Document ID: FDA-2011-N-0003-0040
Agency: fda
Document Type: Rule
Title: Ophthalmic and Topical Dosage Form New Animal Drugs; Eprinomectin
Posted Date: 2011-11-25T05:00Z

[Federal Register Volume 76, Number 227 (Friday, November 25, 2011)]
[Rules and Regulations]
[Page 72619]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30328]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

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

Ophthalmic and Topical Dosage Form New Animal Drugs; Eprinomectin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Merial Ltd. The supplemental NADA provides 
for addition of a warning statement against the use of eprinomectin 
topical solution in preruminating calves intended for veal.

DATES: This rule is effective November 25, 2011.

FOR FURTHER INFORMATION CONTACT:  Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, (240) 276-8341, email: 
cindy.burnsteel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg. 
500, Duluth, GA 30096-4640 filed a supplement to NADA 141-079 for 
EPRINEX (eprinomectin) Pour-On for Beef and Dairy Cattle, a topical 
solution used for the treatment and control of internal and external 
parasites of cattle on pasture with persistent effectiveness. The 
supplemental NADA provides for addition of a warning statement against 
the use of eprinomectin topical solution in preruminating calves 
intended for veal. The NADA is approved as of September 23, 2011, and 
the regulations are amended in 21 CFR part 524 to reflect the approval.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    The Agency 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 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 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 part 524 is 
amended as follows:

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

0
1. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

0
2. Revise Sec.  524.814 to read as follows:

Sec.  524.814  Eprinomectin.

    (a) Specifications. Each milliliter (mL) contains 5 milligrams (mg) 
of eprinomectin.
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.227 of this chapter.
    (d) Special considerations. See Sec.  500.25 of this chapter.
    (e) Conditions of use in cattle--(1) Amount. Apply 5 mg (1 mL) per 
10 kilograms (kg) of body weight (500 micrograms/kg) applied topically 
along backbone from withers to tailhead.
    (2) Indications for use. For treatment and control of 
gastrointestinal roundworms (Haemonchus placei (adult and L4), 
Ostertagia ostertagi (adult and L4, including inhibited L4), 
Trichostrongylus axei (adult and L4), T. colubriformis (adult and L4), 
T. longispicularis (adult), Cooperia oncophora (adult and L4), C. 
punctata (adult and L4), C. surnabada (adult and L4), Nematodirus 
helvetianus (adult and L4), Bunostomum phlebotomum (adult and L4), 
Oesophagostomum radiatum (adult and L4), Strongyloides papillosus 
(adults), Trichuris spp. (adults)); lungworms (Dictyocaulus viviparus, 
adult and L4); cattle grubs (all parasitic stages Hypoderma lineatum, 
H. bovis); lice (Damalinia bovis, Linognathus vituli, Haematopinus 
eurysternus, Solenopotes capillatus); mange mites (Chorioptes bovis, 
Sarcoptes scabiei); and horn flies (Haematobia irritans). Controls and 
protects from reinfection of D. viviparus for 21 days after treatment 
and H. irritans for 7 days after treatment.
    (3) Limitations. A withdrawal period has not been established for 
preruminating calves. Do not use in calves to be processed for veal.

    Dated: November 18, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2011-30328 Filed 11-23-11; 8:45 am]
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