SOLICITATION NOTICE
65 -- Coronary Stents
- Notice Date
- 7/28/2014
- 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, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-14-223-1128354
- Archive Date
- 8/22/2014
- 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
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This solicitation is being issued in conjunction with FAR Part 13 Simplified Acquisition Procedures, as applicable. The solicitation number is FDA-14-223-1128354. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2005-74, dated July 1, 2014. The associated North American Industry Classification System (NAICS) Code is - 541711 - Research and Development in Biotechnology; Small Business Size Standard is 500 in number of employees. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the following specifications below. SUPPLIES OR SERVICES AND PRICES/COSTS CLIN Item Description; Qty U/I Unit Price Extended Price 0001 Integrity over the wire 3.0x18, item #INT30018W 10 EA $ $ 0002 Xience over the wire 3.0x18, item #1011709-18 10 EA $ $ 0003 Shipping $ TOTAL (to include any delivery/shipping charges) $ I. Background Heart disease is still the number one leading cause of death for both men and women in the United States today- affecting over 620,000 people per year. From the latest CDC report, coronary artery disease is the most common type of heart disease - with over 400,000 individuals dying each year. Without the many successful percutaneous coronary interventions that are performed each year, this number would be much higher. According to the American Heart Association (AHA) 2012 update report, over 785,000 Americans have a first coronary attack and another 470,000 people who have already had one or more attacks have another one. And, according to another AHA report in 2009, over 1.2 million stents are deployed in U.S. patients every year and 70 percent of them are drug-eluting stents. However, a number of these stent implants are prematurely failing because of material fractures- which affect 3.5% to 4.5% of coronary stents, 28% of carotid artery stents and up to 37% of peripheral stents. It turns out that there is a major disconnect between the stent manufacturers' bench-top fatigue test results using the current standard test methods versus the actual clinical results. Over the past four years, FDA-WEAC and MIT have been engaged in a close collaborative five-front research project (animal studies, FEA, bench tests, advanced in vivo imaging and analysis of FDA stent fracture reports) to determine and understand the underlying causes and any subsequent clinical consequences of stent fracture. II. Objectives In conjunction with the findings and results of this project's FEA analysis, bench tests and two previously completed porcine studies, it is hoped this third porcine study 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. III. Scope The purpose of the stent fatigue bench tests under single and multi-mode simulated-use arterial boundary conditions is to determine the susceptibility and predictability of the most highly U.S. used stent designs (or brands) to fracture in vivo. It is hoped that that these tests will reveal how (and when) stents sequentially fracture and propagate throughout the stents' structures. The requested post-market stents below will be used for this purpose as well as to validate the computational stent models (currently being developed by FDA-WEAC's academic collaborators at MIT) to accurately predict the areas of critical stress within a stent structure using the most current in vivo boundary conditions for the human coronary and peripheral arteries. The ultimate goal is to provide the clinicians and the regulators an understanding as to which stent fractures (or sequence of fractures) are critical to the overall stent's structural integrity. IV. Requirements WEAC needs to purchase the type/quantity of bare metal and drug-eluting stents identified above for the on-going simulated-use bench tests for the FDA-WEAC's Collaborative Stent Research Project with MIT. Place of Delivery: HHS/FDA/ORA/WEAC, 109 Holton St., Winchester, MA 01890. Delivery Period: Ninety (90) days after award. The following FAR and HHSAR clauses apply to this acquisition. FAR clauses and provisions can be obtained at https://www.acquisition.gov/far/index.html. The provision at 52.212-1, Instructions to Offerors-Commercial Items (Apr 2014), applies to this acquisition with the following addenda to the provision. Period for Acceptance of Offers: The offeror agrees to hold the prices firm through September 30, 2013. The provision at 52.212-2, Evaluation-Commercial Items (Jan 1999), is applicable to this requirement. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: (i) Technical capability of the items/services offered to meet or exceed the Government's requirement. (ii) Price Technical is significantly more important when compared to price in determining the best value to the government. Technical capability will be determined by review of information submitted by the offeror which shall provide sufficient technical information necessary for the Government to conclusively determine that the offered products meet the technical requirement identified above. Offerors shall provide technical specifications, descriptive material, literature, brochures and other information which demonstrates the capabilities of the offeror. The price proposed shall be detailed and represent the offeror's response to the schedule of supplies above. Understanding the possibility that only one vendor might respond with a quote, absent competitive pricing, offerors are encouraged to include a commercial price list with their quote. The government is not responsible for locating or securing any information, which is not identified in the quote however the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government. Include the firm's DUNS number with quote. A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (May 2014), applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (May 2014), applies to this acquisition with the following addenda: Invoice Submission: The contractor shall submit one (1) original of each invoice to the address specified below and one (1) copy of each invoice to the COR (specified at time of award): Office of Financial Services Food and Drug Administration 10903 New Hampshire Ave WO32-Second Floor, MAIL HUB 2145 Silver Spring, MD 20993-0002 Attn: Vendor Payments 301.827.3742 OR 866.807.3742 fdavendorpaymentsteam@fda.gov Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (PROMPT PAYMENT) and 52.232-33 (PAYMENT BY ELECTRONIC FUNDS TRANSFER - SYSTEM FOR AWARD MANAGEMENT) and/or other applicable far clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (I) name and address of the contractor; (II) invoice date and invoice number; (III) purchase order/award number; (IV) description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; and (c) any other supporting information necessary to clarify questionable expenditures; (V) shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading; (VI) terms of any discount for prompt payment offered; (VII) name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (VIII) name, title, and phone number of person to notify in event of defective invoice; (IX) taxpayer identification number (TIN); (X) electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited; (XI) name and telephone number of the FDA contracting officer representative (COR) or other program center/office point of contact, as referenced on the purchase order; and (XII) any other information or documentation required by the purchase order/award. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (I) through (XII) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing. QUESTIONS REGARDING INVOICE PAYMENTS SHOULD BE DIRECTED TO THE FDA PAYMENT OFFICE AT A TELEPHONE NUMBER PROVIDED ABOVE. The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items (Jun 2014), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition: (b) 52.204-10, 52.209-6, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.223-18, 52.225-3 Alt I, 52.225-13, and 52.232-33. FAR 52.232-18, Availability of Funds (APR 1984) FAR 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.html 352.202-1 Definitions (JAN 2006) 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (JAN 2010) 352.223-70 Safety and Health (Jan 2006) 352.231-71 Pricing of Adjustments (JAN 2001) 352.242-71 Tobacco-Free Facilitates (JAN 2006) The supplies delivered hereunder shall be inspected and accepted at destination by the Contracting Officer's Representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. The COR name will be provided at time of award. The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. All responsible sources may submit a quote, which if timely received, shall be considered. The quote shall reference solicitation number FDA-14-223-1128354. The quotes are due by email to the point of contact listed below on or before August 7, 2014, by 1000am ET.
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