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FBO DAILY ISSUE OF JUNE 10, 2008 FBO #2388
DOCUMENT

A -- Biomarker Development for Evaluation of Device Interventions for Recovery from Heart Failure - ATTACHMENT A FOR REQ1042835

Notice Date

6/8/2008
 

Notice Type

ATTACHMENT A FOR REQ1042835
 

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

REQ1042835
 

Point of Contact

Monifa N Coleman, Phone: 301-827-7164
 

E-Mail Address

monifa.coleman@fda.hhs.gov
 

Small Business Set-Aside

Total Small Business
 

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-25. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 541712, is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. This is a 100% small business set-aside. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. ******** This solicitation is issued as a Request for Quote (RFQ). Quotations are limited to 15 pages, not including resumes. If any quotations are submitted in excess of the page limit, they may not be considered for this procurement. ******** The Food and Drug Administration (FDA) intends to award a purchase order for professional services to develop a method to non-invasively characterize cardiac dynamics, including stroke volume and cardiac output. The Statement of Work is as follows: Background and Objective: Our research goal at FDA/CDRH/OSEL/DP 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 would determine the 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 magneto-hydrodynamic (MHD) signal recorded on the ECG while the subject is in the strong static magnetic field of a magnetic resonance imager (MRI). This signal is caused by blood flow in the magnetic field. Therefore, we hypothesize 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. Such electromagnetic modeling has been done by Dr. Wolfgang Kainz at FDA/CDRH/OSEL/DP with anatomically accurate electromagnetic models of the human. Dr. Kainz’s model will permit determination of locations and blood-flow vectors (magnitude and direction) that may be used as functional biomarkers for cardiac function in healthy and HF subjects. The overall goals of the modeling work are to: 1) solve the problem of how aortic blood flow in an MRI field reflects as voltage changes in a 12-lead ECG; 2) determine whether there are unique solutions for blood flow, blood velocity and volume; 3) determine the limits of spatial resolution for this technique, for example whether pulmonary artery flow can be resolved from aortic flow. FDA/CDRH/OSEL/DP currently uses the electromagnetic simulation platforms SEMCAD and XFDTD. Either software platform will require a magneto-hydrodynamic solver for generic and anatomical models. Scope of Work: Requirements for the Magneto-Hydrodynamic Solver: The graphical user interface (GUI) of SEMCAD or XFTTD shall be extended through modeling capabilities for blood vessels. The blood vessels shall be defined either generically in the form of cylinders or as existing vessels in anatomical computer models. The magneto-hydrodynamic solver shall be able to import a velocity field for the given blood vessels based on the solution of a separate fluid flow solver. The fluid flow solver returns the velocity field for the blood vessels as they are modeled in the GUI. Therefore the GUI needs to be able to export the blood vessels to the fluid flow solver in a standardized CAD format. The data format of this velocity field shall be defined during the development of the magneto-hydrodynamic solver. FDA will provide the results of the fluid flow solver in the agreed data format. The GUI shall include extensive modeling capabilities, graded rectilinear grid, customizable post-processing, and a scripting language for the blood flow network. The kernel of SEMCAD or XFDTD shall be updated to calculate the electric field (E) based on a static external B0 field. The permeability throughout the complete computational domain shall be considered as constant. Only the lossy domain is discretized and hence, the electric field E is only calculated inside the lossy domain and on the surface of the lossy domain. If perfect electric conductor objects are added to the lossy domain, their potential value needs to be specified by the user. In post-processing the electric field, the scalar potential phi and the H field can be investigated and graphically displayed for the whole simulation domain and as surface fields over the lossy domain. In addition, various derived quantities like current density, spatial peak specific absorption rate, averaged specific absorption rate, D, B, etc. shall be displayed and it shall be possible to export the values. Surface values of the lossy domain are of special interest and it shall be possible to display and investigate these surface values for generic and anatomical models. A user manual for the magneto-hydrodynamic solver shall be provided. Requirements Under Section 508. Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Provisions (36 CFR part 1194), require that, unless an exception applies, all EIT products and services developed, acquired, maintained, or used by any Federal department or agency permit: (1) Federal employees with disabilities to have access to and use information and data that is comparable to the access and use of information and data by Federal employees who are not individuals with disabilities; and (2) Members of the public with disabilities seeking information or services from a Federal agency to have access to and use of information and data that is comparable to the access and use of information and data by members of the public who are not individuals with disabilities. ************************************************* The vendor shall develop this software program according to the applicable Section 508 Standards found in Attachment A. ************************************************* The vendor shall complete an HHS Section 508 Product Evaluation Template located at http://508.hhs.gov/vendors.htm. Reports Deliverables: The Contractor shall submit the following reports/deliverables: 1) solve the problem of how aortic blood flow in an MRI field reflects as voltage changes in a 12-lead ECG. 2) determine whether there are unique solutions for blood flow, blood velocity and volume. 3) determine the limits of spatial resolution for this technique, for example whether pulmonary artery flow can be resolved from aortic flow. FDA/CDRH/OSEL/DP currently uses the electromagnetic simulation platforms SEMCAD and XFDTD. Either software platform will require a magneto-hydrodynamic solver for generic and anatomical models. Period of Performance: The period of performance is for one year effective ARO. EVALUATION FOR AWARD Basis for Award: a. Proposals received will first be evaluated from a technical standpoint without regard to proposed cost. Those proposals considered to be technically acceptable will then be evaluated from a financial and management standpoint. b. Technical factors are significantly more important than cost or price. It is pointed out, however, that should technical competence between offerors be considered approximately the same, then cost or price could become primary. c. FDA will base its award decision using a best value analysis that results in the most advantageous acquisition for the government. FDA’s acquisition strategy used to obtain best value may result in an award to other than the lowest priced, technically rated offeror. Best value analysis spans a continuum from the lowest priced, technically acceptable proposal to those proposals in which tradeoffs between price, past performance, and each offeror’s technical solution is evaluated. This tradeoff process (see FAR 15.101-1) depends on the government’s assessment of quality factors, including but not limited to past performance, compliance with solicitation requirements, technical excellence, management capability, personnel qualifications and prior experience, and price. TECHNICAL EVALUATION CRITERIA: 1. Modeling capabilities for blood vessels in the graphical user interface (GUI). Weight = 10% 2. Import capability of a velocity field for the given blood vessels based on the solution of a separate fluid flow solver. Weight = 25% 3. Export capability of the blood vessels to the fluid flow solver in a standardized CAD format. Weight = 10% 4. Extent of modeling capabilities in the GUI. Weight = 5% 5. Calculation of the electric field (E) based on a static external B0 field in the presence of a velocity field. Weight = 25% 6. Ability to investigate and graphically display the scalar potential phi and the H field. Weight = 15% 7. Education and experience of key personnel assigned to this contract. Weight = 10% PAYMENT SCHEDULE: Payment will be made in monthly installments based on level of effort (hours worked). CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to Monifa.Coleman@fda.hhs.gov no later than June 12, 2008, 2:00pm EST. QUOTATIONS DUE: All quotations are due, via email to: Monifa.Coleman@fda.hhs.gov, no later than 10:00am, EST on June 18, 2008. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. Responses to this notice must be sent via email to Monifa.Coleman@fda.hhs.gov. No phone calls will be accepted.
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=ab6eaa02b679cb4f4605c06ca1a4b396&tab=core&_cview=1)
 

Document(s)

ATTACHMENT A FOR REQ1042835
 

File Name: SECTION 508 APPLICABLE STANDARDS (Attachment A for REQ1042835.doc)

Link: https://www.fbo.gov//utils/view?id=fd714ec09df2c836cecc6fdf2dcc640e

Bytes: 31.00 Kb
 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: 10903 New Hampshire Avenue, Silver Springs, Maryland, 20993, United States

Zip Code: 20993
 

Record

SN01589048-W 20080610/080608213034-ab6eaa02b679cb4f4605c06ca1a4b396 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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