[Federal Register: November 21, 2006 (Volume 71, Number 224)]
[Rules and Regulations]
[Page 67299-67300]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21no06-4]
[[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.
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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 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.
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\.......................................
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\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.
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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]
BILLING CODE 4160-01-S