# [Amended]
**AGENCY:**
Food and Drug Administration, HHS.
**ACTION:**
Final rule; technical amendments.
**SUMMARY:**
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January, February, and March 2022. 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 of the regulations.
**DATES:**
This rule is effective September 29, 2022.
**FOR FURTHER INFORMATION CONTACT:**
George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5689, *[email protected].*
**SUPPLEMENTARY INFORMATION:**
**I. Approvals**
FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during January, February, and March 2022, 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.
| Approval date | File No. | Sponsor | Product name | Species | Effect of the action | Public |
| --- | --- | --- | --- | --- | --- | --- |
| January 10, 2022 | 131-675 | Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 | SAFE-GUARD (fenbendazole), Type A Medicated Article | Cattle | Supplemental approval to establish withdrawal periods in accordance with repartitioning of acceptable daily intake; and to add fourth-stage larval indications for certain endoparasites of cattle | |
| January 13, 2022 | 141-546 | Zoetis Inc, 333 Portage St., Kalamazoo, MI 49007 | SOLENSIA (frunevetmab injection), Injectable Solution | Cats | Original approval for the control of pain associated with osteoarthritis | FOI Summary. |
| January 20, 2022 | 141-547 | Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 | ZORBIUM (buprenorphine transdermal solution), Transdermal Solution | Cats | Original approval for the control of postoperative pain associated with surgical procedures | FOI Summary. |
| January 25, 2022 | 200-707 | Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str.,1113 Sofia, Bulgaria | TILMOVET AC (tilmicosin), Solution | Swine | Original approval as a generic copy of NADA 141-361 | FOI Summary. |
| January 28, 2022 | 200-716 | Norbrook Laboratories Ltd., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom | MIDAMOX for Dogs (imidacloprid and moxidectin), Topical Solution | Dogs | Original approval as a generic copy of NADA 141-251 | FOI Summary. |
| February 7, 2022 | 200-665 | Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 | INCREXXA 25 (tulathromycin injection), Injectable Solution | Cattle and Swine | Original approval as a generic copy of NADA 141-349 | FOI Summary. |
| February 7, 2022 | 200-717 | Aurora Pharmaceutical, Inc,1196 Highway 3 South, Northfield, MN 55057-3009 | TIAGARD 12.5% (tiamulin hydrogen fumarate), Liquid Concentrate | Swine | Original approval as a generic copy of NADA 140-916 | FOI Summary. |
| February 7, 2022 | 200-718 | ......do | BARRIER for Dogs (imidacloprid and moxidectin), Topical Solution | Dogs | Original approval as a generic copy of NADA 141-251 | FOI Summary. |
| February 9, 2022 | 200-715 | Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 | AROVYN (tulathromycin injection), Injectable Solution | Cattle and Swine | Original approval as a generic copy of NADA 141-244 | FOI Summary. |
| March 11, 2022 | 200-720 | Norbrook Laboratories Ltd., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom | ENROFLOX (enrofloxacin), Chewable Tablets | Dogs | Original approval as a generic copy of NADA 140-441 | FOI Summary. |
| March 23, 2022 | 200-723 | ......do | TULIEVE (tulathromycin injection), Injectable Solution | Cattle and Swine | Original approval as a generic copy of NADA 141-244 | FOI Summary. |
| March 28, 2022 | 200-721 | ......do | MIDAMOX for Cats (imidacloprid and moxidectin), Topical Solution | Cats | Original approval as a generic copy of NADA 141-254 | FOI Summary. |
| March 28, 2022 | 200-722 | ......do | FIROX (firocoxib), Chewable Tablets | Dogs | Original approval as a generic copy of NADA 141-230 | FOI Summary. |
| March 28, 2022 | 200-688 | Virbac AH, Inc., P.O .Box 162059, Fort Worth, TX 76161 | TENOTRYL (enrofloxacin), Injectable Solution | Cattle and Swine | Original approval as a generic copy of NADA 141-068 | FOI Summary. |
| March 30, 2022 | 141-551 | Vetcare Oy, P.O. Box 26 (Liedontie 45), Mäntsälä, Uusimaa, 04601, Finland | ZENALPHA (medetomidine and vatinoxan injection) | Dogs | Original approval for use as a sedative and analgesic to facilitate clinical examination, clinical procedures, and minor surgical procedures | FOI Summary. |
**II. Withdrawals of Approval**
Lloyd, Inc., 604 W. Thomas Ave., Shenandoah, IA 51601, has requested that FDA withdraw approval of NADA 140-908 for VET-METH Bolus, a bolus containing sulfamethazine for use in cattle because the product is no longer manufactured or marketed. As provided in the regulatory text of this document, the animal drug regulations in 21 CFR 520.2260a are amended to reflect this action.
