[Federal Register Volume 65, Number 229 (Tuesday, November 28, 2000)]
[Rules and Regulations]
[Pages 70790-70791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30327]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558


New Animal Drugs for Use in Animal Feeds; Salinomycin 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 new animal drug application 
(NADA) filed by Alpharma, Inc. The NADA provides for use of approved, 
single-ingredient salinomycin and bacitracin methylene disalicylate 
Type A medicated articles to make two-way combination drug Type C 
medicated feeds for broiler, roaster, and replacement (breeder and 
layer) chickens. The Type C medicated feeds are used for prevention of 
coccidiosis and as an aid in the prevention and control of necrotic 
enteritis in broiler, roaster, and replacement (breeder and layer) 
chickens; and for prevention of coccidiosis, increased rate of weight 
gain, and improved feed efficiency in roaster and replacement (breeder 
and layer) chickens. Previously established acceptable daily intakes 
(ADI's) for total residues of bacitracin and salinomycin are also being 
codified.

DATES: This rule is effective November 28, 2000.

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.

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed NADA 141-136 that provides for use of 
approved BIO-COX (30 or 60 grams per pound (g/lb) of 
salinomycin activity) and BMD (10, 25, 30, 40, 50, 60, or 75 
g/lb bacitracin methylene disalicylate) Type A medicated articles to 
make combination drug Type C medicated feeds for use in broiler, 
roaster, and replacement (breeder and layer) chickens. The combination 
Type C medicated feeds containing 40 to 60 g/ton salinomycin and 4 to 
50 g/ton bacitracin methylene disalicylate are used for prevention of 
coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. 
maxima, E. brunetti, and E. mivati, and for increased rate of weight 
gain and improved feed efficiency in roaster and replacement (breeder 
and layer) chickens. The combination Type C medicated feeds containing 
40 to 60 g/ton salinomycin and 50 g/ton bacitracin methylene 
disalicylate are used for the prevention of coccidiosis caused by E. 
tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. 
mivati, and as an aid in the prevention of necrotic enteritis caused or 
complicated by Clostridium spp. or other organisms susceptible to 
bacitracin in broiler, roaster, and replacement (breeder and layer) 
chickens. The combination Type C medicated feeds containing 40 to 60 g/
ton salinomycin and 100 to 200 g/ton bacitracin methylene disalicylate 
are used for the prevention of coccidiosis caused by E. tenella, E. 
necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as 
an aid in the control of necrotic enteritis caused or complicated by 
Clostridium spp. or other organisms susceptible to bacitracin in 
broiler, roaster, and replacement (breeder and layer) chickens. The 
NADA is approved as of September 20, 2000, and the regulations are 
amended in 21 CFR 558.550 to reflect the approval. The basis for 
approval is discussed in the freedom of information summary.
    In addition, the regulations are amended in 21 CFR part 556 to add 
the previously established ADI's for total residues of bacitracin and 
salinomycin, and editorially, to reflect current format.
    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 (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

21 CFR Part 556

    Animal drugs, Food.

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 parts 556 and 
558 are amended as follows:

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

    1. The authority citation for 21 CFR part 556 continues to read as 
follows:


[[Page 70791]]


    Authority: 21 U.S.C. 342, 360b, 371.


    2. Section 556.70 is revised to read as follows:


Sec. 556.70  Bacitracin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
bacitracin is 0.05 milligram per kilogram of body weight per day.
    (b) Tolerances. The tolerance for residues of bacitracin from zinc 
bacitracin or bacitracin methylene disalicylate in uncooked edible 
tissues of cattle, swine, chickens, turkeys, pheasants, and quail, and 
in milk and eggs is 0.5 part per million.

    3. Section 556.592 is added to subpart B to read as follows:


Sec. 556.592  Salinomycin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
salinomycin is 0.005 milligram per kilogram of body weight per day.
    (b) [Reserved]

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 558.550 is amended by adding paragraphs (a)(3), 
(d)(1)(xx), and (d)(1)(xxi); by redesignating paragraphs (d)(3)(ii), 
(d)(3)(iii), and (d)(3)(iv) as paragraphs (d)(3)(iv), (d)(3)(vi), and 
(d)(3)(vii), respectively; and by adding paragraphs (d)(3)(ii), 
(d)(3)(iii), and (d)(3)(v) to read as follows:


Sec. 558.550  Salinomycin.

