82 FR 21688 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 89 (May 10, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 89 (May 10, 2017)
| 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
![21688 Federal Register / Vol. 82, No. 89 / Wednesday, May 10, 2017 / Rules and Regulations
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Administration (FDA or we) is default.htm. Marketing exclusivity and
amending the animal drug regulations to I. Approval Actions patent information may be accessed in
reflect application-related actions for FDA is amending the animal drug FDA’s publication, Approved Animal
new animal drug applications (NADAs) regulations to reflect approval actions Drug Products Online (Green
and abbreviated new animal drug for NADAs and an ANADA during Book) at: http://www.fda.gov/
applications (ANADAs) during January January and February 2017, as listed in AnimalVeterinary/Products/
and February 2017. FDA is also table 1. In addition, FDA is informing ApprovedAnimalDrugProducts/
informing the public of the availability the public of the availability, where default.htm.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY AND FEBRUARY 2017
Public
Approval date File No. Sponsor Product name Species Effect of the action documents
January 13, 2017 ....... 141–468 Phibro Animal Health Corp., STAFAC (virginiamycin) Chickens ......... Original approval for pre- FOI Summary.
GlenPointe Centre East, plus BIO–COX vention of necrotic enter-
3d Floor, 300 Frank W. (salinomycin) combination itis and coccidiosis in
Burr Blvd., Suite 21, Tea- drug Type C medicated broiler chickens.
neck, NJ 07666. feeds.
January 13, 2017 ....... 141–469 Phibro Animal Health Corp., STAFAC (virginiamycin) Chickens ......... Original approval for pre- FOI Summary.
GlenPointe Centre East, plus AMPROL vention of necrotic enter-
3d Floor, 300 Frank W. (amprolium) combination itis and coccidiosis in
Burr Blvd., Suite 21, Tea- drug Type C medicated broiler chickens.
neck, NJ 07666. feeds.
January 13, 2017 ....... 141–470 Phibro Animal Health Corp., STAFAC (virginiamycin) Chickens ......... Original approval for pre- FOI Summary.
GlenPointe Centre East, plus AVATEC (lasalocid) vention of necrotic enter-
3d Floor, 300 Frank W. combination drug Type C itis and coccidiosis in
Burr Blvd., Suite 21, Tea- medicated feeds. broiler chickens.
neck, NJ 07666.
January 13, 2017 ....... 141–472 Huvepharma AD, 5th Floor, STAFAC (virginiamycin) Chickens ......... Original approval for pre- FOI Summary.
3A Nikolay Haytov plus CLINACOX vention of necrotic enter-
Str.,1113 Sophia, Bul- (diclazuril) combination itis and coccidiosis in
garia. drug Type C medicated broiler chickens.
feeds.
February 13, 2017 ...... 141–445 Intervet, Inc., 2 Giralda REVALOR–XR (trenbolone Cattle ............... Original approval for in- FOI Summary;
Farms,Madison, NJ acetate and estradiol) Ex- creased rate of weight EA/FONSI.1
07940. tended-Release Implant. gain and improved feed
efficiency during 70 to
200 days after implanta-
tion in beef steers and
heifers fed in confinement
for slaughter.
February 17, 2017 ...... 200–609 Anzac Animal Health, LLC, DIROBAN (melarsomine Dogs ................ Original approval as a ge- FOI Summary.
218 Millwell Dr., Suite B, dihydrochloride) Powder neric copy of NADA 141–
Maryland Heights, MO for Injection. 042.
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 signifi-
cant impact (FONSI).
