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FBO DAILY ISSUE OF SEPTEMBER 11, 2008 FBO #2481
SOLICITATION NOTICE

D -- Comprehensive Data Mining

Notice Date

9/9/2008
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541511 — Custom Computer Programming 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-SOL-09-00976
 

Archive Date

9/30/2008
 

Point of Contact

Tawana Parker,, Phone: 301-827-7152
 

E-Mail Address

tawana.parker@fda.hhs.gov
 

Small Business Set-Aside

N/A
 

Description

This is a combined synopsis /solicitation for commercial items prepared in accordance with FAR 13.5 and the format in FAR 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. Quotations are being requested and a written solicitation will not be issued. Solicitation FDA-SOL-08-00976 is issued as a Request for Quotation (RFQ) using Simplified Acquisition Procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-24. The NAICS code is 541511 with a small business size standard of 23M. This is a firm fixed price contract. The period of performance is from effective date of award through 12 months period. The U.S. Department of Food & Drug Administration (FDA) proposed to apply WebVDME (web-based Visual Data Mining Environment), a data mining tool developed under a (Food and Drug Administration) FDA Cooperative Research and Development Agreement (CRADA) with Lincoln Technologies, Inc. to the Manufacturer and User Facility Device Experience (MAUDE) data at the Center for Devices and Radiological Health (CDRH). WebVDME supports the detection and quantification of safety signals in post-marketing data. The software utilizes advanced data mining techniques, including: Multi-Gamma Poisson Shrinker (MGPS), Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR) and Logistic Regression. WebVDME is currently being used to detect signals of adverse events in the Adverse Event Reporting System (AERS) database and has been applied to the Vaccine Adverse Event Reporting System (VAERS) data. It is also being piloted at the FDA to analyze medical device adverse events reported into the MAUDE database. The contractor shall customize the software, data preparation and provide refreshing processes, training, and consulting support. An important component of this project is cleaning and preparing the MAUDE data which will provide FDA with an improved capability to extract actionable intelligence from its data. Device information from safety reports is captured in the MAUDE database as a verbatim representation of the original text in the report. As a result, the same device may be referred to by many different names, for example with or without the manufacturer name, type number or other specifics, as well as a variety of possible misspellings. In order to be able to consistently identify a specific device or device class for data mining purposes, this data will need to be cleaned up. The proposed approach for cleaning up the MAUDE data is based on proven techniques that are currently being applied on a monthly basis to internally released data from the AERS database, and which include mapping-based automatic spelling correction, synonym mapping and other data transformations. After such an approach has been developed and implemented, it can be re-applied on a regular basis with ever-increasing efficiency due to the gradual increase in size of mapping and synonym tables, covering an ever greater proportion of possible misspellings and synonyms. Once the cleanup has been completed it will be possible to apply quantitative signal detection against the cleaned MAUDE database at various aggregation levels dependent on the desired granularity of the result. During the data mining pilot the MAUDE database has been found to contain a significant number of duplicate reports which could negatively influence the reliability of the data mining results. Therefore the cleaning process will also include identification of duplicate reports in order to be able to exclude such reports from data mining. The contractor shall provide the following tasks: The Contractor shall assist FDA in developing and operating an advanced safety data mining application for use with the FDA Manufacturer and User Facility Device Experience (MAUDE) database which represents reports of adverse events involving medical devices. 1) In consultation with FDA staff, develop data cleaning procedures as necessary to prepare MAUDE for use in data mining, addressing issues such as manufacturer and device brand name normalization, use of hierarchical classification information to support data aggregation at multiple levels, and detection of duplicate reports. The work for coronary stents and oxygenators has been completed. The project will be extended to up to 15 device categories. The following device types will be included: a) Glucose meters and glucose test strips b) Implantable cardiac defibrillators (ICDs) and pacemakers (including leads and generators) c) Fluoroscopes and related accessories d) Intraocular lenses e) Electro-surgical units and accessories Furthermore, manufacturer name normalization will be extended for all device types. 2) MAUDE data for coronary stents and oxygenators has previously been prepared for use in data mining. This data will be refreshed monthly.3) MAUDE data for infusion pumps has been previously prepared for use in data mining. The contractor shall address issues such as device brand name normalization, use of hierarchical classification information to support data aggregation at multiple levels, and detection of duplicate reports. This data will be refreshed monthly. 4) Make up to four snapshots of the MAUDE data available over the course of year 1 for use with WebVDME, including transforming the MAUDE data to conform to the WebVDME data model, creating the WebVDME configuration (metadata) needed for Query and Reporting, and identifying MAUDE data cleaning needs. 