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

                              * * * * * * *
Piramal Enterprises Ltd., Ananta, Agastya Corporate               065085
 Park, Opp Fire Brigade, Kamani Junction, LBS Mag Kurla
 (West), Mumbai, 400070, India..........................

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

    (2) * * *

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

                              * * * * * * *
065085..................  Piramal Enterprises Ltd., Ananta, Agastya
                           Corporate Park, Opp Fire Brigade, Kamani
                           Junction, LBS Mag Kurla (West), Mumbai,
                           400070, India.

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

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

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

Sec.  520.88f   [Amended]

0
4. In Sec.  520.88f, in paragraph (c)(2), remove ``lacerations) due to
S. aureus, Streptococcus spp., E. coli'' and in its place add
``lacerations) due to S. aureus, Enterococcus faecalis, E. coli''.

Sec.  520.816   [Amended]

0
5. In Sec.  520.816, in paragraph (b), remove ``050604'' and in its
place add ``054771''.

0
6. Add Sec.  520.2335 to read as follows:

Sec.  520.2335  Telmisartan.

    (a) Specifications. Each milliliter of solution contains 10
milligrams (mg) telmisartan.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer 1.5 mg/kilogram (kg)
(0.68 mg/pound (lb)) orally twice daily for 14 days, followed by 2 mg/
kg (0.91 mg/lb) orally once daily.
    (2) Indications for use. For the control of systemic hypertension
in cats.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

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

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

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

0
8. Revise Sec.  522.1077 to read as follows:

Sec.  522.1077   Gonadorelin.

    (a) Specifications. Each milliliter (mL) of solution contains:
    (1) 43 micrograms ([mu]g) of gonadorelin as gonadorelin acetate;
    (2) 100 [mu]g of gonadorelin as gonadorelin acetate;
    (3) 43 [mu]g of gonadorelin as gonadorelin diacetate tetrahydrate;
or
    (4) 50 [mu]g of gonadorelin as gonadorelin hydrochloride.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this
chapter.
    (1) No. 000061 for use of the 43-[mu]g/mL product described in
paragraph (a)(1) as in paragraphs (d)(1)(i), (d)(1)(iv), and (d)(2) of
this section.
    (2) No. 068504 for use of the 100-[mu]g/mL product described in
paragraph (a)(2) as in paragraphs (d)(1)(ii), (d)(1)(v), and (d)(2) of
this section.
    (3) No. 061623 for use of the 43-[mu]g/mL product described in
paragraph (a)(3) as in paragraphs (d)(1)(i) and (d)(2) of this section.
    (4) No. 050604 for use of the 43-[mu]g/mL product described in
paragraph (a)(3) as in paragraphs (d)(1)(i), (d)(1)(vi), and (d)(2) of
this section.
    (5) No. 054771 for use of the 50-[mu]g/mL product described in
paragraph (a)(4) as in paragraphs (d)(1)(iii), (d)(1)(vii), and (d)(2)
of this section.
    (c) Special considerations. Concurrent luteolytic drug use is
approved as follows:
    (1) Cloprostenol injection for use as in paragraph (d)(1)(iv) of
this section as provided by No. 000061 in Sec.  510.600(c) of this
chapter.
    (2) Cloprostenol injection for use as in paragraph (d)(1)(v) and
(d)(1)(vi) of this section as provided by No. 000061 or No. 068504 in
Sec.  510.600(c) of this chapter.
    (3) Dinoprost injection for use as in paragraph (d)(1)(vii) of this
section as provided by No. 054771 in Sec.  510.600(c) of this chapter.
    (d) Conditions of use in cattle--(1) Indications for use and
amounts--(i) For the treatment of ovarian follicular cysts in dairy
cattle: Administer 86 [mu]g gonadorelin (No. 000061) or 100 [mu]g
gonadorelin diacetate tetrahydrate (Nos. 061623 and 050604) by
intramuscular or intravenous injection.
    (ii) For the treatment of ovarian follicular cysts in dairy cattle:
Administer 100 [mu]g gonadorelin by intramuscular or intravenous
injection.
    (iii) For the treatment of ovarian follicular cysts in cattle:
Administer 100 [mu]g gonadorelin by intramuscular injection.
    (iv) For use with cloprostenol injection to synchronize estrous
cycles to allow for fixed-time artificial insemination (FTAI) in
lactating dairy cows: Administer to each cow 86 [mu]g gonadorelin by
intramuscular injection, followed 6 to 8 days later by 500 [mu]g
cloprostenol by intramuscular injection, followed 30 to 72 hours later
by 86 [mu]g gonadorelin by intramuscular injection.
    (v) For use with cloprostenol sodium to synchronize estrous cycles
to allow for fixed-time artificial insemination (FTAI) in lactating
dairy cows and beef cows: Administer to each cow 100 [mu]g gonadorelin
by intramuscular injection, followed 6 to 8 days later by 500 [mu]g
cloprostenol by intramuscular injection, followed 30 to 72 hours later
by 100 [mu]g gonadorelin by intramuscular injection.
    (vi) For use with cloprostenol sodium to synchronize estrous cycles
to allow for fixed-time artificial insemination (FTAI) in lactating
dairy cows and beef cows: Administer to each cow 100 [mu]g gonadorelin
diacetate tetrahydrate by intramuscular injection, followed 6 to 8 days
later by 500 [mu]g cloprostenol by intramuscular injection, followed 30
to 72 hours later by 100 [mu]g gonadorelin diacetate tetrahydrate by
intramuscular injection.
    (vii) For use with dinoprost injection to synchronize estrous
cycles to allow fixed-time artificial insemination (FTAI) in lactating
dairy cows: Administer to each cow 100 to 200 [mu]g gonadorelin by
intramuscular injection, followed 6 to 8 days later by 25 mg dinoprost
by intramuscular injection, followed 30 to 72 hours later by 100 to 200
[mu]g gonadorelin by intramuscular injection.
    (2) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

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

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

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

0
10. In Sec.  524.957, revise paragraph (a) to read as follows:

Sec.  524.957  Florfenicol, terbinafine, and mometasone otic solution.

    (a) Specifications. Each single-dose, prefilled dropperette
contains 1 milliliter (mL) of a solution containing 16.6 milligrams
(mg) florfenicol, 14.8 mg terbinafine (equivalent to 16.6 mg
terbinafine hydrochloride), and 2.2 mg mometasone furoate.
* * * * *

0
11. Add Sec.  524.1448 to read as follows:

Sec.  524.1448   Mirtazapine transdermal ointment.

