88 FR 233 pgs. 84696-84704 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
Type: RULEVolume: 88Number: 233Pages: 84696 - 84704
Pages: 84696, 84697, 84698, 8469984700, 84701, 84702, 84703, 84704, Docket number: [Docket No. FDA–2023–N–0002]
FR document: [FR Doc. 2023–26545 Filed 12–5–23; 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, 516, 520, 522, 524, and 558
[Docket No. FDA-2023-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule; technical amendments.
SUMMARY:
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during July, August, and September 2023. The animal drug regulations are also being amended to improve their accuracy and readability.
DATES:
This rule is effective December 6, 2023.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5689, George.Haibel@fda.hhs.gov .
SUPPLEMENTARY INFORMATION:
I. Approvals
FDA is amending the animal drug regulations to reflect approval actions for NADAs, ANADAs, and CNADAs during July, August, and September 2023, 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 (FOIA Summaries) under the Freedom of Information Act (FOIA). These documents, along with marketing exclusivity and patent information, may be obtained at AnimalDrugs@FDA: https://animaldrugsatfda.fda.gov/adafda/views/#/search.
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| Approval date | File No. | Sponsor | Product name | Effect of the action | 21 CFR section |
|---|---|---|---|---|---|
| July 6, 2023 | 200-752 | Cronus Pharma Specialties India Private Ltd., Sy No-99/1, M/s GMR Hyderabad Aviation SEZ Ltd., Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, India | DEXMEDVET (dexmedetomidine hydrochloride) Injectable Solution | Original approval as a sedative, analgesic, and preanesthetic in dogs and cats as a generic copy of NADA 141-267 | 522.558 |
| July 11, 2023 | 200-753 | Do | CROPAMEZOLE (atipamezole hydrochloride) Injectable Solution | Original approval for reversal of sedation and analgesia in dogs as a generic copy of NADA 141-033 | 522.147 |
| July 19, 2023 | 141-554 | Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA30096 | NEXGARD PLUS (afoxolaner, moxidectin, and pyrantel chewable tablets) | Original approval for the prevention, treatment, and control of internal and external parasites in dogs | 520.35 |
| August 3, 2023 | 200-755 | Felix Pharmaceuticals Pvt. Ltd., 25-28 North Wall Quay, Dublin 1, Ireland | Firocoxib Chewable Tablets | Original approval for the control of pain and inflammation associated with osteoarthritis and for the control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery as a generic copy of NADA 141-230 | 520.928 |
| August 3, 2023 | 200-756 | Ceva Sante Animale, 10 Avenue de la Ballastière, 33500 Libourne, France | FIRODYL (firocoxib) Chewable Tablets | Original approval for the control of pain and inflammation associated with osteoarthritis and for the control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery as a generic copy of NADA 141-230 | 520.928 |
| August 10, 2023 | 141-568 | Boehringer Ingelheim Animal Health USA, Inc., 3239 Satellite Blvd., Duluth, GA30096 | SENVELGO (velagliflozin oral solution) | Original approval to improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin | 520.2654 |
| August 31, 2023 | 200-757 | ZyVet Animal Health, Inc., 73 Route 31N, Pennington, NJ 08534 | Acepromazine Maleate Tablets (acepromazine maleate tablets) | Original approval as an aid in tranquilization and as a preanesthetic agent in dogs as a generic copy of NADA 117-532 | 520.23 |
| September 6, 2023 | 141-578 | Genus Lifesciences Inc., 700 N Fenwick St., Allentown, PA 18109 | FIDOQUEL-CA1 (phenobarbital tablets) | Conditional approval for the control of seizures associated with idiopathic epilepsy in dogs | 516.1760 |
| September 20, 2023 | 200-310 | Parnell Technologies Pty. Ltd., Unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia | ESTROPLAN (cloprostenol injection) Injectable Solution | Supplemental approval for use with gonadorelin to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows as a generic copy of NADA 113-645 | 522.460 |
II. Withdrawals of Approval
Oasmia Pharmaceutical AB, Vallongatan 1, Uppsala, 75228 Sweden requested that FDA withdraw conditional approval of CNADA 141-422 for PACCAL VET-CA1 (paclitaxel for injection) because the product is no longer manufactured or marketed. Also, Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767-1861 requested that FDA withdraw approval of the eight abbreviated applications 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.
