80 FR 13226 - New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 49 (March 13, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 49 (March 13, 2015)
| Page Range | 13226-13232 | |
| FR Document | 2015-05644 |
[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)] [Rules and Regulations] [Pages 13226-13232] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-05644] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 556, and 558 [Docket No. FDA-2014-N-0002] New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2014. 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 a change of sponsorship of eight NADAs and nine ANADAs, and to make correcting amendments for a drug labeler code. DATES: This rule is effective March 13, 2015. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, george.haibel@fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during November and December 2014, 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 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: http://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: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm. In addition, Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144, has transferred ownership of, and all rights and interest in, the following approved applications to Pharmgate LLC, 161 North Franklin Turnpike, Suite 2C, Ramsey, NJ 07446: ------------------------------------------------------------------------ File No. Product name 21 CFR Cite ------------------------------------------------------------------------ 065-480............ Chlortetracycline Soluble Powder 520.441. 138-934............ PENNCHLOR SP (chlortetracycline, 558.145. sulfamethazine, penicillin) Type A medicated articles. 138-935............ PENNCHLOR (chlortetracycline) 558.128. Type A medicated articles. 138-938............ PENNOX (oxytetracycline) Type A 558.450. medicated articles. 138-939............ NEO-OXY (neomycin sulfate and 558.455. oxytetracycline) Type A medicated articles. 140-680............ TYLAN (tylosin phosphate) Type A 558.625. medicated articles. 140-681............ TYLAN Sulfa-G (tylosin phosphate 558.630. and sulfamethazine) Type A medicated articles. 141-137............ PENITRACIN (bacitracin Not codified. methylenedisalicylate) 50 Type A medicated article. 200-026............ PENNOX 343 (oxytetracycline).... 520.1660d. 200-154............ PENNOX 200 (oxytetracycline).... 558.450. 200-295............ PENNCHLOR 64 (chlortetracycline) 558.128. 200-314............ PENNCHLOR S (chlortetracycline). 558.140. 200-354............ PENNCHLOR (chlortetracycline)/ 558.355. COBAN (monensin). 200-356............ PENNCHLOR (chlortetracycline)/ 558.600. DENAGARD (tiamulin). [[Page 13227]] 200-357............ PENNCHLOR (chlortetracycline)/ 558.550. BIO-COX (salinomycin). 200-358............ PENNCHLOR (chlortetracycline)/ 558.76. BMD (bacitracin MD). 200-359............ PENNCHLOR (chlortetracycline)/ 558.195. DECCOX (decoquinate). ------------------------------------------------------------------------ At this time, the regulations are being amended to reflect these changes of sponsorship. Following these changes of sponsorship, Pharmgate LLC will now be the sponsor of an approved application while Pennfield Oil Co. will no longer be the sponsor of an approved application. Also, Hikma Pharmaceuticals LLC, P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118, has informed FDA that it has changed its name to Hikma International Pharmaceuticals LLC. Accordingly, Sec. 510.600 (21 CFR 510.600) is being amended to reflect these changes. In addition, FDA is amending Sec. 510.600 and several sections of part 520 to reflect a correct drug labeler code for Akorn Animal Health, Inc. FDA is also amending the regulations in 21 CFR parts 520, 522, 556, and 558 to redesignate several sections to reflect alphabetical order and to make minor technical amendments. These corrections and technical amendments are being made to improve the accuracy of the animal drug regulations. Table 1--Original and Supplemental NADAs and ANADAs Approved During November and December 2014 -------------------------------------------------------------------------------------------------------------------------------------------------------- New animal drug product 21 CFR FOIA NEPA NADA/ ANADA Sponsor name Action Sections Summary Review -------------------------------------------------------------------------------------------------------------------------------------------------------- 200-575................ Putney, Inc., One Monument Carprofen Chewable Original approval as a generic 520.309 yes CE \1\ \2\ Sq., suite 400, Portland, Tablets. copy of NADA 141-111. ME 04101. 141-232................ Zoetis Inc., 333 Portage SIMPLICEF (cefpodoxime Supplemental approval of chewable 520.370 yes CE \1\ \3\ St., Kalamazoo, MI 49007. proxetil) Chewable tablet dosage form for dogs. Tablets. 200-512................ Zoetis Inc., 333 Portage TRIAMULOX (tiamulin Original approval as a generic 520.2455 yes CE \1\ \2\ St., Kalamazoo, MI 49007. hydrogen fumarate) copy of NADA 140-916. Liquid Concentrate. 200-573................ Putney, Inc., One Monument Dexmedetomidine HCl...... Original approval as a generic 522.558 yes CE \1\ \2\ Sq., suite 400, Portland, (dexmedetomidine copy of NADA 141-267. ME 04101. hydrochloride). Injectable Solution...... 141-068................ Bayer HealthCare LLC, BAYTRIL 100 Supplemental approval adding 522.812 yes CE\1\ \4\ Animal Health Division, (enrofloxacin). administration by intramuscular P.O. Box 390, Shawnee Injectable Solution...... injection in swine and an Mission, KS 66201. indication for control of colibacillosis in groups or pens of weaned pigs. 141-349................ Zoetis Inc., 333 Portage DRAXXIN 25............... Supplemental approval for 522.2630 yes CE \1\ \4\ St., Kalamazoo, MI 49007. (tulathromycin).......... treatment of bovine respiratory Injectable Solution...... disease (BRD) in suckling calves, dairy calves, and veal calves. 141-437................ Novartis Animal Health US, OSURNIA.................. Original approval for the 524.955 yes CE \1\ \3\ Inc., 3200 Northline (florfenicol, treatment of otitis externa in Ave., suite 300, terbinafine, dogs. Greensboro, NC 27408. betamethasone acetate) Otic Gel. 034-267................ Intervet, Inc., 556 Morris GENTOCIN DURAFILM........ Supplemental approval of 524.1044i yes CE \1\ \3\ Ave., Summit, NJ 07901. (gentamicin sulfate and additional safety information. betamethasone). Ophthalmic Solution...... 141-034................ Huvepharma AD, 5th Floor, GAINPRO.................. Supplemental approval of a free- 558.95 yes CE \1\ \2\ 3A Nikolay Haytov Str., (bambermycins)........... choice Type C medicated loose 1113 Sophia, Bulgaria. Type A medicated article. mineral feed without selenium for pasture cattle. 200-510 \5\............ Pharmgate LLC, 161 North DERACIN.................. Original approval as a generic 558.128 yes CE \1\ \2\ Franklin Turnpike, suite (chlortetracycline)...... copy of NADA 048-761. 2C, Ramsey, NJ 07446. Type A medicated articles 141-258................ Intervet, Inc., 556 Morris ZILMAX (zilpaterol Supplemental approval to provide 558.665 yes CE \1\ \2\ Ave., Summit, NJ 07901. hydrochloride) Type A for component feeding of Type C medicated article. medicated feeds. [[Page 13228]] 141-276 \5\............ Intervet, Inc., 556 Morris ZILMAX (zilpaterol Supplemental approval to provide 558.665 yes CE \1\ \6\ Ave., Summit, NJ 07901. hydrochloride) plus for component feeding of RUMENSIN (monensin) plus combination drug Type C TYLAN (tylosin medicated feeds. phosphate) Type C medicated feeds. -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an environmental impact statement because it is of a type that does not have a significant effect on the human environment. \2\ CE granted under 21 CFR 25.33(a)(1). \3\ CE granted under 21 CFR 25.33(d)(1). \4\ CE granted under 21 CFR 25.33(d)(5). \5\ This application is affected by guidance for industry (GFI) #213, ``New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,'' December 2013. \6\ CE granted under 21 CFR 25.33(a)(2). 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 Parts 520, 522, and 524 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 and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510, 520, 522, 524, 556, and 558 are amended as follows: PART 510--NEW ANIMAL DRUGS 0 1. The authority citation for 21 CFR 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. In the table in paragraph (c)(1), in the entry for ``Akorn Animal Health, Inc.'', in the ''Drug labeler code'' column, remove ``053599'', and in its place add ``059399''; 0 b. In the table in paragraph (c)(1), in the entry for ``Hikma Pharmaceuticals LLC'', in the ``Firm name and address'' column, remove ``Hikma Pharmaceuticals LLC'', and in its place add ``Hikma International Pharmaceuticals LLC''; 0 c. In the table in paragraph (c)(1), remove the entry for ``Pennfield Oil Co.'' and add an entry, in alphabetical order, for ``Pharmgate LLC''; 0 d. In the table in paragraph (c)(2), remove the entries for ``000008'', ``048164'', and ``053599'' and add entries, in numerical order, for ``059399'' and ``069254''; and 0 e. In the table in paragraph (c)(2), in the entry for ``059115'', in the ``Firm name and address'' column, remove ``Hikma Pharmaceuticals LLC'', and in its place add ``Hikma International Pharmaceuticals LLC''. The additions and revisions 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 ------------------------------------------------------------------------ * * * * * * * Pharmgate LLC, 161 North Franklin Turnpike, suite 2C, 069254 Ramsey, NJ 07446....................................... * * * * * * * ------------------------------------------------------------------------ (2) * * * ------------------------------------------------------------------------ Drug labeler code Firm name and address ------------------------------------------------------------------------ * * * * * * * 059399...................... Akorn Animal Health, Inc., 1925 West Field Ct., suite 300, Lake Forest, IL 60045 * * * * * * * 069254...................... Pharmgate LLC, 161 North Franklin Turnpike, suite 2C, Ramsey, NJ 07446 [[Page 13229]] * * * * * * * ------------------------------------------------------------------------ PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 0 3. The authority citation for 21 CFR part 520 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. Sec. 520.310 and 520.312 [Redesignated as Sec. Sec. 520.301 and 520.302] 0 4. Redesignate Sec. Sec. 520.310 and 520.312 as Sec. Sec. 520.301 and 520.302, respectively. Sec. 520.309 [Redesignated as Sec. 520.304 and Amended] 0 5. Redesignate Sec. 520.309 as Sec. 520.304 and revise newly redesignated Sec. 520.304 by adding paragraph (b)(3) to read as follows: Sec. 520.304 Carprofen. * * * * * (b) * * * (3) No. 026637 for use of product described in paragraph (a)(2) of this section as in paragraph (d) of this section. * * * * * 0 6. In Sec. 520.370, revise paragraphs (a) and (b) and in paragraph (c)(2), remove ``intermedius'' and in its place add ``pseudintermedius'' to read as follows: Sec. 520.370 Cefpodoxime tablets. (a) Specifications. (1) Each tablet contains cefpodoxime proxetil equivalent to 100 or 200 milligrams (mg) cefpodoxime. (2) Each chewable tablet contains cefpodoxime proxetil equivalent to 100 or 200 mg cefpodoxime. (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for uses as follows: (1) No. 026637 for use of product in paragraph (a)(1) of this section as in paragraph (c) of this section. (2) No. 054771 for use of products in paragraph (a) of this section as in paragraph (c) of this section. * * * * * Sec. 520.441 [Amended] 0 7. In Sec. 520.441, in paragraph (b)(1), remove ``048164'' and in its place add ``069254''. 0 8. Amend Sec. 520.1660d as follows: 0 a. In paragraph (b)(6), remove ``048164'' and in its place add ``069254''. 0 b. In paragraphs (d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3), and (d)(1)(ii)(C)(3), revise the last sentence. The revisions read as follows: Sec. 520.1660d Oxytetracycline powder. * * * * * (d) * * * (1) * * * (ii) * * * (A) * * * (3) * * * Zero-day withdrawal for those products sponsored by Nos. 054771, 057561, 061133, and 069254. (B) * * * (3) * * * Zero-day withdrawal for those products sponsored by Nos. 054771, 057561, 061133, and 069254. (C) * * * (3) * * * Zero-day withdrawal for those products sponsored by Nos. 054771, 057561, 061133, and 069254. * * * * * 0 9. In Sec. 520.2455, revise paragraphs (b)(3) and (c) to read as follows: Sec. 520.2455 Tiamulin. * * * * * (b) * * * (3) No. 054771 for the product described in paragraph (a)(3) of this section. (c) Related tolerances. See Sec. 556.732 of this chapter. * * * * * PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 10. The authority citation for 21 CFR part 522 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 522.246 [Amended] 0 11. In Sec. 522.246, in paragraph (b)(3), remove ``053599'' and in its place add ``059399''. 0 12. In Sec. 522.558, revise paragraphs (a) and (b) to read as follows: Sec. 522.558 Dexmedetomidine. (a) Specifications. Each milliliter of solution contains: (1) 0.1 milligrams (mg) dexmedetomidine hydrochloride; or (2) 0.5 mg dexmedetomidine hydrochloride. (b) Sponsors. See sponsors in in Sec. 510.600(c) of this chapter for use as in paragraph (c) of this section: (1) No. 026637 for use of product described in paragraph (a)(2) of this section; (2) No. 052483 for use of products described in paragraph (a) of this section. * * * * * 0 13. Amend Sec. 522.812 as follows: 0 a. Revise paragraph (b)(2); 0 b. Remove paragraph (e)(3)(i); 0 c. Redesignate paragraphs (e)(3)(ii) and (e)(3)(iii) as paragraphs (e)(3)(i) and (e)(3)(ii), respectively; and 0 d. Revise newly redesignated paragraph (e)(3)(i). The revisions read as follows: Sec. 522.812 Enrofloxacin. * * * * * (b) * * * (2) No. 055529 for use of product described in paragraph (a)(1) of this section as in paragraph (e)(1) of this section, and use of product described in paragraph (a)(2) of this section as in paragraphs (e)(2)(i)(B), (e)(2)(ii)(B), (e)(2)(iii), (e)(3)(i)(B), and (e)(3)(ii) of this section. * * * * * (e) * * * (3) * * * (i) Amounts and indications for use. (A) Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight for the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica, and Mycoplasma hyopneumoniae. (B) Administer, by subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight for the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis. (C) Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed. * * * * * 0 14. In Sec. 522.1222, revise paragraph (b) to read as follows: Sec. 522.1222 Ketamine. * * * * * [[Page 13230]] (b) Sponsors. See Nos. 000859, 026637, 054628, 054771, 059399, and 063286 in Sec. 510.600(c) of this chapter. * * * * * Sec. 522.2474 [Amended] 0 15. In Sec. 522.2474, in paragraph (b), remove ``053599'' and in its place add ``059399''. 