| Page Range | 21688-21694 | |
| FR Document | 2017-09364 |
[Federal Register Volume 82, Number 89 (Wednesday, May 10, 2017)] [Rules and Regulations] [Pages 21688-21694] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-09364] [[Page 21688]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, and 558 [Docket No. FDA-2017-N-0002] New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; correcting amendments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2017. 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 several changes of sponsorship of applications and to make correcting amendments to improve the accuracy of the regulations. DATES: This rule is effective May 10, 2017, except for amendatory instruction 3 to 21 CFR 510.600, and amendatory instruction 10 to 21 CFR 522.1002, which are effective May 22, 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, [email protected]. SUPPLEMENTARY INFORMATION: I. Approval Actions FDA is amending the animal drug regulations to reflect approval actions for NADAs and an ANADA during January and February 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 (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. Table 1--Original and Supplemental NADAs and ANADAs Approved During January and February 2017 -------------------------------------------------------------------------------------------------------------------------------------------------------- Approval date File No. Sponsor Product name Species Effect of the action Public documents -------------------------------------------------------------------------------------------------------------------------------------------------------- January 13, 2017............ 141-468 Phibro Animal Health STAFAC Chickens............. Original approval FOI Summary. Corp., GlenPointe (virginiamycin) for prevention of Centre East, 3d plus BIO-COX necrotic enteritis Floor, 300 Frank W. (salinomycin) and coccidiosis in Burr Blvd., Suite combination drug broiler chickens. 21, Teaneck, NJ Type C medicated 07666. feeds. January 13, 2017............ 141-469 Phibro Animal Health STAFAC Chickens............. Original approval FOI Summary. Corp., GlenPointe (virginiamycin) for prevention of Centre East, 3d plus AMPROL necrotic enteritis Floor, 300 Frank W. (amprolium) and coccidiosis in Burr Blvd., Suite combination drug broiler chickens. 21, Teaneck, NJ Type C medicated 07666. feeds. January 13, 2017............ 141-470 Phibro Animal Health STAFAC Chickens............. Original approval FOI Summary. Corp., GlenPointe (virginiamycin) for prevention of Centre East, 3d plus AVATEC necrotic enteritis Floor, 300 Frank W. (lasalocid) and coccidiosis in Burr Blvd., Suite combination drug broiler chickens. 21, Teaneck, NJ Type C medicated 07666. feeds. January 13, 2017............ 141-472 Huvepharma AD, 5th STAFAC Chickens............. Original approval FOI Summary. Floor, 3A Nikolay (virginiamycin) for prevention of Haytov Str.,1113 plus CLINACOX necrotic enteritis Sophia, Bulgaria. (diclazuril) and coccidiosis in combination drug broiler chickens. Type C medicated feeds. February 13, 2017........... 141-445 Intervet, Inc., 2 REVALOR-XR Cattle............... Original approval FOI Summary; EA/ Giralda (trenbolone acetate for increased rate FONSI.\1\ Farms,Madison, NJ and estradiol) of weight gain and 07940. Extended-Release improved feed Implant. efficiency during 70 to 200 days after implantation in beef steers and heifers fed in confinement for slaughter. February 17, 2017........... 200-609 Anzac Animal Health, DIROBAN (melarsomine Dogs................. Original approval as FOI Summary. LLC, 218 Millwell dihydrochloride) a generic copy of Dr., Suite B, Powder for NADA 141-042. Maryland Heights, Injection. MO 63043. -------------------------------------------------------------------------------------------------------------------------------------------------------- \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). Following the approval of ANADA 200-609, Anzac Animal Health, LLC will now be included in the lists of sponsors of approved applications in Sec. 510.600(c) (21 CFR 510.600(c)). II. Changes of Sponsorship Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002 has informed FDA that it has transferred ownership of, and all rights and interest in, the following applications to Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201: [[Page 21689]] ---------------------------------------------------------------------------------------------------------------- File No. Product name 21 CFR section ---------------------------------------------------------------------------------------------------------------- 141-099............................. CYDECTIN (moxidectin) Pour-On for Beef and Dairy Cattle. 