[Federal Register Volume 64, Number 171 (Friday, September 3, 1999)]
[Rules and Regulations]
[Pages 48293-48295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22995]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Estradiol and Testosterone, Progesterone and Estradiol, Trenbolone, and 
Trenbolone and Estradiol, With Tylosin

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 four supplemental applications 
filed by Ivy Laboratories, Div. of Ivy Animal Health, Inc., two 
supplemental new animal drug applications (NADA's) and two supplemental 
abbreviated new animal drug applications (ANADA's). The supplemental 
applications provide for addition of tylosin as a local antibacterial 
to estradiol/testosterone, progesterone/estradiol, trenbolone, and 
trenbolone/estradiol cattle ear implants. The products are subcutaneous 
implants for cattle for weight gain and/or feed efficiency.

EFFECTIVE DATE: September 3, 1999.

FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary 
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0217.

SUPPLEMENTARY INFORMATION: Ivy Laboratories, Div. of Ivy Animal Health, 
Inc., 8857 Bond St., Overland Park, KS 66214, filed the following 
applications:
    Supplemental NADA 110-315 for Component E-S with 
Tylan implant (200 milligrams (mg) progesterone and 20 mg 
estradiol benzoate in eight pellets with 29 mg tylosin tartrate in one 
pellet) for increased rate of weight gain and improved feed efficiency 
in steers weighing 400 pounds (lb) or more, and Component E-C 
with Tylan implant (100 mg progesterone and 10 mg estradiol 
benzoate in four pellets with 29 mg tylosin tartrate in one pellet) for 
increased rate of weight gain in suckling beef calves up to 400 lb of 
body weight.
    Supplemental NADA 135-906 for Component E-H with 
Tylan implant (20 mg estradiol benzoate and 200 mg 
testosterone propionate in eight pellets with 29 mg tylosin tartrate in 
one pellet) for growth promotion and improved feed efficiency in 
heifers weighing 400 lb or more.
    Supplemental ANADA 200-221 for Component TE-S with 
Tylan implant (120 mg trenbolone acetate and 24 mg estradiol 
in six pellets with 29 mg tylosin tartrate in one pellet) for increased 
rate of weight gain and improved feed efficiency in feedlot steers.
    Supplemental ANADA 200-224 for Component T-S with 
Tylan implant and Component T-H with 
Tylan implant. Component T-S with Tylan 
implant contains 140 mg trenbolone acetate in seven pellets and 29 mg 
tylosin tartrate in one pellet. It is used for improved feed efficiency 
in growing-finishing feedlot steers. It should be reimplanted once 
after 63 days. Component T-H with Tylan implant 
contains 200 mg trenbolone acetate in 10 pellets and 29 mg tylosin 
tartrate in 1 pellet. It is used for increased rate of weight gain and 
improved feed efficiency in growing-finishing feedlot heifers. It 
should be used in feedlot heifers only, during approximately the last 
63 days prior to slaughter.
    The supplements are approved as of July 20, 1999, and the 
regulations are amended in Sec. 522.842 (21 CFR 522.842) and 21 CFR 
522.1940, 522.2476, and 522.2477 to reflect the approvals. The basis of 
approval is discussed in the freedom of information summaries.
    Also, Sec. 522.842 is amended to remove several outdated 
paragraphs.
    In addition, the sponsor has informed FDA of the change of 
corporate name to Ivy Laboratories, Div. of Ivy Animal Health, Inc. FDA 
is amending 21 CFR 510.600(c) to reflect the new name.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of each supplement 
may be seen in the Dockets Management Branch (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.

[[Page 48294]]

    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), these approvals for food 
producing animals qualify for 3 years of marketing exclusivity 
beginning July 20, 1999, because the supplemental applications contain 
substantial evidence of the effectiveness of the drug involved, any 
studies of animal safety, or, in the case of food-producing animals, 
human food safety studies (other than bioequivalence or residue 
studies) required for the approvals and conducted or sponsored by the 
applicant. The 3 years of marketing exclusivity apply only to the 
addition of tylosin tartrate to the implants as a local antibacterial.
    FDA has carefully considered the potential environmental effects of 
these actions. FDA has concluded that the actions will not have a 
significant impact on the human environment, and that an environmental 
impact statement is not required. The agency's finding of no 
significant impact and the evidence supporting that finding, contained 
in an environmental assessment, may be seen in the Dockets Management 
Branch (address above) between 9 a.m. and 4 p.m., Monday through 
Friday.
    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 practices and procedures, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

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 parts 510 and 
522 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.

Sec. 510.600  [Amended]

    2. Section 510.600 Names, addresses, and drug labeler codes of 
sponsors of approved applications is amended in paragraph (c)(1) in the 
entry for ``Ivy Laboratories, Inc.'' and in paragraph (c)(2) in the 
entry for ``021641'' by removing the sponsor name and adding in its 
place ``Ivy Laboratories, Div. of Ivy Animal Health, Inc.''.

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    3. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

    4. Section 522.842 is amended by removing and reserving paragraph 
(a) and removing paragraph (e), by revising paragraph (b) and the 
introductory text of paragraph (d), by redesignating paragraph (d)(1) 
as paragraph (d)(1)(i) and by adding paragraph (d)(1)(ii) to read as 
follows:


Sec. 522.842  Estradiol benzoate and testosterone propionate in 
combination.

