[Federal Register Volume 59, Number 74 (Monday, April 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9189]
[[Page Unknown]]
[Federal Register: April 18, 1994]
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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; Laidlomycin Propionate
Potassium
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 the approval of a new animal drug
application (NADA) filed by Syntex Animal Health, Division of Syntex
Agribusiness, Inc. The NADA provides for the use of laidlomycin
propionate potassium (CATTLYST) Type A medicated article to
make Type B and Type C medicated feeds for improved feed efficiency and
increased rate of weight gain in cattle fed in confinement for
slaughter.
EFFECTIVE DATE: April 18, 1994.
FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1638.
SUPPLEMENTARY INFORMATION: Syntex Animal Health, Division of Syntex
Agribusiness, Inc., 3401 Hillview Ave., Palo Alto, CA 94304, filed NADA
141-025 which provides for the use of 50 grams (g) per pound of
laidlomycin propionate potassium (CATTLYST) Type A medicated
article to make Type B and Type C medicated feeds for improved feed
efficiency and increased rate of weight gain in cattle fed in
confinement for slaughter. The Type C feed contains 5 g of laidlomycin
propionate potassium per ton of feed to provide not less than 30
milligrams (mg) and not more than 75 mg per head per day for improved
feed efficiency and increased rate of weight gain, and 5 to 10 g of
laidlomycin propionate potassium per ton of feed to provide not less
than 30 mg and not more than 150 mg per head per day for improved feed
efficiency.
The NADA is approved as of March 4, 1994, and the regulations are
amended in part 558 (21 CFR part 558) by adding laidlomycin propionate
potassium to the Category I table in Sec. 558.4(d) and by adding new
Sec. 558.305 to reflect the approval. The basis for 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.
Section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360b(c)(2)(F)(i) provides a 5-year period of
exclusivity to this original NADA beginning March 4, 1994, because no
active ingredient (including any ester or salt of the active
ingredient) has been approved in any other application under section
512(b)(1) of the act.
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 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 558.4 is amended in paragraph (d) in the ``Category I''
table by alphabetically adding a new entry for ``Laidlomycin propionate
potassium'' to read as follows:
Sec. 558.4 Medicated feed applications.
* * * * *
(d) * * *
* * * * *
Category I
------------------------------------------------------------------------
Assay
limits Type B maximum Assay limits
Drug percent1 (200x) percent\1\ type B/
type A C2
------------------------------------------------------------------------
*******
Laidlomycin 90-110 1 g/pound (0.22%). 90-115/85-115
propionate
potassium.
*******
------------------------------------------------------------------------
\1\Percent of labeled amount.
\2\Values given represent ranges for either Type B or Type C medicated
feeds. For those drugs that have two range limits, the first set is
for a Type B medicated feed and the second set is for a Type C
medicated feed. These values (ranges) have been assigned in order to
provide for the possibility of dilution of a Type B medicated feed
with lower assay limits to make Type C medicated feed.
* * * * *
3. New Sec. 558.305 is added to subpart B to read as follows:
Sec. 558.305 Laidlomycin propionate potassium.
(a) Approvals. Type A medicated articles: 50 grams per pound to
000033 in Sec. 510.600(c) of this chapter.
(b) Conditions of use. Used in cattle feed as follows:
(1) Amount. Laidlomycin propionate potassium, 5 grams per ton.
(i) Indications for use. For improved feed efficiency and increased
rate of weight gain.
(ii) Limitations. Feed only to cattle being fed in confinement for
slaughter. Feed continuously in a Type C feed at a rate of 30 to 75
milligrams per head per day.
(2) Amount. Laidlomycin propionate potassium, 5 to 10 grams per
ton.
(i) Indications for use. For improved feed efficiency.
(ii) Limitations. Feed only to cattle being fed in confinement for
slaughter. Feed continuously in a Type C feed at a rate of 30 to 150
milligrams per head per day.
(3) Special considerations--(i) Do not allow horses or other
equines access to feeds containing laidlomycin propionate potassium.
(ii) The safety of laidlomycin propionate potassium in unapproved
species has not been established.
(iii) Not for use in animals intended for breeding.
Dated: April 8, 1994.
Richard H. Teske,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 94-9189 Filed 4-15-94; 8:45 am]
BILLING CODE 4160-01-F