SOURCES SOUGHT
B -- Evaluation of Long-term Safety and Effectiveness of Joint Replacement Devices
- Notice Date
- 7/14/2008
- 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
- FDA-SOl-08-1045851
- Response Due
- 7/21/2008
- Archive Date
- 8/5/2008
- Point of Contact
- SANDRA K. DAVIS,, Phone: (870) 543-7469, Marcia O Park,, Phone: (870) 543-7405
- E-Mail Address
-
SANDRA.DAVIS@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) that can provide the following: collaboration 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: •Evaluate long-term safety and effectiveness of artificial joints. •Development of a de-identified dataset that includes demographic, device and outcome information, a memorandum of understanding or an agreement for specified analyses in house. •Data analysis. And, •Development and dissemination of manuscripts. Methods: Specific information required to be included in the registry: •All artificial joint replacements •Demographic characteristics •Device characteristics •Survival information •Revision Rates •Adverse Events, and •Short and long-term outcomes Additional methods – •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 Deliverables: The successful contract will be required to submit the following items to FDA: 1.A de-identified dataset or a memorandum regarding how data will be analyzed. 2.Data cleaning methods, or analysis procedures. 3.Results of data analysis, and 4.Participation in manuscript preparation. Projected outcomes The results of this project will be disseminated to all interested parties in the FDA and in the participating institutions within the registry. These data will also be presented at National and international orthopedic meetings and prepared for publication in peer-reviewed journals. Firms responding to this SOURCES SOUGHT announcement should indicated whether they are small business (please include the name of the Small Business Specialist and telephone number, if applicable). This information will be used to determine the appropriateness and type of small business set-aside. The applicable North American Industry Classification System (NAICS) Code is 541990 and the size standard is $6.5 million. A fixed price contract is contemplated with one-year period of performance which will begin September 1, 2008. Qualification statements are due no later than 10 business days after publication of this notice (or July 7, 2008) and should reference Sources Sought No. FDA-SOL-08-1045851.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=7c7889a4a63acd2cef53794a5744e14d&tab=core&_cview=1)
- Record
- SN01613145-W 20080716/080714221942-7c7889a4a63acd2cef53794a5744e14d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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