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Federal Register/Vol. 84, No. 154/Friday, August 9, 2019/Rules Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Rules and Regulations 39179 DEPARTMENT OF HEALTH AND informing the public of the availability informing the public of the availability, HUMAN SERVICES of summaries of the basis of approval where applicable, of documentation of and of environmental review environmental review required under Food and Drug Administration documents, where applicable. Technical the National Environmental Policy Act amendments are also being made to (NEPA) and, for actions requiring 21 CFR Parts 510, 520, 522, 524, and improve the accuracy, consistency, and review of safety or effectiveness data, 558 readability of the regulations. summaries of the basis of approval (FOI [Docket No. FDA–2019–N–0002] DATES: This rule is effective August 9, Summaries) under the Freedom of 2019, except for amendatory Information Act (FOIA). These public New Animal Drugs; Approval of New instructions 51 to 21 CFR 524.916 and documents may be seen in the office of Animal Drug Applications; Withdrawal 63 to 21 CFR 558.325, which are the Dockets Management Staff (HFA– of Approval of New Animal Drug effective August 19, 2019, and 305), Food and Drug Administration, Applications; Changes of instruction 60 to 21 CFR 558.235, which 5630 Fishers Lane, Rm. 1061, Rockville, Sponsorship; Change of Sponsors’ is effective September 9, 2019. MD 20852, between 9 a.m. and 4 p.m., Names and Addresses FOR FURTHER INFORMATION CONTACT: Monday through Friday. Persons with AGENCY: Food and Drug Administration, George K. Haibel, Center for Veterinary access to the internet may obtain these HHS. Medicine (HFV–6), Food and Drug documents at the CVM FOIA Electronic Administration, 7500 Standish Pl., Reading Room: https://www.fda.gov/ ACTION: Final rule; technical Rockville, MD 20855, 240–402–5689, AboutFDA/CentersOffices/ amendments. [email protected]. OfficeofFoods/CVM/ SUMMARY: The Food and Drug SUPPLEMENTARY INFORMATION: CVMFOIAElectronicReadingRoom/ Administration (FDA or we) is default.htm. Marketing exclusivity and amending the animal drug regulations to I. Approval Actions patent information may be accessed in reflect application-related actions for FDA is amending the animal drug FDA’s publication, Approved Animal new animal drug applications (NADAs) regulations to reflect approval actions Drug Products Online (Green Book) at: and abbreviated new animal drug for NADAs and ANADAs during https://www.fda.gov/AnimalVeterinary/ applications (ANADAs) during January, January, February, and March 2019, as Products/ApprovedAnimal February, and March 2019. FDA is listed in table 1. In addition, FDA is DrugProducts/default.htm. TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY, FEBRUARY, AND MARCH 2019 Approval date File No. Sponsor Product name Species Effect of the action Public documents January 27, 2019 ........................ 009–476 Phibro Animal NICARB 25% Chickens ............... Supplemental approval of revised N/A. Health Corp., (nicarbazin) assay limits for nicarbazin GlenPointe Type A medi- (powder) Type A medicated ar- Centre East, cated article. ticle. 3d Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666. January 28, 2019 ........................ 200–616 Norbrook Lab- CEFENIL RTU Swine and cattle... Original approval as a generic FOI Summary. oratories, Ltd., (ceftiofur hy- copy of NADA 140–890. Station Works, drochloride Newry BT35 sterile suspen- 6JP, Northern sion). Ireland. January 31, 2019 ........................ 200–450 Bimeda Animal BIMECTIN Cattle .................... Original approval as a generic FOI Summary. Health Ltd., PLUS copy of NADA 140–833. 1B The Her- (ivermectin/ bert Building, clorsulon) In- The Park, jection for Cat- Carrickmines, tle. Dublin, 18, Ireland. February 4, 2019 ........................ 200–637 Provetica AH DOXIDYL Dogs ..................... Original approval as a generic FOI Summary. LLC, 455 Sov- (deracoxib) copy of NADA 141–203. ereign Ct., Chewable Baldwin, MO Tablet. 63011. February 8, 2019 ........................ 141–297 Boehringer PROZINC (prot- Dogs ..................... Supplemental approval for the re- FOI Summary. Ingelheim amine zinc re- duction of hyperglycemia and Vetmedica, combinant hyperglycemia-associated clin- Inc., 2621 human insulin) ical signs in dogs with diabetes North Belt Injectable mellitus. Highway, St. Suspension. Joseph, MO 64506–2002. VerDate Sep<11>2014 15:42 Aug 08, 2019 Jkt 247001 PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 E:\FR\FM\09AUR1.SGM 09AUR1 khammond on DSKBBV9HB2PROD with RULES 39180 Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Rules and Regulations TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY, FEBRUARY, AND MARCH 2019—Continued Approval date File No. Sponsor Product name Species Effect of the action Public documents March 29, 2019 .......................... 048–761 Zoetis Inc., 333 AUREOMYCIN Cattle .................... Supplemental approval adding re- N/A. Portage St., (chlortetra- placement dairy heifers to the Kalamazoo, cycline) Type indications for use of chlortetra- MI 49007. C medicated cycline Type C medicated cat- feeds. tle feeds for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline. March 29, 2019 .......................... 141–517 Pegasus Lab- PROIN ER Dogs ..................... Original approval for the control FOI Summary. oratories, Inc., (phenyl- of urinary incontinence due to 8809 Ely Rd., propanolamine urethral sphincter hypotonus. Pensacola, FL hydrochloride 32514. extended-re- lease tablets) Tablets. II. Changes of Sponsors’ Names and 11967 has informed FDA that it has to Ceva Sante Animale, 10 Avenue de la Addresses changed its name to American Regent, Ballastie`re, 33500 Libourne, France. Inc. Aurora Pharmaceutical, LLC, 1196 Following this change of sponsorship, Pharmgate LLC, 1800 Sir Tyler Dr., Provetica AH LLC is no longer the Highway 3 South, Northfield, MN Wilmington, NC 28405 has informed 55057–3009 has informed FDA that it sponsor of an approved application. FDA that it has changed its name to Accordingly, it will not be added to the has changed its name to Aurora Pharmgate, Inc. Pharmaceutical, Inc. list of sponsors of approved applications Accordingly, we are amending in § 510.600(c) (21 CFR 510.600(c)). Boehringer Ingelheim Vetmedica, Inc., § 510.600(c) to reflect these changes. 2621 North Belt Highway, St. Joseph, Merial, Inc., 3239 Satellite Blvd., MO 64506–2002 has informed FDA that III. Changes of Sponsorship Bldg. 500, Duluth, GA 30096–4640 has it has changed its name and address to Provetica AH LLC, 455 Sovereign Ct., informed FDA that it has transferred Boehringer Ingelheim Animal Health Baldwin, MO 63011 has informed FDA ownership of, and all rights and interest USA, Inc., 3239 Satellite Blvd., Duluth, that it has transferred ownership of, and in, the following applications to GA 30096. all rights and interest in, newly Boehringer Ingelheim Animal Health Luitpold Pharmaceuticals, Inc., approved ANADA 200–637 for USA, Inc., 3239 Satellite Blvd., Duluth, Animal Health Division, Shirley, NY DOXIDYL (deracoxib) Chewable Tablets GA 30096: File No. Proprietary name 006–623 CAPARSOLATE (arsenamide sodium) Injection. 008–422 SELEEN (selenium disulfide) Suspension. 010–424 NALLINE (nalorphine hydrochloride) Injection. 011–080 HYDELTRONE-TBA (prednisolone and tertiary butylacetate) Suspension. 011–437 HYDELTRONE (prednisolone sodium phosphate and neomycin sulfate) Ointment. 011–532 SULFABROM (sulfabromomethazine sodium) Bolus. 011–678 DIURIL (chlorothiazide) Tablets. 012–734 DIURIL (chlorothiazide) Bolus. 013–022 THIBENZOLE (thiabendazole) Sheep & Goat Wormer. 013–407 EQUIZOLE (thiabendazole) Horse Wormer. 013–674 HYDROZIDE (hydrochlorothiazide) Injection. 013–954 THIBENZOLE (thiabendazole) 20% Swine Premix. 014–350 OMNIZOLE (thiabendazole). 015–123 TBZ® (thiabendazole) Cattle Wormer (Drench). 015–875 TBZ 200 (thiabendazole) Medicated Premix. 030–103 THIBENZOLE (thiabendazole) Suspension. 034–114 EQUIZOLE (thiabendazole). 035–631 THIBENZOLE (thiabendazole) Pig Wormer. 037–410 EQUIZOLE A (thiabendazole and piperazine phosphate). 042–633 TRESADERM (thiabendazole, dexamethasone, neomycin sulfate solution) Dermatologic Solution. 043–141 THIBENZOLE 300 (thiabendazole) Medicated. 044–654 EQUIZOLE (thiabendazole) Horse Wormer Pellets. 047–333 EQUIZOLE A (thiabendazole and piperazine citrate) Liquid. 048–487 TBZ (thiabendazole) Wormer Paste 50%. 042–633 TRESADERM (thiabendazole, dexamethasone, neomycin sulfate solution) Dermatologic Solution. 043–141 THIBENZOLE 300 (thiabendazole) Medicated. 044–654 EQUIZOLE (thiabendazole) Horse Wormer Pellets. 047–333 EQUIZOLE A (thiabendazole and piperazine citrate) Liquid. 048–487 TBZ (thiabendazole) Wormer Paste 50%. 049–461 TBZ (thiabendazole) Wormer Paste 43%. 065–275 Penicillin VK Filmtab (penicillin V potassium) 250 mg. 065–276 VEESYN (penicillin V potassium) Granules for Oral Solution. 094–642 CAMVET (cambendazole) Suspension Horse Wormer. VerDate Sep<11>2014 15:42 Aug 08, 2019 Jkt 247001 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 E:\FR\FM\09AUR1.SGM 09AUR1 khammond on DSKBBV9HB2PROD with RULES Federal Register / Vol. 84, No. 154 / Friday, August 9, 2019 / Rules and Regulations 39181 File No. Proprietary name 096–506 CAMVET (cambendazole) Horse Wormer Pellets. 096–731 CAMVET (cambendazole) Horse Wormer Paste 45%. 098–379 CYSTORELIN. 098–689 EQUIZOLE (thiabendazole) 50% Wormer Paste; EQUIZOLE 50% Wormer Paste for
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