Amendment 1: The purpose of Amendment 1 is to correct the Place of Performance to the following: 10903 New Hampshire Ave, Silver Spring, MD 20993 MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Office of Vaccines Research and Review (OVRR), Division of Viral Products (DVP), Laboratory Pediatric & Respiratory Viral Diseases (LPRVD) requires a Preparation Grade High Performance Liquid Chromatography System compatible to an existing high throughput analytical HPLC. LPRVD recently acquired a high throughput analytical HPLC (Agilent 1260 prime system) to characterize influenza antigens that is being used to optimize different manufacturing aspects for egg-based, cell-based and recombinant protein influenza vaccines. The primary focus is to improve the productive immune response to the surface antigen NA. Now a larger preparative grade system is needed to scale up promising approaches from 10-20 μl of material to 1-2 ml. The new preparative system shall utilize similar functional parameters and columns as the analytical system to stream-line the scaling up process. The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the items described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort: The associated North American Industry Classification System (NAICS) Code is 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1,000 or fewer employees. Technical Requirements: Shall be compatible with a current Agilent 1260 Prime System equipped with the following columns Agilent Bio SAX, Bio SCX, and an advancebio SEC 300 Angstrom System shall come with a variable wave length detector (minimum two wavelengths at a time) for protein tracking. A fraction collector shall be included that can accommodate 1 ml fraction volumes and is temperature regulated. System shall be compatible and use the procedure templates made in OpenLAB CDS software. The vendor shall provide technical support for the HPLC, columns and analysis software. Provide a one-year warranty. Installation and training shall be included Period of Performance: Delivery, installation and training shall be completed within 30 days of award. Warranty period will begin on date of acceptance and continue for a period of one year. Place of Delivery: 10903 New Hampshire Ave Bldg. 52/72 Room 1328 Silver Spring, MD 20993 The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered product/services meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying services of a small business, all interested parties may respond. At a minimum, responses shall include the following: Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm); Sufficient descriptive literature that unequivocally demonstrates that offered service can meet the above requirements. All descriptive material necessary for the government to determine whether the service offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement. Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment. If a large business, identify the subcontracting opportunities that would exist for small business concerns; Standard commercial warranty and payment terms; and Though this is not a request for quote, informational pricing is encouraged. The government is not responsible for locating or securing any information, not identified in the response. The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before May 5, 2020 by 1:00 PM (Central Time in Jefferson, Arkansas) to
[email protected], Reference: FDA-SSN-1227914. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in beta.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).