83 FR 189 pgs. 48940-48950 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name
Type: RULEVolume: 83Number: 189Pages: 48940 - 48950
Pages: 48940, 48941, 48942, 48943, 48944, 48945, 48946, 48947, 48948, 48949, 48950Docket number: [Docket No. FDA-2018-N-0002]
FR document: [FR Doc. 2018-21146 Filed 9-27-18; 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, 529, 556, and 558
[Docket No. FDA-2018-N-0002]
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule; technical amendments.
SUMMARY:
[top] 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 2018. FDA is informing the public of the availability
DATES:
This rule is effective September 28, 2018, except for amendatory instructions 7 to 21 CFR 520.580, 18 to 21 CFR 520.905d, 20 to 21 CFR 520.1182, 29 to 21 CFR 520.1840, 33 to 21 CFR 520.2380a, 37 to 21 CFR 522.1182, 51 to 21 CFR 524.900, 62 to 21 CFR 558.185, 68 to 21 CFR 558.365, and 70 to 21 CFR 558.485, which are effective October 9, 2018.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5689, george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Approval Actions
FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during January, February, and March 2018, 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. Persons with access to the internet may obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and patent information may be accessed in FDA's publication, Approved Animal Drug Products Online (Green Book) at: https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
| Approval date | File No. | Sponsor | Product name | Species | Effect of the action | Public documents |
|---|---|---|---|---|---|---|
| January 5, 2018 | 141-449 | Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940 | SAFE-GUARD AquaSol (fenbendazole oral suspension), Suspension Concentrate | Chickens | Supplemental approval for the treatment and control of certain nematode worms in laying hens; and of a tolerance in chicken eggs | FOI Summary; EA/FONSI?1 . |
| January 16, 2018 | 200-563 | Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland | EPRIZERO (eprinomectin), Pour-On for Beef and Dairy Cattle | Cattle | Original approval as a generic copy of NADA 141-079 | FOI Summary. |
| January 19, 2018 | 141-494 | Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 | CREDELIO (lotilaner), Chewable Tablet | Dogs | Original approval for killing adult fleas, and for the treatment of flea infestations and the treatment and control of tick infestations in dogs | FOI Summary. |
| January 29, 2018 | 200-622 | Pharmgate LLC, 1800 Sir Tyler Dr., Wilmington, NC 28405 | Chlortetracycline and decoquinate, Type C medicated feeds | Cattle | Original approval as a generic copy of NADA 141-185 | FOI Summary. |
| February 28, 2018 | 141-482 | Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 | LINCOMIX (lincomycin) and ROBENZ (robenidine hydrochloride), Type C medicated feeds | Chickens | Original approval for the control of necrotic enteritis and for the prevention of coccidiosis in broiler chickens | FOI Summary. |
| February 28, 2018 | 141-483 | Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 | LINCOMIX (lincomycin) and DECCOX (decoquinate), Type C medicated feeds | Chickens | Original approval for the control of necrotic enteritis and for the prevention of coccidiosis in broiler chickens | FOI Summary. |
| March 2, 2018 | 141-484 | Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 | LINCOMIX (lincomycin) and BIO-COX (salinomycin sodium), Type C medicated feeds | Chickens | Original approval for the control of necrotic enteritis and for the prevention of coccidiosis in broiler chickens | FOI Summary. |
| March 5, 2018 | 141-489 | Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 | LINCOMIX (lincomycin) and ZOAMIX (zoalene), Type C medicated feeds | Chickens | Original approval for the control of necrotic enteritis and for the prevention and control of coccidiosis in broiler chickens | FOI Summary. |
| March 8, 2018 | 141-492 | Merial, Inc., 3239 Satellite Blvd., Bldg. 500, Duluth, GA 30096-4640 | CENTRAGARD (eprinomectin and praziquantel transdermal solution) | Cats | Original approval for the prevention of heartworm disease, and for the treatment and control of roundworms, hookworms, and tapeworms in cats and kittens | FOI Summary. |
| March 26, 2018 | 141-491 | Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 | LINCOMIX (lincomycin) and COBAN (monensin), Type C medicated feeds | Chickens | Original approval for the control of necrotic enteritis and as an aid in the prevention of coccidiosis in broiler chickens | FOI Summary. |
| 1 ?The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of no significant impact (FONSI). | ||||||
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II. Change of Sponsorship
Agri Laboratories Ltd., P.O. Box 3103, St. Joseph, MO 64503 has informed FDA that it has transferred ownership of, and all rights and interest in, the following applications to Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sofia, Bulgaria:
| File No. | Product name | 21 CFR section |
|---|---|---|
| 200-030 | DI-METHOX (sulfadimethoxine) 12.5% Solution | 520.2220a |
| 200-031 | DI-METHOX (sulfadimethoxine) Soluble Powder | 520.2220a |
| 200-037 | LEGACY (gentamicin sulfate) Solution | 529.1044a |
| 200-038 | DI-METHOX (sulfadimethoxine) Injection 40% | 522.2220 |
| 200-049 | TETRA-BAC 324 (tetracycline hydrochloride) Soluble Powder | 520.2345d |
| 200-061 | FLU-NIX (flunixin meglumine) Injection | 522.970 |
| 200-066 | AGRIMYCIN-343 (oxytetracycline hydrochloride) Soluble Powder | 520.1660d |
| 200-128 | AGRIMYCIN-200 (oxytetracycline dihydrate) Injection | 522.1660a |
| 200-185 | GEN-GARD (gentamicin sulfate) Soluble Powder | 520.1044c |
| 200-225 | PROHIBIT (levamisole hydrochloride) Soluble Drench Powder | 520.1242a |
| 200-271 | Levamisole Phosphate Injection | 522.1242 |
| 200-407 | Lincomycin-Spectinomycin (lincomycin hydrochloride/spectinomycin dihydrochloride pentahydrate) Water Soluble Powder | 520.1265 |
Following this withdrawal of approval, Agri Laboratories Ltd. is no longer the sponsor of an approved application. Accordingly, it will be removed from the list of sponsors of approved applications in §?510.600(c) (21 CFR 510.600(c)).
