Department of Health and Human Services March 13, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material from Cattle'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests.'' This guidance describes some statistically appropriate practices for reporting results from different studies evaluating diagnostic tests and identifies some common inappropriate practices. Special attention is given to describing a practice called discrepant resolution and its associated problems.

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Administration (FDA) are seeking sponsors interested in participating in a pilot project to test the submission of case report form (CRF) data provided electronically in extensible markup language (XML) based on the Operational Data Model (ODM) developed by the Clinical Data Interchange Standards Consortium (CDISC). This pilot will test the ability of a new data format to support all review activity, which our current submission format is incapable of doing. Data supplied in ODM format by sponsors during the pilot project will not replace any regulatory requirements for submitting CRFs. We anticipate that a successful pilot will allow CDER and CBER to routinely accept CRFs from studies employing electronic data capture (EDC) in ODM format in marketing applications provided in electronic format.

The Food and Drug Administration (FDA) is announcing the availability of a draft final guidance document entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables'' (the draft final fresh-cut guidance). This document complements FDA's Current Good Manufacturing Practice (CGMP) requirements for foods by providing specific guidance on the processing of fresh-cut produce. The draft final fresh-cut guidance and the CGMP regulations are intended to assist processors in minimizing microbial food safety hazards common to the processing of most fresh-cut fruits and vegetables sold to consumers and retail establishments in a ready- to-eat form. FDA also 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 PRA).