The U.S. Food and Drug Administration (FDA), is conducting market research to support the National Center for Toxicological Research (NCTR) requirement for Human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs).

The FDA is seeking small business sources 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 for the items described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.

The associated North American Industry Classification System (NAICS) Code is-325414- Biological Product (except Diagnostic) Manufacturing; Small Business Size Standard is 1,250 employees.

NCTR is in needs of hiPSC-CMs for an accurate and comprehensive analysis of drug-induced cardiotoxicity. Drug-induced cardiotoxicity is the leading cause of late stage drug attrition and drug withdraw. Because many of the cardiotoxicities are often discovered in late-stage clinical trials or even years after drug approval, there is an urgent need to develop translational and sensitive preclinical methods to assess potential drug-induced cardiotoxicities early in drug development and well before human clinical trials
are initiated.

Human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) are gaining recognition for in vitro cardiac toxicity screening of new drug candidates and have been used to support investigational new drug applications and to reveal mechanisms of drug actions. hiPSC-CMs offer several advantages comparing with other in vitro models such as human cadaveric tissue or primary cultures of human cardiac cell lines. Different to human heart tissue, the resource of the hiPSC-CMs is theoretically unlimited (typically via skin biopsy or blood draws). hiPSC-CMs can be functionally characterized in vitro
to model the complex cellular physiology of cardiomyocytes. Additionally, hiPSC-CMs recapitulate the genome of a subject, allowing for the assessment of genotype-phenotype associations.

Performance requirements

• Cells must be highly purified hiPSC-CMs with the purity of cardiomyocytes > 90%.
• The cells must be rigorously scrutinized for quality control.
• The cells must recover rapidly (within one week) from cryopreservation to generate a mixture of spontaneously electrically active atrial-, nodal-, and ventricular-like myocytes.
• Cells must possess typical electrophysiological characteristics and exhibit expected electrophysiological and biochemical responses upon exposure to exogenous agents.
• The spontaneous beating rate of the hiPSC-CMs shall be less than 45 bpm. The cells must be able to be cultured for months and keep the typical electrophysiological characteristics
• Cells must be derived from adult somatic cells.
• The cells must be from the same batch of iPSC-CMs. Each vial must have at least 5 million viable cells with a plating efficiency close to 50%.
• Cell type must be consistent to that used in preliminary and on-going studies.

FOB Point Destination. All items shall include shipping, handling and delivery to the destination identified herein. Delivery date is within 60 calendar days after receipt of order. FOB Point of Delivery for Services and Supplies will be the FDA located at 3900 NCTR Road, Jefferson, AR 72079.

Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum brand name or equal technical requirements.

The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a 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 can meet the above requirements. 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 in which the offeror has provided same or substantially similar items and used for same or near-same applications as set forth herein. For each past performance reference include the 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. Detailed list of items included and not included on the GSA contract to meet this requirement.
• Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment.
• If a large business, identify the subcontracting opportunities that would exist for small business concerns;
• Standard commercial warranty and payment terms; and
• Though this is not a request for quote, informational pricing is encouraged.

The government is not responsible for locating or securing any information, not identified in the response.

The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

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 April 18, 2019 by 13:00 hours (Central Time in Jefferson, Arkansas) to [email protected], or mail to the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, Building 50, Room 422, Jefferson, AR 72079-9502. Reference FDA1211907.

Notice of Intent
Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

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 FedBizOpps. 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).