Department of Health and Human Services April 30, 2007 – Federal Register Recent Federal Regulation Documents

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 PRA).

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the National Cancer Institute (NCI), part of the National Institutes of Health of the Department of Health and Human Services. The purpose of this MOU is to establish a formal collaboration between FDA and NCI regarding proteomics science and technology to accelerate proteomics technology development and application in clinical settings. FDA and NCI intend to collaborate in areas involving proteomics such as: Sample collection, preparation, storage and processing; bioinformatics and data analysis; discovery and validation of biomarkers; and surrogate biomarkers of cancer development and drug response, including standardization among technology platforms and assay standards development.