[Federal Register Volume 84, Number 49 (Wednesday, March 13, 2019)]
[Rules and Regulations]
[Pages 8967-8982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04226]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 526, 529, 556, and 558
[Docket No. FDA-2018-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications; Changes of
Sponsorship
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during July, August, and September 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 readability of the regulations.
DATES: This rule is effective March 13, 2019, except for amendatory
instruction 25 to 21 CFR 520.2041, which is effective March 25, 2019.
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,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Approval Actions
FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during July, August, and September 2018,
as listed
[[Page 8968]]
in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents may be seen in the
office of the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday. Persons with access
to the internet may obtain these documents at the CVM FOIA Electronic
Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing
exclusivity and patent information may be accessed in FDA's
publication, Approved Animal Drug Products Online (Green Book) at:
https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
Table 1--Original and Supplemental NADAs and ANADAs Approved During July, August, and September 2018
--------------------------------------------------------------------------------------------------------------------------------------------------------
Approval date File No. Sponsor Product name Species Effect of the action Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 2, 2018............. 200-624 Modern Veterinary REVERTIDINE Dogs................. Original approval as FOI Summary.
Therapeutics, LLC, (atipamezole a generic copy of
14343 SW 119th Ave., hydrochloride) NADA 141-033.
Miami, FL 33186. Sterile Injectable
Solution.
July 6, 2018............. 200-495 Norbrook Laboratories, ENROFLOX 100 Swine................ Supplemental approval FOI Summary.
Ltd., Station Works, (enrofloxacin) of additional
Newry BT35 6JP, Injectable Solution. indications and
Northern Ireland. routes of
administration.
July 11, 2018............ 138-952 Elanco US Inc., 2500 MAXIBAN 72 (narasin Chickens............. Supplemental approval FOI Summary EA/
Innovation Way, and nicarbazin) Type of a revised tissue FONSI.\1\
Greenfield, IN 46140. A medicated article. residue tolerance
for nicarbazin and
withdrawal period
for narasin and
nicarbazin Type C
medicated feeds.
July 13, 2018............ 200-484 Huvepharma EOOD, 5th TYLOVET (tylosin Swine and cattle..... Supplemental approval FOI Summary.
Floor, 3A Nikolay phosphate) Type A of a 40 g/lb
Haytov Str., 1113 medicated articles. strength Type A
Sophia, Bulgaria. medicated article.
July 13, 2018............ 141-406 Merial, Inc., 3239 NEXGARD (afoxolaner) Dogs................. Supplemental approval FOI Summary.
Satellite Blvd., Chewable Tablets. for the prevention
Bldg. 500, Duluth, GA of Borrelia
30096-4640. burgdorferi
infections as a
direct result of
killing Ixodes
scapularis vector
ticks.
July 30, 2018............ 200-608 Piedmont Animal BAYTRIL Dogs................. Original approval as FOI Summary.
Health, 204 Muirs (enrofloxacin) Soft a generic copy of
Chapel Rd., Suite Chewable Tablets. NADA 140-441.
200, Greensboro, NC
27410.
August 3, 2018........... 141-461 Aratana Therapeutics, NOCITA (bupivacaine Cats................. Supplemental approval FOI Summary.
Inc., 11400 Tomahawk liposome injectable to provide for use
Creek Pkwy., Leawood, suspension). as a peripheral
KS 66211. nerve block to
provide regional
postoperative
analgesia following
onychectomy in cats.
August 8, 2018........... 141-439 Elanco US Inc., 2500 INTEPRITY Chickens............. Supplemental approval FOI Summary EA/
Innovation Way, (avilamycin) Type A of a revised age FONSI.\1\
Greenfield, IN 46140. medicated article. restriction caution
statement from 10
days to 18 days for
use of avilamycin
Type C medicated
broiler feeds.
August 9, 2018........... 200-630 Aurora Pharmaceutical, COCCIAID (amprolium) Chickens and turkeys. Original approval as FOI Summary.
LLC, 1196 Highway 3 9.6% Oral Solution. a generic copy of
South, Northfield, MN NADA 013-149.
55057-3009.
August 10, 2018.......... 141-488 Zoetis Inc., 333 Lincomycin and Chickens............. Original approval for FOI Summary.
Portage St., lasalocid Type C use of LINCOMIX
Kalamazoo, MI 49007. medicated feeds. (lincomycin) and
AVATEC (lasalocid)
Type A medicated
articles in the
manufacture of Type
C medicated broiler
chicken feeds for
the control of
necrotic enteritis
caused or
complicated by
Clostridium spp. or
other organisms
susceptible to
lincomycin, and for
the prevention of
coccidiosis caused
by Eimeria tenella,
E. necatrix, E.
acervulina, E.
brunetti, E. mivati,
and E maxima.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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. Change of Sponsorship
Piedmont Animal Health, 204 Muirs Chapel Rd., Suite 200,
Greensboro, NC 27410 has informed FDA that it has transferred ownership
of, and all rights and interest in, newly approved ANADA 200-608 for
BAYTRIL (enrofloxacin) Soft Chewable Tablets to Bayer HealthCare LLC,
Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201.
Following this change of sponsorship, Piedmont Animal Health is no
longer the sponsor of an approved application. Accordingly, it will not
be added to the
[[Page 8969]]
list of sponsors of approved applications in Sec. 510.600(c) (21 CFR
510.600(c)).
Cronus Pharma LLC, 2 Tower Center Blvd., Suite 1101, East
Brunswick, NJ 08816 has informed FDA that it has transferred ownership
of, and all rights and interest in, the following applications to
Cronus Pharma Specialities India Private Ltd., Sy No: 99/1, M/s GMR
Hyderabad Aviation SEZ L, Mamidipalli Village, Shamshabad Mandal,
Ranga, Hyderabad, Telangana 501218, India:
------------------------------------------------------------------------
File No. Product name
------------------------------------------------------------------------
011-531...................... DIZAN (dithiazanine iodide) Tablets.
011-674...................... DIZAN (dithiazanine iodide) Powder.
012-469...................... DIZAN (dithiazanine iodide) Suspension
with Piperazine.
031-512...................... ATGARD (dichlorvos) Swine Wormer.
033-803...................... TASK (dichlorvos) Dog Anthelmintic.
035-918...................... EQUIGARD (dichlorvos).
039-483...................... BIO-TAL (thiamylal sodium).
040-848...................... ATGARD C (dichlorvos) Swine Wormer.
043-606...................... ATGARD V (dichlorvos) Swine Wormer.
045-143...................... OXIJECT (oxytetracycline hydrochloride).
047-278...................... BIO-MYCIN (oxytetracycline
hydrochloride).
047-712...................... BIZOLIN-100 (phenylbutazone).
048-010...................... ANAPLEX (dichlorophene and toluene)
Capsules.
048-237...................... EQUIGEL (dichlorvos).
048-271...................... TASK (dichlorvos) Tablets.
049-032...................... ATGARD C (dichlorvos) Premix.
055-002...................... TEVCOCIN (chloramphenicol).
065-461...................... ANACETIN (chloramphenicol) Tablets.
065-481...................... Chlortetracycline Calf Scour Boluses.
065-486...................... CTC Bisulfate (chlortetracycline
bisulfate) Soluble Powder.
065-491...................... MEDICHOL (chloramphenicol) Tablets.
092-837...................... NEMACIDE (diethylcarbamazine citrate)
Oral Syrup.
093-516...................... BIZOLIN (phenylbutazone) Injection 20%.
094-170...................... Phenylbutazone Tablets, U.S.P. 100 mg.
097-452...................... OXYJECT 100 (oxytetracycline
hydrochloride).
098-569...................... MEDACIDE-SDM (sulfadimethoxine) Injection
10%.
099-618...................... BIZOLIN (phenylbutazone) 1-gram.
108-963...................... MEDAMYCIN (oxytetracycline
hydrochloride).
117-689...................... NEUROSYN (primidone) Tablets.
123-815...................... Dexamethasone Sodium Phosphate Injection.
125-797...................... Nitrofurazone Dressing.
126-236...................... Nitrofurazone Soluble Powder.
126-676...................... D & T (dichlorophene and toluene) Worm
Capsules.
127-627...................... NEMACIDE-C (diethylcarbamazine citrate).
128-069...................... NEMACIDE (diethylcarbamazine citrate)
Chewable Tablets.
132-028...................... ANESTATAL (thiamylal sodium).
135-771...................... Methylprednisolene Tablets.
136-212...................... Methylprednisolone Acetate Injection.
137-310...................... Gentamicin Sulfate Injectable Solution.
138-869...................... Triamcinolone Acetonide Suspension.
140-442...................... Xylazine Hydrochloride Injection.