    (a) * * *
    (3) To 046573 for use as in paragraphs (d)(1)(xv), (d)(1)(xvi), 
(d)(1)(xviii) through (d)(1)(xxi), and (d)(3)(ii) through (d)(3)(vii) 
of this section.
* * * * *
    (d) * * *
    (1) * * *
    (xx)(A) Amount per ton. Salinomycin, 40 to 60 grams; and bacitracin 
methylene disalicylate, 50 grams.
    (B) Indications for use. For the prevention of coccidiosis caused 
by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, 
and E. mivati, and as an aid in the prevention of necrotic enteritis 
caused or complicated by Clostridium spp. or other organisms 
susceptible to bacitracin.
    (C) Limitations. Feed continuously as sole ration. Do not feed to 
laying chickens. May be fatal if fed to adult turkeys or to horses. 
Salinomycin as provided by 063238; bacitracin methylene disalicylate as 
provided by 046573 in Sec. 510.600(c) in this chapter.
    (xxi)(A) Amount per ton. Salinomycin, 40 to 60 grams; and 
bacitracin methylene disalicylate, 100 to 200 grams.
    (B) Indications for use. For the prevention of coccidiosis caused 
by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, 
and E. mivati, and as an aid in the control of necrotic enteritis 
caused or complicated by Clostridium spp. or other organisms 
susceptible to bacitracin.
    (C) Limitations. Feed continuously as sole ration. To control 
necrotic enteritis, start medication at first clinical signs of 
disease; vary dosage based on the severity of infection; administer 
continuously for 5 to 7 days or as long as clinical signs persist, then 
reduce bacitracin to prevention level (50 grams per ton). Do not feed 
to laying chickens. May be fatal if fed to adult turkeys or to horses. 
Salinomycin as provided by 063238; bacitracin methylene disalicylate as 
provided by 046573 in Sec. 510.600(c) in this chapter.
* * * * *
    (3) * * *
    (ii) Amount per ton. Salinomycin, 40 to 60 grams, and bacitracin 
methylene disalicylate, 4 to 50 grams.
    (A) Indications for use. For the prevention of coccidiosis caused 
by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, 
and E. mivati, and for increased rate of weight gain and improved feed 
efficiency.
    (B) Limitations. Feed continuously as sole ration. Discontinue use 
prior to sexual maturity. Do not feed to laying chickens. May be fatal 
if fed to adult turkeys or to horses. Salinomycin as provided by 
063238; bacitracin methylene disalicylate as provided by 046573 in 
Sec. 510.600(c) of this chapter.
    (iii) Amount per ton. Salinomycin, 40 to 60 grams, and bacitracin 
methylene disalicylate, 50 grams.
    (A) Indications for use. For the prevention of coccidiosis caused 
by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, 
and E. mivati, and as an aid in the prevention of necrotic enteritis 
caused or complicated by Clostridium spp. or other organisms 
susceptible to bacitracin.
    (B) Limitations. Feed continuously as sole ration. Discontinue use 
prior to sexual maturity. Do not feed to laying chickens. May be fatal 
if fed to adult turkeys or to horses. Salinomycin as provided by 
063238; bacitracin methylene disalicylate as provided by 046573 in 
Sec. 510.600(c) of this chapter.
* * * * *
    (v) Amount per ton. Salinomycin, 40 to 60 grams, and bacitracin 
methylene disalicylate, 100 to 200 grams.
    (A) Indications for use. For the prevention of coccidiosis caused 
by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, 
and E. mivati, and as an aid in the control of necrotic enteritis 
caused or complicated by Clostridium spp. or other organisms 
susceptible to bacitracin.
    (B) Limitations. Feed continuously as sole ration. To control 
necrotic enteritis, start medication at first clinical signs of 
disease; vary dosage based on the severity of infection; administer 
continuously for 5 to 7 days or as long as clinical signs persist, then 
reduce bacitracin to prevention level (50 grams per ton). Discontinue 
use prior to sexual maturity. Do not feed to laying chickens. May be 
fatal if fed to adult turkeys or to horses. Salinomycin as provided by 
063238; bacitracin methylene disalicylate as provided by 046573 in 
Sec. 510.600(c) of this chapter.
* * * * *

    Dated: November 6, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-30327 Filed 11-27-00; 8:45 am]
BILLING CODE 4160-01-F