83 FR 48940 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 189 (September 28, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 189 (September 28, 2018)
| Page Range | 48940-48950 | |
| FR Document | 2018-21146 |
[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)] [Rules and Regulations] [Pages 48940-48950] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21146] ======================================================================= ----------------------------------------------------------------------- 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: 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 [[Page 48941]] of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the withdrawal of approval of applications, changes of sponsorship of applications, and a change of a sponsor's name, and to make technical amendments to improve the accuracy of the regulations. 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, [email protected]. 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. Table 1--Original and Supplemental NADAs and ANADAs Approved During January, February, and March 2018 -------------------------------------------------------------------------------------------------------------------------------------------------------- Effect of the Approval date File No. Sponsor Product name Species action Public documents -------------------------------------------------------------------------------------------------------------------------------------------------------- January 5, 2018.................. 141-449 Intervet, Inc., 2 SAFE-GUARD AquaSol Chickens............ Supplemental FOI Summary; EA/ Giralda Farms, (fenbendazole oral approval for the FONSI \1\. Madison, NJ 07940. suspension), treatment and Suspension control of certain Concentrate. nematode worms in laying hens; and of a tolerance in chicken eggs. January 16, 2018................. 200-563 Norbrook EPRIZERO Cattle.............. Original approval FOI Summary. Laboratories, (eprinomectin), as a generic copy Ltd., Station Pour-On for Beef of NADA 141-079. Works, Newry BT35 and Dairy Cattle. 6JP, Northern Ireland. January 19, 2018................. 141-494 Elanco US Inc., CREDELIO Dogs................ Original approval FOI Summary. 2500 Innovation (lotilaner), for killing adult Way, Greenfield, Chewable Tablet. fleas, and for the IN 46140. treatment of flea infestations and the treatment and control of tick infestations in dogs. January 29, 2018................. 200-622 Pharmgate LLC, 1800 Chlortetracycline Cattle.............. Original approval FOI Summary. Sir Tyler Dr., and decoquinate, as a generic copy Wilmington, NC Type C medicated of NADA 141-185. 28405. feeds. February 28, 2018................ 141-482 Zoetis Inc., 333 LINCOMIX Chickens............ Original approval FOI Summary. Portage St., (lincomycin) and for the control of Kalamazoo, MI ROBENZ (robenidine necrotic enteritis 49007. hydrochloride), and for the Type C medicated prevention of feeds. coccidiosis in broiler chickens. February 28, 2018................ 141-483 Zoetis Inc., 333 LINCOMIX Chickens............ Original approval FOI Summary. Portage St., (lincomycin) and for the control of Kalamazoo, MI DECCOX necrotic enteritis 49007. (decoquinate), and for the Type C medicated prevention of feeds. coccidiosis in broiler chickens. March 2, 2018.................... 141-484 Zoetis Inc., 333 LINCOMIX Chickens............ Original approval FOI Summary. Portage St., (lincomycin) and for the control of Kalamazoo, MI BIO-COX necrotic enteritis 49007. (salinomycin and for the sodium), Type C prevention of medicated feeds. coccidiosis in broiler chickens. March 5, 2018.................... 141-489 Zoetis Inc., 333 LINCOMIX Chickens............ Original approval FOI Summary. Portage St., (lincomycin) and for the control of Kalamazoo, MI ZOAMIX (zoalene), necrotic enteritis 49007. Type C medicated and for the feeds. prevention and control of coccidiosis in broiler chickens. March 8, 2018.................... 141-492 Merial, Inc., 3239 CENTRAGARD Cats................ Original approval FOI Summary. Satellite Blvd., (eprinomectin and for the prevention Bldg. 500, Duluth, praziquantel of heartworm GA 30096-4640. transdermal disease, and for solution). the treatment and control of roundworms, hookworms, and tapeworms in cats and kittens. March 26, 2018................... 141-491 Zoetis Inc., 333 LINCOMIX Chickens............ Original approval FOI Summary. Portage St., (lincomycin) and for the control of Kalamazoo, MI COBAN (monensin), necrotic enteritis 49007. Type C medicated and as an aid in feeds. the prevention of coccidiosis in broiler chickens. -------------------------------------------------------------------------------------------------------------------------------------------------------- \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). [[Page 48942]] 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 520.2220a (sulfadimethoxine) 12.5% Solution. 200-031...................... DI-METHOX 520.2220a (sulfadimethoxine) Soluble Powder. 200-037...................... LEGACY (gentamicin 529.1044a sulfate) Solution. 200-038...................... DI-METHOX 522.2220 (sulfadimethoxine) Injection 40%. 200-049...................... TETRA-BAC 324 520.2345d (tetracycline hydrochloride) Soluble Powder. 200-061...................... FLU-NIX (flunixin 522.970 meglumine) Injection. 200-066...................... AGRIMYCIN-343 520.1660d (oxytetracycline hydrochloride) Soluble Powder. 200-128...................... AGRIMYCIN-200 522.1660a (oxytetracycline dihydrate) Injection. 200-185...................... GEN-GARD (gentamicin 520.1044c sulfate) Soluble Powder. 200-225...................... PROHIBIT (levamisole 520.1242a hydrochloride) Soluble Drench Powder. 200-271...................... Levamisole Phosphate 522.1242 Injection. 200-407...................... Lincomycin-Spectinomycin 520.1265 (lincomycin hydrochloride/ spectinomycin dihydrochloride pentahydrate) Water Soluble Powder. ------------------------------------------------------------------------ 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 Sec. 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 520.763a iodide) Tablets. 011-674...................... DIZAN (dithiazanine 520.763b iodide) Powder. 012-469...................... DIZAN (dithiazanine 520.763c iodide) Suspension with Piperazine Citrate. 031-512...................... ATGARD (dichlorvos) Swine 558.205 Wormer. 033-803...................... TASK (dichlorvos) Dog 520.600 Anthelmintic. 035-918...................... EQUIGARD; VERDISOL 520.596 (dichlorvos). 039-483...................... BIO-TAL (thiamylal 522.2424 sodium) Injection. 040-848...................... ATGARD C (dichlorvos) 558.205 Swine Wormer. 043-606...................... ATGARD V (dichlorvos) 558.205 Swine Wormer. 045-143...................... OXYJECT (oxytetracycline 522.1662a hydrochloride) Injection. 047-278...................... BIO-MYCIN OXY-TET 50 522.1662a (oxytetracycline hydrochloride) Injection. 047-712...................... BIZOLIN-100; BIZOLIN-200 522.1720 (phenylbutazone) Injection. 048-010...................... ANAPLEX (dichlorophene 520.580 and toluene) Canine and Feline Wormer Caps. 048-237...................... EQUIGEL (dichlorvos)..... 520.602 048-271...................... TASK (dichlorvos) Tablets 520.598 049-032...................... ATGARD C (dichlorvos) 558.205 Premix 9.6%. 065-461...................... ANACETIN 520.390a (chloramphenicol) Tablets. 065-481...................... Calf Scour Boluses 520.443 (chlortetracycline hydrochloride). 065-486...................... CTC Bisulfate 520.441 (chlortetracycline bisulfate) Soluble Powder. 065-491...................... MEDICHOL 520.390a (chloramphenicol) Tablets. 092-837...................... NEMACIDE 520.622b (diethylcarbamazine citrate) Oral Syrup. 093-516...................... BIZOLIN (phenylbutazone) 522.1720 Injection 20%. 097-452...................... OXYJECT 100 522.1662a (oxytetracycline hydrochloride) Injection. 098-569...................... MEDACIDE-SDM 522.2220 (sulfadimethoxine) Injection 10%. 099-618...................... BIZOLIN (phenylbutazone) 520.1720a 1-G Bolus. 108-963...................... MEDAMYCIN 522.1662a (oxytetracycline hydrochloride) Injectable Solution. 117-689...................... NEUROSYN (primidone) 520.1900 Tablets. 125-797...................... Nitrofurazone Dressing... 524.1580a 126-236...................... Nitrofurazone Soluble 524.1580b Powder. 126-676...................... D & T (dichlorophene and 520.580 toluene) Worm Capsules. 127-627...................... NEMACIDE; NEMACIDE-C 520.622a (diethylcarbamazine citrate) Tablets. 128-069...................... NEMACIDE 520.622c (diethylcarbamazine citrate) Chewable Tablets. 132-028...................... ANESTATAL (thiamylal 522.2424 sodium) Injectable Solution. 135-771...................... Methylprednisolene 520.1408 Tablets. 136-212...................... Methylprednisolone 522.1410 Acetate Injection. 137-310...................... Gentamicin Sulfate 522.1044 Injectable Solution. 138-869...................... Triamcinolone Acetonide 522.2483 Suspension. 140-442...................... Xylazine HCl Injection... 522.2662 200-023...................... Gentamicin Sulfate 522.1044 Solution 100 mg/mL. 200-029...................... Ketamine Hydrochloride 522.1222 Injection. 200-165...................... SDM (sulfadimethoxine) 520.2220a Concentrated Solution 12.5%. ------------------------------------------------------------------------ [[Page 48943]] 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 100 522.1182 (colloidal ferric oxide). 040-205...................... PURINA Horse Wormer 520.2380a Medicated (thiabendazole). 042-116...................... PURINA 6 DAY WORM-KILL 558.185 Feed Premix (coumaphos). 043-215...................... PURINA GRUB-KILL Pour-on 524.900 Cattle Insecticide (famphur). 046-700...................... STATYL (nequinate) 558.365 Medicated Premix. 091-260...................... PULVEX WORM CAPS 520.1804 (piperazine phosphate monohydrate). 097-258...................... PURINA BAN-WORM for Pigs 558.485 (pyrantel tartrate). 102-942...................... PULVEX Multipurpose Worm 520.580 Caps (dichlorophene, toluene). 113-748...................... PURINA PIGEMIA Oral (iron 520.1182 dextran complex). 135-941...................... CHECK-R-TON BM (pyrantel 558.485 tartrate). 136-116...................... PURINA WORM-A-RESTTM 520.905d Litter Pack Premix (fenbendazole). 140-869...................... PURINA SAF-T-BLOC BG 520.1840 Medicated Feed Block (poloxalene, 6.6%). ------------------------------------------------------------------------ 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 Sec. 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 0 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. 