[Federal Register Volume 60, Number 25 (Tuesday, February 7, 1995)]
[Rules and Regulations]
[Page 7121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-2990]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Tylosin

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 approval of a supplemental new animal drug 
application (NADA) filed by Premiere Agri Technologies, Inc., providing 
for making a 20-gram-per-pound (g/lb) tylosin Type A medicated article 
in addition to existing approvals for 40- and 100-g/lb Type A medicated 
articles.

EFFECTIVE DATE: February 7, 1995

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-142), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1700.

SUPPLEMENTARY INFORMATION: Premiere Agri Technologies, Inc. (Premiere), 
P.O. Box 2508, Fort Wayne, IN 46801-2508, filed a supplement to NADA 
91-582 (formerly sponsored by Central Soya Co., Inc.) that provides for 
making a new 20-g/lb tylosin Type A medicated article used to make Type 
C medicated feeds for cattle, chickens, and swine for use as in 
Sec. 558.625(f)(1)(i) through (f)(1)(vi) (21 CFR 558.625(f)(1)(i) 
through (f)(1)(vi)). Premiere currently has approval for 40- and 100-g/
lb Type A medicated articles. The supplemental NADA is approved and the 
regulations are amended in Sec. 558.625(b)(10) to reflect the approval.
    Approval of this supplemental NADA is an administrative action that 
did not require the generation of new safety or effectiveness data. 
Therefore, a freedom of information summary is not required for this 
action.
    The agency has determined under 21 CFR 25.24(d)(1)(iii) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the 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).

    2. Section 558.625 is amended by revising paragraph (b)(10) to read 
as follows:


Sec. 558.625  Tylosin.

* * * * *
    (b) * * *
    (10) To 012286: 0.4, 0.8, and 1.6 grams per pound, paragraph 
(f)(1)(vi)(a) of this section; 20, 40, and 100 grams per pound, 
paragraphs (f)(1)(i) through (f)(1)(vi) of this section.
* * * * *

    Dated: January 11, 1995.
Andrew J. Beaulieau,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 95-2990 Filed 2-6-95; 8:45 am]
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