New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor's Name and Address; Change of Sponsor's Address, 59131-59135 [2016-19914]

Download as PDF Federal Register / Vol. 81, No. 167 / Monday, August 29, 2016 / Rules and Regulations § 101.2 [Amended] PART 1—GENERAL ENFORCEMENT REGULATIONS 1. The authority citation for part 1 continues to read as follows: Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342i, 343, 350c, 350d, 350e, 352, 355, 360b, 360ccc, 360ccc–1, 360ccc–2, 362, 371, 373, 374, 381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264. § 1.1 [Amended] [Amended] § 101.7 Declaration of net quantity of contents. * * § 101.13 * * [Amended] 11. Amend paragraphs (d)(2), (h)(4)(i), and (i)(2) by removing ‘‘§ 101.105(i)’’ and adding in its place ‘‘§ 101.7(i)’’. ■ § 101.30 [Amended] 12. Amend § 101.30(g) by removing ‘‘§ 101.105(i)’’ and adding in its place ‘‘§ 101.7(i)’’. ■ PART 104—NUTRITIONAL QUALITY GUIDELINES FOR FOODS 3. In § 1.20, by removing ‘‘§ 101.105(f)’’ and adding in its place ‘‘§ 101.7(f)’’. ■ § 1.24 [Redesignated as § 101.7] 9. Redesignate § 101.105 as § 101.7. 10. Revise newly designated § 101.7 section heading to read as follows: ■ ■ * 2. Amend § 1.1(c) as follows: a. Remove ‘‘101.105(f)’’ and add in its place ‘‘101.7(f)’’. ■ b. Remove ‘‘101.105(i)’’ and add in its place ‘‘101.7(i)’’. ■ c. Remove ‘‘101.105(j)’’ and add in its place ‘‘101.7(j)’’. ■ d. Remove ‘‘101.105(o)’’ and add in its place ‘‘101.7(o)’’. ■ ■ § 1.20 § 101.105 13. The authority citation for part 104 continues to read as follows: ■ [Amended] Authority: 21 U.S.C. 321, 343, 371(a). 4. Amend § 1.24 as follows: a. Remove ‘‘§ 101.105’’ in paragraph (a)(2) and add in its place ‘‘§ 101.7’’. ■ b. Remove ‘‘§ 101.105(b)(2)’’ wherever it appears and add in its place ‘‘§ 101.7(b)(2)’’. ■ c. Remove ‘‘§ 101.105(f)’’ wherever it appears and add in its place ‘‘§ 101.7(f)’’. ■ d. Remove ‘‘§ 101.105(j)’’ wherever it appears and add in its place ‘‘§ 101.7(j)’’. ■ e. Remove ‘‘§ 101.105(j)(1)’’ wherever it appears and add in its place ‘‘§ 101.7(j)(1)’’. § 104.5 PART 100—GENERAL Food and Drug Administration ■ 5. The authority citation for part 100 continues to read as follows: 21 CFR Parts 510, 520, 522, 524, and 558 Authority: 21 U.S.C. 321, 331, 337, 342, 343, 348, 371. [Docket No. FDA–2016–N–0002] ■ ■ § 100.155 [Amended] 6. Amend § 100.155 in paragraphs (a) and (b) by removing ‘‘§ 101.105’’ and adding in its place ‘‘§ 101.7’’. ■ PART 101—FOOD LABELING 7. The authority citation for part 101 continues to read as follows: jstallworth on DSK7TPTVN1PROD with RULES ■ 14:52 Aug 26, 2016 Jkt 238001 14. Amend § 104.5(b) by removing ‘‘§ 101.105’’ and adding in its place ‘‘§ 101.7’’. ■ Dated: August 16, 2016. Jeremy Sharp, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2016–19925 Filed 8–26–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor’s Name and Address; Change of Sponsor’s Address Food and Drug Administration, HHS. Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, 264, 271. VerDate Sep<11>2014 [Amended] AGENCY: Final rule; technical amendment. ACTION: PO 00000 Frm 00003 Fmt 4700 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 May and June 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications, changes of sponsors’ names and addresses, and the voluntary withdrawals of approval of applications. DATES: This rule is effective August 29, 2016, except for the amendments to 21 CFR 558.274, 58.355, 58.363, 58.550, 558.625, and 558.630, which are effective September 8, 2016. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV–6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–5689, george.haibel@fda.hhs.gov. SUMMARY: 8. Amend § 101.2 in paragraph (c) introductory text by removing ‘‘§ 101.105(h)(1)’’ and adding in its place ‘‘§ 101.7(h)(1)’’. ■ ■ 59131 Sfmt 4700 SUPPLEMENTARY INFORMATION: I. Approval Actions FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during May and June 2016, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (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/ApprovedAnimalDrug Products/default.htm. E:\FR\FM\29AUR1.SGM 29AUR1 59132 Federal Register / Vol. 81, No. 167 / Monday, August 29, 2016 / Rules and Regulations TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING MAY AND JUNE 2016 Approval date Sponsor File No. Product name Species Indications for use/effect of the action Public documents Original approval for the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens in broiler chickens. Original approval for appetite stimulation in dogs. FOI Summary, EA/FONSI.1 Original approval for the control of postoperative pain and inflammation associated with soft tissue surgery in dogs. Original approval of a generic copy of NADA 141–177. FOI Summary. Original approval for use in two-way, combination drug Type B and Type C medicated feeds for cattle fed in confinement for slaughter. Original approval as a generic copy of NADA 110–399. FOI Summary. May 2, 2016 .......... 141–439 Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285. INTEPRITY (avilamycin) Type A medicated article. Chickens .... May 16, 2016 ........ 141–457 ENTYCE (capromorelin solution). oral Dogs ........... May 17, 2016 ........ 141–463 Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS 66211. Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140. ONSIOR (robenacoxib) Tablets for Dogs. Dogs ........... May 17, 2016 ........ 200–536 Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767–1861. Dogs ........... May 24, 2016 ........ 200–596 Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria. MOMETAVET (gentamicin sulfate, USP; mometasone furoate anhydrous, USP; and clotrimazole, USP) Otic Suspension. TILMOVET 90 (tilmicosin phosphate) and RUMENSIN 90 (monensin) Type A medicated articles. June 20, 2016 ....... 