PV Works Enhancements

The US Food and Drug Administration, Office of Acquisitions and Grant Services intends to award a sole source simplified acquisition for PVWorks COTS Software Enhancements on behalf of the FDA Center for Veterinary Medicine. The scope of this SOW is to modify the existing PVWorks System in order for CVM to accept electronic reporting of public reporting of animal drugs issues including medicated feed (Form FDA1932a), including the creation of the electronic forms necessary for submission of the reports. Reporting of experiences by licensed feed manufacturers is mandatory in accordance with Title 21 CFR 510.301. Additionally, several enhancements to PVWorks will be done to ensure the adverse event information received electronically is submitted to the application of the responsible sponsor; provide regularly updated adverse event information in 508 compliant format so that it is accessible by the general public; provide quarterly adverse event information to openFDA in XML format; and provide timely and complete response to FOI requests. The proposed acquisition action is for services for which the government intends to solicit and negotiate with only one source. Interested parties may identify their interests and capabilities to respond to the requirement or submit quotes within fifteen (15) days after the date of publication of this notice. A determination by the government not to compete this proposed acquisition based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive requirement. No further solicitation is available. All responsible vendors are encouraged to submit a response to this notice. FDA will consider all responses received prior to the closing date of this notice and will use responses in determining whether it is necessary to use full and open competition for this requirement. Please contact Sherry Rowlett, FDA/OAGS, Contract Specialist by email at sherry.rowlett@fda.hhs.gov or by phone at 240.402.7549. Capability statements/Quotes can be emailed to Sherry Rowlett at the above email address no later than August 19, 2015 12:00 pm EST.