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Rule

Oral Dosage Form New Animal Drugs; Spectinomycin

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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 correct an error in the indications for use for spectinomycin oral solution in swine. FDA is also amending the regulations for other oral dosage forms of spectinomycin to reflect a current format. These actions are being taken to improve the accuracy and readability of the animal drug regulations.

DATES:

This rule is effective February 5, 2008.

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FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, e-mail: george.haibel@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

FDA has noticed that the animal drug regulations do not reflect the approved indications for use for spectinomycin oral solution in swine. At this time, FDA is amending the animal drug regulations in § 520.2123c (21 CFR 520.2123c) to correct this error. FDA is also amending the regulations in § 520.2123a for spectinomycin tablets and in § 520.2123b for spectinomycin powder to reflect a current format. These actions are being taken to improve the accuracy and readability of the animal drug regulations.

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 520

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Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine,

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PART 520—ORAL 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 § 520.2123 to read as follows:

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Spectinomycin oral dosage forms.
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3. Revise § 520.2123a to read as follows:

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Spectinomycin tablets.

(a) Specifications. Each tablet contains spectinomycin dihydrochloride pentahydrate equivalent to 100 milligrams (mg) spectinomycin.

(b) Sponsor. See No. 061623 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. Administer orally to provide 10 mg per pound (lb) of body weight twice daily. Dosage may be continued for 4 consecutive days.

(2) Indications for use. For the treatment of infectious diarrhea and gastroenteritis caused by organisms susceptible to spectinomycin.

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

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4. Revise § 520.2123b to read as follows:

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Spectinomycin powder.

(a) Specifications. Each gram (g) of powder contains spectinomycin dihydrochloride pentahydrate equivalent to 0.5 g spectinomycin.

(b) Sponsor. See No. 061623 in § 510.600(c) of this chapter.

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

(d) Conditions of use in chickens. It is administered in the drinking water of growing chickens as follows:

(1) Indications for use and amounts—(i) For increased rate of weight gain and improved feed efficiency in broiler chickens, administer 0.5 g per gallon of water as the only source of drinking water for the first 3 days of life and for 1 day following each vaccination.

(ii) As an aid in controlling infectious synovitis due to Mycoplasma synoviae in broiler chickens, administer 1 g per gallon of water as the only source of drinking water for the first 3 to 5 days of life.

(iii) As an aid in the prevention or control of losses due to CRD associated with M. gallisepticum (PPLO) in growing chickens, administer 2 g per gallon of water as the only source of drinking water for the first 3 days of life and for 1 day following each vaccination.

(2) Limitations. Do not administer to laying chickens. Do not administer within 5 days of slaughter.

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5. Revise § 520.2123c to read as follows:

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Spectinomycin solution.

(a) Specifications. Each milliliter of solution contains spectinomycin dihydrochloride pentahydrate equivalent to 50 milligrams (mg) spectinomycin.

(b) Sponsors. See Nos. 000856, 059130, and 061623 in § 510.600(c) of this chapter.

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

(d) Conditions of use in swine—(1) Amount. Administer 5 mg per pound (lb) of body weight orally twice daily for 3 to 5 days.

(2) Indications for use. For the treatment and control of porcine enteric colibacillosis (scours) caused by E. coli susceptible to spectinomycin in pigs under 4 weeks of age.

(3) Limitations. Do not administer to pigs over 15 lb body weight or over 4 weeks of age. Do not administer within 21 days of slaughter.

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Dated: January 24, 2008.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

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[FR Doc. E8-2065 Filed 2-4-08; 8:45 am]

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