SOLICITATION NOTICE
Q -- Ion Channel Testing and Analysis of Genes Mutated
- Notice Date
- 6/4/2013
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- 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
- NIH-NHLBI-CSB-(HG)-2013-169-DLM
- Archive Date
- 6/25/2013
- 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 NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Institute of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) on behalf of the National Human Genome Research Institute, (NHGRI), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Emory University School of Medicine, Department of Pharmacology, Rollins Lab Research Center, 1510 Clifton Road, Atlanta, Georgia 30322. Emory University will collaborate with NHGRI, NIH Undiagnosed Program to provide services: highly specialized ion channel testing and analysis of GRIN2A and GRIN2B genes for the National Human Genome Research Institute, NIH Undiagnosed Disease Program (UDP). Procurement: Anticipate a rate of approximately 5-weeks per variant for this analysis: Number Sub-unit Mutation Location 1 GluN2A c.623C>T:p.T208I ATD 2 GluN2A c.712C>G:p.L238V ATD 3 GluN2A c.1141C>T:p.H381Y ATD 4 GluN2A c.2434C>A:p.L812M S2-M4 linker 5 GluN2A c.3228C>A:p.N1076K CTD 6 GluN2A c.3505C>T:p.R1169W CTD 7 GluN2A c.3515T>C:p.L1172S CTD 8 GluN2A c.4343G>A:p.C1448Y CTD 9 GluN2B p.E413G ABD 10 GluN2B c.140A>G:p.E47G ATD 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 National Human Genome Research Institute (NHGRI), National Institutes of Health Undiagnosed Disease Program (UDP) is a trans-National Institute of Health (NIH) initiative that focuses on the most puzzling medical cases referred to the NIH Clinical Center in Bethesda, Md. It was organized by the National Human Genome Research Institute (NHGRI), the NIH Office of Rare Diseases Research (ORDR) and the NIH Clinical Center. Many medical specialties from other NIH research centers and institutes contribute the expertise needed to conduct the program, including endocrinology, immunology, oncology, dermatology, dentistry, cardiology and genetics, among the dozens of participating senior attending physicians. A longstanding medical condition that eludes diagnosis by a referring physician can be considered undiagnosed and may be of interest to this clinical research program. Emory University, Department of Pharmacology, will provide highly specialized ion channel testing using xenopus oocyte and cell culture models as a comprehensive analysis of the role of mutations in the GRIN2A and GRIN2B genes in altering the function of the encoded channels. Emory University shall collaborate with the Undiagnosed Disease Program on clinically identified new and rare diseases. Period of Performance for 12-Months : July 1, 2013 through June 30, 2014 JUSTIFICATION: The services will be a part of an existing NHGRI- Undiagnosed Diseases program (UDP) protocol 76-HG-0238, Clinical Trial Number: NCT00369421. Under this observational protocol study, the Researchers in the Protocol study have identified patients exhibiting variants in ion channel genes that are linked to neurological disease. In order to determine the pathogenic nature of these mutations, specialized patch clamp analysis will be performed using specified mutations on Xenopus oocytes and cultured cells and compared to the respective wild type channel. UDP has a critical need to collaborate with Emory University School of Medicine, Department of Pharmacology expertise in patch clamp analysis of mutation ion channels on GRIN2A and GRIN2B genes in order to determine the mechanism that produces neurological disease in UDP patients. No other source can be used for this specific part of this protocol study, therefore Emory University, Department of Pharmacology is the sole source for this acquisition requirement. CONTRACTOR REQUIREMENTS: 1. The Contractor shall provide cutting edge patch clamp analysis of mutant ion channels expressed in Xenopus oocytes and cultured cells. The results will be compared to the respective wild type ion channel. 2. The Contractor shall provide test results in a format that can be integrated with understanding the patient phenotype and support the ongoing collaborative research expertise needed by the NHGRI, UDP. 3. The Contractor shall provide unique services specific to delineating the pathogenicity of ion channel variants and thus the program goals of the UDP. 4. The Contractor's turn-around-time for UDP to receive results will be 5 weeks per variant. 5. The Government will be contacted if any patient results need to be evaluated urgently for impact on caring for patients in the UDP. 6. The Contractor shall supply electronic copies of all reports appropriate for deposition in the UDP process management system and for exome sequence variant analysis. B. Desired Results/Functions/End Items : 1. Test results with qualified interpretations each 5 weeks per variant given the requirements of the particular test. 2. Research collaborations will be conducted via Videoconferences, email communications, shared professional presentations, posters and publications. Grand Round presentations at the Contractor's location and the NIH Clinical Center may also occur. C. Technical Specifications/Standards/Methods : 1. The Contractor shall supply results with qualified interpretations in formats appropriate to the exome analysis pipeline and process management systems. D. Special Handling or Handling Requirements : 1. The Contractor shall provide result reports and record methods and materials as appropriate to the highest scientific standards. These materials, methods and results will be shared with agreed upon UDP collaborators. E. Government Responsibilities: The Government will provide to the Contractor: 1. The Government will not furnish any government property to the vendor 2. The Government will provided patient samples will include fibroblasts or iPS cells as the research warrants. 3. The Government will send all patient samples via Fed-Ex overnight to the Contractor for testing. 4. The Government will not furnish any facilities to be used by the vendor. The Government will be responsible for reviewing and approving reports and similar matters generated: 1. Abnormal results will be provided electronically to the UDP via secure email, the UDP ftp site or direct deposition into the UDP process management system. 2. Results will also be shared with UDP collaborators as defined mutually by the Collaborator and the UDP. F. Reporting Requirements and Deliverables : 1. The Government will receive all electronic results within 5 weeks of the Contractor receiving the samples or variant information. 2. The Government will receive additional reports for any test added-on after the Contractor receives the original specimen. 3. The Government will receive additional reports for any parental or sibling testing done for the clarification of a new genetic disease. 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, only one responsible source and no other supplies or services will satisfy agency requirements. ADDITIONAL INFORMATION: Industry Classification (NAICS) Code is 541712, Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) and the Small Business Size Standard is 500. 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) 05-66 (April 1, 2013). This requirement is under the SAT of $150,000.00. The determination by the Government to award a purchase order on a sole source on competitive basis is based on market research conducted. Any information received as a result of this pre-solicitation / notice of intent will be considered solely for the purpose of determining whether to conduct any future competitive procurements. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. Responses to this notice shall contain sufficient documentation to establish the interested parties' bona-fide capabilities for fulfilling the requirement. This notice of intent is not a request for competitive proposals.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NIH-NHLBI-CSB-(HG)-2013-169-DLM/listing.html)
- Place of Performance
- Address: NIH, 9 Memorial Drive, Building 8, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03079940-W 20130606/130605001410-1d612830ef102195919be00bc59f3c9e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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