[Federal Register Volume 62, Number 82 (Tuesday, April 29, 1997)]
[Rules and Regulations]
[Pages 23128-23129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10986]
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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 Rhone-Poulenc, Inc. The supplemental NADA
provides for certain revisions in the Type C medicated feed fed for
prevention of coccidiosis in cattle, sheep, and goats.
EFFECTIVE DATE: April 29, 1997.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1643.
SUPPLEMENTARY INFORMATION: Rhone-Poulenc, Inc., P.O. Box 125, Black
Horse Lane, Monmouth Junction, NJ 66210, filed supplemental NADA 39-
417, which provides for use of 6 percent decoquinate Type A medicated
article to make 0.06 to 0.6 percent decoquinate Type B feeds to make
0.0015 to 0.059 percent decoquinate Type C medicated feed for cattle,
sheep, and goats for prevention of coccidiosis. The supplemental NADA
is approved as of
[[Page 23129]]
March 7, 1997, and the regulations are amended in 21 CFR 558.195(c) and
(d) to reflect the approval.
The supplemental NADA does not contain added safety or
effectiveness data. Therefore, a freedom of information (FOI) summary
for the supplemental approval is not required. An FOI summary for the
currently approved application may be seen in the Dockets Management
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm.
1-23, Rockville, MD 20857, between 9 a.m. to 4 p.m., Monday through
Friday.
The agency has determined under 21 CFR 25.24(d)(1)(iii) 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.
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: Secs. 512, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b, 371).
2. Section 558.195 is amended by adding new paragraph (c)(2) and in
the table in paragraph (d) a new entry for ``13.6 to 535.7 (0.0015 to
0.059 pct)'' to read as follows:
Sec. 558.195 Decoquinate.
* * * * *
(c) * * *
(2) Type A medicated articles containing 6 percent decoquinate may
be used to make dry or liquid Type B cattle (including veal calf),
sheep, and goat feeds as in paragraph (d) of this section.
(d) * * *
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Decoquinate in Combination in
grams per ton grams per ton Indications for use Limitations Sponsor
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* * * * * *
*
13.6 to 535.7 Cattle: prevention Feed Type C feed (including dry milk 011526
(0.0015 to of coccidiosis in replacer) to provide 22.7 mg per 100
0.059 pct) ruminating and lb body weight (0.5 mg per kg) per
nonruminating day. May be prepared from dry Type B
calves (including feed containing 0.06 to 0.6 pct
veal calves) and decoquinate or liquid Type B feed
cattle caused by containing 0.0125 to 0.05 pct
Eimeria bovis and decoquinate. The liquid Type B feed
E. zurnii. must have pH 5.0 to 6.5 and contain
a suspending agent to maintain a
viscosity of not less than 500
centipoises. 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.
Young sheep: do do
prevention of
coccidiosis caused
by Eimeria
ovinoidalis, E.
parva, E.
bakuensis, E.
crandallis.
Young goats: do do
prevention of
coccidiosis caused
by Eimeria
christenseni, E.
ninakohlyakimovae.
* * * * * *
*
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Dated: April 8, 1997.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 97-10986 Filed 4-28-97; 8:45 am]
BILLING CODE 4160-01-F