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This Government Contract opportunity was posted on October 27, 2009. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Pediatric Patients Exposure to BPA and DEHP

Awarded
PRE-09-223-SOL-00213Federal

Contract Overview

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

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General Info

Agency

N/A

Contract Value

$124,056

NAICS

622310 - Specialty (except Psychiatric and Substance Abuse) Hospitals

Place of Performance

5630 Fisher Lane, ROCKVILLE, MD, 20857, USA

Set-Aside

NONE

Award Issued Date

Documents

0

No documents available

Documents will appear here when they are available.

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Timeline

2 updates
PhaseAwarded
Posted

Presolicitation

Notice updated

The notice description changed.

Deadline changed

Response deadline changed from Aug 20, 2009 to Sep 19, 2009.

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 Exposure of Pediatric Patients to BPA (Bisphenol A) and DEHP (Di-2-(ethylhexyl) phthalate) A number of studies have shown that children are more susceptible to the adverse health effects of drugs and chemical compounds than adults. Children can be exposed to two chemical compounds that are of particular interest to the FDA, bisphenol A (BPA), a component of polycarbonate plastic, and di-2-(ethylhexyl) phthalate (DEHP), a plasticizer used to make PVC plastic more flexible. To accurately assess the potential risk posed by exposure of patients to BPA and DEHP, data are urgently needed on the dose of these compounds that is actually received by the patients. In fact, without these data, CDRH cannot complete its safety assessment of BPA. As a result, a clinical study is needed to quantify the dose of BPA and DEHP received by children following CPB, in a control group of critically ill children in the pediatric ICU who have not undergone CPB, and in a control group of relatively healthy children seen in out-patients clinics. The objective of this contract is to obtain urine from three groups of pediatric patients, specifically: 1) cardiac surgery patients undergoing cardiopulmonary bypass, 2) critically ill patients being treated in the Pediatric ICU (PICU), and 3) relatively health patients seen in the cardiology clinic for the analysis of metabolites of BPA and DEHP and for the analysis of renal injury biomarkers. The solicitation number for the procurement will be 09-223-SOL-00213 and the resultant award is expected to be a Labor Hour/Fixed Price contract with a period of performance of one (1) year. 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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