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Following the approval of ANADA II. Changes of Sponsorship it has transferred ownership of, and all
200–609, Anzac Animal Health, LLC rights and interest in, the following
will now be included in the lists of Boehringer Ingelheim Vetmedica, Inc., applications to Bayer HealthCare LLC,
sponsors of approved applications in 2621 North Belt Highway, St. Joseph, Animal Health Division, P.O. Box 390,
§ 510.600(c) (21 CFR 510.600(c)). MO 64506–2002 has informed FDA that Shawnee Mission, KS 66201:
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![Federal Register / Vol. 82, No. 89 / Wednesday, May 10, 2017 / Rules and Regulations 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 Nonlactating Dairy Cattle ..................................... 522.1450
141–247 ............ CYDECTIN (moxidectin) Oral Drench for Sheep ............................................................................................ 520.1454
Ceva Sante Animale, 10 Avenue de la ownership of, and all rights and interest Vetpharm Group Ltd., Broomhill Rd.,
Ballastière, 33500 Libourne, France has in, the following applications to Cross Tallaght, Dublin 24, Ireland:
informed FDA that it has transferred
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., transferred ownership of, and all rights Avenue de la Ballastière, 33500
Broomhill Rd., Tallaght, Dublin 24, and interest in, the following Libourne, France:
Ireland has informed FDA that it has application to Ceva Sante Animale, 10
File No. Product name 21 CFR section
200–587 ............ FERROFORTE (gleptoferron) Solution, 200 mg/mL ....................................................................................... 522.1055
Nexcyon Pharmaceuticals, Inc., P.O. ownership of, and all rights and interest Laboratories, Inc., 8809 Ely Rd.,
Box 259158, Madison, WI 53725 has in, the following applications to Pegasus Pensacola, FL 32514:
informed FDA that it has transferred
File No. Product name 21 CFR section
141–272 ............ RECONCILE (fluoxetine hydrochloride) Chewable Tablets ............................................................................ 520.980
Accordingly, the animal drug Accordingly, it will be removed from requested that FDA withdraw approval
regulations are being amended to reflect the list of sponsors of approved of the NADAs listed in the following
these changes of sponsorship. Following applications in § 510.600(c). table because the products are no longer
this withdrawal of approval, Nexcyon III. Withdrawals of Approval manufactured or marketed:
Pharmaceuticals, Inc. is no longer the
sponsor of an approved application. In addition, during January and
February 2017, the following sponsor
File No. Sponsor Product name 21 CFR section
009–505 ............ Sioux Biochemical, Inc., 204 Third St. NW., Sioux F.S.H.-P (follicle stimulating hormone) Powder for 522.1002
Center, IA 51250. Injection.
Elsewhere in this issue of the Federal Judicious Use Initiative. These actions meet the definition of ‘‘rule’’ in 5 U.S.C.
Register, FDA gave notice that approval are being taken to improve the accuracy 804(3)(A) because it is a ‘‘rule of
of NADA 009–505, and all supplements of the regulations. particular applicability.’’ Therefore, it is
and amendments thereto, is withdrawn, This final rule is issued under Section not subject to the congressional review
effective May 22, 2017. Following this 512(i) of the Federal Food, Drug, and requirements in 5 U.S.C. 801–808.
withdrawal of approval, Sioux Cosmetic Act (21 U.S.C.360b(i)), which Likewise, this is not a rule subject to
Biochemical, Inc., is no longer the requires Federal Register publication of Executive Order 12866 which defines a
sponsor of an approved application. As ‘‘notice[s]. . . effective as a regulation,’’ rule as ‘‘an agency statement of general
provided in the regulatory text of this of the conditions of use of approved applicability and future effect, which
document, the animal drug regulations new animal drugs. This rule sets forth the agency intends to have the force and
are amended to reflect this voluntary technical amendments to the regulations
effect of law, that is designed to
withdrawal of approval. to codify recent actions on approved
implement, interpret, or prescribe law
new animal drug applications and
IV. Technical Amendments or policy or to describe the procedure or
jstallworth on DSK7TPTVN1PROD with RULES
corrections to improve the accuracy of
We are also making several technical the regulations, and as such does not practice requirements of an agency.’’ As
amendments in part 558, which was impose any burden on regulated such, this document is also not subject
amended on December 27, 2016 (81 FR entities. to Executive Order 12866.
94991), and February 24, 2017 (82 FR Although denominated a rule
11510), as part of the FDA Center for pursuant to the Federal Food, Drug, and
Veterinary Medicine’s (CVM’s) Cosmetic Act, this document does not
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List of Subjects authority delegated to the Commissioner (c)(1), alphabetically add an entry for
of Food and Drugs and redelegated to ‘‘Anzac Animal Health, LLC’’, and
21 CFR Part 510
the Center for Veterinary Medicine, 21 remove the entry for ‘‘Nexcyon
Administrative practice and CFR parts 510, 520, 522, 524, and 558 Pharmaceuticals, Inc.’’; and in the table
procedure, Animal drugs, Labeling, are amended as follows: in paragraph (c)(2), remove the entry for
Reporting and recordkeeping ‘‘050929’’, and numerically add an entry
requirements. PART 510—NEW ANIMAL DRUGS for ‘‘086073.’’ The additions read as
21 CFR Parts 520, 522, and 524 follows:
■ 1. The authority citation for part 510
Animal drugs. continues to read as follows: § 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
21 CFR Part 558 Authority: 21 U.S.C. 321, 331, 351, 352, applications.
353, 360b, 371, 379e.
