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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, Bacitracin Methylene Disalicylate, and Roxarsone
DATES: This rule is effective April 23, 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, bacitracin methylene disalicylate, and roxarsone Type A medicated articles to make threeway combination drug Type C medicated feeds for replacement chickens.
SUMMARY: Amprolium, bacitracin methylene disalicylate, and roxarsone,
SUPPLEMENTAL INFORMATION
Alpharma, Inc., One Executive Dr., P.O. Box 1399,[[Page 20402]]
Fort Lee, NJ 07024, filed NADA 141142 that provides for use of Amprol
disalicylate), and 3Nitro
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 (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 entry (i); 50 plus of active bacitracin
roxarsone immunity to methylene
22.7 to 45.4. coccidiosis; disalicylate
as an aid in and roxarsone the control as provided
of necrotic by 046573 in
enteritis Sec. 510.600 caused or (c) of this
complicated chapter.
by
Clostridium
spp. or other
organisms
susceptible
to
bacitracin;
increased
rate of
weight gain,
improved feed
efficiency,
and improved
pigmentation.
* * * *
* * *
* * * * *
Dated: April 9, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 019872 Filed 42001; 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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