Biacore 3000 Annual Service Agreement

MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION This is a sources sought to determine the availability and capability of small businesses to provide a service agreement for an existing laboratory instrument. The associated North American Industry Classification System (NAICS) Code is? 811219 Other Electronic and Precision Equipment Repair and Maintenance; Small Business Size Standard is $19.0 million. Part I: General Information (Introduction/Background/Scope) The U.S. Food and Drug Administration (FDA) is conducting market research to support the Center for Biologics Evaluation and Research (CBER), Office of Blood Research and Review (OBRR) with a requirement for an annual service agreement in support of a GE Healthcare Biacore 3000 Processing unit (Model # 14110045, Serial # CH3370). The OBRR, reviews several different types of regulatory applications with respect to blood and blood components. This includes biologics license applications, called BLAs, which represent the regulatory pathway for blood components. The BLA regulatory process also applies to biological drugs such as fractionated plasma products. OBRR also regulates in-vitro diagnostic devices used for screening of collected blood, and does so also using the BLA regulatory pathway. Review of these devices as biologic licenses allows CBER to apply a higher level of manufacturing oversight, including lot release testing and pre-licensure inspection. This regulatory pathway applies to infectious disease tests for blood screening, as well as blood grouping and phenotyping reagents. Based on the above background information and enormous importance of this instrument for research programs, continuous maintenance is critical. The Biacore 3000 was purchased in 2003 and has been under a service agreement since then. The current service agreement coverage will expire on 8/24/15 and is being provided by GE Healthcare (the original equipment manufacturer-OEM). Part II: Service Requirements At a minimum the Contractor shall include: - Two (2) planned preventative maintenance (PM) visits per contract year - Unlimited corrective/remedial maintenance visits within 2 business days of call for service - Unlimited technical support, Mondays - Fridays (excluding Federal Holidays) between the hours of 8:00 AM - 5:00 PM Eastern Time, within 24 business hours of contact for assistance (e.g., telephone-based, email-based, website-based, etc.) - Unlimited software and firmware updates - All maintenance and repair activities shall be performed by formally trained and certified technicians/engineers, following OEM specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc. - All maintenance pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc. - Service Records and Reports - The Contractor shall, commensurate with the completion of each service call or preventative maintenance visit, provide the end-user of the equipment and the Contracting Officer with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced Part III: Supporting Information A. Place of Performance U.S. FDA/CBER/OBRR 10903 New Hampshire Ave., Bldg. 52/72, Rm. 4140 Silver Spring, MD 20993 Vendor shall coordinate all maintenance with the Project Officer (to be provided with order). B. Period of Performance Base period: 8/25/15 - 8/24/16 Option Period 1: 8/25/16 - 8/24/17 Option Period 2: 8/25/17 - 8/24/18 Option Period 3: 8/25/18 - 8/24/19 Part IV: Instructions to Prospective Respondents Responses to this sources sought shall unequivocally demonstrate respondent capability and prior experience to perform the services. In addition, interested sources may offer cost effective alternatives capable of meeting the requirements listed in Parts I and II above. Though the target audience is small businesses capable of providing service agreements, all interested parties may respond. At a minimum, responses shall include the following: - Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, 8(a), SDB, WOSB, EDWOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; - Three (3) years of past performance information for the service of same or substantially service agreement requirements, to include date of services, description (should also include technical literature and specifications), dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status), if not the respondent; - Descriptive literature, brochures, specifications, marketing material, etc., detailing the nature of the services the responding firm is regularly engaged in providing; - If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this requirement; - If a large business, identify the subcontracting opportunities that would exist for small business concerns; - Although this is not a request for quote, informational pricing is encouraged; - 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. The Government is not responsible for locating or securing any information, not identified in the response. Interested Parties must respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before March, 13, 2015 by 4:00 PM (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: James "Scott" Rawls, 3900 NCTR Road, Bldg 50/Room 430, HFT?320, Jefferson, AR 72079?9502 or email james.rawls@fda.hhs.gov. Reference # FDA-1145715 in all correspondence with the point of contact listed above. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether this requirement should be set aside for small business, made available to full and open competition or procured through other than full and open 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 combined synopsis/solicitation (No. FDA-1145715) may be published via FedBizOpps. 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).