SOLICITATION NOTICE
B -- Molecular and Functional Analysis in Unscheduled DNA Repair Analysis on UDP Patients
- Notice Date
- 8/13/2015
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in 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
- HHS-NIH-NHLBI-CSB-(HG)-2015-214-DLM
- Archive Date
- 9/4/2015
- 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 Scripps Research Institute, 130 Scripps Way #3B3, Jupiter, Florida 33458 to perform molecular and functional analysis on UDP Patients with ERCC4 and other gene mutations that exhibit alterations in unscheduled DNA repair 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 laboratory of Dr. Laura Niedernhofer at The Scripps Research Institute, Department of Metabolism and Aging specializes in studying patients that have rare diseases caused by inherited mutations in genes that regulate normal DNA repair function. The laboratory study of the endonuclease XPF-ERCC1 that is encoded by the ERCC4 and ERCC1 genes and the analysis of mutations that affect the normal function of the endonuclease will continue to support the UDP to provide functional analysis of suspected gene mutations to determine disease causation in UDP patients. Purpose and Objectives : The purpose of this acquisition is to perform necessary molecular and functional analysis on UDP patients with ERCC4 and other gene mutations that exhibit alterations in unscheduled DNA repair. Specifically, this laboratory supports the research needs of the UDP by collaborating on particular clinically identified new and rare patient disease. Period of Performance: 12 Months Upon Award Justification: The laboratory of Dr. Laura Niedernhofer has expertise in performing functional analysis and testing on patient samples for Xeroderma pigmentosum and Cockayne sysndrome, as well as other rare diseases caused by inherited defects in genes associated with DNA regulation and repair. The laboratory performs these assays by a unique and improved method for screening and measuring nucleotide excision repair that they have developed in house, which also serves as a diagnostic test for these disorders. In order to determine the pathogenicity of neurodegenerative disease in 3 UDP patients that have mutations in ERCC4 and related genome instability causing gene mutations, they will perform the following: • The Contractor shall perform quantifying unscheduled DNA synthesis (UDS) by flow cytometry after UV irradiation on patient fibroblasts or peripheral blood mononuclear cells to measure nucleotide excision repair. • The Contractor shall measure the following in patient cells with genome instability disorders: o Expression of repair proteins; o Sub-cellular localization of repair proteins; o Cell cycle analysis; o DNA repair kinetics; o Clonogenic survival assay in response to genotoxic stress; o Chromosomal aberrations; o Mitochondrial function and; o Markers of cell death or senescence. • The Contractor shall use previously developed murine models of Xeroderma pigmentosum, Fanconi anemia, Cockayne syndrome, XFE progeroid syndrome, and Cerebro-oclo facio-skeletal syndrome as needed to test questions of clinical relevance and potential therapeutic interventions for the UDP patients being tested. • 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 541711, Research and Development in Biotechnology with size standard in number of employees 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) 05-83 (August 5, 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 20, 2015; and must reference synopsis number HHS-NIH-NHLBI-CSB-(HG)-2015-214-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."
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