[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
