SOLICITATION NOTICE
65 -- Molecular Roles of Cdk5 in pain signaling
- Notice Date
- 7/14/2016
- Notice Type
- Presolicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- 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-CSB-DE-2016-211-KEW
- Archive Date
- 8/7/2016
- Point of Contact
- Kyle Wisor, Phone: 3014023670, Rashida Ferebee,
- E-Mail Address
-
Kyle.Wisor@nih.gov,
(Kyle.Wisor@nih.gov, ontract)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL AND OPEN COMPETITION (INCLUDING BRAND-NAME). The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA) on behalf of The National Institute of Dental and Craniofacial Reseach (NIDCR) intends to negotiate and award a Purchase Order without providing for full and open competition (Including brand-name) to Anabios Corporation for Molecular Roles of Cdk5 in pain signaling. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541690, Other Scientific and Technical Consulting Services, with a Size Standard $15M. REGULATORY AUTHORITY The resultant Purchase Order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-88 effective 15 June 2016. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($150,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. FAR Subpart 6.302-1-Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1), provides the authority to sole source. DESCRIPTION OF REQUIREMENT Background The National Institutes of Health (NIH) is the nation's leading medical research agency, and the primary Federal agency conducting and supporting medical discoveries that improve people's health and save lives. The mission of the National Institute of Dental and Craniofacial Research (NIDCR) is to "seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability". The Functional Genomics Section (FGS) seeks to delineate precise in-vivo functions of the specific genes involved in the molecular processes underlying the disease conditions involving degenerative processes, metabolic defects and immune disorders. The lab's research focus involves isolation and characterization of candidate genes and analysis of their functions using transgenic and gene knockout techniques. The FGS wants to conduct research using human dorsal root ganglia (hDRG), nerve clusters located along the spinal cord that relay sensory information such as pain. The lab has been conducting experiments on an enzyme known as Cdk5, and in genetically engineered mouse models has shown that increased Cdk5 enzymatic activity leads to an increase in pain sensitivity. The lab need to determine if this is true in human patients as well. In the electrophysiology experiments, the lab will use an adenovirus delivery system to increase Cdk5 activity in human neurons and then test neuronal activity with and without conditions replicating inflammation. The purpose of this is to see if increased Cdk5 enzymatic activity influences the likelihood or rate of neuronal firing. With the human DRG samples, the lab will examine the likely changes in gene expression due to chronic pain and will find out if pain causes any increase in known activators of the enzyme Cdk5 Purpose and Objectives The purpose of this acquisition is to procure high-quality, reserved hDRG research samples obtained from ethically consented donors. Specifically, the Contractor shall extract hDRG from cadaveric organ donors. These are brain dead donors with consent for multiple organ donation for transplant and for research in a for profit environment. In addition, the FGS seeks to determine the differences in gene expression in hDRG from normal donors versus donors with chronic pain. The lab is specifically interested in inflammatory pain, and is seeking hDRG tissue from 10 normal donors and from 10 patients suffering from rheumatoid arthritis, diabetic neuropathy, or fibromyalgia. Period of Performance (Expected) Base Year: July 27th, 2016 - July 27th, 2019 Performance Location Contractor Location Project Description Contractor Tasks: For this study, the tasks to be performed will be divided into two phases. The tasks for each phase are as follows: Phase One • Obtain either first-person consent from cadaveric organ donors (eg. driver's license) or consent from legal next of kin to extract hDRG. • Extract hDRG tissue from 10 normal donors, and from 10 donors with either rheumatoid arthritis, diabetic neuropathy, or fibromyalgia. • Store these tissues in RNAlater or similar stabilization solution until such time as all samples are collected. Phase Two • The Contractor shall acquire hDRG tissue from a healthy donor, dissociate the tissue, and derive cultured neurons. • Treat half of the derived samples with known physiological inflammatory mediators and determine how this affects the thresholds for electrical firing. • Of these two conditions (with or without inflammatory mediators), half will be treated with an empty adenovirus, and half will receive an adenovirus needed to activate an enzyme implicated in increasing pain signaling. • The Contractor shall conduct electrophysiology experiments that will test the four (4) different conditions: (1) hDRG cultures with empty adenovirus, (2) hDRG cultures with inflammatory mediators and an empty adenovirus, (3) hDRG cultures with adenovirus for enzymatic activation, and (4) hDRG cultures with inflammatory mediators and an adenovirus for enzymatic activation. • Contractor will provide FGS with the results of the electrophysiology experiments including electrical traces that measure current and voltage. Contractor Requirements None Government Requirements • The FGS will supply the Contractor with the adenoviral vector needed for phase two. This will activate Cdk5 activity in the neuronal cultures. Government Provided Equipment None Reporting Requirements and Deliverables • Contractor will collect hDRG samples stored in RNAlater and ship the tissues to NIDCR when all tissues are available. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION Justification Rationale: Only one source is available: The determination by the Government to make a single-sole source award is based upon the market research conducted as prescribed in FAR Part 10-Market Research, specifically the results of the market research concluded that Anabios Corporation is the only responsible source to provide the required services. A sources sought was posted on FedBizOps on 6/21/16 for a period of 15 days, no other vendors provided a capability statement. Anabios is the only company available that can provide high quality dorsal root ganglia from cadaveric organ donors. No other company specializes in providing neuronal DRG tissue from donors with doctor verified pain conditions such as rheumatoid arthritis and fibromyalgia. In addition, AnaBios also conducts electrophysiological studies (neuronal firing analysis) from cell cultures derived from the human DRG tissue. With Anabios, the FGS will be able to compare results with NCBI to ensure the cultures are healthy, of adequate number and density, and have typical responses. Anabios is the single responsible source to perform the required services. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by July 23rd, 2016 9:00 AM EST and must reference number NHLBI-CSB-DE-2016-211-KEW. Responses may be submitted electronically to Kyle Wisor, Kyle.Wisor@NIH.GOV, or by U.S. mail to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch,6701 Rockledge Drive, Suite 6150B, Bethesda, MD 20892-7902, Attention: Kyle Wisor. Fax responses will not be accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-DE-2016-211-KEW/listing.html)
- Place of Performance
- Address: Contractor Loaction, United States
- Record
- SN04183625-W 20160716/160714235655-d9ec68d34a5a7cc156eece1b4d1fad4b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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