New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
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 abbrevia...
21 CFR Parts 510, 520, 522, 524, 526, 529, 556, and 558
[Docket No. FDA-2018-N-0002]
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 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,
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 July, August, and September 2018, as listed
( printed 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
Original approval as a generic copy of NADA 013-149
FOI Summary.
August 10, 2018
141-488
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007
Lincomycin and lasalocid Type C medicated feeds
Chickens
Original approval for use of LINCOMIX (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
FOI Summary.
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
( printed page 8969)
list of sponsors of approved applications in § 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.
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 § 510.600(c). As a new sponsor of approved applications, Cronus Pharma Specialities India Private Ltd. will be added to § 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:
( printed page 8970)
File No.
Product name
21 CFR
section
010-092
GALLIMYCIN-100P (erythromycin thiocyanate) Type A Medicated Article
558.248.
010-346
COMBUTHAL (pentobarbital sodium and thiopental sodium) Powder
BIMECTIN (ivermectin) Injection for Cattle and Swine
522.1192.
200-455
BILOVET (tylosin tartrate) Soluble Powder
520.2640.
200-460
TETROXY (oxytetracycline hydrochloride) Aquatic
529.1660.
200-464
AMPROMED (amprolium) For Cattle
520.100.
( printed page 8971)
200-468
GENTAMED-P (gentamicin sulfate) for Poultry Injection
522.1044.
200-481
OVAMED (altrenogest) Solution
520.48.
200-482
AMPROMED (amprolium) for Calves
520.100.
200-488
AMPROMED P (amprolium) for Poultry
520.100.
200-489
FLUNAZINE-S (flunixin meglumine) Injection
522.970.
200-494
GENTAMED (gentamicin sulfate) Soluble Powder
520.1044c.
200-496
AMPROMED P (amprolium) for Poultry
520.100.
200-501
Praziquantel Injection
522.1870.
200-508
BILOVET (tylosin) Injectable Solution
522.2640.
200-523
SULFAMED (sulfadimethoxine) Injection
522.2220.
200-529
XYLAMED (xylazine) Injection
522.2662.
200-538
CLINDAMED (clindamycin) Oral Drops
520.447.
200-581
FLUNAZINE (flunixin meglumine) Paste
520.970.
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 § 510.600(c) (21 CFR 510.600(c)). As a new sponsor of approved applications, Bimeda Animal Health Ltd. will be added to § 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.”
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
1. The authority citation for part 510 continues to read as follows:
2. In § 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”.
Names, addresses, and drug labeler codes of sponsors of approved applications.
* * * * *
(c) * * *
(1) * * *
Firm name and address
Drug labeler code
* * * * * * *
Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland
061133
( printed page 8972)
* * * * * * *
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
069043
* * * * * * *
(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
3. The authority citation for part 520 continues to read as follows:
(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.
6. In § 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”.
21. In § 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”.
34. In § 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”.
(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.
41. In § 522.690, in paragraph (b)(3), remove “061623” and in its place add “061133”.
42. In § 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).
(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.
53. In § 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”.
(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
76. The authority citation for part 558 continues to read as follows:
77. In § 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)”.
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
Drug
Assay limits
percent 1
Type A
Type B
maximum
(100x)
Assay limits
percent 1
Type 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.
79. In § 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”.
(b)
Sponsor.
See No. 016592 in § 510.600(c) of this chapter.
* * * * *
(d)
Conditions of use.
It is used in feed as follows:
(1)
Chickens
—
Halofuginone in grams/ton
Combination in grams/ton
Indications for use
Limitations
Sponsor
(i) 2.72
Broiler chickens: For the prevention of coccidiosis caused by
Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati,
and
E. maxima
Feed continuously as sole ration. Do not feed to layers. Withdraw 4 days before slaughter
016592
(ii) 2.72
Bacitracin methylenedisalicylate, 10 to 50
Broiler chickens: For the prevention of coccidiosis caused by
Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati,
and
E. maxima;
for improved feed efficiency
Feed continuously as sole ration. Do not feed to layers. Withdraw 5 days before slaughter
016592
(iii) 2.72
Bambermycins, 1 to 2
Broiler chickens: For the prevention of coccidiosis caused by
Eimeria tenella, E. necatrix, E, acervulina, E. brunetti, E. mivati,
and
E. maxima;
for increased rate of weight gain and improved feed efficiency
Feed continuously as sole ration. Do not feed to layers. Withdraw 5 days before slaughter
016592
(iv) 2.72
Replacement broiler breeder chickens and replacement cage laying chickens: For the prevention of coccidiosis caused by
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati
/
E. mitis,
and
E. brunetti
Feed continuously as sole ration to replacement cage laying chickens until 20 weeks of age. Feed continuously as sole ration to replacement broiler breeder chickens until 16 weeks of age. Do not feed to laying chickens or water fowl. Withdraw 4 days before slaughter
016592
( printed page 8976)
(2)
Turkeys
—
Halofuginone in grams/ton
Combination in grams/ton
Indications for use
Limitations
Sponsor
(i) 1.36 to 2.72
Growing turkeys: For the prevention of coccidiosis caused by
Eimeria adenoeides, E. meleagrimitis,
and
E. gallopavonis
Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to layers or water fowl
016592
(ii) 1.36 to 2.72
Bacitracin methylenedisalicylate, 10 to 50
Growing turkeys: For the prevention of coccidiosis caused by
Eimeria adenoeides, E. meleagrimitis,
and
E. gallopavonis,
and for increased rate of weight gain
Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or water fowl
016592
(iii) 1.36 to 2.72
Bambermycins, 2
Growing turkeys: For the prevention of coccidiosis caused by
Eimeria adenoeides, E. meleagrimitis,
and
E. gallopavonis,
and for increased rate of weight gain
Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or waterfowl
016592
(3) Halofuginone may also be used in combination with:
(i) Lincomycin as in § 558.325.
