Regulatory Support for Cancer Prevention Agent Development

The National Cancer Institute (NCI), Division of Cancer Prevention (DCP), Repository Services and Regulatory Affairs (RSRA), has a requirement to provide regulatory and technical support to gather and summarize the vast amount of preclinical and clinical data associated with potential cancer preventive agents. Much of this data is used to prepare required reports for Food and Drug Administration (FDA) review. This contract will prepare and maintain documents required by the FDA and other regulatory bodies for clinical trials of investigational agents. The proposed acquisition will involve the following type of activities: 1) Provide regulatory submissions to support the DCP's chemoprevention agent development and clinical research program, 2) Prepare, review, maintain, and track correspondence related to regulatory submission, 3) Provide regulatory support for safety data (adverse event) review, processing, and submission to regulatory agencies and investigators 4) Maintain electronic and paper files of collaborative research agreement records, 5) Assist in scheduling, facilitating, and attending meetings to support DCP's regulatory affairs, agent development, and clinical research programs, 6) Maintain regulatory documents in paper and electronic format in accordance with regulations, laws, and guidance, 7) Perform regulatory and safety reviews, reporting and advisory activities, 8) Prepare, process and establish written Standard Operating Procedures, as well as a written plan for quality assurance and quality control of all data and procedures, 9) Maintain and enhance standard procedures for information management to support DCP's regulatory affairs, and 10) Assist in the transition of the existing contract to the successor contractor, if applicable. The NAICS code for this acquisition is 541690, with a small business size standard of $7 million. The proposed acquisition will be a 100% small business set-aside. The NCI intends to award a cost reimbursement contract on or about September 30, 2011. The contract will be a seven (7) incrementally funded contract. This Request for Proposal (RFP) will be available on or about May 20, 2011, with a due date for receipt of proposals 30 days after the release date. The NCI intends to award one cost-reimbursement contract with a period of performance of five years. The anticipated period of performance for the proposed acquisition will be from September 2011 to September 2018. The Government intends to have a full & open competition for this requirement in the form of a Request for Proposal (RFP). The RFP No. N02-CN-15004-70 is anticipated for release on or about May 20, 2011, and may be accessed through Federal Business Opportunities (http://fbo.gov). Questions regarding this requirement must be submitted in writing and directed to Erin C. Lange, Contracting Officer at langee@mail.nih.gov. The reference number to be used for this announcement is RFP: N02-CN-15004-70. All correspondence must cite the reference number as provided. All responsible sources may submit a proposal which shall be considered by the agency. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.