MODIFICATION
R -- Professional Service Contract to provide database of anatomical vascular models of the human inferior vena cava
- Notice Date
- 9/5/2019
- Notice Type
- Modification/Amendment
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 4041 Powder Mill Road, Beltsville, Maryland, 20705, United States
- ZIP Code
- 20705
- Solicitation Number
- 1214196
- Archive Date
- 9/11/2019
- Point of Contact
- Michelle C. Creenan, Phone: 2404024260
- E-Mail Address
-
michelle.creenan@fda.hhs.gov
(michelle.creenan@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- The purpose of this amendment is to answer questions received. All other terms and conditions remain the same. 1.It appears you want the contractor to obtain data from patients that have had images reviewed by a Radiologist. Is this the case? As indicated in the Description of Work (Section 2.1.1), the contractor should reconstruct three-dimensional anatomical models of the inferior vena cava (IVC) and have the accuracy of the reconstruction confirmed by a vascular surgeon, or an interventional radiologist or another practicing physician who is intimately familiar with IVC anatomy and computed tomography (CT) imaging of the IVC. However, please note that the contractor should not be acquiring any new CT data for this award. The anatomical models should be reconstructed from existing contrast-enhanced CT angiogram data (e.g., acquired in a previous IRB-approved study). 2. In regards to the paragraph shown below. What is your definition of subpopulation? The analysis must include a quantification of a range of different morphological parameters that include at least vessel diameters, lengths, tortuosity, branch angles, and IVC radius of curvature. The analysis must also include the identification and quantification of any stenoses present in the IVC, iliac, or renal veins. Finally, as part of this task, the contractor must perform a statistical analysis using the IVC morphometry data to identify any subpopulations with similar IVC anatomy that may exist within the created database of anatomical models Subpopulation in this context refers to the identification and assignment of individuals into subgroups or clusters based on anatomical and morphometric characteristics. For example, patients may be clustered into groups such as: normal IVC anatomy, IVC with anomalies (iliac, infrarenal, renal, or other), IVC with high curvature, or other possible subgroups.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1214196/listing.html)
- Record
- SN05432549-W 20190907/190905231119-40080d86eefbd89b494cbae8f4cf9abe (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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