Justia Regulation Tracker

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[Federal Register: August 2, 2007 (Volume 72, Number 148)]
[Rules and Regulations]               
[Page 42291]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02au07-6]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

 
Ophthalmic and Topical Dosage Form New Animal Drugs; Emodepside 
and Praziquantel

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 Bayer HealthCare LLC. The NADA provides for veterinary 
prescription use of an emodepside and praziquantel topical solution on 
cats for the treatment and control of infections by several internal 
parasites.

DATES: This rule is effective August 2, 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: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Bayer HealthCare LLC, Animal Health 
Division, P.O. Box 390, Shawnee Mission, KS 66201, filed NADA 141-275 
that provides for veterinary prescription use of PROFENDER (emodepside 
and praziquantel) Topical Solution for the treatment and control of 
infections by several internal parasites of cats. The NADA is approved 
as of June 29, 2007, and the regulations are amended in 21 CFR part 524 
by adding Sec.  524.775 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)(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 on the date of the approval.
    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 524

    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 524 is 
amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

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2. Add Sec.  524.775 to read as follows:

Sec.  524.775  Emodepside and praziquantel.

    (a) Specifications. Each milliliter of solution contains 21.4 
milligrams (mg) emodepside and 85.7 mg praziquantel.
    (b) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in cats--(1) Amount. The recommended minimum 
dose is 1.36 mg/pound (lb) (3 mg/kilogram (kg)) emodepside and 5.45 mg/
lb (12 mg/kg) praziquantel applied as a single topical dose.
    (2) Indications for use. For the treatment and control of hookworm 
infections caused by Ancylostoma tubaeforme (adults, immature adults, 
and fourth stage larvae), roundworm infections caused by Toxocara cati 
(adults and fourth stage larvae), and tapeworm infections caused by 
Dipylidium caninum (adults) and Taenia taeniaeformis (adults).
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: July 17, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-14945 Filed 8-1-07; 8:45 am]

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