SOURCES SOUGHT
70 -- Systematic Data Mining of the Medical Literature: A Novel Analytic Tool for Quantitative Drug-Adverse Event Safety Signal Detection - Attachment 1 - Statement of Tasks
- Notice Date
- 2/21/2012
- Notice Type
- Sources Sought
- NAICS
- 511210
— Software Publishers
- 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-SOL-12-1234567
- Archive Date
- 9/30/2012
- Point of Contact
- Christine Rynkiewicz, , Linda Giles,
- E-Mail Address
-
christine.rynkiewicz@fda.hhs.gov, linda.alexander-giles@fda.hhs.gov
(christine.rynkiewicz@fda.hhs.gov, linda.alexander-giles@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Statement of Tasks Systematic Data Mining of the Medical Literature: A Novel Analytic Tool for Quantitative Drug-Adverse Event Safety Signal Detection This Sources Sought Notice/Request for Information (RFI) is being issued in accordance with Federal Acquisition Regulation Part 10, Market Research. It is for information, planning and market research purposes only and shall not be construed as either a solicitation or obligation on the part of the Food and Drug Administration or its Centers. The purpose of this RFI is to help the FDA understand the industry best practices, technical solutions, and sources capable of meeting the FDA's requirements. Specifically, the Government is seeking verification that its automated, auditable, quantitative data mining requirement is commercially available, determine if there are any questions about the FDA's requirements, determine if industry notes any omissions in the requirements, and information about sources available to meet the FDA's requirements. Sources Sought Another purpose of this Sources Sought Notice/RFI is to determine the availability and capability of qualified small businesses (including Small Business Administration Certified 8(a) companies; firms in Historically Underutilized Business Zones (HUBZone); Service-Disabled Veteran-Owned small businesses; and Women-Owned small businesses). FDA welcomes responses from all interested parties. Background Our aim is to data mine the structured data in the National Library of Medicine's (NLM) electronic scientific literature database, MEDLINE, to detect potential drug-adverse event associations. We seek a verifiable, automated, and fully auditable program capable of quantitative signal detection, where drug-event pairs that occur in disproportionately higher-than-expected frequency are identified. The program should also be capable of visual workflow diagrams of the analysis process, drilling-down to provide access to the source literature articles, and linking to other electronic scientific resource databases that provide scientific data relevant to the biologic plausibility of the identified signal. We prefer data mining programs based on the multi-item gamma poisson -shrinker (MGPS) computational and statistical algorithm for systematically identifying such drug-event pairs (*1). FDA will also consider other approaches to quantitative data mining. We plan to establish an interagency agreement to collaborate with the NLM to map the medical subject headings (MeSH) terms used for indexing of citations in MEDLINE with adverse events terminology in MedDRA and to map the drug names used in the Anatomical Therapeutic Chemical (ATC) Classification System to RxNorm. After we have validated the mapping process, a contractor will be expected to provide either a commercial off-the-shelf software product or a web-based program capable of loading and transforming the structured mapped MEDLINE data, generating the quantitative data mining outputs, providing an audit trail of the process, and providing integrated statistical and visual display tools (such as heat maps or sector maps) to allow users to explore the data, identify potential drug-event associations, and access the literature articles that underpin the identified signals. Requirements The Government requires an automated quantitative data mining application for electronic medical literature databases with audit trail capability. The Government requires a system that has "drill-down" capability to identify and access the original resource materials and provides links to other relevant scientific electronic databases. A software interface that provides graphical display, such a sector maps, is also required. The Government will also require contractor to provide system maintenance, monitoring, and upgrades (as they are released). Instructions Interested parties shall provide responses to the following requested information: 1. Is FDA's desired verifiable, automated, and fully auditable program available commercially or commercially available with enhancement, customization, or configuration? 2. What is the capability to accommodate an electronic database containing greater than 10 million documents? 3. Describe the architecture of the Commercial-Off-The-Shelf (COTS) product to be used. 4. Describe the hosting capability at the contractor's facility. 5. Can the electronic structured literature data be updated to reflect new published literature articles? 6. What is the contractor's ability to update the MeSH terms to MedDRA mapping? FDA will require this to be done at least two times a year. 7. What is the contractor's ability to update the ATC and RxNorm mapping? FDA will require this to be done at least two times a year. 8. Can mock-ups or screen shots of the user-interface and results screens of the proposed COTS product be provided? 