New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Name, 12167-12170 [2017-03930]
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[Federal Register Volume 82, Number 39 (Wednesday, March 1, 2017)] [Rules and Regulations] [Pages 12167-12170] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2017-03930] ======================================================================== Rules and Regulations Federal Register ________________________________________________________________________ This section of the FEDERAL REGISTER contains regulatory documents having general applicability and legal effect, most of which are keyed to and codified in the Code of Federal Regulations, which is published under 50 titles pursuant to 44 U.S.C. 1510. The Code of Federal Regulations is sold by the Superintendent of Documents. Prices of new books are listed in the first FEDERAL REGISTER issue of each week. ======================================================================== Federal Register / Vol. 82, No. 39 / Wednesday, March 1, 2017 / Rules and Regulations [[Page 12167]] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 516, 520, 522, 529, and 558 [Docket No. FDA-2016-N-0002] New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Name AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. ----------------------------------------------------------------------- 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 November and December 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the change of sponsorship of an application and a change of a sponsor's name. DATES: This rule is effective March 1, 2017, except for amendments 2.a and 2.c to 21 CFR 510.600, and the amendments to 21 CFR 522.313c and 529.1186, which are effective March 13, 2017. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, george.haibel@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Approval Actions FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during November and December 2016, 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 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 Division of Dockets Management (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 November and December 2016 -------------------------------------------------------------------------------------------------------------------------------------------------------- Effect of the Approval date File No. Sponsor Product name Species action Public documents -------------------------------------------------------------------------------------------------------------------------------------------------------- November 10, 2016.............. 141-474 Elanco US, Inc., ITRAFUNGOL Cats............. Original approval FOI Summary. 2500 Innovation (itraconazole oral for the treatment Way, Greenfield, IN solution). of dermatophytosis 46140. caused by Microsporum canis in cats. November 16, 2016.............. 141-443 Elanco US Inc., 2500 ONSIOR Dogs............. Supplemental FOI Summary. Innovation Way, (robenacoxib) approval for the Greenfield, IN Injection. control of 46140. postoperative pain and inflammation associated with soft tissue surgery in dogs by subcutaneous injection; and for the use of oral tablets to complete the dosing regimen of a maximum of 3 days. December 12, 2016.............. 141-452 Zoetis Inc., 333 SIMPARICA Dogs............. Supplemental FOI Summary. Portage St., (sarolaner) approval for the Kalamazoo, MI 49007. Chewables. treatment and control of infestations of Ixodes scapularis (black-legged tick) in dogs. [[Page 12168]] December 16, 2016.............. 141-473 Huvepharma AD, 5th LINCOMIX Chickens......... Original approval FOI Summary. Floor, 3A Nikolay (lincomycin for use in two- Haytov Str., 1113 phosphate) plus way, combination Sophia, Bulgaria. STENOROL drug Type C (halofuginone medicated broiler hydrobromide) Type feeds for control C medicated feeds. of necrotic enteritis and prevention of coccidiosis in broiler chickens. December 21, 2016.............. 200-589 Med-Pharmex, Inc., FLORCON Swine............ Original approval FOI Summary. 2727 Thompson Creek (florfenicol) 2.3% of a generic copy Rd., Pomona, CA Concentrate of NADA 141-206. 91767-1861. Solution. December 29, 2016.............. 