    (a) Specifications. Each gram of ointment contains 20 milligrams
(mg) mirtazapine.
    (b) Sponsor. See No. 086078 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer topically by applying
a 1.5 inch ribbon of ointment (approximately 2 mg) on the inner pinna
of the cat's ear once daily for 14 days. Alternate the daily
application of ointment between the left and right inner pinna of the
ears.
    (2) Indications for use. For the management of weight loss in cats.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

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

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

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

0
13. In Sec.  556.428, add paragraph (c) to read as follows:

Sec.  556.428  Narasin.

* * * * *
    (c) Related conditions of use. See Sec. Sec.  558.363 and 558.364
of this chapter.

0
14. Revise Sec.  556.445 to read as follows:

Sec.  556.445  Nicarbazin.

    (a) [Reserved]
    (b) Tolerances. A tolerance of 4 parts per million is established
for residues of nicarbazin in uncooked chicken muscle, liver, skin, and
kidney.
    (c) Related conditions of use. See Sec. Sec.  558.364 and 558.366
of this chapter.

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

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

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

0
16. In Sec.  558.68, revise paragraph (e)(1)(ii) and add paragraph
(e)(1)(v) to read as follows:

Sec.  558.68   Avilamycin.

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

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

                                                  * * * * * * *
(ii) 13.6 to 40.9.......  Monensin, 90 to     Broiler chickens:   Feed as the sole ration for 21          058198
                           110.                For the             consecutive days. To assure
                                               prevention of       responsible antimicrobial drug
                                               mortality caused    use in broiler chickens,
                                               by necrotic         treatment administration must
                                               enteritis           begin on or before 10 days of
                                               associated with     age. See Sec.   558.355(d) of
                                               Clostridium         this chapter. Monensin as
                                               perfringens; and    provided by No. 058198 in Sec.
                                               as an aid in the    510.600(c) of this chapter.
                                               prevention of
                                               coccidiosis
                                               caused by Eimeria
                                               necatrix, E.
                                               tenella, E.
                                               acervulina, E.
                                               brunetti, E.
                                               mivati, and E.
                                               maxima.

                                                  * * * * * * *
(v) 13.6 to 40.9........  Salinomycin         Broiler chickens:   Feed as the sole ration for 21          058198
                           sodium, 40 to 60.   For the             consecutive days. Feed to
                                               prevention of       chickens that are at risk of
                                               mortality caused    developing, but not yet showing
                                               by necrotic         clinical signs of, necrotic
                                               enteritis           enteritis associated with
                                               associated with     Clostridium perfringens. Not
                                               Clostridium         approved for use with pellet
                                               perfringens; and    binders. To assure responsible
                                               for the             antimicrobial drug use in
                                               prevention of       broiler chickens, treatment
                                               coccidiosis         administration must begin on or
                                               caused by Eimeria   before 10 days of age. The
                                               tenella, E.         safety of avilamycin has not
                                               necatrix, E.        been established in chickens
                                               acervulina, E.      intended for breeding purposes.
                                               maxima, E.          Avilamycin has not been
                                               brunetti, and E.    demonstrated to be effective in
                                               mivati.             broiler chickens showing
                                                                   clinical signs of necrotic
                                                                   enteritis prior to the start of
                                                                   medication. Do not feed to
                                                                   laying hens producing eggs for
                                                                   human consumption. May be fatal
                                                                   if fed to adult turkeys or to
                                                                   horses. Salinomycin as provided
                                                                   by No. 016592 in Sec.
                                                                   510.600(c) of this chapter.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
17. In Sec.  558.76, remove and reserve paragraph (e)(1)(viii);
redesignate paragraphs (e)(2)(xiii) through (xvii) as paragraphs
(e)(2)(xiv) through (xviii); add new paragraph (e)(2)(xiii); and revise
newly redesignated paragraph (e)(2)(xiv).
    The addition and revision read as follows:

Sec.  558.76   Bacitracin methylendisalicylate.

* * * * *
    (e) * * *
    (2) * * *
    (xiii) Narasin and nicarbazin as in Sec.  558.364.
    (xiv) Nicarbazin as in Sec.  558.366.
* * * * *

0
18. In Sec.  558.78, add paragraph (d)(3)(vii) to read as follows:

Sec.  558.78  Bacitracin zinc.

* * * * *
    (d) * * *
    (3) * * *
    (vii) Nicarbazin as in Sec.  558.366.
* * * * *

0
19. In Sec.  558.95, revise paragraph (d)(5)(viii); redesignate
paragraphs (d)(5)(ix) through (xi) as paragraphs (d)(5)(x) through
(xii); and add new paragraph (d)(5)(ix).
    The revision and addition read as follows:

Sec.  558.95   Bambermycins.

* * * * *
    (d) * * *
    (5) * * *
    (viii) Narasin as in Sec.  558.363.
    (ix) Narasin and nicarbazin as in Sec.  558.364.
* * * * *

Sec.  558.128   [Amended]

0
20. In Sec.  558.128, in paragraph (e)(3)(iv), in the ``Limitations''
column, at the end of the second sentence, add ``Chlortetracycline and
bacitracin methylenedisalicylate as provided by No. 054771 in Sec.
510.600(c) of this chapter.''

Sec.  558.325   [Amended]

0
21. In Sec.  558.325, in paragraph (e)(1)(iv), in the ``Combination in
grams/ton'' column, remove ``Decoquinate, 2.72'' and in its place add
``Decoquinate, 27.2''.

0
22. Revise Sec.  558.363 to read as follows:

Sec.  558.363   Narasin.

