03-30642. Oral Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride Soluble Powder

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 abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The supplemental ANADA provides for use of oxytetracycline hydrochloride soluble powder in honeybees for the control and treatment of foulbrood, and in swine drinking water with a reduction in preslaughter withdrawal time to zero days.

DATES:

This rule is effective December 10, 2003.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary Medicine (HFV 104), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Phoenix Scientific, Inc., 3915 South 48th St. Terrace, St. Joseph, MO 64503, filed a supplement to ANADA 200-247 that provides for use of Oxytetracycline HCl Soluble Powder-343 for making medicated drinking water for the treatment of various bacterial diseases of livestock. The supplemental ANADA provides for use of oxytetracycline hydrochloride soluble powder in honeybees for the control and treatment of foulbrood, and in swine drinking water with a reduction in preslaughter withdrawal time to zero days. A new container size, a 4.78-ounce packet, is also being approved. The supplemental ANADA is approved as of November 12, 2003, and the regulations are amended in 21 CFR 520.1660d to reflect the approval.

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 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(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 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. Section 520.1660d is amended in the third sentence in paragraph (d)(1)(iii)(C) by removing “withdraw 5 days prior to slaughter those products sponsored by No. 059130 and zero days those products sponsored by No. 000069” and by adding in its place “withdraw zero days prior to slaughter those products sponsored by Nos. 000069 and 059130” and by revising paragraphs (a)(7) and (b)(5) to read as follows:

§ 520.1660d

Oxytetracycline hydrochloride soluble powder.

(a) * * *

* * * * *

(7) Each 1.32 grams of powder contains 1 gram of OTC HCl (packet: 4.78 and 9.6 oz.; pails: 2 and 5 lb); each 18.1 grams of powder contains 1 gram of OTC HCl (packet: 6.4 oz.; pails: 2 and 5 lb).

* * * * *

(b) * * *

* * * * *

(5) No. 059130 for use of OTC HCl concentration in paragraph (a)(7) of this section in chickens, turkeys, swine, cattle, sheep, and honeybees.

* * * * *

Dated: November 21, 2003.

Steven D. Vaughn,

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