Ridley USA, Inc., 111 W. Cherry St., Suite 500, Mankato, MN 56001, has requested that FDA withdraw approval of NADA 136-214 for VMS Bloat Blox, an oral dosage form containing polyoxyethylene (23) lauryl ether for use in beef and nonlactating dairy cattle because the product is no longer manufactured or marketed. As provided in the regulatory text of this document, the animal drug regulations in 21 CFR 520.1846 are amended to reflect this action.
**III. Changes of Sponsorship**
Halocarbon Products Corp., 6525 The Corners Pkwy., Suite 200, Peachtree Corners, GA 30092 has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200-129 for Isoflurane, USP and ANADA 200-467 for Sevoflurane to Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211. As provided in the regulatory text, the animal drug regulations in 21 CFR 529.1186 and 529.2110, respectively, are amended to reflect these changes of sponsorship.
**IV. Change of Sponsor's Name and Address**
Mylan Institutional, Inc., 12720 Dairy Ashford Rd., Sugar Land, TX 77478 has informed FDA that it has changed its name and address to Mylan Institutional, Inc., a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505. As provided in the regulatory text, the animal drug regulations in § 510.600(c) (21 CFR 510.600(c)) are amended to reflect this change of a sponsor's name and address.
**V. Technical Amendments**
FDA is making the following amendments to improve the accuracy of the animal drug regulations:
• Section 510.600 is amended to remove the entry for Halocarbon Products Corp. from, and add Vetcare Oy to, the list of sponsors of approved applications. The entries for Mylan Institutional, Inc. and Norbrook Laboratories Ltd. are revised as well.
• 21 CFR 516.812 is amended to reflect a current drug labeler code for a use of enrofloxacin injectable solution in cattle.
• 21 CFR 520.88g is amended reflect a current sponsor drug labeler code and revised indications for use of tablets containing amoxicillin and clavulanate in dogs and cats.
• 21 CFR 520.530 is amended to conform to content codified for animal drugs available by veterinary prescription.
• 21 CFR 520.905a is amended to reflect revised conditions of use for fenbendazole suspension in horses.
• 21 CFR 520.928 is amended to reflect correct directions for administration of firocoxib chewable tablets in dogs.
• 21 CFR 520.1242a is amended to reflect revised indications for use of a levamisol powder in cattle and sheep.
• 21 CFR 520.1720a is amended to correct an error in the strength of approved phenylbutazone boluses.
• 21 CFR 520.1870 is amended to remove an undefined acronym in the conditions for use of praziquantel tablets.
• 21 CFR 520.1872 is amended to conform to content codified for animal drugs available by veterinary prescription.
• 21 CFR 520.2325a is amended to reflect instructions for use of sulfaquinoxaline powder and solution in poultry and cattle.
• 21 CFR 520.2598 is amended to reflect revised indications for use for trilostane capsules in dogs.
• 21 CFR 522.533 is amended to revise the indications for use of deslorelin injectable solution in mares.
• 21 CFR 522.2615 is amended to reflect revised human food safety warnings for tripelennamine injectable solution in cattle.
• 21 CFR 524.1001 is amended to correct a spelling error in the heading and specifications for fluralaner and moxidectin topical solution.
• 21 CFR 524.2098 is amended to reflect all sponsors of approved applications for selamectin topical solution in dogs and cats.
• 21 CFR 558.4 is amended in the Category II table to reflect the correct assay limits for Type C medicated feeds manufactured using nicarbazin powder.
• 21 CFR 558.128 is amended to reflect the class of cattle and incorporation level for single-ingredient and combination-drug medicated feeds containing chlortetracycline used for control of anaplasmosis in cattle.
• 21 CFR 558.633 is amended to clarify expiration dates for medicated feeds containing tylvalosin.
**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)), 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**
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements.
Animal drugs.
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, 515, 516, 520, 522, 524, 529, and 558 are amended as follows:
**PART 510—NEW ANIMAL DRUGS**
**21 CFR Part 510**
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.
**21 CFR Part 510**
2. In § 510.600:
a. In the table in paragraph (c)(1), remove the entry for “Halocarbon Products Corp.”; revise the entries for “Mylan Institutional, Inc.” and “Norbrook Laboratories Ltd.”; and add in alphabetical order an entry for “Vetcare Oy”; and
b. In the table in paragraph (c)(2), remove the entry for “012164”; revise the entries for “051079” and “055529”; and add in numerical order an entry for “086155”.
