[Federal Register Volume 63, Number 138 (Monday, July 20, 1998)]
[Rules and Regulations]
[Pages 38750-38751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19177]
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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; Bacitracin Methylene
Disalicylate and Zoalene
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 Alpharma Inc. The NADA provides for using approved
bacitracin methylene disalicylate and zoalene Type A medicated articles
to make Type C medicated turkey feeds.
EFFECTIVE DATE: July 20, 1998.
FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1600.
SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box
1399, Fort Lee, NJ 07024, is sponsor of NADA 141-085 which provides for
combining approved BMD (10, 25, 30, 40, 50, 60, or 75 gram
per pound (g/lb) bacitracin methylene disalicylate), and
Zoamix (113.5 g/lb zoalene) Type A medicated articles to make
Type C medicated feeds for growing turkeys containing 4 to 50 g per ton
(g/t) bacitracin methylene disalicylate and 113.5 to 170.3 g/t zoalene.
The Type C medicated turkey feed is used for prevention and control of
coccidiosis, and for increased rate of weight gain and improved feed
efficiency. The NADA is approved as of June 3, 1998, and the
regulations are amended in 21 CFR 558.76(d)(3) by adding paragraph
(d)(3)(xv), and in 21 CFR 558.680(c), in the table, in item (iii) by
adding an entry 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.
FDA 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 558.76 is amended by adding paragraph (d)(3)(xv) to read
as follows:
Sec. 558.76 Bacitracin methylene disalicylate.
* * * * *
(d) * * *
(3) * * *
(xv) Zoalene alone or in combination as in Sec. 558.680.
3. Section 558.680 is amended in the table in paragraph (c)(1) in
item (iii) by alphabetically adding an entry for ``Bacitracin methylene
disalicylate 4-50'' to read as follows:
Sec. 558.680 Zoalene.
* * * * *
(c) * * *
(1) * * *
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Zoalene in grams/ton Combination in grams/ton Indications for use Limitations
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* * * * * *
*
(iii) 113.5-170.3 (0.0125-
0.01875%)
[[Page 38751]]
Bacitracin methylene Turkeys; prevention and For turkeys grown for meat
disalicylate 4-50. control of coccidiosis, purposes only, not to be
and increased rate of fed to laying birds, feed
weight gain and improved continuously as sole
feed efficiency. ration until 14 to 16
weeks of age.
* * * * * *
*
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* * * * *
Dated: July 9, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-19177 Filed 7-17-98; 8:45 am]
BILLING CODE 4160-01-F
