Skip to Content

Rule

New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship

A Rule by the Food and Drug Administration on 10/20/2021

Published Document: 2021-22604 (86 FR 57992)

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Document Headings

Document headings vary by document type but may contain the following:

  1. the agency or agencies that issued and signed a document
  2. the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to
  3. the agency docket number / agency internal file number
  4. the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions

See the Document Drafting Handbook for more details.

Department of Health and Human Services
Food and Drug Administration
  1. 21 CFR Parts 510, 516, 520, 522, 526, 556 and 558
  2. [Docket No. FDA-2021-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), abbreviated new animal drug applications (ANADAs), and conditional new animal drug applications (cNADAs) during January, February, and March 2021. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.

DATES:

This rule is effective October 20, 2021.

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, .

SUPPLEMENTARY INFORMATION:

I. Approvals

FDA is amending the animal drug regulations to reflect approval actions for NADAs, ANADAs, and conditional approval actions for cNADAs during January, February, and March 2021, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the office of the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. Persons with access to the internet may obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/​about-fda/​center-veterinary-medicine/​cvm-foia-electronic-reading-room. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: https://www.fda.gov/​animal-veterinary/​products/​approved-animal-drug-products-green-book.

FDA has verified the website addresses as of the date this document publishes in the Federal Register , but websites are subject to change over time.

Table 1—Original and Supplemental NADAs and ANADAs Approved During January, February, and March 2021
Approval date File No. Sponsor Product name Species Effect of the action Public documents
January 8, 2021 141-336 ECO LLC, 344 Nassau St., Princeton, NJ 08540 AIVLOSIN (62.5% w/w tylvalosin as tylvalosin tartrate) Water Soluble Granules Swine Supplemental approval for the addition of Mycoplasma hyopneumoniae to the list of pathogens for the control of swine respiratory disease indication FOI Summary.
January 11, 2021 141-526 Anivive Lifesciences, Inc., 3250 Airflite Way, Suite 400, Long Beach, CA 90807 LAVERDIA-CA1 (verdinexor tablets) Dogs Conditional approval for the treatment of lymphoma in dogs FOI Summary.
January 12, 2021 200-675 Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria Ractopamine hydrochloride and monensin Type B and Type C medicated feeds Cattle Original approval as a generic copy of NADA 141-225 FOI Summary.
January 12, 2021 200-676 Do Ractopamine hydrochloride, monensin, and tylosin phosphate Type B and Type C medicated feeds Cattle Original approval as a generic copy of NADA 141-224 FOI Summary.
( printed page 57993)
January 12, 2021 200-677 Do Ractopamine hydrochloride, monensin, and melengestrol acetate Type C medicated feeds Cattle Original approval as a generic copy of NADA 141-234 FOI Summary.
January 12, 2021 200-678 Do Ractopamine hydrochloride, monensin, tylosin phosphate, and melengestrol acetate Type C medicated feeds Cattle Original approval as a generic copy of NADA 141-233 FOI Summary.
January 14, 2021 141-544 Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514 KBROVET-CA1 (potassium bromide chewable tablets) Chewable Tablet Dogs Conditional approval for the control of seizures associated with idiopathic epilepsy in dogs FOI Summary.
January 15, 2021 141-539 Neogen Corp., 944 Nandino Blvd., Lexington, KY 40511 THYROKARE (levothyroxine sodium tablets) Dogs Original approval for replacement therapy for diminished thyroid function in dogs FOI Summary.
February 1, 2021 200-683 Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria Melengestrol acetate and monensin Type C medicated feeds Cattle Original approval as a generic copy of NADA 125-476 FOI Summary.
February 1, 2021 200-684 Do Ractopamine hydrochloride, monensin, and melengestrol acetate Type C medicated feeds Cattle Original approval as a generic copy of NADA 141-234 FOI Summary.
February 1, 2021 200-685 Do Melengestrol acetate, monensin, and tylosin phosphate Type C medicated feeds Cattle Original approval as a generic copy of NADA 138-870 FOI Summary.
February 1, 2021 200-686 Do Monensin, ractopamine hydrochloride, tylosin phosphate, and melengestrol acetate Type C medicated feeds Cattle Original approval as a generic copy of NADA 141-233 FOI Summary.
February 8, 2021 200-466 Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215 SPARMECTIN Plus Clorsulon (ivermectin and clorsulon) Injection Cattle Supplemental approval reducing preslaughter withdrawal period to 21 days FOI Summary.
February 16, 2021 200-506 Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland ANIMEC PLUS (ivermectin and clorsulon) Injection Cattle Original approval as a generic copy of NADA 140-833 FOI Summary.
February 18, 2021 200-657 Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland MACROSYN (tulathromycin injection) Injectable Solution Cattle Original approval as a generic copy of NADA 141-244 FOI Summary.
February 18, 2021 200-666 Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 INCREXXA (tulathromycin injection) Injectable Solution Cattle Original approval as a generic copy of NADA 141-244 FOI Summary.
February 26, 2021 141-540 Pharmgate, Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405 PENNITRACIN MD (bacitracin Type A medicated article) and COBAN (monensin Type A medicated article) to be used in the manufacture of Type C medicated feeds Turkeys Original approval for the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis and E. gallopavonis, and for increased rate of weight gain and improved feed efficiency in growing turkeys FOI Summary.
March 11, 2021 200-699 Akorn Animal Health, Inc., 1925 West Field Ct., Suite 300, Lake Forest, IL 60045 Dexmedetomidine Hydrochloride Injection (dexmedetomidine hydrochloride) Dogs and cats Original approval as a generic copy of NADA 141-267 FOI Summary.
( printed page 57994)
March 15, 2021 141-530 Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 MGA (melengestrol acetate Type A medicated article) and AUREOMYCIN (chlortetracycline Type A medicated article) to be used in the manufacture of Type C medicated feeds Cattle Original approval for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) in replacement dairy and beef heifers, or growing beef heifers fed in confinement for slaughter receiving medicated feed containing chlortetracycline for the treatment of bacterial enteritis or pneumonia, control of bacterial pneumonia associated with shipping fever complex, reduction of incidence of liver abscesses, and control of active infection of anaplasmosis FOI Summary.
March 19, 2021 141-531 Do MGA (melengestrol acetate Type A medicated article), AUREOMYCIN (chlortetracycline Type A medicated article), and BOVATEC (lasalocid Type A medicated article) to be used in the manufacture of Type C medicated feeds Cattle Original approval for suppression of estrus (heat) in replacement dairy and beef heifers, or growing beef heifers fed in confinement for slaughter receiving medicated feed containing chlortetracycline for the treatment of bacterial enteritis or pneumonia, control of bacterial pneumonia associated with shipping fever complex, or control of active infection of anaplasmosis; and lasalocid for control of coccidiosis, increased rate of weight gain, and improved feed efficiency FOI Summary.
March 22, 2021 200-625 Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland KETOMED (ketoprofen) Sterile Solution Horses Original approval as a generic copy of NADA 140-269 FOI Summary.
March 24, 2021 132-872 Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 SAFE-GUARD (fenbendazole) Paste 10% Cattle Supplemental approval providing for tolerances, a tissue withdrawal period, and a milk discard time in accordance with a repartitioning of the acceptable daily intake; and the addition of indications for fourth-stage larvae of certain endoparasites FOI Summary.