The revisions and additions read as follows:
§ 510.600
(c) * * *
(1) * * *
| Firm name and address | Drug labeler code |
| --- | --- |
| | |
| * * * * * * * | |
| Mylan Institutional, Inc., a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505 | 051079 |
| | |
| * * * * * * * | |
| Norbrook Laboratories Ltd., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom | 055529 |
| | |
| * * * * * * * | |
| Vetcare Oy, P.O. Box 26 (Liedontie 45), Mäntsälä, Uusimaa, 04601, Finland | 086155 |
| | |
| * * * * * * * | |
(2) * * *
| Drug labeler code | Firm name and address |
| --- | --- |
| | |
| * * * * * * * | |
| 051079 | Mylan Institutional, Inc., a Viatris Company, 3711 Collins Ferry Rd., Morgantown, WV 26505. |
| | |
| * * * * * * * | |
| 055529 | Norbrook Laboratories Ltd., Carnbane Industrial Estate, Newry, County Down, BT35 6QQ, United Kingdom. |
| | |
| * * * * * * * | |
| 086155 | Vetcare Oy, P.O. Box 26 (Liedontie 45), Mäntsälä, Uusimaa, 04601, Finland. |
| | |
| * * * * * * * | |
**PART 515—MEDICATED FEED MILL LICENSE**
**21 CFR Part 515**
3. The authority citation for part 515 continues to read as follows:
**Authority:**
21 U.S.C. 360b, 371.
**21 CFR Part 515**
4. In § 515.10, revise paragraph (a) to read as follows:
§ 515.10
(a) Medicated feed mill license applications (Form FDA 3448) may be obtained from the Public Health Service, Consolidated Forms and Publications Distribution Center, Washington Commerce Center, 3222 Hubbard Rd., Landover, MD 20785, or electronically from the Center for Veterinary Medicine at: *https://www.fda.gov/animal-veterinary/animal-food-feeds/medicated-feeds.*
**PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES**
**21 CFR Part 516**
5. The authority citation for part 516 continues to read as follows:
**Authority:**
21 U.S.C. 360ccc-1, 360ccc-2, 371.
§ 516.812
**21 CFR Part 516**
6. In § 516.812, in paragraph (b), remove “000859” and in its place add “058198”.
**PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS**
**21 CFR Part 520**
7. The authority citation for part 520 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 520**
8. In § 520.88g, revise paragraphs (b)(2), (c)(1)(ii), and (c)(2)(ii) to read as follows:
§ 520.88g
(b) * * *
(2) Nos. 017033 and 069043 for use of tablets as in paragraph (c) of this section.
(c) * * *
(1) * * *
(ii) *Indications for use.* Treatment of skin and soft tissue infections such as wounds, abscesses, cellulitis, superficial/juvenile and deep pyoderma due to susceptible strains of the following organisms: Beta-lactamase-producing *Staphylococcus aureus,* non-beta-lactamase-producing *Staphylococcus aureus, Staphylococcus* spp., *Streptococcus* spp., and *E. coli.* Periodontal infections due to susceptible strains of both aerobic and anaerobic bacteria.
(2) * * *
(ii) *Indications for use.* Treatment of skin and soft tissue infections such as wounds, abscesses, and cellulitis/dermatitis due to susceptible strains of the following organisms: Beta-lactamase-producing *Staphylococcus aureus,* non-beta-lactamase-producing *Staphylococcus aureus, Staphylococcus* spp., *Streptococcus* spp., *E. coli,* and *Pasteurella* spp. Urinary tract infections (cystitis) due to susceptible strains of *E. coli.*
§ 520.530
**21 CFR Part 520**
9. In § 520.530, remove paragraph (c) and redesignate paragraph (d) as paragraph (c).
**21 CFR Part 520**
10. In § 520.812, revise paragraphs (b)(1) and (3) to read as follows:
§ 520.812
(b) * * *
(1) No. 058198 for use of products described in paragraph (a) of this section.
(3) Nos. 055529 and 086101 for use of product described in paragraph (a)(2) of this section.
**21 CFR Part 520**
11. In § 520.905a, revise paragraphs (e)(1)(ii) and (iii) to read as follows:
§ 520.905a
(e) * * *
(1) * * *
(ii) *Indications for use.* For the treatment and control of large strongyles ( *Strongylus edentatus, S. equinus, S. vulgaris, Triodontophorus* species), small strongyles ( *Cyathostomum* species, *Cylicocyclus* species, *Cylicostephanus* species, *Cylicodontophorus* species), pinworms ( *Oxyuris equi* ) and ascarids ( *Parascaris equorum* ).
(iii) *Limitations.* Do not use in horses intended for human consumption.
**21 CFR Part 520**
12. In § 520.928, revise the section heading and paragraphs (a), (b), and (c)(1)(i) to read as follows:
§ 520.928
(a) *Specifications* —(1) Each chewable tablet contains 57 or 227 milligrams (mg) firocoxib.