5) The contractor shall work with FDA staff to explore alternative data mining techniques (including PRR, MGPS, and logistic regression) to determine which approaches are most productive for use in the generation of safety signals on MAUDE data. 6) Collaborate with FDA staff in the initial investigation of safety issues of interest, including for example safety issues related to ICD lead fractures. 7) Provide updates of the WebVDME software as required. 8) Support an initial cadre of FDA users (up to 20 users) by providing: system administration, training and assistance in the use of the system through telephone support, and up to 4 visits or WebEx remote sessions for support and training. 9) The contractor shall work with FDA OIT/SS staff to set up an FDA-provided dedicated computer server for production use with WebVDME, including installation and configuration of foundation software such as operating system, Oracle database, backup utilities, etc. 10) Install WebVDME safety data mining software on the server. 11) Develop a validated production process for the automated periodic refreshing and cleaning of the MAUDE data and place this process into routine operation (e.g., once a month). 12) Work with OIT/SS staff to prepare the necessary documentation, review and approval steps prior to production rollout. 13) Roll the system out to the full community of MAUDE users, including development and delivery of CDRH-specific on-site training at FDA. 14) Provide regular (e.g., first 6 months quarterly, then monthly) refreshes of the MAUDE data. 15) Provide project management resources to coordinate the above activities. All contractor and subcontractor employees are required to sign the Contractor's Commitment to Protect Non-Public Information (NPI) Agreement (Form FDA 3398) provided at website http://intranet.fda.gov/omp/forms/internal/FDA-3398.pdf. The Non-Sensitive Positions position risk levels for this contract is a Level 1. The provisions at FAR 52.212-1 Instructions to Offerors- Commercial Items (November 2007), FAR 52.212-4 Contract Terms and Conditions-Commercial Items- (February 2007), and 52.212-2, Evaluation - Commercial Items are hereby incorporated by reference and apply to this acquisition. The Government will make one award. Technical and past performance when combined are significantly more important than price. The following factors shall be use to evaluate offers: 1. Technical Understanding and Approach. The technical evaluation will be evaluate to determine if the proposed contractor is capable of providing internet crawling, website filtering, website documentation and reporting. The contractors shall furnish as part of their quotation all descriptive material necessary for the government to determine whether the service meets the technical requirements. 2. Experience in - The contractor shall provide experience in searching for relevant websites that would be suitable for regulatory consideration and the ability to monitor and changes the websites. 3. Past performance Offeror should provide three references of similar efforts performed during the last three years. Include a description of the project, project title, contract number, contract amount, client identification including agency or company name, contracting and technical reviewing official, address and telephone number. Offerors shall comply with the provision at FAR 52.212-1(b) and submit 1) an electronic copy to Tawana Parker via email at tawana.parker@fda.hhs.gov. 2) A technical description of the services being offered in sufficient detail to evaluate compliance with the requirements in this solicitation. 3) Quotation. Offeror shall include a completed copy of the provision FAR 52-212-3 Offeror Representations and Certifications- Commercial Items (Nov 2006) which can be accessed electronically from the INTERNET at the following address: All Offerors responding to this RFQ must be registered with the Central Contractor Registration (CCR), http://www.ccr.gov/ FAR 52-212-4 Contract Terms and Conditions- Commercial Item (February 2007) and FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (June 2007), applies as follows: 52.233.-3 Protest After Award (Aug. 1996), 52.233-4 Applicable Law For Breach Of Contract Claim (October 2004), 52.203-6 Restrictions on Subcontractor Sales to the Government (Sep 2006), 52.219-6 Notice of Total Small Business Set-Aside (June 2003), 52.219-8 Utilization of Small Business Concerns (May 2004), 52.222-3 Convict Labor (June 2003), 52.222-21 Prohibition of Segregated Facilities (Feb 1999), 52.222-26 Equal Opportunity (Mar 2007), 52-222-35 Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sep 2006), 52.222-36 Affirmative Action for Workers With Disabilities (Jun 1998), 52.222-37 Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sep 2006), 52.225-13 Restriction on Certain Foreign Purchases (Jun 2008), 52.232-33 Payment by Electronic Funds Transfer--Central Contractor Registration (Oct. 2003), 52.239-1 Privacy or Security Safeguards (Aug. 1996). FAR provisions and clauses may be found at http://www.acquisition.gov/far/index.htmlAll responsible sources that can provide and meet the above requirement shall submit a written quotation. Submission must be received via email 12 Noon Eastern time on September 15, 2008. Questions must be submitted via e-mail to tawana.parker@fda.hhs.gov no later than 12 noon Eastern time September 12, 2008. Questions received and their answers, if any will be published as an amendment to the synopsis/solicitation.
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=3dd0f370641b6d4305af2dc870937944&tab=core&_cview=1)
 

Place of Performance

Address: White Oak Campus, Silver Spring, Maryland, 20993-0002, United States

Zip Code: 20993-0002
 

Record

SN01664911-W 20080911/080909223009-3dd0f370641b6d4305af2dc870937944 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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