SOLICITATION NOTICE
B -- Surgery Device Registry Study
- Notice Date
- 6/12/2007
- Notice Type
- Solicitation Notice
- NAICS
- 813920
— Professional Organizations
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-PR-1029463
- Response Due
- 6/27/2007
- Archive Date
- 6/27/2007
- Description
- This is a Notice of Proposed Contract Action Synopsis. There is no solicitation available at this time. This proposed contract action is published to notify potential sources that the Food and Drug Administration, FDA, intends to award a sole source, fixed price contract to The Society of Thoracic Surgeons (STS), a non-profit organization, located at 633 N. Saint Clair Street - Suite 2320, Chicago, IL 60611. FDA intends to solicit and negotiate with STS as the only source under the authority of FAR 6.302. The responses to the synopsis will be used to confirm that this is a sole source requirement. The desired period of performance for the services described herein is anticipated to be from September 19, 2007 to September 18, 2008 with four (4) year option periods. Independently, and not as an agent of the government the contractor will furnish the necessary materials, personnel, services and facilities to perform the following: The registry will collect information on prevalence of use of medical devices used during thoracic interventional procedures (heart, lung, esophageal and other surgical procedures of the chest), population in which devices are being used and adverse events associated with their use. Specific information to be collected includes demographic characteristics, pre-operative risk factors, history of previous interventions, pre-operative cardiac status, pre-operative hemodynamics, operative procedure, post-operative medications and discharge data and patient status during the first 30 days post-procedure. Study Objectives: The FDA is studying the experience of patients receiving various medical devices during thoracic procedures. The main objectives of this collaboration are to obtain information on: -Prevalence of use of existing and new medical device technology -Device-related adverse events -Short & long-term outcomes of devices used in thoracic surgeries Objectives to: -Linking the STS clinical data to the Centers for Medicare and Medicaid Services (CMS) administrative claims data. -Use the STS Database to determine the clinical characteristics and severity-of-illness factors of a patient -Use the administrative data to determine the clinical course of that patient over the following years. Study Methods: Specific information to be collected by the STS database includes -Demographic characteristics -Pre-operative risk factors -History of previous interventions -Pre-operative cardiac status -Pre-operative hemodynamics -Operative procedure -Post-operative medications -Adverse events -Discharge -Status at 30 days post-procedures -Long-term outcomes (based on CMS data) The contractor shall submit the following items to FDA: -Results of data analysis. The STS shall conduct statistical analysis that the FDA requests and shall provide these results to FDA. -Interim data analysis results shall begin in the second quarter of 2008 and quarterly data analyses shall be conducted. Final data analysis shall be submitted upon completion of the project. This notice is not a request for proposal (RFP). Information received shall be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Respondents will not be notified of the Government's determination. The Government will not pay for any information that is submitted by respondents to this notice of proposed contract action. Contractors who believe they possess the expertise and experience shall submit capabilities in writing [not to exceed five (5) pages] to Harry Brubaker Food and Drug Administration / OAGS 5630 Fishers Lane, Rm 2095 Rockville, MD 20857 Or electronically to: harry.brubakeriii@fda.hhs.gov Responses shall be received no later than June 27, 2007, 5:00 p.m. eastern standard time. All documentation shall become property of the Government. This synopsis neither constitutes a Request for Proposal, nor does it restrict the Government to a particular acquisition approach. This synopsis should not be constructed as commitment by the Government for any purpose other than market research.
- Place of Performance
- Address: 1350 Piccard Drive, Rockville, MD, , ,
- Zip Code: 20850
- Country: UNITED STATES
- Zip Code: 20850
- Record
- SN01316316-W 20070614/070612220401 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |