[Federal Register Volume 69, Number 42 (Wednesday, March 3, 2004)]
[Rules and Regulations]
[Pages 9947-9948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-4654]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Diclazuril

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

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 the use of 
approved, single-ingredient Type A medicated articles containing 
diclazuril and roxarsone to formulate two-way combination drug Type C 
medicated feeds for broiler chickens.

DATES: This rule is effective March 3, 2004.

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 NADA 141-223 for use of CLINACOX 
(diclazuril) and 3-NITRO (roxarsone) Type A medicated articles to 
formulate two-way combination drug Type C medicated feeds for broiler 
chickens. The NADA is approved as of January 27, 2004, and the 
regulations are amended in 21 CFR 558.198 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 application may be seen in the Division of Dockets Management 
(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.

0
2. Section 558.198 is amended in the table in paragraph (d)(1) by 
redesignating paragraphs (d)(1)(vi) and (d)(1)(vii) as paragraphs 
(d)(1)(vii) and (d)(1)(viii), respectively, and by adding new paragraph 
(d)(1)(vi) to read as follows:


Sec.  558.198  Diclazuril.

* * * * *
    (d) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
 Diclazuril grams/   Combination grams/
        ton                 ton               Indications for use               Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
 
(vi) 0.91(1 ppm)    Roxarsone 22.7 to    Broiler chickens: As in item  Feed continuously as the           046573
                     45.4                 (i) of this table; for        sole ration throughout
                                          increased rate of weight      growing period. Use as sole
                                          gain, improved feed           source of organic arsenic;
                                          efficiency, and improved      drug overdose or lack of
                                          pigmentation.                 water may result in leg
                                                                        weakness. Not for use in
                                                                        hens producing eggs for
                                                                        human consumption. Withdraw
                                                                        5 days before slaughter.
                                                                       Roxarsone provided by No.
                                                                        046573 in Sec.   510.600(c)
                                                                        of this chapter.
                                                  * * * * * * *
 
----------------------------------------------------------------------------------------------------------------


[[Page 9948]]

* * * * *

    Dated: February 23, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-4654 Filed 3-2-04; 8:45 am]
BILLING CODE 4160-01-S