PDUFA VII - Best Practices in Communication Assessment

               Notice of Intent Sole Source

This announcement is not a Request for Proposal.

The US Food and Drug Administration {FDA), Office of Finance Budget Acquisition and Planning, intends to award a sole source award to Eastern Research Group, Inc, a current incumbent contract holder; to collect data and to analyze PDUFA meeting
management and deliver an internal report or presentation to FDA; to facilitate a public workshop with stakeholders using data collected and published in the Federal Register Notice; and to deliver a summary of the public workshop and recommendations to inform potential updates to FDA’s guidance(s) at; 

The US Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring MD 20993

The propose simplified acquisition is for services; the Government intends to solicit and negotiate to only one source. Interested parties may identify their interests and capabilities to respond to the requirement within seven (7) days after the publication of this notice. A determination by the Government not to compete this proposed simplified 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.

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. Responses shall be emailed to Natapol Sirikhan, Natapol.Sirikhan@fda.hhs.gov, by August, 01, 2023, 12:00 PM EST.