Document ID: FDA-2008-N-0039-0056
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs; Ivermectin Paste
Posted Date: 2008-06-17T04:00Z

[Federal Register: June 17, 2008 (Volume 73, Number 117)]
[Rules and Regulations]               
[Page 34184]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17jn08-2]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

 
Oral Dosage Form New Animal Drugs; Ivermectin Paste

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 abbreviated new 
animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The 
supplemental ANADA adds effectiveness claims against various species of 
internal parasites when horses are treated with ivermectin paste.

DATES: This rule is effective June 17, 2008.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed a supplement to ANADA 200-326 for 
BIMECTIN (ivermectin) Paste 1.87% adding effectiveness claims against 
various species of internal parasites of horses. The supplemental ANADA 
is approved as of May 23, 2008, and 21 CFR 520.1192 is amended to 
reflect the approval.
    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 in 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 part 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

0
2. In Sec.  520.1192, remove paragraphs (b)(4) and (e)(1)(ii)(C) and 
revise paragraph (b)(3) to read as follows:

Sec.  520.1192  Ivermectin paste.

* * * * *
    (b) * * *
    (3) Nos. 051311, 054925, and 061623 for use of a 1.87 percent paste 
for use as in paragraphs (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of 
this section.
* * * * *

    Dated: June 9, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-13607 Filed 6-16-08; 8:45 am]

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