0 16. In Sec. 522.2630, revise paragraphs (b)(1), (b)(2), (d)(1)(ii)(A), (d)(1)(ii)(B), and (d)(1)(iii) to read as follows: Sec. 522.2630 Tulathromycin. * * * * * (b) * * * (1) Product described as in paragraph (a)(1) of this section for use as in paragraphs (d)(1)(i), (d)(1)(ii), (d)(1)(iii)(A), and (d)(2) of this section. (2) Product described as in paragraph (a)(2) of this section for use as in paragraphs (d)(1)(i), (d)(1)(ii)(B), (d)(1)(iii)(B), and (d)(2) of this section. * * * * * (d) * * * (1) * * * (ii) * * * (A) Beef and non-lactating dairy cattle. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis. For the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis. For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis. For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii. (B) Suckling calves, dairy calves, and veal calves. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis. (iii) Limitations. (A) Cattle intended for human consumption must not be slaughtered within 18 days from the last treatment. Do not use in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (B) Calves intended for human consumption must not be slaughtered within 22 days from the last treatment. Not for use in ruminating cattle. Federal law restricts this drug to use by or on the order of a licensed veterinarian. * * * * * Sec. 522.2662 [Amended] 0 17. In Sec. 522.2662, in paragraph (b)(4), remove ``053599'' and in its place add ``059399''. Sec. 522.2670 [Amended] 0 18. In Sec. 522.2670, in paragraph (b)(1), remove ``053599'' and in its place add ``059399''. PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0 19. The authority citation for 21 CFR part 524 continues to read as follows: Authority: 21 U.S.C. 360b. 0 20. Add Sec. 524.955 to read as follows: Sec. 524.955 Florfenicol, terbinafine, and betamethasone acetate otic gel. (a) Specifications. Each milliliter of gel contains 10 milligrams (mg) florfenicol, 10 mg terbinafine, and 1 mg betamethasone acetate. (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter. (c) Conditions of use in dogs--(1) Amount. Administer one dose (1 tube) per affected ear(s) and repeat administration in 7 days. (2) Indications for use. For the treatment of otitis externa in dogs associated with susceptible strains of bacteria (Staphylococcus pseudintermedius) and yeast (Malassezia pachydermatis). (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 0 21. In Sec. 524.1044i, revise paragraph (c)(2) to read as follows: Sec. 524.1044i Gentamicin and betamethasone ophthalmic solution. * * * * * (c) * * * (2) Indications for use. For treatment of external eye infections and inflammation. * * * * * PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 0 22. The authority citation for 21 CFR part 556 continues to read as follows: Authority: 21 U.S.C. 342, 360b, 371. Sec. 556.738 [Redesignated as Sec. 556.732] 0 23. Redesignate Sec. 556.738 as Sec. 556.732. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 24. The authority citation for 21 CFR part 558 continues to read as follows: Authority: 21 U.S.C. 360b, 371. Sec. 558.76 [Amended] 0 25. In Sec. 558.76, in paragraph (d)(1)(iv), in the ``Limitations'' and ``Sponsor'' columns, remove ``048164'' and in its place add ``069254''. 0 26. In Sec. 558.95, add paragraph (d)(4)(v) to read as follows: Sec. 558.95 Bambermycins. * * * * * (d) * * * (4) * * * (v) Used as a free-choice Type C medicated loose mineral feed for pasture cattle (slaughter, stocker, and feeder cattle; and dairy and beef replacement heifers) as follows: (A) Specifications. ------------------------------------------------------------------------ International Ingredient feed No. Percent ------------------------------------------------------------------------ Deflorinated phosphate (20.5% 6-01-080 42.50 calcium, 18.5% phosphorus)......... Sodium chloride (salt).............. 6-04-152 20.10 Calcium carbonate (38% calcium)..... 6-01-069 15.45 Corn distillers dried grains w/ 5-28-236 9.57 solubles........................... Magnesium oxide..................... 6-02-756 5.15 Vitamin and trace mineral premix *.. ................ 3.72 Mineral oil......................... ................ 1.00 Yeast (primary dehydrated yeast).... 7-05-533 0.75 Bambermycins Type A article (10 g/ ................ 0.60 lb)................................ Iron oxide.......................... 6-02-431 0.50 Magnesium sulfate (67%)............. 6-02-758 0.32 Copper sulfate...................... 6-01-720 0.18 [[Page 13231]] Potassium sulfate (0.33%)........... 6-06-098 0.16 ------------------------------------------------------------------------ * Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18). (B) Amount per ton. 120 grams. (C) Indications for use. For increased rate of weight gain. (D) Limitations. For free-choice feeding to pasture cattle (slaughter, stocker, and feeder cattle; and dairy and beef replacement heifers). Feed a non-medicated commercial mineral product for 6 weeks to stabilize consumption between 2.66 and 10.66 ounces per head per day. Feed continuously to provide 10 to 40 milligrams bambermycins per head per day. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day. * * * * * 0 27. Amend Sec. 558.128 as follows: 0 a. In paragraph (b)(1), remove ``Nos. 054771, 048164, and 066104'' and in its place add ``Nos. 054771, 066104, and 069254''; 0 b. In paragraphs (e)(4)(ii) and (iv), in the ``Limitations'' column, remove ``048164'' wherever it occurs and in its place add ``069254''; 0 c. In paragraphs (e)(1)(i), (ii), and (iii), (e)(2)(i), (ii), (iii), and (iv), (e)(3)(i), (ii), (iii), and (iv), (e)(4)(i), (ii), (iv), (vii), and (viii), and (e)(5)(i) and (ii), in the ``Sponsor'' column, remove ``048164'' wherever it occurs and in its place in numerical order add ``069254''; and 0 d. Revise paragraphs (e)(1)(iv), (e)(4)(v), and (e)(4)(ix). The revisions read as follows: Sec. 558.128 Chlortetracycline. * * * * * (e) * * * (1) * * * ---------------------------------------------------------------------------------------------------------------- Chlortetracycline amount Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (iv) 500 g/ton......................... Chickens: For the 1. Feed for 5 d. To sponsor 054771, reduction of mortality No. 054771 under NADA 048-761 069254. due to E. coli infections and No. 069254 under ANADA susceptible to 200-510: zero withdrawal time. chlortetracycline. 2. Feed for 5 d; withdraw 24 h 012286, prior to slaughter; do not 054771, feed to chickens producing 066104, eggs for human consumption. 