This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov.
The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.
The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts.
Food and Drug Administration, HHS.
The Food and Drug Administration's Center for Veterinary Medicine (CVM) is providing notice that it has approved an original abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for the veterinary prescription use of dexamethasone sodium phosphate injectable solution as a rapid adrenal glucocorticoid and/or anti-inflammatory agent in horses. The applicable sections of the regulations did not require amendment.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Lonnie W. Luther, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: email@example.com.End Further Info End Preamble Start Supplemental Information
In accordance with section 512(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(i)) and 21 CFR 514.105(a) and 514.106(a), CVM is providing notice that it has approved original ANADA 200-317 filed by Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland. ANADA 200-317 provides for the veterinary prescription use of DEXIUM-SP (dexamethasone sodium phosphate) Injection as a rapid adrenal glucocorticoid and/or anti-inflammatory agent in horses. Cross Vetpharm Group's DEXIUM-SP Injection is approved as a generic copy of Steris Laboratories, Inc.'s Dexamethasone Injection, approved under NADA 104-606. The ANADA is approved as of April 29, 2004. 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.
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.Start Signature
Dated: June 4, 2004.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 04-13790 Filed 6-17-04; 8:45 am]
BILLING CODE 4160-01-S