[Federal Register Volume 62, Number 246 (Tuesday, December 23, 1997)]
[Rules and Regulations]
[Pages 66983-66984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33486]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation and Injectable Dosage Form New Animal Drugs; 
Imidocarb Dipropionate

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 Schering-Plough Animal Health Corp. The NADA provides 
for subcutaneous or intramuscular use of imidocarb dipropionate 
solution for dogs for treatment of babesiosis.

EFFECTIVE DATE: December 23, 1997

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1618.

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095 
Morris Ave., Union, NJ 07083, has filed NADA 141-071 Imizol 
(imidocarb dipropionate) solution for subcutaneous or intramuscular use 
for treatment of dogs with clinical signs of babesiosis and/or 
demonstrated Babesia organisms in the blood. The drug is limited to use 
by or on the order of a licensed veterinarian. The NADA is approved as 
of November 7, 1997, and the regulations are amended by adding new

[[Page 66984]]

21 CFR 522.1156 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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act, this approval for use in nonfood-producing animals 
qualifies for 3 years of marketing exclusivity beginning November 7, 
1997, because the application contains substantial evidence of the 
effectiveness of the drug involved and any studies of animal safety or, 
in the case of food-producing animals, human food safety studies (other 
than bioequivalence or residue studies) required for approval of the 
application and conducted or sponsored by the applicant.
    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 in 21 CFR Part 522

    Animal drugs.
    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 522 is 
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. New Sec. 522.1156 is added to read as follows:

Sec. 522.1156  Imidocarb dipropionate solution.

    (a) Specifications. Each milliliter of injectable solution contains 
120 milligrams of imidocarb.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs--(i) Amount. 6.6 milligrams 
imidocarb per kilogram (3 milligrams per pound) of body weight.
    (ii) Indications for use. Treatment of clinical signs of babesiosis 
and/or demonstrated Babesia organisms in the blood.
    (iii) Limitations. Use subcutaneously or intramuscularly. Not for 
intravenous use. Repeat the dose after 2 weeks for a total of two 
treatments. Imidocarb is a cholinesterase inhibitor. Do not use 
simultaneously with or a few days before or after treatment with or 
exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) [Reserved]

    Dated: December 15, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-33486 Filed 12-22-97; 8:45 am]
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