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Data Mining Tool for Drug Adverse Event Safety

Solicitation Number: FDA-SOL-13-1115740
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Location: Office of Acquisitions and Grants Services - Rockville
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Added: Apr 02, 2013 2:09 pm Modified: Apr 02, 2013 3:24 pmTrack Changes
Data Mining Tool for Quantitative Drug-Adverse Event Safety Signal Detection in Literature Reports

This 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 requirement for a Data Mining Tool for Quantitative Drug-Adverse Event Safety Signal Detection in Literature Reports 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: 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) to provide a Data Mining Tool.

FDA welcomes responses from all interested parties.


The Government requires a fully integrated Data Mining Tool for Quantitative Drug-Adverse Event Safety Signal Detection in Literature Reports system that is UFC compliant with a broad spectrum of integrated solutions. The Government requires a system that is modular in design to allow for scalability. The Government will also require the contractor to provide system maintenance, monitoring and upgrades (as they are released).


Interested parties shall provide responses to the following requested information:

1. Is FDA's desired system available "commercially but require modification"? If the model is available is it also capable of scaling to a national operational model?
2. What is the recommended development and testing environment?
a. Hosting at the contractor facility or the Government's facility?
b. Can you host a mirror environment? What are the risks?
c. Provide the risks associated with hosting in your environment and subsequently integrating into FDA's environment.
3. Do you have host facility available for use or would one have to be built? Host facility includes development and testing.
4. Can you identify some general assumptions or dependencies based on the requirements in the RFI SOW?
5. What supporting documentation do you require to be released with the RFP to obtain a better understanding of the requirements and FDA environment?
6. Can this work be accomplished within the specified period of performance (POP)? If not, what is the recommended POP? (Please provide a high level explanation of activities required supporting the recommended POP)
7. Provide comments and recommendations on the structure and content of the SOW.

Business Requirements

8. Can you offer the Data Mining Tool and its support services via GSA Schedule or GWAC available for use by FDA/HHS?

9. Provide the following information to demonstrate your company's capabilities:
a. Provide a brief narrative of experience providing this type of product/service (Commercial or Government)
b. Provide a brief narrative describing experience of creating such a system.
c. Provide specific experience of providing a comparable tool that has had the capability of passive and active surveillance from Healthcare organizations.
d. Provide a statement confirming if the company has previous experience delivering services compliant with HIPAA or FDA security regulations.
e. Provide size of company
f. Provide potential teaming arrangement (name of subcontractor not required, capabilities of teaming partner is required)
Note: Requests for specific experience requires respondents to detail Agency names and brief scope of work.


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 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 system to allow for integration with other public health and public safety 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 Data Mining System. 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. DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the System of Awards Management (SAM, at to be considered as potential sources.
11. 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. RESPONDENTS MUST SUBMIT CAPABILITY STATEMENT VIA E-MAIL to Trevor Edwards at no later than April 16, 2013, 12:00 PM Eastern Time for consideration.

Added: Apr 03, 2013 10:30 am
RFI previously conducted
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Draft SOW

Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Draft SOW
Posted Date:
April 2, 2013
Description: Sources Sought SOW


Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Posted Date:
April 2, 2013
5630 Fishers Lane, Room 2129
Rockville, Maryland 20857-0001
Trevor R. Edwards
Phone: 3018279233