New Animal Drugs; Neomycin Sulfate Soluble Powder; Change of Sponsor's Address

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 Bimeda, Inc., and a change of this sponsor's address. The supplemental ANADA provides for use of neomycin sulfate soluble powder in the drinking water of growing turkeys for the control of mortality associated with Escherichia coli organisms susceptible to neomycin.

DATES:

This rule is effective December 5, 2002.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: lluther@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

Bimeda, Inc., 288 County Rd. 28, LeSueur, MN 56058-9322, filed a supplement to ANADA 200-050 that provides for use of Neomycin 325 Soluble Powder for making medicated drinking water for administration to cattle (excluding veal calves), swine, sheep, and goats for the treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin. The supplemental ANADA provides for use of neomycin in the drinking water of growing turkeys for the control of mortality associated with E. coli organisms susceptible to neomycin. The supplemental application is approved as of July 10, 2002, and the regulations are amended in 21 CFR 520.1484 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In addition, Bimeda, Inc., has informed FDA of a change of sponsor address to 291 Forest Prairie Rd., LeSueur, MN 56058. Accordingly, the agency is amending the regulations in 21 CFR 510.600 to reflect the change of sponsor address.

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)(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

21 CFR Part 510

• Administrative practice and procedure
• Animal drugs
• Labeling
• Reporting and recordkeeping requirements

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 parts 510 and 520 are amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

2. Section 510.600 is amended in the table in paragraph (c)(1) by revising the entry for “Bimeda, Inc.” and in the table in paragraph (c)(2) by revising the entry for “061133” to read as follows:

(c) * * *

(1) * * *

(2) * * *

PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

3. The authority citation for 21 CFR part 520 continues to read as follows:

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

4. Section 520.1484 is amended by revising paragraphs (a) and (b) to read as follows:

(a) Specifications. Each ounce of powder contains 20.3 grams of neomycin sulfate (equivalent to 14.2 grams of neomycin base).

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.

(1) Nos. 000069, 046573, and 051259 for use as in paragraph (d)(1) of this section.

(2) Nos. 000009 and 061133 for use as in paragraphs (d)(1) and (d)(2) of this section.