[Federal Register Volume 64, Number 72 (Thursday, April 15, 1999)]
[Rules and Regulations]
[Pages 18573-18574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-9458]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556


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. The supplemental 
NADA provides for use of a trenbolone acetate-estradiol benzoate 
implant in steers fed in confinement for slaughter for increased rate 
of weight gain. At this time, FDA is also amending the regulation for 
trenbolone tolerances to establish an acceptable daily intake (ADI) for 
the drug.

EFFECTIVE DATE: April 15, 1999.

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, Div. of American 
Home Products Corp., 800 Fifth St. NW., Fort Dodge, IA 50501, filed 
supplemental NADA 141-043 that provides for use of Synovex 
PlusTM (200 milligrams (mg) trenbolone acetate and 28 mg 
estradiol benzoate) implanted in the ear of steers fed in confinement 
for slaughter for increased rate of weight gain in addition to its 
approved use for improved feed efficiency. The supplemental NADA is 
approved as of March 16, 1999. The regulations are amended in 21 CFR 
522.2478 by redesignating paragraph (c) as (d), adding paragraph (c), 
and revising newly redesignated paragraph (d)(1)(ii) to reflect the 
approval. The basis for approval is discussed in the freedom of 
information summary.
     In addition, an ADI for trenbolone has not been previously 
established. At this time, 21 CFR 556.739 is amended to provide an ADI 
for trenbolone.
     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 21 U.S.C. 360b(c)(2)(F)(iii), this approval for food-
producing animals qualifies for 3 years of marketing exclusivity 
beginning March 16, 1999, because the supplement contains substantial 
evidence of the effectiveness of the drug involved, studies of animal 
safety or, in the case of food-producing animals, human food safety 
studies (other than bioequivalence or residue studies) required for 
approval and conducted or sponsored by the applicant. Market 
exclusivity applies only to use of the implant for increased rate of 
weight gain in confined steers.
     FDA has carefully considered the potential environmental effects 
of this action. FDA has concluded that the action will not have a 
significant impact on the human environment, and that an environmental 
impact statement is not required. The agency's finding of no 
significant impact and the evidence supporting that finding, contained 
in an environmental assessment, may be seen in the Dockets Management 
Branch (address above) between 9 a.m. and 4 p.m., Monday through 
Friday.

 List of Subjects

 21 CFR Part 522

    Animal drugs.

 21 CFR Part 556

    Animal drugs, Foods.
     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 parts 522 and 
556 are 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 redesignating paragraph (c) as 
(d), reserving paragraph (c), and revising paragraph (d)(1)(ii) to read 
as follows:


Sec. 522.2478   Trenbolone acetate and estradiol benzoate.

* * * * *
     (c) [Reserved]
     (d) * * *
     (1) * * *
     (ii) Indications for use. For increased rate of weight gain and 
improved feed efficiency in steers fed in confinement for slaughter.
* * * * *

[[Page 18574]]

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

     3. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 360b, 371.
     4. Section 556.739 is revised to read as follows:

Sec. 556.739   Trenbolone.

     (a) Acceptable daily intake (ADI). The ADI for total residues of 
trenbolone is 0.4 microgram per kilogram of body weight per day.
     (b) Tolerances. A tolerance for total trenbolone residues in 
uncooked edible tissues of cattle is not needed.

    Dated: April 1, 1999.
Andrew J. Beaulieu,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 99-9458 Filed 4-14-99; 8:45 am]
BILLING CODE 4160-01-F