Skip to Content

Rule

New Animal Drugs; Change of Sponsor's Address

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's address for Novartis Animal Health US, Inc.

DATES:

This rule is effective November 21, 2000.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Novartis Animal Health US, Inc., P.O. Box 18300, Greensboro, NC 27419-8300, has informed FDA of a change of sponsor's address to 3200 Northline Ave., suite 300, Greensboro, NC 27408. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c)(1) and (c)(2) to reflect the change of sponsor's address.

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 510

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 510—NEW ANIMAL DRUGS

End Part Start Amendment Part

1. The authority citation for

End Amendment Part Start Authority

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

End Authority Start Amendment Part

2. Section 510.600 is amended in the table in paragraph (c)(1) by revising the entry for “Novartis Animal Health US, Inc.” and in the table in paragraph (c)(2) by revising the entry for “058198” to read as follows:

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

(c) * * *

(1) * * *

Firm name and addressDrug labeler code
*         *         *         *         *         *         *
Novartis Animal Health US, Inc., 3200 Northline Ave., suite 300, Greensboro, NC 27408058198
*         *         *         *         *         *         *

(2) * * *

Drug labeler codeFirm name and address
*         *         *         *         *         *         *
058198Novartis Animal Health US, Inc., 3200 Northline Ave., suite 300, Greensboro, NC 27408
*         *         *         *         *         *         *
Start Signature

Dated: November 6, 2000.

Claire M. Lathers,

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

End Signature End Supplemental Information

[FR Doc. 00-29764 Filed 11-20-00; 8:45 am]

BILLING CODE 4160-01-F