200–587 Cross Vetpharm Group Ltd. Broomhill Rd., Tallaght, Dublin 24, Ireland. FERROFORTE injection). Piglets ........ (gleptoferron Cattle .......... FOI Summary. FOI Summary. FOI Summary. 1 The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of no significant impact (FONSI). II. Changes of Sponsorship Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee, Mission, KS 66201 has informed FDA that it has transferred ownership of, and all rights and interest in, the following File No. 200–228 200–254 200–256 200–351 200–389 approved applications to Huvepharma EOOD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria: 21 CFR section Product name PHOENECTIN (ivermectin) Injectable Solution .............................................................................................................. Iron Dextran Injection, 100 mg/mL .................................................................................................................................. Iron Dextran Injection, 200 mg/mL .................................................................................................................................. Lincomycin Injectable, USP ............................................................................................................................................ Amprolium 9.6% Oral Solution ........................................................................................................................................ As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these changes of sponsorship. III. Withdrawals of Approval In addition, during May and June 2016, Elanco US, Inc., 2500 Innovation Way, Greenfield, IN 46140 requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed: 21 CFR section File No. Product name 012–548 1 013–162 1 013–388 1 015–166 1 127–507 1 141–164 1 141–170 1 141–198 1 jstallworth on DSK7TPTVN1PROD with RULES 522.1192 522.1182 522.1182 522.1260 520.100 TYLOSIN (tylosin phosphate)/HYGROMIX (hygromycin B) ........................................................................................... TYLAN TM (tylosin phosphate) Type A medicated article .............................................................................................. TYLAN (tylosin phosphate)/HYGROMIX (hygromycin B) Premix ................................................................................... TYLAN TM (tylosin phosphate) Type A medicated article .............................................................................................. TYLAN 5, 10, 20, or 40 SULFA-G (tylosin phosphate and sulfamethazine) .................................................................. TYLAN (tylosin phosphate)/COBAN (monensin) ............................................................................................................ TYLAN (tylosin phosphate)/MONTEBAN (narasin) ......................................................................................................... TYLAN TM (tylosin phosphate)/BIO-COX (salinomycin) ................................................................................................ 558.274 558.625 558.274 558.625 558.630 558.355 558.363 558.550 1 These NADAs were identified as being affected by guidance for industry #213, ‘‘New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,’’ December 2013. Elsewhere in this issue of the Federal Register, FDA gave notice that approval of NADAs 012–548, 013–162, 013–388, 015–166, 127–507, 141–640, 141–170, and 141–198, and all supplements and VerDate Sep<11>2014 14:52 Aug 26, 2016 Jkt 238001 amendments thereto, is withdrawn, effective September 8, 2016. As provided in the regulatory text of this document, the animal drug regulations PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 are amended to reflect these voluntary withdrawals of approval. E:\FR\FM\29AUR1.SGM 29AUR1 59133 Federal Register / Vol. 81, No. 167 / Monday, August 29, 2016 / Rules and Regulations IV. Technical Amendments FDA has noticed that a drug labeler code in 21 CFR 520.2325a does not accurately reflect the sponsorship of a new animal drug application. At this time, we are amending this section. This action is being taken to improve the accuracy of the regulations. Also, ConAgra Pet Products Co., 3902 Leavenworth St., Omaha, NE 68105 has informed FDA that it is changing its name and address to Sergeant’s Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138. Alexion Pharmaceuticals, Inc., 33 Hayden Ave., Lexington, MA 02421 has informed FDA that it has changed its address to 100 College St., New Haven, CT 06510. At this time, this firm is being added to the list of sponsors of approved application in 21 CFR 510.600(c) which we had not done previously. FDA has noticed that the maximum concentration of sulfadimethoxine with ormetoprim in 2-way, fixed-ratio combination drug Type B medicated feeds in 21 CFR 558.4 was amended in error. At this time, we are revising this section to provide for appropriate concentrations in Type B medicated feeds for salmonids and catfish. This action is being taken to improve the accuracy of the regulations. This rule does not meet the definition of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because it is a rule of ‘‘particular applicability.’’ Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801–808. List of Subjects 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR 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 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. 