II. Changes of Sponsor

The sponsors of the following approved applications have informed FDA that they have transferred ownership of, and all rights and interest in, these applications to another sponsor:

File No. Product name Transferring sponsor New sponsor 21 CFR section
141-175 CAPSTAR (nitenpyram) Tablets Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 Sergeant's Pet Care Products, Inc., 10077 S 134th St., Omaha, NE 68138 520.1510.
141-120 CLOMICALM (clomipramine hydrochloride) Tablets Do Virbac AH, Inc., P.O. Box 162059, Fort Worth, TX 76161 520.455.
141-474 ITRAFUNGOL (itraconazole oral solution) Do Do 520.1189.
065-081 GO-DRY (penicillin G procaine) Intramammary Infusion G. C. Hanford Mfg. Co., P.O. Box 1017, Syracuse, NY 13201 HQ Specialty Pharma Corp., 120 Rte. 17 North, Suite 130, Paramus, NJ 07652 526.1696.
200-335 Ampicillin Sodium Powder for Injection Do Do 522.90c.
200-372 HAN-PEN (penicillin G potassium) Soluble Powder Do Do 520.1696a.
065-071 Chlortetracycline (chlortetracycline hydrochloride) Soluble Powder Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405 520.441.
065-440 CHLORONEX (chlortetracycline hydrochloride) Soluble Powder Do Do Do.
200-441 A-MYCIN (chlortetracycline hydrochloride) Soluble Powder Do Do Do.
200-528 SAVALAN 60 (salinomycin sodium) Type A medicated article Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405 Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria 558.550.
( printed page 57995)
200-237 Isoflurane, U.S.P Piramal Enterprises Ltd., Ananta, Agastya Corporate Park, Opp Fire Brigade, Kamani Junction, LBS Mag Kurla (West), Mumbai, 400070, India Piramal Pharma Ltd., Ground Floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra, 400070, India N/A.

Following these changes of sponsorship, G. C. Hanford Manufacturing Co. and Piramal Enterprises Ltd. are no longer the sponsor of an approved application. Accordingly, the regulations in 21 CFR 510.600(c) are being amended to reflect these changes.

III. Technical Amendments

FDA is making the following amendments to improve the accuracy, consistency, and readability of the animal drug regulations:

  • 21 CFR 510.600 is amended by revising the entries for Cronus Pharma Specialities India Private Ltd. to reflect the correct address for the firm.
  • 21 CFR 520.2090 is amended to reflect the current approved indications for use for sarolaner, moxidectin, and pyrantel tablets.
  • 21 CFR 522.970 is amended to reflect the approved species for a flunixin injectable solution.
  • 21 CFR 558.76 for use of bacitracin methylenedisalicylate in medicated feed is amended to reflect a current tabular format organized by species.
  • 21 CFR 558.128 is amended to reflect sponsors of combination medicated feeds containing chlortetracycline for which there is no preslaughter withdrawal period.
  • 21 CFR 558.355 for use of monensin in medicated feeds is amended to reflect the sponsor of an approved generic product and to remove a redundant condition of use.

IV. Legal Authority

This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)), which requires Federal Register publication of “notice[s] . . . effective as a regulation,” of the conditions of use of approved new animal drugs. This rule sets forth technical amendments to the regulations to codify recent actions on approved new animal drug applications and corrections to improve the accuracy of the regulations, and as such does not impose any burden on regulated entities.

Although denominated a rule pursuant to the FD&C Act, this document does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a “rule of particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive Order 12866, which defines a rule as “an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.”

List of Subjects

21 CFR Part 510

  • Administrative practice and procedure
  • Animal drugs
  • Labeling
  • Reporting and recordkeeping requirements

21 CFR Part 516

  • Administrative practice and procedure
  • Animal drugs
  • Confidential business information
  • Reporting and recordkeeping requirements

21 CFR Parts 520, 522, and 526

  • Animal drugs

21 CFR Part 556

  • Animal drugs
  • Food

21 CFR Part 558

  • Animal drugs
  • Animal feeds

Therefore, under the Federal Food, Drug, and Cosmetic Act, 21 CFR parts 510, 516, 520, 522, 526, 556, and 558 are amended as follows:

PART 510—NEW ANIMAL DRUGS

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

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

2. In § 510.600:

a. In the table in paragraph (c)(1):

i. Add in alphabetical order an entry for “Anivive Lifesciences, Inc.”;

ii. Revise the entry for “Cronus Pharma Specialities India Private Ltd.”;

iii. Remove the entries for “G. C. Hanford Manufacturing Co.” and “Piramal Enterprises Ltd.”; and

iv. Add in alphabetical order an entry for “Piramal Pharma Ltd.”; and

b. In the table in paragraph (c)(2):

i. Remove the entry for “010515”;

ii. Revise the entries for “065085” and “069043”; and

iii. Add in numerical order an entry for “086121”.

The revisions and additions read as follows:

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

(c) * * *

(1) * * *

Firm name and address Drug labeler code
 
*         *         *         *         *         *         *
Anivive Lifesciences, Inc., 3250 Airflite Way, Suite 400, Long Beach, CA 90807 086121
 
*         *         *         *         *         *         *
Cronus Pharma Specialities India Private Ltd., Sy No-99/1, M/s GMR Hyderabad Aviation SEZ Ltd., Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, India 069043
 
*         *         *         *         *         *         *
Piramal Pharma Ltd., Ground Floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra, 400070, India 065085
 
 
( printed page 57996)
*         *         *         *         *         *         *

(2) * * *

Drug labeler code Firm name and address
 
*         *         *         *         *         *         *
065085 Piramal Pharma Ltd., Ground Floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra, 400070, India
 
*         *         *         *         *         *         *
069043 Cronus Pharma Specialities India Private Ltd., Sy No-99/1, M/s GMR Hyderabad Aviation SEZ Ltd., Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, India
 
*         *         *         *         *         *         *
086121 Anivive Lifesciences, Inc., 3250 Airflite Way, Suite 400, Long Beach, CA 90807
 
*         *         *         *         *         *         *

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

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

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

4. Add § 516.1858 to subpart E to read as follows:

Potassium bromide.

(a) Specifications. Each chewable tablet contains 250 or 500 milligrams (mg) potassium bromide.

(b) Sponsor. See No. 055246 in § 510.600(c) of this chapter.

(c) Conditions of use —(1) Amount. Administer 25 to 68 mg per kilogram (11 to 31 mg per pound) of body weight once daily. The dosage can be divided and should be adjusted to clinical response.

