SOLICITATION NOTICE
B -- Characterization Studies of Undiagnosed Diseas Program Genes in Zebrafish
- Notice Date
- 6/21/2016
- 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
- HHS-NIH-NHLBI-CSB-(HG)-2016-163-DM
- Archive Date
- 7/12/2016
- 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) on behalf of the National Human Genome Research Institute, (NHGRI), intends to negotiate and award a purchase order on a non-competitive sole source basis to the University of California, Los Angeles, 11000 Kinross Avenue, Suite 211, Box 951406, Los Angeles, California 90095 to characterize the mutant zebrafish lines that have been previously generated to carry UDP patient gene mutations involving N4BP3 (Nedd 4 Binding Partner 3), Gas7 (Growth arrest specific 7), and ATP6V1H. Follow-On Requirement Procurement: 1. Test the hypothesis that ATP6V1H mutation results in increased activity of ATPase in osteoclasts, which then produce excess amount of MMP13 and MMP9 to cause osteoporosis. 2. Determine if only MMP13 or MMP9 or both are responsible for reduced bone mass and density. This will be achieved by analysis of bone phenotype in conditional overexpression of MMP13 and MMP9 in transgenic zebrafish. Background : The National Institute of Health (NIH) is the nation's leading medical research agency and the primary Federal agency seeking 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 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. 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. 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. Purpose and Objectives : The purpose of this procurement is to characterize the mutant zebrafish lines that have been previously generated to carry UDP patient gene mutations involving N4BP3 (Nedd 4 Binding Partner 3), Gas7 (Growth arrest specific 7), and ATP6V1H. Specifically the laboratory of Dr. Shuo Lin will determine the impact of the patient mutation on gene function and the effects of the N4BP3 and GAS7 mutations on neuronal growth and development, and bone formation in the mutation specific zebrafish lines and in transgenic zebrafish lines expressing GFP or RFP. For studying the ATP6V1H mutation in the UDP patients, the laboratory at the University of California, Los Angeles (UCLA) has generated loss-of-function zebrafish mutants that exhibit a bone phenotype similar to that of the UDP patients. They will currently test whether small molecule inhibitors are the cause of the decreased bone mass and if they can be used as therapeutic targets for treatment of the patients' disease. Scope of Work: The Contractor shall provide a robust methodology for introducing mutations in zebrafish in order to characterize the potential causality of mutations identified in UDP patients. The Contractor shall provide the following to the UDP laboratory : • Establish Adult stocks of N4BP3 and Gas7 individual and compound mutants. • Perform phenotypic analysis on the N4BP3 and Gas7 individual and compound mutant zebrafish. • Establish the working conditions for testing the activity of ATPase in osteoclasts. • Create an ATP6V1H knockout osteoclast cell line by using CRISPR/cas9. • Analyze the ATPase activity in the ATP6V1H knockout zebrafish containing deficient gene expression. • Generate transgenic zebrafish lines expressing mmp9 and mmp13 that have been produced with a vector that contains the heat shock promoter in order to induce expression of these genes. • A turn-around-time (TOT) of 52 weeks or less per 12 genes of interest. • Real time free and full sharing of all data with the UDP and its collaborators. • The potential to extend the studies to define disease mechanisms and identify potential therapeutic interventions. A. Desired Results/Functions/End Items : 1. Test results with qualified interpretations in a timely way given the requirements of the test provided. 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. B. Technical Specifications/Standards/Methods : 1. The Contractor shall supply mutant fish sperm or mutant embryos to the UDP for phenotypic analysis. 2. The Contractor shall supply results with qualified interpretations in formats appropriate to the process management systems and for facilitation of other collaborations. C. 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 will agreed upon UDP collaborators. D. Government Responsibilities : 1. The Government will not furnish any government property to the vendor 2. The Government will provide the names and mutations of the genes of interest to the Contractor. 3. The Government will not furnish any facilities to be used by the vendor. E. The Government will be responsible for reviewing and approving reports and similar matters generated: 1. 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. F. Reporting Requirements and Deliverables : 1. The Government will receive all electronic results and biological materials within 52 weeks of notification for each twelve genes of interest. 2. The Government will receive additional reports for any test added-on after the Contractor receives the original specimen. G. Program Management and Control Requirements : • Any internal management and control systems either specified by the Government or to be developed by the contractor. Period of Performance : 12-Months from Date of Award 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 and is not expected to exceed the simplified acquisition threshold, only one responsible source and no other supplies or services will satisfy agency requirements. This requirement base and option 1 year period is under the SAT of $150,000.00. Statutory Authority: This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. Additional Information : Industry Classification (NAICS) Code is 541712, Research and Development in the Physical, Engineering, and Life Sciences (except biotechnology) and 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) 05-88 (May 16, 2016). This requirement is under the Simplified Acquisition Threshold 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 June 27, 2016 and must reference synopsis number HHS-NIH-NHLBI-CSB-(HG)-2016-163-DM, may be submitted to the National, Heart, Lung and Blood Institute, Office of Acquisition, COAC Services Branch, 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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-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-CSB-(HG)-2016-163-DM/listing.html)
- Place of Performance
- Address: NIH and Contractor's Location, United States
- Record
- SN04156962-W 20160623/160621234649-b8df5736f8da925fbaf7a2d1ac4bdf96 (fbodaily.com)
- Source
-
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