[Federal Register: February 15, 2007 (Volume 72, Number 31)]
[Rules and Regulations]
[Page 7348-7349]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15fe07-3]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
Implantation or Injectable Dosage Form New Animal Drugs;
Trenbolone Acetate and Estradiol
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 reflect approval of a new animal drug application
(NADA) filed by Intervet, Inc. The NADA provides for use of an
additional dose of trenbolone acetate and estradiol implant used for
increased
[[Page 7349]]
rate of weight gain and improved feed efficiency in feedlot steers.
DATES: This rule is effective February 15, 2007.
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, e-mail: eric.dubbin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 29160 Intervet
Ln., Millsboro, DE 19966, filed NADA 141-269 that provides for REVALOR
XS (trenbolone acetate and estradiol), an ear implant, used for
increased rate of weight gain and improved feed efficiency in steers
fed in confinement for slaughter. The supplemental NADA is approved as
of January 19, 2007, and the regulations are amended in Sec. 522.2477
(21 CFR 522.2477) to reflect the approval. The basis of approval is
discussed in the freedom of information summary.
In addition, FDA is revising the regulations in Sec. 522.2477 to
correctly reflect products approved for another sponsor. This action is
being taken to improve the accuracy of the regulations.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to 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 January 19, 2007.
FDA has determined under 21 CFR 25.33(a)(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 in 21 CFR Part 522
Animal drugs.
0
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
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 522.2477, revise paragraphs (b)(1), (b)(2), and (b)(3); and
add paragraph (d)(1)(i)(G) to read as follows:
Sec. 522.2477 Trenbolone acetate and estradiol.
(b) * * *
(1) No. 021641 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(B),
(d)(1)(i)(C), (d)(1)(i)(D), (d)(1)(i)(E), (d)(1)(i)(F), (d)(1)(ii),
(d)(1)(iii), (d)(2), and (d)(3) of this section.
(2) No. 057926 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(C),
(d)(1)(i)(D), (d)(1)(i)(G), (d)(1)(ii), (d)(1)(iii), (d)(2)(i)(A),
(d)(2)(i)(C), (d)(2)(i)(D), (d)(2)(ii), (d)(2)(iii), (d)(3)(i)(A),
(d)(3)(ii), and (d)(3)(iii) of this section.
(3) No. 000856 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(D),
(d)(1)(ii), (d)(1)(iii), (d)(3)(i)(A), (d)(3)(ii), and (d)(3)(iii) of
this section.
(d) * * *
(1) * * *
(i) * * *
(G) 200 milligram (mg) trenbolone acetate and 40 mg estradiol (one
implant consisting of 10 pellets, each pellet containing 20 mg
trenbolone acetate and 4 mg estradiol) per implant dose.
Dated: February 6, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-2580 Filed 2-14-07; 8:45 am]
BILLING CODE 4160-01-S