[Federal Register Volume 71, Number 49 (Tuesday, March 14, 2006)]
[Rules and Regulations]
[Pages 13000-13001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-2396]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Sulfamerazine, Sulfamethazine, 
and Sulfaquinoxaline Powder

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 revised labeling for a 
soluble powder containing sulfamerazine, sulfamethazine, and 
sulfaquinoxaline used in drinking water of chickens and turkeys as an 
aid in the control of coccidiosis and acute fowl cholera.

DATES: The rule is effective March 14, 2006.

FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary 
Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0161, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Drive, Fort 
Lee, NJ 07024, filed NADA 100-094 for POULTRYSULFA (sulfamerazine, 
sulfamethazine, and sulfaquinoxaline) Antimicrobial Soluble Powder, an 
over-the-counter product used in the drinking water of chickens and 
turkeys as an aid in the control of coccidiosis and acute fowl cholera. 
The NADA relies on the National Academy of Sciences/National Research 
Council (NAS/NRC), Drug Efficacy Study Group's (DESI) effectiveness 
evaluation and subsequent FDA conclusions. The findings were published 
in the Federal Register of July 5, 1984 (49 FR 27543).
    Using the official analytical method of detection, residues of 
sulfamethazine and sulfamerazine in edible tissues co-elute and cannot 
be quantified individually. There are no products containing only 
sulfamerazine approved for use in chickens or turkeys. Therefore, a 
tolerance for sulfamerazine residues in edible tissues of chickens or 
turkeys is not established at this time.
    Products that comply with the NAS/NRC findings and FDA's 
conclusions regarding those findings are eligible for immediate copying 
under the Generic Animal Drug and Patent Term Restoration Act (GADPTRA) 
(see the eighth in a series of policy letters issued to facilitate 
implementation of GADPTRA that published in the Federal Register of 
August 21, 1991 (56 FR 41561), available online at http://www.fda.gov/cvm/Documents/8thltr.doc).
    The NADA is approved as of February 2, 2006, and part 520 (21 CFR 
part 520) is amended by adding new Sec.  520.2218 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.

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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:

[[Page 13001]]

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

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2. Add Sec.  520.2218 to read as follows:


Sec.  520.2218  Sulfamerazine, sulfamethazine, and sulfaquinoxaline 
powder.

    (a) Specifications. Each 195-gram (g) packet of powder contains 78 
g sulfamerazine, 78 g sulfamethazine, and 39 g sulfaquinoxaline.
    (b) Sponsor. See No. 046573 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec.  556.670 and 556.685 of this 
chapter.
    (d) Conditions of use--(1) Chickens--(i) Amounts and indications 
for use--(A) As an aid in the control of coccidiosis caused by Eimeria 
tenella and E. necatrix susceptible to sulfamerazine, sulfamethazine, 
and sulfaquinoxaline: provide medicated water (0.4 percent solution) 
for 2 to 3 days, then plain water for 3 days, then medicated water 
(0.25 percent solution) for 2 days. If bloody droppings appear, repeat 
at 0.25 percent level for 2 more days. Do not change litter.
    (B) As an aid in the control of acute fowl cholera caused by 
Pasteurella multocida susceptible to sulfamerazine, sulfamethazine, and 
sulfaquinoxaline: provide medicated water (0.4 percent solution) for 2 
to 3 days. If disease recurs, repeat treatment.
    (ii) Limitations. Make fresh solution daily. Do not treat chickens 
within 14 days of slaughter for food. Do not medicate chickens 
producing eggs for human consumption.
    (2) Turkeys--(i) Amounts and indications for use--(A) As an aid in 
the control of coccidiosis caused by Eimeria meleagrimitis and E. 
adenoeides susceptible to sulfamerazine, sulfamethazine, and 
sulfaquinoxaline: provide medicated water (0.25 percent solution) for 2 
days, then plain water for 3 days, then medicated water (0.25 percent 
solution) for 2 days, then plain water for 3 days, then medicated water 
(0.25 percent solution) for 2 days. Repeat if necessary. Do not change 
litter.
    (B) As an aid in the control of acute fowl cholera caused by 
Pasteurella multocida susceptible to sulfamerazine, sulfamethazine, and 
sulfaquinoxaline: provide medicated water (0.4 percent solution) for 2 
to 3 days. If disease recurs, repeat treatment.
    (ii) Limitations. Make fresh solution daily. Do not treat turkeys 
within 14 days of slaughter for food. Do not medicate turkeys producing 
eggs for human consumption.

    Dated: February 23, 2006.
David E. Wardrop, Jr.,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 06-2396 Filed 3-13-06; 8:45 am]
BILLING CODE 4160-01-S