SOLICITATION NOTICE
B -- Staining techniques for histological analysis including Movat Pentachrome staining for Hutchinson-Gilford Progeria Syndrome
- Notice Date
- 1/22/2016
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- 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)-2016-069-DM
- Archive Date
- 2/12/2016
- 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 CONTRACT 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 without providing for full and open competition to CVPath Institute, 19 Firstfield Road, Gaithersburg, Maryland 20878 Nichols to provide the following: Procurement: 1. Slide Production (Organs): Paraffin Embedding with Heart/Kidney in same block and Liver/Spleen in same block, Microtomy, Staining with H&E (n=1)=Total Blocks/Slides=720; and 2. Slide Production (Vessels): Paraffin Embedding, Microtomy, Staining with H&E (n=1) and Movat (n=1)=Total Blocks=240, Slides=480. Background: The National Institutes 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. NHGRI Molecular Genetics Section (MGS) researchers study a range of inherited conditions, from common to rare. Among the rarest is the Hutchinson-Gilford Progeria syndrome (HGPS), the most dramatic form of premature aging in humans. HGPS patients typically die from heart disease in their teens. Dr. Collins' laboratory discovered that a mutation in the lamin A gene (LMNA) causes HGPS, producing a toxic protein that interferes with the structure and function of the cell nucleus. Prior information about the biology of lamin A suggested that the amount of the toxic protein might be reduced by use of farnesyltransferase inhibitors (FTIs), and experiments in the lab have shown that these drugs improve the nuclear abnormalities of HGPS. Using a mouse model developed in the lab, it has been possible to demonstrate that FTIs can reverse the cardiovascular disease. This research has supported the development of a clinical trial of FTIs in humans, which has now been shown to reduce stiffening of major arteries, and even to prolong survival. Investigators in the Medical Genomics and Metabolic Genetics Branch (MGMGB) use a broad range of tools to understand how health and disease are related to genetic, genomic and metabolic variation. They study a broad spectrum of disorders, from common diseases associated with common variants to the rarest diseases associated with uncommon, sometimes unique variants. They sometimes study disorders that are not inherited at all, which are due to somatic mosaicism-a difference in genetic composition among cells in an individual. They also study how the genome influences normal metabolic processes. MGMGB investigators apply tools ranging from high-throughput biology to clinical and animal research. A unifying theme in their research is that the human is the most complex, fascinating and important system in which one can study the effects of heritable variation. Purpose and Objective: This procurement is under an established protocol under project number Z01-HG200305 Hutchinson-Gilford Progeria syndrome. CVPath Institute has extensive experience in histology, particularly cardiovascular pathology. NHGRI Investigators require special staining techniques for histological analysis including Movat Pentachrome staining. In order to remain consistent between studies we require that the comparative histology be done using the same procedures and protocols. NHGRI Medical Genomics and Metabolic Genetics Branch (MGMGB) continues to require CVpath Institute's expert analysis of histological results pertaining to cardiovascular pathology including but not limited to vascular smooth muscle cell content, vascular media and intima pathology as well as vascular structure, proteoglycan content and effects on vascular adventitia. In addition, expert analysis of the effects of cardiovascular pathology on peripheral tissues is included in the histological survey. CVPath, Inc. has provided histological preparation for the HGPS project under as per protocol throughout the mouse pre-clinical trials. Any deviation from these protocols will be incompatible with previous research in the project. The mouse tissues must be embedded for sectioning promptly to avoid tissue damage due to environmental factors such as heat and time during shipping. CVPath Institute continues to be essential to the clinical trial and CVPath's cardiovascular pathology specialist, histological processor section tissues and stain histological slides to NHGRI Scientific Investigators specifications. The requirement of specific orientation and precision sectioning of aortic vessels and carotid arteries to analyze vascular pathology specific to progeria as presented in these two mouse models of progeria. CVPath has the histological laboratory and the expertise and knowledge of pathology of these mouse models enabling them to section and process staining in the precise manner to evaluate the cardiovascular pathology appropriately Other Consideration: NHGRI Molecular Genetics Section, Medical Genomics and Metabolic Genetics Branchare evaluating both the cardiovascular condition and the condition of other tissues of 2 mouse models of Hutchinson-Gilford Proderia Syndrome (HGPS), and one mouse model with a lack of progerin (the protein overexpressed in HGPS). This requires the intricate analysis of the cardiovascular vessels with specific conditions for pathology. In addition the pathological histology must be performed promptly so as not to incur tissue damage due to environmental factors, (excessive heat or time in shipping). All previous pre-clinical trial vascular pathology has been performed using histological staining performed at CVPath. To be consistent between studies we require the comparative histology to be done using the same procedures and identical protocol as previous studies. CVPath is the only cardiovascular pathology specialist histological processor available locally that can perform histological staining to these specifications for our studies. The HGPS mouse models exhibit the same cardiovascular abnormalities that presents in the patients. We require special staining techniques for histological analysis and require maintaining consistency of sectioning and staining throughout our studies. Contractor's Requirement: • The Contractor shall agree not to use Confidential Information regarding this study for its own use and agrees not to disclose Confidential Information to any third parties or to any of its employees except those who are required to have the Confidential Information to evaluate the transaction. • The Contractor shall agree that it shall protect the confidentiality of and take all reasonable steps to prevent disclosure or use of the Confidential Information in the public domain through lecture, publications, or other electronic means unless there is written consent by the Government. • The Contractor shall upon completion of the study and the Government's request professional archiving of materials at the Government's expense. • The Contractor shall return all materials to the Government upon their request. Government Data Rights: The Government has unlimited rights to all documents and materials produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract will be Government owned and the property of the property of the Government with all rights and privileges of ownership and copyright belonging exclusively to the Government. These documents and materials cannot be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the Government will be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights. Period of Performance: Upon Award 12-Months 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. 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 541990, All Other Professional, Scientific and Technical Services, and the Small Business Size Standard is $15.0M. 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) 05-85-1 (January 4, 2016). 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 by January 28, 2016 and must reference synopsis number HHS-NIH-NHLBI-CSB-(HG)-2016-069-DLM by 7:30 a.m. Eastern Time, 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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- Place of Performance
- Address: Contractor and Government Location, United States
- Record
- SN03998651-W 20160124/160122233811-e952963d51e5fdee9d27c0d96beb07a3 (fbodaily.com)
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