SOLICITATION NOTICE
R -- Researcher
- Notice Date
- 7/28/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 611310
— Colleges, Universities, and Professional Schools
- 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-08-1044229P
- Point of Contact
- Karen R. Petty,, Phone: 301-827-8774
- E-Mail Address
-
karen.petty@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 05-26. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 611310, is to notify contractors that the government is seeking competition under the simplified acquisition procedures in accordance with FAR Part 13.106 for the following: Researcher. 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. Hard copies will be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. 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 Quotes (RFQ) The Government’s period of performance is August 30, 2008 – August 29, 2009. The Food and Drug Administration (FDA) is seeking competition for the following services: Researcher. The Statement of Work is as follows: BACKGROUND AND INFORMATION: The Food and Drug Administration regulates complex medical devices that are in contact with or control the flow of blood (e.g., hemodializers, prosthetic heart valves, cardiopulmonary bypass circuits, ventricular assist systems, and artificial hearts). The safety and effectiveness of these devices can be compromised, with resulting clinical sequelae, if cellular elements in the blood are damaged by contact with the device. Computational fluid dynamic (CFD) techniques for predicting flow fields and forces experienced by blood as it passes through these devices can be a valuable tool to assess new designs and modifications of existing designs. Through FDA’s Critical Path Program, we have initiated a project to design flow models which mimic medical devices and can be simulated computationally (using CFD) and validated experimentally (using flow visualization techniques). CONTRACTOR TASKS AND DELIVERABLES: To research how existing computational fluid dynamic methods may be used in the design and evaluation of safety in new medical devices, the following tasks will be performed: 1) engineering design of flow models representing blood contacting medical devices, 2) consultation on the fabrication of transparent flow models, 3) evaluation of the flow models using flow visualization and other engineering modalities, 4) development of computational representations of the flow models, 5) evaluation of the flow models using computational fluid dynamic simulations, 6) comparison of engineering test results obtained by both flow visualization and computational fluid dynamic simulations, and 7) prediction of the blood damage potential of the flow models based upon mathematical models of blood damage applied to the computational simulations. 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. QUALIFICATIONS: We require our academic collaborators to have demonstrated expertise in the five critical elements of this task: (1) experience with the design and analysis of blood contacting medical devices, (2) engineering design and precise fabrication of flow models, (3) use of computational fluid dynamic techniques to predict flow fields within models, (4) quantitative determination of velocity flow fields (including transient and turbulent measurements) within the models using flow visualization techniques, and (5) experience in analyzing the hemocompatibility and safety of blood contacting medical devices. SECURITY REQUIREMENTS: The Contractor shall obtain FDA security clearance prior to beginning work. Contractor shall sign a confidentiality agreement prior to beginning work under this contract. PAST EXPERIENCE: The contractor must be able to demonstrate past experience directly relevant to the types of work needed. Such experience includes projects performed in the past five years similar in scope to the requirements of this Statement of Work. Interested parties may identify their interest by responding to this requirement within 5 calendar days after the date of publication of this notice. PRICING SCHEDULE: Contractor shall submit a fixed price labor hour cost proposal for a 12 month period. The total number of pages for the technical plan is not expected to exceed ten (10) pages in length. A detailed technical plan must indicate how each aspect of the statement of work is to be accomplished. PAYMENT SCHEDULE: Payment will be made in monthly installments based on level of effort (hours worked). PERIOD OF PERFORMANCE: August 30, 2008 through August 29, 2009. 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 karen.petty@fda.hhs.gov no later than Wednesday, July 30, 2008, 12:00pm EST. QUOTATIONS DUE: All quotations are due, via email to: karen.petty@fda.hhs.gov, no later than 3:00pm, EST on Monday, August 4, 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 Karen.petty@fda.hhs.gov. No phone calls will be accepted.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=ad6b054359e29dc32f9b8ca57256aace&tab=core&_cview=1)
- Place of Performance
- Address: 103 Shields Bldg, State College, Pennsylvania, 16802, United States
- Zip Code: 16802
- Zip Code: 16802
- Record
- SN01624860-W 20080730/080728223346-ad6b054359e29dc32f9b8ca57256aace (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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