SOLICITATION NOTICE
B -- Phospholipid Profiling
- Notice Date
- 8/8/2008
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- 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
- 1043479gh
- Response Due
- 8/13/2008
- Archive Date
- 8/28/2008
- Point of Contact
- Gwen Y Hubbard,, Phone: (301) 827-7172, Patricia M Pemberton,, Phone: 301-827-1022
- E-Mail Address
-
gwendolyn.hubbard@fda.hhs.gov, patricia.pemberton@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- The Food and Drug Administration intends to procure professional services for phospholipid profiling. PERIOD OF PERFORMANCE: One year from award date. Project expected to begin August 20, 2008. Background: The FDA/Center for Drug Evaluation and Research conducts research on the safety, efficacy, metabolism and other aspects of mechanism and effects of pharmaceuticals. Program areas include investigation of the toxicological significance of phospholipidosis using genomic analysis and evaluation of noninvasive biomarkers of phospholipidosis. The purpose of this contract is to provide measurements of the levels of potential lipid biomarkers of phospholipidosis, including 17 different phospholipids and didocosahexaenoyl (c22:6)-bis(monoacylglycerol) phosphate (BMP), using LC/MS/MS in urine samples collected in parallel from studies on the toxicogenomic response to phospholipidosis in rats. The data will allow evaluation of relationships between urinary markers and histopathological observations of drug-induced phospholipidosis in tissues. STATEMENT OF WORK: The contractor will evaluate 17 different phospholipids and didocosahexaenoyl (c22:6)-bis(monoacylglycerol) phosphate (BMP), using LC/MS/MS in urine samples from four studies, each investigating a different phospholipidotic drug. Study 1: Evaluate 48 samples across a time course or dose response in laboratory rats with drug 1 and prepare full report. Study 2: Evaluate 48 samples across a time course or dose response in laboratory rats with drug 2 and prepare full report. Study 3: Evaluate 48 samples across a time course or dose response in laboratory rats with drug 3 and prepare full report. Study 4: Evaluate 48 samples across a time course or dose response in laboratory rats with drug 4 and prepare full report. This will be a total of 200 samples and 4 full reports. REPORTING REQUIREMENTS AND OTHER DELIVERABLE ITEMS: The contractor will provide a report for each study that include phospholipid and BMP levels for individual animals in each treatment group as well as group averages within 120 days of receipt of the samples for each study in the project, along with an invoice for the work performed. The contractor will evaluate urine samples from independent studies within the project that involve 4 different drug treatments (designed as dose response and/or time response studies) in separate shipments. Evaluation 1: evaluate 48 samples per study across a time course or dose response in laboratory rats. Prepare full report per study. Evaluation 2: evaluate 4 independent studies within the project that involve different paradigm compounds. There will be a total of 192 samples and 4 full reports. This acquisition will be conducted under simplified acquisition procedures. The NAICS code classification is 541711. All capability statements received by 2:00 p.m., EST, August 13, 2008 will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Inquiries must be submitted in writing by facsimile on (301) 827-7106 or email. No telephone inquiries will be accepted.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=e603dc68c8d44195a0709cfb5d2ab9eb&tab=core&_cview=1)
- Place of Performance
- Address: Rockville, Maryland, Rockville, Maryland, 20857, United States
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN01634915-W 20080810/080808221402-e603dc68c8d44195a0709cfb5d2ab9eb (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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