[Federal Register Volume 68, Number 188 (Monday, September 29, 2003)]
[Rules and Regulations]
[Pages 55822-55823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24496]


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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; Ivermectin and Pyrantel 
Pamoate Chewable 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 an abbreviated new animal drug 
application (ANADA) filed by Heska Corp. The ANADA provides for use of 
chewable tablets containing ivermectin and pyrantel pamoate for 
prevention of heartworm disease and for treatment and control of 
certain gastrointestinal parasites in dogs.

DATES: This rule is effective September 29, 2003.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Heska Corp., 1825 Sharp Point Dr., Fort 
Collins, CO 80525, filed ANADA 200-338 that provides for veterinary 
prescription use of TRI-HEART PLUS (ivermectin and pyrantel pamoate) 
Chewable Tablets for prevention of canine heartworm disease caused by 
Dirofilaria immitis and for treatment and control of ascarids (Toxocara 
canis, Toxascaris leonina) and hookworms (Ancylostoma caninum, A. 
braziliense, and Uncinaria stenocephala) in dogs. Heska Corp.'s TRI-
HEART PLUS Chewable Tablets is approved as a

[[Page 55823]]

generic copy of Merial's HEARTGARD Plus Chewables, approved under NADA 
140-971. ANADA 200-338 is approved as of August 13, 2003, and 21 CFR 
520.1196 is amended to reflect the approval. The basis of approval is 
discussed in the freedom of information summary.
    In addition, Heska Corp. is not currently listed in the animal drug 
regulations as a sponsor of an approved application. At this time, 21 
CFR 510.600(c) is being amended to add entries for the firm.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 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 Division of Dockets Management 
(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.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

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

21 CFR Part 520

    Animal drugs.

0
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

0
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.

0
2. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding a new entry for ``Heska Corp.'' and in the table 
in paragraph (c)(2) by numerically adding a new entry for ``063604'' to 
read as follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
            Firm name and address                  Drug labeler code
------------------------------------------------------------------------
                                * * * * *
Heska Corp., 1825 Sharp Point Dr., Fort        063604
 Collins, CO 80525.
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
     Drug labeler code                  Firm name and address
------------------------------------------------------------------------
                                * * * * *
063604....................  Heska Corp., 1825 Sharp Point Dr., Fort
                             Collins, CO 80525
                                * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
4. Section 520.1196 is amended by revising paragraph (b) to read as 
follows:


Sec.  520.1196  Ivermectin and pyrantel pamoate chewable tablets.

* * * * *
    (b) Sponsors. See Nos. 050604, 051311, and 063604 in Sec.  
510.600(c) of this chapter.
* * * * *

    Dated: September 15, 2003.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 03-24496 Filed 9-26-03; 8:45 am]
BILLING CODE 4160-01-S