Animal drugs, Animal feeds. * * * * *
Therefore, under the Federal Food, ■ 2. Effective May 10, 2017, in (c) * * *
Drug, and Cosmetic Act and under § 510.600, in the table in paragraph (1) * * *
Drug labeler
Firm name and address code
* * * * * * *
Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043 ........................................................................ 086073
* * * * * * *
(2) * * *
Drug labeler Firm name and address
code
* * * * * * *
086073 ........... Anzac Animal Health, LLC, 218 Millwell Dr., Suite B, Maryland Heights, MO 63043.
* * * * * * *
§ 510.600 [Amended] PART 522—IMPLANTATION OR § 522.1450 [Amended]
INJECTABLE DOSAGE FORM NEW ■ 13. In § 522.1450, in paragraph (b),
■ 3. Effective May 22, 2017, in
ANIMAL DRUGS remove ‘‘000010’’ and in its place add
§ 510.600, in the table in paragraph
(c)(1), remove the entry for ‘‘Sioux ‘‘000859’’.
Biochemical, Inc.’’ .’’; and in the table ■ 8. The authority citation for part 522
■ 14. In § 522.1662a, revise paragraph
in paragraph (c)(2), remove the entry for continues to read as follows:
(e)(1); and in paragraph (e)(3)(i)(c),
‘‘063112’’. Authority: 21 U.S.C. 360b. revise the fifth sentence to read as
follows:
PART 520—ORAL DOSAGE FORM § 522.90b [Amended]
NEW ANIMAL DRUGS § 522.1662a Oxytetracycline hydrochloride
■ 9. In § 522.90b, in paragraph (a), injection.
remove ‘‘50, 100, or 250’’ and in its * * * * *
■ 4. The authority citation for part 520 place add ‘‘200, 250, or 400’’.
continues to read as follows: (e) * * *
Authority: 21 U.S.C. 360b.
§ 522.1002 [Amended] (1) Specifications. Each milliliter of
solution contains 100 milligrams of
§ 520.48 [Amended] ■ 10. Effective May 22, 2017, in oxytetracycline hydrochloride.
§ 522.1002, remove paragraph (b); and
* * * * *
■ 5. In § 520.48, in paragraph (b), redesignate paragraph (c) as paragraph
remove ‘‘013744’’ and in its place add (b). (3) * * *
‘‘061623’’. (i) * * *
§ 522.1055 [Amended] (c) * * * Exceeding the highest
§ 520.980 [Amended] recommended dose of 5 milligrams per
■ 11. In § 522.1055, in paragraph (b),
pound of body weight per day,
■ 6. In § 520.980, in paragraph (b), remove ‘‘Nos. 013744 and 061623’’ and
administering more than the
remove ‘‘050929’’ and in its place add in its place add ‘‘No. 013744’’.
jstallworth on DSK7TPTVN1PROD with RULES
recommended number of treatments,
‘‘055246’’.
§ 522.1362 [Amended] and/or exceeding 10 milliliters
§ 520.1454 [Amended] intramuscularly or subcutaneously per
■ 12. In § 522.1362, in paragraph (b), injection site in adult beef and dairy
■ 7. In § 520.1454, in paragraph (b), remove ‘‘No. 050604’’ and in its place cattle may result in antibiotic residues
remove ‘‘000010’’ and in its place add add ‘‘Nos. 050604 and 086073’’. beyond the withdrawal period. * * *
‘‘000859’’. * * * * *
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![Federal Register / Vol. 82, No. 89 / Wednesday, May 10, 2017 / Rules and Regulations 21691
§ 522.2473 [Amended] in pre-ruminating calves. Effectiveness § 558.76 [Amended]
■ 15. In § 522.2473, in paragraph (b), and animal safety in veal calves have ■ 21. In § 558.76, remove and reserve
remove ‘‘013744’’ and in its place add not been established. Not approved for paragraph (e)(1)(vii).
