Department of Health and Human Services June 15, 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance document for industry (176) entitled ``Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances'' (VICH GL-39). This guidance has been developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to assist to the extent possible, in the establishment of a single set of recommended global specifications for new veterinary drug substances and medicinal products. It provides guidance through recommendations on the setting and justification of acceptance criteria and the selection of test procedures for new veterinary drug substances of synthetic chemical origin, and new medicinal products produced from them, which have not been registered previously in the United States, the European Union, or Japan.

The Food and Drug Administration (FDA) is correcting a document amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) that appeared in the Federal Register of April 27, 2006 (71 FR 24814). FDA is correcting a paragraph designation in the table for lasalocid cattle feeds which was drafted in error. This correction is being made to improve the accuracy of the animal drug regulations.

Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4), the IHS has amended and is publishing the proposed alteration of a system of records, System No. 09-17-0003, ``Medical Staff Credentials and Privileges Records.'' The amended and altered system of records makes only one administrative revision as necessary.