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FBO DAILY ISSUE OF MAY 01, 2011 FBO #3445
SOURCES SOUGHT

A -- Stent Implantation Project

Notice Date
4/29/2011
 
Notice Type
Sources Sought
 
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, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
 
ZIP Code
72079
 
Solicitation Number
1086771-1086769
 
Archive Date
5/24/2011
 
Point of Contact
Marcia O Park, Phone: (870) 543-7405
 
E-Mail Address
marcia.park@fda.hhs.gov
(marcia.park@fda.hhs.gov)
 
Small Business Set-Aside
N/A
 
Description
This is for Market Research purposes only, not a request for proposal or solicitation. The Food and Drug Administration (FDA) is seeking sources, including service-disabled veteran-owned small businesses, HUBzone small businesses, 8(a) certified businesses as well as small businesses. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for providing the equipment described below. Millions of medical device implants are inserted into patients every year and prematurely fail because of material fatigue. Furthering understanding of the fracture of materials commensurate with development of test methods for evaluating fractures in medical devices will advance regulatory science and improved medical safety. As a result of recent approval by Office of Regulatory Affairs (ORA) to expand Winchester Engineering and Analytical Center's (WEAC) collaborative stent project with Massachusetts Institution of Technology (MIT), there is a need to have stents implanted into porcine coronary arteries to determine and understand the conditions that lead to stent fractures and the vascular response to these fractures. The Health assessment and interventional services must be performed by a company in close proximity to WEAC and MIT (located within a 15 minute drive). Services required will include:.Tissue perfusion and fixation. Radiographs. Histomorphometry. Histology. Histopathology. Deliverable (report). Institutional Animal Care and Use Committee (IACUC) Protocol Development. Study Protocol Development. Animal Purchase acclimation and pre-study Health Assessment. OR Hospital Grade Catheter Lab. Interventional procedures. Fluoroscopy and Quantitative Angiography. Housing Husbandry Animal Care. Antiplatelet Therapy. Clinical Pathology Blood Sampling. Necropsy. Assessment Deliverable (Report) In addition to the above services, the following equipment will be purchased:. Stents with delivery system, quantity 100. Remounting on balloons and ethylene oxide (ETO) sterilization post fracture, quantity 30 The associated North American Industry Classification System (NAICS) code is 541711 - Research and Development in Biotechnology; Small Business size standard is 500 employees. Potential contractors must provide: (1) Company contact information, which at a minimum shall include company name, company physical and mailing addresses, company point of contact with phone number, fax number, and email address; (2) Company DUNS number and CAGE code; (3) Socioeconomic size status under the aforementioned NAICS/Size Standard, i.e., large business, small business, veteran-owned small business, service-disabled veteran-owned small business, HUBzone small business, small disadvantaged business, woman-owned small business, 8(a) small business (the Government will verify against annual certifications at https://orca.bpn.gov/ and as such respondents should make sure their representations and certifications are current); (4) GSA Schedule or Other Federal Contract Vehicles under which this technology may be acquired; and (5) Capability statement identifying core competencies related to this requirement, a detailed description of recent prior experience manufacturing or otherwise integrating same or very similar technologies to include client name and current contact information sufficient for the Government to verify the work performed, and technical specification, descriptive material, literature, brochures and other information which clearly demonstrates the capabilities of the contractor to meet this specific requirement. Responses are due in person, by postal mail or email to the point of contact listed below on or before May 9, 2011 by 1:00 CDT at the Food and Drug Administration, OC/OA/OAGS, Attn: Marcia Park, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502. Reference 1086771/1086769. This notice does not obligate the Government to award a contract or otherwise pay for the information provide in response. The Government reserves the right to use information provided by the respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in the Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. No proprietary, classified, confidential or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation that may result from this market survey. For information regarding this notice, contact Marcia Park, 870/543-7405, Fax 870/543-7990 or email marcia.park@fda.hhs.gov.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1086771-1086769/listing.html)
 
Place of Performance
Address: WEAC, 109 Holton Street, Winchester, Massachusetts, 01890, United States
Zip Code: 01890
 
Record
SN02436700-W 20110501/110429234526-92451e879f670925644b4fff751c0c04 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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