97-8049. New Animal Drugs For Use In Animal Feeds; Tylosin; Correction

[Federal Register Volume 62, Number 61 (Monday, March 31, 1997)]
[Rules and Regulations]
[Page 15111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8049]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


New Animal Drugs For Use In Animal Feeds; Tylosin; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
rule that appeared in the Federal Register of December 24, 1996 (61 FR 
67713). The document amended the animal drug regulations to reflect 
approval of a supplemental new animal drug application (NADA) filed by 
Elanco Animal Health, Division of Eli Lilly and Co. The approved use 
level of tylosin Type C medicated swine feed was inadvertently omitted 
from the document. The document also contained certain editorial 
errors. This document corrects those errors.

EFFECTIVE DATE:  December 24, 1996.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for 
Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1644.

    In FR Doc. 96-32549, appearing on page 67713 in the Federal 
Register of Tuesday, December 24, 1996, the following correction is 
made:

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  [Corrected]

    2. On page 67713, in the second column, Sec. 558.625 is amended by 
revising paragraph (f)(1)(vi)(e) to read as follows:

Sec. 558.625  Tylosin.

* * * * *
    (f) * * *
    (1) * * *
    (vi) * * *
    (e) Amount per ton. Tylosin 100 grams.
    (1) Indications for use. Prevention and/or control of porcine 
proliferative enteropathies (ileitis) associated with Lawsonia 
intracellularis.
    (2) Limitations. As tylosin phosphate, administer for 21 days.

    Dated: February 6, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 97-8049 Filed 3-28-97; 8:45 am]
BILLING CODE 4160-01-F