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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

CFR Citation: 21 CFR Part 558

NOTICE: RULES

ACTION: Animal drugs, feeds, and related products:

DOCUMENT ACTION: Final rule, technical amendment.

SUBJECT CATEGORY: New Animal Drugs for Use in Animal Feeds; Lasalocid; Technical Amendment

DATES: This rule is effective June 19, 2003.

DOCUMENT 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 a lasalocid Type A medicated article to make freechoice, loose mineral 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 regulations are also being revised to provide current references for the amounts of selenium and ethylenediamine dihydroiodide (EDDI) permitted in other freechoice cattle feeds.

SUMMARY: Lasalocid,

SUPPLEMENTAL INFORMATION

Alpharma, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, filed a supplement to NADA 96298 that provides for use of BOVATEC 68 (lasalocid) Type A medicated article to make a freechoice high phosphorus loose mineral Type C medicated feed containing 1088 grams lasalocid per ton of feed. The freechoice medicated feed is used for increased rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers). The NADA is approved as of April 9, 2003, 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.

Section 558.311 is also being revised to reflect publication of an updated compliance policy guide (CPG) on permitted levels of EDDI in animal feed (CPG 7125.18, May 1, 2000).

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 Dockets Management Branch (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.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies for 3 years of marketing exclusivity beginning April 9, 2003.

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. 801808.
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:
[[Page 36745]]
PART 558NEW 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. Section 558.311 is amended:

a. In paragraph (b)(4) by removing ``(e)(2) and (e)(3)'' and by adding in its place ``(e)(2), (e)(3), and (e)(4)'';

b. In paragraphs (e)(2)(i) and (e)(3)(i) by revising footnote 1;

c. By redesignating paragraph (e)(4) as paragraph (e)(5); and

d. By adding new paragraph (e)(4).
The revisions and addition read as follows:
Sec. 558.311 Lasolocid.
* * * * *
(e) * * *
(2) * * *
(i) * * *
\1\ Content of this vitamin and trace mineral premixes may be varied; however, they should be comparable to those used by the firm for other freechoice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with Sec. 573.920 of this chapter. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guide Sec. 651.100 (CPG 7125.18).
(3) * * *
(i) * * *
\1\Content of vitamin and trace mineral premixes may be varied; however, they should be comparable to those used for other freechoice liquid feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with Sec. 573.920 of this chapter. EDDI should comply with FDA Compliance Policy Guide Sec. 651.100 (CPG 7125.18).
* * * * *
(4) It is used as a freechoice, loose mineral Type C feed as follows:
(i) Specifications.
International Ingredient Percent feed No. Monocalcium Phosphate (21% P) 57.50 601082 Salt 17.55 604152 Distillers Dried Grains w/Solubles 5.40 528236 Dried Cane Molasses (46% Sugars) 5.20 404695 Potassium Chloride 4.90 603755 Trace Mineral/Vitamin Premix\1\ 3.35 ............. Calcium Carbonate (38% Ca) 2.95 601069 Mineral Oil 1.05 803123 Magnesium Oxide (58% Mg) 1.00 602756 Iron Oxide (52% Fe) 0.10 602431 Lasalocid Type A Medicated Article (68 g per 0.80 ............. pound)
\1\ Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for other freechoice loose mineral feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with Sec. 573.920 of this chapter. EDDI should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).
(ii) Amount. 1,088 grams per ton.
(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day. (iv) Limitations. Feed continuously on a freechoice basis at a rate of 60 to 300 mg lasalocid per head per day.
(v) Sponsor. See No. 046573 in Sec. 510.600(c) of this chapter. * * * * *

Dated: May 29, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 0315541 Filed 61803; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Eric S. Dubbin, Center for Veterinary Medicine (HFV126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855; 3018270232; email: edubbin@cvm.fda.gov.