[Federal Register: November 24, 2004 (Volume 69, Number 226)]
[Rules and Regulations]
[Page 68253]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24no04-5]
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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
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 two supplemental new animal
drug applications (NADAs) filed by Intervet Inc.; three supplemental
abbreviated new animal drug applications (ANADAs) filed by Ivy
Laboratories, Division of Ivy Animal Health, Inc.; and a supplemental
ANADA filed by Fort Dodge Animal Health, Division of Wyeth. The
supplemental NADAs and ANADAs provide for the addition of statements to
labeling of subcutaneous implants containing trenbolone acetate and
estradiol warning against the use of these products in calves to be
processed for veal.
DATES: This rule is effective November 24, 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: Intervet Inc., 29160 Intervet Lane, P.O. Box
318, Millsboro, DE 19966, filed supplements to NADA 140-897 and NADA
140-992 for REVALOR (trenbolone acetate and estradiol) implants. Ivy
Laboratories, Division of Ivy Animal Health, Inc., 8857 Bond St.,
Overland Park, KS 66214, filed supplements to ANADA 200-221 and ANADA
200-346 for COMPONENT (trenbolone acetate and estradiol) and COMPONENT
plus TYLAN (trenbolone acetate and estradiol with tylosin tartrate)
implants. Fort Dodge Animal Health, Division of Wyeth, 800 Fifth St.
NW., Fort Dodge, IA 50501, filed a supplement to ANADA 200-367 for
SYNOVEX (trenbolone acetate and estradiol) implants. The supplemental
NADAs and ANADAs provide for the addition of statements to labeling
warning against the use of these products in calves to be processed for
veal. The supplemental applications are approved as of October 28,
2004, and the regulations are amended in 21 CFR 522.2477 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 20 and 21 CFR 514.11(e)(2)(ii), summaries of safety and
effectiveness data and information submitted to support approval of
these applications 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 these
actions are of a type that do 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
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.
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2. Section 522.2477 is amended by revising paragraphs (d)(1)(iii),
(d)(2)(iii), and (d)(3)(iii) to read as follows:
Sec. 522.2477 Trenbolone acetate and estradiol.
* * * * *
(d) * * *
(1) * * *
(iii) Limitations. Implant subcutaneously in ear only. Do not use
in animals intended for subsequent breeding or in dairy animals. 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. Do not use
in animals intended for subsequent breeding or in dairy animals. 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.
(3) * * *
(iii) Limitations. Implant subcutaneously in ear only. Do not use
in animals intended for subsequent breeding or in dairy animals. 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. 04-25978 Filed 11-23-04; 8:45 am]
BILLING CODE 4160-01-S