Source: https://www.federalregister.gov/documents/2006/03/14/06-2396/oral-dosage-form-new-animal-drugs-sulfamerazine-sulfamethazine-and-sulfaquinoxaline-powder
Timestamp: 2017-11-23 17:32:33
Document Index: 563251284

Matched Legal Cases: ['art 520', 'art 520', '§\u2009520', '§\u2009520', '§\u2009520', '§\u2009510', '§\u2009556']

Federal Register :: Oral Dosage Form New Animal Drugs; Sulfamerazine, Sulfamethazine, and Sulfaquinoxaline Powder
Oral Dosage Form New Animal Drugs; Sulfamerazine, Sulfamethazine, and Sulfaquinoxaline Powder
A Rule by the Food and Drug Administration on 03/14/2006
The rule is effective March 14, 2006.
71 FR 13000
https://www.federalregister.gov/d/06-2396 https://www.federalregister.gov/d/06-2396
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.
Dianne T. McRae, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0161, e-mail: dianne.mcrae@fda.hhs.gov.
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 § 520.2218 to reflect the approval. The basis of approval is discussed in the freedom of information summary.
End Amendment Part Start Part Start Printed Page 13001
2. Add § 520.2218 to read as follows:
§ 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 § 510.600(c) of this chapter.
(c) Related tolerances. See §§ 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.
(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.
David E. Wardrop, Jr.,
[FR Doc. 06-2396 Filed 3-13-06; 8:45 am]