[Federal Register Volume 63, Number 188 (Tuesday, September 29, 1998)]
[Rules and Regulations]
[Pages 51824-51825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25911]
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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 Decoquinate
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 (BMD) and decoquinate Type A
medicated articles to make Type C medicated broiler chicken feeds used
for prevention of coccidiosis, and for increased rate of weight gain
and improved feed efficiency.
EFFECTIVE DATE: September 29, 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 Drive, P.O. Box
1399, Fort Lee, NJ 07024, filed NADA 141-102 that provides for
combining approved BMD (10, 25, 30, 40, 50, 60, or 75 grams
per pound (g/lb) BMD), and Deccox (6 percent decoquinate)
Type A medicated articles to make Type C medicated feeds for broiler
chickens containing 4 to 50 grams per ton (g/t) BMD and 27.2 g/t
decoquinate. The Type C medicated broiler feed is used for the
prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E.
mivati, E. acervulina, E. maxima, and E. brunetti, and for increased
rate of weight gain and improved feed efficiency. The NADA is approved
as of August 3, 1998, and the regulations in 21 CFR 558.76(d)(3) and
the table in 21 CFR 558.195(d) are amended 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
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: 21 U.S.C. 360b, 371.
2. Section 558.76 is amended by adding paragraph (d)(3)(xviii) to
read as follows:
Sec. 558.76 Bacitracin methylene disalicylate.
* * * * *
(d) * * *
(3) * * *
(xviii) Decoquinate as in Sec. 558.195.
3. Section 558.195 is amended in the table in paragraph (d) by
adding an entry under ``27.2(0.003 pct)'' before the entry for
``Bacitracin 10 to 50'' to read as follows:
Sec. 558.195 Decoquinate.
* * * * *
(d) * * *
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Decoquinate Combination
in grams in grams per Indications for use Limitations Sponsor
per ton ton
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* * * * * *
*
27.2 (0.003
pct)
* * * * * *
*
Bacitracin 4 Broiler chickens; for the Do not feed to laying chickens; 046573
to 50 prevention of coccidiosis caused feed continuously as sole
by Eimeria tenella, E. necatrix, ration; bacitracin methylene
E. mivati, E. acervulina, E. disalicylate as provided by
maxima, and E. brunetti, and for 046573 in Sec. 510.600(c) of
increased rate of weight gain this chapter.
and improved feed efficiency.
* * * * * *
*
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[[Page 51825]]
Dated: August 27, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-25911 Filed 9-28-98; 8:45 am]
BILLING CODE 4160-01-F