Strategic Veterinary Pharmaceuticals, Inc., 100 NW Airport Rd., St. Joseph, MO 64503 has informed FDA that it has transferred ownership of, and all rights and interest in, the following applications to Cronus Pharma LLC, 2 Tower Center Blvd., Suite 1101, East Brunswick, NJ 08816:
| File No. | Product name | 21 CFR section |
|---|---|---|
| 011-531 | DIZAN (dithiazanine iodide) Tablets | 520.763a |
| 011-674 | DIZAN (dithiazanine iodide) Powder | 520.763b |
| 012-469 | DIZAN (dithiazanine iodide) Suspension with Piperazine Citrate | 520.763c |
| 031-512 | ATGARD (dichlorvos) Swine Wormer | 558.205 |
| 033-803 | TASK (dichlorvos) Dog Anthelmintic | 520.600 |
| 035-918 | EQUIGARD; VERDISOL (dichlorvos) | 520.596 |
| 039-483 | BIO-TAL (thiamylal sodium) Injection | 522.2424 |
| 040-848 | ATGARD C (dichlorvos) Swine Wormer | 558.205 |
| 043-606 | ATGARD V (dichlorvos) Swine Wormer | 558.205 |
| 045-143 | OXYJECT (oxytetracycline hydrochloride) Injection | 522.1662a |
| 047-278 | BIO-MYCIN OXY-TET 50 (oxytetracycline hydrochloride) Injection | 522.1662a |
| 047-712 | BIZOLIN-100; BIZOLIN-200 (phenylbutazone) Injection | 522.1720 |
| 048-010 | ANAPLEX (dichlorophene and toluene) Canine and Feline Wormer Caps | 520.580 |
| 048-237 | EQUIGEL (dichlorvos) | 520.602 |
| 048-271 | TASK (dichlorvos) Tablets | 520.598 |
| 049-032 | ATGARD C (dichlorvos) Premix 9.6% | 558.205 |
| 065-461 | ANACETIN (chloramphenicol) Tablets | 520.390a |
| 065-481 | Calf Scour Boluses (chlortetracycline hydrochloride) | 520.443 |
| 065-486 | CTC Bisulfate (chlortetracycline bisulfate) Soluble Powder | 520.441 |
| 065-491 | MEDICHOL (chloramphenicol) Tablets | 520.390a |
| 092-837 | NEMACIDE (diethylcarbamazine citrate) Oral Syrup | 520.622b |
| 093-516 | BIZOLIN (phenylbutazone) Injection 20% | 522.1720 |
| 097-452 | OXYJECT 100 (oxytetracycline hydrochloride) Injection | 522.1662a |
| 098-569 | MEDACIDE-SDM (sulfadimethoxine) Injection 10% | 522.2220 |
| 099-618 | BIZOLIN (phenylbutazone) 1-G Bolus | 520.1720a |
| 108-963 | MEDAMYCIN (oxytetracycline hydrochloride) Injectable Solution | 522.1662a |
| 117-689 | NEUROSYN (primidone) Tablets | 520.1900 |
| 125-797 | Nitrofurazone Dressing | 524.1580a |
| 126-236 | Nitrofurazone Soluble Powder | 524.1580b |
| 126-676 | D & T (dichlorophene and toluene) Worm Capsules | 520.580 |
| 127-627 | NEMACIDE; NEMACIDE-C (diethylcarbamazine citrate) Tablets | 520.622a |
| 128-069 | NEMACIDE (diethylcarbamazine citrate) Chewable Tablets | 520.622c |
| 132-028 | ANESTATAL (thiamylal sodium) Injectable Solution | 522.2424 |
| 135-771 | Methylprednisolene Tablets | 520.1408 |
| 136-212 | Methylprednisolone Acetate Injection | 522.1410 |
| 137-310 | Gentamicin Sulfate Injectable Solution | 522.1044 |
| 138-869 | Triamcinolone Acetonide Suspension | 522.2483 |
| 140-442 | Xylazine HCl Injection | 522.2662 |
| 200-023 | Gentamicin Sulfate Solution 100 mg/mL | 522.1044 |
| 200-029 | Ketamine Hydrochloride Injection | 522.1222 |
| 200-165 | SDM (sulfadimethoxine) Concentrated Solution 12.5% | 520.2220a |
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The animal drug regulations are being amended to reflect these changes of sponsorship.