    (a) Specifications. Type A medicated articles containing 36, 45,
54, 72, and 90 grams narasin per pound.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Tolerances. See Sec.  556.428 of this chapter.
    (d) Special considerations. An expiration date of 2 months (8
weeks) is required for narasin Type C medicated swine feeds.
    (e) Conditions of use. It is used as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
                            Combination in grams/
     Narasin grams/ton               ton            Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 54 to 90..............  .....................  Broiler chickens: For  For broiler chickens            058198
                                                    prevention of          only. Feed continuously
                                                    coccidiosis caused     as sole ration. Do not
                                                    by Eimeria necatrix,   allow adult turkeys,
                                                    E. tenella, E.         horses, or other equines
                                                    acervulina, E.         access to narasin
                                                    brunetti, E. mivati,   formulations. Ingestion
                                                    and E. maxima.         of narasin by these
                                                                           species has been fatal.
(ii) 54 to 72.............  Bacitracin             Broiler chickens: For  For broiler chickens            054771
                             methylenedisalicylat   prevention of          only. Feed continuously
                             e, 10 to 50.           coccidiosis caused     as sole ration. Do not
                                                    by Eimeria necatrix,   feed to laying hens. Do
                                                    E. tenella, E.         not allow adult turkeys,
                                                    acervulina, E.         horses, or other equines
                                                    brunetti, E. mivati,   access to narasin
                                                    and E. maxima, and     formulations. Ingestion
                                                    for increased rate     of narasin by these
                                                    of weight gain and     species has been fatal.
                                                    improved feed          Bacitracin
                                                    efficiency.            methylenedisalicylate as
                                                                           provided by No. 054771
                                                                           in Sec.   510.600(c) of
                                                                           this chapter.
(iii) 54 to 72............  Bacitracin zinc, 4 to  Broiler chickens: For  For broiler chickens            054771
                             50.                    prevention of          only. Feed continuously
                                                    coccidiosis caused     as sole ration. Do not
                                                    by Eimeria necatrix,   allow adult turkeys,
                                                    E. tenella, E.         horses, or other equines
                                                    acervulina, E.         access to narasin
                                                    brunetti, E. mivati,   formulations. Ingestion
                                                    and E. maxima, and     of narasin by these
                                                    for increased rate     species has been fatal.
                                                    of weight gain and     Bacitracin zinc as
                                                    improved feed          provided by No. 054771
                                                    efficiency.            in Sec.   510.600(c) of
                                                                           this chapter.
(iv) 54 to 72.............  Bambermycins, 1 to 2.  Broiler chickens: For  For broiler chickens            016592
                                                    prevention of          only. Feed continuously
                                                    coccidiosis caused     as sole ration. Do not
                                                    by Eimeria necatrix,   allow adult turkeys,
                                                    E. tenella, E.         horses, or other equines
                                                    acervulina, E.         access to narasin
                                                    brunetti, E. mivati,   formulations. Ingestion
                                                    and E. maxima, and     of narasin by these
                                                    for increased rate     species has been fatal.
                                                    of weight gain and     Bambermycins as provided
                                                    improved feed          by No. 016592 in Sec.
                                                    efficiency.            510.600(c) of this
                                                                           chapter.
----------------------------------------------------------------------------------------------------------------

    (2) Swine--

----------------------------------------------------------------------------------------------------------------
                            Combination in grams/
     Narasin grams/ton               ton            Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 13.6 to 27.2..........  .....................  Growing-finishing      Feed continuously for at        058198
                                                    swine: For increased   least 4 weeks to swine
                                                    rate of weight gain    during the growing-
                                                    when fed for at        finishing period as the
                                                    least 4 weeks.         sole ration. No
                                                                           increased benefit in
                                                                           rate of weight gain has
                                                                           been shown when narasin
                                                                           concentrations in the
                                                                           diet are greater than
                                                                           13.6 g/ton.
                                                                           Effectiveness has not
                                                                           been demonstrated when
                                                                           fed for durations less
                                                                           than 4 weeks. Do not
                                                                           allow adult turkeys,
                                                                           horses, or other equines
                                                                           access to narasin
                                                                           formulations. Ingestion
                                                                           of narasin by these
                                                                           species has been fatal.
                                                                           Not approved for use in
                                                                           breeding animals because
                                                                           safety and effectiveness
                                                                           have not been evaluated
                                                                           in these animals. Swine
                                                                           being fed with narasin
                                                                           should not have access
                                                                           to feeds containing
                                                                           pleuromutilins (e.g.,
                                                                           tiamulin) as adverse
                                                                           reactions may occur. If
                                                                           signs of toxicity occur,
                                                                           discontinue use.
(ii) 18.1 to 27.2.........  .....................  Growing-finishing      Feed continuously for at        058198
                                                    swine: For increased   least 4 weeks to swine
                                                    rate of weight gain    during the growing-
                                                    and improved feed      finishing period as the
                                                    efficiency when fed    sole ration. No
                                                    for at least 4 weeks.  increased benefit in
                                                                           rate of weight gain has
                                                                           been shown when narasin
                                                                           concentrations in the
                                                                           diet are greater than
                                                                           13.6 g/ton.
                                                                           Effectiveness has not
                                                                           been demonstrated when
                                                                           fed for durations less
                                                                           than 4 weeks. Do not
                                                                           allow adult turkeys,
                                                                           horses, or other equines
                                                                           access to narasin
                                                                           formulations. Ingestion
                                                                           of narasin by these
                                                                           species has been fatal.
                                                                           Not approved for use in
                                                                           breeding animals because
                                                                           safety and effectiveness
                                                                           have not been evaluated
                                                                           in these animals. Swine
                                                                           being fed with narasin
                                                                           should not have access
                                                                           to feeds containing
                                                                           pleuromutilins (e.g.,
                                                                           tiamulin) as adverse
                                                                           reactions may occur. If
                                                                           signs of toxicity occur,
                                                                           discontinue use.
----------------------------------------------------------------------------------------------------------------

    (3) Narasin single-ingredient Type A medicated articles may also be
used in combination with:
    (i) Avilamycin as in Sec.  558.68.
    (ii) [Reserved]

Sec.  558.364   [Redesignated as Sec.  558.365]

0
23. Redesignate Sec.  558.364 as Sec.  558.365.

0
24. Add new Sec.  558.364 to read as follows:

Sec.  558.364   Narasin and nicarbazin.

