[Federal Register Volume 71, Number 195 (Tuesday, October 10, 2006)]
[Rules and Regulations]
[Page 59374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-16604]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Omeprazole

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 Merial Ltd. The supplemental NADA provides 
for administration of omeprazole paste to horses for 8 or 28 days for 
the prevention of gastric ulcers.

DATES: This rule is effective October 10, 2006.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Merial Ltd., 3239 Satellite Blvd., Bldg. 
500, Duluth, GA 30096-4640, filed a supplement to NADA 141-227 for 
ULCERGARD (omeprazole) Paste. The supplemental application provides for 
administration of omeprazole paste to horses for 8 or 28 days for the 
prevention of gastric ulcers. The supplemental NADA is approved as of 
September 15, 2006, and 21 CFR 520.1615 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 September 15, 2006.
    The agency has determined under 21 CFR 25.33(d)(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 520

    Animal drugs.

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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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec.  520.1615  Omeprazole.

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2. In paragraph (d)(1)(ii) of Sec.  520.1615, at the end of the first 
sentence remove ``for up to 28 days'' and add in its place ``for 8 or 
28 days''.

    Dated: September 27, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-16604 Filed 10-6-06; 8:45 am]
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