Legal Status
Legal Status
Rule
Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone and Estradiol
A Rule by the Food and Drug Administration on
Document Details
Information about this document as published in the Federal Register.
- Printed version:
- Publication Date:
- 03/01/2007
- Agencies:
- Food and Drug Administration
- Dates:
- This rule is effective March 1, 2007.
- Effective Date:
- 03/01/2007
- Document Type:
- Rule
- Document Citation:
- 72 FR 9243
- Page:
- 9243-9244 (2 pages)
- CFR:
- 21 CFR 522
- Document Number:
- E7-3620
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Published Document
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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 abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA provides for the addition of tylosin tartrate to an approved subcutaneous implant containing trenbolone and estradiol used for increased rate of weight gain and improved feed efficiency in steers and heifers fed in confinement for slaughter.
DATES:
This rule is effective March 1, 2007.
Start Further InfoFOR 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.
End Further Info End Preamble Start Supplemental InformationSUPPLEMENTARY INFORMATION:
Ivy Laboratories, Div. of Ivy Animal Health, Inc., 8857 Bond St., Overland Park, KS 66214, filed a supplement to ANADA 200-346 for COMPONENT TE-200 with TYLAN (trenbolone acetate and estradiol with tylosin tartrate), a subcutaneous implant used for increased rate of weight gain and improved feed efficiency in steers and heifers fed in confinement for slaughter. The supplemental ANADA provides for the addition of a pellet containing 29 milligrams (mg) tylosin tartrate to the approved COMPONENT TE-200 implant for steers and heifers fed in confinement for slaughter. The supplemental application is approved as of January 26, 2007, and the regulations are amended in 21 CFR 522.2477 to reflect the approval. 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), 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)(iii) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies for 3 years of marketing exclusivity beginning January 26, 2007.
The agency 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.
Start List of Subjects Start Printed Page 9244List of Subjects in 21 CFR Part 522
End List of Subjects Start Amendment PartTherefore, 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,
End Amendment Part Start PartPART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
End Part Start Amendment Part1. The authority citation for
End Amendment Part Start AuthorityAuthority: 21 U.S.C. 360b.
End Authority Start Amendment Part2. In § 522.2477, add paragraph (d)(2)(i)(F) to read as follows:
End Amendment Part(d) * * *
(2) * * *
(i) * * *
(F) 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.
Start SignatureDated: February 12, 2007.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.
[FR Doc. E7-3620 Filed 2-28-07; 8:45 am]
BILLING CODE 4160-01-S