NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is conducting market research to obtain services to obtain electrophysiology and contractility data using adult primary human ventricular tissues from healthy donors for a number of drugs that perturb cardiac functions based on clinical data.

This is a Sources Sought notice to determine the availability of small businesses capable of supplying the required services. This notice is for planning purposes only, and does not constitute an invitation for Bids, Request for Proposal or Request for Quotation or an indication the Government to award a contract, nor does the Government intend to pay for any information submitted in response to 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.

DRAFT Statement of Work (SOW)

Electrophysiological and contractility assessment of drugs on primary adult ventricular tissues
1. Introduction/Background
The heart functions by generating electrical signals called action potentials in individual heart cells that then drive cell contractility to deliver blood throughout the body. Assessments of drug effects on electrical signals generated by individual heart cells and contractile parameters are thus crucial for understand the drug's impact on heart function. As a part of the FDA's mission to protect public health by assuring the safety and efficacy of drug products used to treat human conditions, the Division of Applied Regulatory Science has a need for evaluating the cellular mechanisms that underlie cardiac disturbances for a panel of approved drugs when administered in humans.

2. Scope/Objectives
The objective is obtain electrophysiology and contractility data using adult primary human ventricular tissues from healthy donors for a number of drugs that perturb cardiac functions based on clinical data. Outcomes will lead to a better understanding of mechanisms of drug action. This information will be used directly to support regulatory review of drug applications by FDA review staff, by allowing FDA review scientists to discern the presence or absence of drug class effects regarding cardiac toxicity, provide clear label language including possibility of drug-drug interactions for specific drugs to educate physician practice and general public, and potentially design mitigation strategy to lessen the impact of cardiac side effects for the specific drugs/drug classes.

3. Data collection and analysis. The contractor shall 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.

4. Deliverables
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.

5. 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.

Interested parties shall submit a capability statement no later than 3:00 PM EST February 28, 2019 via e-mail to [email protected].

Note: Responses must reference Request for Information (RFI) #120948

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