141-475 VetDC, Inc., 320 E. TANOVEA-CA1 Dogs............. Conditional FOI Summary. Vine Dr., Suite (rabacfosadine for approval for the 218, Fort Collins, injection). treatment of CO 80524. lymphoma in dogs. -------------------------------------------------------------------------------------------------------------------------------------------------------- Following the conditional approval of NADA 141-175, VetDC, Inc. will now be included in the list of sponsors of approved applications in Sec. 510.600(c) (21 CFR 510.600(c)). II. Change of Sponsorship ECO LLC, 344 Nassau St., Princeton, NJ 08540 has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200-600 for WORMX (pyrantel pamoate) Flavored Tablets to Sergeant's Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138. The regulations will be amended to reflect this change of sponsorship. III. Withdrawals of Approval During November and December 2016, the following sponsors requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed: ---------------------------------------------------------------------------------------------------------------- 21 CFR File No. Sponsor Product name section ---------------------------------------------------------------------------------------------------------------- 135-773................................. Baxter Healthcare Corp., AERRANE (isoflurane USP).. 529.1186 One Baxter Pkwy., Deerfield, IL 60015. 200-421................................. Hospira, Inc., 275 North Ceftiofur (ceftiofur 522.313c Field Dr., Lake Forest, sodium) for Injection. IL 60045. ---------------------------------------------------------------------------------------------------------------- Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADA 135-773 and ANADA 200-524, and all supplements and amendments thereto, is withdrawn, effective March 13, 2017. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect this voluntary withdrawal of approval. Following this withdrawal of approval, neither Baxter Healthcare Corp. nor Hospira, Inc. is the sponsor of an approved application. IV. Technical Amendments iVaoes Animal Health, 4300 SW 73rd Ave., Suite 110, Miami, FL 33155 has informed FDA that it has changed its name to Ivaoes Animal Health. Accordingly, we are amending Sec. 510.600 (c) to reflect this change of sponsor name. We are also making several technical amendments to improve the accuracy of the regulations. This rule 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. List of Subjects 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Part 516 Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements. 21 CFR Parts 520, 522, and 529 Animal drugs. 21 CFR Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510, 516, 520, 522, 529, 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. Amend Sec. 510.600 as follows: 0 a. Effective March 13, 2017, in the table in paragraph (c)(1), remove the entries for ``Baxter Healthcare Corp.'' and ``Hospira, Inc.''; 0 b. Effective March 1, 2017, in the table in paragraph (c)(1), revise the entry for ``iVaoes Animal Health'' and alphabetically add an entry for ``VetDC, Inc.''; 0 c. Effective March 13, 2017, in the table in paragraph (c)(2), remove the entries for ``000409'' and ``010019''; and 0 d. Effective March 1, 2017, in the table in paragraph (c)(2), revise the entry for ``086064'' and numerically add an entry for ``086072''. [[Page 12169]] The revisions and additions read as follows: Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * * * (c) * * * (1) * * * ------------------------------------------------------------------------ Drug labeler Firm name and address code ------------------------------------------------------------------------ * * * * * * * Ivaoes Animal Health, 4300 SW 73rd Ave., Suite 110, 086064 Miami, FL 33155........................................ * * * * * * * VetDC, Inc., 320 E. Vine Dr., Suite 218, Fort Collins, 086072 CO 80524............................................... * * * * * * * ------------------------------------------------------------------------ (2) * * * ------------------------------------------------------------------------ Drug labeler code Firm name and address ------------------------------------------------------------------------ * * * * * * * 086064...................... Ivaoes Animal Health, 4300 SW 73rd Ave., Suite 110, Miami, FL 33155. * * * * * * * 086072...................... VetDC, Inc., 320 E Vine Dr., Suite 218, Fort Collins, CO 80524. * * * * * * * ------------------------------------------------------------------------ PART 516--NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES 0 3. The authority citation for part 516 continues to read as follows: Authority: 360ccc, 360ccc-2, 371. 0 4. Add Sec. 516.2065 to read as follows: Sec. 516.2065 Rabacfosadine. (a) Specifications. Each vial of powder contains 16.4 milligrams (mg) rabacfosadine. Each milliliter of constituted solution contains 8.2 mg rabacfosadine. (b) Sponsor. See No. 086072 in Sec. 510.600(c) of this chapter. (c) Conditions of use in dogs--(1) Amount. Administer rabacfosadine at 1 mg/kilogram body weight as a 30-minute intravenous infusion, once every 3 weeks, for up to 5 doses. (2) Indications for use. For the treatment of lymphoma in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling. PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 0 5. The authority citation for part 520 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 520.370 [Amended] 0 6. In Sec. 520.370, in paragraph (c)(2), remove ``(group G, - hemolytic)'' and in its place add ``(group G, beta-hemolytic)''. 0 7. In Sec. 520.955, revise paragraph (b) to read as follows: Sec. 520.955 Florfenicol. * * * * * (b) Sponsors. See Nos. 000061, 054925, and 058198 in Sec. 510.600(c) of this chapter. * * * * * 0 8. Add Sec. 520.1189 to read as follows: Sec. 520.1189 Itraconazole. (a) Specifications. Each milliliter (mL) of solution contains 10 milligrams (mg) of itraconazole. (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter. (c) Conditions of use--(1) Amount. Administer 5 mg/kilogram (kg) (0.5 mL/kg) of body weight once daily on alternating weeks for 3 treatment cycles. (2) Indications for use. For the treatment of dermatophytosis caused by Microsporum canis in cats. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Sec. 520.2041 [Amended] 0 9. In Sec. 520.2041, in paragraph (b), remove ``017135, 051311, and 066916'' and in its place add ``066916, 017135, and 051311''. 0 10. In Sec. 520.2086, revise paragraph (c)(2) to read as follows: Sec. 520.2086 Sarolaner. * * * * * (c) * * * (2) Indications for use. Kills adult fleas, and for the treatment and prevention of flea infestations (Ctenocephalides felis), and the treatment and control of tick infestations [Amblyomma americanum (lone star tick), Amblyomma maculatum (Gulf Coast tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog tick)] for 1 month in dogs 6 months of age or older and weighing 2.8 pounds or greater. * * * * * Sec. 520.2325b [Amended] 0 11. In Sec. 520.2325b, in paragraph (b), remove ``050749'' and in its place add ``016592''. PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 12. The authority citation for part 522 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 522.313c [Amended] 0 13. Effective March 13, 2017, in Sec. 522.313c, in paragraph (b), remove [[Page 12170]] ``000409, 054771, and 068330'' and in its place add ``054771 and 068330''. 0 14. In Sec. 522.2075, revise paragraph (c) to read as follows: Sec. 522.2075 Robenacoxib. * * * * * (c) Conditions of use--(1) Dogs--(i) Amount. Administer 0.91 mg per pound (2 mg/kilogram (kg)) by subcutaneous injection, once daily, for a maximum of 3 days. After the initial subcutaneous dose, subsequent doses can be given by subcutaneous injection or as the oral tablet in dogs weighing at least 5.5 pounds (2.5 kg) and at least 4 months of age, for a maximum of 3 total doses over 3 days, not to exceed 1 dose per day. See Sec. 520.2075(c)(1) of this chapter. (ii) Indications for use. For the control of postoperative pain and inflammation associated with soft tissue surgery in dogs at least 4 months of age for a maximum of 3 days. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats--(i) Amount. Administer 0.91 mg per pound (2 mg/kg) by subcutaneous injection, once daily, for a maximum of 3 days. (ii) Indications for use. For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy, and castration in cats at least 4 months of age for a maximum of 3 days. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 0 15. The authority citation for part 529 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 529.1186 [Amended] 0 16. Effective March 13, 2017, in Sec. 529.1186, in paragraph (b), remove ``010019,''. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 17. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 0 18. In Sec. 558.325, revise paragraph (e)(1)(ii) to read as follows: Sec. 558.325 Lincomycin. * * * * * (e) * * * (1) * * * ---------------------------------------------------------------------------------------------------------------- Combination in Lincomycin grams/ton grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (ii) 2........................ Halofuginone 2.72 Broiler chickens: For Feed continuously as 016592 the control of sole ration. necrotic enteritis Withdraw 4 days caused or complicated before slaughter. Do by Clostridium spp. not feed to laying or other organisms chickens or susceptible to waterfowl. lincomycin; and the Halofuginone prevention of hydrobromide as coccidiosis caused by provided by No. Eimeria tenella, E. 016592 in Sec. necatrix, E. 510.600 of this acervulina, E. chapter. brunetti, E. mivati, and E. maxima. ---------------------------------------------------------------------------------------------------------------- * * * * * Dated: February 23, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-03930 Filed 2-28-17; 8:45 am] BILLING CODE 4164-01-P
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