MODIFICATION
66 -- Laboratory Case Model Validation
- Notice Date
- 5/15/2009
- Notice Type
- Modification/Amendment
- 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, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA1056086
- Archive Date
- 6/5/2009
- Point of Contact
- David - Kordel, Fax: 301-827-7151
- E-Mail Address
-
david.kordel@fda.hhs.gov
(david.kordel@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Subject: Laboratory Case Model Validation Solicitation Number: FDA1056086 Response Date: 21 May 2009 DESCRIPTION: THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; QUOTATIONS ARE BEING REQUESTED, AND A WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. THIS SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES 13.5. This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-32. The associated North American Industrial Classification System (NAICS) code for this procurement is 541712 for a 100% small business set-aside. The FDA intends to issue a firm fixed-price purchase order for the following laboratory case model validation. Summary: Validation of the Magneto Hydro Dynamic (MHD) simulation platform for the study of MHD induced signals during MRI scans (already developed) and investigation of the MHD effect by simulations and measurements. This work is mainly based on the Virtual Family male model (with revised aorta and vena cava model) and the corresponding MRI measurements. Background: The overall research objective is to investigate and characterize an electromagnetic biomarker for heart failure (HF) and recovery. The goal is to develop a method to non-invasively characterize cardiac dynamics, including stroke volume and cardiac output. The research will assess information about blood flow that can supplement present non-invasive ultrasound techniques for the evaluation of heart failure. The new physiological biomarker that will be evaluated is the MHD signal recorded on the electrocardiograom (ECG) while the subject is in the strong static magnetic field of a magnetic resonance imager (MRI). This MHD signal is caused by blood flow in the magnetic field. Therefore, it is hypothesized that the MHD signal is capable of the rapid and non-invasive flow measurements that are necessary for evaluating HF, particularly diastolic HF. Such signals have been collected in both animals and humans by other investigators. Analysis of the MHD signal recorded with the 12-lead ECG in conjunction with physiological measurements will require electromagnetic modeling to determine the sources of the signals (i.e., ventricle, aorta, coronary arteries, and carotid arteries) and the size of the magnetic field needed to obtain useful physiological signals. The final goal is to determine locations and blood-flow vectors (magnitude and direction) that may be used as functional biomarkers for cardiac function in healthy and HF subjects. Previous work: In the first phase of the this project a MHD solver was developed that reads in a given flow distribution and, based on a novel quasistatic approximation, calculates the resulting electric field distribution due to the application of an external magnetic field and its interaction with the charged particles in the blood flow. The solver has been fully integrated into SEMCAD X and works with the detailed anatomical full-body models available for SEMCAD X. The SEMCAD X modeling, import and export feature have been extended (including scripting interface). Novel postprocessing functionality has been added. Statement of Work: The purpose of this purchase order is the validation of the previously developed MHD solver and its application to a model case (based on Virtual Family male). For this the following tasks need to be performed: 1) Development and delivery of aorta and vena cava models suitable for computational flow simulations based on the Virtual Family male data. The aorta model should include the descending and abdominal aorta with branches into iliac arteries (abdominal bifurcation). The vena cava model should include the anterior and posterior part of the vena cava model. All models should be delivered as CAD models in *.sat format. 2) Transient (pulsatile) simulations of realistic temporal blood flow distribution (unlike the steady state flow solution used under contract HHSF22320081116P) with 0.01 second temporal resolution in the vessel structures developed in Task 1 using flow solvers. 3) Comparison of the spatial and temporal simulated blood flow distribution with MRI velocity measurements which are compatible with the original Virtual Family male model. The simulated data should be within 20% of the MRI velocity measurements. The FDA will use the MHD solver developed under contract HHSF22320081116P to select optimized surface locations, on the Virtual Family male model, for MHD measurements. These locations will be provided to the contractor so that they may: 4) Extract MHD time curves for the selected optimized surface locations from multiple MHD simulations, 5) Compare ECG (free space) and ECG+MHD (in 3 Tesla MRI field) simulations to recorded measurements, under the same conditions, from an anatomy similar to the actual Virtual Family male model. QUESTIONS DEADLINE: all questions must be received by email (david.kordel@fda.hhs.gov) before 4:30 pm (1630) EST on 4 May 2009. Delivery terms shall be FOB Destination. FOB Destination means the contractor shall pack and mark the shipment in conformance with carrier requirements, deliver the shipment in good order and condition to the point of delivery specified in the purchase order, be responsible for loss of and/or damage to the goods occurring before receipt and acceptance of the shipment by the consignee at the delivery point specified in the purchase order; and pay all charges to the specified point of delivery. Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this contract to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor described to "Meet or Exceed the Requirement," 2) Past Performance, and 3) Price. Technical Capability and Past Performance is significantly more important than price. Evaluation of Technical Capability shall be based on the information provided in the quotation. Quoters shall include their understanding of the requirement and any past performance that can support your quote or other literature which CLEARLY DOCUMENTS that the offered service meets or exceeds the specifications stated herein. FAR provisions can be found on the following website: http://www.arnet.gov. The following provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors-Commercial Items; 52.225-2 Buy American Certificate; 52.212-4 Contract Terms and Conditions-Commercial Items; 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items including subparagraphs: 52.222-3, Convict Labor 52.222-19, Child Labor-Cooperation with Authorities and Remedies 52.222-21, Prohibition of Segregated Facilities 52.222-26, Equal Opportunity 52.222-36, Affirmative Action for Workers with Disabilities 52.222-50, Combating Trafficking in Persons 52.225-1, Buy American Act--Supplies 52.225-13, Restrictions on Certain Foreign Purchases 52.232-33, Payment by Electronic Fund Transfer-Central Contractor Registration. This is a Combined Synopsis/Solicitation for laboratory validation service as defined herein. The Government intends to award a Firm Fixed-Price Purchase Order as a result of this Combined Synopsis/Solicitation that will include the terms and conditions that are set forth herein. Additionally, all quotes shall include price (s); FOB point; a poc (name and telephone number); a statement from the offeror verifying that they are CCR Registered under NAICS code 541712; delivery date (delivery date is of the utmost importance); business size; and payment terms. Delivery shall be to FDA, Silver Spring, MD 20993. FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email and be received by 4:30 PM (1630) EST on 21 May 2009 to the attention of David Kordel, david.kordel@fda.hhs.gov. Offerors shall ensure the RFQ number is visible in the header of the email. FAX QUOTES SHALL NOT BE ACCEPTED.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA1056086/listing.html)
- Record
- SN01820464-W 20090517/090516162322-deca86101121aa3cbccc13b3a58e1eee (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |