New Animal Drugs for Use in Animal Feeds; Lasalocid, 67299-67300 [E6-19614]
Download as PDF
<![CDATA[
Federal Register / Vol. 71, No. 224 / Tuesday, November 21, 2006 / Rules and Regulations
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).
This rule is effective November
21, 2006.
DATES:
Eric
S. Dubbin, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
FOR FURTHER INFORMATION CONTACT:
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,
67299
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:
I
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
I
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:
I
§ 558.311
*
Lasalocid.
*
*
*
(e) * * *
(2) * * *
(i) Specification.
Ingredient
*
Percent
Defluorinated phosphate (20.5% Ca, 18.5% P) ..................................................................................................................
Sodium chloride (salt) ..........................................................................................................................................................
Calcium carbonate (38% Ca) ..............................................................................................................................................
Cottonseed meal ..................................................................................................................................................................
Potassium chloride ..............................................................................................................................................................
Selenium premix (0.02 percent Se)1 ...................................................................................................................................
Dried cane molasses (46% sugars) ....................................................................................................................................
Magnesium sulfate ...............................................................................................................................................................
Vitamin premix1 ...................................................................................................................................................................
Magnesium oxide (58% Mg) ................................................................................................................................................
Potassium sulfate ................................................................................................................................................................
Trace mineral premix1 .........................................................................................................................................................
Lasalocid Type A medicated article (68 g/lb)2 ....................................................................................................................
35.9
20.0
18.0
10.0
3.0
3.0
2.5
1.7
1.4
1.2
1.2
1.04
1.06
International
feed No.
6–01–080
6–04–152
6–01–069
5–01–621
6–03–755
....................
4–04–695
6–02–758
....................
6–02–756
6–06–098
....................
....................
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.
cprice-sewell on PROD1PC66 with RULES
Ingredient
Percent
Cane molasses ....................................................................................................................................................................
Condensed molasses fermentation solubles .......................................................................................................................
50% Urea Solution (23% N) ................................................................................................................................................
Ammonium polyphosphate solution .....................................................................................................................................
Phosphoric acid (54%) ........................................................................................................................................................
Xanthan gum .......................................................................................................................................................................
VerDate Aug<31>2005
14:15 Nov 20, 2006
Jkt 211001
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
E:\FR\FM\21NOR1.SGM
21NOR1
55.167
24.0
12.0
1.0
3.0
0.05
International
feed No.
4–13–241
....................
....................
6–08–42
6–03–707
8–15–818
67300
Federal Register / Vol. 71, No. 224 / Tuesday, November 21, 2006 / Rules and Regulations
Ingredient
Percent
Water ...................................................................................................................................................................................
Trace mineral premix1 .........................................................................................................................................................
Vitamin premix1 ...................................................................................................................................................................
Lasalocid Type A medicated article (90.7 g/lb)2 .................................................................................................................
4.0
0.5
0.2
0.083
International
feed No.
....................
....................
....................
....................
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
Monocalcium phosphate (21% P) .......................................................................................................................................
Salt .......................................................................................................................................................................................
Distillers dried grains w/ solubles ........................................................................................................................................
Dried cane molasses (46% Sugars) ....................................................................................................................................
Potassium chloride ..............................................................................................................................................................
Trace mineral/vitamin premix1 .............................................................................................................................................
Calcium carbonate (38% Ca) ..............................................................................................................................................
Mineral oil ............................................................................................................................................................................
Magnesium oxide (58% Mg) ................................................................................................................................................
Iron oxide (52% Fe) .............................................................................................................................................................
Lasalocid Type A medicated article (68 g/lb)2 ....................................................................................................................
57.70
17.55
5.40
5.20
4.90
3.35
2.95
1.05
1.00
0.10
0.80
International
feed No.
6–01–082
6–04–152
5–28–236
4–04–695
6–03–755
....................
6–01–069
8–03–123
6–02–756
6–02–431
....................
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal
Feeds; Ractopamine
AGENCY:
Food and Drug Administration,
HHS.
cprice-sewell on PROD1PC66 with RULES
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of two supplemental new
animal drug applications (NADAs) filed
by Elanco Animal Health. The first
supplemental NADA revises the
concentrations of ractopamine
hydrochloride in single-ingredient Type
B and C medicated swine feeds used for
VerDate Aug<31>2005
14:15 Nov 20, 2006
Jkt 211001
increased rate of weight gain, improved
feed efficiency, and increased carcass
leanness. The other supplemental
NADA revises the concentrations of
ractopamine hydrochloride used with
tylosin phosphate in two-way Type C
medicated swine feeds to conform with
approved single-ingredient ractopamine
use.
DATES: This rule is effective November
21, 2006.
FOR FURTHER INFORMATION CONTACT:
Charles J. Andres, Center for Veterinary
Medicine (HFV–120), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855; tel: 301–827–
7561; e-mail:
charles.andres@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed a
supplement to NADA 140–863 that
provides for use of PAYLEAN
(ractopamine hydrochloride) Type A
medicated articles in Type B and C
medicated feeds used for increased rate
of weight gain, improved feed
efficiency, and increased carcass
leanness in finishing swine. The
supplement revises the concentrations
of ractopamine hydrochloride fed to
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
finishing swine, weighing not less than
150 pounds, fed a complete ration
containing at least 16 percent crude
protein for the last 45 to 90 pounds of
gain prior to slaughter. This
supplemental NADA was approved on
April 25, 2006. 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
supplemental approval qualifies for 3
years of marketing exclusivity beginning
April 25, 2006.
Elanco Animal Health also filed a
supplement to NADA 141–172 that
provides for use of two-way
combination Type C medicated swine
feeds formulated with PAYLEAN
(ractopamine hydrochloride) and
TYLAN (tylosin phosphate) singleingredient Type A medicated articles.
The supplement revises the
concentrations of ractopamine
hydrochloride in Type C medicated
feeds used for increased rate of weight
gain, improved feed efficiency, and
increased carcass leanness; and for
prevention and/or control of porcine
proliferative enteropathies (ileitis)
associated with Lawsonia intracellularis
and for prevention of swine dysentery
(vibrionic) in finishing swine, weighing
E:\FR\FM\21NOR1.SGM
21NOR1
]]>Agencies
[Federal Register Volume 71, Number 224 (Tuesday, November 21, 2006)]
[Rules and Regulations]
[Pages 67299-67300]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-19614]
[[Page 67299]]
-----------------------------------------------------------------------
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.
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]
BILLING CODE 4160-01-S