069254. ---------------------------------------------------------------------------------------------------------------- * * * * * (4) * * * ---------------------------------------------------------------------------------------------------------------- Chlortetracycline amount Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (v) 500 to 4,000 g/ton................. Calves, beef and Feed continuously for not more 054771 nonlactating dairy than 5 days to provide 10 mg/ 069254 cattle; treatment of lb body weight per day. To bacterial enteritis sponsor No. 054771 under NADA caused by E. coli and 046-699: 24-h withdrawal time. bacterial pneumonia To sponsor No. 054771 under caused by P. multocida NADA 048-761 and No. 069254 susceptible to under ANADA 200-510: Zero chlortetracycline. withdrawal time. * * * * * * * (ix) 350 mg/head/day................... 1. Beef cattle: For Withdraw 48 h prior to 012286, control of bacterial slaughter. To sponsor No. 054771, pneumonia associated with 054771 under NADA 046-699: 48- 066104, shipping fever complex h withdrawal time. To sponsor 069254. caused by Pasteurella No. 054771 under NADA 048-761 spp. susceptible to and No. 069254 under ANADA chlortetracycline. 200-510: Zero withdrawal time. 2. Beef cattle (under 700 Withdraw 48 h prior to 012286, lb): For control of slaughter. To sponsor No. 054771, active infection of 054771 under NADA 046-699: 48- 066104, anaplasmosis caused by A. h withdrawal time. To sponsor 069254. marginale susceptible to No. 054771 under NADA 048-761 chlortetracycline. and No. 069254 under ANADA 200-510: zero withdrawal time. ---------------------------------------------------------------------------------------------------------------- * * * * * Sec. 558.140 [Amended] 0 28. In Sec. 558.140, in paragraph (b)(1), remove ``048164'' and in its place add ``069254''. Sec. 558.145 [Amended] 0 29. In Sec. 558.145, in paragraph (a)(2), remove ``048164'' and in its place add ``069254''. Sec. 558.195 [Amended] 0 30. In Sec. 558.195, in paragraph (e)(2)(iv), in the ``Limitations'' and ``Sponsor'' columns, remove ``048164'' and in its place add ``069254''. Sec. 558.355 [Amended] 0 31. In Sec. 558.355, in paragraph (f)(1)(xiv)(b), remove ``048164'' and in its place add ``069254''. [[Page 13232]] Sec. 558.450 [Amended] 0 32. Amend Sec. 558.450 as follows: 0 a. In paragraph (a)(2), remove ``048164'' and in its place add ``069254''; 0 b. In paragraphs (d)(2)(iii), (d)(2)(iv), and (d)(4)(ii), in the ``Limitations'' column, remove ``048164'' wherever it occurs and in its place add ``069254''; and 0 c. In paragraphs (d)(1)(i), (ii), (iii), and (iv), (d)(2)(i), (ii), (iii), and (iv), (d)(3)(i) and (ii), (d)(4)(i), (ii), (iii), (iv), and (v), and (d)(5)(i), (ii), and (iii), in the ``Sponsor'' column, remove ``048164'' and in its place add ``069254''. Sec. 558.455 [Amended] 0 33. Amend Sec. 558.455 as follows: 0 a. In paragraph (b), remove ``Nos. 048164 and 066104'' and in its place add ``Nos. 066104 and 069254''; and 0 b. In paragraphs (e)(1)(i), (ii), (iii), and (iv), (e)(2)(i), (ii), (iii), and (iv), (e)(3)(i) and (ii), and (e)(4)(i), (ii), (iii), (iv), (v), and (vi), in the ``Sponsor'' column, remove ``048164'' and in its place in numerical order add ``069254''. Sec. 558.550 [Amended] 0 34. In Sec. 558.550, in paragraphs (b)(3) and (d)(1)(xvi)(c), remove ``048164'' and in its place add ``069254''. Sec. 558.600 [Redesignated as Sec. 558.612 and Amended] 0 35. Redesignate Sec. 558.600 as Sec. 558.612 and amend newly redesignated Sec. 558.612 as follows: 0 a. In paragraph (c), remove ``Sec. 556.738'' and in its place add ``Sec. 556.732''; and 0 b. In paragraph (e)(1)(iii), in the ``Limitations'' and ``Sponsor'' columns, remove ``048164'' and in its place in numerical order add ``069254''. Sec. 558.615 [Redesignated as Sec. 558.600] 0 36. Redesignate Sec. 558.615 as Sec. 558.600. Sec. 558.625 [Amended] 0 37. In Sec. 558.625, in paragraph (b)(5), remove ``048164'' and in its place add ``069254''. Sec. 558.630 [Amended] 0 38. In Sec. 558.630, in paragraph (b)(2), remove ``No. 054771'' and in its place add ``Nos. 054771 and 069254''. 0 39. Amend Sec. 558.665 as follows: 0 a. Revise paragraphs (d)(1) and (e)(1); 0 b. Redesignate paragraph (d)(2) as paragraph (d)(4); and 0 c. Add paragraphs (d)(2), (d)(3), (e)(7), and (e)(8). The revisions and additions read as follows: Sec. 558.665 Zilpaterol. * * * * * (d) * * * (1) Labeling shall bear the following caution statements: ``Zilpaterol hydrochloride is not for use in animals intended for breeding. Do not allow horses or other equines access to feed containing zilpaterol. Do not use in veal calves.'' (2) Labeling of Type A medicated articles and Type B medicated feeds used to manufacture complete Type C medicated feeds shall bear the caution statements in paragraph (d)(3) of this section. (3) Labeling of complete Type C medicated feeds shall bear the following caution statements: ``Not to be fed to cattle in excess of 90 mg zilpaterol/head/day in complete feed. If pen consumption of complete feed exceeds 26.5 lb/head/day (90 percent dry matter basis), zilpaterol should not be fed in complete feed.'' * * * * * (e) * * * ---------------------------------------------------------------------------------------------------------------- Combination grams/ Zilpaterol in grams/ton ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (1) 6.8......................... ................... Cattle fed in Feed continuously 000061 confinement for as the sole ration slaughter: For during the last 20 increased rate of to 40 days on feed weight gain, improved to provide 60 to feed efficiency, and 90 mg/head/day. increased carcass Withdrawal period: leanness in cattle fed 3 days. in confinement for slaughter during the last 20 to 40 days on feed. * * * * * * * (7) 6.8 to 24................... ................... Cattle fed in Feed continuously 000061 confinement for to cattle during slaughter: For the last 20 to 40 increased rate of days on feed to weight gain, improved provide 60 mg feed efficiency, and zilpaterol increased carcass hydrochloride per leanness in cattle fed head per day. in confinement for Withdrawal period: slaughter during the 3 days. last 20 to 40 days on feed. (8) 6.8 to 24................... Monensin 10 to 40, Cattle fed in Feed continuously 000061 plus tylosin 8 to confinement for to cattle during 10. slaughter: For the last 20 to 40 increased rate of days on feed to weight gain, improved provide 60 mg feed efficiency, and zilpaterol increased carcass hydrochloride per leanness in cattle fed head per day. See in confinement for paragraphs Sec. slaughter during the Sec. 558.355(d) last 20 to 40 days on and 558.625(c). feed; for prevention Monensin and and control of tylosin as coccidiosis due to provided by No. Eimeria bovis and E. 000986 in Sec. zuernii; and for 510.600(c) of this reduction of incidence chapter. of liver abscesses Withdrawal period: caused by 3 days. Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes. ---------------------------------------------------------------------------------------------------------------- Dated: March 9, 2015. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2015-05644 Filed 3-12-15; 8:45 am] BILLING CODE 4164-01-P
![13226 Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Rules and Regulations
We are issuing the SECG consistent will be posted to the docket at http:// correcting amendments for a drug
with our good guidance practices www.regulations.gov. labeler code.
regulation (21 CFR 10.115(c)(2)). The DATES: This rule is effective March 13,
IV. Electronic Access
SECG represents our current thinking on 2015.
