SOLICITATION NOTICE
A -- Three Dimensional Finite Element Grids
- Notice Date
- 8/26/2010
- Notice Type
- Combined Synopsis/Solicitation
- 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
- FDA-SOL-1076319
- Archive Date
- 9/17/2010
- Point of Contact
- kara stith, Phone: 3018277155
- E-Mail Address
-
kara.stith@fda.hhs.gov
(kara.stith@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- 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 05-30. This synopsis, NAICS code 541712, is to notify contractors that the government intends to issue a Firm Fixed Price Purchase Order in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. Any firm that believes it is capable of providing the required service as stated herein may submit a capability statement to document its ability to provide the required services. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. 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). 2.1 Project Title Three Dimensional Finite Element Grids - BRAND NAME 2.2 Description of Product CLIN0001: 3D FINITE ELEMENT GRIDS Quantity: 2 Statement of Need As part of a Critical Path Initiative Project that was funded in FY2010, we require three-dimensional finite element grids based on MRI or CT image data sets of pediatric patients. The finite element grids will be used as input to bidomain finite element solvers CARP and/or CHASTE to conduct computational simulations of ventricular fibrillation and defibrillation. The goal of the project is to optimize electrode placement in defibrillation of pediatric patients. The objective of this procurement is to obtain two specific three-dimensional finite element grids based on known data sets. Justification Brand name justification. The development of the FEA grids is one part of a comprehensive research program investigating the safety of pediatric use of medical devices. Because portions of the project are being done by various groups in various locations it is important they all operate from the same basic models. In order to do the computational fluid dynamics that are part of this project the internal structure of the heart must be faithfully reproduced in the models. Most human computational models simplify the internal structure of the heart making the models unsuitable for computational fluid dynamics problems. The two models required for this project do faithfully reproduce the internal structure of the heart. These models are available from the IT'IS foundation (http://www.itis.ethz.ch/index/index_humanmodels.html). Specifically, the two models required for the two three-dimensional finite element grids (3DFEG) are named "Louis" and "Dizzie". The vendor shall acquire these datasets directly from IT'IS to generate the 3DFEGs. This project is in support of safety research in pediatric medicine and as such is in compliance with the licensing provisions for the models found at - http://www.itis.ethz.ch/virtualfamily/VirtualFamilyClassroom-OrderForm.pdf Deliverables Two three-dimensional finite element grids (3DFEG) of two pediatric human torsos. These 3DFEGs shall be generated from the whole body Virtual Classroom segmented images named "Louis" and "Dizzie", available from the IT'IS foundation (http://www.itis.ethz.ch/index/index_humanmodels.html). The vendor shall acquire these datasets directly from IT'IS to generate the 3DFEGs. The 3DFEGs produced shall be compatible with the finite element bidomain solver CARP (http://carp.meduni-graz.at/). Specifications 1. The 3DFEGs produced shall be compatible with CARP for running active membrane simulations of defibrillation. The vendor shall work with the FDA technical contact and developers of simulation software CARP (http://cardiosolv.com/) to rectify any problems with the Louis and Dizzie data sets and to ensure that the 3DFEGs produced are compatible with CARP. 2. Generated 3DFEGs shall be unstructured, consisting of linear (first order) finite elements including hexahedra, prisms, tetrahedra, and pyramids. 3. Each 3DFEG shall contain both tetrahedral and non-tetrahedral elements in order to reduce memory requirements. 4. Each 3DFEG shall contain different tissue types for: 1. ventricular myocardium, 2. atrial myocardium, 3. lungs, 4. subcutaneous fat, 5. blood, 6. bones, 7. rest of torso tissue, and 8. surrounding medium. 5. Each element in each 3DFEG shall be associated with one of eight tissue types according to the segmented source image stacks. 6. Each element that belongs to the ventricular myocardium shall be assigned with a unit vector that indicates the mean bulk orientation of myocardial fibers in that element. The methodology used to assign the fiber orientations should be accurate in that when the methodology is applied to estimate the fiber orientations of animal hearts, the mean absolute difference of inclination angles of estimated fiber orientations and acquired fiber orientations shall be no greater than 15 degrees. Inclination angle of a fiber orientation is defined as the angle between the axial imaging plane and the projection of the fiber orientation onto the tangent plane, where the tangent plane is perpendicular to the imaging plane and tangential to the epicardium. More details on the definition of inclination angle can be found in [2]. The normal and failing canine heart datasets publicly available at http://www.ccbm.jhu.edu/research/DTMRIDS.php shall be used to test the methodology for estimation of fiber orientations. 7. Each 3DFEG shall be conformal: two adjacent elements are connected by one common face whose nodes and edges are shared between the elements. 8. The total number of nodes in each 3DFEG should be smaller than 11 million. 9. The mean distance of a node on the ventricular epicardial or endocardial surfaces to the centroid of the nearest corresponding surface voxel in the original segmented image dataset shall be no greater than 1000 micrometers. 10. The maximum distance of a node on the surfaces of tissue other than ventricular myocardium to the centroid of the nearest corresponding surface voxel in the original segmented image dataset shall be no greater than 6000 micrometers. 