[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) * * *
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Firm name and address Drug labeler code
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* * * * *
Heska Corp., 1825 Sharp Point Dr., Fort 063604
Collins, CO 80525.
* * * * *
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(2) * * *
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Drug labeler code Firm name and address
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* * * * *
063604.................... Heska Corp., 1825 Sharp Point Dr., Fort
Collins, CO 80525
* * * * *
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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