    (a) Specifications. A fixed-ratio, combination drug Type A
medicated article containing 36 grams narasin and 36 grams nicarbazin
per pound.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Tolerances. See Sec. Sec.  556.428 and 556.445 of this chapter.
    (d) Conditions of use. It is used as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
  Narasin and nicarbazin    Combination in grams/
         grams/ton                   ton            Indications for use          Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 27 to 45 of each drug.  .....................  Broiler chickens: For  Feed continuously as sole       058198
                                                    prevention of          ration. Do not feed to
                                                    coccidiosis caused     laying hens. Withdraw 5
                                                    by Eimeria tenella,    days before slaughter.
                                                    E. necatrix, E.        Do not allow adult
                                                    acervulina, E.         turkeys, horses, or
                                                    maxima, E. brunetti,   other equines access to
                                                    and E. mivati.         narasin formulations.
                                                                           Ingestion of narasin by
                                                                           these species has been
                                                                           fatal.
(ii) 27 to 45 of each drug  Bacitracin             Broiler chickens: For  Feed continuously as sole       058198
                             methylenedisalicylat   prevention of          ration. Do not feed to
                             e, 4 to 50.            coccidiosis caused     laying hens. Withdraw 5
                                                    by Eimeria tenella,    days before slaughter.
                                                    E. necatrix, E.        Do not allow turkeys,
                                                    acervulina, E.         horses, or other equines
                                                    maxima, E. brunetti,   access to formulations
                                                    and E. mivati, and     containing narasin.
                                                    for increased rate     Ingestion of narasin by
                                                    of weight gain and     these species has been
                                                    improved feed          fatal. Bacitracin
                                                    efficiency.            methylenedisalicylate as
                                                                           provided by No. 054771
                                                                           in Sec.   510.600(c) of
                                                                           this chapter.
(iii) 27 to 45 of each      Bacitracin             Broiler chickens: For  Feed continuously as sole       054771
 drug.                       methylenedisalicylat   prevention of          ration. Withdraw 5 days
                             e, 50.                 coccidiosis caused     before slaughter. Do not
                                                    by Eimeria tenella,    feed to laying hens. Do
                                                    E. necatrix, E.        not allow turkeys,
                                                    acervulina, E.         horses, or other equines
                                                    maxima, E. brunetti,   access to formulations
                                                    and E. mivati, and     containing narasin.
                                                    as an aid in the       Ingestion of narasin by
                                                    prevention of          these species has been
                                                    necrotic enteritis     fatal. Bacitracin
                                                    caused or              methylenedisalicylate as
                                                    complicated by         provided by No. 054771
                                                    Clostridium spp. or    in Sec.   510.600(c) of
                                                    other organisms        this chapter.
                                                    susceptible to
                                                    bacitracin.
(iv) 27 to 45 of each drug  Bacitracin             Broiler chickens: For  To control necrotic             054771
                             methylenedisalicylat   prevention of          enteritis, start
                             e, 100 to 200.         coccidiosis caused     medication at first
                                                    by Eimeria tenella,    clinical signs of
                                                    E. necatrix, E.        disease; vary dosage
                                                    acervulina, E.         based on the severity of
                                                    maxima, E. brunetti,   infection; administer
                                                    and E. mivati, and     continuously for 5 to 7
                                                    as an aid in the       days or as long as
                                                    control of necrotic    clinical signs persist,
                                                    enteritis caused or    then reduce bacitracin
                                                    complicated by         to prevention level (50
                                                    Clostridium spp. or    g/ton). Do not feed to
                                                    other organisms        laying hens. Withdraw 5
                                                    susceptible to         days before slaughter.
                                                    bacitracin.            Do not allow turkeys,
                                                                           horses, or other equines
                                                                           access to formulations
                                                                           containing narasin.
                                                                           Ingestion of narasin by
                                                                           these species has been
                                                                           fatal. Bacitracin
                                                                           methylenedisalicylate as
                                                                           provided by No. 054771
                                                                           in Sec.   510.600(c) of
                                                                           this chapter.
(v) 27 to 45 of each drug.  Bambermycins, 1 to 2.  Broiler chickens: As   Feed continuously as sole       058198
                                                    an aid in preventing   ration from time chicks
                                                    outbreaks of cecal     are placed on litter
                                                    (Eimeria tenella)      until past the time when
                                                    and intestinal (E.     coccidiosis is
                                                    acervulina, E.         ordinarily a hazard. Do
                                                    maxima, E. necatrix,   not use as a treatment
                                                    and E. brunetti)       for coccidiosis. Do not
                                                    coccidiosis, and for   feed to laying hens.
                                                    increased rate of      Withdraw 5 days before
                                                    weight gain and        slaughter. Do not allow
                                                    improved feed          turkeys, horses, or
                                                    efficiency.            other equines access to
                                                                           formulations containing
                                                                           narasin. Ingestion of
                                                                           narasin by these species
                                                                           has been fatal.
                                                                           Bambermycins as provided
                                                                           by No. 016592 in Sec.
                                                                           510.600(c) of this
                                                                           chapter.
----------------------------------------------------------------------------------------------------------------

    (2) Narasin and nicarbazin fixed-ratio, combination drug Type A
medicated articles may also be used in combination with:
    (i) Avilamycin as in Sec.  558.68.
    (ii) [Reserved]

0
25. Revise Sec.  558.366 to read as follows:

Sec.  558.366  Nicarbazin.

    (a) Specifications. Type A medicated articles containing 25 percent
nicarbazin.
    (b) Sponsors. See Nos. 058198, 060728, and 066104 in Sec.
510.600(c) of this chapter for use as in paragraph (d) of this section.
    (c) Related tolerances. See Sec.  556.445 of this chapter.
    (d) Conditions of use. It is used as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
                              Combination in grams
Nicarbazin in grams per ton          per ton           Indications for use           Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 90.8 to 181.6..........  ......................  Broiler chickens: As    Feed continuously as sole    066104
                                                      an aid in preventing    ration from time chicks
                                                      outbreaks of cecal      are placed on litter
                                                      (Eimeria tenella) and   until past the time when
                                                      intestinal (E.          coccidiosis is ordinarily
                                                      acervulina, E.          a hazard. Do not use as a
                                                      maxima, E. necatrix,    treatment for outbreaks
                                                      and E. brunetti)        of coccidiosis. Do not
                                                      coccidiosis.            use in flushing mashes.
                                                                              Do not feed to laying
                                                                              hens. Withdraw 4 days
                                                                              before slaughter for use
                                                                              levels at or below 113.5
                                                                              g/ton. Withdraw 5 days
                                                                              before slaughter for use
                                                                              levels above 113.5 g/ton.
(ii) 90.8 to 181.6.........  Bacitracin              Broiler chickens: As    Feed continuously as sole    054771
                              methylenedisalicylate   an aid in preventing    ration from time chicks
                              , 4 to 50.              outbreaks of cecal      are placed on litter
                                                      (Eimeria tenella) and   until past the time when
                                                      intestinal (E.          coccidiosis is ordinarily
                                                      acervulina, E.          a hazard. Do not use as a
                                                      maxima, E. necatrix,    treatment for outbreaks
                                                      and E. brunetti)        of coccidiosis. Do not
                                                      coccidiosis, and for    use in flushing mashes.
                                                      increased rate of       Do not feed to laying
                                                      weight gain and         hens. Withdraw 4 days
                                                      improved feed           before slaughter for use
                                                      efficiency.             levels at or below 113.5
                                                                              g/ton. Withdraw 5 days
                                                                              before slaughter for use
                                                                              levels above 113.5 g/ton.
                                                                              Nicarbazin as provided by
                                                                              No. 066104; bacitracin
                                                                              methylenedisalicylate as
                                                                              provided by No. 054771 in
                                                                              Sec.   510.600(c) of this
                                                                              chapter.

