SOLICITATION NOTICE
A -- Interventional Procedures Device Registry Study
- Notice Date
- 5/22/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- 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
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-06-00221
- Response Due
- 7/6/2006
- Archive Date
- 7/6/2006
- Description
- It is the intent of the FDA?s Center for Devices and Radiological Health (CDRH) to award a contract on a sole-source basis pursuant to FAR 6.302-1 and 41 U.S.C. 253(c)(1) to the American College of Cardiology (ACC). CDRH intends to contract with the ACC to continue to study the experience of patients undergoing implantable cardioverter defibrillator procedures. The main objectives of this contract would be to obtain information on the prevalence of the use of existing and new medical device technology, device-related adverse events, and any additional variables that may be added to study devices and risk factors not represented in variables already collected by this registry. The contract will be awarded on task order basis. The main objectives of the first task order are to collect information on the prevalence of use of implantable cardioverter defibrillator devices, patient population in which implantable cardioverter defibrillator devices are being used, adverse events associated with the use of implantable cardioverter defibrillator devices. 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 Adverse events Discharge The analyses include but are not limited to: Frequency of all data elements Cross tabulations of variables of interest with outcomes Co-variate adjustments as needed Subsequent tasks will include the continuation of the access to the registry and addition of the new variables to the National ICD Registry. The Government intends to solicit and negotiate with ACC as the only one source under the authority of FAR 6.302. This is not a request for quotations (RFQ). Sources interested in this requirement must be able to provide convincing evidence that they possess the requisite expertise and experience to successfully perform the services as specified above. Responses must be in writing and must be received at mgnall@fda.hhs.gov within forty-five (45) calendar days from the publication date of this notice. All responses received in a timely manner will be considered by the Government.
- Record
- SN01054626-W 20060524/060522220237 (fbodaily.com)
- Source
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