[Federal Register Volume 72, Number 206 (Thursday, October 25, 2007)]
[Rules and Regulations]
[Pages 60550-60551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-21058]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Spinosad

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 Elanco Animal Health. The NADA provides for veterinary 
prescription use of spinosad chewable tablets to kill fleas and for the 
prevention and treatment of flea infestations on dogs for 1 month.

DATES: This rule is effective October 25, 2007.

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: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA 
141-277 that provides for veterinary prescription use of COMFORTIS 
(spinosad) Chewable Tablets to kill fleas and for the prevention and 
treatment of flea infestations (Ctenocephalides felis) on dogs for 1 
month. The NADA is approved as of September 25, 2007, and the 
regulations in 21 CFR part 520 are amended by adding Sec.  520.2130 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.
    FDA 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,

[[Page 60551]]

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.  520.2130 to read as follows:


Sec.  520.2130  Spinosad.

    (a) Specifications. Each chewable tablet contains 140, 270, 560, 
810, or 1620 milligrams (mg) spinosad.
    (b) Sponsor. See No. 000986 in Sec.  510.600 of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer tablets once 
a month at a recommended minimum dosage of 13.5 mg per pound (30 mg per 
kilogram) of body weight.
    (2) Indications for use. To kill fleas and for the prevention and 
treatment of flea infestations (Ctenocephalides felis) on dogs for 1 
month.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: October 17, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-21058 Filed 10-24-07; 8:45 am]
BILLING CODE 4160-01-S