SOURCES SOUGHT
66 -- Cardio Monitoring System
- Notice Date
- 6/23/2016
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Jefferson, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1169360
- Archive Date
- 7/16/2016
- Point of Contact
- Regina R. Williams, Phone: (870) 543-7012
- E-Mail Address
-
regina.williams@fda.hhs.gov
(regina.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the National Center for Toxicological Research (NCTR) requirement for a Cardio Monitoring System. 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. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The appropriate NAICS code for this acquisition is 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1,000 employees. Statement of Work (SOW) Background/Objective Numerous drugs have the potential adverse effect of prolonging the QT interval, a marker for torsade de pointes (TdP), which can cause the heart to stop beating. The current FDA guidelines are very useful for identifying QT prolonging drugs, but some QT "positive" drugs have no demonstrable clinical risks of TdP. NCTR aims to establish an appropriate, strong pre-clinical proarrhythmia screening model that can directly measure and rank TdP risk and the influence of sex hormones. Scope NCTR requires a cardio monitoring system that can monitor cells in real-time without the potential artifacts generated through the use of labels. The system shall be a non-invasive measurement method that allows detection of changes in adherence, morphology and viability without the need for over-expression of reporter and target proteins. General Requirement 1. The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration. 2. The instrument shall be warranted for parts and labor from date of installation acceptance. All warranty work shall be performed on-site at NCTR, i.e., returning the equipment to the manufacturer is unacceptable. 3. The system shall be delivered with all components, accessories, start-up supplies required for installation and start-up., i.e., a turn-key solution. 4. The Contractor shall provide on-site (Government-site) operator familiarization training of the system upon completion of installation. Such familiarization shall include system operations, optimization, and basic preventive maintenance procedures. 5. The Contractor shall include all parts, travel, and labor to complete installation. Installation shall be performed and completed during normal duty hours (Monday through Friday, 8:00 AM to 4:30 PM, Central Time). Technical Requirement At a minimum, the system shall meet the following requirement: 1. The system shall be able to measure the electrical function in native cell types that can monitor the action potential duration and beat period of the cardiomyocytes cultured in formats. 2. The system shall have high-throughput screening for cellular electrophysiology using more than 750 simultaneously-recorded electrodes. 3. The system shall be label-free, non-invasive measurement technology that avoids influences on cellular health and function. 4. The system shall allow for interchangeable use of plate types 12-well, 48-well and 96-well, with at least 8 electrodes/well. 5. The system shall have a fully-integrated heater, adjustable in software between ambient temperature and 45°C (Cardiomyocytes are sensitive to temperature drop so it is important to have this heater function). 6. The system shall have a gas mixer that shall enable the use of a 100% CO2. 7. The system shave have an adapter for control of gas environment outside of incubator. 8. Software shall be designed to assess the following: •Visual Activity Map for real-time plate-wide feedback on action potential activity •Integrated control of plate temperature and electrical stimulation •Automatic search of full beat period for cardiac T-wave •Automatic calculation of beat-by-beat measurements and electrode and well averages for field •Potential duration, beat period, and depolarization spike amplitude and slope Four One (1) Year Post Warranty Option Periods Minimum Service Agreement Requirements: 1. Shall include one (1) planned preventative maintenance visit per contract year. 2. Shall include unlimited corrective/remedial maintenance visits within 3 business days of initial call for service if problem(s) can't be resolved remotely. 3. Shall include unlimited technical support, Monday - Friday (excluding Federal Holidays) between the hours of 7:00 AM - 4:00 PM (Central Time) within 24 business hours of contact for assistance (e.g., telephone-based, email-based, website-based, etc.). 4. Shall include unlimited software and firmware updates. 5. All maintenance and repair activities shall be performed by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using new OEM replacement parts, components, subassemblies, etc. 6. All maintenance pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc. Deliverables: 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. FOB Point Destination: Delivery/Installation is within ninety (90) calendar days after receipt of contract award. Delivery Address: National Center for Toxicological Research 3900 NCTR Road Jefferson, AR 72079 POC (To be provided at time of award) The respondent to this source sough shall furnish sufficient technical information necessary for the Government to conclusively determine its capability to provide products/services and components meeting the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying U.S. made system of another small business manufacturer or producer, 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 products and services meet or exceed above specifications. All descriptive material necessary for the government to determine whether the service/product 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. Three (3) years of past performance information for the manufacture and/or sale of same or substantially similar items to include date of sale, description, 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. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. The government is not responsible for locating or securing any information, not identified in the response. Interested parties shall respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before July 1, 2016 by 12:00 PM (Central Time in Jefferson, Arkansas) at the FDA/OO/OFBA/OAGS/DAP, Field Operations Branch, Attn: Regina Williams, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email regina.williams@fda.hhs.gov. Reference FDA1169360. 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA1169360/listing.html)
- Record
- SN04160610-W 20160625/160623235352-56e2f966b5977d6adeb47aa97252234a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |