THIS IS A SOURCES SOUGHT NOTICE FOR INFORMATION AND ACQUISITION PLANNING PURPOSES ONLY. This is not a request for quote or proposal. This notice does not constitute a commitment by the Government to issue an RFP, RFQ, contract, or order. The Government will not pay for any effort expended or any material provided in response to this announcement. Requests for a solicitation will not receive a response.

This Sources Sought is being issued by the Food and Drug Administration (FDA) for the implementation of a Commercial-Over-the-Shelf (COTs) pharmacovigilance software tool that will assist the Office of Surveillance and Epidemiology (OSE), Office of Business Informatics (OBI), and Office of Information Technology Management (OIMT) collect and monitor adverse events and drug quality associated with pharmaceuticals and biologics. The COTS product must provide the features and functionalities listed in RFI Attachment No. 1 - FAERS Requirement Traceability Matrix.

SUBMISSION INSTRUCTIONS
Interested companies must submit the following information:
1. A completed RFI Attachment No 1 - Pharmacovigilance COTs Tool Requirements Traceability Matrix

2. Capability Statement limited to 10 pages addressing at a minimum the following:

• What pharmacovigilance COTS tool does your company recommend and why?
• Are you an authorized reseller or authorized agent to service this COTS tool?
• Please describe and give examples of the analytics capabilities of the proposed COTS solution. Please note, described features must be available in the COTS product now not to be developed during the contract. Some example features may include

Data Mining Safety reports describe specific algorithms
Interactive data discovery and exploration tools
Visual Analytics and Dashboards
Signal Management
External internet links to data sources like Medline
Ad hoc query screens
User built custom reports

• Does your organization have a Capability Maturity Model Level III or higher in Software Development?

• Does your company have a background in providing pharmacovigilance IT Support services for the commercial industry or Government? If yes, please explain.

• Does your company have experience implementing the proposed pharmacovigilance tool? If so, did your company perform services as a prime or subcontractor? Explain your company's role in more detail.

• If your company does not have direct experience implementing the proposed pharmacovigilance product describe your company's ability to enter a partnership or teaming relationship with a company that has direct experience. Have you worked with a company that has experience? How would your company obtain qualified resources?

• Is the proposed COTs tool capable of complying with the following 508 Standards:
SECTION SUBSECTION STANDARD DESCRIPTION
1194.21 a, b, c, d, e, f, g, h, i, j, k ,l Software applications and operating systems
1194.22 a, d, e, f, g, h, I, j, k, l, m, o, p Web-based intranet and internet information and applications
1194.41 a, b, c Information, documentation, and support.

3. Interested companies shall provide the following Business Information for both the seller and manufacturer of the product (if different)(2 pages):
• DUNS Number
• Company Name
• Company Address.
• Company Point of Contact, phone number and email address
• Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov/index.asp.
• Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.);
• Current GSA Schedules appropriate to this Sources Sought
• Current Government Wide Agency Contracts (GWACs)
• Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses.
• Any applicable Socio-Economical Classification(s): 8(a), HUBZone, Service-Disabled Veteran-owned, Veteran-Owned, Women-Owned and Small Disadvantaged Business.

Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.

Interested parties having the capabilities necessary to perform the stated requirements may submit capability statements via email. Responses shall be limited to 10 pages. Responses must be received in writing, by no later than December 12, 2017, 1:30 PM, Eastern Time.

Capability statements will not be returned and will not be accepted after the due date.
Documentation should be emailed to: Jody OKash at [email protected]. The title of the email shall include the FBO Sources Sought Number and Company Name: FDA-SS-18-1182003 / CompanyName.

Bid Protests Not Available