R--Regulatory Support for Cancer Prevention Agent Dev

The purpose of this contract is to provide regulatory services and technical support to the Division of Cancer Prevention (DCP) at the National Cancer Institute (NCI). NCI and DCP has a recurring requirement for regulatory services and technical support to gather and summarize a vast amount of preclinical and clinical data associated with potential cancer preventive agents. This data is generated by the scientific community and NCI contract labs. The majority of the data is used to prepare required regulatory reports and application submissions for the U.S. Food and Drug Administration (FDA), which will be made in accordance with FDA regulations, ICH (International Committee on Harmonization) guidelines, NIH, NCI, and DCP requirements in addition to other relevant regulations, laws, and guidelines. This procurement encompasses the. collection, preparation, submission, and continual update of regulatory data. Successful performance of this requirement is critical to DCP?s ability to further support NCI's mission by leading, supporting, and promoting rigorous, innovative research and training to prevent cancer and its consequences to improve the health of all