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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2019]
[CITE: 21CFR558.95]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E--ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 558 -- NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

Subpart B--Specific New Animal Drugs for Use in Animal Feeds

Sec. 558.95 Bambermycins.

(a) Approvals. See sponsors in 510.600(c) of this chapter for use of Type A medicated articles as in paragraph (d) of this section:

(1) No. 016592: 2, 4, and 10 grams per pound for use as in paragraphs (d)(1), (d)(2), (d)(3), and (d)(4) of this section.

(2) No. 012286: 2 grams for use as in paragraph (d)(2) of this section and 0.4 and 2 grams per pound for use as in paragraph (d)(3).

(b) Special considerations. (1) Bambermycins liquid Type B feeds may be manufactured from dry bambermycins Type A articles. The liquid Type B feeds must have a pH of 3.8 to 7.5, moisture content of 30 to 45 percent.

(2) The expiration date for the liquid Type B feed is 8 weeks after date of manufacture. The expiration date for the dry Type C feed made from the liquid Type B feed is 1 week after date of manufacture.

(c) Related tolerances. See 556.75 of this chapter.

(d) Conditions of use --(1) Chickens. Use in medicated feed as follows:

Bambermycins in grams/ton Indications for use Limitations Sponsor
(i) 1 to 2Broiler chickens: For increased rate of weight gain and improved feed efficiencyFeed continuously as the sole ration016592.
(ii) [Reserved]

(2) Turkeys. Use in medicated feed as follows:

Bambermycins in grams/ton Indications for use Limitations Sponsor
(i) 1 to 2Growing turkeys: For improved feed efficiencyFeed continuously as the sole ration012286, 016592.
(ii) 2Growing turkeys: For increased rate of weight gain and improved feed efficiencyFeed continuously as the sole ration012286, 016592.

(3) Swine. Use in medicated feed as follows:

Bambermycins in grams/ton Indications for use Limitations Sponsor
(i) 2Growing-finishing swine: For increased rate of weight gain and improved feed efficiencyFeed continuously as the sole ration012286, 016592.
(ii) 2 to 4Growing-finishing swine: For increased rate of weightFeed continuously as the sole ration012286, 016592.

(4) Cattle.

Bambermycins in grams/ton Indications for use Limitations Sponsor
(i) 1 to 4Cattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiencyFeed continuously at a rate of 10 to 20 milligrams per head per day016592.
(ii) 2 to 80Pasture cattle (slaughter, stocker, and feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gainFeed continuously on a hand-fed basis at a rate of 10 to 40 milligrams per head per day in 1 to 10 pounds of supplemental Type C medicated feed016592.

(iii) Used as a free-choice Type C medicated loose-mineral feed for pasture cattle (slaughter, stocker, and feeder cattle; and beef replacement heifers) as follows:

(a ) Specifications.

Ingredient International Feed No. Percent
Deflorinated phosphate (20.5% calcium, 18.5% phosphorus)6-01-08042.50
Sodium chloride (salt)6-04-15220.10
Calcium carbonate (38% calcium)6-01-06915.24
Corn distillers dried grains w/solubles5-28-2369.57
Magnesium oxide6-02-7565.15
Vitamin and trace mineral premix *.........3.72
Mineral oil.........1.00
Yeast (primary dehydrated yeast)7-05-5330.75
Bambermycins Type A article (10 g/lb).........0.60
Iron oxide6-02-4310.50
Magnesium sulfate (67%)6-02-7580.32
Selenium premix (270 mg/lb) *.........0.21
Copper sulfate6-01-7200.18
Potassium sulfate (0.33%)6-06-0980.16

*Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).

(b ) Amount per ton. 120 grams.

(c )Indications for use. For increased rate of weight gain.

(d ) Limitations. For free-choice feeding to pasture cattle (slaughter, stocker, and feeder cattle; and beef replacement heifers). Feed a nonmedicated commercial mineral product for 6 weeks to stabilize consumption between 2.66 and 10.66 ounces per head per day. Feed continuously to provide 10 to 40 milligrams bambermycins per head per day. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day.

(iv) Use free-choice Type C medicated feeds for pasture cattle (slaughter, stocker, and feeder cattle; and beef replacement heifers) as follows:

(a ) Amount. Feed continuously to provide 10 to 40 milligrams of bambermycins per head per day.

(b ) Indications for use. For increased rate of weight gain.

(c ) Limitations. Each use in a free-choice Type C medicated feed must be the subject of an approved new animal drug application (NADA) or supplemental NADA as required by 21 CFR 510.455. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day.

(v) Used as a free-choice Type C medicated loose mineral feed for pasture cattle (slaughter, stocker, and feeder cattle; and dairy and beef replacement heifers) as follows:

(A) Specifications.

Ingredient International Feed No. Percent
Deflorinated phosphate (20.5% calcium, 18.5% phosphorus)6-01-08042.50
Sodium chloride (salt)6-04-15220.10
Calcium carbonate (38% calcium)6-01-06915.45
Corn distillers dried grains w/solubles5-28-2369.57
Magnesium oxide6-02-7565.15
Vitamin and trace mineral premix*3.72
Mineral oil1.00
Yeast (primary dehydrated yeast)7-05-5330.75
Bambermycins Type A article (10 g/lb)0.60
Iron oxide6-02-4310.50
Magnesium sulfate (67%)6-02-7580.32
Copper sulfate6-01-7200.18
Potassium sulfate (0.33%)6-06-0980.16

*Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).

(B) Amount per ton. 120 grams.

(C) Indications for use. For increased rate of weight gain.

(D) Limitations. For free-choice feeding to pasture cattle (slaughter, stocker, and feeder cattle; and dairy and beef replacement heifers). Feed a non-medicated commercial mineral product for 6 weeks to stabilize consumption between 2.66 and 10.66 ounces per head per day. Feed continuously to provide 10 to 40 milligrams bambermycins per head per day. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day.

(5) Bambermycins may also be used in combination with:

(i) Amprolium as in 558.55.

(ii) Amprolium and ethopabate as in 558.58.

(iii) Clopidal as in 558.175.

(iv) Diclazuril as in 558.198.

(v) Halofuginone as in 558.265.

(vi) Lasalocid as in 558.311.

(vii) Monensin as in 558.355.

(viii) Narasin as in 558.363.

(ix) Narasin and nicarbazin as in 558.364.

(x) Nicarbazin as in 558.366.

(xi) Salinomycin as in 558.550.

(xii) Zoalene as in 558.680.

[40 FR 13959, Mar. 27, 1975]

Editorial Note:

For Federal Register citations affecting 558.95, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

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