(ii) [Reserved]
82. In § 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:
Broiler chickens: 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
Feed as the sole ration. Type C feed must be used within 4 weeks of manufacture. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Lasalocid as provided by No. 054771 in § 510.600 of this chapter
054771
* * * * * * *
* * * * *
84. In § 558.355, revise paragraph (b), add paragraph (c), and revise paragraph (f) to read as follows:
(b)
Sponsor.
See No. 058198 in § 510.600(c) of this chapter.
(c)
Related tolerances.
See § 556.420 of this chapter.
* * * * *
(f)
Conditions of use.
It is used as follows:
(1)
Chickens
—
Monensin in grams/ton
Combination in grams/ton
Indications for use
Limitations
Sponsor
(i) 90 to 110
Broiler chickens: As an aid in the prevention of coccidiosis caused by
E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati,
and
E. maxima
Feed continuously as the sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens
058198
(ii) 90 to 110
Replacement chickens intended for use as cage layers: As an aid in the prevention of coccidiosis caused by
E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati,
and
E. maxima
Feed continuously as the sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens
058198
( printed page 8977)
(iii) 90 to 110
Bacitracin methylenedisalicylate, 4 to 50
Broiler chickens: As an aid in the prevention of coccidiosis caused by
E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati,
and
E. maxima,
and for improved feed efficiency
Feed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter
054771
(iv) 90 to 110
Bacitracin methylenedisalicylate, 4 to 50
Replacement chickens intended for use as cage layers: As an aid in the prevention of coccidiosis caused by
E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati,
and
E. maxima,
and for increased rate of weight gain and improved feed efficiency
Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. Monensin sodium provided by No. 058198, bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter
054771
(v) 90 to 110
Bacitracin methylenedisalicylate, 5 to 25
Broiler chickens: As an aid in the prevention of coccidiosis caused by
E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati,
and
E. maxima,
and for increased rate of weight gain and improved feed efficiency
Feed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter
058198
(vi) 90 to 110
Bacitracin methylenedisalicylate, 50
Broiler and replacement chickens intended for use as cage layers: As an aid in the prevention of coccidiosis caused by
E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati,
and
E. maxima,
and for improved feed efficiency, 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. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. Monensin sodium provided by No. 058198, bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter
054771
(vii) 90 to 110
Bacitracin zinc, 4 to 50
Broiler chickens: As an aid in the prevention of coccidiosis caused by
E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati,
and
E. maxima,
and for increased rate of weight gain and improved feed efficiency
Feed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter
054771
(viii) 90 to 110
Bacitracin zinc, 10
Broiler chickens: As an aid in the prevention of coccidiosis caused by
E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati,
and
E. maxima,
and for increased rate of weight gain and improved feed efficiency
Feed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter
058198
(ix) 90 to 110
Bacitracin zinc, 10 to 30
Broiler chickens: As an aid in the prevention of coccidiosis caused by
E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati,
and
E. maxima,
and for improved feed efficiency
Feed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter
058198
(x) 90 to 110
Bambermycins, 1 to 2
Broiler chickens: As an aid in the prevention of coccidiosis caused by
E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati,
and
E. maxima,
and for increased rate of weight gain and improved feed efficiency
Feed continuously as sole ration. Do not feed to laying chickens. Bambermycins provided by No. 016592 in § 510.600(c) of this chapter
016592, 058198
(2)
Turkeys—
( printed page 8978)
Monensin in
grams/ton
Combination
in grams/ton
Indications for use
Limitations
Sponsor
(i) 54 to 90
Growing turkeys: For the prevention of coccidiosis caused by
E. adenoeides, E. meleagrimitis,
and
E. gallopavonis
For growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia 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
058198
(ii) 54 to 90
Bacitracin methylenedisalicylate, 4 to 50
Growing turkeys: For the prevention of coccidiosis caused by
E. adenoeides, E. meleagrimitis,
and
E. gallopavonis,
and for increased rate of weight gain and improved feed efficiency
For growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia 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. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter
058198
(iii) 54 to 90
Bacitracin methylenedisalicylate, 200
Growing turkeys: For the prevention of coccidiosis caused by
E. adenoeides, E. meleagrimitis,
and
E. gallopavonis,
and as an aid in the control of transmissible enteritis complicated by organisms susceptible to bacitracin methylenedisalicylate
For growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia 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. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter
058198
(iv) 54 to 90
Bambermycins, 1 to 2
Growing turkeys: For the prevention of coccidiosis in turkeys caused by
E. adenoeides, E. meleagrimitis,
and
E. gallopavonis,
and for improved feed efficiency
For growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter
058198
(v) 54 to 90
Bambermycins, 2
Growing turkeys: For the prevention of coccidiosis caused by
E. adenoeides, E. meleagrimitis,
and
E. gallopavonis,
and for increased rate of weight gain and improved feed efficiency
For growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter
058198
(3)
Cattle
—
Monensin in
grams/ton
Indications for use
Limitations
Sponsor
(i) 5 to 40
Cattle fed in confinement for slaughter: For improved feed efficiency
Feed continuously in complete feed at a rate of 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)
058198
(ii) 10 to 40
Cattle fed in confinement for slaughter: For prevention and control of coccidiosis due to
E. bovis
and
E. zuernii
Feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending upon the severity of challenge, up to maximum of 480 milligrams per head per day
058198
( printed page 8979)
(iii) 10 to 200
Calves excluding veal calves: For prevention and control of coccidiosis due to
E. bovis
and
E. zuernii
Feed at a rate of 0.14 to 1.0 milligram monensin per pound of body weight per day, depending upon the severity of challenge, up to maximum of 200 milligrams per head per day
058198
(iv) 11 to 22
Dairy cows: For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake)
Feed continuously to dry and lactating dairy cows in a total mixed ration (“complete feed”). See special labeling considerations in paragraph (d) of this section
058198
(v) 11 to 400
Dairy cows: For increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake)
Feed continuously to dry and lactating dairy cows in a component feeding system (including top dress). The 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
058198
(vi) 15 to 400
Growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers): For increased rate of weight gain, and for prevention and control of coccidiosis due to
E. bovis
and
E. zuernii
For increased rate of weight gain, feed at a rate of 50 to 200 milligrams monensin per head per day in not less than 1 pound of feed or, after the 5th day, feed at a rate of 400 milligrams per head per day every 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
058198
(vii) 25 to 400
For improved feed efficiency, and for prevention and control of coccidiosis due to
E. bovis
and
E. zuernii
Feed to mature reproducing beef cows. Feed as supplemental feed, either hand-fed in a minimum of 1 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
058198
(4)
Free-choice cattle feeds
—
Monensin
amount
Indications for use
Limitations
Sponsor
(i) 150 milligrams per pound of protein-mineral block (0.033%)
Pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers): For increased rate of weight gain, and for prevention and control of coccidiosis caused by
E. bovis
and
E. zuernii
in pasture cattle which may require supplemental feed
Provide 50 to 200 milligrams of monensin (0.34 to 1.33 pounds of block) per head per day, at least 1 block per 10 to 12 head of cattle. Roughage must be available at all times. Do not allow animals access to other protein blocks, salt 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
058198
(ii) 175 milligrams per pound of protein-mineral block (0.038%)
Pasture cattle (slaughter, stocker, and feeder): For increased rate of weight gain
Provide 40 to 200 milligrams of monensin (0.25 to 1.13 pounds or 4 to 18 ounces of 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
017800
(iii) 400 milligrams per pound of protein-mineral block (0.088%)
Pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers): For increased rate of weight gain
Provide 80 to 200 milligrams of monensin (0.2 to 0.5 pounds of block) per head per day, at least 1 block 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
067949
( printed page 8980)
(iv) 400 milligrams per pound of block (0.088%)
Pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers): For increased rate of weight gain
Provide 50 to 200 milligrams of monensin (2 to 8 ounces of block) per head per day, at least 1 block per 5 head 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
051267
(v) In free-choice Type C medicated feeds to provide 50 to 200 mg per head per day
Growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers): For increased rate of weight gain; for prevention and control of coccidiosis due to
E. bovis
and
E. zuernii
During the first 5 days of feeding, cattle should receive no more than 100 milligrams per day. Do not feed additional salt or minerals. Do not mix with 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 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
058198
(vi) 1,620 grams per ton of mineral granules as specified in paragraph (f)(4)(vi)(A) of this section
Growing cattle on pasture or in dry lot (stocker and feeder cattle and dairy and beef replacement heifers): For increased rate of weight gain, and for prevention and control of coccidiosis due to
E. bovis
and
E. zuernii
Feed at a rate of 50 to 200 milligrams per head per day. During the first 5 days of feeding, cattle should receive no more than 100 milligrams per day. Do not feed additional salt or minerals. Do not mix with 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
058198
(A)
Specifications.
