Implantation or Injectable Dosage Form New Animal Drugs; Moxidectin Solution, 7413-7414 [06-1264]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 71, Number 29 (Monday, February 13, 2006)]
[Rules and Regulations]
[Pages 7413-7414]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-1264]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Moxidectin Solution

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 Fort Dodge Animal Health. The supplemental 
NADA provides for use of an injectable moxidectin solution in cattle 
for the treatment and control of an additional three species of 
internal parasites and an additional three life stages of previously-
approved internal parasites.

DATES: This rule is effective February 13, 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: 
joan.gotthardt@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth, 
800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA 
141-220 that provides for use of CYDECTIN (moxidectin) Injectable 
Solution for Beef and Nonlactating Dairy Cattle for the treatment and 
control of an additional three species of internal parasites and an 
additional three life stages of previously-approved internal parasites. 
The NADA is approved as of January 10, 2006, and the regulations are 
amended in 21 CFR 522.1450 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 supplemental approval 
qualifies for 3

[[Page 7414]]

years of marketing exclusivity beginning January 10, 2006.
    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 522

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 
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 paragraph (d)(2) in Sec.  522.1450 to read as follows:


Sec.  522.1450  Moxidectin solution.

* * * * *
    (d) * * *
    (2) Indications for use. For treatment and control of 
gastrointestinal roundworms: Ostertagia ostertagi (adults, fourth-stage 
larvae, and inhibited larvae), Haemonchus placei (adults), 
Trichostrongylus axei (adults and fourth-stage larvae), 
Trichostrongylus colubriformis (adults and fourth-stage larvae), 
Cooperia oncophora (adults), Cooperia pectinata (adults), Cooperia 
punctata (adults and fourth-stage larvae), Cooperia spatulata (adults), 
Cooperia surnabada (adults and fourth-stage larvae), Nematodirus 
helvetianus (adults), Oesophagostomum radiatum (adults and fourth-stage 
larvae), Trichuris spp. (adults); lungworms: Dictyocaulus viviparus 
(adults and fourth-stage larvae); grubs: Hypoderma bovis and Hypoderma 
lineatum; mites: Psoroptes ovis (Psoroptes communis var. bovis); lice: 
Linognathus vituli and Solenopotes capillatus; for protection of cattle 
from reinfection with D. viviparus and O. radiatum for 42 days after 
treatment, with H. placei for 35 days after treatment, and with O. 
ostertagi and T. axei for 14 days after treatment.
* * * * *

    Dated: February 3, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 06-1264 Filed 2-10-06; 8:45 am]
BILLING CODE 4160-01-S