Professional Service Contract to provide database of anatomical vascular models of the human inferior vena cava

Sources Sought Notice 1214196 U.S. Food and Drug Administration (FDA) - Center of Devices and Radiological Health (CDRH)- Professional Service Contract to Provide Database of Anatomical Vascular Models of the Human Inferior Vena Cava THIS IS NOT A REQUEST FOR PROPOSALS/QUOTES - THIS IS A SOURCES SOUGHT NOTICE/REQUEST FOR INFORMATION, AND INFORMATION SUBMITTED WILL BE USED FOR MARKET RESEARCH PURPOSES ONLY. This Sources Sought/Request for Information (RFI) is for information, planning and market research purposes only and shall not be construed as either a solicitation or obligation on the part of the Food and Drug Administration or its Centers. The purpose of this RFI is to identify INTERESTED VENDORS that are capable of providing the full range of services described in this RFI and the draft statement of work (SOW). FDA will use this market research information to assess the market's capability to successfully meet FDA CDRH's need for Professional Service Contract to Provide Database of Anatomical Vascular Models of the Human Inferior Vena Cava. FDA welcomes responses from all interested businesses. FDA does not intend to make a decision or award a contract on the basis of responses nor otherwise reimburse interested sources for the preparation of any information submitted for FDA's use of such information. FDA reserves the right to contact vendors if additional information is required. Overview: Investigators in the U.S. Food and Drug Administration (FDA), Center of Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL) have undertaken a regulatory research project that seeks to use patient-specific computational modeling to understand the inter-subject variability in the performance of inferior vena cava (IVC) filters in a broad patient population. To perform this research, CDRH requires a database of anatomical vascular models of the human IVC reconstructed from medical image data. The purpose of this service contract is to establish a database of anatomical vascular models of the human inferior vena cava (IVC) to be used for computational modeling of IVC filters. The contractor will provide services to create a database of anatomical vascular models of the human inferior vena cava (IVC) reconstructed from medical image data and perform a quantitative analysis of the data, as described in the attached Statement of Work. It is the Government's intention to award a contract with a base year of 12 months and one (1) option year in accordance with FAR 52.217-9. General Instructions: Respondents to this notice must provide the following information: Completed - Vendor Feedback Form CPARS evaluations for any contract identified in the Vendor Feedback Form Company's Capability Statement Capability to meet the requirements of FAR 52.219-14, Limitations on Subcontracting if the respondent is a small business concern A Cover Page that includes the following 1. Company Name and Address 2. DUNS Number 3. Company socio-economic status (i.e. SB, 8(a), VOSB, SDVOSB, HUBZone, SDB, WOSB, etc.) 4. Point of Contact (Name, Email, and Phone Number) 5. Email Subject: Request for Information- 1214196 Responses to the RFI should not exceed 10 pages in length. The page limitation does not include the attached RFI 1214196 Vendor Feedback Form, completed CPARS evaluations, or comments on the attached draft documents. A complete response to the RFI must include the information requested below. Responses should demonstrate capability, not merely affirm the respondent's capability (e.g., The response must go beyond the statement that, "XYZ company can provide the requested services."). Please provide documentation of the size of your business for the selected North American Industry Classification System (NAICS) code: 541990- All Other Professional, Scientific, and Technical Services Attachments: 1. Draft SOW: See attached DRAFT statement of work (SOW), which is subject to change. Potential offerors responding to this notice are highly encouraged to review the attached DRAFT SOW, and provide comments and feedback using the Tracked Changes and comment features found in MS Word. 2. RFI 1214196 Vendor Feedback Form - Potential offerors must complete the attached response sheet and submit with their RFI submission. Responses to this notice must be submitted via email to Kenneth Bailey (Kenneth.Bailey@fda.hhs.gov), Michelle Creenan (michelle.creenan@fda.hhs.gov) and James Whitt (James.Whitt@fda.hhs.gov). Responses will not be accepted by any other means. Responses are due by 5:00 PM Eastern Time (ET), Wednesday August 14, 2019. Late responses may not be considered. THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for quote/proposals; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred. The result of this market research will contribute to determining the method of procurement.