[Federal Register Volume 71, Number 33 (Friday, February 17, 2006)]
[Rules and Regulations]
[Pages 8457-8458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-1488]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Estradiol Benzoate

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 supplemental new animal drug 
application (NADA) filed by PR Pharmaceuticals, Inc. The supplemental 
NADA provides for subcutaneous injection, in the ear only, of a 
suspension implant of estradiol benzoate microspheres for increased 
rate of weight gain in suckling beef calves. It also adds the 
indication for use for increased rate of weight gain in steers fed in 
confinement for slaughter, previously approved at a lower dose, to the 
higher approved dose level.

DATES: This rule is effective February 17, 2006.

FOR FURTHER INFORMATION CONTACT: Eric S. Dubbin, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0232, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: PR Pharmaceuticals, Inc., 1716 Heath Pkwy., 
Fort Collins, CO 80524, filed a supplement to NADA 141-040 that 
provides for use of DURALEASE (estradiol benzoate) Microencapsulated 
Suspension Implant by subcutaneous injection in the ear for increased 
rate of

[[Page 8458]]

weight gain in suckling beef calves. The supplemental NADA also adds 
the indication for use for increased rate of weight gain in steers fed 
in confinement for slaughter, previously approved at a lower dose, to 
the higher approved dose level. The supplemental NADA is approved as of 
January 19, 2006, and the regulations are amended in 21 CFR 522.841 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.
    The agency has determined under 21 CFR 25.33(c) 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 522

    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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

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2. In Sec.  522.841, revise paragraph (d) to read as follows:


Sec.  522.841  Estradiol benzoate.

* * * * *
    (d) Conditions of use. It is used by subcutaneous injection as 
follows:
    (1) Amount and indications for use--(i) Suckling beef calves. 10 mg 
(1 mL of product described in paragraph (a)(1) of this section or 0.5 
mL of product described in paragraph (a)(2) of this section) for 
increased rate of weight gain.
    (ii) Cattle fed in confinement for slaughter. 20 mg (1 mL of 
product described in paragraph (a)(2) of this section) for increased 
rate of weight gain and improved feed efficiency.
    (2) Limitations. For subcutaneous injection in the ear only. Do not 
use in calves intended for reproduction or calves less than 30 days 
old. A withdrawal period has not been established for this product in 
preruminating calves. Do not use in calves to be processed for veal.

    Dated: February 8, 2006.
David R. Newkirk,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 06-1488 Filed 2-16-06; 8:45 am]
BILLING CODE 4160-01-S