[Federal Register: November 22, 2004 (Volume 69, Number 224)]
[Rules and Regulations]
[Page 67817-67818]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22no04-6]
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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
Wyeth. The supplemental NADA provides for the addition of statements to
labeling of subcutaneous implants containing trenbolone acetate and
estradiol benzoate warning against the use of these products in calves
to be processed for veal.
DATES: This rule is effective November 22, 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: edubbin@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth,
800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA
141-043 for SYNOVEX PLUS (trenbolone acetate and estradiol benzoate)
and SYNOVEX CHOICE (trenbolone acetate and estradiol benzoate), two
subcutaneous implants products used in steers and heifers fed in
confinement for slaughter for increased rate of weight gain and/or
improved feed efficiency. The supplemental NADA provides for the
addition of statements to labeling warning against the use of these
products in calves to be processed for veal. The supplemental
application is approved as of October 28, 2004, and the regulations are
amended in 21 CFR 522.2478 to reflect the approval. The basis of
approval is discussed in the freedom of information summary.
In accordance with the freedom of information provisions of 21 CFR
part
[[Page 67818]]
20 and 21 CFR 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 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 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.
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 522.2478 is amended by revising paragraphs (d)(1)(i)(C),
(d)(1)(ii)(C), and (d)(2)(iii) to read as follows:
Sec. 522.2478 Trenbolone acetate and estradiol benzoate.
* * * * *
(d) * * *
(1) * * *
(i) * * *
(C) Limitations. Implant subcutaneously in ear only. 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.
(ii) * * *
(C) Limitations. Implant subcutaneously in ear only. 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) * * *
(iii) Limitations. Implant subcutaneously in ear only. Not for
subsequent breeding dairy or beef replacement heifers. 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 10, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 04-25878 Filed 11-19-04; 8:45 am]
BILLING CODE 4160-01-S