‘‘061623’’. repeated implantation (reimplantation)
with this or any other cattle ear implant ■ 22. In § 558.115, revise paragraph
■ 16. In § 522.2477, revise paragraph
during the production phase(s) (d)(4) to read as follows:
(b)(2) and add paragraph (d)(4) to read
as follows: identified on labeling (beef steers and § 558.115 Carbadox.
heifers fed in confinement for slaughter)
§ 522.2477 Trenbolone acetate and * * * * *
unless otherwise indicated on labeling
estradiol. because safety and effectiveness have (d) * * *
* * * * * not been evaluated. (4) Carbadox may also be used in
(b) * * * combination with oxytetracycline as in
(2) No. 000061 for use as in PART 524—OPHTHALMIC AND § 558.450.
paragraphs (d)(1)(i)(A), (d)(1)(i)(C), TOPICAL DOSAGE FORM NEW ■ 23. Amend § 558.128 as follows:
(d)(1)(i)(D), (d)(1)(i)(G), (d)(1)(ii), ANIMAL DRUGS ■ a. In paragraph (b)(1), remove ‘‘50, 65,
(d)(1)(iii), (d)(2)(i)(A), (d)(2)(i)(C), or 100’’ and in its place add ‘‘50, 90, or
(d)(2)(i)(D), (d)(2)(ii), (d)(2)(iii), ■ 17. The authority citation for part 524
100’’;
(d)(3)(i)(A), (d)(3)(ii), (d)(3)(iii), and continues to read as follows:
■ b. In paragraphs (e)(1)(i) and (v), in the
(d)(4) of this section. Authority: 21 U.S.C. 360b. ‘‘Limitations’’ column, remove ‘‘Do not
* * * * * feed to chickens producing eggs for
(d) * * * § 524.1450 [Amended]
human consumption.’’ and in its place
(4) Beef steers and heifers fed in ■ 18. In § 524.1450, in paragraph (b)(1), add ‘‘For No. 066104: Do not feed to
confinement for slaughter—(i) Amount. remove ‘‘000010’’ and in its place add chickens producing eggs for human
Each extended- and delayed-release ‘‘000859’’. consumption.’’;
implant contains 200 mg trenbolone
PART 558—NEW ANIMAL DRUGS FOR ■ c. In paragraph (e)(3)(v), in the
acetate and 20 mg estradiol (one implant
consisting of 10 pellets, each pellet USE IN ANIMAL FEEDS ‘‘Sponsor’’ column, add ‘‘054771’’
containing 20 mg trenbolone acetate and before ‘‘069254’’;
2 mg estradiol) per implant dose. ■ 19. The authority citation for part 558 ■ d. In paragraph (e)(4)(iii), in the
(ii) Indications for use. For increased continues to read as follows: ‘‘Indications for use’’ column, remove
rate of weight gain and improved feed Authority: 21 U.S.C. 354, 360b, 360ccc, ‘‘anaplsmosis’’ and in its place add
efficiency during 70 to 200 days after 360ccc–1, 371. ‘‘anaplasmosis’’; and
implantation. ■ e. Redesignate paragraphs (e)(4)(xxiv)
(iii) Limitations. Implant § 558.4 [Amended] and (xxv) as paragraphs (e)(4)(xxv) and
subcutaneously in the ear only. Do not ■ 20. In § 558.4, in paragraph (d), in the (xxvi), respectively, and add new
use in lactating dairy cows or in animals Category I table, remove the row entry paragraph (e)(4)(xxiv).
intended for subsequent breeding. Use for ‘‘Penicillin’’; and in the Category II The addition reads as follows:
in these cattle may cause drug residues table, remove the row entry for
in milk and/or in calves born to these ‘‘Sulfamethazine’’ the first time it § 558.128 Chlortetracycline.