11. The mean distance of a node on the surfaces of tissue other than ventricular myocardium to the centroid of the nearest corresponding surface voxel in the original segmented image dataset shall be no greater than 3500 micrometers. 12. The percentage volume difference of ventricular tissue between the generated 3DFEG and original dataset shall be no greater than 0.5%. 13. The number of elements in the 3DFEG with a skewness greater than 1 shall be smaller than 200. The skewness of a tetrahedral element is defined as 1 - Ve/Vopt where Ve is the volume of the element, and Vopt is the optimal volume of an equilateral tetrahedron whose circumradius is the same as that of the element. The skewness of a non-tetrahedral element is computed by splitting the element into tetrahedra and calculating the maximum skewness value of all the subtetrahedra. 14. The genus of the surfaces of the ventricles in the 3DFEG should be same as those of corresponding surfaces in the virtual family dataset. 15. The ratio of number of elements to number of nodes should be smaller than 3. 16. Each 3DFEG torso shall contain all tissue between and including shoulders and navel. 17. The total number of nodes within the ventricular myocardium shall be no greater than 4 million. 18. The mean edge length of elements that correspond to the ventricular myocardium shall be no greater than 500 micrometers. 19. The maximum edge length of elements that correspond to the ventricular myocardium shall be no greater than 1000 micrometers. 20. The maximum distance of a node on the ventricular epicardial or endocardial surfaces to the centroid of the nearest corresponding surface voxel in the original segmented image dataset shall be no greater than 2000 micrometers. 21. The mean ratio of volumes between two adjacent elements shall be no greater than 1.5, where the ratio is calculated as volume of larger element to that of smaller element. 22. The number of faces for which the ratio of volumes of adjacent elements is more than 2 shall be no greater than 10%. 23. The percentage volume difference of lungs, subcutaneous fat, bone, and blood tissue between the generated 3DFEG and original dataset shall be no greater than 2.5%. 24. The percentage volume difference of the entire torso between the generated 3DFEG and original dataset shall be no greater than 2.5%. 25. The average estimated Gaussian curvature at a node on the epicardial and endocardial surfaces of the ventricles shall be no greater than1.5x10^-8 micrometers^-2, where the Gaussian curvature is estimated using the methodology given in [1]. 26. The average Gaussian curvature at a node on the surface of the torso should be in the order of 10^-10 micrometers^-2. 27. The mean edge length of elements that correspond to any tissue other than ventricular myocardium shall be no greater than 1750 micrometers. 28. The mean edge length of elements that correspond to any tissue other than ventricular myocardium that lies within 20000 micrometers of the ventricular epicardium and endocardium shall be greater than 600 micrometers but less than 1500 micrometers. 29. The maximum edge length of elements that correspond to any tissue other than ventricular myocardium shall be no greater than 3000 micrometers. 30. The standard deviation of edge lengths that lie within the ventricles shall be no greater than 50 micrometers. 2.3 Location 10903 New Hampshire Avenue Building 62 Silver Spring, MD 20993 2.5 Period of Performance Within 60 calendar days from Award PART 6: INSTRUCTIONS TO OFFERORS All quotations are due, via email to: Kara.Stith@fda.hhs.gov, no later than 4:30 PM, EST on August 30, 2010. 6.1 Quote Format The quote shall include a detailed description of the requirement. A successful technical quote shall include price (s); FOB point; a point of contact (name, email, and telephone number); a statement from the offeror verifying that they are CCR Registered under NAICS code 334516; delivery date (delivery date is of the utmost importance); business size; and payment terms. PART 7: EVALUATION FACTORS 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, when combined, are significantly more important than price. 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 Kara.Stith@fda.hhs.gov no later than August 30, 2010, 4:30 PM EST. QUOTATIONS DUE: All quotations are due, via email to: Kara.Stith@fda.hhs.gov, no later than 4:30 PM, EST on September 2, 2010 PROVISIONS and CLAUSES: 52.252-2 Clauses Incorporated by Reference This contract incorporates one of more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at http://www.arnet.gov 52.212-4 CONTRACT TERMS AND CONDITIONS - COMMERCIAL ITEMS (MAR 2009) 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (FEB 2010). (a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (1) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)). ___Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)). (2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553). (3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Pub. L. 108-77, 108-78). (b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: _x_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402). _x_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Dec 2008) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). _x_ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (MAR 2009) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.) __ (4) 52.204-11, American Recovery and Reinvestment Act-Reporting Requirements (Mar 2009) (Pub. L. 111-5). __ (5) 52.219-3, Notice of Total HUBZone Set-Aside (Jan 1999) (15 U.S.C. 657a). __ (6) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (JULY 2005) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a). __ (7) [Reserved] __ (8)(i) 52.219-6, Notice of Total Small Business Set-Aside (June 2003) (15 U.S.C. 644). __ (ii) Alternate I (Oct 1995) of 52.219-6. __ (iii) Alternate II (Mar 2004) of 52.219-6. __ (9)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644). __ (ii) Alternate I (Oct 1995) of 52.219-7. __ (iii) Alternate II (Mar 2004) of 52.219-7. __ (10) 52.219-8, Utilization of Small Business Concerns (May 2004) (15 U.S.C. 637(d)(2) and (3)). __ (11)(i) 52.219-9, Small Business Subcontracting Plan (Apr 2008) (15 U.S.C. 637(d)(4)). __ (ii) Alternate I (Oct 2001) of 52.219-9. __ (iii) Alternate II (Oct 2001) of 52.219-9. __ (12) 52.219-14, Limitations on Subcontracting (Dec 1996) (15 U.S.C. 637(a)(14)). __ (13) 52.219-16, Liquidated Damages-Subcon-tracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). __ (14)(i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (OCT 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer). __ (ii) Alternate I (June 2003) of 52.219-23. __ (15) 52.219-25, Small Disadvantaged Business Participation Program-Disadvantaged Status and Reporting (Apr 2008) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). __ (16) 52.219-26, Small Disadvantaged Business Participation Program- Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). __ (17) 52.219-27, Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (May 2004) (15 U.S.C. 657 f). __ (18) 52.219-28, Post Award Small Business Program Rerepresentation (Apr 2009) (15 U.S.C. 632(a)(2)). _x_ (19) 52.222-3, Convict Labor (June 2003) (E.O. 11755). _x_ (20) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Aug 2009) (E.O. 13126). _x_ (21) 52.222-21, Prohibition of Segregated Facilities (Feb 1999). _x_ (22) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). _x_ (23) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212). __ (24) 52.222-36, Affirmative Action for Workers with Disabilities (Jun 1998) (29 U.S.C. 793). _x_ (25) 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212). __ (26) 52.222-54, Employment Eligibility Verification (JAN 2009). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.) __ (27)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.) __ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.) __ (28) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b). __ (29)(i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (DEC 2007) (E.O. 13423). __ (ii) Alternate I (DEC 2007) of 52.223-16. _x_ (30) 52.225-1, Buy American Act-Supplies (Feb 2009) (41 U.S.C. 10a-10d). __ (31)(i) 52.225-3, Buy American Act-Free Trade Agreements-Israeli Trade Act (June 2009) (41 U.S.C. 10a-10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, Pub. L. 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, and 110-138). __ (ii) Alternate I (Jan 2004) of 52.225-3. __ (iii) Alternate II (Jan 2004) of 52.225-3. __ (32) 52.225-5, Trade Agreements (AUG 2009) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). __ (33) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). __ (34) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). __ (35) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). _x_ (36) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)). __ (37) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)). _x_ (38) 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration (Oct 2003) (31 U.S.C. 3332). __ (39) 52.232-34, Payment by Electronic Funds Transfer-Other than Central Contractor Registration (May 1999) (31 U.S.C. 3332). __ (40) 52.232-36, Payment by Third Party (Feb 2010) (31 U.S.C. 3332). __ (41) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). __ (42)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). __ (ii) Alternate I (Apr 2003) of 52.247-64. (c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: [Contracting Officer check as appropriate.] __ (1) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.). __ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 1989) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.). _x_ (3) 52.222-43, Fair Labor Standards Act and Service Contract Act-Price Adjustment (Multiple Year and Option Contracts) (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.). __ (4) 52.222-44, Fair Labor Standards Act and Service Contract Act-Price Adjustment (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.). __ (5) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (Nov 2007) (41 351, et seq.). __ (6) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Feb 2009) (41 U.S.C. 351, et seq.). __ (7) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247). __ (8) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 2008) (31 U.S.C. 5112(p)(1)). (d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records-Negotiation. (1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract. (2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved. (3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law. (e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause- (i) 52.203-13, Contractor Code of Business Ethics and Conduct (Dec 2008) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). (ii) 52.219-8, Utilization of Small Business Concerns (May 2004) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $550,000 ($1,000,000 for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (iii) [Reserved] (iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). (v) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212). (vi) 52.222-36, Affirmative Action for Workers with Disabilities (June 1998) (29 U.S.C. 793). (vii) [Reserved] (viii) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.). (ix) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)). ___Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)). (x) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (Nov 2007) (41 U.S.C. 351, et seq.). (xi) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Feb 2009) (41 U.S.C. 351, et seq.). (xii) 52.222-54, Employment Eligibility Verification (JAN 2009). (xiii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (xiv) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64. (2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations. Contracting Office Address: 5630 Fishers Lane, Room 2129 Rockville, Maryland 20857-0001
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