SOLICITATION NOTICE
66 -- Wire Fatigue Tester
- Notice Date
- 6/30/2011
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- 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
- 1089124
- Archive Date
- 7/15/2011
- Point of Contact
- Nicholas E Sartain, Phone: 870-543-7370
- E-Mail Address
-
nick.sartain@fda.hhs.gov
(nick.sartain@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; proposals are being requested and a written solicitation will not be issued. This requirement is being issued in conjunction with FAR 13 Simplified Acquisition Procedures, as applicable. The solicitation number is 1089124. This solicitation is issued as a Request for Quote (RFQ). Funds are not presently available for this requirement. Award will be subject to if/when appropriated funds are available. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-52, 31 May 2011. The associated North American Industry Classification System (NAICS) Code is-334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. The Food and Drug Administration (FDA) is soliciting for two wire fatigue testers with temperature controlled water bath and necessary components permitting immediate use. The Division of Solid and Fluid Mechanics (DSFM) participates in the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) mission by conducting research, participating in device review activities, developing consensus standards both domestic and international, developing regulatory guidance, testing forensic and regulatory samples, and providing educational programs in the area of solid and fluid mechanics. DSFM develops measurement methods, instrument calibration capabilities, and analytical procedures to characterize and evaluate devices, device materials, and products, and supports the Center's enforcement and product testing activities. Many medical devices that DSFM researches and for which DSFM provides regulatory guidance contain specialty metal components that are subject to cyclical mechanical loading. Over time, this mechanical loading can lead to device failure through a process known as fatigue. To ensure the safety of implanted devices, such as coronary stents, endovascular grafts, septal occluders, inferior vena cava filters, and numerous dental and orthopedic implants, a complete understanding of the fatigue properties of their specialty metals components is critically important. One of the simplest and most cost effective ways to study fatigue in specialty metal components for medical devices is to perform wire fatigue testing in a rotating beam tester. High speed rotating beam wire fatigue testers would allow DSFM to conduct fatigue research which will assist in the prediction of device safety. The main focus of this research will be on emerging fatigue testing methodologies including Fatigue to Fracture (FtF). FtF is a test method which could provide more predictive information on device failure and shorter test times when compared to the current Test to Success methodology. High speed rotating beam wire fatigue testers will provide DSFM with the research capabilities in order to begin investigations on FtF methodology which will lead to improved long term durability and safety for a broad range of medical devices. These testers will be used as part of a research project for durability testing for specialty metal components in devices. The results of this project will help ensure the safety of a number of implanted medical devices with specialty metal components. High speed rotating beam wire fatigue testers are needed to complete the research proposed in this project. DSFM has indicated that the Blockwise FTX fatigue tester with temperature controlled water bath will meet their requirement, however, quotes will be accepted and evaluated from all interested parties. Performance Requirements The instrument shall be equivalent to the salient characteristics described herein. • Capable of variable high speed rotation. • Rotation clockwise and counterclockwise. • Temperature controlled water bath capable of maintaining 37OC. • Capable of testing a wide range of wire diameters including 0.5mm. • Available optional attachments for different wire diameter sizes. • Ease of operation to include centering of small wires. • Wire break detection and cycle counter. • Available attachments for stents is desired. • Wire driven by chucks at both ends. • Distance between chucks is adjustable. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered instrument and components meet the technical requirements identified above. Scheduled Items include: 1. Wire Fatigue Tester with temperature controlled water bath. Quantity 2 each. Contract Type: Commercial Item-Firm Fixed Price. Simplified acquisition procedures will be utilized. FOB Point destination. To be delivered and ready for use within 60 calendar days or less after receipt of order (ARO) FOB Point of Delivery for Services and Supplies will be the The US Food and Drug Administration White Oak Campus 10903 New Hampshire Avenue WO Building 62, Room 2124 Silver Spring, MD 20993 The price shall include delivery to destination. Standard 1-year commercial warranty is required. The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items applies to this solicitation. The following addenda have been attached to this provision: Addendum Paragraph (c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm until September 30, 2011. The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) 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 the requirement; and (ii) Price. In determining best value to the Government, technical capability is more important than price though price remains a significant factor and must be affordable. The proposals will be analyzed to ensure the fulfillment of the minimum technical specifications as specified above. Proposals considered not to meet the minimum specifications may be excluded from further consideration. The specifications described above should be fulfilled, and all information requested should be provided in order to allow for an appropriate determination of best value. Technical capability will be determined by review of information submitted by the offeror which must provide a description in sufficient detail to show that the product offered meets the Government's requirement. Best value is not limited to the specifications identified above but may consider the unique capability/feature of each offer. The government is not responsible for locating or securing any information, which is not identified in the proposal 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. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the product and/or service meets the technical requirements. Offerors shall specifically address the specifications stated above as well as technical specifications, descriptive material, literature, brochures and other information which demonstrates the capabilities of the offeror. FOB Destination pricing in quote and shall specify the commercial warranty period and nature of support provided during that warranty period. As technical capability of the instrument becomes essentially equal price may become the ultimate determining factor. Include the firms DUNS number with quote and indicate that ORCA information is current, accurate and complete to this solicitation. The government reserves the right to make an award without discussions. Because of the unique features and items of each vendor's instrument accessory items may be added to the successful offerors initial proposal. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, applies to this acquisition. The offeror should complete these electronically via ORCA at http://orca.bpn.gov. The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (JUNE 2010), applies to this acquisition. The following addenda have been attached to the clause. The following additional provisions and/or clauses apply and incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at https://www.acquisition.gov/far/ 52.212-4 (j). Paragraph (j) of the clause is changed to the following: Risk of loss. Risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon: Delivery of the supplies to the Government at the destination specified in the contract. 52.204-4 Printed or Copied Double-Sided on Recycled Paper.(AUG 2000) 52.204-7 Central Contractor Registration. (APR 2008) The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.htm 352.201-70 Paperwork Reduction Act (January 2006) 352.202-1 Definitions (JAN 2006) 352.203-70 Anti-Lobbying (January 2006) 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations. (OCT 2009) 352.223-70 Safety and Health (January 2006) 352.224-70 Privacy Act (January 2006) 352.227-70 Publications and Publicity (January 2006) 352.231-71 Pricing of Adjustments (January 2001) 352.242-73 Withholding of Contract Payments (January 2006) The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Contracting Officer's Technical Representative (COTR) specified at award. If the supplies or services are acceptable, the COTR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COTR shall document the nonconforming items/services and immediately notify the contracting officer. The COTR 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 statement of work; (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 COTR for this order is: To be completed at time of award. An original invoice shall be submitted to the attention of the designated Contract Specialist identified below in accordance with the following instructions. An original and two (2) copies shall be submitted to: Food and Drug Administration Nick Sartain 3900 NCTR Road Building 50, Room 422 Jefferson, AR 72079 Or electrically at nick.sartain@fda.hhs.gov To constitute a proper invoice, the Contractor must submit the invoice on company letterhead and include: (i) Name and address of the contractor; (ii) Invoice date and invoice number; (iii) Contract number; (iv) Description, quantity, unit of measure, unit price and extended price supplies delivered or services performed; (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 Contract 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. (xi) Name and telephone number of the FDA Contracting Officer's Technical Representative referenced on the contract; and (xii) Any other information or documentation required by the Contract. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items (May 2011) applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.204-10, 52.209-6, 52.219-4, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.223-15, 52.223-16, 52.223-18, 52.225-3 Alt I, 52.225-13, and 52.232-33. CCR Requirement - Company must be registered in the Central Contractor Registration (CCR) system before an award could be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov. 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 an offer, which if timely received, shall be considered. The offer must reference solicitation number 1089124. The offers are due in person, by postal mail, fax or email to the point of contact listed below on or before July 14, 2011 by 13:00 hours (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502. For information regarding this solicitation, please contact Nick Sartain at (870) 543-7370, FAX (870) 543-7990 or email nick.sartain@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1089124/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN02487587-W 20110702/110701000000-6cbb5c9ac112b2b8eb2f170c1a4e4cf3 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |