[Federal Register Volume 70, Number 146 (Monday, August 1, 2005)]
[Rules and Regulations]
[Page 44049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-15161]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for a new animal drug 
application (NADA) from North American Nutrition Companies, Inc., to 
Elanco Animal Health, A Division of Eli Lilly & Co.

DATES: This rule is effective August 1, 2005.

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: 
[email protected].

SUPPLEMENTARY INFORMATION: North American Nutrition Companies, Inc., 
C.S. 5002, 6531 St., Rt. 503, Lewisburg, OH 45338, has informed FDA 
that it has transferred ownership of, and all rights and interest in, 
NADA 127-507 for TYLAN SULFA G Type A Medicated Article to Elanco 
Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, 
Indianapolis, IN 46285. Accordingly, the agency is amending the 
regulations in 21 CFR 558.630 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.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

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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, 21 CFR part 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.


Sec.  558.630  [Amended]

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2. Section 558.630 is amended in paragraph (b)(10) by removing 
``017790'' and by adding in numerical sequence ``000986''.

    Dated: July 11, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-15161 Filed 7-29-05; 8:45 am]
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