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Rule

Implantation or Injectable Dosage Form New Animal Drugs; Spectinomycin Sulfate

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Information about this document as published in the Federal Register.

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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 Pharmacia & Upjohn Co., a Div. of Pfizer, Inc. The supplemental NADA provides for revising nomenclature for two bovine respiratory pathogens on labeling for spectinomycin sulfate injectable solution.

DATES:

This rule is effective June 6, 2007.

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FOR FURTHER INFORMATION CONTACT:

Joan C. Gotthardt, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: joan.gotthardt@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

Pharmacia & Upjohn Co., a Div. of Pfizer, Inc., 235 E. 42d St., New York, NY 10017, filed a supplement to NADA 141-077 for ADSPEC (spectinomycin sulfate) Sterile Solution used for the treatment of bovine respiratory disease associated with several bacterial pathogens. The supplemental NADA provides for revising nomenclature for two bacterial pathogens on product labeling. The supplemental NADA is approved as of May 10, 2007, and the regulations in 21 CFR 522.2121 are amended to reflect the approval and a current format.

Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required.

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.

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List of Subjects in 21 CFR Part 522

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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,

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PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for

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

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2. Revise § 522.2121 to read as follows:

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Spectinomycin sulfate.

(a) Specifications. Each milliliter of solution contains spectinomycin sulfate tetrahydrate equivalent to 100 milligrams (mg) spectinomycin.

(b) Sponsor. See No. 000009 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.600 of this chapter.

(d) Conditions of use in cattle—(1) Amount. 10 to 15 mg per kilogram of body weight at 24-hour intervals for 3 to 5 consecutive days.

(2) Indications for use. For the treatment of bovine respiratory disease (pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.

(3) Limitations. Do not slaughter within 11 days of last treatment. Do not use in female dairy cattle 20 months of age or older. Use in this class of cattle may cause residues in milk. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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Dated: May 24, 2007.

Bernadette Dunham,

Deputy Director, Center for Veterinary Medicine.

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[FR Doc. E7-10801 Filed 6-5-07; 8:45 am]

BILLING CODE 4160-01-S