[Federal Register Volume 70, Number 142 (Tuesday, July 26, 2005)]
[Rules and Regulations]
[Pages 43046-43047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-14630]


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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.

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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 Pfizer, Inc. The supplemental NADA provides 
for a period of protection from reinfestation with two species of 
external parasites following topical administration of doramectin 
solution on cattle.

DATES: This rule is effective July 26, 2006.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, 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 
a period of protection from reinfestation with two species of external 
parasites following topical administration of doramectin solution on 
cattle. Specifically, the period of persistent effectiveness is 42 days 
for Linognathus vituli and 77 days for Bovicola (Damalinia) bovis. The 
supplemental NADA is approved as of June 23, 2005, and 21 CFR 524.770 
is amended 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 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 23, 2005. 
Exclusivity applies only to the persistent effectiveness claims for the 
two species of external parasites listed previously in this document.
    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.

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:

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 amended by revising paragraph (e)(2) to read as 
follows:


Sec.  524.770  Doramectin.

* * * * *
    (e) * * *
    (2) Indications for use. For treatment and control of 
gastrointestinal roundworms: Ostertagia ostertagi (adults and fourth-
stage larvae), Ostertagia ostertagi (inhibited fourth-stage larvae), 
Ostertagia lyrata (adults), Haemonchus placei (adults and fourth-stage 
larvae), Trichostrongylus axei (adults and fourth-stage larvae), 
Trichostrongylus colubriformis (adults and fourth-stage larvae), 
Cooperia oncophora (adults and fourth-stage larvae), Cooperia punctata 
(adults and fourth-stage larvae), Cooperia pectinata (adults), Cooperia 
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), Thelazia skrjabini (adults); grubs: 
Hypoderma bovis and Hypoderma lineatum; sucking lice: Linognathus 
vituli, Haematopinus eurysternus, and Solenopotes capillatus; biting 
lice: Bovicola (Damalinia) bovis; mange mites: Chorioptes bovis and 
Sarcoptes scabiei; horn flies: Haematobia irritans; and to control 
infections and to protect from reinfection with Cooperia oncophora, 
Dictyocaulus viviparus, Ostertagia ostertagi, and Oesophagostomum 
radiatum for 28 days; and with Cooperia punctata and Haemonchus placei 
for 35 days after treatment; and to control infestations and to protect 
from reinfestation with Linognathus vituli for 42 days and with 
Bovicola (Damalinia) bovis for 77 days after treatment.
* * * * *


[[Page 43047]]


    Dated: July 11, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-14630 Filed 7-25-05; 8:45 am]
BILLING CODE 4160-01-S