SOURCES SOUGHT
66 -- Human Cardiomyocytes
- Notice Date
- 6/30/2015
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- 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
- FDA1151882
- Archive Date
- 7/21/2015
- 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 US Food and Drug Administration (FDA) National Center for Toxicological Research (NCTR) is requesting Human Cardiomyocytes derived from Induced Pluripotent Stem Cells (iPSC) This is a Sources Sought Notice to determine the availability and capability of small businesses that can meet the requirement set forth herein. 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 associated North American Industry Classification System (NAICS) Code is 541711-Research and Development in Biotechnology with a small business size standard of 500 employees. Statement of Work The US Food and Drug Administration (FDA) National Center for Toxicological Research (NCTR) will be studying male and female cardiomyocytes to establish a model and assess the effects of proarrhythmic drugs. NCTR will be performing the study; the Contractor will merely be providing the cells that will be used in the actual study. Technical Requirement The contractor shall provide the following: • 20 units of cryopreserved Human (Caucasian female) cardiomyocytes derived from induced Pluripotent Stem Cells (iPSC), each unit shall have at least 4 million viable cells per vial shall be from one single lot •Cells shall be derived from iPSC and highly purified with about 95% of cells are cardiomyocytes •Cells shall be pre-matured for short culture times post-thaw. •Physiologically-relevant beat rate, resting membrane potential and more •Cells shall recover rapidly from cryopreservation to generate a mixture of spontaneously beating atrial-, nodal-, and ventricular-like myocytes within one week •Cells shall be provided with culture medium and any required supplements •50 units of cryopreserved Human (Caucasian male) cardiomyocytes derived from induced Pluripotent Stem •Cells (iPSC), each unit shall have at least 4 million viable cells per vial. At least 45 vials of cells shall be from one lot and the rest of the cells shall be from a second lot •Cells shall be derived from iPSC and highly purified with about 95% of cells are cardiomyocytes •Cells shall be pre-matured for short culture times post-thaw •Physiologically-relevant beat rate, resting membrane potential and more •Cells shall recover rapidly from cryopreservation to generate a mixture of spontaneously beating atrial-, nodal-, and ventricular-like myocytes within one week •50 vials of cryopreserved cells with minimum of 4 million viable cells per vial. At least 45 vials of cells shall be from one lot and the rest of the cells shall be from a second lot. • Cells shall be provided with culture medium and any required supplements 25 units of cryopreserved Human (Caucasian male) cardiomyocytes derived from induced Pluripotent Stem •Cells (iPSC), each unit shall have at least 4 million viable cells per via, all from one single lot, and genetically modified to display long-QT phenotype. •Cells shall be derived from iPSC and highly purified with about 95% of cells are cardiomyocytes •Cells shall be pre-matured for short culture times post-thaw •Physiologically-relevant beat rate, resting membrane potential and more •Cells shall recover rapidly from cryopreservation to generate a mixture of spontaneously beating atrial-, nodal-, and ventricular-like myocytes within one week •Cells shall be provided with culture medium and any required supplements Period of Performance Four (4) months after receipt of contract award. The respondent to this source sought shall furnish sufficient technical information necessary for the Government to conclusively determine its capability to provide supplies/services 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, Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, EDWOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Three (3) years of past performance information for the same or similar services to include date of services, description, dollar value, client name, client address, client point of contact name, and client point of contact email address. Descriptive literature, brochures, specifications, marketing material, etc. detailing the nature of the services the responding firm is regularly engaged in providing. 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 6, 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 FDA1151882. 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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