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FBO DAILY ISSUE OF JULY 04, 2009 FBO #2777
SOLICITATION NOTICE

A -- Pharmacokinetic study of V-PROLI/NO - S09-174 RFP

Notice Date
7/2/2009
 
Notice Type
Combined Synopsis/Solicitation
 
NAICS
541711 — Research and Development in Biotechnology
 
Contracting Office
Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 427, Room 12, Frederick, Maryland, 21702
 
ZIP Code
21702
 
Solicitation Number
S09-174
 
Archive Date
9/4/2009
 
Point of Contact
Howard Souder, Jr., Phone: 301-846-5096
 
E-Mail Address
souderhr@mail.nih.gov
(souderhr@mail.nih.gov)
 
Small Business Set-Aside
N/A
 
Description
S09-174 - RFP Cover Sheet - V-PROLI/NO Please note: Offerors are reminded to download the RFP Cover Sheet for this solicitation as it provides instructions as well as the required elements for submission of offers. Last day for written questions is July 24, 2009 at 12 Noon Eastern time. Due date for submission of offers is August 3, 2009 at 3PM Eastern time. STATEMENT OF WORK: A. Overview/Background V-PROLI/NO is an analog of the promising liver-protective agent, V-PYRRO/NO, that is being investigated for its possible therapeutic value in cases of acetaminophen toxicity, fulminant liver failure, and other liver disorders. A key consideration in determining its ultimate utility in the clinical arena is its pharmacokinetic profile. The purpose of this solicitation is to commission a publishable pharmacokinetic study of V-PROLI/NO. (See Chakrapani et al, Org. Lett. 2007, 9, 3409-3412.) B. Description of Work Using a sample of pure V-PROLI/NO that the NCI will supply, the Subcontractor shall provide all the data necessary to coauthor a report in a peer-reviewed journal in collaboration with the providers of the test substance that will include a full pharmacokinetic profile of this compound. The Subcontractor shall develop and validate methods for assaying V-PROLI/NO in blood. Using methods completely consistent with animal welfare procedures approved by the NIH, administer V-PROLI/NO both intravenously, intraperitoneally, and orally to mice. Assay blood samples taken periodically, then convert the analytical data to the full set of pharmacokinetic parameters required for the desired publication, including at least clearance, Cmax, Tmax, AUC, distribution and metabolism half-lives via each route, and oral and intraperitoneal bioavailability. C. Project Requirements and Deliverables Subcontractor shall provide the following: The amount of V-PROLI/NO the Subcontractor believes is necessary to perform the assays, as well as the quantity of mice needed. All tables and graphs necessary for a definitive publication describing the results, plus a full description of methods used for assay development, validation, and pharmacokinetics for inclusion in the Experimental section, and a narrative explaining the tables and graphs to be used in the Results section of the paper. Subcontractor will submit a firm, fixed-price proposal in US Dollars (USD $) to perform the work description and provide the deliverables noted above, including a project schedule. D. Additional Requirements The Subcontractor shall provide all documentation including the results of the project as stated in this SOW in English, and in both printed & electronic formats. E. Advanced Understandings Unless specifically directed in writing by the SAIC-F Contracting Officer, any government furnished material including but not limited to biological organisms, material, compositions, and substances ("Material") provided hereunder, shall be used by the subcontractor solely in connection with the performance of the work as delineated in the Statement of Work (SOW). The Material may be subject of an invention report, patent application, or IND submission and therefore the Subcontractor agrees not to disclose any information about the Material or transfer the Material to any third party without the prior written permission of the SAIC-F Contracting Officer. After the conclusion of the work authorized under the Subcontracting Agreement, the Material (including any improvements to, or modified derivatives of) will be disposed of by the Subcontractor as directed by the SAIC-F Contracting Officer. Patent Rights and Rights in Data will be governed by the applicable Federal Acquisition Regulations incorporated herein.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF/S09-174/listing.html)
 
Place of Performance
Address: Awardee's location, United States
 
Record
SN01865444-W 20090704/090703002644-9c5e50cb378a16bb4ab94a169ed0103a (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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