[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