2. In § 510.600, in the table in paragraph (c)(1), alphabetically add an entry for ‘‘Alexion Pharmaceuticals, Inc.’’, remove the entry for ‘‘ConAgra Pet Products Co.’’, and alphabetically add an entry for ‘‘Sergeant’s Pet Care Products, Inc.’’; and in the table in paragraph (c)(2), revise the entry for ‘‘021091’’ and numerically add an entry for ‘‘069334’’. The additions and revisions read as follows: ■ § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications. * * * (c) * * * (1) * * * * * Drug labeler code Firm name and address * * * * * * Alexion Pharmaceuticals, Inc., 100 College St., New Haven, CT 06510 ........................................................................................... * * * * * * * Sergeant’s Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138 .................................................................................... * * * * * * 069334 021091 * * (2) * * * Drug labeler code Firm name and address * 021091 ........... * * * * Sergeant’s Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 68138. * * * 069334 ........... * * * Alexion Pharmaceuticals, Inc., 100 College St., New Haven, CT 06510. * * * * * * * * * * PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS §§ 520.300, 520.300a, 520.300b, and 520.300c [Redesignated as §§ 520.284, 520.284a, 520.284b, and 520.284c.] 3. The authority citation for part 520 continues to read as follows: ■ jstallworth on DSK7TPTVN1PROD with RULES ■ Authority: 21 U.S.C. 360b. § 520.100 [Amended] § 520.292 4. In § 520.100, remove paragraphs (b)(3) and (4). ■ VerDate Sep<11>2014 14:52 Aug 26, 2016 5. Redesignate §§ 520.300, 520.300a, 520.300b, and 520.300c as §§ 520.284, 520.284a, 520.284b, and 520.284c. ■ 6. Add § 520.292 to read as follows: Jkt 238001 Capromorelin. (a) Specifications. Each milliliter of solution contains 30 milligrams (mg) capromorelin. PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 (b) Sponsor. See No. 086026 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer 3 mg/kg once daily by mouth. (2) Indications for use. For appetite stimulation in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. ■ 7. In § 520.2075, revise paragraphs (a) and (c) to read as follows: E:\FR\FM\29AUR1.SGM 29AUR1 59134 Federal Register / Vol. 81, No. 167 / Monday, August 29, 2016 / Rules and Regulations § 520.2075 Robenacoxib. § 522.1055 (a) Specifications. Each tablet contains 10, 20, or 40 milligrams (mg) robenacoxib for use in dogs, or 6 mg robenacoxib for use in cats. * * * * * (c) Conditions of use—(1) Dogs—(i) Amount. Administer 0.91 mg/lb (2 mg/ kg) orally, once daily, for a maximum of 3 days. (ii) Indications for use. For the control of postoperative pain and inflammation associated with soft tissue surgery in dogs weighing at least 5.5 lb (2.5 kg) and at least 4 months of age for a maximum of 3 days. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats—(i) Amount. Administer 0.45 mg/lb (1 mg/kg) orally, once daily, for a maximum of 3 days. (ii) Indications for use. For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy, and castration in cats weighing at least 5.5 lb (2.5 kg) and at least 4 months of age for a maximum of 3 days. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. § 520.2325a [Amended] 8. In § 520.2325a, in paragraph (a)(3), remove ‘‘053501’’ and in its place add ‘‘054771’’. ■ PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 9. The authority citation for part 522 continues to read as follows: ■ Authority: 21 U.S.C. 360b. Gleptoferron. § 522.1182 [Amended] 11. In § 522.1182, in paragraph (b) introductory text, remove ‘‘baby pigs’’ and in its place add ‘‘young piglets’’; in paragraph (b)(7) introductory text, remove ‘‘000859’’ and in its place add ‘‘016592’’; and in paragraphs (b)(7)(i) and (ii), remove ‘‘baby pig’’. ■ § 522.1192 [Amended] 12. In § 522.1192, in paragraph (b)(2), remove ‘‘000859’’ and in its place add ‘‘016592,’’. ■ § 522.1260 [Amended] 13. In § 522.1260, in paragraph (b)(2), remove ‘‘000859’’ and in its place add ‘‘016592’’. ■ PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 14. The authority citation for part 524 continues to read as follows: ■ 10. Revise § 522.1055 to read as follows: ■ 15. In § 524.1044h, revise paragraphs (a) and (b) to read as follows: ■ (a) Specifications. Each milliliter (mL) contains the equivalent of 200 milligrams of elemental iron as gleptoferron, a complex of ferric hydroxide and dextran glucoheptonic acid. (b) Sponsors. See Nos. 059120 and 061623 in § 510.600(c) of this chapter. (c) Conditions of use in swine—(1) Indications for use and amounts—(i) Prevention of anemia due to iron deficiency: Administer 1 mL (200 mg iron) per pig by intramuscular injection on or before 3 days of age. (ii) Treatment of anemia due to iron deficiency: Administer 1 mL (200 mg iron) per pig by intramuscular injection as soon as signs of deficiency appear. (2) [Reserved] Authority: 21 U.S.C. 360b. § 524.1044h Gentamicin, mometasone, and clotrimazole otic suspension. (a) Specifications. Each gram of suspension contains gentamicin sulfate, United States Pharmacopeia (USP) equivalent to 3 milligram (mg) gentamicin base, mometasone furoate monohydrate or mometasone furoate anhydrous, USP, equivalent to 1 mg mometasone, and 10 mg clotrimazole, USP. (b) Sponsors. See Nos. 000061 and 054925 in § 510.600(c) of this chapter. * * * * * PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 16. The authority citation for part 558 continues to read as follows: ■ Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc–1, 371. § 558.4 [Amended] 17. In § 558.4, in paragraph (d), in the ‘‘Category I’’ table, in the ‘‘Type B maximum (200 ×)’’ column, in the row entry for ‘‘Avilamycin’’, remove ‘‘3.65 g/ lb (0.8%)’’ and in its place add ‘‘7.3 g/ lb (1.6%)’’; and in the ‘‘Category II’’ table, remove the row entry for ‘‘Sulfadimethoxine’’ and two following row entries for ‘‘Ormetoprim’’, and in their place add row entries for ‘‘Sulfadimethoxine’’ and ‘‘Ormetoprim’’. The additions read as follows: ■ § 558.4 Requirement of a medicated feed mill license. * * * (d) * * * * * CATEGORY II Assay limits percent 1 Type A Drug * * * Sulfadimethoxine .................................................... 90–110 Ormetoprim ............................................................. 90–110 jstallworth on DSK7TPTVN1PROD with RULES * * * * * * * ■ 18. In § 558.68, revise paragraphs (a) and (e) to read as follows: VerDate Sep<11>2014 14:52 Aug 26, 2016 * * Jkt 238001 * * Poultry: 5.675 g/lb .................................................. Fish: 85.1 g/lb ......................................................... Poultry: 3.405 g/lb .................................................. Fish: 17.0 g/lb ......................................................... * § 558.68 * Avilamycin. (a) Each pound of Type A medicated article contains 45.4 or 90.7 grams of avilamycin. * * * * * PO 00000 Frm 00006 Assay limits percent Type B/C Type B maximum (100 ×) Fmt 4700 Sfmt 4700 * * 80–115/75–125 80–115 * (e) Conditions of use. Administer in feed as follows: (1) Chickens— E:\FR\FM\29AUR1.SGM 29AUR1 59135 Federal Register / Vol. 81, No. 167 / Monday, August 29, 2016 / Rules and Regulations Avilamycin in grams/ton Combination in grams/ton Indications for use Limitations (i) 13.6 to 40.9 .............. ........................ Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens in broiler chickens. Feed as the sole ration for 21 consecutive days. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 10 days of age. Avilamycin in grams/ton Combinationin grams/ton Indications for use Limitations (i) 73 ............................. ........................ Weaned pigs less than 14 weeks of age: For the reduction in incidence and overall severity of diarrhea in the presence of pathogenic Escherichia coli in groups of weaned pigs. Feed as the sole ration for 21 consecutive days. To assure responsible antimicrobial drug use in pigs, do not administer to pigs 14 weeks of age or older. Sponsor 000986 (ii) [Reserved]. (2) Swine— Sponsor 000986 (ii) [Reserved]. § 558.274 [Amended] 24. Effective September 8, 2016, in § 558.625, revise paragraphs (b)(1), (f)(2)(i), (f)(2)(iii), and (f)(2)(vii) and remove paragraphs (f)(2)(viii) and (ix). The revisions read as follows: ■ 19. Effective September 8, 2016, in § 558.274, remove and reserve paragraphs (c)(1)(ii) and (c)(2)(ii). ■ 20. Effective September 8, 2016, in § 558.355, remove and reserve paragraph (f)(1)(xxviii) and revise paragraphs (f)(8)(i) and (ii). The revisions read as follows: ■ § 558.355 § 558.625 * * * * * (f) * * * (8) * * * (i) Decoquinate alone and in combination as in § 558.195. (ii) Melengestrol acetate alone and in combination as in § 558.342. * * * * * § 558.363 [Amended] 21. Effective September 8, 2016, in § 558.363, remove and reserve paragraph (d)(1)(vi). ■ § 558.550 [Amended] 22. Effective September 8, 2016, in § 558.550, remove and reserve paragraph (d)(1)(xxii). ■ § 558.618 jstallworth on DSK7TPTVN1PROD with RULES Tylosin and sulfamethazine. * [Amended] 23. In § 558.618, in paragraphs (e)(2)(ii) and (iii): ■ a. In the ‘‘Limitations’’ column, add ‘‘Tilmicosin as provided by Nos. 000986 or 016952; monensin as provided by No. 000986 in § 510.600(c) of this chapter.’’ to the end of the existing entries; and ■ b. In the ‘‘Sponsor’’ column, numerically add ‘‘016952’’. ■ * * * * (b) * * * (1) No. 000986: 40 and 100 grams per pound for use as in paragraph (f) of this section. * * * * * (f) * * * (2) * * * (i) Decoquinate alone and in combination as in § 558.195. * * * * * (iii) Melengestrol acetate alone and in combination as in § 558.342. * * * * * (vii) Zilpaterol alone and in combination as in § 558.665. ■ 25. Effective September 8, 2016, in § 558.630, revise paragraph (b)(1) to read as follows: § 558.630 Food and Drug Administration 21 CFR Part 558 Tylosin. * Monensin. DEPARTMENT OF HEALTH AND HUMAN SERVICES * * * * (b) * * * (1) No. 000986: 40 and 100 grams per pound for use as in paragraph (e) of this section. * * * * * Dated: August 8, 2016. Tracey H. Forfa, Deputy Director, Center for Veterinary Medicine. [FR Doc. 2016–19914 Filed 8–26–16; 8:45 am] BILLING CODE 4164–01–P [Docket No. FDA–2016–N–0002] New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of a New Animal Drug Application AGENCY: Food and Drug Administration, HHS. ACTION: Notification of withdrawal. The Food and Drug Administration (FDA) is withdrawing approval of eight new animal drug applications (NADAs) at the sponsor’s request because these products are no longer manufactured or marketed. DATES: Withdrawal of approval is effective September 8, 2016. FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–5761, sujaya.dessai@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285 has requested that FDA withdraw approval of the NADAs listed in the following table because the products are no longer manufactured or marketed: SUMMARY: 21 CFR section File No. Product name 012–548 1 013–162 1 TYLOSIN (tylosin phosphate)/HYGROMIX (hygromycin B) ........................................................................................... TYLAN TM (tylosin phosphate) Type A medicated article .............................................................................................. VerDate Sep<11>2014 14:52 Aug 26, 2016 Jkt 238001 PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 E:\FR\FM\29AUR1.SGM 29AUR1 558.274 558.625

