SOLICITATION NOTICE
B -- Functional Screening Mechanism for a patient PLXNB3 Gene Mutation
- Notice Date
- 8/4/2015
- Notice Type
- Presolicitation
- NAICS
- 622110
— General Medical and Surgical Hospitals
- 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
- HHS-NIH-NHLBI-CSB-(HG)-2015-171-DLM
- Archive Date
- 8/27/2015
- Point of Contact
- Dorothy Maxwell, Phone: 301-435-0352
- E-Mail Address
-
maxwelld@mail.nih.gov
(maxwelld@mail.nih.gov)
- 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 OR OPEN COMPETITION (INCLUDING BRAND-NAME). THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) intends to negotiate and award a purchase order on a noncompetitive sole source basis to Vanderbilt University School of Medicine, Departments of Pediatrics and Neurology, D-4100, MCN, Vanderbilt University Medical Center, Nashville, Tennessee 37232, to provide a functional screening mechanism for a patient PLXNB3 gene mutation in order to determine the mechanism for neurological disease in this Undiagnosed Disease Patient (UDP) for the National Institute of Health (NIH), National Human Genome Research Institute (NHGRI). Background: The sole source determination is based on the fact that the National Institute of Health (NIH) mission 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 National Human Genome Research Institute (NHGRI), mission has expanded to encompass a broad range of studies aimed at understanding the structure and function of the human genome and its role in health and disease. The National Human Genome Research Institute (NHGRI), Undiagnosed Disease Program (UDP) is a program designed to address the needs of persons with debilitating medical conditions for which no diagnosis has been found despite an extensive workup. The goals of the UDP include finding accurate diagnoses and discovering new diseases that provide insight into human physiology and genetics. The UDP was established to evaluate participants who have undiagnosed medical conditions. UDP participants have generally received extensive diagnostic workups before traveling to the NIH and often have numerous and/or complex medical problems. The UDP program makes use of a diverse set of diagnostic and research techniques both to attempt to find a diagnosis and to generate research projects to advance medical knowledge. Purpose and Objectives: The purpose of this acquisition is to provide a functional screening mechanism for a patient PLXNB3 gene mutation in order to determine the mechanism for neurological disease in this patient. Specifically, this laboratory supports the research needs of the UDP by collaborating on particular clinically identified new and rare patient disease. The laboratory of Dr. Kevin Ess at Vanderbilt University School of Medicine, Department of Pediatric Neurology specializes in studying the molecular mechanisms required for normal brain development and how disturbances in this system lead to malformations, seizure disorders, and severe cognitive and behavioral problems. In order to facilitate this knowledge, they have studied tuberous sclerosis complex (TSC), which causes cortical malformations, seizures, and autism in children. Through the use of manipulating Tsc1 and Tsc2 gene expression in patient derived induced pluripotent stem cells (iPSCs), they have been able to determine the role these genes play n neuronal and glial cell differentiation, specification and migration. This collaboration will continue to support the UDP to provide functional analysis materials of suspected gene mutations to determine disease causation in UDP patients that can then be used for future studies. Period of Performance: 12 Months Upon Award Justification: The laboratory of Dr. Kevin Ess at Vanderbilt University School of Medicine has expertise in performing functional analysis of mutations that alter cortical development that can be responsible for seizure activity, cognitive and behavioral problems in pediatric patients. A multidisciplinary approach is by using animal models and cell culture techniques to understand how gene mutations affect normal brain development and lead to disease. In order to establish materials that will facilitate the analysis that the UDP patient PLXNB3 mutation has on development, the laboratory will perform the following: • The contractor shall establish UDP patient specific induced pluripotent stem cells (iPSCs) from fibroblasts containing the PLXNB3 mutation. • The contractor shall produce and validate several iPSC lines. • The contractor shall perform standard assays on the iPSC lines to determine the ability to differentiate into ectoderm, mesoderm and endoderm lineages. • The contractor shall verify iPSC lines that contain normal male karyotypes and UDP patient specific PLXNB3 mutant karyotypes. • The contractor shall use genomic engineering techniques in order to correct the PLXNB3 mutation and to introduce the mutation into control cells. • The contractor shall supply electronic copies of all reports appropriate for deposition in the UDP process management system and for other collaborations. Regulatory Authority: This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b) Soliciting from a single source. Additional Information: Industry Classification (NAICS) Code is 622110, General Medical and Surgical Hospitals with size standard in dollars $38.5M Per Annum. The acquisition is being conducted under FAR Part 13, simplified acquisition procedures, therefore the requirements of FAR Part 6 B Competitive Requirements are not applicable (FAR Part 6.001). The resultant Contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-83 (July 2, 2015). This requirement is under the SAT of $150,000.00. 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 no later than 7:30 a.m. Eastern Standard Time (EST), August 12, 2015; and must reference synopsis number HHS-NIH-NHLBI-CSB-(HG)-2015-171-DLM, may be submitted to the National, Heart, Lung and Blood Institute, COAC Services Branch, Office of Acquisitions, Office of Management, 6701 Rockledge Drive, Suite 6149, Bethesda, Maryland 20892-7902, Attention: Dorothy Maxwell. Response may be submitted electronically to maxwelld@mail.nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-CSB-(HG)-2015-171-DLM/listing.html)
- Record
- SN03822525-W 20150806/150804235702-b3752b7d30f55b7ef2e4ee5b2a1018da (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |