64738 Federal Register / Vol. 83, No. 242 / Tuesday, December 18, 2018 / Rules and Regulations 

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, 240–402–5689, 

george.haibel@fda.hhs.gov. 

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/Officeof

Foods/CVM/CVMFOIAElectronic

ReadingRoom/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/Approved

AnimalDrugProducts/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, 

Inc., 1555 Bayshore 

Hwy., Suite 200, 

Burlingame, CA 

94010.

MIRATAZ (mirtazapine 

transdermal ointment).

Cats .......... Original approval for the management of 

weight loss in cats.

FOI Summary. 

May 15, 2018 ....... 141–501 Boehringer Ingelheim 

Vetmedica, Inc., 

2621 North Belt 

Hwy., St. Joseph, 

MO 64506–2002.

SEMINTRA 

(telmisartan oral solution).

Cats .......... Original approval for the control of systemic 

hypertension in cats.

FOI Summary. 

May 25, 2018 ....... 141–063 Intervet, Inc., 2 Giralda 

Farms, Madison, NJ 

07940.

NUFLOR (florfenicol), 

Injectable Solution.

Cattle ........ Supplemental approval to provide human 

food safety information for the use of the 

inactive ingredient n-methyl-2-pyrrolidone 

(NMP).

FOI Summary. 

May 31, 2018 ....... 141–495 Elanco US Inc., 2500 

Innovation Way, 

Greenfield, IN 46140.

INTEPRITY 

(avilamycin) and 

BIO-COX 

(salinomycin sodium) Type C medicated feeds.

Chickens .. Original approval for the prevention of mortality caused by necrotic enteritis and for 

the prevention of coccidiosis in broiler 

chickens.

FOI Summary. 

June 6, 2018 ........ 141–342 Jurox Pty. Ltd., 85 

Gardiner Rd., Rutherford, NSW 2320, 

Australia.

ALFAXAN 

(alfaxalone), 

Injectable Solution.

Dogs and 

cats.

Supplemental approval providing for addition 

of preservatives and use of a multidose vial.

FOI Summary. 

June 14, 2018 ...... 098–379 Merial, Inc., 3239 Satellite Blvd., Bldg. 

500, Duluth, GA 

30096–4640.

CYSTORELIN 

(gonadorelin), 

Injectable Solution.

Cattle ........ Supplemental approval for use with 

cloprostenol sodium to synchronize estrous 

cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows 

and beef cows.

FOI Summary, EA/ 

FONSI.1

1The 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 

§ 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 § 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 


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Federal Register / Vol. 83, No. 242 / Tuesday, December 18, 2018 / Rules and Regulations 64739 

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 

■ 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. 

■ 2. In § 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: 

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address Drug labeler 

code 

*******

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

* * * * * * * 

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

Mumbai, 400070, India .................................................................................................................................................................... 065085 

* * * * * * * 

(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. 

* * * * * * * 


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64740 Federal Register / Vol. 83, No. 242 / Tuesday, December 18, 2018 / Rules and Regulations 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 3. The authority citation for part 520 

continues to read as follows: 

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

§ 520.88f [Amended] 

■ 4. In § 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’’. 

§ 520.816 [Amended] 

■ 5. In § 520.816, in paragraph (b), 

remove ‘‘050604’’ and in its place add 

‘‘054771’’. 

■ 6. Add § 520.2335 to read as follows: 

§ 520.2335 Telmisartan. 

(a) Specifications. Each milliliter of 

solution contains 10 milligrams (mg) 

telmisartan. 

(b) Sponsor. See No. 000010 in 

§ 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 

■ 7. The authority citation for part 522 

continues to read as follows: 

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

■ 8. Revise § 522.1077 to read as 

follows: 

§ 522.1077 Gonadorelin. 

(a) Specifications. Each milliliter (mL) 

of solution contains: 

(1) 43 micrograms (mg) of gonadorelin 

as gonadorelin acetate; 

(2) 100 mg of gonadorelin as 

gonadorelin acetate; 

(3) 43 mg of gonadorelin as 

gonadorelin diacetate tetrahydrate; or 

(4) 50 mg of gonadorelin as 

gonadorelin hydrochloride. 

(b) Sponsors. See sponsor numbers in 

§ 510.600(c) of this chapter. 

(1) No. 000061 for use of the 43-mg/ 

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-mg/ 

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-mg/ 

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-mg/ 

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-mg/ 

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 § 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 § 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 § 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 mg 

gonadorelin (No. 000061) or 100 mg 

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 mg gonadorelin by 

intramuscular or intravenous injection. 

