SOLICITATION NOTICE
B -- Heart Disease Regisrty for Pediatric Patients
- Notice Date
- 8/7/2009
- Notice Type
- Presolicitation
- NAICS
- 611699
— All Other Miscellaneous Schools and Instruction
- 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
- PRE-09-223-SOL-00214
- Point of Contact
- Jacqueline Richardson, , Doreen Williams ,
- E-Mail Address
-
jacqueline.richardson@fda.hhs.gov, doreen.williams@fda.hhs.gov
(jacqueline.richardson@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Synopsis: The Food and Drug Administration, intends to issue Request for Proposal (RFP) for the Development of a Congenital Heart Disease Registry for Pediatric Patients. There is currently no pediatric cardiology registry that is optimally designed to handle FDA post-market surveillance challenges or to provide valid reference data for the development of alternative premarket clinical trial designs. Issues such as standard definitions, ability to link different databases, and risk-adjustments for the highly heterogeneous pediatric patient population need to be addressed. Such a registry would facilitate pediatric cardiovascular device review, expedite new device approval, facilitate postapproval studies, and enhance ongoing postmarket surveillance. The objective of this contract is to provide a registry that will assess the prevalence, demographics, management, and outcomes of patients with congenital heart disease who are undergoing diagnostic catheterization and catheter-based interventions across the United States. The collection and analysis of this data will facilitate performance measurement, benchmarking, and quality improvement initiatives; and will provide significant contributions to the knowledge base and outcomes associated with congenital heart disease. This registry should also significantly increase our access to data on device use following approval. Long-term data collection is extremely important for this patient population. Additionally, the registry will provide us with the ability to capture imaging and clinical outcomes when patients return for care for related or unrelated issues can provide critical information without exposing patients to unnecessary radiation. The solicitation number for the procurement will be 09-223-SOL-00214 and the resultant award is expected to be a Firm Fixed Price contract with a period of performance of five (5) years with one (1) base and four (4) option years. The requirements under the solicitation will be designated for Full and Open Competition This will be is an unrestricted solicitation being conducted under FAR Part 15. The RFP will be posted on FedBizOpps (FBO) website: http://www.fbo.gov on or about August 21, 2009. All responsible sources may submit proposals which shall be considered by the agency. No bidder's list will be maintained. It is the offerors' responsibility to monitor the FedBizOpps for release of this acquisition and any associated amendments. Offeror must be registered in the Central Contract Registration (CCR) database before an award can be made to them. If the offeror is not registered in the CCR, it may done so through the CCR website at http://www.ccr.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/PRE-09-223-SOL-00214/listing.html)
- Place of Performance
- Address: 5630 Fisher Lane, Rockville, Maryland, 20857, United States
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN01903446-W 20090809/090808000157-551849026b84bf75813f4b23a76e3fb1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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