(2) Indications for use. For the control of seizures associated with idiopathic epilepsy in dogs.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.

5. Add § 516.2980 to subpart E to read as follows:

Verdinexor.

(a) Specifications. Each tablet contains 2.5, 10, or 50 milligrams (mg) verdinexor.

(b) Sponsor. See No. 086121 in § 510.600(c) of this chapter.

(c) Conditions of use —(1) Amount. Administer verdinexor tablets orally at an initial dose of 1.25 mg per kilogram (mg/kg) of body weight twice per week with at least 72 hours between doses. If tolerated after 2 weeks, increase the dose to 1.5 mg/kg twice per week with at least 72 hours between doses.

(2) Indications for use. For the treatment of lymphoma in dogs.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

7. In § 520.441, revise paragraph (b)(1) to read as follows:

Chlortetracycline powder.
* * * * *

(b) * * *

(1) Nos. 000010, 054771, and 069254 for use as in paragraph (d) of this section.

* * * * *

8. In § 520.455, revise the section heading and paragraph (b) to read as follows:

Clomipramine.
* * * * *

(b) Sponsors. See Nos. 051311 and 086039 in § 510.600(c) of this chapter.

* * * * *

9. In § 520.905c, revise paragraph (e)(2) to read as follows:

Fenbendazole paste.
* * * * *

(e) * * *

(2) Beef and dairy cattle —(i) Amount. Administer orally 2.3 mg/lb (5 mg/kg) body weight.

(ii) Indications for use. For the treatment and control of: Lungworms: Adult ( Dictyocaulus viviparus); Stomach worms: Adult brown stomach worms ( Ostertagia ostertagi), adult and fourth-stage larvae barberpole worms ( Haemonchus contortus), fourth-stage larvae barberpole worms ( H. placei), and adult and fourth-stage larvae small stomach worms ( Trichostrongylus axei); Intestinal worms (adult and fourth-stage larvae): Hookworms ( Bunostomum phlebotomum), thread-necked intestinal worms ( Nematodirus helvetianus), small intestinal worms ( Cooperia punctata and C. oncophora), bankrupt worms ( Trichostrongylus colubriformis), and nodular worms ( Oesophagostomum radiatum).

(iii) Limitations. Milk taken during treatment and for 96 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 8 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in preruminating calves.

10. In § 520.1189, revise paragraph (b) to read as follows:

Itraconazole.
* * * * *

(b) Sponsor. See No. 051311 in § 510.600(c) of this chapter.

* * * * *

11. In § 520.1248, revise paragraphs (b) and (c)(1) to read as follows:

Levothyroxine.
* * * * *
( printed page 57997)

(b) Sponsors. See Nos. 059051 and 061690 in § 510.600(c) of this chapter.

(c) * * *

(1) Amount. Administer by mouth as follows:

(i) No. 061690: 0.1 mg/10 pounds (lb) body weight (0.022 mg/kilogram (kg)) as a single dose every 24 hours or as a divided dose every 12 hours.

(ii) No. 059051: 0.1 mg/10 lb (0.01 mg/lb, 0.022 mg/kg) body weight twice daily.

* * * * *

12. In § 520.1510, revise paragraph (b)(1) to read as follows:

Nitenpyram.
* * * * *

(b) * * *

(1) No. 021091 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii)(A), and (d)(2) of this section.

* * * * *

13. In § 520.1696a, revise paragraph (b) to read as follows:

Penicillin G powder.
* * * * *

(b) Sponsors. See Nos. 016592, 042791, 054771, 061133, and 076475 in § 510.600(c) of this chapter.

* * * * *

14. In § 520.2090, revise paragraph (c)(2) to read as follows:

Sarolaner, moxidectin, and pyrantel.
* * * * *

(c) * * *

(2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina) and adult hookworm ( Ancylostoma caninum and Uncinaria stenocephala) infections. Kills adult fleas ( Ctenocephalides felis) and is indicated for the treatment and prevention of flea infestations, and the treatment and control of tick infestations with Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog tick) for 1 month in dogs and puppies 8 weeks of age and older, and weighing 2.8 pounds or greater.

* * * * *

15. In § 520.2645, revise paragraph (d)(2) to read as follows:

Tylvalosin.
* * * * *

(d) * * *

(2) Indications for use. For control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine intended for slaughter in buildings experiencing an outbreak of PPE; and for control of swine respiratory disease (SRD) associated with Bordetella bronchiseptica, Haemophilus parasuis, Pasteurella multocida,Streptococcus suis, and Mycoplasma hyopneumoniae in groups of swine intended for slaughter in buildings experiencing an outbreak of SRD.

* * * * *

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

17. In § 522.90c, revise paragraph (b) to read as follows:

Ampicillin sodium.
* * * * *

(b) See Nos. 042791 and 054771 in § 510.600(c) of this chapter.

* * * * *

18. In § 522.558, revise paragraphs (b)(1) and to read as follows:

Dexmedetomidine.
* * * * *

(b) * * *

(1) Nos. 026637 and 059399 for use of product described in paragraph (a)(2) of this section.

* * * * *

19. In § 522.970, revise paragraph (b)(1) and add paragraph (b)(3) to read as follows:

Flunixin.
* * * * *

(b) * * *

(1) See Nos. 000061, 055529, 058198, and 061133 for use as in paragraph (e) of this section.

* * * * *

(3) See No. 016592 for use as in paragraphs (e)(1) and (e)(2) of this section.

* * * * *

20. In § 522.1193, revise paragraphs (b) and (e)(2) and (3) to read as follows:

Ivermectin and clorsulon.
* * * * *

(b) Sponsors. See Nos. 000010, 055529, 058005, 061133, and 061651 in § 510.600(c) of this chapter.

* * * * *

(e) * * *

(2) Indications for use. For the treatment and control of gastrointestinal nematodes (adults and fourth-stage larvae) ( Haemonchus placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, Trichostrongylus axei,T. colubriformis, Cooperia oncophora,C. punctata, C. pectinata,Oesophagostomum radiatum, Nematodirus helvetianus (adults only), N. spathiger (adults only), Bunostomum phlebotomum; lungworms (adults and fourth-stage larvae) ( Dictyocaulus viviparus); liver flukes (adults only) ( Fasciola hepatica); cattle grubs (parasitic stages) ( Hypoderma bovis, H. lineatum); sucking lice ( Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus); mange mites (cattle scab) ( Psoroptes ovis (syn. P. communis var. bovis), Sarcoptes scabiei var. bovis); and for control of infections of D. viviparus and O. radiatum for 28 days after treatment; O. ostertagi, T. axei, and C. punctata for 21 days after treatment; and H. placei and C. oncophora for 14 days after treatment.

(3) Limitations. Do not treat cattle within 21 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

21. In § 522.1225, revise paragraph (b) to read as follows:

Ketoprofen.
* * * * *

(b) Sponsors. See Nos. 054771 and 061133 in § 510.600(c) of this chapter.

