2010-30814. Oral Dosage Form New Animal Drugs; Tylosin

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Huvepharma AD. The ANADA provides for use of tylosin tartrate soluble powder in drinking water of chickens, turkeys, swine, and honey bees for the treatment or control of various bacterial diseases.

DATES:

This rule is effective December 8, 2010.

FOR FURTHER INFORMATION CONTACT:

John K. Harshman, Center for Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Huvepharma AD, 33 James Boucher Blvd., Sophia 1407, Bulgaria, filed ANADA 200-473 that provides for use of PHARMASIN (tylosin tartrate) Soluble in medicated drinking water for chickens, turkeys, swine, and honey bees for the treatment or control of various bacterial diseases. Huvepharma AD's PHARMASIN Soluble is approved as a generic copy of Elanco Animal Health's TYLAN Soluble, approved under NADA 13-076. The ANADA is approved as of October 1, 2010, and the regulations in 21 CFR 520.2640 are amended to reflect the approval.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application 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.

The Agency has determined under 21 CFR 25.33 that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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 in 21 CFR Part 520

• Animal drugs

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 part 520 is amended as follows:

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 520 continues to read as follows:

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

2. In § 520.2640, revise paragraphs (a), (b), and (d)(3)(ii) to read as follows:

§ 520.2640

Tylosin.

(a) Specifications. Each container contains tylosin tartrate equivalent to 100 grams tylosin base.

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

(1) No. 000986 for use as in paragraph (d) of this section.

(2) No. 016592 for use as in paragraphs (d)(1), (d)(2), (d)(3)(i), (d)(3)(ii)(B), (d)(3)(iii), and (d)(4) of this section.

* * * * *

(d) * * *

(3) * * *

(ii) Indications for use—(A) For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae and for the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.

(B) For the treatment and control of swine dysentery associated with B. hyodysenteriae.

* * * * *

Dated: December 2, 2010.

Bernadette Dunham,

Director, Center for Veterinary Medicine.