0 2. In Sec. 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: Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * * * (c) * * * (1) * * * [[Page 48944]] ------------------------------------------------------------------------ Drug labeler Firm name and address 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 0 3. The authority citation for part 520 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 520.390a [Amended] 0 4. In Sec. 520.390a, in paragraph (b)(1)(i), remove ``054628'' and in its place add ``069043''. Sec. 520.441 [Amended] 0 5. In Sec. 520.441, in paragraph (b)(3), remove ``069254 and 076475'' and in its place add ``069043, 069254, and 076475''. Sec. 520.443 [Amended] 0 6. In Sec. 520.443, in paragraph (b), remove ``054628'' and in its place add ``069043''. Sec. 520.580 [Amended] 0 7. In Sec. 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''. Sec. 520.600 [Redesignated as Sec. 520.596] 0 8. Redesignate Sec. 520.600 as Sec. 520.596 and revise newly redesignated Sec. 520.596 to read as follows: Sec. 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 Sec. 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 Sec. 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: ---------------------------------------------------------------------------------------------------------------- Pounds of mixed Pounds of feed to feed to be Number of pigs to Weight of animal in pounds be mixed with administered to be treated per each 0.08 ounce each pig as a 0.08 ounce of of dichlorvos single treatment 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. (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 [[Page 48945]] recommended dosage and repeated 8 to 12 hours later in the treatment of very aged, emaciated, or debilitated subjects or those reluctant to consume medicated feed. In suspected cases of severe ascarid infection sufficient to cause concern over mechanical blockage of the intestinal tract, the split dosage should be used. (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. 0 9. Add Sec. 520.598 to read as follows: Sec. 520.598 Dichlorvos tablets. (a) Specifications. Each tablet contains 2, 5, 10, or 20 milligrams (mg) dichlorvos. (b) Sponsor. See No. 069043 in Sec. 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. 0 10. Add Sec. 520.600 to read as follows: Sec. 520.600 Dichlorvos capsules and pellets. (a) Specifications. Each capsule contains 2.27 milligrams (mg) (4 percent) dichlorvos. (b) Sponsor. See No. 069043 in Sec. 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. 0 11. Add Sec. 520.602 to read as follows: Sec. 520.602 Dichlorvos gel. (a) Specifications. Each milligram (mg) of gel contains 2.27 milligrams (mg) dichlorvos. (b) Sponsor. See No. 069043 in Sec. 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. Sec. 520.622a [Amended] 0 12. In Sec. 520.622a, in paragraph (a)(6), remove ``054628'' and in its place add ``069043''. Sec. 520.622b [Amended] 0 13. In Sec. 520.622b, in paragraph (c)(2), remove ``054628'' and in its place add ``069043''. Sec. 520.622c [Amended] 0 14. In Sec. 520.622c, in paragraph (b)(6), remove ``054628'' and in its place add ``069043''. Sec. 520.763a [Amended] 0 15. In Sec. 520.763a, in paragraph (b), remove ``054628'' and in its place add ``069043''. Sec. 520.763b [Amended] 0 16. In Sec. 520.763b, in paragraph (b), remove ``000010'' and in its place add ``069043''. Sec. 520.763c [Amended] 0 17. In Sec. 520.763c, in paragraph (b), remove ``054628'' and in its place add ``069043''. 0 18. In Sec. 520.905d, revise paragraphs (a) and (b) to read as follows: Sec. 520.905d Fenbendazole powder. (a) Specifications. Each 2-ounce packet contains 2.27 grams (4 percent) fenbendazole. (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter. * * * * * Sec. 520.1044c [Amended] 0 19. In Sec. 520.1044c, in paragraph (b)(2), remove ``057561'' and in its place add ``016592''. Sec. 520.1182 [Removed] 0 20. Remove Sec. 520.1182. Sec. 520.1242a [Amended] 0 21. In Sec. 520.1242a, in paragraph (b)(3), remove ``057561'' and in its place add ``016592''. Sec. 520.1263c [Amended] 0 22. In Sec. 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''. Sec. 520.1265 [Amended] 0 23. In Sec. 520.1265, in paragraph (b)(2), remove ``057561'' and in its place add ``016592''. 0 24. Add Sec. 520.1286 to read as follows: Sec. 520.1286 Lotilaner. (a) Specifications. Each chewable tablet contains 56.25, 112.5, 225, 450, or 900 milligrams (mg) lotilaner. (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter. [[Page 48946]] (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. Sec. 520.1408 [Amended] 0 25. In Sec. 520.1408, in paragraph (b)(1), remove ``054628'' and in its place add ``069043''. Sec. 520.1660d [Amended] 0 26. In Sec. 520.1660d, in paragraph (b)(4), remove ``No. 057561'' and in its place add ``No. 016592''. Sec. 20.1720a [Amended] 0 27. In Sec. 520.1720a, in paragraph (b)(2), remove ``Nos. 054628 and 069043'' and in its place add ``No. 069043''. Sec. 520.1804 [Removed] 0 28. Remove Sec. 520.1804. Sec. 520.1840 [Amended] 0 29. In Sec. 520.1840, remove paragraph (b)(2), redesignate paragraphs (b)(3) and (4) as paragraphs (b)(2) and (3), and remove paragraph (d)(4). Sec. 520.1900 [Amended] 0 30. In Sec. 520.1900, in paragraph (b)(1), remove ``054628'' and in its place add ``069043''. Sec. 520.2220a [Amended] 0 31. In Sec. 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''. Sec. 520.2345d [Amended] 0 32. In Sec. 520.2345d, in paragraph (b)(4), remove ``Nos. 054925, 057561, 061623, and 076475'' and in its place add ``Nos. 016592, 054925, 061623, and 076475''. Sec. 520.2380a [Amended] 0 33. In Sec. 520.2380a, remove and reserve paragraphs (b)(1) and (d)(1)(i). PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 34. The authority citation for part 522 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 522.970 [Amended] 0 35. In Sec. 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''. Sec. 522.1044 [Amended] 0 36. In Sec. 522.1044, in paragraph (b)(3), remove ``054628'' and in its place add ``069043''. Sec. 522.1182 [Amended] 0 37. In Sec. 522.1182, in paragraph (b)(4), remove ``Nos. 051311 and 054771'' and in its place add ``No. 054771''. Sec. 522.1222 [Amended] 0 38. In Sec. 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''. Sec. 522.1242 [Amended] 0 39. In Sec. 522.1242, in paragraph (b), remove ``057561'' and in its place add ``016592''. Sec. 522.1410 [Amended] 0 40. In Sec. 522.1410, in paragraph (b), remove ``054628 and 054771'' and in its place add ``054771 and 069043''. Sec. 522.1660a [Amended] 0 41. In Sec. 522.1660a, in paragraph (b), remove ``057561,''. Sec. 522.1662a [Amended] 0 42. In Sec. 522.1662a, in paragraphs (a)(2), (b)(2), (g)(2), and (h)(2), remove ``054628'' and in its place add ``069043''. Sec. 522.1720 [Amended] 0 43. In Sec. 522.1720, in paragraph (b)(3), remove ``054628 and 058005'' and in its place add ``058005 and 069043''. Sec. 522.2220 [Amended] 0 44. In Sec. 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''. Sec. 522.2424 [Amended] 0 45. In Sec. 522.2424, in paragraph (b), remove ``054628 and 054771'' and in its place add ``054771 and 069043''. Sec. 522.2483 [Amended] 0 46. In Sec. 522.2483, in paragraph (b), remove ``054628'' and in its place add ``069043''. Sec. 522.2662 [Amended] 0 47. In Sec. 522.2662, in paragraph (b)(1), remove ``054628'' and in its place add ``069043''. PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0 48. The authority citation for part 524 continues to read as follows: Authority: 21 U.S.C. 360b. 0 49. In Sec. 524.814, revise paragraph (b) to read as follows: Sec. 524.814 Eprinomectin. * * * * * (b) Sponsors. See Nos. 050604 and 055529 in Sec. 510.600(c) of this chapter. * * * * * 0 50. Add Sec. 524.815 to read as follows: Sec. 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 Sec. 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. Sec. 524.900 [Amended] 0 51. In Sec. 524.900, in paragraph (b), remove ``Nos. 000061 and 051311'' and in its place add ``No. 000061''. [[Page 48947]] Sec. 524.1580a [Amended] 0 52. In Sec. 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''. Sec. 524.1580b [Amended] 0 53. In Sec. 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 0 54. The authority citation for part 529 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 529.1044a [Amended] 0 55. In Sec. 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 0 56. The authority citation for part 556 continues to read as follows: Authority: 21 U.S.C. 342, 360b, 371. 0 57. In Sec. 556.275, add paragraph (b)(3)(ii) to read as follows: Sec. 556.275 Fenbendazole. * * * * * (b) * * * (3) * * * (ii) Eggs. The tolerance for fenbendazole sulfone (the marker residue) is 1.8 ppm. * * * * * Sec. 556.440 [Removed] 0 58. Remove Sec. 556.440. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 59. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. Sec. 558.4 [Amended] 0 60. In Sec. 558.4, in paragraph (d), in the ``Category I'' table, remove the row entry for ``Nequinate''. Sec. 558.128 [Amended] 0 61. In Sec. 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''. 0 62. In Sec. 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: Sec. 558.185 Coumaphos. * * * * * (b) Sponsor. See No. 000859 in Sec. 510.600(c) of this chapter. * * * * * Sec. 558.195 [Amended] 0 63. In Sec. 558.195, remove and reserve paragraph (e)(2)(v). 0 64. In Sec. 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: Sec. 558.205 Dichlorvos. (a) Specifications. Type A medicated articles containing 3.1 or 9.6 percent dichlorvos. (b) Sponsor. See No. 069043 in Sec. 510.600(c) of this chapter. * * * * * 0 65. In Sec. 558.311, revise paragraph (e)(5) to read as follows: Sec. 558.311 Lasalocid. * * * * * (e) * * * (5) Lasalocid may also be used in combination with: (i) Chlortetracycline as in Sec. 558.128. (ii) Melengestrol as in Sec. 558.342. (iii) Oxytetracycline as in Sec. 558.450. (iv) Tylosin alone or in combination with melengestrol acetate as in Sec. 558.625. (v) Virginiamycin as in Sec. 558.635. 0 66. In Sec. 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: Sec. 558.325 Lincomycin. * * * * * (e) * * * (1) * * * ---------------------------------------------------------------------------------------------------------------- Combination in Lincomycin grams/ton grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (ii) [Reserved] (iii) [Reserved] (iv) 2........................ Decoquinate, Broiler chickens: For Feed as the sole ration. 