* * * * *

22. In § 522.1696a, revise paragraph (d)(2)(iii) to read as follows:

Penicillin G benzathine and penicillin G procaine suspension.
* * * * *

(d) * * *

(2) * * *

(iii) Limitations. Not for use within 30 days of slaughter. For No. 016592: A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

23. In § 522.2630, revise paragraphs (b) and (d)(1)(iii)(A) to read as follows:

Tulathromycin.
* * * * *

(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.

(1) Nos. 054771, 058198, and 061133 for use of product described in paragraph (a)(1) as in paragraphs (d)(1)(i), (d)(1)(ii), (d)(1)(iii)(A), and (d)(2) of this section.

(2) No. 054771 for use of product described in paragraph (a)(2) as in ( printed page 57998) paragraphs (d)(1)(i), (d)(1)(ii)(B), (d)(1)(iii)(B), and (d)(2) of this section.

* * * * *

(d) * * *

(1) * * *

(iii) * * *

(A) Cattle intended for human consumption must not be slaughtered within 18 days from the last treatment. This drug is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

* * * * *

PART 526—INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

24. The authority citation for part 526 continues to read as follows:

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

25. In § 526.1696, revise paragraph (b) to read as follows:

Penicillin G procaine.
* * * * *

(b) See Nos. 042791 and 061133 in § 510.600(c) of this chapter.

* * * * *

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

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

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

27. In § 556.275:

a. Revise paragraph (b)(1)(ii);

b. Remove paragraph (b)(1)(iii); and

c. Remove and reserve paragraphs (b)(3)(ii), (b)(4)(ii), and (b)(5)(ii).

The revision reads as follows:

Fenbendazole.
* * * * *

(b) * * *

(1) * * *

(ii) Milk: 0.22 ppm fenbendazole sulfoxide (marker residue).

* * * * *

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

29. In § 558.76:

a. Revise paragraphs (a)(1) and (2) and (d)(1);

b. Redesignate paragraph (d)(2) as paragraph (d)(6); and

c. Add new paragraph (d)(2) and paragraphs (d)(3) through (5).

The revisions and additions read as follows:

Bacitracin methylenedisalicylate.

(a) * * *

(1) Type A medicated articles containing feed grade bacitracin methylenedisalicylate equivalent to 10, 25, 30, 40, 50, 60, or 75 grams bacitracin per pound.

(2) Type A medicated article containing feed grade bacitracin methylenedisalicylate equivalent to 50 grams bacitracin per pound.

* * * * *

(d) * * *

(1) Chickens —

Bacitracin in grams per ton Indications for use Limitations Sponsor
(i) 4 to 50 Broiler and replacement chickens: For increased rate of weight gain and improved feed efficiency Feed continuously as sole ration 054771 069254
(ii) 10 to 25 Laying hens: For increased egg production and improved feed efficiency Feed continuously as sole ration for the first 7 months of egg production 054771
(iii) 50 Broiler and replacement chickens: 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 054771
(iv) 100 to 200 Broiler and replacement chickens: 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. Start at first clinical signs of disease. Vary dosage based on severity of infection. Administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce medication to prevention level (50 grams/ton) 054771

(2) Turkeys —

Bacitracin in grams per ton Indications for use Limitations Sponsor
(i) 4 to 50 Growing turkeys: For increased rate of weight gain and improved feed efficiency Feed continuously as sole ration 054771 069254
(ii) 200 Growing turkeys: As an aid in the control of transmissible enteritis complicated by organisms susceptible to bacitracin methylenedisalicylate Feed continuously as the sole ration 054771

(3) Swine —

Bacitracin in grams per ton Indications for use Limitations Sponsor
(i) 10 to 30 Growing and finishing swine: For increased rate of weight gain and improved feed efficiency 054771
( printed page 57999)
(ii) 250 Growing and finishing swine: For control of swine dysentery (bloody scours) associated with Brachyspira hyodysenteriae in pigs up to 250 lbs body weight Feed as the sole ration. Feed 250 grams per ton of complete feed on premises with a history of swine dysentery, but where signs of the disease have not yet occurred or following an approved treatment of the disease condition. Diagnosis should be confirmed by a veterinarian a when results are not satisfactory 054771
(iii) 250 Pregnant sows: For control of clostridial enteritis caused by Clostridium perfringens in suckling piglets As the sole ration. Feed to sows from 14 days before through 21 days after farrowing on premises with a history of clostridial scours. Diagnosis should be confirmed by a veterinarian when results are not satisfactory 054771

(4) Cattle —

Bacitracin amount Indications for use Limitations Sponsor
(i) 70 mg per head per day Beef steers and heifers fed in confinement for slaughter: For reduction in the number of liver condemnations due to abscesses Administer continuously throughout the feeding period 054771 069254
(ii) 250 mg per head per day Beef steers and heifers fed in confinement for slaughter: For reduction in the number of liver condemnations due to abscesses Administer continuously for 5 days then discontinue for subsequent 25 days, repeat the pattern during the feeding period 054771 069254

(5) Game birds —

Bacitracin in grams per ton Indications for use Limitations Sponsor
(i) 4 to 50 Growing pheasants: For increased rate of weight gain and improved feed efficiency Feed continuously as sole ration 054771 069254
(ii) 5 to 20 Growing quail: For increased rate of weight gain and improved feed efficiency in quail not over 5 weeks of age Feed continuously as sole ration to quail not over 5 weeks of age 054771 069254
(iii) 200 Growing quail: For the prevention of ulcerative enteritis in growing quail due to Clostridium colinum susceptible to bacitracin methylenedisalicylate Feed continuously as the sole ration 054771
* * * * *

30. In § 558.128, revise paragraphs (d)(4) and (e)(4) to read as follows:

Chlortetracycline.
* * * * *

(d) * * *

(4) Manufacture for use in free-choice feeds as in paragraph (e)(4)(vi) of this section must conform to § 510.455 of this chapter.

