G
Background
The FDA CTP is requesting the NCTR to run various in vitro (cell culture) omics studies to support their regulatory mission. As part of this testing, CTP requires that different tobacco products are tested for their relative toxicity in a heart muscle cell in order to mimic human cardiovascular effects from smoking. These cells offer a major advantage over other cell types since they have all the properties of a cardiomyocyte, exhibit a stable phenotype, and can be supplied in large quantities. NCTR will be performing the study; the Contractor will merely be providing the cells that will be used in the actual study.
The contractor shall provide the following:
Technical Requirement
• 40 units of Human iPS-derived cardiomyocytes, each unit shall have at least 4x10A6 viable
cells, up to 2 years storage stability; ready for xCELLigence e-plate (96well-plate)
• 40 units of Human iPS-derived cardiomyocytes, each unit shall have at least 1x10A6 viable
cells, up to 2 years storage stability; ready for lower throughput assays ( 48well-plate)
• The cells shall begin beating within 24 hrs after thaw and be able to use for assays within 7
days
• Cell culture medium (thawing medium and maintenance medium)
Period of Performance
Four (4) months after receipt of contract award.
Respondents shall furnish sufficient information necessary for the Government to conclusively determine capability to provide the requirements identified above to include three (3) references for the same or similar genome sequencing services, to include instrument used for the sequencing, within the last two years to include name, telephone number, mailing address, email address, contract number and description of services to include dollar amount. Additionally, provide 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. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this 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 27, 2014 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 [email protected]. Reference FDA1135379.
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).