[Federal Register Volume 72, Number 215 (Wednesday, November 7, 2007)]
[Rules and Regulations]
[Page 62771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-21839]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Ivermectin

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 Norbrook Laboratories, Ltd. 
The supplemental ANADA adds claims for persistent effectiveness against 
various species of external and internal parasites when cattle are 
treated with a one percent ivermectin solution by subcutaneous 
injection.

DATES: This rule is effective November 7, 2007.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works, 
Newry BT35 6JP, Northern Ireland, filed a supplement to ANADA 200-437 
that provides for use of NOROMECTIN (ivermectin) Injection for Cattle 
and Swine. The supplemental ANADA adds claims for persistent 
effectiveness against various species of external and internal 
parasites of cattle. The supplemental ANADA is approved as of October 
5, 2007, and the regulations are amended in 21 CFR 522.1192 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 522

    Animal drugs.

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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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

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2. In Sec.  522.1192, revise paragraph (b)(2) and add paragraph (b)(3) 
to read as follows:


Sec.  522.1192  Ivermectin.

* * * * *
    (b) * * *
    (2) No. 055529 for use of the product described in paragraph (a)(2) 
of this section as in paragraphs (e)(2)(i), (e)(2)(ii)(A), 
(e)(2)(ii)(C), (e)(2)(iii), (e)(3), (e)(4) and (e)(5) of this section.
    (3) No. 059130 for use of the product described in paragraph (a)(2) 
of this section as in paragraphs (e)(2)(i), (e)(2)(ii)(A), 
(e)(2)(ii)(B), (e)(2)(iii), (e)(3), (e)(4), and (e)(5) of this section.
* * * * *

    Dated: October 26, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-21839 Filed 11-6-07; 8:45 am]
BILLING CODE 4160-01-S