SOLICITATION NOTICE
B -- Evaluation Study of Implanted Pre-Fractured Coronary Stents
- Notice Date
- 8/6/2014
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-14-SS-1128347
- Archive Date
- 9/5/2014
- Point of Contact
- Phillip K. Frame,
- E-Mail Address
-
Phillip.Frame@fda.hhs.gov
(Phillip.Frame@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Notice of Intent to Sole Source - CBSET, Inc. The Food and Drug Administration intends to award a Sole Source contract to CBSET, Inc. (CBSET), 500 Shire Way, Lexington, MA 02421. The NAICS code is 541711 Research and Development in Biotechnology. The purpose and objective of this acquisition is for a third porcine study that will more conclusively help explain the gap between the manufacturers' bench test results and the clinical findings from stented patients and thus help facilitate the development of realistic simulated-use fatigue test methods for vascular stents. To date, CBSET has performed FEA analysis, bench tests and two previously completed porcine studies. The purpose of this study is to determine the degree to which the tissue structure of porcine coronary arteries are clinically affected (or compromised) as a consequence of implanting pre-fractured stents into these respective arteries for 180 days. More specifically, after pre-fractured stents have been implanted for 180 days inside the porcine coronary arteries, the stented arteries will be extracted from the porcine hearts so that they can be inspected, tested and analyzed for the following adverse conditions: • Restenosis • Thrombosis • Inflammation • Neointimal fibrin • Neointimal maturation • Adventitial fibrosis • Endothelialization • Injury • Mineralization This study consists of a series of complex elements, tasks and procedures has been organized under five integrated phases---(A.) Study Protocol Development Phase, (B.) Procurement and Pre-Study Assessment Phase, (C.) Interventional and 180-Day Follow-up Phase, (D.) Tissue and Stent Evaluation / Analysis Phase, (E.) Final Report Phase. It is imperative that consistent policies and procedures from the previous analysis, bench test and studies are followed to ensure the objective of this third study is met. The Government believes that in going to a different contractor the results from study 3 will be compromised because the study methods will not be consistent with study 1 and 2. This notice is not a request for competitive proposals. The Government intends to solicit and negotiate with only one source under the authority of 41 U.S.C. 253(c)(1), in accordance with FAR part 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. 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 Parts 12 and 13. All inquiries shall be submitted to Phillip.Frame@fda.hhs.gov before 4:30 PM (1630) Eastern Time on 21 August 2014.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-14-SS-1128347/listing.html)
- Record
- SN03452766-W 20140808/140807022409-55f618353701a9a5f77b5440958dee36 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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