cows. Do not use in calves to be appears only along with the subsequent * * * * *
processed for veal. A withdrawal period entries for ‘‘Chlortetracycline’’ and (e) * * *
has not been established for this product ‘‘Penicillin’’. (4) * * *
Chlortetracycline Combination in Indications for use Limitations Sponsor
amount grams/ton
* * * * * * *
(xxiv) 25 to 2,800 to Lasalocid, 30 to Beef cattle weighing under 700 Hand feed continuously at a rate of 350 054771
provide 350 mg/ 181.8. pounds: For control of active mg chlortetracycline and 1 mg lasalocid
head/day. infection of anaplasmosis per 2.2 lb. body weight daily to cattle
caused by Anaplasma with a maximum of 360 mg of lasalocid
marginale susceptible to per head per day. Do not allow horses or
chlortetracycline; and for the other equines access to feeds containing
control of coccidiosis caused lasalocid. No withdrawal period is re-
by Eimeria bovis and E. quired. A withdrawal period has not been
zuernii. established for this product in pre-rumi-
nating calves. Do not use in calves to be
processed for veal. See § 558.311(d) of
this chapter. Chlortetracycline and
lasalocid as provided by No. 054771 in
§ 510.600(c) of this chapter.
* * * * * * *
jstallworth on DSK7TPTVN1PROD with RULES
* * * * * § 558.140 [Amended] ‘‘(e)(1)’’; and in paragraph (b)(2), remove
‘‘(d)(2)’’ and in its place add ‘‘(e)(2)’’.
■ 24. In § 558.140, in paragraph (b)(1),
remove ‘‘(d)(1)’’ and in its place add ■ 25. In § 558.325, redesignate
paragraphs (e)(2)(vii) to (xvi) as
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![21692 Federal Register / Vol. 82, No. 89 / Wednesday, May 10, 2017 / Rules and Regulations
paragraphs (e)(2)(viii) to (xvii), § 558.325 Lincomycin. (2) * * *
respectively, and add new paragraph * * * * *
(e)(2)(vii) to read as follows: (e) * * *
Combination in
Lincomycin grams/ton Indications for use Limitations Sponsors
grams/ton
* * * * * * *
(vii) 40 ......................... Pyrantel, 800 ............ For the treatment and/or control Feed as a single therapeutic treatment at a 066104
of swine dysentery; for re- rate of 1 lb of feed per 40 lb of body
moval and control of large weight for animals up to 200 lb and 5 lb
roundworm (Ascaris suum) of feed per head for animals over 200 lb.
and nodular worm Not to be fed to swine that weigh more
(Oesophagostomum spp.) in- than 250 pounds. Withdraw 24 hours
fections. prior to slaughter. See paragraph (d) of
this section. Lincomycin as provided by
No. 054771; pyrantel as provided by No.
066104 in § 510.600(c) of this chapter.
* * * * * * *
■ 26. In § 558.366, revise paragraph (e) ■ 29. Amend § 558.625 as follows: (2) The expiration date of VFDs for
to read as follows: ■ a. Revise paragraph (d)(2); tylosin medicated feeds must not exceed
■ b. Add paragraphs (d)(4) and (5); 6 months from the date of issuance.
§ 558.366 Nicarbazin. ■ c. In paragraphs (e)(2)(iv), (v), (viii), VFDs for tylosin shall not be refilled.
* * * * * (x), (xii), and (xiii), in the ‘‘Limitations’’ * * * * *
(e) Nicarbazin may also be used in column, add a new sentence ‘‘See
combination with: § 558.355(d) in this chapter.’’ between (4) Tylosin liquid Type B medicated
(1)–(3) [Reserved] the fourth and fifth sentences; feeds must bear an expiration date of 31
(4) Lincomycin as in § 558.325. ■ d. In paragraph (e)(2)(vi), in the days after the date of manufacture.
‘‘Limitations’’ column, add a new (5) Do not use tylosin liquid Type B
§ 558.485 [Amended]
sentence ‘‘See § 558.355(d) in this medicated feeds in any liquid feed
■ 27. In § 558.485, remove paragraph chapter.’’ between the seventh and containing sodium metabisulfite or in
(e)(1)(iv). eighth sentences; and any finished feed (supplement,
■ 28. In § 558.550, add paragraph (d)(5) ■ e. In paragraphs (e)(2)(vii), (ix), (xi), concentrate, or complete feed)
to read as follows: (xiv), and (xv), in the ‘‘Limitations’’ containing in excess of 2 percent
column, add a new sentence ‘‘See bentonite.
§ 558.550 Salinomycin. § 558.355(d) in this chapter.’’ between * * * * *
* * * * * the fifth and sixth sentences.
