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Rule

New Animal Drugs; Change of Sponsor's Name

Document Details

Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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 a change of sponsor's name from Marsam Pharmaceuticals, Inc., to Marsam Pharmaceuticals, LLC.

DATES:

This rule is effective November 6, 2001.

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FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0209, e-mail: lluther@cvm.fda.gov.

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SUPPLEMENTARY INFORMATION:

Marsam Pharmaceuticals, Inc., Bldg. 31, 24 Olney Ave., Cherry Hill, NJ 08034, has informed FDA of a change of sponsor's name to Marsam Pharmaceuticals, LLC. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c)(1) and (c)(2) to reflect the change of sponsor's name.

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 510

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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 21 CFR part 510 continues to read as follows:

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

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[Amended]

2. Section 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications is amended in the table in paragraph (c)(1) in the entry for “Marsam Pharmaceuticals, Inc.” and in the table in paragraph (c)(2) in the entry for “000209” by removing “Inc.” and by adding in its place “LLC”.

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Dated: October 26, 2001.

Claire M. Lathers,

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

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[FR Doc. 01-27813 Filed 11-5-01; 8:45 am]

BILLING CODE 4160-01-S