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This Government Contract opportunity was posted on October 26, 2009. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Heart Disease Regisrty for Pediatric Patients

Awarded
PRE-09-223-SOL-00214Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 611699
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POSTED

3 days ago

DEADLINE

in 15 days

AI Contract Overview

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The Food and Drug Administration is seeking proposals for the development of a Congenital Heart Disease Registry for Pediatric Patients to improve post-market surveillance and provide reference data for premarket clinical trial designs. The registry aims to address current gaps in standard definitions and database linking to better assess the prevalence, demographics, management, and outcomes of pediatric patients undergoing diagnostic catheterization and catheter-based interventions across the United States. By capturing long-term clinical outcomes and imaging, the initiative intends to expedite new device approvals, enhance performance benchmarking, and reduce unnecessary patient radiation exposure. This procurement, identified by solicitation number 09-223-SOL-00214, will be awarded as a Firm Fixed Price contract with a total performance period of five years, consisting of one base year and four option years. The solicitation is open for full and open competition under FAR Part 15, and interested offerors must be registered in the Central Contract Registration database to be eligible for an award. The project will be managed out of Rockville, Maryland, and is designed to significantly increase the availability of data regarding device use following FDA approval.

General Info

Agency

N/A

Contract Value

$100,000

NAICS

611699 - All Other Miscellaneous Schools and Instruction

Place of Performance

5630 Fisher Lane, ROCKVILLE, MD, 20857, USA

Set-Aside

NONE

Award Issued Date

Documents

0

No documents available

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Timeline

PhaseAwarded
Posted

Presolicitation

Type Changed

Presolicitation → Solicitation

Awarded

Contract was awarded

Submission Closed

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Organization & Contact Information

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AgencyN/A
Contacts2 people available
OfficeN/A
Organization / Agency
N/A
Office AddressN/A
Contacts
Jacqueline RichardsonContract Specialist
Doreen WilliamsTeam Lead

Full Description

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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.

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