(d) * * * The revisions and additions read as ■ 30. In § 558.635, revise paragraph
(5) Salinomycin may also be used in follows: (e)(1) to read as follows:
combination with:
§ 558.625 Tylosin. § 558.635 Virginiamycin.
(i)–(ii) [Reserved]
(iii) Chlortetracycline as in § 558.128. * * * * * * * * * *
(iv) Lincomycin as in § 558.325. (d) * * * (e) Conditions of use—(1) Chickens—
Virginiamycin Combination in Indications for use Limitations Sponsors
grams/ton grams/ton
(i) 20 ........................... ................................... Broiler chickens: For prevention Not for use in layers .................................... 066104
of necrotic enteritis caused by
Clostridium perfringens sus-
ceptible to virginiamycin.
(ii) 20 .......................... Amprolium 72.6 to Broiler chickens: For prevention For field conditions where only E. tenella is 066104
113.5. of necrotic enteritis caused by the major problem, feed continuously as
Clostridium perfringens sus- the sole ration. Use as the sole source of
ceptible to virginiamycin; and amprolium. Do not use in feeds con-
for the prevention of coccidi- taining bentonite. Not for use in laying
osis caused by Eimeria chickens. Amprolium as provided by No.
tenella. 016592 in § 510.600(c) of this chapter.
(iii) 20 ......................... Amprolium 113.5 to Broiler chickens: For prevention For most field conditions as they exist 066104
227. of necrotic enteritis caused by under modern management practices,
Clostridium perfringens sus- feed 113.5 g/ton amprolium continuously.
jstallworth on DSK7TPTVN1PROD with RULES
ceptible to virginiamycin; and Where severe coccidiosis conditions
for the prevention of coccidi- exist, feed 227 g/ton. Use as the sole
osis where immunity to coc- source of amprolium. Do not use in
cidiosis is not desired. feeds containing bentonite. Not for use in
laying chickens. Amprolium as provided
by No. 016592 in § 510.600(c) of this
chapter.
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![Federal Register / Vol. 82, No. 89 / Wednesday, May 10, 2017 / Rules and Regulations 21693
Virginiamycin Combination in Indications for use Limitations Sponsors
grams/ton grams/ton
(iv) 20 ......................... Diclazuril 0.91 ........... Broiler chickens: For prevention Feed continuously as the sole ration. Do 016592
of necrotic enteritis caused by not use in hens producing eggs for
Clostridium perfringens sus- human food. Diclazuril as provided by
ceptible to virginiamycin; and No. 016592 in § 510.600(c) of this chap-
for the prevention of coccidi- ter.
osis 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 stud-
ies to reduce lesions scores
and improve performance and
health of birds challenged with
E. maxima.
(v) 20 .......................... Lasalocid 68 to 113 .. Broiler chickens: For prevention Feed continuously as the sole ration. Do 066104
of necrotic enteritis caused by not feed to laying chickens. For broiler or
Clostridium perfringens sus- fryer chickens only. Lasalocid as pro-
ceptible to virginiamycin; and vided by No. 054771 in § 510.600(c) of
for the prevention of coccidi- this chapter.
osis caused by Eimeria
tenella, E. necatrix, E.
acervulina, E. brunetti, E.
mivati, and E. maxima.
(vi) 20 ......................... Monensin 90 to 110 Broiler chickens: For prevention Feed continuously as the sole ration. Do 066104
of necrotic enteritis caused by not feed to laying chickens. See
Clostridium perfringens sus- § 558.355(d) in this chapter. Monensin as
ceptible to virginiamycin; and provided by No. 058198 in § 510.600(c)
as an aid in the prevention of of this chapter.
coccidiosis caused by Eimeria
necatrix, E. tenella, E.
acervulina, E. brunetti, E.
maxima, and E. mivati.
(vii) 20 ........................ Salinomycin 40 to 60 Broiler chickens: For prevention Feed continuously as the sole ration. Do ........................
of necrotic enteritis caused by not feed to chickens over 16 weeks of
Clostridium perfringens sus- age. Do not feed to laying chickens. Not
ceptible to virginiamycin; and approved for use with pellet binders. May
for the prevention of coccidi- be fatal if accidentally fed to adult tur-
osis caused by Eimeria keys or horses. Salinomycin as provided
tenella, E. necatrix, E. by No. 016592 in § 510.600(c) of this
acervulina, E. maxima, E. chapter.
brunetti, and E. mivati.