054771 2.72. the control of Do not use in feeds necrotic enteritis containing bentonite. Not caused or for use in laying hens, complicated by breeding chickens, or Clostridium spp. or turkeys. Do not allow other organisms rabbits, hamsters, guinea susceptible to pigs, horses, or lincomycin; and for ruminants access to feeds the prevention of containing lincomycin. coccidiosis caused Ingestion by these by Eimeria tenella, species may result in E. necatrix, E. severe gastrointestinal acervulina, E. effects. Decoquinate as brunetti, E. mivati, provided by No. 054771 in and E. maxima. Sec. 510.600 of this chapter. * * * * * * * (vi) [Reserved] (vii) 2....................... Monensin, 90 to Broiler chickens: For Feed as the sole ration. 054771 110. the control of Must be thoroughly mixed necrotic enteritis in feeds before use. Do caused or not feed undiluted. Not complicated by for use in laying hens, Clostridium spp. or breeding chickens, or other organisms turkeys. Do not allow susceptible to horses, or other equines, lincomycin, and as mature turkeys, or guinea an aid the fowl access to feed prevention of containing monensin. coccidiosis caused Ingestion of monensin by by Eimeria necatrix, horses and guinea fowl E. tenella, E. has been fatal. Do not acervulina, E. allow rabbits, hamsters, brunetti, E. mivati, guinea pigs, horses, or and E. maxima. ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Monensin as provided by No. 058198 in Sec. 510.600 of this chapter. [[Page 48948]] (viii) 2...................... Robenidine Broiler chickens: For Feed as the sole ration. 054771 hydrochloride, the control of Do not use in feeds 30. necrotic enteritis containing bentonite. Do caused or not feed to laying hens complicated by producing eggs for human Clostridium spp. or consumption. Not for use other organisms in laying hens, breeding susceptible to chickens, or turkeys. Do lincomycin, and as not allow rabbits, an aid in the hamsters, guinea pigs, prevention of horses, or ruminants coccidiosis caused access to feeds by Eimeria mivati, containing lincomycin. E. brunetti, E. Ingestion by these tenella, E. species may result in acervulina, E. severe gastrointestinal maxima, and E. effects. Withdraw 5 days necatrix. 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 Sec. 510.600 of this chapter. (ix) 2........................ Salinomycin Broiler chickens: For Feed as the sole ration to 054771 sodium, 40 to the control of broiler chickens. Do not 60. necrotic enteritis feed to laying hens caused or producing eggs for human complicated by consumption. Not approved Clostridium spp. or for use with pellet other organisms binders. May be fatal if susceptible to accidentally fed to adult lincomycin, and for turkeys or horses. Not the prevention of for use in laying hens, coccidiosis caused breeding chickens, or by Eimeria tenella, turkeys. Do not allow E. necatrix, E. rabbits, hamsters, guinea acervulina, E pigs, horses, or maxima, E. brunetti, ruminants access to feeds and E. mivati. containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Salinomycin sodium as provided by No. 054771 in Sec. 510.600 of this chapter. (x) 2......................... Zoalene, 113.5.. Broiler chickens: For Feed as the sole ration 054771 the control of from the time chicks are necrotic enteritis placed in floor pens caused or until slaughtered for complicated by meat. Not for use in Clostridium spp. or laying hens, breeding other organisms chickens, or turkeys. Do susceptible to not allow rabbits, lincomycin; and for hamsters, guinea pigs, the prevention and horses, or ruminants control of access to feeds coccidiosis. containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Zoalene as provided by No. 054771 in Sec. 510.600 of this chapter. ---------------------------------------------------------------------------------------------------------------- * * * * * 0 67. In Sec. 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: Sec. 558.342 Melengestrol. * * * * * (e) * * * (1) * * * ---------------------------------------------------------------------------------------------------------------- Melengestrol acetate in mg/ Combination in head/day grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (iii) 0.25 to 0.5............. Lasalocid, 10 to Heifers fed in Add at the rate of 0.5 to 054771 30. confinement for 2.0 lb/head/day a 058198 slaughter: For medicated feed (liquid or increased rate of dry) containing 0.125 to weight gain, 1.0 mg melengestrol improved feed acetate/lb to a feed efficiency, and containing 10 to 30 g of suppression of lasalocid per ton to estrus (heat); and provide 0.25 to 0.5 mg for control of melengestrol acetate and coccidiosis caused 100 to 360 milligrams of by Eimeria bovis and lasalocid per head/day. Eimeria zuernii. See Sec. 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in Sec. 510.600(c) of this chapter. (iv) 0.25 to 0.5.............. Monensin, 10 to Heifers fed in Add at the rate of 0.5 to 054771 40. confinement for 2.0 lb/head/day a 058198 slaughter: For medicated feed (liquid or increased rate of dry) containing 0.125 to weight gain, 1.0 mg melengestrol improved feed acetate/lb to a feed efficiency, and containing 10 to 40 g of suppression of monensin per ton to estrus (heat); and provide 0.25 to 0.5 mg for the prevention melengestrol acetate/head/ and control of day and 0.14 to 0.42 mg coccidiosis due to monensin/lb body weight, Eimeria bovis and E. depending on severity of zuernii. coccidiosis challenge, up to 480 mg monensin/head/ day. See Sec. 558.355(d) of this chapter. Monensin as provided by No. 058198 in Sec. 510.600(c) of this chapter. ---------------------------------------------------------------------------------------------------------------- (2) * * * (i) Oxytetracycline as in Sec. 558.450. * * * * * Sec. 558.365 [Removed] 0 68. Remove Sec. 558.365. Sec. 558.450 [Amended] 0 69. In Sec. 558.450, in paragraph (e)(5)(iv) entries 1 and 2, remove ``A. liquefaciens'' and in its place add ``A. hydrophila''. 0 70. Revise Sec. 558.485 to read as follows: Sec. 558.485 Pyrantel. (a) Specifications. Type A medicated articles containing 48 or 80 grams per pound pyrantel tartrate. (b) Sponsors. See sponsors in Sec. 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. (c) Related tolerances. See Sec. 556.560 of this chapter. [[Page 48949]] (d) Special considerations--(1) See Sec. 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 Feed continuously as the sole 066104 prevention of migration ration in a Type C feed. and establishment of large Withdraw 24 hours prior to roundworm (Ascaris suum) slaughter. infections; aid in the prevention of establishment of nodular worm (Oesophagostomum) infections. (ii) 96............................. Swine: For the removal and Feed for 3 days as the sole 066104 control of large roundworm ration in a Type C feed. (Ascaris suum) infections. Withdraw 24 hours prior to slaughter. (iii) 800........................... Swine: For the removal and Feed as the sole ration for a 066104 control of large roundworm single therapeutic treatment in (Ascaris suum) and nodular Type C feed at a rate of 1 lb worm (Oesophagostomum) of feed per 40 lb of body infections. 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. ---------------------------------------------------------------------------------------------------------------- (2) Horses-- ---------------------------------------------------------------------------------------------------------------- Pyrantel grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- To provide 1.2 mg/lb body weight.... Prevention of Strongylus Feed continuously. Administer 017135 vulgaris larval either as a top-dress (not to 054771 infections; control of exceed 20,000 g/ton) or mixed adult large strongyles (S. in the horse's daily grain vulgaris, and S. ration (not to exceed 1,200 g/ edentatus), adult and 4th ton) during the time that the stage larvae small animal is at risk of exposure strongyles (Cyathostomum to internal parasites. Not for spp., Cylicocyclus spp., use in horses intended for Cylicostephanus spp., food. Consult your veterinarian Cylicodontophorus spp., before using in severely Poteriostomum spp., and debilitated animals and for Triodontophorus spp.), assistance in the diagnosis, adult and 4th stage larvae treatment, and control of pinworms (Oxyuris equi), parasitism. and adult and 4th stage larvae ascarids (Parascaris equorum). ---------------------------------------------------------------------------------------------------------------- (3) Pyrantel may also be used in combination with: (i) Carbadox as in Sec. 558.115. (ii) Lincomycin as in Sec. 558.325. (iii) Tylosin as in Sec. 558.625. 0 71. In Sec. 558.625, revise paragraphs (e)(2)(ii) and (iii) to read as follows: Sec. 558.625 Tylosin. * * * * * (e) * * * (2) * * * ---------------------------------------------------------------------------------------------------------------- Combination in Tylosin grams/ton grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (ii) 8 to 10.................. Lasalocid, 100 Heifers fed in Feed continuously as sole 016592 to 1440; plus confinement for ration. Feed to heifers 054771 melengestrol, slaughter: For at the rate of 0.5 to 2.0 058198 0.25 to 2.0. reduction of pound(s) per head per day incidence of liver (specify one level) to abscesses caused by provide 0.25 to 0.5 mg Fusobacterium melengestrol acetate per necrophorum and head per day (specify one Arcanobacterium level), 100 to 360 mg pyogenes; and for lasalocid per head per increased rate of day (specify one level), weight gain, and 90 mg tylosin per improved feed head per day. This Type C efficiency, and product may be top suppression of dressed onto or mixed estrus (heat). 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 Sec. 510.600(c) of this chapter. See Sec. Sec. 558.311(d) and 558.342(d) in this chapter. (iii) 8 to 10................. Melengestrol, Heifers fed in Feed continuously as sole 016592 0.25 to 2.0. confinement for ration. Each pound 054771 slaughter: For contains 0.125 to 1.0 mg 058198 reduction of melengestrol acetate and incidence of liver 45 to 180 mg of tylosin. abscesses caused by Feed to heifers at a rate Fusobacterium of 0.5 to 2.0 pounds per necrophorum and head per day to provide Arcanobacterium 0.25 to 0.5 mg pyogenes; and for melengestrol acetate and increased rate of 60 to 90 mg tylosin per weight gain, head per day. Prior to improved feed feeding, this Type C efficiency, and product must be top- suppression of dressed onto a complete estrus (heat). 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 Sec. 510.600(c) of this chapter. See Sec. 558.342(d) in this chapter. * * * * * * * ---------------------------------------------------------------------------------------------------------------- [[Page 48950]] Dated: September 24, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-21146 Filed 9-27-18; 8:45 am] BILLING CODE 4164-01-P
![48940 Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Rules and Regulations
Authority: 49 U.S.C. 106(g), 40113, 44701. Accomplishment Instructions of BAE paragraph under 5 U.S.C. 552(a) and 1 CFR
Systems (Operations) Limited Service part 51.
