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Rule

Oral Dosage Form New Animal Drugs; Change of Sponsor

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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 the change of sponsor for 13 new animal drug applications (NADA's) from I. D. Russell Co., Laboratories to Alpharma Inc.

DATES:

This rule is effective February 29, 2000.

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FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0213.

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SUPPLEMENTARY INFORMATION:

I. D. Russell Co., Laboratories, 1301 Iowa Ave., Longmont, CO 80501, has informed FDA that it has transferred the ownership of, and all rights and interest in, the following approved NADA's to Alpharma Inc., One Executive Dr., Fort Lee, NJ 07024: Start Printed Page 10705

NADA No.Product name
6-019Zuco Poultry Tabs
6-081Korum
6-77610% Sulfaquinoxaline
6-860Ruco Tablets
6-891Liquid Sul-Q-Nox
8-902Hepasol
100-094Poultry Sulfa
100-17520% Sulfaquinoxaline
100-17634% Sulfaquinoxaline
130-435Oxytet Soluble
200-106R-Pen
200-189Lincomycin Soluble
200-274Lincomycin Injectable 30%

The agency is amending parts 510 and 520 (21 CFR parts 510 and 520) to reflect the change of sponsor. The agency is amending § 510.600(c)(1) and (c)(2) to remove the sponsor name for I. D. Russell Co., Laboratories because the firm no longer is the holder of any approved NADA's.

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 congressional review requirements in 5 U.S.C 801-808.

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List of Subjects

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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, 21 CFR parts 510 and 520 are amended as follows:

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PART 510 NEW ANIMAL DRUGS

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1. The authority citation for

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

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2. Section 510.600

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PART 520 ORAL DOSAGE FORM NEW ANIMAL DRUGS

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3. The authority citation for

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

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[Amended]
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4. Section 520.1263c

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5. Section 520.1660d

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6. Section 520.1696b

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7. Section 520.2088

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8. Section 520.2089

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9. Section 520.2325a

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Dated: February 16, 2000.

Claire M. Lathers,

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

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[FR Doc. 00-4668 Filed 2-28-00; 8:45 am]

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