141-245...................... TRIBUTAME (chloroquine phosphate,
embutramid, lidocaine) Euthanasia
Solution.
200-023...................... Gentamicin Sulfate Solution 100 mg/mL.
200-029...................... Ketamine Hydrochloride Injection.
200-165...................... SDM Sulfadimethoxine Concentrated
Solution 12.5%.
200-178...................... Amikacin Sulfate Injection.
200-193...................... Clindamycin Hydrochloride Oral Liquid.
200-248...................... Pyrantel Pamoate Suspension.
200-265...................... Praziquantel Tablets.
200-287...................... GBC (gentamicin sulfate, betamethasone
valerate, clotrimazole) Ointment.
200-297...................... Ivermectin Chewable Tablets.
200-298...................... Clindamycin Hydrochloride Capsules.
200-365...................... ROBINUL (glycopyrrolate) Injection.
200-382...................... Furosemide Syrup 1%.
------------------------------------------------------------------------
Following this change of sponsorship, Cronus Pharma LLC is no
longer the sponsor of an approved application. Accordingly, it will be
removed from the list of sponsors of approved applications in Sec.
510.600(c). As a new sponsor of approved applications, Cronus Pharma
Specialities India Private Ltd. will be added to Sec. 510.600(c);
however, as the drug labeler code was not changed, no further
amendments are necessary.
Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24,
Ireland has informed FDA that it has transferred ownership of, and all
rights and interest in, the following applications to Bimeda Animal
Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin
18, Ireland:
[[Page 8970]]
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
010-092....... GALLIMYCIN-100P (erythromycin 558.248.
thiocyanate) Type A Medicated
Article.
010-346....... COMBUTHAL (pentobarbital sodium 522.2444b.
and thiopental sodium) Powder.
012-123....... GALLIMYCIN-100 (erythromycin ) 522.820.
Injectable.
035-157....... GALLIMYCIN PFC (erythromycin 520.823.
phosphate) Powder.
035-455....... GALLIMYCIN-36 (erythromycin) Dry 526.820.
Cow Intramammary Infusion.
035-456....... GALLIMYCIN-36 (erythromycin) 526.820.
Sterile Intramammary Infusion.
038-661....... SPECTOGARD (spectinomycin) Water 520.2123b.
Soluble Powder.
044-756....... BUTATRON (phenylbutazone) Tablets 520.1720a.
046-780....... PHEN-BUTA (phenylbutazone) Vet 522.1720.
Injection.
049-187....... PHEN-BUTA (phenylbutazone) Vet 520.1720a.
Tablets.
055-059....... VICETRON (chloramphenicol) 520.390a.
Tablets.
065-383....... UNIBIOTIC (penicillin G procaine) 526.1696a.
Intramammary Infusion.
065-505....... PRO-PEN-G (penicillin G procaine) 522.1696b.
Injectable Suspension.
065-506....... COMBI-PEN-48 (penicillin G 522.1696a.
benzathine and penicillin G
procaine) Injectable Suspension.
092-150....... PURINA (pyrantel tartrate) Horse 520.2046.
& Colt Wormer Pellets.
093-515....... SPECTAM (spectinomycin) Tablets.. 520.2123a.
095-218....... DEXIUM (dexamethasone) Tablets... 520.540b.
096-671....... PHEN-BUTA-Vet (phenylbutazone) 522.1720.
Injection.
096-672....... PHEN-BUTA (phenylbutazone) Vet 520.1720a.
Tablets.
098-288....... PREDNIS-A-Vet (prednisolone 522.1883.
sodium phosphate) Injection.
099-169....... Oxytocin Injection............... 522.1680.
099-604....... DEX-A-VET (dexamethasone) 522.540.
Injection.
099-605....... DEX-A-VET (dexamethasone) 522.540.
Injection.
099-606....... DEXAMETH-A-Vet (dexamethasone ) 522.540.
Injection.
099-607....... DEXAMETH-A-Vet (dexamethasone) 522.540.
Injection.
101-690....... ERYTHRO-100 (erythromycin) 522.820.
Injection.
107-506....... CARBAM (diethylcarbamazine 520.622a.
citrate) Tablets.
109-305....... Oxytocin Injection............... 522.1680.
118-032....... PALATABS (diethylcarbamazine 520.622a.
citrate) Tablets.
118-550....... FUROS-A-Vet (furosemide)......... 522.1010.
118-979....... BUTATRON (phenylbutazone) Gel.... 520.1720d.
119-141....... TRANQUAZINE (promazine 522.1962.
hydrochloride) Injection.
120-615....... SUSTAIN III (sulfamethazine) 520.2260b.
Bolus.
122-447....... FURA-SEPTIN (Nitrofurazone) 524.1580a.
Soluble Dressing.
124-241....... PVL Oxytocin Injection........... 522.1680.
126-504....... Nitrofurazone Ointment........... 524.1580a.
130-136....... Oxytocin Injection............... 522.1680.
138-405....... Pyrilamine Maleate Injection..... 522.2063.
140-582....... Oxytetracycline Hydrochloride 522.1662a.
Injection.
140-583....... ACTH (adrenocorticotropic 522.480.
hormone) Gel.
141-420....... TILDREN (tiludronate disodium) 522.2473.
Powder for Injection.
200-050....... NEOMED (neomycin sulfate) Soluble 520.1484.
Powder.
200-069....... FERTELIN (gonadorelin diacetate 522.1077.
tetrahydrate).
200-103....... PENAQUA Sol-G (penicillin G 520.1696b.
potassium, USP) Soluble Powder.
200-115....... GENTAMEX 100 (gentamicicn 529.1044a.
sulfate).
200-117....... OXYSHOT-LA (oxytetracycline) 522.1660a.
Injectable Solution.
200-144....... TETROXY HCA-280 (oxytetracycline 520.1660d.
hydrochloride) Soluble Powder.
200-146....... TETROXY 25 (oxytetracycline 520.1660d.
hydrochloride) Soluble Powder.
200-176....... PRAZITECH (praziquantel) 522.1870.
Injection.
200-247....... TETROXY 343 (oxytetracycline 520.1660d.
hydrochloride) Soluble Powder.
200-253....... PROSTAMATE (dinoprost 522.690.
tromethamine) Injectable
Solution.
200-312....... DEXIUM (dexamethasone) Injection. 522.540.
200-313....... LEVAMED (levamisole 520.1242a.
hydrochloride) Soluble Powder.
200-317....... DEXIUM-SP (dexamethasone sodium 522.540.
phosphate) Injection.
200-318....... BIMECTIN (ivermectin) Pour-On.... 524.1193.
200-326....... BIMECTIN (ivermectin) Paste...... 520.1192.
200-328....... Oxytocin Injection............... 522.1680.
200-350....... EXODUS (pyrantel pamoate) Paste.. 520.2044.
200-364....... SPECTOGARD SCOUR-CHEK 520.2123c.
(spectinomycin dihydrochloride
pentahydrate) Oral Solution.
200-368....... LINCOMED 100 (lincomycin 522.1260.
hydrochloride) Injectable
Solution.
200-374....... TETRAMED 324 HCA (tetracycline 520.2345d.
hydrochloride) Soluble Powder.
200-376....... SULFAMED-G (sulfadimethoxine) 520.2220a.
Soluble Powder.
200-377....... LINXMED-SP (lincomycin 520.1263c.
hydrochloride) Soluble Powder.
200-380....... SPECLINX-50 (lincomycin 520.1265.
hydrochloride monohydrate and
spectinomycin dihydrochloride
pentahydrate) Soluble Powder.
200-386....... LEVAMED (levamisole 520.1242a.
hydrochloride) Soluble Drench
Powder.
200-387....... FLUNAZINE (flunixin meglumine) 522.970.
Injection.
200-391....... Griseofulvin Powder.............. 520.1100.
200-434....... SMZ-Med 454 (sodium 520.2261b.
sulfamethazine) Soluble Powder.
200-447....... BIMECTIN (ivermectin) Injection 522.1192.
for Cattle and Swine.
200-455....... BILOVET (tylosin tartrate) 520.2640.
Soluble Powder.
200-460....... TETROXY (oxytetracycline 529.1660.
hydrochloride) Aquatic.
200-464....... AMPROMED (amprolium) For Cattle.. 520.100.
[[Page 8971]]
200-468....... GENTAMED-P (gentamicin sulfate) 522.1044.
for Poultry Injection.
200-481....... OVAMED (altrenogest) Solution.... 520.48.
200-482....... AMPROMED (amprolium) for Calves.. 520.100.
200-488....... AMPROMED P (amprolium) for 520.100.
Poultry.
200-489....... FLUNAZINE-S (flunixin meglumine) 522.970.
Injection.
200-494....... GENTAMED (gentamicin sulfate) 520.1044c.
Soluble Powder.
200-496....... AMPROMED P (amprolium) for 520.100.
Poultry.
200-501....... Praziquantel Injection........... 522.1870.
200-508....... BILOVET (tylosin) Injectable 522.2640.
Solution.
200-523....... SULFAMED (sulfadimethoxine) 522.2220.
Injection.
200-529....... XYLAMED (xylazine) Injection..... 522.2662.
200-538....... CLINDAMED (clindamycin) Oral 520.447.
Drops.
200-581....... FLUNAZINE (flunixin meglumine) 520.970.
Paste.
------------------------------------------------------------------------
Following this change of sponsorship, Cross Vetpharm Group Ltd. is
no longer the sponsor of an approved application. Accordingly, it will
be removed from the list of sponsors of approved applications in Sec.
510.600(c) (21 CFR 510.600(c)). As a new sponsor of approved
applications, Bimeda Animal Health Ltd. will be added to Sec.
510.600(c) and the regulations amended to reflect this action. As
provided in the regulatory text of this document, the animal drug
regulations are amended to reflect these changes of sponsorship.
III. Withdrawals of Approval
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140, has
requested that FDA withdraw approval of NADA 140-939 for use of
RUMENSIN (monensin) and TYLAN (tylosin phosphate) Type A medicated
articles in the manufacture of combination drug Type C medicated cattle
feeds because the product is no longer manufactured or marketed.
Also, Sergeant's Pet Care Products, Inc., 10077 S 134th St., Omaha,
NE 68138 has requested that FDA withdraw approval of ANADA 200-600 for
WORMX (pyrantel pamoate) Flavored Tablets because the product is no
longer manufactured or marketed.
Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADA 140-939 and ANADA 200-600, and all supplements
and amendments thereto, is withdrawn, effective March 25, 2019. As
provided in the regulatory text of this document, the animal drug
regulations are amended to reflect these actions.
IV. Technical Amendments
In addition, we are reformatting the regulations to present the
approved conditions of use of halofuginone, monensin, and salinomycin
in tabular format in the respective named sections of 21 CFR part 558.
This action is being taken to improve the readability of the
regulations.
V. 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) because it
is a ``rule of particular applicability'' under 5 U.S.C. 804(3)(A).
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive
Order 12866, which defines a rule as ``an agency statement of general
applicability and future effect, which the agency intends to have the
force and effect of law, that is designed to implement, interpret, or
prescribe law or policy or to describe the procedure or practice
requirements of an agency.''
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, 526, and 529
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, 526, 529, 556, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for part 510 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), remove the
entries for ``Cronus Pharma LLC'' and ``Cross Vetpharm Group Ltd.'' and
alphabetically add entries for ``Bimeda Animal Health Ltd.'' and
``Cronus Pharma Specialities India Private Ltd.''; and in the table in
paragraph (c)(2), numerically add an entry for ``061133'', remove the
entry for ``061623'', and revise the entry for ``069043''.
The additions and revisions 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
------------------------------------------------------------------------
* * * * * * *
Bimeda Animal Health Ltd., 1B The Herbert Building, The 061133
Park, Carrickmines, Dublin 18, Ireland.................
[[Page 8972]]
* * * * * * *
Cronus Pharma Specialities India Private Ltd., Sy No: 99/ 069043
1, M/s GMR Hyderabad Aviation SEZ L, Mamidipalli
Village, Shamshabad Mandal, Ranga, Hyderabad,
Telangana, 501218, India...............................
* * * * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * * * *
061133.................. Bimeda Animal Health Ltd., 1B The Herbert
Building, The Park, Carrickmines, Dublin 18,
Ireland.
* * * * * * *
069043.................. Cronus Pharma Specialities India Private Ltd.,
Sy No: 99/1, M/s GMR Hyderabad Aviation SEZ
L, Mamidipalli Village, Shamshabad Mandal,
Ranga, Hyderabad, Telangana, 501218, India.
* * * * * * *
------------------------------------------------------------------------
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.
0
4. In Sec. 520.43, revise paragraph (c)(2) to read as follows:
Sec. 520.43 Afoxolaner.
* * * * *
(c) * * *
(2) Indications for use. Kills adult fleas; for the treatment and
prevention of flea infestations (Ctenocephalides felis); for the
treatment and control of black-legged tick (Ixodes scapularis),
American dog tick (Dermacentor variabilis), lone star tick (Amblyomma
americanum), and brown dog tick (Rhipicephalus sanguineus) infestations
in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body
weight or greater, for 1 month; and for the prevention of Borrelia
burgdorferi infections as a direct result of killing Ixodes scapularis
vector ticks.
* * * * *
Sec. 520.48 [Amended]
0
5. In Sec. 520.48, in paragraph (b), remove ``061623'' and in its
place add ``061133''.
Sec. 520.100 [Amended]
0
6. In Sec. 520.100, in paragraph (b)(1), remove ``No. 016592'' and in
its place add ``Nos. 016592 and 061133''; and in paragraph (b)(2),
remove ``No. 066104'' and in its place add ``Nos. 051072 and 066104''.
Sec. 520.390a [Amended]
0
7. In Sec. 520.390a, in paragraph (b)(2)(i), remove ``061623'' and in
its place add ``061133''.
Sec. 520.447 [Amended]
0
8. In Sec. 520.447, in paragraph (b), remove ``061623'' and in its
place add ``061133''.
Sec. 520.540b [Amended]
0
9. In Sec. 520.540b, in paragraph (b)(2), remove ``061623'' and in its
place add ``061133''.
Sec. 520.622a [Amended]
0
10. In Sec. 520.622a, in paragraph (a)(3), remove ``061623'' and in
its place add ``061133''.
0
11. In Sec. 520.812, revise paragraphs (a) and (b)(1) and (2) and add
paragraph (b)(3) to read as follows:
Sec. 520.812 Enrofloxacin.
(a) Specifications--(1) Each tablet contains:
(i) 2.7, 68.0, or 136.0 milligrams (mg) enrofloxacin; or
(ii) 22.7, 68.0, 136.0, or 272 mg enrofloxacin.
(2) Each soft chewable tablet contains 22.7, 68.0, or 136.0 mg
enrofloxacin.
(b) * * *
(1) Nos. 000859 and 026637 for use of product described in
paragraph (a)(1)(i) of this section.
(2) No. 058198 for use of product described in paragraph (a)(1)(ii)
of this section.
(3) No. 000859 for use of product described in paragraph (a)(2) of
this section.
* * * * *
Sec. 520.823 [Amended]
0
12. In Sec. 520.823, in paragraph (b), remove ``061623'' and in its
place add ``061133''.
Sec. 520.970 [Amended]
0
13. In Sec. 520.970, in paragraph (b)(2), remove ``061623'' and in its
place add ``061133''.
Sec. 520.1044c [Amended]
0
14. In Sec. 520.1044c, in paragraph (b)(2), remove ``061623'' and in
its place add ``061133''.
Sec. 520.1100 [Amended]
0
15. In Sec. 520.1100, in paragraph (b)(2), remove ``061623'' and in
its place add ``061133''.
Sec. 520.1192 [Amended]
0
16. In Sec. 520.1192, in paragraph (b)(2), remove ``061623'' and in
its place add ``061133''.
Sec. 520.1242a [Amended]
0
17. In Sec. 520.1242a, in paragraph (b)(4), remove ``059130'' and in
its place add ``061133''.
Sec. 520.1263c [Amended]
0
18. In Sec. 520.1263c, in paragraph (b)(2), remove ``061623'' and in
its place add ``061133''.
Sec. 520.1265 [Amended]
0
19. In Sec. 520.1265, in paragraph (b)(2), remove ``061623'' and in
its place add ``061133''.
[[Page 8973]]
Sec. 520.1484 [Amended]
0
20. In Sec. 520.1484, in paragraph (b)(2), remove ``061623'' and in
its place add ``061133''.
Sec. 520.1660d [Amended]
0
21. In Sec. 520.1660d, in paragraphs (b)(5), (b)(7), (d)(1)(ii)(A)(3),
(d)(1)(ii)(B)(3), (d)(1)(ii)(C)(3), and (d)(1)(iii)(C), remove
``061623'' and in its place add ``061133''.
Sec. 520.1696b [Amended]
0
22. In Sec. 520.1696b, in paragraph (b), remove ``061623'' and in its
place add ``061133''.
Sec. 520.1720a [Amended]
0
23. In Sec. 520.1720a, in paragraph (b)(3), remove ``061623'' and in
its place add ``061133''.
