Scientific Consultant to support Regulatory Activities and Agreements for NCI Extramural Clinical Trials

Description: National Cancer Institute (NCI) Office of the Director (OD) plans to procure on a sole source basis expert scientific services, consultation, support and strategic guidance to the Institute and NCI Director on NCI scientific programs and research priorities from Dr. Sherry Ansher, 9116 Willow Gate Lane, Bethesda, MD 20817. This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541690 and the business size standard is $6.5M. Only one (1) award will be made as a result of this solicitation. This will be awarded as a time and materials type contract. The Period of Performance is estimated to be one-year base period with three, twelve (12) month option periods from the effective date stated in the award. It has been determined there are no opportunities to acquire green products or services for this procurement. The position is located under the Office of the Director (OD), National Cancer Institute (NCI). The Institute conducts research in its own facilities, directs research carried out under contracts, and provides grant support of research and training in non-federal institutions in the United States and abroad. The Institute operates with a staff of approximately 3,500 and an annual budget of approximately $5.6 billion. The NCI provides a wide range of operations and scientific support for over 3,500 federal employees, plus 2,500 Federally Funded Research and Development Center (FFRDC) and other contract staff. Contractor shall perform the following: TECHNICAL REQUIREMENTS: - Provide guidance to ACG staff on agreement language - Provide the CTEP regulatory and programmatic rationale for the language in the clinical agreements to pharmaceutical collaborators. - Provide guidance on the collaboration framework to NCI for the launch of new initiatives. - Review and provide guidance on group and company agreements for CTEP funded trials and other groups as requested - Review and provide guidance on international collaborative agreements - Provide expert guidance on CTEP regulatory and agreement guidelines - Provide expert guidance on NCI Protocol language for collaborative agreements. - Review and provide guidance on agreements and policies supporting DCTD special initiatives such as the NCI formulary, CIMAC-CIDC and MATCH. - Assist the ACG staff in interacting with other groups for novel collaborations - Provide expert input into other precision medicine initiatives as required GOVERNMENT RESPONSIBILITIES: Provide the necessary information to the Contractor in order for them to complete Sections 3 and 4 of this Statement of Work. REPORTING REQUIREMENTS AND DELIVERABLES: The Contractor shall deliver the following items within the Period of Performance stated in the contract and as coordinated with the NCI Contracting Officer's Representative (COR): DELIVERABLE DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS DUE DATE 1 Monthly report shall be submitted to the COR detailing activities with allocation of labor hours and identification of work products for the period. Monthly from effective date of contract (Coordinate day of week with the NCI COR.) INSPECTION AND ACCEPTANCE CRITERIA: The NCI COR will perform inspection and acceptance of services to be provided. Acceptance may be presumed unless otherwise indicated in writing by the NCI COR within 30 days of receipt. PERIOD OF PERFORMANCE: The period of performance shall be for a one-year base period with three, 12-month option periods. AWARD TYPE: The award will be time and materials made in the aggregate. PLACE OF PERFORMANCE: Contractor's work site and at NCI, Bethesda, Maryland. PAYMENT: NET 30 days (15 days for Small Business Concerns) from date of invoice. Payment shall be made in monthly increments after satisfactory completion and acceptance of the deliverables stated in Section 8. The Contractor shall be paid after satisfactory completion and acceptance of work provided. Payment authorization requires submission and approval of invoice to the NCI COR and NIH OFM Commercial Accounts per the attached Invoice and Payment Provisions. A copy of each invoice should be e-mailed to the NCI COR's contact information on the first page of the order. These expert services are provided by Dr. Ansher. She has experience working at the FDA and participating in IND reviews as well as licensing applications. She designed and negotiated language for CRADAs to support and expand combination clinical trials. In addition, she was responsible for the implementation of the first version of the Intellectual Property Option to Collaborator, protecting the pharmaceutical company's first right to negotiate a license to any invention based on the use of their pharmaceutical agent. This was incorporated by reference into all CTEP-sponsored protocols as part of the mandatory language identifying trials with pharmaceutical collaborators. With the advent of precision medicine trials and other new DCTD initiatives, she has been instrumental in helping to draft the agreements to support the projects and the guidelines for the initiatives. She has a unique understanding of how to balance industry needs and those of the NCI investigators to support NCI's mission. The proposed source brings a wealth of knowledge for the best way to design agreements for new initiatives and programs and the critical elements that must be included in each. Knowledge of both clinical trials at NCI and collaborative agreements gives her a unique ability to the program's rapidly evolving needs. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 3:30PM ET, on May 22, 2019. All responses and questions must be emailed to Rachel Weiszer, Contracting Officer via electronic mail at rw17g@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference 75N91019Q00038 on all correspondence.