Agencies

[Federal Register Volume 81, Number 167 (Monday, August 29, 2016)]
[Rules and Regulations]
[Pages 59131-59135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19914]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, and 558

[Docket No. FDA-2016-N-0002]


New Animal Drugs; Approval of New Animal Drug Applications; 
Withdrawal of Approval of New Animal Drug Applications; Changes of 
Sponsorship; Change of Sponsor's Name and Address; Change of Sponsor's 
Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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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 May and June 2016. FDA is also informing 
the public of the availability of summaries of the basis of approval 
and of environmental review documents, where applicable. The animal 
drug regulations are also being amended to reflect changes of 
sponsorship of applications, changes of sponsors' names and addresses, 
and the voluntary withdrawals of approval of applications.

DATES: This rule is effective August 29, 2016, except for the 
amendments to 21 CFR 558.274, 58.355, 58.363, 58.550, 558.625, and 
558.630, which are effective September 8, 2016.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-402-5689, 
george.haibel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval 
actions for NADAs and ANADAs during May and June 2016, as listed in 
table 1. In addition, FDA is informing the public of the availability, 
where applicable, of documentation of environmental review required 
under the National Environmental Policy Act (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.

[[Page 59132]]



                                  Table 1--Original and Supplemental NADAs and ANADAs Approved During May and June 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                            Indications for use/
       Approval date          File No.         Sponsor              Product name            Species         effect of the action     Public documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
May 2, 2016................    141-439  Elanco Animal Health,  INTEPRITY              Chickens...........  Original approval for  FOI Summary, EA/
                                         A Division of Eli      (avilamycin) Type A                         the prevention of      FONSI.\1\
                                         Lilly & Co., Lilly     medicated article.                          mortality caused by
                                         Corporate Center,                                                  necrotic enteritis
                                         Indianapolis, IN                                                   associated with
                                         46285.                                                             Clostridium
                                                                                                            perfringens in
                                                                                                            broiler chickens.
May 16, 2016...............    141-457  Aratana Therapeutics,  ENTYCE (capromorelin   Dogs...............  Original approval for  FOI Summary.
                                         Inc., 11400 Tomahawk   oral solution).                             appetite stimulation
                                         Creek Pkwy.,                                                       in dogs.
                                         Leawood, KS 66211.
May 17, 2016...............    141-463  Elanco US, Inc., 2500  ONSIOR (robenacoxib)   Dogs...............  Original approval for  FOI Summary.
                                         Innovation Way,        Tablets for Dogs.                           the control of
                                         Greenfield, IN 46140.                                              postoperative pain
                                                                                                            and inflammation
                                                                                                            associated with soft
                                                                                                            tissue surgery in
                                                                                                            dogs.
May 17, 2016...............    200-536  Med-Pharmex, Inc.,     MOMETAVET (gentamicin  Dogs...............  Original approval of   FOI Summary.
                                         2727 Thompson Creek    sulfate, USP;                               a generic copy of
                                         Rd., Pomona, CA        mometasone furoate                          NADA 141-177.
                                         91767-1861.            anhydrous, USP; and
                                                                clotrimazole, USP)
                                                                Otic Suspension.
May 24, 2016...............    200-596  Huvepharma EOOD, 5th   TILMOVET 90            Cattle.............  Original approval for  FOI Summary.
                                         Floor, 3A Nikolay      (tilmicosin                                 use in two-way,
                                         Haytov Str., 1113      phosphate) and                              combination drug
                                         Sophia, Bulgaria.      RUMENSIN 90                                 Type B and Type C
                                                                (monensin) Type A                           medicated feeds for
                                                                medicated articles.                         cattle fed in
                                                                                                            confinement for
                                                                                                            slaughter.
June 20, 2016..............    200-587  Cross Vetpharm Group   FERROFORTE             Piglets............  Original approval as   FOI Summary.
                                         Ltd. Broomhill Rd.,    (gleptoferron                               a generic copy of
                                         Tallaght, Dublin 24,   injection).                                 NADA 110-399.
                                         Ireland.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
  no significant impact (FONSI).

