[Federal Register Volume 64, Number 95 (Tuesday, May 18, 1999)]
[Rules and Regulations]
[Pages 26844-26845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12393]
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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; Lasalocid and
Bacitracin Zinc
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 new animal drug application
(NADA) filed by Roche Vitamins, Inc. The NADA provides for the use of
approved lasalocid Type A medicated articles and bacitracin zinc Type A
medicated articles in making Type C medicated feed used for the
prevention of coccidiosis caused by Eimeria meleagrimitis, E.
gallopavonis, and E. adenoeides, and for increased rate of weight gain
and improved feed efficiency in growing turkeys.
EFFECTIVE DATE: May 18, 1999.
FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-1600.
SUPPLEMENTARY INFORMATION: Roche Vitamins, Inc., 45 Waterview Blvd.,
Parsippany, NJ 07054-1298, is the sponsor of NADA 141-109 that provides
for the use of 20 percent of lasalocid Type A medicated articles and
bacitracin zinc Type A medicated articles containing 50 grams (g) per
pound bacitracin activity in making Type C medicated feed containing 68
to 113 g/ton (t) lasalocid and 4 to 50 g/t bacitracin zinc used for the
prevention of coccidiosis caused by Eimeria meleagrimitis, E.
gallopavonis, and E. adenoeides and for increased rate of weight gain
and improved feed efficiency in growing turkeys. The NADA is approved
as of April 15, 1999, and the regulations are amended in 21 CFR 558.78
and 558.311 to reflect the approval. The basis for approval is
discussed in the freedom of information summary.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness
data and information submitted to support approval of this application
may be seen in the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday through Friday.
The agency has determined under 21 CFR 25.33(a)(2) 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.
2. Section 558.78 is amended by revising paragraph (d)(3)(xii) to
read as follows:
Sec. 558.78 Bacitracin zinc.
* * * * *
(d) * * *
(3) * * *
(xii) Lasalocid sodium alone or with roxarsone as in Sec. 558.311.
* * * * *
3. Section 558.311 is amended in the table by revising paragraph
(e)(1)(xiv) to read as follows:
Sec. 558.311 Lasalocid.
* * * * *
[[Page 26845]]
(e)(1) * * *
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Lasalocid sodium
activity in grams per Combination in grams Indications for use Limitations Sponsor
ton per ton
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* * * * * *
*
(xiv) 68 (0.0075 pct) Growing turkeys; for Feed continuously as 000004
to 113 (0.0125 pct) prevention of sole ration
coccidiosis caused
by E. meleagrimitis,
E. gallopavonis, and
E. adenoeides.
Bacitracin 4 to 50 Growing turkeys; for Feed continuously as 063238
prevention of sole ration
coccidiosis caused
by E. meleagrimitis,
E. gallopavonis, and
E. adenoeides; for
increased rate of
weight gain and
improved feed
efficiency.
* * * * * *
*
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* * * * *
Dated: April 30, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-12393 Filed 5-17-99; 8:45 am]
BILLING CODE 4160-01-F