* * * * *

(e) * * *

(4) * * *

Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor
(i) to provide 70 mg/head/day Growing cattle (over 400 lb): For reduction of liver condemnation due to liver abscesses Feed to provide chlortetracycline at the rate of 70 mg per animal daily. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal 054771 066104 069254
(ii) 5.83 to 14 g/ton to provide 70 mg/head/day Melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg melengestrol acetate per head per day Growing beef heifers fed in confinement for slaughter (over 400 lb): For reduction of the incidence of liver abscesses, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) Melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with the Type C medicated feed containing 5.83 to 14 g/ton chlortetracycline. Chlortetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter 054771
( printed page 58000)
(iii) to provide 0.5 mg/lb of body weight daily Beef cattle (over 700 lb): For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline Feed to provide chlortetracycline at the rate of 0.5 mg per pound of body weight daily in beef cattle under 700 pounds. Withdraw 48 hours prior to slaughter. To sponsor Nos. 054771 and 069254: Zero withdrawal time 054771 066104 069254
(iv) 33.33 to 50 g/ton to provide 0.5 mg/lb of body weight per day Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg melengestrol acetate per head per day Replacement beef heifers over 700 lb: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline and for suppression of estrus (heat) Melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 33.33 to 50 g/ton chlortetracycline. Feeding a Type C top-dress medicated feed containing melengestrol acetate shall not exceed 24 days. Chlortetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter 054771
(v) 25 to 1,100 g/ton to provide 0.5 mg/lb of body weight daily Lasalocid, 30 to 600 Pasture cattle (slaughter, stocker, feeder cattle, beef replacement heifers) over 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline; and for increased rate of weight gain Feed continuously on a hand-fed basis 0.5 mg chlortetracycline per lb. body weight per day and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 069254
(vi) 25 to 1,100 g/ton to provide 0.5 mg/lb of body weight daily Lasalocid, 30 to 600; melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate Replacement beef heifers on pasture over 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline, increased rate of weight gain, and suppression of estrus (heat) The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 1,100 g/ton of chlortetracycline and 30 to 600 g/ton lasalocid to provide 0.5 mg chlortetracycline per lb body weight per day and not less than 60 mg or more than 300 mg lasalocid per head per day in at least 1 pound of feed. Do not exceed 24 days of feeding. See § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter 054771
(vii) to provide 0.5 to 2.0 mg/lb of body weight daily Beef cattle and nonlactating dairy cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline In free-choice cattle feeds such as feed blocks or salt-mineral mixes manufactured from approved Type A articles. See paragraph (d)(4) of this section 054771 069254
( printed page 58001)
(viii) to provide 10 mg/lb of body weight daily Calves, beef and nonlactating dairy cattle: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Treat for not more than 5 days. To sponsor No. 054771 (NADAs 048-761 and 046-699) and to sponsor No. 069254 (ANADA 200-510): May be mixed in the cattle's daily ration or administered as a top-dress. In feed including milk replacers withdraw 10 days prior to slaughter. To sponsor Nos. 054771 and 069254: Zero withdrawal time. See paragraph (d)(3) of this section 054771 066104 069254
(ix) to provide 10 mg/lb of body weight daily Calves (up to 250 lb): For the treatment of bacterial enteritis caused by Escherichia coli susceptible to chlortetracycline A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal 054771 066104 069254
(x) to provide 10 mg/lb of body weight daily Laidlomycin, 5 Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for increased rate of weight and improved feed efficiency Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day for not more than 5 days. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter 054771
(xi) to provide 10 mg/lb of body weight daily Laidlomycin, 5 to 10 Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for improved feed efficiency Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day for not more than 5 days. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter 054771
(xii) 500 to 2,000 to provide 10 mg/lb of body weight daily Lasalocid, 10 to 30 Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for improved feed efficiency Feed continuously in complete feed for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 100 mg or more than 360 mg lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 069254
( printed page 58002)
(xiii) to provide 10 mg/lb of body weight daily Lasalocid, 25 to 30 Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency Feed continuously in complete feed for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 250 mg or more than 360 mg lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 069254
(xiv) 500 to 4,000 to provide 10 mg/lb of body weight daily Lasalocid, 30 to 600 Pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heifers): For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain Feed continuously on a hand-fed basis for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 60 mg or more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 069254
(xv) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily Lasalocid, 30 to 600: Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate Replacement dairy heifers on pasture less than 20 months of age and replacement beef heifers on pasture: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, increased rate of weight gain, and suppression of estrus (heat) The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton of chlortetracycline and 30 to 600 g/ton lasalocid to provide 10 mg chlortetracycline per lb body weight per day and not less than 60 mg or more than 300 mg lasalocid per head per day in at least 1 pound of feed for not more than 5 days. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone for a total time not exceeding 24 days of feeding. See § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter 054771
( printed page 58003)
(xvi) 500 to 4,000 g/ton Calves, beef and nonlactating dairy cattle: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline Hand feed continuously for not more than 5 days to provide 10 mg/lb body weight per day. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. To sponsor No. 054771 under NADA 046-699: 24-hour withdrawal period. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200-510: Zero withdrawal period 054771 069254
(xvii) 500 to 4,000 g/ton Decoquinate, 12.9 to 90.8 Calves, beef and non-lactating dairy cattle: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for the prevention of coccidiosis caused by Eimeria bovis and E. zuernii Feed at a rate of 1g chlortetracycline per 100 lb body weight/day and 22.7 mg decoquinate per 100 lb of body weight/day for not more than 5 days. When it is fully consumed, resume feeding 22.7 mg decoquinate per 100 lb of body weight/day for a total of 28 days to prevent coccidiosis. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in § 510.600(c) of this chapter 054771 069254
(xviii) 500 to 4,000 to provide 10 mg per pound of body weight Melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg melengestrol acetate per head per day Growing beef heifers fed in confinement for slaughter: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) Melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton chlortetracycline for not more than 5 days. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone. Chlortetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter 054771
(xix) 500 to 4,000 to provide 10 mg per pound of body weight Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg melengestrol acetate per head per day Replacement dairy heifers less than 20 months of age and replacement beef heifers: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, and for suppression of estrus (heat) Melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton chlortetracycline for not more than 5 days. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone for a total time not exceeding 24 days. Use in dairy heifers less than 20 months of age may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Chlortetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter 054771
( printed page 58004)
(xx) 4,000 to 20,000 g/ton Calves, beef and nonlactating dairy cattle: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline Administer as a top dress, varying with body weight and feed consumption, to provide 10 mg/lb per day. Treat for not more than 5 days. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal 054771 069254
(xxi) 4,000 to 20,000 g/ton Decoquinate, 90.8 to 535.7 Calves, beef and non-lactating dairy cattle: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for the prevention of coccidiosis caused by Eimeria bovis and E. zuernii Feed at a rate of 1g chlortetracycline per 100 lb body weight/day and 22.7 mg decoquinate per 100 lb of body weight/day for not more than 5 days. When it is fully consumed, resume feeding 22.7 mg decoquinate per 100 lb of body weight/day for a total of 28 days to prevent coccidiosis. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in § 510.600(c) of this chapter 054771 069254
(xxii) 4,000 to 20,000 g/ton to provide 10 mg/lb of body weight per day Melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg melengestrol acetate per head per day Growing beef heifers fed in confinement for slaughter: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) Top dress 0.5 to 2 pounds of this medicated feed containing both drugs onto or mix at feeding with a non-medicated feed for not more than 5 days. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Chlortetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter 054771
(xxiii) 4,000 to 20,000 g/ton to provide 10 mg/lb of body weight per day Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg melengestrol acetate per head per day Replacement dairy heifers less than 20 months of age and replacement beef heifers: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, and for suppression of estrus (heat) Top dress 0.5 to 2 pounds of this medicated feed containing both drugs onto or mix at feeding with a non-medicated feed for not more than 5 days. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone for a total time not exceeding 24 days. Use in dairy heifers less than 20 months of age may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Chlortetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter 054771
( printed page 58005)
