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Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Pour-On

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 [Federal Register: January 30, 2003 (Volume 68, Number 20)]
[Rules and Regulations]
[Page 4712-4713]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ja03-8]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 524
 
Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin 
Pour-On

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 ECO LLC. The ANADA provides for topical 
use of ivermectin on cattle for treatment and control of various 
species of external and internal parasites.

DATES: This rule is effective January 30, 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: 
lluther@cvm.fda.gov.

SUPPLEMENTARY INFORMATION: ECO LLC, 8209 Hollister Ave., Las Vegas, NV 
89131, filed ANADA 200-348 for ECOMECTIN (ivermectin). The application 
provides for topical use of 0.5 percent ivermectin solution on cattle 
for the treatment and control of various species of gastrointestinal 
nematodes, lungworms, grubs, horn flies, lice, and mites. ECO's 
ECOMECTIN is approved as a generic copy of Merial Limited's IVOMEC 
Pour-On for Cattle, approved under NADA 140-841. The ANADA is approved 
as of November 15, 2002, and 21 CFR 524.1193 is amended to reflect the 
approval. The basis of approval is discussed in the freedom of 
information summary.
    In addition, ECO LLC has not been previously 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 Dockets Management Branch (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 524

    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 parts 510 and 
524 are amended as follows:

PART 510--NEW ANIMAL DRUGS

    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.
    2. Section 510.600 is amended in the table in paragraph (c)(1) by 
alphabetically adding an entry for ``ECO LLC'' and in the table in 
paragraph (c)(2) by numerically adding an entry for ``066916'' 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
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                                * * * * *
ECO LLC, 8209 Hollister Ave., Las Vegas, NV   066916
 89131.
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

[[Page 4713]]

------------------------------------------------------------------------
      Drug labeler code                 Firm name and address
------------------------------------------------------------------------
                                * * * * *
066916                       ECO LLC, 8209 Hollister Ave., Las Vegas, NV
                              89131
                                * * * * *
------------------------------------------------------------------------

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

Sec.  524.1193  [Amended]

    4. Section 524.1193 Ivermectin pour-on is amended in paragraph (b) 
by removing ``and 059130'' and by adding in its place ``, 059130, and 
066916''.

    Dated: January 6, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 03-2111 Filed 1-29-03; 8:45 am]
BILLING CODE 4160-01-S

 
 

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