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 

70056 Federal Register / Vol. 69, No. 231 / Thursday, December 2, 2004 / Rules and Regulations 

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 522.2476 is amended by 

removing paragraph (a); by redesignating 

paragraphs (b), (c), and (d) as paragraphs 

(a), (b), and (c); and by revising newly 

redesignated paragraphs (a)(1), (a)(2), 

(c)(1)(iii), and (c)(2)(iii) to read as 

follows:

§ 522.2476 Trenbolone acetate.

(a) * * *

(1) No. 021641 for use as in paragraph 

(c) of this section.

(2) No. 057926 for use as in 

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

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

(c)(2)(iii) of this section.

* * * * *

(c) * * *

(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.

Dated: November 18, 2004.

Steven D. Vaughn,

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine.

[FR Doc. 04–26552 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 558

New Animal Drugs for Use in Animal 

Feeds; Coumaphos

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule; technical 

amendment.

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to remove 

conditions of use in cattle and chickens 

for a coumaphos Type A medicated 

article for which approval was 

withdrawn in July 1996. This action is 

being taken to improve the accuracy of 

the agency’s regulations.

DATES: This rule is effective December 2, 

2004.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary 

Medicine (HFV–6), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 301–827–4567, email: george.haibel@fda.gov.

SUPPLEMENTARY INFORMATION: FDA has 

found that parts 500 to 599 (21 CFR 

parts 500 to 599) of the Code of Federal 

Regulations reflect conditions of use in 

cattle for a coumaphos Type A 

medicated article for which approval 

was withdrawn by FDA, at the sponsors 

request, on July 3, 1996 (61 FR 34727). 

At this time, FDA is amending the 

regulations in § 558.185 to reflect the 

remaining approved uses of coumaphos 

in medicated cattle feeds.

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 558

Animal drugs, Animal feeds.

■ 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 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS

■ 1. The authority citation for 21 CFR 

part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

■ 2. Section 558.185 is amended by 

redesignating paragraph (d) as paragraph 

(e); by revising paragraphs (a), (b), and 

newly redesignated (e)(1); and by adding 

paragraph (d) to read as follows:

§ 558.185 Coumaphos.

(a) Specifications. Type A medicated 

articles containing 1.12, 2.0, 11.2, or 50 

percent coumaphos.

(b) Approvals. See sponsors in 

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

paragraph (e) of this section.

(1) No. 000859 for use of Type A 

medicated articles containing 1.12, 2.0, 

11.2, or 50 percent coumaphos as in 

paragraphs (e)(2) and (e)(3) of this 

section.

(2) No. 017800 for use of Type A 

medicated articles containing 1.12 or 

11.2 percent coumaphos as in paragraph 

(e)(1) of this section.

* * * * *

(d) Special considerations. Labeling 

shall bear the following caution 

statement: ‘‘The active ingredient 

coumaphos is a cholinesterase inhibitor. 

Do not use this product on animals 

simultaneously or within a few days 

before or after treatment with or 

exposure to cholinesterase-inhibiting 

drugs, pesticides, or chemicals.’’ Also, 

see § 500.25 of this chapter.

(e) Conditions of use—(1) Beef and 

dairy cattle—(i) Amount. 0.0002 lb. 

(0.091 gram) per 100 lb. body weight per 

day for 6 consecutive days. Should 

conditions warrant, repeat treatment at 

30-day intervals.

(ii) Indications for use. Control of 

gastrointestinal roundworms 

(Haemonchus spp., Ostertagia spp., 

Cooperia spp., Nematodirus spp., 

Trichostrongylus spp.).

(iii) Limitations. Feed in the normal 

grain ration to which the animals are 

accustomed, but not in rations 

containing more than 0.1 percent 

coumaphos. Do not feed to animals less 

than 3 months old. Do not feed to sick 

animals or animals under stress, such as 

those just shipped, dehorned, castrated, 

or weaned within the last 3 weeks. Do 

not feed in conjunction with oral