(2) Each tablet contains 57 mg firocoxib.
(b) *Sponsors.* See sponsors in § 510.600(c) of this chapter as follows:
(1) Nos. 000010 and 055529 for use of products described in paragraph (a)(1) as in paragraph (c)(1) of this section; and
(2) No. 000010 for use of the product described in paragraph (a)(2) as in paragraph (c)(2) of this section.
(c) * * *
(1) * * *
(i) *Amount.* 5 mg/kg (2.27 mg/lb) body weight. Administer once daily as needed for osteoarthritis and for 3 days as needed for postoperative pain and inflammation associated with soft-tissue and orthopedic surgery. Administer approximately 2 hours before soft tissue or orthopedic surgery.
**21 CFR Part 520**
13. In § 520.1242a, revise paragraph (b)(3) to read as follows:
§ 520.1242a
(b) * * *
(3) No. 016592 for use of 46.8- and 544.5-g packages as in paragraphs (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) and (e)(2)(i), (e)(2)(ii)(B), and (e)(2)(iii) of this section.
**21 CFR Part 520**
14. In § 520.1720a, revise paragraph (a) to read as follows:
§ 520.1720a
(a) *Specifications.* Each tablet contains 100, 200, or 400 milligrams (mg), or 1 gram (g) phenylbutazone. Each bolus contains 1, 2, or 4 g phenylbutazone.
§ 520.1846
**21 CFR Part 520**
15. Remove § 520.1846.
§ 520.1870
**21 CFR Part 520**
16. In § 520.1870, in paragraph (c)(2)(iii), in the third sentence, remove “OTC” and in its place add “over the counter”.
**21 CFR Part 520**
17. In § 520.1872, revise paragraph (c)(1)(iii) and add reserved paragraph (c)(2) to read as follows:
§ 520.1872
(c) * * *
(1) * * *
(iii) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
**21 CFR Part 520**
18. Revise § 520.2260a to read as follows:
§ 520.2260a
(a) *Specifications.* Each oblet or bolus contains:
(1) 2.5, 5, or 15 grams sulfamethazine.
(2) 5 grams sulfamethazine.
(b) *Sponsors.* See sponsors in § 510.600(c) of this chapter for use of products described in paragraph (a) of this section.
(1) No. 016592 for use of products described in paragraph (a)(1) of this section.
(2) No. 054771 for use of product described in paragraph (a)(2) of this section.
(c) *Related tolerances.* See § 556.670 of this chapter.
(d) *Conditions of use.* (1) Oblets and boluses described in paragraph (a)(1) of this section:
(i) *Amount.* Administer as a single dose 100 milligrams per pound (mg/lb) of body weight the first day and 50 mg/lb of body weight on each following day.
(ii) *Indications for use.* (A) *Beef cattle and nonlactating dairy cattle.* For the treatment of bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) ( *Pasteurella* spp.), colibacillosis (bacterial scours) ( *Escherichia coli* ), necrotic pododermatitis (foot rot) ( *Fusobacterium necrophorum* ), calf diphtheria ( *Fusobacterium necrophorum* ), acute mastitis ( *Streptococcus* spp.), acute metritis ( *Streptococcus* spp.), and coccidiosis ( *Eimeria bovis* and *E. zurnii* ).
(B) *Horses.* For the treatment of bacterial pneumonia (secondary infections associated with *Pasteurella* spp.), strangles ( *Streptococcus* equi), and bacterial enteritis ( *Escherichia coli* ).
(iii) *Limitations.* Administer daily until animal's temperature and appearance are normal. If symptoms persist after using for 2 or 3 days consult a veterinarian. Fluid intake must be adequate. Treatment should continue 24 to 48 hours beyond the remission of disease symptoms, but not to exceed 5 consecutive days. Follow dosages carefully. Do not treat cattle within 10 days of slaughter. Do not use in female dairy cattle 20 months of age or older. Use of sulfamethazine in this class of cattle may cause milk residues. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Do not use in horses intended for human consumption.
(2) Boluses described in paragraph (a)(2) of this section:
(i) *Amount.* Administer 10 grams (2 boluses) of sulfamethazine per 100 pounds of body weight the first day, then 5 grams (1 bolus) of sulfamethazine per 100 pounds of body weight daily for up to 4 additional consecutive days.