III. Withdrawals of Approval
Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137 has requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed:
| File No. | Product name | 21 CFR section |
|---|---|---|
| 011-779 | PURINA PIGEMIA 100 (colloidal ferric oxide) | 522.1182 |
| 040-205 | PURINA Horse Wormer Medicated (thiabendazole) | 520.2380a |
| 042-116 | PURINA 6 DAY WORM-KILL Feed Premix (coumaphos) | 558.185 |
| 043-215 | PURINA GRUB-KILL Pour-on Cattle Insecticide (famphur) | 524.900 |
| 046-700 | STATYL (nequinate) Medicated Premix | 558.365 |
| 091-260 | PULVEX WORM CAPS (piperazine phosphate monohydrate) | 520.1804 |
| 097-258 | PURINA BAN-WORM for Pigs (pyrantel tartrate) | 558.485 |
| 102-942 | PULVEX Multipurpose Worm Caps (dichlorophene, toluene) | 520.580 |
| 113-748 | PURINA PIGEMIA Oral (iron dextran complex) | 520.1182 |
| 135-941 | CHECK-R-TON BM (pyrantel tartrate) | 558.485 |
| 136-116 | PURINA WORM-A-REST TM Litter Pack Premix (fenbendazole) | 520.905d |
| 140-869 | PURINA SAF-T-BLOC BG Medicated Feed Block (poloxalene, 6.6%) | 520.1840 |
Elsewhere in this issue of the Federal Register , FDA gave notice that approval of NADAs 011-779, 040-205, 042-116, 043-215, 046-700, 091-260, 097-258, 102-942, 113-748, 135-941, 136-116, and 140-869, and all supplements and amendments thereto, is withdrawn, effective October 9, 2018. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these actions.
IV. Technical Amendments
JBS United Animal Health II LLC, 322 S Main St., Sheridan, IN 46069 has informed FDA that it has changed its name to United-AH II LLC. Accordingly, we are amending §?510.600(c) to reflect this change.
We are also making technical amendments to update the scientific name of a pathogenic bacterium and to accurately list the concentrations of new animal drug ingredients in combination drug medicated feeds. These actions are being taken to improve the accuracy of the regulations.
V. Legal Authority
This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)), which requires Federal Register publication of "notice[s] . . . effective as a regulation," of the conditions of use of approved new animal drugs. This rule sets forth technical amendments to the regulations to codify recent actions on approved new animal drug applications and corrections to improve the accuracy of the regulations, and as such does not impose any burden on regulated entities.
Although denominated a rule pursuant to the FD&C Act, this document does not meet the definition of "rule" in 5 U.S.C. 804(3)(A) because it is a "rule of particular applicability." Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive Order 12866, which defines a rule as "an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency."
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
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, 529, 556, and 558 are amended as follows:
PART 510-NEW ANIMAL DRUGS
1. The authority citation for part 510 continues to read as follows:
Authority:
21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
2. In §?510.600, in the table in paragraph (c)(1), remove the entry for "JBS United Animal Health II LLC", and alphabetically add an entry for "United-AH II LLC"; and in the table in paragraph (c)(2), revise the entry for "051233" to 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 |
|---|---|
| * * * * * * * | |
| United-AH II LLC, 322 S Main St., Sheridan, IN 46069 | 051233 |
| * * * * * * * | |
| * * * * * * * |
(2) * * *
| Drug labeler code | Firm name and address |
|---|---|
| * * * * * * * | |
| 051233 | United-AH II LLC, 322 S Main St., Sheridan, IN 46069 |
| * * * * * * * |
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.
§?520.390a [Amended]
4. In §?520.390a, in paragraph (b)(1)(i), remove "054628" and in its place add "069043".
§?520.441 [Amended]
5. In §?520.441, in paragraph (b)(3), remove "069254 and 076475" and in its place add "069043, 069254, and 076475".
§?520.443 [Amended]
6. In §?520.443, in paragraph (b), remove "054628" and in its place add "069043".
§?520.580 [Amended]
7. In §?520.580, in paragraph (b)(1), remove "051311"; and in paragraph (b)(2), remove "000061 and 054771", and in its place add "000061, 054771, and 069043".
§?520.600 [Redesignated as §?520.596]
8. Redesignate §?520.600 as §?520.596 and revise newly redesignated §?520.596 to read as follows:
§?520.596 Dichlorvos powder.
(a) Specifications -(1) Each 2-ounce packet contains 2.27 grams (4 percent) dichlorvos.
(2) Each milligram of powder contains 2.27 milligrams (mg) dichlorvos.
(b) Sponsor. See No. 069043 in §?510.600(c) of this chapter for use of the product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section and the product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section.
(c) Related tolerances. See §?556.180 of this chapter.
