[Federal Register Volume 69, Number 159 (Wednesday, August 18, 2004)]
[Rules and Regulations]
[Page 51173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18844]


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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; Carbadox and 
Oxytetracycline

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 Phibro Animal Health. The NADA provides for the use of 
approved, single-ingredient Type A medicated articles containing 
carbadox and oxytetracycline to formulate two-way combination drug Type 
C medicated feeds for swine.

DATES: This rule is effective August 18, 2004.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Phibro Animal Health, 710 Rt. 46 East, suite 
401, Fairfield, NJ 07004, filed NADA 141-211 that provides for the use 
of MECADOX (carbadox), approved under NADA 41-061, and TERRAMYCIN 
(oxytetracycline) Type A medicated articles, approved under NADA 95-
143, to formulate two-way combination drug Type C medicated feeds for 
swine. The Type C medicated feeds are used for treatment of bacterial 
enteritis caused by Escherichia coli and Salmonella choleraesuis 
susceptible to oxytetracycline, for treatment of bacterial pneumonia 
caused by Pasteurella multocida susceptible to oxytetracycline; and for 
increased rate of weight gain and improved feed efficiency. The 
application is approved as of July 21, 2004, and the regulations are 
amended in 21 CFR 558.115 and 558.450 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 558.115 is amended by adding paragraph (d)(4) to read as 
follows:

Sec.  558.115   Carbadox.

* * * * *
    (d) * * *
    (4) Amount. Carbadox, 10 to 25 grams per ton of feed; plus 
oxytetracycline, 10 milligrams per pound of body weight.
    (i) Indications for use. For treatment of bacterial enteritis 
caused by Escherichia coli and S. choleraesuis susceptible to 
oxytetracycline, for treatment of bacterial pneumonia caused by 
Pasteurella multocida susceptible to oxytetracycline; and for increased 
rate of weight gain and improved feed efficiency.
    (ii) Limitations. Feed continuously for 7 to 14 days. Not for use 
in pregnant swine or swine intended for breeding purposes. Do not feed 
to swine within 42 days of slaughter.

0
3. Section 558.450 is amended by redesignating paragraph (d)(3)(i) as 
paragraph (d)(3)(iv); and by adding new paragraph (d)(3)(i) to read as 
follows:


Sec.  558.450   Oxytetracycline.

* * * * *
    (d) * * *
    (3) * * *
    (i) Carbadox as in Sec.  558.115 of this chapter.
* * * * *

    Dated: August 2, 2004.
Linda Tollefson,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 04-18844 Filed 8-17-04; 8:45 am]
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