(ii) *Indications for use.* (A) *Ruminating beef and dairy calves.* For treatment of the following diseases caused by organisms susceptible to sulfamethazine: bacterial scours (colibacillosis) caused by *Escherichia coli;* necrotic pododermatitis (foot rot) and calf diphtheria caused by *Fusobacterium necrophorum;* bacterial pneumonia associated with *Pasteurella* spp.; and coccidiosis caused by *Eimeria bovis* and *E. zurnii.*
(B) [Reserved]
(iii) *Limitations.* Do not administer for more than 5 consecutive days. Do not treat calves within 11 days of slaughter. Do not use in calves to be slaughtered under 1 month of age or in calves being fed an all milk diet. Do not use in female dairy cattle 20 months of age or older; such use may cause drug residues in milk. Administer with adequate supervision. Follow recommended dosages carefully. Fluid intake must be adequate. If symptoms persist after 2 or 3 days, consult a veterinarian.
**21 CFR Part 520**
19. In § 520.2325a, revise paragraphs (c)(4)(iii) and (d) to read as follows:
§ 520.2325a
(c) * * *
(4) * * *
(iii) In lieu of treatment as provided in paragraph (c)(4)(ii) of this section, administer 1 teaspoon of 25 percent sulfaquinoxaline soluble powder per day for each 125 pounds of body weight for 3 to 5 days in drinking water.
(d) *Limitations.* A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Not for use in lactating dairy cattle. Do not give to chickens, turkeys, or cattle within 10 days of slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
**21 CFR Part 520**
20. In § 520.2455, revise paragraph (b)(3) to read as follows:
§ 520.2455
(b) * * *
(3) Nos. 016592, 051072, 051311, and 061133 for product described in paragraph (a)(2) of this section.
**21 CFR Part 520**
21. In § 520.2471, revise paragraph (b) to read as follows:
§ 520.2471
(b) *Sponsors.* See Nos. 016592 and 058198 in § 510.600(c) of this chapter.
**21 CFR Part 520**
22. In § 520.2598, revise paragraph (c)(2) to read as follows:
§ 520.2598
(c) * * *
(2) *Indications for use.* For the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism in dogs.
**PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS**
**21 CFR Part 522**
23. The authority citation for part 522 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 522**
24. In § 522.533, revise paragraphs (c)(1)(ii) and (c)(2)(ii) to read as follows:
§ 522.533
(c) * * *
(1) * * *
(ii) *Indications for use.* For inducing ovulation within 48 hours in estrous mares with an ovarian follicle greater than 30 millimeters (mm) in diameter.
(c) * * *
(2) * * *
(ii) *Indications for use.* For inducing ovulation within 48 hours in cyclic estrous mares with an ovarian follicle between 30 and 40 mm in diameter.
**21 CFR Part 522**
25. In § 522.812, revise paragraph (b)(2) to read as follows:
§ 522.812
(b) * * *
(2) Nos. 051311, 055529, 058005, 058198, and 061133 for use of product described in paragraph (a)(2) of this section as in paragraphs (e)(2) and (3) of this section.
**21 CFR Part 522**
26. Add § 522.1008 to read as follows:
§ 522.1008
(a) *Specifications.* Each milliliter (mL) of solution contains 7 milligrams (mg) frunevetmab.
(b) *Sponsor.* See No. 054771 in § 510.600(c) of this chapter.
(c) *Conditions of use* —(1) *Cats* —(i) *Amount.* Administer once a month by subcutaneous injection the full contents of one or two 1-mL vials to achieve a minimum dosage of 0.45 mg/lb (1 mg/kg) body weight.
(ii) *Indications for use.* For the control of pain associated with osteoarthritis in cats.
(iii) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
**21 CFR Part 522**
27. Add § 522.1338 to read as follows:
§ 522.1338
(a) *Specifications.* Each milliliter of solution contains 0.5 milligrams (mg) medetomidine hydrochloride and 10 mg vatinoxan hydrochloride.
(b) *Sponsor.* See No. 086155 in § 510.600(c) of this chapter.
(c) *Conditions of use* —(1) *Amount.* Administer by intramuscular injection a dose based on body surface area (BSA). Calculate the dose using 1 mg medetomidine per square meter (/m <sup>2</sup> ) BSA or use the dosing table provided in labeling.
(2) *Indications for use.* For use as a sedative and analgesic in dogs to facilitate clinical examination, clinical procedures, and minor surgical procedures.
(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.
**21 CFR Part 522**
28. In § 522.2615, revise paragraph (d)(3)(iii) to read as follows:
§ 522.2615
(d) * * *
(3) * * *
(iii) *Limitations.* Milk taken during treatment and for 24 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 4 days following the 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 pre-ruminating calves. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
**21 CFR Part 522**
29. In § 522.2630, revise paragraphs (b)(1) and (2) to read as follows:
§ 522.2630
(b) * * *
(1) Nos. 000061, 013744, 051311, 054771, 055529, 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) Nos. 013744, 051311, 054771, and 058198 for use of product described in paragraph (a)(2) as in paragraphs (d)(1)(i), (d)(1)(ii)(B), (d)(1)(iii)(B), and (d)(2) of this section.
**PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS**
**21 CFR Part 524**
30. The authority citation for part 524 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 524**
31. Add § 524.230 to read as follows:
§ 524.230
(a) *Specifications.* Each milliliter (mL) of solution contains 20 milligrams (mg) buprenorphine. The drug is supplied in tubes containing 0.4 mL (8 mg) or 1.0 mL (20 mg).
(b) *Sponsor.* See No. 058198 in § 510.600(c) of this chapter.
(c) *Conditions of use in cats* —(1) *Amount.* Administer topically to the dorsal cervical area at the base of the skull a single dose of 1.2 to 3.1 mg/lb (2.7 to 6.7 mg/kg) approximately 1 to 2 hours before surgery.
(2) *Indications for use.* For the control of postoperative pain associated with surgical procedures in cats.
(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian. Buprenorphine is a Schedule III controlled substance.
**21 CFR Part 524**
32. In § 524.1001, revise the section heading and paragraph (a) to read as follows:
§ 524.1001
(a) *Specifications.* Each milliliter of solution contains 280 milligram (mg) fluralaner and 14 mg moxidectin. Each individually packaged tube contains either 112.5 mg fluralaner and 5.6 mg moxidectin; 250 mg fluralaner and 12.5 mg moxidectin; or 500 mg fluralaner and 25 mg moxidectin.
**21 CFR Part 524**
33. In § 524.1146, revise paragraphs (b)(1) and (2) to read as follows:
§ 524.1146
(b) * * *
(1) Nos. 017030, 051072, 055529, 058198, and 061651 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section.
(2) Nos. 017030, 051072, 055529, 058198, and 061651 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section.
**21 CFR Part 524**
34. In § 524.2098, revise paragraph (b) to read as follows:
§ 524.2098
(b) *Sponsors.* See Nos. 051072, 054771, 055529, 061133, and 061651 in § 510.600(c) of this chapter.
**PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS**
**21 CFR Part 529**
35. The authority citation for part 529 continues to read as follows:
**Authority:**
21 U.S.C. 360b.
**21 CFR Part 529**
36. In § 529.1186, revise paragraph (b) to read as follows:
§ 529.1186
(b) *Sponsors.* See Nos. 017033, 054771, 065085, and 066794 in § 510.600(c) of this chapter.
**21 CFR Part 529**
37. In § 529.2110, revise paragraph (b) to read as follows:
§ 529.2110
(b) *Sponsors.* See Nos. 017033, 054771, and 066794 in § 510.600(c) of this chapter.
**PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS**
**21 CFR Part 558**
38. The authority citation for part 558 continues to read as follows:
**Authority:**
21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
**21 CFR Part 558**
39. In § 558.4, in paragraph (d), in the “Category II” table, revise the entry for “Nicarbazin (powder)” to read as follows:
§ 558.4
(d) * * *
| Drug | Assay limits | Type B maximum | Assay limits |
| --- | --- | --- | --- |
| | | | |
| * * * * * * * | | | |
| Nicarbazin (powder) | 96-104 | 9.08 g/lb (2.00%) | 85-115/80-120 |
| | | | |
| * * * * * * * | | | |
| * * * * * * * | | | |
**21 CFR Part 558**
40. In § 558.128, revise paragraphs (e)(4)(iii) and (xli) to read as follows:
§ 558.128
(e) * * *
(4) * * *
| Chlortetracycline amount | Combination | Indications for use | Limitations | Sponsor |
| --- | --- | --- | --- | --- |
| | | | | |
| * * * * * * * | | | | |
| (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
susceptible to chlortetracycline | Feed to provide chlortetracycline at the rate of 0.5 mg per pound of body weight daily. Withdraw 48 hours prior to slaughter. To sponsor Nos. 054771 and 069254: Zero withdrawal time | 054771 |
| | | | | |
| * * * * * * * | | | | |
| (xli) 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
susceptible to chlortetracycline, control of coccidiosis caused by
and
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 |
| | | | | |
| * * * * * * * | | | | |
| * * * * * * * | | | | |
**21 CFR Part 558**
41. In § 558.258, revise paragraph (e)(1), paragraph (e)(2) table column headings, and paragraphs (e)(2)(i) and (e)(3) through (5) to read as follows:
§ 558.258
(e) * * *
(1) * * *
| Fenbendazole | Combination | Indications for use | Limitations | Sponsor |
| --- | --- | --- | --- | --- |
| (i) 14.5 | | Growing turkeys: For the treatment and control of gastrointestinal worms: roundworms, adults and larvae (
); cecal worms, adults and larvae (
