Epoxy Resin Nodules

Classification Code: 66 Subject: Laboratory Equipment Solicitation Number: FDA1060445 Response Date: 21 August 2009 DESCRIPTION: THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; QUOTATIONS ARE BEING REQUESTED, AND A WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. THIS SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES 13.5. This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-35. The associated North American Industrial Classification System (NAICS) code for this procurement is 333220 for a 100% small business set-aside. The Government intends to award a Firm Fixed-Price Purchase Order for, brand-name or equal for the following laboratory instrument, as a result of this Combined Synopsis/Solicitation that will include the terms and conditions that are set forth herein. In order to facilitate the award process, ALL quotes shall include a statement regarding the terms and conditions herein. CLIN 001: CIRS Homogeneous epoxy resin nodules: including 2 nodules each of 2 sizes (5, and 8 mm), 4 shapes (spherical, elliptical, lobulated, spiculated), 3 densities (-800± 40, -630± 40, +100± 15 HU). Total of 48 nodules, group quantity one (1). CLIN 002: CIRS Homogeneous epoxy resin nodules: including 2 nodules each of 1 sizes (9 mm), 4 shapes (spherical, elliptical, lobulated, spiculated), 4 densities (-800± 40, -630± 40, -10± 15, +100± 15 HU). Total of 32 nodules, group quantity one (1). CLIN 003: CIRS Non-homogenous nodules (outer shape spherical or lobulated with density if -630, -10 or +100 HU, inner shape is sphere with densities of -630, -10 and +100 HU) Total of 32 nodules, group quantity one (1). 1. Description This is for the acquisition of a set of synthetic lung nodules of various shapes, sizes, and densities. Allowed tolerance for CTU values are: -800 ± 40, -630 ± 40, +100 ± 15, -10 ± 15. All nodules should be stringed in the center with surgical prolene 5.0 materials to allow for securing nodules in vasculature without affecting the nodule’s CT characteristics. 2. Intended Use The set of synthetic nodules shall be used in a research project investigating the use of medical imaging techniques to quantify a patient’s response to a drug therapy. This project specifically uses the complex synthetic nodules to investigate the limits of quantization possible in computed tomography imaging for characterizing the size and change in size of a lesion. 3. Current Practices FDA currently has a set of synthetic nodules to evaluate sizing in CT. However, FDA does not have nodules with the specific CTU values (set 1). FDA also does not have a set of 9 mm nodules which will be used to determine the minimum measurable change (set 2). Finally, all of FDA’s current nodules are of fixed density. FDA plans to purchase more realistic non-homogenous nodules to evaluate the impact of multiple densities on size estimation in CT. 4. Anticipated Benefits The purchase of this set will contribute in creating a comprehensive database of phantom CT scans and lead to more generalizable results in out phantom experiments. Delivery terms shall be FOB Destination. FOB Destination means the contractor shall pack and mark the shipment in conformance with carrier requirements, deliver the shipment in good order and condition to the point of delivery specified in the purchase order, be responsible for loss of and/or damage to the goods occurring before receipt and acceptance of the shipment by the consignee at the delivery point specified in the purchase order; and pay all charges to the specified point of delivery. Award will be made to the party whose quote offers the best value to the Government, technical, and price. The Government may award this contract to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor described to "Meet or Exceed the Requirement," and 2) Price. Technical Capability is significantly more important than price. Evaluation of Technical Capability shall be based on the information provided in the quotation. Quoters shall include the manufacturer, make and model of the product, manufacturer sales literature or other product literature which CLEARLY DOCUMENTS that the offered product meets or exceeds the specifications stated herein. FAR provisions can be found on the following website: http://www.arnet.gov. The following provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors-Commercial Items; 52.225-2 Buy American Certificate; 52.212-4 Contract Terms and Conditions-Commercial Items; 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items including subparagraphs: 52.222-3, Convict Labor 52.222-19, Child Labor-Cooperation with Authorities and Remedies 52.222-21, Prohibition of Segregated Facilities 52.222-26, Equal Opportunity 52.222-36, Affirmative Action for Workers with Disabilities 52.222-50, Combating Trafficking in Persons 52.225-1, Buy American Act--Supplies 52.225-13, Restrictions on Certain Foreign Purchases 52.232-33, Payment by Electronic Fund Transfer-Central Contractor Registration. In order to facilitate the award process, ALL quotes shall include a statement regarding the terms and conditions herein. Additionally, all quotes shall include price (s); FOB point; a poc (name and telephone number); a statement from the offeror verifying that they are CCR Registered under NAICS code 333220; delivery date (delivery date is of the utmost importance); business size; and payment terms. Delivery shall be to FDA location in Silver Spring, MD 20993. FDA intends to make an award soon after the response date of this notice and all bids and modifications shall be submitted via email and be received by 4:30 PM (1630) EST on 21 August 2009 to the attention of David Kordel, [email protected]. Offerors shall ensure the RFQ number is visible in the header of the email. FAX QUOTES SHALL NOT BE ACCEPTED.