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FBO DAILY ISSUE OF AUGUST 22, 2008 FBO #2461
DOCUMENT

B -- Evaluating Potential Network Data Sources for Blood and Tissue Product Safety Surveillance and Studies - Amendment 2

Notice Date

8/20/2008
 

Notice Type

Amendment 2
 

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-DataBloodAndTissueProductSafety
 

Response Due

9/2/2008 10:00:00 AM
 

Archive Date

9/8/2008
 

Point of Contact

Terry Frederick,, Phone: 301-827-7043, Lee L Cohen,, Phone: 301-827--7046
 

E-Mail Address

terry.frederick@fda.hhs.gov, lee.cohen@fda.hhs.gov
 

Small Business Set-Aside

N/A
 

Description

The FDA is issuing this Request for Quotations (RFQ) to identify and evaluate population-based data sources that could be used to study the safety of blood and tissue products in furtherance of 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 capitalize on 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 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 content, quality, searchability, and responsiveness of participating data sources and/or data environments. There is a particular need to evaluate the feasibility of these data sources to study blood and tissue products. Many blood products are administered parenterally in outpatient stand alone clinics or infusion centers, settings that are beyond traditional inpatient hospital-based services. Because of these and other varied settings of administration (blood centers, inpatient, ambulatory surgery, outpatient prescription, etc.), accurate identification of blood product utilization will require access to data sources beyond traditional prescription or inpatient claims surveys currently available to FDA. Likewise, useful data sources will require particular capabilities to identify infections and other adverse events in recipients of human tissue products, which may be implanted in inpatient settings, dental offices, or ambulatory surgical settings, and are not usually inventoried in typical inpatient or outpatient pharmacy systems. It is essential that FDA understand the strengths and limitations of potential Sentinel Initiative data sources in studying blood and tissue product safety. The primary goals are to evaluate the ability of the potential data sources and/or environments to: (1) Evaluate the safety of blood and tissue products. (a) Measure blood and tissue product usage including, but not limited to, amounts, frequencies, and indications, as well as demographics and clinical characteristics of recipients. Enrolled populations should be representative of the US population, and usage should be comprehensive enough to cover the varied clinical indications, care settings (inpatient, outpatient, infusion center, etc.), and product types for blood and tissue products. (b) Calculate incidence rates of adverse events by linking blood and tissue uses to subsequent patient healthcare claims. (c) Evaluate potential risk factors for developing adverse events. (d) Assess if adverse outcomes are attributable to the administered blood or tissue product (e.g., if rates are higher than expected based on analysis of appropriate comparison group) (2) Accurately identify exposures (procedures involving tissue or blood products) and outcomes (infections and other adverse events of interest) in covered patients, and validate these data. 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 and evaluation of population-based data sources that could be used to study the safety of blood and tissue products. This work will require a thorough analysis of each data source’s: (1) utility for post-market surveillance of FDA-regulated blood and tissue products (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 blood and tissue 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; (6) potential privacy and security concerns related to the use of electronic health data; and (7) barriers that exist to including each data source in the Sentinel Initiative. These analyses should lead to specific evaluations of the feasibility to conduct safety related studies for blood and tissue products in each data source. 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=a236f48596ac803349ae1001f16d1aac&tab=core&_cview=1)
 

Document(s)

Amendment 2
 

File Name: Blood And Tissue SOL MOD 001, 08.20.2008, SF-30 (Blood And Tissue SOL MOD 001, 08.20.2008, sf30.pdf)

Link: https://www.fbo.gov//utils/view?id=a570c4ee2b24e67af1071294dcc33cfb

Bytes: 120.16 Kb
 

File Name: Blood And Tissue SOL MOD 001, Attachment 1 (Blood And Tissue SOL MOD 001, Attachment 1.doc)

Link: https://www.fbo.gov//utils/view?id=153d8cbf3cf2cac02fe84be02ec0746b

Bytes: 33.00 Kb
 

File Name: Blood And Tissue SOL MOD 001, Attachment 2 (Blood And Tissue SOL MOD 001, Attachment 2.pdf)

Link: https://www.fbo.gov//utils/view?id=fd26463ddd4d0b85a382917d8f0a9e4f

Bytes: 19.46 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

SN01645518-W 20080822/080820220735-a236f48596ac803349ae1001f16d1aac (fbodaily.com)
 

Source

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

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