), an important vector of
(Blackhead) | Feed continuously as the sole ration for 6 days. For growing turkeys only | 000061 |
| (ii) [Reserved] | | | | |
(2) *Swine.*
| Fenbendazole | Combination | Indications for use | Limitations | Sponsor |
| --- | --- | --- | --- | --- |
| (i) 10 to 300 | | Swine: For the treatment and control of Lungworms: adult (
and
); Gastrointestinal worms: adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (
); adult nodular worms (
); adult small stomach worms (
); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (
and Kidney worms: adult and larvae (
) | Feed as the sole ration to provide 9 mg/kg of body weight (4.08 mg/lb) over a period of 3 to 12 consecutive days. Swine must not be slaughtered for human consumption within 4 days following last treatment with this drug product | 000061 |
| | | | | |
| * * * * * * * | | | | |
(3) *Cattle.*
| Fenbendazole | Indications for use | Limitations | Sponsor |
| --- | --- | --- | --- |
| (i) 200 to 1,000 | Dairy and beef cattle: For the treatment and control of: Lungworms: adult (
); Stomach worms: adult brown stomach worms (
), adult and fourth-stage larvae barberpole worms (
), fourth-stage larvae barberpole worms (
), and adult and fourth-stage larvae small stomach worms (
); Intestinal worms (adult and fourth-stage larvae): hookworms (
), thread-necked intestinal worms (
), small intestinal worms (
and
), bankrupt worms (
), and nodular worms (
) | Feed as the sole ration for 1 day to provide 5 mg/kg body weight (2.27 mg/lb). Milk taken during treatment and for 60 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 13 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 pre-ruminating calves | 000061 |
| (ii) [Reserved] | | | |
(iii) *Top dress medicated feed* —(A) *Proprietary formulas.* The following feed can be manufactured only per an approved proprietary formula and specifications:
| Fenbendazole | Indications for use | Limitations | Sponsor |
| --- | --- | --- | --- |
| (
) 2.27 g/lb | Beef and dairy cattle: For the treatment and control of: Lungworms: adult (
); Stomach worms: adult brown stomach worms (
), adult and fourth-stage larvae barberpole worms (
), fourth-stage larvae barberpole worms (
), and adult and fourth-stage larvae small stomach worms (
); Intestinal worms (adult and fourth-stage larvae): hookworms (
), thread-necked intestinal worms (
), small intestinal worms (
), bankrupt worms (
), and nodular worms (
) | Feed as a top dress for 1 day to provide 5 mg/kg body weight (2.27 mg/lb). Milk taken during treatment and for 60 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 13 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 pre-ruminating calves | 000061 |
| (
) [Reserved] | | | |
(B) [Reserved]
(iv) *Free-choice medicated feeds* —(A) *Proprietary formulas (21 CFR 510.455(e)(2)).* The following feeds can be manufactured only per an approved proprietary formula and specifications:
| Fenbendazole | Indications for use | Limitations | Sponsor |
| --- | --- | --- | --- |
| (
) 12,100 g/ton mineral | Beef cattle on pasture: For the treatment and control of: Lungworms: adult (
); Stomach worms: adult brown stomach worms (
), adult and fourth-stage larvae barberpole worms (
), fourth-stage larvae barberpole worms (
), and adult and fourth-stage larvae small stomach worms (
); Intestinal worms (adult and fourth-stage larvae): hookworms (
), thread-necked intestinal worms (
), small intestinal worms (
and
), bankrupt worms (
), and nodular worms (
) | Feed free-choice at the rate of 0.0375 lb per 100 pounds of body weight over a 3- to 6-day period to provide a total of 2.27 mg fenbendazole per pound of body weight. Not for use in dairy cattle. Beef cattle must not be slaughtered for human consumption within 13 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 pre-ruminating calves | 000061 |
| (
) 2.27 g/lb mineral | Beef cattle on pasture: For the treatment and control of: Lungworms: adult (
); Stomach worms: adult brown stomach worms (
), adult and fourth-stage larvae barberpole worms (
), fourth-stage larvae barberpole worms (
), and adult and fourth-stage larvae small stomach worms (
); Intestinal worms (adult and fourth-stage larvae): hookworms (
), thread-necked intestinal worms (
), small intestinal worms (
and
), bankrupt worms (
