Regulatory Support for Cancer Prevention Agent Dev

This pre-solicitation notice seeks proposals for regulatory support services for the Division of Cancer Prevention at the National Cancer Institute. The selected contractor will collect, prepare, submit, and continually update regulatory documents and data required by the FDA and other regulatory bodies for cancer prevention agent development. Key tasks include regulatory correspondence tracking, safety activities, document management, and IT support. The contract will be a cost-plus-fixed-fee arrangement with a 12-month base period and four 12-month options extending over five years. The solicitation containing the evaluation criteria and response date will be available in mid-March 2023 on SAM.gov, with proposals due in August 2023.

The NAICS code for this procurement is 541690 for regulatory affairs consulting services with a size standard of $16.5 million. This will be a competitive set-aside to replace the incumbent contractor. The contract type is cost-plus-fixed-fee over a five year period, which will include a 12-month base period and four 12-month options. Questions may be directed to the points of contact provided in the pre-solicitation notice.