(iii) For the treatment of ovarian 

follicular cysts in cattle: Administer 100 

mg 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 mg 

gonadorelin by intramuscular injection, 

followed 6 to 8 days later by 500 mg 

cloprostenol by intramuscular injection, 

followed 30 to 72 hours later by 86 mg 

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 mg 

gonadorelin by intramuscular injection, 

followed 6 to 8 days later by 500 mg 

cloprostenol by intramuscular injection, 

followed 30 to 72 hours later by 100 mg 

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 mg 

gonadorelin diacetate tetrahydrate by 

intramuscular injection, followed 6 to 8 

days later by 500 mg cloprostenol by 

intramuscular injection, followed 30 to 

72 hours later by 100 mg 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 mg 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 mg 

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 

■ 9. The authority citation for part 524 

continues to read as follows: 

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

■ 10. In § 524.957, revise paragraph (a) 

to read as follows: 

§ 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. 

* * * * * 

■ 11. Add § 524.1448 to read as follows: 

§ 524.1448 Mirtazapine transdermal 

ointment. 

(a) Specifications. Each gram of 

ointment contains 20 milligrams (mg) 

mirtazapine. 

(b) Sponsor. See No. 086078 in 

§ 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 

■ 12. The authority citation for part 556 

continues to read as follows: 


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Federal Register / Vol. 83, No. 242 / Tuesday, December 18, 2018 / Rules and Regulations 64741 

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

■ 13. In § 556.428, add paragraph (c) to 

read as follows: 

§ 556.428 Narasin. 

* * * * * 

(c) Related conditions of use. See 

§§ 558.363 and 558.364 of this chapter. 

■ 14. Revise § 556.445 to read as 

follows: 

§ 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 

§§ 558.364 and 558.366 of this chapter. 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 15. The authority citation for part 558 

continues to read as follows: 

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

360ccc–1, 371. 

■ 16. In § 558.68, revise paragraph 

(e)(1)(ii) and add paragraph (e)(1)(v) to 

read as follows: 

§ 558.68 Avilamycin. 

* * * * * 

(e) * * * 

(1) * * * 

Avilamycin in 

grams/ton 

Combination 

in grams/ton 

Indications for use Limitations Sponsor 

*******

(ii) 13.6 to 40.9 ...... Monensin, 

90 to 110.

Broiler chickens: For the prevention 

of mortality caused by necrotic enteritis associated with Clostridium 

perfringens; and as an aid in the 

prevention of coccidiosis caused 

by Eimeria necatrix, E. tenella, E. 

acervulina, E. brunetti, E. mivati, 

and E. maxima.

Feed as the sole ration for 21 consecutive days. To assure responsible 

antimicrobial drug use in broiler chickens, treatment administration must 

begin on or before 10 days of age. See § 558.355(d) of this chapter. 

Monensin as provided by No. 058198 in § 510.600(c) of this chapter.

058198 

* * * * * * * 

(v) 13.6 to 40.9 ...... Salinomycin 

sodium, 

40 to 60.

Broiler chickens: For the prevention 

of mortality caused by necrotic enteritis associated with Clostridium 

perfringens; and for the prevention 

of coccidiosis caused by Eimeria 

tenella, E. necatrix, E. acervulina, 

E. maxima, E. brunetti, and E. 

mivati.

Feed as the sole ration for 21 consecutive days. Feed to chickens that are 

at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with Clostridium perfringens. Not approved for use 

with pellet binders. To assure responsible antimicrobial drug use in 

broiler chickens, treatment administration must begin on or before 10 

days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Avilamycin has not been demonstrated to be effective in 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 

§ 510.600(c) of this chapter.

058198 

* * * * * 

■ 17. In § 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: 

§ 558.76 Bacitracin methylendisalicylate. 

* * * * * 

(e) * * * 

(2) * * * 

(xiii) Narasin and nicarbazin as in 

§ 558.364. 

(xiv) Nicarbazin as in § 558.366. 

* * * * * 

■ 18. In § 558.78, add paragraph 

(d)(3)(vii) to read as follows: 

§ 558.78 Bacitracin zinc. 

* * * * * 

(d) * * * 

(3) * * * 

(vii) Nicarbazin as in § 558.366. 

* * * * * 

■ 19. In § 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: 

§ 558.95 Bambermycins. 

* * * * * 

(d) * * * 

(5) * * * 

(viii) Narasin as in § 558.363. 

(ix) Narasin and nicarbazin as in 

§ 558.364. 

