Department of Health and Human Services April 27, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry (136) entitled ``Guidance for Industry: Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay Methods.'' This guidance provides our recommendations for protocols for conducting the transfer study of a single-laboratory validated Type C medicated feed assay method to laboratories that have no experience with the test method.

The Food and Drug Administration (FDA) is announcing that a temporary permit has been issued to Canada Ice Enterprises, Inc., to market a product designated as ``80 degrees north Iceberg Water'' that deviates from the U.S. standard of identity for bottled water. The purpose of the temporary permit is to allow the applicant to measure consumer acceptance of the product, identify mass production problems, and assess commercial feasibility.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration is correcting a notice that appeared in the Federal Register of April 18, 2007 (72 FR 19528). The document announced a public meeting on April 30, 2007, to discuss the agency's proposed recommendations for the reauthorization of the Medical Device User Fee and Modernization Act of 2002 (MUDFMA I) for fiscal years 2008 through 2012, as well as other proposals to improve the review of medical devices and the third party inspection program. The correction is being made to reflect a change in location for the April 30, 2007, meeting. The location of the meeting is being changed because of water damage in the original meeting location.