nutrition labeling of standard menu Persons with access to the Internet
items in restaurants and similar retail may obtain the SECG at either http:// FOR FURTHER INFORMATION CONTACT:
food establishments. It does not create www.fda.gov/Food/Guidance George K. Haibel, Center for Veterinary
or confer any rights for or on any person Regulation/GuidanceDocuments Medicine (HFV–6), Food and Drug
and does not operate to bind FDA or the RegulatoryInformation/default.htm or Administration, 7519 Standish Pl.,
public. An alternative approach may be http://www.regulations.gov. Use the Rockville, MD 20855, 240–276–9019,
used if such approach satisfies the FDA Web site listed in the previous george.haibel@fda.hhs.gov.
requirements of the applicable statutes sentence to find the most current
SUPPLEMENTARY INFORMATION: FDA is
and regulations. version of the guidance.
amending the animal drug regulations to
II. Paperwork Reduction Act of 1995 Dated: March 6, 2015. reflect approval actions for NADAs and
Leslie Kux, ANADAs during November and
This SECG refers to collections of
Associate Commissioner for Policy. December 2014, as listed in table 1. In
information described in FDA’s final
[FR Doc. 2015–05590 Filed 3–12–15; 8:45 am] addition, FDA is informing the public of
rule that published in the Federal
BILLING CODE 4164–01–P the availability, where applicable, of
Register of December 1, 2014 (79 FR
documentation of environmental review
71156), and that will be effective on
December 1, 2015. As stated in the final required under the National
DEPARTMENT OF HEALTH AND Environmental Policy Act (NEPA) and,
rule, these collections of information are
HUMAN SERVICES for actions requiring review of safety or
subject to review by the Office of
Management and Budget (OMB) under effectiveness data, summaries of the
Food and Drug Administration basis of approval (FOI Summaries)
the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501–3520). In under the Freedom of Information Act
21 CFR Parts 510, 520, 522, 524, 556, (FOIA). These public documents may be
compliance with the PRA (44 U.S.C. and 558
3507(d)), the Agency has submitted the seen in the Division of Dockets
information collection provisions of the [Docket No. FDA–2014–N–0002] Management (HFA–305), Food and Drug
final rule to OMB for review. FDA will Administration, 5630 Fishers Lane, Rm.
New Animal Drugs; Approval of New 1061, Rockville, MD 20852, between 9
publish a document in the Federal
Animal Drug Applications; Change of a.m. and 4 p.m., Monday through
Register announcing OMB’s decision to
Sponsor Friday. Persons with access to the
approve, modify, or disapprove the
information collection provisions in this AGENCY: Food and Drug Administration, Internet may obtain these documents at
final rule. An Agency may not conduct HHS. the CVM FOIA Electronic Reading
or sponsor, and a person is not required Room: http://www.fda.gov/AboutFDA/
Final rule; technical
ACTION:
CentersOffices/OfficeofFoods/CVM/
to respond to, a collection of amendments.
information unless it displays a CVMFOIAElectronicReadingRoom/
currently valid OMB control number. SUMMARY: The Food and Drug default.htm. Marketing exclusivity and
Administration (FDA) is amending the patent information may be accessed in
III. Comments animal drug regulations to reflect FDA’s publication, Approved Animal
Interested persons may submit either approval actions for new animal drug Drug Products Online (Green Book) at:
electronic comments regarding the applications (NADAs) and abbreviated http://www.fda.gov/AnimalVeterinary/
SECG to http://www.regulations.gov or new animal drug applications Products/
written comments to the Division of (ANADAs) during November and ApprovedAnimalDrugProducts/
Dockets Management (see ADDRESSES). It December 2014. FDA is also informing default.htm.
is only necessary to send one set of the public of the availability of In addition, Pennfield Oil Co., 14040
comments. Identify comments with the summaries of the basis of approval and Industrial Rd., Omaha, NE 68144, has
docket number found in brackets in the of environmental review documents, transferred ownership of, and all rights
heading of this document. Received where applicable. The animal drug and interest in, the following approved
comments may be seen in the Division regulations are also being amended to applications to Pharmgate LLC, 161
of Dockets Management between 9 a.m. reflect a change of sponsorship of eight North Franklin Turnpike, Suite 2C,
and 4 p.m., Monday through Friday, and NADAs and nine ANADAs, and to make Ramsey, NJ 07446:
File No. Product name 21 CFR Cite
065–480 ........ Chlortetracycline Soluble Powder .................................................................................................. 520.441.
138–934 ........ PENNCHLOR SP (chlortetracycline, sulfamethazine, penicillin) Type A medicated articles ....... 558.145.
138–935 ........ PENNCHLOR (chlortetracycline) Type A medicated articles ........................................................ 558.128.
138–938 ........ PENNOX (oxytetracycline) Type A medicated articles ................................................................. 558.450.
138–939 ........ NEO–OXY (neomycin sulfate and oxytetracycline) Type A medicated articles ........................... 558.455.
140–680 ........ TYLAN (tylosin phosphate) Type A medicated articles ................................................................ 558.625.
140–681 ........ TYLAN Sulfa-G (tylosin phosphate and sulfamethazine) Type A medicated articles .................. 558.630.
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141–137 ........ PENITRACIN (bacitracin methylenedisalicylate) 50 Type A medicated article ............................ Not codified.
200–026 ........ PENNOX 343 (oxytetracycline) ..................................................................................................... 520.1660d.
200–154 ........ PENNOX 200 (oxytetracycline) ..................................................................................................... 558.450.
200–295 ........ PENNCHLOR 64 (chlortetracycline) .............................................................................................. 558.128.
200–314 ........ PENNCHLOR S (chlortetracycline) ............................................................................................... 558.140.
200–354 ........ PENNCHLOR (chlortetracycline)/COBAN (monensin) .................................................................. 558.355.
200–356 ........ PENNCHLOR (chlortetracycline)/DENAGARD (tiamulin) ............................................................. 558.600.
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![Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Rules and Regulations 13229
Drug labeler Firm name and address
code
* * * * * * *
PART 520—ORAL DOSAGE FORM The revisions read as follows: (2) No. 052483 for use of products
NEW ANIMAL DRUGS described in paragraph (a) of this
§ 520.1660d Oxytetracycline powder.
section.
■ 3. The authority citation for 21 CFR * * * * * * * * * *
part 520 continues to read as follows: (d) * * *
■ 13. Amend § 522.812 as follows:
Authority: 21 U.S.C. 360b. (1) * * * ■ a. Revise paragraph (b)(2);
(ii) * * * ■ b. Remove paragraph (e)(3)(i);
§§ 520.310 and 520.312 [Redesignated as (A) * * * ■ c. Redesignate paragraphs (e)(3)(ii)
§§ 520.301 and 520.302] (3) * * * Zero-day withdrawal for and (e)(3)(iii) as paragraphs (e)(3)(i) and
■ 4. Redesignate §§ 520.310 and 520.312 those products sponsored by Nos. (e)(3)(ii), respectively; and
as §§ 520.301 and 520.302, respectively. 054771, 057561, 061133, and 069254. ■ d. Revise newly redesignated
(B) * * * paragraph (e)(3)(i).
