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FBO DAILY ISSUE OF AUGUST 13, 2008 FBO #2452
DOCUMENT

B -- Evaluation of Existing Methods for Safety Signal Identification - Solicitation 1

Notice Date

8/11/2008
 

Notice Type

Solicitation 1
 

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
 

Response Due

9/2/2008 10:00:00 AM
 

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 is issuing 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 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 anticipated 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.
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=e64cbac4d55203e19a190ea40d7cd02d&tab=core&_cview=1)
 

Document(s)

Solicitation 1
 

File Name: Safety Signal RFQ, 08.11.2008 (Sentinel RFQ..Safety Signal...149.pdf)

Link: https://www.fbo.gov//utils/view?id=39e90a86751154638efecc65353846ae

Bytes: 140.12 Kb
 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Contractor's preferred location... Travel will be required to Washington, DC / Maryland, Rockville, Maryland, 20857, United States

Zip Code: 20857
 

Record

SN01636290-W 20080813/080811222835-e64cbac4d55203e19a190ea40d7cd02d (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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