SOLICITATION NOTICE
R -- Expert Consultants
- Notice Date
- 8/18/2008
- Notice Type
- Modification/Amendment
- 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, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-08-00815
- Archive Date
- 10/1/2008
- Point of Contact
- Dominique H Malone, Phone: (301) 827-7227
- E-Mail Address
-
dominique.malone@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- THE PURPOSE OF THIS MODIFICATION IS THE FOLLOWING: 1. Change the NAICS code from 541690 to 813920. 2. Add updated Backround information 3. Update the solicitation release date to August 19,2008. THE ANNOUCEMENT IS NOW CHANGED TO READ AS FOLLOWS: The Food and Drug Administration (FDA) intends to solicit proposals for a contractor to fulfill a requirement for the following: A. BACKROUND The Society of Thoracic Surgeons (STS) is a not-for-profit organization representing more than 5,400 surgeons, researchers, and other health professionals worldwide who are performing heart, lung, esophageal, and other surgical procedures for the chest. The mission of STS is to enhance the ability of cardiothoracic surgeons to provide the highest quality patient care through education, research, and advocacy. The STS offers outcome programs in the areas of Adult Cardiac, General Thoracic and Congenital Heart-defect surgery. The STS National Database is a comprehensive national registry that collects information from over 600 participating hospitals on patients undergoing thoracic surgery. Since 2003, the Registry collected information on over 1,800,000 procedures. It is a confidential, voluntary, and national in scope. As an independent source of information on patients undergoing cardio-thoracic surgeries, this registry is superior to manufacturer initiated studies (both FDA mandated and voluntary). The analytical support for the STS National database is conducted by the Duke Clinical Research Institute (DCRI). Since 1994, there have been over 50 of publications in peer-reviewed journals resulting from the studies conducted through this Registry. The FDA in mid-1990s very successfully studied Transmyocardial Revascularization (TMR) devices in using the data from the STS registry to obtain valuable information that supplemented FDA postmarket surveillance programs. The Centers for Medicare and Medicaid Services (CMS) administrative claims data. contain long-term patient information that includes hospital admissions, admission diagnoses, and other information that can be used to determine clinical events over time. The Center for Devices and Radiological Health (CDRH) would like to collaborate with the STS in studying the experience of patients receiving various medical devices during cardio-thoracic procedures. The NAICS Code is 813920, with a small business size standard 6.5 million. B. Objectives: The main objectives of this study would be to: 1. Explore linking the STS clinical data to the CMS administrative claims data and/or other long-term clinical/administrative data. 2. Based on the demographic and clinical information from the STS Database (age, admission diagnosis, date of surgery, date of discharge, etc), match the database patient to the same patient in the administrative data set. 3. Use the STS Database to determine the device and clinical characteristics and severity-of-illness factors of a patient, and use the administrative data to determine the clinical course of that patient over the following years. Methods: Specific information to be collected by the STS database includes Demographic characteristics Device characteristics Pre-operative risk factors History of previous interventions Pre-operative cardiac status Pre-operative hemodynamics Operative procedure Post-operative medications Adverse events Discharge data Status at 30 days post-procedures Long-term outcomes (based on the CMS data) C. Contract period of performance The study will begin in September 2008. The duration of the first task of this five- year contract will be two years. D. Procurement/Contract Strategy: It is anticipated that a contract indefinite delivery, indefinite quantity task order contract. The contract will have a period of performance of 1 base year with 4 option year. This is a new requirement. The NAICS Code is 813920 with a small business size standard of $6.5 mil. E. Additional Information FDA intends to solicit this requirement as “Full and Open” competitive requirement. This announcement is not a request for proposal (RFP). FDA anticipates release of the RFP during on or around August 19, 2008. It will be available on the Federal Business Opportunities (FedBizOpps) website. The anticipated award date for this effort September 2008.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=5f1b76506d32a03236d5e6ff7acd29ea&tab=core&_cview=1)
- Place of Performance
- Address: 1350 Piccard Dr, Rockville, Maryland, 20850, United States
- Zip Code: 20850
- Zip Code: 20850
- Record
- SN01642935-W 20080820/080818215840-5f1b76506d32a03236d5e6ff7acd29ea (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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