§ 520.309 [Redesignated as § 520.304 and (3) * * * Zero-day withdrawal for The revisions read as follows:
Amended]
those products sponsored by Nos.
■ 5. Redesignate § 520.309 as § 520.304 054771, 057561, 061133, and 069254. § 522.812 Enrofloxacin.
and revise newly redesignated § 520.304 (C) * * * * * * * *
by adding paragraph (b)(3) to read as (3) * * * Zero-day withdrawal for (b) * * *
follows: those products sponsored by Nos. (2) No. 055529 for use of product
054771, 057561, 061133, and 069254. described in paragraph (a)(1) of this
§ 520.304 Carprofen. section as in paragraph (e)(1) of this
* * * * * * * * * *
section, and use of product described in
(b) * * * ■ 9. In § 520.2455, revise paragraphs paragraph (a)(2) of this section as in
(3) No. 026637 for use of product (b)(3) and (c) to read as follows: paragraphs (e)(2)(i)(B), (e)(2)(ii)(B),
described in paragraph (a)(2) of this (e)(2)(iii), (e)(3)(i)(B), and (e)(3)(ii) of
§ 520.2455 Tiamulin.
section as in paragraph (d) of this this section.
section. * * * * *
(b) * * * * * * * *
* * * * * (e) * * *
(3) No. 054771 for the product
■ 6. In § 520.370, revise paragraphs (a) (3) * * *
described in paragraph (a)(3) of this (i) Amounts and indications for use.
and (b) and in paragraph (c)(2), remove section.
‘‘intermedius’’ and in its place add (A) Administer, either by intramuscular
(c) Related tolerances. See § 556.732 or subcutaneous (behind the ear)
‘‘pseudintermedius’’ to read as follows:
of this chapter. injection, a single dose of 7.5 mg/kg of
§ 520.370 Cefpodoxime tablets. * * * * * body weight for the treatment and
(a) Specifications. (1) Each tablet control of swine respiratory disease
contains cefpodoxime proxetil PART 522—IMPLANTATION OR (SRD) associated with Actinobacillus
equivalent to 100 or 200 milligrams (mg) INJECTABLE DOSAGE FORM NEW pleuropneumoniae, Pasteurella
cefpodoxime. ANIMAL DRUGS multocida, Haemophilus parasuis,
(2) Each chewable tablet contains Streptococcus suis, Bordetella
cefpodoxime proxetil equivalent to 100 ■ 10. The authority citation for 21 CFR
bronchiseptica, and Mycoplasma
or 200 mg cefpodoxime. part 522 continues to read as follows:
hyopneumoniae.
(b) Sponsors. See sponsors in Authority: 21 U.S.C. 360b. (B) Administer, by subcutaneous
§ 510.600(c) of this chapter for uses as (behind the ear) injection, a single dose
§ 522.246 [Amended]
follows: of 7.5 mg/kg of body weight for the
(1) No. 026637 for use of product in ■ 11. In § 522.246, in paragraph (b)(3), treatment and control of swine
paragraph (a)(1) of this section as in remove ‘‘053599’’ and in its place add respiratory disease (SRD) associated
paragraph (c) of this section. ‘‘059399’’. with Actinobacillus pleuropneumoniae,
(2) No. 054771 for use of products in ■ 12. In § 522.558, revise paragraphs (a) Pasteurella multocida, Haemophilus
paragraph (a) of this section as in and (b) to read as follows: parasuis, and Streptococcus suis.
paragraph (c) of this section. (C) Administer, either by
* * * * * § 522.558 Dexmedetomidine. intramuscular or subcutaneous (behind
(a) Specifications. Each milliliter of the ear) injection, a single dose of 7.5
§ 520.441 [Amended] solution contains: mg/kg of body weight for the control of
■ 7. In § 520.441, in paragraph (b)(1), (1) 0.1 milligrams (mg) colibacillosis in groups or pens of
remove ‘‘048164’’ and in its place add dexmedetomidine hydrochloride; or weaned pigs where colibacillosis
‘‘069254’’. (2) 0.5 mg dexmedetomidine associated with Escherichia coli has
■ 8. Amend § 520.1660d as follows: hydrochloride. been diagnosed.
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■ a. In paragraph (b)(6), remove (b) Sponsors. See sponsors in in * * * * *
‘‘048164’’ and in its place add § 510.600(c) of this chapter for use as in ■ 14. In § 522.1222, revise paragraph (b)
‘‘069254’’. paragraph (c) of this section: to read as follows:
■ b. In paragraphs (d)(1)(ii)(A)(3), (1) No. 026637 for use of product
(d)(1)(ii)(B)(3), and (d)(1)(ii)(C)(3), revise described in paragraph (a)(2) of this § 522.1222 Ketamine.
the last sentence. section; * * * * *
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![13230 Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Rules and Regulations
(b) Sponsors. See Nos. 000859, slaughtered within 18 days from the last ■ 21. In § 524.1044i, revise paragraph
026637, 054628, 054771, 059399, and treatment. Do not use in female dairy (c)(2) to read as follows:
063286 in § 510.600(c) of this chapter. cattle 20 months of age or older. Federal
law restricts this drug to use by or on § 524.1044i Gentamicin and
* * * * * betamethasone ophthalmic solution.
the order of a licensed veterinarian.
§ 522.2474 [Amended] (B) Calves intended for human * * * * *
■ 15. In § 522.2474, in paragraph (b), consumption must not be slaughtered (c) * * *
remove ‘‘053599’’ and in its place add within 22 days from the last treatment. (2) Indications for use. For treatment
‘‘059399’’. Not for use in ruminating cattle. Federal of external eye infections and
law restricts this drug to use by or on inflammation.
■ 16. In § 522.2630, revise paragraphs
the order of a licensed veterinarian.
(b)(1), (b)(2), (d)(1)(ii)(A), (d)(1)(ii)(B), * * * * *
and (d)(1)(iii) to read as follows: * * * * *
§ 522.2662 [Amended] PART 556—TOLERANCES FOR
§ 522.2630 Tulathromycin. RESIDUES OF NEW ANIMAL DRUGS
* * * * * ■ 17. In § 522.2662, in paragraph (b)(4), IN FOOD
(b) * * * remove ‘‘053599’’ and in its place add
(1) Product described as in paragraph ‘‘059399’’. ■ 22. The authority citation for 21 CFR
(a)(1) of this section for use as in § 522.2670 [Amended] part 556 continues to read as follows:
paragraphs (d)(1)(i), (d)(1)(ii),
■ 18. In § 522.2670, in paragraph (b)(1), Authority: 21 U.S.C. 342, 360b, 371.
(d)(1)(iii)(A), and (d)(2) of this section.
(2) Product described as in paragraph remove ‘‘053599’’ and in its place add
‘‘059399’’. § 556.738 [Redesignated as § 556.732]
(a)(2) of this section for use as in
paragraphs (d)(1)(i), (d)(1)(ii)(B), ■ 23. Redesignate § 556.738 as
PART 524—OPHTHALMIC AND
(d)(1)(iii)(B), and (d)(2) of this section. § 556.732.
TOPICAL DOSAGE FORM NEW
* * * * * ANIMAL DRUGS
(d) * * * PART 558—NEW ANIMAL DRUGS FOR
(1) * * * ■ 19. The authority citation for 21 CFR USE IN ANIMAL FEEDS
(ii) * * * part 524 continues to read as follows:
(A) Beef and non-lactating dairy ■ 24. The authority citation for 21 CFR
Authority: 21 U.S.C. 360b.
cattle. For the treatment of bovine part 558 continues to read as follows:
respiratory disease (BRD) associated ■ 20. Add § 524.955 to read as follows: Authority: 21 U.S.C. 360b, 371.
with Mannheimia haemolytica, § 524.955 Florfenicol, terbinafine, and
Pasteurella multocida, Histophilus betamethasone acetate otic gel. § 558.76 [Amended]
somni, and Mycoplasma bovis. For the (a) Specifications. Each milliliter of
control of respiratory disease in cattle at ■ 25. In § 558.76, in paragraph (d)(1)(iv),
gel contains 10 milligrams (mg) in the ‘‘Limitations’’ and ‘‘Sponsor’’
high risk of developing BRD associated florfenicol, 10 mg terbinafine, and 1 mg
with M. haemolytica, P. multocida, H. columns, remove ‘‘048164’’ and in its
betamethasone acetate. place add ‘‘069254’’.
somni, and M. bovis. For the treatment (b) Sponsor. See No. 058198 in
of infectious bovine keratoconjunctivitis § 510.600(c) of this chapter. ■ 26. In § 558.95, add paragraph
(IBK) associated with Moraxella bovis. (c) Conditions of use in dogs—(1) (d)(4)(v) to read as follows:
For the treatment of bovine foot rot Amount. Administer one dose (1 tube)
(interdigital necrobacillosis) associated § 558.95 Bambermycins.
per affected ear(s) and repeat
with Fusobacterium necrophorum and administration in 7 days. * * * * *
Porphyromonas levii. (2) Indications for use. For the (d) * * *
(B) Suckling calves, dairy calves, and treatment of otitis externa in dogs (4) * * *
veal calves. For the treatment of bovine associated with susceptible strains of
respiratory disease (BRD) associated bacteria (Staphylococcus (v) Used as a free-choice Type C
with Mannheimia haemolytica, pseudintermedius) and yeast medicated loose mineral feed for
Pasteurella multocida, Histophilus (Malassezia pachydermatis). pasture cattle (slaughter, stocker, and
somni, and Mycoplasma bovis. (3) Limitations. Federal law restricts feeder cattle; and dairy and beef
(iii) Limitations. (A) Cattle intended this drug to use by or on the order of replacement heifers) as follows:
for human consumption must not be a licensed veterinarian. (A) Specifications.
International feed
Ingredient Percent
No.
Deflorinated phosphate (20.5% calcium, 18.5% phosphorus) ........................................................................ 6–01–080 42.50
Sodium chloride (salt) ...................................................................................................................................... 6–04–152 20.10
Calcium carbonate (38% calcium) ................................................................................................................... 6–01–069 15.45
Corn distillers dried grains w/solubles ............................................................................................................. 5–28–236 9.57
Magnesium oxide ............................................................................................................................................. 6–02–756 5.15
Vitamin and trace mineral premix * .................................................................................................................. ............................ 3.72
Mineral oil ........................................................................................................................................................ ............................ 1.00
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Yeast (primary dehydrated yeast) ................................................................................................................... 7–05–533 0.75
Bambermycins Type A article (10 g/lb) ........................................................................................................... ............................ 0.60
Iron oxide ......................................................................................................................................................... 6–02–431 0.50
Magnesium sulfate (67%) ................................................................................................................................ 6–02–758 0.32
Copper sulfate ................................................................................................................................................. 6–01–720 0.18
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![Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Rules and Regulations 13231
International feed
Ingredient Percent
No.
Potassium sulfate (0.33%) ............................................................................................................................... 6–06–098 0.16
* Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free-choice feeds. For-
mulation modifications require FDA approval prior to marketing. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Pol-
icy Guides Sec. 651.100 (CPG 7125.18).
(B) Amount per ton. 120 grams. have not been shown to be more (iii), and (iv), (e)(4)(i), (ii), (iv), (vii), and
(C) Indications for use. For increased effective than 20 mg/head/day. (viii), and (e)(5)(i) and (ii), in the
rate of weight gain. * * * * * ‘‘Sponsor’’ column, remove ‘‘048164’’
(D) Limitations. For free-choice ■ 27. Amend § 558.128 as follows: wherever it occurs and in its place in
feeding to pasture cattle (slaughter, ■ a. In paragraph (b)(1), remove ‘‘Nos. numerical order add ‘‘069254’’; and
stocker, and feeder cattle; and dairy and 054771, 048164, and 066104’’ and in its ■ d. Revise paragraphs (e)(1)(iv),
beef replacement heifers). Feed a non- place add ‘‘Nos. 054771, 066104, and (e)(4)(v), and (e)(4)(ix).
medicated commercial mineral product 069254’’;
for 6 weeks to stabilize consumption The revisions read as follows:
■ b. In paragraphs (e)(4)(ii) and (iv), in
between 2.66 and 10.66 ounces per head the ‘‘Limitations’’ column, remove § 558.128 Chlortetracycline.
per day. Feed continuously to provide ‘‘048164’’ wherever it occurs and in its * * * * *
10 to 40 milligrams bambermycins per place add ‘‘069254’’;
head per day. Daily bambermycins ■ c. In paragraphs (e)(1)(i), (ii), and (iii), (e) * * *
intakes in excess of 20 mg/head/day (e)(2)(i), (ii), (iii), and (iv), (e)(3)(i), (ii), (1) * * *
Chlortetracycline amount Indications for use Limitations Sponsor
* * * * * * *
(iv) 500 g/ton ..................... Chickens: For the reduction of mortality 1. Feed for 5 d. To sponsor No. 054771 under NADA 054771,
due to E. coli infections susceptible to 048–761 and No. 069254 under ANADA 200–510: 069254.
chlortetracycline. zero withdrawal time.
2. Feed for 5 d; withdraw 24 h prior to slaughter; do 012286,
not feed to chickens producing eggs for human con- 054771,
sumption. 066104,
069254.
* * * * * (4) * * *
Chlortetracycline amount Indications for use Limitations Sponsor
* * * * * * *
(v) 500 to 4,000 g/ton ........ Calves, beef and nonlactating dairy cattle; Feed continuously for not more than 5 days to provide 054771
treatment of bacterial enteritis caused by 10 mg/lb body weight per day. To sponsor No. 069254
E. coli and bacterial pneumonia caused 054771 under NADA 046–699: 24-h withdrawal time.
by P. multocida susceptible to chlortetra- To sponsor No. 054771 under NADA 048–761 and
cycline. No. 069254 under ANADA 200–510: Zero with-
drawal time.
* * * * * * *
(ix) 350 mg/head/day ......... 1. Beef cattle: For control of bacterial pneu- Withdraw 48 h prior to slaughter. To sponsor No. 012286,
monia associated with shipping fever 054771 under NADA 046–699: 48-h withdrawal 054771,
complex caused by Pasteurella spp. sus- time. To sponsor No. 054771 under NADA 048–761 066104,
ceptible to chlortetracycline. and No. 069254 under ANADA 200–510: Zero with- 069254.
drawal time.
