[Federal Register Volume 72, Number 95 (Thursday, May 17, 2007)]
[Rules and Regulations]
[Pages 27734-27735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9515]


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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 an abbreviated new animal drug 
application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA 
provides for use of a one percent ivermectin solution by subcutaneous 
injection in cattle, swine, reindeer, and American bison for the 
treatment and control of various internal and external parasites.

DATES: This rule is effective May 17, 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 supplemental ANADA 200-437 that 
provides for use of NOROMECTIN (ivermectin) Injection for Cattle and 
Swine by subcutaneous injection in cattle, swine, reindeer, and 
American bison for the treatment and control of various internal and 
external parasites. Norbrook Laboratories, Ltd.'s NOROMECTIN Injection 
for Cattle and Swine is approved as a generic copy of Merial, Ltd.'s 
IVOMEC Injection for Cattle and Swine approved under NADA 128-409. The 
ANADA is approved as of April 20, 2007, and the regulations are amended 
in 21 CFR 522.1192 to reflect the approval and a current format.
    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.
    FDA 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.

[[Page 27735]]

List of Subjects in 21 CFR Part 522

    Animal drugs.

0
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. Revise Sec.  522.1192 to read as follows:


Sec.  522.1192  Ivermectin.

    (a) Specifications--(1) Each milliliter (mL) of solution contains 
20 milligrams (mg) ivermectin.
    (2) Each mL of solution contains 10 mg ivermectin.
    (3) Each mL of solution contains 2.7 mg ivermectin.
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (e) of this section.
    (1) No. 050604 for use of the product described in paragraph (a)(1) 
of this section as in paragraph (e)(1) of this section; 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; and the product described in paragraph 
(a)(3) of this section as in paragraphs (e)(3) and (e)(6) of this 
section.
    (2) Nos. 059130 and 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)(B), (e)(2)(iii), (e)(3), (e)(4), and (e)(5) 
of this section.
    (c) Related tolerances. See Sec.  556.344 of this chapter.
    (d) Special considerations--(1) See Sec.  500.25 of this chapter.
    (2) Labeling shall bear the following precaution: ``This product 
should not be used in other animal species as severe adverse reactions, 
including fatalities in dogs, may result.''
    (e) Conditions of use--(1) Horses--(i) Amount. 200 micrograms per 
kilogram ([micro]g/kg) of body weight by intramuscular injection.
    (ii) Indications for use. For the treatment and control of large 
strongyles (adult) (Strongylus vulgaris, S. edentatus, Triodontophorus 
spp.), small strongyles (adult and fourth stage larvae) (Cyathostomum 
spp., Cylicocyclus spp., Cylicostephanus spp.), pinworms (adult and 
fourth-stage larvae) (Oxyuris equi), large roundworms (adult) 
(Parascaris equorum), hairworms (adult) (Trichostrongylus axei), large 
mouth stomach worms (adult) (Habronema muscae), neck threadworms 
(microfilariae) (Onchocerca spp.), and stomach bots (Gastrophilus 
spp.).
    (iii) Limitations. Not for use in horses intended for human 
consumption. Federal law restricts this drug to use by or on the order 
of a licensed veterinarian.
    (2) Cattle--(i) Amount. 200 [micro]g/kg of body weight by 
subcutaneous injection.
    (ii) Indications for use--(A) For the treatment and control of 
gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus 
placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, 
T. axei, T. colubriformis, Cooperia oncophora, C. punctata, C. 
pectinata, Oesophagostomum radiatum, Nematodirus helvetianus (adults 
only), N. spathiger (adults only), Bunostomum phlebotomum); lungworms 
(adults and fourth-stage larvae) (Dictyocaulus viviparus); grubs 
(parasitic stages) (Hypoderma bovis, H. lineatum); sucking lice 
(Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus); 
mites (scabies) (Psoroptes ovis (syn. P. communis var. bovis), 
Sarcoptes scabiei var. bovis).
    (B) For control of infections of D. viviparus for 28 days after 
treatment, and O. ostertagi for 21 days after treatment, and H. placei, 
T. axei, C. punctata, C. oncophora, and O. radiatum for 14 days after 
treatment.
    (C) For control of infections and to protect from reinfection with 
D. viviparus and O. radiatum for 28 days after treatment; O. ostertagi, 
T. axei, and C. punctata for 21 days after treatment; H. placei and C. 
oncophora for 14 days after treatment.
    (iii) Limitations. Do not treat cattle within 35 days of slaughter. 
Because a withdrawal time in milk has not been established, do not use 
in female dairy cattle of breeding age. A withdrawal period has not 
been established for this product in pre-ruminating calves. Do not use 
in calves to be processed for veal.
    (3) Swine--(i) Amount. 300 [micro]g/kg of body weight by 
subcutaneous injection.
    (ii) Indications for use. For the treatment and control of 
gastrointestinal roundworms (adults and fourth-stage larvae) (large 
roundworm, Ascaris suum; red stomach worm, Hyostrongylus rubidus; 
nodular worm, Oesophagostomum spp.; threadworm, Strongyloides ransomi 
(adults only)); somatic roundworm larvae (threadworm, S. ransomi 
(somatic larvae)); lungworms (Metastrongylus spp. (adults only)); lice 
(H. suis); and mites (S. scabiei var. suis).
    (iii) Limitations. Do not treat swine within 18 days of slaughter.
    (4) American bison--(i) Amount. 200 [micro]g/kg of body weight by 
subcutaneous injection.
    (ii) Indications for use. For the treatment and control of grubs 
(H. bovis).
    (iii) Limitations. Do not slaughter within 56 days of last 
treatment.
    (5) Reindeer--(i) Amount. 200 [micro]g/kg of body weight by 
subcutaneous injection.
    (ii) Indications for use. For the treatment and control of warbles 
(Oedemagena tarandi).
    (iii) Limitations. Do not treat reindeer within 56 days of 
slaughter.
    (6) Ranch-raised foxes--(i) Amount. 200 [micro]g/kg of body weight 
by subcutaneous injection. Repeat in 3 weeks.
    (ii) Indications for use. For treatment and control of ear mites 
(Otodectes cynotis).

    Dated: May 7, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-9515 Filed 5-16-07; 8:45 am]
BILLING CODE 4160-01-S