70054 Federal Register / Vol. 69, No. 231 / Thursday, December 2, 2004 / Rules and Regulations 

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.

Under section 512(c)(2)(F)(ii) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b(c)(2)(F)(ii)), this 

approval qualifies for 3 years of 

marketing exclusivity beginning 

November 5, 2004.

The agency has determined under 21 

CFR 25.33(d)(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

21 CFR Part 510

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements.

21 CFR Part 520

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 

parts 510 and 520 are amended as 

follows:

PART 510—NEW ANIMAL DRUGS

■ 1. The authority citation for 21 CFR 

part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e.

■ 2. Section 510.600 is amended in the 

table in paragraph (c)(1) by 

alphabetically adding an entry for 

‘‘Animal Health Pharmaceuticals, LLC’’; 

and in the table in paragraph (c)(2) by 

numerically adding an entry for 

‘‘068718’’ to read as follows:

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications.

* * * * *

(c) * * *

(1) * * *

Firm name and address Drug labeler 

code 

*****

Animal Health Pharmaceuticals, LLC, 1805 Oak 

Ridge Circle, suite 101, 

St. Joseph, MO 64506

068718

*****

(2) * * *

Drug labeler 

code Firm name and address 

*****

068718 ....... Animal Health Pharmaceuticals, LLC, 1805 Oak 

Ridge Circle, suite 101, 

St. Joseph, MO 64506

*****

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS

■ 3. The authority citation for 21 CFR 

part 520 continues to read as follows:

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

■ 4. Section 520.2215 is added to read as 

follows:

§ 520.2215 Sulfadiazine/pyrimethamine 

suspension.

(a) Specifications. Each milliliter (mL) 

of suspension contains 250 milligrams 

(mg) sulfadiazine (as the sodium salt) 

and 12.5 mg pyrimethamine.

(b) Sponsor. See No. 068718 in 

§ 510.600(c) of this chapter.

(c) Conditions of use in horses—(1) 

Amount. Administer orally 20 mg 

sulfadiazine per kilogram (kg) body 

weight and 1 mg/kg pyrimethamine 

daily.

(2) Indications for use. For the 

treatment of equine protozoal 

myeloencephalitis (EPM) caused by 

Sarcocystis neurona.

(3) Limitations. Not for use in horses 

intended for food. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian.

Dated: November 23, 2004.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 04–26528 Filed 12–1–04; 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; Progesterone 

and Estradiol Benzoate

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 supplemental new animal 

drug applications (NADAs) filed by Fort 

Dodge Animal Health, Division of 

Wyeth, and Ivy Laboratories, Division of 

Ivy Animal Health, Inc. The 

supplemental NADAs provide for the 

addition of statements to labeling of 

subcutaneous implants containing 

progesterone and estradiol benzoate 

warning against the use of these 

products in calves to be processed for 

veal.

DATES: This rule is effective December 2, 

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: Fort 

Dodge Animal Health, Division of 

Wyeth, 800 Fifth St. NW., Fort Dodge, 

IA 50501, filed a supplement to NADA 

009–576 for SYNOVEX C and 

SYNOVEX S (progesterone and estradiol 

benzoate). Ivy Laboratories, Division of 

Ivy Animal Health, Inc., 8857 Bond St., 

Overland Park, KS 66214, filed a 

supplement to NADA 110–315 for 

COMPONENT E–C and COMPONENT 

E–S (progesterone and estradiol 

benzoate), and COMPONENT E–C with 

TYLAN and COMPONENT E–S with 

TYLAN (progesterone and estradiol 

benzoate with tylosin tartrate). The 

supplemental NADAs 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 

522.1940 to reflect the approval and a 

current format. 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 

Federal Register / Vol. 69, No. 231 / Thursday, December 2, 2004 / Rules and Regulations 70055

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 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

■ 1. The authority citation for 21 CFR 

part 522 continues to read as follows:

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

■ 2. Section 522.1940 is revised to read 

as follows:

§ 522.1940 Progesterone and estradiol 

benzoate.

(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 

paragraphs (c)(1)(i)(A), (c)(1)(ii), 

(c)(1)(iii), (c)(2)(i)(A), (c)(2)(ii), (c)(2)(iii), 

and (c)(3) of this section.

(2) No. 021641 for use as in 

paragraphs (c)(1) and (c)(2) of this 

section.

(b) Related tolerances. See §§ 556.240 

and 556.540 of this chapter.

(c) Conditions of use in cattle. It is 

used for implantation as follows:

(1) Suckling beef calves—(i) 

Amount—(A) 100 milligrams (mg) 

progesterone and 10 mg estradiol 

benzoate (one implant consisting of 4 

pellets, each pellet containing 25 mg 

progesterone and 2.5 mg estradiol 

benzoate) per implant dose.

(B) 100 mg progesterone and 10 mg 

estradiol benzoate (one implant 

consisting of 5 pellets, each of 4 pellets 

containing 25 mg progesterone and 2.5 

mg estradiol benzoate, and 1 pellet 

containing 29 mg tylosin tartrate) per 

implant dose.

(ii) Indications for use. For increased 

rate of weight gain.

(iii) Limitations. For use in suckling 

beef calves (at least 45 days of age) up 

to 400 pounds (lb) of body weight. For 

subcutaneous ear implantation, one 

dose per animal. Do not use in bull 

calves intended for reproduction. 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) Steers—(i) Amount—(A) 200 mg 

progesterone and 20 mg estradiol 

benzoate (one implant consisting of 8 

pellets, each pellet containing 25 mg 

progesterone and 2.5 mg estradiol 

benzoate) per implant dose.

(B) 200 mg progesterone and 20 mg 

estradiol benzoate (one implant 

consisting of 9 pellets, each of 8 pellets 

containing 25 mg progesterone and 2.5 

mg estradiol benzoate, and 1 pellet 

containing 29 mg tylosin tartrate) per 

implant dose.

(ii) Indications for use. For increased 

rate of weight gain and improved feed 

efficiency.

(iii) Limitations. For animals weighing 

400 lb or more; for subcutaneous ear 

implantation, one dose per animal. 

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) Steers fed in confinement for 

slaughter—(i) Amount. Reimplant 200 

mg progesterone and 20 mg estradiol 

benzoate on approximately day 70 

following an initial implant of 100 mg 

progesterone and 10 mg estradiol 

benzoate or 200 mg progesterone and 20 

mg estradiol benzoate.

(ii) Indications for use. For additional 

improvement in rate of weight gain.

(iii) Limitations. For subcutaneous ear 

implantation. 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 23, 2004.

Steven D. Vaughn,

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine.

[FR Doc. 04–26530 Filed 12–1–04; 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

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 a supplemental new animal 

drug application (NADA) and an 

abbreviated supplemental new animal 

drug application (ANADA) filed by 

Intervet, Inc., and Ivy Laboratories, 

Division of Ivy Animal Health, Inc., 

respectively. The supplemental NADA 

and ANADA provide for the addition of 

statements to labeling of subcutaneous 

implants containing trenbolone acetate 

warning against the use of these 

products in calves to be processed for 

veal.

DATES: This rule is effective December 2 

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 a supplement 

to NADA 138–612 for FINAPLIX-H 

(trenbolone acetate). Ivy Laboratories, 

Division of Ivy Animal Health, Inc., 

8857 Bond St., Overland Park, KS 

66214, filed a supplement to ANADA 

200–224 for COMPONENT T-H and 

COMPONENT T-S (trenbolone acetate), 

COMPONENT T-H with TYLAN and 

COMPONENT T-S with TYLAN 

(trenbolone acetate with tylosin 

tartrate). The supplemental NADA and 

ANADA 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 

22, 2004, and the regulations are 

amended in 21 CFR 522.2476 to reflect 

the approval and a current format. 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