[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]


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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; Lasalocid and 
Virginiamycin

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 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
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  *                    *                    *                    *                    *                    *
                                                             *
(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.
  *                    *                    *                    *                    *                    *
                                                             *
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    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