New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address, 67149-67153 [2016-23230]

Download as PDF asabaliauskas on DSK3SPTVN1PROD with RULES Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations a petition is classified, as identified by documentation supplied to the Commission and any supporting information obtained by the Commission. (2) A determination of whether or not domestic production of the article that is the subject of the petition exists, taking into account the report of the Secretary of Commerce under section 3(c)(1) of the Act, and, if such production exists, whether or not a domestic producer of the article objects to the duty suspension or reduction. (3) Any technical changes to the description of the article that is the subject of the petition for the duty suspension or reduction that are necessary for purposes of administration when the article is presented for importation, taking into account the report of the Secretary of Commerce under section 3(c)(2) of the Act. (4) An estimate of the amount of loss in revenue to the United States that would no longer be collected if the duty suspension or reduction takes effect. (5) A determination of whether or not the duty suspension or reduction is available to any person that imports the article that is the subject of the duty suspension or reduction. (6) The likely beneficiaries of each duty suspension or reduction, including whether the petitioner is a likely beneficiary. (b) The preliminary report will also include the following information: (1) A list of petitions for duty suspensions and reductions that meet the requirements of the Act without modifications. (2) A list of petitions for duty suspensions and reductions for which the Commission recommends technical corrections (i.e., corrections to the article description that do not otherwise substantially alter the scope or HTS classification of the articles covered by the petition) in order to meet the requirements of the Act, with the correction specified. (3) A list of petitions for duty suspensions and reductions for which the Commission recommends modifications to the amount of the duty suspension or reduction that is the subject of the petition to comply with the requirements of the Act, with the modification specified. (4) A list of petitions for duty suspensions and reductions for which the Commission recommends modifications to the scope of the articles that are the subject of the petitions in order to address objections by domestic producers to such petitions, with the modifications specified. (5) A list of the following: VerDate Sep<11>2014 18:28 Sep 29, 2016 Jkt 238001 (i) Petitions for duty suspensions and reductions that the Commission has determined do not contain the information required under section 3(b)(2) of the Act. (ii) Petitions for duty suspensions and reductions with respect to which the Commission has determined the petitioner is not a likely beneficiary. (6) A list of petitions for duty suspensions and reductions that the Commission does not recommend for inclusion in a miscellaneous tariff bill, other than petitions specified in section 3(b)(3)(C)(ii)(V) of the Act. (c) The Commission will forward to the Committees any additional information submitted to the Commission by the Secretary of Commerce after the Commission transmits its preliminary report. § 220.12 Commission final report. (a) The Commission will submit its final report on each petition for a duty suspension or reduction specified in the preliminary report to the Committees not later than 60 days after the Commission submits its preliminary report. The final report will contain the following information— (1) The information required to be included in a preliminary report under section 3(b)(3)(C)(i)–(ii) of the Act and updated as appropriate after considering any information submitted by the Committees under section 3(b)(3)(D) of the Act. (2) A determination of the Commission whether— (i) The duty suspension or reduction can likely be administered by U.S. Customs and Border Protection; (ii) The estimated loss in revenue to the United States from the duty suspension or reduction does not exceed $500,000 in a calendar year during which the duty suspension or reduction would be in effect; and (iii) The duty suspension or reduction is available to any person importing the articles that is the subject of the duty suspension or reduction. (b) [Reserved] § 220.13 Confidential business information. PO 00000 Frm 00059 Fmt 4700 Sfmt 4700 (b) Exceptions. (1) In calculating the estimated revenue loss required under the Act, the Commission may base its estimates in whole or in part on the estimated values of imports submitted by petitioners in their petitions. (2) The Commission may disclose some or all of the confidential business information provided to the Commission in petitions and public comments to the U.S. Department of Commerce for use in preparing its report to the Commission and the Committees, and to the U.S. Department of Agriculture and CBP for use in providing information for Commerce’s report. § 220.14 rules. Application of other Commission Commission rules applicable to the initiation and conduct of investigations, including rules set out in subpart B of part 201 of this chapter (except § 201.9 (methods employed in obtaining information), § 201.14(a) (computation of time), and § 201.15 (attorneys or agents)), shall not apply to Commission proceedings under this part. By order of the Commission. Issued: September 21, 2016. Lisa R. Barton, Secretary to the Commission. [FR Doc. 2016–23229 Filed 9–29–16; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 529, and 558 [Docket No. FDA–2016–N–0002] New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor’s Address AGENCY: Food and Drug Administration, HHS. Final rule; technical amendment. ACTION: The Food and Drug Administration (FDA, 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 July and August 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 a change of a sponsor’s address. SUMMARY: (a) In general. The Commission will not release information which the Commission considers to be confidential business information within the meaning of § 201.6(a) of this chapter unless the party submitting the confidential business information had notice, at the time of submission, that such information would be released by the Commission, or such party subsequently consents to the release of the information. 