(a) Approvals. See sponsors in Sec. 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.
(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) [Reserved]
(d) Conditions of use--(1) Chickens. Use in medicated feed as follows: ----------------------------------------------------------------------------------------------------------------
(i) 1 to 2...................... Broiler chickens: For Feed continuously as 016592.
increased rate of the sole ration.
weight gain and
improved feed
efficiency.(ii) [Reserved].................----------------------------------------------------------------------------------------------------------------
(2) Turkeys. Use in medicated feed as follows: ----------------------------------------------------------------------------------------------------------------
(i) 1 to 2...................... Growing turkeys: For Feed continuously as 012286, 016592.
improved feed the sole ration.
efficiency.(ii) 2.......................... Growing turkeys: For Feed continuously as 012286, 016592.
increased rate of the sole ration.
weight gain and
improved feed
efficiency.----------------------------------------------------------------------------------------------------------------
(3) Swine. Use in medicated feed as follows: ----------------------------------------------------------------------------------------------------------------
(i) 2........................... Growing-finishing Feed continuously as 012286, 016592.
swine: For increased the sole ration.
rate of weight gain
and improved feed
efficiency.(ii) 2 to 4..................... Growing-finishing Feed continuously as 012286, 016592.
swine: For increased the sole ration.
rate of weight.----------------------------------------------------------------------------------------------------------------
(4) Cattle. ----------------------------------------------------------------------------------------------------------------
(i) 1 to 4...................... Cattle fed in Feed continuously at 016592.
confinement for a rate of 10 to 20
slaughter: For milligrams per head
increased rate of per day.
weight gain and
improved feed
efficiency.(ii) 2 to 40.................... Pasture cattle Feed continuously at 016592.
(slaughter, stocker, a rate of 10 to 40
and feeder cattle, milligrams per head
and dairy and beef per day in at least
replacement 1 pound and not more
heifers): For than 10 pounds of
increased rate of feed. Daily
weight gain. bambermycins intakes
in excess of 20 mg/
head/day have not
been shown to be
more effective than
20 mg/head/day.----------------------------------------------------------------------------------------------------------------
(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. ------------------------------------------------------------------------
International Feed
Ingredient No. Percent------------------------------------------------------------------------Deflorinated phosphate (20.5% 6-01-080.......... 42.50
calcium, 18.5% phosphorus).Sodium chloride (salt).......... 6-04-152.......... 20.10Calcium carbonate (38% calcium). 6-01-069.......... 15.24Corn distillers dried grains w/ 5-28-236.......... 9.57
solubles.Magnesium oxide................. 6-02-756.......... 5.15Vitamin and trace mineral premix .................. 3.72
*.Mineral oil..................... .................. 1.00Yeast (primary dehydrated yeast) 7-05-533.......... 0.75Bambermycins Type A article (10 .................. 0.60
g/lb).Iron oxide...................... 6-02-431.......... 0.50
Magnesium sulfate (67%)......... 6-02-758.......... 0.32Selenium premix (270 mg/lb) *... .................. 0.21Copper sulfate.................. 6-01-720.......... 0.18Potassium sulfate (0.33%)....... 6-06-098.......... 0.16------------------------------------------------------------------------*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. ------------------------------------------------------------------------
International Feed
Ingredient No. Percent------------------------------------------------------------------------Deflorinated phosphate (20.5% 6-01-080.......... 42.50
calcium, 18.5% phosphorus).Sodium chloride (salt).......... 6-04-152.......... 20.10Calcium carbonate (38% calcium). 6-01-069.......... 15.45Corn distillers dried grains w/ 5-28-236.......... 9.57
solubles.Magnesium oxide................. 6-02-756.......... 5.15Vitamin and trace mineral premix .................. 3.72
*.Mineral oil..................... .................. 1.00Yeast (primary dehydrated yeast) 7-05-533.......... 0.75Bambermycins Type A article (10 .................. 0.60
g/lb).Iron oxide...................... 6-02-431.......... 0.50Magnesium sulfate (67%)......... 6-02-758.......... 0.32Copper sulfate.................. 6-01-720.......... 0.18Potassium sulfate (0.33%)....... 6-06-098.......... 0.16------------------------------------------------------------------------* 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 Sec. 558.55.
(ii) Amprolium and ethopabate as in Sec. 558.58.
(iii) Clopidal as in Sec. 558.175.
(iv) Diclazuril as in Sec. 558.198.
(v) Halofuginone as in Sec. 558.265.
(vi) Lasalocid as in Sec. 558.311.
(vii) Monensin as in Sec. 558.355.
(viii) Narasin alone or with nicarbazin as in Sec. 558.363.
(ix) Nicarbazin as in Sec. 558.366.
(x) Salinomycin as in Sec. 558.550.
(xi) Zoalene as in Sec. 558.680. [40 FR 13959, Mar. 27, 1975]
Editorial Note: For Federal Register citations affecting Sec. 558.95, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.