SOLICITATION NOTICE
A -- Collaborative Stent Project
- Notice Date
- 8/24/2011
- Notice Type
- Combined Synopsis/Solicitation
- 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
- 1086769-1086771
- Archive Date
- 9/16/2011
- 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 a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 in conjunction with FAR 13.5, as applicable and as supplemented with additional information included in this notice. The announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is 1086769/1086771.This solicitation is issued as a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-53, dated August 4. 2011. This acquisition is not set aside for small businesses. The appropriate NIACS code for this acquisition is 541711 - Research and Development in Biotechnology with a small business size standard of 500 employees. The purchase order awarded as a result of this RFQ shall be firm fixed price, with a period of performance of 90 days. Advance payments are not authorized. 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 the U.S. Food and Drug Administration's (FDA) Office of Regulatory Affairs (ORA) to expand the Winchester Engineering and Analytical Center (WEAC) collaborative stent project with the Massachusetts Institution of Technology (MIT), the center requires the services (and materials) of a contractor to implant stents 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) in order to assess extracted tissue that begins to degrade upon harvesting. Services required include implementation, monitoring and assessment of a series of stents into porcine coronary arteries The contractor shall implant up to 3 coronary artery stents on 8 animals. The contractor shall perform tissue perfusion and fixation, radiographs, histology, histomorphometry on stented sections of harvested arteries, histopathology, 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, and necropsy. A pathology report shall also be delivered to include summary, general information, materials and methods, results, conclusions and a representative microphotograph panel. In addition to the services listed above, the following equipment shall be required.. Stents with delivery system, quantity 100. Remounting on balloons and ethylene oxide (ETO) sterilization post fracture, quantity of 30. Evaluation of offers: Technical merit is of greater importance than cost. Deliverables are to be delivered 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. The provision at FAR 52.212-3 Offer Representations and Certifications - Commercial Items, applies to this acquisition. The offeror shall complete only paragraph (b) if applicable, of this provision if the offeror has completed the Annual Representations and Certifications electronically at http://orca.bpn.gov. 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 following additional FAR clauses in this clause are applicable: 52.222-50 Combating Trafficking in Persons (FEAB 2009) (22 U.S>C. 7104 g) 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 (SEP 2010)(29 U.S.C. 793) 52.225-3 Buy American Act - Free Trade Agreements - Israeli Trade Act (JUN 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, 109-302, 109-53, 109-283 and 110-138) 52.225-13 Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s proclamations, and statutes administered by the Office of the Foreign Assets Control of the Department of the Treasury) 52.232-33 Payment by Electronic Funds Transfer - Central Contract Registration (OCT 2003) (31 U.S.C. 3332) 52.232-34 Payment by Electronic Funds Transfer - Other Than Central Contractor Registration (MAY 1999) (31 U.S.C. 3332) Clauses and Provisions can be obtained by accessing http://acquisitions.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. The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation. 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 1086769/1086771. 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 September 1, 2011, in Jefferson, AR 72079-9502. Any questions regarding this notice shall be submitted no later than August 30, 2011. For information regarding this RFQ, please contact Marcia Park at 870/543-7405 voice, 870/543-7990 fax or email to marcia.park@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1086769-1086771/listing.html)
- Place of Performance
- Address: Winchester Engineering and Analytical Center (WEAC), 109 Holton Street, Winchester, Massachusetts, 08190, United States
- Zip Code: 08190
- Zip Code: 08190
- Record
- SN02548463-W 20110826/110825000919-b7cc6ff60632f37a6279a8dc580a1185 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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