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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
CFR Citation: 21 CFR Part 558
NOTICE: RULES
ACTION: Animal drugs, feeds, and related products:
DOCUMENT ACTION: Final rule.
SUBJECT CATEGORY: New Animal Drugs for Use in Animal Feeds; Amprolium and Bacitracin Methylene Disalicylate
DATES: This rule is effective April 19, 2001.
DOCUMENT 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, singleingredient amprolium and bacitracin methylene disalicylate Type A medicated articles to make twoway 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.
SUMMARY: Amprolium and bacitracin methylene disalicylate,
SUPPLEMENTAL INFORMATION
Alpharma, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, filed NADA 141156 that provides for use of AmprolIn 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 (HFA305), 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. 801808.
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 558NEW 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) * * *
Amprolium in
grams per Combination in Indications Limitations Sponsor ton grams per ton for use
(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.
* * * *
* * *
[[Page 20084]]
* * * * *
Dated: April 9, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 019651 Filed 41801; 8:45 am]
BILLING CODE 416001S
FOR FURTHER INFORMATION CONTACT Charles J. Andres, Center for Veterinary Medicine (HFV128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 3018271600.
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