[Federal Register Volume 64, Number 177 (Tuesday, September 14, 1999)]
[Rules and Regulations]
[Pages 49655-49656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23970]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use in Animal Feeds; Lasalocid and
Virginiamycin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a new animal drug application
(NADA) filed by Roche Vitamins, Inc. The NADA provides for
[[Page 49656]]
use of approved lasalocid and virginiamycin Type A medicated articles
to make Type C medicated feeds used for prevention of coccidiosis and
for increased rate of weight gain and improved feed efficiency in
growing turkeys.
EFFECTIVE DATE: September 14, 1999.
FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-1600.
SUPPLEMENTARY INFORMATION: Roche Vitamins, Inc., 45 Waterview Blvd.,
Parsippany, NJ 07054-1298, filed NADA 141-150 that provides for use of
Avatec (90.7 grams per pound (g/lb) of lasalocid as lasalocid
sodium) and Stafac (20 or 227 g/lb of virginiamycin) Type A
medicated articles to make Type C medicated feeds for growing turkeys.
The Type C medicated feeds are used for prevention of coccidiosis
caused by Eimeria meleagrimitis, E. gallopavonis, and E. adenoeides,
and for increased rate of weight gain and improved feed efficiency in
growing turkeys. The NADA is approved as of August 6, 1999, and the
regulations are amended in 21 CFR 558.311 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 21 CFR
part 20 and 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)(2) 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. 801-808.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the 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: 21 U.S.C. 360b, 371.
2. Section 558.311 is amended in the table in paragraph
(e)(1)(xiv), under the ``Combination in grams per ton'' column, by
alphabetically adding an entry for ``Virginiamycin 10 to 20'' to read
as follows:
Sec. 558.311 Lasalocid.
* * * * *
(e)(1) * * *
----------------------------------------------------------------------------------------------------------------
Lasalocid sodium
activity in grams per Combination in grams Indications for use Limitations Sponsor
ton per ton
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
(xiv) 68 (0.0075 pct) * * * * * * * * *
to 113 (0.0125 pct).
* * * * * *
*
Virginiamycin 10 to 20 Growing turkeys; for Feed continuously as 063238
prevention of sole ration. As
coccidiosis caused lasalocid sodium
by E. meleagrimitis, provided by 063238
E. gallopavonis, and and virginiamycin
E. adenoeides, and provided by 000069.
for increased rate
of weight gain and
improved feed
efficiency.
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
* * * * *
Dated: August 30, 1999.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 99-23970 Filed 9-13-99; 8:45 am]
BILLING CODE 4160-01-F
