SOURCES SOUGHT
D -- Develop a Mobile Device and Web Application
- Notice Date
- 4/7/2011
- Notice Type
- Sources Sought
- 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, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1086335
- Archive Date
- 5/7/2011
- Point of Contact
- Regina R. Williams, Phone: (870) 543-7012
- E-Mail Address
-
regina.williams@fda.hhs.gov
(regina.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a SOURCES SOUGHT NOTICE to determine the availability and capability of potential small businesses (including HUBZone firms; certified 8(a), Small Disadvantaged, veteran and service-disabled veteran-owned small businesses, and women-owned small businesses. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, Solicitation, Request for Quotes, or an indication the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The Government does not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this sources sought. Any responses received will not be used as a proposal. The U.S. Food and Drug Administration (FDA) is seeking capability statements or prior experience on Developing a Mobile Device and Web Application for reporting adverse events associated with medical products. 1. Purpose The purpose of this project is to develop a mobile device and web application for reporting adverse events associated with medical products to FDA including an in-depth module for products associated with medical countermeasures (MCM). An existing mobile device application covers drug adverse event reporting. A similar application needs to be developed for medical devices. A module to collect additional information is also needed for medical products likely to be associated with chemical, biological, radiation, or nuclear (CBRN) attacks. The MCM module will be used to evaluate medical products as they are used and assess potential signals associated with safety and effectiveness of these devices before, during, and after any potential attacks. In using the data generated from this application, the Center for Devices and Radiological Health (CDRH) and all of FDA will be able to determine any adverse effects associated with medical products. 2. Background In the event of an emergency, it is possible that either fast-to-market devices will be needed or that currently marketed medical devices will be used in ways that warrant surveillance. A pre-developed post-market device surveillance plan is needed to systematically monitor for potential safety and effectiveness signals during and after an event of chemical, biological, radiological and nuclear (CBRN) agent attacks. Surveillance of medical devices used with medical countermeasures (MCM) would allow us to capture needed data regarding potential safety and effectiveness signals. In addition, the information would be incorporated with existing medical device reports (MDRs) sent to FDA to develop a full picture of adverse events associated with MCM emergencies. This surveillance project would not be specific to any particular device; rather, it will be available for the public to provide reports on any medical device use or adverse event during an emergency situation. A cross-CDRH team will discuss the minimum data elements needed for such a system and the types of devices that are likely to need enhanced surveillance under various scenarios. Based on the list of data elements and potential devices and in collaboration with a contractor, a website and cellular phone application will be developed to solicit reports from medical personnel and the general public regarding use and adverse events associated with medical devices. A protocol for evaluating these reports will be developed in conjunction with the contractor. The reporting system and evaluation methods will be tested for each of use. With need, the website and application will be available for postmarket surveillance of medical devices. 3. Performance Work Statement A) Objective: To develop a mobile device and web application for reporting adverse events associated with medical products to FDA including an in-depth module for products associated with medical countermeasures (MCM). B) Scope of Work: Independently and not as agents of the Government, the contractor shall furnish the necessary personnel, material, services, facilities, and otherwise do all things necessary for or incident to the performance of the work described below: The contractor shall work with CDRH and its partners in identifying items/variables that need to be incorporated in the mobile device and web application. The contractor shall develop or modify an existing mobile device and web application for collection of medical device data and collection of additional information for MCM-associated devices. With available funds in subsequent years, similar MCM-associated applications will be developed for drugs and biologics. The contractor shall determine what information and formatting is necessary to comply with federal regulations related to the collection of identifying information and web-based data collection. Moreover, they will ensure that the application is compliant with 508 requirements. The contractor shall conduct pilot testing (validation checks, quality control, collecting the data, and basic metrics) to ensure the web application is easy to use by the intended end users and functions as specified. The contractor shall develop algorithms for evaluation of reports and for monitoring of emergency events requiring MCM. These algorithms will be tested and improved as needed (at least every 6 months) throughout the contract. The contractor shall ensure adequate security and encryption measures are undertaken in the development, testing, and transfer of reportable data to the adverse event reporting system(s) at FDA. The contractor shall ensure that the data for the MCM module can be accessed by the FDA for regulation and surveillance at any time and can be easily analyzed using standard statistical software (e.g., SAS or STATA). The contractor shall provide maintenance of the web application and generate reports over the course of the contract. If necessary, the contractor will provide training in the use of the application to end users and/or personnel at the FDA (e.g. via educational video