Sec. 520.1720d [Amended]
0
24. In Sec. 520.1720d, in paragraph (b), remove ``061623'' and in its
place add ``061133''.
Sec. 520.2041 [Amended]
0
25. Effective March 25, 2019, in Sec. 520.2041, in paragraph (b),
remove ``066916, 017135,'' and add in its place ``017135''.
Sec. 520.2044 [Amended]
0
26. In Sec. 520.2044, in paragraph (b)(3), remove ``061623'' and in
its place add ``061133''.
Sec. 520.2046 [Amended]
0
27. In Sec. 520.2046, in paragraph (b)(2), remove ``061623'' and in
its place add ``061133''.
Sec. 520.2123a [Amended]
0
28. In Sec. 520.2123a, in paragraph (b), remove ``061623'' and in its
place add ``061133''.
Sec. 520.2123b [Amended]
0
29. In Sec. 520.2123b, in paragraph (b), remove ``061623'' and in its
place add ``061133''.
Sec. 520.2123c [Amended]
0
30. In Sec. 520.2123c, in paragraph (b), remove ``061623'' and in its
place add ``061133''.
Sec. 520.2220a [Amended]
0
31. In Sec. 520.2220a, in paragraph (b)(2), remove ``061623'' and in
its place add ``061133''.
Sec. 520.2260b [Amended]
0
32. In Sec. 520.2260b, in paragraphs (c)(1) and (e)(1), remove
``061623'' and in its place add ``061133''.
Sec. 520.2261b [Amended]
0
33. In Sec. 520.2261b, in paragraph (b), remove ``061623'' and in its
place add ``061133''.
Sec. 520.2345d [Amended]
0
34. In Sec. 520.2345d, in paragraph (b)(4), remove ``061623'' and in
its place add ``061133''; and in paragraphs (d)(1)(iii) and
(d)(2)(iii), remove ``059130, and 061623'' and in its place add ``and
061133''.
Sec. 520.2640 [Amended]
0
35. In Sec. 520.2640, in paragraph (b)(2), remove ``061623'' and in
its place add ``061133''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
36. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.147 [Amended]
0
37. In Sec. 522.147, in paragraph (b), remove ``No. 052483'' and in
its place add ``Nos. 015914 and 052483''.
0
38. In Sec. 522.224, revise paragraph (c) to read as follows:
Sec. 522.224 Bupivacaine.
* * * * *
(c) Conditions of use--(1) Dogs--(i) Amount. Administer 5.3 mg/kg
(0.4 mL/kg) by infiltration injection into the tissue layers at the
time of incisional closure.
(ii) Indications for use. For single-dose infiltration into the
surgical site to provide local postoperative analgesia for cranial
cruciate ligament surgery.
(2) Cats--(i) Amount. Administer 5.3 mg/kg per forelimb (0.4 mL/kg
per forelimb), for a total dose of 10.6 mg/kg/cat, as a 4-point nerve
block prior to onychectomy.
(ii) Indications for use. For use as a peripheral nerve block to
provide regional postoperative analgesia following onychectomy.
Sec. 522.480 [Amended]
0
39. In Sec. 522.480, in paragraph (b)(1), remove ``061623'' and in its
place add ``061133''.
Sec. 522.540 [Amended]
0
40. In Sec. 522.540, in paragraphs (a)(2)(i), (b)(2), and (c)(2),
remove ``061623'' and in its place add ``061133''.
Sec. 522.690 [Amended]
0
41. In Sec. 522.690, in paragraph (b)(3), remove ``061623'' and in its
place add ``061133''.
0
42. In Sec. 522.812, revise paragraph (b)(1); remove paragraph (b)(2)
and redesignate paragraph (b)(3) as paragraph (b)(2); remove paragraph
(e)(3)(i)(B) and redesignate paragraph (e)(3)(i)(C) as (e)(3)(i)(B);
and revise paragraphs (e)(3)(i)(A) and newly designated (e)(3)(i)(B).
The revisions read as follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(b) * * *
(1) Nos. 000859 and 055529 for use of product described in
paragraph (a)(1) of this section as in paragraph (e)(1) of this
section, and use of product described in paragraph (a)(2) of this
section as in paragraphs (e)(2) and (3) of this section.
* * * * *
(e) * * *
(3) * * *
(i) * * *
(A) Administer 7.5 mg/kg of body weight once, by intramuscular or
subcutaneous injection behind the ear, for the treatment and control of
swine respiratory disease (SRD) associated with Actinobacillus
pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis,
Streptococcus suis, Bordetella bronchiseptica, and Mycoplasma
hyopneumoniae.
(B) Administer 7.5 mg/kg of body weight once, by intramuscular or
subcutaneous injection behind the ear, for the control of
colibacillosis in groups or pens of weaned pigs where colibacillosis
associated with Escherichia coli has been diagnosed.
* * * * *
Sec. 522.820 [Amended]
0
43. In Sec. 522.820, in paragraph (b), remove ``061623'' and in its
place add ``061133''.
Sec. 522.970 [Amended]
0
44. In Sec. 522.970, in paragraph (b)(1), remove ``061623'' and in its
place add ``061133''.
Sec. 522.1010 [Amended]
0
45. In Sec. 522.1010, in paragraph (b)(2), remove ``061623'' and in
its place add ``061133''.
Sec. 522.1044 [Amended]
0
46. In Sec. 522.1044, in paragraph (b)(4), remove ``061623'' and in
its place add ``061133''.
Sec. 522.1077 [Amended]
0
47. In Sec. 522.1077, in paragraph (b)(3), remove ``061623'' and in
its place add ``061133''.
[[Page 8974]]
Sec. 522.1192 [Amended]
0
48. In Sec. 522.1192, in paragraph (b)(2), remove ``061623'' and in
its place add ``061133''.
Sec. 522.1260 [Amended]
0
49. In Sec. 522.1260, in paragraph (b)(4), remove ``061623'' and in
its place add ``061133''.
Sec. 522.1660a [Amended]
0
50. In Sec. 522.1660a, in paragraph (b), remove ``061623'' and in its
place add ``061133''.
Sec. 522.1662a [Amended]
0
51. In Sec. 522.1662a, in paragraph (k)(2), remove ``061623'' and in
its place add ``061133''.
Sec. 522.1680 [Amended]
0
52. In Sec. 522.1680, in paragraph (b), remove ``061623'' and in its
place add ``061133''.
Sec. 522.1696a [Amended]
0
53. In Sec. 522.1696a, in paragraphs (b)(1), (b)(2), and (d)(2)(iii),
remove ``061623'' and in its place add ``061133''; and in paragraphs
(d)(1)(ii) and (d)(2)(ii), remove ``Conditions of use'' and in its
place add ``Indications for use''.
Sec. 522.1696b [Amended]
0
54. In Sec. 522.1696b, in paragraphs (b)(2), (d)(2)(i)(A), and
(d)(2)(iii)(A), remove ``061623'' and in its place add ``061133''.
Sec. 522.1720 [Amended]
0
55. In Sec. 522.1720, in paragraph (b)(2), remove ``061623'' and in
its place add ``061133''.
Sec. 522.1870 [Amended]
0
56. In Sec. 522.1870, in paragraph (b), remove ``061623'' and in its
place add ``061133''.
Sec. 522.1883 [Amended]
0
57. In Sec. 522.1883, in paragraph (b), remove ``061623'' and in its
place add ``061133''.
Sec. 522.1962 [Amended]
0
58. In Sec. 522.1962, in paragraph (b)(2), remove ``061623'' and in
its place add ``061133''.
Sec. 522.2063 [Amended]
0
59. In Sec. 522.2063, in paragraph (b)(2), remove ``061623'' and in
its place add ``061133''.
Sec. 522.2220 [Amended]
0
60. In Sec. 522.2220, in paragraph (b)(3), remove ``061623'' and in
its place add ``061133''.
Sec. 522.2444b [Amended]
0
61. In Sec. 522.2444b, in paragraph (b), remove ``061623'' and in its
place add ``061133''.
Sec. 522.2473 [Amended]
0
62. In Sec. 522.2473, in paragraph (b), remove ``061623'' and in its
place add ``061133''.
Sec. 522.2640 [Amended]
0
63. In Sec. 522.2640, in paragraph (b)(2), remove ``061623'' and in
its place add ``061133''.
Sec. 522.2662 [Amended]
0
64. In Sec. 522.2662, in paragraph (b)(2), remove ``061623'' and in
its place add ``061133''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
65. The authority citation for part 524 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1193 [Amended]
0
66. In Sec. 524.1193, in paragraph (b)(1), remove ``061623'' and in
its place add ``061133''.
