06-55520. New Animal Drugs For Use in Animal Feeds

CFR Correction

In Title 21 of the Code of Federal Regulations, Parts 500 to 599, revised as of April 1, 2006, on page 391, in § 558.76, paragraphs (a), (b), and (d)(1) are corrected to read as follows:

§ 558.76

Bacitracin methylene disalicylate.

(a) Approvals. Type A medicated articles: 10, 25, 30, 40, 50, 60, or 75 grams per pound to 046573 in § 510.600(c) of this chapter.

(b) Special considerations. The quantities of antibiotics are expressed in terms of the equivalent amount of antibiotic standard.

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(d) Conditions of use. (1) It is used as follows:

Bacitracin methylene disalicylate in grams per ton	Combination in grams per ton	Indications for use	Limitations	Sponsor
(i) 4 to 50		Chickens, turkeys, and pheasants; increased rate of weight gain and improved feed efficiency 1		046573
(ii) 5 to 20		Quail not over 5 weeks of age; increased rate of weight gain and improved feed efficiency 1		046573
(iii) 10 to 25		Chickens; for increased egg production and improved feed efficiency for egg production	For first 7 months of production	046573
(iv) 10 to 30		Swine: for increased rate of weight gain and improved feed efficiency	For growing and finishing swine	046573
	Chlortetracycline approximately 400, varying with body weight and food consumption to provide 10 milligrams per pound of body weight per day	Swine; for increased rate of weight gain and improved feed efficiency; for treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline	Feed for not more than 14 days; bacitracin methylene disalicylate provided by No. 046573; chlortetracycline provided by Nos. 046573 and 048164 in § 510.600(c) of this chapter	046573 048164
		Swine; for control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline	Feed for not more than 14 days; chlortetracycline and BMD as provided by 046573 in § 510.600(c) of this chapter	046573
(v) [Reserved]
(vi) 50		Broiler chickens; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin		046573
		Replacement chickens; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.	Feed continuously as sole ration	046573
(vii)-(viii) [Reserved]
(ix) 100 to 200		Broiler chickens; as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin		046573
		Replacement chickens; as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.	Feed continuously as sole ration. Start at first clinical signs of disease, vary dosage based on severity of infection, administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce medication to prevention level (50 g/t)	046573
(x) 200		Turkeys; as an aid in the control of transmissible enteritis in growing turkeys complicated by organisms susceptible to bacitracin methylene disalicylate		046573
		Quail; for the prevention of ulcerative enteritis in growing quail due to Clostridium colinum susceptible to bacitracin methylene disalicylate.	From Type A medicated articles containing 25, 40, or 50 grams of bacitracin methylene disalicylate. Feed continuously as the sole ration	046573
(xi) 250		1. Growing/Finishing Swine: For control of swine dysentery associated with Treponema hyodysenteriae on premises with a history of swine dysentery but where signs of the disease have not yet occurred; or following an approved treatment of the disease condition	As the sole ration. Not for use in swine weighing more than 250 pounds. Diagnosis should be confirmed by a veterinarian when results are not satisfactory	046573
		2. Pregnant sows: For control of clostridial enteritis caused by C. perfringens in suckling piglets	As the sole ration. Feed to sows from 14 days before through 21 days after farrowing on premises with a history of clostridial scours. Diagnosis should be confirmed by a veterinarian when results are not satisfactory
1 These conditions are NAS/NRC reviewed and found effective. Applications for these uses may not require effectiveness data as specified by § 514.111 of this chapter, but may require bioequivalency and safety information.

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