524.1450 141-220............................. CYDECTIN (moxidectin) Injectable Solution for Beef and 522.1450 Nonlactating Dairy Cattle. 141-247............................. CYDECTIN (moxidectin) Oral Drench for Sheep............. 520.1454 ---------------------------------------------------------------------------------------------------------------- Ceva Sante Animale, 10 Avenue de la Ballasti[egrave]re, 33500 Libourne, France has informed FDA that it has transferred ownership of, and all rights and interest in, the following applications to Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland: ---------------------------------------------------------------------------------------------------------------- File No. Product name 21 CFR section ---------------------------------------------------------------------------------------------------------------- 141-420............................. TILDREN (tiludronate disodium) Powder for Infusion...... 522.2473 200-481............................. ALTRESYN (altrenogest) Solution 0.22%................... 520.48 ---------------------------------------------------------------------------------------------------------------- Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland has informed FDA that it has transferred ownership of, and all rights and interest in, the following application to Ceva Sante Animale, 10 Avenue de la Ballasti[egrave]re, 33500 Libourne, France: ---------------------------------------------------------------------------------------------------------------- File No. Product name 21 CFR section ---------------------------------------------------------------------------------------------------------------- 200-587............................. FERROFORTE (gleptoferron) Solution, 200 mg/mL........... 522.1055 ---------------------------------------------------------------------------------------------------------------- Nexcyon Pharmaceuticals, Inc., P.O. Box 259158, Madison, WI 53725 has informed FDA that it has transferred ownership of, and all rights and interest in, the following applications to Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514: ---------------------------------------------------------------------------------------------------------------- File No. Product name 21 CFR section ---------------------------------------------------------------------------------------------------------------- 141-272............................. RECONCILE (fluoxetine hydrochloride) Chewable Tablets... 520.980 ---------------------------------------------------------------------------------------------------------------- Accordingly, the animal drug regulations are being amended to reflect these changes of sponsorship. Following this withdrawal of approval, Nexcyon Pharmaceuticals, Inc. is no longer the sponsor of an approved application. Accordingly, it will be removed from the list of sponsors of approved applications in Sec. 510.600(c). III. Withdrawals of Approval In addition, during January and February 2017, the following sponsor requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed: ------------------------------------------------------------------------ File No. Sponsor Product name 21 CFR section ------------------------------------------------------------------------ 009-505............. Sioux F.S.H.-P 522.1002 Biochemical, (follicle Inc., 204 stimulating Third St. NW., hormone) Sioux Center, Powder for IA 51250. Injection. ------------------------------------------------------------------------ Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADA 009-505, and all supplements and amendments thereto, is withdrawn, effective May 22, 2017. Following this withdrawal of approval, Sioux Biochemical, Inc., is no longer the sponsor of an approved application. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect this voluntary withdrawal of approval. IV. Technical Amendments We are also making several technical amendments in part 558, which was amended on December 27, 2016 (81 FR 94991), and February 24, 2017 (82 FR 11510), as part of the FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. These actions are being taken to improve the accuracy of the regulations. This final rule is issued under Section 512(i) of the Federal Food, Drug, and Cosmetic 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 Federal Food, Drug, and Cosmetic 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.'' As such, this document is also not subject to Executive Order 12866. [[Page 21690]] 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 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, 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. Effective May 10, 2017, in Sec. 510.600, in the table in paragraph (c)(1), alphabetically add an entry for ``Anzac Animal Health, LLC'', and remove the entry for ``Nexcyon Pharmaceuticals, Inc.''; and in the table in paragraph (c)(2), remove the entry for ``050929'', and numerically add an entry for ``086073.'' The 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 ------------------------------------------------------------------------ * * * * * * * Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, 086073 Maryland Heights, MO 63043............................. * * * * * * * ------------------------------------------------------------------------ (2) * * * ------------------------------------------------------------------------ Drug labeler code Firm name and address ------------------------------------------------------------------------ * * * * * * * 086073....................... Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043. * * * * * * * ------------------------------------------------------------------------ Sec. 510.600 [Amended] 0 3. Effective May 22, 2017, in Sec. 510.600, in the table in paragraph (c)(1), remove the entry for ``Sioux Biochemical, Inc.'' .''; and in the table in paragraph (c)(2), remove the entry for ``063112''. PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 0 4. The authority citation for part 520 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 520.48 [Amended] 0 5. In Sec. 520.48, in paragraph (b), remove ``013744'' and in its place add ``061623''. Sec. 520.980 [Amended] 0 6. In Sec. 520.980, in paragraph (b), remove ``050929'' and in its place add ``055246''. Sec. 520.1454 [Amended] 0 7. In Sec. 520.1454, in paragraph (b), remove ``000010'' and in its place add ``000859''. PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 0 8. The authority citation for part 522 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 522.90b [Amended] 0 9. In Sec. 522.90b, in paragraph (a), remove ``50, 100, or 250'' and in its place add ``200, 250, or 400''. Sec. 522.1002 [Amended] 0 10. Effective May 22, 2017, in Sec. 522.1002, remove paragraph (b); and redesignate paragraph (c) as paragraph (b). Sec. 522.1055 [Amended] 0 11. In Sec. 522.1055, in paragraph (b), remove ``Nos. 013744 and 061623'' and in its place add ``No. 013744''. Sec. 522.1362 [Amended] 0 12. In Sec. 522.1362, in paragraph (b), remove ``No. 050604'' and in its place add ``Nos. 050604 and 086073''. Sec. 522.1450 [Amended] 0 13. In Sec. 522.1450, in paragraph (b), remove ``000010'' and in its place add ``000859''. 0 14. In Sec. 522.1662a, revise paragraph (e)(1); and in paragraph (e)(3)(i)(c), revise the fifth sentence to read as follows: Sec. 522.1662a Oxytetracycline hydrochloride injection. * * * * * (e) * * * (1) Specifications. Each milliliter of solution contains 100 milligrams of oxytetracycline hydrochloride. * * * * * (3) * * * (i) * * * (c) * * * Exceeding the highest recommended dose of 5 milligrams per pound of body weight per day, administering more than the recommended number of treatments, and/or exceeding 10 milliliters intramuscularly or subcutaneously per injection site in adult beef and dairy cattle may result in antibiotic residues beyond the withdrawal period. * * * * * * * * [[Page 21691]] Sec. 522.2473 [Amended] 0 15. In Sec. 522.2473, in paragraph (b), remove ``013744'' and in its place add ``061623''. 