* * * * * 

§ 558.128 [Amended] 

■ 20. In § 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 § 510.600(c) of this 

chapter.’’ 

§ 558.325 [Amended] 

■ 21. In § 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’’. 

■ 22. Revise § 558.363 to read as 

follows: 

§ 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 

§ 510.600(c) of this chapter. 

(c) Tolerances. See § 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— 


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64742 Federal Register / Vol. 83, No. 242 / Tuesday, December 18, 2018 / Rules and Regulations 

Narasin 

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

(i) 54 to 90 .............. ............................................ Broiler chickens: For prevention of coccidiosis caused by Eimeria necatrix, E. 

tenella, E. acervulina, E. brunetti, E. 

mivati, and E. maxima.

For broiler chickens only. Feed continuously as sole 

ration. Do not allow adult turkeys, horses, or other 

equines access to narasin formulations. Ingestion of 

narasin by these species has been fatal.

058198 

(ii) 54 to 72 ............. Bacitracin 

methylenedisalicylate, 10 

to 50.

Broiler chickens: For prevention of coccidiosis caused by Eimeria necatrix, E. 

tenella, E. acervulina, E. brunetti, E. 

mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency.

For broiler chickens only. Feed continuously as sole 

ration. Do not feed to laying hens. Do not allow 

adult turkeys, horses, or other equines access to 

narasin formulations. Ingestion of narasin by these 

species has been fatal. Bacitracin 

methylenedisalicylate as provided by No. 054771 in 

§ 510.600(c) of this chapter.

054771 

(iii) 54 to 72 ............ Bacitracin zinc, 4 to 50 ...... Broiler chickens: For prevention of coccidiosis caused by Eimeria necatrix, E. 

tenella, E. acervulina, E. brunetti, E. 

mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency.

For broiler chickens only. Feed continuously as sole 

ration. Do not allow adult turkeys, horses, or other 

equines access to narasin formulations. Ingestion of 

narasin by these species has been fatal. Bacitracin 

zinc as provided by No. 054771 in § 510.600(c) of 

this chapter.

054771 

(iv) 54 to 72 ............ Bambermycins, 1 to 2 ....... Broiler chickens: For prevention of coccidiosis caused by Eimeria necatrix, E. 

tenella, E. acervulina, E. brunetti, E. 

mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency.

For broiler chickens only. Feed continuously as sole 

ration. Do not allow adult turkeys, horses, or other 

equines access to narasin formulations. Ingestion of 

narasin by these species has been fatal. 

Bambermycins as provided by No. 016592 in 

§ 510.600(c) of this chapter.

016592 

(2) Swine— 

Narasin 

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

(i) 13.6 to 27.2 ........ ............................................ Growing-finishing swine: For increased 

rate of weight gain when fed for at 

least 4 weeks.

Feed continuously for at least 4 weeks to swine during 

the growing-finishing period as the 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.

058198 

(ii) 18.1 to 27.2 ....... ............................................ Growing-finishing swine: For increased 

rate of weight gain and improved feed 

efficiency when fed for at least 4 

weeks.

Feed continuously for at least 4 weeks to swine during 

the growing-finishing period as the 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.

058198 

(3) Narasin single-ingredient Type A 

medicated articles may also be used in 

combination with: 

(i) Avilamycin as in § 558.68. 

(ii) [Reserved] 

§ 558.364 [Redesignated as § 558.365] 

■ 23. Redesignate § 558.364 as 

§ 558.365. 

■ 24. Add new § 558.364 to read as 

follows: 

§ 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 

§ 510.600(c) of this chapter. 

(c) Tolerances. See §§ 556.428 and 

556.445 of this chapter. 

(d) Conditions of use. It is used as 

follows: 

(1) Chickens— 


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Federal Register / Vol. 83, No. 242 / Tuesday, December 18, 2018 / Rules and Regulations 64743 

Narasin and 

nicarbazin 

grams/ton 

Combination in grams/ton Indications for use Limitations Sponsor 

(i) 27 to 45 of each 

drug.

............................................ Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. 

necatrix, E. acervulina, E. maxima, E. 

brunetti, and E. mivati.

Feed continuously as sole ration. Do not feed to laying 

hens. Withdraw 5 days before slaughter. Do not 

allow adult turkeys, horses, or other equines access 

to narasin formulations. Ingestion of narasin by 

these species has been fatal.

058198 

(ii) 27 to 45 of each 

drug.

Bacitracin 

methylenedisalicylate, 4 

to 50.

Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. 

necatrix, E. acervulina, E. maxima, E. 

brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency.

Feed continuously as sole ration. Do not feed to laying 

hens. Withdraw 5 days before slaughter. 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 

§ 510.600(c) of this chapter.

058198 

(iii) 27 to 45 of each 

drug.

Bacitracin 

methylenedisalicylate, 50.

Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. 

necatrix, E. acervulina, E. maxima, E. 

brunetti, and E. mivati, and as an aid 

in the prevention of necrotic enteritis 

caused or complicated by Clostridium 

spp. or other organisms susceptible to 

bacitracin.

Feed continuously as sole ration. Withdraw 5 days before slaughter. Do not feed to laying hens. 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 

§ 510.600(c) of this chapter.

054771 

(iv) 27 to 45 of each 

drug.

Bacitracin 

methylenedisalicylate, 

100 to 200.

Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. 

necatrix, E. acervulina, E. maxima, E. 

brunetti, and E. mivati, and as an aid 

in the control of necrotic enteritis 

caused or complicated by Clostridium 

spp. or other organisms susceptible to 

bacitracin.

To control necrotic enteritis, start medication at first 

clinical signs of disease; vary dosage based on the 

severity of infection; administer continuously for 5 to 

7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ton). Do not 

feed to laying hens. Withdraw 5 days before slaughter. 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 § 510.600(c) of this chapter.

054771 

(v) 27 to 45 of each 

drug.

Bambermycins, 1 to 2 ....... Broiler chickens: As an aid in preventing 

outbreaks of cecal (Eimeria tenella) 

and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis, and for increased rate of 

weight gain and improved feed efficiency.

Feed continuously as sole ration from time chicks are 

placed on litter until past the time when coccidiosis 

is ordinarily a hazard. Do not use as a treatment for 

coccidiosis. Do not feed to laying hens. Withdraw 5 

days before slaughter. Do not allow turkeys, horses, 

or other equines access to formulations containing 

narasin. Ingestion of narasin by these species has 

been fatal. Bambermycins as provided by No. 

016592 in § 510.600(c) of this chapter.

058198 

(2) Narasin and nicarbazin fixed-ratio, 

combination drug Type A medicated 

articles may also be used in 

combination with: 

(i) Avilamycin as in § 558.68. 

(ii) [Reserved] 

■ 25. Revise § 558.366 to read as 

follows: 

§ 558.366 Nicarbazin. 

(a) Specifications. Type A medicated 

articles containing 25 percent 

nicarbazin. 

(b) Sponsors. See Nos. 058198, 

060728, and 066104 in § 510.600(c) of 

this chapter for use as in paragraph (d) 

of this section. 

(c) Related tolerances. See § 556.445 

of this chapter. 

(d) Conditions of use. It is used as 

follows: 

(1) Chickens— 

Nicarbazin in 

grams per ton 

Combination 

in grams per ton Indications for use Limitations Sponsor 

(i) 90.8 to 181.6 .... .............................................. Broiler chickens: As an aid in preventing 

outbreaks of cecal (Eimeria tenella) and 

intestinal (E. acervulina, E. maxima, E. 

necatrix, and E. brunetti) coccidiosis.

Feed continuously as sole ration from time chicks are 

placed on litter until past the time when coccidiosis is 

ordinarily a hazard. Do not use as a treatment for outbreaks of coccidiosis. Do not 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.

066104 

(ii) 90.8 to 181.6 .... Bacitracin 

methylenedisalicylate, 4 to 

50.

Broiler chickens: As an aid in preventing 

outbreaks of cecal (Eimeria tenella) and 

intestinal (E. acervulina, E. maxima, E. 

necatrix, and E. brunetti) coccidiosis, 

and for increased rate of weight gain 

and improved feed efficiency.

Feed continuously as sole ration from time chicks are 

placed on litter until past the time when coccidiosis is 

ordinarily a hazard. Do not use as a treatment for outbreaks of coccidiosis. Do not 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. Nicarbazin as provided by No. 066104; 

bacitracin methylenedisalicylate as provided by No. 

054771 in § 510.600(c) of this chapter.

054771 


amozie on DSK3GDR082PROD with RULES
64744 Federal Register / Vol. 83, No. 242 / Tuesday, December 18, 2018 / Rules and Regulations 

Nicarbazin in 

grams per ton 

Combination 

in grams per ton Indications for use Limitations Sponsor 

(iii) 90.8 to 181.6 ... Bacitracin 

methylenedisalicylate, 30.

Broiler chickens; As an aid in preventing 

outbreaks of cecal (Eimeria tenella) and 

intestinal (E. acervulina, E. maxima, E. 

necatrix, and E. brunetti) coccidiosis, 

and for increased rate of weight gain 

and improved feed efficiency.