Sec. 524.1580a [Amended]
0
67. In Sec. 524.1580a, in paragraph (b)(1), remove ``061623'' and in
its place add ``061133''.
PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
0
68. The authority citation for part 526 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 526.820 [Amended]
0
69. In Sec. 526.820, in paragraph (b), remove ``061623'' and in its
place add ``061133''.
Sec. 526.1696a [Amended]
0
70. In Sec. 526.1696a, in paragraph (c), remove ``061623'' and in its
place add ``061133''.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
71. The authority citation for part 529 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 529.1044a [Amended]
0
72. In Sec. 529.1044a, in paragraph (b), remove ``061623'' and in its
place add ``061133''.
Sec. 529.1660 [Amended]
0
73. In Sec. 529.1660, in paragraphs (b)(1) and (2), remove ``061623''
and in its place add ``061133''.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
74. The authority citation for part 556 continues to read as follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
75. In Sec. 556.445, add paragraph (a) and revise paragraph (b) to
read as follows:
Sec. 556.445 Nicarbazin.
(a) Acceptable daily intake (ADI). The ADI for total residues of
nicarbazin (4,4'-dinitrocarbanilide and 2-hydroxy-4,6-
dimethylpyrimidine) is 200 micrograms per kilogram of body weight per
day.
(b) Tolerance. The tolerance for 4,4'-dinitrocarbanilide (marker
residue) is:
(1) Chickens--Liver (target tissue): 52 ppm.
(2) [Reserved]
* * * * *
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
76. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
77. In Sec. 558.4, in paragraph (d), in the ``Category I'' table,
revise the entry for ``Narasin'', alphabetically add an entry for
``Nicarbazin (granular)'' followed immediately by an indented entry for
``Narasin''; and in the ``Category II'' table, remove the entry for
``Narasin'' and revise the entry for ``Nicarbazin (powder)''.
The revisions and addition read as follows:
Sec. 558.4 Requirement of a medicated feed mill license.
* * * * *
(d) * * *
[[Page 8975]]
Category I
----------------------------------------------------------------------------------------------------------------
Assay limits Assay limits
Drug percent \1\ Type Type B maximum (200x) percent \1\ Type
A B/C \2\
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Narasin.................................... 90-110 9.0 g/lb (1.98%)............. 85-115/75-125.
Nicarbazin (granular)...................... 90-110 9.0 g/lb (1.98%)............. 85-115/75-125.
Narasin.................................... 90-110 9.0 g/lb (1.98%)............. 85-115/75-125.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed.
These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B
medicated feed with lower assay limits to make a Type C medicated feed.
Category II
----------------------------------------------------------------------------------------------------------------
Assay limits Assay limits
Drug percent \1\ Type Type B maximum (100x) percent \1\ Type
A B/C \2\
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Nicarbazin (powder)........................ 90-110 9.08 g/lb (2.00%)............ 85-115/75-125.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed.
These values (ranges) have been assigned to provide for the possibility of dilution of a Type B medicated feed
with lower assay limits to make a Type C medicated feed.
* * * * *
Sec. 558.68 [Amended]
0
78. In Sec. 558.68, in paragraph (e)(1)(i), in the ``Limitations''
column, remove ``10 days of age'' and in its place add ``18 days of
age''.
Sec. 558.128 [Amended]
0
79. In Sec. 558.128, in paragraph (e)(4)(iv), in the row for ``1.'',
in the ``Limitations'' column, remove ``sponsor No. 069254'' and in its
place add ``sponsor Nos. 054771 and 069254''.
Sec. 558.248 [Amended]
0
80. In Sec. 558.248, in paragraph (b), remove ``061623'' and in its
place add ``061133''.
0
81. In Sec. 558.265, revise paragraphs (b) and (d) to read as follows:
Sec. 558.265 Halofuginone.
* * * * *
(b) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter.
* * * * *
(d) Conditions of use. It is used in feed as follows:
(1) Chickens--
----------------------------------------------------------------------------------------------------------------
Combination in
Halofuginone in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 2.72...................... ................. Broiler chickens: For Feed continuously as 016592
the prevention of sole ration. Do not
coccidiosis caused by feed to layers.
Eimeria tenella, E. Withdraw 4 days
necatrix, E. before slaughter.
acervulina, E.
brunetti, E. mivati,
and E. maxima.
(ii) 2.72..................... Bacitracin Broiler chickens: For Feed continuously as 016592
methylenedisalic the prevention of sole ration. Do not
ylate, 10 to 50. coccidiosis caused by feed to layers.
Eimeria tenella, E. Withdraw 5 days
necatrix, E. before slaughter.
acervulina, E.
brunetti, E. mivati,
and E. maxima; for
improved feed
efficiency.
(iii) 2.72.................... Bambermycins, 1 Broiler chickens: For Feed continuously as 016592
to 2. the prevention of sole ration. Do not
coccidiosis caused by feed to layers.
Eimeria tenella, E. Withdraw 5 days
necatrix, E, before slaughter.
acervulina, E.
brunetti, E. mivati,
and E. maxima; for
increased rate of
weight gain and
improved feed
efficiency.
(iv) 2.72..................... ................. Replacement broiler Feed continuously as 016592
breeder chickens and sole ration to
replacement cage replacement cage
laying chickens: For laying chickens
the prevention of until 20 weeks of
coccidiosis caused by age. Feed
Eimeria tenella, E. continuously as sole
necatrix, E. ration to
acervulina, E. replacement broiler
maxima, E. mivati/E. breeder chickens
mitis, and E. until 16 weeks of
brunetti. age. Do not feed to
laying chickens or
water fowl. Withdraw
4 days before
slaughter.
----------------------------------------------------------------------------------------------------------------
[[Page 8976]]
(2) Turkeys--
----------------------------------------------------------------------------------------------------------------
Combination in
Halofuginone in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 1.36 to 2.72.............. ................. Growing turkeys: For Feed continuously as 016592
the prevention of sole ration.
coccidiosis caused by Withdraw 7 days
Eimeria adenoeides, before slaughter. Do
E. meleagrimitis, and not feed to layers
E. gallopavonis. or water fowl.
(ii) 1.36 to 2.72............. Bacitracin Growing turkeys: For Feed continuously as 016592
methylenedisalic the prevention of sole ration.
ylate, 10 to 50. coccidiosis caused by Withdraw 7 days
Eimeria adenoeides, before slaughter. Do
E. meleagrimitis, and not feed to laying
E. gallopavonis, and chickens or water
for increased rate of fowl.
weight gain.
(iii) 1.36 to 2.72............ Bambermycins, 2.. Growing turkeys: For Feed continuously as 016592
the prevention of sole ration.
coccidiosis caused by Withdraw 7 days
Eimeria adenoeides, before slaughter. Do
E. meleagrimitis, and not feed to laying
E. gallopavonis, and chickens or
for increased rate of waterfowl.
weight gain.
----------------------------------------------------------------------------------------------------------------
(3) Halofuginone may also be used in combination with:
(i) Lincomycin as in Sec. 558.325.
(ii) [Reserved]
0
82. In Sec. 558.311, redesignate paragraphs (e)(5)(ii) through (v) as
paragraphs (e)(5)(iii) and (vi), and add new paragraph (e)(5)(ii) to
read as follows:
Sec. 558.311 Lasalocid.
* * * * *
(e) * * *
(5) * * *
(ii) Lincomycin as in Sec. 558.325.
* * * * *
0
83. In Sec. 558.325, add paragraph (e)(1)(vi) to read as follows:
Sec. 558.325 Lincomycin.
* * * * *
(e) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Combination in
Lincomycin grams/ton grams/ton Indications for use Limitations Sponsors
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(vi) 2........................ Lasalocid, 68 to Broiler chickens: For Feed as the sole 054771
113. the control of ration. Type C feed
necrotic enteritis must be used within
caused or complicated 4 weeks of
by Clostridium spp. manufacture. Not for
or other organisms use in laying hens,
susceptible to breeding chickens,
lincomycin, and for or turkeys. Do not
the prevention of allow rabbits,
coccidiosis caused by hamsters, guinea
Eimeria tenella, E. pigs, horses, or
necatrix, E. ruminants access to
acervulina, E. feeds containing
brunetti, E. mivati, lincomycin.
and E maxima. Ingestion by these
species may result
in severe
gastrointestinal
effects. Lasalocid
as provided by No.
054771 in Sec.
510.600 of this
chapter.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
84. In Sec. 558.355, revise paragraph (b), add paragraph (c), and
revise paragraph (f) to read as follows:
Sec. 558.355 Monensin.
* * * * *
(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.420 of this chapter.
