71 FR 224 pgs. 67299-67300 - New Animal Drugs for Use in Animal Feeds; Lasalocid
Type: RULEVolume: 71Number: 224Pages: 67299 - 67300
FR document: [FR Doc. E6-19614 Filed 11-20-06; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Lasalocid
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule.
SUMMARY:
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Alpharma Inc. The supplemental NADA provides for the use of lasalocid Type A medicated articles containing 20 percent lasalocid activity per pound to make free-choice Type C medicated feeds used for increased rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers).
DATES:
This rule is effective November 21, 2006.
FOR FURTHER INFORMATION CONTACT:
Eric S. Dubbin, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855; tel: 301-827-0232; e-mail: eric.dubbin@fda.hhs.gov .
SUPPLEMENTARY INFORMATION:
Alpharma Inc., One Executive Dr., Fort Lee, NJ 07024, filed a supplement to NADA 96-298 for use of BOVATEC 91 (lasalocid) Type A medicated article (20 percent lasalocid activity per pound) to make free-choice Type C medicated feeds used for increased rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers). The supplemental NADA is approved as of October 20, 2006, and the regulations are amended in 21 CFR 558.311 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.
The agency 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 Subject in 21 CFR Part 558
Animal drugs, Animal feeds.
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 558 is amended as follows:
PART 558-NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR part 558 continues to read as follows:
Authority:
21 U.S.C. 360b, 371.
2. In § 558.311, revise paragraphs (e)(2)(i), (e)(2)(ii), (e)(3)(i), (e)(3)(ii), and (e)(4)(i) to read as follows:
§ 558.311 Lasalocid.
(e) * * *
(2) * * *
(i) Specification .
| Ingredient | Percent | International feed No. |
|---|---|---|
| Defluorinated phosphate (20.5% Ca, 18.5% P) | 35.9 | 6-01-080 |
| Sodium chloride (salt) | 20.0 | 6-04-152 |
| Calcium carbonate (38% Ca) | 18.0 | 6-01-069 |
| Cottonseed meal | 10.0 | 5-01-621 |
| Potassium chloride | 3.0 | 6-03-755 |
| Selenium premix (0.02 percent Se)1 | 3.0 | |
| Dried cane molasses (46% sugars) | 2.5 | 4-04-695 |
| Magnesium sulfate | 1.7 | 6-02-758 |
| Vitamin premix1 | 1.4 | |
| Magnesium oxide (58% Mg) | 1.2 | 6-02-756 |
| Potassium sulfate | 1.2 | 6-06-098 |
| Trace mineral premix1 | 1.04 | |
| Lasalocid Type A medicated article (68 g/lb)2 | 1.06 | |
| 1 Content of the vitamin and trace mineral premixes may be varied; however, they should be comparable to those used by the firm 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). | ||
| 2 To provide 1,440 g lasalocid per ton, use 21.2 lbs (1.06%) of a lasalocid Type A medicated article containing 68 g/lb. If using a lasalocid Type A medicated article containing 90.7 g/lb, use 15.88 lbs per ton (0.794%), adding molasses. | ||
(ii) Amount . 1,440 grams per ton.
(3) * * *
(i) Specification .
| Ingredient | Percent | International feed No. |
|---|---|---|
| Cane molasses | 55.167 | 4-13-241 |
| Condensed molasses fermentation solubles | 24.0 | |
| 50% Urea Solution (23% N) | 12.0 | |
| Ammonium polyphosphate solution | 1.0 | 6-08-42 |
| Phosphoric acid (54%) | 3.0 | 6-03-707 |
| Xanthan gum | 0.05 | 8-15-818 |
| Water | 4.0 | |
| Trace mineral premix1 | 0.5 | |
| Vitamin premix1 | 0.2 | |
| Lasalocid Type A medicated article (90.7 g/lb)2 | 0.083 | |
| 1 Content of the vitamin and trace mineral premixes may be varied; however, they should be comparable to those used by the firm 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). | ||
| 2 To provide 150 gm lasalocid per ton, use 1.652 lb (0.083%) of a lasalocid liquid Type A medicated article containing 90.7 g/lb. If using a dry lasalocid Type A medicated article containing 68 g/lb, use, use 2.206 lbs per ton (0.111%), replacing molasses. If using a dry lasalocid Type A medicated article containing 90.7 g/lb, use 1.652 lbs per ton (0.083%), adding molasses. | ||
(ii) Amount . 150 grams per ton.
(4) * * *
(i) Specification .
| Ingredient | Percent | International feed No. |
|---|---|---|
| Monocalcium phosphate (21% P) | 57.70 | 6-01-082 |
| Salt | 17.55 | 6-04-152 |
| Distillers dried grains w/ solubles | 5.40 | 5-28-236 |
| Dried cane molasses (46% Sugars) | 5.20 | 4-04-695 |
| Potassium chloride | 4.90 | 6-03-755 |
| Trace mineral/vitamin premix1 | 3.35 | |
| Calcium carbonate (38% Ca) | 2.95 | 6-01-069 |
| Mineral oil | 1.05 | 8-03-123 |
| Magnesium oxide (58% Mg) | 1.00 | 6-02-756 |
| Iron oxide (52% Fe) | 0.10 | 6-02-431 |
| Lasalocid Type A medicated article (68 g/lb)2 | 0.80 | |
| 1 Content of the vitamin and trace mineral premixes may be varied; however, they should be comparable to those used by the firm 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). | ||
| 2 To provide 1,088 g lasalocid per ton, use 16 lbs (0.80%) of a lasalocid Type A medicated article containing 68 g/lb. If using a lasalocid Type A medicated article containing 90.7 g/lb, use 12 lbs per ton (0.6%), adding molasses. | ||
Dated: November 7, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. E6-19614 Filed 11-20-06; 8:45 am]
BILLING CODE 4160-01-S