Proposal_Intent_Response_Form.pdf

This document contains a proposal intent response form and details of a federal contract opportunity for drug formulation and manufacturing services. The proposal intent response form seeks feedback on a request for proposal by March 22, 2019. The related federal contract opportunity is solicitation number 75N98019R00005 for a drug formulation and manufacturing program. It will establish multiple award indefinite delivery/indefinite quantity contracts to develop and manufacture investigational drug compounds for preclinical, IND-enabling, and clinical studies. Services include all manufacturing, documentation, formulation, fill and finish, packaging, and labeling. Contractors must maintain cGMP compliance and technical capabilities. The requirement is classified under NAICS 325412 and intends a partial small business set-aside. The Clinical Center Pharmacy Department, Investigational Drug Management and Research Service, Office of Research Support and Compliance, and Office of Logistics and Acquisition Operations of the National Institutes of Health Department of Health and Human Services are partnering for this program.