SOLICITATION NOTICE
99 -- Data for Ceramic-on-Ceramic Devices
- Notice Date
- 9/4/2009
- Notice Type
- Combined Synopsis/Solicitation
- 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
- 1060776
- Archive Date
- 9/18/2009
- Point of Contact
- Karen J. Moore, Phone: (870) 543-7479
- E-Mail Address
-
karen.moore@fda.hhs.gov
(karen.moore@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This requirement is being issued in conjunction with FAR part 13 Simplified Acquisition Procedures, as applicable. The solicitation number is 1060776. This solicitation is issued as a Request for Quote. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC 05-36) This RFQ (Request for Quote) is a request for pricing for the following data collaboration with an active registry outside the United States. The Food and Drug Administration (FDA) and The Center for Devices and radiological Health (CDRH) would like to collaborate with active registries outside the United States who are collecting extensive information on Ceramic-on-Ceramic hip replacement devices and have least 1000 participants included in the registry that have been followed for at least five (5) years. Specific information required in the registry includes: a)All ceramic-on-ceramic hip replacement devices b)Demographic characteristics c)survival information d)Revision Rates e)Adverse Events f)Short and long term outcomes Reporting Requirements and Deliverable Items: The contractor shall submit the following items to FDA: 1.Specific data analysis including; a.Survival analysis of length of the duration of ceramic-on-ceramic hip replacement devices related to revision rates, infection rates and other indications of adverse events or device effectiveness. b.Evaluation of adverse events and relatedness to the device c.Evaluation of revision rates 2.Quarterly progress report 3.Final Report 4.Collaborate with the FDA on the development of manuscript(s) Timeline: The study duration is planned to be from approximately September 25, 2009 to August 24, 2010. Budget: The cost of this project will include the cost for access to, collaborative efforts and analysis of the registry. A Fixed Price purchase order is anticipated. Evaluation of the long-term performance of ceramic on ceramic hip replacement devices will assist the FDA in promoting the health of older Americans and monitor the potential risks associated with these common procedures. The data collected is expected to have an impact on both FDA regulation and the thousands of citizens who receive hip replacement devices. The findings may be used to modify performance expectations during pre-market review and lead to the revision of the current FDA guidelines on pre-market notification of hip replacement devices, or provide support to instilling changes to current labeling practices for hip replacement devices. You are invited to submit a quote based on the above statement of work. Your response will be evaluated based on the following: 1. Established registry with response rate over 80% and a minimum of 1000 observations. 2. Long-term follow-up medical information for a minimum of five years. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. The clauses at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. Responses to this notice must be sent via email to Karen.moore@fda.hhs.gov Prospective contractor should consider the rate of exchange and make their bid in US dollars. Also include in your quote a copy of the completed Representations and Certifications which can be found at http://orca.bpn.gov. This purchase will be made under Simplified Acquisition Procedures as authorized by FAR 13.501.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1060776/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Avenue, Building WO66, Silver Springs, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN01941606-W 20090906/090905000726-7c5063e6588993bfc695476c314e150e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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