MODIFICATION
R -- Notice of Intent to Award Sole Source
- Notice Date
- 5/15/2013
- Notice Type
- Modification/Amendment
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-CSB-(EB)-2013-109-JES
- Archive Date
- 6/14/2013
- Point of Contact
- Jennifer Swift, Phone: 3014350358
- E-Mail Address
-
Jennifer.Swift@nih.gov
(Jennifer.Swift@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- NOTICE OF INTENT INTRODUCTION This is a pre-solicitation / notice of intent synopsis for a sole source noncompetitive (including brand-name) award to Radiological Society of North America, for Services. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA) on behalf of the National institute of Biomedical Imaging and Bioengineering (NIBIB), intends to negotiate and award a Firm Fixed Price Contract on a sole source noncompetitive basis for Servces to Radiological Society of North America, 820 Jorie Boulevard, Suite 202, Oak Brook, Il 60523-2251 BACKGROUND Healthcare research and delivery in the modern era of molecular and personalized medicine requires reliable quantification of biomedical imaging data. Achieving reliable extraction of quantitative results from imaging scans requires a standardized approach to data acquisition, process and interpretation. Broad multidisciplinary stakeholder collaboration is needed to achieve cross-industry consensus on and adoption of quantitative imaging biomarkers, and this can only be achieved through a multi-stakeholder coalition supported by an entity recognized and trusted nationally and internationally as objective and balanced. Once achieved, reliable imaging quantification will lead to validation and qualification of imaging biomarkers for use in clinical trials, drug development and clinical decision-making. PERIOD OF PERFORMANCE This Firm Fixed Price, contract will be awarded with a one year period of performance from 9/30/2013 to 9/29/2014, with a one year option period from 9/30/14 to 9/29/15. PROJECT DESCRIPTION The purpose of this acquisition is to maintain the multi-stakeholder coalition already developed to achieve cross-industry consensus on and adoption of quantitative imaging biomarkers. The coalition must be supported by an entity recognized and trusted nationally and internationally as objective and balanced, in order to establish standardized approaches to data acquisition, process and interpretation. Once achieved, reliable imaging quantification will lead to validation and qualification of imaging biomarkers for use in clinical trials, drug development and clinical decision-making. JUSTIFICATION The justification for other than full and open competition is: This requirement is a follow-on to an existing contract, HHSN268201000050C. The existing contract is ramp-up work to the next phase, which will be completed with the next award. If this requirement were to be competed, there would be excessive delays and duplication of all work which has currently been completed under the existing contract. The duplicate work would result in costs in excess of $2 Million. This determination is based on the current value of the existing contract which has been awarded for $2.4 Million, as all the work completed under the existing contract would need to be completed over again by the new incumbent. The cost of the existing contract was determined to be fair and reasonable prior to award and was in line with the IGCE. It is widely acknowledged that the primary factor limiting large-scale deployment of imaging biomarkers is the lack of consensus on how to select, use, and qualify them across each of the stakeholders. The nature of this acquisition is to maintain a complex coalition of diverse stakeholders, collect data from multi-disciplinary teams and establish consensus that will serve as industry and clinical standards. Once these cross-industry standards are created and accepted, they need to be disseminated and adopted, again, by a wide range of stakeholders. The coalition must be supported by an entity recognized and trusted nationally and internationally, with a productive overall structure for integrated activity by the collective industries wherein stakeholders would collaborate on the methodology to qualify candidate quantitative imaging biomarkers. Due to this unique nature of this acquisition, RSNA is the only entity that can meet the requirements of bringing in all representatives from clinical practice, professional imaging societies, regulatory agencies, government-sponsored scientific institutes, biopharmaceutical companies, image analysis software developers, and the imaging device industry. This is because RSNA is the largest professional organization for radiologists and associated imaging scientists in the world, with over 50,000 members, encompassing all imaging modalities. It is a global international organization, and has a decades-long history of being the interface between the practicing and academic professionals and all segments of the industry that supports clinical imaging. Other companies and organizations may have representations from some of the stakeholders, however, RSNA is the only entity with full representation. In addition, RSNA does not copyright, license or otherwise create intellectual property (IP) protection around the work of its volunteers. All of the work done by RSNA volunteer participants is in the public domain. Moreover, RSNA has worked over the past four years to assemble a unique working coalition of public and private stakeholders for imaging biomarkers qualification. They have successful work in process, existing infrastructure, and open channels of communication and collaboration among the stakeholder groups that allows them to progress toward contract fulfillment without start-up delays and expense. Specifically, during the previous contracting period RSNA has improved its process for the development, validation, qualification and use of accurate, repeatable quantitative imaging biomarkers (e.g. CT, DCE-MRI, and FDG-PET) across instruments and settings. They coordinated broadly with various stakeholders to create, for each imaging biomarker, QIBA protocol and profile. They partnered with the Biomarkers Consortium of the Foundation for the NIH and completed the submission of the Briefing Documents to the FDA for two of the imaging biomarkers. In summary, the success of this acquisition relies heavily on the infrastructure and process that only RSNA QIBA possesses, in order to establish industry and clinical standards. RSNA has established itself as a collaborative, multidisciplinary infrastructure to foster research, approval, and use of quantitative imaging biomarkers. Once established, the same paradigm will be applied to other applications including oncologic, neurologic, and cardiovascular disease diagnosis and treatment. Based on RSNA's previous and current success in imaging biomarker qualification, it is solely qualified to conduct the scope of work. The government stands to gain by taking the advantage of its outstanding personnel, investigative team, infrastructure and well-documented management approaches already established. REGULATORY AUTHORITY This acquisition is conducted under the authority of 41 U.S.C. 253(c) as set forth in FAR Part 6.302-1(b), only one responsible source and no other supplies or services will satisfy agency requirements. ADDITIONAL INFORMATION The North American Industry Classification Code (NAICS) is 541690 and the Size Standard is $14 Million This notice of intent is not a request for competitive proposals. This announcement constitutes the only notice; proposals are not being requested and a written solicitation will not be issued. The determination by the Government to award a contract on a sole source noncompetitive basis for Services to Radiological Society of North America, 820 Jorie Boulevard, Suite 202, Oak Brook, Il 60523-2251 is based upon the responses to the sources sought synopsis published in the FedBizOpps on April 18, 2013 synopsis number HHS-NIH-NHLBI-SS-EB-2013-109-JES, title: Quantitative Imaging Biomarkers Alliance (QIBA). All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. Responses to this notice, in writing, are extended from May 24, 2013 to no later than May 30, 2013, by 4PM EST. Responses to this notice shall contain sufficient documentation to establish the interested parties' bona-fide capabilities for fulfilling the requirement. All responses must reference this Notice of Intent number NHLBI-CSB-(EB)-2013-109-JES and may be submitted electronically to Jennifer Swift, Contracting Specialist at Jennifer.Swift@nih.gov.
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- Record
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FedBizOpps Link to This Notice
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