Development of physiologically-based pharmacokinetic (PBPK) models t determine the optimal safe and appropriate dose of oncology drugs for pregnant women with cancer

This announcement is not a Request for Proposal.

The US Food and Drug Administration {FDA), Office of Finance Budget Acquisition and Planning, intends to issue a single award  from a fair opportunity competition, amongst current incumbent IDIQ contract holders; to provide analyses in the development of physiologically-based pharmacokinetic (PBPK) models to determine the optimal safe and appropriate dose of oncology drugs for pregnant women with cancer.; 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 identified source only. 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,02, 2023, 12:00 PM EST.