Oral Dosage Form New Animal Drugs; Sulfamethazine Soluble Powder, 70302-70304 [E6-20404]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 232 (Monday, December 4, 2006)]
[Rules and Regulations]
[Pages 70302-70304]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-20404]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Sulfamethazine Soluble Powder

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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[[Page 70303]]

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of an abbreviated new animal drug 
application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA 
provides for use of sulfamethazine soluble powder to create a solution 
administered as a drench to swine or cattle, or in the drinking water 
of chickens, turkeys, swine, or cattle for the treatment of coccidiosis 
or various bacterial diseases.

DATES: This rule is effective December 4, 2006.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed ANADA 200-434 that provides for use 
of SMZ-MED 454 (sulfamethazine sodium) Soluble Powder to create a 
solution administered as a drench to swine or cattle, or in the 
drinking water of chickens, turkeys, swine, or cattle for the treatment 
of coccidiosis or various bacterial diseases. Cross Vetpharm Group 
Ltd.'s SMZ MED 454 Soluble Powder is approved as a generic copy of Fort 
Dodge Animal Health, a Division of Wyeth Holdings Corp.'s, SULMET 
Soluble Powder which was approved under NADA 122-272. The ANADA is 
approved as of November 3, 2006, and the regulations are amended in 21 
CFR 520.2261b 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.
    FDA has determined under 21 CFR 25.33(a)(1) 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 520

    Animal drugs.

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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
2. Revise Sec.  520.2261b to read as follows:


Sec.  520.2261b  Sulfamethazine powder.

    (a) Specifications. A soluble powder composed of 100 percent 
sulfamethazine sodium.
    (b) Sponsors. See Nos. 053501 and 061623 in Sec.  510.600(c) of 
this chapter.
    (c) Related tolerances. See Sec.  556.670 of this chapter.
    (d) Conditions of use--(1) Chickens--(i) Amount. Administer in 
drinking water to provide 58 to 85 milligrams (mg) per pound (/lb) of 
body weight per day.
    (ii) Indications for use. For control of infectious coryza 
(Haemophilus gallinarum), coccidiosis (Eimeria tenella, E. necatrix), 
acute fowl cholera (Pasteurella multocida), and pullorum disease 
(Salmonella pullorum).
    (iii) Limitations. Add the required dose to that amount of water 
that will be consumed in 1 day. Consumption should be carefully 
checked. Have only medicated water available during treatment. Withdraw 
medication 10 days prior to slaughter for food. Do not medicate 
chickens producing eggs for human consumption. Treatment of all 
diseases should be instituted early. Treatment should continue 24 to 48 
hours beyond the remission of disease symptoms. Medicated chickens must 
actually consume enough medicated water which provides the recommended 
dosages.
    (2) Turkeys--(i) Amount. Administer in drinking water to provide 50 
to 124 mg/lb of body weight per day
    (ii) Indications for use. For control of coccidiosis (E. 
meleagrimitis, E. adenoeides).
    (iii) Limitations. Add the required dose to that amount of water 
that will be consumed in 1 day. Consumption should be carefully 
checked. Have only medicated water available during treatment. Withdraw 
medication 10 days prior to slaughter for food. Do not medicate turkeys 
producing eggs for human consumption. Treatment of all diseases should 
be instituted early. Treatment should continue 24 to 48 hours beyond 
the remission of disease symptoms. Medicated turkeys must actually 
consume enough medicated water which provides the recommended dosages.
    (3) Swine--(i) Amount. Administer in drinking water, or as a 
drench, to provide 108 mg/lb of body weight on the first day and 54 mg/
lb of body weight per day on the second, third, and fourth days of 
administration.
    (ii) Indications for use. For treatment of porcine colibacillosis 
(bacterial scours) (E. coli), and bacterial pneumonia (Pasteurella 
spp.).
    (iii) Limitations. Add the required dose to that amount of water 
that will be consumed in 1 day. Consumption should be carefully 
checked. Have only medicated water available during treatment. Withdraw 
medication 15 days prior to slaughter for food. Treatment of all 
diseases should be instituted early. Treatment should continue 24 to 48 
hours beyond the remission of disease symptoms, but not to exceed a 
total of 5 consecutive days. Medicated swine must actually consume 
enough medicated water which provides the recommended dosages.
    (4) Cattle--(i) Amount. Administer in drinking water, or as a 
drench, to provide 108 mg/lb of body weight on the first day and 54 mg/
lb of body weight per day on the second, third, and fourth days of 
administration.
    (ii) Indications for use in beef and nonlactating dairy cattle. 
Treatment of bacterial pneumonia and bovine respiratory disease complex 
(shipping fever complex) (Pasteurella spp.), colibacillosis (bacterial 
scours) (E. coli), necrotic pododermatitis (foot rot) (Fusobacterium 
necrophorum), calf diphtheria (F. necrophorum), acute mastitis 
(Streptococcus spp.), and acute metritis (Streptococcus spp.)
    (iii) Limitations. Add the required dose to that amount of water 
that will be consumed in 1 day. Consumption should be carefully 
checked. Have only medicated water available during treatment. Withdraw 
medication 10 days prior to slaughter for food. Treatment of all 
diseases should be instituted early. Treatment should continue 24 to 48 
hours beyond the remission of disease symptoms, but not to exceed a 
total of 5 consecutive days. Medicated cattle must actually consume 
enough medicated water which provides the recommended dosages.


[[Page 70304]]


    Dated: November 17, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-20404 Filed 12-1-06; 8:45 am]
BILLING CODE 4160-01-S