§ 522.2477 - Trenbolone acetate and estradiol.

§ 522.2477 Trenbolone acetate and estradiol.

(a) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (d) of this section.

(1) No. 058198 for use as in paragraphs (d)(1)(i)(AB), (d)(1)(iii)(B), (d)(12)(i)(CB), (d)(12)(i)(D), (d)(12)(ii), (d)(3)(i)(EB), (d)(13)(i)(FD), (d)(13)(ii), (d)(14)(iiii)(A), (d)(2)4)(i)(B), and (d)(34)(ii) of this section.

(2) No. 000061 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(C), (d)(1)(i)(D), (d)(1)(ii), (d)(1)(iii), (d)(2)(i)(A), (d)(2)(i)(C), (d)(2)(i)(DE), (d)(2)(ii), (d)(23)(iiii)(A), (d)(3)(i)(AC), (d)(3)(iii)(E), (d)(3)(iiiii), (d)(4), (di)(5A), and (d)(64)(ii) of this section.

(3) No. 054771 for use as in paragraphs (d)(12)(i)(A), (d)(1)(i)(D)C), (d)(12)(ii), (d)(14)(iii), (d)(3)(i)(A), and (d)(34)(ii), and (d)(3)(iii) of this section.

(b) Related tolerances. See §§ 556.240 and 556.739 of this chapter.

(c) Special considerations. Labeling of implants described in paragraphs (d)(1)(i)(B), (Ed), and (F)2)(i)(B), (d)(2)(i)(BD), (E), and (F)d)(3)(i)(B), (d)(3)(i)(D), and (d)(34)(i)(B) of this section shall bear the following: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”.

(d) Conditions of use —

(1)Steers Growing beef steers and heifers fed in confinement for slaughter—

(i) AmountAmounts and indications.

(A)

120 milligrams (mg)

An implant containing 200 mg trenbolone acetate and

24

20 mg estradiol (one implant consisting of

6

10 pellets

,

each

pellet

containing 20 mg trenbolone acetate and

4

2 mg estradiol)

per implant dose

for increased rate of weight gain and improved feed efficiency.

(B) 120 An implant containing 200 mg trenbolone acetate and 24 mg estradiol (one implant consisting of 7 pellets, each of 6 pellets containing 20 mg trenbolone acetate and 4 mg estradiol, and 1 pellet containing 29 mg tylosin tartrate ) per implant dose. (

C) 200 mg trenbolone acetate and 20 mg estradiol (

one implant consisting of 10 pellets, each

pellet

containing 20 mg trenbolone acetate and 2 mg estradiol

) per implant dose.(D) 80 mg trenbolone acetate and 16 mg estradiol (one implant consisting of 4 pellets

,

each pellet containing 20 mg trenbolone acetate

and

4 mg estradiol) per implant dose.(E) 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of 11 pellets, each of 10 pellets containing 20 mg trenbolone acetate and 2 mg estradiol, and

1 pellet containing 29 mg tylosin tartrate)

per implant dose

for increased rate of weight gain and improved feed efficiency.

(

F) 80

C) An extended- and delayed-release implant containing 200 mg trenbolone acetate and

16

20 mg estradiol (

one

1 implant consisting of

5

10 coated pellets, each

of 4 pellets

containing 20 mg trenbolone acetate and

4

2 mg estradiol

, 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 during 70 to 200 days after implantation.

(

iii

ii)Limitations.

Administer implant

Implant pellets subcutaneously in

the

ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef steers and heifers fed in confinement for slaughter. Do not use in

animals intended for subsequent breeding or in dairy animals. Safety and

beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been

established in veal calves. A withdrawal period has not been established for this product in preruminating calves.

evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or calves

to be processed for veal

born to these cows.

(i) Amount. (A) 40

(2) Heifers Growing beef steers fed in confinement for slaughter —

(i) AmountAmounts and indications.

(A)

140

An implant containing 80 mg trenbolone acetate and

14

16 mg estradiol (one implant consisting of

7

four pellets, each

pellet

containing 20 mg trenbolone acetate and

2

4 mg estradiol)

per implant dose for use as in paragraph (d)(2)(ii)(A) of this section

for increased rate of weight gain and improved feed efficiency.

(B) 140 An implant containing 80 mg trenbolone acetate, 16 mg estradiol, and 14 29 mg estradiol tylosin tartrate (one implant consisting of 8 four pellets, each of 7 pellets containing 20 mg trenbolone acetate and 2 4 mg estradiol, and 1 one pellet containing 29 mg tylosin tartrate) per implant dose for use as in paragraphs (d)(2)(ii)(A) of this sectionfor increased rate of weight gain and improved feed efficiency.

(C) 80 An implant containing 120 mg trenbolone acetate and 8 24 mg estradiol (one implant consisting of 4 six pellets, each pellet containing 20 mg trenbolone acetate and 2 4 mg estradiol) per implant dose for use as in paragraph (d)(2)(ii)(B) of this sectionfor increased rate of weight gain and improved feed efficiency.

(D) 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of 10 pellets, each pellet containing 20 An implant containing 120 mg trenbolone acetate and 2 mg estradiol) per implant dose for use as in paragraph (d)(2)(ii)(A) of this section.

(E) 80 mg trenbolone acetate and 8 mg estradiol

, 24 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of

5

six pellets, each

of 4 pellets

containing 20 mg trenbolone acetate and

2

4 mg estradiol, and

1

one pellet containing 29 mg tylosin tartrate)

per implant dose for use as in paragraph (d)(2)(ii)(B) of this section. (F)

for increased rate of weight gain and improved feed efficiency.

(E) An extended-release implant containing 200 mg trenbolone acetate and

20

40 mg estradiol (one implant consisting of

11 pellets

six coated pellets and four uncoated pellets, each

of 10 pellets

containing 20 mg trenbolone acetate and

2

4 mg estradiol

, and 1 pellet containing 29 mg tylosin tartrate

)

per implant dose.

(ii) Indications

for

use.(A) For

increased rate of weight gain and improved feed efficiency for up to 200 days after implantation.

(

B) For increased rate of weight gain.

(iii) Limitations. Administer implant subcutaneously in the 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) Pasture cattle (slaughter, stocker, and feeder steers and heifers)—

ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef steers fed in confinement for slaughter. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or calves born to these cows.

(i) Amount. Each extended- and delayed-release implant contains 200

(3) Growing beef heifers fed in confinement for slaughter —

(i) Amounts and indications.

(A) An implant containing 80 mg trenbolone acetate and 8 mg estradiol (one implant consisting of

2

four pellets, each

pellet

containing 20 mg trenbolone acetate and

4

2 mg estradiol)

per implant dose

for increased rate of weight gain.

(B) 40 An implant containing 80 mg trenbolone acetate and , 8 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of 3 four pellets, each of 2 pellets containing 20 mg trenbolone acetate and 4 2 mg estradiol, and 1 one pellet containing 29 mg tylosin tartrate) per implant dose.

(ii) Indications

for

use. For

increased rate of weight gain

.

(iii) Limitations. Administer implant subcutaneously in the 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.

(4) Beef steers and heifers fed in confinement for slaughter —

and improved feed efficiency.

(C) An implant containing 140 mg trenbolone acetate and

20

14 mg estradiol (one implant consisting of

10

seven pellets, each

pellet

containing 20 mg trenbolone acetate and 2 mg estradiol)

per implant dose.(ii) Indications

for

use. For

increased rate of weight gain and improved feed efficiency

during 70 to 200 days after implantation

.

(

iii

D)

Limitations. Administer implant subcutaneously in the ear only. Do not use in lactating dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Do not use in calves to be processed for veal. A withdrawal period has not been established for this product in pre-ruminating calves. Effectiveness and animal safety in veal calves have not been established. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant during the production phase(s) identified on labeling (beef steers and heifers fed in confinement for slaughter) unless otherwise indicated on labeling because safety and effectiveness have not been evaluated.

(5) Beef heifers fed in confinement for slaughter —

(i) Amount. Each extended-release implant contains

An implant containing 140 mg trenbolone acetate, 14 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of seven pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency.

(E) An extended-release implant containing 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of

6

six coated pellets and

4

four uncoated pellets, each

pellet

containing 20 mg trenbolone acetate and 2 mg estradiol)

.(ii) Indications

for

use. For

increased rate of weight gain and improved feed efficiency for up to 200 days after implantation.

(

iii

ii)Limitations.

Administer implant

Implant pellets subcutaneously in

the

ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef heifers fed in confinement for slaughter. Do not use in

lactating dairy

beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or

in

calves born to these cows.

Do not use in calves to be processed for veal. A withdrawal period has not been established for this product in pre-ruminating calves. Effectiveness and animal safety in veal calves have not been established. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant during the production phase(s) identified on labeling (beef heifers fed in confinement for slaughter) unless otherwise indicated on labeling because safety and effectiveness have not been evaluated.

(6) Steers fed in confinement for slaughter —

(i) Amount. Each extended-release implant contains 200 mg trenbolone acetate and 40

(4) Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) —

(i) Amounts and indications for use.

(A) An implant containing 40 mg trenbolone acetate and 8 mg estradiol (one implant consisting of

6 coated and 4 uncoated

two pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol) for increased rate of weight gain.

(

ii) Indications for use. For

B) An implant containing 40 mg trenbolone acetate, 8 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of two pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain

and improved feed efficiency for up to 200 days after implantation

.

(

iii

ii)Limitations.

Administer implant

Implant pellets subcutaneously in

the

ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant in growing beef steers and heifers on pasture (stocker, feeder, and slaughter). Do not use in

lactating dairy

beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or

in

calves born to these cows.

A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Effectiveness and animal safety in veal calves have not been established. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant during the production phase(s) identified on labeling (steers fed in confinement for slaughter) unless otherwise indicated on labeling because safety and effectiveness have not been evaluated.

[60 FR 4376, Jan. 23, 1995]

Editorial Note

Editorial Note:

For Federal Register citations affecting § 522.2477, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

[89 FR 42359, May 15, 2024]