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New Animal Drugs; Change of Sponsor's Name; Liquid Crystalline Trypsin, Peru Balsam, Castor Oil

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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; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Mylan Bertek Pharmaceuticals, Inc., to UDL Laboratories, Inc.

DATES:

This rule is effective July 5, 2007.

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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: david.newkirk@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

Mylan Bertek Pharmaceuticals, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478, has informed FDA that it has changed its name to UDL Laboratories, Inc., and is using a new drug labeler code. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect these changes. A conforming change is being made in 21 CFR 524.2620 for this sponsor's sole product.

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. In § 510.600, in the table in paragraph (c)(1), remove the entry for “Mylan Bertek Pharmaceuticals, Inc.” and alphabetically add a new entry for “UDL Laboratories, Inc.”; and in the table in paragraph (c)(2) remove the entry for “062749” and numerically add a new entry for “051079” 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
*    *    *    *    *
UDL Laboratories, Inc., 12720 Dairy Ashford, Sugar Land, TX 77478051079
*    *    *    *    *

(2) * * *

Drug labeler codeFirm name and address
*    *    *    *    *
051079UDL Laboratories, 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. In paragraph (a)(2) of § 524.2620, remove “062794” and add in its place “051079”.

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Dated: June 21, 2007.

Bernadette Dunham,

Deputy Director, Center for Veterinary Medicine.

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[FR Doc. E7-13010 Filed 7-3-07; 8:45 am]

BILLING CODE 4160-01-S