Regulatory Support for Cancer Prevention Agent Development

Note: This synopsis follows a Small Business Sources Sought notice that was released on April 12, 2017 under HHS-NIH-NCI-SBSS-PCPSB-75008-10THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE.Title: Regulatory Support for Cancer Prevention Agent DevelopmentDescription:The purpose of the acquisition (re-competition) is to provide regulatory services and technical support to the Division of Cancer Prevention (DCP) at the National Cancer Institute (NCI). Technical Support is required to gather, interpret and summarize the 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. Much of this data is used to prepare required reports for FDA review. This contract will prepare and maintain documents required by the Food and Drug Administration (FDA) and other regulatory bodies for clinical trials of investigational

agents.Background:The National Cancer Institute (NCI), Division of Cancer Prevention (DCP) has over 40 active clinical trials, 15 trials in development and is the sponsor for approximately 35 INDs (Investigational New Drug Applications). DCPs INDs are located in six Divisions at the FDA. The mission of DCP is to plan and direct cancer prevention research, including testing promising agents in human clinical trials as part of a drug development program. Such testing falls under the purview of regulatory agencies such as the FDA and requires certain documentation for the use of the investigational agent. The collection, preparation, submission and continual update of this documentation is the focus of this acquisition. The current contractor for this acquisition is CCS Associates Inc., 1923 Landings Dr. Mountain View, CA 94043.Technical and Contractual Requirement:The proposed acquisition will involve the following type of activities, further defined in the attached Statement of Work (Attachment 1):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 agreement documents and other documents from pharmaceutical companies.5) Assist in scheduling, facilitating, and attending meetings to support DCP's regulatory affairs, agent development, and clinical research programs.6) Manage regulatory documents such as Investigational New Drug Applications (INDs) and Drug Master Files (DMFs) in accordance with regulations, laws, and guidance.7) Perform regulatory and safety reviews, reporting and advisory activities.8) Prepare, process and establish 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.10) Assist in the transition of the existing contract to the successor contractor.This acquisition will be a total small business set-aside. The Government anticipates that one (1) contract will be awarded with a base period of one year and four one-year option periods. The Product Service Code is R499 and the NAICs Code is 541690; the size standard for this acquisition is $15,000,000.The RFP will be available electronically on or about March 2018 and may be accessed through the FedBizOpps at www.fbo.gov. WE ENCOURAGE ALL RESPONSIBLE SMALL BUSINESS SOURCES, TO SUBMIT A PROPOSAL, WHICH WILL BE CONSIDERED BY THE AGENCY. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted. IT IS THE OFFEROR'S RESPONSIBILITY TO MONITOR THE ABOVE-MENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS.Contracting Office Address:9609 Medical Center DriveBethesda, Maryland 20852Primary Point of Contact:Yifan YangContracting Officeryifan.yang@nih.govPhone: 240-276-5282Secondary Point of Contact:Sara McLaurinContracting Officermclaurinsm@mail.nih.govPhone: 240-276-5488Contact Information: Yifan Yang, Contracting Officer, Phone 2402765282, Email yifan.yang@nih.gov - Sara M. McLaurin, Contracting Officer, Phone 2402765438, Email mclaurinsm@mail.nih.gov Office Address :9609 Medical Center Drive, Room 1E128 Rockville MD 20852 Location: National Cancer Institute, Office of Acquisitions Set Aside: Total Small Business