[Federal Register: December 5, 2002 (Volume 67, Number 234)]
[Rules and Regulations]
[Page 72370-72373]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05de02-8]
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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; Decoquinate
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 decoquinate Type A medicated articles to make
Type C medicated feeds for cattle, sheep, and goats at a broader range
of concentrations for the prevention of coccidiosis.
DATES: This rule is effective December 5, 2002.
FOR FURTHER INFORMATION CONTACT: Janis R. Messenheimer, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7578, e-mail:
jmessenh@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box
1399, Fort Lee, NJ 07024, filed a supplement to NADA 39-417 that
provides for use of DECCOX (decoquinate) Type A medicated articles to
make Type C medicated feeds for cattle, sheep, and goats at a broader
range of concentrations for the prevention of coccidiosis caused by
various Eimeria species. The NADA is approved as of September 4, 2002,
and the regulations are amended in 21 CFR 558.195 to reflect the
approval. Section 558.195 is also revised to reflect a current format.
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.
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 Subjects 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:
PART 558--NEW 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 558.195 is revised to read as follows:
Sec. 558.195 Decoquinate.
(a) Specifications. Type A medicated article containing 6 percent
decoquinate.
(b) Approvals. See No. 046573 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.170 of this chapter.
(d) Special considerations. (1) Bentonite should not be used in
decoquinate feeds.
(2) Type A medicated articles may be used to manufacture dry or
liquid Type B cattle (including veal calf), sheep, and goat feeds as in
paragraphs (e)(2) and (e)(3) of this section.
(3) Type C cattle feeds may be manufactured from decoquinate liquid
Type B feeds having a pH between 5.0 to 6.5 and containing a suspending
agent to maintain a viscosity of not less than 500 centipoises.
(e) Conditions of use. It is used as follows:
(1)Chickens.
------------------------------------------------------------------------
Decoquinate in Combination in Indications
grams/ton grams/ton for use Limitations Sponsor
------------------------------------------------------------------------
(i) 27.2 .............. Broiler Do not feed 046573
chickens: For to laying
prevention of chickens.
coccidiosis
caused by
Eimeria
tenella, E.
necatrix, E.
mivati,E.
acervulina,
E. maxima,
and E.
brunetti.
(ii) 27.2 Bacitracin Broiler Feed 046573
methylene chickens: As continuously
disalicylate in paragraph as sole
4 to 50 (e)(1)(i) of ration; do
this section; not feed to
and for laying
increased chickens.
rate of Bacitracin
weight gain methylene
and improved disalicylate
feed as provided
efficiency. by No.
046573 in
Sec.
510.600(c)
of this
chapter.
(iii) 27.2 Bacitracin Broiler Feed 046573
zinc 10 to 50 chickens: As continuously
in paragraph as sole
(e)(1)(ii) of ration; do
this section. not feed to
laying
chickens.
Bacitracin
zinc as
provided by
No. 046573
in Sec.
510.600(c)
of this
chapter.
(iv) 27.2 Bacitracin Broiler Do not feed 046573
zinc 12 to 50 chickens: As to laying
plus in paragraph chickens;
roxarsone 11 (e)(1)(ii) of withdraw 5
to 45 this section. days before
slaughter;
as sole
source of
organic
arsenic.
.............. .............. Bacitracin .........
zinc and
roxarsone as
provided by
No. 046573
in Sec.
510.600(c)
of this
chapter.
[[Page 72371]]
(v) 27.2 Bacitracin Broiler Feed 046573
methylene chickens: As continuously
disalicylate in paragraph as sole
50 and (e)(1)(ii) of ration; do
roxarsone this section; not feed to
22.7 to 45.4 as an aid in laying
the chickens;
prevention of withdraw 5
necrotic days before
enteritis slaughter.
caused or Not for use
complicated in breeder
by chickens.
Clostridium Use as sole
spp. or other source of
organisms organic
susceptible arsenic.
to Poultry
bacitracin; should have
and for access to
improved drinking
pigmentation. water at all
times. Drug
overdosage
or lack of
drinking
water may
result in
leg weakness
or
paralysis.
Bacitracin
methylene
disalicylate
and
roxarsone as
provided by
No. 046573
in Sec.
510.600(c)
of this
chapter.
(vi) 27.2 Chlortetracycl Chickens: As Feed 046573
ine 100 to in paragraph continuously
200 (e)(1)(i) of for 7 to 14
this section; days; do not
control of feed to
infectious chickens
synovitis producing
caused by eggs for
Mycoplasma human
synoviae consumption.
susceptible
to
chlortetracyc
line.
(vii) 27.2 Chlortetracycl Chickens: As As in 046573
ine 200 to in paragraph paragraph
400 (e)(1)(i) of (e)(1)(vi)
this section; of this
and for section.
control of
chronic
respiratory
disease (CRD)
and air sac
infection
caused by M.
gallisepticum
and
Escherichia
coli
susceptible
to
chlortetracyc
line.
(viii) 27.2 Lincomycin 2 Broiler Feed as sole 000009
chickens: As ration; do 046573
in paragraph not feed to
(e)(1)(ii) of laying
this section. chickens;
lincomycin
provided by
No. 000009
in Sec.
510.600(c)
of this
chapter.
(ix) 27.2 Roxarsone 45.4 Broiler Do not feed 046573
chickens: As to laying
in paragraph chickens;
(e)(1)(ii) of withdraw 5
this section; days before
and for slaughter;
improving as sole
pigmentation. source of
organic
arsenic.
------------------------------------------------------------------------
(2) Cattle.
------------------------------------------------------------------------
Decoquinate in Combination in Indications
grams/ton grams/ton for use Limitations Sponsor
------------------------------------------------------------------------
(i) 12.9 to .............. Cattle Feed Type C 046573
90.8 (including feed or milk
ruminating replacer at
and a rate to
nonruminating provide 22.7
calves and milligrams
veal calves): (mg) per 100
For pounds (lb)
prevention of of body
coccidiosis weight (0.5
caused by mg/kilogram
Eimeria bovis (kg)) per
and E. day. Feed at
zuernii. least 28
days during
periods of
exposure to
coccidiosis
or when it
is likely to
be a hazard.
Do not feed
to cows
producing
milk for
food. May be
prepared
from dry or
liquid Type
B feed
containing
0.0125 to
0.5 percent
decoquinate.
See
paragraph
(d)(3) of
this
section.
(ii) 90.9 to .............. Cattle Feed as a top 046573
535.7 (including dress at a
ruminating rate to
and provide 22.7
nonruminating mg per 100
calves and lb of body
veal calves): weight (0.5
As in mg/kg) per
paragraph day. Feed at
(e)(2)(i) of least 28
this section. days during
periods of
exposure to
coccidiosis
or when it
is likely to
be a hazard.
Do not feed
to cows
producing
milk for
food. May be
prepared
from dry or
liquid Type
B feed
containing
0.0125 to
0.5 percent
decoquinate.
See
paragraph
(d)(3) of
this
section.
[[Page 72372]]
(iii) 13.6 Chlortetracycl Calves, beef Feed Type C 046573
ine and feed to
approximately nonlactating provide 22.7
400 (varying dairy cattle: mg
with body As in decoquinate
weight and paragraph and 1 gram
feed (e)(2)(i) of (g)
consumption this section; chlortetracy
to provide 10 for treatment cline per
mg/lb of body of bacterial 100 lb body
weight per enteritis weight (0.5
day) caused by E. mg/kg) per
coli; and for day for not
treatment of more than 5
bacterial days. Type C
pneumonia feed may be
caused by prepared
Pasteurella from Type B
multocida feed
organisms containing
susceptible 535.8 to
to 5,440 g/ton
chlortetracyc decoquinate
line. and 6,700 to
80,000 g/ton
chlortetracy
cline. When
consumed,
feed 22.7 mg
decoquinate
per 100 lb
body weight/
day for a
total of 28
days to
prevent
coccidiosis.
Withdraw 24
hours prior
to slaughter
when
manufactured
from CTC
(chlortetrac
ycline) Type
A medicated
articles
under NADA
141-147.
