SOURCES SOUGHT
D -- Request for Information - e-Platform
- Notice Date
- 3/27/2007
- Notice Type
- Sources Sought
- NAICS
- 541519
— Other Computer Related 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, MD, 20857-0001, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- e-Platform-RFI
- Response Due
- 4/20/2007
- Archive Date
- 4/30/2007
- Description
- This is a Request for Information (RFI) only. This is not a solicitation or Request for Proposals. At this time, the Government is only seeking information for market research purposes. The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) are seeking information from interested parties on the formation of a public-private partnership whose goal it would be to establish and maintain a common electronic platform (e-platform) for the exchange of clinical research data (i.e., the data normally collected during the course of a clinical trial), as well as the submission, receipt, and management of regulatory product information. Such a platform for managing data gathered on medical products all along the regulatory product information supply chain would make use of available bioinformatics technology to systematize the exchange of medical product information beginning in the earliest stage of clinical research through approval to postmarket surveillance, greatly enhancing the efficiency of exchanging medical product information among all interested parties. Such an effort would also be a big step toward the fulfillment of the President?s National health IT effort, one goal of which is to make medical products safer and more effective than ever before. FDA and NIH are seeking information from persons who are interested in participating in and willing to serve as the conveners of such a public-private partnership. The partnership would develop, maintain, and manage a common e-platform and also identify and encourage development of standards relevant to these activities. These functions would support the exchange of data among members of the clinical research community, the exchange of medical product information for regulatory review, and the sharing of data for other, yet-to-be-identified purposes. The public private partnership that undertakes this effort would (1) transition existing electronic components into the e-platform, (2) work with standards development organizations (SDOs) (e.g., ISO, Health Level Seven) to develop and approve standards, (3) develop and implement additional supporting functions and exchange tools, including the necessary server security requirements, and (4) oversee management and maintenance of the e-platform. A. PURPOSE THIS IS A REQUEST FOR INFORMATION (RFI) ONLY. This RFI is issued solely for information and planning purposes. It does not constitute a solicitation (Request for Proposal (RFP) or Request for Quotations (RFQ)) or a promise to issue a solicitation in the future. This RFI does not commit the Government to contract for any supply or service whatsoever. Furthermore, we are not at this time seeking proposals and will not accept unsolicited proposals. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI. All costs associated with responding to this RFI will be solely at the responding party?s expense. All information received in response to this RFI that is marked PROPRIETARY will be handled accordingly. The Government shall not be liable for or suffer any consequential damages for any proprietary information not properly identified. Proprietary information will be safeguarded in accordance with the applicable Government regulations. Proprietary information or trade secrets should be clearly identified. We also are requesting information from small businesses, which includes Small Disadvantaged Businesses, Women-Owned Small Businesses, HUBZone Small Businesses, and Service-Disabled Veteran-Owned Small Businesses. All small businesses are strongly encouraged to provide responses to this RFI. This will assist us in determining the potential levels of interest, competition, and technical capability to provide the required services within the Small Business community. In addition, this information may also be used to assist in establishing a baseline for developing any subsequent potential subcontracting plan small business goal percentages, as necessary. Responses to this notice are not offers and cannot be accepted by the U.S. Government to form a binding contract or agreement. Neither FDA nor NIH will be obligated to pursue any particular acquisition alternative as a result of this RFI. Responses to the RFI will not be returned. Not responding to this RFI does not preclude participation in any future solicitation, if one is issued. B. DEFINITIONS e-Platform: a common electronic platform for the efficient collection, management, and exchange of data related to clinical research, medical product development, and regulatory product submissions. Public-private partnership: an entity convened among government and private organizations with the intent of accomplishing common goal. Frequently an organization, often a nonprofit entity, serves as the focal point for organizing a public-private partnership. C. GENERAL BACKGROUND INFORMATION FDA is in the process of developing an e-platform for the receipt, management, review, and storage of regulatory product information. The interest of the NIH in the development of such an e-platform is in the interface of drug development and research. On December 18, FDA and NIH held a public hearing (November 21, 2006; 71 FR 67356) to solicit general views and information from interested persons on issues concerning the electronic submission of product information to the agency. Among other things, the agencies were interested in hearing the views of, and soliciting information from, interested persons on the feasibility of developing and implementing an all-electronic submission environment, as well as on issues related to developing an electronic regulatory information exchange platform that would be managed and maintained by a third party. In the notice announcing the Public Hearing, FDA explained that, during the past decade, it has been moving toward transforming all regulatory submissions from paper to electronic means. In addition, FDA and NIH have been collaborating on a number of projects that will automate, thus improve, data sharing between NIH-funded clinical investigators and the FDA. To meet this goal, a series of actions have already been undertaken: FDA issued regulations related to voluntary electronic submission of regulatory information and provided a docket listing all submissions that we accept electronically (e.g., electronic records and electronic signatures, 21 CFR part 11; docket 92S?0251; http://www.fda.gov/ohrms/dockets/dockets/ 92s0251/92s0251.htm) IFDA issued regulations requiring, or proposing to require, electronic submission of certain regulatory information (e.g., the electronic submission of the content of labeling (December 11, 2003; 68 FR 69009), and manufacturer registration and listing of drug products (August 29, 2006; 71 FR 51275)) FDA issued numerous guidance