(viii) 20 ....................... Semduramicin 22.7 .. Broiler chickens: For prevention Feed continuously as the sole ration. Do 066104
of necrotic enteritis caused by not feed to laying hens. Semduramicin
Clostridium perfringens sus- as provided by No. 066104 in
ceptible to virginiamycin; and § 510.600(c) of this chapter.
for the prevention of coccidi-
osis caused by Eimeria
acervulina, E. brunetti, E.
maxima, E mivati/mitis, E.
necatrix, and E. tenella.
(ix) 20 ......................... Semduramicin (bio- Broiler chickens: For prevention Feed continuously as the sole ration. With- 066104
mass) 22.7. of necrotic enteritis caused by draw 1 day before slaughter. Do not feed
Clostridium perfringens sus- to laying hens. Semduramicin as pro-
ceptible to virginiamycin; and vided by No. 066104 in § 510.600(c) of
for the prevention of coccidi- this chapter.
osis caused by Eimeria
acervulina, E. brunetti, E.
maxima, E mivati/mitis, E.
necatrix, and E. tenella.
jstallworth on DSK7TPTVN1PROD with RULES
* * * * * § 558.680 Zoalene. (i)–(ii) [Reserved]
■ 31. In § 558.680, remove paragraph (e) * * * * * (iii) Lincomycin as in § 558.325.
and add paragraph (d)(3) to read as (d) * * *
follows: (3) Zoalene may also be used in
combination with:
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![21694 Federal Register / Vol. 82, No. 89 / Wednesday, May 10, 2017 / Rules and Regulations
Dated: May 4, 2017. DEPARTMENT OF HOUSING AND withhold information only if it is
Anna K. Abram, URBAN DEVELOPMENT reasonably foreseeable that disclosure
Deputy Commissioner for Policy, Planning, would harm an interest protected by an
Legislation, and Analysis. 24 CFR Part 15 exemption, or if disclosure is prohibited
[FR Doc. 2017–09364 Filed 5–9–17; 8:45 am] [Docket No. FR–5986–C–02] by law. HUD also sought to redesignate
BILLING CODE 4164–01–P the undesignated introductory text as
RIN 2501–AD81 paragraph (b), redesignate paragraphs (a)
through (i) as (b)(1) through (b)(9), and
DEPARTMENT OF HEALTH AND Revision of Freedom of Information amend redesignated paragraph (b)(5),
HUMAN SERVICES Act Regulation; Correction the deliberative process privilege, to add
AGENCY: Office of the Secretary, HUD. a sunset clause after 25 years.
Food and Drug Administration ACTION: Final rule; correction. As discussed above, HUD’s final rule
did not accurately restructure § 15.107
21 CFR Part 522 SUMMARY: On January 12, 2017, HUD as intended. This final rule restates in
[Docket No. FDA–2017–N–0002] issued a final rule amending HUD’s whole § 15.107 to reflect the changes
Freedom of Information Act (FOIA) required by the 2016 Act to the
New Animal Drugs; Withdrawal of regulation to implement the FOIA deliberative process privilege
Approval of a New Animal Drug Improvement Act of 2016, which exemption, and restores all other FOIA
Application enacted a range of procedural changes, disclosure exemptions.
including a change to the procedures for In addition, HUD is fixing an
AGENCY: Food and Drug Administration, withholding information and an incorrect Web site link in § 15.101,
HHS. amendment to one of the nine FOIA removing two misplaced words in
ACTION: Notification of withdrawal. exemptions that authorizes an agency to § 15.105, and correcting the number of
withhold various records from days a FOIA requester has to appeal an
SUMMARY: The Food and Drug
disclosure. After publication, HUD adverse determination in § 15.109(a),
Administration (FDA) is withdrawing
discovered that a portion of the consistent with the change HUD made
approval of a new animal drug
regulation was not published as in § 15.105(d)(2)(iv).
application (NADA). This action is
intended. Specifically, the published
being taken at the sponsors’ request List of Subjects in 24 CFR Part 15
rule deleted several of the nine statutory
because these products are no longer Classified information, Courts,
FOIA disclosure exemptions and
manufactured or marketed. Freedom of information, Government
duplicated another. HUD also noticed
DATES: Withdrawal of approval is employees, Reporting and
minor technical changes required
effective May 22, 2017. elsewhere in its regulations. This recordkeeping requirements.
