00-18823. New Animal Drugs for Use in Animal Feeds; 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 supplemental new animal drug application (NADA) filed by Alpharma, Inc. The supplemental NADA provides for use of approved chlortetracycline (CTC) Type A medicated articles to make Type C medicated feeds used for control of porcine proliferative enteropathies (ileitis) in swine.

DATES:

This rule is effective July 26, 2000.

FOR FURTHER INFORMATION CONTACT:

Diane D. Jeang, Center for Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7574.

SUPPLEMENTARY INFORMATION:

Alpharma Inc., One Executive Dr., PO Box 1399, Fort Lee, NJ 07024, filed a supplement to approved NADA 046-699 that provides for use of CHLORMAX^TM (50, 65, or 70 grams per pound (g/lb) chlortetracycline as chlortetracycline hydrochloride) Type A medicated articles to make Type C medicated feeds for use in growing and finishing swine. The Type C medicated feeds contain approximately 400 g per ton CTC (to provide 10 milligrams/lb body weight) and are used for the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline. The supplemental NADA is approved as of July 7, 2000, and the regulations are amended in 21 CFR 558.128 to reflect the approval. 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 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this supplemental 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.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for food-producing animals qualifies for 3 years of marketing exclusivity beginning on July 7, 2000, because the application contains substantial evidence of the effectiveness of the drug involved, any studies of animal safety, or in the case of food-producing animals, human food safety studies (other than bioequivalence or residue studies) required for the approval of the application and conducted or sponsored by the applicant. The 3 years of marketing exclusivity applies only to the new claim for which the supplemental application was approved.

The agency 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. Section 558.128 is amended in the table in paragraph (d)(1)(xii) by adding an entry “4.” to read as follows:

§ 558.128

Chlortetracycline.

* * * * *

(d) * * *

(1) * * *

Chlortetracycline amount	Combination	Indications for use	Limitations	Sponsor
*          *          *          *          *          *          *
(xii) 10 mg/lb of body weight		* * *
		4. Swine; for control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline.	Feed for not more than 14 d.	046573
*          *          *          *          *          *          *

* * * * *

Dated: July 18, 2000.

Claire M. Lathers,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.