67149 E:\FR\FM\30SER1.SGM 30SER1 67150 Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations This rule is effective September 30, 2016. and August 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 DATES: 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 July 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. TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY AND AUGUST 2016 Approval date Sponsor File No. Product name Species Effect of the action/ indications for use Original approval for the control of pain and inflammation associated with osteoarthritis in horses. Original approval for killing adult fleas, for the treatment and prevention of flea infestations, and for the treatment and control of tick infestations in dogs and cats. Original approval to provide local postoperative analgesia for cranial cruciate ligament surgery in dogs. Original approval of a generic copy of NADA 111–607. FOI Summary. Original approval of a generic copy of NADA 012–965. FOI Summary. July 24, 2016 .................. 141–458 Merial, Inc., 3239 Satellite Blvd., bldg. 500, Duluth, GA 30096–4640. EQUIOXX (firocoxib) Tablets. Horses .............. July 20, 2016 .................. 141–459 Intervet, Inc., 2 Giralda Farms, Madison, NJ 07940. BRAVECTO (fluralaner topical solution) for Dogs. BRAVECTO (fluralaner topical solution) for Cats. Dogs, cats ........ August 12, 2016 ............. 141–461 NOCITA (bupivacaine liposome injectable suspension). Dogs ................. July 1, 2016 .................... 200–501 Praziquantel (praziquantel) Injection. Dogs ................. August 5, 2016 ............... 200–508 Aratana Therapeutics, Inc., 11400 Tomahawk Creek Pkwy., Leawood, KS 66211. Cross Vetpharm Group Ltd. Broomhill Rd., Tallaght, Dublin 24, Ireland. Cross Vetpharm Group Ltd. Broomhill Rd., Tallaght, Dublin 24, Ireland. BILOVET (tylosin) Injection. Cattle, swine ..... asabaliauskas on DSK3SPTVN1PROD with RULES II. Change of Sponsor’s Address Nexcyon Pharmaceuticals, Inc., 644 West Washington Ave., Madison, WI 53719 has informed FDA that it has changed its address to P.O. Box 259158, Madison, WI 53725. Accordingly, the regulations at 21 CFR 510.600(c) will be amended to reflect this sponsor’s change of address. III. Technical Amendments FDA has noticed that drug labeler codes (DLCs) in several sections of part 558 (21 CFR part 558) do not accurately reflect the sponsorship of a new animal drug application. At this time, we are amending part 558 to remove these VerDate Sep<11>2014 18:28 Sep 29, 2016 Jkt 238001 DLCs. Also, FDA is amending the regulations to revise a human food safety warning for tulathromycin injectable solution in 21 CFR 522.2630 and to correct a cross-reference for combination medicated feeds in § 558.128 (21 CFR 558.128). These actions are being taken to improve the accuracy of the regulations. The restrictions for veterinary feed directive (VFD) drugs in part 558 are being revised to reflect a uniform text. In addition, we are revising § 558.59 to reflect a current format. These actions are being taken to improve the clarity of the regulations. This rule does not meet the definition of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because PO 00000 Frm 00060 Fmt 4700 Sfmt 4700 Public documents FOI Summary. FOI Summary. FOI Summary. 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, 524, and 529 Animal drugs. 21 CFR Part 558 Animal drugs, Animal feeds. E:\FR\FM\30SER1.SGM 30SER1 Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations 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, 529, 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. § 510.600 [Amended] § 520.2345c 2. Revise § 510.600 as follows: a. In the table in paragraph (c)(1): i. In the entries for ‘‘Cronus Pharma LLC’’, ‘‘HQ Specialty Pharma Corp.’’, ‘‘OXIS International, Inc.’’, ‘‘Pharmgate LLC ‘‘, ‘‘Putney, Inc.’’, ‘‘SmartVet USA, Inc.’’, and ‘‘Wildlife Laboratories, Inc.’’, remove ‘‘Suite’’ and in its place add ‘‘suite’’; ■ ii. In the entry for ‘‘Merial, Inc.’’, remove ‘‘Bldg.’’ and in its place add ‘‘bldg.’’; ■ iii. In the entry for ‘‘Nexcyon Pharmaceuticals, Inc.’’, remove ‘‘644 West Washington Ave., Madison, WI 53719’’ and in its place add ‘‘P.O. Box 259158, Madison, WI 53725’’; ■ b. In the table in paragraph (c)(2): ■ i. In the entries for ‘‘024991’’, ‘‘026637’’, ‘‘042791’’, ‘‘053923’’, ‘‘069043’’, ‘‘069254’’, and ‘‘086001’’, remove ‘‘Suite’’ and in its place add ‘‘suite’’; ■ ii. In the entry for ‘‘050604’’, remove ‘‘Bldg.’’ and in its place add ‘‘bldg.’’; and ■ iii. In the entry for ‘‘050929’’, remove ‘‘644 West Washington Ave., Madison, WI 53719’’ and in its place add ‘‘P.O. Box 259158, Madison, WI 53725’’. ■ ■ ■ PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for part 520 continues to read as follows: ■ 4. In § 520.928, revise paragraph (c) to read as follows: ■ Firocoxib tablets. asabaliauskas on DSK3SPTVN1PROD with RULES * * * * * (c) Conditions of use—(1) Dogs—(i) Amount. 5 mg/kg (2.27 mg/lb) body weight. Administer once daily for osteoarthritis. Administer approximately 2 hours before soft tissue or orthopedic surgery. (ii) Indications for use. For the control of pain and inflammation associated with osteoarthritis; and for the control of postoperative pain and inflammation associated with soft-tissue and orthopedic surgery. VerDate Sep<11>2014 18:28 Sep 29, 2016 Jkt 238001 [Amended] 5. In § 520.2345c, remove paragraph (d)(1)(iii). PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 6. The authority citation for part 522 continues to read as follows: ■ Authority: 21 U.S.C. 360b. ■ 7. Add § 522.224 to read as follows: § 522.224 Bupivacaine. (a) Specifications. Each milliliter (mL) of liposomal suspension contains 13.3 milligrams (mg) bupivacaine. (b) Sponsor. See No. 086026 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. Administer 5.3 mg/kg (0.4 mL/ kg) by infiltration injection into the tissue layers at the time of incisional