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Rule

New Animal Drugs; Carprofen; Enrofloxacin; Florfenicol; Tildipirosin; Zilpaterol

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2013. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.

DATES:

This rule is effective August 27, 2013.

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FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, george.haibel@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during June 2013, 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 (Freedom of Information 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 Center for Veterinary Medicine FOIA Electronic Reading Room: http://www.fda.gov/​AboutFDA/​CentersOffices/​OfficeofFoods/​CVM/​CVMFOIAElectronicReadingRoom/​default.htm.

In addition, the animal drug regulations are being amended at 21 CFR 510.600 to correct a sponsor's name and at 21 CFR 556.733 to correct the acceptable daily intake of total residues of tildipirosin. This is being done 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.

Table 1—Original and Supplemental NADAs and ANADAs Approved During June 2013

NADA/ANADASponsorNew animal drug product nameAction21 CFR sectionFOIA summaryNEPA review
200-524Putney, Inc., 400 Congress St., suite 200, Portland, ME 04101Mupirocin Ointment 2%Original approval as a generic copy of NADA 140-839524.1465yesCE.1
200-517Novartis Animal Health US, Inc., 3200 Northline Ave., suite 300, Greensboro, NC 27408ZOBUXA (enrofloxacin) Flavored Antibacterial TabletsOriginal approval as a generic copy of NADA 140-441520.812yesCE.1
200-519Novartis Animal Health US, Inc., 3200 Northline Ave., suite 300, Greensboro, NC 27408FLORVIO (florfenicol) 2.3% Concentrate SolutionOriginal approval as a generic copy of NADA 141-206520.995yesCE.1
200-547Huvepharma AD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, BulgariaZILMAX (zilpaterol hydrochloride) plus RUMENSIN (monensin USP) plus TYLOVET 100 (tylosin phosphate) Type A medicated articlesOriginal approval as a generic copy of NADA 141-276558.665yesCE.1
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200-555Piedmont Animal Health, 204 Muirs Chapel Rd., suite 200, Greensboro, NC 27410LIBREVIA (carprofen) Soft Chewable TabletsOriginal approval as a generic copy of NADA 141-111520.309yesCE.1
1 The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an environmental impact statement because it is of a type that does not individually or cumulatively have a significant effect on the human environment.
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List of Subjects

and 524

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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, 524, 556, and 558 are amended as follows:

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PART 510—NEW ANIMAL DRUGS

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1. The authority citation for

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Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

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2. In § 510.600, in the table in paragraph (c)(1), remove the entry for “Purina Nutrition LLC”, and alphabetically add entries for “Piedmont Animal Health” and “Purina Animal Nutrition LLC”; and in the table in paragraph (c)(2), in the entry for “017800”, remove “Purina Nutrition” and in its place add “Purina Animal Nutrition”, and numerically add an entry for “058147” to read as follows:

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

(c) * * *

(1) * * *

Firm name and addressDrug labeler code
*         *         *         *         *         *         *
Piedmont Animal Health, 204 Muirs Chapel Rd., suite 200, Greensboro, NC 27410058147
*         *         *         *         *         *         *
Purina Animal Nutrition LLC, 1080 County Road F West, Shoreview, MN 55126-2910017800
*         *         *         *         *         *         *

(2) * * *

Drug labeler codeFirm name and address
*         *         *         *         *         *         *
058147Piedmont Animal Health, 204 Muirs Chapel Rd., suite 200, Greensboro, NC 27410
*         *         *         *         *         *         *
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PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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3. The authority citation for

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

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[Amended]
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4. In paragraph (b)(2) of § 520.309, remove “Nos. 000115, 055529, and 062250” and in its place add “Nos. 000115, 055529, 058147, and 062250”.

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5. In § 520.812, revise paragraphs (a) and (b) to read as follows:

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Enrofloxacin.

(a) Specifications. Each tablet contains:

(1) 22.7, 68.0, or 136.0 milligrams (mg) enrofloxacin; or

(2) 22.7, 68.0, 136.0, or 272 mg enrofloxacin.

(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use as in paragraph (c) of this section.

(1) Nos. 000859 and 026637 for use of product described in paragraph (a)(1) of this section.Start Printed Page 52854

(2) No. 058198 for use of product described in paragraph (a)(2) of this section.

* * * * *
[Amended]
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6. In paragraph (b) of § 520.955, remove “No. 000061” and in its place add “Nos. 000061 and 058198”.

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PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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7. The authority citation for

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

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[Amended]
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8. In paragraph (b) of § 524.1465, add “026637,” after “025463,”.

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PART 556—TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

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9. The authority citation for

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Authority: 21 U.S.C. 342, 360b, 371.

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[Amended]
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10. In paragraph (a) of § 556.733, remove “10 micrograms” and in its place add “50 micrograms”.

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PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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11. The authority citation for

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Authority: 21 U.S.C. 360b, 371.

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12. In § 558.665, in the table, revise paragraph (e)(5) to read as follows:

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Zilpaterol.
* * * * *

(e) * * *

Zilpaterol in grams/tonCombination in grams/tonIndications for useLimitationsSponsor
*         *         *         *         *         *         *
(5) 6.8 to provide 60 to 90 mg/head/dayMonensin 10 to 40, plus tylosin 8 to 10Cattle fed in confinement for slaughter: As in paragraph (e)(1) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterum (Actinomyces) pyogenesAs in paragraph (e)(1) of this section; see §§ 558.355(d) and 558.625(c) of this chapter. Monensin as provided by No. 000986; tylosin as provided by Nos. 000986 or 016592 in § 510.600(c) of this chapter000061 016592
*         *         *         *         *         *         *
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Dated: August 19, 2013.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

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[FR Doc. 2013-20538 Filed 8-26-13; 8:45 am]

BILLING CODE 4160-01-P