* * * * *
(f) Conditions of use. It is used as follows:
(1) Chickens--
----------------------------------------------------------------------------------------------------------------
Combination in
Monensin in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 90 to 110................. ................. Broiler chickens: As Feed continuously as 058198
an aid in the the sole ration. In
prevention of the absence of
coccidiosis caused by coccidiosis, the use
E. necatrix, E. of monensin with no
tenella, E. withdrawal period
acervulina, E. may limit feed
brunetti, E. mivati, intake resulting in
and E. maxima. reduced weight gain.
Do not feed to
laying chickens.
(ii) 90 to 110................ ................. Replacement chickens Feed continuously as 058198
intended for use as the sole ration. Do
cage layers: As an not feed to chickens
aid in the prevention over 16 weeks of
of coccidiosis caused age. Do not feed to
by E. necatrix, E. laying chickens.
tenella, E.
acervulina, E.
brunetti, E. mivati,
and E. maxima.
[[Page 8977]]
(iii) 90 to 110............... Bacitracin Broiler chickens: As Feed continuously as 054771
methylenedisalic an aid in the sole ration. In the
ylate, 4 to 50. prevention of absence of
coccidiosis caused by coccidiosis, the use
E. necatrix, E. of monensin with no
tenella, E. withdrawal period
acervulina, E. may limit feed
brunetti, E. mivati, intake resulting in
and E. maxima, and reduced weight gain.
for improved feed Do not feed to
efficiency. laying chickens.
Bacitracin
methylenedisalicylat
e provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(iv) 90 to 110................ Bacitracin Replacement chickens Feed continuously as 054771
methylenedisalic intended for use as sole ration. Do not
ylate, 4 to 50. cage layers: As an feed to chickens
aid in the prevention over 16 weeks of
of coccidiosis caused age. Do not feed to
by E. necatrix, E. laying chickens.
tenella, E. Monensin sodium
acervulina, E. provided by No.
brunetti, E. mivati, 058198, bacitracin
and E. maxima, and methylenedisalicylat
for increased rate of e provided by No.
weight gain and 054771 in Sec.
improved feed 510.600(c) of this
efficiency. chapter.
(v) 90 to 110................. Bacitracin Broiler chickens: As Feed continuously as 058198
methylenedisalic an aid in the sole ration. In the
ylate, 5 to 25. prevention of absence of
coccidiosis caused by coccidiosis, the use
E. necatrix, E. of monensin with no
tenella, E. withdrawal period
acervulina, E. may limit feed
brunetti, E. mivati, intake resulting in
and E. maxima, and reduced weight gain.
for increased rate of Do not feed to
weight gain and laying chickens.
improved feed Bacitracin
efficiency. methylenedisalicylat
e provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(vi) 90 to 110................ Bacitracin Broiler and Feed continuously as 054771
methylenedisalic replacement chickens sole ration. Do not
ylate, 50. intended for use as feed to chickens
cage layers: As an over 16 weeks of
aid in the prevention age. Do not feed to
of coccidiosis caused laying chickens.
by E. necatrix, E. Monensin sodium
tenella, E. provided by No.
acervulina, E. 058198, bacitracin
brunetti, E. mivati, methylenedisalicylat
and E. maxima, and e provided by No.
for improved feed 054771 in Sec.
efficiency, and as an 510.600(c) of this
aid in the prevention chapter.
of necrotic enteritis
caused or complicated
by Clostridium spp.
or other organisms
susceptible to
bacitracin.
(vii) 90 to 110............... Bacitracin zinc, Broiler chickens: As Feed continuously as 054771
4 to 50. an aid in the sole ration. In the
prevention of absence of
coccidiosis caused by coccidiosis, the use
E. necatrix, E. of monensin with no
tenella, E. withdrawal period
acervulina, E. may limit feed
brunetti, E. mivati, intake resulting in
and E. maxima, and reduced weight gain.
for increased rate of Do not feed to
weight gain and laying chickens.
improved feed Bacitracin zinc
efficiency. provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(viii) 90 to 110.............. Bacitracin zinc, Broiler chickens: As Feed continuously as 058198
10. an aid in the sole ration. In the
prevention of absence of
coccidiosis caused by coccidiosis, the use
E. necatrix, E. of monensin with no
tenella, E. withdrawal period
acervulina, E. may limit feed
brunetti, E. mivati, intake resulting in
and E. maxima, and reduced weight gain.
for increased rate of Do not feed to
weight gain and laying chickens.
improved feed Bacitracin zinc
efficiency. provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(ix) 90 to 110................ Bacitracin zinc, Broiler chickens: As Feed continuously as 058198
10 to 30. an aid in the sole ration. In the
prevention of absence of
coccidiosis caused by coccidiosis, the use
E. necatrix, E. of monensin with no
tenella, E. withdrawal period
acervulina, E. may limit feed
brunetti, E. mivati, intake resulting in
and E. maxima, and reduced weight gain.
for improved feed Do not feed to
efficiency. laying chickens.
Bacitracin zinc
provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(x) 90 to 110................. Bambermycins, 1 Broiler chickens: As Feed continuously as 016592, 058198
to 2. an aid in the sole ration. Do not
prevention of feed to laying
coccidiosis caused by chickens.
E. necatrix, E. Bambermycins
tenella, E. provided by No.
acervulina, E. 016592 in Sec.
brunetti, E. mivati, 510.600(c) of this
and E. maxima, and chapter.
for increased rate of
weight gain and
improved feed
efficiency.
----------------------------------------------------------------------------------------------------------------
(2) Turkeys--
[[Page 8978]]
----------------------------------------------------------------------------------------------------------------
Combination in
Monensin in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 54 to 90.................. ................. Growing turkeys: For For growing turkeys 058198
the prevention of only. Feed
coccidiosis caused by continuously as sole
E. adenoeides, E. ration. Some strains
meleagrimitis, and E. of turkey coccidia
gallopavonis. may be monensin
tolerant or
resistant. Monensin
may interfere with
development of
immunity to turkey
coccidiosis. Do not
allow horses, other
equines, mature
turkeys, or guinea
fowl access to feed
containing monensin.
Ingestion of
monensin by horses
and guinea fowl has
been fatal.
(ii) 54 to 90................. Bacitracin Growing turkeys: For For growing turkeys 058198
methylenedisalic the prevention of only. Feed
ylate, 4 to 50. coccidiosis caused by continuously as sole
E. adenoeides, E. ration. Some strains
meleagrimitis, and E. of turkey coccidia
gallopavonis, and for may be monensin
increased rate of tolerant or
weight gain and resistant. Monensin
improved feed may interfere with
efficiency. development of
immunity to turkey
coccidiosis. Do not
allow horses, other
equines, mature
turkeys, or guinea
fowl access to feed
containing monensin.
Ingestion of
monensin by horses
and guinea fowl has
been fatal.
Bacitracin
methylenedisalicylat
e as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(iii) 54 to 90................ Bacitracin Growing turkeys: For For growing turkeys 058198
methylenedisalic the prevention of only. Feed
ylate, 200. coccidiosis caused by continuously as sole
E. adenoeides, E. ration. Some strains
meleagrimitis, and E. of turkey coccidia
gallopavonis, and as may be monensin
an aid in the control tolerant or
of transmissible resistant. Monensin
enteritis complicated may interfere with
by organisms development of
susceptible to immunity to turkey
bacitracin coccidiosis. Do not
methylenedisalicylate. allow horses, other
equines, mature
turkeys, or guinea
fowl access to feed
containing monensin.
Ingestion of
monensin by horses
and guinea fowl has
been fatal.
Bacitracin
methylenedisalicylat
e as provided by No.
054771 in Sec.
510.600(c) of this
chapter.
(iv) 54 to 90................. Bambermycins, 1 Growing turkeys: For For growing turkeys 058198
to 2. the prevention of only. Feed
coccidiosis in continuously as sole
turkeys caused by E. ration. Some strains
adenoeides, E. of turkey coccidia
meleagrimitis, and E. may be monensin
gallopavonis, and for tolerant or
improved feed resistant. Monensin
efficiency. may interfere with
development of
immunity to turkey
coccidiosis.
Bambermycins as
provided by No.
016592 in Sec.
510.600(c) of this
chapter.
(v) 54 to 90.................. Bambermycins, 2.. Growing turkeys: For For growing turkeys 058198
the prevention of only. Feed
coccidiosis caused by continuously as sole
E. adenoeides, E. ration. Some strains
meleagrimitis, and E. of turkey coccidia
gallopavonis, and for may be monensin
increased rate of tolerant or
weight gain and resistant. Monensin
improved feed may interfere with
efficiency. development of
immunity to turkey
coccidiosis.
Bambermycins as
provided by No.