| File No. | New animal drug | 21 CFR section |
|---|---|---|
| 200-190 | GENTORAL (gentamicin sulfate) Concentrate Solution | 520.1044a |
| 200-241 | LINCOSOL (lincomycin hydrochloride) Soluble Powder | 520.1263b |
| 200-245 | DERMA-VET (neomycin sulfate, nystatin, thiostrepton, triamcinolone acetonide) Cream | 524.1600a |
| 200-275 | MEDALONE (triamcinolone acetonide) Cream | 524.2483 |
| 200-289 | NEOSOL-ORAL (neomycin sulfate) Concentrate Solution | 520.1484 |
| 200-292 | IVERSOL (ivermectin) Liquid for Horses | 520.1195 |
| 200-299 | IVER-ON (ivermectin) Topical Solution | 524.1193 |
| 200-456 | Dexamethasone Solution | 522.540 |
III. Change of Sponsor
The sponsors of the approved applications listed in table 3 have informed FDA that they have transferred ownership of, and all rights and interest in, these applications to another sponsor. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions.
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| File No. | Product name | Transferring sponsor | New sponsor | 21 CFR section |
|---|---|---|---|---|
| 141-342 | ALFAXAN Multidose (alfaxalone) injectable solution | Jurox Pty. Ltd., 85 Gardiner St., Rutherford, NSW 2320, Australia | Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 | 522.52 |
| 200-699 | Dexmedetomidine hydrochloride injection | Akorn Operating Co. LLC, 5605 Centerpoint Ct., Suite A, Gurnee, IL 60031 | Parnell Technologies Pty. Ltd., Unit 4, 476 Gardeners Rd., Alexandria, New South Wales 2015, Australia | 522.558 |
| 200-614 | Pentobarbital sodium and phenytoin sodium injectable solution | Do | Noble Pharma, LLC, 4602 Domain Dr., Menomonie, WI 54751 | 522.1700 |
| 141-559 | Pentosan polysulfate sodium injectable solution | Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043 | Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom | 522.1704 |
| 200-553 | Bacitracin, neomycin, polymyxin B ophthalmic ointment | Akorn Operating Co. LLC, 5605 Centerpoint Ct., Suite A, Gurnee, IL 60031 | Domes Pharma S.A., ZAC de Champ Lamet, 3 rue Andre Citroen, Pont-du-Chateau, Auvergne-Rhône-Alpes, 63430, FRANCE | 524.154 |
As provided in the regulatory text of this document, the animal drug regulations cited in table 3 are amended to reflect these actions.
IV. Change of Sponsor Address
Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525 has informed FDA that it has changed its address to 3760 Rocky Mountain Ave., Loveland, CO 80538-7084. The entries in §?510.600(c) are amended to reflect this action.
V. Technical Amendments
FDA is making the following amendments to improve the accuracy of the animal drug regulations.
• 21 CFR 510.600 is amended to reflect sponsors of approved applications by adding entries for Domes Pharma S.A., Genus Lifesciences, Inc., and Noble Pharma, LLC, by revising the entry for Heska Corp., and by removing the entries for Jurox Pty. Ltd. and Oasmia Pharmaceutical AB.
• 21 CFR 520.23 is amended to reflect approved strengths of acepromazine maleate tablets for dogs and cats.
• 21 CFR 522.460 is amended to reflect current labeling for cloprostenol injectable solution for use in cattle.
• 21 CFR 522.2640 is amended to reflect the approved strengths of generic tylosin injectable solutions.
• 21 CFR 558.330 is amended to reflect the sponsors of drugs approved for use in combination medicated feeds containing lubebegron and monensin.
• 21 CFR 558.355 is amended to reflect the classes of pasture cattle approved for use of a monensin free-choice block.
• 21 CFR 558.625 is amended to reflect the sponsors of drugs approved for use in combination medicated feeds containing lubebegron, monensin, and tylosin.
VI. 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 Part 516
Administrative practice and procedure, Animal drugs, Confidential business information, 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, 516, 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.