(d) Conditions of use -(1) Swine (adult gilts, sows, and boars)-(i) Amount. Add powder to the indicated amount of feed and administered shortly after mixing, as follows:
| Weight of animal in pounds | Pounds of feed to be mixed with each 0.08 ounce of dichlorvos | Pounds of mixed feed to be administered to each pig as a single treatment | Number of pigs to be treated per 0.08 ounce of dichlorvos |
|---|---|---|---|
| 20-30 | 4 | 0.33 | 12 |
| 31-40 | 5 | 0.56 | 9 |
| 41-60 | 6 | 1.00 | 6 |
| 61-80 | 5 | 1.00 | 5 |
| 81-100 | 4 | 1.00 | 4 |
| 16 | 4.00 | 4 |
(ii) Indications for use. For the removal and control of sexually mature (adult), sexually immature and/or 4th stage larvae of the whipworm ( Trichuris suis ), nodular worms ( Oesophagostomum spp.), large round-worm ( Ascaris suum ), and the mature thick stomach worm ( Ascarops strongylina ) occurring in the lumen of the gastrointestinal tract of pigs, boars, and open or bred gilts and sows.
(iii) Limitations. Do not use this product on animals either simultaneously or within a few days before or after treatment with or exposure to cholinesterase inhibiting drugs, pesticides, or chemicals. The preparation should be mixed thoroughly with the feed on a clean, impervious surface. Do not allow swine access to feed other than that containing the preparation until treatment is complete. Do not treat pigs with signs of scours until these signs subside or are alleviated by proper medication. Resume normal feeding schedule afterwards. Swine may be retreated in 4 to 5 weeks.
[top] (2) Horses -(i) Amount. Administer in the grain portion of the ration at a dosage of 14.2 to 18.5 mg per pound of body weight as a single dose. Administered at one-half of the single
(ii) Indications for use. For the removal and control of bots ( Gastrophilus intestinalis, G. nasalis ), large strongyles ( Strongylus vulgaris, S. equinus, S. edentatus ), small strongyles (of the genera Cyathostomum, Cylicocercus, Cylicocyclus, Cylicodontophorus, Triodontophorus, Poteriostomum, Gyalocephalus ), pinworms ( Oxyuris equi ), and large roundworm ( Parascaris equorum ) in horses including ponies and mules. Not for use in foals (sucklings and young weanlings).
(iii) Limitations. Do not use in horses which are severely debilitated, suffering from diarrhea or severe constipation, infectious disease, toxemia, or colic. Do not administer in conjunction with or within 1 week of administration of muscle relaxant drugs, phenothiazine derived tranquilizers or central nervous system depressant drugs. Horses should not be subjected to insecticide treatment for 5 days prior to or after treating with the drug. Do not administer to horses afflicted with chronic alveolar emphysema (heaves) or related respiratory conditions. The product is a cholinesterase inhibitor and should not be used simultaneously or within a few days before or after treatment with or exposure to cholinesterase inhibiting drugs, pesticides or chemicals. Do not use in animals other than horses, ponies, and mules. Do not use in horses, ponies, and mules intended for food purposes. Do not allow fowl access to feed containing this preparation or to fecal excrement from treated animals.
9. Add §?520.598 to read as follows:
§?520.598 Dichlorvos tablets.
(a) Specifications. Each tablet contains 2, 5, 10, or 20 milligrams (mg) dichlorvos.
(b) Sponsor. See No. 069043 in §?510.600(c) of this chapter.
(c) Conditions of use in dogs, puppies, cats, and kittens- (1) Amount. Administer orally at 5 mg dichlorvos per pound of body weight.
(2) Indications for use -(i) Dogs and puppies: Removal and control of intestinal roundworms ( Toxocara canis and Toxascaris leonina ) and hookworms ( Ancylostoma caninum and Uncinaria stenocephala ).
(ii) Cats and kittens: Removal and control of intestinal roundworms ( Toxocara cati and Toxascaris leonina ) and hookworms ( Ancylostoma tubaeforme and Uncinaria stenocephala ).
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
10. Add §?520.600 to read as follows:
§?520.600 Dichlorvos capsules and pellets.
(a) Specifications. Each capsule contains 2.27 milligrams (mg) (4 percent) dichlorvos.
(b) Sponsor. See No. 069043 in §?510.600(c) of this chapter.
(c) Conditions of use in dogs- (1) Amount. Administer any combination of capsules and/or pellets so that the animal receives a single dose equaling 12 to 15 mg of dichlorvos per pound of body weight.
(2) Indications for use. For removal of Toxocara canis and Toxascaris leonina (roundworms), Ancylostoma caninum and Uncinaria stenocephala (hookworms), and Trichuris vulpis (whipworm) residing in the lumen of the gastrointestinal tract.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
11. Add §?520.602 to read as follows:
§?520.602 Dichlorvos gel.
(a) Specifications. Each milligram (mg) of gel contains 2.27 milligrams (mg) dichlorvos.
(b) Sponsor. See No. 069043 in §?510.600(c) of this chapter.
