[Federal Register Volume 71, Number 224 (Tuesday, November 21, 2006)]
[Rules and Regulations]
[Pages 67299-67300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19614]



[[Page 67299]]

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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

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: 
[email protected].

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.

0
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

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

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

0
2. In Sec.  558.311, revise paragraphs (e)(2)(i), (e)(2)(ii), 
(e)(3)(i), (e)(3)(ii), and (e)(4)(i) to read as follows:


Sec.  558.311  Lasalocid.

* * * * *
    (e) * * *
    (2) * * *
    (i) Specification.

------------------------------------------------------------------------
                                                           International
                  Ingredient                     Percent      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 premix\1\.............................       1.4   .............
Magnesium oxide (58% Mg)......................       1.2       6-02-756
Potassium sulfate.............................       1.2       6-06-098
Trace mineral premix\1\.......................       1.04  .............
Lasalocid Type A medicated article (68 g/            1.06  .............
 lb)\2\.......................................
------------------------------------------------------------------------
\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.

------------------------------------------------------------------------
                                                           International
                  Ingredient                     Percent      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

[[Page 67300]]

 
Water.........................................      4.0    .............
Trace mineral premix\1\.......................      0.5    .............
Vitamin premix\1\.............................      0.2    .............
Lasalocid Type A medicated article (90.7 g/         0.083  .............
 lb)\2\.......................................
------------------------------------------------------------------------
\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.

------------------------------------------------------------------------
                                                           International
                  Ingredient                     Percent      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 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/            0.80  .............
 lb)\2\.......................................
------------------------------------------------------------------------
\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]
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