[Federal Register Volume 69, Number 55 (Monday, March 22, 2004)]
[Rules and Regulations]
[Pages 13219-13220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-6248]


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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 Paste

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 new animal drug application 
(NADA) filed by Merial Ltd. The NADA provides for oral administration 
of omeprazole paste to horses for the prevention of gastric ulcers.

DATES: This rule is effective March 22, 2004.

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 NADA 141-227 for ULCERGARD 
(omeprazole) Paste. The application provides for oral use of omeprazole 
paste in horses for the prevention of gastric ulcers. The NADA is 
approved as of February 18, 2004, and the regulations are amended in 21 
CFR 520.1615 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)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning February 18, 2004.
    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

[[Page 13220]]

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.

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2. Section 520.1615 is revised to read as follows:


Sec.  520.1615  Omeprazole.

    (a) Specifications. Each gram of paste contains 0.37 gram 
omeprazole.
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Special considerations. When labeled for use as in paragraph 
(d)(2)(i) of this section, product labeling shall bear: ``Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.''
    (d) Conditions of use in horses--(1) Amount--(i) For treatment of 
gastric ulcers, 1.8 milligrams per pound (mg/lb) of body weight (4 
milligrams per kilogram (mg/kg)) once daily for 4 weeks. For prevention 
of recurrence of gastric ulcers, 0.9 mg/lb of body weight (2 mg/kg) 
once daily for at least an additional 4 weeks.
    (ii) For prevention of gastric ulcers using the premarked syringe, 
one dose per day for up to 28 days. Each dose delivers at least 1 mg/kg 
of body weight. Horses over 1,200 lb body weight should receive two 
doses per day.
    (2) Indications for use. (i) For treatment and prevention of 
recurrence of gastric ulcers in horses and foals 4 weeks of age and 
older.
    (ii) For prevention of gastric ulcers in horses.
    (3) Limitations. Do not use in horses intended for human 
consumption.

    Dated: March 11, 2004.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 04-6248 Filed 3-19-04; 8:45 am]
BILLING CODE 4160-01-S