SOURCES SOUGHT
66 -- Cardiac Imaging System
- Notice Date
- 6/17/2015
- 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, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1151342
- Archive Date
- 6/25/2015
- 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 Cardiac Imaging 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 500 employees. Statement of Work (SOW) Objective The NCTR are conducting studies focused on developing early biomarkers drug-related cardiotoxicity. Ejection fraction is an important determinant of the severity of systolic heart failure. Ejection fraction is commonly measured by echocardiography, in which the volumes of the heart's chambers are measured during the cardiac cycle. Several studies at NCTR are focused on cardiac injury using animal models. To fulfill the need of the cardiotoxicity studies, NCTR requires an instrument to assess the left ventricular ejection fraction (L VEF) which indicates the severity of cardiac damage to the heart after drug treatment. General Requirement 1. The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration. 2. The entire system shall be warranted for parts and labor for a minimum of 12 months 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 necessary supplies and accessories required for installation and start-up. 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 am to 4:30 pm, Central Time). 6. The Contractor shall provide technical support. Technical Requirement At a minimum, the Contractor shall provide an instrument that shall meet the following: 1. Shall include four different imaging modes: B-mode, M-mode, PW Doppler Mode, and Color Doppler Mode. 2. Sampling rate shall be up to 128MHz with max frame rate at 1000 frames/second. 3. Shall provide linear array with high frequency (up to 70 MHz) and resolution down to 30 11m. 4. Shall be designed for preclinical cardiac study using small animals such as mice and rats. 5. Shall provide extensive small animal-based measurements and calculations for accurate data analysis. 6. Shall provide LV (Left Ventricular) analysis with integrated BP (blood pressure). Period of Performance: Ninety (90) calendar days after contract award. Place of Performance National Center for Toxicological Research 3900 NCTR Road Jefferson, AR 72079 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 June 24, 2015 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 1151342. 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)."
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- Record
- SN03768119-W 20150619/150617235909-4f47828f9ea2bd393c123b4510bffa70 (fbodaily.com)
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