[Federal Register Volume 63, Number 31 (Tuesday, February 17, 1998)]
[Rules and Regulations]
[Pages 7701-7702]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3896]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556


Implantation or Injectable Dosage Form New Animal Drugs; 
Ivermectin

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 Merial Ltd. The supplemental NADA provides 
for use of 1 percent ivermectin injection for treatment and control of 
grubs in American bison and a tolerance for residues of ivermectin and 
its metabolites in edible tissues.

EFFECTIVE DATE: February 17, 1998.

FOR FURTHER INFORMATION CONTACT: Estella Z. Jones, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Merial Ltd., 2100 Ronson Rd., Ilesin, NJ 
08830-3077, is sponsor of NADA 128-409, which provides for the use of 
Ivomec Injection (1 percent ivermectin) for cattle, swine, 
and reindeer. The firm filed a supplement that provides for use

[[Page 7702]]

of 1 percent ivermectin injection for treatment and control of grubs 
(Hypoderma bovis) in American bison. The supplemental NADA is approved 
as of December 19, 1997, and the regulations are amended in 21 CFR 
522.1192 in paragraph (a)(2) and by adding new paragraph (d)(6) to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summary.
    A tolerance for residues of ivermectin in the edible tissues of 
bison has not previously been established. At this time, a tolerance 
for residues of ivermectin and its metabolites in American bison is 
established in Sec. 556.344 (21 CFR 556.344). Also, Sec. 556.344 is 
revised to reflect a newer 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 application 
may be seen in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
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 522

    Animal drugs.

21 CFR Part 556

     Animal drugs, Foods.
    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 parts 522 and 
556 are amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 522 continues to read as 
follows:

    Authority:  21 U.S.C. 360b.
    2. Section 522.1192 is amended in paragraph (a)(2) by revising the 
heading and by adding new paragraph (d)(6) to read as follows:

Sec. 522.1192   Ivermectin injection.

    (a) * * *
    (2) Cattle, reindeer, swine, and American bison. * * *
    (d) * * *
    (6) American bison--(i) Amount. 200 micrograms per kilogram (10 
milligrams per 110 pounds) of body weight.
    (ii) Indications for use. It is used in American bison for the 
treatment and control of grubs (Hypoderma bovis).
    (iii) Limitations. For subcutaneous use. Do not slaughter within 56 
days of last treatment. Consult your veterinarian for assistance in the 
diagnosis, treatment, and control of parasitism.

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

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

    Authority: 21 U.S.C. 342, 360b, 371.
    4. Section 556.344 is revised to read as follows:

Sec. 556.344   Ivermectin.

    The marker residue used to monitor the total residues of ivermectin 
and its metabolites in American bison is 22,23-dihydroavermectin 
B1a. The target tissue is liver. A tolerance is established 
for 22,23-dihydroavermectin B1a in liver as follows:

    (a) Cattle: 100 parts per billion.
    (b) Swine: 20 parts per billion.
    (c) Sheep: 30 parts per billion.
    (d) Reindeer: 15 parts per billion.
    (e) American bison. 15 parts per billion.

    Dated: January 30, 1998.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 98-3896 Filed 2-13-98; 8:45 am]
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