II. Changes of Sponsorship

    Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, 
Shawnee, Mission, KS 66201 has informed FDA that it has transferred 
ownership of, and all rights and interest in, the following approved 
applications to Huvepharma EOOD, 5th Floor, 3A Nikolay Haitov Str., 
1113 Sofia, Bulgaria:

------------------------------------------------------------------------
        File No.                   Product name           21 CFR section
------------------------------------------------------------------------
200-228................  PHOENECTIN (ivermectin)                522.1192
                          Injectable Solution.
200-254................  Iron Dextran Injection, 100 mg/        522.1182
                          mL.
200-256................  Iron Dextran Injection, 200 mg/        522.1182
                          mL.
200-351................  Lincomycin Injectable, USP.....        522.1260
200-389................  Amprolium 9.6% Oral Solution...         520.100
------------------------------------------------------------------------

    As provided in the regulatory text of this document, the animal 
drug regulations are amended to reflect these changes of sponsorship.

III. Withdrawals of Approval

    In addition, during May and June 2016, Elanco US, Inc., 2500 
Innovation Way, Greenfield, IN 46140 requested that FDA withdraw 
approval of the NADAs listed in the following table because the 
products are no longer manufactured or marketed:

------------------------------------------------------------------------
        File No.                   Product name           21 CFR section
------------------------------------------------------------------------
012-548 \1\............  TYLOSIN (tylosin phosphate)/            558.274
                          HYGROMIX (hygromycin B).
013-162 \1\............  TYLAN TM (tylosin phosphate)            558.625
                          Type A medicated article.
013-388 \1\............  TYLAN (tylosin phosphate)/              558.274
                          HYGROMIX (hygromycin B) Premix.
015-166 \1\............  TYLAN TM (tylosin phosphate)            558.625
                          Type A medicated article.
127-507 \1\............  TYLAN 5, 10, 20, or 40 SULFA-G          558.630
                          (tylosin phosphate and
                          sulfamethazine).
141-164 \1\............  TYLAN (tylosin phosphate)/COBAN         558.355
                          (monensin).
141-170 \1\............  TYLAN (tylosin phosphate)/              558.363
                          MONTEBAN (narasin).
141-198 \1\............  TYLAN TM (tylosin phosphate)/           558.550
                          BIO-COX (salinomycin).
------------------------------------------------------------------------
\1\ These NADAs were identified as being affected by guidance for
  industry #213, ``New Animal Drugs and New Animal Drug Combination
  Products Administered in or on Medicated Feed or Drinking Water of
  Food-Producing Animals: Recommendations for Drug Sponsors for
  Voluntarily Aligning Product Use Conditions with GFI #209,'' December
  2013.

    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of NADAs 012-548, 013-162, 013-388, 015-166, 127-507, 
141-640, 141-170, and 141-198, and all supplements and amendments 
thereto, is withdrawn, effective September 8, 2016. As provided in the 
regulatory text of this document, the animal drug regulations are 
amended to reflect these voluntary withdrawals of approval.

[[Page 59133]]

IV. Technical Amendments

    FDA has noticed that a drug labeler code in 21 CFR 520.2325a does 
not accurately reflect the sponsorship of a new animal drug 
application. At this time, we are amending this section. This action is 
being taken to improve the accuracy of the regulations.
    Also, ConAgra Pet Products Co., 3902 Leavenworth St., Omaha, NE 
68105 has informed FDA that it is changing its name and address to 
Sergeant's Pet Care Products, Inc., 10077 S. 134th St., Omaha, NE 
68138.
    Alexion Pharmaceuticals, Inc., 33 Hayden Ave., Lexington, MA 02421 
has informed FDA that it has changed its address to 100 College St., 
New Haven, CT 06510. At this time, this firm is being added to the list 
of sponsors of approved application in 21 CFR 510.600(c) which we had 
not done previously.
    FDA has noticed that the maximum concentration of sulfadimethoxine 
with ormetoprim in 2-way, fixed-ratio combination drug Type B medicated 
feeds in 21 CFR 558.4 was amended in error. At this time, we are 
revising this section to provide for appropriate concentrations in Type 
B medicated feeds for salmonids and catfish. This action is being taken 
to improve the accuracy of the regulations.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR 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. In Sec.  510.600, in the table in paragraph (c)(1), alphabetically 
add an entry for ``Alexion Pharmaceuticals, Inc.'', remove the entry 
for ``ConAgra Pet Products Co.'', and alphabetically add an entry for 
``Sergeant's Pet Care Products, Inc.''; and in the table in paragraph 
(c)(2), revise the entry for ``021091'' and numerically add an entry 
for ``069334''.
    The additions and revisions read as follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------
 
                              * * * * * * *
Alexion Pharmaceuticals, Inc., 100 College St., New               069334
 Haven, CT 06510........................................
 