2. In §?510.600, in the table in paragraph (c)(1), add entries for "Domes Pharma S.A.", "Genus Lifesciences, Inc.", and "Noble Pharma, LLC"; revise the entry for "Heska Corp."; and remove the entries for "Jurox Pty. Ltd." and "Oasmia Pharmaceutical AB".
3. In the table in paragraph (c)(2), remove the entries for "049480" and "052818", revise the entry for "063604", and add entries for "064950", "086119", and "086189".
The revisions read as follows:
§?510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.
(c) * * *
(1) * * *
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| Firm name and address | Drug labeler code |
|---|---|
| * * * * * * * | |
| Domes Pharma S.A., ZAC de Champ Lamet, 3 rue Andre Citroen, Pont-du-Chateau, Auvergne-Rhône-Alpes, 63430, FRANCE | 086189 |
| * * * * * * * | |
| Genus Lifesciences Inc., 700 N Fenwick St., Allentown, PA 18109 | 064950 |
| * * * * * * * | |
| Heska Corp., 3760 Rocky Mountain Ave., Loveland, CO 80538-7084 | 063604 |
| * * * * * * * | |
| Noble Pharma, LLC, 4602 Domain Dr., Menomonie, WI 54751 | 086119 |
| * * * * * * * |
(2) * * *
| Drug labeler code | Firm name and address |
|---|---|
| * * * * * * * | |
| 063604 | Heska Corp., 3760 Rocky Mountain Ave., Loveland, CO 80538-7084. |
| * * * * * * * | |
| 064950 | Genus Lifesciences Inc., 700 N Fenwick St., Allentown, PA 18109. |
| * * * * * * * | |
| 086119 | Noble Pharma, LLC, 4602 Domain Dr., Menomonie, WI 54751. |
| * * * * * * * | |
| 086189 | Domes Pharma S.A., ZAC de Champ Lamet, 3 rue Andre Citroen, Pont-du-Chateau, Auvergne-Rhône-Alpes, 63430, FRANCE. |
| * * * * * * * |
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-1, 360ccc-2, 371.
§?516.1684 [Removed]
4. Remove §?516.1684.
5. Add §?516.1760 to subchapter E to read as follows:
§?516.1760 Phenobarbital.
(a) Specifications. Each tablet contains 16.2, 32.4, 64.8, or 97.2 milligrams (mg) phenobarbital.
(b) Sponsor. See No. 064950 in §?510.600(c) of this chapter.
(c) Conditions of use -(1) Amount. Administer phenobarbital as tablets given orally twice a day at the minimum dosage of 2.5 mg per kilogram of body weight (mg/kg) and may be titrated to effect to a maximum dosage of 5 mg/kg. The dosage of phenobarbital tablets should be adjusted based on monitoring the clinical response of the individual patient.
(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.
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 §?520.23, revise paragraphs (a) and (b) to read as follows:
§?520.23 Acepromazine.
(a) Specifications. Each tablet contains 10 or 25 milligrams (mg) acepromazine maleate.
(b) Sponsors. See Nos. 000010 and 086117 in §?510.600(c) of this chapter.
8. Add §?520.35 to read as follows:
§?520.35 Afoxolaner, moxidectin, and pyrantel.
(a) Specifications. Each chewable tablet contains 9.375 milligrams (mg) afoxolaner, 45 micrograms (mcg) moxidectin, and 18.75 mg pyrantel; 18.75 mg afoxolaner, 90 mcg moxidectin, and 37.5 mg pyrantel; 37.5 mg afoxolaner, 180 mcg moxidectin, and 75 mg pyrantel; 75 mg afoxolaner, 360 mcg moxidectin, and 150 mg pyrantel; or 150 mg afoxolaner, 720 mcg moxidectin, and 300 mg pyrantel.
(b) Sponsor. See No. 000010 in §?510.600(c) of this chapter.
(c) Conditions of use -(1) Amount. Administer orally once a month at the minimum dose of 1.14 mg/lb (2.5 mg/kg) afoxolaner, 5.45 mcg/lb (12 mcg/kg) moxidectin, and 2.27 mg/lb (5.0 mg/kg) pyrantel. For heartworm disease prevention, give once monthly for at least 6 months after last exposure to mosquitoes.
