Generic Drug Pathway Curriculum: From ANDA Submission to Global Reliance

5.101 Presolicitation Notice.

(vii) For noncompetitive contract actions (including those at or below the SAT), identify the intended source and explain why competition is lacking.

Based market research conducted in accordance with FAR Part 10, the contracting officer has determined that soliciting from a single source is appropriate for this requirement under the following circumstances: Unique Capability and Immediate Availability to Complete All Requirements, Highly Specialized Services Requiring Institutional Knowledge, and Time-Sensitive Mission Requirements.

The U.S. Food and Drug Administration (FDA) intends to solicit a 1-year base, sole source (in accordance with FAR 6.103-1), firm-fixed-price order from .... Read More