[Federal Register Volume 60, Number 200 (Tuesday, October 17, 1995)]
[Rules and Regulations]
[Pages 53701-53702]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25623]
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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 use of decoquinate Type A medicated articles to make Type
C medicated feeds for young sheep for the prevention of certain forms
of coccidiosis.
EFFECTIVE DATE: October 17, 1995.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary
[[Page 53702]]
Medicine (HFV-135), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1643.
SUPPLEMENTARY INFORMATION: Rhone-Poulenc, Inc., 500 Northridge Rd.,
suite 620, Atlanta, GA 30350, filed supplemental NADA 39-417, which
provides for use of Deccox (decoquinate) Type A medicated
article to make a Type C medicated feed for young sheep for the
prevention of coccidiosis caused by Eimeria bakuensis, E. crandallis,
E. ovinoidalis, and E. parva.
The supplemental NADA is approved as of August 28, 1995, and the
regulations are amended in 21 CFR 558.195 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 part 20
(21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for food-
producing animals qualifies for 3 years of marketing exclusivity
beginning August 28, 1995, because the supplemental NADA contains
reports of new clinical or field investigations (other than
bioequivalence or residue studies) essential to approval and conducted
or sponsored by the applicant. Marketing exclusivity applies only to
the use for which the supplemental NADA is approved.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
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 in paragraph (d) in the table by
numerically adding a new entry to read as follows:
Sec. 558.195 Decoquinate.
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(d) * * *
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Combination in grams
Decoquinate in grams per ton per ton Indications for use Limitations Sponsor
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13.6 (0.0015 pct).............. ....................... Young sheep; for Feed Type C feed at 011526
the prevention of a rate to provide
coccidiosis caused 22.7 mg per 100 lb
by Eimeria of body weight
ovinoidalis, E. (0.5 mg per kg)
crandallis, E. per day. Feed at
parva, E. least 28 days
bakuensis. during periods of
exposure to
coccidiosis or
when it is likely
to be a hazard. Do
not feed to sheep
producing milk for
food.
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Dated: October 5, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-25623 Filed 10-16-95; 8:45 am]
BILLING CODE 4160-01-F