(c) Conditions of use in horses- (1) Amount. Administer 20 mg per kilogram of body weight for the removal of bots and ascarids. Repeat administration every 21 to 28 days for the control of bots and ascarids. For the control of bots only, the repeat dosage is 10 milligrams per kilogram of body weight every 21 to 28 days during bot fly season.
(2) Indications for use. For the removal and control of first, second, and third instar bots ( Gastrophilus intestinalis and G. nasalis ), sexually mature and sexually immature (4th stage) ascarids ( Parascaris equorum ) in horses and foals.
(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§?520.622a [Amended]
12. In §?520.622a, in paragraph (a)(6), remove "054628" and in its place add "069043".
§?520.622b [Amended]
13. In §?520.622b, in paragraph (c)(2), remove "054628" and in its place add "069043".
§?520.622c [Amended]
14. In §?520.622c, in paragraph (b)(6), remove "054628" and in its place add "069043".
§?520.763a [Amended]
15. In §?520.763a, in paragraph (b), remove "054628" and in its place add "069043".
§?520.763b [Amended]
16. In §?520.763b, in paragraph (b), remove "000010" and in its place add "069043".
§?520.763c [Amended]
17. In §?520.763c, in paragraph (b), remove "054628" and in its place add "069043".
18. In §?520.905d, revise paragraphs (a) and (b) to read as follows:
§?520.905d Fenbendazole powder.
(a) Specifications. Each 2-ounce packet contains 2.27 grams (4 percent) fenbendazole.
(b) Sponsor. See No. 000061 in §?510.600(c) of this chapter.
§?520.1044c [Amended]
19. In §?520.1044c, in paragraph (b)(2), remove "057561" and in its place add "016592".
§?520.1182 [Removed]
20. Remove §?520.1182.
§?520.1242a [Amended]
21. In §?520.1242a, in paragraph (b)(3), remove "057561" and in its place add "016592".
§?520.1263c [Amended]
22. In §?520.1263c, in paragraph (b)(1), remove "Nos. 016592 and 054771" and in its place add "No. 054771"; and in paragraph (b)(2), remove "Nos. 054925, 061623, and 076475" and in its place add "Nos. 016592, 054925, 061623, and 076475".
§?520.1265 [Amended]
23. In §?520.1265, in paragraph (b)(2), remove "057561" and in its place add "016592".
24. Add §?520.1286 to read as follows:
§?520.1286 Lotilaner.
(a) Specifications. Each chewable tablet contains 56.25, 112.5, 225, 450, or 900 milligrams (mg) lotilaner.
[top] (b) Sponsor. See No. 058198 in §?510.600(c) of this chapter.
(c) Conditions of use in dogs -(1) Amount. Administer orally once a month at the recommended minimum dosage of 9 mg/lb (20 mg/kg).
(2) Indications for use. Kills adult fleas, and for the treatment of flea infestations ( Ctenocephalides felis ), and the treatment and control of tick infestations ( Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog tick)) for 1 month in dogs and puppies 8 weeks of age or older and weighing 4.4 pounds or greater.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§?520.1408 [Amended]
25. In §?520.1408, in paragraph (b)(1), remove "054628" and in its place add "069043".
§?520.1660d [Amended]
26. In §?520.1660d, in paragraph (b)(4), remove "No. 057561" and in its place add "No. 016592".
§?20.1720a [Amended]
27. In §?520.1720a, in paragraph (b)(2), remove "Nos. 054628 and 069043" and in its place add "No. 069043".
§?520.1804 [Removed]
28. Remove §?520.1804.
§?520.1840 [Amended]
29. In §?520.1840, remove paragraph (b)(2), redesignate paragraphs (b)(3) and (4) as paragraphs (b)(2) and (3), and remove paragraph (d)(4).
§?520.1900 [Amended]
30. In §?520.1900, in paragraph (b)(1), remove "054628" and in its place add "069043".
§?520.2220a [Amended]
31. In §?520.2220a, in paragraph (b)(1), remove "Nos. 016592, 054628, 054771, 054925, and 057561" and in its place add "Nos. 016592, 054771, 054925, and 069043"; and in paragraph (b)(2), remove "Nos. 054771, 054925, 057561, 058829, 061623, and 066104" and in its place add "Nos. 016592, 054771, 054925, 058829, 061623, and 066104".
§?520.2345d [Amended]
32. In §?520.2345d, in paragraph (b)(4), remove "Nos. 054925, 057561, 061623, and 076475" and in its place add "Nos. 016592, 054925, 061623, and 076475".
§?520.2380a [Amended]
33. In §?520.2380a, remove and reserve paragraphs (b)(1) and (d)(1)(i).
PART 522-IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
34. The authority citation for part 522 continues to read as follows:
Authority:
21 U.S.C. 360b.
§?522.970 [Amended]
35. In §?522.970, in paragraph (b)(1), remove "Nos. 000061, 000859, 055529, 057561, and 061623" and in its place add "Nos. 000061, 000859, 016592, 055529, and 061623".
