Document ID: FDA-2011-N-0003-0048
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs: Estriol
Posted Date: 2011-12-16T05:00Z

[Federal Register Volume 76, Number 242 (Friday, December 16, 2011)]
[Rules and Regulations]
[Pages 78149-78150]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32214]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2011-N-0003]

Oral Dosage Form New Animal Drugs; Estriol

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 an original new animal drug 
application (NADA) filed by Intervet, Inc. The NADA provides for the 
veterinary prescription use of estriol tablets for the control of 
estrogen-responsive urinary incontinence in ovariohysterectomized 
female dogs.

DATES: This rule is effective December 16, 2011.

FOR FURTHER INFORMATION CONTACT: Lisa M. Troutman, Center for 
Veterinary Medicine (HFV-116), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, (240) 276-8322, email: 
lisa.troutman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Intervet, Inc., 556 Morris Ave., Summit, NJ 
07901, filed NADA 141-325 that provides for the veterinary prescription 
use of INCURIN (estriol) Tablets for the control of estrogen-responsive 
urinary incontinence in ovariohysterectomized female dogs. The NADA is 
approved as of July 24, 2011, and the regulations are amended in 21 CFR 
part 520 to reflect the approval.
    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.
    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.
    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.
    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.
    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:

[[Page 78150]]

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

0
2. Add Sec.  520.852 to read as follows:

Sec.  520.852  Estriol.

    (a) Specifications. Each tablet contains 1 milligram (mg) estriol.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer at an initial 
dose of 2 mg per dog per day. The dosage may be titrated to as low as 
0.5 mg per dog every second day, depending on response.
    (2) Indications for use. For the control of estrogen-responsive 
urinary incontinence in ovariohysterectomized female dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: December 9, 2011.
 Bernadette Dunham,
 Director, Center for Veterinary Medicine.
[FR Doc. 2011-32214 Filed 12-15-11; 8:45 am]
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