(iii) 90.8 to 181.6........  Bacitracin              Broiler chickens; As    Feed continuously as sole    066104
                              methylenedisalicylate   an aid in preventing    ration from time chicks
                              , 30.                   outbreaks of cecal      are placed on litter
                                                      (Eimeria tenella) and   until past the time when
                                                      intestinal (E.          coccidiosis is ordinarily
                                                      acervulina, E.          a hazard. Do not use as a
                                                      maxima, E. necatrix,    treatment for
                                                      and E. brunetti)        coccidiosis. Do not use
                                                      coccidiosis, and for    in flushing mashes. Do
                                                      increased rate of       not feed to laying hens.
                                                      weight gain and         Withdraw 4 days before
                                                      improved feed           slaughter for use levels
                                                      efficiency.             at or below 113.5 g/ton.
                                                                              Withdraw 5 days before
                                                                              slaughter for use levels
                                                                              above 113.5 g/ton.
                                                                              Nicarbazin as provided by
                                                                              No. 066104; bacitracin
                                                                              methylenedisalicylate as
                                                                              provided by No. 054771 in
                                                                              Sec.   510.600(c) of this
                                                                              chapter.
(iv) 90.8 to 181.6.........  Bacitracin              Broiler chickens: As    Feed continuously as sole    054771
                              methylenedisalicylate   an aid in preventing    ration from time chicks
                              50.                     outbreaks of cecal      are placed on litter
                                                      (Eimeria tenella) and   until past the time when
                                                      intestinal (E.          coccidiosis is ordinarily
                                                      acervulina, E.          a hazard. Do not use as a
                                                      maxima, E. necatrix,    treatment for outbreaks
                                                      and E. brunetti)        of coccidiosis. Do not
                                                      coccidiosis, and as     use in flushing mashes.
                                                      an aid in the           Do not feed to laying
                                                      prevention of           hens. Withdraw 4 days
                                                      necrotic enteritis      before slaughter for use
                                                      caused or complicated   levels at or below 113.5
                                                      by Clostridium spp.     g/ton. Withdraw 5 days
                                                      or other organisms      before slaughter for use
                                                      susceptible to          levels above 113.5 g/ton.
                                                      bacitracin.             Nicarbazin as provided by
                                                                              No. 066104; bacitracin
                                                                              methylenedisalicylate as
                                                                              provided by No. 054771 in
                                                                              Sec.   510.600(c) of this
                                                                              chapter.
(v) 113.5..................  ......................  Chickens: As an aid in  Feed continuously as sole    058198
                                                      preventing outbreaks    ration from time chicks     060728
                                                      of cecal (Eimeria       are placed on litter
                                                      tenella) and            until past the time when
                                                      intestinal (E.          coccidiosis is ordinarily
                                                      acervulina, E.          a hazard. Do not use as a
                                                      maxima, E. necatrix,    treatment for
                                                      and E. brunetti)        coccidiosis. Do not use
                                                      coccidiosis.            in flushing mashes. Do
                                                                              not feed to laying hens.
                                                                              Withdraw 4 days before
                                                                              slaughter.
(vi) 113.5.................  Bacitracin              Broiler chickens; aid   Feed continuously as sole    060728
                              methylenedisalicylate   in preventing           ration from time chicks
                              , 30.                   outbreaks of cecal      are placed on litter
                                                      (Eimeria tenella) and   until past the time when
                                                      intestinal (E.          coccidiosis is ordinarily
                                                      acervulina, E.          a hazard. Do not use as a
                                                      maxima, E. necatrix,    treatment for
                                                      and E. brunetti)        coccidiosis. Do not use
                                                      coccidiosis, and for    in flushing mashes. Do
                                                      increased rate of       not feed to laying hens.
                                                      weight gain and         Withdraw 4 days before
                                                      improved feed           slaughter. Nicarbazin as
                                                      efficiency.             provided by No. 066104;
                                                                              bacitracin
                                                                              methylenedisalicylate as
                                                                              provided by No. 054771 in
                                                                              Sec.   510.600(c) of this
                                                                              chapter.
(vii) 113.5................  Bacitracin zinc, 4 to   Broiler chickens; aid   For broiler chickens only.   054771
                              50.                     in preventing           Feed continuously as sole   066104
                                                      outbreaks of cecal      ration from time chicks
                                                      (Eimeria tenella) and   are placed on litter
                                                      intestinal (E.          until past the time when
                                                      acervulina, E.          coccidiosis is ordinarily
                                                      maxima, E. necatrix,    a hazard. Do not use in
                                                      and E. brunetti)        flushing mashes. Do not
                                                      coccidiosis, and for    feed to laying hens.
                                                      increased rate of       Withdraw 4 days before
                                                      weight gain and         slaughter. Nicarbazin as
                                                      improved feed           provided by No. 066104,
                                                      efficiency.             bacitracin zinc as
                                                                              provided by No. 054771 in
                                                                              Sec.   510.600(c) of this
                                                                              chapter.
(viii) 113.5...............  Bambermycins, 1 to 2..  Broiler chickens: As    Feed continuously as sole    016592
                                                      an aid in preventing    ration from time chicks
                                                      outbreaks of cecal      are placed on litter
                                                      (Eimeria tenella) and   until past the time when
                                                      intestinal (E.          coccidiosis is ordinarily
                                                      acervulina, E.          a hazard; do not use as a
                                                      maxima, E. necatrix,    treatment for
                                                      and E. brunetti)        coccidiosis. Do not use
                                                      coccidiosis, and for    in flushing mashes. Do
                                                      increased rate of       not feed to laying hens.
                                                      weight gain and         Withdraw 4 days before
                                                      improved feed           slaughter. Nicarbazin as
                                                      efficiency.             provided by No. 066104;
                                                                              bambermycins as provided
                                                                              by No. 016592 in Sec.
                                                                              510.600(c) of this
                                                                              chapter.
----------------------------------------------------------------------------------------------------------------

    (2) [Reserved]

Sec.  558.485   [Amended]

0
26. In Sec.  558.485, in paragraph (e)(2), in the ``Limitations''
column, remove ``Not for use in horses intended for food.'' and in its
place add ``Do not use in horses intended for human consumption.''

