Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances   7

Background
The National Institutes of Health (NIH), specifically the NIDA Office of Acquisitions, is issuing this solicitation for Chemistry, Manufacturing, and Control (CMC) services for drug substances.

The objective of these support services is to ensure the receipt of Drug Substances (DS) of sufficient quality and quantity to support preclinical and IND-enabling studies.

Work Details
The contractor will be required to furnish all necessary services, qualified personnel, materials, equipment, and facilities needed to perform the Statement of Work dated August 28, 2024.

Key tasks include:
1. Preparation and submission of Technical Progress Reports on a monthly basis, detailing activities undertaken during the reporting period and planned activities for future periods.
2. Submission of a summary report with salient results achieved during the performance of the task order upon completion.
3. Reporting on Select Agents or Toxins and/or Highly Pathogenic Agents if applicable, including any changes in use or biocontainment level.
4. Compliance with Section 508 of the Rehabilitation Act for all reports submitted electronically.
5. Adherence to NIH policies regarding reproducibility and public access to archived publications resulting from NIH-funded research.

Period of Performance
The ordering period for this contract is anticipated to be seven years, from September 1, 2025 through May 14, 2031.

Place of Performance
The contract will be performed at locations specified in individual task orders.