SOLICITATION NOTICE
66 -- Multi-Electrode Recording Array - FDA-RFQ-1166007
- Notice Date
- 5/4/2016
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-RFQ-1166007
- Archive Date
- 6/3/2016
- Point of Contact
- Lisa K. Yaw, Phone: 2404024018
- E-Mail Address
-
lisa.yaw@fda.hhs.gov
(lisa.yaw@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- The Center for Devices and Radiological Health has a requirement for a multi-electrode recording array system for retinal prosthesis studies. Part 1 - Description The Center for Devices and Radiological Health has a requirement for a multi-electrode recording array system for retinal prosthesis studies. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued. This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-87. The North American Industry Classification System (NAICS) code for the proposed acquisition is 334516, Analytical Laboratory Instrument Manufacturing.. The associated small business standard is 500 employees. This is for a small business set-aside. Part 2 - Supplies or Services and Prices/Costs Purchase Order Type: Firm-Fixed Price Base Year ManufacturerProduct CodeDescriptionQuantityPrice Multi-electrode recording array Shipping Installation and training One (1) year warranty on parts and labor Total Firm-Fixed Price Option Years Option YearDescriptionPrice 1Service Agreement 2Service Agreement 3Service Agreement 4Service Agreement Total Firm Fixed Price The total price for the base and four option years is $____________. Part 3 - Description/Specifications 3.1 Background The Center for Devices and Radiological Health has a requirement for a multi-electrode recording array system for retinal prosthesis studies at their White Oak facility. The requested multi-electrode array is required for a series of retinal physiology studies for evaluating whether prosthesis stimulus electrodes activate the overlying optic nerve fibers of the live retinal ganglion cells, similar to the current arc-like percepts of retinal implant patient reports, and for optogenetic studies. The unit must have a minimum of 60 extra-cellular recording/stimulation disc electrodes mounted in a transparent flat array. Each electrode must have an amplifier with an analog to digital converter (A/D) with a sampling rate ≥22KHz, and the ability to either record or stimulate the local retina via the electrodes. The objective of this procurement is to obtain a reusable flat ≥ 60 multi electrode recording array with a bank of low noise amplifiers and high speed analog to digital converters (A/D) for simultaneous extracellular recording of retinal ganglion cell action potentials from retinal flat mounts. The unit must have the ability to stimulate a subset of recording electrodes, while simultaneously faithfully recording retinal ganglion cell action potentials on the neighboring electrodes. The base of the chamber around the recording array must be flat and ≥2 cm in diam. to allow positioning of retinal tissue perfusion apparatus to be placed over the array for obtaining good signals. 3.2 Salient Characteristics To meet the purpose and objective of this requirement, the Contractor shall provide a multi-electrode recording array system capable of meeting the salient characteristics below and installation of the proposed system on-site at FDA's facility in Silver Spring, MD. 1.The multi-electrode array shall be flat and have ≥ 60 electrodes arranged in an approximate square. 2.The electrode amplifiers shall have a bandwidth of 0.1 Hz - ≥10 kHz. 3.The device shall have a minimum diam. of 2 cm around the recording array to allow mounting tissue perfusion apparatus which aids retina survival/recording fidelity. 4.The electrode amplifier shall analog to digital converter rate shall be ≥ 16bit resolution. 5.The sampling rate of the voltage on each electrode when recording all shall be ≥ 22KHz. 6.Two or more electrodes are required to be optionally used for biphasic pulse electrical stimulation instead of recording. 7.The recording/stimulation electrodes shall be round discs composed of Titanium Nitride. 8.The unit shall have the ability to suppress/reduce the stimulation electrode artifacts from saturating the neighboring recording electrodes. The unit shall be easily mountable on a microscope as a stage, or in place of the stage. 9.Array recording/analysis software shall be provided with the multi-electrode array. 10.The electrode array shall be reusable at least 20 times. 11.Shipping, delivery, setup, and installation of hardware and software, interfacing, and training for FDA scientists shall be provided. 12.All labor, parts, and travel expenses for a one year warranty period of system and components shall be included. 3.3 Optional Service/Maintenance Agreement The FDA shall have a unilateral right to exercise optional periods to continue the maintenance work described below: The offerors pricing for optional service agreement shall include coverage of labor, parts and travel expenses. Parts- The service plan will use all Original Equipment Manufacturer (OEM) certified parts. Services On-site- The contractor will initiate corrective maintenance/repairs within 48 hours from the service call. The repairs will be completed within 72 hours from the on-site arrival of the technician/service engineer. There will be no limit to the number of on-site repair service visits. The service must be delivered by an authorized OEM service provider. Services Off-site- Technical support and troubleshooting assistance will be provided by the contractor via phone, email, or live-chat interface within 1 hour of initial contact. Part 4 -Performance and Deliverables 4.1 Place of Performance and Work Hours All applicable equipment is located at the location listed below. Normal workdays are Monday through Friday except US Federal Holidays. Work hours are typically from 8 am to 5 pm (ET). Service visits shall be coordinated with, see below. Location and Point of Contact: Food and Drug Administration White Oak Campus WO62 Rm 1204 10903 New Hampshire Avenue Silver Spring, MD 20993 ATTN: TBD TBD@fda.hhs.gov The component will be delivered to the WO Bldg 62, and transported to room 1204 for installation and integration. 4.2 Period of Performance The equipment shall be delivered by June 1, 2016. The warranty shall start when equipment is installed and accepted by FDA and be in effect for one year. Optional Periods DeliverablePeriod of Performance Option Period 1 -Service AgreementTo begin 1st year following receipt of equipment Option Period 2 -Service AgreementTo begin 2nd year following receipt of equipment Option Period 3 -Service AgreementTo begin 3rd year following receipt of equipment Option Period 4 -Service AgreementTo begin 4th year following receipt of equipment Part 5 -Contract Administration 5.1 Representative's The Contracting Officer's Representative (COR) will perform inspection and acceptance of materials and services to be provided. For the purpose of this PART, (COR TBD - TBD@fda.hhs.gov) is the authorized representative of the Contracting Officer. The COR is responsible for the following as required by this order: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order. The contact information for the Contracting Officer is the following: Sean Wybenga U.S. Food and Drug Administration Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 Sean.Wybenga@fda.hhs.gov; (240) 402-7629 The contact information for the Contract Specialist is the following: Lisa Yaw U.S. Food and Drug Administration Office of Acquisitions and Grants Services 5630 Fishers Lane Rockville, MD 20857 Lisa.Yaw@fda.hhs.gov; (240) 402-4018 The contact information for the Contractor is the following: (TBD)
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-RFQ-1166007/listing.html)
- Place of Performance
- Address: White Oak Campus, Silver Spring, Maryland, 20878, United States
- Zip Code: 20878
- Zip Code: 20878
- Record
- SN04105310-W 20160506/160504234326-32524038d7dbca7dcd8804bea69efe15 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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