[Federal Register Volume 64, Number 51 (Wednesday, March 17, 1999)]
[Rules and Regulations]
[Pages 13068-13069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6461]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558


New Animal Drugs For Use In Animal Feeds; Lasalocid

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 Roche Vitamins, Inc. The supplemental NADA 
provides for use of a lower concentration lasalocid Type A medicated 
article to make a Type C rabbit feed used for prevention of coccidiosis 
and to provide for a tolerance for drug residues in rabbits.

EFFECTIVE DATE: March 17, 1999.

FOR FURTHER INFORMATION CONTACT: Estella Z. Jones, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7575.

SUPPLEMENTARY INFORMATION: Roche Vitamins, Inc., 45 Waterview Blvd., 
Parsippany, NJ 07054-1298, filed supplemental NADA 96-298 that provides 
for use of Bovatec (15 percent lasalocid) in addition to 
previously approved use of Avatec (20 percent lasalocid) Type 
A medicated articles to make 113 grams per ton lasalocid Type C rabbit 
feeds used for prevention of coccidiosis caused by Eimeria stiedae. The 
supplemental NADA is approved as of February 5, 1999, and the 
regulations are amended in 21 CFR 558.311(b)(4) to reflect the 
approval. The basis of approval is discussed in the freedom of 
information summary.
    At this time, the human food safety data originally submitted in 
public master file 5042 for use of lasalocid in rabbits was reevaluated 
and a tolerance for drug residues in edible rabbit tissues is 
established in 21 CFR 556.347. Also, that section is revised to reflect 
current format.
    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 supplemental 
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)(1) 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.

List of Subjects

21 CFR Part 556

     Animal drugs, Foods.

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

[[Page 13069]]

CFR parts 556 and 558 are amended as follows:

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

    1. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 360b, 371.
    2. Section 556.347 is revised to read as follows:


Sec. 556.347  Lasalocid.

    (a) [Reserved]
    (b) Tolerances--(1) Chickens. A tolerance is established for 
lasalocid residues of 0.3 part per million (ppm) parent lasalocid 
(marker residue) in skin with adhering fat (target tissue).
    (2) Cattle. A tolerance is established for lasalocid residues of 
0.7 ppm parent lasalocid (marker residue) in liver (target tissue).
    (3) Sheep. A tolerance for residues of lasalocid is not needed.
    (4) Rabbits. A tolerance is established for lasalocid residues of 
0.7 ppm parent lasalocid (marker residue) in liver (target tissue).

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    3. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.
    4. Section 558.311 is amended by revising paragraph (b)(4) to read 
as follows:


Sec. 558.311  Lasalocid.

 * * * * *
    (b) * * *
    (4) 15 percent activity to No. 063238 for use in Type C rabbit 
feeds as in paragraph (e)(1)(xvi) of this section and for use in 
ruminant free-choice Type C feeds as in paragraphs (e)(2) and (e)(3) of 
this section.
 * * * * *

    Dated: February 23, 1999.
 Andrew J. Beaulieu,
 Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 99-6461 Filed 3-16-99; 8:45 am]
BILLING CODE 4160-01-F