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 FAR PART 13.

This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-40.

The associated North American Industrial Classification System (NAICS) code for this procurement is 541711 and is a small business set aside with a size standard of 500 employees.

The FDA intends to issue a firm fixed-price purchase order for Ricin Biothreat and Elisa Kits that meets or exceeds the following specifications:

Non-Coated Ricin ELISA Quantity: 40ea
Rinin Biothreat Kits Quantity:       40ea

RICIN TEST: FOR THE RAPID QUALITATIVE DETERMINATION OF RICINUS COMMUNIS AGGLUTININ II (RICIN TOXIN)

USE:
The Ricin test strip is a hand-held biological agent detection and identification device for Ricinus Communis Agglutinin II the causative agent for Ricin poisoning. It is intended for use in the field for performing rapid analysis contained in samples collected from the environment. The Ricin test strip is NOT a diagnostic device, and is not intended for testing on samples collected from humans or intended for any medical use. The lateral flow devices (LFDs) are reported to enable the rapid, less than 15 minutes, detection of ricin in various environmental samples.

LFDs must employ antibodies which tightly bind compounds referred to as antigens. The high specificity and affinity of antibodies for their respective antigens must enable them to detect specific antigens at concentrations well below 1 ppm in the presence of other compounds in vast excess.

The Ricin ELISA kit must employ a commercially available enzyme linked immunosorbent assay (ELISA) for the detection of ricin in environmental samples and has been adapted to the detection of ricin in food samples. This ELISA must successfully be applied to the detection of ricin in juices (apple, orange, pineapple, prune, V-8), milk (2%), infant formula (soy-based), soda (cola), produce (grapes, lettuce, grapefruit), breads (wheat bread, ‘everything' bagel, tortilla), milk chocolate, sunscreen, body gel/lotion, and shampoo with conditioner at levels less than 1 mg/kg (< 1 ppm).

TESTING PRINCIPALS:
ELISAs must employ antibodies, proteins which tightly bind compounds referred to as antigens. The high specificity and affinity of antibodies for their respective antigens must enable them to detect specific antigens at concentrations well below 1 ppm in the presence of other compounds in vast excess.

TESTING PRINCIPALS:
LFDs must provide a rapid qualitative test to detect the presence of Ricin Toxin. The test should utilize a combination of monoclonal and polyclonal antibodies to selectively detect the presence of biological threat agents in aqueous samples. The assay should be conducted by the addition of sample into a test device Sample Port and observing the formation of colored labeled antibody, than migrates via capillary action along the membrane. A positive sample should react with the agent-specific labeled antibody conjugate and form a line in the S (sample) Window. In the absence of the specific agent, no line will develop, suggesting a negative result. To serve as a control for the procedure, a colored line in the C (control) Window should always appear regardless of the presence or absence of specific biological agents in the sample. The test should be invalid if no colored line appears in the C (control) Window.

VALADATION:
These methods should be validated by the FDA and acceptable for uses that meet the specifications for the rapid detection of the stated toxin.

QUESTIONS DEADLINE: all questions must be received by email ([email protected]) before 1:00 pm (1300) ET on 01 June 2010.

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, price, and other factors considered. 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 requirements provided in the quotation. Offerors 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:
52.219-6, Notice of Total Small Business Set-Aside
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

This is a Combined Synopsis/Solicitation for laboratory equipment and service maintenance as defined herein. The Government intends to award a Firm Fixed-Price Purchase Order as a result of this Combined Synopsis/Solicitation that will include the terms and conditions that are set forth 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 541711; delivery date (delivery date is of the utmost importance); business size; and payment terms. Delivery shall be to FDA, 8301 Muirkirk, Laurel, MD 20708.

FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email and be received by 1:00 PM (1300) ET on 07 June 2010 to the attention of George Gonzalez, [email protected]. Offerors shall ensure the RFQ number is visible in the header of the email.

FAX QUOTES SHALL NOT BE ACCEPTED.