[Federal Register Volume 63, Number 167 (Friday, August 28, 1998)]
[Rules and Regulations]
[Page 45945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23109]


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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; 
Progesterone and 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 Fort Dodge Animal Health. The supplemental 
NADA provides for reimplantation of steers fed in confinement for 
slaughter with a progesterone-estradiol implant 70 days following an 
initial implant of a lower dose implant.

EFFECTIVE DATE: August 28, 1998.

FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center For Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0217.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of 
American Home Products Corp., 800 Fifth St., NW., P.O. Box 518, Fort 
Dodge, IA 50501, filed supplemental NADA 9-576 that provides for use of 
Synovex S (200 milligrams (mg) progesterone and 20 mg 
estradiol benzoate) implanted in the ear of steers fed in confinement 
for slaughter at approximately day 70 following initial implant of 
Synovex C (100 mg progesterone and 10 mg estradiol benzoate) 
when used as part of a reimplant program for increased rate of weight 
gain. The supplemental NADA is approved as of July 14, 1998, and the 
regulations in 21 CFR 522.1940 are amended by adding paragraph (d)(3) 
to reflect the approval. The basis for approval is discussed in the 
freedom of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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 Dockets Management Branch (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 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.

List of Subjects in 21 CFR Part 522

    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 522 is 
amended as follows:

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

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

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

    2. Section 522.1940 is amended by adding paragraph (d)(3) to read 
as follows:


Sec. 522.1940  Progesterone and estradiol benzoate in combination.

* * * * *
    (d) * * *
    (3) Steers fed in confinement for slaughter--(i) Amount. Reimplant 
200 milligrams of progesterone and 20 milligrams of estradiol benzoate 
on approximately day 70 following an initial implant of 100 milligrams 
of progesterone and 10 milligrams of estradiol benzoate or 200 
milligrams of progesterone and 20 milligrams of estradiol benzoate.
    (ii) Indications for use. For additional improvement in rate of 
weight gain.
    (iii) Limitations. For subcutaneous ear implantation.

    Dated: August 18, 1998.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-23109 Filed 8-27-98; 8:45 am]
BILLING CODE 4160-01-F