SPECIAL NOTICE
66 -- Notice of Intent to Sole Source for Additional computational modeling of pediatric growing rod devices to improve model validation
- Notice Date
- 6/23/2017
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-ISS-1183116
- Point of Contact
- Sarah Hussain, Phone: 2404023796
- E-Mail Address
-
sarah.hussain@fda.hhs.gov
(sarah.hussain@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is not a request for a proposal, this is a notice that the U.S. Food & Drug Administration intends to award a Sole Source award to the University of Toledo to perform additional deliverables under existing contract HHSF223201610591P. The Government intends to award a sole source award in accordance with FAR Part 13, Simplified Acquisitions and will be made pursuant to the authority of FAR 6.302-1 only one responsible source and no other will satisfy the agency requirements for the above stated service. The North American Industry Classification (NAICS) Code for this requirement is 541712. The U.S. Food & Drug Administration intends to issue a sole-source purchase order to University of Toledo to perform additional computational modeling of pediatric growing rod devices to improve model validation. This work is requested in addition to previous work conducted by University of Toledo. The work is for a series of validated computational, solid mechanics finite element models to predict rod fracture in growing rod constructs for pediatric patients with Early Onset Scoliosis. The models will further be used to identify patient factors and features of scoliotic curves that increase fracture risk. The University of Toledo has conducted significant work towards this requirement on an existing contract but the studies completed to date have raised additional validation questions. Therefore, additional case studies are needed for the previously planned anatomical models which are in scope of the requirement. The models generated in this new contract will be extensions of the models developed in existing studies to improve the validation. The additional work is a continuation and advancement of work conducted under the existing contract. This will entail the efforts to develop and validate anatomical patient-specific computational models of pediatric growing rods implanted into scoliotic curves based on real clinical data available to FDA. FDA will provide blinded clinical information to generate the patient specific scoliotic curves. The University of Toledo will then create computational models of different growing rod configurations implanted into the curve. The computational model results for critical stress regions will be compared to clinical data existing at FDA. The models to be generated will incorporate unique patient-specific anatomy and growth terms based on software add-on tools developed by the original awardee (i.e., University of Toledo). These tools are not available in commercial versions of the modeling software or widely available for purchase. The University of Toledo is the only contractor who can perform this work due to their expertise in pediatric spinal computational modeling and experimental testing as well as their access to unique software tools for creating computer models of spinal curves. This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement to Sarah Hussain, sarah.hussain@fda.hhs.gov in writing and must be within seven (7) days after the publication of this synopsis which will be considered by the agency. Responses received after 7 days or without the required information may not be considered. A determination by the Government not to compete as a result of information received is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No phone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-ISS-1183116/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN04556170-W 20170625/170623235047-b9b075d8464fa56f1444a4f519770819 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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