2. Beef cattle (under 700 lb): For control of Withdraw 48 h prior to slaughter. To sponsor No. 012286,
active infection of anaplasmosis caused 054771 under NADA 046–699: 48-h withdrawal 054771,
by A. marginale susceptible to chlortetra- time. To sponsor No. 054771 under NADA 048–761 066104,
cycline. and No. 069254 under ANADA 200–510: zero with- 069254.
drawal time.
* * * * * § 558.145 [Amended] ‘‘Sponsor’’ columns, remove ‘‘048164’’
■ 29. In § 558.145, in paragraph (a)(2), and in its place add ‘‘069254’’.
§ 558.140 [Amended]
tkelley on DSK3SPTVN1PROD with RULES
remove ‘‘048164’’ and in its place add § 558.355 [Amended]
■ 28. In § 558.140, in paragraph (b)(1), ‘‘069254’’.
remove ‘‘048164’’ and in its place add ■ 31. In § 558.355, in paragraph
§ 558.195 [Amended]
‘‘069254’’. (f)(1)(xiv)(b), remove ‘‘048164’’ and in
■ 30. In § 558.195, in paragraph its place add ‘‘069254’’.
(e)(2)(iv), in the ‘‘Limitations’’ and
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![13232 Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Rules and Regulations
§ 558.450 [Amended] § 558.600 [Redesignated as § 558.612 and The revisions and additions read as
Amended] follows:
■ 32. Amend § 558.450 as follows:
■ a. In paragraph (a)(2), remove ■ 35. Redesignate § 558.600 as § 558.612
§ 558.665 Zilpaterol.
‘‘048164’’ and in its place add and amend newly redesignated
‘‘069254’’; § 558.612 as follows: * * * * *
■ b. In paragraphs (d)(2)(iii), (d)(2)(iv), ■ a. In paragraph (c), remove (d) * * *
and (d)(4)(ii), in the ‘‘Limitations’’ ‘‘§ 556.738’’ and in its place add
column, remove ‘‘048164’’ wherever it (1) Labeling shall bear the following
‘‘§ 556.732’’; and caution statements: ‘‘Zilpaterol
occurs and in its place add ‘‘069254’’; ■ b. In paragraph (e)(1)(iii), in the
and hydrochloride is not for use in animals
‘‘Limitations’’ and ‘‘Sponsor’’ columns,
■ c. In paragraphs (d)(1)(i), (ii), (iii), and intended for breeding. Do not allow
remove ‘‘048164’’ and in its place in
(iv), (d)(2)(i), (ii), (iii), and (iv), (d)(3)(i) horses or other equines access to feed
numerical order add ‘‘069254’’.
and (ii), (d)(4)(i), (ii), (iii), (iv), and (v), containing zilpaterol. Do not use in veal
and (d)(5)(i), (ii), and (iii), in the § 558.615 [Redesignated as § 558.600] calves.’’
‘‘Sponsor’’ column, remove ‘‘048164’’ ■ 36. Redesignate § 558.615 as (2) Labeling of Type A medicated
and in its place add ‘‘069254’’. § 558.600. articles and Type B medicated feeds
§ 558.455 [Amended] used to manufacture complete Type C
§ 558.625 [Amended] medicated feeds shall bear the caution
■ 33. Amend § 558.455 as follows:
■ 37. In § 558.625, in paragraph (b)(5), statements in paragraph (d)(3) of this
■ a. In paragraph (b), remove ‘‘Nos.
remove ‘‘048164’’ and in its place add section.
048164 and 066104’’ and in its place
add ‘‘Nos. 066104 and 069254’’; and ‘‘069254’’. (3) Labeling of complete Type C
■ b. In paragraphs (e)(1)(i), (ii), (iii), and § 558.630 [Amended] medicated feeds shall bear the following
(iv), (e)(2)(i), (ii), (iii), and (iv), (e)(3)(i) caution statements: ‘‘Not to be fed to
and (ii), and (e)(4)(i), (ii), (iii), (iv), (v), ■ 38. In § 558.630, in paragraph (b)(2),
cattle in excess of 90 mg zilpaterol/
and (vi), in the ‘‘Sponsor’’ column, remove ‘‘No. 054771’’ and in its place
head/day in complete feed. If pen
remove ‘‘048164’’ and in its place in add ‘‘Nos. 054771 and 069254’’.
consumption of complete feed exceeds
numerical order add ‘‘069254’’. ■ 39. Amend § 558.665 as follows: 26.5 lb/head/day (90 percent dry matter
■ a. Revise paragraphs (d)(1) and (e)(1);
§ 558.550 [Amended] basis), zilpaterol should not be fed in
■ b. Redesignate paragraph (d)(2) as
complete feed.’’
■ 34. In § 558.550, in paragraphs (b)(3) paragraph (d)(4); and
and (d)(1)(xvi)(c), remove ‘‘048164’’ and ■ c. Add paragraphs (d)(2), (d)(3), (e)(7), * * * * *
in its place add ‘‘069254’’. and (e)(8). (e) * * *
Combination grams/
Zilpaterol in grams/ton Indications for use Limitations Sponsor
ton
(1) 6.8 ........................ ................................... Cattle fed in confinement for slaughter: For Feed continuously as the sole ra- 000061
increased rate of weight gain, improved tion during the last 20 to 40 days
feed efficiency, and increased carcass on feed to provide 60 to 90 mg/
leanness in cattle fed in confinement for head/day. Withdrawal period: 3
slaughter during the last 20 to 40 days on days.
feed.
* * * * * * *
(7) 6.8 to 24 .............. ................................... Cattle fed in confinement for slaughter: For Feed continuously to cattle during 000061
increased rate of weight gain, improved the last 20 to 40 days on feed to
feed efficiency, and increased carcass provide 60 mg zilpaterol hydro-
leanness in cattle fed in confinement for chloride per head per day. With-
slaughter during the last 20 to 40 days on drawal period: 3 days.
feed.
(8) 6.8 to 24 .............. Monensin 10 to 40, Cattle fed in confinement for slaughter: For Feed continuously to cattle during 000061
plus tylosin 8 to 10. increased rate of weight gain, improved the last 20 to 40 days on feed to
feed efficiency, and increased carcass provide 60 mg zilpaterol hydro-
leanness in cattle fed in confinement for chloride per head per day. See
slaughter during the last 20 to 40 days on paragraphs §§ 558.355(d) and
feed; for prevention and control of coc- 558.625(c). Monensin and
cidiosis due to Eimeria bovis and E. tylosin as provided by No.
zuernii; and for reduction of incidence of 000986 in § 510.600(c) of this
liver abscesses caused by Fusobacterium chapter. Withdrawal period: 3
necrophorum and Arcanobacterium days.
(Actinomyces) pyogenes.
Dated: March 9, 2015.
tkelley on DSK3SPTVN1PROD with RULES
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015–05644 Filed 3–12–15; 8:45 am]
BILLING CODE 4164–01–P
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Document Created: 2015-12-18 11:41:52
Document Modified: 2015-12-18 11:41:52
| 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 March 13, 2015. | |
| Contact | George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, [email protected] | |
| FR Citation | 80 FR 13226 | |
| CFR Citation | 21
CFR
510 21 CFR 520 21 CFR 522 21 CFR 524 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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