[Federal Register Volume 68, Number 61 (Monday, March 31, 2003)]
[Rules and Regulations]
[Pages 15370-15371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7535]


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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; Lasalocid 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 supplemental new animal drug 
application (NADA) filed by Alpharma, Inc. The supplemental NADA 
provides for a 0-day withdrawal period for the use of approved two-way 
combination drug Type C medicated feeds containing lasalocid and 
bacitracin methylene disalicylate in broiler and fryer chickens.

DATES: This rule is effective March 31, 2003.

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, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed a supplement to NADA 107-996 for use of 
AVATEC (lasalocid sodium) and BMD (bacitracin methylene disalicylate) 
Type A medicated articles to formulate two-way combination drug Type C 
medicated chicken feeds. The supplemental NADA provides for a 0-day 
withdrawal period

[[Page 15371]]

for broiler and fryer chicken feeds containing 68 grams/ton (g/ton) 
lasalocid and 10 to 50 g/ton bacitracin methylene disalicylate used for 
the prevention of coccidiosis, and for increased rate of weight gain 
and improved feed efficiency; and for broiler chicken feeds containing 
68 to 113 g/ton lasalocid and 4 to 50 g/ton bacitracin methylene 
disalicylate used for the prevention of coccidiosis, and for improved 
feed efficiency. The NADA is approved as of December 4, 2002, and the 
regulations are amended in 21 CFR 558.311 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 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this supplemental 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.

0
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

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.


Sec.  558.311  [Amended]

0
2. Section 558.311 Lasalocid is amended in the table in paragraph 
(e)(1)(iv) under the ``Limitations'' column by removing ``withdraw 3 
days before slaughter'', and in the table in paragraph (e)(1)(x) under 
the ``Limitations'' column by removing ``withdraw 3 days before 
slaughter;''.

    Dated: March 21, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-7535 Filed 3-31-03; 8:45 am]
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