[top] (2) Indications for use in dogs. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult hookworm ( Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala ) and roundworm ( Toxocara canis and Toxascaris leonina ) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis ) and the treatment and control of Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), Dermacentor variabilis (American dog tick), and Amblyomma americanum (lone star tick) infestations for 1 month in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§?520.928 [Amended]
9. In §?520.928, in paragraph (b)(1), remove "Nos. 000010, 055246, and 055529" and in its place add "Nos. 000010, 013744, 055246, 055529, and 086101".
§?520.1044a [Amended]
10. In §?520.1044a, in paragraph (b), remove "Nos. 000061 and 054925" and in its place add "No. 000061".
11. In §?520.1195, revise paragraph (b)(1) to read as follows:
§?520.1195 Ivermectin liquid.
(b) * * *
(1) Nos. 058005 and 058198 for use of product described in paragraph (a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section.
12. In §?520.1263b, revise paragraphs (b)(2) and (d)(1)(iii) to read as follows:
§?520.1263b Lincomycin powder.
(b) * * *
(2) Nos. 016592 and 076475 for use as in paragraphs (d)(1) and (2) of this section.
(d) * * *
(1) * * *
(iii) Limitations. Discard medicated drinking water if not used within 2 days. Prepare fresh stock solution daily. Do not use for more than 10 days. If clinical signs of disease have not improved within 6 days, discontinue treatment and reevaluate diagnosis. The safety of lincomycin has not been demonstrated in pregnant swine or swine intended for breeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§?520.1484 [Amended]
13. In §?520.1484, in paragraph (b)(1), remove "Nos. 054771 and 054925" and in its place add "No. 054771"; and remove paragraph (b)(4).
14. Add §?520.2654 to read as follows:
§?520.2654 Velagliflozin.
(a) Specifications. Each milliliter of solution contains 15 milligrams (mg) velagliflozin.
(b) Sponsor. See No. 000010 in §?510.600(c) of this chapter.
(c) Conditions of use -(1) Amount. Administer orally 0.45 mg per pound of body weight (1 mg per kilogram) velagliflozin once daily.
(2) Indications for use. To improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
PART 522-IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
15. The authority citation for part 522 continues to read as follows:
Authority:
21 U.S.C. 360b.
§?522.52 [Amended]
16. In §?522.52, in paragraph (b), remove "049480" and in its place add "054771".
17. In §?522.147, revise paragraphs (b), (c)(1), and (2) to read as follows:
§?522.147 Atipamezole.
(b) Sponsors. See Nos. 015914, 052483, and 069043 in §?510.600(c) of this chapter.
(c) * * *
(1) Amount. Administer 3,750 mcg/m 2 intramuscularly for the reversal of intravenous dexmedetomidine hydrochloride or medetomidine hydrochloride and 5,000 mcg/m 2 intramuscularly for the reversal of intramuscular dexmedetomidine hydrochloride or medetomidine hydrochloride.
(2) Indications for use. For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride and medetomidine hydrochloride.
18. In §?522.460, revise paragraphs (b) and (c) to read as follows:
§?522.460 Cloprostenol.
(b) Sponsors. See sponsors in §?510.600(c) of this chapter.
(1) No. 000061 for use of product described in paragraph (a)(1) of this section as in paragraphs (c)(1)(i) and (c)(2) of this section.
(2) No. 000061 for use of product described in paragraph (a)(2) as in paragraphs (c)(1)(ii) through (viii) and (c)(2) of this section.
(3) No. 068504 for use of product described in paragraph (a)(2) as in paragraphs (c)(1)(ii) through (vii), (c)(1)(ix), and (c)(2) of this section.
(c) Conditions of use in cattle -(1) Amount and indications for use.
(i) Administer 375 µg by intramuscular injection to induce abortion in pregnant feedlot heifers from 1 week after mating until 4 1⁄2 months of gestation.
(ii) Administer 500 µg by intramuscular injection for unobserved or non-detected estrus in beef cows, lactating dairy cows, and replacement beef and dairy heifers.
(iii) Administer 500 µg by intramuscular injection for treatment of pyometra or chronic endometritis in beef cows, lactating dairy cows, and replacement beef and dairy heifers.
