Federal Register / Vol. 69, No. 226 / Wednesday, November 24, 2004 / Rules and Regulations 68253

§ 522.842 Estradiol benzoate and 

testosterone propionate.

(a) Sponsors. See sponsors in 

§ 510.600(c) of this chapter for use as in 

paragraph (c) of this section.

(1) No. 000856 for use as in paragraph 

(c)(1)(i), (c)(2), and (c)(3) of this section.

(2) No. 021641 for use as in paragraph 

(c) of this section.

(b) Related tolerances. See §§ 556.240 

and 556.710 of this chapter.

(c) Conditions of use. For 

implantation in heifers as follows:

(1) Amount. (i) 20 milligrams (mg) 

estradiol benzoate and 200 mg 

testosterone propionate (one implant 

consisting of 8 pellets, each pellet 

containing 2.5 mg estradiol benzoate 

and 25 mg testosterone propionate) per 

implant dose.

(ii) 20 mg estradiol benzoate and 200 

mg testosterone propionate (one implant 

consisting of 9 pellets, each of 8 pellets 

containing 2.5 mg estradiol benzoate 

and 25 mg testosterone propionate, and 

1 pellet containing 29 mg tylosin 

tartrate) per implant dose.

(2) Indications for use. For increased 

rate of weight gain and improved feed 

efficiency.

(3) Limitations. For heifers weighing 

400 pounds or more; for subcutaneous 

ear implantation, one dose per animal; 

not for use in 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 5, 2004.

Steven D. Vaughn,

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine.

[FR Doc. 04–25977 Filed 11–23–04; 8:45 am]

BILLING CODE 4160–01–S

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.

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, email: 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.

■ 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

■ 1. The authority citation for 21 CFR 

part 522 continues to read as follows:

Authority: 21 U.S.C. 360b.

■ 2. Section 522.2477 is amended by 

revising paragraphs (d)(1)(iii), (d)(2)(iii), 

and (d)(3)(iii) to read as follows:

§ 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