SOLICITATION NOTICE
B -- Evaluation of Existing Methods for Safety Signal Identification
- Notice Date
- 7/25/2008
- Notice Type
- Presolicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-08-EvaluationOfSafetySignalIdentification
- Archive Date
- 9/8/2008
- Point of Contact
- Terry Frederick, Phone: 301-827-7043, Ron Loube,, Phone: (301) 827-7031
- E-Mail Address
-
terry.frederick@fda.hhs.gov, Ronald.Loube@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- The FDA intends to issue a Request for Quotations (RFQ) to identify, describe, and evaluate existing signal detection methods that could be employed by the FDA in support of the Sentinel Initiative. 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 be responsible for the identification, description, and evaluation of existing signal detection methods that could be employed in the Sentinel Initiative. This work will require a thorough analysis of each methodology’s: (1) utility for post-market surveillance of FDA-regulated drugs, biologics, and devices; (2) sensitivity, or ability to appropriately identify important safety signals; (3) specificity, or ability to appropriately identify the absence of important safety signals; (4) ability to minimize both false positive and false negative safety signals; (5) robustness of methodology to perform across different types of data systems for detection of different types of safety signals; (6) flexibility of the methodology to adapt to different situations and to change thresholds for different safety issues as desired and; (7) barriers that exist to using each identified methodology in the Sentinel Initiative. These analyses should lead to specific recommendations for further involvement of the most promising signal detection methodologies as the Sentinel Initiative moves forward. The anticipated Period of Performance is Six Months from date of award. The anticipated award type is Firm-Fixed-Price (FFP). There is no anticipated Set-Aside Designation. Competition is expected to be “Full and Open.” The anticipated Procurement Procedures are those proscribed by FAR Part 13 for Simplified Acquisition Procedures. And, the anticipated Basis of Award is “Best Value.” The primary location of performance is anticipated to be at the contractor’s preferred location; however, the contractor may be required to travel to the Washington, DC/Maryland geographical area. The designated North American Industry Classification System (NAICS) code is anticipated to be: 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 not a RFQ. FDA anticipates release of the RFQ on or around August 9, 2008. It will be available on the Federal Business Opportunities Web Site Home Page: http://fedbizopps.gov. The anticipated quotation due date and award date for this effort is expected to be on or around September 8, 2008, and September 18, 2008, respectively.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=fd8588ee149f3a5e02dbae734919fd23&tab=core&_cview=1)
- Place of Performance
- Address: Contractor's preferred location... Travel may be required to Washington, DC / Maryland, Rockville, Maryland, 20857, United States
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN01623132-W 20080727/080725222448-fd8588ee149f3a5e02dbae734919fd23 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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