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[Federal Register: August 5, 2002 (Volume 67, Number 150)]
[Rules and Regulations]               
[Page 50596-50597]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05au02-3]                         

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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 Liquid

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 an abbreviated new animal drug 
application (ANADA) filed by First Priority, Inc. The ANADA provides 
for oral use of an ivermectin solution in sheep for the treatment and 
control of various internal parasites.

DATES: This rule is effective August 5, 2002.

[[Page 50597]]


FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-101), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209, e-mail: 
<A HREF="mailto:lluther@cvm.fda.gov">lluther@cvm.fda.gov</A>.

SUPPLEMENTARY INFORMATION: First Priority, Inc., 1585 Todd Farm Dr., 
Elgin, IL 60123, filed ANADA 200-327 for PRIVERMECTIN (ivermectin) 
Drench for Sheep. The application provides for oral use of a 0.08 
percent ivermectin solution in sheep for the treatment and control of 
various internal parasites. First Priority's PRIVERMECTIN Drench for 
Sheep is approved as a generic copy of Merial Limited's IVOMEC Drench 
for Sheep, approved under NADA 131-392. ANADA 200-327 is approved as of 
May 15, 2002, and the regulations are amended in Sec. 520.1195 (21 CFR 
520.1195) to reflect the approval. The basis of approval is discussed 
in the freedom of information summary. Section 520.1195 is also being 
amended to correctly describe the concentration of the product and to 
incorporate 21 CFR 520.1194 in a current format.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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 congressional review requirements in 5 
U.S.C. 801-808.

List of Subjects in 21 CFR Part 520

    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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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


Sec. 520.1194  [Removed]

    2. Section 520.1194 Ivermectin drench is removed.

    3. Section 520.1195 is revised to read as follows:


Sec. 520.1195  Ivermectin liquid.

    (a) Specifications--(1) Each milliliter (mL) contains 10 milligrams 
(mg) ivermectin.
    (2) Each mL of micellar solution contains 0.8 mg ivermectin.
    (b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this 
chapter.
    (1) Nos. 050604, 051259, 058829, and 059130 for use of product 
described in paragraph (a)(1) of this section as in paragraph (e)(1) of 
this section.
    (2) Nos. 050604 and 058829 for use of product described in 
paragraph (a)(2) of this section as in paragraph (e)(2) of this 
section.
    (c) Related tolerances. See Sec. 556.344 of this chapter.
    (d) Special considerations. See Sec. 500.25 of this chapter.
    (e) Conditions of use--(1) Horses--(i) Amount. 200 micrograms (mcg) 
per kilogram (/kg) of body weight as a single dose by stomach tube or 
as an oral drench.
    (ii) Indications for use. For the treatment and control of large 
strongyles (Strongylus equinus (adult), S. vulgaris (adult and arterial 
larval stages), S. endentatus (adult and migrating tissue stages), 
Triodontophorus spp. (adult)); small strongyles, including those 
resistant to some benzimidazole class compounds (Cyathostomum spp. 
(adult and fourth-stage larvae), Cylicocyclus spp., Cylicodontophorus 
spp., Cylicostephanus spp.); pinworms (Oxyuris equi (adult and fourth-
stage larvae)); ascarids (Parascaris equorum (adult and third- and 
fourth-stage larvae)); hairworms (Trichostongylus axei(adult)); large-
mouth stomach worms (Habronema muscae (adult)); stomach bots 
(Gastrophilus spp. (oral and gastric stages)); lungworms (Dictyocaulus 
arnfieldi (adult and fourth-stage larvae)); intestinal threadworms 
(Strongyloides westeri (adult)); summer sores caused by Habronema and 
Draschia spp. cutaneous third-stage larvae; and dermatitis caused by 
neck threadworm microfilariae (Onchocerca spp.).
    (iii) Limitations. Do not use in horses intended for food purposes. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) Sheep--(i) Amount. 200 mcg/kg (3 mL/26 pounds) of body weight 
as a single dose oral drench.
    (ii) Indications for use. For treatment and control of the adult 
and fourth-stage larvae of gastrointestinal roundworms (Haemonchus 
contortus, H. placei (adults only), Ostertagia circumcincta, 
Trichostrongylus axei, T. colubriformis, Cooperia oncophora (adults 
only), C. curticei, Oesophagostomum columbianum, O. venulosum(adults 
only), Nematodirus battus, N. spathiger, S. papillosus (adults only), 
Chabertia ovina (adult only), Trichuris ovis (adults only)); lungworms 
(D. filaria); and all larval stages of the nasal bot Oestrus ovis.
    (iii) Limitations. For use in sheep only. Do not use in other 
animal species as severe adverse reactions, including fatalities in 
dogs, may result. Do not treat sheep within 11 days of slaughter.

    Dated: July 17, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-19729 Filed 8-2-02; 8:45 am]
BILLING CODE 4160-01-S

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