                              * * * * * * *
Sergeant's Pet Care Products, Inc., 10077 S. 134th St.,           021091
 Omaha, NE 68138........................................
 
                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
        Drug labeler code                  Firm name and address
------------------------------------------------------------------------
 
                              * * * * * * *
021091..........................  Sergeant's Pet Care Products, Inc.,
                                   10077 S. 134th St., Omaha, NE 68138.
 
                              * * * * * * *
069334..........................  Alexion Pharmaceuticals, Inc., 100
                                   College St., New Haven, CT 06510.
 
                              * * * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for part 520 continues to read as follows:

    Authority:  21 U.S.C. 360b.


Sec.  520.100   [Amended]

0
4. In Sec.  520.100, remove paragraphs (b)(3) and (4).


Sec. Sec.  520.300, 520.300a, 520.300b, and 520.300c  [Redesignated as 
Sec. Sec.  520.284, 520.284a, 520.284b, and 520.284c.]

0
5. Redesignate Sec. Sec.  520.300, 520.300a, 520.300b, and 520.300c as 
Sec. Sec.  520.284, 520.284a, 520.284b, and 520.284c.

0
6. Add Sec.  520.292 to read as follows:


Sec.  520.292  Capromorelin.

    (a) Specifications. Each milliliter of solution contains 30 
milligrams (mg) capromorelin.
    (b) Sponsor. See No. 086026 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 3 mg/kg once 
daily by mouth.
    (2) Indications for use. For appetite stimulation in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
7. In Sec.  520.2075, revise paragraphs (a) and (c) to read as follows:

[[Page 59134]]

Sec.  520.2075  Robenacoxib.

    (a) Specifications. Each tablet contains 10, 20, or 40 milligrams 
(mg) robenacoxib for use in dogs, or 6 mg robenacoxib for use in cats.
* * * * *
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 0.91 mg/lb 
(2 mg/kg) orally, once daily, for a maximum of 3 days.
    (ii) Indications for use. For the control of postoperative pain and 
inflammation associated with soft tissue surgery in dogs weighing at 
least 5.5 lb (2.5 kg) and at least 4 months of age for a maximum of 3 
days.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer 0.45 mg/lb (1 mg/kg) orally, once 
daily, for a maximum of 3 days.
    (ii) Indications for use. For the control of postoperative pain and 
inflammation associated with orthopedic surgery, ovariohysterectomy, 
and castration in cats weighing at least 5.5 lb (2.5 kg) and at least 4 
months of age for a maximum of 3 days.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.


Sec.  520.2325a  [Amended]

0
8. In Sec.  520.2325a, in paragraph (a)(3), remove ``053501'' and in 
its place add ``054771''.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
9. The authority citation for part 522 continues to read as follows:

    Authority: 21 U.S.C. 360b.


0
10. Revise Sec.  522.1055 to read as follows:


Sec.  522.1055  Gleptoferron.

    (a) Specifications. Each milliliter (mL) contains the equivalent of 
200 milligrams of elemental iron as gleptoferron, a complex of ferric 
hydroxide and dextran glucoheptonic acid.
    (b) Sponsors. See Nos. 059120 and 061623 in Sec.  510.600(c) of 
this chapter.
    (c) Conditions of use in swine--(1) Indications for use and 
amounts--(i) Prevention of anemia due to iron deficiency: Administer 1 
mL (200 mg iron) per pig by intramuscular injection on or before 3 days 
of age.
    (ii) Treatment of anemia due to iron deficiency: Administer 1 mL 
(200 mg iron) per pig by intramuscular injection as soon as signs of 
deficiency appear.
    (2) [Reserved]


Sec.  522.1182  [Amended]

0
11. In Sec.  522.1182, in paragraph (b) introductory text, remove 
``baby pigs'' and in its place add ``young piglets''; in paragraph 
(b)(7) introductory text, remove ``000859'' and in its place add 
``016592''; and in paragraphs (b)(7)(i) and (ii), remove ``baby pig''.


Sec.  522.1192  [Amended]

0
12. In Sec.  522.1192, in paragraph (b)(2), remove ``000859'' and in 
its place add ``016592,''.


Sec.  522.1260  [Amended]

0
13. In Sec.  522.1260, in paragraph (b)(2), remove ``000859'' and in 
its place add ``016592''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
14. The authority citation for part 524 continues to read as follows:

    Authority: 21 U.S.C. 360b.

0
15. In Sec.  524.1044h, revise paragraphs (a) and (b) to read as 
follows:


Sec.  524.1044h  Gentamicin, mometasone, and clotrimazole otic 
suspension.

