[Federal Register Volume 69, Number 231 (Thursday, December 2, 2004)]
[Rules and Regulations]
[Pages 70054-70055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26530]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Progesterone and Estradiol Benzoate

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of supplemental new animal drug 
applications (NADAs) filed by Fort Dodge Animal Health, Division of 
Wyeth, and Ivy Laboratories, Division of Ivy Animal Health, Inc. The 
supplemental NADAs provide for the addition of statements to labeling 
of subcutaneous implants containing progesterone and estradiol benzoate 
warning against the use of these products in calves to be processed for 
veal.

DATES: This rule is effective December 2, 2004.

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: Fort Dodge Animal Health, Division of Wyeth, 
800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA 
009-576 for SYNOVEX C and SYNOVEX S (progesterone and estradiol 
benzoate). Ivy Laboratories, Division of Ivy Animal Health, Inc., 8857 
Bond St., Overland Park, KS 66214, filed a supplement to NADA 110-315 
for COMPONENT E-C and COMPONENT E-S (progesterone and estradiol 
benzoate), and COMPONENT E-C with TYLAN and COMPONENT E-S with TYLAN 
(progesterone and estradiol benzoate with tylosin tartrate). The 
supplemental NADAs provide for the addition of statements to labeling 
warning against the use of these products in calves to be processed for 
veal. The supplemental applications are approved as of October 28, 
2004, and the regulations are amended in 21 CFR 522.1940 to reflect the 
approval and a current format. 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), summaries of safety and 
effectiveness

[[Page 70055]]

data and information submitted to support approval of these 
applications 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(a)(1) that these 
actions are of a type that do 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.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 
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

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. Section 522.1940 is revised to read as follows:


Sec.  522.1940  Progesterone and estradiol benzoate.

    (a) Sponsors. See sponsors in Sec.  510.600(c) of this chapter for 
use as in paragraph (c) of this section:
    (1) No. 000856 for use as in paragraphs (c)(1)(i)(A), (c)(1)(ii), 
(c)(1)(iii), (c)(2)(i)(A), (c)(2)(ii), (c)(2)(iii), and (c)(3) of this 
section.
    (2) No. 021641 for use as in paragraphs (c)(1) and (c)(2) of this 
section.
    (b) Related tolerances. See Sec. Sec.  556.240 and 556.540 of this 
chapter.
    (c) Conditions of use in cattle. It is used for implantation as 
follows:
    (1) Suckling beef calves--(i) Amount--(A) 100 milligrams (mg) 
progesterone and 10 mg estradiol benzoate (one implant consisting of 4 
pellets, each pellet containing 25 mg progesterone and 2.5 mg estradiol 
benzoate) per implant dose.
    (B) 100 mg progesterone and 10 mg estradiol benzoate (one implant 
consisting of 5 pellets, each of 4 pellets containing 25 mg 
progesterone and 2.5 mg estradiol benzoate, and 1 pellet containing 29 
mg tylosin tartrate) per implant dose.
    (ii) Indications for use. For increased rate of weight gain.
    (iii) Limitations. For use in suckling beef calves (at least 45 
days of age) up to 400 pounds (lb) of body weight. For subcutaneous ear 
implantation, one dose per animal. Do not use in bull calves intended 
for reproduction. Safety and effectiveness have not been established in 
veal calves. A withdrawal period has not been established for this 
product in preruminating calves. Do not use in calves to be processed 
for veal.
    (2) Steers--(i) Amount--(A) 200 mg progesterone and 20 mg estradiol 
benzoate (one implant consisting of 8 pellets, each pellet containing 
25 mg progesterone and 2.5 mg estradiol benzoate) per implant dose.
    (B) 200 mg progesterone and 20 mg estradiol benzoate (one implant 
consisting of 9 pellets, each of 8 pellets containing 25 mg 
progesterone and 2.5 mg estradiol benzoate, and 1 pellet containing 29 
mg tylosin tartrate) per implant dose.
    (ii) Indications for use. For increased rate of weight gain and 
improved feed efficiency.
    (iii) Limitations. For animals weighing 400 lb or more; for 
subcutaneous ear implantation, one dose per animal. Safety and 
effectiveness have not been established in veal calves. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal.
    (3) Steers fed in confinement for slaughter--(i) Amount. Reimplant 
200 mg progesterone and 20 mg estradiol benzoate on approximately day 
70 following an initial implant of 100 mg progesterone and 10 mg 
estradiol benzoate or 200 mg progesterone and 20 mg estradiol benzoate.
    (ii) Indications for use. For additional improvement in rate of 
weight gain.
    (iii) Limitations. For subcutaneous ear implantation. Safety and 
effectiveness have not been established in veal calves. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal.

    Dated: November 23, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-26530 Filed 12-1-04; 8:45 am]
BILLING CODE 4160-01-S