[Federal Register: April 15, 1999 (Volume 64, Number 72)]
[Rules and Regulations]
[Page 18571-18572]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ap99-7]

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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<Register>
(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