§ 39.13 [Amended] Bulletin J41–26–009, dated November 23, (2) You must use this service information
■ 2. The FAA amends § 39.13 by adding 2016. as applicable to do the actions required by
the following new airworthiness (2) If, during any inspection as required by this AD, unless this AD specifies otherwise.
paragraph (g) or (h) of this AD, as applicable, (i) BAE Systems (Operations) Limited
directive (AD): one or more spacers are found inside the Service Bulletin J41–26–009, dated
2018–19–30 BAE Systems (Operations) airplane electrical connector: Before further November 23, 2016.
Limited: Amendment 39–19431; Docket flight, remove all spacers from the inside of (ii) Reserved.
No. FAA–2018–0555; Product Identifier the airplane electrical connector in (3) For service information identified in
2017–NM–152–AD. accordance with the Accomplishment this AD, contact BAE Systems (Operations)
Instructions of BAE Systems (Operations) Limited, Customer Information Department,
(a) Effective Date Limited Service Bulletin J41–26–009, dated Prestwick International Airport, Ayrshire,
This AD is effective November 2, 2018. November 23, 2016. KA9 2RW, Scotland, United Kingdom;
(3) If, during any inspection as required by telephone +44 1292 675207; fax +44 1292
(b) Affected ADs
paragraph (g) or (h) of this AD, as applicable, 675704; email RApublications@
None. no blue spacer is found inside the cartridge baesystems.com; internet http://
(c) Applicability electrical connector body: Before further www.baesystems.com/Businesses/
flight, replace the cartridge in accordance RegionalAircraft/index.htm.
This AD applies to BAE Systems with the Accomplishment Instructions of the (4) You may view this service information
(Operations) Limited Model 4101 airplanes, BAE Systems (Operations) Limited Service at the FAA, Transport Standards Branch,
certificated in any category, all serial Bulletin J41–26–009, dated November 23, 2200 South 216th St., Des Moines, WA. For
numbers. 2016. information on the availability of this
(d) Subject (j) Other FAA AD Provisions material at the FAA, call 206–231–3195.
Air Transport Association (ATA) of (5) You may view this service information
The following provisions also apply to this that is incorporated by reference at the
America Code 26, Fire protection. AD:
National Archives and Records
(e) Reason (1) Alternative Methods of Compliance
Administration (NARA). For information on
(AMOCs): The Manager, International
This AD was prompted by a report of an the availability of this material at NARA, call
Section, Transport Standards Branch, FAA,
improperly installed spacer around the 202–741–6030, or go to: http://
has the authority to approve AMOCs for this
electrical pins in the cartridge connector for www.archives.gov/federal-register/cfr/ibr-
AD, if requested using the procedures found
the fire bottle extinguisher cartridge. We are locations.html.
in 14 CFR 39.19. In accordance with 14 CFR
issuing this AD to detect and correct 39.19, send your request to your principal Issued in Des Moines, Washington, on
excessive or missing spacers, which could inspector or local Flight Standards District September 14, 2018.
result in the fire extinguisher bottle not Office, as appropriate. If sending information John P. Piccola,
discharging when required, possibly directly to the International Section, send it
resulting in damage to the airplane. Acting Director, System Oversight Division,
to the attention of the person identified in
Aircraft Certification Service.
(f) Compliance paragraph (k)(2) of this AD. Information may
be emailed to: 9-ANM-116-AMOC- [FR Doc. 2018–20923 Filed 9–27–18; 8:45 am]
Comply with this AD within the REQUESTS@faa.gov. Before using any BILLING CODE 4910–13–P
compliance times specified, unless already approved AMOC, notify your appropriate
done. principal inspector, or lacking a principal
(g) Inspection inspector, the manager of the local flight
standards district office/certificate holding DEPARTMENT OF HEALTH AND
Within 12 months after the effective date district office. HUMAN SERVICES
of this AD, do a general visual inspection of (2) Contacting the Manufacturer: For any
the inside of the cartridge electrical requirement in this AD to obtain corrective Food and Drug Administration
connector and the inside of the airplane actions from a manufacturer, the action must
electrical connector in accordance with the be accomplished using a method approved 21 CFR Parts 510, 520, 522, 524, 529,
Accomplishment Instructions of the BAE by the Manager, International Section, 556, and 558
Systems (Operations) Limited Service Transport Standards Branch, FAA; or the
Bulletin J41–26–009, dated November 23, European Aviation Safety Agency (EASA); or [Docket No. FDA–2018–N–0002]
2016. BAE Systems (Operations) Limited’s EASA
(h) Inspections After Maintenance Design Organization Approval (DOA). If New Animal Drugs; Approval of New
approved by the DOA, the approval must Animal Drug Applications; Withdrawal
As of the effective date of this AD, before include the DOA-authorized signature. of Approval of New Animal Drug
further flight after each accomplishment of a
maintenance task involving disconnection or (k) Related Information Applications; Changes of
(re-)connection of an electrical connector of Sponsorship; Change of a Sponsor’s
(1) Refer to Mandatory Continuing
a fire bottle extinguisher cartridge, do a Airworthiness Information (MCAI) EASA AD Name
general visual inspection of the inside of the 2017–0212, dated October 25, 2017, for
cartridge electrical connector and the inside
AGENCY: Food and Drug Administration,
related information. This MCAI may be
of the airplane electrical connector in found in the AD docket on the internet at
HHS.
accordance with the Accomplishment http://www.regulations.gov by searching for Final rule; technical
ACTION:
Instructions of BAE Systems (Operations) and locating Docket No. FAA–2018–0555. amendments.
Limited Service Bulletin J41–26–009, dated (2) For more information about this AD,
November 23, 2016. contact Todd Thompson, Aerospace SUMMARY: The Food and Drug
(i) Corrective Actions
Engineer, International Section, Transport Administration (FDA or we) is
Standards Branch, FAA, 2200 South 216th amending the animal drug regulations to
daltland on DSKBBV9HB2PROD with RULES
(1) If, during any inspection as required by St., Des Moines, WA 98198; telephone and reflect application-related actions for
paragraph (g) or (h) of this AD, as applicable, fax 206–231–3228.
more than one spacer is found inside the new animal drug applications (NADAs)
cartridge electrical connector: Before further (l) Material Incorporated by Reference and abbreviated new animal drug
flight, remove the excessive spacer(s) from (1) The Director of the Federal Register applications (ANADAs) during January,
the inside of the cartridge electrical approved the incorporation by reference February, and March 2018. FDA is
connector in accordance with the (IBR) of the service information listed in this informing the public of the availability
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![Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Rules and Regulations 48943
The animal drug regulations are being III. Withdrawals of Approval FDA withdraw approval of the NADAs
amended to reflect these changes of listed in the following table because the
sponsorship. Virbac AH, Inc., 3200 Meacham Blvd., products are no longer manufactured or
Ft. Worth, TX 76137 has requested that marketed:
21 CFR
File No. Product name 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–RESTTM 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 animal drugs. This rule sets forth 21 CFR Part 556
Register, FDA gave notice that approval technical amendments to the regulations
of NADAs 011–779, 040–205, 042–116, to codify recent actions on approved Animal drugs, Foods.