closure. (2) Indications for use. For single-dose infiltration into the surgical site to provide local postoperative analgesia for cranial cruciate ligament surgery in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. ■ 8. In § 522.1870, revise paragraphs (a), (c)(1)(i) and (iii), and (c)(2)(i) and (iii) to read as follows: Praziquantel. (a) Specifications. Each milliliter (mL) of solution contains 56.8 milligrams of praziquantel. * * * * * (c) * * * (1) * * * (i) Amount. Administer by subcutaneous or intramuscular injection for dogs and puppies 5 pounds (lb) and under, 0.3 mL; for 6 to 10 lb, 0.5 mL; for 11 to 25 lb, 1.0 mL; if over 25 lb, 0.2 mL/5 lb body weight to a maximum of 3 mL. * * * * * (iii) Limitations. Federal law restricts the drug to use by or on the order of a licensed veterinarian. PO 00000 Frm 00061 Fmt 4700 Sfmt 4700 (2) * * * (i) Amount. Administer by subcutaneous or intramuscular injection for cats and kittens under 5 lb, 0.2 mL; 5 to 10 lb, 0.4 mL; 11 lb and over, 0.6 mL maximum. * * * * * (iii) Limitations. Federal law restricts the drug to use by or on the order of a licensed veterinarian. ■ 9. In § 522.2630, revise paragraph (d)(1)(iii)(A) to read as follows: § 522.2630 Tulathromycin. * ■ § 522.1870 Authority: 21 U.S.C. 360b § 520.928 (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Horses—(i) Amount. Administer one 57-mg tablet to horses weighing 800 to 1,300 lb once daily for up to 14 days. (ii) Indications for use. For the control of pain and inflammation associated with osteoarthritis. (iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 67151 * * * * (d) * * * (1) * * * (iii) * * * (A) Cattle intended for human consumption must not be slaughtered within 18 days from the last treatment. This drug is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Federal law restricts this drug to use by or on the order of a licensed veterinarian. * * * * * ■ 10. Revise § 522.2640 to read as follows: § 522.2640 Tylosin. (a) Specifications. Each milliliter (mL) of solution contains 50 or 200 milligrams (mg) of tylosin activity (as tylosin base). (b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows: (1) No. 000986 for use of 50- or 200mg/mL solutions as in paragraph (e) of this section. (2) Nos. 000010 and 061623 for use of a 200-mg/mL solution as in paragraphs (e)(1) and (2) of this section. (c) Related tolerances. See § 556.740 of this chapter. (d) Special considerations. Labeling must bear the warning statements: ‘‘Do not administer to horses or other equines. Injection of tylosin in equines has been fatal.’’ (e) Conditions of use—(1) Beef cattle and nonlactating dairy cattle—(i) Amount. Administer 8 mg per pound (mg/lb) of body weight by intramuscular injection once daily for not more than 5 consecutive days. Continue treatment 24 hours after symptoms disappear. (ii) Indications for use. Treatment of bovine respiratory complex (shipping fever, pneumonia) usually associated with Pasteurella multocida and Arcanobacterium pyogenes; foot rot (necrotic pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum and metritis caused by A. pyogenes. E:\FR\FM\30SER1.SGM 30SER1 asabaliauskas on DSK3SPTVN1PROD with RULES 67152 Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations (iii) Limitations. Do not inject more than 10 mL per site. Use a 50-mg/mL solution for calves weighing less than 200 pounds. Cattle intended for human consumption must not be slaughtered within 21 days of the last use of this drug product. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. This product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in preruminating calves. (2) Swine—(i) Amount. Administer 4 mg/lb of body weight by intramuscular injection twice daily for not more than 3 consecutive days. Continue treatment 24 hours after symptoms disappear. If tylosin medicated drinking water is used as a followup treatment for swine dysentery, the animal should thereafter receive feed containing 40 to 100 grams of tylosin per ton for 2 weeks to assure depletion of tissue residues. (ii) Indications for use. Treatment of swine arthritis caused by Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp.; swine erysipelas caused by Erysipelothrix rhusiopathiae; swine dysentery associated with Treponema hyodysenteriae when followed by appropriate medication in the drinking water and/or feed. (iii) Limitations. Do not inject more than 5 mL per site. Adverse reactions, including shock and death may result from overdosage in baby pigs. It is recommended that tylosin 50-mg/mL injection be used in pigs weighing less than 25 lbs. Swine intended for human consumption must not be slaughtered within 14 days of the last use of this drug product. (3) Dogs and cats—(i) Amount. Administer 3 to 5 mg/lb of body weight by intramuscular injection at 12- to 24hour intervals. (ii) Indications for use—(A) Dogs. Treatment of upper respiratory infections such as bronchitis, tracheobronchitis, tracheitis, laryngitis, tonsillitis, and pneumonia caused by Staphylococci spp., hemolytic Streptococci spp., and Pasteurella multocida. (B) Cats. Treatment of upper respiratory infections when caused by Staphylococci spp. and hemolytic Streptococci spp. and for feline pneumonitis when caused by tylosinsusceptible organisms. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. VerDate Sep<11>2014 18:28 Sep 29, 2016 Jkt 238001 PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 11. The authority citation for part 524 continues to read as follows: ■ Authority: 21 U.S.C. 360b. ■ 12. Add § 524.998 to read as follows: § 524.998 Fluralaner. (a) Specifications. Each milliliter of solution contains 280 milligrams (mg) fluralaner. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. Administer topically as a single dose every 12 weeks according to the label dosage schedule to provide a minimum dose of 11.4 mg/lb (25 mg/kg) body weight. May be administered every 8 weeks in case of potential exposure to Amblyomma americanum ticks. (ii) Indications for use. Kills adult fleas; for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations (Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog tick)) for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lb or greater; for the treatment and control of A. americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 lb or greater. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 13. The authority citation for part 529 continues to read as follows: ■ Authority: 21 U.S.C. 360b. § 529.400 [Amended] 14. In § 529.400, in paragraph (a), remove footnote 1. PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 15. The authority citation for part 558 continues to read as follows: ■ Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc–1, 371. [Amended] 16. In § 558.58, in paragraph (e)(6), remove ‘‘3.6’’ and in its place add ‘‘36.6’’. ■ 17. Revise § 558.59 to read as follows: ■ PO 00000 Frm 00062 Fmt 4700 Sfmt 4700 Apramycin. (a) Specifications. Each pound of Type A article contains 75 grams apramycin (as apramycin sulfate). (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) [Reserved] (d) Related tolerances. See § 556.52 of this chapter. (e) Conditions of use in swine—(1) Amount. Feed at 150 grams apramycin per ton of Type C medicated feed as the sole ration for 14 consecutive days. (2) Indications for use. For control of porcine colibacillosis (weanling pig scours) caused by susceptible strains of Escherichia coli. (3) Limitations. Withdraw 28 days before slaughter. § 558.68 [Amended] 18. In § 558.68, redesignate paragraphs (c) and (d) as paragraphs (d) and (c); and in paragraphs (e)(1)(i) and (e)(2)(i), remove ‘‘000986’’ and in its place add ‘‘058198’’. ■ § 558.128 [Amended] 19. In § 558.128, in paragraph (e)(7)(xi), remove ‘‘§ 558.600’’ and in its place add ″§ 558.612″. ■ § 558.195 [Amended] 20. In § 558.195, in paragraph (e)(1)(vi), remove ‘‘000009’’ and in its place add ‘‘054771’’; and in paragraphs (e)(2)(iii) and (v), remove ‘‘000986’’ wherever it appears and in its place add ‘‘058198’’. ■ § 558.261 [Amended] 21. In § 558.261, redesignate paragraphs (c) and (d) as paragraphs (d) and (c). ■ § 558.295 [Amended] 22. In § 558.295, remove and reserve paragraph (b). ■ 23. In § 558.325, revise paragraph (d)(3) to read as follows: ■ § 558.325 Lincomycin. * ■ § 558.58 § 558.59 * * * * (d) * * * (3) Labeling of Type A medicated articles and single-ingredient Type B and Type C medicated feeds containing lincomycin intended for use in swine shall bear the following caution statement: ‘‘The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined. Not for use in swine intended for breeding when lincomycin is fed at 20 grams per ton of complete feed.’’ * * * * * § 558.342 [Amended] 24. In § 558.342, in paragraphs (e)(1)(iv),(ix), (x), and (xi), remove ■ E:\FR\FM\30SER1.SGM 30SER1 Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Rules and Regulations ‘‘000986’’ wherever it appears and in its place add ‘‘058198’’. § 558.366 [Amended] 25. In § 558.366, in paragraph (d), in the entry for ‘‘113.5 (0.0125 pct)’’, remove ‘‘000986’’ and in its place add ‘‘058198’’. ■ § 558.618 [Amended] 26. In § 558.618, redesignate paragraphs (c) and (d) as paragraphs (d) and (c). ■ 27. In § 558.633, revise paragraph (d)(1) to read as follows: ■ § 558.633 Tylvalocin. * * * * * (d) * * * (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements. * * * * * Dated: September 21, 2016. Tracey Forfa, Deputy Director, Center for Veterinary Medicine. [FR Doc. 2016–23230 Filed 9–29–16; 8:45 am] BILLING CODE 4164–01–P Electronic Submissions Submit electronic objections in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Objections submitted electronically, including attachments, to http:// www.regulations.gov will be posted to the docket unchanged. Because your objection will be made public, you are solely responsible for ensuring that your objection does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your objection, that information will be posted on http://www.regulations.gov. • If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket No. FDA–2014–F–0988] Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. The Food and Drug Administration (FDA, we, the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of feed grade sodium formate as a feed acidifying agent in complete swine feeds. This action is in response to a food additive petition filed by BASF Corp. asabaliauskas on DSK3SPTVN1PROD with RULES SUMMARY: This rule is effective September 30, 2016. Submit either electronic or written objections and requests for a hearing by October 31, 2016. See section V of this document for further information on the filing of objections. ADDRESSES: You may submit objections and requests for a hearing as follows: DATES: VerDate Sep<11>2014 18:28 Sep 29, 2016 Jkt 238001 Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper objections submitted to the Division of Dockets Management, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2014–F–0988 for ‘‘Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate.’’ Received objections will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit an objection with confidential information that you do not wish to be made publicly available, submit your objections only as a written/paper submission. You should submit two copies total. One copy will include the PO 00000 Frm 00063 Fmt 4700 Sfmt 4700 67153 information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your objections and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper objections received, go to http:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Chelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–6729, chelsea.trull@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In a document published in the Federal Register of July 25, 2014 (79 FR 43325), FDA announced that we had filed a food additive petition (animal use) (FAP 2286) submitted by BASF Corp., 100 Park Ave., Florham Park, NJ 07932. The petition proposed that the regulations for food additives permitted in feed and drinking water of animals be amended to provide for the safe use of feed grade sodium formate as a feed acidifying agent in complete swine feeds. The notice of petition provided for a 30-day comment period on the petitioner’s request for categorical exclusion from preparing an environmental assessment or environmental impact statement. E:\FR\FM\30SER1.SGM 30SER1

