[Federal Register Volume 64, Number 23 (Thursday, February 4, 1999)]
[Rules and Regulations]
[Pages 5596-5597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2687]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene 
Disalicylate and Roxarsone With Monensin

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 supplemental new animal drug 
application (NADA) filed by Alpharma Inc. The supplemental NADA 
provides for using approved single ingredient bacitracin methylene 
disalicylate (BMD), monensin, and roxarsone Type A medicated articles 
to make an additional use level of BMD in Type C medicated broiler 
chicken feeds.

EFFECTIVE DATE: February 4, 1999.

FOR FURTHER INFORMATION CONTACT: Estella Z. Jones, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7575.

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed supplemental NADA 116-088 that provides 
for combining approved BMD (10, 25, 30, 50, 60, or 75 grams 
per pound (g/lb) BMD), Coban (45 or 60 g/lb monensin sodium), 
and 3-Nitro (45.4, 90, 227, or 360 g/lb roxarsone) Type A 
medicated articles to make Type C medicated broiler chicken feeds 
containing 100 to 200 g/ton(t) BMD, 90 to 110 g/t monensin sodium, and 
22.7 to 45.4 g/t roxarsone. The BMD, monensin, and 22.7 to 34 g/t 
roxarsone Type C medicated feeds are used as an aid in the control of 
necrotic enteritis caused or complicated by Clostridium spp. or other 
organisms susceptible to BMD; as an aid in the prevention of 
coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. 
brunetti, E. mivati, and E. maxima; and for increased rate of weight 
gain and improved feed efficiency. The BMD, monensin, and 22.7 to 45.4 
g/t roxarsone Type C medicated feeds are used as an aid in the control 
of necrotic enteritis caused or complicated by Clostridium spp. or 
other organisms susceptible to BMD; as an aid in the prevention of 
coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. 
brunetti, E. mivati, and E. maxima; and for increased rate of weight 
gain. The supplemental NADA is approved as of December 24, 1998, and 
the regulations are amended in 21 CFR 558.355 by revising paragraph 
(b)(11) and adding paragraphs (f)(1)(xxvi) and (f)(1)(xxvii) to reflect 
the approval. The basis for approval is discussed in the freedom of 
information summary.
    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 the 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

[[Page 5597]]

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.

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 558--NEW 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 558.355 is amended in paragraph (b)(11) by deleting 
``and (xxv)'' and adding in its place ``(xxv), (xxvi), and (xxvii)'' 
and by adding paragraphs (f)(1)(xxvi) and (f)(1)(xxvii) to read as 
follows:


Sec. 558.355  Monensin.

* * * * *
    (f) * * *
    (1) * * *
    (xxvi) Amount per ton. Monensin 90 to 110 grams plus bacitracin 100 
to 200 grams and roxarsone 22.7 to 34.0 grams.
    (a) Indications for use. As an aid in the control of necrotic 
enteritis caused or complicated by Clostridium spp. or other organisms 
susceptible to bacitracin methylene disalicylate; as an aid in the 
prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. 
acervulina, E. maxima, E. brunetti, and E. mivati; for increased rate 
of weight gain and improved feed efficiency.
    (b) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Use as sole source of organic arsenic. Withdraw 5 days 
before slaughter. Do not feed to laying hens. To control necrotic 
enteritis, start medication at first clinical signs of disease. The 
dosage range permitted provides for different levels based on the 
severity of infection. Use continuously for 5 to 7 days or as long as 
clinical signs persist, then reduce dosage to prevention level. Animals 
should have access to drinking water at all times. Drug overdosage or 
lack of water may result in leg weakness. As roxarsone and bacitracin 
methylene disalicylate provided by No. 046573 in Sec. 510.600(c) of 
this chapter.
    (xxvii) Amount per ton. Monensin 90 to 110 grams plus bacitracin 
100 to 200 grams and roxarsone 22.7 to 45.4 grams.
    (a) Indications for use. As an aid in the control of necrotic 
enteritis caused or complicated by Clostridium spp. or other organisms 
susceptible to bacitracin methylene disalicylate; as an aid in the 
prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. 
acervulina, E. maxima, E. brunetti, and E. mivati; for increased rate 
of weight gain.
    (b) Limitations. For broiler chickens only. Feed continuously as 
sole ration. Use as sole source of organic arsenic. Withdraw 5 days 
before slaughter. Do not feed to laying hens. To control necrotic 
enteritis, start medication at first clinical signs of disease. The 
dosage range permitted provides for different levels based on the 
severity of infection. Use continuously for 5 to 7 days or as long as 
clinical signs persist, then reduce dosage to prevention level. Animals 
should have access to drinking water at all times. Drug overdosage or 
lack of water may result in leg weakness. As roxarsone and bacitracin 
methylene disalicylate provided by No. 046573 in Sec. 510.600(c) of 
this chapter.
* * * * *

    Dated: January 13, 1999.
 Andrew J. Beaulieu,
 Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 99-2687 Filed 2-3-99; 8:45 am]
BILLING CODE 4160-01-F