06-3353. New Animal Drugs; Change of Sponsor; Soluble Bacitracin Methylene Disalicylate and Streptomycin Sulfate Oral 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 a change of sponsor for a new animal drug application (NADA) for bacitracin methylene disalicylate and streptomycin sulfate oral powder from Veterinary Specialties, Inc., to Alpharma Inc.

DATES:

This rule is effective April 7, 2006.

FOR FURTHER INFORMATION CONTACT:

David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Veterinary Specialties, Inc., 387 North Valley Ct., Barrington, IL 60010, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 65-107 for ENTROMYCIN (bacitracin methylene disalicylate and streptomycin sulfate) Powder to Alpharma Inc., One Executive Dr., Fort Lee, NJ 07024. Accordingly, the regulations are amended in 21 CFR 520.154b to reflect this change of sponsorship and a current format.

Following these changes of sponsorship, Veterinary Specialties, Inc., is no longer the sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for Veterinary Specialties, Inc.

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. In § 510.600, in the table in paragraph (c)(1) remove the entry for “Veterinary Specialties, Inc.”; and in the table in paragraph (c)(2) remove the entry for “062925”.

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. Revise § 520.154b to read as follows:

§ 520.154b

Bacitracin methylene disalicylate and streptomycin sulfate powder.

(a) Specifications. Each gram of powder contains 200 units bacitracin methylene disalicylate and streptomycin sulfate equivalent to 20 milligrams of streptomycin.

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

(c) Conditions of use in dogs—(1) Amount. Administer 1 level teaspoonful per 10 pounds of body weight three times daily, mixed in a small quantity of liquid or feed.

(2) Indications for use. For the treatment of bacterial enteritis caused by pathogens susceptible to bacitracin and streptomycin such as Escherichia coli, Proteus spp., Staphylococcus spp., and Streptococcus spp., and for the symptomatic treatment of associated diarrhea.

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

Dated: March 30, 2006.

Steven D. Vaughn,

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