Agencies

[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Rules and Regulations]
[Pages 67149-67153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23230]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 529, and 558

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


New Animal Drugs; Approval of New Animal Drug Applications; 
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, 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 July and August 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 a change of a 
sponsor's address.

[[Page 67150]]


DATES: This rule is effective September 30, 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 July and August 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.

                                Table 1--Original and Supplemental NADAs and ANADAs Approved During July and August 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                Effect of the
         Approval date            File No.        Sponsor          Product name             Species          action/indications      Public documents
                                                                                                                   for use
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 24, 2016..................    141-458  Merial, Inc., 3239  EQUIOXX             Horses.................  Original approval   FOI Summary.
                                             Satellite Blvd.,    (firocoxib)                                  for the control
                                             bldg. 500,          Tablets.                                     of pain and
                                             Duluth, GA 30096-                                                inflammation
                                             4640.                                                            associated with
                                                                                                              osteoarthritis in
                                                                                                              horses.
July 20, 2016..................    141-459  Intervet, Inc., 2   BRAVECTO            Dogs, cats.............  Original approval   FOI Summary.
                                             Giralda Farms,      (fluralaner                                  for killing adult
                                             Madison, NJ 07940.  topical solution)                            fleas, for the
                                                                 for Dogs.                                    treatment and
                                                                BRAVECTO                                      prevention of
                                                                 (fluralaner                                  flea
                                                                 topical solution)                            infestations, and
                                                                 for Cats.                                    for the treatment
                                                                                                              and control of
                                                                                                              tick infestations
                                                                                                              in dogs and cats.
August 12, 2016................    141-461  Aratana             NOCITA              Dogs...................  Original approval   FOI Summary.
                                             Therapeutics,       (bupivacaine                                 to provide local
                                             Inc., 11400         liposome                                     postoperative
                                             Tomahawk Creek      injectable                                   analgesia for
                                             Pkwy., Leawood,     suspension).                                 cranial cruciate
                                             KS 66211.                                                        ligament surgery
                                                                                                              in dogs.
July 1, 2016...................    200-501  Cross Vetpharm      Praziquantel        Dogs...................  Original approval   FOI Summary.
                                             Group Ltd.          (praziquantel)                               of a generic copy
                                             Broomhill Rd.,      Injection.                                   of NADA 111-607.
                                             Tallaght, Dublin
                                             24, Ireland.
August 5, 2016.................    200-508  Cross Vetpharm      BILOVET (tylosin)   Cattle, swine..........  Original approval   FOI Summary.
                                             Group Ltd.          Injection.                                   of a generic copy
                                             Broomhill Rd.,                                                   of NADA 012-965.
                                             Tallaght, Dublin
                                             24, Ireland.
--------------------------------------------------------------------------------------------------------------------------------------------------------

