B08-HT942726RE009-RPP-AttachF-CDRL-A001-A003-20260608-Final-Redacted.pdf

This is a Contract Data Requirements List (DD Form 1423) for a Single Use Analgesic Product Development contract under the Defense Health Agency (DHA). The contract line item is 0001, with the data category marked as "Other - General Data." The contract is controlled by the Defense Health Agency with distribution and dissemination restricted to the federal government only (SSEL).

The form specifies multiple data deliverables required throughout the contract development process, including: a Quality Management Plan, Regulatory Strategy, Regulatory Correspondence and FDA Submissions, Written FDA Responses and Meeting Minutes, Clinical Documentation/Reports, Interim and Final Clinical/Non-Clinical/Human Factors Study Execution and Reports, Stability Test Plans, Stability Studies Reports, Manufacturing Process Validation Reports, Manufacturing Documentation/Reports/Submissions, and Clinical/Non-Clinical/Human Factors Study Protocols. All deliverables must be submitted in accordance with the Statement of Objectives (SOO) referenced as DI-TCSP-82040, with specific section citations provided for each deliverable. Submissions are to be made via email in PDF format to the Government Agreement Officer Representative (AOR). Acceptance and inspection of technical data and deliverables will be performed by the Portfolio Acquisition Executive Medical Products (PAEMP), with a five-day response period for questions on Data Deliverables. Data incorporated with government-approved changes must be resubmitted within five days of government receipt of comments.