or webinar). C) Tasks: The contractor shall attend all meetings (in person or by phone) as requested. The contractor shall develop a mobile device and web application as a collection tool for adverse event reporting. The contractor shall ensure that all legal issues related to collecting this data online are addressed and that the application can be maintained over time and scaled to accommodate an increase in volume during a CBRN attack or other emergency situation. The contractor shall ensure that the application interface is compliant with section 508 of the Rehabilitation Act. The contractor will be required to commit to scheduled and ad hoc telephone interaction with the FDA research staff. During the initial development phases, it is expected that weekly meetings will be held with the contractor and the FDA research group with quarterly reports being generated. Upon piloting the application, quarterly reports will be submitted with a final report for the initial medical device application, including application development, testing, and algorithm evaluation provided at the end of the initial twelve month contract. 4. Period of Performance: The anticipated period of performance is a base period of 1 year plus 4 one year option periods. 5. Deliverables: Base Year : 1. Develop a mobile application and website for submitting medical device reports to FDA. Include adaptable module for additional information solicitation in the event of a chemical, biological, radiation, or nuclear (CBRN) agent attack or emergency. a. define platform needs b. set up servers for secure data storage c. create cross-platform mobile application and website for data collection d. usability testing in intended use environment e. stress testing of application and website f. data security, quality assurance, testing of data transfer to FDA g. launch application and website 2. Work interactively with FDA to conduct pilot testing and promotion of system. a. soft launch and early adopter pilot b. user interviews (with transcription and analysis) c. meetings with intended use population (ensure knowledge of product availability) d. hospital setting testing e. re-testing based on feedback 3. Conduct curation of reports, triage information provided in reports, and establish algorithms for determination of emergency event through evaluation of reports. a. develop information flow architecture protocol b. creation of artificial intelligence algorithms to triage reports (signal to noise ratios, etc.) c. develop protocol for evaluation of reports and implement semi-automated process d. perform maintenance on application and website as needed 4. Generate a final document detailing the development of the medical device application, pilot testing, algorithm development, and evaluation of reports. Option Year 2: Development of Drug Application, activate CBRN module as needed. Option Year 3: Development of Biologic Application, activate CBRN module as needed. Option Year 4: Integration of System across all Medical Products, activate CBRN module as needed. Option Year 5: Improve Algorithms and Application Capabilities, Maintain System, activate CBRN module as needed. Interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents' capacity and capability to perform the specific work as required. Responses must directly demonstrate the company's capability, experience, and/or ability to marshal resources to effectively and efficiently perform the scope of work described above at a sufficient level of detail to allow definitive numerical evaluation; and evidence that the contractor can satisfy the minimum requirements listed above in compliance with FAR 52.219-14 ("Limitations of Subcontracting"). Failure to definitively address each of these factors will result in a finding that respondent lacks capability to perform the work. REQUIRED DATA: Interested offerors should submit their capability statement not exceeding ten (10) pages in length, excluding standard brochures, identified with the Sources Sought Notice number and must include: 1. Company name, mailing address, e-mail address, telephone and fax numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. Business size for NAICS 611310 and size standards of $7M. If qualified as an 8(a) firm (must be certified by the Small Business Administration (SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran Owned Small Business (must be listed in the VetBiz Vendor Information Pages), please submit copies of any documentation, such as letters or certificates to indicate the firm's status. 4. DUNS number, CAGE Code, Tax Identification Number (TIN), and company structure (Corporation, LLC, partnership, joint venture, etc). Companies also must be registered in the Central Contractor Registration (CCR) at www.ccr.gov to be considered as potential sources. 5. Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. SUBMISSIONS ARE DUE in person, by mail, or email on or before April 22, 2011 by 13:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, Office of Acquisitions & Grants Services, Attn: Regina Williams, 3900 NCTR Road, HFT-320, Jefferson, AR 72079. Responses to the notice will not be returned, nor there be any ensuing discussions or debriefings of any responses. Information provided in response to this notice will be used to assess alternatives available for determining how to proceed in the acquisition process. This notice is part of Government Market Research, a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for or award a competitive contract. The FDA will use the information submitted in response to this notice at its discretion and will not provide comments to any submission; however, the content of any responses to this notice may be reflected in subsequent solicitation. FDA reserves the right to contact any respondent to this notice for the sole purpose of enhancing FDA's understanding of the notice submission. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. It is emphasized that this is a notice for planning and information purposes only and is not be construed as a commitment by the government to enter into a contractual agreement, nor will the government pay for information solicited.
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