| Page Range | 14584-14588 | |
| FR Document | 2018-06961 |
[Federal Register Volume 83, Number 66 (Thursday, April 5, 2018)] [Rules and Regulations] [Pages 14584-14588] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06961] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 526, and 558 [Docket No. FDA-2017-N-0002] New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- 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 October, November, and December 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and a change of a sponsor's name and address. DATES: This rule is effective April 5, 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: [[Page 14585]] I. Approval Actions FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during October, November, and December 2017, 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 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 October, November, and December 2017 ---------------------------------------------------------------------------------------------------------------- Effect of the Approval date File No. Sponsor Product name Species action Public documents ---------------------------------------------------------------------------------------------------------------- October 27, 141-467 Elanco US Inc., Avilamycin and Chickens...... Original FOI Summary; EA/ 2017. 2500 Innovation narasin Type C approval for FONSI. \1\ Way, medicated feeds. use of Greenfield, IN INTREPITY 46140. (avilamycin) and MONTEBAN (narasin) Type A medicated articles to manufacture Type C medicated broiler chicken feeds for the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens, and the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima. October 27, 141-466 Elanco US Inc., Avilamycin, Chickens...... Original FOI Summary; EA/ 2017. 2500 Innovation narasin, and approval for FONSI. \1\ Way, nicarbazin Type use of Greenfield, IN C medicated INTREPITY 46140. feeds. (avilamycin) and MAXIBAN (narasin and nicarbazin) Type A medicated articles to manufacture Type C medicated broiler chicken feeds for the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens, and the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima. November 9, 106-111 Zoetis Inc., 333 TELAZOL Dogs.......... Supplemental FOI Summary. 2017. Portage St., (tiletamine and approval for Kalamazoo, MI zolazepam for intravenous 49007. injection). administration in dogs for induction of anesthesia followed by maintenance with an inhalant anesthetic. November 21, 200-473 Huvepharma EOOD, TYLOVET (tylosin Chickens...... Supplemental FOI Summary. 2017. 5th Floor, 3A tartrate) approval for Nikolay Haytov Soluble Powder. the control of Str., 1113 mortality Sofia, Bulgaria. caused by necrotic enteritis associated with Clostridium perfringens in broiler chickens. November 30, 097-505 Zoetis Inc., 333 Lincomycin Type Swine......... Supplemental ................ 2017. Portage St., B and Type C approval for Kalamazoo, MI medicated feeds. use of 49007. LINCOMIX (lincomycin) Type A medicated articles to manufacture Type B and Type C medicated swine feeds for reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae. December 11, 141-441 Virbac AH, Inc., IVERHART MAX Dogs.......... Original FOI Summary. 2017. 3200 Meacham (ivermectin, approval of a Blvd., Ft. pyrantel soft chewable Worth, TX 76137. pamoate, tablet to praziquantel) prevent canine Soft Chew. heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection and for the treatment and control of roundworm (Toxocara canis, Toxascaris leonina), hookworm (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense), and tapeworm (Dipylidium caninum, Taenia pisiformis) infections. December 12, 200-617 Pharmgate LLC, Chlortetracyclin Cattle........ Original ................ 2017. 1800 Sir Tyler e and lasalocid approval for Dr., Type B and Type use of DERACIN Wilmington, NC C medicated (chlortetracyc 28405. feeds. line) and BOVATEC (lasalocid) Type A medicated articles to manufacture Type B and Type C medicated cattle feeds as a generic copy of NADA 141-250. ---------------------------------------------------------------------------------------------------------------- \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). II. Changes of Sponsorship Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS 66211 has informed FDA that it has transferred ownership of, and all rights and interest in, the following application to Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140: [[Page 14586]] ------------------------------------------------------------------------ File No. Product name 21 CFR section ------------------------------------------------------------------------ 141-455........................ GALLIPRANT (grapiprant) 520.1084 Tablets. ------------------------------------------------------------------------ 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 HQ Specialty Pharma Corp., 120 Rte. 17 North, suite 130, Paramus, NJ 07652: ------------------------------------------------------------------------ File No. Product name 21 CFR section ------------------------------------------------------------------------ 055-097........................ DRY-MAST (pen G 526.1696b procaine/ dihydrostreptomycin sulfate) Infusion. ------------------------------------------------------------------------ Ridley Block Operations Inc., 424 North Riverfront Dr., P.O. Box 8500, Mankato, MN 56002-8500 has informed FDA that it has transferred ownership of, and all rights and interest in, the following applications to Ridley USA, Inc., 111 W Cherry St., suite 500, Mankato, MN 56001: ------------------------------------------------------------------------ File No. Product name 21 CFR section ------------------------------------------------------------------------ 141-187........................ CRYSTALYX IONO-LYX 558.311 (lasalocid) Type C Medicated Protein Block. ------------------------------------------------------------------------ Ridley U.S. Holdings, Inc., 424 North Riverfront Dr., P.O. Box 8500, Mankato, MN 56002-8500 has informed FDA that it has transferred ownership of, and all rights and interest in, the following application to Ridley USA, Inc., 111 W Cherry St., suite 500, Mankato, MN 56001: ------------------------------------------------------------------------ File No. Product name 21 CFR section ------------------------------------------------------------------------ 033-733........................ SWEETLIX BLOAT-GUARD 520.1840 (poloxalene) Pressed Block. ------------------------------------------------------------------------ Accordingly, the animal drug regulations are being amended to reflect these changes of sponsorship. Following these withdrawals of approval, neither Ridley Block Operations, Inc. nor Ridley U.S. Holdings, Inc. is the sponsor of an approved application. Accordingly, these firms will be removed from the list of sponsors of approved applications in Sec. 510.600(c) (21 CFR 510.600(c)). III. 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, and 526 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, 21 CFR parts 510, 520, 522, 526, 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 ``Ridley Block Operations, Inc.'' and revise the entry for ``Ridley U.S. Holdings, Inc.''; and in the table in paragraph (c)(2), remove the entry for ``068287'' and revise the entry for ``067949''. The revisions read as follows: Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * * * (c) * * * (1) * * * [[Page 14587]] ------------------------------------------------------------------------ Firm name and address Drug labeler code ------------------------------------------------------------------------ * * * * * * * Ridley USA, Inc., 111 W Cherry St., Suite 500, 067949 Mankato, MN 56001............................ * * * * * * * ------------------------------------------------------------------------ (2) * * * ------------------------------------------------------------------------ Drug labeler code Firm name and address ------------------------------------------------------------------------ * * * * * * * 067949........................................ Ridley USA, Inc., 111 W Cherry St., Suite 500, Mankato, MN 56001. * * * * * * * ------------------------------------------------------------------------ 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. 520.1084 [Amended] 0 4. In Sec. 520.1084, in paragraph (b), remove ``086026'' and in its place add ``058198''. Sec. 520.1199 [Amended] 0 5. In Sec. 520.1199, in paragraph (a) introductory text, remove ``chewable tablet'' and in its place add ``chewable tablet or soft chewable tablet''; and in paragraph (c)(2), remove ``Prevents'' and in its place add ``To prevent''. 0 6. In Sec. 520.2640, revise paragraphs (b)(1) and (2) to read as follows: Sec. 520.2640 Tylosin. * * * * * (b) * * * (1) Nos. 016592 and 058198 for use as in paragraph (e) of this section. (2) No. 061623 for use as in paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2), (e)(3), and (e)(4) of this section. * * * * * PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 7. The authority citation for part 522 continues to read as follows: Authority: 21 U.S.C. 360b. 0 8. In Sec. 522.2470, revise paragraphs (b) and (c) to read as follows: Sec. 522.2470 Tiletamine and zolazepam for injection. * * * * * (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter: (1) No. 054771 for use as in paragraph (c) of this section. (2) Nos. 026637 and 051311 for use as in paragraphs (c)(1)(i)(A), (c)(1)(ii)(A), (c)(1)(iii) and (c)(2) of this section. (c) Conditions of use--(1) Dogs--(i) Amount. Expressed as milligrams of the drug combination: (A) An initial intramuscular dosage of 3 to 4.5 milligrams per pound (mg/lb) of body weight for diagnostic purposes; 4.5 to 6 mg/lb of body weight for minor procedures of short duration such as repair of lacerations and wounds, castrations, and other procedures requiring mild to moderate analgesia. Supplemental doses when required should be less than the initial dose and the total dose given should not exceed 12 mg/lb of body weight. The maximum total safe dose is 13.6 mg/lb of body weight. (B) Administer intravenously at 1 to 2 mg/lb (2.2 to 4.4 mg/kg) body weight to effect for induction of anesthesia followed by maintenance with an inhalant anesthetic. (ii) Indications for use. (A) Intramuscular administration in dogs for restraint and minor procedures of short duration (30 minutes average) requiring mild to moderate analgesia. (B) Intravenous administration in dogs for induction of anesthesia followed by maintenance with an inhalant anesthetic. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats--(i) Amount. An initial intramuscular dosage of 4.4 to 5.4 mg/lb of body weight is recommended for such procedures as dentistry, treatment of abscesses, foreign body removal, and related types of surgery; 4.8 to 5.7 mg/lb of body weight for minor procedures requiring mild to moderate analgesia, such as repair of lacerations, castrations, and other procedures of short duration. Initial dosages of 6.5 to 7.2 mg/lb of body weight are recommended for ovariohysterectomy and onychectomy. When supplemental doses are required, such individual supplemental doses should be given in increments that are less than the initial dose and the total dose given (initial dose plus supplemental doses) should not exceed the maximum allowable safe dose of 32.7 mg/lb of body weight. (ii) Indications for use. For restraint or for anesthesia combined with muscle relaxation. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS 0 9. The authority citation for part 526 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 526.1696b [Amended] 0 10. In Sec. 526.1696b, in paragraph (b), remove ``054628'' and in its place add ``042791''. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 11. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. 0 12. In Sec. 558.68, add paragraphs (e)(1)(iii) and (iv) to read as follows: Sec. 558.68 Avilamycin. * * * * * (e) * * * (1) * * * [[Page 14588]] ---------------------------------------------------------------------------------------------------------------- Combination in Avilamycin in grams/ton grams/ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (iii) 13.6 to 40.9.............. Narasin,........... Broiler chickens: Feed as the sole ration 058198 54 to 90........... For the prevention for 21 consecutive of mortality days to chickens that caused by necrotic are at risk of enteritis developing, but not associated with yet showing clinical Clostridium signs of, necrotic perfringens; and enteritis associated for the prevention with Clostridium of coccidiosis perfringens. To assure caused by Eimeria responsible necatrix, E. antimicrobial drug use tenella, E. in broiler chickens, acervulina, E. treatment brunetti, E. administration must mivati, and E. begin on or before 10 maxima. days of age. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Narasin as provided by No. 058198 in Sec. 510.600(c) of this chapter. (iv) 13.6 to 40.9............... Narasin............ Broiler chickens: Feed as the sole ration 058198 27 to 45;.......... For the prevention for 21 consecutive nicarbazin......... of mortality days to chickens that 27 to 45........... caused by necrotic are at risk of enteritis developing, but not associated with yet showing clinical Clostridium signs of, necrotic perfringens; and enteritis associated for the prevention with Clostridium of coccidiosis perfringens. To assure caused by Eimeria responsible necatrix, E. antimicrobial drug use tenella, E. in broiler chickens, acervulina, E. treatment brunetti, E. administration must mivati, and E. begin on or before 10 maxima. days of age. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Do not feed to laying hens. Withdraw 5 days before slaughter. Narasin and nicarbazin as provided by No. 058198 in Sec. 510.600(c) of this chapter. ---------------------------------------------------------------------------------------------------------------- * * * * * Sec. 558.128 [Amended] 0 13. In Sec. 558.128, in paragraph (e)(4), in the ``Sponsor'' column, numerically add ``069254'' to paragraphs (e)(4)(ii), (vii), (viii), (ix), and (xviii) through (xxvi). Sec. 558.311 [Amended] 0 14. In Sec. 558.311, in paragraph (b)(9) and in paragraph (e)(1)(xix), in the ``Sponsor'' column, remove ``068287'' and in its place add ``067949''. 0 15. In Sec. 558.325 revise paragraph (e)(2)(xiv) to read as follows: Sec. 558.325 Lincomycin. * * * * * (e) * * * (2) * * * ---------------------------------------------------------------------------------------------------------------- Combination in Lincomycin grams/ton grams/ton Indications for use Limitations Sponsors ---------------------------------------------------------------------------------------------------------------- * * * * * * * (xiv) 100 to 200............... .................. For reduction in the Feed as sole 054771 severity of the ration for 21 effects of respiratory days. disease associated with Mycoplasma hyopneumoniae. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * Dated: March 29, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-06961 Filed 4-4-18; 8:45 am] BILLING CODE 4164-01-P
| 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. | |
| Dates | This rule is effective April 5, 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 14584 | |
| CFR Citation | 21
CFR
510 21 CFR 520 21 CFR 522 21 CFR 526 21 CFR 558 | |
| CFR Associated | Administrative Practice and Procedure; Animal Drugs; Labeling; Reporting and Recordkeeping Requirements and Animal Feeds |