§?522.1044 [Amended]
36. In §?522.1044, in paragraph (b)(3), remove "054628" and in its place add "069043".
§?522.1182 [Amended]
37. In §?522.1182, in paragraph (b)(4), remove "Nos. 051311 and 054771" and in its place add "No. 054771".
§?522.1222 [Amended]
38. In §?522.1222, in paragraph (b), remove "Nos. 000859, 026637, 054628, 054771, 059399, and 063286" and in its place add "Nos. 000859, 026637, 054771, 059399, 063286, and 069043".
§?522.1242 [Amended]
39. In §?522.1242, in paragraph (b), remove "057561" and in its place add "016592".
§?522.1410 [Amended]
40. In §?522.1410, in paragraph (b), remove "054628 and 054771" and in its place add "054771 and 069043".
§?522.1660a [Amended]
41. In §?522.1660a, in paragraph (b), remove "057561,".
§?522.1662a [Amended]
42. In §?522.1662a, in paragraphs (a)(2), (b)(2), (g)(2), and (h)(2), remove "054628" and in its place add "069043".
§?522.1720 [Amended]
43. In §?522.1720, in paragraph (b)(3), remove "054628 and 058005" and in its place add "058005 and 069043".
§?522.2220 [Amended]
44. In §?522.2220, in paragraph (b)(1), remove "054628" and in its place add "069043"; and in paragraph (b)(3), remove "Nos. 016592, 057561, and 061623" and in its place add "Nos. 016592 and 061623".
§?522.2424 [Amended]
45. In §?522.2424, in paragraph (b), remove "054628 and 054771" and in its place add "054771 and 069043".
§?522.2483 [Amended]
46. In §?522.2483, in paragraph (b), remove "054628" and in its place add "069043".
§?522.2662 [Amended]
47. In §?522.2662, in paragraph (b)(1), remove "054628" and in its place add "069043".
PART 524-OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
48. The authority citation for part 524 continues to read as follows:
Authority:
21 U.S.C. 360b.
49. In §?524.814, revise paragraph (b) to read as follows:
§?524.814 Eprinomectin.
(b) Sponsors. See Nos. 050604 and 055529 in §?510.600(c) of this chapter.
50. Add §?524.815 to read as follows:
§?524.815 Eprinomectin and praziquantel.
(a) Specifications. Each milliliter (mL) of solution contains 4 milligrams (mg) eprinomectin and 83 mg praziquantel.
(b) Sponsor. See No. 050604 in §?510.600(c) of this chapter.
(c) Conditions of use in cats -(1) Amount. Using the 0.3 mL and 0.9 mL unit applicators, administer a minimum dose of 0.23 mg eprinomectin per pound body weight and 4.55 mg praziquantel per pound body weight by topical application on the dorsal midline between the base of the skull and the shoulder blades.
(2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis, and for the treatment and control of roundworms (adult and fourth stage larval Toxocara cati ), hookworms (adult and fourth stage larval Ancylostoma tubaeforme; adult Ancylostoma braziliense ), and tapeworms (adult Dipylidium caninum and Echinococcus multilocularis ), in cats and kittens 7 weeks of age and older and 1.8 lbs or greater.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
§?524.900 [Amended]
51. In §?524.900, in paragraph (b), remove "Nos. 000061 and 051311" and in its place add "No. 000061".
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52. In §?524.1580a, in paragraph (b)(1), remove "Nos. 054628, 054925, 058005, 059051, and 061623" and in its place add "Nos. 054925, 058005, 059051, 061623, and 069043".
§?524.1580b [Amended]
53. In §?524.1580b, in paragraph (b), remove "054628 and 059051" and in its place add "059051 and 069043".
PART 529-CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
54. The authority citation for part 529 continues to read as follows:
Authority:
21 U.S.C. 360b.
§?529.1044a [Amended]
55. In §?529.1044a, in paragraph (b), remove "Nos. 000061, 000859, 054628, 054771, 057561, 058005, and 061623" and in its place add "Nos. 000061, 000859, 016592, 054628, 054771, 058005, and 061623".
PART 556-TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
56. The authority citation for part 556 continues to read as follows:
Authority:
21 U.S.C. 342, 360b, 371.
57. In §?556.275, add paragraph (b)(3)(ii) to read as follows:
§?556.275 Fenbendazole.
(b) * * *
(3) * * *
(ii) Eggs. The tolerance for fenbendazole sulfone (the marker residue) is 1.8 ppm.
§?556.440 [Removed]
58. Remove §?556.440.
PART 558-NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
59. The authority citation for part 558 continues to read as follows:
Authority:
21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
§?558.4 [Amended]
60. In §?558.4, in paragraph (d), in the "Category I" table, remove the row entry for "Nequinate".
§?558.128 [Amended]
61. In §?558.128, in paragraphs (e)(4)(xi) and (xiii), in the "Indications for use" column, remove " P. multocida" and in its place add " P. multocida organisms".
62. In §?558.185, revise paragraph (b), remove paragraph (e)(1), and redesignate paragraphs (e)(2) and (3) as paragraphs (e)(1) and (2).
The revision reads as follows:
§?558.185 Coumaphos.
