2011-24461. 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 Cross Vetpharm Group, Ltd. The ANADA provides for use of tylosin tartrate soluble powder in chickens, turkeys, swine, and honey bees.

DATES:

This rule is effective September 23, 2011.

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:

Cross Vetpharm Group, Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland, filed ANADA 200-455 for use of TYLOMED-WS (tylosin tartrate), a water soluble powder, in chickens, turkeys, swine, and honey bees. The abbreviated application is approved as of July 5, 2011, and the regulations are amended in 21 CFR 520.2640 to reflect the approval and to make minor revisions that will improve accuracy of the regulations.

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, add paragraph (b)(3); and revise paragraphs (a), (b)(1), (b)(2), (d)(2)(ii), (d)(3)(ii)(A), (d)(3)(ii)(B), and (d)(3)(iii) to read as follows:

§ 520.2640

Tylosin.

(a) Specifications. Each container of soluble powder contains tylosin tartrate equivalent to either 100 or 256 grams tylosin base.

(b) * * *

(1) No. 000986 for use of a 100-gram jar as in paragraph (d) of this section.

(2) No. 016592 for use of a 100-gram jar or pouch as in paragraphs (d)(1), (d)(2), (d)(3)(i), (d)(3)(ii)(B), (d)(3)(iii), and (d)(4) of this section.

(3) No. 061623 for use of a 100- or 256-gram jar or pouch as in paragraphs (d)(1), (d)(2), (d)(3)(i), (d)(3)(ii)(B), (d)(3)(iii), and (d)(4) of this section.

* * * * *

(d) * * *

(2) * * *

(ii) Indications for use. For maintaining weight gain and feed efficiency in the presence of infectious sinusitis associated with Mycoplasma gallisepticum sensitive to tylosin.

* * * * *

(3) * * *

(ii) * * *

(A) For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae when followed immediately by tylosin phosphate medicated feed; and for the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis when followed immediately by tylosin phosphate medicated feed.

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

(iii) Limitations. Prepare a fresh solution daily. Do not administer within 48 hours of slaughter. As indicated in paragraph (d)(3)(ii)(A) of this section, follow with tylosin phosphate medicated feed as in § 558.625(f)(1)(vi)(c) of this chapter.

* * * * *

Dated: September 20, 2011.

Bernadette Dunham,

Director, Center for Veterinary Medicine.