), and nodular worms (
) | Feed free-choice at the rate of 0.10 lb (1.6 oz) per 100 pounds of body weight over a 3- to 6-day period, to deliver a total of 2.27 mg fenbendazole per pound of body weight. Not for use in dairy cattle. Beef cattle must not be slaughtered for human consumption within 13 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 pre-ruminating calves | 000061 |
(B) *Published formulas (§ 510.455(e)(1) of this chapter).* The following feeds can be manufactured only per one of the formulas and specifications published below:
( *1* ) *Amount.* 5 mg/kg body weight (2.27 mg/lb), including the following formulations:
| Ingredient | Percent | International Feed No. |
| --- | --- | --- |
| (
) Free-choice, dry Type C feed: | | |
| Salt (sodium chloride) | 59.00 | 6-04-152 |
| Monosodium phosphate | 31.16 | 6-04-288 |
| Dried cane molasses | 3.12 | 4-04-695 |
| Zinc sulfate | 0.76 | 6-05-556 |
| Copper sulfate | 0.45 | 6-01-720 |
| Fenbendazole 20% Type A article | 5.51 | n/a |
| (
) Free-choice, dry Type C feed: | | |
| Salt (sodium chloride) | 35.93 | 6-04-152 |
| Dicalcium phosphate (18.5% P) | 32.44 | 6-00-080 |
| Calcium carbonate (38% Ca) | 15.93 | 6-01-069 |
| Magnesium oxide (56% Mg) | 10.14 | 6-02-756 |
| Zinc sulfate | 1.47 | 6-05-556 |
| Mineral oil | 1.00 | 8-03-123 |
| Dried cane molasses (46% sugars) | 0.98 | 4-04-695 |
| Potassium iodide | 0.01 | 6-03-759 |
| Fenbendazole 20% Type A article | 2.10 | n/a |
| (
) Free-choice, liquid Type C feed
: | | |
| Cane molasses | 80.902 | 4-13-251 |
| Water | 9.36 | n/a |
| Urea solution, 55% | 7.05 | 5-05-707 |
| Phosphoric acid 75% (feed grade) | 2.00 | 6-03-707 |
| Xantham gum | 0.20 | 8-15-818 |
| Trace minerals | 0.20 | n/a |
| Vitamin premix | 0.01 | n/a |
| Fenbendazole 20% Type A article | 0.278 | n/a |
( *2* ) *Indications for use.* As in paragraph (e)(3)(i) of this section.
( *3* ) *Limitations.* Feed a total of 5 mg of fenbendazole per kg (2.27 mg/lb) of body weight to cattle over a 3- to 6-day period. Milk taken during treatment and for 60 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 13 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 pre-ruminating calves.
(4) *Horses.*
| Fenbendazole | Indications for use | Limitations | Sponsor |
| --- | --- | --- | --- |
| (i) 4,540 | 5 mg/kg body weight (2.27 mg/lb) for the control of large strongyles (
spp.), small strongyles (
spp.,
spp.,
spp.), and pinworms (
); 10 mg/kg body weight (4.54 mg/lb) for the control of ascarids (
) | Feed at the rate of 0.1 lb of feed per 100 lb of body weight to provide 2.27 mg fenbendazole/lb of body weight in a 1-day treatment or 0.2 lb of feed per 100 lb of body weight to provide 4.54 mg fenbendazole/lb of body weight in a 1-day treatment. All horses must be eating normally to ensure that each animal consumes an adequate amount of the medicated feed. Do not use in horses intended for human consumption | 000061 |
| (ii) [Reserved] | | | |
(5) *Zoo and wildlife animals.*
| Species/Class | Fenbendazole | Indications for use | Limitations | Sponsor |
| --- | --- | --- | --- | --- |
| (i) Feral swine (
): | 90 to 325 | For the treatment and control of kidney worm (
), roundworm (
), nodular worm (
) | Use as a complete feed at a rate to provide 3 mg/kg/day for 3 consecutive days. Prior withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not use 14 days before or during the hunting season | 000061 |
| (ii) Ruminants (subfamily Antilopinae, Hippotraginae, Caprinae) | 50 to 300 | For the treatment and control of small stomach worm (
spp.), thread necked intestinal worm (
spp.), barberpole worm (
spp.), whipworm (
spp.) | Use as a complete feed at a rate to provide 2.5 mg/kg/day for 3 consecutive days. Prior withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not use 14 days before or during the hunting season | 000061 |
| (iii) Rocky mountain bighorn sheep (
) | 375 to 1,000 | For the treatment and control of
spp. | Use as a complete feed at a rate to provide 10 mg/kg/day for 3 consecutive days. Prior withdrawal of feed or water is not necessary. Retreatment may be required in 6 weeks. Do not use 14 days before or during the hunting season | 000061 |
§ 558.633
42. In § 558.633, in paragraph (d)(3), remove the first sentence.
Dated: September 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.