documents to assist in the submission of various regulatory documents in electronic format (e.g., electronic common technical document, certain premarket applications, and postmarketing information; see http://www.fda.gov/cder/guidance/index.htm#electronic%20submissions) FDA issued notices related to electronic submission (e.g., availability of the FDA electronic submissions gateway (http://www.fda.gov/esg/default.htm)) NIH and FDA collaborated with manufacturers vendors, healthcare information suppliers, and other interested parties to develop data standards, and to build databases for sharing certain clinical trial information, such as FIREBIRD and Janus (see http://crix.nci.nih.gov/projects/Firebird/ and http://crix.nci.nih.gov/projects/janus/, respectively). The notice announcing the part 15 public hearing also explained that FDA and NIH were considering technological and other feasibility issues related to the electronic submission of premarket applications to FDA, as well as the electronic submission of other regulatory information (e.g., postmarketing information and amendments to applications). FDA had concluded that, rather than continue to encourage voluntary electronic submissions?although the agency still encourages such submissions?proactively facilitating electronic submissions by requiring such submissions would help promote the automation of healthcare information, a key goal in the President?s electronic health initiative and part of the long-term Federal goal of ensuring that health information systems are interoperable. Advances such as these will speed development of new medical technology and provide healthcare professionals and consumers the information they need to make well informed decisions regarding the safe and effective use of medical products, resulting in better health outcomes. In their collaborations on FIREBIRD and Janus, FDA and NIH have also become aware of the potential benefits of having a common e-platform that could be administered by a third party entity or entities (e.g. private or nonprofit entities not otherwise engaged in clinical research activities, as is currently the case with small components of FDA?s electronic infrastructure) with relevant expertise and organizational leadership who could facilitate, coordinate, and manage all of the functions necessary for efficient collection and maintenance of clinical research data as well as pre- and postmarket electronic submissions. For example, a third party entity might perform the following tasks: Build an electronic platform Maintain data warehouses Transition existing electronic data and information repositories to the electronic platform Work with SDOs Produce other necessary components to facilitate electronic access and management of information Manage and support these functions At the Part 15 public hearing, stakeholders had the opportunity to address specific topics and present their views, recommendations, and any other pertinent information related to these issues. In particular, FDA and NIH asked stakeholders to present input on issues related to the concept and feasibility of an electronic platform that would facilitate the exchange of clinical research information among research organizations and the exchange of regulatory product information between sponsors and the FDA, the role of a public-private partnership in the creation and assessment of such a platform, and the management of the platform after its creation by a private entity or entities with the relevant technological expertise. In this request for information, FDA and NIH are soliciting additional detail about such a plan and are seeking specific input related to issues raised during the Part 15 public hearing. D. QUESTIONS ASKED IN ANTICIPATION OF THE PART 15 HEARING In the notice announcing the Part 15 hearing, FDA and NIH asked for input on the following questions: What are your general viewpoints on a third party entity or entities providing services related to such an electronic platform? What are your views on the establishment of a public-private partnership to initiate formation of an electronic platform? How do you envision the business model and nature of the third party entity or entities? What are the necessary attributes and characteristics of the third party entity or entities? What services could the third party entity or entities provide? What collaborative efforts on the part of FDA and NIH with a third party entity would be beneficial to establish services? E. ADDITIONAL QUESTIONS RESULTING FROM INPUT GATHERED DURING AND AFTER THE PART 15 PUBLIC HEARING What characteristics of the business plan for a public-private partnership would ensure that such an entity would be self-sustaining? What would the membership of such a public-private partnership look like and how would the engagement of stakeholders be obtained and maintained? How would international standards be used and extended, and how would prototype infrastructure and applications be developed and extended into production capability? What would an e-platform look like and how would the interfaces between the research components and the FDA and among various members of the broad research community be structured and supported? How would data security be guaranteed? What is the optimum approach to building the electronic platform? If a modular approach is used, what order of implementation would be best? How can we contain costs to the government and to stakeholders? How can we balance benefit and cost for stakeholders who are small businesses? What is a reasonable estimate of time from concept to implementation? F. DESIRED TECHNICAL GOALS The desired technical goal is the development of an e-platform for the exchange of clinical data and the receipt, management, exchange, review, and storage of regulatory product information. G. DESIRED BUSINESS INFORMATION The desired business information is how best to create a public-private partnership that is self-sustaining to undertake the goal outlined in section F. H. SUBMISSION OF COMMENTS: ALL COMMENTS SHALL BE SUBMITTED VIA EMAIL. Responses to this RFI should be submitted using MS Word (12 point font). Proprietary information should be identified as such. Responses to the RFI SHALL include the following: Submitter?sName Street Address, City, State, NINE-Digit zip code Point of Contact (POC), POC Telephone and facsimile numbers Status (e.g. women-owned small business or service-disabled veteran owned small business). If the company address includes a post office box, the complete street address must also be provided. North American Industry Classification System (NAICS) Code 541519 will be used for determining company size status. ALL inquiries regarding these capabilities shall be submitted electronically. The point of contact is Sandra Bellinger, at Sandra.Bellinger@FDA.HHS.GOV. The final responses must be sent via email by April 20, 2007, 5:00 p.m. Eastern. Responses received after this date may not be considered.
- Record
- SN01259765-W 20070329/070327220303 (fbodaily.com)
- Source
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