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Rule

Ophthalmic and Topical 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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Start Preamble

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 an approved new animal drug application (NADA) from Dow B. Hickam, Inc., to Bertek Pharmaceuticals, Inc.

DATES:

This rule is effective September 5, 2001.

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FOR FURTHER INFORMATION CONTACT:

Norman J. Turner, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0214.

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SUPPLEMENTARY INFORMATION:

Dow B. Hickam, Inc., Pharmaceuticals, P.O. Box 35413, Houston, TX 77035, has informed FDA that it has transferred to Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478, ownership of, and all rights and interests in NADA 39-583. Accordingly, the agency is amending the regulations in 21 CFR 524.2620 to reflect the transfer of ownership.

In addition, Bertek Pharmaceuticals, Inc., has not been previously listed in the animal drug regulations as a sponsor of an approved application. At this time, 21 CFR 510.600(c)(1) and (c)(2) is being amended to add entries for the firm.

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

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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 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 is amended in the table in paragraph (c)(1) by removing the entry for “Dow B. Hickam, Inc.” and by alphabetically adding an entry for “Bertek Pharmaceuticals, Inc.” and in the table in paragraph (c)(2) by removing the entry for “000514” and by numerically adding an entry for “062794” to read as follows:

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Names, addresses, and drug labeler codes of sponsors of approved applications.
* * * * *

(c) * * *

(1) * * *

Firm name and addressDrug labeler code
*         *         *         *         *         *         *
Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478062794
*         *         *         *         *         *         *

(2) * * *

Drug labeler codeFirm name and address
*         *         *         *         *         *         *
062794Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478
*         *         *         *         *         *         *
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PART 524—OPHTHALMIC AND TOPICAL 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 524.2620

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Dated: August 23, 2001.

Claire M. Lathers,

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

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[FR Doc. 01-22198 Filed 9-4-01; 8:45 am]

BILLING CODE 4160-01-S