II. Change of Sponsor's Address

    Nexcyon Pharmaceuticals, Inc., 644 West Washington Ave., Madison, 
WI 53719 has informed FDA that it has changed its address to P.O. Box 
259158, Madison, WI 53725. Accordingly, the regulations at 21 CFR 
510.600(c) will be amended to reflect this sponsor's change of address.

III. Technical Amendments

    FDA has noticed that drug labeler codes (DLCs) in several sections 
of part 558 (21 CFR part 558) do not accurately reflect the sponsorship 
of a new animal drug application. At this time, we are amending part 
558 to remove these DLCs. Also, FDA is amending the regulations to 
revise a human food safety warning for tulathromycin injectable 
solution in 21 CFR 522.2630 and to correct a cross-reference for 
combination medicated feeds in Sec.  558.128 (21 CFR 558.128). These 
actions are being taken to improve the accuracy of the regulations.
    The restrictions for veterinary feed directive (VFD) drugs in part 
558 are being revised to reflect a uniform text. In addition, we are 
revising Sec.  558.59 to reflect a current format. These actions are 
being taken to improve the clarity 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, 524, and 529

    Animal drugs.

21 CFR Part 558

    Animal drugs, Animal feeds.


[[Page 67151]]


    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, 529, 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.


Sec.  510.600  [Amended]

0
2. Revise Sec.  510.600 as follows:
0
a. In the table in paragraph (c)(1):
0
i. In the entries for ``Cronus Pharma LLC'', ``HQ Specialty Pharma 
Corp.'', ``OXIS International, Inc.'', ``Pharmgate LLC ``, ``Putney, 
Inc.'', ``SmartVet USA, Inc.'', and ``Wildlife Laboratories, Inc.'', 
remove ``Suite'' and in its place add ``suite'';
0
ii. In the entry for ``Merial, Inc.'', remove ``Bldg.'' and in its 
place add ``bldg.'';
0
iii. In the entry for ``Nexcyon Pharmaceuticals, Inc.'', remove ``644 
West Washington Ave., Madison, WI 53719'' and in its place add ``P.O. 
Box 259158, Madison, WI 53725'';
0
b. In the table in paragraph (c)(2):
0
i. In the entries for ``024991'', ``026637'', ``042791'', ``053923'', 
``069043'', ``069254'', and ``086001'', remove ``Suite'' and in its 
place add ``suite'';
0
ii. In the entry for ``050604'', remove ``Bldg.'' and in its place add 
``bldg.''; and
0
iii. In the entry for ``050929'', remove ``644 West Washington Ave., 
Madison, WI 53719'' and in its place add ``P.O. Box 259158, Madison, WI 
53725''.

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

0
4. In Sec.  520.928, revise paragraph (c) to read as follows:


Sec.  520.928  Firocoxib tablets.

* * * * *
    (c) Conditions of use--(1) Dogs--(i) Amount. 5 mg/kg (2.27 mg/lb) 
body weight. Administer once daily for osteoarthritis. Administer 
approximately 2 hours before soft tissue or orthopedic surgery.
    (ii) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis; and for the control of postoperative 
pain and inflammation associated with soft-tissue and orthopedic 
surgery.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Horses--(i) Amount. Administer one 57-mg tablet to horses 
weighing 800 to 1,300 lb once daily for up to 14 days.
    (ii) Indications for use. For the control of pain and inflammation 
associated with osteoarthritis.
    (iii) Limitations. Do not use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.


Sec.  520.2345c  [Amended]

0
5. In Sec.  520.2345c, remove paragraph (d)(1)(iii).

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

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

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

0
7. Add Sec.  522.224 to read as follows:


Sec.  522.224  Bupivacaine.

    (a) Specifications. Each milliliter (mL) of liposomal suspension 
contains 13.3 milligrams (mg) bupivacaine.
    (b) Sponsor. See No. 086026 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 5.3 mg/kg 
(0.4 mL/kg) by infiltration injection into the tissue layers at the 
time of incisional closure.
    (2) Indications for use. For single-dose infiltration into the 
surgical site to provide local postoperative analgesia for cranial 
cruciate ligament surgery in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
0
8. In Sec.  522.1870, revise paragraphs (a), (c)(1)(i) and (iii), and 
(c)(2)(i) and (iii) to read as follows:


Sec.  522.1870  Praziquantel.