(iv) Administer 500 µg by intramuscular injection for treatment of mummified fetus in beef cows, lactating dairy cows, and replacement beef and dairy heifers.
(v) Administer 500 µg by intramuscular injection for treatment of luteal cysts in beef cows, lactating dairy cows, and replacement beef and dairy heifers.
(vi) Administer 500 µg by intramuscular injection for abortion of beef cows, lactating dairy cows, and replacement beef and dairy heifers from 1 week after mating until 5 months of gestation. Not for use in heifers placed in feedlots.
(vii) Administer 500 µg by intramuscular injection as a single injection regimen or double injection regimen with a second injection 11 days after the first injection, for estrus synchronization in beef cows, lactating dairy cows, and replacement beef and dairy heifers.
(viii) For use with gonadorelin acetate to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows: administer to each cow 86 µg gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 86 µg gonadorelin by intramuscular injection. Gonadorelin acetate as provided in §?522.1077(a)(1) of this chapter.
(ix) For use with gonadorelin to synchronize estrous cycles to allow for FTAI in lactating dairy cows: administer to each cow by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by gonadorelin by intramuscular injection. Gonadorelin as provided in §?522.1077(a)(1) through (3) of this chapter.
(2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§?522.540 [Amended]
[top] 19. In §?522.540, in paragraph (a)(2)(ii), remove " Sponsors. See Nos.
§?522.558 [Amended]
20. In §?522.558, in paragraph (b)(1), remove "Nos. 017033, 059399, and 086117" and in its place add "Nos. 017033, 068504, 069043, and 086117".
§?522.1700 [Amended]
21. In §?522.1700, in paragraph (b), remove "059399" and in its place add "086119".
§?522.1704 [Amended]
22. In §?522.1704, in paragraph (b), remove "086073" and in its place add "043264".
23. In §?522.2640, revise paragraphs (b)(1) and (2) to read as follows:
§?522.2640 Tylosin.
(b) * * *
(1) Nos. 016592 and 058198 for use of 50- or 200-mg/mL solutions as in paragraph (e) of this section.
(2) No. 061133 for use of a 200-mg/mL solution as in paragraphs (e)(1) and (2) of this section.
PART 524-OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
24. The authority citation for part 524 continues to read as follows:
Authority:
21 U.S.C. 360b.
§?524.154 [Amended]
25. In §?524.154, in paragraph (b)(2), remove "059399" and in its place add "086189".
§?524.1193 [Amended]
26. In §?524.1193, in paragraph (b)(2), remove "Nos. 016592 and 054925" and in its place add "No. 016592".
27. In §?524.1600a, revise paragraph (b) to read as follows:
§?524.1600a Nystatin, neomycin, thiostrepton, and triamcinolone ointment.
(b) Sponsors. See sponsors in §?510.600(c) of this chapter:
(1) For petrolatum base ointments: Nos. 025463 and 054771; or
(2) For vanishing cream base ointments: Nos. 025463 and 054771.
§?524.2483 [Removed]
28. Remove §?524.2483.
PART 558-NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
29. The authority citation for part 558 continues to read as follows:
Authority:
21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
30. In §?558.330, revise paragraphs (d)(1)(ii) and (iii) and (d)(2)(i) and (ii) to read as follows:
§?558.330 Lubabegron.
(d) * * *
(1) * * *
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| Lubabegron fumarate in grams/ton | Combination in grams/ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|---|
| * * * * * * * | ||||
| (ii) 1.25 to 4.54 | Monensin, 5 to 40 | Beef steers and heifers fed in confinement for slaughter: for reduction of ammonia gas emissions per pound of live weight and hot carcass weight and for improved feed efficiency during the last 14 to 91 days on feed | Feed continuously as the sole ration to provide 13 to 90 mg lubabegron/head/day and 50 to 480 mg monensin/head/day during the last 14 to 91 days on feed. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 g/ton (360 mg monensin/head/day). A decrease in dry matter intake may be noticed in some animals receiving lubabegron. Lubabegron has not been approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed containing lubabegron and monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal. See special labeling considerations in §?558.355(d) of this chapter. Lubabegron fumarate as provided by No. 058198, monensin as provided by No. 016592 or 058198 in §?510.600(c) of this chapter | 016592, 058198 |
| (iii) 1.25 to 4.54 | Monensin, 10 to 40 | Beef steers and heifers fed in confinement for slaughter: for reduction of ammonia gas emissions per pound of live weight and hot carcass weight; and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii during the last 14 to 91 days on feed | Feed continuously as the sole ration to provide 13 to 90 mg lubabegron/head/day and 0.14 to 0.42 mg monensin/lb body weight per day, depending upon severity of coccidiosis challenge, during the last 14 to 91 days on feed. A decrease in dry matter intake may be noticed in some animals receiving lubabegron. Lubabegron has not been approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed containing lubabegron and monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal. See special labeling considerations in §?558.355(d) of this chapter. Lubabegron fumarate as provided by No. 058198, monensin as provided by No. 016592 or 058198 in §?510.600(c) of this chapter | 016592, 058198 |
(2) * * *
(i) Monensin as in §?558.355.
