[Federal Register Volume 63, Number 191 (Friday, October 2, 1998)]
[Rules and Regulations]
[Pages 52968-52969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26426]


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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; Tiamulin and 
Chlortetracycline

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 Boehringer Ingelheim Vetmedica, Inc. The 
supplemental NADA provides for an additional source of 
chlortetracycline (CTC) Type A medicated articles used to make Type B 
and C medicated swine feeds containing tiamulin and CTC.

EFFECTIVE DATE: October 2, 1998.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc. (BIV), 
2621 North Belt Hwy., St. Joseph, MO 64506-2002, has filed supplemental 
NADA 141-011 that provides for using an additional source of CTC Type A 
medicated articles (Pennfield Oil Co.'s Pennchlor) for the 
feed-mixed combination use with tiamulin Type A medicated articles 
(BIV's Denagard) to make tiamulin/CTC Type B or C medicated 
swine feeds for use as

[[Page 52969]]

described in Sec. 558.600(c)(4) (21 CFR 558.600(c)(4)). The 
supplemental NADA is approved as of August 6, 1998, and the regulations 
are amended in Sec. 558.600(c)(4)(ii) to reflect the approval.
    Approval of this supplemental NADA does not require additional 
safety or effectiveness data. A freedom of information summary as 
provided under 21 CFR part 20 and 514.11(e)(2)(ii) is not required.
    The agency has determined under 21 CFR 25.33(a)(3) 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 
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: 21 U.S.C. 360b, 371.


Sec. 558.600  [Amended]

    2. Section 558.600 Tiamulin is amended in paragraph (c)(4)(ii) by 
removing ``046573 and 063238'' and adding in its place ``046573, 
053389, and 063238''.

    Dated: September 20, 1998.
 Margaret Ann Miller,
 Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-26426 Filed 10-1-98; 8:45 am]
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