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FBO DAILY ISSUE OF JULY 31, 2010 FBO #3171
SOLICITATION NOTICE

B -- Testing Services

Notice Date
7/29/2010
 
Notice Type
Presolicitation
 
NAICS
611310 — Colleges, Universities, and Professional Schools
 
Contracting Office
Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
 
ZIP Code
20892-7902
 
Solicitation Number
NHLBI-PB-HG-2010-258-RSF
 
Archive Date
8/20/2010
 
Point of Contact
Rashida S. Ferebee, Phone: 3014352605
 
E-Mail Address
ferebeers@nhlbi.nih.gov
(ferebeers@nhlbi.nih.gov)
 
Small Business Set-Aside
N/A
 
Description
THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSALS. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. It is the intent of the National Heart, Lung, and Blood Institute (NHLBI) for the National Human Genome Research Institute (NHGRI), to negotiate/award a purchase order to the Washington University School of Medicine, Ory Laboratory located at 660 S. Euclid Avenue, Saint Louis, MO, 63130-4862 for the testing of the efficacy of tocopherol isomers in NPC1-null mice. The Ory laboratory is chosen as the sole source based upon their previous experience studying NPC1 mouse model in several compounds. Their previous experience provides a unique understanding of biomarkers for measuring the therapeutic effect of compounds on the NPC mice. Dr. Ory is a co-inventor of a biomarker patent for NPC drug development. Additionally, Dr. Ory is well recognized as the world leader in studying the cholesterol accumulation in NPC. He has served on numerous boards, including as Chair of the National Niemann-Pick Disease Foundation in the U.S. Dr. Ory currently leads SOAR-NPC, an international collaborative who goal is to develop new therapies to NPC disease. Background: The tocopherol compounds were identified in a high-throughput screen performed at NCGC. These compounds have been shown to have efficacy in cell-based models of Niemann-Pick C disease (NPC). Project Objectives and Requirements: The goal of the contracted studies is to determine whether the compounds have efficacy in an in vivo model of NPC1 disease. Contract Research Activity Parameters and Contract Deliverables (1) The NIH compound(s) will be delivered orally mixed with chow, or will be given by intraperitoneal or subcutaneous injection. In the case of chow administration, chow consumption per/box/week will be measured to provide data on drug delivery. (2)For each study we will test four groups of mice: WT and Npc1-/-, both compound-treated and vehicle-treated (n=8 per group, total 32 mice). (3) Data to be collected on mice include weekly weights and functional neurological testing (tremor monitoring), measurement of gene expression and biomarkers, and survival data. Blood and tissue samples will be collected for biomarker assessment and gene expression analysis, which will be performed in the Ory lab. Tissues will be processed for routine histology, and for in depth CNS analysis for cholesterol/ganglioside storage (will be shipped to Walkley lab). (4)The goal of these studies will be to test alpha- and delta-tocopherols as well as the additional identified isoforms of tocopherol and tocotrienol as requested by TRND/NCGC. Individual drugs will be tested in accordance with a priority established through discussions with TRND/NCGC. (5) As tocopherols with efficacy are discovered, it will be important to further test these agents in combination with known efficacious drugs for NPC disease Approximately 4 overlapping studies (drug tests) could be accomplished in one year. Period of performance: Project Initiation Date: August 30, 2010 Project Completion Date: December 31, 2010 Mandatory Certification: Animal Welfare Assurance Certificate on file with OPRR”. The OPRR is an abbreviation for “Office for Protection from Research Risks” at NIH. This acquisition is being conducted under FAR Part 13, Simplified Acquisition Procedures, and is exempt from the requirements of FAR Part 6, Competition Requirements. The North American Industry Classification (NAICS) Code is 611310 and the Size Standard is $7.0 Million. This notice of intent is not a request for competitive proposals. The determination by the Government not to compete the proposed purchase order based upon responses to this notice is solely within the discretion of the Government. Comments to this announcement, referencing synopsis number NHLBI-PB-HG-2010-258-RSF may be submitted by mail to the National Heart, Lung and Blood Institute, Office of Acquisitions, Procurement Branch, 6701 Rockledge Drive, Suite 6151, Bethesda, MD 20892-7902, Attention: Rashida Ferebee, by fax transmission to (301) 480-3345 or by email to ferebeers@nhlbi.nih.gov This action is under the authority of 41.U.S.C.253(c)(1), as set forth in FAR 13.106(b)(2), and HHSAR 306-302-1. Interested parties responding to this announcement need to do so by 9:00am Eastern Standard Time on August 5, 2010.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-PB-HG-2010-258-RSF /listing.html)
 
Place of Performance
Address: Washington University in St. Louis School of Medicine, 660 S. Euclid Ave., St. Louis, Missouri, 63110, United States
Zip Code: 63110
 
Record
SN02223006-W 20100731/100730000239-2d99c72ada23094fd34a8897663c2f71 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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