FDA-SS NOI-116799.doc

FDA-Sole Source- 116799 Materials Performance Study Extension

The Food and Drug Administration intends to make a sole source award for the continuation of a research and development project to maintain and update previously published materials safety reports.

Emergency Care Research Institute 5200 Butler Pike Plymouth Meeting, PA 19462-1298 In accordance with FAR 6.302-1 (a)(2)(ii), FAR 13.106(b) and FAR 5.203, this solicitation contains circumstances permitting other than full and open competition for developmental and/or research capabilities.

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. Providing patients with access to safe medical devices that meet their health care needs remains a top FDA priority. The objective of this procurement is to obtain a service contract to maintain and update the previously published material safety reports, and to ensure that all new information is made publicly and broadly available through reports and the available previously developed powerBI application. Information is publicly available to link specific materials (as opposed to the device) with safety and performance, but CDRH does not have access to a considered summary: in essence, the real world data exists, but there is an ongoing need to collate the data and turn it into real world evidence as it relates to the use of these materials in medical devices that seek FDA approval, and inform the Agency on development and modification of these types of devices.

ECRI (Emergency Care Research Institute) is uniquely qualified for CDRH’S current and unique requirement, and will provide support in the following critical areas:

• Completing up to 3 new literature reviews with materials specified by the FDA.

• Maintaining and updating the previously published material safety reports, available at https://www.fda.gov/medical-devices/science-and-research-medical-devices/medical-devicematerial-safety-summaries. The proposed Contractor has already completed the work and published the material safety reports in the contract PO#7540120Q00045. Switching to a different vendor who does not have background in the previously completed work, would result in significantly delayed project timelines and significant re-work to get to the proposed contractor’s expertise level. Additionally, another vendor would result in increased cost and time to validate the new vendor, on behalf of the FDA, as such it would be an unnecessary cost to the government to make this an open competition. In accordance with FAR 6.302-1, a sole source award shall be made to Emergency Care Research Institute for the continued development of essential research. It is in the best interest of the government to plan an award in the estimated amount of $822,197.33 to Emergency Care Research Institute.

This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement within fifteen (15) days after the publication of this synopsis which shall be considered by the agency. Responses received after 15 days or without the required information may not be considered. For information concerning this acquisition contact:

Nikola Zuber Contract Specialist Nikola.Zuber@fda.hhs.gov

(301) 796 - 9671 A determination by the Government not to compete because of information received is solely within the discretion of the Government. Information received will normally be considered solely for determining whether to conduct a competitive procurement.

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