Regulatory Support for Cancer Prevention Agent Dev   3

Background
The Department of Health and Human Services (HHS), National Cancer Institute (NCI), Office of Acquisitions (OA), on behalf of the Division of Cancer Prevention (DCP), intends to procure, through a competitive small business set-aside, the specialized, recurring, services for the “Regulatory Support for Cancer Prevention Agent Development” (RSCPAD) effort. The primary mission of the DCP is to conduct and support preclinical and clinical research in cancer prevention through medical and scientific expertise. The primary focus of the RSCAPD effort is to provide qualified regulatory expertise and technical support for the collection, preparation, submission, and continual update of regulatory data.

This procurement will allow for the following tasks: (1) Regulatory correspondence and administrative tracking (2) Safety activities (3) Maintenance of collaborating research agreement records (4) Coordination and documentation of Regulatory meetings (5) Document Management (6) Regulatory review, reporting, and advisory activities (7) Process and Quality Assurance (8) information technology support, to include Information Management System and (9) review of Informed consent documents.

Period of Performance
The resultant contract is anticipated to be a definitive, Cost-plus Fixed Fee (CPFF), contract with a 12-month base period and four 12-month option periods. This action will be competed and set aside for certified small businesses. The services will extend for five years, to include one 12-month base period and four 12-month option periods.

Place of Performance
No specific geographic location(s) for performance provided.