016592 in Sec.
510.600(c) of this
chapter.
----------------------------------------------------------------------------------------------------------------
(3) Cattle--
----------------------------------------------------------------------------------------------------------------
Monensin in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 5 to 40......................... Cattle fed in confinement Feed continuously in 058198
for slaughter: For improved complete feed at a rate of
feed efficiency. 50 to 480 milligrams of
monensin per head per day.
No additional improvement
in feed efficiency has been
shown from feeding monensin
at levels greater than 30
grams per ton (360
milligrams per head per
day).
(ii) 10 to 40....................... Cattle fed in confinement Feed at a rate of 0.14 to 058198
for slaughter: For 0.42 milligram per pound of
prevention and control of body weight per day,
coccidiosis due to E. bovis depending upon the severity
and E. zuernii. of challenge, up to maximum
of 480 milligrams per head
per day.
[[Page 8979]]
(iii) 10 to 200..................... Calves excluding veal Feed at a rate of 0.14 to 058198
calves: For prevention and 1.0 milligram monensin per
control of coccidiosis due pound of body weight per
to E. bovis and E. zuernii. day, depending upon the
severity of challenge, up
to maximum of 200
milligrams per head per day.
(iv) 11 to 22....................... Dairy cows: For increased Feed continuously to dry and 058198
milk production efficiency lactating dairy cows in a
(production of marketable total mixed ration
solids-corrected milk per (``complete feed''). See
unit of feed intake). special labeling
considerations in paragraph
(d) of this section.
(v) 11 to 400....................... Dairy cows: For increased Feed continuously to dry and 058198
milk production efficiency lactating dairy cows in a
(production of marketable component feeding system
solids-corrected milk per (including top dress). The
unit of feed intake). Type C medicated feed must
be fed in a minimum of 1 lb
of feed to provide 185 to
660 mg/head/day monensin to
lactating cows or 115 to
410 mg/head/day monensin to
dry cows. See special
labeling considerations in
paragraph (d) of this
section.
(vi) 15 to 400...................... Growing cattle on pasture or For increased rate of weight 058198
in dry lot (stocker and gain, feed at a rate of 50
feeder cattle and dairy and to 200 milligrams monensin
beef replacement heifers): per head per day in not
For increased rate of less than 1 pound of feed
weight gain, and for or, after the 5th day, feed
prevention and control of at a rate of 400 milligrams
coccidiosis due to E. bovis per head per day every
and E. zuernii. other day in not less than
2 pounds of feed. For
prevention and control of
coccidiosis, feed at a rate
of 0.14 to 0.42 milligram
per pound of body weight
per day, depending on
severity of challenge, up
to 200 milligrams per head
per day. During first 5
days of feeding, cattle
should receive no more than
100 milligrams per day in
not less than 1 pound of
feed.
(vii) 25 to 400..................... For improved feed Feed to mature reproducing 058198
efficiency, and for beef cows. Feed as
prevention and control of supplemental feed, either
coccidiosis due to E. bovis hand-fed in a minimum of 1
and E. zuernii. pound of feed or mixed in a
total ration. For improved
feed efficiency, feed
continuously at a rate of
50 to 200 milligrams
monensin per head per day.
For prevention and control
of coccidiosis, feed at a
rate of 0.14 to 0.42
milligram per pound of body
weight per day, depending
upon severity of challenge,
up to a maximum of 200
milligrams per head per
day. During first 5 days of
feeding, cattle should
receive no more than 100
milligrams per head per day.
----------------------------------------------------------------------------------------------------------------
(4) Free-choice cattle feeds--
----------------------------------------------------------------------------------------------------------------
Monensin amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 150 milligrams per pound of Pasture cattle (slaughter, Provide 50 to 200 milligrams 058198
protein-mineral block (0.033%). stocker, feeder, and dairy of monensin (0.34 to 1.33
and beef replacement pounds of block) per head
heifers): For increased per day, at least 1 block
rate of weight gain, and per 10 to 12 head of
for prevention and control cattle. Roughage must be
of coccidiosis caused by E. available at all times. Do
bovis and E. zuernii in not allow animals access to
pasture cattle which may other protein blocks, salt
require supplemental feed. or mineral, while being fed
this product. The
effectiveness of this block
in cull cows and bulls has
not been established. See
paragraph (d)(10)(i) of
this section.
(ii) 175 milligrams per pound of Pasture cattle (slaughter, Provide 40 to 200 milligrams 017800
protein-mineral block (0.038%). stocker, and feeder): For of monensin (0.25 to 1.13
increased rate of weight pounds or 4 to 18 ounces of
gain. block) per head per day, at
least 1 block per 4 head of
cattle. Do not allow cattle
access to salt or mineral
while being fed this
product. Ingestion by
cattle of monensin at
levels of 600 milligrams
per head per day and higher
has been fatal. The
effectiveness of this block
in cull cows and bulls has
not been established. See
paragraph (d)(10)(i) of
this section.
(iii) 400 milligrams per pound of Pasture cattle (slaughter, Provide 80 to 200 milligrams 067949
protein-mineral block (0.088%). stocker, feeder, and dairy of monensin (0.2 to 0.5
and beef replacement pounds of block) per head
heifers): For increased per day, at least 1 block
rate of weight gain. per 5 head of cattle. Feed
blocks continuously. Do not
feed salt or minerals
containing salt. The
effectiveness of this block
in cull cows and bulls has
not been established. See
paragraph (d)(10)(i) of
this section.
[[Page 8980]]
(iv) 400 milligrams per pound of Pasture cattle (slaughter, Provide 50 to 200 milligrams 051267
block (0.088%). stocker, feeder, and dairy of monensin (2 to 8 ounces
and beef replacement of block) per head per day,
heifers): For increased at least 1 block per 5 head
rate of weight gain. of cattle. Feed blocks
continuously. Do not feed
salt or mineral supplements
in addition to the blocks.
Ingestion by cattle of
monensin at levels of 600
milligrams per head per day
and higher has been fatal.
The effectiveness of this
block in cull cows and
bulls has not been
established. See paragraph
(d)(10)(i) of this section.
(v) In free-choice Type C medicated Growing cattle on pasture or During the first 5 days of 058198
feeds to provide 50 to 200 mg per in dry lot (stocker and feeding, cattle should
head per day. feeder cattle and dairy and receive no more than 100
beef replacement heifers): milligrams per day. Do not
For increased rate of feed additional salt or
weight gain; for prevention minerals. Do not mix with
and control of coccidiosis grain or other feeds.
due to E. bovis and E. Monensin is toxic to cattle
zuernii. when consumed at higher
than approved levels.
Stressed and/or feed- and/
or water-deprived cattle
should be adapted to the
pasture and to unmedicated
supplement before using the
monensin medicated
supplement. The product's
effectiveness in cull cows
and bulls has not been
established. See paragraph
(d) of this section for
other required label
warnings.
(vi) 1,620 grams per ton of mineral Growing cattle on pasture or Feed at a rate of 50 to 200 058198
granules as specified in paragraph in dry lot (stocker and milligrams per head per
(f)(4)(vi)(A) of this section. feeder cattle and dairy and day. During the first 5
beef replacement heifers): days of feeding, cattle
For increased rate of should receive no more than
weight gain, and for 100 milligrams per day. Do
prevention and control of not feed additional salt or
coccidiosis due to E. bovis minerals. Do not mix with
and E. zuernii. grain or other feeds.
Monensin is toxic to cattle
when consumed at higher
than approved levels.
Stressed and/or feed- and/
or water-deprived cattle
should be adapted to the
pasture and to unmedicated
mineral supplement before
using the monensin mineral
supplement. The product's
effectiveness in cull cows
and bulls has not been
established.
----------------------------------------------------------------------------------------------------------------
(A) Specifications. Use as free-choice Type C medicated feed
formulated as mineral granules as follows:
------------------------------------------------------------------------
International
Ingredient Percent feed No.
------------------------------------------------------------------------
Monocalcium phosphate (21% phosphorus, 29.49 6-01-082
15% calcium)...........................
Sodium chloride (salt).................. 24.37 6-04-152
Dried cane molasses..................... 20.0 4-04-695
Ground limestone (33% calcium) or 13.75 6-02-632
calcium carbonate (38% calcium)........
Cane molasses........................... 3.0 4-04-696
Processed grain by-products (as approved 5.0 ..............
by AAFCO)..............................
Vitamin/trace mineral premix \1\........ 2.5 ..............
Monensin Type A article, 90.7 grams per 0.89 ..............
pound..................................
Antidusting oil......................... 1.0 ..............
------------------------------------------------------------------------
\1\ Content of vitamin and trace mineral premixes may be varied.