0 16. In Sec. 522.2477, revise paragraph (b)(2) and add paragraph (d)(4) to read as follows: Sec. 522.2477 Trenbolone acetate and estradiol. * * * * * (b) * * * (2) No. 000061 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(C), (d)(1)(i)(D), (d)(1)(i)(G), (d)(1)(ii), (d)(1)(iii), (d)(2)(i)(A), (d)(2)(i)(C), (d)(2)(i)(D), (d)(2)(ii), (d)(2)(iii), (d)(3)(i)(A), (d)(3)(ii), (d)(3)(iii), and (d)(4) of this section. * * * * * (d) * * * (4) Beef steers and heifers fed in confinement for slaughter--(i) Amount. Each extended- and delayed-release implant contains 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of 10 pellets, each pellet containing 20 mg trenbolone acetate and 2 mg estradiol) per implant dose. (ii) Indications for use. For increased rate of weight gain and improved feed efficiency during 70 to 200 days after implantation. (iii) Limitations. Implant subcutaneously in the ear only. Do not use in lactating dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Do not use in calves to be processed for veal. A withdrawal period has not been established for this product in pre-ruminating calves. Effectiveness and animal safety in veal calves have not been established. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant during the production phase(s) identified on labeling (beef steers and heifers fed in confinement for slaughter) unless otherwise indicated on labeling because safety and effectiveness have not been evaluated. PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 0 17. The authority citation for part 524 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 524.1450 [Amended] 0 18. In Sec. 524.1450, in paragraph (b)(1), remove ``000010'' and in its place add ``000859''. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 19. The authority citation for part 558 continues to read as follows: Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371. Sec. 558.4 [Amended] 0 20. In Sec. 558.4, in paragraph (d), in the Category I table, remove the row entry for ``Penicillin''; and in the Category II table, remove the row entry for ``Sulfamethazine'' the first time it appears only along with the subsequent entries for ``Chlortetracycline'' and ``Penicillin''. Sec. 558.76 [Amended] 0 21. In Sec. 558.76, remove and reserve paragraph (e)(1)(vii). 0 22. In Sec. 558.115, revise paragraph (d)(4) to read as follows: Sec. 558.115 Carbadox. * * * * * (d) * * * (4) Carbadox may also be used in combination with oxytetracycline as in Sec. 558.450. 0 23. Amend Sec. 558.128 as follows: 0 a. In paragraph (b)(1), remove ``50, 65, or 100'' and in its place add ``50, 90, or 100''; 0 b. In paragraphs (e)(1)(i) and (v), in the ``Limitations'' column, remove ``Do not feed to chickens producing eggs for human consumption.'' and in its place add ``For No. 066104: Do not feed to chickens producing eggs for human consumption.''; 0 c. In paragraph (e)(3)(v), in the ``Sponsor'' column, add ``054771'' before ``069254''; 0 d. In paragraph (e)(4)(iii), in the ``Indications for use'' column, remove ``anaplsmosis'' and in its place add ``anaplasmosis''; and 0 e. Redesignate paragraphs (e)(4)(xxiv) and (xxv) as paragraphs (e)(4)(xxv) and (xxvi), respectively, and add new paragraph (e)(4)(xxiv). The addition reads as follows: Sec. 558.128 Chlortetracycline. * * * * * (e) * * * (4) * * * ---------------------------------------------------------------------------------------------------------------- Combination in Indications for Chlortetracycline amount grams/ton use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (xxiv) 25 to 2,800 to provide Lasalocid, 30 to Beef cattle Hand feed continuously 054771 350 mg/head/day. 181.8. weighing under at a rate of 350 mg 700 pounds: For chlortetracycline and control of active 1 mg lasalocid per 2.2 infection of lb. body weight daily anaplasmosis to cattle with a caused by maximum of 360 mg of Anaplasma lasalocid per head per marginale day. Do not allow susceptible to horses or other chlortetracycline equines access to ; and for the feeds containing control of lasalocid. No coccidiosis withdrawal period is caused by Eimeria required. A withdrawal bovis and E. period has not been zuernii. established for this product in pre- ruminating calves. Do not use in calves to be processed for veal. See Sec. 558.311(d) of this chapter. Chlortetracycline and lasalocid as provided by No. 054771 in Sec. 510.600(c) of this chapter. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * Sec. 558.140 [Amended] 0 24. In Sec. 558.140, in paragraph (b)(1), remove ``(d)(1)'' and in its place add ``(e)(1)''; and in paragraph (b)(2), remove ``(d)(2)'' and in its place add ``(e)(2)''. 