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FBO DAILY ISSUE OF MARCH 07, 2009 FBO #2658
SOURCES SOUGHT

B -- Evaluation of Long-Term Safety and Effectiveness of Joint Replacement Devices

Notice Date

3/5/2009
 

Notice Type

Sources Sought
 

NAICS

541990 — All Other Professional, Scientific, and Technical Services
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Field Finance & Acquisition Services, HFT-320, 3900 NCTR Road, Jefferson, Arkansas, 72079-9502
 

ZIP Code

72079-9502
 

Solicitation Number

FDA1055062
 

Archive Date

3/28/2009
 

Point of Contact

Regina R. Williams,, Phone: (870) 543-7012, Marcia O Park,, Phone: (870) 543-7405
 

E-Mail Address

regina.williams@fda.hhs.gov, marcia.park@fda.hhs.gov
 

Small Business Set-Aside

N/A
 

Description

This is a SOURCES SOUGHT NOTICE to determine the availability and capability of potential small businesses (including HUBZone firms; certified 8(a), Small Disadvantaged, veteran and service-disabled veteran-owned small businesses, and women-owned small businesses). The Food and Drug Administration/Center for Devices and Radiological Health would like to collaborate with Countries and other entities outside the United State who are collecting extensive information on artificial joint replacements and have at least 300 participants included in their registry that have been followed for at least one year. The proposed study would produce valid and precise estimates of device performance following the implantation of this invaluable device that would benefit the decision-making of patients, clinicians and CDRH. Crucial variables include device survival and device related adverse events. Objectives: Consistent with the FDA’s mission to protect and promote the public health, CDRH is exploring innovative approaches to monitor the safety of medical devices postmarket. One method is the use of registry information. Information analyzed from databases collecting long-term follow-up data is essential in developing estimates of device performance. The study would require a thorough analysis of the long-term safety and effectiveness of artificial joint with a focus on ceramic-on-ceramic hip replacement devices and other artificial joint devices. The main objectives of this study would be to: 1. Evaluate long-term safety and effectiveness of artificial joints through the use registry data that includes adequate long-term follow-up information. • Analysis of common factors associated with implant success and safety such as revision rates, infection rates, quality of life measures (i.e. Harris Hip Scores, improvement in activities of daily living, etc). 2. Develop a mechanism for CDRH to analyze or receive specified analyses related to safety and effectiveness of artificial joints such as: • Collaboration with doctoral students, academic institutions, medical centers, etc. to jointly conduct analyses; • Access to data through a secure web portal where CDRH epidemiologists can perform their own epidemiological analyses; • Conduct of analyses on a per-request basis. 3. Develop, collaborate and disseminate manuscripts, reports and/or presentations. Methods: Specific information required in the registry includes • All artificial joint replacements; • Demographic characteristics; • Device characteristics; • Survival information; • Revision Rates; • Adverse Events; • Short- and long-term outcomes. Access to data analysis through web portal or requests of specific data analysis or collaboration with a designated individual within the country who will work with CDRH to conduct any of the following: • Survival analysis of length of the duration of implant; • Evaluation of adverse events and relatedness to the device; • Evaluation of revision rates. Reporting Requirements and Deliverable Items The successful contract will be required to submit the following items to FDA: 1. A proposed mechanism for CDRH to analyze or receive specified analysis related to safety and effectiveness of artificial joints such as: • Collaboration with doctoral students, academic institutions, medical centers, etc. to jointly conduct analyses (i.e. the in-country designee may have sole access and conduct analyses in collaboration with the CDRH designee); • Access to data through a secure web portal where CDRH epidemiologists can perform their own epidemiological analyses; • Conduct of analyses on a per-request basis. 2. Development of an agreement based on the proposed mechanism. 3. Access to data analysis through web portal or requests of specific data analysis or collaboration with a designated individual within the country who will work with CDRH to conduct the following: • Survival analysis of length of the duration of implant related to revision rates, infection rates and other indications of adverse events or device effectiveness; • Evaluation of adverse events and relatedness to the device; • Evaluation of revision rates. 4. Development of a report or manuscript that has the potential to be published. Projected outcomes: The results of this project will be disseminated to all interested parties in the FDA and to the participating institutions within the registry. They will also be presented at national and international orthopedic meetings and prepared for publication in peer-reviewed journals as agreed upon between CDRH and the contractor. The associated North American Industry Classification System (NAICS) Code is- 541990-All Other Professional, Scientific, and Technical Services and the size standard is $6.5 million. A fixed price contract is contemplated with one-year period of performance which will begin May 1, 2009. Interested contractors are encouraged to submit a capability statement if they have the capacity and capability to provide the required specifics for this study and include the following: Company name and address, phone number, point of contact, email address, business size, proof of any set-aside certification and company’s DUNS number. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents. Capability statements are due in person, by mail, fax or email on or before March 13, 2009 by 13:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, National Center for Toxicological Research, Attn: Regina Williams, 3900 NCTR Road, HFT-320, Jefferson, AR 72079 and should reference Sources Sought No. FDA1055062.
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=6abaa83a610a1b3a27a37fceec2f6bfa&tab=core&_cview=1)
 

Place of Performance

Address: To be determined, United States
 

Record

SN01763205-W 20090307/090305221503-6abaa83a610a1b3a27a37fceec2f6bfa (fbodaily.com)
 

Source

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

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