02-30864. New Animal Drugs; Tilmicosin

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 subcutaneous injection of tilmicosin phosphate solution for the treatment of ovine respiratory disease (ORD). FDA is also amending the regulations to add tolerances for residues of tilmicosin in sheep muscle and liver and in cattle muscle.

DATES:

This rule is effective December 5, 2002.

FOR FURTHER INFORMATION CONTACT:

Naba K. Das, Center for Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7569, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a supplemental application to NADA 140-929 that provides for the use of MICOTIL 300 (tilmicosin phosphate) Injection by subcutaneous injection for the treatment of ORD associated with Mannheimia (Pasteurella) haemolytica. The supplemental NADA is approved as of September 4, 2002, and the regulations are amended in 21 CFR 522.2471 and § 556.735 (21 CFR 556.735) to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In addition, § 556.735 is amended by adding a tolerance for residues of tilmicosin in sheep muscle and liver and in cattle muscle, and editorially, to reflect a current format.

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 Dockets Management Branch (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(d)(4) 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

21 CFR Part 522

• Animal drugs

21 CFR Part 556

• Animal drugs
• Foods

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 522 and 556 are amended as follows:

PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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

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

2. Section 522.2471 is revised to read as follows:

§ 522.2471

Tilmicosin.

(a) Specifications. Each milliliter of solution contains 300 milligrams (mg) tilmicosin base as tilmicosin phosphate.

(b) Sponsor. See No. 000986 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.735 of this chapter.

(d) Special considerations. (1) Not for human use. Use of this antibiotic in humans may prove fatal. Do not use in automatically powered syringes.

(2) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(e) Conditions of use—(1) Cattle—(i) Amount. 10 mg per kilogram (kg) body weight as a single subcutaneous injection.

(ii) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia (Pasteurella) haemolytica. For the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia (P.) haemolytica.

(iii) Limitations. Do not use in female dairy cattle 20 months of age or older. Use of this antibiotic in this class of cattle may cause milk residues. Do not slaughter within 28 days of last treatment.

(2) Sheep—(i) Amount. 10 mg/kg body weight as a single subcutaneous injection.

(ii) Indications for use. For the treatment of ovine respiratory disease (ORD) associated with Mannheimia (P.) haemolytica.

(iii) Limitations. Do not slaughter within 28 days of last treatment.

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

3. The authority citation for 21 CFR part 556 continues to read as follows:

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

4. Section 556.735 is amended by revising paragraph (b) to read as follows:

§ 556.735

Tilmicosin.

* * * * *

(b) Tolerances—(1) Cattle—(i) Liver (the target tissue). The tolerance for parent tilmicosin (the marker residue) is 1.2 parts per million (ppm).

(ii) Muscle. The tolerance for parent tilmicosin (the marker residue) is 0.1 ppm.

(2) Swine—(i) Liver (the target tissue). The tolerance for parent tilmicosin (the marker residue) is 7.5 ppm.

(ii) Muscle. The tolerance for parent tilmicosin (the marker residue) is 0.1 ppm.

(3) Sheep—(i) Liver (the target tissue). The tolerance for parent tilmicosin (the marker residue) is 1.2 ppm.

(ii) Muscle. The tolerance for parent tilmicosin (the marker residue) is 0.1 ppm.

Dated: November 21, 2002.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.