E8-13606. New Animal Drugs For Use in Animal Feeds; 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 a supplemental new animal drug application (NADA) filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA provides for revision of an effectiveness claim and pathogen nomenclature for a tylosin phosphate and sulfamethazine Type A medicated article used to manufacture medicated swine feeds.

DATES:

This rule is effective June 17, 2008.

FOR FURTHER INFORMATION CONTACT:

Timothy Schell, Center for Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8116, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplement to NADA 41-275 that provides for use of TYLAN 40 SULFA-G (tylosin phosphate and sulfamethazine) Elliptical Pellets, a Type A medicated article. The supplement provides for revision of an effectiveness claim and pathogen nomenclature. The supplemental NADA is approved as of May 8, 2008, and the regulations in 21 CFR 558.630 are amended to reflect the approval.

Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required.

FDA has determined under 21 CFR 25.33(a)(1) 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 558

• Animal drugs
• Animal feeds

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 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

2. Revise § 558.630 to read as follows:

§ 558.630

Tylosin and sulfamethazine.

(a) Specifications. Type A medicated articles containing equal amounts of tylosin phosphate and sulfamethazine, available in concentrations of 4, 5, 10, 20, or 40 grams each, per pound.

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

(1) No. 000986: 10 or 40 grams per pound each for use as in paragraph (e)(2)(i) of this section.

(2) No. 021930: 2 grams per pound each for use as in paragraph (e)(2)(i) of this section.

(3) No. 051311: 40 grams per pound each for use as in paragraph (e)(2)(ii) of this section.

(4) No. 017139: 4, 10, or 20 grams per pound each for use as in paragraph (e)(2)(ii) of this section.

(5) Nos. 000986, 010439, 016968, 021930, 024174, 030841, 034936, 035098, 046573, 046987, and 051359: 5, 10, 20, or 40 grams per pound each for use as in paragraph (e)(2)(ii) of this section.

(6) No. 000986: 40 grams per pound each for use as in paragraph (e)(2)(iii) of this section.

(c) Special considerations. Labeling shall bear the statement: “Do not use in medicated feeds containing in excess of 2% bentonite.”

(d) Related tolerances. See §§ 556.670 and 556.740 of this chapter.

(e) Conditions of use. It is used in feed for swine as follows:

(1) Amount per ton. 100 grams tylosin and 100 grams sulfamethazine.

(2) Indications for use-(i) Maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Corynebacterium pyogenes); for reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci. Only the sulfamethazine portion of this combination is active in controlling jowl abscesses.

(ii) Maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Corynebacterium pyogenes).

(iii) For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery associated with Brachyspira hyodysenteriae; and control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Arcanobacterium pyogenes).

(3) Limitations. Withdraw 15 days before swine are slaughtered.

Dated: June 9, 2008.

Bernadette Dunham,

Director, Center for Veterinary Medicine.