NATIONAL CANCER INSTITUTE (NCI) SMALL BUSINESS INNOVATION RESEARCH (SBIR) INNOVATIVE CONCEPT PHASE I AWARD PROGRAM

DEPARTMENT OF HEALTH AND HUMAN SERVICES SMALL BUSINESS INNOVATION RESEARCH PROGRAM PHASE I CONCEPT AWARD TECHNICAL PROPOSAL SUBMISSION CHECKLIST Complete Proposal Cover Sheet Page Complete Abstract of the Research Plan and Public Health Relevance Page Complete Technical Proposal Content Complete Identification and Significance of the Problem or Opportunity Section Complete Proposed Technological Solution Section Optionally Attach 1-Page Preliminary Data/Figures Document Complete Innovation Section Complete Approach and Methodology Section Complete Product Discovery and Development Section Complete Potential Commercial Application Section Complete Resources Section Complete Authentication of Key Biological and/or Chemical Resources Complete Scientific Data Sharing Plan Section Complete References Section Complete Statement of Work Pages Attach Biosketches Document -- 1 of 19 -- DEPARTMENT OF HEALTH AND HUMAN SERVICES SMALL BUSINESS INNOVATION RESEARCH PROGRAM PHASE I PROPOSAL COVER SHEET TOPIC NO.: PROJECT TITLE: FAST TRACK PROPOSAL: YES NO SUBMITTED BY (Firm name, address, and telephone number): YEAR FIRM FOUNDED: NO. OF EMPLOYEES (Include all affiliations): NOTICE TO OFFERORS The offeror organization and the principal investigator are jointly responsible for the accuracy and validity of all the administrative, fiscal, and scientific information in the proposal. Deliberate withholding, falsification, or misrepresentation of information could result in a determination of non- responsibility [see Federal Acquisition Regulation (FAR) 9.104] which would preclude an award to the offeror. In addition, sanctions such as suspension, debarment, and criminal penalties could apply. YES NO CERTIFICATIONS 1. The above organization certifies that it is a small business concern as defined in this Solicitation. 2. The above organization also certifies that it is one or more of the following small business concerns as defined in FAR 2.101: 8(a) HubZone Service-Disabled Veteran-Owned Small Disadvantaged Business Woman-Owned * Note: Capture of this information is strictly for statistical purposes. 3. The above organization certifies that, if this proposal results in a contract award, more than one-half of the principal investigator's time will be spent in the employ of the firm. 4. The above organization and / or principal investigator(s) have submitted contract proposals or grant applications for essentially equivalent work (as defined in this Solicitation) under other federal programs, or have received other federal awards containing a significant amount of essentially equivalent work. (If YES, include information required for “Prior, Current, or Pending Support of Similar Proposals or Awards” in Appendix C – Pricing Proposal, as described in the solicitation.) 5. If this proposal does not result in an award, is the Government permitted to disclose the title and abstract of your research project, and the name, address and telephone number of the corporate official of your firm, to organizations that may be interested in contacting you for further information or possible investment? 6. This proposed project involves human subjects. (See instructions in Solicitation.) Clinical Trial? Yes No Agency-Defined Phase III Clinical Trial? Yes No 7. This proposed project involves vertebrate animals. (See instructions in Solicitation.) If YES, identify by common names and circle primates. NOTICE OF PROPRIETARY INFORMATION The information identified by asterisks (*) on pages of this proposal constitutes trade secrets or information that is commercial or financial and confidential or privileged. It is furnished to the Government in confidence with the understanding that such information shall be used or disclosed only for evaluation of this proposal; provided that, if a contract is awarded as a result of or in connection with the submission of this proposal, the Government shall have the right to use or disclose information herein to the extent provided by law. This restriction does not limit the Government’s right to use the information if it is obtained without restriction from another source. PRINCIPAL INVESTIGATOR/PROJECT MANAGER CORPORATE OFFICIAL NAME: NAME: SIGNATURE: SIGNATURE: DATE: DATE: TITLE: TITLE: PHONE: PHONE: E-MAIL ADDRESS: E-MAIL ADDRESS: -- 2 of 19 -- ABSTRACT OF RESEARCH PLAN NAME, ADDRESS, AND TELEPHONE NUMBER OF OFFEROR ORGANIZATION AGENCY NAME: SOLICITATION NUMBER: TOPIC NUMBER: TITLE OF PROJECT KEY PERSONNEL ENGAGED ON PROJECT Name (First, Middle, Last) POSITION TITLE ORGANIZATION ABSTRACT OR RESEARCH PLAN: State the proposal’s long-term objectives and specific aims, making reference to the health-relatedness of the project. Describe concisely the research design and methods for achieving these goals, and discuss the potential of the research for technological innovation. Summarize the results that are expected. Avoid summaries of past accomplishments and the use of the first person. This abstract is meant to serve as a succinct and accurate description of the proposed work when separated from the application. If the proposal is funded, this description, as is, will become public information. Therefore, do not include proprietary/confidential information. DO NOT EXCEED 200 WORDS. Provide key words (8 maximum) to identify the research or technology. Provide a brief summary of the potential commercial applications of the research. -- 3 of 19 -- Technical Proposal Content Technology/Product Overview ☐ Cell/Gene Therapy ☐ Drug Delivery Device ☐ Biologics/Vaccine ☐ Hospital Device ☐ Imaging Agent ☐ Bioinformatics/Health IT/Digital Health ☐ Small Molecule ☐ Surgical or Ablative Device ☐ Imaging Device ☐ In Vitro Diagnostic ☐ Research Tool Targeted Pediatric/Rare Cancer (Please state the rare/pediatric cancer your technology addresses) A) Identification and Significance of the Problem or Opportunity. Provide a clear statement of the specific technical problem or opportunit…