SOLICITATION NOTICE
R -- Bridging Scientific and Translational Gaps in Nanotechnology and Nanomedicine
- Notice Date
- 8/23/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- 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-RFQ-1048351-1
- Archive Date
- 9/23/2008
- Point of Contact
- Lee Cohen,, Phone: 3018277046
- E-Mail Address
-
lee.cohen@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- Solicitation Number: FDA-RFQ-1048351-1 Title: Bridging Scientific and Translational Gaps in Nanotechnology and Nanomedicine Notice Type: Combined Synopsis/Solicitation Synopsis: 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 541690, 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. 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) The Food and Drug Administration (FDA) intends to award a purchase order for professional services as described in the following Statement of Work: SCIENTIFIC SERVICES PROGRAM (SSP) STATEMENT OF WORK (SOW) 1.TITLE – Bridging Scientific and Translational gaps in Nanotechnology and Nanomedicine 2. GENERAL – In FDA's view, the applied sciences needed for medical product development have not kept pace with the tremendous advances in the basic sciences. The new science is not being used to guide the technology development process in the same way that it is accelerating the technology discovery process. For medical technology, performance is measured in terms of product safety and effectiveness. Not enough applied scientific work has been done to create new tools to get fundamentally better answers about how the safety and effectiveness of new products can be demonstrated, in faster time frames, with more certainty, and at lower costs. In many cases, developers have no choice but to use the tools and concepts of the last century to assess this century's candidates. As a result, the vast majority of investigational products that enter clinical trials fail. Often, product development programs must be abandoned after extensive investment of time and resources. This high failure rate drives up costs, and developers are forced to use the profits from a decreasing number of successful products to subsidize a growing number of expensive failures. As such, the path to market even for successful candidates is long, costly, and inefficient, due in large part to the current reliance on cumbersome assessment methods. In no areas of science are these challenges more obvious than in nanomedicine and nanotechnology. FDA anticipates that all products under its jurisdiction: drugs, biological therapeutics, biologics, medical devices, combination products, foods, veterinary products, cosmetics and foods, will all be impacted by nanotechnology. As such, it is incumbent upon FDA to help lead and facilitate efforts that will stimulate innovation in these fields and ensure the safety and effectiveness of nanoengineered products for the benefit of the patients and consumers that use them. In the fields of nanotechnology and nanomedicine there is a need to enhance the existing product development toolkit -- containing powerful new scientific and technical methods such as animal or computer-based predictive models, biomarkers for safety and effectiveness, and new clinical evaluation techniques. FDA sees these tools as urgently needed to improve predictability and efficiency along the critical path from laboratory concept to commercially viable nanoengineered products to ensure that basic discoveries turn into new and better medical treatments and other products. Such tools are also needed for the fast-developing fields of nanotechnology and nanomedicine—fields that have the potential to impact all the products under FDA’s jurisdiction—which has both untold benefits to public health and risks that are yet to be elucidated. Soon predicted to be a trillion dollar industry, nanotechnology holds huge promise for the design and manufacture of many types of novel medical products—from devices to therapeutics to combination products. There remain, however, a number of questions about the behavior of nanoparticles and the potential effects of products containing nanoparticles once they are introduced into complex biological systems. We need to better understand the physical, chemical and biological characteristics of different nanomaterials, and we need new test methods, characterization protocols, and standards so sponsors can efficiently move nanoproducts from preclinical through clinical development, to commercialization. An area of critical need in bringing nanoengineered products to patients is that of reproducible and quantitative tools and tests to access the distribution of nano-particulate carriers in the body following systemic administration through any route. This involves the development of imaging modalities that allow for the visualization of biodistribution over time. The ability to account for the full administered dose and its fate is paramount to ensure safety. Research into biodistribution is expected to drive and synergize the development of new imaging platforms and protocols that can best exploit the molecularly targeting advantages offered by nanotechnological imaging probes. These of course will likely contribute to the development of diagnostics imaging techniques and early disease