[Federal Register Volume 75, Number 210 (Monday, November 1, 2010)]
[Rules and Regulations]
[Page 67031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27524]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520
[Docket No. FDA-2010-N-0002]
Oral Dosage Form New Animal Drugs; Domperidone
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 the original approval of a new animal drug
application (NADA) filed by Dechra, Ltd. The NADA provides for the
veterinary prescription use of domperidone oral gel for prevention of
fescue toxicosis in periparturient mares.
DATES: This rule is effective November 1, 2010.
FOR FURTHER INFORMATION CONTACT: Amy L. Omer, Center for Veterinary
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-8336, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: Dechra, Ltd., Dechra House, Jamage
Industrial Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW,
United Kingdom, filed NADA 141-314 that provides for veterinary
prescription use of EQUIDONE (domperidone) Gel for prevention of fescue
toxicosis in periparturient mares. The NADA is approved as of September
9, 2010, and the regulations in 21 CFR part 520 are amended by adding
Sec. 520.766 to reflect the approval.
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)(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for
5 years of marketing exclusivity beginning on the date of approval.
The agency has determined under 21 CFR 25.33 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.
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2. Add Sec. 520.766 to read as follows:
Sec. 520.766 Domperidone.
(a) Specifications. Each milliliter of gel contains 110 milligrams
(mg) domperidone.
(b) Sponsor. See No. 043264 in Sec. 510.600 of this chapter.
(c) Conditions of use in horses--(1) Amount. Administer 0.5 mg per
pound (mg/lb) (1.1 mg/kilogram (kg)) by mouth once daily starting 10 to
15 days prior to the expected foaling date. Treatment may be continued
for up to 5 days after foaling if mares are not producing adequate
milk.
(2) Indications for use. For prevention of fescue toxicosis in
periparturient mares.
(3) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
Dated: October 27, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-27524 Filed 10-29-10; 8:45 am]
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