Use as free-choice Type C medicated feed formulated as mineral granules as follows:
Ground limestone (33% calcium) or calcium carbonate (38% calcium)
13.75
6-02-632
Cane molasses
3.0
4-04-696
Processed grain by-products (as approved by AAFCO)
5.0
Vitamin/trace mineral premix 1
2.5
Monensin Type A article, 90.7 grams per pound
0.89
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 the prevention of coccidiosis caused by
Eimeria dispersa
and
E. lettyae
Feed continuously in complete feed at a rate of 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)
058198
(ii) [Reserved]
( printed page 8981)
(6)
Goats
—
Monensin in
grams/ton
Indications for use
Limitations
Sponsor
(i) 5 to 40
For the prevention of coccidiosis caused by
Eimeria crandallis, E. christenseni,
and
E. ninakohlyakimovae
Feed only to goats being fed in confinement. Do not feed to lactating goats. See paragraph (d)(13) of this section for provisions for monensin liquid Type C goat feeds
058198
(ii) [Reserved]
(7) Monensin may also be used in combination with:
(i) Avilamycin as in § 558.68.
(ii) Chlortetracycline as in § 558.128.
(iii) Decoquinate as in § 558.195.
(iv) Lincomycin as in § 558.325.
(v) Melengestrol acetate as in § 558.342.
(vi) Oxytetracycline as in § 558.450.
(vii) Ractopamine alone or in combination as in § 558.500.
(viii) Tilmicosin as in § 558.618.
(ix) Tylosin as in § 558.625.
(x) Virginiamycin as in § 558.635.
(xi) Zilpaterol alone or in combination as in § 558.665.
85. In § 558.364, revise paragraph (d)(1)(i) to read as follows:
Broiler chickens: For prevention of coccidiosis caused by
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti,
and
E. mivati
Feed continuously as the sole ration. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to 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 § 510.600(c) of this chapter may be used in the combination
058198
* * * * * * *
* * * * *
86. In § 558.550, revise paragraph (b), add paragraph (c), revise paragraph (d), and add paragraph (e) to read as follows:
(b)
Sponsor.
See No. 016592 in § 510.600(c) of this chapter.
(c)
Related tolerances.
See § 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
—
Salinomycin in grams/ton
Combination in
grams/ton
Indications for use
Limitations
Sponsor
(i) 40 to 60
Broiler, roaster, and replacement (breeder and layer) chickens: For the 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 producing eggs for human consumption. May be fatal if accidentally fed to adult turkeys or horses
016592
(ii) 40 to 60
Bacitracin methylenedisalicylate, 4 to 50
Broiler, roaster, and replacement (breeder and layer) chickens: For the 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 chickens. May be fatal if fed to adult turkeys or horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter
016592
054771
(iii) 40 to 60
Bacitracin methylenedisalicylate, 50
Broiler chickens: For the 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. Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) in this chapter
054771
( printed page 8982)
(iv) 40 to 60
Bacitracin methylenedisalicylate, 100 to 200
Broiler chickens: For the 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
Feed continuously as sole ration. 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 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 methylenedisalicylate as provided by No. 054771 in § 510.600(c) in this chapter
054771
(v) 40 to 60
Bacitracin zinc, 10 to 50
Broiler chickens: For the 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
Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter
016592
054771
(vi) 40 to 60
Bambermycins, 1 to 3
Broiler chickens: For the prevention of coccidiosis caused by
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti,
and
E. mivati,
and for improved feed efficiency
Feed continuously as sole ration. Do not feed to laying chickens. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Salinomycin and bambermycins as provided by No. 016592 in § 510.600(c) in this chapter
016592
(2)
Game birds
—
Salinomycin in grams/ton
Combination in
grams per ton
Indications for use
Limitations
Sponsor
(i) 50
Quail: For the prevention of coccidiosis caused by
E. dispersa
and
E. lettyae
Feed continuously as sole ration. Not approved for use with pellet binders. 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 § 558.128.
(ii) Lincomycin as in § 558.325.
(iii) Oxytetracycline as in § 558.450.
(iv) Virginiamycin as in § 558.635.
87. In § 558.625, revise paragraphs (b)(1) through (4) to read as follows:
Use this for formal legal and research references to the published document.
84 FR 8967
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship,” thefederalregister.org (March 13, 2019), https://thefederalregister.org/documents/2019-04226/new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-new-animal-drug-applications-changes.