[Federal Register Volume 60, Number 127 (Monday, July 3, 1995)]
[Rules and Regulations]
[Pages 34460-34461]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16091]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 558
New Animal Drugs For Use In Animal Feeds; Decoquinate; Technical
Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to clarify the conditions of use in the approved new
animal drug application (NADA) for Type C decoquinate cattle feed. This
amendment was requested by the sponsor, Rhone-Poulenc, Inc.
EFFECTIVE DATE: July 3, 1995.
FOR FURTHER INFORMATION CONTACT: Naba K. Das, Center for Veterinary
Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1644.
SUPPLEMENTARY INFORMATION: In the Federal Register of December 3, 1976
(41 FR 53002), FDA published a document reflecting approval of
supplemental NADA 39-417V filed by Hess and Clark, Division of Rhodia,
Inc., Ashland, OH, proposing safe and effective use of a 6 percent
decoquinate premix for manufacturing a cattle feed used as an aid in
the prevention of coccidiosis. The supplemental NADA amended
Sec. 558.195(g)(2) (21 CFR 558.195(g)(2)) in the table to reflect the
approval.
In the Federal Register of September 30, 1986, FDA published a
document reflecting a change of sponsor of NADA 39-417 Deccox
(decoquinate) from Hess & Clark, Inc., to Rhone Poulenc, Inc. The new
sponsor of decoquinate, Rhone-Poulenc, Inc., P.O. Box 125, Black Horse
Lane, Monmouth Junction, NJ 08852, informed FDA that the regulation for
use of Type C decoquinate cattle feed that reflects the conditions of
use in its approved NADA were incorrect. Section 558.195(d) in the
table in the entry for ``22.7 mg per 100 lb * * *'' provides the
feeding level for the cattle feed. This information usually is provided
in the ``Limitations'' column. The firm requested that the entry be
revised to place the concentration of active ingredient in the
``Decoquinate in grams per ton'' column and the feeding level in the
``Limitations'' column. FDA concurs
[[Page 34461]]
with the firm's request and is amending the regulations accordingly. In
addition, Sec. 558.195(c)(2) provides status of this product for the
National Academy of Sciences/National Research Council. The status is
outdated based upon the Generic Animal Drug and Patent Term Restoration
Act of 1988, therefore, Sec. 558.195(c)(2) is removed and reserved.
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 removing and reserving paragraph
(c)(2), and in the table in paragraph (d) by removing the entry for
``22.7 mg per 100 lb of body weight per day (0.5 mg per kilogram)'' and
adding a new entry in numerical order to read as follows:
Sec. 558.195 Decoquinate.
* * * * *
(d) * * *
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Decoquinate in grams Combination in grams
per ton per ton Indications for use Limitations Sponsor
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13.6 to 27.2 (0.0015 to ..................... Cattle; for the Feed Type C feed at a
0.003 pct). ............... prevention of rate to provide 22.7 mg
coccidiosis in per 100 lb of body
ruminating and weight (0.5 mg per kg)
nonruminating calves and per day. May be
cattle caused by Eimeria prepared from dry or
bovis and E. zumii. liquid Type B feed
containing 0.0125 to
0.5 pct decoquinate.
Liquid Type B feed must
have a pH range of 5.0
to 6.5 and contain a
suspending agent to
maintain a viscosity of
not less tha 500
centipoises. Feed at
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.
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Dated: June 23, 1995.
Andrew J. Beaulieau,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 95-16091 Filed 6-30-95; 8:45 am]
BILLING CODE 4160-01-F