    (a) Specifications. Each gram of suspension contains gentamicin 
sulfate, United States Pharmacopeia (USP) equivalent to 3 milligram 
(mg) gentamicin base, mometasone furoate monohydrate or mometasone 
furoate anhydrous, USP, equivalent to 1 mg mometasone, and 10 mg 
clotrimazole, USP.
    (b) Sponsors. See Nos. 000061 and 054925 in Sec.  510.600(c) of 
this chapter.
* * * * *

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
16. 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
17. In Sec.  558.4, in paragraph (d), in the ``Category I'' table, in 
the ``Type B maximum (200 x)'' column, in the row entry for 
``Avilamycin'', remove ``3.65 g/lb (0.8%)'' and in its place add ``7.3 
g/lb (1.6%)''; and in the ``Category II'' table, remove the row entry 
for ``Sulfadimethoxine'' and two following row entries for 
``Ormetoprim'', and in their place add row entries for 
``Sulfadimethoxine'' and ``Ormetoprim''.
    The additions read as follows:


Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   Category II
----------------------------------------------------------------------------------------------------------------
                                                Assay limits
                    Drug                      percent \1\ Type      Type B maximum (100 x)        Assay limits
                                                     A                                          percent Type B/C
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Sulfadimethoxine...........................             90-110  Poultry: 5.675 g/lb..........      80-115/75-125
                                                                Fish: 85.1 g/lb..............
Ormetoprim.................................             90-110  Poultry: 3.405 g/lb..........             80-115
                                                                Fish: 17.0 g/lb..............
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
18. In Sec.  558.68, revise paragraphs (a) and (e) to read as follows:


Sec.  558.68  Avilamycin.

    (a) Each pound of Type A medicated article contains 45.4 or 90.7 
grams of avilamycin.
* * * * *
    (e) Conditions of use. Administer in feed as follows:
    (1) Chickens--

[[Page 59135]]



----------------------------------------------------------------------------------------------------------------
                                    Combination in
      Avilamycin in grams/ton          grams/ton     Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 13.6 to 40.9..................  ..............  Broiler chickens: For  Feed as the sole               000986
                                                     the prevention of      ration for 21
                                                     mortality caused by    consecutive days. To
                                                     necrotic enteritis     assure responsible
                                                     associated with        antimicrobial drug
                                                     Clostridium            use in broiler
                                                     perfringens in         chickens, treatment
                                                     broiler chickens.      administration must
                                                                            begin on or before
                                                                            10 days of age.
(ii) [Reserved]...................
----------------------------------------------------------------------------------------------------------------

    (2) Swine--

----------------------------------------------------------------------------------------------------------------
                                     Combinationin
      Avilamycin in grams/ton          grams/ton     Indications for use        Limitations           Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 73............................  ..............  Weaned pigs less than  Feed as the sole               000986
                                                     14 weeks of age: For   ration for 21
                                                     the reduction in       consecutive days. To
                                                     incidence and          assure responsible
                                                     overall severity of    antimicrobial drug
                                                     diarrhea in the        use in pigs, do not
                                                     presence of            administer to pigs
                                                     pathogenic             14 weeks of age or
                                                     Escherichia coli in    older.
                                                     groups of weaned
                                                     pigs.
(ii) [Reserved]...................
----------------------------------------------------------------------------------------------------------------

Sec.  558.274  [Amended]

0
19. Effective September 8, 2016, in Sec.  558.274, remove and reserve 
paragraphs (c)(1)(ii) and (c)(2)(ii).

0
20. Effective September 8, 2016, in Sec.  558.355, remove and reserve 
paragraph (f)(1)(xxviii) and revise paragraphs (f)(8)(i) and (ii).
    The revisions read as follows:


Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (8) * * *
    (i) Decoquinate alone and in combination as in Sec.  558.195.
    (ii) Melengestrol acetate alone and in combination as in Sec.  
558.342.
* * * * *


Sec.  558.363  [Amended]

0
21. Effective September 8, 2016, in Sec.  558.363, remove and reserve 
paragraph (d)(1)(vi).


Sec.  558.550  [Amended]

0
22. Effective September 8, 2016, in Sec.  558.550, remove and reserve 
paragraph (d)(1)(xxii).


Sec.  558.618  [Amended]

0
23. In Sec.  558.618, in paragraphs (e)(2)(ii) and (iii):
0
a. In the ``Limitations'' column, add ``Tilmicosin as provided by Nos. 
000986 or 016952; monensin as provided by No. 000986 in Sec.  
510.600(c) of this chapter.'' to the end of the existing entries; and
0
b. In the ``Sponsor'' column, numerically add ``016952''.

0
24. Effective September 8, 2016, in Sec.  558.625, revise paragraphs 
(b)(1), (f)(2)(i), (f)(2)(iii), and (f)(2)(vii) and remove paragraphs 
(f)(2)(viii) and (ix).
    The revisions read as follows:


Sec.  558.625  Tylosin.

* * * * *
    (b) * * *
    (1) No. 000986: 40 and 100 grams per pound for use as in paragraph 
(f) of this section.
* * * * *
    (f) * * *
    (2) * * *
    (i) Decoquinate alone and in combination as in Sec.  558.195.
* * * * *
    (iii) Melengestrol acetate alone and in combination as in Sec.  
558.342.
* * * * *
    (vii) Zilpaterol alone and in combination as in Sec.  558.665.

0
25. Effective September 8, 2016, in Sec.  558.630, revise paragraph 
(b)(1) to read as follows:


Sec.  558.630  Tylosin and sulfamethazine.

* * * * *
    (b) * * *
    (1) No. 000986: 40 and 100 grams per pound for use as in paragraph 
(e) of this section.
* * * * *

    Dated: August 8, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-19914 Filed 8-26-16; 8:45 am]
 BILLING CODE 4164-01-P