[Federal Register: January 6, 2004 (Volume 69, Number 3)]
[Rules and Regulations]
[Page 500-501]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06ja04-10]
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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 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 an abbreviated new animal drug
application (ANADA) filed by Fort Dodge Animal Health, Division of
Wyeth. The ANADA provides for use of three different strength
trenbolone acetate and estradiol implants in cattle.
DATES: This rule is effective January 6, 2004.
FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail:
lluther@cvm.fda.gov.
SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth,
500 Fifth St. NW., Fort Dodge, IA 50501, filed ANADA 200-367 for the
use of three different strength trenbolone acetate and estradiol
implants in cattle. SYNOVEX T120 and SYNOVEX T80 are for use in steers
fed in confinement for slaughter for increased rate of weight gain and
improved feed efficiency. SYNOVEX T40 is for use in pasture cattle
(slaughter, stocker, and feeder steers and heifers) for increased rate
of weight gain. Fort Dodge Animal Health's SYNOVEX T120, SYNOVEX T80,
and SYNOVEX T40 are approved as generic copies of Intervet, Inc.'s
REVALOR-S, REVALOR-IS, and REVALOR-G, approved under NADA 140-897. The
application is approved as of November 18, 2003, 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), 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.
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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
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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 adding paragraph (b)(3) and by
revising the heading of paragraph (d)(3) to read as follows:
Sec. 522.2477 Trenbolone acetate and estradiol.
* * * * *
(b) * * *
[[Page 501]]
(3) No. 000856 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(D),
(d)(1)(ii), (d)(1)(iii), (d)(3)(i)(A), (d)(3)(ii), and (d)(3)(iii).
* * * * *
(d) * * *
(3) Pasture cattle (slaughter, stocker, and feeder steers and
heifers)--* * *
* * * * *
Dated: December 23, 2003.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-131 Filed 1-5-04; 8:45 am]
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