(b) Sponsor. See No. 000859 in §?510.600(c) of this chapter.
§?558.195 [Amended]
63. In §?558.195, remove and reserve paragraph (e)(2)(v).
64. In §?558.205, revise paragraph (a); redesignate paragraphs (b) through (d) as paragraphs (c) through (e); and add new paragraph (b).
The revision and addtion read as follows:
§?558.205 Dichlorvos.
(a) Specifications. Type A medicated articles containing 3.1 or 9.6 percent dichlorvos.
(b) Sponsor. See No. 069043 in §?510.600(c) of this chapter.
65. In §?558.311, revise paragraph (e)(5) to read as follows:
§?558.311 Lasalocid.
(e) * * *
(5) Lasalocid may also be used in combination with:
(i) Chlortetracycline as in §?558.128.
(ii) Melengestrol as in §?558.342.
(iii) Oxytetracycline as in §?558.450.
(iv) Tylosin alone or in combination with melengestrol acetate as in §?558.625.
(v) Virginiamycin as in §?558.635.
66. In §?558.325, redesignate paragraph (e)(1)(ii) as paragraph (e)(1)(v); add reserved paragraphs (e)(1)(ii), (iii), and (vi); and add paragraphs (e)(1)(iv), (vii), (viii), (ix), and (x) to read as follows:
§?558.325 Lincomycin.
(e) * * *
(1) * * *
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| Lincomycin grams/ton | Combination in grams/ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|---|
| * * * * * * * | ||||
| (ii) [Reserved] | ||||
| (iii) [Reserved] | ||||
| (iv) 2 | Decoquinate, 2.72 | Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin; and for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima | Feed as the sole ration. Do not use in feeds containing bentonite. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Decoquinate as provided by No. 054771 in §?510.600 of this chapter | 054771 |
| * * * * * * * | ||||
| (vi) [Reserved] | ||||
| (vii) 2 | Monensin, 90 to 110 | Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and as an aid the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima | Feed as the sole ration. Must be thoroughly mixed in feeds before use. Do not feed undiluted. Not for use in laying hens, breeding chickens, or turkeys. Do not allow horses, or other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Monensin as provided by No. 058198 in §?510.600 of this chapter | 054771 |
| (viii) 2 | Robenidine hydrochloride, 30 | Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and as an aid in the prevention of coccidiosis caused by Eimeria mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix | Feed as the sole ration. Do not use in feeds containing bentonite. Do not feed to laying hens producing eggs for human consumption. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Withdraw 5 days prior to slaughter. Type C feed containing robenidine hydrochloride must be fed within 50 days from the date of manufacture. Robenidine hydrochloride as provided by No. 054771 in §?510.600 of this chapter | 054771 |
| (ix) 2 | Salinomycin sodium, 40 to 60 | Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E maxima, E. brunetti, and E. mivati | Feed as the sole ration to broiler chickens. Do not feed to laying hens producing eggs for human consumption. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Salinomycin sodium as provided by No. 054771 in §?510.600 of this chapter | 054771 |
| (x) 2 | Zoalene, 113.5 | Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin; and for the prevention and control of coccidiosis | Feed as the sole ration from the time chicks are placed in floor pens until slaughtered for meat. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Zoalene as provided by No. 054771 in §?510.600 of this chapter | 054771 |
67. In §?558.342, in paragraph (e)(1), revise the table headings, add paragraphs (e)(1)(iii) and (iv), and remove paragraphs (e)(1)(v) through (xi); and in paragraph (e)(2), redesignate paragraphs (e)(2)(i) through (iii) as paragraphs (e)(2)(ii) through (iv) and add new paragraph (e)(2)(i).
The revisions and additions read as follows:
§?558.342 Melengestrol.
(e) * * *
(1) * * *
| Melengestrol acetate in mg/head/day | Combination in grams/ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|---|
| * * * * * * * | ||||
| (iii) 0.25 to 0.5 | Lasalocid, 10 to 30 | Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat); and for control of coccidiosis caused by Eimeria bovis and Eimeria zuernii | Add at the rate of 0.5 to 2.0 lb/head/day a medicated feed (liquid or dry) containing 0.125 to 1.0 mg melengestrol acetate/lb to a feed containing 10 to 30 g of lasalocid per ton to provide 0.25 to 0.5 mg melengestrol acetate and 100 to 360 milligrams of lasalocid per head/day. See §?558.311(d) of this chapter. Lasalocid as provided by No. 054771 in §?510.600(c) of this chapter | 054771 058198 |
| (iv) 0.25 to 0.5 | Monensin, 10 to 40 | Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat); and for the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii | Add at the rate of 0.5 to 2.0 lb/head/day a medicated feed (liquid or dry) containing 0.125 to 1.0 mg melengestrol acetate/lb to a feed containing 10 to 40 g of monensin per ton to provide 0.25 to 0.5 mg melengestrol acetate/head/day and 0.14 to 0.42 mg monensin/lb body weight, depending on severity of coccidiosis challenge, up to 480 mg monensin/head/day. See §?558.355(d) of this chapter. Monensin as provided by No. 058198 in §?510.600(c) of this chapter | 054771 058198 |
(2) * * *
(i) Oxytetracycline as in §?558.450.
