Loren Data's SAM Daily™

FBO DAILY ISSUE OF AUGUST 17, 2008 FBO #2456
SOURCES SOUGHT

D -- Technical Support for Operation and Maintenance of the Web Virtual Data Mining Environment (WebVDME) Application

Notice Date

8/15/2008
 

Notice Type

Sources Sought
 

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

1042253
 

Point of Contact

Brenda K. Lee,, Phone: 301-827-7036, Ted L Weitzman,, Phone: 301-827-7178
 

E-Mail Address

brenda.lee@fda.hhs.gov, ted.weitzman@fda.hhs.gov
 

Small Business Set-Aside

N/A
 

Description

This is a SOURCES SOUGHT NOTICE to determine the availability and capability of qualified small businesses that may provide operation and maintenance for FDA’s WebDME software, to expand the use of WebVDME throughout FDA division and to develop a signal annotation feature that allows users to differentiate signals that are already labeled or disease related. The U.S. Department of Food & Drug Administration (FDA) explored the utility of data mining for pharmacovigilance, and entered into a Cooperative Research and Development Agreement (CRADA) with Lincoln Technologies, Inc. The purpose of this CRADA, was to develop a web-based data mining software tool. The WebVDME has been use by safety evaluators, epidemiologists, and medical officers since 2005. FDA has an interest in maintenance and operations of its current instances of WebVDME and further development and piloting of statistical data mining techniques/tools and to include techniques/tools based on WebVDME that are capable of generating—in an automated, reproducible and systematic way—a set of important and useful safety signals in a graphical illustration of the data that can serve as valuable input to the overall process of drug safety monitoring and review. Safety Signals are individual drug-event combinations that occur in a higher than expected proportion. These signals need to be carefully investigated to understand if regulatory action needs to be taken. These regulatory actions might include additional information to the drug label, programs to mitigate risk for the drug, or in extreme cases removal of the drug from the market. The detection of safety signals in data from adverse event reports is an important challenge to the FDA and essential for good pharmacovigilance—a key component of FDA’s mission. The contractor shall provide the following: 1) Project management to maintain and expand the use and functionality of WebVDME throughout the Center for Drug Research and Evaluation (CDER). 2) Application support, including Oracle database maintenance and WebVDME data refresh. 3) Support for new and advanced users. 4) Software Change Management. 5) Provide and support updates of the WebVDME software. 6)Provide periodic remote and on-site training. 7) Assisting with full-scale implementation of a signal management capability based on WebVDME throughout CDER and increasing the functionality of WebVDME so that signals can be annotated in a way such that those signals that are already labeled or consistent with the disease state being treated can be readily identified by the users. 8)Establish a pilot tool to facilitate the recoding of adverse events by medical officers. The NAICS Code is 541511. The small business size standard is 23M. Interested small business must provide a capability statement demonstrating their experience, skills and capability to fulfill the Government requirement that is stated above. However, be advised that generic capability statements are not sufficient to evaluate your capability statement effectively. Information submitted must be in sufficient detail to permit the government to determine whether your organization meets the government requirement. This notice is for planning purposes only, and does not constitute a Request for Quotation. This request is not to be construed as a commitment on the part of the Government to award a purchase order or 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. Interested small business organizations that believe they possess the capabilities necessary to undertake this project should submit via email copies of their capability statement, addressing the areas above. Capability statements must identify the business status of the organization. NO COLLECT CALLS WILL BE ACCEPTED. RESPONDENTS MUST SUBMIT CAPABILITY STATEMENT VIA E-MAIL to Brenda Lee at brenda.lee@fda.hhs.gov, no later than August 20, 2008 at 2:00 PM Eastern Time for consideration.
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=697db9802756ac9b32d6bd12df67c74e&tab=core&_cview=1)
 

Place of Performance

Address: White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993-0002, United States

Zip Code: 20993-0002
 

Record

SN01642053-W 20080817/080815224821-697db9802756ac9b32d6bd12df67c74e (fbodaily.com)
 

Source

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

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