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Rule

New Animal Drugs; Change of Sponsor's Address

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.

 

Table of Contents Back to Top

DATES: Back to Top

This rule is effective November 21, 2000.

FOR FURTHER INFORMATION CONTACT: Back to Top

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

SUPPLEMENTARY INFORMATION: Back to Top

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.

List of Subjects in 21 CFR Part 510 Back to Top

begin regulatory text

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, 21 CFR part 510 is amended as follows:

PART 510—NEW ANIMAL DRUGS Back to Top

1.The authority citation for 21 CFR part 510 continues to read as follows:

Authority:

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

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:

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

* * * * *

(c) * * *

(1) * * *

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

(2) * * *

Drug labeler code Firm name and address
*******  
058198 Novartis Animal Health US, Inc., 3200 Northline Ave., suite 300, Greensboro, NC 27408
*******  
end regulatory text

Dated: November 6, 2000.

Claire M. Lathers,

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

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

BILLING CODE 4160-01-F

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