    (a) [Reserved]
    (b) Sponsors. See 000856 in Sec. 510.600(c) of this chapter for use 
as in paragraph (d)(1)(i), (d)(2), and (d)(3) of this section. See 
021641 in Sec. 510.600(c) of this chapter for use as in paragraph (d) 
of this section.
* * * * *
    (d) Conditions of use--Heifers. For implantation as follows:

    (1) Amount. (i) 20 milligrams estradiol benzoate and 200 milligrams 
testosterone propionate in eight pellets per implant dose.
    (ii) 20 milligrams estradiol benzoate and 200 milligrams 
testosterone propionate in eight pellets with 29 milligrams tylosin 
tartrate as a local antibacterial in one pellet, per implant dose.
* * * * *
    5. Section 522.1940 is amended by revising paragraph (b); by 
redesignating paragraphs (d)(1)(i) and (d)(2)(i) as paragraphs 
(d)(1)(i)(A) and (d)(2)(i)(A); by revising newly redesignated 
(d)(1)(i)(A) and (d)(2)(i)(A); and by adding paragraphs (d)(1)(i)(B), 
and (d)(2)(i)(B) to read as follows:


Sec. 522.1940  Progesterone and estradiol benzoate in combination.

* * * * *
    (b) Sponsors. See 000856 in Sec. 510.600(c) of this chapter for use 
as in paragraphs (d)(1)(i)(A), (d)(1)(ii), (d)(1)(iii), (d)(2)(i)(A), 
(d)(2)(ii), (d)(2)(iii), and (d)(3) of this section. See 021641 in 
Sec. 510.600(c) of this chapter for use as in paragraphs (d)(1) and 
(d)(2)(i) through (d)(2)(iii)(A) of this section.
* * * * *
    (d) * * *
    (1) Suckling beef calves--(i) Amount. (A) 100 milligrams of 
progesterone and 10 milligrams of estradiol benzoate in four pellets 
per implant dose.
    (B) 100 milligrams of progesterone and 10 milligrams of estradiol 
benzoate in four pellets with 29 milligrams of tylosin tartrate as a 
local antibacterial in one pellet per implant dose.
* * * * *
    (2) Steers--(i) Amount--(A) 200 milligrams of progesterone and 20 
milligrams estradiol benzoate in eight pellets per implant dose.
    (B) 200 milligrams progesterone and 20 milligrams estradiol 
benzoate in eight pellets with 29 milligrams tylosin tartrate as a 
local antibacterial in one pellet per implant dose.
* * * * *
    6. Section 522.2476 is amended by revising paragraph (b), by 
redesignating the text of paragraphs (d)(1) and (d)(2) as paragraphs 
(d)(1)(i) and (d)(2)(i), and by adding paragraphs (d)(1)(ii) and 
(d)(2)(ii) to read as follows:


Sec. 522.2476  Trenbolone acetate.

* * * * *
    (b) Sponsors. See 012579 in Sec. 510.600(c) of this chapter for use 
as in paragraphs (d)(1)(i), (d)(2)(i), and (d)(3) of this section. See 
021641 in Sec. 510.600(c) of this chapter for use as in paragraphs 
(d)(1), (d)(2), and (d)(3) of this section.
* * * * *
    (d) * * *
    (1) * * *
    (ii) 200 milligrams trenbolone acetate (10 pellets of 20 milligrams 
each) with 29 milligrams tylosin tartrate as a local antibacterial (1 
pellet) per implant dose, for increased rate of weight gain and 
improved feed efficiency in growing-finishing feedlot heifers. Use last 
63 days prior to slaughter.
    (2) * * *
    (ii) 140 milligrams trenbolone acetate (seven pellets of 20 
milligrams each) with 29 milligrams tylosin tartrate as a local 
antibacterial (one pellet) per implant dose, for improved feed 
efficiency in growing-finishing feedlot steers. Use 126 days prior to 
slaughter. Should be reimplanted once 63 days prior to slaughter.
* * * * *
    7. Section 522.2477 is amended by redesignating paragraphs (a), 
(b), (c), and (c)(1)(i) as paragraphs (b), (c), (d), and (d)(1)(i)(A); 
by reserving paragraph (a); by revising newly redesignated paragraph 
(b); and by adding paragraph (d)(1)(i)(B) to read as follows:


Sec. 522.2477  Trenbolone acetate and estradiol.

    (a) [Reserved]

[[Page 48295]]

    (b) Sponsors. See 012579 in Sec. 510.600(c) of this chapter for use 
as in paragraphs (d)(1)(i)(A), (d)(1)(ii), (d)(1)(iii), (d)(2), and 
(d)(3) of this section. See 021641 in Sec. 510.600(c) of this chapter 
for use as in paragraph (d)(1) of this section.
* * * * *
    (d) * * *
    (1) * * *
    (i) * * *
    (B) 120 milligrams trenbolone acetate and 24 milligrams estradiol 
in 6 pellets with 29 milligrams tylosin tartrate as a local 
antibacterial in 1 pellet per implant dose.
* * * * *

    Dated: August 24, 1999.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 99-22995 Filed 9-2-99; 8:45 am]
BILLING CODE 4160-01-F