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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

CFR Citation: 21 CFR Part 558

NOTICE: RULES

ACTION: Animal drugs, feeds, and related products:

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: New Animal Drugs For Use in Animal Feeds; Decoquinate

DATES: This rule is effective December 5, 2002.

DOCUMENT 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.

SUMMARY: Decoquinate,

SUPPLEMENTAL INFORMATION

Alpharma, Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, filed a supplement to NADA 39417 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. 801808.
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 558NEW 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 141147.
Zero
withdrawal time when
manufactured from
AUREOMYCIN (chlortetrac ycline) Type A medicated articles
under NADA 141185. 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.

Dated: November 25, 2002.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. 0230863 Filed 12402; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Janis R. Messenheimer, Center for Veterinary Medicine (HFV135), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 3018277578, email:
jmessenh@cvm.fda.gov.