SOLICITATION NOTICE
B -- Exposure of Pediatric Patients to BPA and DEHP
- Notice Date
- 8/7/2009
- Notice Type
- Presolicitation
- NAICS
- 622310
— Specialty (except Psychiatric and Substance Abuse) Hospitals
- 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-00213A
- 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 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/PRE-09-223-SOL-00213A/listing.html)
- Place of Performance
- Address: 5630 Fisher Lane, Rockville, Maryland, 20857, United States
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN01903167-W 20090809/090807235715-1c02fa2597d0c51dedb17bae99fe87d2 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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