    Dated: December 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27238 Filed 12-17-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 118 (Thursday, June 19, 2014)]
[Notices]
[Pages 35206-35208]
[FR Doc No: 2014-14313]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72387; File No. SR-CHX-2014-09]

Self-Regulatory Organizations; Chicago Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Remove Obsolete Rule Language and To Permit the Exchange To Enable or
Disable Trade Adjustment Functionalities Pursuant to Notice

June 13, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 \2\ thereunder, notice is hereby given
that on June 10, 2014, the Chicago Stock Exchange, Inc. (``CHX'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    CHX proposes to amend Article 1, Rule 1 (Definitions); Article 20,
Rule 4 (Eligible Orders); Article 20, Rule 9 (Cancellation or
Adjustment of Bona Fide Error Trades); Article 20, Rule 9A (Error
Correction Transactions); and Article 20, Rule 11 (Cancellation or
Adjustment of Stock Leg Trades) to remove obsolete rule language and to
permit the Exchange to enable or disable trade adjustment
functionalities pursuant to notice. The Exchange has designated this
proposal as non-controversial and provided the Commission with the
notice required by Rule 19b-4(f)(6)(iii) under the Act.\3\
---------------------------------------------------------------------------

    \3\ 17 CFR 240.19b-4(f)(6)(iii).
---------------------------------------------------------------------------

    The text of this proposed rule change is available on the
Exchange's Web site at (www.chx.com) and in 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 CHX included statements
concerning the purpose of and basis for the proposed rule changes and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The CHX has prepared summaries, set forth in sections A,
B and C below, of the most significant aspects of such statements.

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

1. Purpose
    The Exchange proposes to amend Article 1, Rule 1 (Definitions);
Article 20, Rule 4 (Eligible Orders); Article 20, Rule 9 (Cancellation
or Adjustment of Bona Fide Error Trades); Article 20,

Rule 9A (Error Correction Transactions); and Article 20, Rule 11
(Cancellation or Adjustment of Stock Leg Trades) to remove obsolete
rule language and to permit the Exchange to enable or disable trade
adjustment functionalities pursuant to notice. Aside from these
amendments, the Exchange does not propose to modify the operation of
any of the foregoing rules.
Background
    On October 31, 2013, the Securities and Exchange Commission
(``Commission'') approved a proposed rule change to amend Article 20,
Rule 9 to adopt new and modified rules for the cancellation and
adjustment of trades based on Bona Fide Error; to adopt Article 20,
Rule 9A to detail the Exchange's then-current requirements for Error
Correction Transactions; and to adopt Article 20, Rule 11 to adopt new
and modified rules for the cancellation or adjustment of the stock leg
trade of Stock-Option or Stock-Future orders.\4\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 70791 (October 31,
2013), 78 FR 66791 (November 6, 2013) (Order Approving a Proposed
Rule Change to Adopt Standards for the Cancellation or Adjustment of
Bona Fide Error Trades, the Submission of Error Correction
Transactions, and the Cancellation or Adjustment of Stock Leg Trades
of Stock-Option or Stock-Future Orders).
---------------------------------------------------------------------------

    Subsequently, on November 12, 2013, the Exchange filed a proposed
rule change to, inter alia, adopt an operative date of December 2, 2013
for all changes approved under 34-70791 and to readopt the previous
version of Article 20, Rule 9 (Cancellation of Transactions), so that
it would remain operative through December 1, 2013.\5\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 70894 (November 18,
2013), 78 FR 70085 (November 22, 2013) (SR-CHX-2013-19).
---------------------------------------------------------------------------

Proposed Deletion of Obsolete Rule Language
    Given that the rule amendments approved under 34-70791 are all
currently operative, the Exchange proposes to delete the previous
version of Article 20, Rule 9, as it ceased to be operative as of
December 2, 2013. The Exchange also proposes to delete language under
current Article 1, Rule 1 and Article 20, Rules 9, 9A and 11 that
provide that these rules ``shall be operative as of December 2, 2013,''
as all of these rules are currently operative.
Proposed Amendments to Article 20, Rules 9(b) and 11(c)(3)
    Current Article 20, Rule 9(b) permits a Participant to request an
adjustment of trades made in Bona Fide Error to the extent necessary to
correct Bona Fide Errors.\6\ Moreover, current Article 20, Rule
11(c)(3) permits the Participant that submitted the stock leg trade to
request an adjustment of the stock leg trade, pursuant to one of the
options enumerated under subparagraphs (A)-(C), per Stock-Option or
Stock-Future order.\7\
---------------------------------------------------------------------------

    \6\ CHX Article 1, Rule 1(ii) defines ``Bona Fide Error'' as
follows:
    ``Bona Fide Error'' means:
    (1) The inaccurate conveyance or execution of any term of an
order, including, but not limited to, price, number of shares or
other unit of trading; identification of the security;
identification of the account for which securities are purchased or
sold; lost or otherwise misplaced order tickets; or the execution of
an order on the wrong side of a market;
    (2) the unauthorized or unintended purchase, sale, or allocation
of securities, or the failure to follow specific client
instructions;
    (3) the incorrect entry of data into relevant systems, including
reliance on incorrect cash positions, withdrawals, or securities
positions reflected in an account; or
    (4) a delay, outage, or failure of a communication system used
to transmit market data prices or to facilitate the delivery or
execution of an order.

    \7\ Under CHX Article 20, Rule 11(c)(3), assuming that the other
requirements of Article 20, Rule 11 are met, a Participant may
request to adjust (A) the price of a stock leg trade to maintain the
originally-agreed aggregate cash flow of all components of the
related Stock-Option or Stock-Future order; (B) the quantity of a
stock leg trade to maintain the originally-agreed hedge ratio
between all components of the related Stock-Option or Stock-Future
order; or (C) the quantity of a stock leg trade to maintain the
originally-agreed delta-based hedge ratio of all components of the
related Stock-Option order.
---------------------------------------------------------------------------

    While current Article 20, Rules 9 and 11 provide that Exchange
operations personnel shall decide whether or not the requirements for
trade cancellations or adjustments have been met, the rules do not,
however, explicitly provide that the adjustment functionalities
described therein shall be made available to Participants at the
discretion of the Exchange. The Exchange submits that this discretion
is necessary to provide the Exchange with rule-based authority to
disable certain adjustment functionalities for all Participants when,
for example, the Exchange decides to upgrade tools used to receive and
verify a specific adjustment option, so as to better ensure compliance
with CHX rules and securities laws. If the Exchange deactivates certain
adjustment functionalities pursuant to the proposed rule, the
Participant seeking a trade adjustment would still be permitted to
cancel Bona Fide Error trades pursuant to Article 20, Rule 9(b) and
stock leg trades pursuant to Article 20, Rule 11(b).
    As such, the Exchange now proposes adopt the following language
within current Article 20, Rule 9(b):

    Bona Fide Error trade adjustments shall be available to
Participants at the discretion of the Exchange. Announcements
regarding the availability of Bona Fide Error trade adjustments
shall be made by the Exchange via Information Memorandum and will be
provided in a manner to give reasonable advance notice to its
Participants.

