This is a Sources Sought Notice to determine the availability and capability of Small Business Manufacturers or Small Businesses capable of supplying a U.S. made product of a small business manufacturer or producer. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposals or Request for Quotation, or an indication the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The applicable North American Industry Classification System (NAICS) code is 334516, Analytical Laboratory Instrument Manufacturing and the size standard is 500 employees. The U.S. Food and Drug Administration (FDA) is seeking to identify sources that can provide single-cell auto prep system with the minimum system requirements listed below.

Background

The Center for Biologics Evaluation and Research is attempting to define Quality Attributes for cellular products by analyzing mRNA transcripts in single cells. The Laboratory's current procedure requires isolation of single cells by way of a conventional flow cytometer, and initiating reverse transcription and specific target amplification in separate manual steps. This process does not allow the evaluation of the morphology of the isolated single cells. In addition, individual cell viability cannot be assessed nor can the size of the cell be measured. The objective is both to automate this process and to allow for measuring the size of each cell before lysis, allowing at the end for transfer of mRNA prepared from separate cells and subjected to Specific Target Amplification to be loaded directly onto microfluidic chips for single cell qPCR.

Minimum System Requirements:

. The system shall perform automated isolation and capture of single cells, followed by their lysis, isolation of mRNA, reverse transcription and specific target amplification in a format directly compatible with the laboratory's existing Biomark microfluidic analyzer.

. The system shall isolate at least 96 single cells when charged with 1000 cells and allow for staining, lysis, reverse transcription, and specific target preamplification of the mRNA in each of the cells separately.

. The system shall conduct simultaneous expression profiling of multiple genes on multiple single cells.

. Post-Warranty System Annual Preventive and Corrective Maintenance Requirements for up to four (4) option years to include:

. Minimum of one on-site preventive maintenance per year
. Unlimited corrective repairs to include all parts, labor and travel with maximum of 72 hour onsite response
. Unlimited Software and Firmware updates
. Unlimited phone and email Technical Support with response time within 24 hours of request for support
. Preventive and Corrective Maintenance performed by OEM-certified technicians, following OEM specifications, manuals, and service bulletins, using OEM-certified tools and replacement parts, components, subassemblies, etc.

Parties submitting capability statements shall be advised that generic capability statements are not sufficient for effective evaluation of respondents' capacity and capability of providing the required equipment. Respondents should limit their capability statements to no more than ten (10) pages in length, excluding standard brochures, technical specifications, descriptive literature and any other information that demonstrates the capabilities of the contractor to meet the Government's requirement. Provide two contact names, email and phone numbers for users of the proposed product that may be contacted by the Government. Potential contractors must indicate business size, proof of any set-aside certification and company's DUNS number and provide a contact name, the mailing address, phone number, email address of point of contact and reference AUTOPREP 1114978. Identification of the firm's GSA Schedule contract(s) Schedule number and contract number that may be applicable to this potential requirement are also requested.

Interested parties must respond with capability statements in person on or before March 7, 2013 by 1:00 PM (Central Time) Jefferson, Arkansas, at the Food and Drug Administration, Office of Acquisitions and Grants Services, Field Operations Branch, Attn: Marcia Park, 3900 NCTR Road, HFT-322, Jefferson, AR 72079-9502; Faxed to 870/543-7990 or emailed to [email protected].

Bid Protests Not Available