screening as well as improved imaging contrast agents. Yet another fundamental scientific gap in translating nanoengineered products from the bench into the clinic is the need to fully elucidate the mechanism of mass transport across compartmental boundaries in complex biological systems. A full understanding of the basic science of nanoparticles transport in view of these barriers will lead to an improved understanding of their basic biology, improved control over potential adverse effects, and ultimately the development of improved classes of therapeutic agents. A desired outcome of the work under this contract, and other aligned efforts, is the development of tools that can guide on the development of nanotherapies by predicting where and how fast the particles will distribute, as a function of their size, shape, physical properties, and surface chemistries. Equally important is the establishment of standards, reference materials and consensus testing protocols that can provide benchmarks for the development of novel classes of materials. Yet another need in these fields is the realization of an analytical toolkit for nanopharmaceutical manufacturing, accompanied by specification sheets of toxicological, safety, and biodistribution properties obtained through standardized, validated methods. Therefore, FDA seeks, under its Office of Scientific and Medical programs, its public health mission, and its Critical Path Initiative, to award a contract for the development of an infrastructure to support a multidisciplinary, multi-phased nanotechnology program and subsequent related studies as identified in: “Seven Challenges for Nanomedicine” Nature Nanotechnology Vol 3, May 2008” (www.nature.com/naturenanotechnology). Such an infrastructure will include, but will not be limited to, co-development of study priorities, clinical and non-clinical protocols, and publications at specified program milestones related to the scientific and regulatory priorities under FDA’s mission. 3. OBJECTIVES – Nanotechnology raises the need to answer fundamental questions pertaining to nanoparticle characterization, detection, biodistribution, and biological impact and therapeutic effect. Developing safe and effective therapy and diagnostic tools necessitates the integration of nanotechnology with molecular biology, engineering, computational mathematics, chemistry, physics, and the medical sciences. Experts from different fields of discipline will be required to transcend scientific and cultural boundaries of their respective areas of specialty, and work together to translate novel laboratory innovation into safe, commercially viable medical products. A cogent approach to supersede the apparent translational challenges will come from leveraging robust resources and expertise from multiple sources with common goals. Safety is the paramount concern as scientists and clinicians develop a generation of nanoengineered materials that confronts and often surpasses the parametric boundaries of conventional methods of characterization, evaluation, and validation. Prudence demands that the innovators of tomorrow’s therapies and diagnostic agents should also shoulder the responsibility, or at the minimum, contribute to the development of tools and methods that provide reasonable evidence of safety. However, nanotechnology presents a duality of challenges in the context of public health and safety. Environmental exposure to nanoparticulates engineered for both medical and non-medical applications is a serious concern. Numerous sectors of industry are also exploiting the unique properties of nanoparticles to engineer the next generation of such products as fuel cells, paints, adhesives, and sporting equipment, without full knowledge of the potential impact that such products may elicit upon the overall health and safety of the general population. It is anticipated that the administrative and scientific infrastructure established under this contract will facilitate the development of new tools and methods to evaluate the safety of nanoparticulates associated with clinical administration and environmental exposure. It is anticipated that a multi-disciplinary research team will be required to sufficiently address the scientific demands of this initiative. Further, it is anticipated that activities under this contract with support and facilitate the implementation of scientific projects under the following areas of priorities in an attempt to bridge translational gaps in moving nanoengineered medical products from the preclinical stages of development through clinical stages and then to commercialization, all with immediate benefit to public health. 4. SPECIFIC TASKS – The contractor must: •Establish an adequate administrative and scientific infrastructure to implement and manage a collaborative nanotechnology program and to support: a.Development and refinement of the preclinical and early clinical pathway(s) for nanotechnology-based drugs, biologics, devices and combination products to guide technology development leading to medical products under FDA’s jurisdiction; b.Development and validation of standards, risk/benefit analyses and other evaluative tools to identify risks and assess safety and efficacy in newly emerging nanoengineered products; c.Generation of data and best practices that will be publicly available e.g. protocols, assay cascades, and other pre-competitive tools developed collaboratively by the Parties, and that may guide further advancement in the field of nanotechnology; d.Development, validation, and assessment of assays and other appropriate test methods, with close review and input from all Parties prior to standardization and validation of said assays; e.Development of joint translational research programs that also support academic scientists, trainees and scientific fellows identified under joint training programs, and under the FDA’s Critical Path Initiative, to perform research at the respective facilities of the Parties and in collaboration with respective scientists and staff comprising the Parties, as well as potential research collaborations with other organizations; and f.Representation for each Party at jointly held meetings and other scientific conferences, as applicable and appropriate. g.Development of computational mathematical models to compliment empirical results for the above priorities if possible. h.Development of measurement methods and standard protocols appropriate to innovative technologies •Manage a collaborative infrastructure for fostering additional concepts or ideas involving joint projects or integrated approaches to science or technology development specifically aimed at developing nanoengineered products •Identify sufficiently qualified personnel and research sites to conduct the necessary research and project-manage activities under the aforementioned areas of priorities, including review of project milestones for degree of completion, preparation/reporting of project findings, periodic and final reports, all for approval by FDA, and for subsequent distribution in the public domain •In conjunction with FDA, and other experts in the field of nanotechnology, develop study protocols for the subsequent conduct studies under the aforementioned priority areas •Demonstrate the ability to gain access to relevant databases and core facilities for the subsequent conduct of studies under the aforementioned areas of priorities •Propose related studies that can build on the findings of the aforementioned studies, once they are successfully implemented, and ensure that said findings are shared, through peer-reviewed and other publications, in the public domain for the benefit of patients and leverage established resources and personnel •Assemble multi-disciplinary research team to develop necessary study protocols and feasibility plans for subsequent implementation under the aforementioned areas of priorities •Develop strategies to address safety of nanoparticles in a broad spectrum of products under FDA’s jurisdiction •The contractor shall plan and coordinate, with FDA, a scientific workshop to further the activities of a multi-phased collaborative effort and under the aforementioned areas of priorities. Such a workshop shall include input and participation from multiple stakeholders including Federal and State bodies, industry, academia and other potential partners in the field of nanotechnology. The details of logistics, agenda, attendees and workshop objectives shall be developed with the FDA Project Officer and designated FDA staff, and shall be outlined in separate documents. 5. REPORTING REQUIREMENTS – The contractor will need to make an oral report to the Project Officer and other designated staff at FDA. The CONTRACTORs will also need to produce a quarterly update, in electronic format as well as a final report of all the key findings of the study, in electronic format. The format, length and other specifications of the final report shall be determined by the Project Officer and communicated, in writing, to each of the contractors, such report to contain, at a minimum: (1) a summary of all work conducted; (2) the results and conclusions derived from the study/ies; (3) the next steps (if the study is not completed). The final report shall be submitted in both electronically and in hard copy to the Project Officer within thirty (30) days after the end of the contract period of performance. As requested by the Project Officer, the CONTRACTOR, or his/her designate, shall be required to present and/or co-present at designated scientific meetings and conferences, with FDA staff, the findings of the study in an agreed-upon format. The PIs shall be required to co-author, with FDA, as designated by the Project Officer, scientific writings in scientific and/or peer-reviewed journals to ensure that the findings of the study/ies, are widely communicated in the public domain for the benefit of the scientific community, clinicians and patients. The aforementioned reports and publications may be used by FDA in its normal business in informing regulatory review and in the conduct of additional studies. 6. QUALIFICATION REQUIREMENTS – The CONTRACTOR selected for the performance of this statement of work must have specific experience in nanotechnology as evidenced by publications in peer-reviewed journals. The consultant/analyst must have achieved technical training equivalent to an M.D. or Ph.D. (or both) level with a strong background in material science, clinical medicine, mathematical modeling, imaging and nanoparticle fabrication and characterization. It is imperative that the CONTRACTOR has access to the necessary expertise and resources to complete the objectives of the contract. 