(xxiv) to provide 350 mg/head/day Beef cattle: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline Feed to provide chlortetracycline at the rate of 350 mg per animal daily. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Withdrawal periods: To sponsor No. 054771 under NADAs 046-699 and 049-287, No. 066104 under NADA 092-286, and No. 069254 under NADA 048-480: Withdraw 48 hours prior to slaughter. To sponsor No. 054771 under NADA 048-761 and No. 069254 under NADA 138-935 and ANADA 200-510: Zero withdrawal period 054771 066104 069254
(xxv) to provide 350 mg/head/day Beef cattle (under 700 lb): For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline Feed to provide chlortetracycline at the rate of 350 mg per animal daily. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Withdrawal periods: To sponsor No. 054771 under NADAs 046-699 and 049-287, No. 066104 under NADA 092-286, and No. 069254 under NADA 048-480: Withdraw 48 hours prior to slaughter. To sponsor No. 054771 under NADA 048-761 and No. 069254 under NADA 138-935 and ANADA 200-510: Zero withdrawal period 054771 066104 069254
(xxvi) 50 to 350 g/ton to provide 350 mg/head/day Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg melengestrol acetate per head per day Replacement beef heifers under 700 lb: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline and for suppression of estrus (heat) Melengestrol acetate Type C top-dress medicated feed must be top dressed or mixed at feeding with the Type C medicated feed containing 50 to 350 g/ton chlortetracycline for up to 24 days of feeding. Do not exceed 24 days of feeding. Chlortetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter 054771
(xxvii) 20 to 350 g/ton Beef cattle and replacement dairy heifers: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline Feed to provide chlortetracycline at the rate of 350 mg per head per day. This drug is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200-510: Zero withdrawal period 054771 069254
(xxviii) 20 to 350 g/ton to provide 350 mg/head/day Melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg melengestrol acetate per head per day Growing beef heifers fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) Melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with the Type C medicated feed containing 20 to 350 g/ton chlortetracycline. Chlortetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter 054771
( printed page 58006)
(xxix) 20 to 350 g/ton to provide 350 mg/head/day Melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg melengestrol acetate per head per day Replacement dairy heifers less than 20 months of age and replacement beef heifers: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline and suppression of estrus (heat) Melengestrol acetate Type C top-dress medicated feed must be top dressed or mixed at feeding with the Type C medicated feed containing 20 to 350 g/ton chlortetracycline. Use in dairy heifers less than 20 months of age may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Chlortetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter 054771
(xxx) to provide 350 mg/head/day Laidlomycin, 5 Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for increased rate of weight and improved feed efficiency Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter 054771
(xxxi) to provide 350 mg/head/day Laidlomycin, 5 to 10 Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for improved feed efficiency Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter 054771
(xxxii) 25 to 42.2 g/ton to provide 350 mg/head/day Lasalocid, 25 to 30 Cattle under 700 pounds fed in confinement for slaughter: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 250 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 069254
(xxxiii) 25 to 42.2 g/ton to provide 350 mg/head/day Lasalocid, 25 to 30 Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiency Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 250 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 069254
( printed page 58007)
(xxxiv) 25 to 100 g/ton to provide 350 mg/head/day Lasalocid, 10 to 30 Cattle under 700 pounds fed in confinement for slaughter: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline; and for improved feed efficiency Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 100 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 069254
(xxxv) 25 to 100 g/ton to provide 350 mg/head/day Lasalocid, 10 to 30 Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for improved feed efficiency Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 100 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 069254
(xxxvi) 25 to 700 to provide 350 g/head/day Lasalocid, 30 to 600 Pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heifers): For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain Feed continuously on a hand-fed basis at a rate of 350 mg chlortetracycline and not less than 60 mg nor more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 069254
(xxxvii) 25 to 700 g/ton to provide 350 mg/head/day Lasalocid, 30 to 600; melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate Replacement beef heifers on pasture: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline, increased rate of weight gain, and suppression of estrus (heat) The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 700 g/ton of chlortetracycline and 30 to 600 g/ton lasalocid to provide 350 mg chlortetracycline per head daily and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 pound of feed. Do not exceed 24 days of feeding. See § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter 054771
( printed page 58008)
(xxxviii) 25 to 700 to provide 350 mg/head/day Lasalocid, 30 to 600 Pasture cattle (slaughter, stocker, feeder cattle, beef replacement heifers) under 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline; and for increased rate of weight gain Feed continuously on a hand-fed basis at a rate of 350 mg chlortetracycline and not less than 60 mg nor more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 069254
(xxxix) 25 to 700 g/ton to provide 350 mg/head/day Lasalocid, 30 to 600; melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate Replacement beef heifers on pasture under 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline, increased rate of weight gain, and suppression of estrus (heat) The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 700 g/ton of chlortetracycline and 30 to 600 g/ton lasalocid to provide 350 mg chlortetracycline per head daily and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 pound of feed. Do not exceed 24 days of feeding. See § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter 054771
(xl) 25 to 2,800 to provide 350 mg/head/day Lasalocid, 30 to 181.8 Beef cattle weighing under 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline; and for the control of coccidiosis caused by Eimeria bovis and E. zuernii Hand feed continuously at a rate of 350 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Chlortetracycline and lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 069254
(xli) 25 to 2,80 g/ton to provide 350 mg/head/day Lasalocid, 30 to 181.8; melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg/head/day melengestrol acetate Growing beef heifers fed in confinement for slaughter under 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline, control of coccidiosis caused by Eimeria bovis and E. zuernii, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 2,800 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 350 mg chlortetracycline per head per day and 1 mg lasalocid per 2.2 lb. of body weight daily with a maximum of 360 mg lasalocid per head per day. See § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter 054771
( printed page 58009)
(xlii) 25 to 2,800 to provide 350 mg/head/day Lasalocid, 30 to 181.8 Beef cattle weighing up to 800 pounds: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for the control of coccidiosis caused by Eimeria bovis and E. zuernii Hand feed continuously at a rate of 350 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 069254
(xliii) 25 to 2,800 g/ton to provide 350 mg/head/day Lasalocid, 30 to 181.8; melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg/head/day melengestrol acetate Growing beef heifers fed in confinement for slaughter up to 800 pounds: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline, control of coccidiosis caused by Eimeria bovis and E. zuernii, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 2,800 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 350 mg chlortetracycline per head daily and 1 mg lasalocid per 2.2 lb. of body weight daily with a maximum of 360 mg lasalocid per head per day. See § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter 054771
(xliv) 25 to 2,800 g/ton to provide 350 mg/head/day Lasalocid, 30 to 181.8; melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate Replacement beef heifers up to 800 pounds: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline, control of coccidiosis caused by Eimeria bovis and E. zuernii, and suppression of estrus (heat) The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 2,800 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 350 mg chlortetracycline per head daily and 1 mg lasalocid per 2.2 lb. of body weight daily with a maximum of 360 mg lasalocid per head per day. Do not exceed 24 days of feeding. See § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter 054771
(xlv) 500 to 4,000 to provide 10 mg/head/day Lasalocid, 30 to 181.8 Cattle weighing up to 800 pounds: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline; and for the control of coccidiosis caused by Eimeria bovis and E. zuernii Hand feed continuously for not more than 5 days at a rate of 10 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter 054771 069254
( printed page 58010)
(xlvi) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily Lasalocid, 30 to 181.8; melengestrol acetate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg/head/day melengestrol acetate Growing beef heifers fed in confinement for slaughter up to 800 pounds: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, control of coccidiosis caused by Eimeria bovis and E. zuernii, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 10 mg chlortetracycline per lb of body weight per day and 1 mg lasalocid per 2.2 lb of body weight per day with a maximum of 360 mg lasalocid per head per day for not more than 5 days of feeding. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone. See § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter 054771
(xlvii) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily Lasalocid, 30 to 181.8; melengestrol acetate, 0.5 to 2 g/ton to provide 0.5 mg/head/day melengestrol acetate Replacement dairy heifers up to 800 pounds and less than 20 months of age and replacement beef heifers up to 800 pounds: For the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline, control of coccidiosis caused by Eimeria bovis and E. zuernii, and suppression of estrus (heat) The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 10 mg chlortetracycline per lb of body weight per day and 1 mg lasalocid per 2.2 lb of body weight per day with a maximum of 360 mg lasalocid per head per day for not more than 5 days. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone. See § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter 054771
* * * * *

31. In § 558.342, revise paragraph (e)(1)(iv) to read as follows:

Melengestrol.
* * * * *

(e) * * *

(1) * * *

Melengestrol acetate in mg/head/day Combination in mg/head/day Indications for use Limitations Sponsor
 
*         *         *         *         *         *         *
(iv) 0.25 to 0.5 Monensin, 10 to 40 Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat); and for the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii Add at the rate of 0.5 to 2.0 lb/head/day a medicated feed (liquid or dry) containing 0.125 to 1.0 mg melengestrol acetate/lb to a feed containing 10 to 40 g of monensin per ton to provide 0.25 to 0.5 mg melengestrol acetate/head/day and 0.14 to 0.42 mg monensin/lb body weight, depending on severity of coccidiosis challenge, up to 480 mg monensin/head/day. See § 558.355(d) of this chapter. Monensin as provided by No. 016592 or 058198; melengestrol acetate as provided by No. 016952, 054771, or 058198 in § 510.600(c) of this chapter 016592 045771 058198
 
( printed page 58011)
*         *         *         *         *         *         *
* * * * *

32. In § 558.355, revise paragraphs (b)(2), (f)(2)(ii), (f)(3), and (f)(4)(i) and (ii), remove paragraph (f)(4)(v), redesignate paragraph (f)(4)(vi) as paragraph (f)(4)(v) and revise it, and revise paragraphs (f)(6)(i) and (f)(7)(viii)

The revisions read as follows:

Monensin.
* * * * *

(b) * * *

(2) No. 016592 for use of a Type A medicated article containing 90.7 grams monensin, USP, per pound as in paragraphs (f)(3), (f)(4)(v), and (f)(6) of this section.

* * * * *

(f) * * *

(2) * * *

Monensin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor
 
*         *         *         *         *         *         *
(ii) 54 to 90 Bacitracin methylenedisalicylate, 4 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 and improved feed efficiency Feed continuously as the sole ration. The optimum level depends upon the severity of coccidiosis exposure. 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. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with development of immunity to turkey coccidiosis. Bacitracin methylenedisalicylate as provided by No. 054771 or 069254 in § 510.600(c) of this chapter 058198 069254
 
*         *         *         *         *         *         *

(3) * * *

Monensin in grams/ton Indications for use Limitations Sponsor
(i) 5 to 40 Growing beef steers and heifers 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). See special labeling considerations in paragraph (d) of this section 016592 058198
(ii) 10 to 40 Growing beef steers and heifers fed in confinement for slaughter: For prevention and control of coccidiosis due to Eimeria 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. See special labeling considerations in paragraph (d) of this section 016592 058198
(iii) 10 to 200 Calves excluding veal calves: For prevention and control of coccidiosis due to Eimeria 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. See special labeling considerations in paragraph (d) of this section 016592 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 016592 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 016592 058198
( printed page 58012)
(vi) 15 to 400 Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) or in a dry lot and replacement beef and dairy heifers: For increased rate of weight gain, and for prevention and control of coccidiosis due to Eimeria 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. See special labeling considerations in paragraph (d) of this section 016592 058198
(vii) 25 to 400 Beef cows: For improved feed efficiency when receiving supplemental feed, and for the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii 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 in not less than 1 pound of feed. See special labeling considerations in paragraph (d) of this section 016592 058198

(4) * * *

Monensin amount Indications for use Limitations Sponsor
(i) 150 milligrams per pound of protein-mineral block (0.033%) Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) and replacement beef heifers on pasture: For increased rate of weight gain, and for prevention and control of coccidiosis caused by Eimeria 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. See paragraph (d)(10)(i) of this section 012286
(ii) 175 milligrams per pound of protein-mineral block (0.038%) Growing beef steers and heifers on pasture (stocker, feeder, and slaughter): 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. See paragraph (d)(10)(i) of this section 017800
 
*         *         *         *         *         *         *
(v) 1,620 grams per ton of mineral granules as specified in paragraph (f)(4)(v)(A) of this section Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) or in a dry lot and replacement beef and dairy heifers: For increased rate of weight gain, and for prevention and control of coccidiosis due to Eimeria 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 016592 058198

(A) Specifications. Use as free-choice Type C medicated feed formulated as mineral granules as follows:

Ingredient Percent International feed No.
Monocalcium phosphate (21% phosphorus, 15% calcium) 29.49 6-01-082
Sodium chloride (salt) 24.37 6-04-152
Dried cane molasses 20.0 4-04-695
Ground limestone (33% calcium) or calcium carbonate (38% calcium) 13.75 6-02-632
( printed page 58013)
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 should comply with FDA Compliance Policy Guide Sec. 651.100 (CPG 7125.18).

(B) [Reserved]

* * * * *

(6) * * *

Monensin in grams/ton Indications for use Limitations Sponsor
(i) 20 Goats maintained in confinement: For the prevention of coccidiosis caused by Eimeria crandallis, E. christenseni, and E. ninakohlyakimovae Feed continuously. Do not feed to lactating goats. See paragraph (d)(11) of this section for provisions for monensin liquid Type C goat feeds 016592 058198
 
*         *         *         *         *         *         *

(7) * * *

(viii) Ractopamine as in § 558.500.

* * * * *

33. In § 558.500, revise paragraphs (e)(2)(ii), (iv), (v), and (vii) to read as follows:

Ractopamine.
* * * * *

(e) * * *

(2) * * *

Ractopamine in grams/ton Combination in grams/ton Indications for use Limitations Sponsor
 
*         *         *         *         *         *         *
(ii) 8.2 to 24.6 to provide 70 to 430 mg/head/day Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and prevention and control of coccidiosis due to Eimeria bovis and E. zuernii during the last 28 to 42 days on feed Feed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding. See special labeling considerations in § 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter 016592 054771 058198
 
*         *         *         *         *         *         *
(iv) 9.8 to 24.6 to provide 90 to 430 mg/head/day Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, and prevention and control of coccidiosis due to Eimeria bovis and E. zuernii during the last 28 to 42 days on feed Feed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding. See special labeling considerations in § 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter 016592 054771 058198
(v) 9.8 to 24.6 to provide 90 to 430 mg/head/day Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day, plus melengestrol acetate to provide 0.25 to 0.5 mg/head/day Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, and suppression of estrus (heat) during the last 28 to 42 days on feed Feed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding. See special labeling considerations in §§ 558.342(d) and 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198; melengestrol acetate as provided by No. 016592, 054771 or 058198 in § 510.600(c) of this chapter 016592 054771 058198
 
( printed page 58014)
*         *         *         *         *         *         *
(vii) Not to exceed 800; to provide 70 to 400 mg/head/day Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and prevention and control of coccidiosis due to Eimeria bovis and E. zuernii during the last 28 to 42 days on feed Top dress ractopamine at a minimum of 1.0 lb/head/day of medicated feed continuously during the last 28 to 42 days on feed. Not for animals intended for breeding. See special labeling considerations in § 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter 016592 054771 058198
 
*         *         *         *         *         *         *
* * * * *

34. In § 558. 550, revise paragraphs (a), (b), (e)(1)(i), and (e)(2)(i) to read as follows:

Salinomycin.

(a) Specifications. Type A medicated articles containing 30 or 60 grams of salinomycin sodium activity per pound.

(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter for use as in paragraph (e) of this section.

* * * * *

(e) * * *

(1) * * *

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 birds producing eggs for human consumption. May be fatal if accidentally fed to adult turkeys or horses 016592
 
*         *         *         *         *         *         *

(2) * * *

Salinomycin in grams/ton Combination in grams per ton Indications for use Limitations Sponsor
(i) 50 Quail: For the prevention of coccidiosis caused by Eimeria dispersa and E. lettyae Feed continuously as sole ration. Do not feed to birds producing eggs for human consumption. May be fatal if accidentally fed to adult turkeys or horses 016592
 
*         *         *         *         *         *         *
* * * * *

35. In § 558.625, revise paragraphs (e)(2)(i) and (e)(2)(ix) through (xiii) to read as follows:

Tylosin.
* * * * *

(e) * * *

(2) * * *

Tylosin grams/ton Combination in grams/ton Indications for use Limitations Sponsor
(i) 8 to 10 Beef cattle: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes Feed continuously as the sole ration to provide 60 to 90 mg/head/day tylosin 016592 054771 058198 066104
 
( printed page 58015)
*         *         *         *         *         *         *
(ix) 8 to 10 Monensin 10 to 40 plus melengestrol 0.25 to 2.0 Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii; and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) Feed continuously as sole ration to heifers at a rate of 0.5 to 2 pounds per head per day to provide 0.25 to 0.5 mg/head/day melengestrol acetate and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin. The melengestrol acetate portion of this Type C medicated feed must be mixed into the complete feed containing 10 to 40 g/ton monensin and 8 to 10 g/ton tylosin at feeding into the amount of complete feed consumed by an animal per day. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. See §§ 558.342(d) and 558.355(d) of this chapter. Tylosin provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; melengestrol provided by No. 016592, 054771, or 058198 in § 510.600(c) of this chapter 016592 054771 058198
(x) 8 to 10 Monensin 10 to 40 plus ractopamine 8.2 to 24.6 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii; and for increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter for the last 28 to 42 days on feed Feed continuously as sole ration to provide 70 to 430 mg/head/day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin for the last 28 to 42 days on feed. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. See special labeling considerations in §§ 558.355(d) and 558.500(d) of this chapter. Tylosin provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; ractopamine provided by No. 016592, 054771, or 058198 in § 510.600(c) of this chapter 016592 054771 058198
(xi) 8 to 10 Monensin 10 to 40 plus ractopamine, not to exceed 800 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii; and for increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter for the last 28 to 42 days on feed Feed a minimum of 1.0 lb/head/day ractopamine Type C top dress feed continuously to cattle fed in confinement for slaughter, to provide 70 to 400 mg/head/day ractopamine for the last 28 to 42 days on feed. Feed on top of a ration containing 10 to 40 g/ton monensin and 8 to 10 g/ton tylosin phosphate, to provide 0.14 to 0.42 mg monensin/lb body weight/day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. See special labeling considerations in §§ 558.355(d) and 558.500(d) of this chapter. Tylosin provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; ractopamine provided by No. 016592, 054771, or 058198 in § 510.600(c) of this chapter 016592 054771 058198
( printed page 58016)
(xii) 8 to 10 Monensin 10 to 40 plus ractopamine 9.8 to 24.6 Cattle fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 28 to 42 days on feed Feed continuously as sole ration to provide 90 to 430 mg/head/day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin for the last 28 to 42 days on feed. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. See special labeling considerations in §§ 558.355(d) and 558.500(d) of this chapter. Tylosin as provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; ractopamine as provided by No. 016592, 054771, or 058198 in § 510.600(c) of this chapter 016592 054771 058198
(xiii) 8 to 10 Monensin, 10 to 40 plus ractopamine, 9.8 to 24.6, plus melengestrol, 0.125 to 1 mg/lb Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii; for increased rate of weight gain, improved feed efficiency, and increased carcass leanness; and suppression of estrus (heat) in heifers fed in confinement for slaughter for the last 28 to 42 days on feed Feed continuously as sole ration to provide 90 to 430 mg/head/day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin for the last 28 to 42 days on feed. Feed melengestrol as a top dress or mixed with a complete ration at the rate of 0.5 to 2.0 pound/head/day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate/head/day (specify one level). A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be processed for veal. See special labeling considerations in §§ 558.342(d), 558.355(d), and 558.500(d) of this chapter. Tylosin provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; ractopamine as provided by No. 016592, 054771, or 058198; melengestrol acetate as provided by No. 016592 or 054771 in § 510.600(c) of this chapter 016592 054771 058198
 
*         *         *         *         *         *         *
* * * * *

Dated: October 12, 2021.

Lauren K. Roth,

Associate Commissioner for Policy.

[FR Doc. 2021-22604 Filed 10-19-21; 8:45 am]

BILLING CODE 4164-01-P

Published Document: 2021-22604 (86 FR 57992)