    (a) Specifications. Each milliliter (mL) of solution contains 56.8 
milligrams of praziquantel.
* * * * *
    (c) * * *
    (1) * * *
    (i) Amount. Administer by subcutaneous or intramuscular injection 
for dogs and puppies 5 pounds (lb) and under, 0.3 mL; for 6 to 10 lb, 
0.5 mL; for 11 to 25 lb, 1.0 mL; if over 25 lb, 0.2 mL/5 lb body weight 
to a maximum of 3 mL.
* * * * *
    (iii) Limitations. Federal law restricts the drug to use by or on 
the order of a licensed veterinarian.
    (2) * * *
    (i) Amount. Administer by subcutaneous or intramuscular injection 
for cats and kittens under 5 lb, 0.2 mL; 5 to 10 lb, 0.4 mL; 11 lb and 
over, 0.6 mL maximum.
* * * * *
    (iii) Limitations. Federal law restricts the drug to use by or on 
the order of a licensed veterinarian.
0
9. In Sec.  522.2630, revise paragraph (d)(1)(iii)(A) to read as 
follows:


Sec.  522.2630  Tulathromycin.

* * * * *
    (d) * * *
    (1) * * *
    (iii) * * *
    (A) Cattle intended for human consumption must not be slaughtered 
within 18 days from the last treatment. This drug is not approved for 
use in female dairy cattle 20 months of age or older, including dry 
dairy cows. Use in these cattle may cause drug residues in milk and/or 
in calves born to these cows. Federal law restricts this drug to use by 
or on the order of a licensed veterinarian.
* * * * *
0
10. Revise Sec.  522.2640 to read as follows:


Sec.  522.2640  Tylosin.

    (a) Specifications. Each milliliter (mL) of solution contains 50 or 
200 milligrams (mg) of tylosin activity (as tylosin base).
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter as 
follows:
    (1) No. 000986 for use of 50- or 200-mg/mL solutions as in 
paragraph (e) of this section.
    (2) Nos. 000010 and 061623 for use of a 200-mg/mL solution as in 
paragraphs (e)(1) and (2) of this section.
    (c) Related tolerances. See Sec.  556.740 of this chapter.
    (d) Special considerations. Labeling must bear the warning 
statements: ``Do not administer to horses or other equines. Injection 
of tylosin in equines has been fatal.''
    (e) Conditions of use--(1) Beef cattle and nonlactating dairy 
cattle--(i) Amount. Administer 8 mg per pound (mg/lb) of body weight by 
intramuscular injection once daily for not more than 5 consecutive 
days. Continue treatment 24 hours after symptoms disappear.
    (ii) Indications for use. Treatment of bovine respiratory complex 
(shipping fever, pneumonia) usually associated with Pasteurella 
multocida and Arcanobacterium pyogenes; foot rot (necrotic 
pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum 
and metritis caused by A. pyogenes.

[[Page 67152]]

    (iii) Limitations. Do not inject more than 10 mL per site. Use a 
50-mg/mL solution for calves weighing less than 200 pounds. Cattle 
intended for human consumption must not be slaughtered within 21 days 
of the last use of this drug product. This drug product is not approved 
for use in female dairy cattle 20 months of age or older, including dry 
dairy cows. Use in these cattle may cause drug residues in milk and/or 
in calves born to these cows. This product is not approved for use in 
calves intended to be processed for veal. A withdrawal period has not 
been established in preruminating calves.
    (2) Swine--(i) Amount. Administer 4 mg/lb of body weight by 
intramuscular injection twice daily for not more than 3 consecutive 
days. Continue treatment 24 hours after symptoms disappear. If tylosin 
medicated drinking water is used as a followup treatment for swine 
dysentery, the animal should thereafter receive feed containing 40 to 
100 grams of tylosin per ton for 2 weeks to assure depletion of tissue 
residues.
    (ii) Indications for use. Treatment of swine arthritis caused by 
Mycoplasma hyosynoviae; swine pneumonia caused by Pasteurella spp.; 
swine erysipelas caused by Erysipelothrix rhusiopathiae; swine 
dysentery associated with Treponema hyodysenteriae when followed by 
appropriate medication in the drinking water and/or feed.
    (iii) Limitations. Do not inject more than 5 mL per site. Adverse 
reactions, including shock and death may result from overdosage in baby 
pigs. It is recommended that tylosin 50-mg/mL injection be used in pigs 
weighing less than 25 lbs. Swine intended for human consumption must 
not be slaughtered within 14 days of the last use of this drug product.
    (3) Dogs and cats--(i) Amount. Administer 3 to 5 mg/lb of body 
weight by intramuscular injection at 12- to 24-hour intervals.
    (ii) Indications for use--(A) Dogs. Treatment of upper respiratory 
infections such as bronchitis, tracheobronchitis, tracheitis, 
laryngitis, tonsillitis, and pneumonia caused by Staphylococci spp., 
hemolytic Streptococci spp., and Pasteurella multocida.
    (B) Cats. Treatment of upper respiratory infections when caused by 
Staphylococci spp. and hemolytic Streptococci spp. and for feline 
pneumonitis when caused by tylosin-susceptible organisms.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

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

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

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

0
12. Add Sec.  524.998 to read as follows:


Sec.  524.998  Fluralaner.

