[Federal Register Volume 61, Number 78 (Monday, April 22, 1996)]
[Rules and Regulations]
[Page 17566]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9784]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


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 the change of sponsor name for a new animal 
drug application (NADA) from MAC-PAGE, Inc., to ADM Animal Health & 
Nutrition Div.

EFFECTIVE DATE: April 22, 1996.

FOR FURTHER INFORMATION CONTACT: Thomas J. McKay, Center for Veterinary 
Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0213.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 6, 1994 
(59 FR 50828), FDA published a final rule amending the animal drug 
regulations to reflect the change of sponsors for all NADA's held by 
Central Soya, P. O. Box 1400, Fort Wayne, IN 46801-2508, including MAC-
PAGE, Inc., 1600 South Wilson Ave., Dunn, NC 28334, a wholly-owned 
subsidiary of Central Soya, transferred to Premiere Agri Technologies, 
Inc. The subsidiaries retained their names and drug labeler codes. In 
the Federal Register of September 11, 1995 (60 FR 40752), FDA published 
a final rule amending the animal drug regulations to reflect the change 
of sponsor name from Premiere Agri Technologies, Inc., and the names of 
all wholly-owned subsidiaries, to ADM Animal Health & Nutrition Div., 
P.O. Box 2508, Fort Wayne, IN 46801-2508. Both final rules, which 
reflected these changes, inadvertently did not include NADA 131-957 
(Tylosin). This document corrects that error. Accordingly, FDA is 
amending the regulations in 21 CFR 558.625 to reflect the change of 
sponsor.

List of Subject in 21 CFR Part 558

    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 558 is 
amended as follows:

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

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

    Authority: Secs. 512, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b, 371).


Sec. 558.625  [Amended]

    2. Section 558.625 Tylosin is amended in paragraph (b)(79) by 
removing ``047427'' and adding in its place ``012286''.

    Dated: April 4, 1996.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 96-9784 Filed 4-19-96; 8:45 am]
BILLING CODE 4160-01-F