Document ID: FDA-2011-N-0003-0028
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs: Ivermectin
Posted Date: 2011-09-19T04:00Z

[Federal Register Volume 76, Number 181 (Monday, September 19, 2011)]
[Rules and Regulations]
[Pages 57905-57906]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23865]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2011-N-0003]

Implantation or Injectable Dosage Form New Animal Drugs; 
Ivermectin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

[[Page 57906]]

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 Cross Vetpharm Group Ltd. The ANADA 
provides for use of an ivermectin injectable solution for treatment and 
control of various internal and external parasites in cattle, swine, 
reindeer, and American bison.

DATES: This rule is effective September 19, 2011.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-170), 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 ANADA 200-447 for the use of 
BIMECTIN (ivermectin) Injection for Cattle and Swine for treatment and 
control of various internal and external parasites in cattle, swine, 
reindeer, and American bison. Cross Vetpharm Group Ltd.'s BIMECTIN 
Injection for Cattle and Swine is approved as a generic copy of Merial 
Ltd.'s IVOMEC (ivermectin) Injection for Cattle and Swine, approved 
under NADA 128-409. The ANADA is approved as of July 5, 2011, and the 
regulations in 21 CFR 522.1192 are amended to reflect the approval.
    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.
    FDA has determined under 21 CFR 25.33 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.

    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

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. In Sec.  522.1192, revise paragraph (b)(2) to read as follows:

Sec.  522.1192  Ivermectin.

* * * * *
    (b) * * *
    (2) Nos. 055529, 058005, 059130, and 061623 for use of the product 
described in paragraph (a)(2) of this section as in paragraphs (e)(2), 
(e)(3), (e)(4), and (e)(5) of this section.
* * * * *

    Dated: September 13, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-23865 Filed 9-16-11; 8:45 am]
BILLING CODE 4160-01-P