[Federal Register Volume 59, Number 84 (Tuesday, May 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-10458]


[[Page Unknown]]

[Federal Register: May 3, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

 

Oral Dosage Form New Animal Drugs; 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 three new animal 
drug applications (NADA's) from SmithKline Beecham Animal Health to 
Solvay Animal Health, Inc.

EFFECTIVE DATE: May 3, 1994.

FOR FURTHER INFORMATION CONTACT: Benjamin A. Puyot, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1646.

SUPPLEMENTARY INFORMATION: SmithKline Beecham Animal Health, 1600 Paoli 
Pike, West Chester, PA 19380, has informed FDA that it has transferred 
ownership of, and all rights and interests in, approved NADA's 49-892, 
126-232, and 140-909 to Solvay Animal Health, Inc., 1201 Northland Dr., 
Mendota Heights, MN 55120. Accordingly, FDA is amending the regulations 
in 21 CFR 520.2260a, 520.2260b, and 520.2260c to reflect the change of 
sponsor.

List of Subjects in 21 CFR Part 520

     Animal drugs.
     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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

     1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

Sec. 520.2260a  [Amended]

     2. Section 520.2260a Sulfamethazine oblets and boluses is amended 
in paragraph (b)(1) by removing ``053571'' and adding in its place 
``053501''.


Sec. 520.2260b  [Amended]

     3. Section 520.2260b Sulfamethazine sustained-release boluses is 
amended in paragraph (b)(1) by removing ``053571'' and adding in its 
place ``053501''.


Sec. 520.2260c  [Amended]

     4. Section 520.2260c Sulfamethazine sustained-release tablets is 
amended in paragraph (a) by removing ``053571'' and adding in its place 
``053501''.

    Dated: April 22, 1994.
 Robert C. Livingston,
 Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 94-10458 Filed 5-2-94; 8:45 am]
BILLING CODE 4160-01-F