(ii) Tylosin in §?558.625.
31. In §?558.355, revise paragraph (f)(4)(iv) to read as follows:
§?558.355 Monensin.
(f) * * *
(4) * * *
| Monensin amount | Indications for use | Limitations | Sponsor |
|---|---|---|---|
| * * * * * * * | |||
| (iv) 400 mg per pound of block | Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) and beef replacement heifers): for increased rate of weight gain | Provide 50 to 200 mg of monensin (2 to 8 ounces of block) per head per day, in at least one block per five head of cattle. Feed blocks continuously. Do not feed salt of mineral supplements in addition to this block. Discontinue feeding if block consumption falls below 2 ounces or rises above 8 ounces daily. See paragraph (d)(10)(i) of this section. | 086113 |
| * * * * * * * |
32. In §?558.625, revise paragraphs (e)(2)(vii) and (viii) to read as follows:
§?558.625 Tylosin.
(e) * * *
(2) * * *
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| Tylosin grams/ton | Combination in grams/ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|---|
| * * * * * * * | ||||
| (vii) 8 to 10 | Monensin, 5 to 40 plus lubabegron fumarate, 1.25 to 4.54 | Beef steers and heifers fed in confinement for slaughter: for reduction of ammonia gas emissions per pound of live weight and hot carcass weight; for reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and Arcanobacterium pyogenes and for improved feed efficiency during the last 14 to 91 days on feed | Feed continuously as sole ration to provide 13 to 90 mg lubabegron/head/day, 50 to 480 mg monensin/head/day, and 60 to 90 mg tylosin/head/day during the last 14 to 91 days on feed. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 g/ton (360 mg monensin/head/day). A decrease in dry matter intake may be noticed in some animals receiving lubabegron. Lubabegron has not been approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed containing lubabegron and monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal. See special labeling considerations in §?558.355(d) of this chapter. Tylosin as provided by No. 016592 or 058198, monensin as provided by No. 016592 or 058198, lubabegron fumarate as provided by No. 058198 in §?510.600(c) of this chapter | 016592, 058198 |
| (viii) 8 to 10 | Monensin, 10 to 40 plus lubabegron fumarate, 1.25 to 4.54 | Beef steers and heifers fed in confinement for slaughter: for reduction of ammonia gas emissions per pound of live weight and hot carcass weight, for reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and Arcanobacterium pyogenes and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii during the last 14 to 91 days on feed | Feed continuously as sole ration to provide 13 to 90 mg lubabegron/head/day, 0.14 to 0.42 mg monensin/lb body weight per day, depending upon severity of coccidiosis challenge, up to 480 mg/head/day, and 60 to 90 mg tylosin/head/day during the last 14 to 91 days on feed. A decrease in dry matter intake may be noticed in some animals receiving lubabegron. Lubabegron has not been approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed containing lubabegron and monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic reactions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal. See special labeling considerations in §?558.355(d) of this chapter. Tylosin as provided by No. 016592 or 058198, monensin as provided by No. 016592 or 058198, lubabegron fumarate as provided by No. 058198 in §?510.600(c) of this chapter | 016592, 058198 |
| * * * * * * * |
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Dated: November 29, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26545 Filed 12-5-23; 8:45 am]
BILLING CODE 4164-01-P