043–215, 046–700, 091–260, 097–258, new animal drug applications and 21 CFR Part 558
102–942, 113–748, 135–941, 136–116, corrections to improve the accuracy of
and 140–869, and all supplements and the regulations, and as such does not Animal drugs, Animal feeds.
amendments thereto, is withdrawn, impose any burden on regulated
effective October 9, 2018. As provided entities. Therefore, under the Federal Food,
in the regulatory text of this document, Although denominated a rule Drug, and Cosmetic Act and under
the animal drug regulations are pursuant to the FD&C Act, this authority delegated to the Commissioner
amended to reflect these actions. document does not meet the definition of Food and Drugs, 21 CFR parts 510,
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 520, 522, 524, 529, 556, and 558 are
IV. Technical Amendments amended as follows:
it is a ‘‘rule of particular applicability.’’
JBS United Animal Health II LLC, 322 Therefore, it is not subject to the
S Main St., Sheridan, IN 46069 has PART 510—NEW ANIMAL DRUGS
congressional review requirements in 5
informed FDA that it has changed its U.S.C. 801–808. Likewise, this is not a
name to United-AH II LLC. Accordingly, rule subject to Executive Order 12866, ■ 1. The authority citation for part 510
we are amending § 510.600(c) to reflect which defines a rule as ‘‘an agency continues to read as follows:
this change. statement of general applicability and Authority: 21 U.S.C. 321, 331, 351, 352,
We are also making technical future effect, which the agency intends 353, 360b, 371, 379e.
amendments to update the scientific to have the force and effect of law, that
name of a pathogenic bacterium and to is designed to implement, interpret, or ■ 2. In § 510.600, in the table in
accurately list the concentrations of new prescribe law or policy or to describe paragraph (c)(1), remove the entry for
animal drug ingredients in combination the procedure or practice requirements ‘‘JBS United Animal Health II LLC’’, and
drug medicated feeds. These actions are of an agency.’’ alphabetically add an entry for ‘‘United-
being taken to improve the accuracy of AH II LLC’’; and in the table in
the regulations. List of Subjects paragraph (c)(2), revise the entry for
21 CFR Part 510 ‘‘051233’’ to read as follows:
V. Legal Authority
Administrative practice and § 510.600 Names, addresses, and drug
This final rule is issued under section labeler codes of sponsors of approved
512(i) of the Federal Food, Drug, and procedure, Animal drugs, Labeling,
Reporting and recordkeeping applications.
Cosmetic Act (FD&C Act) (21 U.S.C.
requirements. * * * * *
360b(i)), which requires Federal
Register publication of ‘‘notice[s] . . . 21 CFR Parts 520, 522, 524, and 529 (c) * * *
effective as a regulation,’’ of the (1) * * *
Animal drugs.
conditions of use of approved new
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![48944 Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Rules and Regulations
Drug labeler
Firm name and address code
* * * * * * *
United-AH II LLC, 322 S Main St., Sheridan, IN 46069 ..................................................................................................................... 051233
* * * * * * *
* * * * * * *
(2) * * *
Drug labeler Firm name and address
code
* * * * * * *
051233 ............ United-AH II LLC, 322 S Main St., Sheridan, IN 46069
* * * * * * *
PART 520—ORAL DOSAGE FORM § 520.443 [Amended] § 520.596 Dichlorvos powder.
NEW ANIMAL DRUGS (a) Specifications—(1) Each 2-ounce
■ 6. In § 520.443, in paragraph (b),
packet contains 2.27 grams (4 percent)
remove ‘‘054628’’ and in its place add dichlorvos.
■ 3. The authority citation for part 520 ‘‘069043’’.
continues to read as follows: (2) Each milligram of powder contains
§ 520.580 [Amended] 2.27 milligrams (mg) dichlorvos.
Authority: 21 U.S.C. 360b.
(b) Sponsor. See No. 069043 in
§ 520.390a [Amended] ■ 7. In § 520.580, in paragraph (b)(1), § 510.600(c) of this chapter for use of the
remove ‘‘051311’’; and in paragraph product described in paragraph (a)(1) of
■ 4. In § 520.390a, in paragraph (b)(1)(i), (b)(2), remove ‘‘000061 and 054771’’, this section as in paragraph (d)(1) of this
remove ‘‘054628’’ and in its place add and in its place add ‘‘000061, 054771, section and the product described in
‘‘069043’’. and 069043’’. paragraph (a)(2) of this section as in
paragraph (d)(2) of this section.
§ 520.441 [Amended] § 520.600 [Redesignated as § 520.596] (c) Related tolerances. See § 556.180
of this chapter.
■ 5. In § 520.441, in paragraph (b)(3), ■ 8. Redesignate § 520.600 as § 520.596 (d) Conditions of use—(1) Swine
remove ‘‘069254 and 076475’’ and in its and revise newly redesignated § 520.596 (adult gilts, sows, and boars)—(i)
place add ‘‘069043, 069254, and to read as follows: Amount. Add powder to the indicated
076475’’. amount of feed and administered
shortly after mixing, as follows:
Pounds of feed to Pounds of mixed Number of pigs
be mixed with feed to be to be treated
Weight of animal in pounds each 0.08 administered to per 0.08
ounce of each pig as a ounce of
dichlorvos single treatment 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 (iii) Limitations. Do not use this Do not treat pigs with signs of scours
removal and control of sexually mature product on animals either until these signs subside or are
(adult), sexually immature and/or 4th simultaneously or within a few days alleviated by proper medication.
stage larvae of the whipworm (Trichuris before or after treatment with or Resume normal feeding schedule
suis), nodular worms exposure to cholinesterase inhibiting afterwards. Swine may be retreated in 4
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(Oesophagostomum spp.), large round- drugs, pesticides, or chemicals. The to 5 weeks.
worm (Ascaris suum), and the mature preparation should be mixed thoroughly (2) Horses—(i) Amount. Administer in
thick stomach worm (Ascarops with the feed on a clean, impervious the grain portion of the ration at a
strongylina) occurring in the lumen of surface. Do not allow swine access to dosage of 14.2 to 18.5 mg per pound of
the gastrointestinal tract of pigs, boars, feed other than that containing the body weight as a single dose.
and open or bred gilts and sows. preparation until treatment is complete. Administered at one-half of the single
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recommended dosage and repeated 8 to (Toxocara cati and Toxascaris leonina) § 520.622b [Amended]
12 hours later in the treatment of very and hookworms (Ancylostoma ■ 13. In § 520.622b, in paragraph (c)(2),
aged, emaciated, or debilitated subjects tubaeforme and Uncinaria remove ‘‘054628’’ and in its place add
or those reluctant to consume medicated stenocephala). ‘‘069043’’.
feed. In suspected cases of severe (3) Limitations. Federal law restricts
ascarid infection sufficient to cause this drug to use by or on the order of § 520.622c [Amended]
concern over mechanical blockage of the a licensed veterinarian. ■ 14. In § 520.622c, in paragraph (b)(6),
intestinal tract, the split dosage should remove ‘‘054628’’ and in its place add
be used. ■ 10. Add § 520.600 to read as follows:
‘‘069043’’.
(ii) Indications for use. For the § 520.600 Dichlorvos capsules and pellets.
removal and control of bots § 520.763a [Amended]
(Gastrophilus intestinalis, G. nasalis), (a) Specifications. Each capsule
contains 2.27 milligrams (mg) (4 ■ 15. In § 520.763a, in paragraph (b),
large strongyles (Strongylus vulgaris, S. remove ‘‘054628’’ and in its place add
equinus, S. edentatus), small strongyles percent) dichlorvos.
‘‘069043’’.
(of the genera Cyathostomum, (b) Sponsor. See No. 069043 in
Cylicocercus, Cylicocyclus, § 510.600(c) of this chapter. § 520.763b [Amended]
Cylicodontophorus, Triodontophorus, (c) Conditions of use in dogs—(1) ■ 16. In § 520.763b, in paragraph (b),
Poteriostomum, Gyalocephalus), Amount. Administer any combination remove ‘‘000010’’ and in its place add
pinworms (Oxyuris equi), and large of capsules and/or pellets so that the ‘‘069043’’.
roundworm (Parascaris equorum) in animal receives a single dose equaling
horses including ponies and mules. Not 12 to 15 mg of dichlorvos per pound of § 520.763c [Amended]
for use in foals (sucklings and young body weight. ■ 17. In § 520.763c, in paragraph (b),
weanlings). (2) Indications for use. For removal of remove ‘‘054628’’ and in its place add
(iii) Limitations. Do not use in horses Toxocara canis and Toxascaris leonina ‘‘069043’’.
which are severely debilitated, suffering (roundworms), Ancylostoma caninum ■ 18. In § 520.905d, revise paragraphs
from diarrhea or severe constipation, and Uncinaria stenocephala (a) and (b) to read as follows:
infectious disease, toxemia, or colic. Do (hookworms), and Trichuris vulpis
not administer in conjunction with or (whipworm) residing in the lumen of § 520.905d Fenbendazole powder.
within 1 week of administration of the gastrointestinal tract. (a) Specifications. Each 2-ounce
muscle relaxant drugs, phenothiazine (3) Limitations. Federal law restricts packet contains 2.27 grams (4 percent)
derived tranquilizers or central nervous this drug to use by or on the order of fenbendazole.
system depressant drugs. Horses should (b) Sponsor. See No. 000061 in
a licensed veterinarian.
not be subjected to insecticide treatment § 510.600(c) of this chapter.
for 5 days prior to or after treating with ■ 11. Add § 520.602 to read as follows: * * * * *
the drug. Do not administer to horses § 520.602 Dichlorvos gel.
