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FBO DAILY ISSUE OF AUGUST 08, 2008 FBO #2447
DOCUMENT

B -- Evaluation of Potential Data Sources - Amendment 1

Notice Date

8/6/2008
 

Notice Type

Amendment 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-EvaluationOfPotentialDataSources
 

Archive Date

9/8/2008
 

Point of Contact

Terry F 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 potential data sources and/or data environments that could participate in the FDA’s 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 work requires the identification, description, and evaluation of potential data sources and/or data environments that could participate in the Sentinel Initiative. This work will require a thorough analysis of each data source’s: (1) utility for post-market surveillance of FDA-regulated drugs, biologics (excluding blood and tissue products), and devices; (2) scope, content, structure, quality, and timeliness of data; (3) patient population(s), duration of follow up and capture of care across all settings; (4) availability, experience and interest of investigators with knowledge of the data in using it for post-market product safety surveillance as well as plans for further data source enhancements; (5) availability, experience and interest of investigators with knowledge of the data in participating in a distributed data network; and (6) potential privacy and security concerns related to the use of electronic health data; (7) barriers that exist to including each data source in the Sentinel Initiative. These analyses should lead to specific recommendations for further involvement of the most promising data sources and/or environments 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 2, 2008, and September 18, 2008, respectively.
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=a7b69033aa5cde5dfe5f425ad1d1ef40&tab=core&_cview=1)
 

Document(s)

Amendment 1
 

File Name: Pre-Solicitation Notice Amendment 001 (SOW Sentinel Data Sources, 08.06.2008.pdf)

Link: https://www.fbo.gov//utils/view?id=2e4b6a8549046cb7421bfe483ed4f24b

Bytes: 31.23 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 may be required to Washington, DC / Maryland, Rockville, Maryland, 20857, United States

Zip Code: 20857
 

Record

SN01632609-W 20080808/080807103023-a7b69033aa5cde5dfe5f425ad1d1ef40 (fbodaily.com)
 

Source

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

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