§?558.365 [Removed]
68. Remove §?558.365.
§?558.450 [Amended]
69. In §?558.450, in paragraph (e)(5)(iv) entries 1 and 2, remove " A. liquefaciens" and in its place add " A. hydrophila".
70. Revise §?558.485 to read as follows:
§?558.485 Pyrantel.
(a) Specifications. Type A medicated articles containing 48 or 80 grams per pound pyrantel tartrate.
(b) Sponsors. See sponsors in §?510.600(c) of this chapter for uses as in paragraph (e) of this section.
(1) No. 066104: 48 and 80 grams per pound for use as in paragraph (e)(1) of this section.
(2) Nos. 017135 and 054771: 48 grams per pound for use as in paragraph (e)(2) of this section.
[top] (c) Related tolerances. See §?556.560 of this chapter.
(d) Special considerations -(1) See §?500.25 of this chapter. Consult a veterinarian before using in severely debilitated animals.
(2) Do not mix in Type B or Type C medicated feeds containing bentonite.
(e) Conditions of use -(1) Swine -
| Pyrantel grams/ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|
| (i) 96 | Swine: As an aid in the prevention of migration and establishment of large roundworm ( Ascaris suum ) infections; aid in the prevention of establishment of nodular worm ( Oesophagostomum ) infections | Feed continuously as the sole ration in a Type C feed. Withdraw 24 hours prior to slaughter | 066104 |
| (ii) 96 | Swine: For the removal and control of large roundworm ( Ascaris suum ) infections | Feed for 3 days as the sole ration in a Type C feed. Withdraw 24 hours prior to slaughter | 066104 |
| (iii) 800 | Swine: For the removal and control of large roundworm ( Ascaris suum ) and nodular worm ( Oesophagostomum ) infections | Feed as the sole ration for a single therapeutic treatment in Type C feed at a rate of 1 lb of feed per 40 lb of body weight for animals up to 200 lb, and 5 lb of feed per head for animals 200 lb or over. Withdraw 24 hours prior to slaughter | 066104 |
(2) Horses -
| Pyrantel grams/ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|
| To provide 1.2 mg/lb body weight | Prevention of Strongylus vulgaris larval infections; control of adult large strongyles ( S. vulgaris, and S. edentatus ), adult and 4th stage larvae small strongyles ( Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., Poteriostomum spp., and Triodontophorus spp.), adult and 4th stage larvae pinworms ( Oxyuris equi ), and adult and 4th stage larvae ascarids ( Parascaris equorum ) | Feed continuously. Administer either as a top-dress (not to exceed 20,000 g/ton) or mixed in the horse's daily grain ration (not to exceed 1,200 g/ton) during the time that the animal is at risk of exposure to internal parasites. Not for use in horses intended for food. Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism | 017135 054771 |
(3) Pyrantel may also be used in combination with:
(i) Carbadox as in §?558.115.
(ii) Lincomycin as in §?558.325.
(iii) Tylosin as in §?558.625.
71. In §?558.625, revise paragraphs (e)(2)(ii) and (iii) to read as follows:
§?558.625 Tylosin.
(e) * * *
(2) * * *
| Tylosin grams/ton | Combination in grams/ton | Indications for use | Limitations | Sponsor |
|---|---|---|---|---|
| * * * * * * * | ||||
| (ii) 8 to 10 | Lasalocid, 100 to 1440; plus melengestrol, 0.25 to 2.0 | Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) | Feed continuously as sole ration. Feed to heifers at the rate of 0.5 to 2.0 pound(s) per head per day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate per head per day (specify one level), 100 to 360 mg lasalocid per head per day (specify one level), and 90 mg tylosin per head per day. This Type C product may be top dressed onto or mixed into a complete feed prior to feeding. Tylosin as provided by Nos. 016592 and 058198; lasalocid as provided by No. 054771; melengestrol as provided by Nos. 054771 and 058198 in §?510.600(c) of this chapter. See §§?558.311(d) and 558.342(d) in this chapter | 016592 054771 058198 |
| (iii) 8 to 10 | Melengestrol, 0.25 to 2.0 | Heifers fed in confinement for slaughter: For reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) | Feed continuously as sole ration. Each pound contains 0.125 to 1.0 mg melengestrol acetate and 45 to 180 mg of tylosin. Feed to heifers at a rate of 0.5 to 2.0 pounds per head per day to provide 0.25 to 0.5 mg melengestrol acetate and 60 to 90 mg tylosin per head per day. Prior to feeding, this Type C product must be top-dressed onto a complete feed or mixed into the amount of complete feed consumed by an animal per day. Tylosin provided by Nos. 016592 and 058198; melengestrol provided by Nos. 054771 and 058198 in §?510.600(c) of this chapter. See §?558.342(d) in this chapter | 016592 054771 058198 |
| * * * * * * * |
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Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21146 Filed 9-27-18; 8:45 am]
BILLING CODE 4164-01-P