afflicted with chronic alveolar § 520.1044c [Amended]
emphysema (heaves) or related (a) Specifications. Each milligram ■ 19. In § 520.1044c, in paragraph (b)(2),
respiratory conditions. The product is a (mg) of gel contains 2.27 milligrams remove ‘‘057561’’ and in its place add
cholinesterase inhibitor and should not (mg) dichlorvos. ‘‘016592’’.
be used simultaneously or within a few (b) Sponsor. See No. 069043 in
days before or after treatment with or § 510.600(c) of this chapter. § 520.1182 [Removed]
exposure to cholinesterase inhibiting (c) Conditions of use in horses—(1) ■ 20. Remove § 520.1182.
drugs, pesticides or chemicals. Do not Amount. Administer 20 mg per
§ 520.1242a [Amended]
use in animals other than horses, kilogram of body weight for the removal
ponies, and mules. Do not use in horses, of bots and ascarids. Repeat ■ 21. In § 520.1242a, in paragraph (b)(3),
ponies, and mules intended for food administration every 21 to 28 days for remove ‘‘057561’’ and in its place add
purposes. Do not allow fowl access to the control of bots and ascarids. For the ‘‘016592’’.
feed containing this preparation or to control of bots only, the repeat dosage
§ 520.1263c [Amended]
fecal excrement from treated animals. is 10 milligrams per kilogram of body
■ 9. Add § 520.598 to read as follows: weight every 21 to 28 days during bot ■ 22. In § 520.1263c, in paragraph (b)(1),
fly season. remove ‘‘Nos. 016592 and 054771’’ and
§ 520.598 Dichlorvos tablets. in its place add ‘‘No. 054771’’; and in
(2) Indications for use. For the
(a) Specifications. Each tablet removal and control of first, second, and paragraph (b)(2), remove ‘‘Nos. 054925,
contains 2, 5, 10, or 20 milligrams (mg) third instar bots (Gastrophilus 061623, and 076475’’ and in its place
dichlorvos. intestinalis and G. nasalis), sexually add ‘‘Nos. 016592, 054925, 061623, and
(b) Sponsor. See No. 069043 in 076475’’.
mature and sexually immature (4th
§ 510.600(c) of this chapter.
stage) ascarids (Parascaris equorum) in § 520.1265 [Amended]
(c) Conditions of use in dogs, puppies,
horses and foals.
cats, and kittens—(1) Amount. ■ 23. In § 520.1265, in paragraph (b)(2),
Administer orally at 5 mg dichlorvos (3) Limitations. Do not use in horses remove ‘‘057561’’ and in its place add
per pound of body weight. intended for human consumption. ‘‘016592’’.
(2) Indications for use—(i) Dogs and Federal law restricts this drug to use by
■ 24. Add § 520.1286 to read as follows:
or on the order of a licensed
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puppies: Removal and control of
intestinal roundworms (Toxocara canis veterinarian. § 520.1286 Lotilaner.
and Toxascaris leonina) and § 520.622a [Amended] (a) Specifications. Each chewable
hookworms (Ancylostoma caninum and tablet contains 56.25, 112.5, 225, 450, or
Uncinaria stenocephala). ■ 12. In § 520.622a, in paragraph (a)(6), 900 milligrams (mg) lotilaner.
(ii) Cats and kittens: Removal and remove ‘‘054628’’ and in its place add (b) Sponsor. See No. 058198 in
control of intestinal roundworms ‘‘069043’’. § 510.600(c) of this chapter.
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(c) Conditions of use in dogs—(1) § 520.2380a [Amended] § 522.2424 [Amended]
Amount. Administer orally once a ■ 33. In § 520.2380a, remove and ■ 45. In § 522.2424, in paragraph (b),
month at the recommended minimum reserve paragraphs (b)(1) and (d)(1)(i). remove ‘‘054628 and 054771’’ and in its
dosage of 9 mg/lb (20 mg/kg). place add ‘‘054771 and 069043’’.
(2) Indications for use. Kills adult PART 522—IMPLANTATION OR
fleas, and for the treatment of flea INJECTABLE DOSAGE FORM NEW § 522.2483 [Amended]
infestations (Ctenocephalides felis), and ANIMAL DRUGS ■ 46. In § 522.2483, in paragraph (b),
the treatment and control of tick remove ‘‘054628’’ and in its place add
infestations (Amblyomma americanum ■ 34. The authority citation for part 522
‘‘069043’’.
(lone star tick), Dermacentor variabilis continues to read as follows:
(American dog tick), Ixodes scapularis Authority: 21 U.S.C. 360b. § 522.2662 [Amended]
(black-legged tick), and Rhipicephalus ■ 47. In § 522.2662, in paragraph (b)(1),
§ 522.970 [Amended]
sanguineus (brown dog tick)) for 1 remove ‘‘054628’’ and in its place add
month in dogs and puppies 8 weeks of ■ 35. In § 522.970, in paragraph (b)(1), ‘‘069043’’.
age or older and weighing 4.4 pounds or remove ‘‘Nos. 000061, 000859, 055529,
greater. 057561, and 061623’’ and in its place PART 524—OPHTHALMIC AND
(3) Limitations. Federal law restricts add ‘‘Nos. 000061, 000859, 016592, TOPICAL DOSAGE FORM NEW
this drug to use by or on the order of 055529, and 061623’’. ANIMAL DRUGS
a licensed veterinarian. § 522.1044 [Amended] ■ 48. The authority citation for part 524
§ 520.1408 [Amended] ■ 36. In § 522.1044, in paragraph (b)(3), continues to read as follows:
remove ‘‘054628’’ and in its place add Authority: 21 U.S.C. 360b.
■ 25. In § 520.1408, in paragraph (b)(1),
‘‘069043’’.
remove ‘‘054628’’ and in its place add ■ 49. In § 524.814, revise paragraph (b)
‘‘069043’’. § 522.1182 [Amended] to read as follows:
§ 520.1660d [Amended] ■ 37. In § 522.1182, in paragraph (b)(4), § 524.814 Eprinomectin.
remove ‘‘Nos. 051311 and 054771’’ and
■ 26. In § 520.1660d, in paragraph * * * * *
in its place add ‘‘No. 054771’’.
(b)(4), remove ‘‘No. 057561’’ and in its (b) Sponsors. See Nos. 050604 and
place add ‘‘No. 016592’’. § 522.1222 [Amended] 055529 in § 510.600(c) of this chapter.
■ 38. In § 522.1222, in paragraph (b), * * * * *
§ 20.1720a [Amended]
remove ‘‘Nos. 000859, 026637, 054628, ■ 50. Add § 524.815 to read as follows:
■ 27. In § 520.1720a, in paragraph (b)(2), 054771, 059399, and 063286’’ and in its
remove ‘‘Nos. 054628 and 069043’’ and § 524.815 Eprinomectin and praziquantel.
place add ‘‘Nos. 000859, 026637,
in its place add ‘‘No. 069043’’. 054771, 059399, 063286, and 069043’’. (a) Specifications. Each milliliter (mL)
of solution contains 4 milligrams (mg)
§ 520.1804 [Removed] § 522.1242 [Amended] eprinomectin and 83 mg praziquantel.
■ 28. Remove § 520.1804. ■ 39. In § 522.1242, in paragraph (b), (b) Sponsor. See No. 050604 in
remove ‘‘057561’’ and in its place add § 510.600(c) of this chapter.
§ 520.1840 [Amended] ‘‘016592’’. (c) Conditions of use in cats—(1)
Amount. Using the 0.3 mL and 0.9 mL
■ 29. In § 520.1840, remove paragraph § 522.1410 [Amended] unit applicators, administer a minimum
(b)(2), redesignate paragraphs (b)(3) and
■ 40. In § 522.1410, in paragraph (b), dose of 0.23 mg eprinomectin per pound
(4) as paragraphs (b)(2) and (3), and
remove ‘‘054628 and 054771’’ and in its body weight and 4.55 mg praziquantel
remove paragraph (d)(4).
place add ‘‘054771 and 069043’’. per pound body weight by topical
§ 520.1900 [Amended] application on the dorsal midline
§ 522.1660a [Amended] between the base of the skull and the
■ 30. In § 520.1900, in paragraph (b)(1), ■ 41. In § 522.1660a, in paragraph (b), shoulder blades.
remove ‘‘054628’’ and in its place add remove ‘‘057561,’’. (2) Indications for use. For the
‘‘069043’’. prevention of heartworm disease caused
§ 522.1662a [Amended] by Dirofilaria immitis, and for the
§ 520.2220a [Amended]
■ 42. In § 522.1662a, in paragraphs treatment and control of roundworms
■ 31. In § 520.2220a, in paragraph (b)(1), (a)(2), (b)(2), (g)(2), and (h)(2), remove (adult and fourth stage larval Toxocara
remove ‘‘Nos. 016592, 054628, 054771, ‘‘054628’’ and in its place add cati), hookworms (adult and fourth stage
054925, and 057561’’ and in its place ‘‘069043’’. larval Ancylostoma tubaeforme; adult
add ‘‘Nos. 016592, 054771, 054925, and Ancylostoma braziliense), and
069043’’; and in paragraph (b)(2), § 522.1720 [Amended] tapeworms (adult Dipylidium caninum
remove ‘‘Nos. 054771, 054925, 057561, ■ 43. In § 522.1720, in paragraph (b)(3), and Echinococcus multilocularis), in
058829, 061623, and 066104’’ and in its remove ‘‘054628 and 058005’’ and in its cats and kittens 7 weeks of age and
place add ‘‘Nos. 016592, 054771, place add ‘‘058005 and 069043’’. older and 1.8 lbs or greater.