Feed continuously as sole ration from time chicks are 

placed on litter until past the time when coccidiosis is 

ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not 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. Nicarbazin 

as provided by No. 066104; bacitracin 

methylenedisalicylate as provided by No. 054771 in 

§ 510.600(c) of this chapter.

066104 

(iv) 90.8 to 181.6 ... Bacitracin 

methylenedisalicylate 50.

Broiler chickens: As an aid in preventing 

outbreaks of cecal (Eimeria tenella) and 

intestinal (E. acervulina, E. maxima, E. 

necatrix, and E. brunetti) coccidiosis, 

and as an aid in the prevention of necrotic enteritis caused or complicated by 

Clostridium spp. or other organisms susceptible to bacitracin.

Feed continuously as sole ration from time chicks are 

placed on litter until past the time when coccidiosis is 

ordinarily a hazard. Do not use as a treatment for outbreaks of coccidiosis. Do not 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. Nicarbazin as provided by No. 066104; 

bacitracin methylenedisalicylate as provided by No. 

054771 in § 510.600(c) of this chapter.

054771 

(v) 113.5 ................ .............................................. Chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. 

necatrix, and E. brunetti) coccidiosis.

Feed continuously as sole ration from time chicks are 

placed on litter until past the time when coccidiosis is 

ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not use in flushing mashes. Do not feed to 

laying hens. Withdraw 4 days before slaughter.

058198 

060728 

(vi) 113.5 ............... Bacitracin 

methylenedisalicylate, 30.

Broiler chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. 

necatrix, and E. brunetti) coccidiosis, 

and for increased rate of weight gain 

and improved feed efficiency.

Feed continuously as sole ration from time chicks are 

placed on litter until past the time when coccidiosis is 

ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not use in flushing mashes. Do not feed to 

laying hens. Withdraw 4 days before slaughter. 

Nicarbazin as provided by No. 066104; bacitracin 

methylenedisalicylate as provided by No. 054771 in 

§ 510.600(c) of this chapter.

060728 

(vii) 113.5 .............. Bacitracin zinc, 4 to 50 ........ Broiler chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. 

necatrix, and E. brunetti) coccidiosis, 

and for increased rate of weight gain 

and improved feed efficiency.

For broiler chickens only. Feed continuously as sole ration from time chicks are placed on litter until past the 

time when coccidiosis is ordinarily a hazard. Do not 

use in flushing mashes. Do not feed to laying hens. 

Withdraw 4 days before slaughter. Nicarbazin as provided by No. 066104, bacitracin zinc as provided by 

No. 054771 in § 510.600(c) of this chapter.

054771 

066104 

(viii) 113.5 ............. Bambermycins, 1 to 2 ......... Broiler chickens: As an aid in preventing 

outbreaks of cecal (Eimeria tenella) and 

intestinal (E. acervulina, E. maxima, E. 

necatrix, and E. brunetti) coccidiosis, 

and for increased rate of weight gain 

and improved feed efficiency.

Feed continuously as sole ration from time chicks are 

placed on litter until past the time when coccidiosis is 

ordinarily a hazard; do not use as a treatment for coccidiosis. Do not use in flushing mashes. Do not feed to 

laying hens. Withdraw 4 days before slaughter. 

Nicarbazin as provided by No. 066104; bambermycins 

as provided by No. 016592 in § 510.600(c) of this 

chapter.

016592 

(2) [Reserved] 

§ 558.485 [Amended] 

■ 26. In § 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 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2018–0864] 

RIN 1625–AA00 

Safety Zone; Tumon Bay, Tumon, GU 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone for 

navigable waters within a 190 yard 

radius of a fireworks barge located in 

Tumon Bay for the New Year’s Eve 

Fireworks display. The Coast Guard 

believes this safety zone is necessary to 

protect the public from potential 

hazards created by the fireworks display 

fallout. This safety zone will prohibit 

persons and vessels from being in the 

safety zone unless authorized by the 

Captain of the Port Guam (COTP). 

DATES: This rule is effective from 9 p.m. 

on December 31, 2018 through 1 a.m. on 

January 1, 2019. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2018– 

0864 in the ‘‘SEARCH’’ box and click 

‘‘SEARCH.’’ Click on Open Docket 

Folder on the line associated with this 

rule. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email Chief Todd Wheeler, Waterways 

Management, U.S. Coast Guard; 

telephone 671–355–4566, email 

wwmguam@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

DHS Department of Homeland Security 


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