0 25. In Sec. 558.325, redesignate paragraphs (e)(2)(vii) to (xvi) as [[Page 21692]] paragraphs (e)(2)(viii) to (xvii), respectively, and add new paragraph (e)(2)(vii) to read as follows: Sec. 558.325 Lincomycin. * * * * * (e) * * * (2) * * * ---------------------------------------------------------------------------------------------------------------- Combination in Indications for Lincomycin grams/ton grams/ton use Limitations Sponsors ---------------------------------------------------------------------------------------------------------------- * * * * * * * (vii) 40....................... Pyrantel, 800..... For the treatment Feed as a single 066104 and/or control of therapeutic treatment swine dysentery; at a rate of 1 lb of for removal and feed per 40 lb of body control of large weight for animals up roundworm to 200 lb and 5 lb of (Ascaris suum) feed per head for and nodular worm animals over 200 lb. (Oesophagostomum Not to be fed to swine spp.) infections. that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. See paragraph (d) of this section. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in Sec. 510.600(c) of this chapter. * * * * * * * ---------------------------------------------------------------------------------------------------------------- 0 26. In Sec. 558.366, revise paragraph (e) to read as follows: Sec. 558.366 Nicarbazin. * * * * * (e) Nicarbazin may also be used in combination with: (1)-(3) [Reserved] (4) Lincomycin as in Sec. 558.325. Sec. 558.485 [Amended] 0 27. In Sec. 558.485, remove paragraph (e)(1)(iv). 0 28. In Sec. 558.550, add paragraph (d)(5) to read as follows: Sec. 558.550 Salinomycin. * * * * * (d) * * * (5) Salinomycin may also be used in combination with: (i)-(ii) [Reserved] (iii) Chlortetracycline as in Sec. 558.128. (iv) Lincomycin as in Sec. 558.325. 0 29. Amend Sec. 558.625 as follows: 0 a. Revise paragraph (d)(2); 0 b. Add paragraphs (d)(4) and (5); 0 c. In paragraphs (e)(2)(iv), (v), (viii), (x), (xii), and (xiii), in the ``Limitations'' column, add a new sentence ``See Sec. 558.355(d) in this chapter.'' between the fourth and fifth sentences; 0 d. In paragraph (e)(2)(vi), in the ``Limitations'' column, add a new sentence ``See Sec. 558.355(d) in this chapter.'' between the seventh and eighth sentences; and 0 e. In paragraphs (e)(2)(vii), (ix), (xi), (xiv), and (xv), in the ``Limitations'' column, add a new sentence ``See Sec. 558.355(d) in this chapter.'' between the fifth and sixth sentences. The revisions and additions read as follows: Sec. 558.625 Tylosin. * * * * * (d) * * * (2) The expiration date of VFDs for tylosin medicated feeds must not exceed 6 months from the date of issuance. VFDs for tylosin shall not be refilled. * * * * * (4) Tylosin liquid Type B medicated feeds must bear an expiration date of 31 days after the date of manufacture. (5) Do not use tylosin liquid Type B medicated feeds in any liquid feed containing sodium metabisulfite or in any finished feed (supplement, concentrate, or complete feed) containing in excess of 2 percent bentonite. * * * * * 0 30. In Sec. 558.635, revise paragraph (e)(1) to read as follows: Sec. 558.635 Virginiamycin. * * * * * (e) Conditions of use--(1) Chickens-- ---------------------------------------------------------------------------------------------------------------- Combination in Indications for Virginiamycin grams/ton grams/ton use Limitations Sponsors ---------------------------------------------------------------------------------------------------------------- (i) 20......................... .................. Broiler chickens: Not for use in layers.. 066104 For prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin. (ii) 20........................ Amprolium 72.6 to Broiler chickens: For field conditions 066104 113.5. For prevention of where only E. tenella necrotic is the major problem, enteritis caused feed continuously as by Clostridium the sole ration. Use perfringens as the sole source of susceptible to amprolium. Do not use virginiamycin; in feeds containing and for the bentonite. Not for use prevention of in laying chickens. coccidiosis Amprolium as provided caused by Eimeria by No. 016592 in Sec. tenella. 