[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 4160-01-F