However, they should be comparable to those used for other free-choice
feeds. Formulation modifications require FDA approval prior to
marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine
dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides
Sec. 651.100 (CPG 7125.18).
(B) [Reserved]
(5) Bobwhite quail--
----------------------------------------------------------------------------------------------------------------
Monensin in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 73.............................. Growing bobwhite quail: For Feed continuously in 058198
the prevention of complete feed at a rate of
coccidiosis caused by 50 to 480 milligrams of
Eimeria dispersa and E. monensin per head per day.
lettyae. No additional improvement
in feed efficiency has been
shown from feeding monensin
at levels greater than 30
grams per ton (360
milligrams per head per
day).
(ii) [Reserved]..................... ............................ ............................ ..............
----------------------------------------------------------------------------------------------------------------
[[Page 8981]]
(6) Goats--
----------------------------------------------------------------------------------------------------------------
Monensin in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 5 to 40......................... For the prevention of Feed only to goats being fed 058198
coccidiosis caused by in confinement. Do not feed
Eimeria crandallis, E. to lactating goats. See
christenseni, and E. paragraph (d)(13) of this
ninakohlyakimovae. section for provisions for
monensin liquid Type C goat
feeds.
(ii) [Reserved]..................... ............................ ............................ ..............
----------------------------------------------------------------------------------------------------------------
(7) Monensin may also be used in combination with:
(i) Avilamycin as in Sec. 558.68.
(ii) Chlortetracycline as in Sec. 558.128.
(iii) Decoquinate as in Sec. 558.195.
(iv) Lincomycin as in Sec. 558.325.
(v) Melengestrol acetate as in Sec. 558.342.
(vi) Oxytetracycline as in Sec. 558.450.
(vii) Ractopamine alone or in combination as in Sec. 558.500.
(viii) Tilmicosin as in Sec. 558.618.
(ix) Tylosin as in Sec. 558.625.
(x) Virginiamycin as in Sec. 558.635.
(xi) Zilpaterol alone or in combination as in Sec. 558.665.
0
85. In Sec. 558.364, revise paragraph (d)(1)(i) to read as follows:
Sec. 558.364 Narasin and nicarbazin.
* * * * *
(d) * * *
(1) * * *
----------------------------------------------------------------------------------------------------------------
Narasin and nicarbazin in Combination in
grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 27 to 45 of each drug.... ................... Broiler chickens: For Feed continuously as 058198
prevention of the sole ration. Do
coccidiosis caused not feed to laying
by Eimeria tenella, hens. Do not allow
E. necatrix, E. adult turkeys,
acervulina, E. horses, or other
maxima, E. brunetti, equines access to
and E. mivati. formulations
containing narasin.
Ingestion of narasin
by these species has
been fatal. The two
drugs can be
combined only at a
1:1 ratio for the 27
to 45 grams per ton
range. Only granular
nicarbazin as
provided by No.
058198 in Sec.
510.600(c) of this
chapter may be used
in the combination.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
86. In Sec. 558.550, revise paragraph (b), add paragraph (c), revise
paragraph (d), and add paragraph (e) to read as follows:
Sec. 558.550 Salinomycin.
* * * * *
(b) Sponsor. See No. 016592 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.592 of this chapter.
(d) Special considerations. Not approved for use with pellet
binders.
(e) Conditions of use. It is used as follows:
(1) Chickens--
----------------------------------------------------------------------------------------------------------------
Combination in
Salinomycin in grams/ton grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 40 to 60.................. ................. Broiler, roaster, and Feed continuously as 016592
replacement (breeder sole ration. Do not
and layer) chickens: feed to laying hens
For the prevention of producing eggs for
coccidiosis caused by human consumption.
Eimeria tenella, E. May be fatal if
necatrix, E. accidentally fed to
acervulina, E. adult turkeys or
maxima, E. brunetti, horses.
and E. mivati.
(ii) 40 to 60................. Bacitracin Broiler, roaster, and Feed continuously as 016592
methylenedisalic replacement (breeder sole ration. Do not 054771
ylate, 4 to 50. and layer) chickens: feed to laying
For the prevention of chickens. May be
coccidiosis caused by fatal if fed to
Eimeria tenella, E. adult turkeys or
necatrix, E. horses. Salinomycin
acervulina, E. as provided by No.
maxima, E. brunetti, 016592; bacitracin
and E. mivati, and methylenedisalicylat
for increased rate of e as provided by No.
weight gain and 054771 in Sec.
improved feed 510.600(c) of this
efficiency. chapter.
(iii) 40 to 60................ Bacitracin Broiler chickens: For Feed continuously as 054771
methylenedisalic the prevention of sole ration. Do not
ylate, 50. coccidiosis caused by feed to laying
Eimeria tenella, E. chickens. May be
necatrix, E. fatal if fed to
acervulina, E. adult turkeys or to
maxima, E. brunetti, horses. Salinomycin
and E. mivati, and as as provided by No.
an aid in the 016592; bacitracin
prevention of methylenedisalicylat
necrotic enteritis e as provided by No.
caused or complicated 054771 in Sec.
by Clostridium spp. 510.600(c) in this
or other organisms chapter.
susceptible to
bacitracin.
[[Page 8982]]
(iv) 40 to 60................. Bacitracin Broiler chickens: For Feed continuously as 054771
methylenedisalic the prevention of sole ration. To
ylate, 100 to coccidiosis caused by control necrotic
200. Eimeria tenella, E. enteritis, start
necatrix, E. medication at first
acervulina, E. clinical signs of
maxima, E. brunetti, disease; vary dosage
and E. mivati, and as based on the
an aid in the control severity of
of necrotic enteritis infection;
caused or complicated administer
by Clostridium spp. continuously for 5
or other organisms to 7 days or as long
susceptible to as clinical signs
bacitracin. persist, then reduce
bacitracin to
prevention level (50
grams per ton). Do
not feed to laying
chickens. May be
fatal if fed to
adult turkeys or to
horses. Salinomycin
as provided by No.
016592; bacitracin
methylenedisalicylat
e as provided by No.
054771 in Sec.
510.600(c) in this
chapter.
(v) 40 to 60.................. Bacitracin zinc, Broiler chickens: For Feed continuously as 016592
10 to 50. the prevention of sole ration. Not 054771
coccidiosis caused by approved for use
Eimeria tenella, E. with pellet binders.
necatrix, E. Do not feed to
acervulina, E. layers. May be fatal
maxima, E. brunetti, if accidentally fed
and E. mivati, and to adult turkeys or
for increased rate of horses. Bacitracin
weight gain. zinc as provided by
No. 054771 in Sec.
510.600(c) of this
chapter.
(vi) 40 to 60................. Bambermycins, 1 Broiler chickens: For Feed continuously as 016592
to 3. the prevention of sole ration. Do not
coccidiosis caused by feed to laying
Eimeria tenella, E. chickens. Not
necatrix, E. approved for use
acervulina, E. with pellet binders.
maxima, E. brunetti, May be fatal if
and E. mivati, and accidentally fed to
for improved feed adult turkeys or
efficiency. horses. Salinomycin
and bambermycins as
provided by No.
016592 in Sec.
510.600(c) in this
chapter.
----------------------------------------------------------------------------------------------------------------
(2) Game birds--
----------------------------------------------------------------------------------------------------------------
Combination in
Salinomycin in grams/ton grams per ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 50........................ ................. Quail: For the Feed continuously as ..............
prevention of sole ration. Not
coccidiosis caused by approved for use
E. dispersa and E. with pellet binders.
lettyae. Do not feed to
laying hens
producing eggs for
human consumption.
May be fatal if
accidentally fed to
adult turkeys or
horses.
(ii) [Reserved]............... ................. ...................... ..................... ..............
----------------------------------------------------------------------------------------------------------------
(3) Salinomycin may also be used in combination with:
(i) Chlortetracycline as in Sec. 558.128.
(ii) Lincomycin as in Sec. 558.325.
(iii) Oxytetracycline as in Sec. 558.450.
(iv) Virginiamycin as in Sec. 558.635.
0
87. In Sec. 558.625, revise paragraphs (b)(1) through (4) to read as
follows:
Sec. 558.625 Tylosin.
* * * * *
(b) * * *
(1) No. 016592: Type A medicated articles containing 40 or 100
grams per pound (g/lb).
(2) No. 054771: Type A medicated article containing 40 g/lb.
(3) No. 058198: Type A medicated articles containing 10, 40, or 100
g/lb.
(4) No. 066104: Type A medicated articles containing 20 or 40 g/lb.
* * * * *
Dated: March 5, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04226 Filed 3-12-19; 8:45 am]
BILLING CODE 4164-01-P