03-6508. New Animal Drugs for Use in Animal Feeds; Laidlomycin and Chlortetracycline

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 new animal drug application (NADA) filed by Alpharma, Inc. The NADA provides for the use of approved, single-ingredient Type A medicated articles containing laidlomycin and chlortetracycline to formulate two-way combination drug Type C medicated feeds for cattle fed in confinement for slaughter.

DATES:

This rule is effective March 21, 2003.

FOR FURTHER INFORMATION CONTACT:

Eric S. Dubbin, Center for Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0232, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Alpharma, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, filed NADA 141-201 for use of CATTLYST (laidlomycin propionate potassium) and AUREOMYCIN (chlortetracycline) Type A medicated articles to formulate two-way combination drug Type C medicated feeds for cattle fed in confinement for slaughter. The NADA is approved as of December 18, 2002, and the regulations are amended in 21 CFR 558.128 and 558.305 to reflect the approval and a current format. The basis of approval is discussed in the freedom of information summary.

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(a)(2) 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. Section 558.128 Chlortetracycline is amended in paragraph (e)(6) by redesignating paragraphs (e)(6)(vii) through (e)(6)(xii) as paragraphs (e)(6)(viii) through (e)(6)(xiii); and by adding new paragraph (e)(6)(vii) to read as follows:

§ 558.128

Chlortetracycline.

* * * * *

(e) * * *

(6) * * *

(vii) Laidlomycin in accordance with § 558.305.

* * * * *

3. Section 558.305 is amended by:

a. Revising the section heading;

b. Redesignating paragraph (b) as paragraph (c);

c. Adding new paragraphs (b) and (c)(3); and

d. Revising paragraphs (a) and (d) to read as follows:

§ 558.305

Laidlomycin.

(a) Specifications. Type A medicated articles containing 50 grams laidlomycin propionate potassium per pound.

(b) Approvals. See No. 046573 in § 510.600(c) of this chapter.

(c) Special considerations.

* * * * *

(3) Labeling for all Type B feeds (liquid and dry) and Type C feeds containing laidlomycin shall bear the following statements:

(i) Do not allow horses or other equines access to feeds containing laidlomycin propionate potassium.

(ii) The safety of laidlomycin propionate potassium in unapproved species has not been established.

(iii) Not for use in animals intended for breeding.

(d) Conditions of use. It is used in cattle being fed in confinement for slaughter as follows:

Laidlomycin in grams per ton	Combination in grams per ton	Indications for use	Limitations	Sponsor
(1) 5		For improved feed efficiency and increased rate of weight gain.	Feed continuously in a Type C feed at a rate of 30 to 75 mg/head/day.	046573
(2) 5	Chlortetracycline10 mg/lb body weight	For improved feed efficiency and increased rate of weight gain; and for treatment of bacterial enteritis caused by Echerichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline.	Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day for not more than 5 days. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.	046573
(3) 5	Chlortetracycline 350 mg/head/day	For improved feed efficiency and increased rate of weight gain; and for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline.	Feed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.	046573
(4) 5 to 10		For improved feed efficiency.	Feed continuously in a Type C feed at a rate of 30 to 150 milligrams/head/day.	046573
(5) 5 to 10	Chlortetracycline 10 mg/pound body weight	For improved feed efficiency; and for treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline.	Feed continuously at a rate of 30 to 150 mg laidlomycin propionate potassium per head per day for not more than 5 days. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.	046573
(6) 5 to 10	Chlortetracycline 350 mg/head/day	For improved feed efficiency; and for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline.	Feed continuously at a rate of 30 to 150 mg laidlomycin propionate potassium per head per day. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.	046573

Dated: February 25, 2003.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.