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

B -- Evaluation of Timeliness of Medical Update for Surveillance in Health Care Databases - 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-MedicalUptake_HealthCareDatabases
 

Response Due

9/2/2008 10:00:00 AM
 

Archive Date

9/19/2008
 

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 examine two recent medical product launches each in at least two different types of health care databases to assess the timeliness of uptake of these products by patients in each database. 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 examine two recent medical product launches each in at least two different types of health care databases that could participate in the Sentinel Initiative in order to assess the timeliness of uptake of these products by patients in each database. This work will require a thorough analysis of two medical products launched within the past several years in at least two different health care databases for: (1) the number of patients identified as using each medical product each month in each health care database throughout the first year after launch; (2) a description of the patients using the product, and characteristics of that use (e.g., product strength, days supply and overall duration of use); (3) the time elapsed before 1 patient, 100 patients, 1000 patients, 10,000 patients and 100,000 patients could be identified in each database using these products; (4) identification of factors that influence the uptake of new medical products in each of the databases examined. These analyses will be interpreted in the context of the population included and represented by the health care database to determine the generalizability of the findings to the nation as a whole. These analyses should lead to specific recommendations for important characteristics or minimum criteria relating to medical product uptake that could be considered when evaluating health care data systems for inclusion as the Sentinel Initiative moves forward. The 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 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 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 September 18, 2008.
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=1fad183e04e8e4b13898201a99d47ae3&tab=core&_cview=1)
 

Document(s)

Solicitation 1
 

File Name: Uptake RFQ, 08.11.2008 (Sentinel RFQ...Uptake...148.pdf)

Link: https://www.fbo.gov//utils/view?id=5a91f65e7bb703d4d6c9071ada174f9e

Bytes: 141.03 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

SN01636297-W 20080813/080811222850-1fad183e04e8e4b13898201a99d47ae3 (fbodaily.com)
 

Source

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

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