Notice of Intent to Sole Source to M2S, Inc.

FDA1123317 Notice of Intent to Sole Source - M2S, Inc The Food and Drug Administration intends to award a Sole Source contract to M2S, Inc., 12 Commerce Ave, West Lebanon, NH in accordance with FAR part 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. The project is Abdominal Aortic Aneurysms: analysis of patient Characteristics and Anatomy Related to EVAR treatment and outcomes - AAA-CARE. The purpose of this contract is to collect the patient demographics and clinical data associated with each anatomical record that FDA has in the Characterization of Human Aortic Anatomy Project (CHAP) database so that we can perform our analysis under AAA-CARE. This research project is designed to retrospectively collect patient demographics, medical history, anatomic data, and treatment history from different clinical centers in the United States. To achieve this objective, the contractor will collect this data and enter it into an Electronic Data Capture (EDC) system for analysis by FDA. M2S, Inc. (M2S) is a partner in the Characterization of Human Aortic Anatomy Project (CHAP), which is a Critical Path Project being funded by FDA's CDRH. The goal of CHAP is to collect de-identified anatomical data from patients with infrarenal abdominal aortic aneurysms (AAA). All of the clinical centers enrolled in CHAP were selected because our collaborator at that clinical site consecutively submits all of his pre-operative CT scans of his patients with AAA to the third party core lab M2S, Inc. (Lebanon, NH) for analysis. M2S independently reviews each scan and records anatomic measurements into its database. These measurements are directly entered in the patient records and sent back to the vascular surgeon at M2S. This information is then used to make important clinical decisions. The consecutive patient enrollment is crucial as it eliminates bias in the data. There are many centers that submit CT scans of their patients' anatomy to M2S for analysis. However, some clinical centers self-select cases for M2S analysis. The reason could be that the cases are challenging and that the clinical site is not equipped with tools to assess the severity of the disease. The clinical centers (and respective collaborators) enrolled in CHAP do not self-select. Therefore, we have assurance that the data gathered from those sites represent the clinically treated population, which is important for addressing our public health mission in AAA-CARE. Hence, the goal of this contract is to provide FDA with a database that contains the data gathered from the clinical centers enrolled in CHAP, which will help meet the research objectives in AAA-CARE. The NAICS code is 541712 - RESEARCH AND DEVELOPMENT IN THE PHYSICAL, ENGINEERING, AND LIFE SCIENCES (EXCEPT BIOTECHNOLOGY) This notice is not a request for competitive proposals. However, any party that believes it is capable of meeting this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. This procurement is being conducted under simplified acquisitions procedures in accordance with FAR Part 13. Response Date: 3:30 p.m. ET September 12, 2013. Please email inquires to Beth Goldberg at beth.goldberg@fda.hhs.gov