054925, 058829, 061623, and 066104’’. (3) Limitations. Federal law restricts
§ 522.2220 [Amended] this drug to use by or on the order of
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§ 520.2345d [Amended]
■ 44. In § 522.2220, in paragraph (b)(1), a licensed veterinarian.
■ 32. In § 520.2345d, in paragraph remove ‘‘054628’’ and in its place add
§ 524.900 [Amended]
(b)(4), remove ‘‘Nos. 054925, 057561, ‘‘069043’’; and in paragraph (b)(3),
061623, and 076475’’ and in its place remove ‘‘Nos. 016592, 057561, and ■ 51. In § 524.900, in paragraph (b),
add ‘‘Nos. 016592, 054925, 061623, and 061623’’ and in its place add ‘‘Nos. remove ‘‘Nos. 000061 and 051311’’ and
076475’’. 016592 and 061623’’. in its place add ‘‘No. 000061’’.
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§ 524.1580a [Amended] (ii) Eggs. The tolerance for ■ 64. In § 558.205, revise paragraph (a);
■ 52. In § 524.1580a, in paragraph (b)(1), fenbendazole sulfone (the marker redesignate paragraphs (b) through (d)
remove ‘‘Nos. 054628, 054925, 058005, residue) is 1.8 ppm. as paragraphs (c) through (e); and add
059051, and 061623’’ and in its place * * * * * new paragraph (b).
add ‘‘Nos. 054925, 058005, 059051, The revision and addtion read as
§ 556.440 [Removed] follows:
061623, and 069043’’.
■ 58. Remove § 556.440.
§ 524.1580b [Amended] § 558.205 Dichlorvos.
■ 53. In § 524.1580b, in paragraph (b), PART 558—NEW ANIMAL DRUGS FOR (a) Specifications. Type A medicated
remove ‘‘054628 and 059051’’ and in its USE IN ANIMAL FEEDS articles containing 3.1 or 9.6 percent
place add ‘‘059051 and 069043’’. dichlorvos.
■ 59. The authority citation for part 558
(b) Sponsor. See No. 069043 in
continues to read as follows:
PART 529—CERTAIN OTHER DOSAGE § 510.600(c) of this chapter.
FORM NEW ANIMAL DRUGS Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
* * * * *
■ 54. The authority citation for part 529 ■ 65. In § 558.311, revise paragraph
§ 558.4 [Amended] (e)(5) to read as follows:
continues to read as follows:
■ 60. In § 558.4, in paragraph (d), in the
Authority: 21 U.S.C. 360b. § 558.311 Lasalocid.
‘‘Category I’’ table, remove the row entry
§ 529.1044a [Amended] for ‘‘Nequinate’’. * * * * *
(e) * * *
■ 55. In § 529.1044a, in paragraph (b), § 558.128 [Amended] (5) Lasalocid may also be used in
remove ‘‘Nos. 000061, 000859, 054628, ■ 61. In § 558.128, in paragraphs combination with:
054771, 057561, 058005, and 061623’’ (e)(4)(xi) and (xiii), in the ‘‘Indications (i) Chlortetracycline as in § 558.128.
and in its place add ‘‘Nos. 000061, for use’’ column, remove ‘‘P. multocida’’
000859, 016592, 054628, 054771, (ii) Melengestrol as in § 558.342.
and in its place add ‘‘P. multocida (iii) Oxytetracycline as in § 558.450.
058005, and 061623’’. organisms’’. (iv) Tylosin alone or in combination
■ 62. In § 558.185, revise paragraph (b), with melengestrol acetate as in
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS remove paragraph (e)(1), and § 558.625.
IN FOOD redesignate paragraphs (e)(2) and (3) as (v) Virginiamycin as in § 558.635.
paragraphs (e)(1) and (2).
The revision reads as follows: ■ 66. In § 558.325, redesignate
■ 56. The authority citation for part 556
paragraph (e)(1)(ii) as paragraph
continues to read as follows: § 558.185 Coumaphos. (e)(1)(v); add reserved paragraphs
Authority: 21 U.S.C. 342, 360b, 371. * * * * * (e)(1)(ii), (iii), and (vi); and add
■ 57. In § 556.275, add paragraph (b) Sponsor. See No. 000859 in paragraphs (e)(1)(iv), (vii), (viii), (ix),
(b)(3)(ii) to read as follows: § 510.600(c) of this chapter. and (x) to read as follows:
* * * * *
§ 556.275 Fenbendazole. § 558.325 Lincomycin.
* * * * * § 558.195 [Amended] * * * * *
(b) * * * ■ 63. In § 558.195, remove and reserve (e) * * *
(3) * * * paragraph (e)(2)(v). (1) * * *
Lincomycin Combination Indications for use Limitations Sponsor
grams/ton in grams/ton
* * * * * * *
(ii) [Reserved]
(iii) [Reserved]
(iv) 2 ............................ Decoquinate, 2.72 .... Broiler chickens: For the control of necrotic Feed as the sole ration. Do not use in feeds con- 054771
enteritis caused or complicated by Clos- taining bentonite. Not for use in laying hens, breed-
tridium spp. or other organisms suscep- ing chickens, or turkeys. Do not allow rabbits, ham-
tible to lincomycin; and for the prevention sters, guinea pigs, horses, or ruminants access to
of coccidiosis caused by Eimeria tenella, feeds containing lincomycin. Ingestion by these spe-
E. necatrix, E. acervulina, E. brunetti, E. cies may result in severe gastrointestinal effects.
mivati, and E. maxima. Decoquinate as provided by No. 054771 in
§ 510.600 of this chapter.
* * * * * * *
(vi) [Reserved]
(vii) 2 ........................... Monensin, 90 to 110 Broiler chickens: For the control of necrotic Feed as the sole ration. Must be thoroughly mixed in 054771
enteritis caused or complicated by Clos- feeds before use. Do not feed undiluted. Not for use
tridium spp. or other organisms suscep- in laying hens, breeding chickens, or turkeys. Do not
tible to lincomycin, and as an aid the pre- allow horses, or other equines, mature turkeys, or
vention of coccidiosis caused by Eimeria guinea fowl access to feed containing monensin. In-
necatrix, E. tenella, E. acervulina, E. gestion of monensin by horses and guinea fowl has
daltland on DSKBBV9HB2PROD with RULES
brunetti, E. mivati, and E. maxima. been fatal. Do not allow rabbits, hamsters, guinea
pigs, horses, or ruminants access to feeds con-
taining lincomycin. Ingestion by these species may
result in severe gastrointestinal effects. Monensin as
provided by No. 058198 in § 510.600 of this chapter.
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![48948 Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Rules and Regulations
Lincomycin Combination Indications for use Limitations Sponsor
grams/ton in grams/ton
(viii) 2 .......................... Robenidine hydro- Broiler chickens: For the control of necrotic Feed as the sole ration. Do not use in feeds con- 054771
chloride, 30. enteritis caused or complicated by Clos- taining bentonite. Do not feed to laying hens pro-
tridium spp. or other organisms suscep- ducing eggs for human consumption. Not for use in
tible to lincomycin, and as an aid in the laying hens, breeding chickens, or turkeys. Do not
prevention of coccidiosis caused by allow rabbits, hamsters, guinea pigs, horses, or
Eimeria mivati, E. brunetti, E. tenella, E. ruminants access to feeds containing lincomycin. In-
acervulina, E. maxima, and E. necatrix. gestion by these species may result in severe gas-
trointestinal effects. Withdraw 5 days prior to slaugh-
ter. Type C feed containing robenidine hydrochloride
must be fed within 50 days from the date of manu-
facture. Robenidine hydrochloride as provided by
No. 054771 in § 510.600 of this chapter.
(ix) 2 ............................ Salinomycin sodium, Broiler chickens: For the control of necrotic Feed as the sole ration to broiler chickens. Do not 054771
40 to 60. enteritis caused or complicated by Clos- feed to laying hens producing eggs for human con-
tridium spp. or other organisms suscep- sumption. Not approved for use with pellet binders.
tible to lincomycin, and for the prevention May be fatal if accidentally fed to adult turkeys or
of coccidiosis caused by Eimeria tenella, horses. Not for use in laying hens, breeding chick-
E. necatrix, E. acervulina, E maxima, E. ens, or turkeys. Do not allow rabbits, hamsters,
brunetti, and E. mivati. 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.
(x) 2 ............................. Zoalene, 113.5 .......... Broiler chickens: For the control of necrotic Feed as the sole ration from the time chicks are 054771
enteritis caused or complicated by Clos- placed in floor pens until slaughtered for meat. Not
tridium spp. or other organisms suscep- for use in laying hens, breeding chickens, or tur-
tible to lincomycin; and for the prevention keys. Do not allow rabbits, hamsters, guinea pigs,
and control of coccidiosis. horses, or ruminants access to feeds containing lin-
comycin. Ingestion by these species may result in
severe gastrointestinal effects. Zoalene as provided
by No. 054771 in § 510.600 of this chapter.
* * * * * and in paragraph (e)(2), redesignate § 558.342 Melengestrol.
paragraphs (e)(2)(i) through (iii) as * * * * *
■ 67. In § 558.342, in paragraph (e)(1),
paragraphs (e)(2)(ii) through (iv) and
revise the table headings, add (e) * * *
add new paragraph (e)(2)(i).
paragraphs (e)(1)(iii) and (iv), and The revisions and additions read as (1) * * *
remove paragraphs (e)(1)(v) through (xi); follows:
Melengestrol Combination
acetate in Indications for use Limitations Sponsor
in grams/ton
mg/head/day
* * * * * * *
(iii) 0.25 to 0.5 ............. Lasalocid, 10 to 30 ... Heifers fed in confinement for slaughter: Add at the rate of 0.5 to 2.0 lb/head/day a medicated 054771
For increased rate of weight gain, im- feed (liquid or dry) containing 0.125 to 1.0 mg 058198
proved feed efficiency, and suppression melengestrol acetate/lb to a feed containing 10 to 30
of estrus (heat); and for control of coc- g of lasalocid per ton to provide 0.25 to 0.5 mg
cidiosis caused by Eimeria bovis and melengestrol acetate and 100 to 360 milligrams of
Eimeria zuernii. lasalocid per head/day. See § 558.311(d) of this
chapter. Lasalocid as provided by No. 054771 in
§ 510.600(c) of this chapter.