FOR FURTHER INFORMATION CONTACT: document corrects HUD’s January 12, Accordingly, 24 CFR part 15 is
Sujaya Dessai, Center for Veterinary 2017, final rule and makes the minor corrected by making the following
Medicine (HFV–212), Food and Drug technical changes. correcting amendments:
Administration, 7519 Standish Pl., DATES: Effective: May 10, 2017.
Rockville, MD 20855, 240–402–5761, PART 15—PUBLIC ACCESS TO HUD
FOR FURTHER INFORMATION CONTACT:
sujaya.dessai@fda.hhs.gov. RECORDS UNDER THE FREEDOM OF
Helen Goff Foster, Chief Administrative INFORMATION ACT AND TESTIMONY
SUPPLEMENTARY INFORMATION: Sioux
Officer, Office of Administration, AND PRODUCTION OF INFORMATION
Biochemical, Inc., 204 Third St. NW., Department of Housing and Urban
Sioux Center, IA 51250 has requested BY HUD EMPLOYEES
Development, 451 7th Street SW., Room
that FDA withdraw approval of NADA 6100, Washington, DC 20410–0500,
009–505 for F.S.H.-P (follicle ■ 1. The authority for part 15 continues
telephone number 1–202–402–6838 to read as follows:
stimulating hormone) Powder for (this is not a toll-free number). Hearing-
Injection because the product is no Authority: 42 U.S.C. 3535(d), 5 U.S.C. 552.
or speech-impaired individuals may
longer manufactured or marketed. access this number via TTY by calling § 15.101 [Amended]
Therefore, under authority delegated
the toll-free Federal Relay Service at ■ 2. In § 15.101(b)(2), remove the link
to the Commissioner of Food and Drugs
telephone number 1–800–877–8339 ‘‘http://www/data/gov’’ and add in its
and redelegated to the Center for
(this is a toll-free number). place the link ‘‘http://www.data.gov’’.
Veterinary Medicine, and in accordance
SUPPLEMENTARY INFORMATION: On
with § 514.116 Notice of withdrawal of
January 12, 2017 (82 FR 3623), HUD § 15.105 [Amended]
approval of application (21 CFR
514.116), notice is given that approval issued a final rule amending HUD’s ■ 3. In § 15.105, in paragraph (d)(2)(iv)
of NADA 009–505, and all supplements Freedom of Information Act (FOIA) remove the word ‘‘and’’ and in
and amendments thereto, is hereby regulation at 24 CFR part 15 to paragraph (d)(2)(v) remove the word
withdrawn, effective May 22, 2017. implement the FOIA Improvement Act ‘‘and’’.
Elsewhere in this issue of the Federal of 2016 (Pub. L. 114–185, approved June ■ 4. Revise § 15.107 to read as follows:
Register, FDA is amending the animal 30, 2016) (2016 Act). Upon review of the
published rule, HUD determined that § 15.107 Documents generally protected
drug regulations to reflect the voluntary
§ 15.107 was not published as intended. from disclosure.
withdrawal of approval of this
application. The amendatory instruction excluded (a) HUD shall withhold information
jstallworth on DSK7TPTVN1PROD with RULES
three of the nine statutory FOIA only if HUD reasonably foresees that
Dated: May 4, 2017. exemptions (5 U.S.C. 552(b)) and disclosure would harm an interest
Anna K. Abram, included a duplicate exemption in protected by an exemption as provided
Deputy Commissioner for Policy, Planning, § 15.107(b). in paragraph (b) of this section, or
Legislation, and Analysis. HUD’s January 12, 2017, final rule disclosure is prohibited by law. HUD
[FR Doc. 2017–09365 Filed 5–9–17; 8:45 am] sought to restructure § 15.107 by adding will consider whether partial disclosure
BILLING CODE 4164–01–P paragraph (a) to provide that HUD shall of information is possible whenever
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Document Created: 2017-05-10 00:01:13
Document Modified: 2017-05-10 00:01:13
| 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 |
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