SOLICITATION NOTICE
A -- Expanded Emergency Capacity of Medical Device Production through 3D Printing of Radiation Cross Linked Polymers
- Notice Date
- 8/30/2011
- 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-11-1092096
- Archive Date
- 9/21/2011
- Point of Contact
- ZetherineGore, Phone: (301) 827-5093
- E-Mail Address
-
zetherine.gore@fda.hhs.gov
(zetherine.gore@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Request for Quotations (RFQ) issued in accordance with FAR Part 5. The NAICS code is 541712. The solicitation is being issued using simplified acquisition procedures. This requirement identified as RFQ FDA-11-1092096 is to notify prospective contractors that the government intends to issue a purchase order in accordance with FAR Part 13 for the following Statement of Work not to exceed the simplified acquisition threshold: A. Background The Food and Drug Administration (FDA) has been tasked under Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) to rapidly develop, stockpile, and deploy effective medical countermeasures to protect the America people by establishing the foundational elements that will support medical countermeasure availability and utilization. 3D printing has emerged as a technology that will allow for dispersed manufacturing capability of complex parts in the event of a mass medical emergency (pandemic, chemical, biological, radiological, or nuclear (CBRN) event, or natural disaster). However, the properties required in a polymer to be printable result in poor mechanical properties in the finished product and preclude medical devices from being manufactured by this method. The FDA is pursuing the development of a 3D printable polymer system that is cross linkable post printing and robust enough to produce highly complex parts/devices and in an emergency would insure an uninterrupted supply of items ranging from respirator parts, emergency medical devices, and pedestrian but vital medical devices. B. Project Purpose and Objectives The Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Solid and Fluid Mechanics is requires research to support its Medical Counter Measure (MCM) Initiative titled "Expanded Emergency Capacity of Medical Device Production through 3D Printing of Radiation Cross Linked Polymers." The project calls for the development of a printable (low molecular weight polymer) that can be radiation cross-linked after being printed. This requires expertise in polymer synthesis, chemistry, and radiation crosslinking. This project will result in a greater understanding of the challenges and viability of using 3D printing manufacturing for medical devices and equipment. C. Project Requirements This project includes the design, synthesis, and optimization of a 3D printable polymer system that can be radiation cross linked post printing along with supplying the FDA radiation cross linked polymers for mechanical characterization. This includes polymer synthesis and optimization and polymer design to support the Medical Counter-Measure Initiative project. The work to be conducted is highly specialized and requires demonstrated expertise in polymer design, radiation cross-linked of polymers, and polymer characterization. Expertise in the following four critical elements is required: (1) with the design of radiation crosslinking polymers, (2) utilizing novel and cutting edge polymer chemistries and techniques for advanced polymer systems, (3) with the needs and requirements for thermal and mechanical testing of advanced polymers, (4) optimizing polymer chemistry and structure for use in bulk manufacturing processes. D. Statement of Work The contractor shall furnish the necessary personnel, materials, services, and facilities to perform the work described below. TASKS: 1) Select base polymer chemistry(s) suitable for 3D printing. These polymers must have a comparable melt temperature and melt viscosity of current 3D printable polymers and have the ability to be radiation cross linked. (2) Identify and supply radiation cross linked (mnemosynated) materials relevant to the project to the FDA for mechanical and thermal testing. Relevant materials would be current mnemosynated systems with similar chemistries to Task 1 materials and systems that are currently optimized for mechanical properties. (3) Engineer, synthesize, and cross link materials identified in Task 1 to prove system viability. (4) Supply materials from Task 3 to FDA for mechanical and thermal testing. Materials must be supplied in both pre- and post- cross linked forms. (5) Supply materials from Task 3 to FDA for 3D printing. (6) Participate in teleconferences, workshops, and the preparation of reports and presentations as a member of the FDA Technical Working Group. (7) Preparation of a technical summary report at the mid-point and conclusion of the contract E. Deliverables The contractor shall provide reports which describe the activities performed and the results accomplished during the performance period. (1) Semi-Annual Technical Summary Report (2) Final Technical Report Requests for changes/additions to the report shall be made by the FDA within 30 days of the original submission, and an updated report should be provided within 30 days after receiving FDA comments. F. Period of Performance The period of performance is twelve (12) months. G. Basis for Award The Offeror should demonstrate the statement of work is understood and offer a logical approach to its achievement. Award will be made to the offeror who is deemed most responsive, whose proposal conforms to all requirements, and is judged to represent the best value. To conduct a best value assessment, FDA will evaluate the offerors proposal submission based on Technical Elements, Price, and Past Performance as described below. As this is a best-value selection, the government may make tradeoffs in the factors below to arrive at a best value decision. The Government may award a purchase order on the basis of initial offers received, without discussions. Therefore, the initial offer should contain the Offeror's best terms from a technical and cost. 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. H. Evaluation Criteria The evaluation will be based on the completeness, thoroughness and demonstrated capabilities of the prospective Offeror in relation to the needs of the Statement of Work as set forth in the RFQ. Each proposal must document the feasibility of successful implementation of the requirements of the RFQ. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria listed below. Offerors should provide information on all of the following criteria. (1) Technical Approach The proposal must demonstrate a thorough understanding of the requirements of the Statement of Work and describe an approach which will demonstrate the achievement of timely and acceptable performance as describe in the Statement of Work. The proposal shall present a comprehensive statement of the problem, scope, and purpose of the project to demonstrate an understanding of the requirements from a management and technical standpoint. (2) Qualifications and Availability of Personnel Offerors shall demonstrate evidence of the qualifications, experience, and availability of professional and technical personnel comprising the necessary project staff. Personnel proposed to be assigned and available for work under the project shall be evaluated on their demonstrated and documented relevant expertise, education, experience, and availability. Supporting documentation about the experience, training, and education (e.g., resumes) of proposed personnel must be provided. Offerors shall demonstrate expertise in four critical elements of this task: (a) Design of radiation crosslinking polymers; (b) Utilizing novel and cutting edge polymer chemestries and techniques for advanced polymer systems; (c) Needs and requirements for thermal and mechanical testing of advanced polymers; (d) Optimizing polymer chemistry and structure for use in bulk manufacturing processes. (3) Past Performance Evaluation FDA will evaluate the offeror's past performance in the conduct of similar tasks and their relevance to this acquisition. (4) Price FDA will evaluate the offeror's submission/proposal on their ability to provide support at a reasonable and realistic price. I. PAYMENT SCHEDULE Payments on the resultant purchase order will be made paid upon satisfactory completion and acceptance of the mid-project and final project tasks: this will include submission of a technical progress report by the academic contractor. J. 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. K. QUESTIONS DEADLINE All questions are to be submitted via email to zetherine.Gore@fda.hhs.gov no later than 12:00 p.m. EST on September 2, 2011 EST. L. OFFERS DUE Quote submissions are restricted to a limit of twenty-five (25) pages, excluding resumes and past performance information. An electronic copy in PDF format of the quote must be received no later than 2::00 p.m. local time on September 6, 2011. Quotes should be submitted via email to zetherine.gore@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-11-1092096/listing.html)
- Place of Performance
- Address: Contractor's off-site location., United States
- Record
- SN02554677-W 20110901/110830235054-e8e10af350dd0e148da302d5453d7a40 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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