Zero
withdrawal
time when
manufactured
from
AUREOMYCIN
(chlortetrac
ycline) Type
A medicated
articles
under NADA
141-185. Do
not feed to
calves to be
processed
for veal. Do
not feed to
animals
producing
milk for
food.
(iv) 13.6 Monensin 5 to Cattle fed in Feed only to 046573
30 confinement cattle fed
for in
slaughter: As confinement
in paragraph for
(e)(2)(i) of slaughter.
this section; Feed
and for continuously
improved feed as the sole
efficiency. ration to
provide 22.7
mg of
decoquinate
per 100 lb
body weight
per day and
50 to 360 mg
of monensin
per head per
day. Feed at
least 28
days during
period of
exposure to
coccidiosis
or when it
is likely to
be a hazard.
Do not feed
to animals
producing
milk for
food. Also
see
paragraph
(d)(1) of
this section
and Sec.
558.355(d)(8
). Monensin
as provided
by No.
000986 in
Sec.
510.600(c)
of this
chapter.
(v) 13.6 Monensin 5 to Cattle fed in Feed only to 046573
30 plus confinement cattle fed
tylosin 8 to for in
10 slaughter: As confinement
in paragraph for
(e)(2)(i) of slaughter.
this section; Feed
for improved continuously
feed as the sole
efficiency; ration to
and for provide 22.7
reduction of mg of
incidence of decoquinate
liver per 100 lb
abscesses body weight
caused by per day, 50
Fusobacterium to 360 mg of
necrophorum monensin per
and head per
Actinomyces day, and 60
(Corynebacter to 90 mg of
ium) tylosin per
pyogenes. head per
day. Feed at
least 28
days during
period of
exposure to
coccidiosis
or when it
is likely to
be a hazard.
Do not feed
to animals
producing
milk for
food. Also
see
paragraph
(d)(1) of
this section
and Sec.
558.355(d)(8
). Monensin
and tylosin
as provided
by No.
000986 in
Sec.
510.600(c)
of this
chapter.
------------------------------------------------------------------------
(3) Minor species.
------------------------------------------------------------------------
Decoquinate in Combination in Indications
grams/ton grams/ton for use Limitations Sponsor
------------------------------------------------------------------------
(i) 12.9 to .............. 1. Young Feed Type C 046573
90.8 sheep: For feed or milk
the replacer at
prevention of a rate to
coccidiosis provide 22.7
caused by mg per 100
Eimeria lb of body
ovinoidalis, weight (0.5
E. mg per kg)
crandallis, per day;
E. parva, and feed for at
E. bakuensis. least 28
days during
periods of
exposure to
coccidiosis
or when it
is likely to
be a hazard.
Do not feed
to sheep
producing
milk for
food.
[[Page 72373]]
.............. 2. Young Feed Type C .........
goats: For feed or milk
the replacer at
prevention of a rate to
coccidiosis provide 22.7
caused by E. mg per 100
christenseni lb of body
and E. weight (0.5
ninakohlyakim mg per kg)
ovae. per day;
feed for at
least 28
days during
periods of
exposure to
coccidiosis
or when it
is likely to
be a hazard.
Do not feed
to goats
producing
milk for
food.
(ii) 90.9 to .............. 1. Young Feed as a top 046573
535.7 sheep: As in dress at a
item 1 of rate to
paragraph provide 22.7
(e)(3)(i) of mg per 100
this section. lb of body
weight (0.5
mg per kg)
per day;
feed for at
least 28
days during
periods of
exposure to
coccidiosis
or when it
is likely to
be a hazard.
Do not feed
to sheep
producing
milk for
food.
.............. 2. Young Feed as a top .........
goats: As in dress at a
item 2 of rate to
paragraph provide 22.7
(e)(3)(i) of mg per 100
this section. lb of body
weight (0.5
mg per kg)
per day;
feed for at
least 28
days during
periods of
exposure to
coccidiosis
or when it
is likely to
be a hazard.
Do not feed
to goats
producing
milk for
food.
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Dated: November 25, 2002.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 02-30863 Filed 12-4-02; 8:45 am]
BILLING CODE 4160-01-S