(iv) 0.25 to 0.5 ............ Monensin, 10 to 40 ... Heifers fed in confinement for slaughter: Add at the rate of 0.5 to 2.0 lb/head/day a medicated 054771
For increased rate of weight gain, im- feed (liquid or dry) containing 0.125 to 1.0 mg 058198
proved feed efficiency, and suppression melengestrol acetate/lb to a feed containing 10 to 40
of estrus (heat); and for the prevention g of monensin per ton to provide 0.25 to 0.5 mg
and control of coccidiosis due to Eimeria melengestrol acetate/head/day and 0.14 to 0.42 mg
bovis and E. zuernii. 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 chap-
ter.
(2) * * * liquefaciens’’ and in its place add ‘‘A. (b) Sponsors. See sponsors in
(i) Oxytetracycline as in § 558.450. hydrophila’’. § 510.600(c) of this chapter for uses as
* * * * * in paragraph (e) of this section.
■ 70. Revise § 558.485 to read as (1) No. 066104: 48 and 80 grams per
follows:
daltland on DSKBBV9HB2PROD with RULES
§ 558.365 [Removed] pound for use as in paragraph (e)(1) of
§ 558.485 Pyrantel. this section.
■ 68. Remove § 558.365. (2) Nos. 017135 and 054771: 48 grams
§ 558.450 [Amended] (a) Specifications. Type A medicated per pound for use as in paragraph (e)(2)
articles containing 48 or 80 grams per of this section.
■ 69. In § 558.450, in paragraph pound pyrantel tartrate. (c) Related tolerances. See § 556.560
(e)(5)(iv) entries 1 and 2, remove ‘‘A. of this chapter.
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![48950 Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Rules and Regulations
Dated: September 24, 2018. 21 CFR on Narcotic Drugs, 1961. Also consistent
File No. Product name
Leslie Kux, section therewith, DEA is adding such drugs to
Associate Commissioner for Policy. 136–116 ... PURINA WORM-A- 520.905d the list of substances that may only be
[FR Doc. 2018–21146 Filed 9–27–18; 8:45 am] RESTTM Litter Pack imported or exported pursuant to a
BILLING CODE 4164–01–P
Premix (fenbendazole). permit.
140–869 ... PURINA SAF-T-BLOC 520.1840
BG Medicated Feed DATES: Effective September 28, 2018.
Block (poloxalene, FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND 6.6%). Kathy L. Federico, Regulatory Drafting
HUMAN SERVICES and Policy Support Section (DPW),
Therefore, under authority delegated Diversion Control Division, Drug
Food and Drug Administration to the Commissioner of Food and Drugs, Enforcement Administration; Mailing
and in accordance with § 514.116 Notice Address: 8701 Morrissette Drive,
21 CFR Parts 520, 522, 524, and 558 of withdrawal of approval of application Springfield, Virginia 22152; Telephone:
[Docket No. FDA–2018–N–0002] (21 CFR 514.116), notice is given that (202) 598–6812.
approval of NADAs 011–779, 040–205,
SUPPLEMENTARY INFORMATION:
New Animal Drugs; Withdrawal of 042–116, 043–215, 046–700, 091–260,
Approval of New Animal Drug 097–258, 102–942, 113–748, 135–941, Background and Legal Authority
Applications 136–116, and 140–869, and all The United States is a party to the
supplements and amendments thereto, Single Convention on Narcotic Drugs,
AGENCY: Food and Drug Administration, is hereby withdrawn, effective October 1961 (Single Convention), and other
HHS. 9, 2018. international conventions designed to
ACTION: Notification of withdrawal. Elsewhere in this issue of the Federal establish effective control over
Register, FDA is amending the animal international and domestic traffic in
SUMMARY: The Food and Drug drug regulations to reflect the voluntary controlled substances. 21 U.S.C. 801(7).
Administration (FDA) is withdrawing withdrawal of approval of these The Single Convention entered into
approval of 12 new animal drug applications. force for the United States on June 24,
applications (NADAs) at the sponsor’s
Dated: September 24, 2018. 1967, after the Senate gave its advice
request because these products are no
Leslie Kux, and consent to the United States’
longer manufactured or marketed.
Associate Commissioner for Policy. accession. See Single Convention, 18
DATES: Withdrawal of approval is U.S.T. 1407. The enactment and
effective October 9, 2018. [FR Doc. 2018–21147 Filed 9–27–18; 8:45 am]
enforcement of the Controlled
BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT: Substances Act (CSA) are the primary
Sujaya Dessai, Center for Veterinary means by which the United States
Medicine (HFV–212), Food and Drug carries out its obligations under the
DEPARTMENT OF JUSTICE
Administration, 7519 Standish Pl., Single Convention.1 Various provisions
Rockville, MD 20855, 240–402–5761, Drug Enforcement Administration of the CSA directly reference the Single
sujaya.dessai@fda.hhs.gov. Convention. One such provision is 21
SUPPLEMENTARY INFORMATION: Virbac 21 CFR Parts 1308, 1312 U.S.C. 811(d)(1), which relates to
AH, Inc., 3200 Meacham Blvd., Ft. scheduling of controlled substances.
[Docket No. DEA–486] As stated in subsection 811(d)(1), if
Worth, TX 76137, has requested that
FDA withdraw approval of the NADAs control of a substance is required ‘‘by
Schedules of Controlled Substances: United States obligations under
listed in the following table because the Placement in Schedule V of Certain
products are no longer manufactured or international treaties, conventions, or
FDA-Approved Drugs Containing protocols in effect on October 27, 1970,
marketed: Cannabidiol; Corresponding Change to the Attorney General shall issue an
21 CFR Permit Requirements order controlling such drug under the
File No. Product name section
AGENCY: Drug Enforcement schedule he deems most appropriate to
011–779 ... PURINA PIGEMIA 100 522.1182 Administration, Department of Justice. carry out such obligations, without
(colloidal ferric oxide).
ACTION: Final order.
regard to the findings required by
040–205 ... PURINA Horse Wormer 520.2380a [subsections 811(a) or 812(b)] and
Medicated
(thiabendazole). SUMMARY: With the issuance of this final without regard to the procedures
042–116 ... PURINA 6 DAY WORM- 558.185 order, the Acting Administrator of the prescribed by [subsections 811(a) and
KILL Feed Premix Drug Enforcement Administration (b)].’’ This provision is consistent with
(coumaphos). the Supremacy Clause of the U.S.
043–215 ... PURINA GRUB-KILL 524.900
places certain drug products that have
Pour-on Cattle Insecti- been approved by the Food and Drug Constitution (art. VI, sec. 2), which
cide (famphur). Administration (FDA) and which provides that all treaties made under the
046–700 ... STATYL Medicated Pre- 558.365 contain cannabidiol (CBD) in schedule authority of the United States ‘‘shall be
mix (nequinate). the supreme Law of the Land.’’ In
091–260 ... PULVEX WORM CAPS 520.1804
V of the Controlled Substances Act
(piperazine phosphate (CSA). Specifically, this order places accordance with this constitutional
monohydrate). FDA-approved drugs that contain CBD
097–258 ... PURINA BAN-WORM for 558.485 derived from cannabis and no more than 1 See S. Rep. No. 91–613, at 4 (1969) (‘‘The United
Pigs (pyrantel tartrate). States has international commitments to help
0.1 percent tetrahydrocannabinols in
daltland on DSKBBV9HB2PROD with RULES
102–942 ... PULVEX Multipurpose 520.580 control the worldwide drug traffic. To honor those
Worm Caps schedule V. This action is required to commitments, principally those established by the
(dichlorophene, tol- satisfy the responsibility of the Acting Single Convention on Narcotic Drugs of 1961, is
uene). Administrator under the CSA to place a clearly a Federal responsibility.’’); Control of
113–748 ... PURINA PIGEMIA Oral 520.1182 Papaver Bracteatum, 1 Op. O.L.C. 93, 95 (1977)
(iron dextran complex).
drug in the schedule he deems most (‘‘[A] number of the provisions of [the CSA] reflect
135–941 ... CHECK-R-TON BM 558.485 appropriate to carry out United States Congress’ intent to comply with the obligations
(pyrantel tartrate). obligations under the Single Convention imposed by the Single Convention.’’).
VerDate Sep<11>2014 17:35 Sep 27, 2018 Jkt 244001 PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 E:\FR\FM\28SER1.SGM 28SER1](https://thefederalregister.org/doc/83_FR_49129/page/11.svg)
Document Created: 2018-09-28 01:23:21
Document Modified: 2018-09-28 01:23:21
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule; technical amendments. | |
| 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. | |
| 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] | |
| FR Citation | 83 FR 48940 | |
| CFR Citation | 21
CFR
510 21 CFR 520 21 CFR 522 21 CFR 524 21 CFR 529 21 CFR 556 21 CFR 558 | |
| CFR Associated | Administrative Practice and Procedure; Animal Drugs; Labeling; Reporting and Recordkeeping Requirements; Foods and Animal Feeds |
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