The solicitation number is 1098224/1098227, and is being issued as a Request for Quotations. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-56, dated March 2, 2012.

The associated North American Industry Classification System Code is 541711 - Research and Development in Biotechnology with a small business size standard of 500 employees. This acquisition is not set aside for small businesses.

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 a U.S. Food and Drug Administration (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 the fractured stent study. This requirement is for the drug-eluting stent stage of the study.

The Health assessment and interventional services must be performed by a company in close proximity to WEAC and MIT (within a 15 minute drive).

The study will include approximately 8 animals (24 stents); the necropsy time is day 30.

The services required include Tissue Perfusion and Fixation, Radiographs, Histomorphometry, Histology, Histopathology, Pathology Report Deliverable, IACUC Protocol Development, Study Protocol Development, Animal purchase acclimation and pre-study health assessment, OR INNOVA Hospital Grade Catheter Lab, Interventional Procedures, Fluoroscopy and Quantitative Angiography, Housing Husbandry Animal Care, Antiplatelet Therapy, Clinical Pathology Blood Sampling, Necropsy, and Assessment Deliverable. These services to be quoted each as one job or collectively as one job but must be clear that all items are included.

In addition to the services listed above, the following equipment is required:

. Vision Stents, Pre-mounted on balloon delivery system, quantity 100 each
. Remounting on balloons and Ethylene Oxide sterilization post fracture, quantity 30
Each

Services are to be performed at the contractors site with deliverables sent to:
Food and Drug Administration
Winchester Engineering and Analytical Center (WEAC)
109 Holton Street
Winchester, MA 08190

An official authorized to bind the offeror must sign the terms and conditions of the offer.
Funding for this project is contingent upon availability of Fiscal Year 2012 funds.
The provision at 52.212-1, Instructions to Offerors - Commercial, applies to this acquisition with no addenda.

Evaluation of offers: Offers will be evaluated on technical approach, past performance and price. Technical approach, past performance combined are more important than price. Offer must include 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 customers of the same services that may be contacted by the Government.

The provision at 52.212-3, Offeror Representations and Certifications - Commercial Items, applies to this acquisition. The offeror shall complete only paragraph (b) of this provision if the offeror has completed the Annual Representations and Certifications and Certificatons electronically at http://orca.bpn.gov.
The clause at FAR 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition with no addenda.
The Clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items, applies to this acquisition. The Contractor shall comply with the additional following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items: 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)). Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).
52.223-18 , Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) (EO 13513)
52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).
52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Pub. L. 108-77, 108-78).
52.222-21, Prohibition of Segregated Facilities (Feb 1999).
52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).
52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).
52.225-3, Buy American Act-Free Trade Agreements-Israeli Trade Act (June 2009) (41 U.S.C. 10a-10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, Pub. L. 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, and 110-138).
52.225-5, Trade Agreements (NOV 2011) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).
52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).
52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration (Oct 2003) (31 U.S.C. 3332).
Full text of clauses and provisions may be obtained by accessing www.acquisition.gov.
CCR Requirement: Contractors must be registered in the Central Contractor Registration (CCR) System before an award can be made. If you are not registered in CCR, you may do so by going to the CCR web site at http://www.ccr.gov.

Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of this solicitation may be excluded from consideration.

All responsible sources may submit an offer, which if timely received, shall be considered. The offer must reference solicitation number 1098224/1098227. The RFQ is due in person, by postal mail, fax or email to the point of contact listed below on or before close of business on March 29, 2012, in Jefferson, AR 72079-9502. Any questions regarding this notice shall be submitted no later than March 26, 2012. For information regarding this RFQ, please contact Marcia Park at 870/543-7405 voice, 870/543-7990 fax or email to [email protected].