510.600(c) of this chapter. (iii) 20....................... Amprolium 113.5 to Broiler chickens: For most field 066104 227. For prevention of conditions as they necrotic exist under modern enteritis caused management practices, by Clostridium feed 113.5 g/ton perfringens amprolium susceptible to continuously. Where virginiamycin; severe coccidiosis and for the conditions exist, feed prevention of 227 g/ton. Use as the coccidiosis where sole source of immunity to amprolium. Do not use coccidiosis is in feeds containing not desired. bentonite. Not for use in laying chickens. Amprolium as provided by No. 016592 in Sec. 510.600(c) of this chapter. [[Page 21693]] (iv) 20........................ Diclazuril 0.91... Broiler chickens: Feed continuously as 016592 For prevention of the sole ration. Do necrotic not use in hens enteritis caused producing eggs for by Clostridium human food. Diclazuril perfringens as provided by No. susceptible to 016592 in Sec. virginiamycin; 510.600(c) of this and for the chapter. prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is effective against E. maxima late in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesions scores and improve performance and health of birds challenged with E. maxima. (v) 20......................... Lasalocid 68 to Broiler chickens: Feed continuously as 066104 113. For prevention of the sole ration. Do necrotic not feed to laying enteritis caused chickens. For broiler by Clostridium or fryer chickens perfringens only. Lasalocid as susceptible to provided by No. 054771 virginiamycin; in Sec. 510.600(c) and for the of this chapter. prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima. (vi) 20........................ Monensin 90 to 110 Broiler chickens: Feed continuously as 066104 For prevention of the sole ration. Do necrotic not feed to laying enteritis caused chickens. See Sec. by Clostridium 558.355(d) in this perfringens chapter. Monensin as susceptible to provided by No. 058198 virginiamycin; in Sec. 510.600(c) and as an aid in of this chapter. the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, and E. mivati. (vii) 20....................... Salinomycin 40 to Broiler chickens: Feed continuously as .............. 60. For prevention of the sole ration. Do necrotic not feed to chickens enteritis caused over 16 weeks of age. by Clostridium Do not feed to laying perfringens chickens. Not approved susceptible to for use with pellet virginiamycin; binders. May be fatal and for the if accidentally fed to prevention of adult turkeys or coccidiosis horses. Salinomycin as caused by Eimeria provided by No. 016592 tenella, E. in Sec. 510.600(c) necatrix, E. of this chapter. acervulina, E. maxima, E. brunetti, and E. mivati. (viii) 20...................... Semduramicin 22.7. Broiler chickens: Feed continuously as 066104 For prevention of the sole ration. Do necrotic not feed to laying enteritis caused hens. Semduramicin as by Clostridium provided by No. 066104 perfringens in Sec. 510.600(c) susceptible to of this chapter. virginiamycin; and for the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E mivati/ mitis, E. necatrix, and E. tenella. (ix) 20........................ Semduramicin Broiler chickens: Feed continuously as 066104 (biomass) 22.7. For prevention of the sole ration. necrotic Withdraw 1 day before enteritis caused slaughter. Do not feed by Clostridium to laying hens. perfringens Semduramicin as susceptible to provided by No. 066104 virginiamycin; in Sec. 510.600(c) and for the of this chapter. prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E mivati/ mitis, E. necatrix, and E. tenella. ---------------------------------------------------------------------------------------------------------------- * * * * * 0 31. In Sec. 558.680, remove paragraph (e) and add paragraph (d)(3) to read as follows: Sec. 558.680 Zoalene. * * * * * (d) * * * (3) Zoalene may also be used in combination with: (i)-(ii) [Reserved] (iii) Lincomycin as in Sec. 558.325. [[Page 21694]] Dated: May 4, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-09364 Filed 5-9-17; 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; correcting amendments. | |
| Dates | This rule is effective May 10, 2017, except for amendatory instruction 3 to 21 CFR 510.600, and amendatory instruction 10 to 21 CFR 522.1002, which are effective May 22, 2017. | |
| Contact | George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689, [email protected] | |
| FR Citation | 82 FR 21688 | |
| CFR Citation | 21
CFR
510 21 CFR 520 21 CFR 522 21 CFR 524 21 CFR 558 | |
| CFR Associated | Administrative Practice and Procedure; Animal Drugs; Labeling; Reporting and Recordkeeping Requirements and Animal Feeds |