[Federal Register Volume 63, Number 221 (Tuesday, November 17, 1998)]
[Rules and Regulations]
[Pages 63788-63789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30611]
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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;
Trenbolone Acetate 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, Division of
American Home Products Corp. The supplemental NADA provides for the use
of a trenbolone acetate and estradiol benzoate ear implant in heifers
fed in confinement for slaughter for increased rate of weight gain.
EFFECTIVE DATE: November 17, 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., Ft. Dodge, IA 50501,
filed supplemental NADA 141-043 that provides for use of an
implantation containing 200 milligrams (mg) trenbolone acetate and 28
mg estradiol benzoate (Synovex Plus) in heifers fed in
confinement for slaughter for increased rate of weight gain. The
supplemental NADA is approved as of September 30, 1998, and the
regulations are amended in 21 CFR 522.2478 by adding paragraph (c)(2)
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.
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for food
producing animals qualifies for 3 years of marketing exclusivity
beginning September 30, 1998, because the supplemental application
contains substantial evidence of the effectiveness of the drug
involved, any studies of animal safety, or, in the case of food
producing animals, human food safety studies (other than bioequivalence
or residue studies) required for the approval of the supplement and
conducted or sponsored by the applicant. The 3 years of marketing
exclusivity applies only to use in confined heifers for increased rate
of weight gain for which the supplemental application is approved.
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
[[Page 63789]]
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 522.2478 is amended by adding paragraph (c)(2) to read
as follows:
Sec. 522.2478 Trenbolone acetate and estradiol benzoate.
* * * * *
(c) * * *
(2) Heifers--(i) Amount. 200 milligrams of trenbolone acetate and
28 milligrams of estradiol benzoate (one implant consisting of 8
pellets, each pellet containing 25 milligrams of trenbolone acetate and
3.5 milligrams of estradiol benzoate) per animal.
(ii) Indications for use. For increased rate of weight gain in
heifers fed in confinement for slaughter.
(iii) Limitations. Implant subcutaneously in ear only. Not for
dairy or beef replacement heifers.
Dated: November 3, 1998.
Andrew J. Beaulieu,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 98-30611 Filed 11-16-98; 8:45 am]
BILLING CODE 4160-01-F