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The appropriate NAICS code for the acquisition is 811219 - Other Electronic and Precision Equipment Repair and Maintenance; Small Business Size standards - $20.5 MIL.
Background:
A major focus of the U.S. Food and Drug Administration (FDA); the Center for Biologics Evaluation and Research (CBER), Division of Blood Components and Devices (DBCD), Office of Blood Research and Review (OBRR) research centers are effects of hemoglobin-based oxygen carriers (HBOCs) and microbial pathogens on the vascular endothelium in various organ systems (e.g. heart, kidney, brain, lung, and liver) and in cell culture systems. Making detailed observations by brightfield and fluorescence microscopy of animal tissue specimens and cells is a vital part of being able to ascertain the safety and/or efficacy of these biological treatments.
The Nanozoomer whole slide scanner is an instrument that can take a whole-slide high quality digital image in a very short amount of time. The instrument is used to characterize the safety of biologics and evaluate the pathogenic mechanisms of bioterrorism threats. This system supports multiple projects within the Laboratory of Biochemistry and Vascular Biology. A Hamamatsu Nanozoomer Worry-Free Warranty extension is required to assure OBRR's lab's NanoZoomer will continue to operate normally at the highest factory specifications for the next year. It will also allow OBRR's lab to get software and firmware upgrades.
Minimum Performance Requirements:
1. Shall include Extended "Worry-Free" Warranty for a coverage period of one (1) year, with the option to add on another year at the end of the coverage period at the same price.
2. Shall include two (2) Preventative Maintenance visits during the year.
3. Shall include all parts and labor, as well as travel costs for the technician.
4. Shall include original equipment manufacturer (OEM) certified parts and technicians.
5. Shall include the replacement of consumables during the coverage period, including up to 2 Brightfield bulbs.
6. Shall include NDP.Scan and NDP firmware updates.
7. Warranty coverage shall include parts and labor for the computer that was included with the system.
8. Shall include unlimited phone and WebEx support during normal business hours.
9. The Maintenance and Repair activities shall be performed following the Original Equipment
10. The Extended "Worry-Free" Warranty activities shall be performed following the Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc.
Service Records and Reports:
The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket by email 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. In addition, the Contractor shall provide a written report to the FDA Contracting Officer's Representative and Contract Specialist by email, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.
Period of Performance: Base + 3 (1 Year) Option Periods
Base Period: September 5, 2019 - September 4, 2020
Option Period 1: September 5, 2020 - September 4, 2021
Option Period 2: September 5, 2021 - September 4, 2022
Option Period 3: September 5, 2022 - September 4, 2023
Place of Performance:
U. S. FDA - CBER
White Oak Campus
10903 New Hampshire Ave.
Bldg. 52/72, Rm. 4148
Silver Spring, MD 20993
Responses to this source sought shall unequivocally demonstrate the respondent is regularly providing Hamamatsu NanoZoomer 2 RS Extended "Worry-Free" Warranty services. Though the target audience is small business vendors or small businesses capable of supplying a U.S.
service of a small business vendor or producer, all interested parties may respond. At a minimum, responses shall include the following:
1. Business name and bio, 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 again if responding to provide a service offered by another firm.
2. Past Performance information shall include date of services, description, dollar value, client name, Client address, client 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 company (to include DUNS number and size status) if not the respondent.
3. Descriptive literature, brochures, marketing material, etc. detailing the nature of the equipment/supply item/services the responding firm is regularly engaged in manufacturing and/or selling.
4. The offeror shall furnish sufficient technical information necessary for the Government to
conclusively determine that the offered services meet the performance requirements identified above.
5. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested. If a large business, provide if subcontracting opportunities exist for small business concerns.
The Government is not responsible for locating or securing any information, not identified in the response.
Interested parties shall respond with capability statements in person, by e-mail, fax, mail or other delivery method before 12:00 pm (Central Time - Local Prevailing Time in Jefferson, Arkansas) on June 14, 2019 to [email protected], Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, OO/OFBA/OAGS/DAP, Attention of Jennifer L. Johnson, 3900 NCTR Rd., Bldg. 50, Rm. 429, Jefferson, AR 72079-9502 and Reference: FDA-SSN-1211637.
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 Federal Business Opportunities. 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).
Additional Notes:
If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.