In addition, the Exchange proposes to adopt the similar language within
current Article 20, Rule 11(c)(3):

    The following adjustment options under subparagraphs (A)-(C)
shall be available to Participants at the discretion of the
Exchange. Announcements regarding the availability of the adjustment
options shall be made by the Exchange via Information Memorandum and
will be provided in a manner to give reasonable advance notice to
its Participants.

Both proposed paragraphs are similar to current Article 20, Rule 4(b),
which permits the Exchange to designate which general order types,
modifiers, and related terms listed under Article 1, Rule 2 may be
eligible for entry to and acceptance by the Matching System, with
notice via Regulatory Circular to its market participants.
    Incidentally, the Exchange proposes to amend Article 20, Rule 4(b)
to replace the term ``Regulatory Circular'' with the more accurate
``Information Memorandum'' and replace the term ``market
participants,'' with the more accurate ``Participants,'' which is a
defined term under Article 1, Rule 1(s).
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6(b) of the Act.\8\
Specifically, the proposal is also consistent with Section 6(b)(1) of
the Act,\9\ which requires that an exchange be so organized and have
the capacity to be able to carry out the purposes of 15 U.S.C. 78a et
seq. and to comply, and to enforce compliance by its members and
persons associated with its members, with the provisions of 15 U.S.C.
78a et seq., the rules and regulations thereunder, and the rules of the
exchange. The proposal is also consistent with Section 6(b)(5) of the
Act,\10\ which requires exchange rules to promote just and equitable
principles of trade, remove impediments to, and perfect the mechanism
of, a free and open market and a national market system, and, in
general, protect investors and the public interest.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(1).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed deletion of obsolete rule

language is consistent with Sections 6(b)(1) and 6(b)(5) of the Act
because it promotes clarity of CHX rules by removing unnecessary and/or
redundant language. This will, in turn, provide clear CHX rules for
Participants to follow and the Exchange to enforce.
    The Exchange also believes the proposed amendment to provide the
Exchange with the discretion to enable or disable certain trade
adjustment functionalities will prevent Participants from utilizing
adjustment functionalities that are in the process of being optimized
by Exchange operations personnel (e.g., systems upgrade for verifying
adjustment parameters).\11\ Moreover, the notice requirements will
provide Participants with reasonable notice as to the availability of
such adjustment options. As such, the proposed rule change is also
consistent with the requirements of Sections 6(b)(1) and 6(b)(5) of the
Act.
---------------------------------------------------------------------------

    \11\ Any substantive changes to adjustment options will only be
effected through a Rule 19b-4 filing.
---------------------------------------------------------------------------

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

    The Exchange believes the proposal is consistent with Section
6(b)(8) of the Act \12\ in that it does not impose any burden on
competition that is not necessary or appropriate in furtherance of the
purposes of the Act. The proposed rule change either deletes obsolete
non-substantive language or provides the Exchange with operational
flexibility concerning the availability of certain trade adjustment
functionalities that are already codified under CHX rules.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78(f)(b)(8) [sic].
---------------------------------------------------------------------------

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

    No written comments were either solicited or received.

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

    Pursuant to Section 19(b)(3)(A) of the Act \13\ and Rule 19b-4(f)
thereunder,\14\ CHX has designated this proposal as one that effects a
change that (A) does not significantly affect the protection of
investors or the public interest; (B) does not impose any significant
burden on competition; and (C) by its terms, does not become operative
for 30 days after the date of the filing, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest. The Exchange has also provided the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.\15\ The
Exchange notes that this proposal does not propose any new policies or
provisions that are unique or unproven, as all changes proposed herein
correct non-substantive taxonomy issues and set an operative date for
functionality that has already been approved by the Commission. Given
these factors, this rule filing qualifies for immediate effectiveness
as a ``non-controversial'' rule change under paragraph (f)(6) of Rule
19b-4.\16\
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A).
    \14\ 17 CFR 240.19b-4(f)(6).
    \15\ 17 CFR 240.19b-4(f)(6)(iii).
    \16\ Id.
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposal 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 No. SR-CHX-2014-09 on the subject line.

Paper Comments

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

All submissions should refer to File No. SR-CHX-2014-09. 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 changes between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the CHX. 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 No. SR-CHX-2014-09 and should be
submitted on or before July 10, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

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

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-14313 Filed 6-18-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 192 (Wednesday, October 3, 2012)]
[Notices]
[Page 60423]
[FR Doc No: 2012-24355]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[ Project No 13482-001]

FFP Project 71 LLC; Notice of Preliminary Permit Application
Accepted For Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

    On September 4, 2012, FFP Project 71, LLC filed an application for
a preliminary permit, pursuant to section 4(f) of the Federal Power Act
(FPA), proposing to study the feasibility of a hydropower project
located on the Mississippi River, near Chatham, in Washington County,
Mississippi and Chicot County, Arkansas. The sole purpose of a
preliminary permit, if issued, is to grant the permit holder priority
to file a license application during the permit term. A preliminary
permit does not authorize the permit holder to perform any land-
disturbing activities or otherwise enter upon lands or waters owned by
others without the owners' express permission.
    The proposed Matthews Bend hydrokinetic project would consist of
the following: (1) Up to 3,524 SmarTurbine generating units installed
in arrays on the bottom of the river; (2) the total capacity of the
installation would be up to 140,960 kilowatts; (3) flexible cables
would convey each arrays power to a metering station; and (4) a
transmission line would interconnect with the power grid. The proposed
project would have an average annual generation of 320,575,000
kilowatt-hours (kWh), which would be sold to a local utility.
    Applicant Contact: Ramya Swaminathan, Free Flow Power Corporation,
239 Causeway Street, Boston, MA 02114; phone<PHONE_NUMBER>.
    FERC Contact: Michael Spencer,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13482) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: September 27, 2012.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2012-24355 Filed 10-2-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 226 (Monday, November 29, 2021)]
[Notices]
[Pages 67727-67729]
[FR Doc No: 2021-25897]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2006-0040]

SGS North America, Inc.: Grant of Expansion of Recognition and
Modification to the NRTL Program's List of Appropriate Test Standards

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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

SUMMARY: In this notice, OSHA announces the final decision to expand
the scope of recognition for SGS North America, Inc., as a Nationally
Recognized Testing Laboratory (NRTL). Additionally, OSHA announces the
addition of one test standard to the NRTL Program's List of Appropriate
Test Standards.

DATES: The expansion of the scope of recognition becomes effective on
November 29, 2021.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor; telephone:<PHONE_NUMBER>;
email: [email protected].
    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor; telephone:
(202) 693-2110; email: [email protected]. OSHA's web page includes
information about the NRTL Program (see http://www.osha.gov/dts/otpca/nrtl/index.html).

SUPPLEMENTARY INFORMATION:

I. Notice of Final Decision

    OSHA hereby gives notice of the expansion of the scope of
recognition of SGS of North America, Inc. (SGS), as a NRTL. SGS's
expansion covers the addition of five test standards to its scope of
recognition. Additionally, OSHA announces the addition of one test
standard to the NRTL Program's List of Appropriate Test Standards.
    OSHA recognition of a NRTL signifies that the organization meets
the requirements specified by 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within the
scope of recognition

and is not a delegation or grant of government authority. As a result
of recognition, employers may use products properly approved by the
NRTL to meet OSHA standards that require testing and certification of
the products.
    The agency processes applications by a NRTL for initial
recognition, or for expansion or renewal of this recognition, following
requirements in Appendix A to 29 CFR 1910.7. This appendix requires
that the agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides a preliminary finding and, in the second
notice, the agency provides the final decision on the application.
These notices set forth the NRTL's scope of recognition or
modifications of that scope. OSHA maintains an informational web page
for each NRTL that details the scope of recognition. These pages are
available from the agency's website at http://www.osha.gov/dts/otpca/nrtl/index.html.
    SGS submitted an application on February 5, 2020 (OSHA-2006-0040-
0067), to expand its scope of recognition to include the addition of
five test standards. OSHA staff performed a detailed analysis of the
application packet and reviewed other pertinent information. OSHA did
not perform any on-site reviews in relation to this application.
    OSHA published the preliminary notice announcing SGS's expansion
application and proposed addition to the NRTL Program's List of
Appropriate Test Standards in the Federal Register on August 24, 2021
(86 FR 47336). The agency requested comments by September 8, 2021, but
it received no comments in response to the preliminary notice. OSHA now
is proceeding with this final notice to grant expansion of SGS's scope
of recognition.
    To obtain or review copies of all public documents pertaining to
SGS's applications, go to http://www.regulations.gov or contact the
Docket Office at<PHONE_NUMBER> (TTY<PHONE_NUMBER>) for assistance in
locating docket submissions. Docket No. OSHA-2006-0040 contains all
materials in the record concerning SGS's recognition.

II. Final Decision and Order

    OSHA staff examined SGS's expansion application, the capability to
meet the requirements of the test standards, and other pertinent
information. Based on a review of this evidence, OSHA finds that SGS
meets the requirements of 29 CFR 1910.7 for expansion of the
recognition, subject to the specified limitation and conditions listed.
OSHA, therefore, is proceeding with this final notice to grant
expansion of SGS's scope of recognition. OSHA limits the expansion of
SGS's scope of recognition to testing and certification of products for
demonstration of conformance to the test standards listed in Table 1.

 Table 1--List of Appropriate Test Standards for Inclusion in SGS's NRTL
                          Scope of Recognition
------------------------------------------------------------------------
             Test standard                     Test standard title
------------------------------------------------------------------------
UL 355.................................  Cord Reels.
UL 1576................................  Flashlights and Lanterns.
UL 1977................................  Component Connectors for Use in
                                          Data, Signal, Control and
                                          Power Applications.
UL 8753................................  Field-Replaceable Light
                                          Emitting Diode (LED) Light
                                          Engines.
UL 61800-5-1...........................  Adjustable Speed Electrical
                                          Power Drive Systems--Part 5-1:
                                          Safety Requirements--
                                          Electrical, Thermal and
                                          Energy.
------------------------------------------------------------------------

    In this notice, OSHA also announces the addition of one new test
standard to the NRTL Program's List of Appropriate Test Standards.
Table 2, below, lists the test standard that is new to the NRTL
Program. OSHA has determined that this test standard is an appropriate
test standard and will include it in the NRTL Program's List of
Appropriate Test Standards.

   Table 2--Test Standard OSHA is Adding to the NRTL Program's List of
                       Appropriate Test Standards
------------------------------------------------------------------------
            Test standard                     Test standard title
------------------------------------------------------------------------
UL 1576.............................  Flashlights and Lanterns.
------------------------------------------------------------------------

    OSHA's recognition of any NRTL for a particular test standard is
limited to equipment or materials for which OSHA standards require
third-party testing and certification before using them in the
workplace. Consequently, if a test standard also covers any products
for which OSHA does not require such testing and certification, a
NRTL's scope of recognition does not include these products.
    The American National Standards Institute (ANSI) may approve the
test standard listed above as an American National Standard. However,
for convenience, OSHA may use the designation of the standards-
developing organization for the standard as opposed to the ANSI
designation. Under the NRTL Program's policy (see OSHA Instruction CPL
01-00-004, Chapter 2, Section VIII), only standards determined to be
appropriate test standards may be approved for NRTL recognition. Any
NRTL recognized for an appropriate test standard may use either the
proprietary version of the test standard or the ANSI version of that
standard. Contact ANSI to determine whether a test standard is
currently ANSI-approved.

A. Conditions

    In addition to those conditions already required by 29 CFR 1910.7,
SGS must abide by the following conditions of the recognition:
    1. SGS must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in the operations as a NRTL, and provide details of the
change(s);
    2. SGS must meet all the terms of the recognition and comply with
all OSHA policies pertaining to this recognition; and
    3. SGS must continue to meet the requirements for recognition,
including all previously published conditions on SGS's scope of
recognition, in all areas for which it has recognition.
    Pursuant to the authority in 29 CFR 1910.7, OSHA hereby expands the
scope of recognition of SGS, subject to the limitation and conditions
specified above. OSHA also adds one new test standard to the NRTL
Program's List of Appropriate Test Standards.

III. Authority and Signature

    James S. Frederick, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, authorized the preparation of this
notice. Accordingly, the agency is issuing this notice pursuant to 29
U.S.C. 657(g)(2), Secretary of Labor's Order No. 8-2020

(85 FR 58393, September 18, 2020), and 29 CFR 1910.7.

    Signed at Washington, DC, on November 22, 2021.
James S. Frederick,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2021-25897 Filed 11-26-21; 8:45 am]
BILLING CODE 4510-26-P