Notice of Intent to Sole Source-Evaluating the Effect of Obesity on the Pharmacokinetics and Pharmacodynamics

The Food and Drug Administration (FDA) intends to award a Sole Source Firm Fixed Price contract order to University of North Carolina at Chapel Hill, 301 Pharmacy Lane, CB 7355, Chapel Hill, NC 27599-7355. In accordance with FAR Part 6.302-1 (a) (2)(ii) which states” Only one responsible source and no other supplies or services will satisfy agency requirement”. The purpose of this notice is to inform the public that the Food and Drug Administration (FDA) anticipates issuing a Firm Fixed Price contract.

MINIMUM REQUIREMENTS: See Attached Statement of Work This notice is not a request for competitive proposals. However, any party that believes it can meet this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement.

A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. It is anticipated that an award will be issued to University of North Carolina at Capital Hill within approximately ten (10) days after the date of this notice unless the Government determines that any other organization has the capability to meet this requirement.

Response Date: June 25, 2024, by 3.00PM EST. Please email responses to Hilda Aryeh –hilda.aryeh@fda.hhs.gov.