Added: Jul 25, 2008 5:56 pm
Modified: Aug 20, 2008 6:02 pm
Track Changes
The FDA is issuing this Request for Quotations (RFQ) to define and critically evaluate possible database models that should be considered for use in FDA s Sentinel Initiative as it evolves to enhance the performance and findings of the system.
Consistent with FDA's mission to protect and promote the public health, the Agency is embarking on the Sentinel Initiative to create a national, electronic distributed network, strengthening FDA's ability to monitor the post-market performance of a product. As currently envisioned, the Sentinel Initiative will enable FDA to utilize the capabilities of multiple, existing data systems (e.g. electronic health record systems, Medicare data, other medical claims databases) to augment the Agency s current surveillance capabilities. The System will enable surveillance or queries of distributed data sources quickly and securely for relevant product safety information. Data will continue to be managed by its owners, and only data of organizations who agree to participate in this system will be included. Operations will adhere to strict privacy and security safeguards.
The success of this Initiative will depend largely on the time it takes for medical products under surveillance to be used by sufficient numbers of patients in participating health care databases. It is essential that FDA understand the timeliness of the surveillance possible in the Sentinel Initiative.
The Sentinel Initiative is intended to be created through a public-private partnership involving a broad spectrum of stakeholders, including government agencies, data holders, academia, patients, consumers, and healthcare professionals. The awardee will define and critically evaluate possible database models that should be considered for use in the Sentinel Initiative as it evolves to enhance the performance and findings of the system.
The awardee will be required to complete the following tasks:
(1.) Develop a comprehensive requirements document detailing actual user needs for monitoring medical product performance throughout its entire life cycle in order to protect and promote the public health.
(2.) Define possible database models that should be considered for use in the Sentinel Initiative. This should include, but not be limited to, distributed and federated models. The list of models to be defined should be developed in consultation with the Agency.
(3.) Compare and contrast the identified database models with the user needs documented in the detailed requirements documents. Characterize the advantages and disadvantages of the models identified in #2 for the intended use of postmarketing surveillance as envisioned by the Sentinel Initiative. Evaluate issues related to policy, performance, privacy and security, robustness of findings, benefits to all stakeholders, and data standards. This requirement should be fulfilled by consulting with all the various stakeholder groups that will be represented in the public-private partnership formed for the implementation of the Sentinel Initiative.
(4.) Identify and evaluate existing data sources and/or environments that operate under each model. Describe the content, quality, flexibility, and timeliness of each system, as well as how each could best contribute to the Sentinel Network.
The Period of Performance will be Six Months from date of award. The award type will be Firm-Fixed-Price (FFP). There is no Set-Aside Designation. Competition is Full and Open. The Procurement Procedures are those proscribed by FAR Part 13 for Simplified Acquisition Procedures. And, the Basis of Award will be Best Value.
The primary location of performance will be at the contractor s preferred location; however, the contractor will be required to travel to the Washington, DC/Maryland geographical area.
The designated North American Industry Classification System (NAICS) code is: 541690 Other Scientific and Technical Consulting Services. This industry comprises establishments primarily engaged in providing advice and assistance to businesses and other organizations on scientific and technical issues (except environmental). The Small Business Size Standard is $6.5 Million.
This announcement is an active RFQ. The quotation due date is September 2, 2008, at 10:00 AM, ET. The anticipated award date is on or around September 18, 2008.