9. Can this work be done with a Fixed Price contract? What type of contract is recommended for the services specified? 10. In the event an RFP is issued, what supporting documentation do you require to be released with the RFP to obtain a better understanding of the requirements and FDA environment? 11. What is the recommended Period of Performance (POP)? Please provide a high level explanation of activities required supporting the recommended POP. 12. Provide a statement or summary of the firms' capability of providing all of the tasks summarized in Attachment 1 - Statement of Tasks. 13. Provide the following information to demonstrate your company's capabilities: a. Provide a brief narrative of experience providing this type of service (commercial or Government). b. Provide a brief narrative describing the firm's experience of pharmacovigilance surveillance systems. c. Provide specific experience of providing a comparable tool that has had the capability of automated quantitative data mining of a large electronic database. d. Provide specific experience of developing automated quantitative data mining applications with audit trail and "drill-down" capabilities. e. Provide a statement confirming if the company has previous experience delivering services compliant with HIPAA or FDA security regulations. f. Provide size of company. g. Provide potential teaming arrangement (name of subcontractor not required, capabilities of teaming partner is required). h. Provide experience with user interface for Section 508 compliance. Note: Requests for specific experience requires respondents to provide agency names and a brief scope of work. Responses Responses to this notice shall be limited to ten pages (excluding marketing literature and/or technical data sheets), 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 technical capabilities identified in the responses. 3. Original Equipment Manufacturer's marketing literature and/or technical data sheets. 4. Customary practices regarding customizing, modifying or tailoring of items to meet customer needs and associated costs. The flexibility of the notification system to allow for integration with other public health and public safety mass notification systems if necessary. Additionally, the possible scalability of available systems. 5. Commercial pricing list or other pricing information. 6. Customary practices, including warranty, discounts, contract type under which commercial sales of the products or services are made. 7. Any questions concerning the FDA's requirements for the automated quantitative data mining application with graphical display. Omissions from the requirements information that are needed to meet the Government's need; such as what services may be required in subsequent years for hosting, operations, maintenance and training. 8. In order to ascertain if the system is commercially available, deployed and proven; a listing of other organizations that have implemented the interested party's system. 9. Business size and status, if qualified as an 8(a) firm (must be certified by 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). 10. For small businesses, please provide a detailed capability statement, focusing on your firm's proven ability to provide the range of requirements. Additionally, please demonstrate your firm's capability to meet the requirements of FAR 52.219-14, Limitations on Subcontracting. 11. DUNS number, CAGE Code, Tax Identification Number, and company structure (corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (CCR, at https://www.bpn.gov/ccr/) to be considered as potential sources. 12. Identification of the available contract vehicles; such as GSA Federal Supply Schedules (schedule/contract number and appropriate Special Item Numbers) or other GWAC vehicles by agency and contract number. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this RFI with any interested parties. This request 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 request. The Government will 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 announcement. However, FDA reserves the right to contact one or more of the respondents if additional information is required or to request demonstrations of available systems. Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, if issued. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. Any questions regarding this notice must be submitted by e-mail to Christine Rynkiewicz at christine.rynkiewicz@fda.hhs.gov. Respondents must submit a capability statement by e-mail to Christine Rynkiewicz at christine.rynkiewicz@fda.hhs.gov no later than March 7, 2012 at 12:00 PM Eastern Standard Time for consideration. (*1): Szarfman A, Machado S, O'Neill R. Use of Screening Algorithms and Computer Systems to Efficiently Signal Higher-Than-Expected Combinations of Drugs and Events in the US FDA's Spontaneous Reports Database. Drug Safety 2002; 25 (6); 381-392 Attachments Attachment 1 - Statement of Tasks
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-12-1234567/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Ave., Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN02679235-W 20120223/120221234401-c22921da1d8abfeab92ec688e18b6280 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |