This notice is for Market Research purposes only, not a request for quotations or solicitation. The Food and Drug Administration (FDA) is seeking sources, including service-disabled veteran-owned small businesses, HUBzone small businesses, 8(a) certified small businesses, woman owned small businesses, small disadvantaged businesses as well as small businesses. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors that can provide the services and supplies described below. All parties may respond to this synopsis.

The North American Industry Classification System (NAICS) code is 541711, Research and Development in Biotechnology, with a small business standard of 500 employees.

Project Background

Millions of vascular stents are inserted into patients every year and a significant percentage of these are prematurely failing because of material fracture. Also, a number of drug-eluting stents have experienced coating problems such as cracking and peeling away from the stent struts resulting in unacceptable biological responses. Furthering understanding of the fracture of materials and thin surface coatings commensurate with development of test methods for evaluating fractures and coating defects in metal devices (starting with vascular stents) will advance regulatory science and improve medical product safety.

As a part of an FDA Office of Regulatory Affairs (ORA) approved collaborative stent project between the FDA ORA Winchester Engineering and Analytical Center (WEAC) and the Massachusetts Institute of Technology (MIT), there is a need to have stents implanted into porcine coronary arteries (up to three coronary arteries per animal) to determine and understand the conditions that lead to stent fractures and the vascular responses to these fractures. In September, 2011, the FDA contracted with CBSET, Inc. of Lexington, MA to conduct Phase 1 of the stent study. The subject of this market research is for Phases 2 and 3 of the same study.

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 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
. Operating Room Hospital Grade Catheter Lab
. Interventional procedure
. Fluoroscopy and Quantitative Angiography
. Housing Husbandry Animal Care
. Antiplatelet Therapy
. Clinical Pathology Blood Sampling
. Necropsy
. Assessment Deliverables (Report)

In addition, the following supplies are required:

. Vision stents, pre-mounted on balloon delivery system, quantity of 100
. Remounting on balloons and Ethylene Oxide (ETO) sterilization post fracture, quantity 30

Funding for this project is contingent upon the availability of Fiscal 2012 funds.

Potential contractors must indicate business size (Note NAICS above), proof of any set-aside certification and company's DUNS number and provide a contact name, the mailing address, phone number and email address of point of contact. Capability statement must provide enough information to determine if company can meet requirements stated above by including technical specifications, descriptive literature, brochures and other information that demonstrates the capabilities of the contractor to meet the requirements. Provide two contact names, email and phone numbers for users of the proposed products that may be contacted by the Government. Identify availability under GSA contract if applicable.

Responses are due in person, by postal mail or by email to the point of contact listed below on or before January 12, 2012, 1:00 CST at the Food and Drug Administration, OC/OM/OAGS, Attn: Marcia Park, 3900 NCTR Road, HFT-322, Jefferson, AR 72079-9502. Reference 1098224.

Questions regarding this posting shall be submitted via email or fax no later than 1:00 PM CST, January 9, 2012.

This notice does not obligate the Government to award a contract or otherwise pay for the information provided 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 provide the services and supplies described. Respondents are advised the Government is under no obligation to acknowledge receipt of any information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a 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 a 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 [email protected].

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