Skip to Content

Rule

Intramammary Dosage Forms; Change of Sponsor

Document Details

Information about this document as published in the Federal Register.

Published Document

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

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 three approved new animal drug applications (NADAs) from Pfizer, Inc., to Schering-Plough Animal Health Corp.

DATES:

This rule is effective July 31, 2003.

Start Further Info

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: dnewkirk@cvm.fda.gov.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Pfizer, Inc., 235 East 42d St., New York, NY 10017, has informed FDA that it has transferred ownership of, and all rights and interest in, the following three approved NADAs to Schering-Plough Animal Health Corp., 1095 Morris Ave., Union, NJ 07083:

NADA No.Trade Name
55-069ORBENIN DC (cloxacillin benzathine)
55-070DARICLOX (cloxacillin sodium)
55-100AMOXI-MAST (amoxicillin trihydrate)

Accordingly, the agency is amending the regulations in 21 CFR 526.88, 526.464b, and 526.464c to reflect the transfer of ownership.

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.

Start List of Subjects

List of Subjects in 21 CFR Part 526

End List of Subjects Start Amendment Part

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,

End Amendment Part Start Part

PART 526—INTRAMAMMARY DOSAGE FORMS

End Part Start Amendment Part

1. The authority citation for

End Amendment Part Start Authority

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

End Authority
[Amended]
Start Amendment Part

2. Section 526.88

End Amendment Part
[Amended]
Start Amendment Part

3. Section 526.464b

End Amendment Part
[Amended]
Start Amendment Part

4. Section 526.464c

End Amendment Part Start Signature

Dated: July 18, 2003.

Steven D. Vaughn,

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

End Signature End Supplemental Information

[FR Doc. 03-19445 Filed 7-30-03; 8:45 am]

BILLING CODE 4160-01-S