7. PLACE AND PERIOD OF PERFORMANCE, WORK DAYS, AND TRAVEL – a. Place of Performance. The place of performance will include any appropriate and necessary laboratories and other facilities necessary for the conduct of the scientific studies and subsequent data analyses. b. Period of Performance. The period of performance shall not to exceed one calendar years from the date of award of the contract. Except for the travel listed in paragraph 7.c. below, all work will be at the performer’s location. c. Travel: Trips are contemplated as follows: One 3-day trip Washington, DC area by the contractor. One 3-day trip to a conference will be travelled by the CONTRACTOR or post-doctoral fellow. 8. RESTRICTIONS & SPECIAL REQUIREMENTS – There are no known regulatory requirements that must be complied with during the performance of this work unless FDA submissions result from any of the work conducted. For any animal studies conducted, appropriate and necessary Institutional Animal Care and Use Committee (IUCAC) reviews and approvals shall be obtained and presented to the FDA. For any clinical studies involving human subjects and/or the use of patient records, necessary reviews and approvals shall be obtained from Institutional Review Boards (IRBs) and compliance with the Health Insurance Portability and Accountability (HIPAA) Act. 9. SECURITY – There are no security clearance is required in the performance of these tasks: the effort is unclassified. 10. HUMAN SUBJECTS & ANIMAL USE – See Article 8 above. RESPONSES TO THIS RFQ shall include a technical and a firm fixed price cost proposal: The technical proposal shall not exceed 20 pages in length, not including resumes. The Font shall be not be smaller than 12 point. Proposals shall be singled-sided, doubled spaced pages. The firm fixed price cost proposal shall provide a breakdown of the labor costs, material costs and any other costs such as travel. 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: Evaluation Factors Technical Evaluation Criteria WEIGHT 1.Technical Approach 45 Points The government will evaluate the offeror's technical approach to meet the needs, technical difficulties, challenges, and objectives of the Statement of Work(SOW). The government will consider the completeness, thoroughness, and soundness of the response to all functions and elements of the SOW. 2.Staffing/Management Approach (sub-criteria of equal importance) 25 Points •Evaluation of the offerors experience and capabilities for developing an administrative and scientific infrastructure to implement and manage a collaborative, multidisciplinary, multi-phased nanotechnology program. •Evaluation of the individuals proposed as key personnel who will be responsible for fulfilling the requirements of this RFP will be based on their qualifications, education, background and previous experience in similar requirements. •Documented availability, qualifications, experience, education and competence of professional, technical and other personnel who will be assigned to work on this contract. •Managerial ability to achieve delivery or performance requirements as demonstrated by the proposed use of management and other personnel resources, and to successfully manage the project. •Evaluation of the project staffing strategy, a plan for the selection and use of expert consultants, estimated hours and labor mix, the experience, skills and qualifications of the proposed personnel to adequately minimize risk and successfully complete the requirements of this Contract. 3.Organizational & Personnel Experience and Resources 30 Points Experience is the opportunity to learn by doing similar work under similar contracts. The Contractor will be evaluated on the quality, applicability, and significance of relevant experience as it relates to the requirements of this SOW. Evaluation of the individuals proposed as key personnel who will be responsible for fulfilling the requirements of this RFP will be based on their education, background and previous experience in similar requirements. Additionally, the Contractor will be evaluated on the documented availability of adequate physical facilities, equipment, and other resources necessary to meet the requirements of this project. TOTAL: 100 Point PAYMENT SCHEDULE: Payment will be made as follows: Delivery and acceptance of 1st quarterly Report – 25% of total award price Delivery and acceptance of 2nd quarterly - 25% of total award price Delivery and acceptance of Final Report – 50% of total award 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 Lee.Cohen@fda.hhs.gov no later than Friday August 29, 2008, 2:00pm EST. QUOTATIONS DUE: All quotations are due, via email to: Lee.Cohen @fda.hhs.gov, no later than 12:00pm, EST on Monday, September 8, 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 Lee.Cohen @fda.hhs.gov. Contracting Office Address: 5630 Fishers Lane, Room 2100 Rockville, Maryland 20852 Place of Performance: Contractor’s facility Primary Point of Contact.: Lee F. Cohen Lee.Cohen @fda.hhs.gov Phone: 301-827-7046 Fax: 301-827-7106
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