[Federal Register Volume 69, Number 153 (Tuesday, August 10, 2004)]
[Rules and Regulations]
[Pages 48391-48392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18165]


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

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 supplemental new animal drug 
application (NADA) filed by Pfizer, Inc. The supplemental NADA provides 
for an increased period of protection from reinfection with three 
species of internal parasites following topical administration of 
doramectin solution on cattle.

DATES: This rule is effective August 10, 2004.

FOR FURTHER INFORMATION CONTACT: Janis Messenheimer, Center for 
Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7578, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017, filed a supplement to NADA 141-095 for DECTOMAX (doramectin) 
Pour-On Solution for Cattle. The supplemental application provides for 
an increased period of protection from reinfection with three species 
of internal parasites following topical administration of doramectin 
solution on cattle. Specifically, the period of persistent 
effectiveness is increased from 21 days to 28 days for Cooperia 
oncophora, from 28 days to 35 days for C. punctata, and from 21 days to 
28 days for Dictyocaulus viviparus. The supplemental NADA is approved 
as of June 30, 2004, and the regulations in 21 CFR 524.770 are amended 
to reflect the approval and a current format. 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 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.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies 
for 3 years of marketing exclusivity beginning June 30, 2004. 
Exclusivity applies only to the extension of the persistent 
effectiveness claims for the three species of parasites listed 
previously.
    The agency has carefully considered the potential environmental 
impact of this action and has concluded that the action will not have a 
significant impact on the human environment and that an environmental 
impact statement is not required. FDA's finding of no significant 
impact and the evidence supporting that finding, contained in an 
environmental assessment, may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
    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.

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 524 is 
amended as follows:

[[Page 48392]]

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. Section 524.770 is revised to read as follows:


Sec.  524.770  Doramectin.

    (a) Specifications. Each milliliter (mL) of solution contains 5 
milligrams (mg) doramectin.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.225 of this chapter.
    (d) Special considerations. See Sec.  500.25 of this chapter.
    (e) Conditions of use in cattle--(1) Amount. Administer topically 
as a single dose 0.5 mg (1 mL) per kilogram (1 mL per 22 pounds) body 
weight.
    (2) Indications for use. For treatment and control of 
gastrointestinal roundworms: Ostertagia ostertagi (adults and fourth-
stage larvae), O. ostertagi (inhibited fourth-stage larvae), O. lyrata 
(adults), Haemonchus placei(adults and fourth-stage larvae), 
Trichostrongylus axei (adults and fourth-stage larvae), T. 
colubriformis (adults and fourth-stage larvae), Cooperia 
oncophora(adults and fourth-stage larvae), C. punctata (adults and 
fourth-stage larvae), C. pectinata (adults), C. surnabada (adults), 
Bunostomum phlebotomum (adults), Oesophagostomum radiatum (adults and 
fourth-stage larvae), Trichuris spp. (adults); lungworms: Dictyocaulus 
viviparus(adults and fourth-stage larvae); eyeworms: Thelazia gulosa 
(adults), T. skrjabini(adults); grubs: Hypoderma bovis and H. lineatum; 
sucking lice: Linognathus vituli, Haematopinus eurysternus, and 
Solenopotes capillatus; biting lice: Damalinia bovis; mange mites: 
Chorioptes bovis and Sarcoptes scabiei; horn flies: Haematobia 
irritans; and to control infections and to protect from reinfection 
with C. oncophora, D. viviparus, O. ostertagi, and O. radiatum for 28 
days; and with C. punctata, and H. placei for 35 days after treatment.
    (3) Limitations. 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.

    Dated: July 28, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-18165 Filed 8-9-04; 8:45 am]
BILLING CODE 4160-01-S