[Federal Register Volume 62, Number 241 (Tuesday, December 16, 1997)]
[Rules and Regulations]
[Pages 65752-65753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32807]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524


Ophthalmic and Topical Dosage Form New Animal Drugs; Doramectin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a new animal drug application 
(NADA) filed by Pfizer, Inc. The NADA provides for topical use of 
doramectin for treatment and control of certain worm, grub, lice, and 
mite infections of cattle.

EFFECTIVE DATE: December 16, 1997.

FOR FURTHER INFORMATION CONTACT: Estella Z. Jones, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1643.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017-5755, is sponsor of NADA 141-095 that provides for the use of 
Dectomax (doramectin) 0.5 percent pour-on solution for beef 
cattle and female dairy cattle less than 20 months of age for treatment 
and control of gastrointestinal roundworms, lungworms, eyeworms, grubs, 
biting and sucking lice, and mange mites, to control infections and 
protect from reinfection with Cooperia oncophora and Dictyocaulus 
viviparus for 21 days, and Ostertagia ostertagia, C. punctata, and 
Oesophagostomum radiatum for 28 days after treatment. The NADA is 
approved as of September 16, 1997, and the regulations are amended by 
adding new Sec. 524.770 to reflect the approval. The basis of approval 
is discussed in the freedom of information summary.
    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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
between 9 a.m. and 4 p.m., Monday through Friday.
    Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval for food-
producing animals qualifies for 3 years of marketing exclusivity 
beginning September 16, 1997, because the NADA contains substantial 
evidence of the effectiveness of the drug involved, studies of animal 
safety or, in the case of food-producing animals, human food safety 
studies (other than bioequivalence or residue studies) required for 
approval and conducted or sponsored by the applicant.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

List of Subjects in 21 CFR Part 524

    Animal drugs.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under

[[Page 65753]]

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 OR TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

    2. Section 524.770 is added to read as follows:

Sec. 524.770  Doramectin.

    (a) Specifications. Each milliliter of solution contains 5 
milligrams of doramectin.
    (b) Sponsor. See 000069 in Sec. 510.600(c) of this chapter.
    (c) Related tolerances. See Sec. 556.225 of this chapter.
    (d) Conditions of use--Cattle--(1) Amount. 5 milligrams per 10 
kilograms (5 milligrams per 22 pounds).
    (2) Indications for use. For treatment and control of infections of 
gastrointestinal roundworms, lungworms, eyeworms, grubs, biting and 
sucking lice, and mange mites, and to control infections and to protect 
from reinfection with Cooperia oncophora and Dictyocaulus viviparus for 
21 days, and Ostertagia ostertagia, C. punctata, and Oesophagostomum 
radiatum for 28 days after treatment.
    (3) Limitations. Administer as a single dose. Do not slaughter 
cattle within 45 days of latest treatment. Not for use in female dairy 
cattle 20 months of age or older. Do not use in calves to be processed 
for veal. Consult your veterinarian for assistance in the diagnosis, 
treatment, and control of parasitism.

    Dated: October 22, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-32807 Filed 12-15-97; 8:45 am]
BILLING CODE 4160-01-F