[Federal Register Volume 68, Number 118 (Thursday, June 19, 2003)]
[Rules and Regulations]
[Pages 36744-36745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-15541]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Lasalocid; Technical 
Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule, technical amendment.

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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 
free-choice, 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 
free-choice cattle feeds.

DATES: This rule is effective June 19, 2003.

FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855; 301-827-0232; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed a supplement to NADA 96-298 that 
provides for use of BOVATEC 68 (lasalocid) Type A medicated article to 
make a free-choice high phosphorus loose mineral Type C medicated feed 
containing 1088 grams lasalocid per ton of feed. The free-choice 
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. 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:

[[Page 36745]]

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

0
1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

0
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 free-choice 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 free-choice 
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 free-choice, loose mineral Type C feed as 
follows:
    (i) Specifications.

------------------------------------------------------------------------
                                                           International
                   Ingredient                     Percent     feed No.
------------------------------------------------------------------------
Monocalcium Phosphate (21% P)                     57.50        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 Premix\1\                    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 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 free-choice
  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 free-choice 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. 03-15541 Filed 6-18-03; 8:45 am]
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