    (a) Specifications. Each milliliter of solution contains 280 
milligrams (mg) fluralaner.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer topically 
as a single dose every 12 weeks according to the label dosage schedule 
to provide a minimum dose of 11.4 mg/lb (25 mg/kg) body weight. May be 
administered every 8 weeks in case of potential exposure to Amblyomma 
americanum ticks.
    (ii) Indications for use. Kills adult fleas; for the treatment and 
prevention of flea infestations (Ctenocephalides felis) and the 
treatment and control of tick infestations (Ixodes scapularis (black-
legged tick), Dermacentor variabilis (American dog tick), and 
Rhipicephalus sanguineus (brown dog tick)) for 12 weeks in dogs and 
puppies 6 months of age and older, and weighing 4.4 lb or greater; for 
the treatment and control of A. americanum (lone star tick) 
infestations for 8 weeks in dogs and puppies 6 months of age and older, 
and weighing 4.4 lb or greater.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) [Reserved]

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
13. The authority citation for part 529 continues to read as follows:

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


Sec.  529.400  [Amended]

0
14. In Sec.  529.400, in paragraph (a), remove footnote 1.

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

0
15. The authority citation for part 558 continues to read as follows:

    Authority:  21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.


Sec.  558.58  [Amended]

0
16. In Sec.  558.58, in paragraph (e)(6), remove ``3.6'' and in its 
place add ``36.6''.
0
17. Revise Sec.  558.59 to read as follows:


Sec.  558.59  Apramycin.

    (a) Specifications. Each pound of Type A article contains 75 grams 
apramycin (as apramycin sulfate).
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) [Reserved]
    (d) Related tolerances. See Sec.  556.52 of this chapter.
    (e) Conditions of use in swine--(1) Amount. Feed at 150 grams 
apramycin per ton of Type C medicated feed as the sole ration for 14 
consecutive days.
    (2) Indications for use. For control of porcine colibacillosis 
(weanling pig scours) caused by susceptible strains of Escherichia 
coli.
    (3) Limitations. Withdraw 28 days before slaughter.


Sec.  558.68  [Amended]

0
18. In Sec.  558.68, redesignate paragraphs (c) and (d) as paragraphs 
(d) and (c); and in paragraphs (e)(1)(i) and (e)(2)(i), remove 
``000986'' and in its place add ``058198''.


Sec.  558.128  [Amended]

0
19. In Sec.  558.128, in paragraph (e)(7)(xi), remove ``Sec.  558.600'' 
and in its place add ''Sec.  558.612''.


Sec.  558.195  [Amended]

0
20. In Sec.  558.195, in paragraph (e)(1)(vi), remove ``000009'' and in 
its place add ``054771''; and in paragraphs (e)(2)(iii) and (v), remove 
``000986'' wherever it appears and in its place add ``058198''.


Sec.  558.261  [Amended]

0
21. In Sec.  558.261, redesignate paragraphs (c) and (d) as paragraphs 
(d) and (c).


Sec.  558.295  [Amended]

0
22. In Sec.  558.295, remove and reserve paragraph (b).
0
23. In Sec.  558.325, revise paragraph (d)(3) to read as follows:


Sec.  558.325  Lincomycin.

* * * * *
    (d) * * *
    (3) Labeling of Type A medicated articles and single-ingredient 
Type B and Type C medicated feeds containing lincomycin intended for 
use in swine shall bear the following caution statement: ``The effects 
of lincomycin on swine reproductive performance, pregnancy, and 
lactation have not been determined. Not for use in swine intended for 
breeding when lincomycin is fed at 20 grams per ton of complete feed.''
* * * * *


Sec.  558.342  [Amended]

0
24. In Sec.  558.342, in paragraphs (e)(1)(iv),(ix), (x), and (xi), 
remove

[[Page 67153]]

``000986'' wherever it appears and in its place add ``058198''.


Sec.  558.366  [Amended]

0
25. In Sec.  558.366, in paragraph (d), in the entry for ``113.5 
(0.0125 pct)'', remove ``000986'' and in its place add ``058198''.


Sec.  558.618  [Amended]

0
26. In Sec.  558.618, redesignate paragraphs (c) and (d) as paragraphs 
(d) and (c).
0
27. In Sec.  558.633, revise paragraph (d)(1) to read as follows:


Sec.  558.633  Tylvalocin.

* * * * *
    (d) * * *
    (1) Federal law restricts medicated feed containing this veterinary 
feed directive (VFD) drug to use by or on the order of a licensed 
veterinarian. See Sec.  558.6 for additional requirements.
* * * * *

    Dated: September 21, 2016.
Tracey Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-23230 Filed 9-29-16; 8:45 am]
 BILLING CODE 4164-01-P