[Federal Register Volume 64, Number 72 (Thursday, April 15, 1999)]
[Rules and Regulations]
[Pages 18571-18572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-9459]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520


Oral Dosage Form New Animal Drugs; Dichlorvos Tablets

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 Boehringer Ingelheim Vetmedica, Inc. The 
supplemental NADA provides for veterinary prescription use of 
additional dichlorvos tablet sizes for the treatment of certain worm 
infections in cats and puppies and for the treatment of dogs and 
kittens.

EFFECTIVE DATE: April 15, 1999.

FOR FURTHER INFORMATION CONTACT:  Dennis M. Bensley, Center for 
Veterinary Medicine (HFV-143), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6956.

SUPPLEMENTARY INFORMATION:  Boehringer Ingelheim Vetmedica, Inc., 2621 
North Belt Hwy., St. Joseph, MO 64506-2002, is the sponsor of NADA 48-
271 that provides for veterinary prescription use of Task 
(dichlorvos) tablets for cats and puppies for removal and control of 
certain intestinal roundworms and hookworms. The firm filed a 
supplemental NADA that provides for the use of 10- and 20-milligram 
(mg) dichlorvos tablets, in addition to 2- and 5-mg tablets, in cats 
and puppies, and for the use of dichlorvos tablets in dogs and kittens. 
The supplemental NADA is approved as of March 4, 1999, and the 
regulations are amended by revising 21 CFR 520.600(i) to reflect the 
approval. The basis for approval is discussed in the freedom of 
information summary.
    Also, the list of sponsors of approved applications in 21 CFR 
510.600(c) is amended to reflect the sponsor's current zip code.
    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(d)(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 510

     Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 520

     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 parts 510 and 
520 are amended as follows:

PART 510--NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

Sec. 510.600   [Amended]

    2. Section 510.600 Names, addresses, and drug labeler codes of 
sponsors of approved applications is amended in the table in paragraph 
(c)(1) in the entry for ``Boehringer Ingelheim Vetmedica, Inc.'' and in 
the table in paragraph (c)(2) in the entry for ``000010'' by removing 
``64502'' and adding in its place ``64506-2002''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

    4. Section 520.600 is amended by revising paragraph (i) to read as 
follows:


Sec. 520.600   Dichlorvos.

* * * * *
    (i) Conditions of use in dogs, cats, puppies, and kittens. (1) Each 
tablet contains 2, 5, 10, or 20 milligrams of dichlorvos.
    (2) It is administered orally at 5 milligrams of dichlorvos per 
pound of body weight.
    (3) Dogs and puppies: Removal and control of intestinal roundworms 
(Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma 
caninum and Uncinaria stenocephala).
    (4) Cats and kittens: Removal and control of intestinal roundworms

[[Page 18572]]

(Toxocara cati and Toxascaris leonina) and hookworms (Ancylostoma 
tubaeforme and Uncinaria stenocephala).
    (5) Dichlorvos is a cholinesterase inhibitor. Do not use 
simultaneously with or within a few days before or after treatment with 
or exposure to cholinesterase-inhibiting drugs, pesticides, or 
chemicals.
    (6) Do not use in animals under 10 days of age or 1 pound of body 
weight.
    (7) Do not administer to animals showing signs of constipation, 
mechanical blockage of the intestinal tract, impaired liver function, 
or recently exposed to or showing signs of infectious disease.
    (8) Do not use in dogs or puppies infected with Dirofilaria 
immitis.
    (9) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

    Dated: April 1, 1999.
Andrew J. Beaulieu,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 99-9459 Filed 4-14-99; 8:45 am]
BILLING CODE 4160-01-F