SOLICITATION NOTICE
A -- Adenoassociated Viral (AAV) Gene Therapy for Methylmalonic
- Notice Date
- 6/24/2016
- 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)-2016-170-DM
- Archive Date
- 7/15/2016
- Point of Contact
- Dorothy Maxwell, Phone: 301-435-0352
- E-Mail Address
-
maxwelld@mail.nih.gov
(maxwelld@mail.nih.gov)
- Small Business Set-Aside
- Total Small Business
- 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 Institutes of Health, National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) the National Human Genome Research Institute (NHGRI), intends to negotiate and award a purchase order on a non-competitive sole source basis to Dr. Lina Li, 11800 Milbern Drive, Potomac, Maryland 20854 will provide the following: Procurement: The Contractor will provide highly specialized molecular biology and genetic analysis of adenoassociated viral (AAV) gene therapy in mice with methylmalonic acidemia (MMA). Background: 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. NHGRI supports the development of resources and technology that will accelerate genome research and its application to human health. A critical part of the NHGRI mission continues to be the study of the ethical, legal and social implications (ELSI) of genome research. NHGRI also supports the training of investigators and the dissemination of genome information to the public and to health professionals. The National Human Genome Research Institute (NHGRI), Division of Intramural Research (DIR) was established to serve as a hub where development of technology for gene therapy will be carried out. The Organic Acid Research Section of MGMGB, NHGRI, NIH studies a group of inherited metabolic disorders that cause increased methylmalonic acid and homocysteine to accumulate in body fluids. The conditions are generally caused by impaired intracellular metabolism of vitamin B12 or by defects in two enzymes - methylmalonyl-CoA mutase (MUT) and methionine synthase - that require the vitamin to function. Isolated methylmalonic acidemia (MMA) is one of the most common inborn errors of organic acid metabolism. The lab uses model organisms to study MMA pathophysiology and has created a number of mouse models to study the disorder. Gene therapy using adeno-associated viral vectors to deliver the MUT gene to mice is a critical mission of the Section. The testing of the effects of gene therapy vectors in mice needed in this procurement relates to both AAV and the main disorder under study, methylmalonic acidemia. Purpose and Objectives: The Contractor has experience, expertise and knowledge to test the effects of new AAV gene therapy vectors in mice using molecular biological techniques, histochemistry, immunohistochemistry, and expression analysis, and is familiar with NIH intramural mouse protocols. Additionally, complete knowledge and understanding of the National Institutes of Health and the National Human Genome Research Institute mission and protocols to conduct scientific research. Period of Performance: Base Year: June 2016 to October 2016 (592 Hours) Option 1 Year: October 2016 to October 2017 (2080 Hours) Option 2 Year: October 2017 to October 2018 (2080 Hours) Contractor Requirements : Specific Tasks to be performed by Contractor : •The Contractor will create AAV vectors. •The Contractor will purify AAV vectors using cell culture and insect platforms •The Contractor will assist with AAV bioreactor design •The Contractor will treat mice with AAV vectors and analyze effects •The Contractor will collect and analyze data from animal; code, score and tabulate research data. •The Contractor will maintain and update records of all animal treatments with AAV. •The Contractor will analyze and interpret research data in preparation for publication. •The Contractor will treat and track mice through studies. •The Contractor will examine effects of vectors on mice including expression analysis at the protein and RNA levels such as Western blotting and qPCR •The Contractor will measure genome copy numbers of AAV vectors in tissues •The Contractor will collect and analyze blood of mice for metabolites and disease related biomarkers •The Contractor will consultation with senior scientific staff on current and future AAV animal protocols. •The Contractor will perform next generation sequencing using tissues from mice to determine AAV integrations. Government Responsibilities : The Government will provide the Contractor: desktop computer, technical support and NIH Network connectivity for the services to be provided, laboratory equipment and supplies for mouse and laboratory studies. Reporting Requirements and Deliverables : Upon request, the contractor shall provide documentation evidence of any and/or all work product, including, but not limited to, the following tasks: oWork products and documents related to AAV gene therapy experiments; collect and analyze data; code, score and tabulate research data. oWork products and documents related to maintaining and updating records of animal studies; analyze and interpret data. oWork products and documents related to AAV gene therapy experiments; conduct reviews and prepare summaries of AAV experiments tests. oWork products and documents related to AAV gene therapy experiments; prepare figures and tables for manuscripts and meetings with regulatory agencies. Program Management and Control Requirements : The contractor shall work independently with direct supervision by NHGRI. Safety Issues : Work is performed in a laboratory setting or in an animal facility; there are no known safety issues. Government-Furnished Equipment and or Facilities Provided : The Government will provide the Contractor: workspace, computer, telephone and other electronic equipment as well as all laboratory equipment and supplies needed to perform task. Security Clearance: The Contractor shall comply with all applicable HHS and NIH Security regulations and procedures during the performance of this Purchase Order. The Contractor shall not disclose and must safeguard procurement sensitive information, computer systems and data, Privacy Act data, and Government personnel work products that are obtained or generated in the performance of this Purchase Order. Regulatory Authority : The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-88-1, June 15, 2016. This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13 Simplified Acquisition Procedures (SAP). 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 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. Additional Information : 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. Industry Classification (NAICS) Code is 541711, Research and Development in Biotechnology and the small business size standard is 1000. 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 no later than 7:30 a.m. Eastern Standard Time (EST), June 30, 2016; and must reference synopsis number HHS-NIH-NHLBI-CSB-(HG)-2016-170-DM, 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, Contracting Officer. 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)-2016-170-DM/listing.html)
- Place of Performance
- Address: NIH & Other Locations, Bethesda, Maryland, United States
- Record
- SN04161980-W 20160626/160624234933-a7fdab2b7d4f957c72a11293c488a29c (fbodaily.com)
- Source
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