89 FR 231 pgs. 95101-95108 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor
Type: RULEVolume: 89Number: 231Pages: 95101 - 95108
Pages: 95101, 95102, 95103, 95104, 95105, 95108Docket number: [Docket No. FDA-2024-N-0002]
FR document: [FR Doc. 2024-28061 Filed 11-29-24; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and 558
[Docket No. FDA-2024-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor
AGENCY:
Food and Drug Administration, HHS.
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ACTION:
Final rule; technical amendments.
SUMMARY:
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2024. The animal drug regulations are also being amended to improve their accuracy and readability.
DATES:
This rule is effective December 2, 2024.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5689, George.Haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Approvals
FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during July, August, and September 2024, 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 and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval under the Freedom of Information Act. These documents, along with marketing exclusivity and patent information, may be obtained at Animal Drugs @FDA: https://animaldrugsatfda.fda.gov/adafda/views/#/search.
| Date of approval | File No. | Sponsor (drug labeler code? 1 ) | Product name | Effect of the action | 21 CFR section |
|---|---|---|---|---|---|
| July 2, 2024 | 200-788 | Bimeda Animal Health Ltd. (061133) | MOXISOLV Injection (moxidectin) | Original approval as a generic copy of NADA 141-220 | 522.1450 |
| July 8, 2024 | 200-771 | Norbrook Laboratories, Ltd. (055529) | FELANORM (methimazole) Oral Solution | Original approval as a generic copy of NADA 141-292 | 520.1372 |
| August 15, 2024 | 200-770 | Pharmgate Inc. (069254) | DERACIN (chlortetracycline) and MGA (melengestrol acetate) Type C medicated feeds | Original approval as a generic copy of NADA 141-530 | 558.128 |
| August 26, 2024 | 200-783 | Huvepharma EOOD (016592) | COXIDIN 90 (monensin) Type C medicated feeds | Original approval as a generic copy of NADA 038-878 and NADA 130-736 | 558.355 |
| September 5, 2024 | 200-795 | Felix Pharmaceuticals Pvt. Ltd. (086101) | CARPROFEN Soft Chewable Tablets (carprofen) | Original approval as a generic copy of NADA 141-111 | 520.304 |
| September 5, 2024 | 200-773 | Cronus Pharma Specialties India Private Ltd. (069043) | TULAJECT 100 (tulathromycin injection) Injectable Solution | Original approval as a generic copy of NADA 141-224 | 522.2630 |
| September 10, 2024 | 200-774 | Do | TULAJECT 25 (tulathromycin injection) Injectable Solution | Original approval as a generic copy of NADA 141-349 | Do. |
| September 19, 2024 | 141-585 | Elanco US Inc. (058198) | ZENRELIA (ilunocitinib tablet) | Original approval for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs | 520.1136 |
| September 23, 2024 | 200-776 | Pharmgate Inc. (069254 | DERACIN (chlortetracycline), BOVATEC (lasalocid), and MGA (melengestrol acetate) Type C medicated feeds | Original approval as a generic copy of NADA 141-531 | 558.128 |
| 1 ?See 21 CFR 510.600(c) for sponsor addresses. | |||||
II. Withdrawals of Approval
Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861 (drug labeler code 054925) requested that FDA withdraw approval of the two NADAs listed in table 2 because the products are no longer manufactured or marketed. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions.
| Date of withdrawal of approval | File No. | Product name | 21 CFR section |
|---|---|---|---|
| August 8, 2024 | 130-872 | Nitrofurazone Anesthetic Dressing (nitrofurazone and butacaine sulfate) | 524.1580c |
| Do | 140-881 | Nitrofurazone Soluble Dressing (nitrofurazone) | 524.1580a |
III. Change of Sponsor
Cephazone Pharma, LLC, 250 East Bonita Ave., Pomona, CA 91767 has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200-420 for Ceftiofur Sodium Sterile Powder to Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211. As provided in the regulatory text, the animal drug regulations are amended to reflect this action.
IV. Technical Amendments
FDA is making the following amendments to improve the accuracy and readability of the animal drug regulations:
• 21 CFR 510.600(c) is amended to remove Cephazone Pharma, LLC and Provetica LLC from the lists of sponsors of approved applications as these firms are no longer the sponsor of an approved application.
• 21 CFR 520.522 is amended to reflect a 2023 change of sponsorship for cyclosporine oral solution.
[top] • 21 CFR 520.2090 is amended to revise the description of a tablet containing sarolaner, moxidectin, and pyrantel.
• 21 CFR 522.2470 is being amended to reflect previous approval of additional indications for use of tiletamine and zolazepam.
V. Legal Authority
This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)). Although deemed 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" and 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.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, and 524
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 510, 520, 522, 524, 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.
§?510.600 [Amended]
2. In §?510.600, in the table in paragraph (c)(1), remove the entries for "Cephazone Pharma, LLC" and "Provetica LLC"; and in the table in paragraph (c)(2), remove the entries for "068330" and "086097".
