SOLICITATION NOTICE
Q -- Finite Element Analysis (FEA) Services
- Notice Date
- 9/13/2012
- Notice Type
- Presolicitation
- NAICS
- 621511
— Medical Laboratories
- 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
- NHLBI-CSB-AR-2012-337-DLM
- Archive Date
- 10/2/2012
- 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
- 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 Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Clinical Trials and Outcomes Branch, NIAMS Intramural Research Program, intends to negotiate and award a purchase order on a noncompetitive sole source basis to O.N. Diagnostics, LLC, 2150 Shattuck Ave., Suite 610, Berkeley, California 94704 to procure their services for Finite Element Analysis (FEA) for a mechanical study of syndesmophytes in ankylosing spondylitis (AS). Period of Performance: October 1, 2012 through March 31, 2013 The sole source determination is based on the fact that National Institute of Health (NIH) is the nation's leading medical research agency and the primary Federal agency conducting and supporting making medical discoveries that improve people's health and save lives. The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Clinical Trials and Outcomes Branch, is engaged in several observational studies to understand the natural history of several rheumatic diseases and to test therapeutic interventions. The NIAMS Intramural Research Program is currently working on a longitudinal protocol study under protocol Number: 04-AR-0205 on the progression of Spinal Fusion in ankylosing Spondylitis in which the services for this contract is for. The study is currently focused on the development of a computed tomography (CT)-based measure of syndesmophytes, which can be used to measure the progression of spinal fusion in these patients and to test the effectiveness of any treatment in slowing this process. Syndesmophytes are preferentially located in the posterior aspect of the vertebral body, rather than randomly distributed around the vertebral circumference as would be expected if inflammation was the primary source. The preferential posterior location suggests an important role for biomechanical influences, as posterior column shares the loading stress in the spine. Identifying mechanical load as a risk factor for spinal fusion would dramatically alter our thinking about how spinal fusion occurs in AS, which currently is focused solely on vertebral inflammation. The overall objective in this proposal is to use finite element analysis to understand the role of biomechanics in the process of spinal fusion in ankylosing spondylitis (AS). O.N. Diagnostics is being procured to provide the service for this requirement. The Contractor has extensive SOPs and internal quality systems in place that provide a structured framework for all analyses, thereby maximizing precision and ensuring the proposed work will be done in an expert and timely manner. O.N. Diagnostics will analyze all quantitative CT scans from 25 AS patients and perform Finite Element Analysis (FEA) in order to estimate bone density and strength from these scans. Additionally, O.N. Diagnostic will assess local stresses in the endplate and surrounding bone, as well as measures of cortical and trabecular density and strength. Analyses will be performed on the vertebral levels regardless of the presence of syndesmophytes or fusion. The use of different types of boundary conditions will also be explored. Together, this should provide a comprehensive first-ever biomechanical assessment of the vertebral bodies in AS patients. The Contractor shall analyze up to seven vertebral levels per patient (nominally, T10-L4), and shall assess two time points each. O.N. Diagnostics is within compliance with the state and federal regulations for the Protection of Human Subjects (CA-HSC-24170, 45 CFR Part 46), Institutional Review Boards (21CFR Part 56), and Good Clinical Practices, and FDA current Good Manufacturing Practice (21 CFR Part 11, 820). Industry Classification (NAICS) Code is 621511 Medical Laboratories, with business size standard of $13.5M. 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).and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-60 (August 27, 2012). This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this synopsis, by September 17, 2012, 7:30 a.m. Eastern Standard Time. 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. Information received will normally be considered solely for the purpose of determining whether to conduct future competitive procurement. Inquires to this announcement, referencing synopsis number NHLBI-CSB-(AR)-2012-337-DLM, 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. Note: In order to receive an award from NIH/NHLBI, contractors must be registered and have a valid CCR and ORCA on-line at https://www.sam.gov/portal/public/SAM/.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-AR-2012-337-DLM/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02882043-W 20120915/120914001758-4bf3711fb094a8a65c70980c86c0bddc (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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