[Federal Register Volume 66, Number 76 (Thursday, April 19, 2001)]
[Rules and Regulations]
[Pages 20083-20084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9651]
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Rules and Regulations
Federal Register
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Federal Register / Vol. 66, No. 76 / Thursday, April 19, 2001 / Rules
and Regulations
[[Page 20083]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Amprolium and
Bacitracin Methylene Disalicylate
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 use of approved,
single-ingredient amprolium and bacitracin methylene disalicylate Type
A medicated articles to make two-way combination drug Type C medicated
feeds used for the development of active immunity to coccidiosis,
increased rate of weight gain, and improved feed efficiency in
replacement chickens.
DATES: This rule is effective April 19, 2001.
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: Alpharma, Inc., One Executive Dr., P.O. Box
1399, Fort Lee, NJ 07024, filed NADA 141-156 that provides for use of
Amprol (25 percent amprolium) and BMD (10, 25, 30,
40, 50, 60, or 75 grams per pound bacitracin methylene disalicylate)
Type A medicated articles to make combination Type C medicated feeds
containing 36.3 to 113.5 grams per ton (g/ton) amprolium and 4 to 50 g/
ton bacitracin methylene disalicylate for use in replacement chickens.
The Type C medicated feeds are used for the development of active
immunity to coccidiosis, increased rate of weight gain, and improved
feed efficiency in replacement chickens. The NADA is approved as of
February 12, 2001, and 21 CFR 558.55 is amended to reflect the
approval. The basis of 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.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
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 558.55 is amended in the table in paragraph (d)(2) by
alphabetically adding an item under entry (i) to read as follows:
Sec. 558.55 Amprolium.
* * * * *
(d) * * *
(2) * * *
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Amprolium in
grams per Combination in Indications Limitations Sponsor
ton grams per ton for use
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(i) 36.3 to
113.5
(0.004% to
0.0125%).
* * * *
* * *
Bacitracin Replacement Feed according 046573
methylene chickens; to subtable
disalicylate development in item (i);
4 to 50. of active bacitracin
immunity to methylene
coccidiosis, disalicylate
increased as provided
rate of by 046573 in
weight gain, Sec. 510.600
and improved (c) of this
feed chapter.
efficiency.
* * * *
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[[Page 20084]]
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Dated: April 9, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-9651 Filed 4-18-01; 8:45 am]
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