Skip to Content

Rule

New Animal Drugs; Enrofloxacin; Tilmicosin; Tylosin

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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 and abbreviated new animal drug applications during February 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.

DATES:

This rule is effective April 3, 2013.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

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 February 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 (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 Center for Veterinary Medicine (CVM) 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 the spelling of a street name in the sponsor's address, and at 21 CFR 558.618 to clarify the dosage of tilmicosin phosphate in medicated feeds for beef and non-lactating dairy cattle.

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.Start Printed Page 19987

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

NADA/ANADASponsorNew animal drug product nameAction21 CFR sectionFOIA SummaryNEPA Review
200-495Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern IrelandENROFLOX 100 (enrofloxacin) Injectable SolutionOriginal approval as a generic copy of NADA 141-068522.812yesCE 1
200-509Huvepharma AD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, BulgariaTILMOVET 90 (tilmicosin phosphate) Type A medicated articleOriginal approval as a generic copy of NADA 141-064558.618yesCE 1
200-531Huvepharma AD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, BulgariaTYLOVET 100 (tylosin phosphate) and RUMENSIN (monensin) Type A medicated articlesOriginal approval as a generic copy of NADA 104-646558.355yesCE 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.
Start List of Subjects

List of Subjects

21 CFR Part 510

  • Administrative practice and procedure
  • Animal drugs
  • Labeling
  • Reporting and recordkeeping requirements

21 CFR Part 522

  • Animal drugs

21 CFR Part 558

  • Animal drugs
  • Animal feed
End List of Subjects

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, 522, and 558 are amended as follows:

Start Part

PART 510—NEW ANIMAL DRUGS

End Part Start Amendment Part

1. The authority citation for 21 CFR part 510 continues to read as follows:

End Amendment Part Start Authority

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

End Authority
[Amended]
Start Amendment Part

2. In § 510.600, in the table in paragraph (c)(1), in the entry for “Huvepharma AD”, remove “Haitov” and in its place add “Haytov”; and in the table in paragraph (c)(2), in the entry for “016592”, remove “Haitov” and in its place add “Haytov”.

End Amendment Part Start Part

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

End Part Start Amendment Part

3. The authority citation for 21 CFR part 522 continues to read as follows:

End Amendment Part Start Authority

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

End Authority Start Amendment Part

4. In § 522.812, revise paragraphs (b) and (e)(3)(ii); and add introductory text to paragraph (e)(2) to read as follows:

End Amendment Part
Enrofloxacin.
* * * * *

(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter:

(1) No. 000859 for use of products described in paragraph (a) as in paragraph (e) of this section; and

(2) No. 055529 for use of product described in paragraph (a)(2) as in paragraphs (e)(2)(i)(B), (e)(2)(ii)(B), (e)(2)(iii), (e)(3)(i), and (e)(3)(iii) of this section.

* * * * *

(e) * * *

(2) Cattle. Use the product described in paragraph (a)(2) of this section as follows:

* * * * *

(3) * * *

(ii) Indications for use—(A) For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica, and Mycoplasma hyopneumoniae.

(B) For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis.

* * * * *
Start Part

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

End Part Start Amendment Part

5. The authority citation for 21 CFR part 558 continues to read as follows:

End Amendment Part Start Authority

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

End Authority Start Amendment Part

6. In § 558.355, remove and reserve paragraph (f)(3)(ix); and in paragraphs (f)(3)(ii)( b) and (f)(3)(xii)(b), add a new last sentence to read as follows:

End Amendment Part
Monensin.
* * * * *

(f) * * *

(3) * * *

(ii) * * *

(b) * * * Tylosin provided by Nos. 000986 and 016592 in § 510.600(c) of this chapter.

* * * * *

(xii) * * *

(b) * * * Tylosin provided by Nos. 000986 and 016592 in § 510.600(c) of this chapter.

* * * * *
[Amended]
Start Amendment Part

7. Amend § 558.618 as follows:

End Amendment Part Start Amendment Part

a. In paragraph (b), remove “No. 000986” and in its place add “Nos. 000986 and 016592”;

End Amendment Part Start Amendment Part

b. In the table in paragraph (e)(1)(i), in the “Sponsor” column, add “, 016592” after “000986”;

End Amendment Part Start Amendment Part

c. In the table in paragraph (e)(1)(ii), in the “Sponsor” column, remove “000986”;

End Amendment Part Start Amendment Part

d. In the table in paragraph (e)(2)(i), in the “Limitations” column, in the first sentence, remove “12.5 milligrams/kilogram/head/day” and in its place add “12.5 mg tilmicosin/kg of bodyweight/day”; and

End Amendment Part Start Amendment Part

e. In the table in paragraphs (e)(2)(ii) and (e)(2)(iii), in the “Limitations” column, in the first sentence, remove “12.5 milligrams tilmicosin/kilogram/head/day” and in its place add “12.5 mg tilmicosin/kg of bodyweight/day”.

End Amendment Part Start Signature

Dated: March 26, 2013.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

End Signature End Supplemental Information

[FR Doc. 2013-07571 Filed 4-2-13; 8:45 am]

BILLING CODE 4160-01-P