1. Data collection and analysis. The contractor shall have the capability to perform activities related to laboratory work that will include procuring healthy adult donor heart tissues for in vitro experiments, measuring drug effects on electrophysiology and contractility parameters using these tissues, and storing tissue and other biological samples from each donor for additional laboratory work to be done at the FDA.

a. For action potential or electrophysiology recordings, data will be collected at different frequencies that are relevant to human heart rhythm. key action potential parameters will be extracted, including but not limited to resting membrane potential, AP peak, AP duration (APD) at various % of repolarization, AP triangulation, AP instability, and effective refractory period. Summary data and raw electrophysiology files will be provided to the FDA.

b. For contractility, the contractor will generate contractility data from either single cardiomyocytes or cardiac tissue/trabeculae isolated from different individuals. This data can include rate-dependent measurements, drug-induced variations in contractility endpoints and reflect measurements done at different conditions (i.e. cell maintenance solutions, ionic conditions, temperature, mechanical load, etc). For each set of data, the Collaborator will also provide information on the time of electrical pacing relative to the time of contractions. Depending on the measurement technique and the measured cellular material, the Collaborator can provide raw data on the following functional endpoints as a function of time: sarcomere length, cell shortening/hedge detection, isometric tension, contractile force, and Frank-Starling relation.
c. Biological sample collection including tissues from each donor associated with each task order will be collected, stored properly, and shipped to the FDA for additional research to be performed in-house.

2. Following completion of work, the contractor shall have the capability to (in discussion with the FDA study team):

a) Complete data quality control (QC) and analysis.

b) Deliver the dataset (raw and analyzed) in an agreed upon format as requested by the COR, CO, or FDA study team.

c) Prepare and deliver draft and final report, as appropriate and as needed.

3. Facilities, Equipment and Other Resources

The Contractor shall be responsible for the adequacy and availability of all facilities, equipment, and other resources necessary for the conduct of assay.

a) Ensuring secure electronic communications, including email, word processing and transmission of data files, between the contractor, FDA staff, subcontractors and consultants.

b) Organizing, maintaining, and transferring information on protocols and test results and provide electronic copies of all reports to the COR, CO, or FDA study team.

c) Maintaining the confidentiality of data received from FDA or third parties and data generated within the scope of the contract.

Capability Statements:

Responses to this sources sought shall unequivocally demonstrate the respondent's capabilities to provide services and facilities described above. Though the target audience is small business, all interested parties may respond. At a minimum, responses shall include the following:

1. Business name and bio, 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 again if responding to provide a service offered by another firm.

2. Past Performance information shall include date of services, description, dollar value, client name,

3. Client address, client 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 company (to include DUNS number and size status) if not the respondent.

4. Descriptive literature, brochures, marketing material, etc. detailing the nature of services the responding firm is regularly engaged in providing.

5. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and Schedule Item Numbers (SIN)s that are applicable to this potential requirement are also requested. If a large business, clarify if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response.

Response Instructions:

Interested parties shall respond with capability statements in person, by e-mail, fax, mail or other delivery method before 3:00 PM Eastern Time on May 7th, 2019 to [email protected].

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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