PART 520-ORAL DOSAGE FORM NEW ANIMAL DRUGS
3. The authority citation for part 520 continues to read as follows:
Authority:
21 U.S.C. 360b.
§?520.304 [Amended]
4. In §?520.304, in paragraph (b)(2), add in numerical order the text "086101".
§?520.522 [Amended]
5. In §?520.522 in paragraph (b)(4), remove the text "086097" and add in its place the text "013744".
6. Add §?520.1136 to read as follows:
§?520.1136 Ilunocitinib.
(a) Specifications. Each tablet contains 4.8, 6.4, 8.5, and 15 milligrams (mg) ilunocitinib.
(b) Sponsor. See No. 058198 in §?510.600(c) of this chapter.
(c) Conditions of use -(1) Amount. Administer orally 0.27 to 0.36 mg ilunocitinib/lb (0.6 to 0.8 mg ilunocitinib/kg) body weight, once daily, with or without food.
(2) Indications for use. For the control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§?520.1372 [Redesignated as §?520.1375]
7. Redesignate §?520.1372 as §?520.1375 and revise the section heading to read as follows:
§?520.1375 Methimazole tablets.
8. Add §?520.1376 to read as follows:
§?520.1376 Methimazole solution.
(a) Specifications. Each milliliter of solution contains 5 milligrams (mg) methimazole.
(b) Sponsor. See No. 055529 in §?510.600(c) of this chapter.
(c) Conditions of use in cats -(1) Amount. Administer a starting dose of 2.5 mg every 12 hours. Following 3 weeks of treatment, the dose should be titrated to effect based on individual serum total T4 (TT4) levels and clinical response. Dose adjustments should be made in 2.5 mg increments with a maximum dosage of 20 mg per day divided, not to exceed 10 mg as a single dose.
(2) Indications for use. For the treatment of hyperthyroidism.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
9. In §?520.2090, revise paragraph (a)(1) to read as follows:
§?520.2090 Sarolaner, moxidectin, and pyrantel.
(a) * * *
(1) 3.0 milligrams (mg) sarolaner, 0.06 mg moxidectin, and 12.5 mg pyrantel (as pamoate salt);
PART 522-IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
10. The authority citation for part 522 continues to read as follows:
Authority:
21 U.S.C. 360b.
11. In §?522.313c, revise paragraph (b) to read as follows:
§?522.313c Ceftiofur sodium.
(b) Sponsors. See Nos. 017033 and 054771 in §?510.600(c) of this chapter.
12. In §?522.1450, revise paragraph (b) to read as follows:
§?522.1450 Moxidectin solution.
(b) Sponsors. See Nos. 055529, 058198, and 061133 in §?510.600(c) of this chapter.
13. In §?522.2470, revise the section heading and paragraph (b) to read as follows:
§?522.2470 Tiletamine and zolazepam.
(b) Sponsors. See Nos. 017033, 051311, and 054771 in §?510.600(c) of this chapter.
§?522.2630 [Amended]
14. In §?522.2630, in paragraphs (b)(1) and (2), add in numerical order the text "069043".
PART 524-OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
15. The authority citation for part 524 continues to read as follows:
Authority:
21 U.S.C. 360b.
§?524.1580a [Amended]
16. Amend §?524.1580a in paragraph (b)(1) by removing the text "054925".
§?524.1580c [Removed]
17. Remove §?524.1580c.
PART 558-NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
18. The authority citation for part 558 continues to read as follows:
Authority:
21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
19. In §?558.128, revise paragraphs (e)(4)(ii), (vi), (viii), (xxviii), (xxxi), (xxxii), (xxxv), (xxxvi), (xxxix), (xli), (xlii), (l), (lii), (liv), (lvi), (lvii), (lix), and (lx) to read as follows:
§?558.128 Chlortetracycline.
(e) * * *
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| Chlortetracycline amount | Combination in grams/ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|---|
| * * * * * * * | ||||
| (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 or mixed at feeding with the Type C medicated feed containing 5.83 to 14 g/ton chlortetracycline. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in §?510.600(c) of this chapter. | 054771 069254 |
| * * * * * * * | ||||
| (vi) 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 or mixed at feeding with the 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 as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in §?510.600(c) of this chapter. | 054771 069254 |
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| (viii) 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 as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in §?510.600(c) of this chapter. | 054771 069254 |
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| (xxviii) 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 as provided by Nos. 054771 or 069254, lasalocid and melengestrol as provided by No. 054771 in §?510.600(c) of this chapter. | 054771 069254 |
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| (xxxi) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily | 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 as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in §?510.600(c) of this chapter. | 054771 069254 |
| (xxxii) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily | 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 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 as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in §?510.600(c) of this chapter. | 054771 069254 |
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| (xxxv) 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 to provide 10 mg chlortetracycline per pound of body weight per day. 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 as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in §?510.600(c) of this chapter. | 054771 069254 |
| (xxxvi) 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 to provide 10 mg chlortetracycline per pound of body weight per day. 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 as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in §?510.600(c) of this chapter. | 054771 069254 |
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| (xxxix) 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. Chlortetracycline as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in §?510.600(c) of this chapter. | 054771 069254 |
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| (xli) 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 as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in §?510.600(c) of this chapter. | 054771 069254 |
| (xlii) 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. Feeding a Type C top-dress medicated feed containing melengestrol acetate shall not exceed 24 days of feeding. 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 as provided by Nos. 054771 or 069254; melengestrol as provided by No. 054771 in §?510.600(c) of this chapter. | 054771 069254 |
| * * * * * * * | ||||
| (l) 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 as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in §?510.600(c) of this chapter. | 054771 069254 |
| * * * * * * * | ||||
| (lii) 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 as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in §?510.600(c) of this chapter. | 054771 069254 |
| * * * * * * * | ||||
| (liv) 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 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 as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in §?510.600(c) of this chapter. | 054771 069254 |
| * * * * * * * | ||||
| (lvi) 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 as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in §?510.600(c) of this chapter. | 054771 069254 |
| (lvii) 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 as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in §?510.600(c) of this chapter. | 054771 069254 |
| * * * * * * * | ||||
| (lix) 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 as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in §?510.600(c) of this chapter. | 054771 069254 |
| (lx) 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 as provided by Nos. 054771 or 069254; lasalocid and melengestrol as provided by No. 054771 in §?510.600(c) of this chapter. | 054771 069254 |
| * * * * * * * |
20. In §?558.355:
a. Revise paragraphs (b)(1) and (2);
b. Revise the headings for paragraphs (d)(9)(i) and (ii) and (d)(10)(i) and (ii);
c. Redesignate paragraph (f) as paragraph (e);
d. Revise newly redesignated paragraphs (e)(1)(i) and (ii), (e)(2)(i), and (e)(5);
e. Remove newly redesignated paragraph (e)(6); and
f. Redesignate newly redesignated paragraph (e)(7) as paragraph (e)(6).
The revisions read as follows:
§?558.355 Monensin.
(b) * * *
(1) No. 058198 for use as in paragraph (e) of this section.
(2) No. 016592 for use of a Type A medicated article containing 90.7 grams monensin, USP, per pound as in paragraphs (e)(1)(i), (e)(1)(ii), (e)(2)(i), (e)(3), (e)(4)(v), and (e)(5) of this section.
(d) * * *
(9) * * *
(i) Cattle (as described in paragraphs (e)(3)(i) through (iii), (vi), and (vii); and (e)(4)(i) through (vi) of this section). * * *
(ii) Dairy cows (as described in paragraphs (e)(3)(iv) and (v) of this section). * * *
(10) * * *
(i) Cattle (as described in paragraphs (e)(3)(i) through (iii), (vi), and (vii); and (e)(4)(i) through (vi) of this section). * * *
(ii) Dairy cows (as described in paragraphs (e)(3)(iv) and (v) of this section). * * *
(e) * * *
[top] (1) * * *
| Monensin in grams/ton | Combination in grams/ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|---|
| (i) 90 to 110 | Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima | Feed continuously as the sole ration. Not for broiler breeder replacement chickens. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. In the absence of coccidiosis in broiler chickens the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. 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. | 016592 058198 | |
| (ii) 90 to 110 | Laying hen replacement chickens and layer breeder replacement chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima | Feed continuously as the sole ration. Not for broiler breeder replacement chickens. Do not feed to chickens over 16 weeks of age. Do not feed to laying chickens. In the absence of coccidiosis in broiler chickens the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. 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. | 016592 058198 | |
| * * * * * * * |
(2) * * *
| Monensin in grams/ton | Combination in grams/ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|---|
| (i) 54 to 90 | Growing turkeys: For the prevention of coccidiosis caused by E. adenoeides, E. meleagrimitis, and E.gallopavonis | For growing turkeys only. Feed continuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Not for broiler breeder replacement chickens. Do not feed to laying hens. Do not feed to chickens over 16 weeks of age. Monensin may interfere with development of immunity to turkey coccidiosis. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. | 016592 058198 | |
| * * * * * * * |
(5) Minor species -
| Monensin in grams/ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|
| (i) 73 | Growing bobwhite quail: For the prevention of coccidiosis caused by Eimeria dispersa and E. lettyae | Feed continuously as sole ration. Not for broiler breeder replacement chickens. Do not feed to laying hens. Do not feed to chickens over 16 weeks of age. 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. | 016592 058198 |
| (ii) 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 |
| * * * * * * * |
Dated: November 20, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-28061 Filed 11-29-24; 8:45 am]
BILLING CODE 4164-01-P